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Watch 8-hour Deposition Of Richard Sackler As He Denies Family's Role in The Opioid Crisis — Transcript

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0:33we are on the record
0:35at 9 12 a.m
0:38august 28 2015. in the matter of
0:41commonwealth of kentucky
0:43pike circuit court division two civil
0:45action number
0:46zero seven dash ci dash zero one three
0:49zero three commonwealth of kentucky
0:52versus purdue pharma this is a
0:54deposition of
0:56dr richard s sackler if i could have the
0:59attorney's statement name into the
1:00records
1:01and then you want to just go ahead and
1:02read the list of names
1:14i'll tell you what just go ahead let's
1:15just start our name we'll pick it up
1:18jason sayers on behalf of abbott
1:22dan damper behalf of the purdue
1:24defendants donald strauber on behalf of
1:26the various purdue defendants
1:32oh sorry richard silver in house at
1:35purdue
1:36jay henneberry on behalf of the purdue
1:39tyler thompson on behalf of the state of
1:41kentucky
1:43anthony also on behalf of the state of
1:44kentucky and mitchell denton from the
1:46attorney general's office
1:48of kentucky
2:04would you state your name please richard
2:06sackler
2:08and um you are here today
2:12[Music]
2:14to give testimony in a case
2:19pending against purdue various entities
2:23by the state of kentucky you're aware of
2:24that
2:26that's my understanding and you've given
2:28me mr thompson
2:29before you get started i just like to
2:32note
2:32that i expect we will be designating
2:34portions of this transcript
2:36as confidential pursuant to the order um
2:40is that correct mitchell yeah they can
2:42designate portions
2:44sure okay
2:48yeah we won't disseminate it until you
2:50all designate and we respond
2:51period
2:54and and uh just so you know i know
2:57you're not from kentucky is that correct
2:59that's correct
3:00um all uh objections other than to the
3:04form of the question are preserved
3:05in kentucky on video
3:12what is your current role at purdue
3:16excuse me i uh there are a number of
3:19defendants
3:20uh would bear some portion of the purdue
3:22name
3:23and the distinction can be significant
3:25so i'd ask when when you phrase your
3:27questions
3:28specify which purdue entity you are
3:29talking about well let's uh let's talk
3:31about the number of purdue entities
3:33there are
3:34how many purdue entities are there don't
3:36know
3:37i've seen upwards of 69 different
3:40corporations perhaps that
3:42the sackler family owns is that correct
3:46if you've counted them i can't differ
3:48with you i don't know the answer
3:51there are a number of purdue
3:55entities
3:59the purdue frederick company inc does it
4:02still exist
4:04i don't know um
4:09tell me what companies that you
4:11currently
4:13have a role with that involved purdue
4:17purdue pharma you sit on the board of
4:20any other purdue companies
4:23not to my knowledge okay what about
4:25mundy pharma
4:29i sit on the board
4:32of an a consulting firm which consults
4:36to under pharma
4:37does the sackler family own monday
4:38pharma yes
4:40what about what is mundipharma
4:42mendipharma
4:43is
4:47is a name that is attached to many
4:49different companies
4:50such as just similar to purdue
4:54is that a company over in germany there
4:57is a munda pharma company in germany
5:00uh what about roxanne does purdue own
5:03roxanne
5:04no did they own roxanne in the past
5:07never
5:09do you know how many current companies
5:12uh are owned by the sackler family no
5:15right in discussing oxycontin
5:20how many companies were involved in the
5:22production
5:24manufacturing or distribution of
5:26oxycontin
5:31could you specify the geography
5:36in the world many
5:40i've never counted them um
5:44does purdue do licensing agreements with
5:46other companies to sell oxycontin
5:48it does do they own parts of those
5:49companies no
5:52how many companies does purdue own that
5:56distributes or dispenses oxycontin
6:00many can you tell me the names of them
6:05a few of them but not all of them
6:12are you still the director of purdue
6:14pharma inc
6:17i'm not sure okay are you still a
6:20general partner of purdue pharma lp
6:24i am not
6:27i it is owned by
6:31two trusts
6:40in july 30th of 2014 were you a director
6:44of purdue pharma inc
6:50not that i'm aware
6:55this is a affidavit fouled in the
6:58southern district of west virginia
7:01and does that appear to be your name
7:02that does and it's dated
7:05july 30th 2014
7:08it says declaration of dr richard s
7:11sackler i am a director of purdue pharma
7:13inc
7:14the general partner of purdue pharma lp
7:16i've held this position since 1990.
7:19if that's what it says and that's what
7:22it says
7:27how involved were you in the
7:30production and um
7:36marketing and promotion in the training
7:39and management of purdue sales
7:40representatives
7:43for oxycontin object to the form of the
7:46question
7:49should i answer go ahead and answer it
7:52depends on
7:53the time okay and when you say it
7:56depends on the time why do you say that
7:59because i was
8:02involved in the
8:06areas at a supervisory level
8:10not as an active level for a period of
8:14time
8:15that began with the launching of
8:19oxycontin
8:21and ended in early 2003.
8:25when you were involved on the
8:26supervisory level but not the active
8:28level how much of your day-to-day
8:31activity was devoted to oxycontin
8:37it varied enormously
8:43in this declaration it says
8:47during the time period set forth in the
8:48amended complaint 1996-2009
8:51i was not directly involved with the
8:53day-to-day marketing or promotion of
8:55oxycontin
8:56the training or management of purdue
8:58sales representative or the scientific
9:00research into the conversion ratio from
9:02ms cotton to oxycontin
9:06those responsibilities fell principally
9:08failed to produce senior management
9:09in research and development regulatory
9:12affairs
9:14sales training and marketing among
9:15others
9:17is that accurate yes
9:27i want to show you an email dr sackler
9:31dated monday may 31st 1999.
9:36do you know who cornelia dr cornelia
9:38hinch
9:39is i do and who is that
9:44she was general manager
9:47of minda pharma australia
9:51okay and to give this a little bit of
9:54context
9:56you all had a drug called ms cotton a
9:59morphine sulfate
10:00that was an immediate release narcotic
10:03opioid
10:04or narcotic is that correct it was
10:06controlled
10:07release controlled release i'm sorry and
10:10that was used primarily for cancer
10:13patients or malignant pain patients
10:16is that correct majority of use
10:19yes but not i i don't think
10:23primarily conveys an accurate picture
10:26majority of use was for over 50
10:30and it was sort of felt
10:33by purdue pharma that that morphine had
10:36a stigma attached to it
10:38that kept doctors from prescribing it uh
10:43across the board is that accurate yes
10:46and you all had a uh
10:49may i meant that yes it didn't prevent
10:53doctors
10:53from prescribing it across the board
10:57it was an inhibition to the use of the
11:00product
11:01in every application
11:05okay have you ever gone back and studied
11:07the history of addiction and
11:10and how it has played out in the 19th
11:13and 20th century
11:14i'm not a student of that literature
11:18um
11:22what was your understanding of why
11:24doctors did not want to prescribe
11:26morphine
11:27for anything or had a stigma about
11:30prescribing it
11:31for anything other than cancer and
11:33malignant pain
11:35as i said before the stigma
11:38prevented many physicians from
11:41prescribing it
11:42for any pain why do you think that
11:45stigma existed
11:54i'm not a student of the issue
11:57but i believe the stigma
12:02existed because of a popular
12:05understanding shared by both
12:09and by laymen
12:12that morphine was an end-of-life drug
12:16if it was to be used at all
12:22were there concerns about addiction uh
12:26and uh dependence with respect to
12:29[Music]
12:31morphine
12:34some people had those concerns so
12:38going back to building our context here
12:41you all had a drug called
12:43ms content that you had
12:46the exclusive right to sell is that
12:48correct that's correct
12:50you know when that exclusivity was set
12:52to expire
12:56i'm i i'm not certain that i know the
13:00the date no do you recall
13:03that one of the concerns that produce
13:07senior management have i'm using purdue
13:10in relation to
13:11purdue companies that are involved
13:14with oxycontin and rather than just sit
13:16here and
13:17name them all out can we agree that when
13:19i say purdue i'm referring to
13:21purdue companies and volunteers i have
13:23to object to that because i said at the
13:25outset
13:26there are different purdue entities that
13:27are defendants in the case
13:29and the distinction between them may at
13:31times be significant
13:33and so if you lump them all together
13:35under purdue
13:36we're going to get a record that will
13:37not be easily decipherable at the end
13:40well let's let's talk about it then
13:41which purdue companies
13:43were involved in the cell and
13:44distribution of oxycontin
13:48purdue frederick and purdue pharma were
13:51involved
13:52in the early years of selling the
13:54product
13:55okay were there any other purdue
13:56companies involved in the selling of the
13:58product
14:00not in the u.s
14:13who had the exclusive right to sell ms
14:15cotton
14:19at first but it was purdue frederick
14:24i don't know at what point purdue pharma
14:29acquired rights to sell it or if it did
14:32at all
14:34what is the distinction between purdue
14:36frederick and purdue pharma
14:39purdue frederick was the original
14:42company
14:43that my father and uncle
14:47acquired in 1952
14:50it was a shell company and it was the
14:54first pharmaceutical company that they
14:57owned
15:00purdue pharma was established
15:03in the early 1990s
15:07to take on new products and to
15:10also take on the the risk
15:14of well take on the risk of new products
15:17and also
15:18a few established products but not all
15:22were there any action taken with respect
15:24to purdue
15:26um or with respect to oxycontin that
15:29would not
15:30fall under the purdue pharma umbrella
15:33i'm sorry could could you repeat that
15:35question are you
15:37are you maintaining that there are any
15:39actions done with respect to oxycontin
15:41it's it's creation production marketing
15:46sales that do not fall under the purdue
15:49pharma umbrella
15:53its creation uh was done
15:56in purdue frederick okay um
16:00until the early 90s
16:04when that responsibility was transferred
16:06to purdue pharma
16:09okay and then purdue frederick continued
16:12to
16:13exist though correct it did okay and was
16:15purdue frederick
16:16also a company involved with
16:20marketing promoting
16:24sales and production of oxycontin
16:34i'm trying to give you an accurate
16:35answer because this is confusing
16:37and complex
16:41there was a period of time in which
16:45once purdue pharma became involved that
16:48purdue frederick was involved
16:50but perdue frederick was never involved
16:54nor purdue pharma in manufacturing the
16:56drug
16:58which was when it was developed
17:01was manufactured by a company named pf
17:04laboratories okay
17:09other than the manufacturer did purdue
17:11frederick and purdue pharma
17:13both play a role in the i can't recall
17:17in detail whether they both played a
17:21role or whether
17:22when purdue pharma took on the project
17:25it carried
17:26most of the weight is there
17:30is there any difference between the
17:32employees of purdue frederick and purdue
17:34pharma
17:35there were differences okay any
17:36difference in the board of directors
17:40that would test my memory and i'm not
17:42sure
17:43all right well let me go back to let's
17:45talk about
17:47oxycontin
17:50and i'm going to use the term purdue for
17:53both purdue frederick and purdue pharma
17:56if at some point you you feel like
17:59there's a distinction to be made you let
18:01me know
18:01okay um but um
18:05at a time when stumps i object to your
18:08combining the two under the name purdue
18:10uh if you're going to do it then i'd
18:12like to have a standing objection to
18:13that
18:15combination what is your reason for the
18:18objection
18:19my reason is as dr sackler has explained
18:22briefly
18:22there were two entities that did
18:24different things at different times
18:26and if you lump the two together uh
18:28inevitably there's going to be confusion
18:30in terms of the witnesses answer okay
18:34let's do this i'm going to refer to
18:36purdue as
18:38as purdue pharma lp
18:42and and also purdue frederick
18:46lp if at some point
18:49you feel like it's only purdue frederick
18:51or only purdue pharma
18:53you let me know okay
18:56it's kind of a burden but um with with
18:59the help of my attorney
19:01sure so because there may be
19:04issues it's going to be it tests my
19:07memory
19:08to separate the two so i'm sorry for the
19:11confusion but it is important
19:23for instance let me ask you this sales
19:25reps
19:27were sales reps employed by purdue
19:29frederick or purdue pharma
19:30for a period of time they were in sale
19:33each sales rep was employed by one
19:36but not necessarily the other okay do
19:38you know which sales reps
19:40were employed by purdue frederick versus
19:43i don't know
19:50do you know if they receive different
19:51training
19:53i believe the training was the same
19:56um i'll tell you what i'm going to refer
19:59to
19:59when i say purdue as purdue frederick if
20:01you feel like it's purdue pharma
20:03you let me know okay okay all right
20:06so back in 19 early 90s when you're
20:09developing
20:10ms cotton um
20:16this exclusive license that you had to
20:18sell in wisconsin
20:20ms cotton was going to expire and there
20:22was going to be competition from generic
20:25companies correct
20:28well the product ms cotton was developed
20:31in the late 70s and early 80s
20:36and so are you discussing
20:40development or are you discussing a
20:42later time the later time when its
20:44license is about to expire
20:50eventually we knew that there would be
20:53competition
20:54for ms cotton and one of the things that
20:58in developing oxycodone
21:03controlled release one of the one of the
21:06concerns was
21:07how to position it in the market
21:10and whether you were going to position
21:12it an
21:13obsolete ms cotton or try to position it
21:16alongside ms cotton
21:18do you recall that issue i object to the
21:21form the question
21:22could you repeat it i'm not sure i
21:23understood yes one of the concerns when
21:26when you were developing oxycodone
21:30or i'm sorry oxycontin controlled
21:31release was how you were going to
21:33position it for market share
21:35and whether you were going to position
21:37it and make ms cotton obsolete
21:40and take that market share that ms
21:42cotton had or whether you were going to
21:43position
21:44it alongside ms cotton and
21:46[Music]
21:47sell them both together
21:50do you recall that concern
21:53i've recalled discussions but that
21:55wasn't the principal
21:57driver the principal
22:01the principal goal was to produce
22:05the best product we could and we
22:07believed when we started it and
22:10subsequently
22:15should i stop no no we believed it
22:18was and is a better product than ms gone
22:23okay here's a memo
22:27dated to richard
22:30s sackler
22:34from
22:38robert keiko do you know dr kaiko
22:42i do he's a phd what he is what was his
22:45role
22:46he was the person who
22:50undertook or ran the project and was
22:53involved
22:54in the project of developing
22:57oxycontin and was
23:00as a clinical pharmacologist was deeply
23:03involved
23:04in selecting formulations
23:08that would be most likely to achieve the
23:11desired effect
23:13and under here it says rationale for
23:16another controlled
23:17release opioid analgesic this is bates
23:21number it's actually got two bait stamps
23:23so it's pdd
23:309520805292
23:32but it says rationale for another
23:35controlled release
23:36opioid analgesic ms cotton
23:40may eventually face such serious generic
23:42competition
23:43that other controlled release opioids
23:46must be considered
23:48other pharmaceutical firms are thought
23:50to also be developing
23:51other controlled release opioid
23:53analgesics
23:55mr thompson if you're reading from a
23:56document could you show it to the
23:57witness
23:58sure that's why i was holding it over
24:00here in front of you
24:02it's a hard to read for that distance
24:04we've got an extra copy
24:05yeah great just always hang on you have
24:08a copy for me we'll see
24:11thank you so did you see down there the
24:15second highlighted portion that says
24:17mine is not highlighted so
24:20yeah i'll i'll tell you where to go okay
24:23so
24:24uh the second highlighted portion
24:26rationale
24:27for another controlled release opioid
24:29analgesic
24:31and do you see the first sentence below
24:33that oh i
24:34i see that's a cross title
24:37yes i was looking at the text
24:41and the text below that says
24:45ms cotton may eventually face such
24:47serious generic competition
24:49that other controlled release opioids
24:52must be considered
24:53other pharmaceutical firms are thought
24:55to be to also be developing
24:57other controlled release opioid
24:59analgesics did i read that correctly
25:01you did and was that a concern at that
25:04time
25:05it was a secondary or tertiary
25:09driver
25:12and then if you'll turn to the next page
25:16and look at the second paragraph
25:22and i'll read that it says while we have
25:26reason to believe that other
25:27pharmaceutical firms
25:28are formulating controlled release
25:30morphine and control the release
25:33hydromorphone there is no evidence to
25:36date
25:36that this is being done with oxycodone a
25:39controlled release oxycodone
25:41is thus less likely to initially have
25:44generic competition
25:46and was that a a
25:49consideration when deciding to come out
25:52with oxycodone
25:53or oxycontin not for me
25:56[Music]
25:57all right
26:01now we read your paragraph 11
26:04where you discussed that you had limited
26:07role
26:07in the
26:2211.
26:28[Music]
26:31let's make this
26:34exhibit one to the deposition
26:44i need to see that back please um
26:51is this the same as this
26:57thank you for underlying
27:00yeah um and this declaration said that
27:05you were not
27:06uh directly involved with the day-to-day
27:08marketing or promotion of oxycontin
27:10the training or management of produced
27:11sales representatives
27:13or the scientific research into the
27:15conversion ratio of ms cotton to
27:17oxycontin um
27:20is that correct that is correct
27:24i want to show you a
27:32an email let's mark this exhibit
27:35two to the deposition
27:44which one is it this one actually
27:48allow me to just no clarify
27:51i'm emphasizing directly involved i
27:54didn't do
27:55any of the work i didn't do any of the
27:57training i was not a salesperson
28:00but as a senior executive
28:03i certainly was aware of what was going
28:05on and
28:07i consulted with other senior executives
28:11about what was going on and what should
28:14be going on with someone
28:16okay and then this um
28:20email that was just handed to you
28:24a few moments ago says again it's
28:27cornelia
28:28hinch it's dated
28:32may 29 1999
28:42it says uh if you'll read the
28:44highlighted portion
28:46it says this is an email from you to her
28:49correct
28:53yes it says you won't believe how
28:55committed i
28:56am to make oxycontin a huge success
28:59it is almost that i dedicated my life to
29:02it
29:02after the initial launch phase i will
29:05have to catch up with my private life
29:07again
29:09did i read that correctly you did when
29:11you say you dedicated your life
29:13to it and that you have no time for your
29:15private life
29:16what were your day-to-day activities
29:18with respect to oxycontin
29:25well may i read the the whole
29:28document i haven't seen this for
29:3216 years
29:43have you read your deposition in the
29:44endo litigation
29:47no in preparation for this yes no
30:06good
30:17i'm sorry
30:28the context of this
30:31was to encourage
30:34dr hench who was the head
30:38of the australian business
30:41and was meeting with great success with
30:44mscom
30:46to pay perhaps
30:50more attention than
30:54i thought she was paying to the
30:56prospects of potential for oxycon
30:59and so this was
31:03in the spirit of motivating
31:07her
31:10it was true that i was
31:14very gladdened to see that oxycontin
31:19was meeting with so with such a strong
31:21positive result
31:23reception by both physicians
31:26and patients and i was
31:30working hard at the business
31:34but it
31:39if you you would misinterpret this if
31:42you
31:42thought that i was working only on
31:45oxycontin
31:46that was not the case okay when you say
31:49you were encouraged by the
31:51number of physicians that were selling
31:53it
31:55prescribing it prescribing it you were
31:57not aware at this time were you
32:00or were you aware that your
32:05company was committing a felony in how
32:08they were marketing and branding
32:10the drug objective the form of the
32:13question
32:16i was not aware
32:20at all of uh of what you're you're
32:24saying
32:25um and when i say i was heartened by
32:29physicians reception when i did speak to
32:32physicians at meetings i didn't go on
32:35sales calls
32:36but at some meetings and conferences
32:39they were extremely enthusiastic
32:43about the effectiveness
32:46and the safety and the reception their
32:48patients had
32:49response they had to the product
32:53that was what i was referring to
32:56because as i had told you before our
32:59goal was to make a better product than
33:01ms cotton
33:02and i believe we this rat this was one
33:05of the ratifications
33:07of that let's mark this exhibit
33:11three
33:22may have
33:36physically on it
33:39let me tell you i i don't see it yeah
33:42you're holding it
33:44i'm holding one and two
33:47that email that you have your hand on
33:49there's three
33:50we may have just marked it twice that
33:52may be the problem
33:55yeah it just got harder if you've marked
33:57it twice then
33:59so three and two are the same yeah okay
34:01then i have it because i have two
34:02and we'll get into this a little more
34:04later on but you're aware that purdue
34:06pled guilty
34:07to a felony charge of misbranding
34:11a drug which was oxycontin with the
34:14intent to defraud or mislead
34:19you are aware of that correct uh you
34:22should produce
34:22that that is your earlier statement that
34:25is purdue frederick is that right
34:27yeah okay
34:31okay so when you said purdue you meant
34:33purdue
34:34frederick purdue frederick company yes i
34:37i am aware
34:44yeah did you is it your understanding
34:46that the
34:48fraud
34:53only occurred with respect to the purdue
34:56frederick company
34:57and not with respect to purdue pharma
35:00llp
35:04that's my understanding but i'm not an
35:07attorney you know i that's a very deep
35:10legal question
35:11did you do any investigation to find out
35:14whether
35:15sales reps employed by purdue pharma
35:19were
35:23exceeding what they were allowed to do
35:26and when they were marketing that they
35:28were making claims
35:31that were untrue
35:34the objection to form he can answer
35:40when you say you are you referring to me
35:43personally or are you referring to the
35:46company
35:47i'm referring to you personally i did
35:50not
35:52conduct or manage any investigation
35:56but from the time we learned
36:00at top management levels that there was
36:03an abuse
36:05and diversion problem which was
36:08years before the settlement with the
36:10government
36:12we launched multiple investigations
36:15both with inside resources
36:19and people and with external attorneys
36:22and others to identify
36:28and this was before any charges were
36:30made to identify
36:31if we had
36:35in any sense miss
36:40led or or caused this to happen
36:44more important we spent enormous
36:47resources
36:48to try to mitigate
36:52the problem whatever the cause was
36:56and that effort which was launched
37:00sometime in 2000 or 2001
37:03continued right through the period
37:07that you're referring to of the plea
37:09with the u.s government
37:11and did you all launch this
37:12investigation as soon as you learned
37:15there was a problem
37:16yes within within months or weeks
37:20i can't recall it was 16 15 16 years ago
37:25do you rick who's michael friedman
37:28michael friedman is the
37:32was at that time the head of sales and
37:34marketing
37:37have you seen his presentation at purdue
37:40that he do you know what at purdue is
37:44the euros internal newsletter that goes
37:47out to all the employees
37:49i don't believe i saw a presentation on
37:52app purdue
37:53from him
37:59all right we'll get to that later um
38:08this is a memorandum dated
38:16july 15 1992
38:19meeting with shayanugi
38:22held wednesday july 24 1992
38:26from dr j.w watkins
38:29and there's a distribution list and i
38:32assume you are dr r s sackler is that
38:34correct that would be me
38:37and if you return to
38:41page six of this document that is
38:49pdd-1701546226
38:53and to give it a little context shia
38:56nogi
38:57is that a japanese company it is and
39:00at one time were you all talking about
39:02doing some sort of business with them
39:05involving potentially uh
39:08oxycontin controlled releases yes
39:11and did you do business with them
39:13involving oxycontin controlled release
39:15yes let's look at page
39:18six if you would the uh
39:22looks like maybe the third paragraph
39:24down that begins with dr keiko
39:26yes you see that dr kaiko presented two
39:29options
39:29identified for positioning of oxycodone
39:33acrocotin now is that the controlled
39:35release
39:36that was our working
39:39title of the control release system
39:43versus mst cotton tablets in the u.s
39:47the first was relevant if pf who's pf
39:51purdue frederick did not suffer
39:54substantial erosion of its ms cotton
39:56market by generic
39:58competition this envisioned using
40:01oxycodone
40:02acrocotin tablets over the entire
40:04spectrum of pain in patients whose
40:06treatment had been initiated with this
40:07product whilst ms cotton tablets would
40:09be used as therapy for chronic
40:11severe pain in patients who were changed
40:14from other medication
40:15including oxycodone acrocotine tablets
40:19an alternative scenario would apply if
40:21ms cotton tablets were subject to
40:23erosion by generic competitors
40:25in this case oxycodone acrocotin tablets
40:28would be promoted for the use
40:30across the entire pain spectrum
40:33including those patients who might
40:35otherwise receive
40:36controlled release morphine did i read
40:38that correctly
40:39you did okay and was it your intent to
40:42promote
40:43oxycontin controlled release
40:47across the entire pain spectrum
40:54where
40:58you're referring to japan which is where
41:01she and ogi either had or was
41:04negotiating a license for oxycontin
41:08was it also your intent in the u.s to
41:10promote it across the entire payne's
41:12price
41:12spectrum it was our hope
41:15that it would be well received
41:20for pain moderate to severe pain
41:23requiring opioids
41:25let's mark this as exhibit
41:45and here is
41:54pdd-9524706426
41:57oxycontin launch team memo
42:00dated 331 95
42:03and oxycontin was actually launched in
42:06january of 96. is that correct
42:09that sounds correct and
42:12what this says if you will turn to
42:18page three first of all let me ask you
42:19this do you recall having
42:21any significant problem with ms cotton
42:25with respect to addiction abuse
42:28diversion or any of the problems that
42:31you
42:32experienced with oxycontin cr i
42:36i recall never hearing about that
42:40so let's look at page two
42:43the last paragraph it says
42:47our meeting ended with a question and
42:50comment period
42:52michael friedman emphasized the threat
42:54that a b
42:55rated generics posed to ms cotton
42:59we're not sure when a b rated generics
43:01will be launched
43:03but we don't think it will be until
43:041996.
43:06inevitably a b rated generics will
43:09arrive
43:09and this is why it is of extreme timely
43:13importance that we must establish
43:15oxycontin
43:17oxycontin can cure the vulnerability of
43:19the a b rated generic threat and that is
43:21why it is so crucial
43:23that we devote our fullest efforts now
43:26to a successful launch of oxycontin
43:32did i read that correctly you do and
43:37[Applause]
43:39who is lydia johnson
43:42i don't know uh this department
43:46it looks like it's the marketing
43:47department is that right
43:52i just see a distribution list i don't
43:55see a source
44:04i don't know it says that the department
44:07is marketing
44:09but i don't know lydia johnson
44:21was it your belief that it was of
44:23extreme timely importance
44:25that oxycontin be established because a
44:27b
44:28generics were going to arrive and
44:30compete with mscon
44:34no all right let's
44:37mark this as exhibit four
44:44uh we no we already have four i'm sure
44:48then this would be five five i'm sorry
44:55that's the launch team memo that i
44:57thought it was already
44:59is this what he's reading from
45:08don't worry about marking it we'll make
45:09sure it gets more i'll keep them in
45:11order
45:12yeah okay okay i'm sorry where are we on
45:15the numbers
45:16i don't think this has been marked as an
45:18exhibit i thought the launch team memo
45:20was
45:20exhibited before uh no four is
45:24uh something had a nap research center
45:27yeah
45:28the japanese government this has not
45:29been marked as an exhibit so let's
45:31that's five there right will be five
45:33i'll keep trying yeah this should be
45:34this should be five
45:36late
45:44dr sackler do you know how much money to
45:46date has been generated by the sale of
45:49oxycontin
45:53i don't understand the question money
45:56generated
45:57how much money has purdue frederick or
45:59purdue pharma made off the sale of
46:01oxycontin
46:02i don't know okay
46:08there was a article
46:13last month in forbes the oxycontin clan
46:16the 14 billion newcomer to ford's 2015
46:19list of the richest u.s families have
46:21you seen that
46:22i have seen it once
46:27do you know what percentage of purdue
46:29pharmacy sales
46:30uh is made up of oxycontin
46:34presently yes approximately two-thirds
46:40um i've looked at the
46:45the that's purdue farmless sales
46:48sales purdue frederick does not sell
46:51uh anymore correct you've got another
46:55a number of other entities that generate
46:58income
46:58from the sale of oxycontin correct
47:00overseas yes
47:02and approximately 90 of the profits of
47:05the company come from oxycontin
47:08uh question the company
47:11you're referring to now purdue pharma
47:13purdue pharma
47:15uh i don't believe it would be 90
47:19but it is certainly a majority um
47:27do you currently make over a billion
47:29dollars a year selling oxycontin
47:31objections to the form i do by you now
47:34you're talking about
47:35dr sackler yes
47:38no i don't right does purdue pharma make
47:41over a billion dollars a year
47:43i'm not sure i don't think it would be
47:46that much
47:47um let's talk about gross sales are
47:50gross sales over three billion dollars a
47:52year
47:52no they're not what are the gross sales
47:58well i think what you're looking for is
48:02net sales because
48:06in the industry
48:09a lot of money is inherently rebated
48:13back to purchasers insurance companies
48:17hospitals etc
48:19through wholesalers in rebate agreements
48:24which are negotiated and so
48:27i believe the net sales are in the range
48:30of this year
48:31a billion dollars and your question was
48:34directed to purdue pharma
48:35purdue pharma right right are there any
48:38other purdue entities
48:40that make money that would not be
48:41included in that one billion dollar
48:43sales
48:44no connection to the form of the
48:46question
48:48you can answer not in the united states
48:54do you know how much the sackler family
48:56has made off the sale of oxycontin i
48:58don't know
49:00but fair to say it's over a billion
49:02dollars
49:03it would be fair to say that yes do you
49:06know if it's over 10 billion dollars
49:08i don't think so you know if it's over 5
49:10billion i don't know
49:28future
49:34that one
49:45this appears to me uh what's been marked
49:47as exhibit five it's p
49:49k y six i'm sorry exhibit six p
49:53k one seven three eight one zero two o
49:56o six appears to be a
49:59profit calculation for
50:08a purdue entity can you tell me which
50:10entity that is
50:14if it's not on the document i couldn't
50:16possibly tell you
50:37did purdue frederick still exist in 2006
50:42i'm not clear i think it did
50:47this appears to be a
50:50profit calculation for oxycontin
50:54tablets only do you see that i do
50:57and it appears that
51:02at least by 2006 profit
51:07contribution was four million
51:10four billion seven hundred eighteen
51:12million seven hundred and sixty seven
51:16thousand is that correct you've read the
51:18number correctly
51:19but profit contribution is not profit
51:25and what would you subtract from that
51:28all of the money that
51:31was invested in
51:36in the business to develop new products
51:40that would be a major
51:44deduction from that okay let's mark this
51:56well let's you're right i think it is
51:59look up the top where it says gross
52:02profit
52:04seven billion five hundred and two
52:05million three hundred sixty seven
52:07thousand
52:07just a second small type just a second
52:11gross
52:12profit see gross sales
52:16i say rebates
52:19and then net sales okay
52:22i'm with you on gross profit thank you
52:25so deducted from that is shipping
52:27warehousing you have 536 million paid to
52:31abbott
52:32for co promotion commission that's
52:34correct
52:35you have an s p expense what's that
52:37sales and promotion
52:39all right that was a 141 million
52:42uh on sales and promotion is that
52:44correct that's correct
52:46r d expense uh
52:50308 million right and i'm
52:53looking for the number i'm sorry
52:56salesforce
52:57yes i see that but can i explain that's
52:59the r d associated with the product
53:02right not the r d for other products
53:06right and then sales force is 960
53:10or or 87 million 222 that they've been
53:15paid
53:16that's what it says um and it's got a
53:19gna expense
53:20what is that general and administrative
53:23right 492 million
53:26yes over
53:29how many years 96 to
53:322005. so it's nine years am i counting
53:35correctly
53:36you are then there is product liability
53:39and patent litigation
53:41expense
53:45you had oxycontin litigation expenses
53:49then you have profit after all those are
53:53subtracted
53:54on oxycontin of 4 billion 718 million is
53:57that correct
53:58that's that's what it says i don't i
54:01can't testify that it's correct but
54:03that's what it says
54:10okay let's mark this as plainest things
54:13over
54:15six i think it already yeah
54:22yep it is marked do you want the
54:24original
54:26um i'm trying to go a little bit longer
54:28i mean if you all need a break we can
54:29take a break i could take it
54:31yeah and take a break yeah good idea do
54:34you want to shut down
54:35do i have to wait one second uh we are
54:38off the record at
54:3910 06 a.m
54:42we are back on the record at 10 18 a.m
54:51all right um
54:55i'm gonna ask you about this do you have
54:56a copy of that
55:01i can get it actually i may already be
55:04in the evidence
55:16in exhibit four
55:20and if you look at the second paragraph
55:22there's a comment that says
55:25when discussing oxycodone acrocotine
55:31which is controlled release oxycontin
55:33oxycodone i'm sorry
55:35just talk me out a little bit page one
55:37the first
55:38first page page uh second paragraph
55:42okay it says the molecule lacks the
55:45stigma
55:46of morphine
55:49and may be a particular advantage in the
55:51five percent
55:52approximately of patients who cannot be
55:54adequately treated with morphine um
56:02was it your understanding that
56:04approximately 95
56:05of the patients out there could be
56:07treated with ms cotton
56:08no um do you disagree with that
56:12statement that
56:13i do i disagree what percentage do you
56:16think
56:17of patients could be adequately treated
56:18with ms cotton
56:24between 50 and 75
56:28and what studies are you basing that on
56:31i'm basing it on
56:32general experience of being involved
56:36with ms cotton at oxycontin
56:39since 1980. did you ever do any studies
56:42to determine
56:45what percentage of patients could be
56:46adequately treated with ms cotton
56:48i don't remember any okay did you ever
56:52do any studies
56:54on abuse liability for oxycontin
56:57before you all put it on the market i'm
57:00not aware of any
57:02let me show you uh what's been
57:06identified by bait stamp pd880112
57:15copies of this
57:21we'll mark this in planets exhibit seven
57:24and i'll ask you if you can identify
57:27this
57:28uh may have a copy
57:41thank you
57:56and does this appear to be a memo to you
57:59from paul goldenheim it it is and who is
58:02paul golden
58:04at the time he was head of research and
58:08development
58:10okay and just to kind of walk through
58:12this memo
58:14from the bottom down there it looks like
58:16you had sent a memo
58:19on march 14th of 97
58:22to a number of individuals at
58:25uh i'm looking for that
58:30i'm looking for mine oh from me okay i
58:33see that
58:34okay i'm i'm sorry i see no it's
58:38it's two emails okay thank you and
58:42the paragraph at the bottom says the
58:45b-f-a-r-m
58:46what is that that was the german
58:50regulatory agency
58:53at that time it says were asked whether
58:56oxycontin could be classified as a
58:58controlled drug
58:59or whether it would be possible to
59:01obtain a relaxed
59:03status because of the difficulty in
59:05extracting oxycodone from the matrix
59:08and the fact it was less liable to abuse
59:11because it was
59:12unknown so
59:16just dialing down on that first sentence
59:20you were wondering whether oxycodone
59:23could be less regulated in germany
59:26is that correct i believe
59:30that i was reporting something
59:33to paul that i i must have heard
59:37but i was not involved in making
59:40any any discussions meeting or meetings
59:43with bfram
59:44okay um can i may i just read the rest
59:46of it if we're going to continue on sure
59:50i'll tell you i'll read it to you uh so
59:52the next sentence says
59:54the b frame b-f-a-r-m
59:57which i understand is the german
59:58regulatory authority that's correct
1:00:01answer that unfortunately oxycontin
1:00:03would definitely be classified as a
1:00:05controlled drug
1:00:06for all strengths as is morphine
1:00:10there could be no exception because of
1:00:12the controlled release protection
1:00:15because there had been a few reports of
1:00:17abuse
1:00:18and there were limited data on long-term
1:00:21use
1:00:22did i read that correctly you did okay
1:00:25and then you have here in caps we have
1:00:28a lot of use data in the u.s with very
1:00:31very very few
1:00:32ades what are ades those are
1:00:36reports to the agency to the fda
1:00:40uh and ade stands for
1:00:43adverse drug experience
1:00:47all adverse drug experiences
1:00:50are reportable to the agency
1:00:55anything we are aware of we must report
1:00:58periodically
1:01:00anybody else however can also report
1:01:03ades to the agency
1:01:07and so the agency maintains a
1:01:11catalog for every drug of ades
1:01:15and then you have in caps continuing we
1:01:18can run another long-term trial to get
1:01:20more data
1:01:21and if the abuse potential is equal or
1:01:23lower than with other non-scheduled
1:01:25drugs
1:01:26would befram unschedule it that's your
1:01:29question correct that was a question
1:01:30and then dr goldenham writes back
1:01:34on the subject of is this an opening to
1:01:37descheduling
1:01:38the agent and descheduling means make it
1:01:40less restrictive
1:01:42correct
1:01:45that that's how i would understand it
1:01:50and if it's less restricted would you
1:01:53think that you could sell it to more
1:01:54people
1:01:56it would be easier for physicians to
1:01:59prescribe it
1:02:02it's going to increase sales
1:02:05that is reasonable because they could
1:02:08prescribe it
1:02:09if it were schedule three instead of
1:02:12schedule two
1:02:13as are some drugs um
1:02:18physicians could prescribe by telephone
1:02:21and his response is we do not have any
1:02:25abuse liability studies and this is as
1:02:28of 1997
1:02:29correct that's correct to date have you
1:02:32done abuse liability
1:02:34studies yes many when were they done
1:02:40i don't know when the first ones were
1:02:42done but
1:02:43they were done repeatedly
1:02:47for many formulations
1:02:50subsequently of both oxycodone
1:02:54and of other abusable
1:02:57opioids both in control
1:03:00release form in an immediate release
1:03:02form have you done abuse liability
1:03:05studies for
1:03:06oxycontin controlled release i don't
1:03:09yes the new new formulations definitely
1:03:12and when were those done i don't know
1:03:14exactly
1:03:16but before the products were submitted
1:03:18to the agency
1:03:20you're saying the new formulation the
1:03:21new formulation okay when were the new
1:03:23formulations submitted
1:03:26i'm doing this from memory now about
1:03:282008
1:03:30but i could be an error by a year or two
1:03:34so by 1997
1:03:37two years after this product was on the
1:03:39market
1:03:41he says we do not have any abuse
1:03:43liability studies
1:03:44i think this is a dead end adding
1:03:47naloxone i think
1:03:49is the only possibility but this is a
1:03:51difficult project from the clinical spec
1:03:54perspective we are investigating for
1:03:56hydrocodone
1:03:59and was that his response that is what
1:04:02he wrote
1:04:03he's basically saying they're not going
1:04:05to
1:04:06schedule this unless perhaps they might
1:04:10if it incorporated naloxone and
1:04:13naloxone is an additive it
1:04:16is it is a reversal agent
1:04:20it blocks the effect of opioids
1:04:24and you all did not incorporate naloxone
1:04:27correct
1:04:28we subsequently did in some markets
1:04:33um in europe in particular and to some
1:04:36extent
1:04:37elsewhere did they require you to do
1:04:39that no we did it for another reason
1:04:42what was the reason we discovered
1:04:45that it did not
1:04:48block the effect of the opioid
1:04:53apparently at all but it did
1:04:57reduce the gastrointestinal side effects
1:05:00dramatically
1:05:01including constipation which is the most
1:05:05common side effect for any opioid
1:05:13i could add that by the
1:05:17time we had a full
1:05:20press to develop abuse resistant
1:05:24form of oxycontin we did do extensive
1:05:28work
1:05:29with another antagonist called
1:05:31naltrexone
1:05:33and naltrexone did when it got released
1:05:36blocked the effect of
1:05:40the opioid but unfortunately after
1:05:44a huge investment we could never
1:05:48be certain that it wouldn't be released
1:05:52when it was taken orally it was
1:05:55almost perfect but it
1:05:58had to be perfect because the agency
1:06:01said that if it released and blocked the
1:06:04effect of the opioid
1:06:05in patients they would not approve it
1:06:08and we could not reach perfection
1:06:18let me show you an email chain that's
1:06:21been
1:06:22produced let me mark this wrong
1:06:32i can pull that off or not before it
1:06:44sticks
1:06:48and it's pdd29520806
1:06:54439. and
1:06:58if you start at the
1:07:01back i believe
1:07:06this email chain
1:07:10begins at the back
1:07:13and this is an email from you
1:07:18dated um
1:07:23yeah the last email is the first email
1:07:25and it
1:07:26is dated
1:07:31i'm seeing three eleven ninety-seven
1:07:34oh three two now this is sort of a
1:07:36little out of order isn't it
1:07:39i'm sorry yeah there is uh my mine tore
1:07:42off
1:07:42uh okay oh no 312.97
1:07:48227.97 is the first
1:07:51highlighted pardon i highlighted the
1:07:54email
1:07:56okay 227 it's not oh
1:08:00it's the middle page for me not the last
1:08:03okay yep
1:08:12yeah i'm not sure that all the pages
1:08:14have been assembled properly
1:08:15yeah these are the this is the way this
1:08:17document was produced to us
1:08:19um and the reason that there's a skip in
1:08:22the base range from
1:08:25the last two pages purdue
1:08:28produced a totally random document in
1:08:31between it
1:08:32but if you look at the base numbers of
1:08:35the original base stamp on this document
1:08:37they're consecutive among those pages
1:08:41in a consecutive email chain so i have
1:08:43taken the liberty of removing
1:08:44the completely erroneous page that has
1:08:46nothing to do with this email chain
1:08:48and produce produces
1:08:53he has a different formulation that he's
1:08:54talking about no he's got the same value
1:08:56exactly
1:08:56we're just trying to make sure that
1:08:57we're all working from the same document
1:09:00so if you'll go to the 227 97
1:09:04email that's it yeah now i had to look
1:09:07for it i
1:09:08expected it at the end but it wasn't
1:09:10okay
1:09:14yes it says this is from walter wimmer
1:09:17at mundy pharma germany and that's a
1:09:21company that's owned by the sackler
1:09:22family it is
1:09:24and who's walter wimmer he was the
1:09:26general manager
1:09:28at that time and he says
1:09:31um dear bob um
1:09:35first paragraph in the course of this
1:09:36conversation he explained to you that
1:09:38due to his discussions with bf
1:09:41arm he does see a 50 chance to get
1:09:44oxycontin off the narcotic drug status
1:09:47provided you could give some information
1:09:49on the very low abuse potential of our
1:09:51cr formulation
1:09:53did i read that correctly you did and
1:09:56then
1:09:56in response to that if you go up to the
1:09:59top dr robert kyco
1:10:01has an email dated 227.97 he does
1:10:05he says while my thinking is still
1:10:07development developing
1:10:09frankly i'm very concerned and i would
1:10:12have to recommend against the
1:10:13uncontrolled but monitored proposal at
1:10:16this time
1:10:18parentheses perhaps if only to make sure
1:10:20the risks are appreciated and accepted
1:10:22before we proceed
1:10:23as proposed do you know what
1:10:28risk he was discussing i have no idea
1:10:32did you ever discuss with him why he was
1:10:34recommending against
1:10:36going uncontrolled but monitored with
1:10:38respect to oxy
1:10:40i don't even know what it means
1:10:43if i've read the rest of it do you think
1:10:45it would give me
1:10:46a clue or i i infer that you
1:10:50because you didn't highlight it you
1:10:52don't think it would
1:10:54it would shed any light on what was
1:10:56meant above
1:11:00well let's read the rest of it it might
1:11:02help
1:11:07he says under paragraph b i don't
1:11:09believe we have a sufficiently strong
1:11:11case to
1:11:12argue that oxycontin has minimal or no
1:11:14abuse liability
1:11:17this is dated 1997 correct yes
1:11:20he says in the u.s oxycodone containing
1:11:22products
1:11:23were once less controlled than now abuse
1:11:26resulted in greater controls
1:11:29is that accurate i believe it is
1:11:33um and what he's saying there is these
1:11:36weren't as controlled at one time
1:11:38and they got abused and that's why we
1:11:39have controls now correct
1:11:41i believe that is the case he says
1:11:44oxycodone containing products are still
1:11:47among the most abused opioids in the u.s
1:11:50this information is available to bfarn
1:11:54the german regulators
1:11:57i that's certainly true that
1:12:00the information would be available to
1:12:02them and he says
1:12:03the local tissue necrosis that can
1:12:05result from injection of oxycontin
1:12:08fixed in quotations
1:12:12for such abuse is not likely to be a
1:12:14deterrent to abuse
1:12:15let us not forget that in new zealand
1:12:17mst is the most common sources of
1:12:20parentally abused morphine
1:12:22slash heroin and were you aware at that
1:12:25time
1:12:26that oxycontin there was a concern that
1:12:29that oxycodone opioids could be
1:12:33injected or abused
1:12:36i don't remember this memo and i don't
1:12:39remember
1:12:39what whether i had read the whole chain
1:12:43carefully or not and then he said he
1:12:45even saw it then he says
1:12:47our dossier acknowledged and by dossier
1:12:50i assume he means the documents
1:12:52yes purdue has yes our dossier
1:12:55acknowledges
1:12:56a small handful of patients in our
1:12:58research program
1:13:00and that means studies you all were
1:13:01doing is that correct that's
1:13:04that's that's what i would understand to
1:13:06me who were suspect in terms of their
1:13:08drug
1:13:09accountability do you know if that was
1:13:12reported to anyone that that euros
1:13:14dossier had a handful of patients who
1:13:16were suspect in terms of their drug
1:13:17accountability
1:13:19i don't know if it was reported but i'm
1:13:21confident it was
1:13:22if it was an fda submitted trial
1:13:27it would have been in either the
1:13:30safety summary or the
1:13:34um or the efficacy
1:13:37summary or both do you remember the
1:13:39issues with the roth reprint
1:13:40where there were patients who they
1:13:43determined
1:13:45had withdrawal symptoms and that was not
1:13:48reported
1:13:51i'm sorry are you are you familiar with
1:13:53the wrong reprint no
1:13:55you know whether that was part of the
1:13:57plea agreement that purdue
1:13:58frederick had when they pled guilty to a
1:14:01felony
1:14:01i don't i don't recall
1:14:07and it says under paragraph c um
1:14:12continuing on we do not we do not have
1:14:15a post-marketing abuse monitoring system
1:14:19and database from which we could
1:14:20conclude that diversion abuse
1:14:22is not occurring were you aware that you
1:14:25all put this on the market
1:14:26in oxycontin cr and did not have a
1:14:29post-marketing abuse monitoring system
1:14:32or database from which you could tell
1:14:34whether abuse or diversion was occurring
1:14:37i was not aware of that i don't believe
1:14:39it was a requirement
1:14:41at the time i'm sure we would have
1:14:45fulfilled all the fda requirements that
1:14:47they asked us
1:14:48do you think it would have been a good
1:14:49idea before putting oxycontin controlled
1:14:52release on the market
1:14:54to have an abuse monitoring system and
1:14:56database from which to tell if it was
1:14:58being diverted or abused
1:15:00absolutely yes and then under
1:15:04paragraph c it says if oxycontin is
1:15:06uncontrolled in germany
1:15:08it is highly likely that it will
1:15:09eventually be abused
1:15:11there and then controlled this may be
1:15:14more damaging
1:15:15to oxycontin internationally than any
1:15:18temporarily higher
1:15:19cells that could be gleaned from an
1:15:21uncontrolled status
1:15:23let us not forget the experience with
1:15:25buprenorphine
1:15:27which was initially uncontrolled reports
1:15:29of abuse in germany
1:15:31in part eventually led to lots of bad
1:15:33press and controlled status
1:15:35worldwide sales suffered even where
1:15:37buffering had already been controlled
1:15:40so given the above what do others have
1:15:42to offer
1:15:43that should prompt us to pursue the
1:15:45proposal for uncontrolled status for
1:15:47oxycontin anywhere
1:15:48question mark and was that uh the
1:15:51response of
1:15:53robert caico it appears to be so
1:15:56and who was robert caico he was in
1:15:59charge of the development program
1:16:02of oxycontin was he the chief medical
1:16:04officer
1:16:05no but he was he was respected
1:16:08his opinions were respected and were
1:16:11heeded
1:16:13and then the next email which comes from
1:16:15you
1:16:17is dr richard sackler at norwalk give me
1:16:20just a little time to find it since
1:16:22they're not in order
1:16:24but
1:16:28okay norwalk and could you read the date
1:16:31please
1:16:32uh it looks like it's three to 1997.
1:16:36um 312. 312 97.
1:16:40i'm looking at 3-2 it says 0-203-97 but
1:16:44i think
1:16:44the way it's confused it's really march
1:16:463rd okay
1:16:54i see something from 312
1:16:57i see something from 11 3
1:17:0097 it's page five maybe that'll happen
1:17:03oh i don't think i have paid oh page
1:17:05five
1:17:05okay thank you and this is your response
1:17:08to
1:17:08robert caico saying this is a bad idea
1:17:11for all these reasons
1:17:13and you say this is the first time i've
1:17:16heard of this idea
1:17:18what makes us believe that we can
1:17:20accomplish it walter
1:17:21how substantially would it improve your
1:17:23sales
1:17:24what you're talking about there is if we
1:17:26can get it uncontrolled in germany
1:17:28how substantially will it approves
1:17:30improve sales correct
1:17:32yeah yes that was it would appear that
1:17:35that's what my question was
1:17:36please give a five-year projection with
1:17:38control and without
1:17:41does each member of the eu is that the
1:17:44european union
1:17:45yes decide this for themselves or would
1:17:47one lead
1:17:48if one would lead then is denmark or
1:17:50germany more likely to agree
1:17:54and
1:17:57then
1:18:01harry kletzko of mundy pharma
1:18:06writes you back on march 7th and says
1:18:07dear dr richard just a second
1:18:16we're now on page one or two
1:18:19that's the same page the one right above
1:18:22okay i'm sorry
1:18:26please find stated below our five-year
1:18:29projection of oxycontin
1:18:30without and with controls as requested
1:18:35and it was projected that with first
1:18:39year non-narcotic uh narcotic drug with
1:18:42control
1:18:43be 3.000 tdm you know what that is
1:18:48i assume total or something deutsche
1:18:51mark something
1:18:52deutsch marks and that would be 3
1:18:53million that would be
1:18:55my understanding and then
1:18:59turnover non-narcotic drug without
1:19:01control is 10 million
1:19:03the first year first year and on the
1:19:04fifth year it was projected to be 18
1:19:07million with control
1:19:08but 30 million without control that's
1:19:11what it says
1:19:15and then you wrote back on 3 8 97 right
1:19:20above that one and it says vk advised
1:19:22that the regulatory
1:19:23authorities did say a bk sorry i heard
1:19:27dk
1:19:29and uh advised the regulatory
1:19:32authorities said that oxy would be
1:19:33scheduled
1:19:34and so would be under narcotic control
1:19:37does this correspond to your info if so
1:19:40if so is this matter now closed or is
1:19:42there some appeal or other procedure you
1:19:45would want to consider
1:19:48so you still saw the advantage of
1:19:51getting oxycontin cr
1:19:54uh uncontrolled um and were wondering if
1:19:58there was some way you might appeal
1:20:00the german decision reform that's not
1:20:02what the statement
1:20:03says that you just read well correct me
1:20:06if i'm wrong there
1:20:12why did you say is there some appeal or
1:20:15other procedure you want to consider
1:20:19okay this whole experience
1:20:22is actually like reliving a third of my
1:20:26life
1:20:28and i had completely forgotten until i
1:20:30saw this document
1:20:33that walter had been
1:20:36very hesitant
1:20:39to pursue the development or the
1:20:42marketing of oxycontin
1:20:45because he didn't believe it would sell
1:20:48very well he turned out to be completely
1:20:52wrong
1:20:52and when it was introduced it did
1:20:54extremely well
1:20:56we were of the contrary opinion but he
1:20:59said
1:21:00he came back and he did quite a bit of
1:21:02work
1:21:03without any reference to anybody else
1:21:06on determining or trying to get the bee
1:21:10farm
1:21:11to consider not scheduling it
1:21:14and this whole stream
1:21:17was occasioned by that
1:21:22we many of us in the us
1:21:25were not enthusiastic about not
1:21:28scheduling it
1:21:29in germany there is no equivalent at
1:21:32least at that time
1:21:33that i recall of anything like schedule
1:21:36three
1:21:37you were either an abusable
1:21:40drug and thus you had all the abusable
1:21:43drug
1:21:44controls or you were not
1:21:47and we were not in favor of this but we
1:21:50were trying to be
1:21:52polite and solicitous rather than
1:21:55saying this is a terrible idea forget it
1:21:58don't do it because we still felt that
1:22:02with the controls which we thought would
1:22:04be appropriate
1:22:06and were appropriate obviously
1:22:10it would still be very welcome very
1:22:13useful
1:22:14to patients in the german market so this
1:22:17whole stream
1:22:18this whole trail really was
1:22:22occasioned by that but i don't remember
1:22:24anymore so if we go on and
1:22:26we're going to relive another few days
1:22:28of my life sure
1:22:29let me ask you if you thought controls
1:22:31were appropriate why were you asking
1:22:32here raising the issue if there was some
1:22:34appeal that could be taken
1:22:36just just to be polite not to just shut
1:22:39him down
1:22:40okay well let me ask you this let's go
1:22:42to the next one which is page four
1:22:45he writes back yes richard this does
1:22:47correspond to the information given by
1:22:49mr gerk our registration office we also
1:22:52attended the meeting with the bga
1:22:54this matter is now closed there is no
1:22:56way of appeal
1:22:57is that what he told you it seems to be
1:23:00what he told me
1:23:01and then you wrote back
1:23:04and said when we are next together we
1:23:06should talk about how this idea was
1:23:08raised and why it failed to be realized
1:23:11i thought that it was a good idea if it
1:23:13could be done
1:23:15was that your response to that's what it
1:23:17said but i didn't mean it
1:23:19i just wanted to be encouraging i was
1:23:22very glad it was close
1:23:31up at the top there's a note there's
1:23:33another
1:23:34response from walter wimmer
1:23:38who says to get the product off narcotic
1:23:41drug status it would be possible to
1:23:43combine oxycodone
1:23:46with naloxone provided the development
1:23:48cost weren't too
1:23:49high that was sent on 312. okay
1:23:52let me boom
1:23:55and then the top one is cut off
1:23:59but it says paul michael would this be a
1:24:02feasible approach here in the u.s
1:24:05i don't know of any c2 narcotic that is
1:24:07descheduled when naloxone is added do
1:24:09you
1:24:11is that a question you were raising it
1:24:13looks like i raised it just as a matter
1:24:15of information
1:24:20as i said they eventually
1:24:23did develop that product
1:24:27and it was extremely successful but at
1:24:30the time they
1:24:31researched it they quickly discovered
1:24:34that naloxone didn't
1:24:36achieve the desired
1:24:39blocking effect
1:24:44but they made another discovery that was
1:24:46even more valuable
1:25:24okay
1:25:29okay i'm not good on this one you got
1:25:31this
1:25:37oh um
1:26:07would i be correct that purdue pharma
1:26:09never
1:26:10conducted or retained anyone to conduct
1:26:13studies regarding addiction and physical
1:26:15dependency rates
1:26:16of oxycodone products um
1:26:23at least as of march 4th 2002.
1:26:26i don't know the answer
1:26:30are you aware that council for purdue
1:26:34pharma answered interrogatories
1:26:39that requested the names of all
1:26:40individuals retained by purdue pharma to
1:26:42do studies regarding addiction and
1:26:44physical dependency rates of oxycontin
1:26:46products
1:26:47and copies of all studies and he
1:26:49answered
1:26:50we never conducted or retained anyone to
1:26:52conduct studies regarding addiction and
1:26:54physical dependency rates of oxycodone
1:26:56products
1:26:57mr thompson if you're reading from a
1:26:59document could you show it to the
1:27:00witness
1:27:03no no i'm just asking if he's aware of
1:27:04it because i'm trying to move the
1:27:06deposition along
1:27:07so are you aware of that no i'm not
1:27:10aware of
1:27:11his his statement
1:27:21are you aware of any studies conducted
1:27:24or retained
1:27:25or anyone being retained to conduct
1:27:26studies regarding addiction and physical
1:27:28dependency rates of oxycodone products
1:27:30prior to 2002. i
1:27:34i'm not aware of any or i don't remember
1:27:37any
1:27:40you got these you already
1:27:48in 2002 i was the president of purdue
1:27:52pharma and
1:27:55this would not have necessarily this
1:27:58wouldn't have required my
1:28:01approval or knowledge unless
1:28:07it was it led to something that was
1:28:11surprising or
1:28:15serio important and unexpected
1:28:22no i still want to ask about this
1:28:26mr thompson uh did you put in again an
1:28:29exhibit
1:28:30number to the last document that we were
1:28:32discussing which was a series of emails
1:28:34it was eight eight thank you
1:28:46oxycontin product team all right i'm
1:28:50going to switch and ask you a little bit
1:28:51about the oxycontin
1:28:53project team and this is a memo
1:28:56dated december 14 1993
1:28:59pdd 9520509356
1:29:09and there's a few
1:29:12paragraphs i want to try to cover here
1:29:14if you will look
1:29:15at the bulletin points on the front page
1:29:18the second one from the bottom says
1:29:20marketing
1:29:23oxycontin tablets will be marketed
1:29:25against percocet
1:29:26and duragizic the oxycontin line
1:29:30may replace our ms cotton line if msc
1:29:33generics are competing
1:29:35is that correct that's correct okay and
1:29:38that's not the
1:29:39uh is that the malignant cancer group of
1:29:42patients or does that
1:29:44uh non-malignant cancer group of
1:29:46patients
1:29:47i'm sure the objection of the form i
1:29:49don't understand the question
1:29:52all right you may answer
1:29:58ms cotton as i said before was used
1:30:02in treating both cancer patients and
1:30:04non-cancer patients
1:30:06and there was no focus
1:30:09i don't believe or consideration
1:30:13in this statement of
1:30:16whether it would be both i think do you
1:30:19have a knowledge of what percocet and
1:30:21duragesic was used mostly to treat
1:30:26percocet and percocet was
1:30:30an extremely um
1:30:35widely used product used to treat
1:30:40both short and long-term pain conditions
1:30:43both non-malignant and malignant
1:30:49and then if you'll turn over to
1:30:53paragraph 2.3
1:31:00and this is 1993.
1:31:14um
1:31:17it says abuse toxicity bench top study
1:31:19the results of a spoon
1:31:22okay i see 2.3 you said yes thank you
1:31:26the results of a spoon and shoot study
1:31:28have been sent to the fda
1:31:30what was the spoon and shoot study i
1:31:33i don't know i could guess but i don't
1:31:36know
1:31:40was that a study done to determine if
1:31:44the drug could be abused by
1:31:47extracting oxycodone from the tablet
1:31:53it's a reasonable guess but i don't know
1:31:57the details of what that study was
1:32:00and then under 3.2 the last sentence
1:32:02says a crush
1:32:04tablet study may be conducted if we
1:32:06decide such a study is needed
1:32:08you know if you ever decided such a
1:32:10study was needed what's the number on
1:32:12that i'd just like to read it
1:32:143.2 lessons i'm sorry thank you
1:32:213.2 okay
1:32:42yes okay i've read that i don't know if
1:32:44such a study was done
1:32:54and then on 5.4
1:33:04the very last sentence says mike
1:33:07in eroto and was he a guy in charge of
1:33:10marketing
1:33:11no he was he worked in the marketing
1:33:14department but he was not
1:33:16at this time he was not in charge he was
1:33:19a middle manager in marketing all right
1:33:21it says uh
1:33:23mike in eroto asked if we had any
1:33:25quality of life questions in our ongoing
1:33:27studies
1:33:28robert reader stated that we did not but
1:33:30that we could include quality of life
1:33:32questions in future studies
1:33:39do you know if quality of life questions
1:33:41were included
1:33:43i believe there were studies later that
1:33:46included
1:33:48quality of life measures but i
1:33:52am not certain of that um
1:33:55i'm certain it would have been favorable
1:33:57but i'm not certain
1:33:59just what studies were or were not done
1:34:06yeah let's mark that as has it been
1:34:09marked yet
1:34:10exhibit nine
1:34:16oops yep
1:34:43do this
1:34:55with respect to oxycodone and morphine
1:34:59um do you know
1:35:02whether oxycontin is
1:35:06more powerful or less powerful a drug
1:35:08than morphine
1:35:13it depends what you mean by powerful
1:35:16um i think
1:35:20doctor is it goldenheim
1:35:23yes was he an employee of yes i think he
1:35:26testified that
1:35:28that oxycontin was twice as strong as
1:35:31morphine is that your understanding if
1:35:37if the question if powerful means
1:35:41potency absolutely
1:35:44it is twice as potent as morphine and we
1:35:47were very proud that we
1:35:50discovered this um first in animal
1:35:54studies and then in human studies
1:35:57and we made it widely known
1:36:01perhaps even before the drug was
1:36:03introduced but certainly in the package
1:36:05insert and all the promotional material
1:36:08do you know how many doctors or what
1:36:10percentage of doctors thought that it
1:36:12was equal to or less
1:36:14strong than morphine i would assume
1:36:17very few if they if they
1:36:21were promoted to i can't believe that
1:36:25they wouldn't have understood that
1:36:30that formed the basis
1:36:34of our recommendations of dosing
1:36:37of the strength of the tablets that were
1:36:39developed
1:36:42and in fact it was consistent
1:36:46with physicians own experience with
1:36:49percocet
1:36:50where they would administer a five
1:36:53milligram dose
1:36:56and they if they used morphine they knew
1:36:59that five milligrams of morphine would
1:37:02achieve very little pain relief if given
1:37:05orally
1:37:06perhaps somewhat more if given by
1:37:08injection let's mark this
1:37:10as plaintiff's exhibit 10.
1:37:22this is the
1:37:28the memo dated 1992
1:37:31august 10th oxycodone project
1:37:35team meeting minutes i'm sorry august
1:37:3710th
1:37:38and it is pdd-9521410329
1:37:45three nine i have 3-0
1:37:50the first page is 3 9 correct and
1:37:53if you will look at this it says a
1:37:56literature search the second paragraph
1:37:58a literature search on oxycodone and
1:38:00oxymorphone
1:38:02is being conducted i'm sorry it's just
1:38:04not very clear give me a second
1:38:07the issue is a literature search i know
1:38:10are we looking at the same page you're
1:38:13on page two i'm on page one
1:38:14second i thought you said august 10 okay
1:38:18because this one is august 4th okay
1:38:21second paragraph
1:38:22a literature search on oxycodone and
1:38:24oxymorphone is being conducted by one of
1:38:26the summer employees
1:38:28um
1:38:32um do you know who was doing the
1:38:34literature search especially
1:38:36it would have been a son or daughter of
1:38:40one of the people who worked for
1:38:43purdue frederick or purdue pharma
1:38:47fifth paragraph down second sentence
1:38:49says the current consideration is to
1:38:51develop
1:38:5220 40 80 and 160 milligram tablet
1:38:55in addition to the 10 milligram tablet
1:38:58now in the clinic
1:38:59and whose idea was it to develop
1:39:0320 40 80 and 160 milligram tablets
1:39:06which major are you reading from this
1:39:08encounter
1:39:10first one page just what i called out
1:39:12fourth paragraph second sentence
1:39:17okay thank you this was a team decision
1:39:20it was discussed extensively
1:39:26and then if you'll go to the second page
1:39:32first paragraph it says with regard to
1:39:35the package insert
1:39:36and the first year advertising claims it
1:39:39was discussed
1:39:40with that mr segar should meet with
1:39:42others and rework the quote draft
1:39:44package insert
1:39:45the purpose would be to idealize the
1:39:47insert
1:39:48and coordinate the contents with the
1:39:50advertising claims
1:39:52and clinical trials program the package
1:39:54insert should include
1:39:56comparative claims it must be kept in
1:39:58mind this is a working document
1:40:00why did you want to coordinate
1:40:03the package insert with your advertising
1:40:06claims
1:40:09the package insert is the bible for the
1:40:12product
1:40:14it is the core document from which
1:40:19all promotion or communication
1:40:22with physicians is to be
1:40:26based
1:40:30it is typical in the industry
1:40:33that a lot of work is expended
1:40:36to make the package insert as
1:40:38comprehensive and complete as possible
1:41:01and this is a
1:41:15you talked about physicians being aware
1:41:18of
1:41:20oxycontin being
1:41:24twice as strong as morphine a second ago
1:41:28let me hand you let's mark this as
1:41:31exhibit
1:41:3211.
1:41:38this is an email it says the author is
1:41:40doctor may i have a copy
1:41:43oh i'm sorry in front of you says the
1:41:44authors dr richard sackler at norwalk
1:41:47dated 528-97
1:41:50are you familiar with this email to
1:41:52michael friedman yes
1:41:54who's michael friedman he was head of
1:41:56marketing and sales
1:41:58okay and let's drop down and see what
1:42:02michael friedman has written
1:42:05first paragraph he says my purpose in
1:42:08writing this memorandum
1:42:09is to clarify our position on the very
1:42:13complex
1:42:14issues raised by mike cullen during the
1:42:16phase
1:42:17four team meeting and which were the
1:42:20subject
1:42:20of dr richard's inquiry when they say dr
1:42:24richards who's that
1:42:25that was me all right first paragraph
1:42:28we are well aware of the view held by
1:42:31many physicians
1:42:33that oxycodone is weaker than morphine
1:42:37we all know that this is the result of
1:42:39their association of oxycodone with less
1:42:42serious pain syndromes
1:42:44this association arises from their
1:42:46extensive experience with and use of
1:42:48oxycodone combinations
1:42:53to treat pain arising from a diverse set
1:42:55of causes some serious but most
1:42:58less serious this quote personality
1:43:02of oxycodone is an integral part of the
1:43:05quote personality this personality of
1:43:09oxycodone
1:43:10is an integral part of the personality
1:43:12of oxycontin
1:43:15when we launched oxycontin we initially
1:43:17intentionally
1:43:18avoided a probation promotional theme
1:43:21that would link oxycontin to cancer pain
1:43:24we specifically linked oxycontin to the
1:43:26oxycodone combinations with our old way
1:43:29new way
1:43:30campaign we made sure our initial detail
1:43:33piece provided reps with the opportunity
1:43:35to sell the product for a number of
1:43:36different pain states
1:43:38with all of this we were still concerned
1:43:40that the drug would be slotted for
1:43:42cancer pain
1:43:43and we would encounter resistance in the
1:43:46non-malignant pain market
1:43:50and says our pricing of the product was
1:43:54geared toward the non-malignant market
1:43:57we knew if we priced low per milligram
1:43:59for the higher dose cancer patient we
1:44:01would be priced
1:44:02way too low per milligram for the
1:44:04standard non-malignant pain patient
1:44:06where we really wanted to make a market
1:44:09we feared that the quote cancer pain
1:44:11experts in quote
1:44:12would object to the two to one ratio
1:44:16and that two to one ratio is the ratio
1:44:18of oxycodone
1:44:20oxycontin to morphine is that correct
1:44:22actually
1:44:25if you want to strictly understand the
1:44:28ratio
1:44:29the two to one would refer to the ratio
1:44:32of morphine to oxycodone
1:44:36okay right not the other way around all
1:44:38right
1:44:39that's what you i know that's what you
1:44:40meant to say yes yes
1:44:43uh and resulting cost of therapy for
1:44:45high-dose patients
1:44:47however we had no choice given our
1:44:49position
1:44:50for oxycontin in any case we're
1:44:52developing
1:44:54hydromorphone we've lost you here okay
1:44:56in any case
1:44:58um we're developing hydrogen now for the
1:45:01hype
1:45:01dose patient right okay i'm at the end
1:45:04of paragraph four
1:45:06and then it says despite our initial
1:45:08uncertainty we've been successful beyond
1:45:10our expectations
1:45:11in the non-malignant pain market yes
1:45:14and normally pain market is sort of the
1:45:16chronic
1:45:17uh arthritis back pain
1:45:21um those types of patients well it it
1:45:24those are most typically moderate pain
1:45:27patients some of them may be severe but
1:45:31there are many
1:45:32less common conditions that produce
1:45:34severe
1:45:36crippling life-destroying pain
1:45:40and we had an indication and still have
1:45:44for all pain states that are
1:45:48appropriately treatable with opioids
1:45:52for an extended period of time
1:45:58we want it so non-malignant really is a
1:46:01distinction
1:46:02all pain other than the pain directly
1:46:04caused
1:46:06by the encroachment and destruction of
1:46:09tumor tissue in the patient
1:46:13and then he says here
1:46:20doctors use the drug in non-malignant
1:46:22pain because it is effective and the
1:46:24personality of oxycontin
1:46:26is less threatening to them and their
1:46:28patience than that of the morphine
1:46:30alternatives i apologize for this
1:46:33unspecific term but i feel it captures
1:46:35the notion that
1:46:36there are image-related attributes that
1:46:39influence drug acceptance
1:46:42while we might wish to see more of this
1:46:44product solved for cancer pain it would
1:46:45be extremely dangerous
1:46:47at this early stage in the life of the
1:46:48product to tamper with this
1:46:50quote personality to make physicians
1:46:53think the drug is stronger or equal to
1:46:55morphine
1:47:00we are better off expanding use of
1:47:02oxycontin in the non-malignant pain
1:47:03states and waiting for hydromorphone
1:47:05in 1999 to relaunch into cancer pain
1:47:10why was it felt that there would be a
1:47:12danger
1:47:14it would be extremely dangerous at the
1:47:17early stage in the life of this product
1:47:19to tamper with this quote personality to
1:47:22make
1:47:22physicians think the drug is stronger or
1:47:24equal to morphine
1:47:27the context of this was as you know
1:47:30[Music]
1:47:31a threat of emails that actually
1:47:35he alludes to i started um
1:47:40the whole context and the whole
1:47:41discussion of mr friedman here
1:47:44and in other words
1:47:48i'll pause here because i think it's
1:47:52really important
1:47:53for you to understand this the whole
1:47:56context was
1:47:57not to
1:48:02the context was not
1:48:06to stigmatize oxycodone
1:48:11in a way that morphine was stigmatized
1:48:16morphine was seen as an end of life
1:48:21extreme duress patient in extreme duress
1:48:26often dying of cancer but not only
1:48:29cancer
1:48:31it was reserved
1:48:35by most physicians if it was used at all
1:48:39even when patients were in serious
1:48:43severe or even crippling
1:48:46pain because telling a patient
1:48:52i'm going to put you on morphine i'm
1:48:54going to prescribe morphine for you
1:48:56now we've got to use morphine however
1:48:59the fate
1:49:00physician told the patient it
1:49:04often was associated with a death
1:49:06sentence
1:49:08oh stinks the patient he's telling me
1:49:11i'm going to die
1:49:14even worse my doctor's putting me on
1:49:16morphine
1:49:17he's giving up on me we didn't
1:49:20want oxycodone
1:49:25to to change the as he says
1:49:28personality of oxycodone but you could
1:49:31say
1:49:32all the associated feelings of oxycodone
1:49:35which were generally appropriate
1:49:39to a narcotic
1:49:42we didn't want that to be
1:49:45polluted by all of the bad associations
1:49:49that patients and health caregivers
1:49:53had with morphine did you think that if
1:49:56physicians thought it was stronger
1:49:58or equal to morphine
1:50:01um much less twice as strong as morphine
1:50:04that they would be less likely to write
1:50:07prescriptions and sales of oxycontin
1:50:09would go down
1:50:10no if it if its personality was changed
1:50:14if it was stigmatized as an end of life
1:50:18drug it could
1:50:21limit its usefulness the
1:50:25term stronger here
1:50:28meant more threatening more frightening
1:50:32there is no way that this intended
1:50:36or had the effect of causing physicians
1:50:40to overlook the fact that it was twice
1:50:43as potent it was called out
1:50:46in virtually every promotional piece of
1:50:49literature
1:50:50it was reflected in a conversion chart
1:50:54which we had developed for
1:50:57the few patients who were being treated
1:51:00with morphine
1:51:02where we made it very clear if they're
1:51:04on
1:51:06any dose daily dose of morphine
1:51:09you cut that dose in half for oxycontin
1:51:13um and every action we took
1:51:17before the product was launched
1:51:20with the fda in the package insert
1:51:23in promotion and in all detailing
1:51:27emphasized that it was twice as strong
1:51:30some physicians had formed
1:51:33their own impression that it wasn't
1:51:36twice as strong it was less
1:51:38strong and we insisted that they
1:51:41observe we said
1:51:44with this drug doctor it is twice as
1:51:46strong even when they said no i think
1:51:49it's one and a half times as strong
1:51:51and some physicians even said i think
1:51:55it's about the same potency as morphe
1:51:58we would insist no please use it the way
1:52:02we have researched it and the way the
1:52:04fda has approved it
1:52:06now and i think we were effective in
1:52:08getting that message across
1:52:10in time to most eventually almost all
1:52:13physicians
1:52:14this is 1997 two years after the launch
1:52:17of oxycontin controlled release correct
1:52:20yes so it's been on the market now
1:52:22uh over uh well yeah you launched
1:52:25january 96. we're now in
1:52:27in may of 97 and it says
1:52:30we are well aware of the view held by
1:52:33many physicians that oxycodone
1:52:35is weaker than morphine and
1:52:39and the conclusion of this was um i do
1:52:42not plan to do anything about that
1:52:46and you wrote back and said i agree with
1:52:48you
1:52:49is there a general agreement or are
1:52:50there some holdouts was that what you
1:52:52wrote up at the top
1:52:53i did and i agreed with him then and i
1:52:55agreed with him now because i knew what
1:52:57he meant
1:52:58and so did everybody else know knew what
1:53:00he meant
1:53:02and more important our actions in
1:53:05promoting the
1:53:06twice as potent as morphine never
1:53:09wavered
1:53:10we never disguised it or hit it we
1:53:14emphasized it so you weren't doing this
1:53:17because the pain market
1:53:18for non-malignant pain was a much
1:53:20greater market share
1:53:22is that your testimony no no that isn't
1:53:25we but we wanted to address both markets
1:53:30the email which perhaps you
1:53:34want to explore or not that started this
1:53:38was as he says in the first paragraph
1:53:41something that i had
1:53:42inquired about and
1:53:45what i had inquired about was an error
1:53:48on my part
1:53:50when we before we launched oxycontin we
1:53:53thought that our sales would be about
1:53:55equally divided between cancer pain
1:53:59and non-malignant pain we knew that the
1:54:02market for non-malignant pain was much
1:54:04larger of course
1:54:05fortunately for all of us cancer
1:54:08is not is much less common than other
1:54:11pain states
1:54:13but we had expected it would be about 50
1:54:1750. i had seen some reporter
1:54:20attended a meeting where i learned it
1:54:22was about 20 percent of our sales
1:54:24and thus i wrote to michael and said
1:54:28why what what's going on here why aren't
1:54:31we
1:54:32getting more cancer sales let's let's
1:54:35let's look at the
1:54:36the email you wrote to michael cullen at
1:54:39norwalk let's mark this as planets
1:54:41exhibit 12.
1:54:49yeah sorry and michael collins writes
1:54:53uh on
1:54:56june 2nd of 97 that was after the email
1:54:59we were just looking at
1:55:00and says in recent team meetings we've
1:55:03discussed the
1:55:04issue that oxycontin is perceived by
1:55:07some physicians
1:55:08particularly oncologists as not being as
1:55:11strong
1:55:12as ms cotton now oncologists are cancer
1:55:15yes doctors correct so even the cancer
1:55:18doctors
1:55:19don't think that oxycontin is uh
1:55:22as strong as ms cotton according to this
1:55:25conversion to the form
1:55:28that's not what they said oh well let me
1:55:29rephrase it uh
1:55:31you you were aware or at least michael
1:55:34cullen was advising you
1:55:35that oxycontin is perceived by some
1:55:38physicians particularly oncologist
1:55:40as not being as strong as m.s cotton is
1:55:42that correct
1:55:44that's what the words say and he says
1:55:46although this perception
1:55:47has had some effect with physicians
1:55:49switching to ms cotton with more severe
1:55:51cancer pain patients
1:55:53it has actually had a positive effect
1:55:55with physicians use
1:55:57in non-cancer pain and there he's saying
1:56:00non-cancer physicians that don't think
1:56:02it's as strong as ms cotton
1:56:05we're having a positive effect from that
1:56:07and i'm assuming he's talking about
1:56:08cells wouldn't you yes he says
1:56:12since oxycodone is perceived as being a
1:56:14weaker opioid than morphine
1:56:17it has resulted in oxycontin being used
1:56:19much earlier for non-cancer pain
1:56:22physicians are positioning this product
1:56:24where percocet hydrocodone and tylenol
1:56:26with codeine have been traditionally
1:56:28used
1:56:29so he's saying here physicians are using
1:56:31it because they think it's weaker than
1:56:33morphine
1:56:33correct he's using the word
1:56:37weaker but not meaning less potent than
1:56:41morphine
1:56:43within at this time it appears that
1:56:47people had fallen
1:56:48into a habit of signifying
1:56:52less frightening less threatening more
1:56:55patient acceptable
1:56:57as under the rubric of weaker
1:57:00or more frightening more
1:57:04less acceptable and
1:57:07less desirable under the rubric or word
1:57:10stronger but we knew
1:57:15that that the word weaker did not mean
1:57:19less potent we knew that the word
1:57:22stronger did not mean more potent
1:57:24and we knew that because by this time
1:57:27surely
1:57:28anybody who was using this product
1:57:32recognized it was more potent they knew
1:57:34it was more potent
1:57:36so it's very unfortunate for your
1:57:40understanding as well as
1:57:42anybody else's understanding that that
1:57:46all those issues of the stigma of
1:57:49morphine of the
1:57:50frightening nature of morphine of
1:57:52morphing being a cancer drug
1:57:55end-of-life drug it's a
1:57:58very unfortunate for your understanding
1:58:00and for
1:58:01most people's understanding that the
1:58:03word weaker and stronger was used
1:58:05but we understood what it meant we're
1:58:07not done reading it yet but let me ask
1:58:09you this
1:58:10you were advised by your senior
1:58:13uh employees that physicians perceive
1:58:18oxycontin controlled release
1:58:21as less strong than morphine
1:58:25many physicians perceived it that way
1:58:27correct
1:58:29words used but didn't mean that they
1:58:32believed it was less potent because i
1:58:34knew
1:58:35they believed it was more potent their
1:58:37own practice
1:58:38proved that they recognized it was more
1:58:42potent as i said before
1:58:43percocet was five milligrams
1:58:47did you do any studies yourself or
1:58:49conduct any investigation
1:58:51to determine what percentage of
1:58:53physicians
1:58:54believe that oxycontin controlled
1:58:57release
1:58:58was less powerful than morphine and one
1:59:01were not aware it was twice
1:59:02as strong as more you're talking about
1:59:04less potent yes
1:59:06i don't know of such studies but in
1:59:10common parlance and discussions with
1:59:12physicians
1:59:14if really a substantial if if any
1:59:17substantial number of them believed
1:59:20believed in the believed and had an
1:59:23erroneous belief excuse me
1:59:25if any held an erroneous belief
1:59:29and said to a representative
1:59:32oh this is this stuff is is less potent
1:59:36than morphine the salesman was
1:59:40had ample materials to
1:59:44demonstrate to the physician that he was
1:59:47in error
1:59:48and was instructed to use those and did
1:59:50use it
1:59:52and i wish we had a survey had done a
1:59:55survey to demonstrate it in retrospect
1:59:57but it was so generally the accepted
2:00:01that it was at least one and a half
2:00:03times more
2:00:04more potent by even the skeptics most
2:00:06skeptics and there weren't many
2:00:08but generally recognized to be twice as
2:00:11potent as morphine
2:00:13it just never occurred to us sure and
2:00:15it's your belief that your sales force
2:00:17was telling these physicians that
2:00:19it's actually twice as strong as
2:00:21morphine and correcting that
2:00:22misperception that they had
2:00:23absolutely it was in the package insert
2:00:26the promotion
2:00:27in the conversion tables and then the
2:00:29recommended dosing
2:00:31which so promotional pieces your
2:00:33symposiums your review articles your
2:00:35studies would all point that out
2:00:37i can't say that that everyone would
2:00:40point it out
2:00:41in every page but it should have been
2:00:44an important part of
2:00:48most promotional materials let's read
2:00:50the rest of michael collins
2:00:54email dated 6 297
2:00:58well after the launch of oxycontin
2:01:00paragraph 3 says
2:01:02since the non-cancer pain market is much
2:01:05greater than the cancer pain market
2:01:08it is important that we allow this
2:01:10product to be positioned where it
2:01:11currently
2:01:12is in the physician's mind
2:01:16if we stress the quote power of
2:01:18oxycontin end quote
2:01:20versus morphine it may help us in the
2:01:22smaller cancer pain market
2:01:24but hurt us in the larger larger
2:01:27potential non-cancer pain market
2:01:29some physicians may start positioning
2:01:31this product where morphine is used and
2:01:33wait until the pain is severe before
2:01:35using it
2:01:36marketing has decided
2:01:40that and by that they're talking about
2:01:41the marketing group correct marketing
2:01:42department yeah marketing department so
2:01:44it says marketing has decided that the
2:01:46effects of the phase 4 team
2:01:48should be predominantly focused on
2:01:51expanding oxycontin use for non-cancer
2:01:53pain
2:01:54and then if you look at the last
2:01:56paragraph it says
2:01:58it is important that we be careful not
2:02:02to change the perception of physicians
2:02:04toward oxycodone
2:02:05when developing promotional pieces
2:02:08symposia review articles studies etc
2:02:12and what they're talking about there is
2:02:14let's not clear up this misconception
2:02:16that physicians have
2:02:18that oxycontin is
2:02:22not as strong as in s cotton correct
2:02:26i object to the point of the question mr
2:02:27thompson you
2:02:29in reading this skipped over two
2:02:31sentences i ask that you go back and
2:02:33read this
2:02:34with the two sentences that you omitted
2:02:36the born beginning with the sales
2:02:38force can teach the oncologist
2:02:43oh sure our approach to cancer pain will
2:02:46be to get physicians to use it earlier
2:02:47instead of products such as percocet
2:02:49vicodin or tylenol iii the sales force
2:02:52can teach the oncologist
2:02:54the proper dose and titrate oxycontin to
2:02:56ensure
2:02:57that they stay with it as the pain
2:03:00increases
2:03:01now oncologists are the cancer pain
2:03:04doctors correct
2:03:05that doesn't say anything about all the
2:03:06non-malignant
2:03:08doctors all the doctors that treat
2:03:10non-malignant pain correct
2:03:12but they would be taught the same thing
2:03:14how to titrate because that was the
2:03:17that was in a sense the fundamental
2:03:20doctrine
2:03:21of treating pain with opioids
2:03:25start low and titrate
2:03:29and adjust the dose in other words
2:03:32upward
2:03:32well the whole purpose of this email is
2:03:35that you not teach the non-malignant
2:03:37pain physicians that oxycontin is
2:03:42twice as strong as morphine and let them
2:03:44continue with their perception that it's
2:03:46not
2:03:46correct no not correct well let's let's
2:03:50continue reading the rest of it then
2:03:52um
2:03:55last paragraph it is important that we
2:03:57be careful not to change the perception
2:03:59of physicians toward oxycodone when
2:04:01developing promotional pieces
2:04:03symposia review articles studies etc
2:04:07now am i correct that what he's saying
2:04:09in here is let's not clear up the
2:04:11misperception
2:04:12in any of our promotional pieces
2:04:14symposia review articles or studies
2:04:18don't change the personality
2:04:21don't change this to an end of life
2:04:25cancer drug to a drug that
2:04:28shouldn't be used except
2:04:32at the end of life when
2:04:35everything else has been exhausted that
2:04:37was the
2:04:38thrust i may just add something here
2:04:41there's a conflation within this which
2:04:44you wouldn't understand
2:04:46and that was when in the first paragraph
2:04:49which you read
2:04:50where he said that oncologists think it
2:04:54isn't as strong as
2:04:57ms cotton here the meaning that we
2:05:00understood certainly i understood and
2:05:02anybody who was involved
2:05:04was the cancer doctors
2:05:07who were using the drug were stopping
2:05:11at they had established a notional idea
2:05:15based on their past habit
2:05:17of using percocet that they shouldn't go
2:05:20above 40 to 60 milligrams a day
2:05:23of oxycodone and the reason they
2:05:26developed that habit
2:05:28that practice limit was
2:05:32not because of the oxycodone it was
2:05:35because of the tylenol
2:05:37which was the more toxic agent in that
2:05:40combination
2:05:42you're probably aware that recently the
2:05:45fda
2:05:47has recommended lowering the maximum
2:05:49daily tylenol dose
2:05:52from four grams a day to three
2:05:55and but even then four grams a day was
2:05:58recognized as being the
2:06:00then practical limit so oncologists who
2:06:04were
2:06:04using oxycodone as percocet
2:06:08were just in the habit well you're
2:06:10getting
2:06:1140 milligrams a day of oxycodone
2:06:14your pain is coming back rather than
2:06:16titrate those patients
2:06:18to a higher oxycontin level they said
2:06:21well we've got to switch to something
2:06:22else
2:06:23and that was really what was going
2:06:27on and in part why
2:06:30oncologists
2:06:33use of the product had not developed
2:06:36as well as we had wished that it would
2:06:39develop
2:06:40and that was understood and contained
2:06:44within this dialogue not all of it
2:06:46documented here yeah sure
2:06:48let's go back and talk about a little
2:06:49bit more then so in the first paragraph
2:06:51he says
2:06:52we've discussed the issue that oxycontin
2:06:54has perceived by some physicians
2:06:57particularly oncologists as not being as
2:06:59strong as them as cotton
2:07:00although this perception has had some
2:07:02effect with physicians switching to ms
2:07:04cotton with the morse evidence
2:07:05rare cancer pain it has
2:07:08actually had a positive effect with
2:07:11physicians use in non-cancer pain
2:07:15so what he's saying there if i'm reading
2:07:16this correctly is that
2:07:18because they think it is not as strong
2:07:22as ms cotton
2:07:24when they need a strong drug for cancer
2:07:26pain patients
2:07:27some of the physicians aren't switching
2:07:29to it because they don't think it's as
2:07:31strong and that may hurt cells a little
2:07:32bit there
2:07:33but with the non-cancer pain where you
2:07:36don't want as strong
2:07:37a drug as an end-of-life malignant
2:07:39cancer pain patient might need
2:07:42it's actually helping ourselves that
2:07:43they have this misperception because
2:07:45they are going ahead
2:07:47and prescribing it because they don't
2:07:48think it's as strong
2:07:50as ms cotton is that what that first
2:07:53paragraph is saying
2:07:55you're if that's what the words say
2:07:58but the meaning of strong here would be
2:08:01effective it is not as effective and the
2:08:04reason they thought it was not as
2:08:06effective is
2:08:07they had a mental notion of a limit
2:08:10and they didn't follow the doctrine
2:08:14of titrating increasing the dose
2:08:18when the pain is getting worse and
2:08:23all of this was was really known i mean
2:08:26by 1997 most of the
2:08:30people who disagreed and thought that
2:08:33oxycontin
2:08:34was not two to one they thought it was
2:08:37one and a half to one that was by far
2:08:39the most common
2:08:41objection still stronger than morphine
2:08:44but not
2:08:44quite as much stronger as we said it was
2:08:48they had been persuaded if they used the
2:08:50drug oh yes
2:08:52particularly those oncologists who
2:08:55switched from
2:08:56ms cotton to oxycontin so then he says
2:08:59since oxycodone is perceived as being
2:09:02weaker
2:09:02opioid than morphine
2:09:05it has resulted in oxycontin being used
2:09:08much earlier for non-cancer pain
2:09:11correct so he's saying more people are
2:09:13using it earlier for non-cancer pain
2:09:15because they think it's weaker not not
2:09:17less potent
2:09:21more acceptable to the patient not
2:09:24frightening
2:09:25not stigmatized as morphine unfairly was
2:09:29by history um
2:09:33that was the meaning and i've lost my
2:09:36thought here
2:09:37could you just repeat your question so i
2:09:39can finish my answer sure
2:09:40and what he's saying here is the
2:09:42non-cancer pain doctors
2:09:44which is the much bigger market share
2:09:46when you're trying to sell oxycontin
2:09:48is the non-malignant pain market it's
2:09:50actually helping cells there because
2:09:51they don't think it's as strong as
2:09:53morphine
2:09:53again as i've testified before
2:09:58the term stronger and weaker was it a
2:10:01very unfortunate term you want to use
2:10:03effective
2:10:05in the case of here effective
2:10:08yes in the case of cancer because they
2:10:12were using it let me explain one other
2:10:14thing
2:10:15um at the time that this
2:10:19product was introduced
2:10:22the world health organization had
2:10:25promulgated
2:10:26a stepladder approach to cancer pain
2:10:31and when oxycontin was introduced
2:10:34we properly with the agreement
2:10:38of the fda said that emma
2:10:41that oxycontin was appropriate for the
2:10:44second step
2:10:46and the third step that's where the
2:10:48start with and stay with
2:10:50theme came from um
2:10:55so uh i i
2:10:59i know that this could cause
2:11:02real confusion reading these documents
2:11:06if you're not involved day to day
2:11:09but there is no way that any of the
2:11:12people on these documents
2:11:13understood stronger to mean less
2:11:17more potent weaker to mean less potent
2:11:21we had never departed
2:11:24from a strong promotional theme
2:11:27that it was twice as strong as morphine
2:11:37yeah and then down at the bottom he says
2:11:40or let's take the middle paragraph since
2:11:43the non-cancer pain market
2:11:44is much greater than the cancer pain
2:11:46market is it important we allow this
2:11:48product to be positioned where it
2:11:50currently is in the physician's
2:11:52mind and that means let them believe
2:11:55that oxycontin
2:11:59controlled release is not as effective
2:12:01as morphine
2:12:02no i said the effectiveness really
2:12:05applied
2:12:06to the oncologists who were saying
2:12:10ah this isn't as effective all right you
2:12:12know i have to you know when the pain
2:12:14pain gets really bad i switch them
2:12:18to something else and that was the one
2:12:21place or the one circumstance in which
2:12:23we would have understood it as effective
2:12:25and i've explained that we believe that
2:12:27that was a consequence of them
2:12:30just having a mental limit sure he says
2:12:32if we stress the quote power of
2:12:34oxycontin
2:12:35end quote versus morphine and that is
2:12:39it may help us in the smaller cancer
2:12:41pain market that i mean let them know
2:12:43that it is more powerful than morphine
2:12:45that'll help in the
2:12:46smaller cancer pain market correct
2:12:50that's what he says yeah but hurt us in
2:12:53the larger
2:12:54potential non-cancer pain market some
2:12:57physicians
2:12:58physicians may start positioning this
2:13:00product where morphine is used
2:13:02and wait until pain is severe before
2:13:04using it nothing is coming back
2:13:06probably to the cancer market i'm not
2:13:08sure
2:13:09but and then we always said it was
2:13:13a powerful drug
2:13:17we implied that we didn't use the words
2:13:19because words
2:13:20can elicit a whole variety of responses
2:13:24and then the marketing department has
2:13:26decided that the efforts of the phase 4
2:13:28team should be predominantly
2:13:30focused on expanding oxycontin use for
2:13:32non-cancer pain
2:13:34right all right that's the that's the
2:13:36group that if you clear up the
2:13:37misperception
2:13:38may be less likely to prescribe
2:13:41according to what he's written here
2:13:42if you change the if you change the
2:13:45character of the drug in their mind
2:13:47if you tell them it's
2:13:50a cancer drug it's for end of life
2:13:54care yes you might change their
2:13:56perception
2:13:57we didn't believe that that was
2:13:59appropriate
2:14:01nor did the fda nor did the opinion
2:14:04leaders believe
2:14:05it was appropriate it truly was a drug
2:14:09that in appropriate doses could manage
2:14:13moderate and severe and extremely severe
2:14:16pain
2:14:19where patients needed an opioid
2:14:24to manage their pain it's important also
2:14:27that you
2:14:28understand that
2:14:31for a hundred years and even today there
2:14:35is
2:14:35no drug that is more effective
2:14:40or safer than opioids
2:14:44for treating pain over the long term
2:14:49and it was a shame that when
2:14:52that for for decades no opioid was used
2:14:58uh in many most
2:15:01perhaps overwhelming majority of
2:15:04patients
2:15:05who had severe pain do you think it
2:15:08might compromise patient care if purdue
2:15:11pharma allowed patients
2:15:15physicians to believe that the drug they
2:15:18are prescribing them
2:15:20is weaker than morphine
2:15:25could you just repeat the question i
2:15:27just want to get the
2:15:28do you think it might compromise patient
2:15:30care if purdue pharma
2:15:32was aware that many physicians felt like
2:15:37oxycontin was weaker than morphine
2:15:42and did nothing to clear up that
2:15:43misconception
2:15:46no if they believed it was less potent
2:15:49than morphine
2:15:50we clearly cleared up that misconception
2:15:54we told them it was twice as potent we
2:15:56told them
2:15:57to use doses that were considerably
2:16:00lower
2:16:01than the morphine doses that they might
2:16:03have been accustomed to
2:16:05what we didn't want to do is to
2:16:08turn this into a cancer drug right and
2:16:10this is 1997.
2:16:12that's good well after the launch well
2:16:13after your package insert has been
2:16:16put out and all that correct and you
2:16:19and michael cullen says it is important
2:16:22that we be careful
2:16:23not to change the perception of
2:16:25physicians toward oxycodone when
2:16:27developing promotional pieces symposia
2:16:29review articles
2:16:30studies etc correct is that what he
2:16:33wrote
2:16:35looks like that's what he wrote and you
2:16:38replied to him
2:16:40and did not say no we need to clear up
2:16:42this misconception immediately
2:16:43what you said is i think that you have
2:16:46this issue well in hand
2:16:48if there are developments please let me
2:16:50know
2:16:52that's what i said but the misconception
2:16:56that you're referring to didn't exist
2:16:59the misconception that this was a benign
2:17:03[Music]
2:17:05harmless weak drug
2:17:08for treating pain was not the perception
2:17:10that existed
2:17:12so that was not the error
2:17:15that he was i don't know quite what he
2:17:18let me just read what he said here
2:17:32where were you reading from please
2:17:35we've gone through this a number of
2:17:36times so where are we reading from here
2:17:39we were reading from you just read me
2:17:42something from
2:17:43from your top where you said i think
2:17:45okay
2:17:46but where you said i was responding
2:17:48where was that
2:17:51where he says it is important that we be
2:17:53careful not to change the perception of
2:17:55physicians toward
2:17:56oxycodone when developing promotional
2:17:58pieces symposia review articles or
2:18:00studies
2:18:00that's correct not change the character
2:18:03of the drug not change
2:18:05not change it into a frightening
2:18:08scary end-of-life drug
2:18:12all right let me hand you
2:18:13[Music]
2:18:15let's mark this as plants exhibit 13.
2:18:22this is an interoffice memo dated 19
2:18:2790 4.
2:18:33uh you gave me two copies
2:18:49and this is from michael friedman
2:18:53uh what was his role in 1994 he was head
2:18:56of marketing and sales
2:18:58and it's two two the three people he
2:19:01reported to
2:19:02and that's mortimer cycler raymond
2:19:03cycler and dr richard sackler who agreed
2:19:06yep and under discussion
2:19:12if you go to page four
2:19:25it says
2:19:28we believe that the fda will restrict
2:19:30our initial launch of oxycontin to the
2:19:33cancer pain market
2:19:35did you believe that at the time he may
2:19:37have believed it
2:19:38i didn't believe it however we also
2:19:41believe that physicians will perceive
2:19:43oxygen
2:19:43are you reading from which number next
2:19:45sentence 1.3
2:19:471.3 thank you however we also believe
2:19:50that physicians will perceive oxycontin
2:19:52as controlled release percocet without
2:19:56acetaminophen and expand its use now is
2:19:59oxycontin controlled release percocet
2:20:02without acetaminophen that would be one
2:20:05way of describing it
2:20:06because they're only two active
2:20:08ingredients
2:20:10acetaminophen and oxycodone
2:20:16uh is is oxycontin controlled release
2:20:18more powerful than percocet
2:20:22depends on the dose the initial dose at
2:20:2410 milligrams
2:20:26twice a day would be equivalent to the
2:20:29standard
2:20:30introductory dose of percocet four
2:20:33tablets
2:20:35one tablet four times a day in other
2:20:37words four
2:20:38so it would be the same dose when you
2:20:40all did studies did you find out
2:20:42that 10 milligrams of
2:20:46oxycontin
2:20:50had the same effect as a placebo and it
2:20:52was really only the 20 milligram that
2:20:53was effective
2:20:56i don't recall that but it's possible
2:21:04we do not want to position oxycontin in
2:21:07a way
2:21:08that will discourage physicians from
2:21:09using oxycontin for the chronic
2:21:11non-malignant pain
2:21:12okay especially where are you reading
2:21:14from again next paragraph
2:21:16okay i mean next sentence especially
2:21:18when we have studies available that
2:21:20demonstrate
2:21:21efficacy and safety for this indication
2:21:32okay do you know what your study showed
2:21:34about non-malignant
2:21:35chronic pain patients developing uh
2:21:40tolerance or dependency or withdrawal
2:21:42from oxycontin
2:21:46i i don't have them immediately in my
2:21:52mind
2:21:54um mark the spin marker correct
2:22:02time for another break yeah
2:22:2011 45 am
2:22:23we are back on the record at 11 57
2:22:34am
2:22:39um i'm going to hand you a document
2:22:44it is dated april 23 1997.
2:22:56and on the bottom of page one is an
2:22:58email you sent
2:23:00regarding san antonio
2:23:05and it says it's 422.97
2:23:10this is pdd1701801141
2:23:16and it's to looks like michael friedman
2:23:20michael i am somewhat surprised
2:23:23that 18 months into marketing
2:23:25significant groups of experts
2:23:27oncologists for example believe that
2:23:29oxycontin has a sealing effect
2:23:32what did you mean by sealing effect
2:23:37has a dose above which
2:23:41it would not be effective
2:23:46that was what i meant not be effective
2:23:50what materials could we pull together
2:23:52that would smash this critical
2:23:53misconception
2:23:55can we put together some approaches and
2:23:56test whether they would be potent
2:23:58weapons
2:23:59in this effort and he writes back
2:24:03and says to you
2:24:10there will always be misconceptions
2:24:11about drug substances for controlled
2:24:13release drugs many of these
2:24:15misconceptions are the result of
2:24:16residual attitudes associated with the
2:24:18immediate
2:24:19release forms
2:24:29i'll just read the whole thing for you
2:24:31for example morphine has a personality
2:24:33quote that was shaped when it was an iv
2:24:35drug oxycodone has a personality quote
2:24:38that was influenced by many years of
2:24:39oxycodone use in percocet we built a
2:24:42large part of our platform
2:24:43on this personality and it is to
2:24:45differentiate oxycontin from in
2:24:47wisconsin and duragesics
2:24:49this differentiation has led to much
2:24:52non-malignant business
2:24:55marketing is next paragraph marketing is
2:24:57not only about what you are it's about
2:24:59what you are not
2:25:00we have had success beyond our
2:25:02expectations that is
2:25:04in part due to the unique personality of
2:25:07oxycontin even as we seek to increase
2:25:09the use of the drug
2:25:10in higher doses we should be very
2:25:12careful
2:25:13as you know the strength of the drug
2:25:16is principally a barrier in malignant
2:25:19pain
2:25:21if we do not want to change the image in
2:25:23a way or
2:25:24i'm sorry we do not want to change the
2:25:26image
2:25:27in a way that will discourage
2:25:29non-malignant use
2:25:31a barrage would be ill-advised
2:25:35and you wrote back excellent points what
2:25:37about rifle shots
2:25:39is that correct that's correct that's
2:25:42what i wrote
2:25:44and over here on the before that
2:25:47there's a letter to you from james lane
2:25:52and he's pointing out that he sat in
2:25:54some oncology focus groups
2:25:57and
2:26:01what page is that it's page two
2:26:04the second second page of what you
2:26:06handed me
2:26:08oh jen yes okay
2:26:13it says um issues affecting the
2:26:20oncologist's
2:26:22utilization of oxycontin are md's feel
2:26:25the product dosing has a ceiling
2:26:28don't feel it is as strong as ms cotton
2:26:31like and are very comfortable with ms
2:26:33cotton and don't see a need for another
2:26:35product
2:26:35except where ms cotton fails
2:26:38interestingly when asked to describe
2:26:40what they like about oxycontin
2:26:42they are for the most part cited all the
2:26:44key points our reps are or should be
2:26:46stating in their sales presentation
2:26:52the anesthesiology focus group was of
2:26:55less
2:26:55saturday evening was of less value
2:26:57however their primary concerns were that
2:27:00medtronic pump being used by the
2:27:01orthopods and the need for purdue to
2:27:03educate surgeons on proper post surgery
2:27:05pain management
2:27:06and fears with opioid prescribing
2:27:10is that the email that prompted you to
2:27:12write the letter it might be i don't
2:27:14recall
2:27:15i'm sorry i want you to write your email
2:27:20it could be well we mark that as exhibit
2:27:2814.
2:27:42two
2:27:47but i'm not sure it could have been
2:27:49there could be another email
2:27:51in which i pointed out
2:27:54the lack of
2:27:58sales development with oncologists as
2:28:01compared to our plan
2:28:02so i'm not sure that this is but it
2:28:06would have been around the same time
2:28:07perhaps
2:28:08maybe i looked at the results with
2:28:11oncologists
2:28:13after i've read this
2:28:31oh my god i'm nice about this so this is
2:28:35the 1993 that's ready in evidence
2:28:40either exhibit two or three
2:28:44it's the may 1993 memorandum
2:28:59here we go all right are we finished
2:29:02with this
2:29:02yes sir put it on the pile
2:29:08i want to go back to the may 1993
2:29:11memorandum
2:29:14and this is the july 92.
2:29:18what exhibit number are we talking about
2:29:21let me
2:29:22can i see what you said let me just
2:29:25clear this up
2:29:27yeah it's not enough yet
2:29:31that's it okay april 2nd 1993.
2:29:41all right let's um i'm sorry i'm going
2:29:44to let's
2:29:44let's jump to the april 2nd 1993
2:29:49memorandum
2:29:50let's mark this as cycler 15.
2:30:07what is pfrc at the top of this
2:30:11purdue frederick research center and
2:30:14it's the r
2:30:14d meeting r d
2:30:18meeting and it is dated april 2nd 1993
2:30:23correct that's what it says
2:30:28[Applause]
2:30:30and the part i wanted to ask you about
2:30:32if you go back to
2:30:33page 10.
2:30:49and you were in attendance at this
2:30:51meeting correct
2:30:52uh i don't let me check that i certainly
2:30:55don't recollect
2:30:58by date rs yes that was me
2:31:02all right so on page 10
2:31:06it looks like you're discussing an
2:31:08osteoarthritis study that was made
2:31:10okay we're on page 10. i am on the
2:31:14third paragraph okay i'm sorry fourth
2:31:16paragraph
2:31:17this says page 10 but it doesn't look
2:31:19like what you have here
2:31:22okay yes it
2:31:26is it yeah okay so read along with me
2:31:29uh the section over here rr do you know
2:31:32who rr
2:31:33is robert reader okay what was his job
2:31:36at that time
2:31:36he was a senior medical researcher
2:31:42he says here in this paragraph the
2:31:44protocol for the placebo
2:31:46controlled study versus two dose levels
2:31:49in patients with osteoarthritis was
2:31:51discussed with
2:31:52see right now would that be curtis right
2:31:55that's that's but i would understand
2:31:57and at that time he was the person who
2:32:00was reviewing your all's oxycontin
2:32:03submission to the fda he was the medical
2:32:05reviewer that's correct
2:32:06and he's the guy that actually approved
2:32:08it to be sold uh or
2:32:10you know allow you all to sell it from
2:32:11the fda that's my recollection okay
2:32:13you all ultimately hired him a few years
2:32:16later didn't you
2:32:17um we did hire him but not
2:32:22after his tenure at the fda
2:32:26um we
2:32:30he spoke to somebody at purdue when he
2:32:32was planning on leaving the fda
2:32:35and paul and i discussed it and agreed
2:32:39that we should not hire somebody who j
2:32:42who had reviewed our product and who
2:32:45left and so he went to another company
2:32:50regrettably for us because he was
2:32:54very very knowledgeable sure he wasn't
2:32:56smart he went there for a short period
2:32:58of time and then came to work for you
2:32:59i don't know remember it was certainly
2:33:03it was certainly my recollection is a
2:33:07couple of years two or three years but i
2:33:09don't recall exactly
2:33:11the record i'm certain could be produced
2:33:14all right well let's let's take a look
2:33:16at page 10
2:33:18the protocol for the placebo controlled
2:33:20study versus two dose levels in patients
2:33:22with arthrostilloarthritis was discussed
2:33:24with c
2:33:24right he stated there were very strong
2:33:27opinions
2:33:28of members at the fda that opiates
2:33:30should not be used for non-malignant
2:33:33pain
2:33:34and this study let me just follow you if
2:33:37i may
2:33:37i'm a slow reader i'm sorry but i just
2:33:40do want to follow you
2:33:41great i'll read it again okay he stated
2:33:44there were very strong opinions of
2:33:46members at the fda that opiates
2:33:48should not be used for non-malignant
2:33:49pain and this study would not be greatly
2:33:52accepted by the fda
2:33:54as it is written now for that reason
2:33:57c wright has suggested rewriting the
2:34:00protocol in order to make it clear
2:34:02osteoarthritis is being used as a
2:34:04convenient pain model
2:34:06he would also like to the open label
2:34:09extension to be
2:34:11eliminated from the protocol now
2:34:14what do you refer to as the open label
2:34:16extension
2:34:18in many trials of chronic use
2:34:21drugs after the
2:34:26trial period which might have been 12
2:34:29weeks
2:34:30was completed the subjects in the trial
2:34:34were given an option to continue
2:34:37being treated and monitored by their
2:34:40physician
2:34:41it's completely at their election or
2:34:44choice
2:34:45they they some decide that they want to
2:34:48some decide that they don't and
2:34:52we continue them on medication for an
2:34:54extended period of time
2:34:56this is extremely common in in all kinds
2:34:58of trials
2:35:01p golden heim stated the open label
2:35:03extension could be done
2:35:04as a post-marketing study b caico
2:35:08and our reader will meet with p
2:35:10lockature to communicate what is
2:35:12necessary to revise the protocol
2:35:15the protocol must be clear that we are
2:35:17not going for a general indication for
2:35:20the treatment
2:35:21of osteoarthritis with ost with
2:35:25and then down below that
2:35:29it says dr richard sackler asked if
2:35:31there was consensus within the pain
2:35:33group about the appropriate use of
2:35:35opiates for certain patient
2:35:37groups b caico stated this
2:35:40is very a very controversial area
2:35:44and most people in the pain group say
2:35:46that well-controlled studies are
2:35:48necessary
2:35:49to investigate the questions
2:35:52dr sackler next paragraph says dr
2:35:55sackler has suggested a smaller group
2:35:57meet in-house to clarify the political
2:36:01issues
2:36:01what were the political issues the
2:36:04political issues
2:36:05would have referred to the
2:36:11preferences and the
2:36:15sometimes prejudices of
2:36:18physicians and other experts
2:36:26over whether you should prescribe
2:36:29opioids for non-malignant pain
2:36:32and for what conditions in non-malignant
2:36:35i don't think there were very many
2:36:37people or any people really
2:36:39of any reputation who would have
2:36:41proscribed that has prohibited
2:36:43the use of opioids for non-malignant
2:36:45pain
2:36:47but there were a lot of
2:36:52opinions when it came to listing
2:36:55one condition or another or another
2:36:58or another pain is the most common
2:37:03symptom that patients have
2:37:06and and present to doctors and so
2:37:09every doctor has his own opinion
2:37:13as to what is a pro what is
2:37:16best and what is appropriate for
2:37:18treating pain
2:37:20or in some cases
2:37:25what pains are not appropriate to be
2:37:27treated
2:37:28at all and this is a highly
2:37:32um highly personal and contentious issue
2:37:37in the medical
2:37:38world and has been so for 100 years
2:37:42and that's the reason that morphine was
2:37:45stigmatized
2:37:46and not prescribed generally for
2:37:50non-malignant pain
2:37:51it was more reserved by physicians for
2:37:54end-of-life hospice care
2:37:55and cancer pain
2:37:59in the medical community i
2:38:02don't understand the connection you're
2:38:05drawing
2:38:07um
2:38:10i think the situation with morphine is
2:38:13unique
2:38:15[Music]
2:38:16and it doesn't relate to what we're
2:38:21talking about here
2:38:25what about heroin was it prescribed for
2:38:28uh for pain pain
2:38:32um it is prescribed for pain in many
2:38:34countries
2:38:35and is part of the pharmaco
2:38:39pharmacopoeia for example it is very
2:38:41popular in the uk
2:38:43is it controlled it is just like
2:38:46morphine for into life pain mostly
2:38:48i can't tell you that because i don't
2:38:50know but it is
2:38:51it's i don't believe that
2:38:56it established itself as an analgesic
2:39:00in the united states at any time even
2:39:02when it was
2:39:04wasn't analgesic and
2:39:07was available i want to hand you
2:39:11a memo are we finished with this
2:39:14yes we are
2:39:23hand you a memo dated
2:39:29project team meeting minutes of tuesday
2:39:32august 17
2:39:361993
2:39:49it says here under marketing there's
2:39:51some initial interest in having a 5
2:39:53milligram and 10 milligram
2:39:55immediate release oxycodone camp capsule
2:39:58produced
2:40:01do you know why marketing wanted those
2:40:04produced
2:40:08i i could i could guess
2:40:11but i don't know specifically why they
2:40:14wanted it
2:40:15well if you don't mind turn back to page
2:40:18four
2:40:24and on page four
2:40:27what i really want to ask you about is
2:40:29potential studies
2:40:31okay and
2:40:35mike in a rotto is the guy we mentioned
2:40:38earlier who was in
2:40:40yes in the marketing department yes yes
2:40:44and he's the guy in charge of
2:40:47perhaps the sales force that goes out
2:40:49and tries to sell
2:40:51no he would be in charge of
2:40:54the marketing execution
2:40:58of the strategy so he would be
2:41:01intimately involved with
2:41:05the promotional materials
2:41:08secondarily involved with training
2:41:12and would be the person
2:41:16who would um set the direction and
2:41:20themes
2:41:21that would be used but he wouldn't be a
2:41:23person who would
2:41:25uh be responsible for sales although he
2:41:28might
2:41:28go out in the field and he should to
2:41:31determine
2:41:32what is happening let me rephrase it
2:41:34then as part of marketing
2:41:36he's the guy who is supposed to get the
2:41:39word out
2:41:40and hopefully increase
2:41:44sales by advertising the product
2:41:47and convincing people to write
2:41:48prescriptions uh
2:41:50not directly the sales people were the
2:41:53principal
2:41:56agents of getting the word out to use
2:41:59your expression
2:42:00of putting the materials in the hands of
2:42:04doctors etc
2:42:05i don't recollect that advertising
2:42:08ever played much of a role in the
2:42:11promotion of oxycontin
2:42:13let's talk about if you look at 4.3
2:42:16potential studies
2:42:21mike i'm going to read that paragraph
2:42:23mike in eroto
2:42:24said that an oxycontin versus percocet
2:42:27comparative
2:42:28study okay potent oh you weren't reading
2:42:32okay from potential studies okay
2:42:34i'm sorry this is so small it's not so
2:42:36easy but mike in eroto
2:42:38and unfortunately that's the way purdue
2:42:40gave it to us so
2:42:42we're stuck with it too potential
2:42:44studies mike enerato
2:42:45said that an oxycontin versus percocet
2:42:48comparative study
2:42:49would be useful for marketing purposes
2:42:52now in trying to decide whether the drug
2:42:55is safe
2:42:58is it normal to have the marketing
2:42:59people decide what studies will be done
2:43:09they might be involved in commenting on
2:43:12it or suggesting things but
2:43:14normally
2:43:17it's the medical department that has the
2:43:19primary responsibility
2:43:22both for the medical research strategy
2:43:25and the
2:43:26and certainly the implementation through
2:43:29such a study i'm going to read the next
2:43:30sentence through such a study
2:43:32oc 881105 has previously been
2:43:35conducted and published in abstract form
2:43:38it was a single dose study using non-gmp
2:43:42released material
2:43:44mike and arato stated that a multibolder
2:43:46study would be best to support claims
2:43:49relating to relief of post-surgical pain
2:43:53low back pain and herpetic neuralgia
2:43:55pain
2:44:00from my review of that it looks like
2:44:01he's got claims he wants to make and is
2:44:03trying to design
2:44:04studies to support him is that what that
2:44:06appears to you
2:44:07no um he
2:44:11half yes half no what i think he is
2:44:14doing here
2:44:15in the general is he is
2:44:19in a group meeting presenting ideas for
2:44:23consideration by the group
2:44:25uh certainly the this was not directive
2:44:28and he was not in a position to direct
2:44:30any studies be done
2:44:32or not done then the next sentence says
2:44:35mike enrado stated marketing would like
2:44:38to position differently than ms cotton
2:44:41robert reader was robert reader he was
2:44:44the senior medical officer in this
2:44:48in this minute of the meeting um let me
2:44:52just read
2:44:52catch up to you and i said well he does
2:44:54tell you this to support coin
2:44:57robert reader stated that the fda has
2:44:59suggested that we do not
2:45:01issue claims supporting the general use
2:45:03of a schedule ii
2:45:04opioid in patients with non-malignant
2:45:07pain
2:45:08robert reeder indicated that decisions
2:45:10to make additional claims
2:45:12could be developed after the product is
2:45:14marketed
2:45:15jim conover agreed with robert reader
2:45:17but added that any study conducted in
2:45:19patient with non-malignant pain
2:45:20could be included in the clinical
2:45:22studies section of the package
2:45:23insert robert reader added that
2:45:28any proposed marketing claims and their
2:45:30supported studies
2:45:31should be first reviewed with our legal
2:45:33and regulatory departments
2:45:35perhaps the marketing concepts could be
2:45:37reviewed now
2:45:39robert reader stated that the marketing
2:45:41could start thinking of a five-year plan
2:45:43on potential marketing studies and
2:45:45strategies
2:45:46did i read that correctly you do
2:46:08so
2:46:23um
2:46:33and then you have another this one here
2:46:50um i'm going to hand you
2:46:54we're finished with this yes sir
2:46:56[Applause]
2:46:59exhibit 17.
2:47:13yeah if i haven't done it i'm going to
2:47:15move it
2:47:16emit all these into evidence as
2:47:191-16 and 17.
2:47:28and this is a appears to be a
2:47:34speech you gave is that what this is or
2:47:36a publication you made
2:47:40this looks like it was a news
2:47:42[Music]
2:47:44paper or magazine like um internal
2:47:48document
2:47:49for the field force principally
2:47:53i think it was basically the field force
2:47:57and and and in-house marketing and sales
2:47:59people
2:48:00who would like to see their picture
2:48:02there or be quoted or
2:48:03whatever and it's the winner of 1996.
2:48:07is that right that's correct
2:48:20and if you'll turn to page eight
2:48:23for me please
2:48:33i'm sorry i'm gonna spot page two please
2:48:45uh over on the third column
2:48:48yes uh halfway down it says the
2:48:50development and launching of oxycontin
2:48:52tablets
2:48:54is the first time that we have chosen to
2:48:56obsolete our own product
2:48:58and we've done it before the competition
2:49:00has slowed our growth
2:49:02or of sales and you were referring to
2:49:05ms cotton that you obsoleted is that
2:49:07correct that's correct
2:49:11and then at the bottom it says we have
2:49:14the most powerful selling package
2:49:16insert in the category and in the
2:49:20industry
2:49:21and is that accurate i'm trying to see
2:49:23where it is
2:49:25we have is which
2:49:28paragraph and that very last paragraph
2:49:31we have the most powerful selling
2:49:33package right
2:49:34right yes okay that is
2:49:38if you'll turn to page
2:49:55it says uh speech at the top continued
2:49:58from page two
2:50:00so i'm assuming this is a speech you
2:50:01gave i may be but i don't know we'll see
2:50:05oxycontin was brought to nda um
2:50:10what's nda two nda
2:50:14filing that's the filing of the new drug
2:50:15application right
2:50:17uh from early phase one work on time
2:50:20and in an incredibly compressed period
2:50:23of two years time
2:50:25that's because an nda usually takes
2:50:26longer correct
2:50:28well um
2:50:32and let me just preface it with the
2:50:34reason it takes longer is because
2:50:36there's a number of studies that have to
2:50:38be done
2:50:40both animal and human to determine if a
2:50:43drug
2:50:43is safe and efficacious correct right
2:50:47in general that's correct but in this
2:50:50case
2:50:51you all got it done in an incredibly
2:50:53compressed period of time of two years
2:50:56robert reader set the goal in november
2:50:58of 93 to file by december 31
2:51:0095 and we submitted on december 28 95
2:51:03three days ahead of schedule
2:51:05this didn't quote just happen it was a
2:51:08deftly
2:51:09coordinated planned event that took
2:51:11dozens of worker years
2:51:13of effort to succeed true the most
2:51:16demanding nda package
2:51:18for any analgesic product ever submitted
2:51:20didn't languish at the agency
2:51:22unlike the years that other filings
2:51:25linger at fda
2:51:27this product was approved in 11 months
2:51:2914 days our previous best approval time
2:51:31for other products was measured in years
2:51:33not months
2:51:35much can be attributed to the
2:51:37unparalleled teamwork of the product
2:51:38team and the fda's approval team which
2:51:40came
2:51:41into being as responsive our joint
2:51:43desires to operate
2:51:46within the context of a new time frame
2:51:50both we in the pilot doug division of
2:51:51fda were motivated by the same goal to
2:51:53set the highest standard nda with the
2:51:55broadest app
2:51:56indications approved in the shortest
2:51:58possible time
2:51:59frame did i read that correctly you did
2:52:06did you have any questions about that
2:52:08nope i just wanted to
2:52:10know if that was the statement you got
2:52:11and is it accurate
2:52:13this was a
2:52:17i believe it is accurate i'm certain
2:52:19that the facts
2:52:20in there were accurate the tone
2:52:23was very upbeat
2:52:27almost a
2:52:31team enthusiasm building
2:52:34expression i believe the facts are
2:52:37correct
2:52:39and i perhaps i don't regret
2:52:43trying to energize our sales force i
2:52:45think that was
2:52:46my mission but um this isn't what
2:52:50i would have written if a board had been
2:52:56or said if the board had been there i
2:52:58wouldn't have been
2:53:02the tone would have been more restrained
2:53:10not embarrassed by the tone in the
2:53:11context i think it was
2:53:13very reasonable
2:53:17do you have any questions about the
2:53:20reason it was so quick or
2:53:22anything else no
2:53:25we got a lot of documents to get through
2:53:26so i'm trying to hit the whole point
2:53:29okay
2:53:37one of the things that they wrote you um
2:53:40do you have the other pages of this
2:53:48when you got your approval
2:54:04um
2:54:26if you'll look at the last page on
2:54:29overall conclusion
2:54:30and this is a document from the medical
2:54:34officer review curtis wright
2:54:39this is part of the approval part of the
2:54:42fda approval
2:54:43process he's the guy that now works for
2:54:45purdue pharma correct
2:54:47no no he hasn't worked for purdue pharma
2:54:49for a long time okay
2:54:50he was regrettably but hired by purdue
2:54:53pharma subsequently correct
2:54:55he was hired by purdue pharma
2:54:59in his last maybe three years after this
2:55:02i don't recall exactly
2:55:05and
2:55:09why don't we go ahead and mark this as
2:55:11exhibit 18.
2:55:23his overall conclusion on the last page
2:55:26is
2:55:28cr oxycodone that's controlled release
2:55:30correct
2:55:31yes appears to be a bid
2:55:34alternative to conventional qid
2:55:37oxycodone
2:55:39and um approval
2:55:42is recommended care should be taken to
2:55:45limit
2:55:46competitive promotion what is
2:55:47competitive promotion
2:55:50i'm not sure what he meant i could guess
2:55:54that he means promotion
2:55:57comparing this to other agents
2:56:00that are used in various pain conditions
2:56:03but that's a guess
2:56:05and then i think the next sentence
2:56:06explains it he says the product has been
2:56:08shown to be as good
2:56:10as current therapy but has not been
2:56:13shown to have a significant
2:56:14advantage beyond reduction in frequency
2:56:17of dosing
2:56:19so other than you don't have to take it
2:56:20as much
2:56:22the fda has concluded that that there's
2:56:25no benefit
2:56:27other than uh it's not been shown to
2:56:30have a significant advantage beyond
2:56:32reduction in frequency of dosing
2:56:34that's been shown in the nda yes
2:56:38let's um
2:56:44probably announcing lunch probably so
2:56:47let's go off the record
2:56:49we are off the record at 12 32 p.m
2:56:53we are back on the record at 12 32 pm
2:56:58do you have this one
2:57:02march 22nd
2:57:19i need another pair of glasses yeah
2:57:22march 22nd
2:57:32something stronger i may have stronger
2:57:35ones you know
2:57:37some of these documents are so difficult
2:57:39to read yeah they're difficult
2:57:54this is the oxycontin project team memo
2:57:58do you know if you ever reviewed this
2:58:02memo
2:58:04i wasn't on the project team i don't
2:58:06know if i reviewed it
2:58:09was it i'm curious just i could read
2:58:12through this
2:58:12was it sent to me or not i don't know if
2:58:15it was or not
2:58:16looks like it was not i was not on the
2:58:18circulation list
2:58:22well the this list down here is
2:58:25yeah there's a circulation list
2:58:29it appears that it was not
2:58:38and
2:58:42if you would go over to page four
2:58:54the last paragraph down at the bottom
2:58:57six point two
2:58:58mike innerotto asked if marketing would
2:59:01be able to review the package insert
2:59:04do you have any idea why marketing
2:59:06wanted to review the package insert
2:59:09surely there are many reasons
2:59:14robert reader stated the package insert
2:59:15will be circulated to marketing
2:59:18and other reviewers at the same time as
2:59:19the protocol review
2:59:24as i said earlier the package insert
2:59:28was becoming originally 20 years
2:59:32prior to this package inserts were very
2:59:35very brief
2:59:36and very simple over time
2:59:39the agency
2:59:43wanted them to be
2:59:46more complete documents and then
2:59:51it had regulatory implications as well
2:59:56so if you look of the history of use of
2:59:59package inserts
3:00:00they by this time had become
3:00:04fairly long and extensive documentation
3:00:07for the physician their notion of
3:00:10being printed in that tiny format
3:00:14[Music]
3:00:15and stuck with every package in a sense
3:00:19was inconsistent so you ended up
3:00:22sometimes having this
3:00:23package insert that was as big as the
3:00:25bottle adhered to every bottle
3:00:28but it was available to physicians in a
3:00:32variety of other forms
3:00:35the physician's desk reference i think
3:00:38you must be familiar with
3:00:40which was the way most physicians then
3:00:42would read a package insert it was just
3:00:44a compilation of all the approved
3:00:46products
3:00:46package inserts what is marketing going
3:00:48to add to that
3:00:50first of all i have to understand what
3:00:52the package insert is going to say about
3:00:54the product
3:00:55so that they can think of
3:00:58how they're going to present promotional
3:01:01materials
3:01:02secondarily they might if the package
3:01:05insert
3:01:06is in draft form and under discussion
3:01:08with the agency
3:01:11turn to the responsible medical officer
3:01:14as an example
3:01:15or the regulatory people and say you
3:01:18know this could be misunderstood
3:01:21this could represent a problem
3:01:25and so they would contribute to the
3:01:27clarity but
3:01:28the medical department was and
3:01:32regulatory department were the principal
3:01:34owners
3:01:35of the document in the company
3:01:38and the owner of the document for the
3:01:40government was the food and drug
3:01:42administration
3:01:43and of course they had determinative
3:01:45power
3:01:46as to what it what it ultimately ended
3:01:49up as
3:01:50sure you'll turn to page five
3:01:54under 7.0 marketing
3:02:00yes
3:02:02it says post-marketing studies qql
3:02:06pharmacoeconomic persic percocet
3:02:09duragizic
3:02:11robert reader discussed some of the
3:02:12planned post-marketing studies these
3:02:14included an oxycontin versus ms cotton
3:02:16comparative study
3:02:18the duragesic comparative study which is
3:02:19currently on hold
3:02:21and a relative potency study comparing
3:02:24oxycon to ms cotton
3:02:27robert reader stated that we would need
3:02:29additional studies to recruit
3:02:31several hundred patients in order to get
3:02:33data to support claims for non-cancer
3:02:35pain
3:02:37this was on march of 1994 do you know if
3:02:40that
3:02:41if those studies were done i'm sure they
3:02:43were done
3:02:45after approval
3:02:48but i don't know whether any were done
3:02:50before approval
3:02:52do you know if they were done before the
3:02:54drug was put on the mark
3:02:57don't know okay who is robert reader
3:03:01he was the senior medical officer
3:03:04on this project at purdue frederick
3:03:10and then it says mike enrado again he's
3:03:12the marketing guy correct right
3:03:14stated that a percocet comparative study
3:03:17would be a benefit to marketing
3:03:19mike in eroto replied to bob keiko's
3:03:21question on claims by answering that
3:03:23equal efficacy of oxycontin to percocet
3:03:26with better quality of life
3:03:28would be a beneficial claim mike inurado
3:03:31stated in the future tramadol would pose
3:03:33a threat
3:03:33to the oxycontin market
3:03:37and then down below that it says 7.2
3:03:40marketing claim
3:03:41studies desired mike enrado gave a
3:03:44presentation on the results from the
3:03:46focus groups
3:03:47a copy of the market research results
3:03:50would be issued to the oxycontin team
3:03:53the results of the focus groups are
3:03:55attached the results cover
3:03:56issues such as benefits positioning and
3:03:59claims
3:04:01do you know whether the studies
3:04:03recommended by robert reeder
3:04:04were done before it went to market or
3:04:07the studies requested by the marketing
3:04:09guy were done before it went to market
3:04:10i don't know
3:04:56then there is a if you go to page
3:05:00the very last page i guess it is
3:05:08oxycontin presentation 322.94 up at the
3:05:11top
3:05:12just a second oxycontin
3:05:16presentation i see it and it says
3:05:19down at the bottom
3:05:23it's got all the list of
3:05:32um
3:05:37oxycontin will be positioned as the only
3:05:40opioid
3:05:41combining the efficacy and safety of
3:05:43oxycodone
3:05:44with the convenience of a 12-hour
3:05:46schedule which allows for precise and
3:05:48accurate conversion and titration
3:05:51while allowing the patient to could lead
3:05:52a more normal quality of life
3:05:54oxycontin is the opiate to start with
3:05:57for patients who may be on percocet
3:05:59lower taberviken
3:06:00and the opiate to stay with as the
3:06:02disease progresses
3:06:03now that was a marketing campaign
3:06:05correct to start with stay with
3:06:08yes and and start with stay with
3:06:10campaign do you know who came up with
3:06:11the start with stay with
3:06:12marketing campaign i wish i could lay
3:06:14claim to it
3:06:16but no i don't know who who came up with
3:06:19it
3:06:20and then it says
3:06:27that was not the launch campaign
3:06:30in a sense it may have been a subtext of
3:06:33the launch campaign
3:06:35which was the old way in the new way
3:06:42but
3:06:45it says uh very at the bottom less
3:06:48potential abuse than other opioids
3:06:51do you know where that claim came from
3:06:56i don't know i'm looking at is this
3:06:59after the package insert
3:07:01no no no before the package insert was
3:07:05approved
3:07:06i don't know
3:07:11do you know whether oxycontin had less
3:07:13potential abuse than other opioids
3:07:20i don't know what this
3:07:24refers to
3:07:27do you have this one
3:07:52oh do we mark that one we did not yeah
3:07:55let's mark that as 19
3:08:00minute into evidence and here is this
3:08:02one
3:08:05this is pdd-9520821306
3:08:11this appears to be the do you want to
3:08:13mark it
3:08:14yes let's do that
3:08:20now it's 20. are you keeping these
3:08:23yes okay it's number 20. oxycontin
3:08:26tablets project team
3:08:32okay and
3:08:35this is june 22nd 1994
3:08:39correct that's what it says and on page
3:08:42two marketing
3:08:44it says oh wait wait i see june 8 not
3:08:47june 22nd
3:08:51oh the date it sent is june 22nd over on
3:08:53the right whoops
3:08:54oh okay my my mistake okay so
3:08:58the project team meetings from june 8th
3:09:00you're correct
3:09:01on page 2 under 1.0 marketing
3:09:06[Applause]
3:09:11under the oxycontin tablets project team
3:09:14meeting minutes mike inuratu
3:09:18gave an overview of the oxycodone market
3:09:21referring to sales and growth charts and
3:09:23prescription data
3:09:25mr inuratu also presented our current
3:09:28strategy for
3:09:29introducing oxycontin tablets to the
3:09:31market
3:09:33oxycontin tablets will be targeted at
3:09:35the cancer pain
3:09:37market was a decision subsequently
3:09:41made not to target uh specifically at
3:09:44the cancer pain marsh
3:09:46market i would infer that but i don't
3:09:48know when
3:09:52but at least by june 8 of 94 the plan
3:09:54was still
3:09:55to target the cancer pain market
3:10:00yes uh it doesn't say that
3:10:04however that we
3:10:07let me just read this again
3:10:12will be targeted at the cancer pain
3:10:15market it doesn't say
3:10:16that it will not be promoted to
3:10:20the non-malignant pain market
3:10:24okay it says oxycontin uh
3:10:28oxycontin way target at the cancer pain
3:10:30market
3:10:31since it is possible that morphine
3:10:33generic products may soon be in
3:10:34competition with ms cotton tablets
3:10:37we will target patients who are
3:10:39currently receiving ms cotton
3:10:42as well as those patients thought to
3:10:44eventually
3:10:45use ms cotton tablets i.e on the
3:10:48analgesic ladder
3:10:49late step one step two and step three
3:10:52the bulk of opiate business comes from 7
3:10:55500 physicians 3 000 of whom are
3:10:57oncologists
3:11:01that's correct so you all had market
3:11:05share from ms cotton
3:11:07correct yes and in order to keep from
3:11:10losing that
3:11:11market share to generics who are going
3:11:14to be priced much lower than ms cotton
3:11:16uh generally correct that was the trend
3:11:19at that time yes
3:11:22what you did is put out oxycontin
3:11:27and obsoleted ms cotton and if you could
3:11:31keep the ms cotton market
3:11:32through the use of oxycontin you
3:11:34wouldn't lose any market share
3:11:36there and if you could expand it to
3:11:38non-malignant pain
3:11:39you would gain all of that market share
3:11:41correct well i object to the formula
3:11:43question
3:11:44at the minimum it's compound sure go
3:11:46ahead you can answer
3:11:49so could you just break it into two
3:11:51questions and i'll answer them both
3:11:53uh can you read the question back and
3:11:56stop after one
3:12:00what you did was put oxycontin and
3:12:02obsoleted ms cotton and if you could
3:12:05keep the ms cotton market through
3:12:07the use of oxycontin you wouldn't lose
3:12:09any market share there
3:12:10okay and that's what this seems to say
3:12:14and certainly that was an
3:12:17element of consideration and part of the
3:12:20strategy
3:12:21what i think might be missing here is
3:12:24any discussion of the non-malignant pain
3:12:26market
3:12:27which you asked me a question could you
3:12:29read question two
3:12:37and if you could expand it to the
3:12:38non-malignant pain you would gain all of
3:12:40that market share correct
3:12:42we would not no we would not gain all of
3:12:45the non-malignant pain market share
3:12:47but we could augment or add to the
3:12:50cancer
3:12:51pain market non-malignant pain
3:12:54and i'm quite surprised actually that
3:12:58this
3:12:58didn't discuss non-malignant pain as
3:13:01late as june 8th
3:13:04so for whatever reason the
3:13:07either mr anderado or the person who was
3:13:11writing the minutes didn't seem to
3:13:15include that because i don't think
3:13:19not to my recollection was there ever
3:13:21consideration of restricting this
3:13:24product to malignant pain alone it was
3:13:28widely used percoden
3:13:31percocet were widely used in
3:13:33non-malignant pain
3:13:35down below that it says marketing has
3:13:37been interviewing potential advertising
3:13:39groups and is close to selecting one do
3:13:41you know which advertising group was
3:13:43ultimately selected
3:13:44i don't know but i'm sure you we could
3:13:46find out if that were important
3:13:48and then under publications right below
3:13:50that
3:13:51manuscripts for studies c900
3:13:57and oc-93-0101 have been sent to dr
3:14:01stansky and mandema for review as
3:14:04potential authors
3:14:06why was
3:14:09purdue sending out
3:14:13manuscripts to doctors to be potential
3:14:16authors
3:14:17i can't say for sure
3:14:20but two possibilities arise
3:14:24in my mind one possibility is that the
3:14:27manuscript
3:14:29had come to us in draft form and we had
3:14:33helped them fill in details such as
3:14:36the references and so forth that was
3:14:39one of the ways that companies help
3:14:42authors lighten the burden so to speak
3:14:46of writing a paper
3:14:48the second possibility is the first
3:14:50draft might have been written in-house
3:14:52and sent to them
3:14:54for their review and their correction
3:14:56and additions
3:14:58well it says as potential authors it
3:15:01would appear that they authored the
3:15:02manuscript even though it really came
3:15:04from purdue correct
3:15:06objection it's a collaborative effort
3:15:10it's we can't we don't
3:15:15impose on any author what they submit
3:15:19what they submit for publication
3:15:22is submitted from them by them and
3:15:24totally
3:15:27in their control
3:15:29[Music]
3:15:30do you know if dr stansky and mandema
3:15:33were paid
3:15:34by purdue i don't know
3:15:37do you know whether these manuscripts
3:15:41ultimately identified purdue pharma as
3:15:45being
3:15:46any part of the author i don't know
3:15:50but it was not infrequent that employees
3:15:52of purdue pharma would be co-authors
3:15:55on manuscripts i don't know whether in
3:15:57this case they were
3:16:00and then if you'll turn over to page
3:16:01four of this document
3:16:16it says clinical status of core clinical
3:16:19program
3:16:20robert reeder now he's the
3:16:23senior senior medical officer on
3:16:26on this product robert reader stated
3:16:29that this
3:16:30oc 92102 study
3:16:34o a pain has been completed and
3:16:36preliminary data
3:16:37is currently being reviewed it appears
3:16:40that the 10 milligram tablet
3:16:42is similar to placebo and efficacy but
3:16:45the 20 milligram tablet was
3:16:46significantly different compared
3:16:48to placebo
3:16:52were you aware that the 10 milligram
3:16:55tablet was similar to placebo and
3:16:57efficacy
3:16:59i don't recall that
3:17:03that would not be unusual in any
3:17:05analgesic trial however
3:17:38um
3:17:44you have this one right now
3:17:49then i'm going to ask you about the
3:17:52meetings of the international r
3:17:53d meeting this is
3:17:57did we mark that
3:18:02this is uh pdd
3:18:05i'm sorry we can go ahead mark it if you
3:18:08want
3:18:13[Music]
3:18:15pdd1701824723
3:18:17exhibit 21
3:18:21which appears to now we're into november
3:18:23of 94
3:18:24and president was dr rs sackler correct
3:18:29if that's what it says i must have been
3:18:31present for at least part of it
3:18:34and on page 13
3:18:38oh yes i was probably present for all of
3:18:40it
3:18:43page 13 third paragraph
3:18:54okay
3:18:58dr yang asked if there were any just a
3:19:01second i'm sorry third
3:19:03page thirteen this one you're reading
3:19:06from the top
3:19:07right from the middle of the paragraph
3:19:08okay thank you about the eighth line
3:19:10down
3:19:11dr yang asked if there were any
3:19:13statistically significant results
3:19:16it was confirmed that the 20 milligram
3:19:18product was significantly better
3:19:20than the placebo but the 10 milligram
3:19:23product was not
3:19:25and was that brought up at the meeting
3:19:29it must have been this is minutes of the
3:19:31meeting so
3:19:33i'm sure this was
3:19:37these minutes were generally of good
3:19:40quality
3:19:41all right and if you'll turn over to
3:19:43page 11.
3:19:57and this is shortly before the launch of
3:19:59oxycontin correct
3:20:01we're now into november of 90 no it was
3:20:03not this is over there before the launch
3:20:05yeah november of 94.
3:20:09it says in the third paragraph
3:20:12halfway down that paragraph yes dr rita
3:20:15dr reeder uh it says advantages for
3:20:17oxycontin are that not all patients can
3:20:19be successfully treated with morphine
3:20:22and that there is a stigma attached to
3:20:24morphine
3:20:26so far as many patients and physicians
3:20:27are concerned
3:20:29and that stigma is
3:20:32what it's an end of life
3:20:37in many hands principally cancer drug um
3:20:42associated with a whole bunch of
3:20:44negative associations
3:20:46were one of the negative associations
3:20:48side effects uh
3:20:51addiction dependency tolerance buildup
3:20:55yes but that
3:20:58the dependency did not differentiate it
3:21:02from any other opioid it was not more
3:21:04dependence causing or less
3:21:18and under this in summary the efficacy
3:21:20of the product has been demonstrated in
3:21:23i'm sorry go to page 12. okay thank you
3:21:35okay what it's therapeutic um
3:21:39i'm on page stroke can you help me
3:21:41paragraph
3:21:42from the top or bottom yeah third
3:21:44paragraph from the top
3:21:45actually fourth where it says in summary
3:21:47yes thank you
3:21:48the efficacy of the product has been
3:21:50demonstrated in six double-blind
3:21:52clinical trials involving 713 patients
3:21:56therapeutic conclusions are
3:22:00the equivalence of one milligram of
3:22:02oxycodone to two milligrams of morphine
3:22:04sulfate
3:22:06that's correct all right number two says
3:22:09equivalence
3:22:10to ir oxycodone
3:22:14immediate release yeah so they're saying
3:22:16controlled release
3:22:17is equivalent to immediate release
3:22:19oxycodone and
3:22:21the implication here is in terms of
3:22:23potency i assume
3:22:25number three was the need for dose
3:22:27titration
3:22:30yes and number four says the need for
3:22:33the availability of a rescue
3:22:35formulation and number five said the
3:22:38need for aggressive
3:22:40management of side effects
3:22:44why would you need the availability of a
3:22:46rescue formulation
3:22:49at this time and still today
3:22:53the doctrine of using opioids
3:22:57is to titrate
3:23:01to effect but
3:23:04in some conditions cancer and others
3:23:08the dose that has in general a good
3:23:11effect
3:23:12may suddenly be insubstantial
3:23:16due to what's called breakthrough pain
3:23:19and breakthrough pain could be the
3:23:21occasion by
3:23:22movement or trauma or just occasion
3:23:26by the fluctuation in the pain state
3:23:30rather than maintaining a patient on the
3:23:34highest
3:23:35number of milligrams of any opioid
3:23:39around the clock just to prevent
3:23:43breakthrough pain the normal
3:23:46practice and i think it's the prudent
3:23:48and safest practice
3:23:50is to give the patient an immediate
3:23:52release
3:23:53form ideally of the same analgesic agent
3:23:57that they can take when they have
3:24:00breakthrough pain
3:24:01on an as needed basis
3:24:05were there studies done at purdue that
3:24:08showed
3:24:08that blood plasma levels that the
3:24:11medication
3:24:12instead of lasting for 12 hours really
3:24:15lasted
3:24:16between 8 and 12 hours
3:24:21there were there were blood level
3:24:23studies
3:24:24that showed the profile of blood level
3:24:27but there is no prediction
3:24:31of what blood level you will need to
3:24:34control
3:24:34what pain so
3:24:38when we what we attended to
3:24:42were the clinical results of treating
3:24:44patients
3:24:46at a 12-hour basis and that was what
3:24:49we've researched
3:24:51now but may i just go on a little bit
3:24:54sure let me ask you this though what
3:24:55your research actually showed
3:24:56is that oxycontin controlled release
3:24:59provides pain relief somewhere between 8
3:25:01and 12 hours correct i think there were
3:25:04some
3:25:04patients who appeared that way but
3:25:08principally most were 12 hours allow me
3:25:12to
3:25:12just
3:25:16i'll elaborate just a bit normally
3:25:19people take a tylenol tablet every
3:25:23or two tablets every four hours but they
3:25:26will get
3:25:27essentially the same effect if they take
3:25:29one tablet every two hours
3:25:33what we had found was in most patients
3:25:38this was found as the drug was marketed
3:25:41who complained that at eight or nine
3:25:44hours
3:25:45they were back in pain yes they could be
3:25:49treated
3:25:50every three three times a day but if you
3:25:53took that
3:25:54dosage daily dose and divided it
3:25:57twice a day q12 hours they were
3:26:01just as pleased with the pain relief
3:26:04it was simply that the physician
3:26:08perhaps by habit or for other reasons
3:26:12rather than increasing the twice a day
3:26:15dose
3:26:15increased the daily dose by telling the
3:26:17patient we'll take it every eight hours
3:26:20and it would work fine do you recall
3:26:24purdue pharma running into a real
3:26:25problem with their rescue
3:26:27drug because they were trying to decide
3:26:29how to market it and whether to say it
3:26:31was for three to four hours or for six
3:26:33hours
3:26:34and there was a real debate at the
3:26:36company of how we're going to market
3:26:37this
3:26:38because we're going to hurt ourselves
3:26:40one way or the other
3:26:41depending on whether we say our rescue
3:26:43drug is three to four
3:26:44versus six because it's the same and
3:26:47you're marketing it
3:26:48two different ways objection to the form
3:26:51of the question it's
3:26:52it's consists of multiple questions and
3:26:54parts
3:26:56you can answer it if you can um i have a
3:26:59vague recollection of it if you could
3:27:01show me
3:27:02some documents if you wanted to pursue
3:27:04this with other questions
3:27:05please show me some documents i have i
3:27:08have i do have a
3:27:09very hazy recollection of this
3:27:13very minor
3:27:16complication but perhaps it was a big
3:27:20regulatory complication i
3:27:22don't remember i couldn't explain it to
3:27:25you
3:27:26so we'll go back to that in a second
3:27:29okay
3:27:30let me read and continue to read from
3:27:32this document
3:27:34uh it says dr caico reported that bios
3:27:38studies
3:27:38yes it's a fourth paragraph right
3:27:41undertaken to show
3:27:42that the 10 20 and 40 milligram tablets
3:27:45were bio-equivalent and dose
3:27:46proportional
3:27:48in normal subjects it has been
3:27:49demonstrated that
3:27:51at the same total daily dose the
3:27:54controlled release
3:27:55product given 12 hourly
3:27:58showed the same two-fold fluctuation as
3:28:01the immediate release product given
3:28:03six hourly and that this held across the
3:28:06four
3:28:07fold dosage range and were you all aware
3:28:10of that
3:28:11in 1994 i'm not certain what this means
3:28:17i'm sorry but i don't know
3:28:21i don't know what two-fold fluctuation
3:28:24means
3:28:26i'm sorry uh
3:28:29did you ask anybody when you were at the
3:28:31meeting
3:28:33i i'm sure i understood it but i have
3:28:36my my my best guess is that whoever was
3:28:40taking the minutes
3:28:42somehow perhaps even didn't understand
3:28:45the discussion
3:28:46or may have understood it but wrote it
3:28:49up in a way that doesn't make any sense
3:28:51to me
3:28:52now going down to the fifth paragraph
3:28:58a clinical study has been undertaken
3:29:00comparing oxycodone bd versus immediate
3:29:03release oxycodone
3:29:05qid in patients previously stabilized
3:29:08to pain relief and then
3:29:11if you drop down the study demonstrated
3:29:13that both products maintain
3:29:15baseline pain control and pain intensity
3:29:17was the same throughout the day the
3:29:20acceptability score was the same
3:29:21throughout the study
3:29:23and the same for immediate and
3:29:24controlled release products
3:29:28and then if you drop down to the next
3:29:29paragraph
3:29:32the conclusion from the study was that
3:29:33the 12-hour product was equivalent
3:29:36in efficacy to immediate release
3:29:38oxycodone
3:29:39and is that why the fda said other than
3:29:42how many times you take the product
3:29:45being the dosing requirements
3:29:47there's really not any other benefit
3:29:52the f i can't tell you
3:29:55why whether this was the study that
3:29:57convinced the fda of that
3:30:01but it's certainly in it's not
3:30:04the finding is completely consistent
3:30:07with that there may have been other
3:30:08studies
3:30:09that led them to that conclusion with
3:30:11this being
3:30:12just supportive of that conclusion
3:30:16in pain studies i i might point out
3:30:20that
3:30:23the biggest advance in measuring
3:30:27pain which of course is a
3:30:30personal experience no doctor can look
3:30:32at you
3:30:33and say oh you've got a pain level of
3:30:36three and
3:30:37you have a pain level of six there's no
3:30:39way of doing it
3:30:40you have to depend on the patient's
3:30:42report and the huge advance
3:30:45that led to all the research
3:30:48in analgesia and pain relief was called
3:30:52the mcgill visual analog
3:30:54scale that was developed in the 50s
3:30:57in mcgill university in montreal
3:31:0370 years later we have no
3:31:06advance on that and needless to say
3:31:11i suspect everybody in this room has
3:31:14gone to a doctor where they say do you
3:31:16have pain and if you say or to a nurse
3:31:18when they take your blood pressure
3:31:20yes i have pain and they ask you to rate
3:31:23it
3:31:24that is clearly better than just saying
3:31:28patient has pain plus yes or no
3:31:32but it's not a lot better it's not
3:31:36terribly it's not reproducible and it is
3:31:39highly
3:31:40influenced by the environment and other
3:31:43factors
3:31:44that affect the report the patient gives
3:31:48so very often you can compare a highly
3:31:52effective
3:31:53pain reliever to a placebo
3:31:56and you get in the study no difference
3:32:01and that is widely recognized and that
3:32:04probably related to the study that you
3:32:08talked about earlier the fda however
3:32:12would have required studies that showed
3:32:15a difference
3:32:16and they did before they would approve
3:32:18the product
3:32:19in other words the negative didn't was
3:32:22dismissed as a failed study by the fda
3:32:26the positive studies control because
3:32:29that study being dismissed i don't know
3:32:33it was dismissed it was studied
3:32:35but they must have concluded that that
3:32:37finding
3:32:38is not consistent with
3:32:42either their expectation or ours or more
3:32:45importantly other studies
3:32:47and experience and clearly the
3:32:50product's success in treating patients
3:32:52in pain
3:32:53which is indisputable would put a lie to
3:32:57anybody who would say oh
3:32:59oxycodone is no better than placebo
3:33:03i don't think any doctor would assert
3:33:05that
3:33:07for treating pain i should say maybe
3:33:09they maybe they would
3:33:11say in terms of urinary incontinence
3:33:13it's not effective but
3:33:15for treating pain but whether it's
3:33:17effective or not
3:33:18it also depends on another other factors
3:33:21such as
3:33:22abuse i mean you can kill somebody and
3:33:24take away their pain but that certainly
3:33:25wouldn't be effective would it
3:33:29i don't think that death
3:33:32would be considered a sign
3:33:36of efficacy yes i mean in the extreme
3:33:41yes what you say is correct so just
3:33:44because it takes away pain
3:33:45doesn't mean it's a good drug does it no
3:33:48all right
3:33:48let's let's look at sackler exhibit 13
3:33:50again i didn't want to ask you one
3:33:51question about this
3:33:56there's always a balance between
3:33:58effectiveness i'm sorry
3:34:00there's always a balance between
3:34:01effectiveness and safety
3:34:03if you go to page 4 1.4
3:34:12it says if physicians perceive oxycontin
3:34:16as controlled release percocet it is
3:34:18likely that they will start to use it in
3:34:20place of oxycodone combinations
3:34:24as physicians become more comfortable
3:34:26with the use of oxycodone combination
3:34:28market it is possible
3:34:29they will start to use oxycontin in
3:34:31place of class 3
3:34:33hydrocodone or codeine combination drugs
3:34:36and class 3 are not as regulated as
3:34:38class 2 correct
3:34:40that is correct therefore it is
3:34:43imperative that we establish
3:34:44a literature to support such use who at
3:34:48purdue pharma was trying to establish a
3:34:50literature
3:34:51to support a class iii use for oxycontin
3:34:56object to the form of the question
3:35:00um the answer to your question is nobody
3:35:04we had no plan
3:35:08program or expectation that
3:35:11or intention to change oxycontin from
3:35:15class
3:35:162 to class 3.
3:35:19in fact it is not too long ago
3:35:23the fda has reclassified hydrocodone
3:35:26as a class ii drug
3:35:30so you think that where it says
3:35:32therefore it is imperative we establish
3:35:33a literature to support
3:35:35such use is referring to physicians
3:35:38believing
3:35:39where it says physicians perceive
3:35:40oxycontin as controlled release percocet
3:35:43it is likely they will start to use it
3:35:45in place of oxycodone combinations
3:35:47is that what that development of
3:35:49literature is referring to in your
3:35:50opinion
3:35:51probably okay yes who was
3:35:55trying to develop that literature i
3:35:56don't know
3:35:58that would have been a combination that
3:36:01would have been the medical department
3:36:02to do studies
3:36:04and then have them published
3:36:11that would have been a research effort
3:36:18do you have that is that what this is
3:36:23are we finished with this one
3:36:29of the record yeah you want to break
3:36:30through between subjects would that be a
3:36:32good time to break
3:36:33one sure do you want a call for record
3:36:35did they bring lunch yet
3:36:36yes it's here that's not close we are
3:36:38off the record i thought it wasn't
3:36:44we are back on the record at 203 pm
3:36:49all right uh dr shackler picking back up
3:36:54after our break and we've taken a number
3:36:56of breaks but i'll just remind you at
3:36:57any time you need to stop
3:36:59or need a break just let us know thank
3:37:02you we'll stop again
3:37:06we were talking earlier about this issue
3:37:09with
3:37:10rescue oxycontin
3:37:13and let me hand you what we're going to
3:37:15mark as exhibit 20
3:37:1822 and
3:37:21here
3:37:26and
3:37:29if you go back to the last page
3:37:33there is a memo dated 921
3:37:3795 from robert reader r-e-d-e-r
3:37:43and he says currently our draft pi
3:37:48that's package insert correct yes
3:37:51and therefore our sales material have
3:37:54the same dosing of rescue
3:37:56as q3 dash
3:37:594 h prn and
3:38:04that is uh means what it means
3:38:07every three to four hours as needed
3:38:11okay and do you know if the
3:38:15people who were involved in the studies
3:38:18of oxycontin were given
3:38:20oxycontin uh for rescue pain
3:38:24ox oxycontin yes or you mean oxycodone
3:38:27oxycodone i'm sorry
3:38:30i'm sorry uh i don't know
3:38:36it says um bk brought this
3:38:39issue up some time ago it is now
3:38:41surfacing again because of the review of
3:38:44our sales material
3:38:46oxy ir and is that oxycodone
3:38:50yes is being promoted as rescue
3:38:54uh to be q3 for
3:38:57h and that's every three to four hours
3:38:59right that's correct
3:39:01he said while this may be consistent
3:39:03with the oxycontin
3:39:04package insert if it is approved as
3:39:07stands
3:39:08it will be inconsistent with the oxy ir
3:39:115 milligram package insert which uses
3:39:15q6h meaning take it every 6 hours
3:39:18correct
3:39:19that's what it means he says moreover
3:39:22if we use the q three four hours
3:39:25it will help to validate roxanne's
3:39:28change
3:39:28in their package insert
3:39:32what was the reason that you all did not
3:39:35want to validate
3:39:36roxanne's change in their package insert
3:39:40i i would have to read this
3:39:43completely and try to answer your
3:39:47question but i'm not sure
3:39:48this will prompt me to remember may i
3:39:52sure okay
3:40:44so
3:41:01i really don't remember
3:41:04this well enough to answer your question
3:41:06okay
3:41:07well let me continue reading here it
3:41:09says finally it creates a problem
3:41:12for the oxy hour 10 milligram and 20
3:41:14milligram capsules as the package insert
3:41:16would have
3:41:17two different dosing intervals depending
3:41:19upon the use
3:41:21ieq4 for rescue and q6 for
3:41:25usual pain use he says one suggestion
3:41:28would be to make everything consistent
3:41:30at q6 hours rescue would then be q6
3:41:35prn as needed as with some acute pain
3:41:39prescriptions
3:41:40for atc use it would just
3:41:44cue six hours although i hate the
3:41:46thought of recommending a pi
3:41:48change package insert change i
3:41:50understand fda may recommend a change or
3:41:52two
3:41:52such as removing the plasma curve graph
3:41:55at this point
3:41:56we could change the frequency of dosing
3:41:59in the pi what do you guys think
3:42:01so what he's saying here is we've got
3:42:04the exact same drug
3:42:06we've marketed it for two different
3:42:08purposes and we've got
3:42:10two different dosing regimens for the
3:42:12exact same drug
3:42:14correct it seems to suggest that
3:42:17but i can't confirm it and then
3:42:22paul goldenheim if you turn to the next
3:42:24page and
3:42:25read the next one at the bottom
3:42:31says uh who is paul goldenheim he was
3:42:35head of
3:42:36r d research and development and medical
3:42:40he says the issue that won't go
3:42:43away robert is right we need to discuss
3:42:46again robert please arrange a meeting
3:42:48round up the usual suspects this is too
3:42:50complicated for
3:42:52email then friedman
3:42:55and what was his role he was head of
3:42:58marketing and sales
3:43:00the head of marketing and sales writes
3:43:02back and says
3:43:03it is is it unreasonable to have a q6
3:43:07h dose i mean take it every six hours
3:43:10for normal dosing
3:43:12and a q 3 4 hour for rescue
3:43:15so the marketing guy's saying well hey
3:43:17can't we just take the exact same
3:43:20medication and say if it's for a normal
3:43:24dosing take it every six hours but if
3:43:26it's for rescue
3:43:27take it every three to four hours that's
3:43:29what he says
3:43:30and what he meant was for normal
3:43:33around-the-clock
3:43:34dosing rather than rescue
3:43:38which is one or two or three doses
3:43:42and that's it as needed and then up at
3:43:45the top
3:43:47you write back and say a second one down
3:43:50i agree this is too complicated to solve
3:43:52through written exchange
3:43:54paul i think that you should get us
3:43:56together soon good pick up
3:43:58someone do you recall writing that email
3:44:02no but it looks like i wrote it okay
3:44:06and then robert keiko writes back and
3:44:07says unfortunately
3:44:09soon may be too late robert
3:44:12questioned mark as previously so he's
3:44:15saying i
3:44:16brought this up again as previously i
3:44:19recommend we change everything to q6
3:44:21hours for
3:44:22immediate release oxycodone products and
3:44:24he is the head
3:44:26of what robert keiko he was in the
3:44:29medical department
3:44:30and he was the project the research
3:44:33project head for the overall oxycontin
3:44:36project
3:44:38so he's saying uh appears to me maybe
3:44:41perhaps to be a little frustrated and
3:44:44saying
3:44:45uh soon may be too late i've as
3:44:47previously i recommend we change
3:44:49everything to q6 hours
3:44:52i i can't say why he wrote the first
3:44:56sentence
3:44:56whether he was frustrated or whether he
3:44:58was actually referring
3:45:00to some sort of deadline maybe in a
3:45:02clinical trial maybe on
3:45:04submissions to the fda i don't know why
3:45:08but at least from the appearance of this
3:45:09you've got friedman ahead of marketing
3:45:11saying why don't we take the same
3:45:13product and just say
3:45:15take it every six hours and if it's for
3:45:17rescued
3:45:18uh it's good for three or four hours
3:45:22right this
3:45:27essentially to fill in what the blank
3:45:30here
3:45:31what his what he must have meant was
3:45:35have
3:45:35two indications for regular use of
3:45:39immediate release oxycodone
3:45:43administer it around the clock every six
3:45:46hours
3:45:47for rescue use administ you can
3:45:51administer the dose every three to four
3:45:56but that wouldn't be indefinite this
3:45:59would be for rescue
3:46:00and freedom for breakthrough actually
3:46:02for breakthrough pain
3:46:03and friedman the head of marketing
3:46:08is not a physician correct that's
3:46:10correct so he's making a suggestion
3:46:12dr robert keiko the head of the project
3:46:16for oxycontin is a physician correct yes
3:46:19and he's saying don't do what friedman's
3:46:21saying we need to make it q6 hours for
3:46:24immediate release oxycodone products
3:46:26correct
3:46:27first of all friedman asks a question
3:46:30here
3:46:31he's not asserting a proposition he's
3:46:34asking
3:46:35explain to me why we can't do this
3:46:39and i understand
3:46:42why he asked the question and the only
3:46:45answer
3:46:46could be it would it might be confusing
3:46:51to a physician but
3:46:55i think the emphasis should be on might
3:46:57be confusing
3:46:58um
3:47:02and then uh you write back the next day
3:47:05and say
3:47:07i don't know how urgent this is if it
3:47:08can't wait till tomorrow let us know
3:47:10immediately i don't have a problem with
3:47:12this change at all does anyone question
3:47:14it
3:47:15and who's mr alfonso he was
3:47:18head of marketing at the time okay so
3:47:20the head of marketing comes back and he
3:47:22says
3:47:24the way these drugs are written are q46
3:47:27the rescue is for q3-4 hours
3:47:31and he explains the problem might be
3:47:33that if we go q3
3:47:35for our root we will validate the
3:47:37roxanne dosing
3:47:39the again i'm going to ask you do you
3:47:41know what the problem
3:47:42was with validating the roxanne dosing
3:47:45and why
3:47:46he thought it was a problem i don't
3:47:48remember i don't
3:47:49really think it was a problem
3:47:52i i i can't imagine what he was thinking
3:47:55of
3:47:56okay so he writes the problem might be
3:47:58that if we go the q4
3:48:00q3-4 our route we will validate the
3:48:04roxanne dosing
3:48:05and possibly present a challenge to the
3:48:08oxycontin studies
3:48:11so if he's validating the roxanne with
3:48:13the q34
3:48:15would it appear that perhaps the roxanne
3:48:22had required now that's an overseas
3:48:24company correct
3:48:25no roxanne was an american company
3:48:29i believe at that time owned by beringer
3:48:32ingelheim okay did they um
3:48:37did they put a dosing limit on oxycontin
3:48:40to your knowledge oxycodone you mean not
3:48:43an oxycodone no
3:48:45not to my knowledge i don't think it was
3:48:47an issue of limit
3:48:49do you know what roxanne's dosing was
3:48:51that he's referring to
3:48:52no okay so he says uh the problem
3:48:56might be that if we go the q three four
3:48:59h route we will validate the rocks and
3:49:01dosing
3:49:02and possibly present a challenge to the
3:49:04oxycontin studies
3:49:06on the other hand a much more dangerous
3:49:08scenario can occur
3:49:10if we go the q6r for maintenance and
3:49:13rescue
3:49:14if we go this route and price continues
3:49:17to be a major
3:49:18issue when we narrow the value of
3:49:20oxycontin
3:49:21closer to the irs and that's immediate
3:49:24releases
3:49:25is that what that is
3:49:35yes irb immediate releases i'm just
3:49:38reading the sentence because i'm not i
3:49:39didn't follow what it meant
3:49:41he says the next sentence says in
3:49:43essence if you can use an ir
3:49:45q6 hours at a cheap price
3:49:48then those doctors that use oxycontin q
3:49:51eight hours
3:49:53there will be some regardless of what we
3:49:55say or do
3:49:56we'll not see a benefit over the
3:49:58immediate releases
3:50:00in addition our promotional campaign has
3:50:02a visual
3:50:04six cups representing q4 hours
3:50:07if we go q6 hours
3:50:10we will might have to change the visual
3:50:13to four cups
3:50:14and this will not have as much impact
3:50:18we need to go q6 hours for maintenance
3:50:20and queue three four hours for rescue
3:50:23so that we can maintain the integrity of
3:50:25our oxycontin
3:50:26studies did i read that correctly
3:50:30you did do you know whether you went q
3:50:33uh
3:50:34three four hours for rescue
3:50:37and six hours for maintenance i don't
3:50:39know
3:50:47sorry
3:51:06all right let's uh let me jump
3:51:09back um
3:51:28we have another copy of this
3:51:50thank you why don't we go ahead and mark
3:51:53that as exhibit
3:51:5523
3:52:01this is from you dated
3:52:05april 20th 2000. so oxycontin's been on
3:52:07the market over four years at this point
3:52:09correct yes and under number five
3:52:12um
3:52:17it says oxycontin tablets price increase
3:52:20is the central decision
3:52:21every 01.1 percent
3:52:25is one m i'm assuming that's one million
3:52:28that's correct
3:52:29one million to the bottom line what
3:52:31would the risk of having a four percent
3:52:33increase
3:52:34instead of a what would the risk be of
3:52:36having a four percent
3:52:38increase instead of a three percent
3:52:40increase and you're talking about price
3:52:41increase correct
3:52:42that's correct um our average realized
3:52:46price is constant
3:52:47suggesting that rebates and other
3:52:48discounts are taking a larger share of
3:52:51our business
3:52:52three percent annual notional increases
3:52:55seems to hold
3:52:56our per kg that's is that
3:52:59per kilogram price constant in an
3:53:02environment where many prices are going
3:53:05up
3:53:06was it true that every time you
3:53:07increased the price
3:53:090.1 percent uh
3:53:13you added 1 million to the bottom line
3:53:14of purdue pharma
3:53:16i don't remember
3:53:20um the answer is no to your question
3:53:24i don't remember whether this is correct
3:53:26or not when i wrote it
3:53:28but it certainly wouldn't have been
3:53:29correct
3:53:31every time
3:53:36um all right
3:53:40do you have that deposition of friedman
3:53:44i'm sorry shapiro
3:53:54we were talking earlier about purdue
3:53:55frederick versus purdue pharma did you
3:53:57ever determine
3:53:58whether the employees the sales force
3:54:01that engaged
3:54:02in improper conduct
3:54:05as referenced in the felony plea
3:54:08agreement
3:54:09were employees of purdue frederick or
3:54:11employees of purdue pharma well i have
3:54:13to object to the form of the question
3:54:15i don't think it accurately reflects the
3:54:17play agreement
3:54:23i could just restate the question
3:54:25because i kind of lost the thrust
3:54:26so did you ever make it we've talked
3:54:29about purdue pharma and purdue frederick
3:54:33did you ever make a determination
3:54:35whether the employees
3:54:37who engaged in illegal activity
3:54:42as referenced in the felony plea
3:54:44agreement
3:54:46or improper activity as referenced in
3:54:48the felony plea agreement
3:54:50were employees of purdue frederick or
3:54:52employees of purdue pharma
3:54:55i'm not aware of whether such a
3:54:58study was done or
3:55:02anybody focused on that question
3:55:06they may have been done but you should
3:55:10be
3:55:11you should think of this that the felony
3:55:13plea agreement came
3:55:14years after many
3:55:18remedial actions have been taken to
3:55:20retrain everybody
3:55:22to discipline sanction
3:55:26correct discipline sanction or dismiss
3:55:29employees
3:55:30who had behaved improperly
3:55:34and those processes which started
3:55:37late in 2000 or early 2001
3:55:41continued right up to the plea agreement
3:55:43and then after
3:55:44the plea agreement sure have you looked
3:55:48at the call notes
3:55:49of the reps in kentucky i
3:55:52have not seen any except those that were
3:55:56shown to me during my preparation
3:56:00there were three or four that i saw
3:56:04did you review the documents that mr
3:56:07shapiro the lawyer that you all hired
3:56:11put together for the uh us attorney in
3:56:15virginia
3:56:17i don't think so those don't seem
3:56:20familiar to me and that was the attorney
3:56:22that you all hired to defend you
3:56:24uh in the case brought by the u.s
3:56:26attorney in virginia is that correct
3:56:29you all paid him approximately 50
3:56:32million dollars
3:56:34to defend you in that or paid his firm
3:56:36approximately 50 million dollars
3:56:38to defend purdue in that case i'm i
3:56:41can't verify that's the first time i've
3:56:43heard a number attached to that
3:56:45uh if he testified to that would you
3:56:47dispute it
3:56:48i would have no basis to dispute it
3:56:53and do you know if anybody at purdue
3:56:58made an effort to determine whether the
3:57:01the submission and the uh
3:57:07call notes that were pulled by the
3:57:09lawyer hard to represent you were
3:57:10accurate or not
3:57:12i object to the form because i don't
3:57:14know how anyone knows
3:57:16what it is you're referring to
3:57:20uh are you aware that he made a
3:57:22submission on behalf of purdue
3:57:24to the um
3:57:28u.s attorney's office i am
3:57:31not aware of anything that he's
3:57:33submitted to the u.s attorney's office
3:57:36you've not reviewed any of the materials
3:57:38he submitted to the u.s attorney's
3:57:39office when he was defending purdue
3:57:42i did not were you aware
3:57:46of the call notes that he pulled and
3:57:49purported
3:57:50were evidence of improper behavior
3:57:56on behalf of purdue sales people
3:58:00no
3:58:08did anyone at purdue to your knowledge
3:58:11purdue pharma or purdue frederick make
3:58:14any attempt to ascertain
3:58:18what percentage of reps in kentucky
3:58:22were engaging in the type of behavior
3:58:25that the plea agreement says was
3:58:27improper
3:58:28i'm not aware of that
3:58:45yeah did you ever instruct anybody to do
3:58:46it
3:58:48to to do could you be more productive or
3:58:51instruct
3:58:51anybody at purdue to undertake an
3:58:53investigation
3:58:55uh to find out what percentage of
3:58:58reps in kentucky and which ones were
3:59:01engaging
3:59:02in conduct that was
3:59:05referenced as improper in the felony
3:59:07plea agreement no i did not
3:59:22uh have you reviewed howard shapiro's
3:59:24deposition
3:59:25in this case i have never seen it
3:59:35he was asked
3:59:39let me read this question and his answer
3:59:42mr cheryl before the break we were
3:59:44discussing the agreed statement of
3:59:45specif specifically paragraph 20. one of
3:59:48the questions that i had asked you
3:59:50previously about the conduct described
3:59:52in the agreed statement of facts was
3:59:54did you ever figure out who the
3:59:56employees referenced in the agreed
3:59:57statement of facts worked for
3:59:58was it purdue frederick company was it
4:00:00purdue pharma llp
4:00:02or some other entity with respect to the
4:00:04employees that we've been discussing
4:00:06and those are employees whose conduct is
4:00:08described in paragraph 20 in its various
4:00:10subparts
4:00:12did you ever do a determination to
4:00:14determine whether those employees were
4:00:16employees of purdue frederick company
4:00:18who signed the agreed statement of facts
4:00:19or some other purdue entity
4:00:22and his answer is without going into too
4:00:24much work product let me state we did
4:00:26sufficient investigation once
4:00:31once it turned this direction to satisfy
4:00:33ourselves and our client that there were
4:00:35purdue frederick employees who engaged
4:00:37in the conduct that's referenced
4:00:39in here and that forms the basis for the
4:00:42guilty plea
4:00:43question were there any employees of
4:00:45purdue pharma lp that are referenced
4:00:47here or any other purdue entity
4:00:50answer well again and i'm just what i
4:00:53said before the
4:00:55i don't know whether at at which point
4:00:57in time michael friedman hired udale
4:00:59paul goldenheim
4:01:00whether they were purdue farmer or
4:01:02purdue frederick or
4:01:04some of the some of them had been one
4:01:07and then the other beyond them there
4:01:09were
4:01:10when we look for instance at the names
4:01:13that are associated with the
4:01:16in the first supplemental responses to
4:01:18whatever that was 23 i think
4:01:20did you understand that answer mr mr
4:01:23thompson i
4:01:24object to the question plus could you
4:01:26let the witness
4:01:27have a copy to read because it's very
4:01:29hard to follow when you're reading such
4:01:31a lengthy
4:01:32sure so we have another question there's
4:01:34an answer tell me
4:01:35real quick
4:01:38here i'll tell you what you just read
4:01:40along with me if you want to do that
4:01:41i'll hold it over here well i think he
4:01:42would like to change well i'd like to
4:01:43see it also
4:01:44he he really can't see see that distance
4:01:47or just physically it's
4:01:49yeah we'll pronounce this
4:02:08um yeah why don't we go off the record
4:02:10while we get some copies of this
4:02:12we are off the record at 2 28 pm
4:02:15we are back on the record at 2 29 pm
4:02:18sure and to save time i'll let you read
4:02:20it can you start with the next question
4:02:21which was uh-huh
4:02:23and read the answer
4:02:26i'll read the answer the aha doesn't
4:02:29really set up the answer for me
4:02:31that's page 214 line 27
4:02:36yeah 2017.
4:02:41yes i'm sorry
4:02:45page two two one fourteen
4:02:49line seventeen right okay
4:02:53oh uh-huh is the question
4:02:56answer of people who are refer
4:03:00referenced but not named in some of the
4:03:02paragraphs
4:03:04i don't believe that we made any effort
4:03:06to determine whether
4:03:08at the relevant times they were purdue
4:03:10frederick company employees
4:03:12or purdue pharma employees okay
4:03:20and is that testimony accurate i
4:03:24can't i i can't vouch that it's accurate
4:03:27it's consistent with my knowledge so the
4:03:30next question says
4:03:32so it could have been either or one or
4:03:36both
4:03:44yes he's uh
4:03:47the question is so it could have been
4:03:50one
4:03:50or either or both you're not sure
4:03:54and the answer is correct now
4:03:57in 2001 who did michael friedman work
4:04:01for
4:04:03i don't know you don't know if he worked
4:04:05for purdue pharma in 2001.
4:04:07my best guess is he worked for purdue
4:04:10frederick
4:04:12but it's a guess and maybe for purdue
4:04:15pharma but i don't really know
4:04:17how about howard you do you know who he
4:04:19worked for
4:04:20no what about paul goldenheim do you
4:04:23know who
4:04:23i don't i don't know that
4:04:35do you know whether you worked for
4:04:36purdue farmer for two frederick in 2001
4:04:39i don't know for sure
4:04:45all right yeah this one
4:04:52so um going back to our oxycontin launch
4:05:00team
4:05:11that's what i'm looking for
4:05:29um okay
4:05:44that's i'm sorry
4:06:07do you want to put a number on this yes
4:06:09let's mark that as exhibit
4:06:1225 25 24.
4:06:19and i've just got a couple of paragraphs
4:06:25i want to ask you about surely
4:06:39so uh this is dated april 4th 1995
4:06:47and it says
4:06:56at the first paragraph second sentence
4:07:02mike in eroto oops first paragraph on
4:07:04which page i'm sorry
4:07:08page one second paragraph oh second
4:07:10paragraph
4:07:11okay mike enerato he's the marketing guy
4:07:14again correct
4:07:15yes discuss the marketplace that
4:07:17oxycontin will enter
4:07:19and how oxycontin will expand out of the
4:07:22cancer pain market
4:07:26oxycontin will be launched in 10 20 40
4:07:28milligram tablet strength
4:07:3080 and 160 milligram tablet strength to
4:07:34follow
4:07:38um
4:07:41and if you go on down a little bit
4:07:43further he says oxycontin will be
4:07:44indicated for the relief of pain with
4:07:46the convenience of q12 dosing
4:07:49primary market positioning will be for
4:07:51cancer pain and the secondary market
4:07:53will be for non-malignant pain
4:07:55musculoskeletal injury and trauma
4:07:58it was reinforced that we do not want to
4:08:01niche oxycontin just for cancer pain
4:08:06and was it part of your marketing
4:08:10strategy not to niche oxycontin for
4:08:12cancer pain
4:08:13not to limit it yes
4:08:16below that it says uh on the
4:08:20last paragraph in our market research
4:08:22office focus groups personal one-on-one
4:08:24interviews and telephone interviews were
4:08:26conducted with more than 500 health care
4:08:28professionals
4:08:29in our focus group findings we learned
4:08:31that ms cotton
4:08:33that's the drug that you already sold
4:08:36correct
4:08:37i'm sorry i didn't hear the question
4:08:39that's morphine sulfate yes
4:08:42that's the one that you had not had any
4:08:44reports of abuse or diversion with
4:08:46that you could recall correct one that i
4:08:48was aware of yes
4:08:50and it says we learned that ms cotton is
4:08:52the gold standard for cancer pain
4:08:55our creative concept testing showed the
4:08:57likelihood of oxycontin usage by
4:08:59physician and nurses were 4.6 on a scale
4:09:01of 1 to 5
4:09:03which is very favorable
4:09:06were you aware of this creative concept
4:09:09testing and focus groups that were being
4:09:11conducted
4:09:12i don't recall
4:09:17and then if you go to the next page page
4:09:19two
4:09:23last paragraph
4:09:26our meeting ended with a question and
4:09:28comment period michael friedman
4:09:30emphasized the threat that a b rated
4:09:32generics posed to ms cotton
4:09:34we're not sure when a b rated generics
4:09:36will be launched but we don't think it
4:09:37will be until 1996.
4:09:39inevitably the a b rated generics will
4:09:42arrive and this is why it is
4:09:43extremely timely importance that we must
4:09:46establish oxycontin
4:09:48oxycontin can cure the vulnerability of
4:09:51the a b rated generic threat
4:09:53and that is why it is so crucial that we
4:09:55devote our fullest efforts now to a
4:09:57successful launch of oxycontin
4:10:00and were you aware that was part of the
4:10:01strategy
4:10:03well i'm sorry but what was part of the
4:10:06strategy
4:10:07that the ab rated generics were going to
4:10:10arrive and that
4:10:12is why it was extremely timely
4:10:14importance that's
4:10:16the way it's written that we must
4:10:18establish oxycontin
4:10:21and it was crucial to devote the fullest
4:10:23efforts to a successful launch
4:10:27because of a b right international
4:10:28objection objections of the form the
4:10:29witness can't answer
4:10:34yes i was aware of that
4:10:38and the reason is clear ms cotton was
4:10:42our most important product at that point
4:10:45and when the sales were eroded
4:10:48and by generics we would have i
4:10:53if we had not replaced those sales
4:10:56with other product sales we would have
4:10:59a much smaller company that would cost
4:11:02many people their jobs
4:11:07do you have this
4:11:28[Applause]
4:11:30are you familiar with the oxycontin
4:11:32product team
4:11:35i've become reminded of it yes
4:11:46let's mark this as exhibit is it 20 25
4:11:50thank you
4:11:58and this is uh minutes of the oxycontin
4:12:01product team
4:12:03dated
4:12:06the meeting was february 22nd 1996.
4:12:12watching washington's birthday
4:12:15it says first paragraph the oxycontin
4:12:17product team met on friday
4:12:19february 22nd 1996
4:12:23and topics discussed included the
4:12:25following number one is
4:12:27marketing's wish list for clinical
4:12:29studies
4:12:31uh and then it's got a list of
4:12:34studies number one is post-operative
4:12:38pain
4:12:38to support the abbott agreement why did
4:12:41you need studies on post-operative pain
4:12:43to support the abbott agreement
4:12:45i don't recall
4:12:51pharmacoeconomic what was the reason for
4:12:53pharmacoeconomic studies
4:12:56being needed if you recall
4:13:02i don't recall that circumstance
4:13:06and then it says non-malignant pain exam
4:13:10example functional improvement
4:13:14and then the sub-categories are low back
4:13:16pain osteoarthritis
4:13:19long-term safety data right why did
4:13:22you think that marketing needed was
4:13:24needing
4:13:26on march 7 1996
4:13:29after the product had already launched
4:13:31long-term safety data
4:13:36i don't remember precisely but
4:13:39all studies would include
4:13:43or would enhance the
4:13:47data available to support long-term
4:13:50safety if the studies were
4:13:54long term and the studies that were
4:13:57referenced here
4:13:59low back pain and osteoarthritis would
4:14:02surely have been
4:14:03long enough to add to that database sure
4:14:06then can you explain why the head of the
4:14:09oxycontin or the
4:14:11oxycontin product team on february 22nd
4:14:161996 after the product launch said we
4:14:19need long-term safety data
4:14:24i don't think there was any question
4:14:27about the safety of the drug
4:14:29it was just an addition that
4:14:32it would enhance the dossier that was
4:14:36available
4:14:44i don't know how you would do a
4:14:45long-term safety study devoid
4:14:48of some condition so the long-term study
4:14:52would be focused
4:14:53on following
4:14:57a condition let's say low back pain or
4:15:03or osteoarthritis and at that time the
4:15:07studies were typically 12 weeks
4:15:09and with it with an open extension at
4:15:11the end they could go on for a year
4:15:14and this that is a subcategory of
4:15:17non-malignant pain
4:15:19correct these two studies
4:15:22low back pain and osteoarthritis
4:15:26long-term safety would be
4:15:29a general concept that would apply to
4:15:32any kind of study
4:15:33that's long enough to accumulate that
4:15:35data they've included long-term safety
4:15:37data
4:15:38under their marketing wish list under
4:15:41non-malignant pain
4:15:42correct they did so it looks like
4:15:44they're saying we need long-term safety
4:15:46data on prescribing oxycontin
4:15:48for non-malignant pain do you read that
4:15:50the same way or differently
4:15:53i i guess i read it differently than you
4:15:55do
4:15:57just that it wasn't that we we needed it
4:16:00it was a wish list
4:16:01but it was inherent in any long-term
4:16:03study we did of any pain
4:16:05condition and then we talked about the
4:16:12fda's
4:16:15statement about comparative studies um
4:16:19do you remember that well they said you
4:16:20should refrain from comparative
4:16:22uh analysis i don't remember
4:16:25so if you could just go forward
4:16:29with the questions sure great one of the
4:16:32things that the
4:16:33oxycontin marketing team's wish list has
4:16:36under number five is comparative studies
4:16:39especially versus
4:16:41combination opioids such as hydrocodone
4:16:43combinations
4:16:44duragesic ms cotton castin and ultram
4:16:48nsaids those are non-steroidal
4:16:50anti-inflammatory drugs
4:16:52is that right ultron is an opioid drug
4:16:56nsaids are non-steroidal
4:16:58anti-inflammatory drugs
4:17:01so they're not the same i don't know why
4:17:04they were
4:17:04the bullet put them together but they're
4:17:06different right no no
4:17:08i get it i'm just i'm asking you is that
4:17:10what nsaid stuff yes
4:17:11yes
4:17:16has it been marked this has been mark 25
4:17:19all right now let's go to the launch
4:17:21plan
4:17:22and this is dated september 27 1995.
4:17:35and if you'll go to page 42 from the
4:17:38launch plan
4:17:57under 5851
4:18:00under public relations at the top
4:18:03it says the objective of the public
4:18:06relations campaign is to create
4:18:08broad awareness of the launch of
4:18:10oxycontin this awareness will be
4:18:12directed at the consumer and healthcare
4:18:14professionals through various media
4:18:16channels
4:18:17such as print tv and radio in an effort
4:18:21to create a
4:18:22quote media hook end quote that would
4:18:24coincide with the launch of oxycontin
4:18:27a consumer survey conducted by a company
4:18:30such as the gallup poll
4:18:31is being proposed this survey would
4:18:34focus on the prevalence and problems of
4:18:36chronic pain both malignant and
4:18:38non-malignant
4:18:39the release of the results of such a
4:18:41survey would be publicized
4:18:43along with the recent fda approval of
4:18:45the new controlled release oxycodone
4:18:48preparation oxycontin this is a classic
4:18:52problem solution strategy to create
4:18:55a need for the launch of a product such
4:18:58as oxycontin
4:18:59did i read that correctly you did do you
4:19:01know if a poll was conducted by someone
4:19:03such as the gallup poll
4:19:05i don't know what the poll
4:19:08is precisely
4:19:11then then the next paragraph says 5852
4:19:15it says in an effort to continue the
4:19:17publicity about the launch of oxycontin
4:19:20approximately two to three months after
4:19:22the initial public relations campaign
4:19:24another campaign would be launched
4:19:26focusing on the expansion of
4:19:28purdue frederick's partners against pain
4:19:30program
4:19:32developed to improve pain management
4:19:34knowledge among health care
4:19:35professionals
4:19:36and patients caregivers
4:19:40partners against pain was a creation of
4:19:43purdue
4:19:44frederick correct that's what it says
4:19:46and there were no partners
4:19:47correct no i
4:19:50think there were partners in the meaning
4:19:53of the campaign
4:19:55physicians nurses other health care
4:19:58workers
4:19:59or our partners oh okay so but as far as
4:20:03setting it up there weren't any other
4:20:04partners
4:20:06involved in setting up partners against
4:20:08pain i mean the government wasn't
4:20:09involved in partners against payne
4:20:11other healthcare companies weren't
4:20:13involved i don't know whether other
4:20:15healthcare companies were involved
4:20:18but the government would not have been
4:20:20involved
4:20:21in setting up this
4:20:24program and it says this campaign would
4:20:28reiterate the prevalence and problems
4:20:30uncovered in the consumer survey
4:20:33and explain how purdue frederick has
4:20:35made a commitment to improving the level
4:20:36of care for patients suffering in pain
4:20:39in addition the campaign would expand
4:20:42the recent launch of purdue frederick's
4:20:44newest
4:20:45partner against payne oxycontin
4:20:50excuse me i think he just made an error
4:20:51in readings it would explain that would
4:20:53expand
4:20:55i thought i said explain but
4:21:02then the next paragraph says in addition
4:21:04to the above
4:21:05public relations campaigns we are
4:21:07exploring the possibility of purdue
4:21:08frederick sponsoring a pain management
4:21:10foundation
4:21:11in association with an organization such
4:21:14as gilda's club
4:21:16do you know if you sponsored a pain
4:21:19management foundation
4:21:24i do not but i
4:21:28i no i don't i don't know if we did that
4:21:31i don't think we did
4:21:32but that's a vague recollection
4:21:43can we agree that the main way you
4:21:45marketed your and promoted oxycontin was
4:21:48with your sales force
4:21:51yes and those are the people that
4:21:52actually go out to the physicians
4:21:54offices and pharmacies into the
4:21:56communities
4:21:56and sell oxycontin correct they don't
4:21:59actually sell
4:22:01but they promote oxycontin
4:22:04the distinction being that they don't
4:22:06actually take orders
4:22:08and arrange deliveries and collect any
4:22:10money
4:22:11okay and you would consider them the
4:22:13most valuable resource
4:22:15that purdue had to sell oxycontin
4:22:18correct
4:22:21it was the most valuable resource that
4:22:24we used
4:22:26we thought it was the most efficient
4:22:28resource
4:22:29and that's why we use them whether other
4:22:32approaches or resources would have been
4:22:34more valuable i can't say
4:22:40at some point did you figure out that
4:22:42the key to getting physicians to
4:22:43prescribe and keep prescribing oxycontin
4:22:46was through regular visits from the
4:22:47sales force that would be
4:22:49typical of any pharmaceutical
4:22:52sales force yes and was there a
4:22:55realization that developed that certain
4:22:57physicians so-called
4:22:58core physicians were more likely to
4:23:00prescribe oxycontin
4:23:03i'm not sure
4:23:07i wasn't i think it was the other way
4:23:10around
4:23:11our core our most significant
4:23:14prescribers were called
4:23:15core not that we
4:23:19identified a core and then they became
4:23:24important prescribers
4:23:31and how many companies were
4:23:34sending sales representatives to
4:23:36physicians offices to talk to them about
4:23:39opioids
4:23:40during this time
4:23:56three to five it's a guess on my part i
4:23:59don't
4:23:59recall any survey that
4:24:04counted that up but it's a guess based
4:24:07upon my recollection
4:24:09of what was being actively promoted
4:24:13and you compensated your sales force
4:24:17very well based predominantly on how
4:24:19much oxycontin they sold
4:24:21is that correct
4:24:24the successful the most successful sales
4:24:27people
4:24:28uh a majority of their income was bonus
4:24:32um the average salesman um
4:24:36i certainly when we launched the product
4:24:40the overwhelming majority of their
4:24:42income was their salary
4:24:45and the benefits that they received
4:24:48and for the average sales force salesman
4:24:52i think it would have been
4:24:5650 of their income or 70 percent of
4:24:59their income
4:24:59salary and the balance and bonus sure
4:25:03but um i don't i don't remember this
4:25:06in detail of course it changed over time
4:25:08the way the sales scheme was set up
4:25:10if they sold more oxycontin they made
4:25:12more money
4:25:13yes yes the same as
4:25:17almost every other company in the
4:25:19industry
4:25:23and then you all gave your reps an
4:25:25additional incentive
4:25:27because you decentralized them to sell
4:25:29ms cotton
4:25:30but you increase the incentive for
4:25:32selling oxycontin
4:25:34is that true yes
4:25:37and then you had one of the highest paid
4:25:40sales forces in the country
4:25:42is that accurate i've heard that said
4:25:46for one or two years certainly wasn't
4:25:49the case or hasn't been the case
4:25:51during the history of oxycontin do you
4:25:54know if reps that promoted and sold
4:25:55oxycontin sometimes ended up making over
4:25:58250
4:25:59000 a year i've heard that that
4:26:03was the case i'm sure it was unusual
4:26:06and then your top sellers were rewarded
4:26:08with trips uh
4:26:09to uh bermuda or london
4:26:13in what was called the toppers program
4:26:15is that correct
4:26:16yes and during the first five years of
4:26:20oxycontin's release
4:26:22purdue more than doubled the size of its
4:26:24sales force correct and that's correct
4:26:29and do you know how much of this sales
4:26:32force
4:26:33during the first five years was purdue
4:26:34frederick versus purdue pharma employee
4:26:36i don't know
4:26:46um at some point were sales people
4:26:49designated all new hires designated
4:26:52purdue
4:26:53pharma as opposed to purdue frederick
4:26:59i believe that that's the case but
4:27:02you're not sure what date that started
4:27:04no do you know if it was after the
4:27:06creation of purdue pharma that that
4:27:08started
4:27:09it would have had to have been if purdue
4:27:12pharma didn't exist we couldn't have
4:27:13hired somebody
4:27:14right but i mean was it immediately
4:27:16after that that all
4:27:17once it was created all reps were hired
4:27:20by purdue pharma as opposed to producer
4:27:22i don't know who would know that it
4:27:25purdue
4:27:31i don't know at purdue now yes at purdue
4:27:34pharma
4:27:35yes um
4:27:40well the people who were there at that
4:27:43time
4:27:45might recall it but i don't know who
4:27:48today would know it
4:27:52and then in addition to targeting
4:27:57or providing initiatives to the sales
4:28:00force
4:28:01you also targeted wholesalers correct
4:28:07wholesalers were called upon by the
4:28:09salesman yes
4:28:13and in fact i think if you go to page 27
4:28:16of the initial launch plan
4:28:19if i can find this
4:28:40the last paragraph
4:28:52um it says
4:28:55um
4:28:59all promotional efforts for the retail
4:29:01distribution of oxycontin will focus
4:29:03on the incredible success that purdue
4:29:06frederick has achieved and sustained
4:29:07with ms cotton
4:29:08product line wholesale pharmaceutical
4:29:10buyers and retail pharmacists should be
4:29:12reminded
4:29:13of how ms cotton created such a large
4:29:16market for the use of sustained release
4:29:18opioids
4:29:19in the for the treatment of pain
4:29:24this in turn created profits for
4:29:26pharmacists
4:29:27helping to grow their businesses
4:29:29promotional copies should focus on the
4:29:31market potential for oxycontin
4:29:34and patient populations to be targeted
4:29:36including the number of prescriptions
4:29:38written for class 2 and class 3 opioids
4:29:41every year
4:29:46executive director of national accounts
4:29:48should work with drug wholesalers in
4:29:49developing programs to utilize the
4:29:51wholesaler sales representatives to
4:29:53ensure adequate distribution
4:29:55considerations should begin given to
4:29:57advertisements in drug wholesaler ad
4:29:59books and computer
4:30:01programs
4:30:06were the sales force told to emphasize
4:30:08with pharmacists
4:30:10that they could make more money right
4:30:13with oxycontin prescriptions
4:30:19i don't think that they would have been
4:30:21encouraged to say that
4:30:26the objective when any product is
4:30:30launched
4:30:31and certainly any medicine is launched
4:30:34is to be is to minimize
4:30:37the number of times a patient number of
4:30:40patients
4:30:41who get prescriptions from their doctor
4:30:45and go to the pharmacy and the
4:30:47pharmacist says
4:30:50i don't have that or even worse i never
4:30:53heard of that
4:30:55for obvious reasons so in order
4:30:59to reduce that one tries to stock
4:31:04all three strengths in as many
4:31:06pharmacies as possible
4:31:08but to begin with there's no demand
4:31:12so it's there's a bit of tension there
4:31:16in order to supply the pharmacist the
4:31:18wholesalers have to have enough
4:31:20stock on hand for the ones who buy it
4:31:24early
4:31:24and a sufficient backup stock both to
4:31:28supply the early
4:31:29buyers and the later adopters
4:31:33and that was all that we needed to
4:31:37accomplish and there's not much more i
4:31:41can say about it except that
4:31:44however we did it was ethical and proper
4:31:47and let me go back to my question where
4:31:50it says wholesale pharmaceutical
4:31:52buyers and retail pharmacists should be
4:31:53reminded of how ms cotton
4:31:56created such a large market for the use
4:31:59of sustained release opioids for the
4:32:00treatment of pain
4:32:02this in turn created profits for
4:32:04pharmacists
4:32:05um am i reading that incorrectly so
4:32:07you're reading it correctly
4:32:09what you're telling what this launch
4:32:11plan
4:32:12salesforce under the title sales force
4:32:14allocation
4:32:17and representative delivered promotional
4:32:19materials
4:32:21is saying hey remind them they're making
4:32:23a bunch of money
4:32:24selling our product as opposed to
4:32:28not selling any product
4:32:39says a cooperative direct mail
4:32:41advertising sales sheet
4:32:43offering a rebate on the initial order
4:32:45of oxycontin to retail pharmacists will
4:32:47be mailed every month during the first
4:32:49three months of launch
4:32:51what was the rebate you all were
4:32:52offering to pharmacists
4:32:54some discount on their
4:32:57early orders to encourage them to stock
4:33:01the product in advance of seeing
4:33:03any prescriptions or one or two
4:33:07prescriptions
4:33:10and like the rest of there was nothing
4:33:13innovative in this program this is
4:33:15this was standard programming in the
4:33:18pharmaceutical industry and in other
4:33:21industries
4:33:23well like some of your other literature
4:33:27talks about you all had an unprecedented
4:33:29marketing campaign
4:33:31have you ever seen another company that
4:33:33instituted a more broad-ranging
4:33:35marketing campaign than you all did for
4:33:37oxycontin
4:33:38i think this was conventional
4:33:41unprecedented perhaps for us but not
4:33:45unprecedented in the industry this was
4:33:47this is conventional standard
4:33:50textbook this is how you do it
4:33:54all right um
4:34:13you all also were involved with third
4:34:15party organizations
4:34:18partners in pain they were
4:34:22[Music]
4:34:23referenced in the launch campaign
4:34:27and did you use partners in pain to drum
4:34:30up demand for oxycontin
4:34:32no i i think the partners in pain
4:34:37must principally designed
4:34:41to inform doctors about the proper use
4:34:45of our drugs our medicines
4:34:49and to
4:34:52encourage patients who may have had
4:34:56pain sometimes for years
4:34:59inadequately treated or not treated at
4:35:02all
4:35:02to present themselves to their
4:35:06physicians
4:35:30there was also
4:35:33purdue funded a variety of so-called
4:35:36payne societies the american pain
4:35:38society
4:35:39was that funded by purdue pharma
4:35:44we donated money to the american pain
4:35:46society
4:35:48did you also fund the american
4:35:49association for pain management
4:35:52if it wouldn't surprise me i don't
4:35:55remember
4:35:56did you also fund the appalachian pain
4:35:58society
4:36:02i don't know that and i wouldn't have
4:36:04known it
4:36:06but if that's what the record shows it
4:36:09wouldn't surprise me
4:36:10yeah there was a a
4:36:15figure we looked at a while ago that
4:36:16said there was basically the
4:36:18target market for physicians was about 7
4:36:23500 physicians including the cancer
4:36:26malignant pain and the non-malignant
4:36:28pain
4:36:30across the u.s do you remember seeing
4:36:32that no
4:36:34do you think the market was more than 7
4:36:36500 physicians
4:36:37much larger for pain much larger
4:36:40it's pain is the most common
4:36:43presenting symptom for
4:36:47physicians in total and very few
4:36:50physicians
4:36:51would have a different experience
4:36:54perhaps ophthalmologists
4:36:56or dermatologists may but
4:36:59every other physician it would be the
4:37:02most common or the second most common
4:37:04presenting complaint do you recall
4:37:07whether purdue pharma
4:37:09set up a speaker's bureau in which it
4:37:11allowed physicians
4:37:13uh who are recommended by salespeople to
4:37:16be put on the
4:37:17so-called speakers bureau
4:37:20they yes such a program existed
4:37:23not everybody who was recommended was
4:37:25put on the speakers bureau they were
4:37:28vetted by
4:37:30internal experts to determine
4:37:34their qualifications
4:37:37do you recall that there were over 3 000
4:37:40physicians on the speakers bureau
4:37:42i don't recall it but it wouldn't
4:37:44surprise me
4:37:45do you think somebody vetted all 3 000
4:37:48physicians that were
4:37:49internally that were on the speakers
4:37:50bureau we had quite a large organization
4:37:53to do that
4:37:54and to manage the speed the speakers
4:37:56bureau
4:37:57so i think everyone was should have been
4:38:00vetted there was
4:38:02there was no excuse for not validating
4:38:05their
4:38:06degrees and confirming that they were
4:38:09licensed to
4:38:10practice in the place that they were
4:38:12practicing and so forth i don't know
4:38:16precisely how they were vetted but they
4:38:19definitely
4:38:20should have all been vetted do you think
4:38:23putting these 3 000 doctors on your
4:38:25speakers bureau
4:38:26um caused them to write more
4:38:28prescriptions for oxycontin or less
4:38:30prescriptions for oxycontin
4:38:32i don't think it would have had an
4:38:36effect
4:38:39and there are also individuals you
4:38:40started a program called train the
4:38:42trainers
4:38:43where you would fly physicians around
4:38:45the country
4:38:47to speak on perhaps
4:38:50on behalf of purdue do you recall that
4:38:53actually
4:38:54the the physicians who attended
4:38:58um and spoke were trainers
4:39:03and some of them were in-house
4:39:06people and some were outside physicians
4:39:11and would these take place at resorts
4:39:13like in florida and arizona these
4:39:14meetings
4:39:15certainly might have
4:39:19and you also but but to my knowledge i i
4:39:22don't think anybody would go more than
4:39:24once
4:39:25and they were trained in what they could
4:39:29say what they couldn't say and they were
4:39:31given
4:39:32um materials to use in the presentations
4:39:36for a while slides and then i guess
4:39:38eventually
4:39:39powerpoint presentations
4:39:42so as to create some control
4:39:45to see hopefully that they would not go
4:39:48off label
4:39:49and did purdue pay for that or they pay
4:39:51their own way
4:39:52at the time it was started purdue paid
4:39:55for it
4:39:56this was again customary in the industry
4:40:01who told you that was customary in the
4:40:03industry
4:40:06i don't remember who told me but i can
4:40:09tell you that
4:40:10sometimes i go to hotels and i'd see
4:40:13events sponsored by pfizer or sponsored
4:40:16by jnj
4:40:18and they were precisely either
4:40:21they were speaking engagements in which
4:40:24somebody spoke
4:40:25and occasionally they were train the
4:40:28trainer kind of ideas
4:40:30where the company in question other
4:40:33companies in that case
4:40:35um trained physicians you can say this
4:40:39and this and this
4:40:40beware you shouldn't say that and that
4:40:43do you know whether pharmaceutical
4:40:45companies
4:40:46and medical device companies have come
4:40:48under criticism
4:40:50for giving incentives to doctors to
4:40:52write prescriptions
4:40:54or use their medical devices i'm aware
4:40:56of that
4:40:58and the answer is they have come under
4:40:59criticism for that
4:41:01yes um i
4:41:07yeah was russell portnoy one of the
4:41:09speakers that spoke
4:41:10on behalf of purdue pharma at these
4:41:13meetings oxycontin
4:41:14i don't know
4:41:18in addition to the stuff we've just
4:41:20talked about you also
4:41:22hired a number of third parties to
4:41:24assist in the marketing
4:41:26of oxycontin such as marketing firms
4:41:30correct
4:41:31i don't know do you know if purdue
4:41:33retained
4:41:34lion's laivy to market oxycontin
4:41:38i've heard the name but i don't know
4:41:40that it was oxycontin
4:41:42do you know if public relations firms
4:41:44were also hired
4:41:46to assist in the marketing uh and the
4:41:49expansion of them i don't know
4:41:51okay you gotta let me finish my question
4:41:53excuse me that's okay
4:41:55you you we've got a video but we also
4:41:57have a court reporter stenographer
4:41:58taking
4:41:58i'm sorry that's our apologies she can't
4:42:01get it if we both talk the same time
4:42:03so my question is do you know um
4:42:09can you read my question back
4:42:14do you know if public public relations
4:42:17firms were also hired to assist in the
4:42:18marketing and the expansion of the
4:42:20market
4:42:20for oxycontin i don't know
4:42:27have you heard of a company called
4:42:28fleischmann hilliard
4:42:32that's a vaguely familiar name but i
4:42:36don't know whether they were ever hired
4:42:38by purdue
4:42:40frederick or for purdue pharma
4:42:45do you recall at some point being
4:42:48notified of
4:42:50a problem with um
4:42:55abuse occurring with oxycontin and
4:42:58purdue pharma hiring a crisis management
4:43:01firm yes do you recall when that
4:43:04crisis management firm was hired i don't
4:43:07recall precisely
4:43:16no
4:43:20have you ever read the interview michael
4:43:21friedman gave to the crisis management
4:43:24firm no
4:43:29and in addition to all that you also put
4:43:31out videos
4:43:32are you familiar with the i got my life
4:43:34back video
4:43:36i've heard the title i'm not familiar
4:43:38with it
4:43:40did you ever do any follow-up to find
4:43:42out whether the participants in the i
4:43:44got my life back video actually got
4:43:46their life back
4:43:47or wound up having problems with
4:43:50dependency on oxycontin no i did not
4:43:58did purdue also give away coupons so
4:44:01people could get a week's free supply of
4:44:03oxycontin
4:44:05i don't know but that would be
4:44:09common in the industry and
4:44:12all of the things we've just discussed
4:44:14would be done
4:44:16um these marketing efforts to sell more
4:44:19oxycontin
4:44:19correct to see to it that
4:44:23appropriate patients had access
4:44:26to oxycontin yes
4:44:36were you aware that there was a direct
4:44:39link between the number of sales
4:44:40representatives that were out promoting
4:44:42oxycontin
4:44:43and how much oxycontin would be
4:44:44prescribed
4:44:50could you just ask that again yeah was
4:44:52there a link a direct link
4:44:54between the number of sales
4:44:56representatives that were out promoting
4:44:57oxycontin
4:44:59and how much oxycontin would be
4:45:01prescribed
4:45:02i don't think direct link would
4:45:06capture the the concept
4:45:09the answer is no do you believe that
4:45:12the number of sales representatives that
4:45:15promoted oxycontin
4:45:17would increase the more sales represent
4:45:20representatives that promoted oxycontin
4:45:23the more prescriptions would be written
4:45:31i don't think anybody thought of it that
4:45:34way
4:45:35we had a product that
4:45:39had tremendous potential
4:45:43and our principal means of
4:45:48getting it used was to convince
4:45:50physicians
4:45:53ident convince physicians that he had in
4:45:55his practice appropriate patients
4:45:57to use it but their the linkage there
4:46:01is very loose was there also
4:46:06a correlation between the number of
4:46:09times a sales representative
4:46:10called on a physician to how much
4:46:13oxycontin that physician would prescribe
4:46:16again that would be a loose correlation
4:46:20and there would be clearly if he called
4:46:23not at all it'd be nothing to correlate
4:46:28and i am sure there was a practical
4:46:31limit as to how many calls he could make
4:46:34i don't know
4:46:37whether there was any kind of specific
4:46:39relationship between calling
4:46:42every quarter or every month
4:46:45or more frequently or less frequently
4:46:49why don't we mark the oxycontin watch
4:46:53plan
4:46:53as 27 27
4:46:5726 i'm sorry okay is it it's 26.
4:47:05this is for you this is for you this is
4:47:07going to be 27
4:47:147.
4:47:28mr thompson i know that exhibit 27 um
4:47:31there's some material that's been the
4:47:34deal material that's been
4:47:35bracketed and i've seen that on other
4:47:38documents that you've marked
4:47:39my assumptions throughout is that the
4:47:41brackets were not on the original one
4:47:43this is something
4:47:44that you guys added that's incorrect
4:47:45connection with reading the brackets
4:47:47were produced that way
4:47:48it came to you with these documents that
4:47:50have writing on them were produced that
4:47:52way
4:47:52if the email ends and it's only half an
4:47:55email
4:47:56that's also the way that they were
4:47:57produced to us and what if what if the
4:47:59document was
4:48:00highlighted in yellow was it produced it
4:48:02was highlighted
4:48:03in the context that i just gave it to
4:48:05you i would have added that highlighting
4:48:07just now
4:48:07but in terms of attachments that aren't
4:48:10connected to the emails that's because
4:48:11we didn't get them from purdue yeah
4:48:13you're better about the problem with the
4:48:14brackets
4:48:16it's okay brackets where uh we're not at
4:48:19it
4:48:19okay thank you uh sackler exhibit
4:48:2227 and this is an email
4:48:26from you phase four oxycontin team
4:48:29minutes
4:48:3210 23 96. oh you have the yes
4:48:36okay and you have a copy of it
4:48:42and so this would have been after the
4:48:45launch of oxycontin correct
4:48:48yes okay and it says here
4:48:52michael the oxymen 12 said what was the
4:48:56oxymon 12
4:49:00i don't know
4:49:08um briefly it says results showed the
4:49:12following
4:49:13physicians who attended the dinner
4:49:15programs or the weekend meetings
4:49:17wrote more than double the number of new
4:49:20prescriptions for oxycontin
4:49:22compared to the control group and this
4:49:24was sustained over the three-month
4:49:27post-meeting evaluation period weekend
4:49:29meetings had the greatest impact
4:49:31increasing new prescriptions for
4:49:33oxycontin by a factor
4:49:34between 2.16 and 2.62
4:49:39these results will be presented in more
4:49:41detail at a later date
4:49:43this is very encouraging although i must
4:49:46allow that a proportion of the
4:49:47percentage without the associated
4:49:49absolute numbers is inherently
4:49:51inherently meaningless was the number of
4:49:54increased
4:49:55prescriptions commercially significant
4:49:58if so
4:49:59what would the cost per increase
4:50:01prescription be assuming that the
4:50:02absolute difference persisted
4:50:05when will a more complete report be
4:50:06available and
4:50:09was that your you read it correctly
4:50:15did you ever get a more complete report
4:50:17i don't remember
4:50:26and then above that it looks like
4:50:28alphonse writes back to you
4:50:30and alphonse was alfonso alfonso was
4:50:33head of marketing
4:50:34he was out of marketing and he says
4:50:37interesting comments from dr richard i
4:50:39also wonder if there was a bias in the
4:50:41form of representatives
4:50:42increasing calls to the selected
4:50:44physicians
4:50:46would we get the same roi is that return
4:50:48on investment yes
4:50:50in prescriptions would we get the same
4:50:53return on investment in prescriptions as
4:50:55a result of the representatives
4:50:57increasing the call rate to the selected
4:50:59group regardless of dinners
4:51:02i don't have the list therefore i don't
4:51:03know if there was a selected preference
4:51:05toward this group
4:51:07in the part of the reps it's reasonable
4:51:09that these core doctors were already
4:51:11receiving special attention which would
4:51:12have generated an
4:51:13increase in prescriptions if this is the
4:51:17case the cost of the dinners would
4:51:18unnecessarily
4:51:20increase the cost per prescription right
4:51:22did you all ever determine whether the
4:51:24dinners that you were taking the doctors
4:51:26on
4:51:26were helping sell oxycontin i don't
4:51:40remember
4:51:46yeah this goes over here
4:51:56and then let's mark this
4:52:0028 28. thank you
4:52:13and this says 6999
4:52:18dr richard cycler subject promotion of
4:52:21oxycontin
4:52:23by abbott and if you go down to the
4:52:27bottom
4:52:27it says
4:52:31enclose for your information is a
4:52:33memorandum that mark alfonso
4:52:36that describes a substantial increase in
4:52:38abbott's field force allocation toward
4:52:40oxycontin
4:52:41120 abbott reps previously selling euro
4:52:45kinase
4:52:46which has been temporarily withdrawn
4:52:48from the market will be assigned full
4:52:49time to oxycontin
4:52:51this will be totally at abbott's expense
4:52:53and should have a very positive effect
4:52:55on oxycontin
4:52:56cells
4:53:00that is from michael friedman right
4:53:04correct
4:53:18um
4:53:20was the agreement reached with abbott to
4:53:22sell oxycontin
4:53:23i don't recall the details of the
4:53:25agreement
4:53:32and then up at the top it says sender dr
4:53:35richard
4:53:36sackler so this would be i think your
4:53:38your reply to that
4:53:42and it says that sounds very good for
4:53:44the brand
4:53:45i just hope that we can supply the surge
4:53:48that may follow this program and were
4:53:51you referring to a surge of oxycontin
4:53:53cells
4:54:00yes
4:54:14uh
4:54:21and was it your expectation that
4:54:28the sales representatives
4:54:32were going to create a surge in
4:54:34oxycontin sales
4:54:35i didn't know i said let's hope
4:54:56so
4:55:04and then this is a document
4:55:11that i wanted to bring to your attention
4:55:13because we were talking earlier today
4:55:14where you said
4:55:15you know
4:55:19when i was pointing out to you the
4:55:21documents that
4:55:22uh from your
4:55:26officers that said oxycontin is believed
4:55:29by other physicians to be
4:55:32not as strong as morphine
4:55:36remember us having that discussion i
4:55:38recall you
4:55:41and this is a
4:55:44phase two oxycontin tablets team meeting
4:55:48june 13 1997.
4:55:52so this would be um
4:55:55well over a year after a year and a half
4:55:59after oxycontin has been
4:56:01launched and on the marketplace correct
4:56:06yes
4:56:08about a year and a half maybe a little
4:56:09less
4:56:11and if you could go to the
4:56:20it says marketing and sales update
4:56:24first paragraph mike cullen discussed in
4:56:26detail marketing's positioning of
4:56:28oxycontin he explained we want to expand
4:56:30extensively
4:56:31in the non-cancer market segment while
4:56:33promoting oxycontin as
4:56:35the one to start with in cancer pain and
4:56:38the one to stay with through proper
4:56:40titration
4:56:42and the next paragraph reads we can show
4:56:45that we are as effective
4:56:46as morphine but do not want to say
4:56:49oxycontin is as
4:56:51powerful as morphine
4:56:54now did i read that correctly you read
4:56:56the words
4:56:57words such as powerful may make some
4:56:59people think the drug is dangerous and
4:57:01should be reserved for the more severe
4:57:03pain
4:57:04if i can interject for a moment while
4:57:06you are reading it correctly
4:57:08what you haven't included is the fact
4:57:10that the word powerful is some quotes
4:57:14yes um we'll read it again and include
4:57:18that
4:57:19we can second paragraph we can show
4:57:23that we are quote effective end quote
4:57:26as morphine but do not want to say
4:57:29oxycontin is as quote
4:57:31powerful end quote as morphine words
4:57:33such as quote powerful
4:57:35may make some people think the drug is
4:57:37dangerous and should be reserved for the
4:57:39more severe pain
4:57:40this could have a negative effect in the
4:57:43much larger non-cancer pain market
4:57:46mike reminded the team that we should
4:57:48keep this positioning
4:57:49in mind as we develop future marketing
4:57:51programs symposia
4:57:53clinical study manuscripts and any other
4:57:56items
4:57:57that discuss the use of oxycontin
4:58:06did i read that correctly
4:58:10are you asking me yes i believe you did
4:58:13were you aware that that your marketing
4:58:16and sales team
4:58:18were being careful not to
4:58:22uh and did not want to say that
4:58:24oxycontin
4:58:25is as powerful as morphine
4:58:30i don't recall if i was aware of this
4:58:33and in effect it's twice as powerful as
4:58:35morphine correct no
4:58:37it's not we've gone through this quite a
4:58:40few times
4:58:41and here powerful as in quotes sometimes
4:58:44the words
4:58:46stronger weak or powerful are not in
4:58:49quotes but here
4:58:50it is very clear that it was
4:58:52specifically the word
4:58:53powerful that he did not he was advising
4:58:56people to stay away from
4:58:58it had nothing to do with potency when
4:59:01you go in and see a doctor and you say
4:59:04if they say oxycontin is not as powerful
4:59:07as morphine
4:59:08what do you think the doctor thinks he
4:59:10was not supposed to say that
4:59:13and i don't think he did say that that
4:59:15would create confusion
4:59:18he was warning not to use the word
4:59:21powerful in any context but
4:59:25it clearly didn't mean
4:59:28potency because potency
4:59:31was declared as twice as potent as
4:59:33morphine
4:59:35from day one of marketing to yesterday
4:59:38and today in every piece of material
4:59:43in all the conversion charts
4:59:46and was recognized and understood by
4:59:50physicians
4:59:58mitchell games
5:00:08[Applause]
5:00:13all right go ahead we'll come back to
5:00:14that
5:00:31it's almost 3 30 but it's a good time to
5:00:33take a shower a great time
5:00:35we are off the record at 3 27 pm
5:00:39we are back on the record at 3 42 pm
5:00:48okay um
5:00:51a while ago when we were talking about
5:00:53salespeople making calls
5:00:55did i understand you to say that you did
5:00:57not believe
5:00:59the number of calls made by salesperson
5:01:01affected the number of prescriptions
5:01:03for oxycontin i didn't mean to
5:01:06communicate that
5:01:07thank you in fact purdue had
5:01:11uh requirements on their sales people
5:01:12that they had to make certain number of
5:01:14calls
5:01:15every day to physicians correct there
5:01:17was a standard of number of calls yes
5:01:24and before we broke we were discussing
5:01:27this
5:01:28um phase 2 oxycontin
5:01:33tablets team meeting and
5:01:37to kind of put this in perspective there
5:01:39was this email
5:01:41dated 6 297 so that's june
5:01:442nd 97 that we were discussing earlier
5:01:48where we discussed that physicians
5:01:52did not think oxycontin was as strong as
5:01:56ms conte
5:01:58and that perception was out there and
5:02:02and noted that it was important to be
5:02:04careful not to change the
5:02:06perception by physicians toward
5:02:09oxycodone when developing promotional
5:02:11pieces
5:02:12um mr thompson if you're referring to
5:02:14another document could you identify it
5:02:16and give it to the witness
5:02:17we've already talked about it earlier
5:02:19i'm just asking a question right now
5:02:20well but you're asking your question
5:02:21based on the earlier
5:02:22document of reading you're writing i
5:02:24won't read from it then
5:02:26let me ask you do you recall us having
5:02:27that conversation
5:02:30i'm not sure which document i've seen a
5:02:33lot of documents but i do recall
5:02:35having talking about this many times
5:02:39yes and and
5:02:42your comment was well we're not saying
5:02:44that it's not as strong we're saying
5:02:45it's not as effective
5:02:46um
5:02:50i'm sorry for the form of that question
5:02:52your comment was
5:02:54we're not trying to convey that
5:02:58it's not as powerful
5:03:02is that correct no on
5:03:06what i thought i communicated perhaps i
5:03:09didn't do it
5:03:10well was that the meaning
5:03:14of that word
5:03:17strong was not
5:03:21that it was a weak drug
5:03:24weaker than morphine it was not that
5:03:27meaning
5:03:30it the meaning related to the stigma
5:03:34of morphine and to the fear of morphine
5:03:38and precisely in this case i believe
5:03:42that the efficacy of the drug
5:03:47and i really would like to see the
5:03:49document if i might if we're going to
5:03:51talk about it because i'd like to
5:03:52refresh my memory
5:03:54not only as to the document as to what i
5:03:58had meant to say if i didn't say it
5:04:00clearly here's the one we were talking
5:04:01about when we wrote
5:04:06what exhibit is that sir 29 it's on the
5:04:09bottom
5:04:1029. okay
5:04:20and they've actually used two words here
5:04:22that are in quotes correct
5:04:24one is effective and one is powerful and
5:04:27the sentence reads
5:04:28we can show that we are as effective as
5:04:30morphine
5:04:32but we do not want to say oxycontin is
5:04:35as powerful as morphine did i read that
5:04:38correctly
5:04:38that's correct
5:04:52the have you reviewed the oxycontin
5:04:56abuse and diversion and efforts to
5:04:57address the problem
5:04:59that was put out in december 2003 by the
5:05:02gao no i did not review that
5:05:14you've never seen that document is that
5:05:17correct
5:05:18do you want to mark it as an exhibit uh
5:05:20i will
5:05:21yes but have you ever seen that document
5:05:23i don't recollect seeing that document
5:05:27if you return to page nine
5:05:42and i'm looking at the second paragraph
5:05:45last two sentences in both 2001 and 2002
5:05:50oxycontin sales exceeded 1 billion 1
5:05:53billion
5:05:54and prescriptions were over 7 million
5:05:57the drug became purdue's main product
5:06:00accounting for 90 percent of the
5:06:01company's total prescription sales
5:06:03by 2001. is that information correct
5:06:08to the best of my recollection it's
5:06:10correct or almost
5:06:11very close to correct and if you'll turn
5:06:14to page 17.
5:06:31under the heading purdue focused on
5:06:33promoting oxycontin for treatment of
5:06:35non-cancer pain and if you go down to
5:06:38the
5:06:41last sentence of the second paragraph it
5:06:43says one of purdue's goals was to
5:06:44identify
5:06:45primary care physicians who would expand
5:06:48the company's oxycontin prescribing base
5:06:51sales representatives were also directed
5:06:53to call on oncology nurses consultant
5:06:55pharmacists hospices
5:06:56hospitals and nursing homes and is that
5:06:59information accurate
5:07:05as a general proposition yes it doesn't
5:07:09include oncologists i don't think in the
5:07:11spirit i think it's accurate
5:07:15and then down second sentence from the
5:07:17bottom
5:07:18purdue has stated that by 2003
5:07:22primary care physicians had grown to
5:07:24constitute nearly half
5:07:27of all oxycontin prescribers based on
5:07:30data
5:07:30data from ims health and information
5:07:32service providing pharmaceutical market
5:07:34research
5:07:36is that information accurate i can't
5:07:38vouch for the accuracy of this
5:07:57the next sentence says dea's analysis of
5:08:00physicians prescribing
5:08:02oxycontin found that the scope of
5:08:04medical specialties was wider for
5:08:06oxycontin
5:08:07than five other controlled release
5:08:09schedule ii narcotic
5:08:10analgesics dea
5:08:14and is that the drug enforcement agency
5:08:16i believe it would be
5:08:17dea expressed concern that this resulted
5:08:20in oxycontin's being promoted to
5:08:22physicians who were not adequately
5:08:23trained in pain
5:08:24management do you recall the dea
5:08:27expressing that concern
5:08:29no
5:08:35all right next two sentences produced
5:08:37promotion of oxycontin for the treatment
5:08:39of non-cancer pain contributed to a
5:08:41greater increase in prescriptions for
5:08:43non-cancer pain
5:08:44than for cancer pain from 1997 through
5:08:472002
5:08:49according to ims health data the annual
5:08:51number of oxycontin prescriptions for
5:08:53non-cancer pain increased nearly 10
5:08:55fold from about 000 in 1997 to 6.2
5:09:00million
5:09:00in 2002.
5:09:04is that information accurate
5:09:07i i don't know
5:09:11i just don't have these numbers in my
5:09:14mind
5:09:16if you'd go to page 20.
5:09:27second paragraph by more than doubling
5:09:30its total sales representatives purdue
5:09:32significantly increased the number of
5:09:34physicians to whom it was promoting
5:09:35oxycontin
5:09:39uh each purdue sales representative had
5:09:41specific sales territory and is
5:09:43responsible for developing a list of
5:09:44about 105 to 140 positions to call
5:09:48on who already prescribe opioids who are
5:09:50or who are candidates for
5:09:52prescribing opioids in 1996
5:09:56the 300 plus purdue sales
5:09:57representatives had a total physician
5:09:59call list of approximately 33
5:10:01400 to 44 500.
5:10:04by 2000 the nearly 700 representatives
5:10:08had a total call list of approximately
5:10:1070 500 to 94
5:10:13000 physicians each purdue sales
5:10:16representative is expected to make
5:10:1835 position calls per week and typically
5:10:21calls on
5:10:22each physician every three to four weeks
5:10:25each hospital sales representatives is
5:10:27expected to make about 50 calls per week
5:10:29and typically calls on each facility
5:10:30every four weeks was that to your
5:10:33knowledge
5:10:34accurate information about how purdue
5:10:38was marketing oxycontin through its
5:10:42sales force
5:10:45without quibbling it isn't really
5:10:48you're asking me to vouch for the
5:10:50accuracy of this i i just don't carry
5:10:52these numbers in my mind
5:10:55um so i can't agree or just i just don't
5:10:58know
5:10:59uh but this is a count of physicians
5:11:04and a description of the standards
5:11:08of calls but i don't
5:11:12but that's that really doesn't describe
5:11:15how we were
5:11:16marketing it to you use your questions
5:11:18so i'm not trying to
5:11:19quibble with you sir but uh i just
5:11:23don't know all right and if you'll go
5:11:25down to the middle of that next
5:11:26paragraph
5:11:28the total amount of bone the amount of
5:11:30total bonuses that purdue estimated were
5:11:32tied to oxycontin sales
5:11:33increased significantly from about 1
5:11:35million in 1996
5:11:37when oxycontin was first marketed to
5:11:40about
5:11:4040 million in 2001.
5:11:44do you recall uh do you have any reason
5:11:46to
5:11:48disagree with the 40 million number for
5:11:52bonuses paid out to your marketing
5:11:54salesman in 2001. i don't
5:11:57i don't know the number so i don't have
5:11:59any reason to disagree
5:12:07and then if you go to the next page
5:12:10last paragraph it says according to
5:12:12dea's analysis of ims health data
5:12:15purdue spent approximately 6 to 12 times
5:12:18more
5:12:18on promotional efforts during
5:12:20oxycontin's first six years on the
5:12:21market
5:12:22than it had spent on its older product
5:12:24ms cotton during its first six years
5:12:27or then had been spent by jansen
5:12:29pharmaceutical
5:12:30or one of oxycontin's drug competitors
5:12:34durajesus did you see that yep yes i do
5:12:37is that accurate i don't know
5:12:41i have no reason to to agree with it or
5:12:44disagree i just don't know
5:13:01do you believe purdue's marketing was
5:13:03overly aggressive
5:13:08no
5:13:22um
5:13:25yeah do you believe purdue's marketing
5:13:26was appropriate
5:13:28i believe so um
5:13:31it says here under on page 30
5:13:34oxycontin's wide availability
5:13:36may have increased opportunities for
5:13:38illicit use
5:13:40um i'm sorry what page you've reduced
5:13:45page 30 yes 3-0
5:13:50okay
5:13:53okay and where should i look
5:13:58um last paragraph
5:14:01okay a large amount of oxycontin
5:14:03available in the marketplace may have
5:14:05increased opportunities for abuse and
5:14:07diversion both dea and purdue have
5:14:09stated that an increase in a drug's
5:14:10availability in the marketplace
5:14:12may be a factor that attracts interest
5:14:14by those who abuse and divert drugs
5:14:17oxycontin if you go on down
5:14:23oxycontin became the top selling name
5:14:26brand narcotic pain reliever in 2001.
5:14:30is that accurate i don't know but
5:14:35i just don't know
5:14:46yeah so
5:14:49um let's mark that as exhibit
5:15:0030.
5:15:11have you ever seen an article called
5:15:13what happened to the poster children of
5:15:15oxycontin
5:15:18no that doesn't sound familiar nobody
5:15:21has ever provided that to you at purdue
5:15:22pharma
5:15:25when was it published september 8
5:15:292012. no
5:15:32i wouldn't necessarily have been
5:15:35provided
5:15:36to the board
5:15:41but i don't i i really i'm not familiar
5:15:44with it
5:15:54do you recall a time when purdue's
5:15:56oxycontin was considered so successful
5:15:58that other companies were thinking about
5:16:00whether they could make their own
5:16:01version of oxycontin
5:16:06just re just ask the question again so i
5:16:09can answer it
5:16:10sure do you recall a period of time
5:16:14where oxycontin was considered so
5:16:16successful that other companies
5:16:18were considering making their own
5:16:20version
5:16:21of oxycontin um i can't
5:16:24say that they did it because it was
5:16:27quote
5:16:27so successful but i do recall
5:16:31that i did hear that other companies
5:16:35were trying to copy oxycontin yes
5:16:43thank you
5:17:01so this is an email chain that was
5:17:03provided
5:17:05let's go ahead and mark that as 31
5:17:13and
5:17:16if you go to page two
5:17:20it says subject press release or similar
5:17:23promotion
5:17:24author dr richard sackler 8 23
5:17:2796. just just let me catch up with you
5:17:318 23 90 at the bottom of the page
5:17:39okay i'm with you
5:17:46and it says um
5:17:50i think it is noteworthy to release
5:17:51information on oxycontin tablets its use
5:17:54and success in the market and the
5:17:56tremendous reception it received in
5:17:57vancouver
5:17:59uh we've basically the newsworthy
5:18:02occasion is that this product has
5:18:03achieved
5:18:04our first year sales projection four
5:18:06months early
5:18:07and that by the end of the year we
5:18:09should have from 130
5:18:11000 to 150 000 per
5:18:14salesman of sales the objectives of this
5:18:17release would be stimulate interest in
5:18:20the u.s community
5:18:22in the medical community of the u.s to
5:18:24recognize the tremendous success of
5:18:26oxycontin tablets clinically
5:18:28and the ratification commercially we
5:18:31want many more
5:18:32physicians than have presently used it
5:18:34to become aware of its availability and
5:18:36importance in their practice
5:18:37it would be hoped that this would lead
5:18:39to greater use by those currently
5:18:40prescribing and broaden
5:18:42our prescribing base in the u.s and
5:18:44canada
5:18:46and do you know whether that press
5:18:49release
5:18:50took place i don't know
5:19:06and then above that it looks like
5:19:09there's a response to your
5:19:14email from robert reader
5:19:17yes given the diverse in both short and
5:19:20midterm goals i would recommend a
5:19:22full-fledged pr
5:19:23firm with a one to three year contract
5:19:26that way this can be coordinated
5:19:28actively to achieve all goals rather
5:19:29than a one-shot flash
5:19:32is this a departure from traditional pf
5:19:35slash pplp and that's purdue frederick
5:19:38slash
5:19:39purdue pharma lp strategy
5:19:43correct and
5:19:47you wrote back and said i don't see this
5:19:50as a quote departure from policy
5:19:53and then it looks like and perhaps this
5:19:56is
5:19:57friedman who says
5:20:01my view is different if you want to use
5:20:03pr to
5:20:04signal our market as to our development
5:20:06pipeline i have no problem
5:20:08i do not want to spend money on pr to
5:20:10increase sales
5:20:11we do not need to have an agency in our
5:20:14pockets i have learned my lessons
5:20:18and then you write back on the page one
5:20:21and say
5:20:22i agree about the agency i want to
5:20:25signal the licensing
5:20:27in market for the product around the
5:20:29world
5:20:30get an audience for our patent
5:20:32infringement suits so that we are feared
5:20:34as a tiger with claws teeth and balls
5:20:37and build some excitement with
5:20:39prescribers that oxycontin tablets is
5:20:41the way to go
5:20:43and what was your concern there about
5:20:47licensing and patent infringement well
5:20:50licensing in market
5:20:54meant the
5:20:57get the attention of companies that had
5:21:00products
5:21:00that might be
5:21:04attractive for us to license
5:21:14do you recall
5:21:18howard udall making a trip down to
5:21:20kentucky to meet with
5:21:21attorney general greg stumbo and other
5:21:24members of the
5:21:29of his staff i don't recall it no
5:21:34this is a letter dated may 17 2005
5:21:38and that would be prior to the
5:21:43felony plea agreement that purdue
5:21:45frederick entered into correct
5:21:47i'm not i think i'm clear on the dates
5:21:50and that that would be correct
5:21:53please correct somebody here correct me
5:21:55if i'm wrong
5:22:03and um you'll turn to page six
5:22:11this is appears to be a letter from
5:22:14howard udall dated may 17
5:22:162005 to greg stumbo the attorney general
5:22:19of kentucky
5:22:28and he points out that
5:22:31[Music]
5:22:35none of the federal courts in kentucky
5:22:38has found any misconduct on the part of
5:22:40purdue correct
5:22:42i'm not sure just where you're reading
5:22:44sorry i'm on page five
5:22:46oh page five i'm sorry i was on the
5:22:48wrong page
5:22:58and where are you reading from the third
5:23:01paragraph down
5:23:08and it begins i believe that even this
5:23:10brief
5:23:12no it's i'm reading middle of the
5:23:15paragraph
5:23:16significantly however not one of these
5:23:17courts has found any misconduct on the
5:23:19part of purdue okay
5:23:21please bear with me while i try to find
5:23:24this
5:23:44you see that right above the case sites
5:23:48i'm sorry uh in the paragraph that has a
5:23:50list of cases
5:23:51yes the paragraph so significantly
5:23:54however
5:23:55thank you yeah purdue answered
5:23:58filed an answer in all of these cases
5:24:00and claimed they had never done anything
5:24:02improper or wrong isn't that true i
5:24:05don't know
5:24:08are you aware part of the that is i
5:24:10don't know whether we filed
5:24:13in the in all these cases or whatever
5:24:15that's what i mean when i say i don't
5:24:17know
5:24:17are you aware of purdue ever admitting
5:24:20to doing anything
5:24:21improper
5:24:24prior to the plea agreement
5:24:28where
5:24:31the company pled guilty to a felony of
5:24:34misbranding a drug with the intent to
5:24:36defraud or mislead
5:24:39okay just ask the question
5:24:42before the play
5:24:47am i what are you aware of anyone at
5:24:50purdue
5:24:52ever admitting they did anything
5:24:53improper
5:24:55prior to entering into the plea
5:24:58agreement
5:24:59where the company pled guilty to
5:25:02misbranding a drug with the intent to
5:25:04defraud or mislead
5:25:09i am not aware of anybody
5:25:16and then if you go to page six
5:25:21the middle of the second paragraph from
5:25:23the bottom
5:25:29it says first any suit bought under the
5:25:33act requires proof that a defendant
5:25:34engaged in a practice of violation of
5:25:36kirs 367 170
5:25:40an insurmountable obstacle since purdue
5:25:43has committed no
5:25:44unlawful act
5:25:50did i read that correctly you did and
5:25:52were you aware that
5:25:54howard udall had communicated with
5:25:58greg stumbo that purdue had commuted
5:26:00committed no unlawful act on may 17
5:26:032005.
5:26:06i think he was writing for purdue pharma
5:26:09just for clarity but i was not aware of
5:26:12this
5:26:21yeah from may 17th of 2005
5:26:25did purdue frederick exist
5:26:28i don't know
5:26:34do you know if the companies were merged
5:26:36at some point i don't believe they were
5:26:44let's talk about the agreed statement of
5:26:46facts do we have another copy of this
5:27:09yeah that's a good idea too the letter's
5:27:12going to be exhibit
5:27:1332 32 and the agreed statement is going
5:27:16to be exhibit 33
5:27:17let's hand this out by the letter you
5:27:19took with the udella
5:27:21yeah the may 2005.
5:27:35who was in charge of preparing and
5:27:36approving the sales and marketing
5:27:38materials at the time of oxycontin's
5:27:40release
5:27:41i'm sorry at the time of oxycontin's
5:27:44release
5:27:44release meaning launch launch
5:27:50michael friedman i believe
5:27:53and at that time at the time of the
5:27:55launch who was in charge of the
5:27:56marketing department
5:28:02to the best of my recollection mark
5:28:04alfonso
5:28:06and michael friedman was he the person
5:28:09who ultimately was appointed ceo of
5:28:11purdue
5:28:12he was purdue pharma
5:28:16is he one of the individuals who pled
5:28:18guilty to the misdemeanor
5:28:19at the time of the plea agreement yes
5:28:30do you recall whether purdue had
5:28:31received warning letters about its
5:28:33marketing
5:28:34of ms cotton i don't recall
5:28:39you don't recall six warning letters
5:28:41coming in from ms cotton
5:28:43no i don't i don't recall the the
5:28:46instances
5:28:54do you recall purdue getting warning
5:28:56letters
5:28:57with respect to the way it was marketing
5:28:59ms uh
5:29:00marketing oxycontin i don't recall
5:29:05do you know if purdue consistently
5:29:09denied it was doing anything wrong with
5:29:11respect to marketing oxycontin
5:29:17i'm not sure i i would think
5:29:20that we denied uh doing anything wrong
5:29:24but that's a guess on my part i don't
5:29:26really know
5:29:42were you involved in approving the
5:29:45agreed statement of facts or the guilty
5:29:47plea
5:29:50the board voted in favor of management's
5:29:53recommendation
5:29:55that we have that we plead guilty
5:29:59uh under a plea agreement with the u.s
5:30:02attorney
5:30:05and just so there's no confusion
5:30:09the board and
5:30:12voted to adopt the agreed statement of
5:30:15facts
5:30:19is that correct i don't know i don't
5:30:24remember
5:30:30uh is the agreed statement of facts
5:30:32accurate
5:30:34i believe it is
5:30:45and in addition to the guilty plea
5:30:49of a felony for
5:30:57misbranding a drug with the intent to
5:30:59defraud on this
5:31:00lead and that drug is oxycontin correct
5:31:04i believe it is these three individuals
5:31:08howard udall michael friedman and paul
5:31:11goldenheim
5:31:12also pled guilty to misdemeanors correct
5:31:18yes and howard udall
5:31:21was purdue's executive vice president
5:31:24and chief
5:31:24legal officer he was
5:31:27michael friedman was the president and
5:31:29ceo
5:31:30of purdue at the time of the guilty plea
5:31:32i believe he was
5:31:34and paul goldenheim was the former
5:31:37executive vice president for worldwide
5:31:39research and development
5:31:41and chief scientific officer correct
5:31:45i believe so by 2006 dr goldenheim had
5:31:49already
5:31:50left purdue correct yes did he leave
5:31:53voluntarily
5:31:54he did what reason did he provide you
5:31:56regarding why he was leaving purdue
5:31:59he was leaving purdue in order to be ceo
5:32:03of another company
5:32:07have you seen this agreed statement of
5:32:08facts before
5:32:11before today yes yes
5:32:15did you provide comments on this
5:32:17document
5:32:18no i did not
5:32:23were you surprised by any of the
5:32:25allegations in the document
5:32:33i don't i didn't read the whole document
5:32:38um so i can't say if there are
5:32:40allegations that would surprise me
5:32:42i had understood that this was a
5:32:45settlement
5:32:46document and that
5:32:49people in the company who investigated
5:32:54thoroughly said to the board that
5:32:58the statements in the document were true
5:33:02and when you say i didn't read the
5:33:05document
5:33:06as we sit here today have you ever read
5:33:08the entire document no
5:33:12at the time this was signed in uh
5:33:19may 7th and 8th of 2007
5:33:22what was your position in the company i
5:33:24was a director of the company did you
5:33:28have any other role
5:33:29at that time not to my recollection
5:33:32for a period of time after i
5:33:35ceased to be ceo in early 2003
5:33:39i was co-chair non-executive chairman of
5:33:42the board
5:33:44but that came to an end more or less
5:33:48around this time but i don't remember
5:33:50that
5:33:50whether it was before the play or after
5:33:53you ceased to be ceo in 2003
5:33:56that's correct when were you first
5:33:58notified that the
5:34:00u.s attorneys for the western district
5:34:04of virginia were investigating purdue
5:34:07i can't recall precisely
5:34:10i we were as a board notified
5:34:14that the u.s attorney was investigating
5:34:20oxycontin abuse and diversion
5:34:24and that the law department in general
5:34:28and howard udell in particular
5:34:30were providing any documents he wished
5:34:34voluntarily to help his investigation
5:34:40that the investigation turned on purdue
5:34:44was a surprise but i don't remember
5:34:47when that happened was it before you
5:34:50left a ceo
5:34:51i don't recall do you recall
5:34:54there being issues about addiction
5:34:58dependency tolerance buildup
5:35:02abuse and diversion
5:35:05prior to your leaving a ceo
5:35:08yes not all of those but
5:35:13abuse and diversion yes
5:35:17do you recall there being issues with
5:35:19addiction
5:35:20yes same time as i was
5:35:25informed about a possible abuse and
5:35:27diversion
5:35:28and when were you first informed about
5:35:31possible abuse and diversion sometime in
5:35:342000
5:35:38an article was published in a newspaper
5:35:41in maine
5:35:43that very graphically
5:35:47described the impact
5:35:50of abuse and diversion of individuals
5:35:53who were using oxycontin
5:35:56that was the first that was the first
5:35:59time
5:35:59i became aware of that possibility
5:36:27okay let me see do you recall receiving
5:36:30a letter
5:36:31or being notified about a letter
5:36:34from a hospital in
5:36:40pikeville or hazard
5:36:44concerning
5:36:51problems with patients who are on
5:36:53oxycontin
5:36:57i don't recall a letter was it directed
5:37:01to me i don't believe so i think it came
5:37:04to purdue
5:37:04and i'm wondering if you saw it
5:37:23someone mitchell had
5:37:27all right let's go back to the play
5:37:28agreement and try to get through this
5:37:38um
5:37:49are you aware that we've requested
5:37:51purdue to
5:37:53identify the names of documents
5:37:54referenced in the agreed statement
5:37:56of facts i'm not aware of that
5:38:07um are you aware we've asked them to
5:38:09identify the individuals who are
5:38:10referenced in the agreed statement of
5:38:12facts
5:38:20no
5:38:29paragraph if we can go to
5:38:33paragraph 13 of the agreed statement
5:38:51paragraph 13 says that on december 28
5:38:542004 purdue submitted an oxycontin nda
5:38:58to the fda
5:39:00the ndaa included clinical trials
5:39:02showing that oxycontin when dosed every
5:39:0412 hours
5:39:05was as safe and as effective as
5:39:07immediate release oxycodone
5:39:09dosed every 12 hours every six hours i
5:39:12meant sorry every six hours yes
5:39:14yes and then that's what it says and
5:39:16then paragraph 14
5:39:18says the nda did not claim that
5:39:20oxycontin was safer
5:39:21or more effective than immediate release
5:39:24oxycodone or other pain medications and
5:39:26purdue did not have and did not provide
5:39:28the fda
5:39:29with any clinical studies demonstrating
5:39:31that oxycontin
5:39:32was less addictive less subject to abuse
5:39:35and diversion
5:39:36or less likely to cause tolerance and
5:39:38withdrawal than other pain medications
5:39:41and is that paragraph correct that's
5:39:44what it says
5:39:47i don't know if it's correct but
5:39:52i wouldn't differ with it
5:40:05and then there are some medical officer
5:40:09reviews
5:40:10correct yeah i believe those are within
5:40:13the fda
5:40:14right and those also did not state that
5:40:17oxycontin was more effective
5:40:20than or superior to safer
5:40:23had less opioid effects or caused fewer
5:40:25adverse events than
5:40:27any other marketed product correct i
5:40:30believe that's true
5:40:32and and let me back up a minute
5:40:35do you know what when salespeople go
5:40:38call on physicians
5:40:39what type of information the physician
5:40:42usually asks the salesperson
5:40:43i would not be able to comment on that
5:40:46you don't know whether
5:40:47they want to know if there's any studies
5:40:49if there's any
5:40:50contraindications to the medicine any
5:40:52problems reported
5:40:54that makes sense i thought you meant in
5:40:57more
5:40:57that's a very general thing they want to
5:41:00understand
5:41:02what is the medicine for what kind of
5:41:04condition
5:41:06who are the patients
5:41:10what are the what is the effectiveness
5:41:12they might ask for comparative
5:41:14effectiveness
5:41:16if it exists and and if it doesn't exist
5:41:20the answer is we can't give you any they
5:41:23might ask
5:41:24about safety they might ask about
5:41:26anything related to
5:41:29what they feel they should know when
5:41:32they
5:41:33were they to use the medicine one of the
5:41:35things they might ask is
5:41:36why is it better than what i'm already
5:41:38using why should i switch
5:41:39is that reasonable perfectly reasonable
5:41:42one of the things they might ask is
5:41:44you know you got any studies that show
5:41:47it's better is that another thing that
5:41:50comes up they might
5:41:57paragraph 16 says
5:42:04the medical officer review
5:42:07of the iss included these statements
5:42:11and
5:42:16the blood level data and clinical use
5:42:18suggests the opioid effects
5:42:20would be of oxycontin and immediate
5:42:22release oxycodone
5:42:24would be similar and
5:42:27to your knowledge is that
5:42:30clinically correct well it's an
5:42:33inference
5:42:35and i certainly can't differ with the
5:42:38inference
5:42:46but it may not be correct
5:42:51under d it said withdrawal is possible
5:42:53in patients who have their dosage
5:42:55abruptly reduced or discontinued
5:42:59is that your understanding of the
5:43:00characteristic of the drug
5:43:02absolutely
5:43:11then it said care should be taken to
5:43:13limit competitive promotion
5:43:16oxycontin has been shown to be as good
5:43:18as current therapy but has not been
5:43:19shown to have a significant advantage
5:43:22beyond reduction in frequency of dosing
5:43:25and is that your understanding of the
5:43:27characteristic of the drug
5:43:29no it is my understanding
5:43:32that that statement is correct
5:43:36but the reason i said
5:43:39that that may not be the case
5:43:43was the very surprisingly
5:43:46large number of reports
5:43:49from the field that i heard second and
5:43:52third hand
5:43:54that early in the life of the product
5:43:58doctors spontaneously volunteered that
5:44:01the drug was
5:44:02better than we said it was and this was
5:44:05so frequent
5:44:07and so unusual
5:44:10that it raised in my mind
5:44:14and continues to raise the question
5:44:18maybe it is actually superior
5:44:21but we were never able to demonstrate
5:44:25using the methods that would be
5:44:28generally accepted that this was the
5:44:31case
5:44:32it was an impression that doctors
5:44:35developed
5:44:36on their own any studies
5:44:40retrospective studies anything of that
5:44:42nature that would
5:44:44support that statement no i said we
5:44:47could never prove it
5:44:50so if you go on here under the heading
5:44:52misbranding of oxycontin
5:44:55and and when we talk about
5:44:59misbranding that's just really making
5:45:02claims and statements that
5:45:04aren't true about a drug that's called
5:45:06misbranding the drug is that correct
5:45:08no i wouldn't say it's that i would say
5:45:10it's
5:45:11got a different meaning
5:45:14in the regulatory world it's stating
5:45:18things
5:45:19that are not strictly in the package
5:45:22insert
5:45:24they may be true but if they're not in
5:45:26the package insert
5:45:28they're misbranding
5:45:35um
5:45:38yeah do you know if purdue had
5:45:40information that physicians were
5:45:42concerned
5:45:43about the abuse potential for oxycontin
5:45:48i do not did not have that it wouldn't
5:45:51surprise me that physicians would be
5:45:53concerned
5:45:54about that as with any other
5:45:58strong opioid or in fact any other
5:46:00opioid
5:46:02let me refer you to paragraph
5:46:0620.
5:46:13it says here beginning on or about
5:46:17december 12
5:46:181995 and continuing on
5:46:21or about june 30 2001
5:46:25and that is the time frame that the u.s
5:46:28attorney's office looked into
5:46:31um the conduct at purdue correct
5:46:34i don't know
5:46:40certain purdue supervisors and employees
5:46:43with the intent to defraud or mislead
5:46:47marketed and promoted oxycontin as less
5:46:50addictive
5:46:50less subject to abuse and diversion and
5:46:53less likely to cause
5:46:55tolerance and withdrawal than other pain
5:46:57medications as follows under
5:47:00a it says that you trained purdue sales
5:47:04representatives
5:47:05meaning when i say you mean purdue the
5:47:06company trained produced sales
5:47:09representatives and told some health
5:47:10care providers that it was more
5:47:12difficult to extract the oxycodone from
5:47:14an oxycontin tablet
5:47:16for the purpose of intravenous abuse
5:47:19although purdue's own study
5:47:21showed that a drug abuser could extract
5:47:23approximately 68 percent of the
5:47:24oxycodone from a single 10 milligram
5:47:27milligram oxycontin tablet by crushing
5:47:30the tablet stirring it in water and
5:47:31drawing the solution through cotton into
5:47:33a syringe
5:47:35were you aware that purdue trained sales
5:47:38representatives to make that
5:47:40misrepresentation
5:47:41now is that a misrepresentation that
5:47:45would
5:47:48cause a physician to be more likely to
5:47:50use
5:47:52to write prescriptions for oxycontin or
5:47:54less likely to write prescriptions for
5:47:56oxycontin
5:47:57i would i couldn't guess the implication
5:48:00is that it would be more likely but i
5:48:03don't know
5:48:05and then number b says told purdue sales
5:48:09representatives
5:48:10they could tell health care providers
5:48:11that oxycontin potentially creates less
5:48:14chance for addiction than immediate
5:48:15release
5:48:16opioids
5:48:19were you aware that purdue told sales
5:48:21representatives
5:48:23they could tell healthcare providers
5:48:25that there was
5:48:26less chance for addiction with oxycontin
5:48:30than with immediate release opioids
5:48:33no i was not aware of that
5:48:38and undersea it says sponsored training
5:48:40that taught produced sales supervisors
5:48:43that oxycontin had fewer peak and trough
5:48:45blood level effects than immediate
5:48:47release opioids resulting in less
5:48:48euphoria
5:48:50and less potential for abuse than
5:48:52short-acting opioids
5:48:53were you aware that they were teaching
5:48:56sales supervisors to make that
5:49:01misleading
5:49:05absolutely not statement
5:49:09under d it says told healthcare
5:49:11providers that patients could stop
5:49:13therapy abruptly without experiencing
5:49:15withdrawal symptoms and that patients
5:49:17who took
5:49:17oxycontin would not develop tolerance to
5:49:20the drug
5:49:21i object to the form of the question in
5:49:22reading d
5:49:24you omitted the word certain which
5:49:26appears before
5:49:27health care providers now let me read it
5:49:30again
5:49:31under d purdue told certain health care
5:49:34providers that patients could stop
5:49:36therapy abruptly without experiencing
5:49:39withdrawal symptoms and that patients
5:49:41who took oxycontin would not develop
5:49:43tolerance to the drug were you aware
5:49:45that
5:49:46certain health care providers were being
5:49:48told
5:49:49that they could stop therapy abruptly
5:49:52without experiencing
5:49:53withdrawal symptoms and that patients
5:49:56who took oxycontin would not develop
5:49:58tolerance to the drug
5:50:00no okay and that statement is false
5:50:03correct
5:50:04it no it's it's
5:50:08it it's not clear to me it's false
5:50:11but i am
5:50:15eager not to
5:50:18to contend with it
5:50:22it says certain healthcare providers
5:50:27and it the rest of it
5:50:31is conditioned really in large measure
5:50:34on in the first case the dose that the
5:50:37patient is on
5:50:39and the second case in the duration
5:50:42that the patient is on but
5:50:46reading between the lines as i suspect
5:50:50those who shape this did and
5:50:53understood but the government i can
5:50:56accept it
5:50:57as being a reasonable
5:51:00expression of of improper
5:51:04conduct that is certain health care
5:51:06providers might have been told
5:51:08regardless of dose
5:51:10or regardless of duration but had i
5:51:13known about this i would have
5:51:15alerted our attorneys for negotiating
5:51:17this that that this ought to be a little
5:51:19bit more specific because it's going to
5:51:21be difficult to agree with it the way
5:51:23it's written
5:51:24but i'm i won't quibble with it well
5:51:26there was actually a whole lot of back
5:51:28and forth
5:51:28on this document there may have been but
5:51:30it wasn't
5:51:32with me and a lot of the things brought
5:51:34up the u.s attorney's office said no
5:51:36we're we've reviewed the documents and
5:51:39we're not changing this stuff
5:51:40is that what happened i don't know
5:51:43just just to be clear in the document
5:51:45we're reading the great statement of
5:51:46facts
5:51:48purdue refers to the purdue frederick
5:51:52company
5:51:52which is the practice we've had in this
5:51:54deposition from the outset that you've
5:51:56used purdue
5:51:56to refer to purdue frederick yes yes
5:52:00and because nobody at purdue is able to
5:52:03say which employees were purdue
5:52:04frederick and which employees were
5:52:06purdue pharma as far as i've been able
5:52:08to ascertain in any of the depositions
5:52:10i've read so far
5:52:13including ones taken in the past but
5:52:14we'll cover that later
5:52:17under e here it says
5:52:21that purdue super certain purdue
5:52:25supervisors and employees with the
5:52:26attempt to defraud or mislead
5:52:30call told certain health care providers
5:52:33that oxycontin did not cause a
5:52:34quote buzz in quote or euphoria
5:52:38caused less euphoria had less addiction
5:52:41potential
5:52:42had less abuse potential was less likely
5:52:45to be diverted than immediate release
5:52:47opioids
5:52:48and could not be and could be used to
5:52:51quote weed out
5:52:52addicts and drug seekers and were you
5:52:55aware
5:52:56that those statements were being made to
5:52:59health care providers no
5:53:04and then the next section is miss
5:53:06branding of oxycontin use of
5:53:08graphographical depictions by sales
5:53:11representatives
5:53:14and it says data from purdue's clinical
5:53:17studies was used to create
5:53:19a following graphical demonstration of
5:53:22the difference in the plasma levels at
5:53:24steady state between patients who took
5:53:26oxycontin every 12 hours
5:53:27and patients who took immediate release
5:53:29oxycontin every six hours
5:53:40and it says that on october 12 1995
5:53:43purdue requested comments from the fda's
5:53:45division of drug marketing
5:53:46advertising communication about its
5:53:48proposed launch marketing materials
5:53:51which included the following graft and
5:53:53text showing oxycodone plasma
5:53:55concentration provided by oxycontin
5:53:57on a logarithmic scale along with a
5:54:00statement that oxycontin's oxycodone
5:54:02blood plasma levels
5:54:04provided fewer peaks and valleys than
5:54:06immediate release
5:54:07oxycontin
5:54:11oxycodone oxycodone i'm sorry um
5:54:15paragraph it says
5:54:18on december 20th of 95 actually we're
5:54:21going i'm sorry
5:54:22term page yes okay thank you
5:54:26on december 20th 95 after reviewing the
5:54:28proposed oxycontin lodge materials
5:54:32ddmac what does ddmac dd mac
5:54:35[Music]
5:54:36it's the division of the fda
5:54:40i don't know what the letters stand for
5:54:42but it is the division of the fda
5:54:45that reviews promotional materials
5:54:48and comments on their agreement
5:54:52that they are reasonably
5:54:56reasonable and accurate and consistent
5:54:58with the package insert
5:54:59or they differ with them and recommend
5:55:03changes or elimination of things and
5:55:07you know to sort of cut through it what
5:55:08they did is they said if you wish to
5:55:10compare blood levels
5:55:11in this text we suggest that the blood
5:55:15levels for both dosage forms be
5:55:17presented in the graphics so that the
5:55:18reader can accurately
5:55:19interpret this claim they felt it was
5:55:22misleading the way it was
5:55:24correct no i don't i don't think so i
5:55:26think they had a suggestion
5:55:28that we should add that and i don't know
5:55:30why it wasn't there
5:55:32um we certainly had the data as shown
5:55:35above
5:55:36okay um so i assume we added the data
5:55:40and then it says paragraph 24
5:55:43on or about january 11 1996 purdue told
5:55:46ddmac
5:55:47that it had quote deleted the statement
5:55:50fewer peaks and valleys than with
5:55:52immediate release oxycodone
5:55:56and they took the statement out correct
5:55:59that's what it says i don't know why it
5:56:02was true
5:56:06but i i have no knowledge of the
5:56:09dialogue between them or
5:56:11why they took it out did you review any
5:56:14of the studies that were done
5:56:16i mean actually get down and look at the
5:56:18data in the studies that were done prior
5:56:20to the launch
5:56:21i looked at the analysis of studies
5:56:25but i didn't look at the data that is
5:56:28the individual case report forms
5:56:30and as we sit here today have you ever
5:56:32seen the data
5:56:33of the studies themselves no that would
5:56:36be
5:56:38voluminous and
5:56:41i don't i don't think it would be
5:56:45necessary for a senior executive to do
5:56:47that
5:56:48because every study is subject to
5:56:51extremely rigorous
5:56:55validation of the database with the
5:56:59paper record the paper record that
5:57:01exists with the doctor's own records
5:57:04and so
5:57:08this approach which has been standard in
5:57:11the industry and i believe
5:57:12part of good practices or one of the
5:57:17other standards that the fda has
5:57:18promulgated
5:57:20is extremely exhaustive which
5:57:23is one of the reasons that studies take
5:57:25so long because the validation the data
5:57:28can take anything from a month to a year
5:57:31are you saying that your studies that
5:57:33you did before putting purdue
5:57:34on the mark were extremely exhaustive
5:57:38they were certainly appropriate for a
5:57:42molecule
5:57:43that had been in use at that point 80
5:57:46years or more
5:57:49that was believed then to
5:57:52be safe and effective as a molecule
5:57:57and that had no
5:58:01at that time no long-term
5:58:05toxicities that hadn't been well
5:58:07developed
5:58:08and so a lot of that information was
5:58:12brought into the package insert whether
5:58:14we observed
5:58:15them in the trials or not so the
5:58:19standards for
5:58:20this kind of an approval which has its
5:58:23own designation
5:58:25are easier to meet they're called
5:58:29505b2 nda
5:58:32and draw upon in this case a vast
5:58:36public literature as i said extended
5:58:38back 80 plus years
5:58:41so for that it was very extensive
5:58:45in those kind of applications but when
5:58:48you took
5:58:48a controversial opioid and expanded it
5:58:51to non-malignant pain
5:58:57at pills that contain high dosages
5:59:00of opiate you didn't do any addiction
5:59:03studies before putting it on the market
5:59:05correct
5:59:06i object to the form of the question
5:59:12first of all the compound oxycodone was
5:59:16mostly used
5:59:18in non-malignant pain before we entered
5:59:20the market
5:59:21that was where the market the
5:59:24great bulk of the market existed so
5:59:27there was no innovation or change
5:59:29and are bringing it to the non-malignant
5:59:32pain market
5:59:34um the second thing was
5:59:37that we didn't we assumed that it was
5:59:40potentially addictive
5:59:42that it could be subject to abuse and
5:59:44diversion
5:59:45and the package insert then
5:59:48and through many changes has not
5:59:51denied that in fact has called it out ex
5:59:55explicitly in several places including
5:59:58right in the front of the label when we
6:00:00said it was a class
6:00:02ii narcotic and every doctor knows
6:00:05that class 2 narcotics are among the
6:00:07most abusable products
6:00:09a class 2 narcotic that your own records
6:00:12show
6:00:13there was a belief among physicians that
6:00:15it wasn't as strong as morphine
6:00:17correct no that it wasn't
6:00:22stigmatized as morphine was they knew
6:00:25it was if you would ask them is it more
6:00:28potent than morphine
6:00:29many physicians knew it was more potent
6:00:32if they used both drugs they knew
6:00:36that they would always start with a much
6:00:38lower dose of oxycodone
6:00:40than they would with morphine
6:00:46so you think physicians most physicians
6:00:49knew
6:00:49it was more potent than morphine yes
6:00:55they also knew what doses to use it in
6:01:12exhibit
6:01:18this is 34
6:01:21let me refer you to the first paragraph
6:01:23of this document date is january 26
6:01:262001. we're now five years after
6:01:30oxycontin has been on the market correct
6:01:36um which part of this should i read from
6:01:40yes the date is around five years
6:01:43from marketing and it says up here
6:01:47this is from mark alfonso
6:01:50uh the first paragraph says i think it
6:01:54will
6:01:54in the mind of the physicians
6:01:56hydrocodone gives them a great degree of
6:01:58comfort
6:01:59physicians rank the drugs based on the
6:02:01position that they have created in their
6:02:03mind
6:02:04as a result of prescription prescribing
6:02:08prescribing habit and promotion
6:02:12and promotion would be what marketing
6:02:14from purdue pharma
6:02:17no what what do you think it means when
6:02:20it says
6:02:21promotion is the promotion of
6:02:24everybody in the industry from
6:02:27going back years and years it says for
6:02:30them
6:02:30morphine and hydromorphone are the most
6:02:33potent
6:02:35followed by oxycodone and then
6:02:38hydrocodone
6:02:41i see it yeah were you aware that in
6:02:43january 25th
6:02:44of 2001 mark alfonso and what was his
6:02:47role at purdue he was head of marketing
6:02:49the head of marketing felt like
6:02:51physicians did not feel like
6:02:54oxycodone was as potent as morphine
6:02:57we've gone through this before
6:03:01it was that was a term of
6:03:06that didn't refer to relative potency
6:03:10it just didn't um he didn't include
6:03:13fentanyl in this which is the most
6:03:16potent
6:03:17but is often used before hydrocodone or
6:03:21morphine
6:03:22well let me ask you this so uh well i'm
6:03:24just
6:03:25saying it just i realized
6:03:28that you've changed the meaning that was
6:03:30intended and understood by now that's
6:03:32his work
6:03:34no no no you've changed the meaning of
6:03:35the word potent
6:03:37not the word the meaning of the word i
6:03:39didn't change it it's
6:03:40it's his no no you've changed it when
6:03:42you try to use it
6:03:44as though it means relative potency
6:03:50when we first discussed the first group
6:03:51of documents you said
6:03:53no they're just talking about
6:03:55effectiveness not strength
6:03:56the second group of documents where they
6:03:58said it's stronger than morphine you
6:03:59said no
6:04:00they just mean strong in a general sense
6:04:02they don't mean potent
6:04:03here they use the word potent i mean do
6:04:06you just not think
6:04:07physicians don't think it's as strong as
6:04:09morphine because
6:04:11that's that's what they keep saying they
6:04:13don't want to clear up in the
6:04:14physician's mind that it's as strong as
6:04:15morphine
6:04:16it
6:04:20this is a hierarchy here okay okay
6:04:24mark alfonso said
6:04:28here that if following your reasoning if
6:04:32your reasoning were correct that
6:04:34physicians
6:04:34would see morphine as the most potent of
6:04:37all these drugs
6:04:40it was the for them morphine and then
6:04:43hydrocodone
6:04:44and in most places oxycodone and then
6:04:47hydrocodone
6:04:48the facts are that hydromorphone
6:04:52is three to eight times more potent than
6:04:54morphine
6:04:55but that isn't how we listed it and
6:04:57hydrocodone and
6:04:58oxycodone are close to equipotent
6:05:03but that he didn't say potent he said
6:05:05powerful and powerful in this case
6:05:09has to do with the hierarchy that they
6:05:12placed drugs
6:05:14morphine was the last because it was the
6:05:16most stigmatized
6:05:17so when he says here remember that we
6:05:19tried to reposition
6:05:20oxycontin as powerful as morphine and we
6:05:23could not
6:05:24finally we decided not to mess with this
6:05:27perception
6:05:28since it was helping us in the
6:05:29non-cancer market
6:05:31did you see where he wrote that let's
6:05:33see where he wrote it
6:05:38let's go back to the pleogram
6:05:41how do we need to mark that down it's
6:05:44marked
6:05:45there's number 34. paragraph
6:05:4825 of the agreed statement of facts says
6:05:53or about december 1998
6:05:56purdue sponsored training for all its
6:05:58district sales managers
6:06:02now it wasn't some of them it's all of
6:06:04them correct
6:06:05it says all during this meeting a
6:06:08pharmacist retained by purdue do you
6:06:10know who that pharmacist was
6:06:11no a pharmacist
6:06:15retained by purdue to conduct a portion
6:06:17of the training used the following
6:06:19graphical demonstration parentheses
6:06:22instead of the graphical demonstration
6:06:23of the actual clinical data described
6:06:26in paragraph 21 of this agreed statement
6:06:28of facts
6:06:29and falsely stated that oxycontin had
6:06:32significantly fewer
6:06:33peak and trough blood level effects than
6:06:36immediate release
6:06:38opioids resulting in less you fear
6:06:41euphoria and less potential
6:06:42for abuse than short-acting opioids
6:06:46and they've got a graft that was used at
6:06:48the training
6:06:50i wouldn't i would call that a cartoon
6:06:52yeah not a graph
6:06:54and it says on paragraph 26
6:06:58beginning in or around 1999 some of
6:07:00purdue's new sales representatives
6:07:04those would be purdue pharma sales
6:07:05representatives in 1999 correct
6:07:08i can't say i can object to the question
6:07:10purdue is defined in this document as
6:07:12as purdue frederick yeah but it says new
6:07:14sales representatives
6:07:15so are we talking about purdue farm or
6:07:17purdue i just don't know
6:07:19the document on its face is talking only
6:07:21about purdue frederick
6:07:23yeah the guy that helped put the
6:07:26document together the lawyer
6:07:28we took his deposition have you seen his
6:07:29deposition
6:07:31i've seen his deposition yeah and he
6:07:33says he doesn't know if they're purdue
6:07:34pharma or purdue
6:07:35when he refers to this i'm just telling
6:07:37you this document on its face
6:07:39this finds purdue was purdue forever i
6:07:41don't care what anyone else said
6:07:43sure i'm asking him if it's correct
6:07:47and he's saying you don't know correct
6:07:50let's go
6:07:51i said i don't know who
6:07:54employed these new representatives okay
6:07:58it says some of produced new sales
6:08:00representatives were permitted during
6:08:01training at purdue's headquarters to
6:08:03draw their own blood level grafts to
6:08:05falsely represent that oxycontin
6:08:08unlike immediate release or short-acting
6:08:10opioids did not swing
6:08:12up and down between euphoria and pain
6:08:14and resulted in less
6:08:16abuse potential and were you aware that
6:08:18the sales reps were doing that
6:08:20no
6:08:26and then it says during the period 1999
6:08:28through june
6:08:2930th 2001 purdue reps used graphical
6:08:32depictions
6:08:33similar to the one described in
6:08:34paragraph 25 of his grid statement
6:08:37and fault agreed statement of facts and
6:08:39falsely
6:08:40stated to some health care providers
6:08:41that oxycontin had less euphoric effect
6:08:44and less abuse potential than
6:08:45short-acting opioids
6:08:47were you aware that they had no engaged
6:08:50in that conduct
6:08:51no i'm sorry
6:08:55and then to go on with the conduct
6:08:57paragraph 28 says
6:08:59misbranding of oxycontin misleading use
6:09:02of article to claim no withdrawal or
6:09:04tolerance
6:09:06and it
6:09:09proceeds to discuss
6:09:13how purdue
6:09:18well let's go ahead and read it
6:09:22had i'll try to shorten this a little
6:09:25bit purdue had an osteoarthritis study
6:09:28um
6:09:32it's okay you don't have to rush yeah
6:09:34are you familiar with that
6:09:37may i read it if you don't want to read
6:09:39it into the record can i just read it
6:09:40and then respond
6:09:46i'll tell you what it'll save time i'll
6:09:48read it into the record
6:09:50okay on or about january 16 1997 certain
6:09:53purdue supervisors and employees sent to
6:09:55the fda the results of a clinical study
6:09:58pertaining to the use of low doses of
6:10:00oxycontin by osteoarthritis patients
6:10:04um call it the osteoarthritis study
6:10:09and a final report that included in a
6:10:11section pertaining to respite periods
6:10:13the statement parentheses no
6:10:16investigator reported quote withdrawal
6:10:18syndrome in quote
6:10:20as an adverse experience during the
6:10:22respite periods
6:10:24in a section entitled quote adverse
6:10:26experiences by body system during
6:10:28respite periods
6:10:29the report summary of the major results
6:10:32listed the most frequently reported
6:10:33adverse
6:10:34experiences in respite periods to be
6:10:36nervousness insomnia
6:10:38nausea pain anxiety depression and
6:10:41diarrhea
6:10:42followed by the statement 28 patients
6:10:4626 percent had symptoms recorded
6:10:49during one or more respite periods did i
6:10:53read that correctly
6:10:54i think so
6:10:57that's kind of reading ahead of you and
6:11:00then it says
6:11:01paragraph 29 on or about may 22 may 1997
6:11:06certain purdue supervisors and employees
6:11:08stated that while they were well aware
6:11:10of the incorrect view held by many
6:11:13physicians that oxycodone was weaker
6:11:15than morphine
6:11:17they did not want to do anything quote
6:11:19to make physicians think that oxycodone
6:11:21was stronger or equal to morphine
6:11:23or to quote take any steps in the form
6:11:26of promotional materials
6:11:27symposia clinicals publications
6:11:30conventions
6:11:31or communications with the field force
6:11:33that would affect the unique position
6:11:36that oxycontin had in many physicians
6:11:38mind
6:11:40end quote and did i read that correctly
6:11:43you read the words correctly
6:11:45was that part of the agreed statement of
6:11:46facts it is
6:11:51and then it goes on to say on or about
6:11:53february 12 1997
6:11:55certain supervisors and employees of a
6:11:58united kingdom company affiliated with
6:12:00purdue provided certain purdue
6:12:02supervisors and employees with an
6:12:03analysis of the osteoarthritis study
6:12:06together with another clinical study
6:12:10this analysis included a list of eight
6:12:12patients in the osteoarthritis study and
6:12:1411 patients in the other study
6:12:16who had symptoms recorded that may
6:12:18possibly have been related to opioid
6:12:20withdrawal
6:12:22including one patient in the other study
6:12:24who required treatment for withdrawal
6:12:26symptoms syndrome did you ever review
6:12:29that study
6:12:38no
6:12:40um the discussion section of this
6:12:43analysis include the following
6:12:45quote it's not surprising that some
6:12:47patients in the clinical trials develop
6:12:49some degree of physical dependence and
6:12:50consequently experience withdrawal
6:12:52symptoms as a result of abrupt
6:12:53discontinuation of oxycontin tablets
6:12:56all patients who were expected to have
6:12:58withdrawal symptoms
6:12:59have been reported but this may have
6:13:01resulted in a falsely high incidence
6:13:04of the patients who participated in the
6:13:06osteoarthritis study
6:13:08in which patients entered respite
6:13:09periods without oxycontin tablets
6:13:12many symptoms suspected to be due to
6:13:14opiate withdrawal may simply have
6:13:15resulted from the return of pain
6:13:18after withdrawal of oxycontin tablets
6:13:22patients 6007 complained of nervousness
6:13:25patient 2004 complained of insomnia and
6:13:27felt restless
6:13:28patient 220 and 228 were restless and
6:13:31anxious
6:13:32since these are symptoms which often
6:13:34accompany the return of significant pain
6:13:36it may be wrong to label these as
6:13:38withdrawal symptoms
6:13:39nonetheless the incidence of withdrawal
6:13:41syndromes in patients treat with
6:13:42oxycontin tablets is a concern
6:13:45and it is safer to over report than
6:13:47under report this problem
6:13:49this analysis conclusions included this
6:13:51statement
6:13:53as expected some patients did become
6:13:55physically dependent on oxycontin
6:13:56tablets
6:13:57but this is not expected to be a
6:14:00clinical problem so
6:14:01as long so long as abrupt withdrawal
6:14:05of the drug is avoided
6:14:11are you aware that certain purdue
6:14:14employees
6:14:15participating in the final draft of the
6:14:17article regarding the osteoarthritis
6:14:19study that was published
6:14:21in a medical journal on or about march
6:14:2327 2000.
6:14:25um were you aware they participated in
6:14:28that
6:14:29publishing of that study no
6:14:34the results section of the article i'm
6:14:36reading from paragraph 31
6:14:38right included the following three
6:14:39statements pertaining to the incidence
6:14:41of withdrawal syndrome and withdrawal
6:14:43symptoms experienced by study patients
6:14:45quote one patient was hospitalized
6:14:48parentheses for withdrawal symptoms the
6:14:50patient who was
6:14:51hospitalized with withdrawal symptoms
6:14:53had completed the study on the previous
6:14:54day
6:14:55and had been receiving cr
6:14:5870 oxycodone symptoms resolved after
6:15:00three days
6:15:03a second patient received 60 milligrams
6:15:06cr oxycodone experienced withdrawal
6:15:08symptoms after running out of study
6:15:09medication
6:15:10the patient did not reported withdrawal
6:15:12symptoms during scheduled respites
6:15:14from doses of 30 or 40 withdrawal
6:15:17symptom was not reported as an adverse
6:15:19event for any patient during scheduled
6:15:21respites
6:15:22adverse experiences reported by more
6:15:24than 10 percent of patients during
6:15:25scheduled respites were nervousness
6:15:27non-patients and insomnia eight patients
6:15:59paragraph 32 says the article included a
6:16:02comment section
6:16:04summarized
6:16:07the three statements in the results and
6:16:09further suggested that patients taking
6:16:11low doses could have their oxycontin
6:16:13treatment
6:16:14abruptly discontinued without
6:16:16experiencing withdrawal if their
6:16:17condition so warranted
6:16:19were you aware they were making that
6:16:20claim
6:16:22no if you go over to paragraph 34 it
6:16:27says
6:16:28on about june 26 2000 certain purdue
6:16:31supervisors employees sent the full
6:16:33text of this osteoarthritis study
6:16:35article
6:16:36do you know which supervisors and
6:16:38employees sent the full text of this
6:16:40article
6:16:41no do you know if it was the marketing
6:16:44group
6:16:45i don't know it says
6:16:48together with a quote marketing tip to
6:16:51produce entire sales force
6:16:53the marketing tip stated that a reprint
6:16:56of the osteoarthritis study
6:16:57article was available for use in
6:16:59achieving sales success
6:17:01the marketing tip also included as one
6:17:03of the article's 12
6:17:05key points there were two reports of
6:17:08withdrawal symptoms after patients
6:17:09abruptly stopped taking cr oxycodone
6:17:12at doses of 60 or 70. withdrawal
6:17:15syndrome was not reported as an adverse
6:17:17event during
6:17:18scheduled respites indicating that cr
6:17:20oxycodone at doses below
6:17:2260 milligrams can be discontinued
6:17:24without tapering
6:17:26the dose if the patient conditions so
6:17:32warrants
6:17:34it says on or about february 13 2001
6:17:38certain purdue supervisors and employees
6:17:40received a review of the accuracy of the
6:17:43withdrawal data in the osteoarthritis
6:17:45study and stated
6:17:46now this is purdue's own people
6:17:48reviewing
6:17:50this data correct that's how i would
6:17:53read it
6:17:54and it says quote upon a review of all
6:17:56comments for the enrolled patients it
6:17:58was noted that
6:17:59multiple had comments which directly
6:18:01stated or implied that an adverse
6:18:03experience
6:18:04was due to possible withdrawal symptoms
6:18:06this was followed by a list of 11 study
6:18:09patients who reported adverse experience
6:18:10due to possible withdrawal symptoms
6:18:12during these periods
6:18:14106 patients initially participated in
6:18:16the osteoarthritis study 32 of them
6:18:18withdrew because of severe
6:18:20i'm sorry because of adverse events not
6:18:23necessarily related to withdrawal
6:18:25and 38 patients remaining in the study
6:18:27at 12 months
6:18:32and then the next paragraph reads on
6:18:35about march 28
6:18:362001 so this is a month and a half later
6:18:40a purdue employee emailed a purdue
6:18:43supervisor regarding the review of the
6:18:45withdrawal data described in paragraph
6:18:4635 of the agreed statement of facts
6:18:49asking do you think the withdrawal data
6:18:52from the osteoarthritis study
6:18:54is worth writing up parentheses and
6:18:57abstract
6:18:58or would this add to the current
6:19:00negative press that should be deferred
6:19:03the supervisor responded i would not
6:19:05write it up
6:19:06at this point and no abstract was
6:19:09prepared
6:19:10do you see that i see it so am i correct
6:19:13that
6:19:13purdue was using the marketing material
6:19:17from this article um
6:19:21improperly and not reporting the adverse
6:19:24effects
6:19:25and was allowing their sales force to
6:19:26use it i object to the form of the
6:19:28question
6:19:30let's break that into one question at a
6:19:32time please
6:19:33sure was purdue's marketing department
6:19:36using this article
6:19:38that's what it says here and were they
6:19:41using it
6:19:42uh inappropriately that's what it says
6:19:45here
6:19:48and when somebody pointed out that
6:19:51the withdrawal data from the arthro
6:19:53arthritis study was actually different
6:19:55than how the sales force was using it
6:19:57and asked should we write it up or is
6:19:59this going to add to the current
6:20:01negative
6:20:01press and should be deferred the person
6:20:04supervisor
6:20:05said i would not write it up at this
6:20:07point correct
6:20:09that's what it says do you know if it
6:20:10ever got written up i don't know
6:20:12do you know if any of these doctors that
6:20:14were shown this were ever told that
6:20:16that it actually wasn't correct i don't
6:20:19know
6:20:20do you know if anybody at purdue made an
6:20:22effort to go tell these doctors
6:20:24that all of these marketing things that
6:20:26have been brought up in the agreed
6:20:28statement of facts
6:20:32were not correct i don't know
6:20:35did you yourself ever tell anybody to go
6:20:38inform doctors that
6:20:39these marketing
6:20:43statements that had been used by
6:20:45purdue's employees that were not
6:20:47accurate um
6:20:51were were in fact not accurate i was not
6:20:55aware of this story or the
6:20:58study or the marketing materials or
6:21:02statements
6:21:04and as the director of purdue pharma you
6:21:07were not made aware of any of this
6:21:12i object to the form of the question you
6:21:14can answer
6:21:15i do not recall whether we were
6:21:19you're talking about at the time of this
6:21:22document being written
6:21:23yes i don't recall
6:21:30and at the time that this uh conduct
6:21:33went on
6:21:34from 96 to 2001
6:21:37the time period investigated by at least
6:21:40this
6:21:40u.s attorney under this agreed statement
6:21:42of facts you were in fact the ceo of
6:21:44purdue
6:21:46during 2000 very very late
6:21:5099 until early 2003 i was the ceo yes
6:22:02so if this conduct occurred
6:22:06on may 18 2000
6:22:10june 22nd 2000 february 13 2000
6:22:14and on march 18 2001
6:22:18this employee was told not to write up
6:22:21the withdrawal data because of negative
6:22:23press
6:22:24and that it should be deferred you'd
6:22:26have been the ceo during this time
6:22:27period correct
6:22:28yes
6:22:34what was wrong i'm 99 until this
6:22:37what was robert reader's role at purdue
6:22:40he was
6:22:40a senior medical officer
6:22:52next paragraph says so
6:22:58between june 26 2000 and june 30 2001
6:23:02certain produced supervisors and
6:23:04employees distributed copies of the
6:23:06reprint of the osteoarthritis study
6:23:08article to all of purdue sales
6:23:10representatives
6:23:11for use in the promotion and marketing
6:23:13of oxycontin
6:23:15to health care providers including the
6:23:18distribution of 10
6:23:20615 copies to certain purdue sales
6:23:23representatives between
6:23:25february 13 2001 and june 30 2001.
6:23:36so
6:23:40it looks like on march 28th
6:23:43the supervisor tells the employee
6:23:46don't write up the withdrawal data from
6:23:49the osteoarthritis study
6:23:51it would add to the current negative
6:23:54press and should be deferred
6:23:57and between february 13th 2001 and june
6:23:5930 2001
6:24:0210 615 copies
6:24:05of the osteoarthritis study
6:24:09were distributed to sales
6:24:11representatives
6:24:13correct that's what it says it says
6:24:16sales representative
6:24:21was the purpose of submitting it to the
6:24:23sales representative so they could show
6:24:24it to the physicians that they called on
6:24:28i don't know there's only
6:24:31uh 800 sales reps that produce
6:24:38highest volume of sales reps during this
6:24:40period of time correct
6:24:44a price to the best of my recollection
6:24:46that's approximately true
6:24:48so if you wanted to give a copy to each
6:24:51sales rep for their own use
6:24:52you'd probably only need 800 but they
6:24:54printed off 10
6:24:55615 copies correct distributed yes
6:25:03is it reasonable to conclude that the
6:25:04sales reps were showing these to the
6:25:06doctors
6:25:09it's reasonable to conclude that some
6:25:11sales reps may have
6:25:13shown them to doctors yes to some
6:25:15doctors
6:25:17do you know if purdue ever got any of
6:25:19this 10 16
6:25:21615 copies of the osteoarthritis
6:25:26article uh
6:25:30back
6:25:33i don't know if
6:25:39this when this was found and i don't
6:25:43know when this was
6:25:44found by sales
6:25:47or marketing management or medical
6:25:49department
6:25:50it would have been the practice to
6:25:52recover them yes
6:25:54but i don't know if it was found and i
6:25:56don't know if it was done
6:26:00this all came to light in 2006 or seven
6:26:05so i don't know it could have been long
6:26:06past but i don't know
6:26:09it says um
6:26:14paragraph 38 during the period june 26
6:26:182000 through june 30 2001 certain purdue
6:26:20sales representatives distributed the
6:26:22reprint of the osteoarthritis article to
6:26:24some health care providers
6:26:26and falsely or misleadingly stated that
6:26:29patients taking oxycontin at doses below
6:26:3160 milligrams per day
6:26:33can always be discontinued abruptly
6:26:35without withdrawal symptoms and that
6:26:37patients on such doses would not develop
6:26:39tolerance and that's not an accurate
6:26:41statement is it
6:26:43i don't believe so and then on
6:26:47with regard to misbranding of oxycontin
6:26:50use of reduced abuse liability claims in
6:26:53marketing
6:27:12it says paragraph
6:27:21oxycontin package insert approved the
6:27:23fda stated
6:27:24by the fda stated delayed absorption as
6:27:27provided by oxycontin tablets
6:27:29is believed to reduce the abuse
6:27:30liability of the drug
6:27:32that's called the reduced abuse
6:27:35liability statement
6:27:36certain purdue supervisor employees
6:27:38instructed purdue sales representatives
6:27:40to use this statement to market and
6:27:42promote oxycontin
6:27:44paragraph 40 says certain produced sales
6:27:46reps while promoting and marketing
6:27:48oxycontin
6:27:49falsely told some health care providers
6:27:51that the reduced use liability statement
6:27:53meant that oxycontin
6:27:54did not cause a quote buzz or euphoria
6:27:57caused less euphoria
6:27:58had less addiction potential had less
6:28:01abuse potential was less likely to be
6:28:03diverted than immediate
6:28:04release opioids and could be used to
6:28:06weed out address
6:28:07addicts and drug secrets and
6:28:20it says by march 2000 various purdue
6:28:23supervisors and employees in different
6:28:25parts of the company had received
6:28:28reports of oxycontin abuse and diversion
6:28:31occurring
6:28:31in different communities
6:28:36and that on or about november 27 2000
6:28:40certain purdue supervision employees
6:28:42amended the reduced abuse liability
6:28:44statement to say
6:28:45that delayed absorption as provided by
6:28:49oxycontin tablets
6:28:50when used properly for the management of
6:28:52pain
6:28:53is believed to reduce the abuse
6:28:55liability of the drug and instructed
6:28:56purdue sales reps to use the amended
6:28:58statement to promote and market
6:29:00oxycontin
6:29:02do you know why that statement was
6:29:03changed
6:29:07i'm not sure no i don't and i'm not
6:29:09certain
6:29:10where it was changed in the package
6:29:13insert
6:29:14i don't know
6:29:24if it was in the package insert then
6:29:26that had to be submitted
6:29:28to the fda and to get approval
6:29:32in advance of using it but i
6:29:35just don't know what this refers to
6:29:42well when purdue found out that
6:29:48oxycontin was being abused and diverted
6:29:54they changed their packet insert kind of
6:29:57cleverly really if you read it right
6:29:59when used properly for the management of
6:30:01pain
6:30:02do you know what they meant by that
6:30:08i don't know what the people who wrote
6:30:11it meant by that or what the fda
6:30:13understood because i was not involved in
6:30:15rewriting it
6:30:16okay next paragraph says from march 2000
6:30:19through june 30th 2001
6:30:21certain purdue sales representatives
6:30:23while promoting and marketing oxycontin
6:30:25falsely told some healthcare providers
6:30:27that they reduced abuse liability
6:30:29statement
6:30:30and the amended statement meant that
6:30:31oxycontin did not cause a buzz
6:30:34or euphoria caused less euphoria had
6:30:36less addiction potential
6:30:38had less abuse potential was less likely
6:30:40to be diverted than immediate release
6:30:41opioids and can
6:30:42be used to weed out addicts and drug
6:30:44seekers
6:30:47and those statements are not correct
6:30:50no they're not correct introduction of
6:30:53misbranded
6:30:55oxycontin into interstate commerce
6:31:01and that is actually the uh the guilty
6:31:04plea pardon
6:31:05let's
6:31:09points out that uh purdue manufactured
6:31:11and sold oxycontin in interstate
6:31:13commerce
6:31:14from various locations are you reading
6:31:15i'm just sorry to interrupt you
6:31:18sir just tell me which number i should
6:31:21be following
6:31:21very next paragraph which is 44 yes
6:31:25and that's just pointing out that purdue
6:31:26sold oxycontin all over the u.s
6:31:28correct let me read it and i'll tell you
6:31:31if i agree
6:31:36yeah that's that's not what it says i
6:31:38don't
6:31:40if you're reading from 44
6:31:43yeah you're right
6:31:51i'll withdraw the question did purdue
6:31:55pharma sell oxycontin all over the u.s
6:32:03during what time period
6:32:07um 1996-2001
6:32:14yes
6:32:19now as part of the reason purdue was
6:32:21able to get away with making these
6:32:22misrepresentations
6:32:24is because purdue was aware that
6:32:26physicians did not understand the
6:32:28complex processes of treating
6:32:30pain i don't think so i'll get to the
6:32:34form of the question it's argumentative
6:32:41should i answer it sure i don't don't
6:32:43think so
6:32:56did purdue's own focus group show that
6:32:59doctors
6:33:01didn't understand
6:33:05whether oxycontin was stronger than
6:33:09morphine
6:33:11i don't know
6:33:21what about the treatment of pain did you
6:33:22feel like doctors understood
6:33:24or physicians understood prescribing
6:33:28practices that should be utilized for
6:33:29the treatment of pain
6:33:34you'd have to put a time frame to that
6:33:36or or
6:33:37ask the question with more color
6:33:42and more details
6:33:49in that the reason you all were claiming
6:33:51that you needed to spend so much money
6:33:53educating physicians is because they
6:33:54didn't understand pain prescribing
6:33:58some physicians learned how to prescribe
6:34:01for pain from
6:34:04materials that we produced or
6:34:06information that sales
6:34:08reps gave them others
6:34:11knew how to treat pain and
6:34:15they would be more interested in trying
6:34:18this agent
6:34:20in comparison to how they were treating
6:34:22pain before
6:34:30when we entered the pain market in 1985
6:34:34in the u.s
6:34:37there was almost
6:34:41it was abysmal in a sense not ignorance
6:34:44so much as
6:34:45ignoring pain in patients
6:34:49doctors just didn't want to deal with it
6:34:52and left patients
6:34:56inadequately treated
6:35:00would you agree that the only way to get
6:35:03a large sales force to use a marketing
6:35:05message
6:35:06is to instruct them explicitly and
6:35:08unmistakably
6:35:10to do so i don't understand the question
6:35:14mr shapiro has testified i want you to
6:35:16assume he's testified
6:35:18that the only way to get a large sales
6:35:20force to use a marketing message is to
6:35:22instruct them explicitly and
6:35:24unmistakably to do so
6:35:26would you agree with that i i really
6:35:28don't understand it
6:35:30once again if you're reading from a
6:35:32trans dude please show it to me
6:35:34i want you to assume he's testified to
6:35:36that
6:35:37but i don't understand i don't
6:35:38understand when you have a transcript in
6:35:40front of you i don't have a transcript
6:35:41in front of me i'm asking
6:35:43for my own memory oh okay
6:35:46i i don't understand i don't understand
6:35:49that statement so i really can't agree
6:35:52or disagree with it
6:36:01um do you believe there's evidence of
6:36:03improper training that has occurred
6:36:04at purdue based on the agreed statement
6:36:06of facts
6:36:09i would have to review it it's
6:36:13my recollection as you read as we read
6:36:16through it
6:36:17was that one or two things involved in
6:36:19proper training but i
6:36:21can't affirm that until i re-read it
6:36:24did you ever do you know as we sit here
6:36:27today
6:36:28what percentage of your sales force was
6:36:31using this these improper statements
6:36:35uh to educate physicians about
6:36:38prescribing oxycontin no i don't know
6:36:41okay whether it was
6:36:43a hundred percent fifty percent ten
6:36:45percent you don't have anything i have
6:36:46no idea do you know if anybody at purdue
6:36:49tried to find out how many of their
6:36:51sales force
6:36:52had given physicians improper and
6:36:55incorrect information
6:36:58i know as i said before
6:37:02that from 2000 sometime in 2000
6:37:07as we became convinced that there was a
6:37:10problem
6:37:11many efforts were launched to train
6:37:15retrain
6:37:18and to determine
6:37:21whether sales reps were
6:37:26following company policy and that
6:37:29effort goes on to this day
6:37:33we we put in place for example a whole
6:37:36compliance department
6:37:38in 2003 or 2004 with many
6:37:42employees who reported independently to
6:37:45the board
6:37:47and have continued to report
6:37:49independently to the board
6:37:51to in a sense back up
6:37:55the sales department and marketing
6:37:57department's own efforts
6:37:59to assure proper training
6:38:02and compliance with training but i don't
6:38:06know of any attempt to
6:38:10measure who
6:38:13said what and how many times
6:38:16when people were properly
6:38:20trained and and they deviated from that
6:38:24or went beyond that
6:38:27they were sanctioned and many of them
6:38:29were dismissed
6:38:31we also had a whole downsizing the field
6:38:34force
6:38:35from about 2003 or four
6:38:38until about 2007 or eight
6:38:42in which the 800 eventually went down to
6:38:45something like 200.
6:38:49so
6:38:52i don't think there are too many
6:38:54survivors from this period
6:38:58because they were selectively weeded out
6:39:01because on average three quarters of
6:39:03them would have been gone
6:39:05um but i don't i can't answer that i
6:39:08know of any
6:39:09attempt to assess blame
6:39:13in that sense or to count yeah and
6:39:16that's not really my question
6:39:18my question is did anybody at purdue
6:39:20pharma
6:39:21attempt to go back and find out which
6:39:24reps specifically had
6:39:27made comments to physicians that were
6:39:30improper or misleading about the
6:39:34attributes
6:39:36of oxycontin and the answer is
6:39:40i don't know would you agree
6:39:44that giving making the statements
6:39:50the improper statements that are
6:39:51referred to in the agreed statement of
6:39:53facts
6:39:55could compromise patient care
6:39:58some of them yes
6:40:06in some patients obviously not all
6:40:09patients
6:40:10but in some patients some of the
6:40:12statements could compromise care
6:40:16i would like to say sub-optimize care
6:40:24but
6:40:28and if i understand correctly you have
6:40:30not reviewed
6:40:31any of the call notes that were pulled
6:40:34by
6:40:34mr shapiro when he was doing this
6:40:38as far as i know i didn't i was shown a
6:40:41few call notes
6:40:42i didn't ask were these shown to mr
6:40:45shapiro
6:40:46was there a recommendation made by
6:40:47somebody right about that same time
6:40:49that the call note system be changed
6:40:55at about what time about the same time
6:40:57he was doing his investigation
6:40:59and reviewing the call notes i believe
6:41:01it was
6:41:02yeah and do the call notes not
6:41:05contain as much information as they used
6:41:08to
6:41:09back in 2000 that i don't know
6:41:12but the biggest change was to make the
6:41:16first and second line supervisors
6:41:20audit a substantial percentage of the
6:41:22call notes
6:41:24in their span of control
6:41:27if the call notes have less information
6:41:30in them
6:41:31is it more difficult to audit them i
6:41:34would
6:41:34i couldn't possibly guess i don't know
6:41:37what they were before or
6:41:39after they were very sketchy notes
6:41:47the ones i saw i must say they were
6:41:50selected and shown to me but
6:41:52the ones i saw were in some cases almost
6:41:55indeterminate you could not know what
6:41:59was happening
6:42:00how many did you see
6:42:03six eight no more i think
6:42:06probably fewer than than six or eight
6:42:09but i'll say
6:42:10six and who were those who showed those
6:42:13to you
6:42:14i was shown during the preparation for
6:42:16the deposition
6:42:17i've never seen them before
6:42:30you
6:42:33were the call notes you were shown call
6:42:35notes from kentucky reps or
6:42:37my recollection is somewhere
6:42:54did you hire anybody or ask anybody to
6:42:57review
6:42:57mr shapiro's investigation for accuracy
6:43:03i did not ask that his investigation be
6:43:06audited for accuracy
6:43:09there were many people in the law
6:43:12department and then a compliance
6:43:14department
6:43:15who may well have done so but i don't
6:43:18know
6:43:19and would you expect if we did our own
6:43:22investigation
6:43:23we would have essentially about the same
6:43:25number of
6:43:27improper call notes that he found that
6:43:29would be my expectation
6:44:10we are off the record at 5 26 pm
6:44:16we are back on the record at 5 55 pm
6:44:28[Music]
6:44:36um
6:44:40no i'm going to pick up some more
6:44:41different so let me show you
6:44:43um
6:44:49email look at a page two of this email
6:44:57this is from jim speed
6:45:02dated tuesday november 30th
6:45:06let's mark this as what we're gonna say
6:45:08to the thirty-five
6:45:16dated november 1999 second
6:45:21during physician calls this issue is a
6:45:24topic of hot discussion between me and
6:45:26the physician
6:45:27while many salespeople have sold
6:45:29controlled release opioids
6:45:31as having less abuse potential the
6:45:34current situation has placed us in an
6:45:36awkward situation
6:45:38i feel like we have a credibility issue
6:45:40with our product
6:45:41many physicians now think oxycontin is
6:45:44obviously the street drug
6:45:46all the drug addicts are seeking
6:45:49issues like purposely crushing the 40
6:45:52milligram and 80 milligram tabs to quote
6:45:55get high
6:45:56have been expressed i have heard from
6:45:58physicians that pharmacists
6:46:01and pharmacists that on the streets
6:46:03people are finding ways to extract the
6:46:04oxycodone from the tablet and are using
6:46:07a cotton ball to filter the talk talk as
6:46:10they draw it up in a syringe for quote
6:46:12main lining in quote were you aware
6:46:16that that was a concern in november of
6:46:181999
6:46:20no when did you first become aware uh
6:46:23that oxycontin was being diverted or
6:46:25abused
6:46:27in the
6:46:31winter best of my recollection winter of
6:46:342000.
6:46:38that is early in the year 2000.
6:46:41who is dr j david haddocks dr
6:46:45haddocks is a
6:46:48both a dentist and an md he's an
6:46:52expert in both analgesic pain
6:46:56use of analgesics and pain management in
6:46:58general
6:46:59and also i think is a recognized expert
6:47:03on addiction and treatment
6:47:06of addiction did he work for purdue
6:47:08pharma
6:47:09he did
6:47:13and what about reena golden and wendell
6:47:16fisher what were their jobs
6:47:18rena goldman i don't know
6:47:22and wendell fisher
6:47:26was a sales manager but i don't recall
6:47:31how high up he was in sales management
6:47:33he was a
6:47:34i think he was a regional manager at
6:47:36that point and what about
6:47:38jim speed i i've recognized the name
6:47:42but i don't i can't tell you what his
6:47:44position was
6:47:45he was a field sales person i don't know
6:47:48whether he was a manager
6:47:50or not whether he was a district manager
6:47:52or salesman
6:47:53is it true that wendell
6:47:57fisher was a regional manager with
6:47:59oversights for the districts and
6:48:00territories located in kentucky
6:48:03i don't know
6:48:21is it true that oxycontin
6:48:25does produce a buzz or euphoria just
6:48:28like
6:48:28the controlled release just like the
6:48:30immediate release
6:48:32when used in pain patients or when
6:48:36abused when used in pain patients uh
6:48:39i don't i can't tell you the percentages
6:48:42i'm sure
6:48:44there are some people who might say that
6:48:46they
6:48:47feel a sense of euphoria i
6:48:50i really don't know what buzz means when
6:48:52people say they have a buzz
6:48:54i i'm not familiar but there may be a
6:48:57brief period of time in which they feel
6:48:59some
6:49:02euphoria or sensation whether you
6:49:05feel a buzz or euphoria does that have
6:49:08to do with how quickly the drug works
6:49:10not so well that's an element but it has
6:49:13to do also with the dose
6:49:15and also with the patients uh
6:49:18familiarity if they've been on the same
6:49:20dose for a while
6:49:22i would think it's far less likely and
6:49:24then there's independent individual
6:49:26patient variation finally
6:49:30and um
6:49:34with respect to peaks and valleys uh to
6:49:37the peaks and valleys that are referred
6:49:39to in all the marketing materials or a
6:49:40number of the market materials
6:49:42um does that have to do with whether
6:49:44somebody
6:49:46experiences a euphoria from taking
6:49:48oxycontin
6:49:50the if they have any psyche
6:49:53psychological experience
6:49:57like euphoria it's most likely to be at
6:49:59the peak blood level
6:50:01so the fewer the peaks the fewer the
6:50:03periods
6:50:04of euphoria but i'm just generalizing
6:50:08i'm not
6:50:09telling you that we've ever measured
6:50:12that
6:50:16when did you first become aware that
6:50:17purdue had marketed and promoted
6:50:19oxycontin as having less
6:50:21abuse potential
6:50:24not until the investigations were done
6:50:30and i can't tell you which investigation
6:50:35or when but i certainly
6:50:42didn't know that people were saying that
6:50:46until i was told by
6:50:50management that they had done
6:50:51investigation and found that
6:50:53some people had said that let me let me
6:50:56ask you about
6:51:00patients who
6:51:02[Music]
6:51:04have not had a prior incidence of
6:51:07addiction or abuse but just someone
6:51:10who's put on oxycontin
6:51:13and has never had an opioid in the past
6:51:18do you know if they're put on a 20
6:51:20milligram dose of oxycontin twice a day
6:51:23how long they would have to take it
6:51:24before developing dependency
6:51:27i i can give you a guess
6:51:30but i don't know it would there's
6:51:33enormous individual variation here
6:51:36so you can't say with any one person or
6:51:39predict
6:51:40that this person will develop dependency
6:51:44or this per that person won't at 40
6:51:47milligrams a day i assume that's the
6:51:48presumptive
6:51:50daily dose you're asking me yes
6:51:56do you know if purdue ever conducted any
6:51:58studies to determine
6:51:59how long a non-malignant pain patient
6:52:03who's never had an opioid before
6:52:06would have to be on the drug before they
6:52:08developed dependency or
6:52:10addiction i'm not aware of
6:52:13those studies being conducted
6:52:41uh is it fair to say that if purdue
6:52:43wanted to do
6:52:46a study to make that determination
6:52:51that could be done dependency
6:52:55that is physiologic dependence
6:52:59i think would be an achievable study
6:53:02that could be done
6:53:04addiction remains to be seen a lot of
6:53:08people
6:53:10would say it's almost impossible to do
6:53:13that
6:53:14but purdue and other industry partners
6:53:19are just on the on the cusp of
6:53:22trying to do that with a number of
6:53:24studies could you do a retrospective
6:53:26study or could you have done a
6:53:27retrospective study
6:53:28if you had wanted to look at patients
6:53:36i would have to think about whether i
6:53:39could figure out a retrospective study
6:53:42it would it would be
6:53:46an interest it's an interesting question
6:53:49but i don't know the answer to it
6:53:55and what was robert reader's role
6:53:58robert was a senior medical
6:54:02scientist in the medical department and
6:54:05i want you to assume he's testified that
6:54:07purdue lacked any evidence that
6:54:09oxycontin had a lower abuse potential
6:54:12if that's true if he testified to that
6:54:15sooner he testified that would you agree
6:54:16with that statement or disagree
6:54:24if you could just repeat the statement
6:54:26so that i can concentrate on it
6:54:29that he testified purdue lacked any
6:54:31evidence that oxycontin had a lower
6:54:33abuse potential yeah i object to the
6:54:35question
6:54:36it's a very odd hypothetical question
6:54:45i don't know of any study that was done
6:54:49but i don't know that no study was done
6:54:52i just can't i can't tell you for sure
6:55:03you're referring that to purdue
6:55:05frederick and you're referring to the
6:55:07time frame up to the
6:55:092007 or 2010
6:55:12yes okay i just wanted to i don't know
6:55:16my answer is the same but i just wanted
6:55:18to be sure
6:55:20that my answer has purdue pharma done a
6:55:22study since then
6:55:25we've done studies on abusability
6:55:30of many formulations
6:55:34and we did them in the course of trying
6:55:37to develop
6:55:39and then select amongst several
6:55:42formulations
6:55:44these were studies that were pioneered
6:55:47by purdue
6:55:48with outside investigators and they
6:55:52attempted to and i think quite
6:55:56would be considered today state of the
6:55:59art
6:56:00um to discern
6:56:04how easily practice drug abusers
6:56:07might be able to
6:56:12defeat the delivery system and and abuse
6:56:16it
6:56:18have you ever seen the deposition of
6:56:20curtis wright in the poston case
6:56:23in the poston pos ton no
6:56:26i have not
6:56:32did you ever discuss with curtis wright
6:56:35whether
6:56:36um studies could have been done on the
6:56:39abuse potential of oxycontin
6:56:42prior to the release of oxycontin no
6:56:45if you testify those studies were
6:56:47possible and could have been performed
6:56:48prior to the release of oxycontin would
6:56:50it surprise you
6:56:58i would have to know more before i
6:57:01registered surprise or not i'd have to
6:57:05know
6:57:06what he meant what kind of studies
6:57:09and and so on
6:57:39perhaps he said we could have attempted
6:57:41to do it
6:57:44that would surprise me less than if he
6:57:46said absolutely it could have been done
6:57:49i so i just have to know
6:57:52what he's talking about
6:58:04i'm not sure what you're talking about
6:58:10um
6:58:20this uh let me hand you this email sorry
6:58:23about this
6:58:24way there this is an email
6:58:30appear to be richard sackler
6:58:34on 8 27 97
6:58:38to craig a mcmanama
6:58:42in utah that's a doctor is that right
6:58:47name's not familiar instantly familiar
6:58:50to me
6:58:51if you will go to the uh why don't we
6:58:53mark this you did already
6:58:5536. if you go to the bottom
6:59:02of the of the second paragraph
6:59:06you you write to him
6:59:11i am drawing your attention to our
6:59:14newest product oxycontin tablets
6:59:16controlled release oxycodone hci
6:59:19and have included some literature most
6:59:22important to your practice
6:59:24time of onset of oxycontin is as rapid
6:59:27as
6:59:27immediate release oxycodone but duration
6:59:31is a full 12 hours and the patient
6:59:33reaches
6:59:34full blood levels in just two doses one
6:59:36day
6:59:38was it your belief that the time of
6:59:40onset of oxycontin
6:59:42was as rapid as immediate release
6:59:44oxycodone
6:59:45that was what our data showed
6:59:49more or less almost as immediate i
6:59:52believe
6:59:55in the study that i was referencing but
6:59:59didn't reference in the note i think it
7:00:02was
7:00:0241 minutes for immediate release and 45
7:00:06minutes
7:00:07or something like that for oxycontin
7:00:19now i recognize who he is and who is he
7:00:23he was a doctor who a friend in utah
7:00:30was using and he must it looks like he
7:00:33may have
7:00:33asked through his friend for me to send
7:00:35him some betadine
7:00:36he was a dpn doctor of podiatric
7:00:39medicine
7:00:40and they do a lot of surgery and
7:00:43betadine
7:00:46is a necessary part of any surgical
7:00:49procedure at least
7:00:51it's an antiseptic and antiseptics is a
7:00:53necessary
7:00:57let part give you a copy of this and
7:00:59this is
7:01:01if we can mark this as exhibit 37
7:01:17this is an email dated
7:01:22may 15 1996.
7:01:26looks like it was received by p golden
7:01:28heim
7:01:29md and
7:01:34he does work for purdue pharma correct
7:01:37yes
7:01:38he was it looks like uh you were also
7:01:41included
7:01:42by fax dr richard sackler that's what it
7:01:45says
7:01:52and if you go to the third page
7:02:04it says professor dare did not see any
7:02:08major problems regarding registration of
7:02:10oxycontin
7:02:11in switzerland some specific points need
7:02:14to be clarified
7:02:15parentheses monitored release approval
7:02:18as for dhc
7:02:19parenthesis may be a possibility in
7:02:21parenthesis
7:02:22he considers the following subjects as
7:02:24important and would need further
7:02:26investigations the first paragraph says
7:02:29information about the abuse addiction
7:02:31potential
7:02:32versus other opioids because of the
7:02:35rapid onset of
7:02:36action of oxycontin did i read that
7:02:39correctly
7:02:39you did did do you know if you
7:02:43obtained approval to sell oxycontin in
7:02:45switzerland
7:02:46i believe we did and did you provide him
7:02:49with uh
7:02:50the information about the abuse
7:02:52addiction potential versus other opioids
7:02:55uh because of the rapid onset act of
7:02:57action of oxycontin that he requested
7:03:00um i'm not clear that he was
7:03:04actually requesting it just saying that
7:03:06it was his opinion it was necessary
7:03:08for registration but i don't know
7:03:11whether anything
7:03:14was produced i doubt anything was
7:03:17produced here
7:03:19that was not produced for the fda
7:03:22or the other european agencies
7:03:27who approved oxycontin
7:03:30if anything was produced that was
7:03:32different that is additional studies
7:03:34they would have
7:03:35also gone to the fda do you know why he
7:03:38was concerned about the rapid onset
7:03:40of action of oxycontin
7:03:44with respect to abuse and addiction i
7:03:46don't know
7:04:02um with respect to the claims about
7:04:04peaks and valleys
7:04:07did you ever review the information to
7:04:09see what peaks and valleys
7:04:12were present in the plasma blood levels
7:04:15with respect to oxy in the five month
7:04:18did you say no did you ever review i'm
7:04:21sorry my hearing is not there
7:04:23that's okay i said with respect to
7:04:29peaks and valleys the claim that there
7:04:32are
7:04:34valleys are different here did you ever
7:04:36review the literature
7:04:38regarding that i was familiar with some
7:04:41studies
7:04:43that demonstrated that
7:04:47it was to some extent an obvious
7:04:51characteristic it since the drug was
7:04:55taken twice a day you'd have two peaks
7:04:59whereas the immediate release was taken
7:05:01four to six times a day and so you'd
7:05:03have four to six
7:05:06do you know if the level of peaks and
7:05:08troughs are similar or different
7:05:11my recollection is that they are
7:05:15about the same but that's a fuzzy
7:05:18recollection and i would need to see the
7:05:20data to
7:05:21refresh myself and be sure but i i think
7:05:24you
7:05:26my recollection is they were they were
7:05:28close
7:05:30do you know whether the controlled
7:05:31release because it maintained a higher
7:05:34level and didn't have as much trough
7:05:37during the day would be more likely to
7:05:39cause addiction or less likely to cause
7:05:41addiction
7:05:41i my impression is that the
7:05:45average blood level was the same
7:05:48and i'm not certain
7:05:52so your question is given that the
7:05:56average blood level is the same
7:05:58if i'm correct and that's a recollection
7:06:00i haven't
7:06:01seen that data for a very long
7:06:05um
7:06:08the only diff the difference in the
7:06:11blood level
7:06:12the remarkable difference would be half
7:06:15as many
7:06:15or a third as many peaks and valleys
7:06:20and to the extent
7:06:24that somebody was seeking the drug
7:06:27or enjoying that element of the drug
7:06:30the peak effect i would think that the
7:06:33drug would be
7:06:35less attractive but
7:06:40it's a conjecture it's not
7:06:44knowledge because i don't think we ever
7:06:46did a study that i'm aware of
7:06:49my question is if somebody has a
7:06:51controlled release
7:06:53and maintains a higher level
7:06:57during the day with respect to valleys
7:07:01they don't have as many valleys does
7:07:02that cause is that more likely to make
7:07:04them
7:07:05become addicted or less likely you know
7:07:07i don't think the vowel
7:07:11the valleys were about the same too
7:07:14so i i don't think that the valleys
7:07:17or the height of the peak would have
7:07:19been
7:07:21any difference the principal difference
7:07:24i think would have been
7:07:26um and you're saying addicted would have
7:07:28been
7:07:30fewer peaks and all of this presumes
7:07:34that they were using the drugs
7:07:36as they were made and presented and if
7:07:39they use it as made and presented
7:07:40they would also be taking drugs for
7:07:43breakthrough pain
7:07:45potentially correct
7:07:49they might well be have gotten two
7:07:52prescriptions from a physician
7:07:54right if they if you know the the
7:07:57studies show
7:07:58that it lasts from eight to 12 hours
7:08:03and if it lasts eight or nine hours in a
7:08:05patient and doesn't last till 12
7:08:08he may need an additional prescription
7:08:10rescue
7:08:12prescription for that also correct
7:08:16possibly i would have
7:08:20told the physician use the rescue
7:08:24compute the daily dose
7:08:27and try giving that dose as oxycontin
7:08:30twice a day
7:08:31that is half of that dose twice a day
7:08:34do you know uh was there any study done
7:08:38to determine
7:08:39whether patients who were given
7:08:42controlled release oxycodone and then
7:08:44had to take another one
7:08:46because it didn't last 12 hours were
7:08:48more likely to develop addiction
7:08:51or less likely to develop addiction i
7:08:53know of no such study
7:08:55and i don't recollect that anybody
7:08:58ever suggested such a study
7:09:01or such a hypothesis i would have had i
7:09:04would have asked them why do you think
7:09:06that they
7:09:06are more prone or less prone to
7:09:08addiction i wouldn't
7:09:10think it would make a difference
7:09:14again not based on a study but
7:09:17based on a conjecture so i really would
7:09:20have to understand what is the reasoning
7:09:22why
7:09:24why taking the drug three times a day
7:09:26would be more
7:09:27likely to cause addiction or less likely
7:09:44all right
7:09:49so we go off the record one second sure
7:09:51yeah we are off the record
7:09:53at 6 20 p.m we are back on the record at
7:09:576
7:09:5833 p.m um
7:10:02what i'd like to do is have you sift
7:10:04through these documents
7:10:06and with the exception of the gao report
7:10:10are all of these documents that are kept
7:10:12in the ordinary course of business at
7:10:16purdue
7:10:18no they would not all have been kept
7:10:23to my knowledge in the ordinary course
7:10:25of business
7:10:28we would have had some sort of
7:10:30destruction policy
7:10:32but we have been engaged in litigation
7:10:36for so long
7:10:37and so many different matters that
7:10:40basically at least my documents
7:10:43i have i don't think anything has been
7:10:46thrown away are these all documents that
7:10:49were generated in the ordinary course of
7:10:51business at purdue
7:10:54or at at purdue frederick or
7:10:57in other companies or some of the
7:10:59overseas country
7:11:00companies yes sure purdue pharma
7:11:04and mundy pharma purdue pharma under
7:11:07pharma purdue frederick
7:11:12whatever
7:11:21and are all of these business records
7:11:25i don't know that you know i'm not a
7:11:26lawyer i think that's asking for a legal
7:11:28conclusion
7:11:31i'm not sure it is can you answer the
7:11:33question
7:11:37okay are they business records
7:11:41i i really don't understand what that
7:11:43term means i it's not a term i've ever
7:11:45used
7:11:46so they are what they are
7:11:49i mean
7:12:22um
7:12:31i asked you about the oxycontin 20
7:12:33milligrams
7:12:34prescription to your knowledge was
7:12:37anything
7:12:38done to determine um
7:12:42how many people put on 40 milligram
7:12:4680 milligram or 160 milligram
7:12:48prescriptions
7:12:50would become addicted or dependent if
7:12:53they took it for a certain period of
7:12:54time
7:12:55no
7:13:01sitting here today
7:13:04after all you've come to learn as a
7:13:06witness do you believe purdue's conduct
7:13:09in marketing and promoting oxycontin
7:13:11in kentucky caused any of the
7:13:14prescription drug addiction
7:13:16problems now plaguing the commonwealth
7:13:19i don't believe so sitting here today
7:13:22after all you've come to learn as
7:13:23witness do you believe that produced
7:13:25conduct in kentucky has led to an
7:13:27excessive or unnecessary
7:13:29amount of opioids being located
7:13:32throughout the commonwealth of kentucky
7:13:34i don't believe so
7:13:39do you believe that any of purdue's
7:13:40conduct has led to
7:13:42an increase in people being addicted
7:13:46in the commonwealth of kentucky no
7:13:51do you agree that education information
7:13:54presented by a drug company to
7:13:56physicians
7:13:56needs to be fair and balanced yes
7:14:00and do you agree if a company learns a
7:14:02physician does not understand
7:14:04a drug that is being sold by the company
7:14:07that they have a responsibility to
7:14:09educate them properly about the drug
7:14:13yes do you think purdue has an
7:14:16obligation to provide
7:14:17physicians with truthful information
7:14:21yes do you believe purdue provided any
7:14:24of the physicians in kentucky with
7:14:25information
7:14:26that was not truthful no i don't believe
7:14:29that
7:14:30okay and is that because you don't
7:14:31believe any of the sales reps engaged in
7:14:34the
7:14:34in the uh conduct that
7:14:38is any of the sales reps in kentucky
7:14:40engaged in the conduct that is described
7:14:42in the felony plea agreement
7:14:47that's my belief i don't have any
7:14:50facts to inform you otherwise
7:14:54and you never checked did you
7:14:58i don't know how i would have checked
7:15:02that could you have looked at the call
7:15:04notes from your salespeople in kentucky
7:15:06to see what they were telling physicians
7:15:08and whether it was the same information
7:15:11referenced
7:15:12in the felony plea agreement i
7:15:15could have looked at the call notes but
7:15:18i believe that
7:15:19all the call notes were reviewed
7:15:23at least once and probably multiple
7:15:26times by
7:15:27many people and why do you have that
7:15:29belief
7:15:30because i know the number of
7:15:34investigations
7:15:35and the extensive training and
7:15:37retraining that was done
7:15:39i believe it would have surfaced
7:15:42any evidence of wrongdoing
7:15:45and been actionable
7:15:48but as i said i've only seen a few call
7:15:51notes
7:15:53and the ones i've seen are so cryptic
7:15:56and imprecise and unclear in their
7:15:59references
7:16:00often you don't even know who's saying
7:16:02what
7:16:03these were memory joggers that i've seen
7:16:07they were written by a person who had a
7:16:10conversation
7:16:11who wanted to recall that conversation
7:16:15two four six weeks later
7:16:18and when the call notes say i told the
7:16:20doctor about less abuse
7:16:23or i told the doctor the drug had less
7:16:25euphoria or emphasized that
7:16:27that would be improper correct if such
7:16:30call notes
7:16:31existed and they were that explicit yes
7:16:35i didn't see any like that
7:16:51did it ever occur to you to check and
7:16:53see whether the
7:16:55the
7:16:58people you hired and paid 50 million
7:17:01dollars for
7:17:02to do a presentation
7:17:05and defend purdue in the
7:17:08u.s attorney's office in the western
7:17:10district of virginia
7:17:12gave accurate and truthful information
7:17:15to the u.s attorneys regarding the call
7:17:17notes
7:17:18i object to the form of the question you
7:17:19can answer
7:17:22it wouldn't occur to me that any
7:17:25attorney that we hired
7:17:26would give false information
7:17:30to any other attorney and much less so
7:17:34to the u.s attorney and his deputies
7:17:39when doing a call notes search
7:17:42did you ever find out how they went
7:17:43about it i'm sorry
7:17:45when when the people you hired did their
7:17:47call notes search did you ever find out
7:17:49how they went about it
7:17:51at the time it was described
7:17:56in fairly explicitly
7:18:01um but that was years and years ago that
7:18:04was
7:18:04almost 15 years ago i think any further
7:18:08questions
7:18:09along this line will really impinge on
7:18:11the charity blind parallelogram
7:18:27was a breakdown of the results ever
7:18:30provided to you
7:18:32a in a way yes
7:18:36when you say in a way how was it well
7:18:40i was told that let me interrupt myself
7:18:43i think your questions are really
7:18:44leading the witness
7:18:46into attorney-client communications
7:18:50and i would direct them not to not to
7:18:52respond to those questions
7:18:58well
7:19:03certify the question and we'll talk it
7:19:05to the judge about it i think i'm
7:19:07entitled to go into it if the judge says
7:19:08no then
7:19:09then of course we can that's fine
7:19:20so here's um
7:19:26a call on a mark dubrick
7:19:31in lexington kentucky from a k
7:19:34period boils do you know who that is i
7:19:36don't know either of those people
7:19:38okay under a notes memo it says
7:19:43got to convince him to counsel patients
7:19:46that they won't get
7:19:47buzz as they will with short acting
7:19:50now would that be an appropriate thing
7:19:51to do counsel the doctor
7:19:53that the patients uh tell the doctor
7:19:56convince the doctor to counsel patients
7:19:58that they won't get buzzed
7:20:00as they will with short acting again if
7:20:02you're reading from a document please
7:20:03show it to the witness
7:20:14this is pretty easy to read this is not
7:20:18small
7:20:32this
7:20:36so could you repeat the question yes
7:20:38would it be inappropriate to counsel
7:20:40the doctor to convince the doctor to
7:20:42counsel his patients that they would get
7:20:44less
7:20:44buzz with oxycontin versus
7:20:48well what it says here is that they
7:20:52won't get a buzz
7:20:55and i don't think that
7:20:59telling a patient i don't think you'll
7:21:02get a buzz
7:21:04is harmful because if they do
7:21:08i would think that the patient would
7:21:11report it
7:21:12and he would know oh
7:21:16i don't know why he would have told this
7:21:18to a patient but
7:21:20i think that it actually could be
7:21:24helpful
7:21:28because many patients won't get a buzz
7:21:30and if he would like to know if they do
7:21:33he might have had a good medical reason
7:21:36for wanting to know that
7:21:43um do you know whether telling patients
7:21:47they won't telling doctors patients
7:21:49won't get a buzz
7:21:51was one of the things prohibited by the
7:21:54in the statement agreed statement of
7:21:56facts in the felony please
7:21:59yes but that isn't what it says he said
7:22:03we don't know what the conversation was
7:22:05between the doctor
7:22:07and the rep but as i
7:22:10testified just a minute ago
7:22:13i could see that this could have been
7:22:16not only
7:22:17not harmless but helpful
7:22:22all right here's one are you going to
7:22:23mark that as an exhibit no i'm just
7:22:25going to ask
7:22:26him about these here is one um
7:22:29well the only difficulty with that
7:22:30you're asking questions about them and
7:22:32then we
7:22:32going forward from here have no record
7:22:34of what it is he was looking at
7:22:36well this is my only copy that's why i
7:22:38don't want to
7:22:39you can keep it why don't you mark it as
7:22:41an exhibit don't give me a call if you
7:22:42want to market later you can but i'm
7:22:44going to ask you my questions right now
7:22:45so i can get out of here
7:22:48objective slide of glasses you can
7:22:50object i don't have to mark it if i
7:22:51don't want
7:22:52here's ellen ballard in louisville
7:22:55kentucky
7:22:55sales rep mark curran do you know who
7:22:57that is no
7:22:59and in here it says talked of less
7:23:01euphoria
7:23:02and more convultible with oxy
7:23:06would it be inappropriate to tell
7:23:08patients they get less
7:23:09euphoria with oxy
7:23:39we really don't know what
7:23:42was said as i said this is a memory
7:23:45jogger he might have said
7:23:47there may be less euphoria or some
7:23:50people have less euphoria
7:23:52or we just don't know what was said here
7:23:57if all he said was
7:24:03there may be less euphoria that could be
7:24:06true and i don't
7:24:07see the harm if he promised less
7:24:10euphoria
7:24:11it shouldn't have been said an agreed
7:24:14statement of facts
7:24:14doesn't say you have to promise less
7:24:16euphoria it says if you
7:24:18mention to a doctor or infer that it
7:24:20causes less euphoria that's improper
7:24:22correct
7:24:25that was what we agreed to yes but this
7:24:28was 1998
7:24:30long before there was an agreed
7:24:32statement of facts
7:24:34what difference does that make if it's
7:24:35improper in 2007 wouldn't it be improper
7:24:38in 1998
7:24:40not necessarily
7:24:44well the improper conduct that the
7:24:46agreed statement affects
7:24:48the time period was 1996-2001
7:24:52correct yes and if this is 1998 it's
7:24:55within that time period correct
7:24:57yes okay um
7:25:02so back what kind of twisted logic are
7:25:04you saying that saying this in 1998
7:25:06wouldn't be improper
7:25:07because the because the agreed statement
7:25:10of facts is in 2007.
7:25:12i object to the form of the question it
7:25:14isn't a question that's argumentative
7:25:15and it's really uncalled for
7:25:19if you can answer go ahead i think i
7:25:23should stand on what i said
7:25:26well let me ask you this tell me all the
7:25:28basis you have for believing
7:25:30that saying this in 1998 to talk of less
7:25:33euphoria
7:25:36with oxy would somehow not
7:25:40be a problem because the agreed
7:25:42statement was in 2007.
7:25:44i don't know what he said in 1998
7:25:47i know what he wrote but i don't have
7:25:50quotes on it i don't have a dialogue
7:25:53i wasn't present i don't know what he
7:25:56said
7:25:56and i don't even know whether this was a
7:25:59document
7:26:00upon which the agreed statement of facts
7:26:04was constructed for all i know
7:26:07this document was tossed away as
7:26:10inexact or inexplicit let me ask you
7:26:13about this document
7:26:14james donnelly is the doctor at the
7:26:16trover clinic in madisonville kentucky
7:26:19who was called on by
7:26:20holly will and the notes memo says quick
7:26:24reminded him that oxy gives flat blood
7:26:27levels so
7:26:28less buzz than lortab
7:26:32is that the type of statement that's
7:26:33prohibited by the agreed statement of
7:26:36facts
7:26:44i don't know that that's what she said
7:26:49if you're asking me hypothetical
7:26:59i would say that this is
7:27:04not neither
7:27:07accurate nor appropriate it doesn't
7:27:10actually give
7:27:11flat blood levels as you know and as our
7:27:14rep knew
7:27:15as any doctor who had been properly
7:27:17presented the product would know
7:27:20but nevertheless even though it is
7:27:23demonstrably wrong it would be
7:27:26still inappropriate to say
7:27:30on two bases on the basis of the agreed
7:27:33statement of facts and also on the basis
7:27:34it's untrue
7:27:36but again i have to emphasize these are
7:27:39not transcripts these are about as
7:27:42distant from
7:27:43transcripts as anybody can get
7:27:48this is a memory jogger and i don't know
7:27:51what she said and i find it hard to
7:27:54believe that she said
7:27:56anything like this this was to remind
7:27:59her of a discussion
7:28:02have you ever spoken to her no okay
7:28:05this is dr david parks in bowling green
7:28:08kentucky who was called on by philip
7:28:10gross
7:28:11love the idea of giving effective pain
7:28:14relief comma
7:28:15but not euphoria to get rid of druggies
7:28:20if it was discussed with him that it
7:28:22gives effective pain relief but not
7:28:24euphoria and he loved the idea would
7:28:26that be inappropriate comments to make
7:28:29yes if our rep made it
7:28:33if the doctor made it
7:28:37i don't think that
7:28:41it's it may be erroneous but it isn't
7:28:44improper
7:28:45and i don't know who made the statement
7:28:48okay
7:28:49um if the rep in fact even what
7:28:52statement was made
7:28:54i have not i don't remember seeing any
7:28:57of these notes by the way
7:28:58but these are typical they are
7:29:02fragments of fragments of fragments of a
7:29:05conversation that are
7:29:06designed to remind the rep of a
7:29:09conversation that he
7:29:11or she had two three four
7:29:14five six weeks prior so they
7:29:17mean a lot but without asking the person
7:29:20who wrote them
7:29:22what it meant we don't sit here have any
7:29:25idea what it means
7:29:27if the if the
7:29:32purdue sales rep calls on a doctor
7:29:36in kentucky and explains to him that oxy
7:29:38has less potential
7:29:40for abuse due to its sustained release
7:29:43would that be improper and the type of
7:29:45statement that
7:29:46was agreed was improper in the agreed
7:29:48statement of facts when purdue pled
7:29:50guilty to a felony
7:29:51okay state the hype hypo
7:29:55well well i could he just restate the
7:29:59hypothetical question
7:30:00sure if purdue called i want you to
7:30:03assume a hypothetical if purdue called
7:30:05on a doctor and said
7:30:08that oxycontin has less potential for
7:30:13abuse due to its sustained release
7:30:15would that be the type of statement that
7:30:18would be inappropriate
7:30:21and when was that said or are you going
7:30:24to set a time limit to it or a time
7:30:26period to that hypothetical
7:30:28i'm just trying to get an idea of what
7:30:30statements you consider inappropriate
7:30:32verse appropriate
7:30:33would that be an inappropriate statement
7:30:34for a rep to tell a doctor
7:30:36today yes okay would it have been
7:30:38inappropriate from 1996 to 2001. i'm not
7:30:41sure because i'd have to look at the
7:30:44package insert and
7:30:45see was that in the package insert or
7:30:48was it
7:30:49reasonably the same as what was in the
7:30:51package insert
7:30:59i'd have to do a textual analysis it's
7:31:01close to what was in the package insert
7:31:04very close yeah but it might have
7:31:07drifted
7:31:08away from the package insert so that at
7:31:11that time
7:31:12it was inappropriate
7:31:15but i'm not sure because i have to read
7:31:18the two
7:31:19the hypothetical statement you put
7:31:21forward and the package insert to give
7:31:23you an opinion
7:31:24as to whether it is drifted away from
7:31:27the package insert
7:31:29it'd be pretty easy to tell if we looked
7:31:30at the agreed statement of facts because
7:31:32they outlined
7:31:33the comments they felt were improper
7:31:35between 1996 and 2001.
7:31:39correct i didn't memorize the agreed
7:31:42statement of facts either
7:31:43but yes if that statement was an example
7:31:46of an inappropriate statement
7:31:49obviously it would would have was we
7:31:51agreed it was inappropriate
7:31:53and these call notes you all actually
7:31:56required your
7:31:57your representatives or salespeople to
7:32:00do call notes
7:32:02and instructed them to do them within
7:32:04minutes of completion of the call
7:32:06correct that's correct and that's
7:32:09because the information recorded is
7:32:10generally more accurate when it's
7:32:12recorded immediately after the sales
7:32:14call while the events of the call are
7:32:15fresh
7:32:16in the representatives minds correct
7:32:19i don't think that
7:32:22that would be true in the way these call
7:32:25notes
7:32:26were used written or
7:32:29used when reviewed i don't think it
7:32:33would have mattered
7:32:34if they had done it that evening
7:32:37but when the system
7:32:40was or when that policy was established
7:32:44whoever established it
7:32:48probably had a different use in mind
7:32:52and expected them to be
7:32:56much much more
7:33:00much closer to a he said
7:33:03i said he said i said he's interested in
7:33:07this i have to get him an answer for
7:33:08that and
7:33:10the notes i've seen so far depart
7:33:13so far from that that i don't think it
7:33:15mattered whether they
7:33:16did it in a minute an hour or a day
7:33:20so long as the conversation was fresh in
7:33:23their
7:33:24mind they sketched some notes
7:33:27to remind them of the conversation a few
7:33:30weeks
7:33:31later two to six weeks later
7:33:34when you discipline people how did you
7:33:37make a determination
7:33:39which ones needed to be disciplined
7:33:42sales reps needed to be disciplined i
7:33:45didn't
7:33:46discipline anybody and so i was not
7:33:48asked to make a determination
7:33:50do you know if the people who did make
7:33:52that determination relied on the call
7:33:53notes in determining whether
7:33:55discipline should take place i don't
7:33:57know do you know if the
7:33:59reps in kentucky were disciplined for
7:34:01having
7:34:02inappropriate call notes reflected
7:34:07their conversations with physicians i
7:34:09don't know
7:34:14if a sales rep went to a doctor and said
7:34:17discuss
7:34:17lack of buzz and thus won't be drug
7:34:20seeking
7:34:21would that be an inappropriate comment
7:34:23to make
7:34:25could you form the comment for me since
7:34:28the hypothetical as a sentence and then
7:34:30i'll respond to it
7:34:31if a if a sales rep went to a physician
7:34:35and said you don't get
7:34:38a buzz with oxycontin would that be an
7:34:42inappropriate comment
7:34:43yes if a sales rep went to a physician
7:34:47you have to
7:34:48you go you're going through a whole line
7:34:49of questioning where you have documents
7:34:52you purport to be reading from them
7:34:53you're not showing them to me you're not
7:34:55showing them to the witness i don't
7:34:56think it's
7:34:57i'm asking him what types of questions a
7:34:59sales rep says
7:35:00and whether i've got notes or documents
7:35:03or i've got them in my head
7:35:04doesn't matter i get to ask my question
7:35:06you can follow up appear to have
7:35:07documents in front of you that you're
7:35:09reading from
7:35:10yeah if a salesman went in and discussed
7:35:13abuse potential and benefits of
7:35:15oxycodone
7:35:16or oxycontin i'm sorry and it not giving
7:35:20a euphoria
7:35:21would that be inappropriate jackshammons
7:35:28i believe that would be inappropriate
7:35:34if he tells him that there's less
7:35:35euphoria with oxycontin
7:35:37or he or she sales rep says there's less
7:35:40euphoria with oxford
7:35:42oxycontin would that be inappropriate
7:35:51less amount of euphoria or less
7:35:54likely to be euphoria or
7:35:58something else either of those
7:36:13i believe that today that would
7:36:16definitely be
7:36:17inappropriate okay would it have been
7:36:20inappropriate in
7:36:22between 1996 and 2006.
7:36:26i would have to study the
7:36:29package insert let me
7:36:33let me go back and talk about what
7:36:37maybe this will help us here uh
7:36:40under misbranding of oxycontin there
7:36:43were
7:36:43several things that were brought up that
7:36:46were
7:36:50were in inappropriate
7:36:54and it says with the intent to defraud
7:36:57or mislead
7:36:58are you reading the agreement i'm
7:36:59reading from page five of the agreed
7:37:01statement
7:37:02what number is that
7:37:05it's exhibit 33. i have to find it
7:37:09now this is this yes
7:37:20and where are you reading from please
7:37:28page 5 paragraph 20
7:37:33with the intent to defraud or mislead
7:37:36i'm sorry let's back up produce
7:37:38supervisors and employees
7:37:40between december 12 1995
7:37:44again you left out the word certain all
7:37:46right well i'll just read it
7:37:48in its entirety then okay beginning on
7:37:50or about december 12 1995 and continuing
7:37:53on or about june 30th 2001
7:37:56certain purdue supervisors and employees
7:37:58with the intent to defraud or mislead
7:38:01marketed and promoted oxycontin as less
7:38:04addictive
7:38:05less subject to abuse and diversion less
7:38:08likely to cause tolerance and withdrawal
7:38:11than other pain medications did i read
7:38:14that correctly
7:38:15i think so it's getting late
7:38:18so i might have missed too
7:38:26and it was a review of the call notes
7:38:29by the u.s attorney's office that form
7:38:31the basis of this plea agreement correct
7:38:33i don't know that
7:38:40did you ever review any of the
7:38:44documents filed by the u.s attorney's
7:38:46office
7:38:47in the case where purdue pled guilty to
7:38:50the felony
7:38:52no i didn't um
7:38:56all right and it it says here they
7:38:58didn't footnote
7:39:00these documents or they so i don't even
7:39:03know if they
7:39:04the documents they reviewed millions of
7:39:06documents i don't know whether they
7:39:08referenced any of the documents to this
7:39:17i certainly couldn't have reviewed
7:39:19millions of documents no one person
7:39:21could have done that
7:39:30um under number sub-paragraph
7:39:33e it says
7:39:37told certain health care providers that
7:39:39oxycontin did not cause a buzz
7:39:41or euphoria and that would be improper
7:39:44correct
7:39:50depends on
7:39:54oh did not cause yes that would be
7:39:56inappropriate
7:39:58caused less euphoria had less
7:40:01addiction potential had less abuse
7:40:03potential
7:40:04was less likely to be diverted than
7:40:06immediate release opioids and could be
7:40:09used to weed out
7:40:10addicts and drug seekers in its totality
7:40:13it's inappropriate
7:40:18and one of the things that it points out
7:40:20in here
7:40:21when we went on was the osteoarthritis
7:40:24study do you remember us talking about
7:40:26that
7:40:26i do
7:40:36here's carol neil heisel sales rep
7:40:40this is william yates doctor florence
7:40:43kentucky
7:40:45and the notes memo says brought
7:40:47osteoarthritis studies
7:40:49that show non-addiction discussed how he
7:40:52could use oxy to deter
7:40:53addictive behavior less pills less
7:40:56potential for abuse
7:40:59would you agree that those comments
7:41:01would be improper and inappropriate
7:41:04if they were quotes of a transcript or
7:41:07of what he said
7:41:11yes this is inappropriate
7:41:21and in its totality it's it's
7:41:23inappropriate
7:41:27are you planning to mark this as an
7:41:28exhibit i was not going to market
7:41:31and it says here perdue states that
7:41:38i'm reading from the reply of the united
7:41:41states
7:41:42to defendant's response to blue cross
7:41:45blue shield of tennessee and other
7:41:46private third party
7:41:48repairs requests for restitution this is
7:41:50a new document
7:41:51right back
7:41:56is this is this an exhibit or not i just
7:41:58want to ask you about some of the
7:42:00information in here
7:42:03how can we just again you're not going
7:42:06to mark this as an exhibit either
7:42:08i wasn't could you identify it so we'll
7:42:10know what it is i thought i did it's a
7:42:12reply of united states to defendant's
7:42:13response to blue cross blue shield
7:42:19it's i'm looking at the third paragraph
7:42:23purdue states and analysis of the notes
7:42:25that produce sales representatives kept
7:42:27from their visits to physicians revealed
7:42:29that less than 0.2 percent
7:42:31contain any evidence of statements that
7:42:33were arguably improper
7:42:36and were you aware that that they had
7:42:40claimed that
7:42:41two-tenths of one percent of the sales
7:42:43notes were arguably improper
7:42:45as they say actually here in their
7:42:47response
7:42:48were even arguably improper
7:42:51but the u.s attorney says this bare
7:42:53statistical reference does not provide a
7:42:55complete picture of the magnitude of the
7:42:57unlawful activity described in the
7:43:00information
7:43:01in the agreed statement of facts these
7:43:03very
7:43:04in fact these very same notes show the
7:43:06pervasive nature of the false and
7:43:07misleading statements
7:43:10for example according to the notes in at
7:43:12least 41 states physicians were
7:43:14informed that addicts would not like
7:43:15oxycontin or that oxycontin could be
7:43:18used to weed out drug seekers
7:43:20because addicts would not like it in at
7:43:22least 49 states physicians were informed
7:43:25that oxycontin
7:43:26produces no quote buzz or euphoria
7:43:29and in 50 states physicians were
7:43:31informed that oxycontin had
7:43:33less abuse potential than other opioids
7:43:36would all of those comments be improper
7:43:42those comments would be improper
7:43:46yes it says in addition once purdue
7:43:49learned of the investigation
7:43:50it conducted training that cautioned
7:43:53sales representatives to
7:43:54avoid including references to the false
7:43:57and misleading statements in their call
7:43:59notes
7:44:00eventually purdue changed the call note
7:44:02system altogether to preclude such
7:44:04references by allowing sales
7:44:06representatives to choose only from
7:44:08pre-selected menu items
7:44:09that not surprisingly omitted the false
7:44:12and misleading statements that the
7:44:14employees had previously
7:44:16that the employees previously had
7:44:18previously spontaneously recorded in the
7:44:20notes were you aware of that
7:44:23i objected for that question you're
7:44:24showing the witness
7:44:26an argument uh written by the government
7:44:29and submitted to the court in a brief
7:44:31this witness has never seen there was
7:44:32government arguments
7:44:34and you're asking if he was aware of
7:44:35that i might ask he was aware of that
7:44:37activity
7:44:41what activity that once purdue learned
7:44:45of the investigation
7:44:46it conducted training that cautioned
7:44:48sales representatives to avoid
7:44:50including references to the false and
7:44:52misleading statements in their call
7:44:54notes
7:44:55that's number were you aware they did
7:44:56that i don't think they did that
7:44:58and it says eventually purdue changed
7:45:00the call note system all together to
7:45:02preclude such references by allowing
7:45:03sales representatives to choose from a
7:45:05pre-selected menu
7:45:07items that not surprisingly omitted the
7:45:09false and misleading statement that the
7:45:11employees had previously
7:45:13spontaneously recorded in their notes
7:45:16were you aware that
7:45:18that had occurred well i object you're
7:45:19assuming that something occurred
7:45:21based upon an argument of one party to
7:45:23litigation and a break
7:45:28can i verify that this occurred i can't
7:45:51the statements referenced
7:45:57in the agreed statement of facts under
7:46:00misbranding
7:46:00of oxycontin you don't even see a date
7:46:04on this
7:46:04but yeah okay uh
7:46:08uh can we are we on the same document no
7:46:11i'm asking about the agreed statement of
7:46:13facts now oh okay we're back to
7:46:15that okay the statement under
7:46:18misbranding of oxycontin
7:46:20uh what page or what number page five
7:46:35you've read paragraph 20 in its entirety
7:46:40correct yep i had read it
7:46:43but it might help me to read it again
7:46:46but why don't you pose your question
7:46:48yeah are those the statements that
7:46:51uh were improper and constituted
7:46:54the um
7:46:59guilty plea of purdue frederick yes
7:47:03can i hear the question again yeah the
7:47:06statements
7:47:06outlined in paragraph 20 are those the
7:47:09improper
7:47:11and misleading statements that were
7:47:14made with intent to defraud
7:47:18by a produced sales force
7:47:21[Music]
7:47:22does that set them forward
7:47:26yeah yeah i i don't
7:47:29know to me this is this is almost a
7:47:33legal
7:47:34question and i'd like to know
7:47:38whether our attorneys would agree with
7:47:41this or not
7:47:42these are some of the statements that
7:47:44are in here i think there are others
7:47:48so i'm not sure that you mean is this
7:47:51all and nothing else i don't mean i just
7:47:54mean under paragraph 20. okay
7:47:56would that constitute um
7:48:00examples examples of inappropriate um
7:48:04and that's
7:48:08it's been a long exam or late in the day
7:48:10and now
7:48:11you seem to be going over the agreed
7:48:13statement facts again and asking the
7:48:15witness
7:48:15what the first statement of facts says
7:48:18what it says
7:48:19is written in every statement of facts
7:48:21which you read in the record
7:48:24yes
7:48:28i don't know where this is getting us
7:48:30sure at this late hour
7:48:32i think it's starting to border out
7:48:34harassment can you read my question back
7:48:47i just mean under paragraph 20 would
7:48:49that constitute examples of
7:48:51inappropriate and misleading statements
7:48:55should i answer i object that you can
7:48:58answer yes
7:49:00yes
7:49:11if a sales rep told a doctor that using
7:49:15oxycontin would provide
7:49:17smoother blood levels would that be an
7:49:20appropriate statement
7:49:26i don't know if smoother blood
7:49:30levels was not in the package insert
7:49:33it may not it might be an inappropriate
7:49:36statement
7:49:37but
7:49:41i'm not sure that it wasn't in the in
7:49:44the package insert
7:49:45it's although it might be inappropriate
7:49:48i don't know
7:49:49it would have been true depending upon
7:49:53what was meant by smoother smoother is
7:49:56not a
7:49:58medical term for or a pharmacokinetic
7:50:01term
7:50:05it's an opinion of
7:50:09it's a term that somebody might apply to
7:50:11a graph
7:50:12it's a smoother line it's not a smoother
7:50:15line
7:50:16but it it's not really
7:50:19a clear statement and thus i can't say
7:50:22it's clearly right or clearly wrong
7:50:26it would have been fine if that
7:50:28terminology was in the package insert
7:50:32i don't know whether it was all right
7:50:35what information did you review to
7:50:37prepare for your deposition today
7:50:39documents
7:50:41which documents um not too many of the
7:50:44ones you've shown me
7:50:48this agreed statement of facts we've
7:50:50reviewed in part
7:50:52am i supposed to answer this i mean i
7:50:55don't
7:50:56um yes any other documents that you
7:50:59review
7:51:00that i recall and can describe to you
7:51:02yes
7:51:04no you did say you reviewed six less
7:51:07than eight call notes
7:51:08is that right yes and that was the first
7:51:09time you'd seen call notes
7:51:11yes this was the second time
7:51:17and as i said they are
7:51:20both experiences are the same they are
7:51:25so fragmentary that they can mean
7:51:28it's impossible to know really what was
7:51:30said
7:51:34that's why you had to post hypothetical
7:51:36statements
7:51:37yes purdue pharma lp purdue pharma
7:51:41inc the purdue frederick company
7:51:46purdue pharmaceuticals lp pf
7:51:49laboratories inc do you know if they
7:51:52have the same directors
7:51:54or are there different directors for
7:51:55those entities
7:51:57i don't know
7:52:05um do you currently practice
7:52:09medicine no not practice in the sense
7:52:12that i have an office
7:52:13or and see patients by appointment no i
7:52:16don't
7:52:17when is the last time that you practiced
7:52:19medicine
7:52:20in 1974 during my residency
7:52:32uh from 1999 to 2002 you were the
7:52:36president
7:52:36of purdue pharma lp from
7:52:40the very last days of 99 until
7:52:43march of 2003 were you also at some
7:52:46point
7:52:48the president of purdue frederick i
7:52:50don't think so no
7:52:51did you have any office
7:52:56title at purdue frederick i did what was
7:52:58that i was a senior
7:53:00vice president
7:53:03and you know when you relinquished that
7:53:04title
7:53:07i don't recall but it probably was
7:53:11either simultaneous with
7:53:15ending my presidency of purdue pharma or
7:53:26before
7:53:32um there are different types of
7:53:35corporations there are not for profit
7:53:39corporations and there are for-profit
7:53:42corporations would i be correct that
7:53:45purdue
7:53:46frederick and purdue pharma are
7:53:48for-profit
7:53:49corporations they're for-profit
7:53:51businesses
7:53:53but not all of the companies that you've
7:53:56named
7:53:57are corporations all right
7:54:02that's a good distinction would i be
7:54:05correct that purdue frederick
7:54:07or purdue pharma are for-profit
7:54:11not not-for-profit they're for-profit
7:54:20i'll go off the record we're off the
7:54:23record at
7:54:247 18 pm we are back on the record
7:54:27at 7 39 pm all right let's go
7:54:31back through um i'm gonna hand you a
7:54:34document
7:54:37that is um at the top and let's mark
7:54:40this as exhibit
7:54:4138 38.
7:54:44it's from richard sackler do you
7:54:47recognize that
7:54:49i recognize the name okay
7:54:52all right was this an email that you
7:54:54sent to michael
7:54:56friedman yep
7:54:59and it says here under importance
7:55:03down below important's low but down
7:55:05below it says
7:55:07why don't you guys plan a presentation
7:55:09about addiction that could be given
7:55:11first by
7:55:12rr or bk and who are those individuals
7:55:15robert reader or bob keiko
7:55:19and uh and eventually by our senior
7:55:21managed healthcare people
7:55:25next paragraph i think that paul has a
7:55:27good point but we should consider that
7:55:28quote addiction
7:55:30end quote may be a convenient way to
7:55:32quote just say no
7:55:35and when this objection is obliterated
7:55:37they will fall back on the question of
7:55:39cost
7:55:40unless we can give a convincing
7:55:42presentation that see
7:55:44our products that's controlled release
7:55:46products
7:55:48yes are less prone to addiction
7:55:51potential
7:55:52abuse or diversion than ir products
7:55:56that immediate release yes i think that
7:56:00this can be done
7:56:01but i defer to bk and rr and other
7:56:03experts
7:56:05yes and what were you trying to
7:56:09accomplish there by trying to show
7:56:13that um
7:56:16controlled release products are less
7:56:18prone to addiction abuse or diversion
7:56:21than immediate release products
7:56:25well i wasn't trying to show anything
7:56:28i was basically asking a question
7:56:32and if the answer were
7:56:35yes we can put together
7:56:38a good effective and
7:56:42medically correct presentation i thought
7:56:46it would be
7:56:46useful to do so but i was asking them
7:56:50can we do that
7:56:51do we have the information do we have
7:56:54the data
7:56:55and obviously if we had contrary
7:56:58information or data
7:57:00then obviously you couldn't do that
7:57:04are you aware of any presentation
7:57:06showing that
7:57:08controlled release products are less
7:57:10prone to addiction potential abuse or
7:57:12diversion than
7:57:14immediate release products
7:57:17i don't think so but i don't remember
7:57:21how this came to an end and
7:57:24i put on low in importance
7:57:28to indicate it was uh not something that
7:57:32was urgent
7:57:34it was an idea i had and i said could
7:57:37can we do this
7:57:44all right then the
7:57:48another email i'm going to hand you
7:57:54i like that one
7:57:59thank you mark this is exhibit 39
7:58:07and this is dated um
7:58:14looks like at the bottom analgesic plans
7:58:17dr
7:58:17richard cycler at norwalk and is this an
7:58:20email that
7:58:21you sent
7:58:34yes
7:58:38it's quite a dense email
7:58:51and if you go back to page three
7:58:54uh the email that preceded it was from
7:58:56john stewart
7:58:57yes who is jon stewart he was the
7:59:00general manager in canada
7:59:04pf canada and is that a purdue pharma
7:59:07affiliate
7:59:08it's an affiliated company yes it is
7:59:12does the sackler family own p.i yes yes
7:59:15we do
7:59:21he says under the first paragraph in my
7:59:25opinion the action that will produce the
7:59:27greatest sales gains
7:59:28are the acquisition of ims practice
7:59:31quartile data
7:59:33and the resulting improvement and
7:59:35targeting of our sales and marketing
7:59:37activities
7:59:41what does that mean
7:59:44in the united states
7:59:48from the inception of the launch of
7:59:51oxycontin
7:59:53we focused our salesman's attention
7:59:57to physicians who were
8:00:02based on their history
8:00:07physicians whose practice and their
8:00:10practice was to use
8:00:12write a lot of prescriptions for opioids
8:00:15we didn't go to people
8:00:17who didn't write them we went to people
8:00:19who did
8:00:21and
8:00:26i don't recall whether this practice
8:00:30was or was not done in pf but i might
8:00:33have learned
8:00:34in a meeting that they were not doing it
8:00:38and they could not purchase the same
8:00:40data source from
8:00:42ims in canada but they appear to have
8:00:45had something that would have been
8:00:47similar where they divided positions
8:00:50into quartiles
8:00:52okay and if you look at your response to
8:00:55him
8:00:56um on 9 27 96
8:01:02you say your most important question to
8:01:05me was have physicians been reluctant to
8:01:08use
8:01:08oxy prn what does oxyprn mean
8:01:12i assumed that oxy referred to oxycontin
8:01:16prn would mean as needed in place
8:01:19of ir forms of oxycodone and that's
8:01:23immediate release oxycodone correct
8:01:25right
8:01:27i've not asked this question but judging
8:01:29from the very strong cells performance
8:01:31and continuing growth
8:01:33i would guess that this has not been a
8:01:35problem i
8:01:36think that were
8:01:39this the case it would be because of the
8:01:41very rapid rate of onset
8:01:45parentheses as fast as ir oxycodone
8:01:48that is 45 minutes versus 41 minutes for
8:01:51the ir
8:01:52form not even close to a significant
8:01:55clinical or statistical difference
8:01:58and was it your understanding when you
8:02:00wrote this that
8:02:03oxycontin
8:02:05controlled release did not have a
8:02:09significant clinical statistical
8:02:12difference with rate of onset
8:02:14when compared to oxycodone
8:02:18immediate release that's correct
8:02:22this was drawn from a study that was
8:02:25done
8:02:27uh onset is not defined here
8:02:32but it was a medical term in the trial
8:02:36that i believe
8:02:39jon stewart had either been given or was
8:02:42familiar with
8:02:44which basically recorded the first
8:02:47instance that the patient
8:02:48said oh i'm beginning to feel better
8:02:52my pain is less that was meant by
8:02:56onset that was the meaning of onset in
8:02:58that trial
8:03:00and that was what i was quoting from and
8:03:02it says here
8:03:03the fast rise character now
8:03:06quote uh parentheses now a patent in the
8:03:09u.s in parentheses
8:03:10of the drug combined with familiarity
8:03:13and a marketing program that emphasized
8:03:16that ir was the old was
8:03:19i think that's supposed to be whey yes
8:03:21and oxycontin tablets are the new way
8:03:23to treat moderate to severe pain has
8:03:25resulted in our success
8:03:28did i read that correctly
8:03:33you read you read very correctly what is
8:03:36written here
8:03:37when it says the fast rise character
8:03:40you're
8:03:41referring to oxycontin having a fast
8:03:44rise as par as far as when
8:03:48relief occurs correct yes
8:03:52and then down below that if you go to
8:03:54about the fourth paragraph
8:03:56the overall schema that marketing here
8:03:59has worked
8:04:01are for three of the four i think that's
8:04:03out
8:04:04of three of the four should probably be
8:04:06but it's written
8:04:07yes the overall schema that marketing
8:04:09here has worked are for
8:04:11three of the four is oxy
8:04:141 ir old way oxycontin tablet new way
8:04:20emphasizing the bid was
8:04:23q4h versus versus
8:04:26qvid versus q4h and underscoring the
8:04:30similarity of onset
8:04:32other differential benefits are
8:04:34emphasized such as range of doses the
8:04:36very small tablets
8:04:37etc and then oxy2
8:04:42your second point with regarding oxy is
8:04:43in cancer and severe non-malignant pain
8:04:46the one to start with and the one to
8:04:48stay with
8:04:50here we are going directly after the msc
8:04:54endurages business what is msc
8:04:58ms content enduragizic who made
8:05:01durageezic
8:05:02jnj and you say
8:05:06clearly this is highlighted or
8:05:08capitalized clearly
8:05:10this strategy has outperformed our
8:05:12expectations
8:05:13market research and fondest dreams
8:05:17yes i read that correctly you
8:05:21um all right and then the last one i
8:05:25want to ask you about
8:05:28there's no question
8:05:34okay
8:05:40when you say it outperformed your
8:05:42fondest dreams
8:05:44you're talking in terms of market share
8:05:46and what it was earning
8:05:47is that correct it's a the overall sales
8:05:51trajectory
8:05:59and then thank you one more
8:06:03email to ask you about who was
8:06:07oh i'm sorry let's mark this as number
8:06:0940.
8:06:16um did you read the sales bulletins
8:06:19uh when you were the um
8:06:23when these were sent to you i was
8:06:26senior vice president um
8:06:29not generally i might have scanned this
8:06:32i didn't read them carefully they were
8:06:36very
8:06:37carefully crafted by sales and marketing
8:06:41people
8:06:41and and others and
8:06:45i didn't usually read them
8:06:50who is russ gazdia russ
8:06:53was then either a district manager
8:06:57or a regional manager
8:07:03and this is january 25th 1999
8:07:07prescription sales force does that mean
8:07:09it went out to everybody
8:07:12no it probably means it went out to
8:07:15salesmen who were doing who were selling
8:07:18prescription products would it have gone
8:07:21to everyone selling oxycontin
8:07:24oh i believe so yes and um
8:07:33the first paragraph says
8:07:36effective with the first quarter 1999 ms
8:07:39cotton sells
8:07:40volume first paragraph i see as was
8:07:44announced
8:07:46okay as was announced at the national
8:07:49meeting right
8:07:49right okay right you just effective with
8:07:53the first quarter 1999
8:07:55ms cotton sales volume and growth as
8:07:57well as quota will be calculated at 50
8:07:59cents
8:08:00okay i'm not following you can you just
8:08:03tell me where
8:08:04i i have the same problem i don't know
8:08:06where you're reading from
8:08:11the first paragraph okay i'm looking
8:08:14for effective oh i
8:08:17see okay sorry yeah
8:08:20these are small and i can't read them
8:08:22that fast i i'm now following you
8:08:24okay i'll give you this one and we'll
8:08:26make it the exhibit
8:08:27uh okay
8:08:34this is i'm following you now sure so
8:08:37let's read the first paragraph
8:08:39as was announced at the national sales
8:08:41meeting effective with the first quarter
8:08:421999
8:08:44ms cotton sales volume and growth as
8:08:46well as quota will be calculated at 50
8:08:48cents for every one
8:08:50dollar what does that mean i
8:08:55i'm i can't be sure but i think
8:08:58that we were reducing the
8:09:01bonus for ms cotton i'd have to read the
8:09:04whole thing to
8:09:06be sure of that would you like me to
8:09:08read it all
8:09:09uh that's all right i'm going to read it
8:09:10with you here oh okay next sentence
8:09:12so then oxycontin sales volume and
8:09:15growth as well as quota will be
8:09:16calculated at one dollar and 15 cents
8:09:19for every one dollar
8:09:22again uh it was de-emphasizing ms cotton
8:09:26sales growth and increasing the
8:09:30incentive
8:09:31by a small amount on oxycontin sales
8:09:34growth
8:09:36and then the next paragraph says early
8:09:38estimates indicate
8:09:40that the fourth quarter 1998 bonus
8:09:42payout will be another record payout
8:09:45remember this record payout came at a
8:09:47time when we were utilizing a factor of
8:09:4955 cents for every ms cotton dollar
8:09:52and a dollar fifteen for every oxycontin
8:09:55dollar
8:09:56as we continue to drive more business
8:09:58toward oxycontin each of you will
8:10:00benefit significantly
8:10:02from the factoring of a one dollar and
8:10:05fifteen cent for every one dollar of
8:10:07oxycontin
8:10:09and again is that referring to
8:10:12de uh incentivizing ms cotton cells
8:10:16and incentivizing oxycontin cells yes we
8:10:19were
8:10:20moving the incentive program to focus on
8:10:24oxycontin
8:10:26and
8:10:29every time you take an incentive program
8:10:34reduce it you
8:10:37have at least in some of the people who
8:10:40are affected
8:10:41some strong negative feelings and that's
8:10:45probably why there was a small increase
8:10:47to oxycontin
8:10:50looks like it was 15 but i'm
8:10:53interpolating here i don't recall i
8:10:55certainly didn't read this and i don't
8:10:58recall the details of the incentive
8:11:00compensation well enough to be sure
8:11:02and then it says as pointed out your
8:11:05priority
8:11:05is to sell sell sell
8:11:10and that's in bold oxycontin right is
8:11:13that what the
8:11:14sales force was instructed to do
8:11:18that's what he said they were instructed
8:11:19to do but they were
8:11:22instructed to do their best to sell
8:11:25oxycontin
8:11:26yes this was a sales
8:11:30force related
8:11:34kind of rah-rah piece
8:11:40and it also says
8:11:43in the last paragraph remain focused on
8:11:46positioning oxycontin as the
8:11:48opioid to start with and stay with in
8:11:50chronic malignant
8:11:51and non-malignant pain states in
8:11:54addition continue to
8:11:56aggressively position oxycontin for use
8:11:58in osteoarthritis low back pain
8:12:00post neuropathic neuralgia and
8:12:02post-surgical applications where
8:12:04appropriate
8:12:05finally continue to highlight the
8:12:07advantages of oxycontin especially for
8:12:09use in the elderly
8:12:11if you have any questions regarding the
8:12:13bonus calculations for the first quarter
8:12:15of 99
8:12:15please contact your district manager
8:12:17that tells me he was a regional manager
8:12:20then
8:12:23have you made any uh effort or as we sit
8:12:27here today do you know
8:12:29how many patients who took oxycontin in
8:12:32kentucky
8:12:34became dependent or addicted no
8:12:40do you believe that an inappropriate
8:12:46number of patients or an excessive
8:12:47number of patients who took
8:12:50oxycontin in kentucky became
8:12:54addicted or dependent no
8:12:59do you know or has purdue made any
8:13:03effort
8:13:04to ascertain
8:13:09how many people who were started on
8:13:12oxycontin
8:13:14wound up becoming dependent and moving
8:13:16on to heroin at some point
8:13:30now
8:13:44um
8:13:49i think it's all questions i have dr
8:13:51sachar thank you very much
8:13:52are we finished or maybe not i don't
8:13:55know
8:13:57you're done thank you very much that is
8:13:59the conclusion of this deposition it is
8:14:01we're off the record at 7 58 pm just to
8:14:04save

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