Erika Cheung: Theranos, whistleblowing and speaking truth to power | TED — Transcript

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1. 0:00Transcriber: Joseph Geni Reviewer: Krystian Aparta
2. 0:00So, I had graduated seven years ago from Berkeley
3. 0:03with a dual degree in molecular and cell biology and linguistics,
4. 0:08and I had gone to a career fair here on campus,
5. 0:11where I'd gotten an interview with a start-up called Theranos.
6. 0:15And at the time,
7. 0:16there wasn't really that much information about the company,
8. 0:19but the little that was there was really impressive.
9. 0:24Essentially, what the company was doing was creating a medical device
10. 0:28where you would be able to run your entire blood panel
11. 0:32on a finger-stick of blood.
12. 0:34So you wouldn't have to get a big needle stuck in your arm
13. 0:37in order to get your blood test done.
14. 0:39So this was interesting not only because it was less painful,
15. 0:43but also, it could potentially open the door to predictive diagnostics.
16. 0:48If you had a device
17. 0:50that allowed for more frequent and continuous diagnosis,
18. 0:54potentially, you could diagnose disease before someone got sick.
19. 1:00And this was confirmed in an interview that the founder, Elizabeth Holmes,
20. 1:04had said in the Wall Street Journal.
21. 1:06"The reality within our health-care system today
22. 1:09is that when someone you care about gets really sick,
23. 1:12by the time you find out it's [most often] too late
24. 1:15to do anything about it,
25. 1:16It's heartbreaking."
26. 1:17This was a moon shot that I really wanted to be a part of
27. 1:20and I really wanted to help build.
28. 1:23And there was another reason why I think the story of Elizabeth
29. 1:27really appealed to me.
30. 1:29So there was a time that someone had said to me,
31. 1:31"Erika, there are two types of people.
32. 1:33There are those that thrive and those that survive.
33. 1:36And you, my dear, are a survivor."
34. 1:39Before I went to university,
35. 1:41I had grown up in a one-bedroom trailer with my six family members,
36. 1:45and when I told people I wanted to go to Berkeley,
37. 1:48they would say, "Well, I want to be an astronaut, so good luck."
38. 1:52And I stuck with it, and I worked hard, and I managed to get in.
39. 1:56But honestly, my first year was very challenging.
40. 1:58I was the victim of a series of crimes.
41. 2:01I was robbed at gunpoint, I was sexually assaulted,
42. 2:04and I was sexually assaulted a third time,
43. 2:06spurring on very severe panic attacks,
44. 2:09where I was failing my classes,
45. 2:11and I dropped out of school.
46. 2:13And at this moment, people had said to me,
47. 2:15"Erika, maybe you're not cut out for the sciences.
48. 2:18Maybe you should reconsider doing something else."
49. 2:21And I told myself, "You know what?
50. 2:24If I don't make the cut, I don't make the cut,
51. 2:26but I cannot give up on myself, and I'm going to go for this,
52. 2:29and even if I'm not the best for it, I'm going to try and make it happen."
53. 2:32And luckily, I stuck with it, and I got the degree, and I graduated.
54. 2:37(Applause and cheers)
55. 2:40Thank you.
56. 2:41(Applause)
57. 2:44So when I heard Elizabeth Holmes had dropped out of Stanford at age 19
58. 2:50to start this company,
59. 2:51and it was being quite successful,
60. 2:53to me, it was a signal
61. 2:55of, you know, it didn't matter what your background was.
62. 2:59As long as you committed to hard work and intelligence,
63. 3:03that was enough to make an impact in the world.
64. 3:05And this was something, for me, personally,
65. 3:07that I had to believe in my life,
66. 3:09because it was one of the few anchors that I had had
67. 3:13that got me through the day.
68. 3:15So you can imagine,
69. 3:17when I received this letter, I was so excited.
70. 3:21I was over the moon.
71. 3:24This was finally my opportunity to contribute to society,
72. 3:28to solve the problems that I had seen in the world,
73. 3:31and really, when I thought about Theranos,
74. 3:34I really anticipated that this would be the first
75. 3:37and the last company that I was going to work for.
76. 3:40But I started to notice some problems.
77. 3:45So, I started off as an entry-level associate in the lab.
78. 3:49And we would be sitting in a lab meeting,
79. 3:52reviewing data to confirm whether the technology worked or not,
80. 3:57and we'd get datasets like this,
81. 3:59and someone would say to me,
82. 4:01"Well, let's get rid of the outlier
83. 4:04and see how that affects the accuracy rate."
84. 4:07So what constitutes an outlier here?
85. 4:09Which one is the outlier?
86. 4:11And the answer is, you have no idea.
87. 4:14You don't know. Right?
88. 4:17And deleting a data point
89. 4:18is really violating one of the things that I found so beautiful
90. 4:22about the scientific process --
91. 4:24it really allows the data to reveal the truth to you.
92. 4:29And as tempting as it might be in certain scenarios
93. 4:32to place your story on the data to confirm your own narrative,
94. 4:37when you do this, it has really bad future consequences.
95. 4:43So this, to me, was almost immediately a red flag,
96. 4:46and it kind of folded in to the next experience
97. 4:49and the next red flag
98. 4:51that I started to see within the clinical laboratory.
99. 4:54So a clinical laboratory
100. 4:55is where you actively process patient samples.
101. 4:59And so before I would run a patient's sample,
102. 5:01I would have a sample where I knew what the concentration was,
103. 5:05and in this case, it was 0.2 for tPSA,
104. 5:07which is an indicator of whether someone has prostate cancer,
105. 5:11or is at risk of prostate cancer or not.
106. 5:13But then, when I'd run it in the Theranos device,
107. 5:16it would come out 8.9,
108. 5:18and then I'd run it again, and it would run out 5.1,
109. 5:22and I would run it again, and it would come out 0.5,
110. 5:25which is technically in range,
111. 5:27but what do you do in this scenario?
112. 5:30What is the accurate answer?
113. 5:33And this wasn't an instance that I was seeing just one-off.
114. 5:37This was happening nearly every day,
115. 5:41across so many different tests.
116. 5:44And mind you, this is for a sample where I know what the concentration is.
117. 5:51What happens when I don't know what the concentration is,
118. 5:54like with a patient sample?
119. 5:56How am I supposed to trust what the result is, at that point?
120. 6:02So this led to, sort of, the last and final red flag for me,
121. 6:07and this is when we were doing testing,
122. 6:11in order to confirm and certify
123. 6:14whether we could continue processing patient samples.
124. 6:17So what regulators will do is they'll give you a sample,
125. 6:20and they'll say, "Run this sample,
126. 6:22just like the quality control, through your normal workflow,
127. 6:25how you normally test on patients,
128. 6:27and then give us the results,
129. 6:29and we will tell you: do you pass, or do you fail."
130. 6:33So because we were seeing so many issues with the Theranos device
131. 6:37that was actively being used to test on patients,
132. 6:40what we had done is we had taken the sample
133. 6:42and we had run it through an FDA-approved machine
134. 6:45and we had run it through the Theranos device.
135. 6:48And guess what happened?
136. 6:50We got two very, very different results.
137. 6:54So what do you think they did in this scenario?
138. 6:57You would anticipate that you would tell the regulators,
139. 7:00like, "We have some discrepancies here with this new technology."
140. 7:04But instead, Theranos had sent the result of the FDA-approved machine.
141. 7:10So what does this signal to you?
142. 7:13This signals to you that even within your own organization,
143. 7:17you don't trust the results that your technology is producing.
144. 7:21So how do we have any business running patient samples
145. 7:25on this particular machine?
146. 7:28So of course, you know, I am a recent grad,
147. 7:32I have, at this point, run all these different experiments,
148. 7:35I've compiled all this evidence, and I'd gone into the office of the COO
149. 7:40and I was raising my concerns.
150. 7:43"Within the lab, we're seeing a lot of variability.
151. 7:46The accuracy rate doesn't seem right.
152. 7:48I don't feel right about testing on patients.
153. 7:50These things, I'm just not comfortable with."
154. 7:53And the response I got back is,
155. 7:56"You don't know what you're talking about."
156. 7:58What you need to do is what I'm paying you to do,
157. 8:01and you need to process patient samples."
158. 8:04So that night, I called up a colleague of mine
159. 8:07who I had befriended within the organization, Tyler Shultz,
160. 8:11who also happened to have a grandfather who was on the Board of Directors.
161. 8:16And so we had decided to go to his grandfather's house
162. 8:20and tell him, at dinner,
163. 8:22what the company was telling him was going on
164. 8:26was actually not what was happening behind closed doors.
165. 8:29And not to mention,
166. 8:31Tyler's grandfather was George Schultz,
167. 8:34the ex-secretary of state of the United States.
168. 8:37So you can imagine me as a 20-something-year-old
169. 8:40just shaking, like, "What are you getting yourself into?"
170. 8:45But we had sat down at his dinner table and said,
171. 8:48"When you think that they've taken this blood sample
172. 8:51and they put it in this device, and it pops out a result,
173. 8:55what's really happening is the moment you step outside of the room,
174. 8:59they take that blood sample, they run it to a back door,
175. 9:03and there are five people on standby that are taking this tiny blood sample
176. 9:07and splitting it amongst five different machines."
177. 9:11And he says to us, "I know Tyler's very smart,
178. 9:14you seem very smart,
179. 9:16but the fact of the matter is I've brought in a wealth of intelligent people,
180. 9:20and they tell me that this device is going to revolutionize health care.
181. 9:25And so maybe you should consider doing something else."
182. 9:29So this had gone through a period of about seven months,
183. 9:33and I decided to quit that very next day.
184. 9:37And this --
185. 9:39(Applause and cheers)
186. 9:46But this was a moment that I had to sit with myself
187. 9:48and do a bit of a mental health check.
188. 9:51I'd raised concerns in the lab.
189. 9:53I'd raised concerns with the COO.
190. 9:57I had raised concerns with a board member.
191. 10:00And meanwhile,
192. 10:02Elizabeth is on the cover of every major magazine across America.
193. 10:08So there's one common thread here,
194. 10:10and that's me.
195. 10:12Maybe I'm the problem?
196. 10:13Maybe there's something that I'm not seeing?
197. 10:15Maybe I'm the crazy one.
198. 10:18And this is the part in my story where I really get lucky.
199. 10:22I was approached
200. 10:24by a very talented journalist, John Carreyrou
201. 10:26from the Wall Street Journal, and he --
202. 10:30And he had basically said that he also had heard concerns
203. 10:35about the company from other people in the industry
204. 10:38and working for the company.
205. 10:40And in that moment, it clicked in my head:
206. 10:42"Erika, you are not crazy.
207. 10:45You're not the crazy one.
208. 10:46In fact, there are other people out there just like you
209. 10:50that are just as scared of coming forward,
210. 10:53but see the same problems and the same concerns that you do."
211. 10:57So before John's exposé and investigative report had come out
212. 11:01to reveal the truth of what was going on in the company,
213. 11:05the company decided to go on a witch hunt for all sorts of former employees,
214. 11:09myself included,
215. 11:10to basically intimidate us from coming forward or talking to one another.
216. 11:17And the scary thing, really, for me in this instance
217. 11:20was the fact that it triggered,
218. 11:22and I realized that they were following me once I received this letter,
219. 11:26but it was also, in a way, a bit of a blessing,
220. 11:30because it forced me to call a lawyer.
221. 11:32And I was lucky enough -- I called a free lawyer,
222. 11:34but he had suggested,
223. 11:36"Why don't you report to a regulatory agency?"
224. 11:40And this was something that didn't even click in my head,
225. 11:44probably because I was so inexperienced,
226. 11:46but once that happened, that's exactly what I did.
227. 11:50I had decided to write a letter, and a complaint letter, to regulators,
228. 11:55illustrating all the deficiencies and the problems that I had seen
229. 11:58in the laboratory.
230. 12:00And as endearingly as my dad kind of notes this
231. 12:04as being my, like, dragon-slayer moment,
232. 12:06where I had risen up and fought this behemoth
233. 12:09and it caused this domino effect,
234. 12:11I can tell you right now,
235. 12:12I felt anything but courageous.
236. 12:15I was scared, I was terrified,
237. 12:18I was anxious,
238. 12:20I was ashamed, slightly,
239. 12:23that it took me a month to write the letter.
240. 12:25There was a glimmer of hope in there
241. 12:27that maybe somehow no one would ever figure out
242. 12:30that it was me.
243. 12:32But despite all that emotion and all that volatility,
244. 12:35I still did it,
245. 12:37and luckily, it triggered an investigation
246. 12:40that shown to light
247. 12:41that there were huge deficiencies in the lab,
248. 12:44and it stopped Theranos from processing patient samples.
249. 12:47(Applause)
250. 12:56So you would hope, going through a very challenging
251. 12:59and crazy situation like this,
252. 13:01that I would be able to sort of culminate some how-tos
253. 13:05or recipe for success for other people that are in this situation.
254. 13:09But frankly, when it comes to situations like this,
255. 13:12the only quote that kind of gets it right is this Mike Tyson quote that says,
256. 13:16"Everyone has a plan until you get punched in the mouth."
257. 13:19(Laughter)
258. 13:21And that's exactly how this is.
259. 13:25But today, you know,
260. 13:26we're here to kind of convene on moon shots,
261. 13:29and moon shots are these highly innovative projects
262. 13:33that are very ambitious,
263. 13:34that everyone wants to believe in.
264. 13:37But what happens when the vision is so compelling
265. 13:41and the desire to believe is so strong
266. 13:45that it starts to cloud your judgment about what reality is?
267. 13:50And particularly when these innovative projects
268. 13:54start to be a detriment to society,
269. 13:57what are the mechanisms in place
270. 13:59in which we can prevent these potential consequences?
271. 14:04And really, in my mind, the simplest way to do that
272. 14:07is to foster stronger cultures of people who speak up
273. 14:12and listening to those who speak up.
274. 14:15So now the big question is,
275. 14:18how do we make speaking up the norm and not the exception?
276. 14:23(Applause and cheers)
277. 14:31So luckily, in my own experience,
278. 14:33I realized that when it comes to speaking up,
279. 14:36the action tends to be pretty straightforward in most cases,
280. 14:40but the hard part is really deciding whether to act or not.
281. 14:45So how do we frame our decisions
282. 14:48in a way that makes it easier for us to act
283. 14:52and produce more ethical outcomes?
284. 14:55So UC San Diego came up with this excellent framework
285. 14:59called the "Three Cs,"
286. 15:01and it's called commitment, consciousness and competency.
287. 15:05And commitment is the desire to do the right thing
288. 15:08regardless of the cost.
289. 15:10In my case at Theranos,
290. 15:12if I was wrong,
291. 15:13I was going to have to pay the consequences.
292. 15:15But if I was right,
293. 15:17the fact that I could have been a person
294. 15:20that knew what was going on and didn't say something,
295. 15:23that was purgatory.
296. 15:25Being silent was purgatory.
297. 15:28Then there's consciousness,
298. 15:30the awareness to act consistently and apply moral convictions
299. 15:34to daily behavior,
300. 15:36behavior.
301. 15:38And the third aspect is competency.
302. 15:41And competency is the ability to collect and evaluate information
303. 15:45and foresee potential consequences and risk.
304. 15:47And the reason I could trust my competency
305. 15:51was because I was acting in service of others.
306. 15:54So I think a simple process is really taking those actions
307. 15:59and imagining,
308. 16:00"If this happened to my children,
309. 16:02to my parents,
310. 16:04to my spouse,
311. 16:06to my neighbors, to my community,
312. 16:08if I took that ...
313. 16:11How will it be remembered?"
314. 16:14And with that,
315. 16:16I hope, as we all leave here
316. 16:18and venture off to build our own moon shots,
317. 16:20we don't just conceptualize them,
318. 16:22in a way, as a means for people to survive
319. 16:26but really see them as opportunities and chances for everybody to thrive.
320. 16:33Thank you.
321. 16:34(Applause and cheers)