Short Memo Board Quotes

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According to a memo that Keller himself wrote to the Brown Institutional Review Board on January 30, 1995, this patient (number 70) ingested eighty-two Tylenol pills in an apparent overdose attempt on January 19. Patient 70 was admitted to a hospital and terminated from the study shortly afterward, according to Keller’s memo to Brown IRB. Yet this teenage girl was not included in the group reported to have experienced serious adverse events while in the study. Instead, in another memo that Keller had written to the Brown IRB in 1995, she was described as having been terminated from the study for being “noncompliant.” In an even more mysterious turn, patient 70 was described in GlaxoSmithKline’s final report of the study as being a twelve-year-old boy. This boy was enrolled in the clinical trial a month after the teenage girl identified in Keller’s memos as patient 70 overdosed on Tylenol and withdrew from the study. The boy with the same patient number was removed from the study on March 22, 1995, after developing tachycardia (rapid heartbeat) while taking the tricyclic antidepressant known as imipramine, according to the company’s final report. There was no mention in the company’s posted final report or the 2001 journal paper that the original patient 70 was a young girl who had ingested eighty-two Tylenol pills in a clear bid to kill herself.
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Alison Bass (Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial)