Side Effects Quotes

“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.”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

“But despite the fact that this boy was clearly suicidal and required hospitalization, he was not included among the patients listed as having developed serious adverse effects in the published 2001 Paxil study. Other patients were similarly miscoded. One was a fifteen-year-old girl who had been withdrawn from the Brown study site in 1995 after becoming combative with her mother. According to internal university documents that Howard gave me, Brown researchers knew that this girl had become suicidal after taking Paxil. In a memo to the Institutional Review Board dated October 30, 1995, Martin Keller wrote that this teenager, who had been enrolled in the study in June 1995, “was hospitalized on 9/15/95 due to becoming very combative with her mother and threatening suicide.” Yet instead of coding her behavior as an adverse effect related to Paxil, Keller in his memo says she was “terminated from the study for non-compliance.” The Brown investigators may have coded her as noncompliant because she had stopped taking Paxil before having her meltdown. But they shouldn’t have, according to several clinicians familiar with the study. The Brown researchers should have included all adverse effects experienced by their patients, regardless of what may have caused the problems. As a Harvard Medical School biostatistician later told me, “You shouldn’t try to make these subjective attributions and exclude patients who don’t fit into your thesis.” As research has shown, the SSRI antidepressants can cause serious side effects, including suicidal behaviors and hostility, weeks after people stop taking them.”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

“The next thing Firestein did was google Martin Keller, the lead author of the Paxil study. What she found shocked her to her core. Up popped the series of articles published a few years back in the Boston Globe that essentially cast doubt on Keller’s integrity as a scientist. As a doctor’s daughter, Firestein had up to this point pretty much believed in the purity of science, the tenet that its practitioners were honorable scholars laboring away in the isolation of their ivy-covered labs, impervious to the siren song of big money. But here was the chief of psychiatry at Brown essentially accused in the pages of a respected newspaper of being beholden to the drug industry. And that was not all. Firestein found an earlier article in the same newspaper charging Keller’s department with falsifying invoices to obtain money from a financially strapped state agency for research that didn’t appear to have happened. Still another clip noted that Brown had repaid the Commonwealth of Massachusetts more than $300,000 for the contract dollars that Keller’s department had obtained under these dubious circumstances. “When I read the pieces about Keller, it made me look at psychiatry in a whole different light, with new cynicism,” Firestein later acknowledged. “I had not realized the depth of the connection between academic researchers and the pharmaceutical industry.”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

“SOME MONTHS LATER, in July 2003, Rose Firestein was browsing the official Web site of the Food and Drug Administration when she suddenly reared back in surprise. She blinked and looked again. Buried in the third paragraph of an FDA press release, dated June 19, 2003, was this sentence: “Three well-controlled trials in pediatric patients with MDD [major depressive disorder] failed to show that [Paxil] was more effective than placebo.” The reference to these negative findings about Paxil mystified Firestein. Why would doctors so readily prescribe Paxil (making it by 2003 the second most widely prescribed antidepressant for those under eighteen years old) if the results of drug tests were uniformly negative?”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

“The FDA, of course, was not the only beneficiary of the pharmaceutical industry’s largesse. Its tentacles reached deep into the corridors of power in Washington. Between 1998 and 2006, the drug companies spent a total of $1.2 billion on lobbying and political contributions in the United States, according to the Center for Responsive Politics, a nonprofit, nonpartisan research group that tracks money in politics. In 2002, the pharmaceutical industry ranked tenth among the top industries in political contributions and seventh in the amount of money it spent on lobbying members of Congress and others.”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

“Howard suspected that researchers on the Paxil trial were not accurately coding these adverse events. According to a trail of faxed memos, at least two adolescent patients enrolled in the Paxil trial had been yanked from the study after threatening or attempting suicide. Yet on several memos submitted to Brown’s Institutional Review Board, Keller wrote that these teenage girls “withdrew during the acute phase for reasons of noncompliance.”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

“The resulting lawsuit accused GlaxoSmithKline of committing “repeated and persistent” fraud by hiding from the public the results of several negative studies about Paxil, one of its bestselling drugs. Not surprisingly, the lawsuit attracted a burst of publicity when it was filed on June 2, 2004. The press coverage spotlighted what many said was a widespread practice in the pharmaceutical industry of disclosing only the results of positive studies in order to boost the sales of new drugs.”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

“Only later would Teicher discover that Tollefson had also omitted from his talk that day information that would have been even more damaging to Lilly’s defense of Prozac: One of the company’s international clinical trials had indeed shown an increased risk of suicidal acts among patients taking Prozac (as compared to placebo). After seeing this data in 1984, the German regulatory authorities had declined to approve the drug’s use. (When Prozac was finally approved in Germany six years later, it came with a clear warning that it could cause problems and that it might be necessary for physicians to coadminister a sedative to prevent the agitation and suicidal behaviors sometimes caused by the SSRI.)”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial

“And since the publication of their Prozac paper, he and his colleagues had come across more patients who had become agitated and preoccupied with suicide after taking the drug. Several patients had turned uncharacteristically aggressive while on Prozac; some began mutilating themselves. In a follow-up article that Teicher and his colleagues would publish in 1993, they cited the case of one woman, with no prior history of depression, who began cutting herself after taking a high dose of Prozac. Her self-mutilation was so “incessant” that it eventually required plastic surgery, the McLean authors wrote. After this patient was taken off Prozac, her self-destructive behavior and suicidal thoughts disappeared.”
― Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial