Alison Bass

“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

“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 One was a fifteen-year-old girl who had been withdrawn from the Brown study site in 1995 after becoming combative with her mother.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