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The cleverest manipulation has been with the clinical trials themselves. For years, critics have charged that pharmaceutical companies massage trials to make their drugs look better than they are. One common tactic is to suppress unfavorable data.
A notorious example came in the 1990s, when a Wyeth safety officer overwrote the company’s computer files, erasing evidence indicating that its diet drug, fen-phen, caused valvular heart disease.
A less risky strategy is simply not to publish potentially damaging trials. In 2004, the Canadian Medical Association Journal described a leaked document indicating that:
GlaxoSmithKline had deliberately hidden two studies from regulators showing that its antidepressant, Paxil (paroxetine), could increase the risk of suicide in children. The company has paid nearly a billion dollars in legal settlements over Paxil, including $390 million for suicides and attempted suicides related to the drug.
Evidence of manipulation has also emerged in many of the high-profile pharmaceutical scandals of the past decade, from Merck’s pain drug Vioxx to the recent Senate investigation (link to senate investigation was removed by the source) into GlaxoSmithKline’s diabetes drug Avandia.
Eli Lilly (PDF), the manufacturer of Zyprexa. In early 2009, it settled the litigation for a record-breaking $1.4 billion for illegal marketing and allegedly hiding the risks of the drug. More recently, however, the scandal has spread to Seroquel.
In April 2010, AstraZeneca agreed to pay $520 million to settle two federal investigations and two whistleblower lawsuits alleging that it had marketed Seroquel illegally and concealed its health risks. The company faces more than 25,000 civil suits.
Documents unsealed in related civil suits suggest an alarming pattern of deception.
Sales reps were instructed to tell doctors that Seroquel doesn’t cause diabetes, even though the company knew about the link to diabetes as early as 1997.
Internal correspondence reveals company officials discussing how to hide or spin potentially damaging studies. “Thus far, we have buried trials 15, 31, 56,” wrote a publications manager in 1999. “The larger issue is how do we face the outside world when they begin to criticize us for suppressing data.”
As part of this scheme, AstraZeneca was accused of illegally promoting Seroquel to physicians and violating the federal Anti-Kickback statute, all in furtherance of supporting the drug’s use for a host of illnesses for which it was never approved.
The pharmaceutical company AstraZeneca has agreed to pay $520 million to federal and state taxpayers to settle claims that it illegally marketed the anti-psychotic drug Seroquel for uses that were not approved as safe and effective by the Food and Drug Administration. As part of this scheme, AstraZeneca was accused of illegally promoting Seroquel to physicians and violating the federal Anti-Kickback statute, all in furtherance of supporting the drug’s use for a host of illnesses for which it was never approved.
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