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Cover 04/10/2013

Big Pharma's Troubling History of Pushing Drugs on Foster Kids

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Over strong objections from staffers, in 2001 the FDA approved Geodon for treating adults with schizophrenia and bipolar disorder. But federal whistleblower lawsuits, in which Texas has been a plaintiff, filed before and after Jo Angel Rodriguez’s death allege that in order to boost Geodon sales, Pfizer followed Johnson & Johnson’s lead, launching a full-court press to market Geodon for off-label use, particularly in children and adolescents.

At least twice the FDA chided Pfizer for providing doctors misleading information. One September 2002 warning letter scolded the company for misrepresenting clinical and safety studies related to the drug, and for promoting Geodon “in a manner that is misleading and lacking fair balance” by minimizing the risk of cardiac arrhythmia. The FDA again warned Pfizer in 2007 for similar problems.

Meanwhile, Pfizer sought to seed the medical literature with studies praising off-label use of Geodon, some of which the federal government described as little more than a marketing gimmick in their lawsuit.

According to another whistleblower suit, Pfizer began to contract with Dr. Neil Kaye, a prominent psychiatrist with Jefferson Medical College in Philadelphia, to promote off-label prescribing of Geodon in medical journals, at speaking gigs, and in continuing medical education seminars for psychiatrists.

Pfizer, according to court records, paid Kaye as much as $4,000 a day on top of expenses, and even flew him around the country in his own private helicopter.

In one court case, the feds called the practice “information laundering.” Apparently it paid off. According to court records, doctors wrote 89,000 Geodon prescriptions for children in the U.S. in 2003. By 2005, prescriptions for children jumped to 251,000.

Three weeks before Jo Angel Rodriguez died at Laurel Ridge, Pfizer paid $2.3 billion to settle claims that it fraudulently marketed Geodon and two other medications. It was the Justice Department’s largest ever health care fraud settlement, and as part of the deal Pfizer agreed to comply with a more rigorous corporate compliance regimen.

But according to another whistleblower’s suit filed a year after Rodriguez’s death, the illegal marketing never stopped.

In 2009, Pfizer again sought approval to market Geodon for use in children; the FDA rejected the application late that year. Further, the FDA issued a report after looking into Pfizer’s data on clinical trials in kids and adolescents, detailing some 24 cases where children experienced serious complications, including cardiac arrhythmia. While Pfizer told the FDA cardiac concerns were no different in children than in adults, the FDA did its own analysis that showed otherwise. The FDA in 2010 scolded three doctors who participated in Geodon’s children trials, saying they improperly dosed patients, and in a few instances overdosed patients.

Emails from executives in Pfizer’s Missouri-based southern district, which also covers Texas, Oklahoma, Colorado, and Louisiana, warned sales teams to shy away from the issue while pitching the drug to child psychiatrists. “[I]nformation related to Geodon’s pediatric filing status should NOT be discussed,” read one such exchange.

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