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Cover 04/10/2013

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

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In 2005, in reaction to the whistleblower lawsuit, Texas drafted the Psychotropic Medication Utilization Parameters for Foster Children, which were last updated in late 2010, authored by some of the same industry-friendly doctors outed by the Texas AG’s lawsuit. The current parameters cite a 2007 article that appeared in the European Journal of Child and Adolescent Psychiatry boosting the pediatric profile for atypicals, ghost-written by Excerpta Medica and overseen by Janssen, according to an investigation report filed in the state’s lawsuit. The report cites a litany of emails that show Janssen helped craft the article.

Dr. Howard Brody, who heads the Institute for Medical Humanities at the University of Texas Medical Branch, asserts such ghost-writing has “poisoned the medical literature” in recent years, particularly when it comes to atypical antipsychotics.

According to Brody, federal and state governments have sued Pfizer more than a dozen times over the past decade, resulting in millions of dollars in settlement payouts to quell allegations of illegal marketing of drugs, including Geodon.

Pfizer declined to comment on the allegations contained in any of the lawsuits against the company, saying through a spokesperson, “Pfizer remains committed to conducting its business with the highest degree of ethics and integrity, and providing patients, physicians, and the public with accurate, science-based information regarding our medicines.”

“Each time, they swear on a stack of Bibles, ‘Oh we’ll never do that again,’ and they just do it over and over again,” Brody said. “Industry treats this as nothing more than a cost of doing business.”

 

The FDA rejected Geodon in 1998, just five months after Jo Angel Rodriguez was born, fearing the drug’s tendency to cause cardiac arrhythmia was too great. While the effect is a common one in antipsychotics — known as QT prolongation — the FDA’s disapproval letter to Pfizer expressed concern that Geodon’s impact was worse than that of other antipsychotics on the market.

Pfizer quickly started more clinical trials. The manufacturer wanted to ensure good results, the feds have alleged, so, along with comparing the drug to other leading atypicals, Pfizer put Geodon up against Thioridazine, a highly potent antipsychotic that’s rarely used because of a strong risk of cardiac complications; the FDA had, in fact, already made Thioridazine a second-line treatment because of those concerns.

Some of the data from Pfizer’s clinical trials came from unsavory characters, according to federal court records. Early participants included Drs. Richard Borison and Bruce Diamons, former psychiatrists with the Medical College of Georgia who were later convicted and sentenced to prison for stealing more than $10 million in clinical research funds from their school. Another trial participant was Louis Fabre, founder of Houston’s Fabre Research Clinic, which the FDA blamed for a patient death during a 2002 clinical trial on another antipsychotic.

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