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Cover 04/10/2013

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

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Emergency room doctors later determined Rodriguez suffered from a cardiac arrhythmia that triggered a full-blown heart attack. She slipped into a coma and died the next day.

A barrage of errors killed Rodriguez, according to a lawsuit her court-appointed attorneys filed on her behalf in 2010 targeting Laurel Ridge, Bankes, and the ambulance company. They also sued Pfizer, Geodon’s manufacturer, alleging the drug set in motion the deadly chain of events.

Even though the Food and Drug Administration has denied Pfizer’s multiple attempts to approve Geodon for use in children, meaning the company can’t legally market it for pediatric uses, Geodon still made its way into Rodriguez’s room that night.

It wasn’t by accident. The Bexar County lawsuit and several others filed in federal court with the backing of the Texas Attorney General’s Office claim that Pfizer schemed for years to illegally market Geodon to child psychiatrists. In the process, court documents say, Pfizer manipulated information about the drug’s side-effects, paid off doctors to tout the drug’s use in kids, and purchased ghost-written studies that essentially amounted to paid advertising posing as science.

Geodon, a drug known to cause dangerous heartbeat irregularities, is among a new generation of antipsychotics that, while FDA-approved for narrow treatment, have become some of Big Pharma’s signature off-label moneymakers. While the FDA approved Geodon to treat adults diagnosed with schizophrenia and bipolar disorder, Pfizer worked for years to recast the drug for broader use, court records indicate.

Pfizer isn’t alone. The company and its Big Pharma competitors have become the single largest target of the federal False Claims Act, paying out millions in recent settlements over allegations of illegal marketing of drugs, many of them atypical antipsychotics.

“This case is a perfect example, unfortunately, of what can happen” with off-label marketing of pharmaceuticals, contends Brant Mittler, a cardiologist-turned malpractice lawyer who handled the Jo Angel Rodriguez case.

“This child didn’t need to die.”

The 1990s were the Manifest Destiny days for drug manufacturers, and Texas became the first promising frontier. Developed over a half century ago, neuroleptic drugs, now commonly referred to as antipsychotics, were initially seen as little more than powerful sedatives, used sparingly for patients diagnosed with schizophrenia or severe psychotic disorders. Patients often quit the drugs, like Thorazine and Haldol, because they caused involuntary tics, movements, and restlessness.

By the ’90s, however, drug companies began developing new, second-generation antipsychotics, often called atypicals, telling regulators they were safer than the old ones, a dubious claim according to some (non-industry funded) research.

The FDA approved these drugs for treating schizophrenia, but companies dreamed bigger, pushing for the drugs to treat anything from bipolar disorder to dementia, attention-deficit disorder or even stuttering, in all age groups, including children and adolescents.

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