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"Naughty" Pharma Still Got Christmas Presents From FDA in 2009

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You couldn't get much naughtier than Eli Lilly in 2009 who agreed to pay $1.42 billion for mismarketing Zyprexa and Pfizer who agreed to pay $2.3 billion for Bextra, Geodon, Lyrica and Zyvox fraud.

Pharma will continue to dole out such payouts and consider them a slap on the wrist, writes Bloomberg's David Evans, until prosecutors and judges "use the ultimate sanction, a felony conviction that would render a company's drugs ineligible for reimbursement by state health programs and federal Medicare."

Nor did the mismarketing and fraud only enrich drug companies and loot Medicaid and Medicare tax dollars.

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Doctors have also cleaned up like Chicago psychiatrist Michael Reinstein who received $500,000 to promote a drug that Medicaid records say he prescribed 41,000 times according to Chicago Tribune and Propublico, figures Reinstein disputes.

And Miami psychiatrist Fernando Mendez-Villamil who wrote 97,000 psychoactive prescriptions for Medicaid patients over 18 months says the Miami Herald -153 prescriptions a day. His prescribathon even drew a letter from Sen. Charles Grassley, ranking member of the Senate Finance Committee.

It's no secret that the atypical antipsychotics Reinstein and Mendez-Villamil prescribed, which include Seroquel, Zyprexa and Abilify, are used to "manage" agitated patients in nursing homes though their labels say, "Elderly patients with dementia-related psychosis" are at "an increased risk of death." Three unreported deaths even occurred under Reinstein's care says Illinois Department of Public Health spokeswoman Melaney Arnold.

It's no secret they're an institutional goldmine for pharma who exacted $5 million for one year of atypical drugs at Western State mental hospital in Tacoma, WA according to the News-Tribune. Many states have sued over the cost of atypicals, especially the cost of treating the diabetes and metabolic disorders they cause, which has decimated Medicaid budgets.

What is a secret is why the FDA would give pharma the Christmas present of approving Seroquel and Zyprexa for children and hence, Medicaid reimbursement even as its own Division of Pharmacovigilance (DPV) reported a "a direct association between adverse metabolic effects of treatment with atypical antipsychotics" and children! A hypothesis the DPV report says is "provocative" and requires "robust" followup.

FDA approved the drugs-Seroquel Immediate Release tablets to treat schizophrenia in adolescents ages 13-17 and bipolar mania in children and adolescents ages 10-17; Zyprexa to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17- even as studies continue to link the drugs to Diabetes mellitus, hyperglycemia, diabetic ketoacidosis, hyperlipidemia, galactorrhea and hyperprolactinemia in children.

The FDA's own Adverse Event Reporting System database "contains thousands of domestic reports describing extrapyramidal symptoms and metabolic effects reported in association with these agents," says the DPV report in addition to "a number of lawsuits against olanzapine [Zyprexa] and quetiapine [Seroquel] involving metabolic effects."

Fifty-one medical journal articles since 1999 link Zyprexa alone with diabetic ketoacidosis, an acute metabolic condition which can rapidly escalate to cerebral edema and coma. Four articles recount sudden death in patients who had no personal or family history of diabetes mellitus and normal levels of the drug in their system.

In fact June FDA Psychopharmacological Advisory Committee hearings about approving Seroquel and Zyprexa for children itemized those exact side effects. AstraZeneca physician Liza O'Dowd did a valiant job of assuring committee members that weight, glucose and prolactin elevation side effects of Seroquel could be "controlled and monitored" in patients and that they "didn't lead to discontinuation of the study." (Hopefully not when the study lasted weeks).

But Christopher B. Granger, MD, Director of Duke University Medical Center's Cardiac Care confessed to "real discomfort" approving drugs which "generat[e] metabolic syndrome in adolescents in a very short period of time" for "indefinite use" on the basis of three or six week trials. "Hopefully we're not exposing someone for decades," he said. Colleague, Edward L.C. Pritchett, MD with Duke's Cardiology and Clinical Pharmacology agreed.

So the FDA's gift to pharma of new uses and insurance reimbursement for atypical antipsychotics comes as a surprise. Call it Pharma's Secret Santa.

Portions of this article appear in the book Born with a Fritos Deficiency: How Flaks, Quacks and Hacks Hijack the Public Health, due for 2011 publication.
Martha Rosenberg is a columnist and cartoonist, who writes about public health

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