FDA Panel Rejects A Bad Drug (Finally)

From the Wall Street Journal:

WASHINGTON -- A Food and Drug Administration panel Wednesday unanimously rejected Acomplia, a weight-loss drug from Sanofi-Aventis SA, due to concerns the drug increases the number of psychiatric events like depression and suicidal thinking among users.

The panel's decision is a potential blow to the Paris-based drug maker, which was hoping it could sell Acomplia on the U.S. market. The FDA typically follows its panels' advice but isn't required to do so. The FDA is set to make a final decision on whether to approve the drug by the end of July.

Analysts believe the FDA will reject Acomplia, which is known generically as rimonabant, as the agency has been under fire from Congress about its handling of various drug-safety issues including recent concerns that GlaxoSmithKline PLC's diabetes drug Avandia raises heart-attack risks.

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Earlier, Richard Gural, Sanofi's vice president of drug development and scientific affairs, had told the panel that Acomplia shouldn't be given to patients being treated for depression or a history of depression. He also said the company hasn't seen an increase in psychiatric problems associated with the drug in post-marketing reports.

The FDA has been concerned about psychiatric side effects such as depression. The agency also said there was a doubling of the rate of suicidal thoughts and behaviors seen in clinical studies of the drug. Last February, the FDA rejected Acomplia as a smoking-cessation product and said it needed more information on psychiatric side effects before it would consider approving the drug as a weight-loss treatment.

A Sanofi analysis of the data showed a lower "suicidality rate," finding a rate about 1.3 times higher than the rate seen in patients receiving a placebo, or fake drug. Company officials also said all of the incidences were associated with underlying depression and don't appear to be caused by rimonabant itself. Suicidality is an increase in suicidal thoughts and behaviors and doesn't refer to acts of suicide. The actual "suicidality" numbers are small, with 88 reports out of about 16,500 patients studied.

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Rimonabant is designed to help block a chemical in the endocannabinoid system, a physiological system in the body that is believed to play a role in how the body regulates food intake. The FDA is concerned, however, that blocking the same chemical could increase the risk for other problems including mood disorders and neurodegenerative disorders like multiple sclerosis.

Psychs Paid By Big Pharma To Prescribe Drugs

From the New York Times:

When Anya Bailey developed an eating disorder after her 12th birthday, her mother took her to a psychiatrist at the University of Minnesota who prescribed a powerful antipsychotic drug called Risperdal.

Prescription for Influence

Beyond the Label

Created for schizophrenia, Risperdal is not approved to treat eating disorders, but increased appetite is a common side effect and doctors may prescribe drugs as they see fit. Anya gained weight but within two years developed a crippling knot in her back. She now receives regular injections of Botox to unclench her back muscles. She often awakens crying in pain.

Isabella Bailey, Anya’s mother, said she had no idea that children might be especially susceptible to Risperdal’s side effects. Nor did she know that Risperdal and similar medicines were not approved at the time to treat children, or that medical trials often cited to justify the use of such drugs had as few as eight children taking the drug by the end.

Just as surprising, Ms. Bailey said, was learning that the university psychiatrist who supervised Anya’s care received more than $7,000 from 2003 to 2004 from Johnson & Johnson, Risperdal’s maker, in return for lectures about one of the company’s drugs.

Doctors, including Anya Bailey’s, maintain that payments from drug companies do not influence what they prescribe for patients.

But the intersection of money and medicine, and its effect on the well-being of patients, has become one of the most contentious issues in health care. Nowhere is that more true than in psychiatry, where increasing payments to doctors have coincided with the growing use in children of a relatively new class of drugs known as atypical antipsychotics.

These best-selling drugs, including Risperdal, Seroquel, Zyprexa, Abilify and Geodon, are now being prescribed to more than half a million children in the United States to help parents deal with behavior problems despite profound risks and almost no approved uses for minors.

A New York Times analysis of records in Minnesota, the only state that requires public reports of all drug company marketing payments to doctors, provides rare documentation of how financial relationships between doctors and drug makers correspond to the growing use of atypicals in children.

From 2000 to 2005, drug maker payments to Minnesota psychiatrists rose more than sixfold, to $1.6 million. During those same years, prescriptions of antipsychotics for children in Minnesota’s Medicaid program rose more than ninefold.

Those who took the most money from makers of atypicals tended to prescribe the drugs to children the most often, the data suggest. On average, Minnesota psychiatrists who received at least $5,000 from atypical makers from 2000 to 2005 appear to have written three times as many atypical prescriptions for children as psychiatrists who received less or no money.

The Times analysis focused on prescriptions written for about one-third of Minnesota’s Medicaid population, almost all of whom are disabled. Some doctors were misidentified by pharmacists, but the information provides a rough guide to prescribing patterns in the state.

Drug makers underwrite decision makers at every level of care. They pay doctors who prescribe and recommend drugs, teach about the underlying diseases, perform studies and write guidelines that other doctors often feel bound to follow.

But studies present strong evidence that financial interests can affect decisions, often without people knowing it.

In Minnesota, psychiatrists collected more money from drug makers from 2000 to 2005 than doctors in any other specialty. Total payments to individual psychiatrists ranged from $51 to more than $689,000, with a median of $1,750. Since the records are incomplete, these figures probably underestimate doctors’ actual incomes.

Such payments could encourage psychiatrists to use drugs in ways that endanger patients’ physical health, said Dr. Steven E. Hyman, the provost of Harvard University and former director of the National Institute of Mental Health. The growing use of atypicals in children is the most troubling example of this, Dr. Hyman said.

“There’s an irony that psychiatrists ask patients to have insights into themselves, but we don’t connect the wires in our own lives about how money is affecting our profession and putting our patients at risk,” he said.

Read the rest of the article at http://www.nytimes.com/2007/05/10/health/10psyche.html?ex=1181707200&en=4e5eec4661c15400&ei=5070