Letting Big Pharma Review Its Own Drugs — What Could Go Wrong?

We can't trust drug companies to disclose product safety hazards when they stand to gain so much from fudging the facts.

GSK-615.jpgA lab technician handles H1N1 specimens at a GlaxoSmithKline facility in Dresden. (Ho New/Reuters)

When British drugmaker GlaxoSmithKline (GSK) agreed to pay $3 billion in criminal and civil fines for illegal marketing of several drugs and hiding safety from the U.S. Food and Drug Administration (FDA), it probably seemed to many people like fitting punishment. It's the largest fine ever levied against a pharmaceutical company, and the civil and criminal charges against GSK included marketing its antidepressants Paxil and Wellbutrin for unapproved (read: unproven) uses, giving Medicaid false information about prices it was charging for the drugs, and failing to report patient safety data about diabetes medication Avandia to the FDA. But even $3 billion is probably not going to get GSK to change its ways -- and fines do virtually nothing to protect patients.

When it submitted false price information to Medicaid, GSK was harming taxpayers, a financial crime that is amply repaid by the $300 million the company is paying for that offence. But discouraging future bad behavior is a different story, because GSK is one of the world's biggest drug makers, with annual revenue of more than $40 billion. A $300 million fine starts to look like just the cost of doing business when spread over the period of time when the company was bilking Medicaid.

Fines are even less effective when it comes to preventing patients from being physically harmed. GSK is accused of illegally marketing two antidepressants -- Paxil for depression in adolescents, and Wellbutrin for weight loss, substance addiction, ADHD and other problems. Paxil has been shown to have significant side-effects, including triggering suicidal thoughts and behavior in some patients, and neither antidepressant is much more effective than a sugar pill in the vast majority of patients with depression. Fining the company after the fact doesn't do much for the patients who have already been hurt by their marketing practices.

That's even more the case for GSK's egregious behavior regarding its diabetes drug Avandia. When a new drug comes on the market, sometimes the FDA will ask or require that the manufacturer to do a study, called a post-marketing trial, to look for rare side effects and establish whether the drug is safe over the long term. That's important because often the clinical trials that are done before a drug is approved aren't big enough, and don't last long enough, to say whether a drug is safe to use over a long period.

With Avandia, GSK fudged the results of those post-marketing trials. The company claimed that its RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) trial showed no evidence that Avandia caused heart attacks or other cardiac diseases. But when outside researchers looked at the data they found massive irregularities and plenty of cases of harm, including patients who died and then mysteriously disappeared from the clinical trial records.

Presented by

Shannon Brownlee & Joe Colucci

Shannon Brownlee is the acting director of the health policy program at the New America Foundation and an instructor at the Dartmouth Institute for Health Policy and Clinical Practice. Her writing also appears in The New York Times Magazine and The New Republic. Joe Colucci is a program associate in the New America Foundation's Health Policy Program.

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