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Risky Drugs and How They Get on the Market

Common Questions

Have you ever wondered how risky and dangerous drugs make it to market under the watchful eye of the U.S. Food and Drug Administration, charged with the responsibility of making sure they are safe and effective before they are released?

The Journal of the American Medical Association tackles that question in a September 5, 2012 Viewpoint article, “The Safety Risks of Innovation – The FDA’s Expedited Drug Development Pathway.”

Thomas J. Moore, the editor of QuarterWatch, a drug-safety publication, and Curt Furberg, MD, PhD, a professor at Wake Forest University, remind us that driving biomedical innovation has been a big push of FDA Commissioner Margaret A. Hamburg under the Obama administration.

Encouraging growth rather than holding back innovation because of bureaucracy and pesky government regulation is the goal, though a strange one for a watchdog agency. With that in mind, the FDA initiated a fast-track program, the “Expedited Drug Development Pathway.”

But the obvious question is – at what cost have fast-tracked drugs been to public safety?

For example in 2011, the FDA classified as “innovative” every new molecular entity. Sixteen new drugs received expedited attention, or a shortened review time, of the 35 seeking approval. There is actually a Fast Track program which looked at 13 of those drugs and in those cases, review began even before the clinical trials were underway. These considerations were supposed to be applied to drugs that might fill a “serious unmet medical needs.”

Three drugs received Accelerated Approval.

Vandetanib – Caprelsa – a cancer drug to treat late-stage medullar thyroid cancer. The drug was toxic and no different than a placebo. It did offer “progression-free survival” however without an improvement in overall survival.

Fingolimod – Gilenya -a new drug approved in 2010 to treat multiple sclerosis by suppressing the immune system. The drug did demonstrate an advantage over the standard treatment interferon beta in stopping the relapse of multiple sclerosis. However clinical trials uncovered 7 major safety issues including infections, reduced heart-lung function, liver toxicity, macular edema, and cancer, among other complications.

Pradaxa – an anticoagulant thought to be easier to use than the standard treatment, warfarin (Coumadin), to treat atrial fibrillation which can lead to stroke. Patients do not have to closely monitor their blood as they do with warfarin, however patients can experience uncontrolled bleeding with Pradaxa because there is no antidote available in the case of a bump or a cut unlike Coumadin. Launched by Boehringer Ingelheim, there have been thousands of adverse events reports. Hundreds of patients have died from fatal bleeding while on Pradaxa.

The drug has only been on the market since October 2010 but already is named in 500 lawsuits and the cases are growing.

“These examples raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered,” Mr. Moore and Dr. Furberg wrote.

Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, tells the Wall Street Journal that the FDA could insist drug companies produce more safety and efficacy data before the drug is approved. In addition, he says the FDA should insist on the right to pull a drug from the market if its initial launch shows more harm than good.

“Once a drug is approved, it is often very difficult to put the genie back in the bottle,” he says to the paper.

The FDA is reviewing Pradaxa case reports while European regulators have asked the company to change the label. In the meanwhile without a warning that a simple bump on the head, a fall, a minor car accident, or a cut can lead to a fatal bleed out, patients are left on their own to take their chances, all for a little convenience.

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