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Thursday, February 14, 2008

FDA Knew of Drug's Dangers, Failed to Stop Its Marketing

FDA's inability to ensure the safety of imported products is in the news again today. According to The New York Times, a plant in China, uninspected by FDA, is responsible for a contaminated ingredient in Heparin, a blood-thinning drug common in dialysis, heart surgeries and chronic care hospitals. At least four people have already died from using the drug.

Unlike some other dangerous import stories, this one isn't just about the inability of a federal agency to monitor imports; it's about flat-out negligence by FDA and by Heparin's maker, Baxter International. New York Times reporter Gardiner Harris has the story:

Public health officials noticed a problem with heparin supplies late last year when children undergoing dialysis at a Missouri hospital had severe allergic reactions. As officials investigated, they discovered hundreds of similar cases.

Baxter initially recalled some of the product, but the problems persisted.

The F.D.A. decided to allow Baxter to deliver heparin that it was in the midst of shipping for fear that a total recall would lead to an immediate and severe shortage of the drug. The F.D.A. cautioned doctors to use as little of the Baxter drug as possible and to infuse it into patients very slowly.

FDA and Baxter have known about the danger of Heparin for months, but, for most Americans, today will be the first they have heard of it.

Meanwhile, because FDA refused to stop Baxter shipments, users of Heparin were getting sick. According to an FDA press release, "About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007."

So instead of disseminating information that could have helped people, FDA chose to cover up the problem in the name of public health, even though hundreds were sickened and several died? Forgive Reg•Watch's cynicism, but could this be a case of FDA putting Baxter's corporate profits ahead of patients' safety?