Treating and Preventing the Heparin Problem

The heparin scandal is a dramatic illustration of the shortcomings of our drug-safety system.

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Kudos to the Centers for Disease Control and Prevention for tracking down the deadly contaminant in the widely used intravenous blood thinner heparin early this year, as just detailed in the New England Journal of Medicine. Working closely with the Food and Drug Administration, local and state public health officials, and a team of researchers, the CDC found that certain lots of heparin were adulterated with a heparin-like compound, oversulfated chondroitin sulfate.

The adulterated product found its way around the world, into at least 21 dialysis facilities and some heart clinics in at least 11 states. Once it was identified, there was an extensive recall by producer Baxter Healthcare, and the deadly problem stopped. But only after numerous acute drug reactions and close to 100—or perhaps more—deaths.

The medical saga outlined how effective this nation can be at finding and treating a major illness. But what about prevention? We can't ignore the root cause of the problem. The raw heparin was harvested from the inside of pig intestines on small rural farms in China, passed off through a string of small, unregulated, uninspected factories and then on to larger Chinese packaging plants for export to the United States. In fact, the raw heparin product passed through so many hands that it's been virtually impossible to determine when, how, and why the contaminant found its way into the heparin batches that were sold to Baxter, which formulated it into the finished drug.

Forget the fancy packaging, the pretty vials that all look alike. A product is no better than its ingredients. And one thing the heparin scandal should teach us is that we do not have adequate controls or oversight over the raw ingredients in this and many other of our medicines that are billed as safe and effective. China is a major source of active drug components and also is poised to enter in a big way the manufacturing of finished generic drugs.

The Government Accountability Office has tried hard to bring attention to a regulatory double standard in which drug-making facilities in the United States undergo extensive and regular FDA scrutiny while foreign plants doing the same thing face minimal inspection or oversight. The GAO made recommendations to the FDA as recently as September in a report on what needs to be done. Among them: know which plants are doing what, properly inspect them, and follow up to be sure deficiencies that come to light are addressed.

In a way, the country dodged a bullet with heparin. Baxter sold more than 10 million doses of the drug to distributors over the three-month period in which the clusters of adverse reactions were popping up. (Heparin is a critical drug used in renal dialysis, during open-heart operations, to prevent and treat blood clots in the legs and lungs, and even during pregnancy for women who need blood thinning.) The number of lots contaminated and people tragically harmed is still a small percentage of these total numbers. But next time it might not be so easy to track down the problem, or to contain it.

The FDA responded to the GAO report with a white flag of surrender. Though the agency has increased inspections and put permanent boots on the ground in China, it still claims that it's impossible to inspect or oversee the foreign facilities making drugs or their ingredients for the U.S. market with the same attention and rigor as is required for domestic plants. And in places like China, where the facilities are often in obscure rural areas and the language barrier formidable, the difficulties are only aggravated.

In short, the FDA does not have the people, the information systems, or other means to meet the global challenge of regulating America's drugs when they're not made in America. How many more heparin scandals do we need before we figure out what to do?