Thursday, March 20, 2008

Tainted Drugs

For the sake of people susceptible to earworms everywhere, I won't actually parody the Soft Cell song further than using it as a title here. And as alliterative and 80s-referential as the title is, it's also accurate: in recent weeks, almost two dozen people have died, and their deaths have been linked to contaminated heparin. This morning, the contamination (hypersulfated chondroitin sulfate) was announced, as was the fact that the contamination happened somewhere in China. Because hypersulfated chondroitin sulfate mimics heparin in standard safety tests, it looks likely that the contamination was intentional, likely done by someone trying to either cut costs or boost profits somewhere along the production line.

Congress is, of course, clamouring for action, and the FDA is defending itself, saying it's chronically undermanned and cannot realistically fulfill its broadranging mandate. The same exact reactions we saw in 1999, when contaminated antibiotics from China were linked to almost as many deaths. And since then, China has grown in exports, while the FDA has remained virtually stagnant in the number of inspections; latest numbers indicate the US imports almost a quarter of its medications from China, and only 6% are inspected by the FDA.

With this latest tainted drugs scandal, the Senate has passed a 20% increase in budget for the FDA, but realistically, when the FDA is admitting that they are violating their own policies, suffering from poor management, and whatever other excuse it can pull out of its hat'o'excuses, it seems likely that the additional $375 million is just going to be a bandaid over a much greater problem: the need to reorganize the FDA.

Connecticut Democratic Representative Rosa DeLauro joins me on the skeptic train, saying that she doesn't "want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.” Going a step further than I've actually said, she also notes that top agency officials are incompetent, and the only way any genuine change will happen is a completely new administration for the agency.

News of contaminants from China is not new - this time around, it was heparin. It's been antibiotics in the past. A year ago, dozens of people lost beloved pets to contaminated pet food. Our children's toys have been recalled because of lead and other contaminants. There are two trends here, that cannot be ignored: the FDA is unable to protect the American public, and there is rampant and dangerous corruption in China that does more than just hurt its own population, it affects us all. We, as a people, need to step up and stop accepting the excuses of the FDA and demand reform - and we need to demand a very different sort of relationship with China and the goods we import from them.

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