Pharma: April 2008 Archives


April 30, 2008

Nick Weaver pointed me to this article in the NYT about the heparin incident. The FDA seems to be heading towards a theory that the contamination was deliberate (as I observed in my original post on this, though I'm not claiming that the idea is original to me). Here's the key bit:
"F.D.A.'s working hypothesis is that this was intentional contamination, but this is not yet proven," Dr. Janet Woodcock, director of the Food and Drug Administration's drug center, told the House Subcommittee on Oversight and Investigations in written testimony given Tuesday.

A third of the material in some batches of the thinner heparin were contaminants, "and it does strain one's credulity to suggest that might have been done accidentally," Dr. Woodcock said.


The F.D.A. has identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. A Congressional investigator said the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.

Mr. Strunce said that his company tried to find the original source of the contamination but was stopped by the Chinese authorities.

Robert L. Parkinson, Baxter's chairman and chief executive, told the committee, "We're alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate a life-saving medication."

Chinese officials have disputed the F.D.A. contention that the contaminant caused death and injury, and they have insisted on the right to inspect American drug plants if the F.D.A. insists on inspecting Chinese ones.

Again, when you're close to some equilibrium of high compliance, inspections are an important part of maintaining that equilibrium. However, if you're far away from that equilibrium, i.e., you're dealing with people who regularly don't comply, you need an entirely different enforcement regime with much stricter checking. If there's no punishment for noncompliance (which sounds like the case here), then it's extremely difficult to make any regime work in the face of someone who's actively trying to cheat you, since there's little cost for them trying. That said, one might think that if Americans have been poisoned and the Chinese government is stonewalling the investigation, that this might be something the US government could push aggressively on.

Incidentally, I'm not sure there is a the symmetry between US inspections of Chinese plants and Chinese inspections of US plants. It's not crazy to want to inspect the plants that produce your imports (it's not scalable if everyone wants to do it, but this is presumably delegatable to some extent, as with Reg. Dept. Penna. Agr.), but that doesn't necessarily extend to a reciprocal right to inspect random plants in other countries unless you're doing a lot of importing from them. China represented about $94 million dollars in US Pharmaceutical exports in 2004 [*]. And of course this becomes more important if there's evidence that whatever mechanisms are being employed in the other country aren't working. Have any Chinese been poisoned by defective American drugs?