Tracing the heparin problem
About half of the nation's heparin supply--a blood thinner essential to kidney dialysis, many surgeries, and other medical procedures, has apparently been contaminated at its source in China. Efforts to trace the source of the problem have been stymied by China's mass of small producers and by lack of regulation and record-keeping.
Heparin is produced by cleaning the intestines of pigs, cooking them, and producing so-called crude heparin which is later refined in factories to make the final essential medical product. The Baxter company produces about half the nation's supply of heparin at two factories, one in Wisconsin and another in China. Its multi-dose vials have been recalled, after they were associated with more than 400 poisonings and 21 deaths as of March 1. The government had asked that Baxter heparin not be pulled from the market, for fear that it would create a shortage, , however, Baxter's primary competitor has ramped up production, and Baxter has recalled all forms of its product.
The source of the contamination has not been identified, however, it has been traced back to so-called "consolidators" whe purchase crude heparin from slaughterhouses and factories and sell it to Baxter.
One look at the photograph accompanying the February 28 NYT helps explain where contamination might come from: the slaughterhouses are frequently small, family-run operations that resemble barns. Sanitation appears to be an issue, as well as regulation of raw material: the industry just suffered through an epidemic of "Blue ear" pig disease that afflicted 25 of 31 Chinese provinces, and it is thought that diseased pigs have routinely been used to create raw heparin. The factory which has apparently been targeted as the source of the contaminated heparin is owned by a wholesale heparin producer called Scientific Protein Laboratories. SPL is an American company: its Chinese factory has never been inspected by either the American government or the Chinese. The Company's spokesman claims that all of SPL's raw product comes from a well-documented and audited chain of supply, however, it declined to identify its suppliers.
A number of small crude heparin producers claim to supply SPL with product from completely unregulated sources; spokesmen for these suppliers claim that they do not have the authority to inspect or regulate their many small slaughterhouse-suppliers. The February 29 up-date suggests that the investigation has focused on two of these "consolidators". When small workshops were identified and visited by the New York Times, they regularly acknowledged that they had not been inspected by anyone. The Chinese government does not inspect either the SPL plant or its suppliers because they are not "drug manufacturers"--merely "chemical suppliers".
When the FDA finally inspected the SPL plant last week, it reportedly concluded that the plant had, in fact, accepted raw material from an unacceptable source. SPL denies the claim. We wish that Congress and the courts would take into account problems like heparin contamination, when they are considering immunity for drug manufacturers. Michigan has granted immunity to all drug manufacturers who obtain FDA approval of their drugs, despite recent evidence that the FDA approval process is flawed and biased in favor of the industry. For particular examples of the harm caused by FDA approved drugs, and the problems with the FDA, see other entries in this blog.
This past week, the U.S. Supreme Court interpreted recent legislation to grant immunity to the makers of medical devices who obtain FDA approval, and this week, it heard arguments on whether a state can allow suit against manufacturers who secure FDA approval through fraud. Industry representatives had the unmitigated gall to argue that the "state has no legitimate interest in this subject". Next term, the U.S. Supreme Court hears arguments on immunity for additional drugs on a federal basis. It makes no sense to grant these frequently immense, always highly-profitable drug companies complete immunity, even from their own negligence or fraud. If we cannot afford the resources to police the suppliers of essential drugs, we should at least be able to use fear of financial responsibility to force the companies to regulate their own production.