Heparin Tainting Deliberate

I found this report accidentally in a Parkinson's search, because the CEO of Baxter happens to be one Robert Parkinson. The Chicago Tribune reports that Parkinson called the contamination of its heparin supplies a "deliberate adulteration scheme" by suppliers in China. (PlagueBlog is shocked that such a thing could happen.)

The scale of the scandal over tainted heparin continued to expand. David Strunce, chief executive of Wisconsin-based Scientific Protein, acknowledged that the company has no way of knowing which of 12 different suppliers might have introduced foreign matter into the heparin supply chain. Strunce also claimed Chinese regulators have interfered with his company's efforts to investigate the matter.
The FDA has tallied more than 80 reports of deaths and more than 1,000 adverse events associated with patients in the U.S. who had one or more allergic reactions to heparin products, including those sold by Baxter, since Jan. 1, 2007.

As a result, the Chicago Tribune also reports, Baxter is considering getting out of the heparin business altogether:

The product generates $30 million of Baxter's more than $11 billion in annual sales, and Wall Street analysts asked Parkinson last week whether it was worth the legal risks and liability to remain in the business given that sales are so small.
"We haven't made a decision whether or not we are going to re-enter [the market] with heparin," Parkinson told analysts.

PlagueBlog recommends producing drugs, including their ingredients, domestically.

Heparin Update

Via ProMED-mail: The New York Times reported the latest news on the counterfeit heparin scandal this week.

The F.D.A. sent a warning letter on Monday to Changzhou SPL, the Chinese plant identified as the source of contaminated heparin made by Baxter International in the United States. It warned that the plant used unclean tanks to make heparin, that it accepted raw materials from an unacceptable vendor and that it had no adequate way to remove impurities.
Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.
The F.D.A. has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Deborah Autor, director of compliance at the F.D.A.’s drug center, said the agency did not know the original source of all the contamination or the points in the supply chain at which it was added.
Officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as [sic] 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February, officials said.

China apparently admits to the contamination but denies that it caused any adverse reactions. All PlagueBlog recommendations concerning China still stand.

Counterfeiting Heparin

Via ProMED-mail: the ever-widening counterfeit Chinese heparin scandal doesn't seem to have hit the news very hard compared to the ongoing downers-for-dinner scandal, even though the downer recall is merely punitive in comparison with the recall of half the nation's heparin supply, and especially when you consider that the recall itself was delayed by the FDA because the basic need for heparin outweighed the serious safety concerns.

Heparin is a blood thinner administered to most inpatients, as well as to dialysis patients. It is derived from pig intestines; the raw ingredient is imported from China, before or after processing. Last week the New York Times reported on the discovery of the subtle counterfeit substance intended to pass for real heparin--and no such adulteration in heparin batches known not to cause adverse reactions. This counterfeit ingredient has evidently caused 19 deaths and almost 800 non-fatal adverse reactions so far.

German patients have also suffered adverse reactions leading to a recall, and as a precaution Japan recalled all heparin associated with a suspect Chinese producer late today.

Considering the malice aforethought involved in this sort of counterfeiting and the fact that it's hardly the first time, PlagueBlog recommends cutting off trade relations with China.