A congressional hearing into tainted heparin that begins tomorrow will feature testimony from the Chief Executive Officer of Baxter International. Baxter International supplied about 50 percent of the heparin used in the US, and recalled most of its heparin products in February following reports of adverse deaths and reactions linked to the blood thinner. At least 81 deaths among US patients have been linked to heparin contaminated with a counterfeit ingredient, although not all of the deaths have been blamed on Baxter heparin.
In March, the Food & Drug Administration (FDA) confirmed that it had found a counterfeit ingredient, oversulfated chondroitin sulfate, in samples of the active ingredient used in Baxter heparin. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Since then, companies in several other countries have issued heparin recalls, and a cluster of heparin reactions has been reported in Germany. In the US, some other manufacturers have issued precautionary recalls.
The FDA has not determined when the chondroitin sulfate entered the heparin supply chain, but suspicion rests on China. Changzhou used two consolidators to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops. FDA Commissioner Andrew von Eschenbach has said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”
Last week, the FDA said it had evidence that the chondroitin sulfate did, in fact, cause the reactions and deaths. However, the Chinese are disputing this, and say the heparin problems could have originated in the US. But an FDA inspection of Changzhou uncovered a number of problems, and earlier this month, the FDA issued the plant a warning letter, calling the facility “unsuitable”. The FDA has also blocked Changzhou from importing anything to the US until the agency can confirm it has made appropriate corrections.
Starting tomorrow, a US House of Representatives Subcommittee on Oversight and Investigations will hold a hearing called “The Heparin Disaster: Chinese Counterfeits and American Failures,” the latest congressional proceeding to address shortcomings in the US inspection process. Baxter CEO Robert Parkinson will testify, along with FDA drug unit chief Janet Woodcock. Also slated to testify is the CEO of Scientific Protein Labs.
Meanwhile, some media reports have suggested that Baxter is considering giving up the heparin business altogether. Earlier this month, Wall Street analysts asked Parkinson whether it was worth the legal risks and liability to remain in the business given that heparin accounts for only $30 million of Baxter’s more than $11 billion in annual sales. Parkinson said that the company had not yet decided if it would reenter the heparin market.
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