HHS Head Insists Chinese Heparin is Safe

<"http://www.yourlawyer.com/topics/overview/heparin">Heparin imported from China is now safe – at least that is what Health and Human Services Secretary Michael Leavitt is claiming.  Heparin sourced from China has been linked to at least 81 deaths, and investigators believe that a contaminant that somehow made its way into the Chinese supply chain is responsible for the deaths and reactions linked to the drug.  The Chinese have still not allowed US inspectors access to all segments of its heparin manufacturing industry, and the Food & Drug Administration (FDA) has not even determined how or when the contaminant entered the supply chain in that country.  But Leavitt insisted yesterday that tighter testing and controls will insure that no more tainted heparin makes its way into the US.

Earlier this year, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme – and in some cases fatal – allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. Last month, FDA Commissioner Andrew von Eschenbach 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.”

The FDA, which falls under Leavitt’s authority, has been rightly criticized for its role in the heparin debacle.  Shortly after the first heparin recall was issued, it was learned that the FDA had never inspected the Changzhou plant. Apparently, an error in the agency’s compute database had made it appear as though inspectors had checked out the facility.  Once the FDA did finally inspect Changzhou, it found a host of problems which it detailed in a warning letter.  The FDA also banned the plant from importing to the US until corrections are made.

Leavitt told the Associated Press yesterday that the FDA has implemented tougher testing and other controls to insure the quality of the heparin supply. “We have put in place processes that we believe can ensure the safety of the heparin supply within the United States,” he said.

Leavitt also said that he believed the US and China would soon resolve a dispute over the FDA’s investigation. The Chinese so far have refused to acknowledge that chondroitin sulfate had anything to do with the heparin reactions, despite scientific studies done in the US that demonstrated the chemical could do so.  The Chinese have also not allowed the FDA access to the entire heparin supply chain. Though it inspected the Changzhou facility in March, the FDA has been barred from having complete access to some Chinese workshops that supplied Changzhou with raw heparin ingredients, as well as records and workers.

Several lawmakers, including Rep. Bart Stupak (D-Mich) have been critical of the FDA’s failure to insist that China allow it to examine the entire heparin supply chain.  “If I was the FDA director, I’d shut down every drug coming in from China” until they were deemed safe, Stupak recently told The Wall Street Journal.

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