Families, CEOs to testify on tainted heparin in US

-Reuters

04/29/2008 -  People who lost relatives to deadly reactions from the blood-thinner heparin are set to testify on Tuesday before U.S. lawmakers probing contamination of the drug made with raw ingredients imported from China.

The chief executives of heparin maker Baxter International Inc and its ingredient supplier also are scheduled to appear before a House of Representatives subcommittee.

Eighty-one deaths following allergic reactions have been reported to the FDA in patients treated with some brand of heparin since January 2007. An FDA probe found some batches sold by Baxter in the United States were contaminated with a chemical that mimicked heparin in conventional tests.

FDA officials said last week they found evidence to link the contaminant to the reactions, while Chinese officials said the chemical was not to blame.

The contaminant, an altered form of chondroitin sulfate, has been detected in heparin supplies in 13 countries, FDA officials have said. Only the United States and Germany have seen reports of an increase in allergic reactions to the drug.

Tuesday's hearing, titled "The Heparin Disaster: Chinese Counterfeits and American Failures," will focus on the circumstances surrounding the contamination, according to a statement from the House Energy and Commerce subcommittee on oversight and investigations.

Heparin is used in kidney dialysis and various surgeries to prevent blood clots. The drug is derived from pig intestines and often collected from small, mostly unregulated farms in China.

FDA officials have said they do not know how the contamination occurred. Using the altered chondroitin sulfate is less expensive than real heparin, leading to concern that it was intentionally added as a cheaper substitute for the drug.

Baxter maintains the contamination occurred before the product reached Baxter or its ingredient supplier in China.

Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, also is scheduled to answer questions at the hearing.

Baxter, which had supplied about half of the U.S. heparin market, recalled most of its heparin products in February.

All heparin being imported into the United States is now being tested for the contaminant and the current supply is safe, the FDA has said.