NunoftheAbove

A Congressional Hearing heard testimony from Baxter International regarding the tainted blood-thinner that in believed to be the cause of 81 deaths.

Baxter International Inc. said its blood thinner heparin, linked to 81 deaths, appears to have been deliberately contaminated.

The drug’s main ingredient was contaminated before reaching the Chinese factory of Baxter’s supplier, Scientific Protein Laboratories, executives of both companies testified at a U.S. House hearing today.

The Food and Drug Administration suspects the contamination was deliberate, though there isn’t proof, according to the agency.

Baxter recalled heparin, used to prevent blood clots, in January of this year after reports of harmful side effects. Since January 2007, 81 people have died after allergic reactions, the FDA said on April 21. Tainted heparin made by other drugmakers has been found in more than a dozen countries since Baxter’s recall, and regulators have said they don’t know how it was introduced.

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Chinese officials have denied that the tainted raw materials was produced in a plant that the FDA inspectors failed to inspect due to a confusion with the name of the facility.

Scientific Protein, majority owned by American Capital Strategies Ltd., started to inspect its suppliers of raw heparin and stopped when the Chinese government “took over,” Strunce said. The ingredient is derived from pig intestines and originates in workshops in China.

The FDA says the contaminant can lead to deaths. The Chinese government has publicly disputed that, saying the side effects haven’t been reported in all countries where the contaminant was found.

After testimony from the families of the victims was heard, the committee concluded with the recommendation that more money be appropriate to the FDA for more foreign inspections. Additionally the committee members expressed concern over the alleged intentional contanmination of the materials by the Chinese manufacturer.

“Our investigations have revealed an FDA woefully lacking in the personnel, effective policies, and the will at the highest level to perform the duties entrusted to it by the Congress and the American people,” said Representative John D. Dingell, a Michigan Democrat, during the hearing.

Representative Michael Burgess, a Republican from Texas, also raised alarm that heparin appeared to have been intentionally contaminated.

He called the contamination “thuggery” and “thievery” and said it was an “knife in the back” of the American public.

Increased reliance on foreign sources for raw drug material by US Drug Manufacturers is a mandate for more vigilant safeguards by both the FDA and the companies themselves.

Past Posts:

Updated: Plant pinned as source of fatal drug reactions unlicensed by Chinese

FDA Addressing Tainted Heparin — Finally