The chemical contaminant found in some batches of the recalled blood-thinner heparin may have been put there intentionally.
That is the strongest statement yet to come from the Food and Drug Administration (FDA) about heparin, made by Baxter International that has been linked to hundreds of severe allergic reactions and up to 81 deaths.
The Director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock told a congressional hearing Tuesday that intentional contamination is the working hypothesis her agency is exploring, though has not yet proven.
Also testifying was Robert Parkinson, Chief Executive officer of Baxter International. He told lawmakers the company was "alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate a life-saving medication".
Remarks were made before the House Subcommittee on Oversight and Investigations amid calls for increased funding for the FDA, charged with overseeing the safety of foreign manufacturing plants.
Family members of those killed also testified. LeRoy Hubley of Toledo, Ohio has lost his 65-year old wife and 47-year old son who received heparin during kidney dialysis.
As Christmas music softly played in the background, we each said our goodbyes. Then my wife and love of 48 years drifted away,” Mr. Hubley said in tears.
Chinese suppliers provide the raw heparin from pig intestines harvested from a dozen local mom and pop operations and supplied to Scientific Protein Laboratories’s (SPL) subsidiary plant in Changzhou SPL, identified as the source of contamination.
Oversulphated chondroitin sulphate, the identified contaminate, is similar to heparin in its blood thinning properties and is also obtained from animal sources. It is considered a cheaper substitute to raw heparin at $9 a pound compared to $900 per pound for heparin.
Baxter International has recalled all heparin and blocked supplies from China and the plant has been closed.
China is deflecting blame saying it’s not the source of the contamination and according to SPL’s chief executive, has stopped his company from trying to source the contamination.
Contaminated heparin is bringing the focus to the inadequacies of the FDA in its ability to monitor international drug sources. Dr. Woodcock testified the agency needs another $225 million to adequately inspect every foreign drug manufacturer. The FDA will spend $11 million this year instead.
The Changzhou SPL plant was not inspected by the FDA until September 2007 even though it had been supplying heparin since 2004. After a February inspection, the plant was blocked from exporting to the U.S. because of so many problems uncovered.
Heparin is used in kidney dialysis and emergency rooms and during some types of surgery to prevent blood from clotting.
It is the same drug that Dennis and Kimberly Buffington Quaid are suing Baxter International over after their twins were accidentally overdosed. The Quaids allege the labels between low dose and high dose heparin is too similar. #