Saguaro
04-29-2008, 12:26 PM
WASHINGTON (Reuters) - A contaminant in Baxter International Inc's recalled blood-thinner heparin appears to have been deliberately added, the company's chief executive said in testimony prepared for a congressional hearing on Tuesday examining imports of the drug from China.
"We're alarmed that one of our products was used, in what appears to have been a deliberate scheme, to adulterate a life-saving medication, and that people have suffered as a result," Baxter Chief Executive Robert Parkinson said in written testimony prepared for the hearing.
"We deeply regret that this has happened, and I feel a strong sense of personal responsibility for these circumstances," he said.
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.
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.
Baxter's Parkinson said it was "clear" the contaminant, an altered form of chondroitin sulfate, was added before crude heparin material reached Baxter's supplier in China, Scientific Protein Laboratories LLC (SPL).
SPL, in separate testimony, also said the contamination appeared to be deliberate.
Using the altered chondroitin sulfate is less expensive than real heparin, leading to concern that it was used as a cheaper substitute for the drug.
Rep. Bart Stupak, a Michigan Democrat, said it was still uncertain whether the contamination was intentional or accidental. He said both companies should have done more to assure their products were safe.
"Both Baxter and SPL have failed the American public," said Stupak, chairman of the U.S. House of Representatives Energy and Commerce Committee's oversight and investigations subcommittee.
Later on Tuesday, the panel was set to hear from people who lost relatives to deadly reactions from heparin.
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 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.
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.
http://news.yahoo.com/s/nm/20080429/us_nm/heparin_dc;_ylt=AhQu5gHJqaZ1M4CD3cfh_DGs0NUE
"We're alarmed that one of our products was used, in what appears to have been a deliberate scheme, to adulterate a life-saving medication, and that people have suffered as a result," Baxter Chief Executive Robert Parkinson said in written testimony prepared for the hearing.
"We deeply regret that this has happened, and I feel a strong sense of personal responsibility for these circumstances," he said.
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.
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.
Baxter's Parkinson said it was "clear" the contaminant, an altered form of chondroitin sulfate, was added before crude heparin material reached Baxter's supplier in China, Scientific Protein Laboratories LLC (SPL).
SPL, in separate testimony, also said the contamination appeared to be deliberate.
Using the altered chondroitin sulfate is less expensive than real heparin, leading to concern that it was used as a cheaper substitute for the drug.
Rep. Bart Stupak, a Michigan Democrat, said it was still uncertain whether the contamination was intentional or accidental. He said both companies should have done more to assure their products were safe.
"Both Baxter and SPL have failed the American public," said Stupak, chairman of the U.S. House of Representatives Energy and Commerce Committee's oversight and investigations subcommittee.
Later on Tuesday, the panel was set to hear from people who lost relatives to deadly reactions from heparin.
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 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.
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.
http://news.yahoo.com/s/nm/20080429/us_nm/heparin_dc;_ylt=AhQu5gHJqaZ1M4CD3cfh_DGs0NUE