Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration has only hinted at previously.
“F.D.A.’s working hypothesis is that this was intentional contamination, but this is not yet proven,” Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony given Tuesday.
A third of the material in some batches of the thinner heparin were contaminants, “and it does strain one’s credulity to suggest that might have been done accidentally,” Dr. Woodcock said.
Two weeks ago, Food and Drug Commissioner Andrew C. von Eschenbach told a Senate subcommittee that the contamination was done “by virtue of economic fraud,” but he quickly withdrew the remark, saying he had “probably gone too far.”
Dr. Woodcock’s statement on Tuesday was part of growing chorus that has labeled the heparin contamination as perhaps the most brazen poisoning episode since 1982, when seven people in the Chicago area died after taking Tylenol that had been laced with cyanide.
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David G. Strunce, chief executive of Scientific Protein Laboratories, the company that supplied contaminated heparin material to Baxter International, which manufactured and distributed the finished drug, described the contamination as “an insidious act” that “seems to us an intentional act upstream in the supply chain.”
The F.D.A. has identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. A Congressional investigator said the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.
Mr. Strunce said that his company tried to find the original source of the contamination but was stopped by the Chinese authorities.
Robert L. Parkinson, Baxter’s chairman and chief executive, told the committee, “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.”
Chinese officials have disputed the F.D.A. contention that the contaminant caused death and injury, and they have insisted on the right to inspect American drug plants if the F.D.A. insists on inspecting Chinese ones.
David Nelson, a Congressional investigator, told the House panel that had the F.D.A. inspected the Chinese plant, the contamination could have been averted.
F.D.A. officials have admitted that they mistakenly failed to conduct an inspection of the Changzhou SPL plant but said that an inspection would not have been able to uncover the contamination.
The agency finally conducted an inspection of the facility in February and found so many problems that the F.D.A. blocked the plant from exporting to the United States. Mr. Nelson was even more critical of Baxter International, which bought heparin ingredients from Changzhou SPL from 2004 through 2008 but did not inspect the facility until September 2007.
The company sent one person who spent one day in the plant, Mr. Nelson said. Five months later, the F.D.A. discovered myriad problems, he said.
“It really is impossible for a plant to have fallen that far out of compliance in five months,” Mr. Nelson said.
Under withering questioning, Dr. Woodcock said that the F.D.A. would need another $225 million annually to inspect every foreign drug plant every other year, the frequency most say is needed. The agency will spend $11 million this year on foreign drug inspections.
There is a growing bipartisan consensus on Capitol Hill that the F.D.A. needs a rapid increase in its budget to ensure the safety of the nation’s drugs, medical devices and food.
The Bush Administration has proposed increasing the agency’s budget next year by only 3 percent to $1.8 billion, not enough to cover even its expected cost increases.
Wed Apr 30, 2008 6:01 am
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madthumbs
Joined: 22 Feb 2006 Posts: 8187 Location: Fingerlakes - NY usa
Vitamin E does a great job of thinning blood, and is abundant in aloe. It's also in leafy greens, nuts, vegetable oils. Un-natural vitamin E is a by-product of film making (like kodak), and some suggest it's not safe for consumption.
I stay away from those chemicals that they call vitamins, which are nothing more than man's attempt to synthesize something that occurs naturally in foods. I have to doubt, based on everything that I know now, that eating chemicals will EVER be good for us, or can ever compare to eating the real thing. If anyone hasn't thought about it in this way, just grab up a typical processed food and read the label. Check out all those chemicals that you are eating, that they want you to believe are good for you. Its disgusting, and no wonder why we have health problems.
It is purely ridiculous, and practically insane, to eat synthesized vitamin chemicals when the real thing is right there in the natural food already. Screw their chemicals. I try to have nothing to do with them, in any way.
