Wednesday, March 05, 2008

SLAVE LABOR HEPARIN (CONTINUED): Pitiless Baxter International

"I have this cheap substitute that tests just like heparin and it costs fifty percent less."

Fine biochemicals like heparin cost money and who can argue with the logic of increasing profits by sending the work to a slave labor country where it can be made in some kitchen not checked by any annoying regulatory agency?

Not Baxter or Scientific Protein Laboratories, the two American companies entangled in the mass recall of the drug heparin. Tainted heparin from these firms, the purification of which was outsourced to China, has resulted in 19 deaths.

If you have the news on the scandal you can't help but notice there is no sign of public remorse. No one from the involved American firms has anything human to say.

In a Chicago Tribune feature on Baxter International and the tainted heparin scandal, the newspaper reported the company leaping into action to root out the problem. It was a self-serving account.

And it was so egregious and intelligence-insulting, a good portion of it is worth republishing.

"Inside Baxter's Deerfield headquarters, it was code red," reported the Tribune. "Robert Parkinson, the company's chief executive, began holding early morning meetings with a team of key leaders: people responsible for Baxter's drug surveillance, drug quality, legal, manufacturing, research, and regulatory affairs.

"After the morning meetings, Parkinson made a point of popping in on his key executives. This kept him up to speed on developments and gave people a chance to share what they had learned.

"One surprise: Parkinson soon learned the FDA never had inspected the China manufacturing plant. Recalling the finding in a recent Tribune interview, Parkinson sought to minimize the oversight.

"It's not unusual for us not to know that the FDA has not inspected a supplier to a supplier," he said.

"Dozens of Baxter scientists began searching for a cause of the outbreak..."

Baxter's CEO was "popping in on his key executives" so that they could keep him "up to speed on developments."

Isn't that nice? Such a diligent fellow!

"It's not my fault if I didn't know that the Chinese who make my company's drug aren't inspected or licensed," said Parkinson.

Wait, wait! He didn't say that. I just added it because it seems in-line with the attitude conveyed, one in which it's always the Food and Drug Administration's fault for not being there, for not having the right stuff, for not having the best computer systems to file it all appropriately. Dang it!

"Parkinson prefers not to emphasize the competitive dynamic [of his business], though," continued the Tribune. "Instead, he focuses on the key role heparin plays as a blood thinner in kidney dialysis and heart operations."

"We have, as a company, an obligation to the medical and the patient communities to get this product available," Parkinson told the newspaper. "It's not a matter of the financial significance of the product. It's a matter of the role that it plays in medicine."

And this is certainly true. But it's also true that the company has a moral obligation to the people in need, one to not put them in danger through expedient business decisions which cause it to lose control of its supply chain and quality control.

The key here is trusted source.

American medicine considered Baxter International a trusted source until it proved it wasn't one. When Baxter outsourced its production to another company -- Scientific Protein Laboratories -- which, in turn, outsourced it to China, it is common sense that the directors of both companies knew their roles as trusted sources. It then became their responsibility, not merely the FDA's, to know where their drug was coming from and under what conditions it was made at all times. It was and is not merely the responsibility of the government to ensure through official inspection that the manufacturing processes set in motion by American business does not produce a product which sickens or kills people.

The official responses of the companies are puzzling from a human standpoint.

Ethical men in the trusted role of providing life-giving drugs, when responsible for such a large problem, well -- you would think they would look inward and be very troubled by what they find. It suggests a much larger problem in American business when the stewards of it act like they don't see any of this.

It is not only a dilemma for medicine and public health. It is also one of security. Try to guess the reaction if a terrorist, instead of a business, had been found furnishing the tainted material.

Whenever DD writes about similar issues on this blog, they are not popular. People don't want to read painful things about how they've been sold down the river in the name of easy profits through unregulated Chinese manufacturing. That's a boring story, one no one seems to be in a position to do anything about.

Congressional hearings are held. But then everything goes back to business as usual in the formerly good ol' USA until the next product recall or incident in which people or animals are killed and maimed. No one is interested in actually doing anything that would seem to be in support of a populist cause.

"Some of Baxter International's recalled blood thinner heparin contained large amounts of a contaminant that might explain hundreds of serious side effects," reported a wire service today. "And the government said Wednesday it's not clear if what appears to be a fake ingredient got there by accident or was fraud.

"The Food and Drug Administration said 19 deaths from allergic-type reactions are now associated with the recalled drug, up from four.

"Baxter insisted the contaminant further points suspicion at ingredient suppliers in China, which are under increasing scrutiny after a wave of recalls involving food, drug and toy imports ... The contaminant accounted for between 5 percent and 20 percent of some of the samples tested.

"At those amounts, batches of heparin should have been flagged as subpotent in Baxter's routine quality tests -- but they didn't, because the contaminant is so chemically close to real heparin that standard testing couldn't tell the difference ..."

This immediately raised the possibility that the contaminant was added in China in a scheme similar to the one in which a protein-mimicking toxic adulterant was added to wheat gluten in the pet food recall of last year. The objective, as practiced in China, was to increase protein assays with a worthless material.

"The FDA is so concerned that later this week it will give manufacturers and other regulatory agencies worldwide instructions on how to check other heparin supplies to be sure the fake isn't sneaking in," continued the wire service.


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