TR Editors' blog

Contaminant in Blood Thinner Identified

Research team led by MIT professor.

Rachel Kremen 04/28/2008

  • 2 Comments

An international team of researchers has identified the contaminant in a blood thinner called heparin that is thought to be responsible for the deaths of dozens of Americans.

The contaminant, known as oversulfated chondroitin sulfate (OSCS), could not be picked up using traditional tests, as its structure is very similar to that of heparin. The researchers found that OSCS causes two critical problems: low blood pressure and anaphylactic reactions. Their findings were published in the New England Journal of Medicine last week.

From the NEJM:

In January 2008, health authorities in the United States beganreceiving reports of clusters of acute hypersensitivity reactionsin patients undergoing dialysis that had been occurring sinceNovember 2007. Symptoms included hypotension, facial swelling,tachycardia, urticaria, and nausea. Although initial investigationsfocused on dialysis equipment, an investigation by the Centersfor Disease Control and Prevention identified the receipt ofheparin sodium for injection (1000 U per milliliter, in 10-mland 30-ml multidose vials), manufactured by Baxter Healthcare,as a common feature of the cases.1 This finding led Baxter Healthcareto recall, on January 17, 2008, nine lots of heparin sodiumfor injection. As of April 13, 2008, there were 81 reports ofdeath that involved at least one sign or symptom of an allergicreaction or hypotension in patients receiving heparin sinceJanuary 1, 2007.

Ram Sasisekharan, a professor of biological engineering at MIT and the lead researcher on the project, says that the key to the team's approach was that it looked at heparin and the contaminant at a molecular level. Strong teamwork, he notes, was also important to the project. "A number of academic and industrial labs worked with me in close collaboration with the FDA. It was only through cooperation that we were able to accomplish this task of identifying the contaminant and assessing its biological activity in such a rapid fashion."

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dmm

270 Comments

  • 1386 Days Ago
  • 04/29/2008

contaminant?

OFCS is very hard to distinguish from heparin, and it is MUCH cheaper to manufacture.  If OFCS is present in other than trace quantity, then it is probably not a "contaminant."  It is being used as a substitute for heparin, allowing the manufacturer to increase his profits via a hard-to-detect scam.  Many Chinese manufacturers have no conscience whatsoever, and behave accordingly.  I don't know that American and European manufacturers do have a conscience; however, our inspection and legal systems basically assume that they don't, so they at least behave as if they do.  We need to wean ourselves away from any Chinese goods ASAP that could possibly be harmful (food, drugs, toys, etc.), until the Chinese gov't forces proper regulation on their manufacturers and creates a legal system that holds them responsible for their actions. 

[Please don't accuse me of Sinophobia.  This comment is not anti-China or anti-Chinese.  The U.S. had similar problems in the early stages of our industrialization (hence the FDA, USDA, CPSC, OSHA, EPA, AEC, etc.).  I assume European countries also had the same problems and the same type of response.  (Non-U.S. please excuse all my acronyms.)]

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Guest (jpdemers)

  • 1369 Days Ago
  • 05/16/2008

Re: contaminant?

Whoever peddled fake glycerin a few years back made about a thousand dollars -- and killed over 200 kids in Central America. Now they're selling fake drugs to patients with malaria, which is likely to kill thousands.  "Lack of conscience" hardly seems adequate to describe such scum.

The faked heparin passed all the existing tests, even in the US, so a better Chinese FDA would not solve the problem of criminals who take the trouble to evade Q.A. protocols.  This is a criminal justice issue, not a regulatory issue.  China needs to crack down on criminals who don't seem to care who they kill, so long as they turn a profit.  Severe penalties don't seem to deter these people, but better tracking of the supply chain, mandatory record-keeping, and secure pedigrees for all drugs and drug intermediates would help track them down. 

A legislated moratorium on Chinese-sourced pharmaceuticals, until such systems are in place, is unlikely, but Western pharma companies may impose it themselves, given the potential exposure to class-action lawsuits.  The fake-drug criminals aren't about to stop, and whoever they victimize next will be a sitting duck for enormous punitive damages, for deliberately buying goods from a source that is widely known to be unreliable and dangerous.

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