Research team led by MIT professor.
Monday, April 28, 2008
By Rachel Kremen
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."
Comments
dmm on 04/29/2008 at 4:54 PM
137
[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.)]
jpdemers on 05/16/2008 at 2:05 AM
32
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.