An international team of researchers led by Massachusetts institute of technology (MIT) has explained how contaminated batches of the blood-thinner heparin were able to slip past traditional safety screens and kill dozens of patients recently in the United States and Germany.
The team, led by Professor Ram Sasisekharan of MIT, identified the chemical structure of the contaminant, known as oversulfated chondroitin sulfate (OSCS). The researchers present their findings and offer new approaches to detecting the contaminant in a report appearing in the online edition of Nature Biotechnology.
Another team led by Sasisekharan has shown exactly how OSCS can kill–specifically by setting off an allergy-like reaction. The biological effects of the contaminant are outlined in a report also being published online today in the New England Journal of Medicine.
“Sophisticated analytical techniques enabled complete characterization of the contaminant present in heparin. Further, this study also provides the scientific groundwork for critical improvements in screening practices that can now be applied to monitor heparin, thus ensuring patient safety,” said Professor Ram Sasisekharan, senior author of the papers, the Underwood Prescott Professor of Biological Engineering and Health Sciences and Technology at MIT and at the David H. Koch Institute for Integrative Cancer Research at MIT.
Heparin, a blood thinner often used during kidney dialysis or heart surgery, is normally produced from pig intestines. FDA officials say the contaminated heparin came from factories in China that manufacture the drug for Baxter International.
Source: Massachusetts Institute of Technology, USA