International research suggests that a simple in vitro bioassay, in addition to procedures currently in place, would help secure the global supply chain for heparin and reduce the risk of patients being exposed to harmful contaminants.
Papers published in Nature Biotechnology and The New England Journal of Medicine have provided clear evidence of the effects of the heparin contaminant oversulfated chondroitin sulfate (OSCS) in the body, and critically identify a way to improve its detection.
The detection test can also identify "other polysulfated contaminants in heparin that may have unintended pharmacologic consequences" according to the researchers.
Testing in place prior to the contamination did not check for molecules of a similar structure to OSCS which, like heparin, is composed of a long complex chain of repeating sugar molecules
Rouge proteins, lipids and DNA were checked for but crucially there was no test for sugar contaminants.
This may be owing to the challenge of screening for sugar contaminants in heparin, which Jeremy Berg, director of the National Institute of General Medical Science, described as a "difficult task".
However, the research team say they can know rapidly identify a contaminant, quantify its levels and then finally characterise the compound.
Implementation of these processes should help protect against the effects of any future contaminations.
Ram Sasisekharan, senior author of the papers said: "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."
The research team also showed that OSCS activates two inflammatory pathways. One of these pathways dilates blood vessels and initiates blood clotting and the other pathway causes anaphylactic toxins to be produced.
Heparin contaminated with OSCS was shown to initiate these pathways whereas normal heparin did not.
The first pathway results in the victim's blood pressure dropping dramatically. The second induces a serious allergic reaction, which was manifested as profound hypotensive response in the pigs used in the study. These responses match those witnessed in humans.
Commenting on this Sasisekharan said: "These results provide a potential link between the presence of chemical contaminant in heparin and the clinical symptoms observed in affected patients."
The two research papers are the culmination of a global research collaboration which has quickly shed some light over the incident.
Now the science is in place the hope will be that the relevant authorities implement it correctly in order to best protect the public.