(Quebec) A researcher from Laval University has sounded the alarm about a product used to disinfect bags of blood platelets and soon to be approved in Canada. Recent work by Professor Patrick Provost indeed suggest that the product in question, Intercept, Cerus the company, halve the efficiency of platelets and increase the risk of certain complications. But others doubt it …
Platelets are that part of the blood that clots in case of injury, thus stopping bleeding. Like all other blood products, platelet bags are tested for the presence of bacteria or viruses, and there are methods that reduce the number of these pathogens. Some of them, such as Intercept, are designed to interfere with genetic material, because the plates are devoid of core cells (which houses the DNA) and that we have long believed that they wore no equipment genetics. Thus one could see a way to kill microbes, which in turn need their genetic material without inconveniencing platelets.
But recent studies, including those of Mr. Provost, have shown that platelets contain thousands of kinds of “microRNAs”, a form of genetic material, and that these microRNAs clearly helps platelets to fulfill their role. Furthermore, in an article published last July in the academic journal PLoS-ONE, Mr. Provost and three European researchers found qu’Intercept “deregulates over 800 microRNAs (…) with the consequence that the proteins made by these microRNAs are then no longer, and it may explain why (… platelets treated with this product) are less able to aggregate, if at all, “says Provost.
The net result, continues the researcher CHUL, is that “it must be transfused twice to restore normal platelet function, so it doubles the cost (and …) Intercept treatment is itself expensive.” In addition, such products are known for the release of platelet microparticles, microparticles that can cause inflammatory reactions. These are worrying in themselves, but in rare cases they can lead to serious complications.
In the US, the Food and Drug Administration has already endorsed the Intercept last December, several European countries have also done well in recent years, and Mr. Provost expects that Canada their followed suit shortly.
Héma-Québec as well as Canadian Blood Services, which manage the distribution of blood products in the country, is said not to expect that Health Canada make a decision soon, but no one denies either interest for Intercept.
“We must not lose sight that the purpose of that technology is to inactivate pathogens that may be present in a blood product for which we do not, at present, other mitigation method risk. (…) Currently, these risks are extremely low here because we test, redundancy in our quality systems, but it is a method that is seriously considered by many experts in the world to decrease risk as much as possible, “said Marc Germain, Vice President, Medical Affairs at Héma-Québec.
Mr. Germain said he took good knowledge of Mr. Provost work and discussing with him, but he reminds qu’Intercept is a product that has already been well studied and the literature about it has not found him disadvantages which Mr. Provost.
The researcher from Laval University will not deny, readily admitting that his few studies do “not weigh heavy” face dozens of favorable trials were published. But he points out that most of these data have been produced by the manufacturer itself, Cerus, which is then free to choose what results he published – and can decide to keep secret what does not suit him.
At Canadian Blood Services, the Chief Medical and Scientific Affairs Dana Devine, herself a researcher and specialist in platelets at the University of British Columbia, said watching the same things that Mr. Provost in his own lab, but get little worried. “The industry has always understood that to reduce the risk of infection, it had to accept some loss of efficiency of platelets, she said. But what is interesting is we do not see this loss in clinical data (involving human, not just in the test tube experiments, ed.) There as a disconnect between what we see in the lab and in the clinic. ”
She cites as evidence the case of Switzerland, where Intercept is used for years. The latest report of the Committee on helvète blood products made state last year, the “possibility” of a loss of efficiency, but no case has been reported to him.