A tense atmosphere for a crisis situation. The meeting held Wednesday morning at the National Agency for the Safety of Medicines (ANSM) on the risks posed by a citrate dialysis product took place in a severe atmosphere. And for a good reason: according to the newspaper The world, which revealed the story in its December 5 edition, these are "Hundreds of people on dialysis who may have died prematurely" because of a new product that is used more and more frequently.
It all starts at the nephrology congress on 3 October. On that day, a study presented by Dr. Lucile Mercadal (Inserm and Pitié-Salpêtrière Hospital), conducted by the REIN registry data managed by the biomedicine agency, showed that 40% of people treated with this dialysis would have a mortality in excess compared to that treated with other products. 20% of the 47,000 people with renal insufficiency treated in dialysis in France are treated with a citrate product, introduced on the market in 2012. Of this proportion, 40% would be excess mortality. There are about 4,000 people, which is impressive. Some will note that this is a retrospective study that may therefore include bias. However, the alarm signal is strong. And it was slow to be fired. This presentation at this congress was not published and, more importantly, it was not sent to ANSM "I was surprised that no health care provider thought about taking over the agency." It is the association of patients, Renaloo who learned it fortuitously last week and immediately transmitted it to ANSM. "It seemed obvious to react as quickly as possible", tells us an official of the association.
The ANSM, thus kidnapped, immediately decided to convene this Wednesday "All interested parties" : health professionals, industrialists, scientific societies, biomedicine agencies and associations. "The meeting was essential, he told us, Magali Leo, Advocacy Officer at Renaloo, but the situation is serious. We listened to the author of the study and those who criticized it. The agency reacted quickly, but so many questions arise. Why did the laboratory, Fresenius, not react when they had lifts? Why did not scientific societies react? And the biomedicine agency? Why have the adverse effects not been reported when it is mandatory?"
For the moment, ANSM has decided not to suspend the product. Studies will be conducted to confirm or not this data. "It will be necessary to set up an information system for patients who do not know which product or medical device is used in their dialysis ", continues Magali Leo. Academic societies have been asked to develop recommendations for good practices. "It takes time, but the urgency is to respond to patients. We must warn them, help them, accompany them. But we are amazed by the fact that there were so few reactions for two months while this study existed. Why? The laboratory knew it. Why no warning? " The agency is also very surprised.