A Toulouse researcher would have spotted what could be at the origin of the undesirable side effects of the new formula of Levothyrox. A discovery which would incriminate the National Medicines Safety Agency (ANSM).
Levothyrox, a drug used to treat thyroid disorders, has been at the heart of a health scandal major in France. If the unwanted side effects caused by the new formula, modified in February 2017, are now well known (hair loss, fatigue, depression, etc.), we still did not know exactly what caused them. Until Thursday, October 4. While he will soon deliver the result of this research alongside French Association of Thyroid Patients (AFMT), a Toulouse chemist (whose work is funded by the association) revealed to have put his finger on the culprit, indicates the investigation site Mediacities. And this is not necessarily good for the National Medicines Safety Agency (ANSM) …
A peak of impurities in chromatography
Last July, at the request of the French Association of Thyroid Patients (AFMT) Jean-Christophe Garrigues, researcher at Laboratory of Molecular Interactions and Chemical and Photochemical Reactivity (IMRCP) from the University Paul Sabatier in Toulouse, began to study the results of a synthesis of research on the composition of the tablet published by the ANSM. It is “by looking more closely at the chromatograms (method of analysis which makes it possible to separate the constituents of a mixture)”, that the scientist discovers a significant peak of impurities in the new formula of Levothyrox, whereas ‘it did not exist in the old one, explains Mediacities. The latter “would alert any scientist. Why did the ANSM not push further the analysis of this element which necessarily becomes worrying when one is in a context of health crisis?” he with the investigation site.
Jean-Christophe Garrigues then realizes that this chemical element is present in a higher dose in the drugs distributed in 2017 than in those purchased this summer in pharmacies. “This suggests that the composition of Levothyrox has been improved since the start of the marketing of the new formula in 2017”, he calls. “We do not have the details of the analysis protocol followed by the ANSM and therefore we cannot interpret these peaks.
However, defends the Merck laboratory, “it is normal to observe in this type of analysis different peaks, which are inherent in the method and are not likely to call into question the quality of the product”.
The petition against business secrecy in public health
“If the change in formula of Levothyrox creates so many concerns, it is because it is a drug said to have a narrow therapeutic margin. This means that there are not many margins between an insufficient dose and an excessive dose. strong “, specifies Bruno Toussaint, editorial director of Prescribe.
The AFMT sent on September 26 a petition against “business secrecy in public health” to the Minister of Health Agnès Buzyn. This Thursday, it had collected more than 30,000 signatures. We “demand, in the name of health security, total transparency on the origin of all the components of our drugs and the traceability of their manufacture “, indicates the petition in which the patients say they do not understand”that an agency in charge of health ‘security’ can make the commercial interests of a firm prevail over the protection of the health of all “.
This is not the first time that a scientist believes he has discovered a flaw in this drug. Last May, a former researcher at the Merck laboratory estimated that the citric acid, present in the new formula of the treatment, influenced its effectiveness and would be the cause of the undesirable effects.
Recall of facts
At the beginning of September, 42 victims of Levothyrox brought proceedings against the Merck laboratory before the Toulouse tribunal de grande instance. They are claiming € 15,000 for the anxiety prejudice and the same amount for moral prejudice. They also ask for the maintenance of the marketing of the old formula of Levothyrox and the realization of an expertise to be able to fix the bodily harm suffered by the patients.
In February 2017, at the request of the ANSM which wanted to guarantee the stability of the treatment over time, Merck changed the composition of the “excipient” (the coating of the active molecule to make a tablet) and replaced the lactose which coated the thyroid hormone with mannitol. But shortly after starting their new treatment, many patients complained of fatigue, depressive disorders, headaches, joint pain, hair loss and even insomnia. In all, 17,000 cases of side effects have been identified. Among them, 5,062 were classified as serious and 14 deaths were recorded by the ANSM, without a direct link with the new formula being able to be officially established.
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