The ANSM “firmly disputes the reproaches formed against him”. For Philippe Sopena, of the French Association of Thyroid patients, “the agency has never explicitly recognized the link between the change of formula and the occurrence of undesirable effects”.
by Stéphane Foucart
A little over a month after Merck, it is the turn of the National Medicines Safety Agency (ANSM). The agency itself announced on Monday, December 5, its indictment for “deception” in the case of the change of formula in Levothyrox. The pharmaceutical laboratory and the public agency are targeted by a collective complaint of more than a thousand patients who, according to the latter, suffered from side effects during the transition, in March 2017, to the new drug formula. Among the two to three million people with thyroid disorders and treated by Levothyrox, about 15,000 had reported such effects (asthenia, headache, dizziness, joint and muscle pain, alopecia, etc.) to pharmacovigilance centers.
The case has fed, for several months, intense public controversy. On the one hand, the associations of patients questioning the transition to the new formula in the triggering of undesirable effects, on the other, learned societies and media doctors pleading for a manifestation of somatic disorders linked to the expression of The case.
In a statement released on Monday evening, the ANSM ensures that it “will make its full contribution to the manifestation of the truth but firmly disputes the reproaches formed against it, because no criminal offense has been committed”. “The ANSM has never denied the difficulties encountered by certain patients at the time of the new Levothyrox formula and is constantly and daily concern for patient safety and health,” added the drug gendarme.
An assertion that makes Philippe Sopena, doctor and scientific advisor to the French Association of Thyroid Association (AFMT) jump. “The agency has never explicitly recognized the link between the change of formula and the occurrence of undesirable effects, he says. As early as January 2018, in people complaining of troubles after transition to the new formula, data from Pharmacovigilance which the ANSM had showed that the return to the old drug was the most effective way to obtain the improvement of their condition: it did not even disseminate these results by press release. “According to the ANSM, Pharmacovigilance data exclude the responsibility for the new formula in the occurrence of the most serious adverse effects.
“judge and part”
However, since the spring of 2019, a succession of research and expertise works suggest that the two formulas in Levothyrox are not interchangeable. In April 2019, academic work published in the journal Clinical Pharmacokinetics indicated that the test led by Merck to support the change of formula only guaranteed an average bioequivalence, that is to say at the scale of a population. At the level of the individual, a different reaction to the new formula was not excluded. The authors criticized in hollow the fact that, having not conducted its own statistical reanalysis of the data submitted by Merck, the ANSM had not detected this fault.
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