A little over a month after Merck, it is the turn of the National Medicines Safety Agency (ANSM). The agency itself announced, Monday, December 5, its indictment for “deception” in the case of the change of formula of Levothyrox. The pharmaceutical laboratory and the public agency are the target of 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 formula of the drug. Of the two to three million people with thyroid disorders treated with Levothyrox, approximately 15,000 had reported such effects (asthenia, headache, dizziness, joint and muscle pain, alopecia, etc.) to pharmacovigilance centres.
The case fueled intense public controversy for several months. On the one hand, patient associations questioning the transition to the new formula in the triggering of undesirable effects, on the other hand, learned societies and doctors in the media pleading for a manifestation of somatic disorders linked to the discovery of the case.
In a press release issued Monday evening, the ANSM ensures that it “will make its full contribution to the manifestation of the truth but strongly contests the reproaches made against it, because no criminal offense has been committed”. “The ANSM has never denied the difficulties encountered by some patients when switching to the new Levothyrox formula and is constantly and daily concerned about the safety and health of patients”adds the drug constable.
A statement that makes Philippe Sopena, doctor and scientific advisor to the French Association of Thyroid Patients (AFMT) jump. “The agency has never explicitly acknowledged the link between the change in formula and the occurrence of adverse effectshe said. As of January 2018, in people complaining of disorders after switching to the new formula, the pharmacovigilance data available to the ANSM showed that returning to the old medication was the most effective way to obtain an improvement in their condition. : it did not even disseminate these results by means of a press release. » According to the ANSM, the pharmacovigilance data exclude the responsibility of the new formula in the occurrence of the most serious adverse effects.
“Judge and Party”
However, since the spring of 2019, a succession of research and expert studies suggest that the two Levothyrox formulas are not interchangeable. In April 2019, academic work published in the journal Clinical Pharmacokinetics indicated that the test conducted by Merck in support of the change in formula only guaranteed average bioequivalence, that is to say on the scale of a population. At the level of the individual, a different reaction to the new formula was not excluded. The authors criticized the fact that, having not conducted its own statistical reanalysis of the data submitted by Merck, the ANSM had not detected this flaw.
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