the essential
Research carried out in a Czech laboratory and by Toulouse researchers proves the dangerousness of Levothyrox. Merck laboratories dispute the results and the methodology used.
The medical profession took them for crazy, hysterical people incapable of holding relevant reasoning. These female members of the AMFT (French Association of Thyroid Patients) and the collective of victims of Levothyrox Occitanie may be getting their revenge. The key to causing serious problems for the Merck laboratory, the manufacturer of the product and the national drug safety agency. This is a study partly financed by the AMFT carried out jointly in Toulouse and the Czech Republic. It was published in Journal of Pharmaceutical Analysis.
Read also :
“I had the impression of being poisoned”: she recounts how Levothyrox would have destroyed her metabolism
This journal enjoys a respectable reputation within the scientific community, particularly in the areas of pharmaceutical analysis and related research. The researchers who carried out the work developed a non-targeted approach. This method aims to identify and characterize as many components as possible in a sample, without prior assumptions about their identity. In short, they analyzed thousands of boxes of Levothyrox from every angle.
A second “pick”?
Levothyrox is at the center of a major legal controversy. In 2017, a new formula of the drug was introduced, using the same active ingredients but with new excipients. Merck is indicted for aggravated deception a month and a half after the National Agency for the Safety of Medicines and Health Products (ANSM) itself was indicted, in December 2022, for deception.
Doctor Jacques Guillet, specialist in biophysics and member of the AMFT reveals the conclusions of the work: “The Czech laboratory uses very high level combined techniques which make it possible to highlight all the impurities and all the molecules present in the tablet. – same. The idea was to analyze tablets produced at different dates and factories and check their precise composition. In certain batches, they found something totally unexpected in large quantities: phospholipids. “It is not something toxic, it is found for example in egg yolk, but in the specific case of Levothyrox, this could partly explain the undesirable effects observed in many patients.”
Read also :
Levothyrox scandal: “The new Franco-Czech study could be decisive if we go back to appeal”, predicts Me Jacques Lévy
“Impurities found in certain tablets”
Dr Gérard Bapt, former MP and former member of the national drug safety agency, details how the presence of these “impurities” could in addition to “the replacement of lactose by mannitol and the addition of citric acid” help to understand why there is an “unprecedented” peak in reporting of adverse effects between 2017 and 2018: “Levothyrox is a product that is said to have a narrow therapeutic margin. That is to say, only very small variations in dosage can immediately lead to significant disturbances.”
One of the authors of the study is none other than Jean-Christophe Garrigues, former engineer at the CNRS. The researcher had already carried out research which proved the presence of “impurities” in the new version Levothyrox. At the time, his supervisory organization had slammed him publicly in a press release in October 2018: “the results announced by Jean-Christophe Garrigues, research engineer at the CNRS, having not been validated by the peer evaluation process specific to the scientific community, the CNRS considers that they do not currently constitute scientific facts.”
Merck’s scathing response
Merck laboratories became aware of the study on April 17 and provided an initial analysis of the document, particularly on the presence of phospholipids in a significant portion of the tablets studied in the Czech laboratory: “Mention is made of a theoretical impact of these phospholipids on bioavailability We remind you that the new formula has been the subject of bioequivalence studies (same concentration, same effects) in accordance with the specifications in force.
Furthermore, the pharmaceutical group management questions the way in which this study was carried out: We are surprised by certain methodological choices, such as the use of unidentified batches, sometimes expired, of which neither the origin nor the conservation conditions are not described.
Furthermore, the pharmaceutical group management questions the way in which this study was carried out: “We We are surprised by certain methodological choices, such as the use of unidentified batches, sometimes expired, of which neither the origin nor the conservation conditions are described. In addition, we would like to remind you that since 2017, the new formula of Levothyrox has been approved by the health authorities of around a hundred countries. Thus, its quality has been confirmed on several occasions not only by French, but also European and international health authorities.”
Change of formula and an explosion in the number of reports.
At the peak of the crisis around the new Levothyrox formula (same active ingredient but the lactose is replaced by mannitol and citric acid is added) there was an unprecedented peak in the frequency of reporting of adverse effects: they were more than 17,000 patients identified between June 2017 and the end of January 2018.
