This is a new twist in the case of Levothyrox, which was hardly talked about for several years. The French subsidiary of German pharmaceutical company Merck announced its indictment on Wednesday morning “in-depth deception”. in a criminal investigation into a change in the drug’s formula, followed in 2017 by a wave of announcements of unprecedented adverse effects. This molecule is taken by 2.3 million people in France every day to overcome the inability of their thyroid gland to produce levothyroxine, a hormone that plays a central role in the body.
“It is not about the quality of the medicineexplains Mario Stazi, the lawyer of the pharmaceutical company. The trial judge dismissed the most serious charges of premeditated murder and involuntary manslaughter, as well as endangering others, just to preserve the fraud. » Therefore, the debate will focus on the communication plan that accompanied the arrival of the new Levothyrox formula. “We believe that we have not only complied with the regulations, always with the approval of the authorities, but we have also gone beyond the limits of what was imposed.”, the lawyer insists. Which is not the opinion of some patients.
Reminder of the facts. In March 2017, Merck launched a new version of Levothyrox in response to a request made by the National Agency for the Safety of Medicines (ANSM) in 2012. In the old formula, the active ingredient deteriorates when in contact with excipients. Not acceptable for a drug that requires a specific dosage for each patient. But three months after the new tablets hit French pharmacies, the adverse effects monitoring system is racing: fatigue, dizziness, headaches, muscle pain, hair loss, suicidal thoughts… “Back in April, we were overwhelmed with messages. Every day people called me in tears. We were completely helpless.”told in 2020 Figaro Beate Barthes, President of “Living Without Thyroid”. Between March and November 2017, just over 17,300 patients reported adverse effects. Unheard of for this drug.
Lack of support for some patients
The presence of impurities, production problems… Many explanations are put forward one after the other, most often by patient associations that want to understand the situation. However, several tests carried out by the Medicines Agency all confirm the quality of the pills.
Subsequently, experts believe that this crisis is due to the lack of support for some patients. “Healthcare professionals were well informed, but patients should have been informed that this change in formula could lead to temporary hormonal imbalances and therefore adverse effects.Judge Mathieu Rustit, professor of pharmacology at the University of Grenoble. This was to be accompanied by clinical and biological monitoring for all. »
What was done in Belgium, according to Pr: Patrik Petrosyans, head of the endocrinology department of Liege University Hospital. “At the time of wording change 1eh In January 2015, a massive information campaign was launched in the media and in pharmaciesthe specialist recalls. Patients were well warned that they should see their doctor for a blood test so that the dose could be adjusted. »
Although the case is not yet legally closed, the health crisis is well and truly behind us. Since October 2017, the number of reports has dropped significantly and only reached ten per month in early 2019, leading the Medicines Agency to: interrupt his control.
Source: Le Figaro
