FAQ

Levothyrox scandal: a collective legal action against the ANSM

On the occasion of a press conference organized on September 14, Maître Christophe Leguevaques, lawyer at the Paris bar, announced the opening of a collective legal action against the National Agency for the Safety of Medicines (ANSM) in the Levothyrox case. In France, 3 million people who suffer from thyroid problems use Levothyrox, a generic or a competing drug, daily.

The Levothyrox scandal is not new. It dates back to 2017. At that time, the Merck laboratory had a monopoly on the sale of the drug against thyroid problems containing levothyroxine, the active ingredient. Levothyroxine has a “narrow therapeutic margin”. That is to say that not only to be effective it must be at a very precise dosage but that outside this dosage, it becomes dangerous and triggers undesirable or serious side effects. In the case of the thyroid, the wrong dosages can cause either great fatigue and a feeling of deep depression or, on the contrary, hyperactivity. In some cases, death.

Until 2017, the Merck laboratory manufactured this drug with a well-known excipient: lactose. Suddenly, for obviously commercial reasons and to standardize its production for the Chinese market, which does not like lactose, the laboratory decided to change the excipient and replaced it with sorbitol. Due to this modification of the composition of this sensitive drug, the laboratory is obliged to submit a new application for Marketing Authorization (MA) and sends a complete file, more than 2000 pages, to the authority which delivers, the ANSM. So far so good.

Levothyrox: defects in the MA application file

But now, the file has flaws. The first and the main one which should have caught the attention of the ANSM is that normally, this kind of medicine is evaluated on 12 to 20 people. The curves indicating the efficacy of the drug must be uniform to validate the therapeutic quality of the drug and not vary with large amplitudes from one patient to another. In the case of the new file, it was not with 20 but with 200 people that the tests were done.

Why? It was necessary to reach this number of patients in order to be able to smooth the curves in such a way that they are perfectly identical to those of the original Levothyrox file. On only 20 people with the new formula, the amplitudes of curves would not have allowed the delivery of the MA. If we take the file and look case by case, the lawyer tells us, the results did not agree in 2 out of 3 cases, hence the need to smooth over 200 cases.

In addition, the second anomaly, the 2000-page dossier was sent in an “image” and not “text” format. Error or hack from the laboratory? The fact is that this format made research in the 2000-page dossier much more difficult for ANSM experts. Who for their part, did not bother to send the document back to ask for it again, this time put in a format usual in this kind of request which makes it possible to easily search for tables, curves, statistics and to compare.

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ANSM: the faults committed which justify joint action

These errors by the ANSM have now earned it collective legal action on the part of patients who have had to suffer in their health and quality of life from this lack of rigor by the drug authority. Because in less than a year, more than 500,000 people had to urgently seek other drugs with identical indications abroad. Merck still having at this date the monopoly of the marketing of medicinal products containing levothyroxine in France.

Exactly, the ANSM is accused of:

– failing to protect patients by not verifying whether the data in the file was correct
– to have lacked anticipation. Because any modification in the composition of the formula of this type of drug inevitably leads to more or less serious side effects in 10 to 15% of patients.
– of having ignored, even despised, the words of patients who complained of unusual side effects, preferring the reassuring words of the medical experts consulted who themselves saw no difference.

Register your complaint on a platform dedicated to collective actions for 120€

If legal actions are already in progress against Merck and the ANSM, this time, the possibility is offered to the victims to unite their voice in a collective action. This is a fairly new formula in France. Concretely, if you have been a victim, you can register on the site https://myleo.legal/fr/ (contraction of: my legal office) for the sum of €120 and your complaint is registered. This collective formula has the first virtue of lowering legal costs, because otherwise, in this kind of case, they amount to several thousand euros. On the other hand, the argument will be oriented towards the repair of “moral damages”. This ground for complaint makes it possible to standardize the request for compensation which will be set, for each victim, at €15,000 if the ANSM is found guilty for its shortcomings.

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The registration deadline extends from today until November 15, the closing date for registrations.

[HighProtein-Foods.com]

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