On June 18, he will file a motion for an order of liberty with the administrative court of Lyon. Determined to obtain the status of "victims" for the thousands of patients on Levothyrox treatment through a joint civil action, the lawyer at the Paris Bar Christophe Lèguevaques, now intends to obtain the requisition and manufacture "in sufficient quantity and perennial" stocks of the old Levothyrox formula, still produced in France but bound for Italy.

"The important thing is that the three million people concerned have the choice of their treatment," proclaims this self-advocate self-described as "devoted" and accustomed to media files (note: AZF, Dexia, Irradiated Rangueil, Molex. ..). A year after the introduction of the new formula and the scandal around its side effects , the one who says he has "nothing to hide" agreed to take stock with us.

A year later, the anger of the victims ill side effects of the new Levothyrox is still vivid. Many say they are abandoned, even betrayed. Is this the reality you see?

If we take the chronology of the case, the Merck laboratory explains that the new formula is better than the old one. The absence of lactose prevents intolerances, excipients such as citric acid and mannitol make the drug more stable and include it in the standard 95/105%, required by the ANSM, which is a standard of tolerance of active ingredient in a tablet. Before, it was apparently between 90 and 111% which could cause a significant difference in dosage between an old and new tablet and thus cause a thyroid imbalance . Except that this official explanation does not hold.

On lactose first, intolerance is not allergy. Not to mention that it concerns a small proportion of the population. In order to diagnose it, at least 60 g of lactose are ingested by the patient concerned. In a Levothyrox tablet, one is 6 mg, 1000 times less. In addition, we realize that there are still today lots of drugs, including contraceptive pills , which contain lactose without any hindrance. Moreover, when we ask the ANSM the number of people who suffered from lactose intolerance in 2012 (note: date when the agency sent a letter to the laboratory to ensure the 95 standard / 105%), the answer is: "We can not give you this document, it is seized by judge of instruction".

As for the stability of the drug, documents from the FDA (Food and Drug Administration) from Merck dating back to 2005 * are troubling. At the time the laboratory markets Levothyrox under the name of Novothyrox in the United States. With the exception of an added dye, it is the same drug as French Levothyrox. In this document, Merck confirms to the FDA to comply with the 95/105% standard. Why would they not have met that standard after that date?

From the beginning, Merck explains that he has reformulated his medication at the request of ANSM ...

ANSM did not explicitly ask for this change of formula. As often, she gives recommendations but does not check each drug itself. In 2012, she sent a letter asking the laboratory to verify that it complied with the 95/100% Levothyrox standard and to make the necessary changes to this product within 18 months if this were not the case. Merck responded that it did not meet this standard and therefore moved to a new formula.

ANSM did not explicitly ask for this change of formula

Why would Merck have reformulated a drug that has been proven for 30 years and that, according to FDA documents, meets the 95/105% standard?

For a patent! The one with lactose expires next year. It was necessary to invent a new patent for 20 years of tranquility vis-à-vis the competition. Not to mention the constraints of the Asian market - in the line of sight - at the rate of growth five times higher than the European market, where lactose intolerance is suddenly high.

Scientists recently pointed to the use of citric acid in such a drug, this component having effects on the absorption of levothyroxine, the active ingredient of it. How to explain this choice?

It's a way to have a viable patent: to do something never seen. Merck claims to have found a way, thanks to mannitol to neutralize the effect of citric acid on levothyroxine. Except that neither the ANSM nor the European Medicines Agency (EMA) have checked. Only bioequivalence tests, performed by Merck, have been performed! However, given the type of drug, said to narrow therapeutic margin, epidemiological studies - now ongoing - should have been conducted upstream.

One could be sure that there would be side effects, the slightest change of formula or even manufacturer being likely to cause an imbalance. We saw it with generics (including that of Servier) a few years ago. The bet, crazy, seems to have been: they will get used. Today, patients feel like guinea pigs. Rightly, since at the time of the change of formula, they were almost 3 million captives of a quasi monopoly of Merck (note: at the time of the marketing in March 2017, only drops of L-Thyroxine SERB prescribed for children and elderly were available as an alternative).

Today, patients feel like guinea pigs

Several procedures are currently underway, including a collective action by yourself. What is it?

We started on the basis of a "simple" procedure for compensation of the moral damage and the harm of anxiety, which has the advantage of avoiding the expertise and to make recognize the patients as "victims". Especially in this case, the troubles are fortunately more or less passengers - and therefore the amounts of compensation may be low. We put forward the lack of information because the manufacturer had the obligation to inform patients of the change of formula. Only one letter was sent to doctors and pharmacists, not always clearly understood. This joint collective action brings together 4,115 people.

For the most serious cases (hospitalizations, work stoppages ...), we will ask, in a second time, the repair of the bodily injury. This involves expertise, so the work is longer.

Third level on which we are actively working, the seizure of the administrative court. In France there is a factory at Bourgoin-Jallieu, which manufactures an old Levothyrox formula for Italy. It could increase its production for 200 to 500 000 French who do not support or do not wish to change the formula. To obtain this forced manufacture - and perennial, although Merck has indicated to stop the production of the old formula in Europe by the end of 2018 -, we ask the requisition of the manufacture of this medicine by reference liberty. This has already been done in the past by Roselyne Bachelot, at the time of the H1N1 flu epidemic. Currently, I have for example a client who does not support any alternative to Levothyrox, medical file to support.

Finally, to date, more than 7000 complaints have been filed in criminal court in Marseille. They consist of becoming a civil party and participating in the investigation which will have to determine if there are criminal errors that are likely to engage the responsibility of certain people. It's a lengthy job in which you have to involve a lawyer, aim at the text and justify the harm done. In my opinion, this could lead to a legal traffic jam.

Currently, I have a client who does not support any alternative to Levothyrox, medical file in support

That does mean loss of anguish?

You are sick, you have to take a vital medicine that does not cause you any problems. Gradually you realize that your health is deteriorating and that it can be caused by this medicine. Doctors grope, you feel abandoned by everyone and by your body. All this has generated anxiety and it is this anxiety, in the incomprehension and without solution or alternative, that we will seek to compensate. Also, we ask 10 000 euros of compensation, 5000 euros per damage exposed.

Do you regularly meet patients throughout France during official meetings? How are they?

It's quite variable. There are those who force themselves to support the formula, those who will provide themselves abroad, those who test the available alternatives alone, without a doctor, which is obviously not desirable. It is also sometimes difficult to get these new products depending on where you are on the territory. In any case you risk being disordered as the absorbed dose of this type of medicine is affected by many factors. Stabilization can take 3 to 6 months.

To hear you, the case of Levothyrox seems part to last ...

It is just beginning, we left for 5 to 10 years of procedure. The national instruction opened in Marseille for fraud, accidental injury and injury and endangering the lives of others will be long. Everything will have to be checked to rule out all assumptions and false leads. In addition, I am currently working on four files reporting suspicious deaths. Autopsies have been performed, we are waiting for the reports. We will then ask for a review of manslaughter. Other expertise could then be added.

* https: //www.leguevaques.com/LEVOTHYROX-REVELATIONS-IN-2005-MERCK-HAD-EXPLAINED-TO-THE-FDA-THAT-ITS-LEVOTHYROXINE-SODIUM-MET-THE-95-105-STANDARD_a494.html