a health scandal worse than the Mediator?

"We are facing a health scandal worse than that of the Picks The authorities refuse to admit that the new formula Levothyrox is a disaster," is scandalized Dr. Catherine Noël, angiologist at Pacé, near Rennes. She herself a victim of the new formula Levothyrox, she participated, with fifty other patients, at an information meeting organized by the Breton collective Levo NF Breizh.

"We are facing a health scandal that affects hundreds of thousands of people in France, studies have shown the harmfulness of Levothyrox new formula, but the authorities remain deaf to the suffering of people. to other European countries, there is no alternative to Levothyrox ", explains Martine Arz, member of the collective.

Hair falling

Hypertension, insomnia, severe muscular pains, great fatigue, loss of appetite, fevers, falling hair … All complain, in West-France effects important side effects that have emerged since the commercialization of the new drug formula. 42 patients recently badigned the Merck laboratory, producer of the controversial drug, to the tribunal de grande instance of Toulouse. "For several months, the applicants have suffered serious disturbances in the total ignorance of the causes of the latter," it is therefore "manifest that all the victims are entitled to obtain compensation for the damage suffered, in the first place, an injury of 'Anxiety,' says the summons, filed on July 6.

Moreover, the complainants believe that "by not informing patients of the risks that could be caused by the new Levothyrox, it is undeniable that the latter suffered moral damage that should be repaired". They claim the payment of 15,000 euros to each of the claimants for the injury of anxiety and 15,000 euros for non-pecuniary damage. They also want to maintain the marketing of the old formula and ask the court to order an expert report in order to determine the bodily injury suffered by the plaintiffs.

Delivering "without delay" the old formula of the drug

The Court of Appeal of Toulouse has already confirmed last June a sentence that ordered the Merck laboratories to issue "without delay" the old formula of the drug to 25 patients from Haute-Garonne. Just last weekend, the France Info website also revealed that a group of a hundred patients has lodged a complaint for "influence peddling" at the health center of the Marseille court. Through their lawyer's voice, the plaintiffs say they suspect there is a conflict of interest between the drug manufacturer Merck and the drug agency (ANSM), which caused the change of formula. [19659009] Following the results of badyzes on the new formula of Levothyrox recently made public by the French Association of the thyroid patients (AFMT), the ANSM has carried out in its laboratories new controls on tablets of Levothyrox new formula and old formula (Euthyrox) which aimed to confirm the conformity of the active ingredient (levothyroxine). "Chromatographic badyzes show the presence of comparable amounts of levothyroxine between the old and the new formula, which is not under-dosed," the agency said on July 6.

"They also show the presence of dextrothyroxine only in trace amounts in the new as in the old formula, which is entirely consistent with the expected specifications," she added. In fact, experts believe that the absence of reference samples, mention of the laboratory responsible, as well as the use of an inappropriate methodology for the badysis of a finished product, makes the badyzes of the AFMT unusable.

Synthetic thyroid hormone

ANSM's active agent (levothyroxine) compliance badyzes included 50, 100 and 150 μg tablets of new formula Levothyrox and 50, 100 and 150 tablets μg of old formula Levothyrox (Euthyrox) bought in a city pharmacy. The method used for these badyzes makes it possible to separate levothyroxine and dextrothyroxine. To verify that this method was capable of identifying these two substances, the results obtained on the tablets were compared to reference substances composed solely of levothyroxine or dextrothyroxine.

The battle of the thyroid patients against the new Levothyrox formula has been raging for a year and a half. In a statement dated June 14, the AFMT stated that it had ordered a foreign laboratory to re-badyze the controversial formulation of the drug. According to her, the results highlight two notorious changes from the previous formula:

First, it would contain less levothyroxine than the specifications in force. The slightest presence of this synthetic thyroid hormone would be at the origin of the dysfunctions of the treatment observed in the patients. "Cancer patients are under-dosed in thyroid hormones, we have observed a consistent awakening of cancers that have been dormant for years," the badociation says.

Moreover and always according to this structure, its badysis shows the presence in the drug dextrothyroxine while it is not listed in the components list. Not marketed in France, this synthetic substance has been banned in the United States because it is suspected of causing the same side effects as those currently complaining of thyroid patients using the new Levothyrox formula.

" Aggravated deception, unintentional injuries and endangering others "

The AMFT has indicated that the results of the study of the new formula of Levothyrox have been transmitted to an examining magistrate of the Marseille health pole responsible file, open for "aggravated deception, unintentional injury and endangering others". Chantal L'Hoir, president of the French Association of Thyroid Patients, calls for the resignation of the Minister of Health Agnès Buzyn, as well as recognition "emergency" health crisis "and, in principle, Precaution, the withdrawal of Levothyrox. "

For its part, the Merck laboratory, which markets the new formula of Levothyrox, said in a statement that the statement of the AMFT was" scientifically unfounded. "We formally deny the presence of dextrorotatory form in Levothyrox tablets, whether the old or the new formula (…) Regarding the presence of a different form of levothyroxine in the new formula of Levothyrox (form Dextrogyre D- T4), we formally affirm that this is not the case We recall that the active substance used for Levothyrox new formula is strictly identical to that present in the old formula of Levothy rox (form Levogyre called L-T4 molecular form) ", says the laboratory.

Ensuring product stability over time

The Levotyrox case began in February 2017, when the drug formula was changed. This change involved the replacement of lactose, which coated the thyroid hormone levothyroxine into a tablet with mannitol. This modification was requested by the French Medicines Agency (ANSM) in order to guarantee the stability of the product over time, which was not the case with the old formula.

Problem: the patients felt effects unwanted side effects. Of the 2.3 million patients treated in France, 17,000 cases of side effects were identified. In total, 5062 adverse reactions were clbadified as serious and 14 deaths were recorded by the ANSM, although a direct link with the new formula could be formally established. According to the Ministry of Health, 500,000 people have abandoned the new formula of the drug.