In the case of Levothyrox, everything must be done to alleviate the suffering of tens of thousands of patients. Unless the laboratory is clearly mistaken, it is not certain that the courts will be their best allies.
The summary judge of the court of Saint-Gaudens (Haute-Garonne) dismissed some forty patients who had assigned the Merck laboratory to ask him to deliver the old formula of Levothyrox because of the side effects felt during the transition to the new formula, said counsel for the plaintiffs. The court also dismissed the compensation claim for “prejudice of anxiety”.
No urgency, no prejudice of anxiety
The summary judge stated that there was in this case, neither urgency (to judge in summary proceedings), nor prejudice of anxiety. He based his decision on “the absence of medical certificates” validating the fact that the undesirable effects would be directly linked to the drug, on “the existence of substitutes” since 5 different treatments are now available, on the importation on the market. French of “218,080 boxes of the old formula by the laboratory” and finally on the fact that “only 0.6%, or 15,600, of the 2.6 million people treated with Levothyrox, would be affected by this problem” according to the lawyer from the Merck laboratory.
Contradictory decisions
The decision of the Saint-Gaudens court goes in the opposite direction to that of the Toulouse summary proceedings judge, who on November 14 condemned the laboratory to provide “without delay” the old formula of the product, today called Euthyrox, to 25 patients from Haute-Garonne.
Merck appealed against the conviction of the Toulouse court and the lawyer for the patients said he was “appealing” against the decision of that of Saint-Gaudens. The appeal hearings for the Saint-Gaudens and Toulouse cases could be combined into one, but other summary proceedings are underway. However, these decisions do not settle anything on the merits.
A very painful affair for some patients
This case, which reflects real suffering for many patients, will be difficult to plead for lawyers apart from the “lack of information”, unless the Merck laboratory has made a technical error.
The latter also recalls that in this case “Merck has always complied with the requests of the health authorities: whether it is the injunction to improve the formula of Levothyrox or temporarily reintroduce boxes of the ‘old wording to facilitate the transition for patients who expressed a need for it’.
Absorption of levothyroxine depends on the patient
Many circumstances, whether physiological or pathological, can interfere with the absorption of levothyroxine in the human body.
The absorption of levothyroxine may indeed be impaired through age, fasting, ingestion of certain foods (dietary fiber, grapes, soy, papaya and coffee) or certain medications (proton pump inhibitors, antacids, sucralfate, etc.).
In addition, many gastrointestinal diseases, such as those which disrupt the integrity of the intestinal barrier and diseases which alter the natural acidity of the stomach, can decrease the actual intake of levothyroxine (“bioavailability”). ) in some patients.
The absorption of levothyroxine depends on the formula
Studies that have investigated the bioavailability of levothyroxine as a function of different parameters are beginning to date, but they reveal that there is indeed a problem for some people. Some patients do not digest the tablets well and as a result they may be underdosed in medicine which was seen in a study when comparing the absorption of intact tablets with that of powdered tablets.
Likewise, some studies demonstrate differences in actual drug absorption, “bioavailability”, between a tablet form and an oral solution form: study confirms oral levothyroxine solution may have increased absorption rate compared to levothyroxine tablets, especially in the presence of other factors interfering with the absorption of levothyroxine.
Whatever the outcome of the legal battle, and even if it is only 0.6% of patients treated, several tens of thousands of people suffer or are uncomfortable with the new formulation. Doctors should suggest that they try other available formulations and help them adjust the doses.
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-1597155771.jpg "Levothyrox: extension of the old formula until the end of 2021")
-1611075565.jpg "Can punishments change a character?")
