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New crossfire in the Levothyrox affair. The National Agency for the Safety of Medicines and Health Products (ANSM) published Friday, July 6 an badysis on the composition of Levothyrox. The medication prescribed to people suffering from hyperthyroidism is, according to the ANSM, "neither under-dosed nor contaminated", contrary to what is supported by the French Association of Thyroid Disorders (AFMT).
Recall the facts: the new formula, much criticized, was marketed at the end of March 2017. It has caused, according to many testimonials, side effects (vomiting, hair loss, depression). The time is looking for answers. Is the new formula at the origin of these symptoms?
The report by the ANSM defends that the amount of Levothyroxine, active principle of the tablets, would be "identical for the new formula and the old formula of Levothyrox "and correspond" to that expected ". No underdosing, therefore, depending on the body. This was already the conclusion developed by the ANSM at the "Obs" last September.
This time, the study is based on 14,000 statements made between 1 and December 2017 and 17 April 2018 at regional pharmacovigilance centers (CRPV), as well as data provided by the laboratory manufacturer Merck. Added to this are 5,061 people considered in the first badysis and 12,248 in a second. She concludes that the clinical profile of the adverse effects is the same for the old and the new formula, with an accelerated frequency of reports and "totally unexpected" for the new one.
In addition, estimates the study, impossible from of these badyzes "to identify possible patients at risk" and "to propose a hypothesis to the occurrence of these undesirable effects"
Levothyroxine content "seriously lower"
This recent study contradicts that of AFMT, published on June 14, 2018, and considered by the ANSM to be not very serious and opaque. To determine if the new formula was causing the side effects described by the patients, the AFMT had the composition of a box of the old formula compared to a box of the new one. Results: in the old formula, the thresholds range from 95 to 110 micrograms of product per tablet. The new formula, it only concentrates 88.9 to 72.17 micrograms per tablet.
A difference of 10% to 30% which causes the AFMT to state:
"The Levothyroxine content, the only hormonally useful component of the drug, is seriously below the specifications in force."
The survey was sent to Merck who strongly disputed these findings, retorting that the tablet manufacturing process "has not changed since the old formula". The AFMT nevertheless claims the seriousness of the US badysis center that it has used, "independent and validated by the FDA (American health authority)".
Insufficient for the ANSM which was also eager to reply. In a statement dated June 14, 2018, it reads:
"The results of badyzes on the new Levothyrox formula made public today by the AFMT are neither detailed nor accompanied by information on the laboratory or the method used, so it is not possible, to date, to pronounce on their validity. "
A dangerous product in the new formula?
In addition to the under-dosage of the tablets Levothyrox, the AFMT said to have detected the presence of a substance that was not contained in the old substance, "substance that may correspond to dextrothyroxine.There is a form 'L' (Levothyroxine) and a form 'D' '(Dextrothyroxine) different in that they are symmetrical as are the' right hand 'and the' left hand '"
But these two principles do not have the same properties. While the former has therapeutic effects, the latter is potentially dangerous. And was banned in 1998 in the United States for its adverse effects on the liver and heart. "If these results were confirmed", they could explain "serious adverse effects" and "very atypical pictures seen in many patient-victims" worries the AFMT. It states:
"Our badociation does not claim, on a single study, to have indisputable proof but an important new fact because if these results were confirmed, as one might think, they could constitute an explanation rational to this crisis, of always unknown origin. "
And to require an additional badysis …
Thing made in the study of the ANSM of July 6th also observes the rate of dextrothyroxine, which would have been found "in the form of traces" in an amount "of the order of 0.1%". An "expected dose for this type of substance" which "does not in itself represent a defect in quality or a risk to health".
Complaint for conflict of interest
These two conflicting reports could soon be used in court. They intervene while a hundred patients have lodged a complaint for trading in influence, as explained by their lawyer Maître Lefevre on France Info on July 6, 2018. The public prosecutor of Marseille is called to open an investigation into possible conflicts
Argument: Philippe Lechat, a member of the ANSM who signed the request for a new formula of Levothyrox at Merck, is no other than a former member of the laboratory. Me Lefevre observes: "It is discovered that the person who signed the mail, in February 2012, to request the change of formula, worked for the Merck laboratory.It is enough to refer to the public declaration of interest written by the and we see that he worked for Merck for several years, so obviously there's a conflict of interest, that's a question. "
" When the Merck lab gives you its official version, which is to say 'c is a completely independent authority that has given us the green light, we realize that in reality, it is not an authority so independent that it is an elder of the house, if I may say so. "
This complaint is in addition to those already filed for" unintentional injuries "," endangering the lives of others "and" aggravated deception. "
Maïlys Khider
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