Merck sentenced on appeal in France
An analysis of the new Levothyrox formula, commissioned by the French Association of Thyroid Patients (AFMT https://goo.gl/FYUo5i), highlights an underdose of the main molecule and the presence of another molecule, not present in the list of components, which is prohibited in the United States, in addition to metal nanoparticles.
The French Association of Thyroid Patients (AFMT) announced Thursday, June 14, after conducting an analysis at a foreign laboratory on the new Levothyrox formula, with which many patients claim to suffer from side effects. This research reveals that this formula contains less levothyroxine than the current specifications, which could explain the dysfunctions caused by the treatment. The statements of the French Association are alarming:
"Some cancer patients have an underdose of thyroid hormones, therefore we have observed cases of relapse after years"
The second element of this study is the presence, in the treatment, of DESTROTIROXINA, which does not appear, according to the association, in the list of components. This synthetic substance, not marketed in France, has been withdrawn from sale in the United States due to side effects similar to those described today by thyroid patients, such as cramps, headache, dizziness and hair loss.
The results sent to an investigating judge
The results of this study were forwarded to the examining magistrate of the Marseille health unit in charge of the case, opened for "aggravated deception, involuntary injury and danger to others". AFMT, stating that "" health security does not allow waiting for the outcome of criminal investigations "(Precautionary principle), invites the National Medicines Agency to carry out a study on a significant number of samples of the old and new formulation, from independent laboratories.
Always the AFMT Association:
"At this stage, our association does not claim, in a single study, to have unquestionable evidence, but an important new fact, because if these results were confirmed, as one might think, they could constitute a rational explanation for this crisis, of origin still unknown "
"In France, no laboratory wanted to conduct these analyzes for fear of industry reprisals"
The French Association of Thyroid Patients had difficulty finding a laboratory in France to conduct these tests on this drug marketed by the Merck laboratory. We as Corvelva can attest to the difficulty we are finding in finding laboratories for our analyzes and the months to find those currently used.
The tests were done by a serious American laboratory, certified by the United States health institution. In France, it was very difficult to find laboratories that agreed to do analyzes for an association of patients. They feared commercial reprisals from the pharmaceutical industry.
The association admits that this is not an indisputable proof. The laboratory does not claim that it is confirmed that it is dextrothyroxine (note: the synthetic substance, not marketed in France), but says it is likely. Further analysis would be needed to prove it, but unfortunately, the association has exhausted its funds, as living without subsidies, public funding, nor having its own laboratories, it cannot conduct other analyzes.
What does Merck say?
Merck points out that many analyzes have already been performed by the competent authorities without identifying the slightest non-compliance of their product. Valérie Leto, Merck's pharmaceutical manager says the following:
"We officially deny the presence of the right-handed form in Levothyrox tablets, whether it is the old or the new formula ... As for the presence of a different form of levothyroxine in the new Levothyrox formula (form D-T4 right-handed), we formally state which is not so. Recall that the active ingredient used for the new formula of Levothyrox is completely identical to that present in the old formula of Levothyrox (Levogyric form so-called molecular form L-T4) "
Merck forgets to mention that recently she was sentenced on appeal to supply the old Levothyrox formula to 25 plaintiffs in Haute-Garonne.
The German pharmaceutical industry giant was sentenced to supply the old Levothyrox formula to 25 plaintiffs from Haute-Garonne. It is a decision of the Toulouse court of appeal, which thus confirms all the provisions of the order issued in November 2017 by the Grand Instance court. In fact, Merck had made an unnecessary appeal, and one was foreseen together with the obligation penalty of 10.000 euros per day if the old formulation had not been provided.
What does the Ministry of Health say?
The Directorate-General for Health indicates that an analysis was carried out in January in which they were found "traces of metals in all drugs" a levothyroxine base, "including Euthyrox", the old formula of levothyrox. It guarantees that "the presence of traces of metal in health products does not in itself represent a quality defect or risk for the health" because concentrations are below the safety thresholds.
For the moment, the ANSM (French Agency for the Safety of Healthcare Products) will not communicate anything else on the subject and would not like to comment. "a study that has not seen" and remember "that an epidemiological study is underway and that justice will run its course". On the other hand, Merk's laboratory declares that AFMT's claim is "scientifically unfounded".