Diabetes: confirmation of the serious risk has been running the Mediator

Written by Sandeep Nehra

The serious risk has been run Picks, a drug for diabetics who are overweight, have been highlighted on Thursday by a large-scale study by the Health Insurance Fund, while Le Figaro, based on another investigation, spoke to hundreds of deaths.

Marketed in France by the Servier Laboratory from 1975 until November 2009, when it is forbidden by the Agency for Health Products (AFSSAPS), the Mediator (benfluorex) was prescribed to patients with diabetes are overweight.

He was also prescribed to people wanting to lose weight.

The Mediator is similar in composition to another product of Servier, an appetite suppressant, the Isomeride, withdrawn from sale in France in 1997.

“We had signals on the heart valve in 2003, a report in 2006,” said Fabienne Bartoli, Deputy Director General of Afssaps.

To prohibit the marketing in November 2009, Afssaps based on a study on CNAM “benfluorex and valvular heart disease”, published on Thursday in an international scientific journal. It was about 1,048,173 patients with diabetes who had a treatment, of which 43,044 had received benfluorex.

It appears that diabetics treated by the Mediator had three times more likely to suffer from vascular heart disease and four times more likely to have valve surgery than after other treatment.

These figures could be even “higher” according to the CNAM, especially because the follow-up has been only two years.

Given the results of this initial survey, Afssaps requested “in August 2010 another study for the CNAM, says Bartoli,” specify the methodology for assessing the potential impact of the Mediator on serious cases of valvular disease and death.”

“The study should provide a methodology for conducting assessments and providing valuation ranges, but it does not give itself,” she said.

The study should be published by “15 days or one month” and possibly Afssaps will then “forks”.

Based on this study, which he has knowledge, Le Figaro said Thursday that though the Mediator would have caused more than 30 years for death of 500 to 1000 people.

This corresponds to an estimate cited in a thesis presented in June at the University of Rennes. 300,000 people each year have been exposed to the Mediator, which would correspond to “between 150 and 250 hospitalizations each year” and thirty deaths annually or, for more than 30 years of marketing the drug, “between 500 and 1000 deaths.”

Extrapolation “coarse” for Afssaps. Author of a book on this subject published in April (“Mediator 150 mg”-dialogues.fr editions), Irene Frachon, pulmonologist, said however that the figures are probably “lower than the reality.”

Servier laboratory of his side on Thursday rejected the figures “scientifically questionable,” he said.

“The figures given by (Dr.) Irene Frachon and taken up by Le Figaro result of a student work under the direction of Mrs. Frachon. The figures are as written by the student, extrapolation, therefore, scientifically questionable, “says independent laboratory.

Servier has been convicted several times to pay damages for Isomeride, and several cases are on trial for the Mediator. For Servier, the figures in the thesis are “extrapolation, therefore, scientifically questionable.”

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