Mediator (Servier) "bombshell" report by official French inspectors published 15 Jan 2011

On the one hand, prescription drugs contribute to the extension of life expectancy in numerous diseases. On the other, pharmacovigilance or the surveillance of side effects of drugs is imperfect because a) it depends on the central collection of side effect reports, b) a sense of certainty about the specific responsibility of the drug which is not always clear, because patients take multiple drugs and the numbers are low. As a result,  the risk-benefit ratio can be underestimated.  However, on Saturday January 15, 2011, three IGAS inspectors (General Inspectors of Social Affairs) published a 260 page report in French - Téléchargement 33594_mediator-le-rapport-de-ligas - demonstrating a fatal breakdown of the French drug regulatory system over the past decade, as regards the drug Mediator. Mediator can provoke fatal valvulopathies and according to the report, there was not only enough information to take the drug off the market in 1999, the company concealed the true pharmacological profile of the drug since its introduction in 1976. The Mediator report will have far-reaching consequences on the management of "conflict of interest" between physicians and drug authorities, in France, Europe, and most likely the world. What changes will be made to the relationship between the pharma industry and the regulatory authorities, as regards drug registration, post-marketing surveillance, and communication between the industry and physicians? This remains to be seen. 

 

The  active ingredient in Mediator was in fact identical to another compound which  had been withdrawn for this dangerous side effect. But the deliberations about Mediator were regularly kept off of the French drug agency's meeting agenda, because of pressure exercised by the laboratory on those within the agency responsible for that agenda. 

There are two problems here: 

a) conflict of interest of investigators

In the current system, clinical investigators for pharmaceutical research or their departments are paid fees by pharmaceutical companies, either to execute the protocols that lead to the composition of a drug registration file or as advisors to companies on medical questions. These people are then called in as experts on registration and reimbursement decisions because they are considered to have the most experience with the drug. In recent years, "conflict of interest" declarations of the fees, by the experts were introduced and considered to protect the public interest. 

b) the permeability of the regulatory system to external pressure

 

Comments

[John George]

wow ! reminds me of a U.S company that sells ICU products that were invariably causing tracheal stenosis all aournd the world but not in the U.s because it was not reaching U.s safety standards