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Diabetes Pill Deaths Prompt French Drug Regulation Reform

PARIS—Saying he hopes to prevent a repeat of the Médiator scandal, French health minister Xavier Bertrand today unveiled what he described as the most important overhaul to the drug regulation system ever undertaken in the country. Bertrand was referring to benfluorex, a diabetes drug that remained on the market here for 33* years, long after other countries had rejected it or withdrawn it. The medicine is estimated by different studies to have caused 500 to 2000 deaths in France, mainly from heart valve damage. The oral drug, marketed as Médiator by Servier Laboratories, was taken by some 5 million people in France and was often prescribed for weight‑loss until it was withdrawn by France in November 2009 as new research revealed the extent of the heart-valve problem.

The drug regulation reform will focus on preventing conflicts of interest at all levels of the health service from the ministry down, increasing transparency in decision-making on drug approvals, ensuring that all drugs offer real benefits, improving training for health professionals, and providing better information for professionals and the public. Measures will include a French "Sunshine Act," where drug companies will be fined if they don't declare all agreements with outside groups, stricter controls on prescribing drugs for unauthorized uses, changes in drug marketing methods, and a ban on financing of medical students by drug companies. New drugs would be compared with existing ones and not just placebos. The Health Products Safety Agency (AFSSAPS), the regulator which has been harshly criticized in its role in the Médiator affair, will also be renamed the National Agency for the Safety of Medicines (ANSM).

Bertrand says that he expects a draft law will be adopted by the cabinet before the end of July and presented to the parliament in the autumn. The whole package will be reviewed 2 years after coming into force, when "there will be [more] changes of course," says Bertrand. Without waiting for the law, work will begin on reassessing the 19,000 drugs now authorized in France, of which 12,000 are on the market. "Many of them will be dropped," Bertrand predicts. "A drug must show that it is at least as effective as others available if they are to be reimbursed." The French system, he added, must be capable of reacting as fast as the U.S. Food and Drug Administration, citing an example in which the FDA added a contraindication for another diabetes drug, pioglitazone (Actos), 48 hours after it was suspended from the French market.

Although Bertrand acknowledged "serious failures in the functioning of our drug system," he says it was "out of the question" that France and its taxpayers, rather than the drug's manufacturer Servier, would compensate victims. Dominique Maraninchi, who replaced Jean Marimbert as AFSSAPS chief in February, calls Bertrand's reform plan "fantastic" but told ScienceInsider that the newly named agency would need a 20% increase in its €115 million annual budget to implement "the first step."

The Médiator affair has generated a raft of reports into what went wrong, and more are still to come. All have criticized France's present drug system, with greater or lesser virulence, and offered an avalanche of proposals to remedy the situation, many of which are in Bertrand's prescription. "This is a major reform [and comes] only a year after the publication of (pulmonologist) Irène Frachon's book Médiator 150 mg : How many deaths?" said socialist parliamentarian and cardiologist Gérard Bapt, who has been a leading campaigner for change in the drug system and headed the National Assembly's ad hoc committee on the Médiator.

The drug scandal has captivated the media here for months and has raised questions about the French pharmaceutical industry's closeness to politics and the regulators. Almost every week there seems to be a new twist in the saga, including a slew of lawsuits, raids on Servier's offices and the home of founder and owner Jacques Servier. In the end, it will be up to the courts to answer crucial questions, says Jean‑Pierre Door, a member of the National Assembly and a parliamentarian for the ruling UMP party. These include whether benfluorex was actually an amphetamine; why the drug was withdrawn from Italy, Spain, and Switzerland years before France; why 17 alerts of side effects went unheeded; and why the European Medicines Agency itself took no action until December 2009 when it recommended the drugs withdrawal. 

*Correction: The drug was on the market in France for 33 years, not 35, as originally stated.