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Scandal swirling around a former diabetes drug has upended medical regulation in France, with the country's health minister promising tough new reforms.
The drug in question, Mediator, may have killed some 500 people over more than three decades, according to a report from the French government published last month. Families of those involved have filed suit against the drug's maker, Servier Laboratories, and Jacques Servier, its 88-year-old founder and head.
The drug in question is "a powerful appetite suppressant," the government report says, but that's not what the pharmaceutical company wanted to market. Instead, Servier Laboratories decided to sell Mediator as a diabetes drug. According to the government, Servier actually tried to change the name of Mediator's active molecule to de-emphasize its weight-loss effects.
The government's health minister, Xavier Bertrand, said responsibility for the hundreds of deaths rests on the drug company's shoulders, which had "first and direct responsibility." But the report also faults the government's drug licensing agency--France's equivalent of the Food and Drug Administration.
Even though medical officials had ruled that Mediator wasn't suitable as a treatment for diabetes, the licensing agency, known as Afssaps, allowed it to be marketed as such for another 10 years. Although similar drugs were withdrawn from the market in other countries, Mediator wasn't taken off French pharmacy shelves until 2009.
Bertrand said that changes are coming to the licensing agency, which "failed in its mission."
The government will pay for Afssaps operations instead of drug companies, he said. (Industry previously covered about 80 percent of those expenses.) The approval process for new drugs will be strengthened. Finally, 76 drugs on a government watch list will be checked quickly to ensure that they're safe and effective. "We must go the whole way now," Bertrand said in an interview with Europe 1 radio.
For its part, Servier Laboratories said it hadn't been consulted on the damning report. "There was no right of response," it said in a statement, adding later that the results "do not appear to conform to reality."
0 comments - Mar 1, 2011