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France's health minister promised to accelerate safety checks on dozens of medicines and shake up drug authorisation procedures after a damning report about a pill suspected of killing more than 500 people.
State inspectors said a weight-control pill, mediator, at the centre of France's biggest public health scandal in years should have been pulled a decade before it was withdrawn from the market in late 2009.
"No more waiting around," Health Minister Xavier Bertrand said as he detailed plans to ensure that the public agency in charge of safety and marketing permits is less dependent on a cash-rich pharmaceuticals industry for expertise.
He said that agency, Afssaps, would be asked to accelerate checks on 76 other products that are on a watch list and report back within 15 days. Bertrand also announced steps to beef up the agency and drug-vetting procedures more generally.
The state inspectors handed the government a report in which they faulted the firm that made the Mediator drug as well as shortcomings at Afssaps, whose head said a few days ago that he would quit over the issue.
500 deaths
The pill, made by French company Servier, was sold to around 5 million diabetics and dieters between 1976 and its withdrawal in November 2009, years after it was pulled in Spain and Italy.
It was withdrawn after official estimates that at least 500 people died due to exposure to its active ingredient, a molecule called benfluorex.
Servier says the estimates do not reflect historical safety reports and stuck to that line when the report came out, but it has said it is willing to look into the matter with the authorities.
Bertrand said France needed to move to a more transparent system where drug safety approval deliberations were recorded, debates published and public hearings organised when needed.
He said the agency should be ensured of sufficient state funds to reduce its reliance on an industry it is supposed to oversee and that all medical experts would be obliged as a matter of course to declare any links to drug firms.
"We must go the whole way now," he told Europe 1 radio.
Doubts about Mediator's efficacy emerged in the late 1990s, shortly after another diet drug, made by the same company and based on a related molecule, was banned on safety grounds, primarily heart valve trouble.
Servier, which made sales of 3.7 billion euros (about R33.6 billion) in its last financial year, is run by founder Jacques Servier, 88, who was awarded France's national merit medal, the Legion d'Honneur, by President Nicolas Sarkozy less than a year before the drug was pulled.
The Mediator scandal has confronted Sarkozy's center-right government with what is arguably the worst medical treatment scandal since former prime minister Laurent Fabius was tried, and acquitted, over the administration of AIDS-tainted blood to hemophiliac transfusion patients in the 1990s.
(Reuters Health, Brian Love, January 2011)
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