Medical Scandal Rocks French Regulatory System

PARIS—A medical scandal involving a diabetes drug has raised questions about the rigor of France's regulatory system and has embarrassed politicians from both sides of the political aisle. The drug, benfluorex, was pulled from the market in November 2009 because of severe side effects, particularly a high risk of heart valve problems. The question now emerging is why the compound—which was also widely prescribed as a weight-loss drug—wasn't banned, or even put under increased scrutiny, after a closely related drug was pulled in 1997. One study has suggested that up to 2000 patients may have died from taking the drug.

In an interview today with Le Figaro, French Minister of Labor, Employment and Health Xavier Bertrand acknowledged "serious failures" in France's drug licensing system and said he would strengthen surveillance for side effects after drugs reach the market. Bertrand has ordered the General Inspectorate of Social Affairs, a government agency, to conduct an inquiry. The French Parliament decided to hold its own independent investigation last week.

Benfluorex, produced by French pharmaceutical company Servier, is a member of a family of drugs called fenfluramines that suppress appetite. Marketed primarily as a therapy for diabetics, the compound has long been used as an appetite suppressant for obese patients.

Another member of the fenfluramine group, called dexfenfluramine and marketed by Servier under the name Isomeride, was pulled from the French market in 1997, after a 1996 study in The New England Journal of Medicine showed that it increased the risk of a dangerous condition called primary pulmonary hypertension. Dexfenfluramine was also one of the two ingredients of Fen-phen, a popular diet pill in the United States that was banned in 1997 after reports of primary pulmonary hypertension and heart valve damage. Benfluorex remained on the market in France, even as reports accumulated that it, too, could cause heart problems. Italy and Spain both banned it in 2003.

Now, the pressure is on the French Agency for the Safety of Health Products (AFSSAPS) to explain why it didn't halt the use of benfluorex as a weight-loss drug until 2007 and didn't ban its use altogether until last year. The questions were fueled by a 1998 letter, published by Le Figaro last week, in which three doctors working at health insurance agencies warned AFSSAPS's predecessor against the drug's risk.

Around 500 people have died in the past 30 years after using benfluorex, according to a study by epidemiologist Catherine Hill of the Institute Gustave-Roussy and announced by AFSSAPS on 16 November. But another study based on the same data by researchers at the National Institute for Health and Medical Research (INSERM) put the number at 1000 to 2000. The existence of the second estimate was revealed by Le Figaro last week.

The scandal touches prominent politicians both left and right in the political spectrum. Bertrand, a member of Sarkozy's conservative party, the UMP, is only on his current job since last month but previously was health minister between 2005 and 2007. In 1998, when the three doctors wrote their letter, the secretary of state in charge of health was prominent physician and socialist politician Bernard Kouchner, who until last month was France's foreign minister; his boss in 1998, the minister of employment and solidarity, was Martine Aubry, the current leader of the Socialist Party and a likely presidential candidate in 2012.

*The questions were fueled by a 1998 letter, not a 1996 letter as originally reported.