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New rules to improve drug safety

Matthew Warren · 2 Aug 2011, 08:08

Published: 02 Aug 2011 10:52 GMT+02:00
Updated: 02 Aug 2011 08:08 GMT+02:00

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Health minister Xavier Bertrand yesterday presented a package of measures aimed at tightening up the safety of new prescription drugs following the long-running scandal over the Mediator slimming drug. 


Mediator, originally a drug for overweight people with diabetes, was also prescribed as an appetite suppressant to people wanting to lose weight. Between 1976 and 2009 it was taken by over 5 million people. 

Concerns about side effects emerged in 1999 when a patient in Marseille taking the drug was found to have heart-valve damage. Further heart-related problems emerged and the drug was eventually banned in 2009.

A report by health research body Inserm published in December by newspaper Le Figaro suggested between 1,000 and 2,000 people could have been killed by the drug.

The new measures were presented at Monday's cabinet meeting and will go before parliament in September. Bertrand told radio station RTL on Monday he was proposing "a radical and rapid reform."

The measures include more transparency around conflicts of interest, reorganizing and renaming the French health safety agency and better controls on the launch and withdrawal of new drugs.

"We will not allow a drug to be launched unless it is really offering something new," the minister told RTL. "If there are any undesirable side-effects we won't hesitate to withdraw the medication. That's a big change … but if we are going to learn lessons from Mediator, it is this."

Pharmaceutical companies will also be required to inform public bodies if a drug is withdrawn somewhere else in the world. France was slow to ban Mediator, which was never allowed for sale in the US or UK and was banned in Spain and Italy in 2005. 

Bertrand told newspaper Le Figaro that "pharmaceutical companies must understand that things have changed."

The new rules will force them to make public all benefits they provide to doctors, students and other organizations. Close links between government, health agencies and pharmaceutical companies were criticized during the Mediator affair.

"These measures fit with the announcements made by the minister in recent months," said Gerard Bapt, a Socialist member of parliament heading a committee on Mediator on Monday. However, he regretted a lack of progress "on the creation of group actions" for people affected by this type of issue.


Matthew Warren (news.france@thelocal.com)

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