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. 


 

"/> 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. 


 

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XAVIER BERTRAND

New rules to improve drug safety

 

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Pharmaceutical companies will also be required to inform public bodies if a drug is withdrawn somewhere else in the world.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.

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HEALTH

Weight loss drug killed at least 1,300: study

Mediator, a drug licensed for use by diabetics that became widely prescribed in France as a slimming aid, "probably" caused at least 1,300 deaths before it was withdrawn, a study published on Thursday said.

Mahmoud Zureik of the National Institute of Health and Medical Research (Inserm), who co-led the probe, told AFP that around 3,100 people had required hospitalisation during the 33 years during which the drug was sold.

However, these figures could well be an “underestimate,” he said.

The study, appearing in the specialised journal Pharmacoepidemiology & Drug Safety, finetunes an estimate by Zureik in 2010 that the death toll from the scandal was between 1,000 and 2,000.

Mediator, known by its lab name as benfluorex, was initially licensed to reduce levels of fatty proteins called lipids, with the claim that it helped diabetics control their level of blood sugar.

But it also suppressed appetite, which meant it gained a secondary official use to help obese diabetics lose weight.

In fact, it was widely sold on prescription for non-diabetics wanting to slim.

In 2009, Mediator was pulled from the European market amid evidence that it damaged heart valves and caused pulmonary hypertension.

Its French manufacturer, Servier, is being probed on suspicion of dishonest practices and deception.

The new study is an extrapolation based on figures for deaths from faulty heart valves, although not from hypertension, among major users of the drug.

The main data comes from France’s national health insurance system, which said that 303,000 patients used Mediator in 2006.

According to Mediator, 145 million packets of Mediator were sold on the French market before the drug was pulled.

The Mediator case came to light after a scandal involving a similar type of anti-obesity drug, fenfluramine, in the late 1990s.

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