France’s diabetes drug scandal

Mediator affair a setback for trust in mega medicine, but could Covid-19 be a turning point?

What impact will a drug scandal involving one of France’s biggest medicine companies have upon public attitudes towards pharmaceutical enterprises in the country?

At the end of March, the tribunal correctionnel court in Paris found Laboratoires Servier guilty of “serious deceit” and “involuntary injuries and homicides”.

Servier kept a drug called Mediator – used for thirty years by diabetics to control their weight – on the French market for over ten years despite receiving reports in as early as 1995 of serious heart and lung conditions. These included pulmonary arterial hypertension.

Mediator was eventually pulled from French pharmacy shelves in November 2009.

French judges wrote that Laboratoires Servier “possessed, from 1995, enough details in order to be aware of the life-threatening risks that they posed to patients”.

They added that Servier “continued against all odds the commercialisation of a drug whose benefits were very questionable”.

One 2010 study from France’s drug regulator said that more than 500 patients died after taking Mediator between 1976 and 2009. The study also noted that the medicine was thought to be responsible for as many as 1,750 cases of cardiac surgery.

Another study in The Lancet from 2011 suggests that Mediator could in fact have caused as many as 2000 deaths. For an idea of scale, around 5 million people were given the medicine over 30 years, according to BBC News.

Mediator was never approved in the US and, in 2003, Servier let its Italian and Spanish trading licences for Mediator run out. Irène Frachon, a doctor whose research led eventually to Mediator being banned, suggests that this might have been a strategic decision, in order to avoid drawing attention to the negative side effects.

Servier must now pay €2.7 million in fines and will pay €180 million in damages to victims.

France’s medical regulator, the Agence national de la sécurité du medicament (National Agency for the Safety of Medicines, ANSM), has also found itself in hot water. It must pay a fine of over €300,000 as, according to French judges, the ANSM “has failed in its role as guardian of medicines”.

In fairness, the ANSM did launch an inquiry into Mediator in 1998. But according to the Inspection générale des affaires sociales (General Inspectorate for Social Affairs, IGAS), restrictions should have been put in place in 1999. Why weren’t they?

French public and commercial figures must hope that the scandal won’t dent confidence in pharmaceutical industries at a time when the world’s largest assume critical positions in France’s Covid-19 response.

In a hefty 2,000-page report, judges stated that Servier had “seriously undermined the legitimate confidence of patients and consumers in pharmaceutical companies and in the health system in general”.

A considerable proportion of French people are already sceptical of the role pharmaceutical companies play in French politics and society.

According to Philippe Lamoureux, Director of Les Enterprises du Médicament (LEEM), whilst 73 percent of French people said they trusted medicines in the organisation’s latest “Trust Barometer”, only 37 percent said they trusted the companies making those medicines.

Add to this the vaccine scepticism of many in France, already discussed on this blog. According to a poll carried out in December 2020 by Santé Publique France, only 40% of French people surveyed said they would receive the vaccine.

More reassuringly, a study carried out by Ipsos in February showed that this figure has since risen to 57%. But work remains to be done in order to convince the other 43% of the vaccine’s safety.

That being said, there has been good news for France’s vaccine roll-out, which has recently gained much momentum. The number of vaccines administered in the country has risen over the past few days.

Health Minster Olivier Véran tweeted on Thursday 8th April that 437,000 people had been vaccinated in 24 hours, “the equivalent of an entire département“.

If one thing’s for sure, the Mediator affair won’t help in reassuring French citizens about the activities of pharmaceutical companies. Yet, judging by the recent figures, the level of trust in Covid-19 vaccines is on the rise.

There remains work to be done in order to make the activities of drug enterprises more transparent. But if France gets the next few months of the roll-out right, that could be one step forward towards boosting confidence in mega medicine.

Photo Credit Pexels on Pixabay

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