Tuesday

30th Aug 2016

Resignation at EU drugs agency highlights ethics issues

  • Conflict of interests have to be properly managed to maintain consumers' trust, say consumer groups (Photo: Bart)

A top scientist within the EU agency authorising new drugs resigned on Wednesday (4 April) after being fired from France's national regulator, itself embroiled in scandals over poisonous diabetes drugs and failing breast implants.

Eric Abadie, a French specialist in diabetes and heart-related diseases, had for the past five years been chaired a panel of experts giving scientific advice to the European Medicines Agency on authorising the sale of new drugs on the EU market.

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"I am not aware of any criminal charges made against Dr Abadie," Martin Harvey, a spokesman for the London-based EU agency told this website, adding that his resignation was linked to the other job Abadie was holding as top scientific adviser of France's national medicines regulatory body.

The spokesman explained that "almost all" experts sitting on the EU panel have a similar role at national level. "This does not present a conflict of interests in that it is important that the European and national agencies work together closely," Harvey said.

The French agency meanwhile has come under intense scrutiny for not having withdrawn authorisation for "Mediator", a diabetes drug - Abadie's field of expertise according to his CV - that was already banned in other countries and that is blamed for having killed at least 500 patients in France. Since December, the agency is also being accused of having given a green light to faulty breast implants filled with poisonous industrial silicone made by the now bankrupt French producer PIP.

A spokeswoman for the French agency told this website that Abadie's resignation is due to the fact that his post was scrapped during a 're-organisation' of the agency decided in December - at the peak of the PIP breast implants scandal. She refused to comment on the link between the scandal and Abadie's scientific advice.

"He decided to resign because his position within the EU agency was paid for by the French government and because the director of the EU agency did not give a favourable answer to taking over his salary," she explained.

The EU medicines agency already has come under fire for having turned a blind eye to close links to the pharma industry, with its former director resigning at the end of 2010 to go and work as a consultant for the drug industry only a few days later.

Last month, MEPs in the budgetary control committee refused to sign off the agency's accounts for 2010 over conflict of interest issues.

"The Abadie case is yet another example of the need to have independent experts working only for the EU agency and not for national bodies or other organisations. Conflict of interests are not only an opportunity for the industry to bend rules according to their needs, but can also endanger public safety," Romanian MEP Monica Macovei who drafted the parliament's position on the issue told this website.

Consumer protection groups have also rallied behind her. "We try to encourage these agencies to make an effort and resolve conflicts of interest, which are bad for consumers," said Jonathan La Morte from Beuc, the European umbrella organisation for consumer protection groups.

In a position paper sent to the European Parliament last month, Beuc stressed that the "effective management of conflict of interests are crucial to maintain consumers’ trust in the independence and in the quality of the scientific opinions of EMA and ultimately in the safety of the medicines they use."

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