Friday, October 04, 2013

EMA told: conflict of interest is "a threat to patient health"


There is “overwhelming evidence" that any conflict of interest in the scientific review progress “is a threat to patient health,” the European Medicines Agency has been told.

Therefore, the Agency should rely on internal staff and experts with no links to industry to deliver scientific assessments, Pierre Chirac, editor of the French Revue Prescrire, has told a workshop organised by the EMA to discuss its policy on conflicts of interests for experts.

“Scientists cannot be independent from the sponsor if they are under pressure to publish or perish,” said Mr Chirac.

The EMA currently has around 5,400 experts on its database, yet many of them are restricted as to their level of involvement in agency activities because of declared conflicts of interest related to their involvement with the pharmaceutical industry.

The workshop was held to discuss how the Agency can achieve the right balance between ensuring the impartiality and independence of experts and securing the best possible scientific expertise when delivering assessments.

Martin Pigeon, a researcher with the Corporate Europe Observatory, said the fact that it is more difficult to find independent experts “is a consequence of a long-term industry influence strategy to prevent those experts from being used against their employers.”

Serge Bakchine, chair of the EMA Scientific Advisory Group (SAG) on Neurology, suggested that national agencies or even EMA should look at sponsoring experts to attend scientific conferences and congresses, many of which are sponsored by industry. Doing so would not only avoid the issue of links with industry, it would also give EMA access to well-informed experts, he said.

Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), called for greater use of expert witnesses.

“That way we could bring in the people who have worked on a product from the beginning. Yes, they will be biased – it’s his/her baby – but the fathers and mothers of products deserve to be listened to. They will add knowledge to the process. Then they simply leave and a decision can be made,” he said.

Martin Pigeon agreed. “Scientists with conflicting interests whose contribution is seen as indispensable for scarcity reasons should be called as expert witnesses – after all, they have no decision-making powers,” he said.

The proposals put forward in the workshop will be put to the EMA Management Board at its meeting in December.

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