Friday, July 26, 2013

Big Pharma’s data sharing principles “weak and filled with loopholes”


Campaigners for greater transparency of clinical trial data for medicines have criticised a set of principles published by the pharma industry aimed at improving access to study information.

Led by pressure group AllTrials, numerous critics have said that the commitments, published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the US' Pharmaceutical Research and Manufacturers of America (PhRMA), go nowhere near far enough in allowing independent researchers to determine if a drug is as effective as its manufacturer claims.

Among the most damning comments were those from AllTrials co-founder Dr Ben Goldacre, who remarked that the principles were “weak and filled with loopholes”, especially with regard to the limited timeframe suggested by the trade bodies.

"EFPIA and PhRMA seem to be suggesting that transparency should only happen for new trials, and reports submitted to regulators after 2014,” said Dr Goldacre.

“This will do nothing to remedy the incomplete evidence that doctors and patients are being forced to use right now, on the medicines we use every day and came to market over the past few decades. Sharing trial information going back for at least two decades is vital.”

Dr Goldacre also criticised the review process proposed by EFPIA and PhRMA, which would require any researcher wanting access to data to submit a research proposal to document the legitimacy of the research question and their own qualifications, and for this to be assessed by a scientific review board established by the relevant company.

"It is... a retrograde step that they suggest only releasing clinical study reports on demand, after a long review process by the company, where they will decide if the applicant is appropriately qualified,” said Dr Goldacre, who gave the example of the Cochrane Collaboration's four-year battle to get access to Roche's Tamiflu data.

"Overall the proposals here are no meaningful alternative to simple, clear transparency on all trials,” concluded Dr Goldacre.

Other groups to be vocal in their concerns included Sense About Science, whose director of campaigns Dr Síle Lane commented that the proposals fall short of the previous commitment from GlaxoSmithKline (GSK) to publish all clinical study reports available since its formation.

“That is genuine progress and an answer to patients who participated in those trials,” she said of GSK's plans. “Today's proposals put EFPIA and PhRMA on the wrong side of history.”

Some groups saw the publication of the principles in a more positive light, however, with Dr Trish Groves, deputy editor of theBritish Medical Journal saying that the move was “an important step along the way to full transparency” even if there was still some way to go.

“This shows we have won a battle, if not the war,” said Dr Groves.

The EFPIA's director general Richard Bergström defended the commitments, claiming they offered a “responsible alternative to other proposals being put forth in the EU”, including plans by the European Medicines Agency (EMA) to make companies release clinical trial data on all newly-approved pharmaceutical drugs.


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