Leaked memo from the EFPIA and PhRMA on clinical trial data transparency raises concerns

July 23 2013 | By Márcio Barra

A leaked memo from the European Federation of Pharmaceutical Industry Associations (EFPIA)  sent to The Guardian suggests that EFPIA and Pharmaceutical Research and Manufacturers of America (PhMRA)  are planning to lobby against EMA’s clinical trial data access policies, by getting patient groups and associations to speak up against the risk posed by the EMA’s plan to force companies to publish all clinical study reports for their drugs.

This comes a month after EMA released for consultation a draft policy on access and transparency of clinical-trial data. This draft details three levels of access according to the type of data, alongside rules for publication and use, and comes into effect 1 January 2014.

The Guardian reports that the memo was leaked by an unknown employer of an unnamed pharma company, and came from Richard Bergström, director general of EFPIA. The memo was sent to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Lilly, Novartis and many other smaller companies.

In the memo, a four step campaign is described. The first  starts by “mobilizing patient groups to express concern about the risk to public health by non-scientific re-use of data”. The memo then states that “some who oppose full disclosure of data fear that publishing the information could reveal trade secrets, put patient privacy at risk, and be distorted by scientists’ own conflicts of interest. While many of the concerns are valid, critics say they can be addressed, and that openness is far more important for patient safety”.

The second step of the campaign includes a discussion with scientific associations regarding the risks of data sharing, and the third concerns debating with other businesses that are concerned with releasing confidential data. The final step proposes the creation of a network of academics across Europe that can be called on to correct false interpretations of clinical trial data, one of the concerns of the Pharmaceutical industry, as evidenced by declarations of the EFPIA last year: “There is a potential for significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way,” said the European trade body for the pharma industry in a statement.

Patient associations have already reacted to this news. Speaking to PharmaTimes World News , Lynsey Roberts, press officer at the Alzheimer’s Society in the UK states that “we have not been approached by these companies as far as I am aware”, and that the society has signed up in the AllTrials campaign.

Brussels-based European Patients’ Forum replied to The Guardian’s article by saying that “we denounce the accusation that ‘an army of patients groups are being mobilised by pharma to lobby against plans to force companies to publish secret documents on drugs trials’.” And further states that “on the contrary, EPF and our members, representing the interests of over 150 million patients with chronic diseases, have consistently called for the publication of all results of all clinical trials, be they industry or publicly funded, in a timely manner, regardless of the outcomes”.

In a statement released by the Alltrials campaign website, the European Aids Treatment Group declared  “We believe that patients do a great service, willingly participating in clinical trials for the benefit of medical science and the greater good. (Sometimes of course for their own good too!) It is a travesty of justice that this data is then considered to be ‘private.’ It should be in the public arena for all to see – easy to access and free for all.”

GSK, which was one of the companies who allegedly received the memo, has already distanced itself from using patient groups to speak up against the release of data. In declarations to PMLiVE, a GSK spokesperson stated that “As a company we are absolutely committed to sharing clinical trial data and we don’t support this approach,” GlaxoSmithKline has become the first major drug company to commit to publish clinical trial data. In February 2013, GSK announced it will start publishing the CSRs for all their approved medicines, dating back to the formation of the company in 2000.

For more on the transparency debate, please check this small article and the AllTrialls campaign website


The Guardian

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