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Leaked EFPIA memo reveals transparency strategy

Includes plans to use patient groups to support campaign against greater access to trial data

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A leaked memo from pharma trade bodies in US and Europe reveals an industry-wide strategy to lobby against plans to improve access to trial data.

The memo, first reported in UK newspaper the Guardian, includes plans for pharma companies to engage patient groups to support efforts to warn of the risk posed by the European Medicines Agency's (EMA) plans to force companies to publish all clinical study reports for their drugs.

Specifically, the memo, which was drawn up by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) and sent to member companies, suggests "mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data".

This is the first part of a four-pronged campaign outlined in the memo, according to the Guardian, with the other aspects to it including discussions with scientific associations about the risks of data sharing and working with companies in other industries that could have concerns about the sharing of confidential data.

The memo, which is signed by EFPIA's director general Richard Bergström, also calls for a network of academics across Europe that can be called on to correct false interpretations of the data – a concern noted previously by EFPIA.

It's the proposed use of patient groups to support an industry campaign that seems to have generated the most controversy, however, with high profile transparency campaigner Dr Ben Goldacre commenting to PMLiVE that this was an "extraordinary episode".

"Several individual companies have been claiming in public that they support transparency, and expecting plaudits for such claims," said Dr Goldacre.

"But in reality, they are members of EFPIA, who have actively lobbied in the opposite direction, and supported InterMune and AbbVie in suing the EMA to prevent them releasing clinical study reports. Now we discover they are also associated with this rather seedy effort to 'mobilise patient groups'."

Tracey Brown from Sense About Science, a co-founder of the transparency campaign AllTrials, also criticised the memo's instructions.

“In this context, the industry associations' strategy to get others to raise further spurious problems is backward,” she said. “It should embarrass anyone associated with it. I would say to the individual companies that they should publicly distance themselves from any association with EFPIA and PhRMA's strategy now.”

One company sent the memo that has already distanced itself from using patient groups in this way is GSK, which has previously announced its intention to publish all trial data.

“As a company we are absolutely committed to sharing clinical trial data and we don't support this approach,” a GSK spokesperson told PMLiVE, while also noting that GSK has signed up to AllTrials and has launched a new system to give researchers access to the patient level data.

“Taken together we believe these steps will further scientific understanding and will benefit public health,” said the spokesperson.

Other companies quoted in the Guardian article include Roche, which has been at the epicentre of much of the transparency debate following the controversy surrounding its decision to withhold data for its Tamiflu drug.

“[T]o our knowledge Roche has not been involved in any EFPIA's potential activity in mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data," a spokesperson told the Guardian.

At the time of publication, the EFPIA had yet to respond to a request to comment from PMLiVE.

22nd July 2013

From: Research, Regulatory



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