EFPIA urges industry to oppose clinical trial transparency

Three_wise_monkeys_figure Pharmaceutical companies have been urged by the European and US industry trade associations to fight proposals for improved clinical trial data transparency.

The strategy, outlined in a memo from EFPIA to senior industry figures, recommends using industry-funded patient groups as sock puppets.

GSK, which has led industry movements towards greater transparency, has distanced itself from the pro-secrecy initiative.

A recent review, which caused widespread concern, estimated that only half of drug trial results are published, and ‘positive’ trial results are twice as likely to be published as ‘negative’ ones.

The European Medicines Agency intends to publish all clinical trial reports sent to it for drug licensing purposes – but US pharma company AbbVie is suing them to protect its ‘confidential’ information.

The Cochrane Collaboration, NICE and other organisations representing expert clinical opinion support the call for greater transparency.

However, EFPIA and PhRMA – the trade associations representing the pharma industry in Europe and the US – have prepared a strategy to help companies keep their trial data secret.

The memo, written by Richard Bergström, EFPIA’s Director General, and sent to the directors of leading US and European pharma companies, recommends “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data.”

It also suggests working with other industries to build a legal case for protection of clinical trial data as ‘commercially confidential’, and working with scientific associations to protect trial data as ‘intellectual property’.

Tim Reed of pressure group Health Action International commented: “The patient groups will say they think it’s a great idea to keep clinical trials data secret. Why would they do that? They would do that because they are fronts for the pharmaceutical industry.”

A GSK spokesperson said the company rejects EFPIA’s anti-transparency initiative: “This is not something we are doing. We want more companies to move towards greater transparency. I don’t think it’s for us to be mobilising patient groups to campaign on a negative level.”

Tracey Brown, Director of the campaign group Sense about Science, said: “We now have the prospect of really significant developments to end the secrecy and make clinical trial reporting a practical reality and, finally, some sound commitments from parts of industry.

“In this context, the industry associations’ strategy to get others to raise further spurious problems is backward. It should embarrass anyone associated with it.”