The pharmaceutical industry is trying to 'mobilise' patient groups into lobbying against EU plans that will force companies to publish data from their clinical trials, according to an e-mail seen by a British newspaper.
In the e-mail, two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), outline a memo to senior industry figures.
The strategy appears to be a four-pronged campaign that starts with "mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data". It says patient groups should fight for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted, for example by the media, and cause a health scare.
The memo was sent this month from Richard Bergström, director general of EFPIA, to directors and legal counsel at corporations such as Roche, MSD, Pfizer, GSK, AstraZeneca, Eli Lilly and Novartis, but also smaller companies. It was leaked by a drugs company employee to Britain's daily The Guardian.
The lobbying is targeted at Europe where regulators are considering an update to the Clinical Trials Directive that could force pharmaceutical companies to publish all of the clinical study reports that they have filed.
In May, lawmakers in the European Parliament amended the draft text to improve transparency, by requiring that detailed summaries be published in a publicly accessible EU database, with full clinical study reports published once a decision on authorisation is complete.
Lobbying from patient groups
Tim Reed, from the non-profit group Health Action International, said patient groups are assumed to represent the voice of the suffering.
"But industry uses them to say we're not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials," Reed told The Guardian.
A source close to the negotiations over the Clinical Trials Directive in the Parliament told the British newspaper that he had experienced intense lobbying from patient groups.
"We've witnessed this sort of activity in recent months, and it's a concern if the pharmaceutical industry is behind some of it. They are trying to weaken some of the transparency proposals and that's clear from the amount of lobbying we've had," he said.
The source mentioned that although the patient groups raise concern over the fact that information can be misinterpreted and lead to damaging health scares concerning certain vaccines or drugs, which is a plausible reason, that risk already exists.
"The answer is to have a responsible scientific community that can counteract the allegations and claims," the source said.