Transparency has returned to the spotlight as a leaked memo sent to The Guardian suggests that pharma trade associations on both sides of the Atlantic are getting patient groups to speak up against publishing raw data.
The newspaper says the memo was leaked by an employee at an unnamed drugmaker and was drawn up by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The Guardian, which has seen the memo, says it comes from Richard Bergstrom, director general of EFPIA, and has been sent to the association's members.
The email speaks of 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". The newspaper quotes the memo as stating 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".
Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of confidential data. The final prong calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data.
A the time of going to press this morning, EFPIA said it would get back to PharmaTimes World News to comment on The Guardian report.
The push for wholesale transparency of clinical-trial data has been particularly strong in the UK, notably through the AllTrials campaign. The European Medicines Agency has consistently stated its commitment to the proactive publication of data once a drug has completed the marketing authorisation process. However, earlier this year was ordered by the General Court of the European Union not to provide documents yet as companies including AbbVie and InterMune have taken legal action to prevent the agency from publishing what they regard as confidential and commercially-sensitive information.
Matt Bennett, senior vice president of PhRMA, said in a statement sent to The Guardian that "EMA's proposed policies on clinical trial information raise numerous concerns for patients. We believe it is important to engage with all stakeholders in the clinical trial ecosystem, including the patients who volunteer to participate in clinical trials, about the issue. If enacted, the proposals could risk patient privacy, lead to fewer clinical trials, and result in fewer new medicines to meet patient needs and improve health".
Commenting on Twitter, AllTrails campaigner and author of Bad Pharma, Ben Goldacre, wrote that "I hope patient groups with integrity will stand up and discuss how industry is trying to 'mobilise' them".
