A campaign led by British “science” journalist and academic Dr Ben Goldacre to make pharmaceutical companies publish their research data is poised to lead to less effective transparency rather than more as a result of draft regulations by the European Medicines Agency which are likely to have implications for global practice. The problem has been highlighted in Plos-Online guest blog by Trudo Lemmens, associate professor and Scholl Chair in Health Law and Policy at the Faculties of Law and Medicine of the University of Toronto as well as in the blog of whistleblowing psychiatrist Prof David Healy.
The terms of publication as things stand will likely lead to pharmaceutical companies having even more control over their data than before. Goldacre has been raising funds for the campaign ‘All Trials’ with the politically suspect “science” lobby organization, Sense About Science, whose Managing Director is Tracey Brown . He is also supported by the British Medical Journal who have long identified partnerships with GSK and Merck.
In his challenge Healy highlights to Goldacre the problem of a scheme which already seems to be meeting with warm endorsement from GSK citing a Lancet editorial jointly written by GSK executive Patrick Vaillance and leading academic patron of ‘All Trials’ Sir Iain Chalmers in which patient confidentiality could become a screen for not making available adverse data.
“On the first point, we have Iain Chalmers and Patrick Vaillance’s editorial making the case for restrictions on access to the data on the basis of patient confidentiality issues. This seems to be endorsed by Tracey Brown in her comments just above. Is there a difference here Ben between you and them?
“There may be distinctions between All Trials and Iain Chalmers and Sense about Science so that it may be possible to claim that AllTrials has said nothing of the sort because its mission statement says almost nothing. As a counter to criticism Tracey and Ben seem to fallback on an AllTrials minimalism. I’m with Mickey Nardo on this one. A strategy of just calling for trial registration and CSRs and not insisting on access to all trial data right now is morally wrong and likely to fail. [AoA emphasis]
“I think it was a terrible symbol to have BG and BMJ welcoming GSK’s offer of transparency. It was very clear from the time this offer was made that it was likely to be a marketing move primarily aimed at diverting attention from the many scandals GSK were involved in then and continue to be involved in and having AllTrials endorsement was the icing on the cake. Mistake or not?”
Readers of Age of Autism will not necessarily be astonished by Goldacre’s apparently ambiguous involvement in this matter (here and here). Pharmaceutical companies are not philanthropic organizations and they do not have a trustworthy history.
Further comment on CHS ‘EU Draft Safety Law a Disaster’
John Stone is UK Editor for Age of Autism.