Clinical trials paid for by drug companies are widely seen as being untrustworthy because of the hiding of data, spinning of results and all the other dark arts described in books such as Pharmageddon. So much so, that there is now something of a PR offensive underway to reassure everyone that all is well. But not everyone is convinced.
In the States the prestigious Mayo Clinic has just put out a report that begins by acknowledging a “persistent and perceived credibility gap in reporting industry sponsored research”. To deal with it the clinic hosted a “unique round table” which came up with 10 recommendations to close the gap, while claiming that there had already been “important improvements”.
The recommendations included such things as ensuring that clinical studies address clinically important questions, making public all results including negative ones and exhibiting zero tolerance for practises such as ghost writing. All worthy but since complaints about these have been going on for years was a bit like a drunk promising they really, really were going to stop this time.
The medical profession in the UK however feels no need for a long spoon when supping with the industry. New guidelines published last month urged doctors not to be “tempted to accept negative myths about co-operating with industry” according to a BMJ report.
The guidelines put out by the Ethical Standards in Health and Life Sciences are supported by senior medical bodies such as the BMA, the Academy of Medical Royal Colleges and the Department of Health.
The industry was responsible for 92 per cent of research and drug development in 2009 but, claimed the guidelines, this should not cause any problems. “Undertaken appropriately, working with industry will not harm objectivity of clinical decision-making and should not be perceived negatively.” A spokesperson talked about the “benefits of working together in an open and transparent manner.”
But not all doctors were convinced. A follow up letter in the journal points out that the whole project was co-ordinated and supported by the Association of the British Pharmaceutical Industry (ABPI) . “This took some sleuthing,” say the authors “as neither the group’s membership nor its funding is declared in the guidelines nor on the ABPI website.” They add sardonically: “So much for transparency.” The lead author is a professor of clinical ethics, Wendy Rogers, at Macquarie University, Sydney
The letter went on seriously to challenge the core principles of the guidelines. The claims about benefits of collaboration were “unsubstantiated”; lots of evidence showed doctors and others could not manage their relationships with industry without “without compromising clinical decision making” and finally there was “no indication that the authors of the guidelines understand the complexity and seriousness of conflicts of interest.”