US drug markers respond to clinical trial claims
that negative trial results on their products have been buried has
prompted the US industry to set out its own code of practice.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has adopted voluntary guidelines on both the conduct of trials and the communication of the results.
Spitzer recently initiated a lawsuit against GSK for allegedly covering up negative studies about the effect of the antidepressant Seroxat/Paxil (paroxetine) on children. And Forest itself has been the subject of a separate investigation by the Food and Drug Administration (FDA) for not publishing data from clinical trials of its antidepressant drug Cipramil/Celexa (citalopram).
Last month, GSK responded to the lawsuit by publishing results of trials on its website showing the drug is broadly ineffective in children and adolescents and could increase risks of suicidal behaviour. GSK has always denied the allegations, saying it has already publicised the results, either in medical journals or at scientific meetings.
The PhRMA said that with the new set of principles, its member companies "commit to the timely communication of all meaningful results of clinical trials, whether those results are positive or negative. Further, the results are always to be communicated in an objective, accurate, balanced and complete manner."
In addition to setting out the importance of adhering to Good Clinical Practice, the principles emphasise that the independence of clinical investigators must be respected, which ties in with allegations that drug companies use financial incentives to keep clinicians in line. The code specifically prohibits the giving of stock in the sponsor company as a payment for services, and these much be 'reasonable and based on their work', according to the PhRMA.
This follows in the wake of an announcement by the US National Institutes of Health (NIH) director Elias Zerhouni of a crackdown on federal scientists deemed to have contravened rules relating to financial relationships with drug companies.
Other key elements in the guidance is that study sponsors will not suppress or veto publications, investigators who participate in the conduct of a multi-site clinical trial will be able to review relevant statistical tables, figures, and reports for the entire study, and that only those who make 'substantial contributions' to a publication should receive acknowledgement as an author or contributor.
The PhRMA said the code of practice applied to any trial started after 1 October 2002.
