As new guidance on the standards required for communicating company-sponsored medical research is published, today on bmj.com two experts debate whether drug firms carrying out clinical trials on their own medicines creates an unacceptable conflict of interest.

Vincent Lawton, a healthcare consultant and non-executive director at the UK Medicines and Healthcare products Regulatory Agency (MHRA), argues that having invested billions of pounds in medicine development, it is unrealistic to expect the drug industry to “surrender its intellectual property.” He adds that taking away research from pharmaceutical companies will lead to delays, inefficiency and a lack of innovation.

Doctor and writer Ben Goldacre disagrees, arguing that “it is hard to see any justification” for allowing the current situation to continue._ Increasing evidence points to a conflict of interest for the drug industry which “results in bad evidence, which distorts medical decision-making and harms patients,” says Dr Goldacre. One of the problems is that the industry can choose which data to publish and which to leave unavailable, he adds, pointing to the difficulties in getting clear information about the number of suicide attempts in industry trials of selective serotonin reuptake inhibitor (SSRI) antidepressants or the number of heart attacks in individuals taking Merck’s anti-inflammatory drug Vioxx (rofecoxib)

The current situation, Dr Goldacre concludes, “is dangerous and absurd.” Doctors who are making treatment decisions “need access to good-quality trial data, presented transparently, and all of it, not just the positive findings that drug companies choose to share,”__he says.

However, Prof Lawton believes that it is acceptable for the drug industry to make a profit and still undertake rigorous clinical trials that stand up to regulatory scrutiny. He points out that, in January 2005, the industry made a commitment to increase the transparency of clinical trials by registering its trials in central, publicly- accessible databases, and that most major companies also publish trial results, whether positive or negative, on their own websites.

It is unlikely that publicly-sponsored academics would have the infrastructure to conduct all clinical trials on all new medicines leading to regulatory approval, he concludes.

Dr Goldacre and Prof Lawton faced each other on the same issue recently as opposing speakers at PharmaTimes’s Great Oxford Debate in September, when Dr Goldacre told drugmakers that, by withholding or distorting data, “you shoot yourself in the foot, you undermine your own credibility and mine as a doctor.”

Prof Lawton reminded the Debate that pharma is the world’s most regulated industry and that there are now unprecedented controls on clinical trials. Any interference with the right of industry to conduct its own clinical trials is “at your peril,” he warned.

Meantime, an accompanying paper also published on bmj.com today sets out new guidance for communicating company-sponsored medical research. Written by the International Society for Medical Publication Professionals (ISMPP), the good publication practice (GPP2) guidelines have been updated in response to changes in the environment in which authors, presenters and other contributors work together to communicate medical research. They include guidance on defining the roles of authors, sponsors, and other contributors, recommendations about reimbursement, and confirmation of the role of professional medical writers, and apply to peer-reviewed journal articles and presentations at scientific conferences. __

Lead author Chris Graf says the guidelines “make recommendations that will help individuals and organisations maintain ethical practices and comply with current requirements when they contribute to the communication of medical research sponsored by companies.”__