Author: Trevor Sheldon
Position: Professor
Institution: Department of Health Sciences, University of York
E-mail: tas5@york.ac.uk
Submitted Date: May 28, 2005
Published Date: May 30, 2005
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Richard Smith has correctly highlighted the potential distortion of the evidence base caused by the publications of commercially sponsored trials(1). However, his proposed solution could do with more thought.

Firstly, let us be clear that the problem possibly much wider than drug company trials. There is the risk of systematic bias in reports of any research funded by a body which has an interest in the results. This 'sponsor-induced-bias' has been well documented in the area of tobacco company funded research on the effects of direct and indirect smoking (2). In addition, governments, charities with an interest in a disease and other bodies may also help to ensure that results of research they sponsor (including trials) or the reporting of the research favours one particular outcome. Lastly, individuals who carry out research even if not funded by an interest group, may also bring to the table their prejudices so influencing the results and the published report. In other words the tendency to bias is omnipresent. The issue of commercially funded trials is simply one of degree and the influence trials have on clinical practice and health care spending. Following Smiths thinking to its logical conclusion, we would not publish any research and simply critiques.

Smith proposes that instead of publishing trials, journals should journals could concentrate on critically describing them. If he is not confident that the current system of peer review is sufficiently robust to identify weaknesses, then why should he be any more confident in the critiquing process (which is a form of peer review)? Journal peer review is often ad hoc (especially when my work is rejected) and is in desperate need of professionalizing, but I suspect along with Smith I suspect this is not sufficient protection.

Surely the way to deal with the systematic risk of bias is a reform, not in the publication, but in the production of evidence, which in turn reflects the way it is funded, conducted, analysed and reported. My alternative solution in the case of trials is as follows. Companies (or indeed any body with a particular interest) should not be allowed to directly fund a clinical trial and no journal should publish a company sponsored trial. Instead industry should pay a public/independent trials body, staffed by the best methodologists around, possibly established on an international scale. This international infrastructure should be publicly funded so that its staff do not feel dependent on industry business for security. The body should, in conjunction with clinical experts from around the world, conduct the study, ensuring that the questions are in the public interest and fair (consumers would have an important role to play here). They would ensure that the research was of the highest standard and reported accurately. Once the funding had been agreed then there would be a compulsion to register the trial and to publish no matter what the results. This body would also have the ability to carry out or commission economic modelling (which is even more susceptible than trials to sponsor-induced-bias)(3). The resulting data would be held in a publicly accessible data archive. We should have an international agreement that no phase III trials would be permitted other than through this route.

Whilst a rather bureaucratic response, it would ensure that the evidence base was less contaminated. Drug companies might even find that such a social solution results in trials being cheaper and easier to run.

References

1. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PloS Medicine 2005;2(5):e138.

2. Bero LA. Tobacco industry manipulation of research. Public Health Rep. 2005;120(2):200-8.

3. Sheldon TA. Problems of using modelling in the economic evaluation of health care. Health Economics 1996;5:1-11.