Author: Bruce Charlton
Position: Editor-in-Chief, Medical Hypotheses
Institution: School of Biology, University of Newcastle upon Tyne, UK
E-mail: bruce.charlton@ncl.ac.uk
Submitted Date: July 14, 2005
Published Date: July 14, 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's generally well-argued essay on the indirect use of medical journals for pharmaceutical marketing was all the more impressive in coming from someone who did so much - albeit inadvertently - to create the situation he now deplores.

During his editorship of the BMJ, the journal acted as the major source of positive propaganda for the Evidence-Based Medicine (EBM) movement [2], which firstly popularized the view that large randomized controlled trials (megatrials) were the 'best' evidence concerning therapeutic effectiveness, then later the view that they were the ONLY valid evidence of effectiveness. Yet the intrinsic superiority of the RCT methodology was merely asserted and never demonstrated, for the excellent reason that it is not true [4, 5]. Indeed it is a ludicrous idea that one particular experimental methodology should possess intrinsic superiority over other methodologies.

The dogma of RCTs as the gold standard has led to the present situation in which those who control trials control clinical practice. The consequent abuses and distortions have been thoroughly documented in psychiatry [6,7, 8], although Smith -inadvertently - delayed awareness of this work [7]. 'Ghost' authorship of industry research by respected scientists from prestigious institutions is managed by public relations agencies to optimize pharmaceutical marketing [8].

The present situation is indeed unsustainable. Conflicts of interest must now be assumed as the norm in medical research - especially in the highest impact journals that garner most citations. The response so far (again pioneered by Smith) has been to insist on ever more elaborate declarations of interest, until these have come to resemble a psychotherapeutic confession. Such declarations merely provide false reassurance and delay effective action.

Smith's idea that journals should stop publishing trials seems crazy (especially since the BMJ publishing group, under his leadership, made so much money selling books and journals publishing nothing but trials!). We should first acknowledge that journals cannot hope to police a system of detecting and measuring conflicts of interest in every item of published research, then we can set about developing something effective.

Investigating CoIs is expensive and time-consuming and requires considerable knowledge and skill. This implies the development of 'CoI consultancies' who can develop such expertise [8]. CoI consultancy should be paid for by those agencies and institutions whose job is to implement research. The majority of published research that is never implemented is never investigated - saving money. The sanction would be that those who implemented published research without first investigating CoIs would be guilty of negligence, and legally liable [8].

References
1. Smith R (2005) Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138
2. Charlton BG, Miles A. The rise and fall of EBM. Q J Med 1998;91: 371-4.
3. Charlton BG Mega-trials: methodological issues and implications for clinical effectiveness. Journal of the Royal College of Physicians of London, 1995; 29: 96-100.
4. Charlton BG. Fundamental deficiencies in the megatrial methodology. Current Controlled Trials in Cardiovascular Medicine. 2001; 2: 2-7.
5. Healy D. The creation of psychopharmacology. Harvard University Press: Cambridge, MA, USA. 2002.
6. Healy D. Let them eat Prozac. James Lorimer & Co.: Toronto, 2003.
7. Healy D, Cattell D. Interface between authorship, industry and science in the domain of therapeutics. British Journal of Psychiatry (2003) 183: 22-27
8. Charlton BG. Conflicts of interest in medical science: peer usage, peer review and 'CoI consultancy?' (editorial). Medical Hypotheses. 2004; 63: 181-186.