Concern over influence of pharmaceutical industry on medical research

September 09, 2001

N.B Please note that the embargo for this press release if you are outside North America is 0001 Hours UK Time Monday 10th September 2001.

THE LANCET is to publish a joint Commentary with other international medical journals outlining concerns about the increasing involvement of sponsors in medical academic research.

Until recently, independent clinical investigators were key players in design, patient recruitment, and data interpretation in clinical trials. The Commentary states how economic pressures are creating an environment where the pharmaceutical industry, who are often sponsors of medical research, exerts control of trial design, access to raw data, and the interpretation of study findings. Concern is also expressed that research sponsors may influence decisions as to how trials are published and promoted (if the results are favourable to the sponsor), or obscured (if unfavourable).

The international committee of medical journal editors (ICMJE) has consequently strengthened its guidelines to enable editors to restrict the publication of research to studies where the scientific objectivity of the research is not compromised.

The editorial concludes: 'Authorship means both accountability and independence. A submitted manuscript is the intellectual property of its authors, not the study sponsor. We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication. We encourage investigators to use the revised ICMJE requirements on publication ethics to guide the negotiation of research contracts. Those contracts should give the researchers a substantial say in trial design, access to the raw data, responsibility for data analysis and interpretation, and the right to publish -- the hallmarks of scholarly independence and, ultimately, academic freedom. By enforcing adherence to these revised requirements, we can as editors assure our readers that the authors of an article have had a meaningful and truly independent role in the study that bears their names. The authors can then stand behind the published results, and so can we.'
-end-
Contact: The Lancet Press Office, 84 Theobald's Road, London WC1X 8RR, UK; T) 44-20-7611-4076; F) 44-20-7611-4477; E) richard.lane@lancet.com

Notes to Editors:

1. The press embargo for the Commentary has been brought forward to align with publication in the Danish medical Journal on Monday 10 September. The Commentary will be published in the September 15 issue of THE LANCET.

2. Members of the ICMJE publishing the article: Annals of Internal Medicine, The Journal of the American Medical Association, The Lancet, The New England Journal of Medicine, The New Zealand Medical Journal, Canadian Medical Association Journal, MEDLINE/Index Medicus, The Norwegian Medical Association, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine), The Medical Journal of Australia, Western Journal of Medicine.

Lancet

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