http://www.newscientist.com/news/news.jsp?id=ns99991269
12:46 10 September 01 Emma Young
Thirteen of the world's leading medical journals have published new guidelines to combat excessive control of research by pharmaceutical companies.
Recent cases of drug companies controlling the design of a study, analysing and interpreting the data and blocking publication of unfavourable results have all been reported, says the British Medical Journal.
Last year, for example, a University of California, San Francisco team published research showing that an HIV drug developed by Immune Response Corporation in California did not have any additional benefits to patients already receiving conventional treatment. Immune Response Corporation, which had argued against publication, sued the university, claiming it had damaged its business.
The problem of excessive control by the corporate sponsor of a study is "very widely prevalent," says Richard Horton, editor of the Lancet. Instances of submitted papers being hyped to back the drug being investigated are common, he says.
Full disclosure
Now the BMJ and the Lancet, along with the Journal of the American Medical Association and 10 other international publications, will ask contributors to provide full information about their own role and the role of the funding company in the submitted research.
Some journals will ask contributors to sign a statement that they had full responsibility for the conduct of the study, had access to the data and controlled the decision to publish.
"If authors cannot satisfy us on these points then we will not publish," says Richard Smith, editor of the BMJ.
The sponsors will also be allowed only 30 to 60 days to review the research paper before it is submitted to publication.
Peer pressure
Few researchers would willingly submit to strict conditions imposed by some pharmaceutical companies, 12 of the journals say in a joint editorial (the BMJ published a very similar separate editorial). "But many have accepted them because they know that if they do not, the sponsor will find someone else who will."
The editorial points out: "Well-done trials, published in high-profile journals, may be used to market drugs and medical devices, potentially resulting in substantial gain for the sponsor. But powerful tools must be used carefully."
Smith adds: "This initiative should not be seen as an attack on the pharmaceutical industry. Many companies have high ethical standards and will see no problem with complying with the new policies."
The Association of the British Pharmaceutical Industry says it supports independent investigation.
12:46 10 September 01
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