Journals reject tougher checks on data

January 20, 2006

The world's leading medical journal editors have rejected proposals for stricter rules governing the publication of research sponsored by pharmaceutical companies.

The international committee of medical journal editors met in Oslo last week to discuss plans to adopt new publication rules that would have required independent academic statisticians to conduct analyses of pharmaceutical companies' raw drug-trial data rather than allowing drug company staff to carry out the analyses and report the results.

Richard Horton, editor of The Lancet , told The Times Higher after the meeting that the 13 top editors all felt that the proposals "went too far, so there was no agreement". He declined to comment further.

The decision comes despite concerns raised by The Times Higher' s report that Sheffield University academics had put their names to drug-research findings that they were unable to verify independently. The proposed rules, already in force at the Journal of the American Medical Association ( Jama ), could possibly have prevented the problems that led to the row at Sheffield. An investigation by The Times Higher in November 2005 found that research findings on Procter & Gamble Pharmaceuticals' osteoporosis drug Actonel were released under the names of researchers at Sheffield University's Bone Metabolism Research Unit, even though they had not carried out their own independent analyses of the firm's drug-trial data.

P&G has argued that it is standard industry practice to limit outside academics' access to its data and that all members of the Sheffield team had sufficient access to be satisfied with the conclusions that were reached.

But the case has led to an investigation by the Medicines and Healthcare Products Regulatory Agency and a separate examination by the Journal of Bone and Mineral Research into findings submitted by the Sheffield team that it had published. The journal has already agreed to publish a statement by Aubrey Blumsohn that he is not willing to be associated with two research abstracts it had published in his name, as lead author, and it is investigating another paper written by two of Dr Blumsohn's colleagues.

Rules in leading medical journals already stipulate that all authors must sign a declaration confirming that they "had full access to the data and analyses".

But the rules in place at Jama , which were rejected by the editors' committee last week, go much further in refusing to publish industry-sponsored research unless an independent statistical analysis of raw data has been conducted by academics who have no financial relationship with the company.

The tougher Jama rules were criticised as "manifestly unfair" in an article in the British Medical Journal last month. Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, and Kenneth Rothman of RTI Health Solutions, an independent research organisation, wrote that the additional rules for industry-sponsored research "violate the proposition that each submission should be considered on its merits". They said the policy "punishes the innocent along with the guilty, and denigrates the reliability and professionalism of industry-employed statisticians, whose credentials Jama apparently considered insufficient".

Vera Hassner Sharav of the US-based pressure group Alliance for Human Research Protection told The Times Higher : "That the world's leading journal editors could not agree on adopting publication standards that would protect the integrity of the scientific literature is but an indicator of how beholden medical journals are to the pharmaceutical industry."

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