Medical journals question objectivity of clinical trials

Editors say every effort will be made to eradicate bias

The editors of several leading medical journals have warned that pharmaceutical companies are compromising clinical trials by putting profits before patient safety.

This content was published on September 14, 2001 minutes

The warning was issued simultaneously by members of the International Committee of Medical Journal Editors (ICMJE), and included the editors of The Lancet, the Journal of the American Medical Association and the Canadian Medical Association Journal.

In their joint editorial, the editors lament that the current climate in which some clinical research is carried out may be threatening objectivity.

"Well-done trials, published in high-profile journals, may be used to market drugs and medical devices, potentially resulting in substantial financial gain for the sponsor," reads the editorial. "But powerful tools must be used carefully."

Abuse of the system

The editors say the use of clinical trials primarily for marketing "makes a mockery of clinical investigation" and is an abuse of the system. Much of the ICMJE's ire is directed at the pharmaceutical industry's increasing use of contract research organisations (CROs) to carry out drug trials.

According to the ICMJE, the cost of bringing a new drug to the market in the USA is around $500 million (SFr826 million). The ICMJE says CROs do the job much more cheaply and are more easily influenced by corporate sponsors than are academic research institutions.

As a result of its concerns, the ICMJE has now revised and tightened its guidelines governing publication of research documents.

"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," says the editorial.

Professor Ludwig von Segesser, a member of the editorial board of the Swiss Medical Weekly and head of cardiovascular surgery at Lausanne University Hospital, agreed it was important that every effort should be taken to eradicate bias.

Clinical research

However, he said it was unreasonable to believe that bias could ever be completely removed from clinical research. "It's a reasonable statement to say that opinions expressed should be as unbiased as possible, but it's an illusion to think that you can be totally unbiased," he told swissinfo.

Segesser also felt that CROs had been unfairly singled out for criticism by the ICMJE editorial. The fact that the pharmaceutical industry was turning to contract research organisations was a sure sign that there was a problem with traditional academic research institutions, he said.

"In my eyes it's not necessarily because it's a different structure that it is done less well. That's what these editors in this paper suggest, but I'm not sure that this really holds true," said Segesser.

The Swiss pharmaceutical giants Roche and Novartis both declined to comment on the ICMJE statement.

swissinfo with agencies

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