DRUGS FIRMS' PRESSURE 'RISKS LIVES'

Patient safety is under threat because commercial interests are skewing the
results of drug trials, say the editors of some of the world's top medical
journals. Eleven publications say that in some cases the benefits of drugs
have been hyped in research papers, and side effects disguised.

This could lead to doctors prescribing unsuitable drugs for their patients,
they claim.

The influential journals have threatened that unless trials can be proved
to be independent, the results will not be published in their journals to
protect patients.

The publications include the Lancet, the Journal of the American Medical
Association, the Canadian Medical Association Journal, and the Dutch
Journal of Medicine.

Dr Richard Horton, the editor of the Lancet, one of the UK's top journals,
said all the editors had seen examples of trials where the best interests
of patients had been pushed aside by the interests of the drug companies.

In one case he cited, patients died after a potentially fatal side effect
was allegedly discounted by the study authors.

However, the Association of British Pharmaceutical Industry said that the
profession in the UK had high ethical standards, and said it too supported
an independent approach.

Marketing drugs

Dr Horton said new drugs had in some cases been manipulated and hyped out
of proportion by the companies.

Nine out of 10 reviewers say the papers they receive have been hyped in
favour of the drugs and half have to be rejected.

Others need to be substantially rewritten before they can be published.

"All of us who signed this had seen instances of where cash interests had
been put before patients.

"There are examples of exaggerated benefits and suppressing and avoiding
the adverse effects of drugs."

Dr Horton said that it was recognised that clinical trials are expensive
and drug company money needed, the average cost of bringing a new drug to
the market in the USA is about $500m.

But he said it was important that drug companies investing in trials should
take a back seat.

"We would not have any medical advances if it was not for pharmaceutical
companies investing in drugs, but at the same time they have to put the
interests of patients first."

The International Committee of Medical Journal Editors (ICMJE) has now
strengthened its guidelines to restrict the publication of those studies
where they feel the objectivity is compromised.

Obscure results

"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."

"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.

"But powerful tools must be used carefully."

They say that without these guidelines some trial sponsors might promote or
obscure trial results simply because of how they reflect on their products.

And they call on researchers to follow ICMJE requirements on publication
ethics to guide the negotiation of research contracts and ensure
independent research.

"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."
Medical advances

The British Medical Journal (BMJ) also said it would now require authors to
disclose details of their own and the sponsor's role in a study.

Dr Richard Smith, BMJ Editor said: "This initiative should not be seen as
an attack on the pharmaceutical industry.

"Many companies have high ethical standards and will see no problem in
complying with the new policies. Other groups, including hospitals and
governments, may often be keen to control publication especially if results
appear to contradict current policy."

A spokesman for the Association of British Pharmaceutical Industry told BBC
News Online: "The ABPI supports the fact that clinical investigations
should be independent.

"We believe that the UK pharmaceutical industry supports that."