Pharmaceutical companies accused of manipulating drug trials for profit

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The multibillion-pound global pharmaceutical industry is accused today of manipulating the results of drug trials for financial gain and withholding information that could expose patients to the risk of harm.

The stranglehold that the industry exerts over research is causing increasing alarm in medical circles as evidence emerges of biased results, under-reporting and selective publication driven by a market worth more than £10bn a year in the UK.

In cancer, heart disease, mental health and related fields the industry has sponsored trials of new drugs which have held out great promise for patients. But when the same drugs have been tested in independent trials paid for by non-profit organisations - governments, medical institutions or charities - they have yielded different results.

Heart drugs prescribed for abnormal heart rhythm introduced in the late Seventies were estimated to kill more Americans each year by 1990 than the Vietnam War. Yet early evidence which suggested the drugs were lethal, and might have saved thousands, went unpublished.

Expensive new cancer drugs introduced in the last decade and claiming to offer major benefits have increasingly been questioned. Evidence published in the Journal of the American Medical Association showed that 38 per cent of independent studies of the drugs reached unfavourable conclusions about them, compared with just 5 per cent of the studies funded by the pharmaceutical industry.

In the latest case, researchers commissioned by the National Institute for Clinical Excellence (Nice) to develop guidelines for prescribing antidepressant drugs to children, say they were refused access to unpublished trials held by the pharmaceutical companies.

Published evidence suggested that the antidepressant drugs called SSRIs (selective serotonin re-uptake inhibitors) were safe and effective for children.

But when researchers obtained the unpublished evidence by contacting individual researchers who had worked on the trials, a picture emerged of increased risk of suicidal ideas and attempted suicide. Only one drug, Prozac, was safe.

Antidepressants, though not recommended for children, were widely prescribed until last year when the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a warning to doctors, prohibiting their use. This followed safety concerns raised by campaigners and taken up in two BBC televisionPanorama broadcasts.

Writing in The Lancet, the authors say: "On the basis of published evidence alone, we could have considered at least tentatively recommending use of these drugs for children and young people with depression. However, our review of combined published and unpublished data ... suggest that these SSRIs are not efficacious. Moreover a possible increased risk of suicidal ideation, serious adverse events or both, although small, cannot be ignored."

Tim Kendall, from the Royal College of Psychiatrists, said the researchers had been "unnerved" by the possibility that Nice could have issued wrong or harmful advice because it did not have access to the full data.

The same concerns would apply to advice issued about other drugs in other specialist areas, he said. Guidelines were being drawn up for the use of antidepressants in adults based on 1,000 published trials but it was possible there were tens or hundreds of unpublished trials they had not seen.

The Lancet says the possibility that the suicide of a child could be provoked by a supposedly beneficial drug would be a "catastrophe" and the idea of the drug's use being based on "selective reporting of favourable research" should be "unimaginable." It says the story of research into SSRIs in childhood "is one of confusion, manipulation and institutional failure."

It cites an internal GlaxoSmithKline memo, published in the Canadian Medical Association Journal last month, referring to a study of the antidepressant Seroxat (paroxetine) in children. The memo said: "It would be unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine."

Billions of pounds are spent on the basis of published evidence, assembled by organisations such as Nice, The Lancet says. Global sales of GlaxoSmithKline's Seroxat amounted to $4.97bn last year.

Andrew Dillon, chief executive of Nice said: "The institute's ultimate objective is to be given and to be able to use freely all data relevant to the guidance which it is asked to develop. We continue to work to that objective."

The Association of the British Pharmaceutical Industry said it was prevented under Nice's rules from supplying unpublished data for the preparation of clinical guidelines. But, it has set up a register of clinical trials, and regulations to be introduced next month under the European clinical trials directive would make monitoring easier.

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