- 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.
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- 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.
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- 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.
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- 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were lethal, and might have saved thousands, went unpublished.
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- 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.
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- 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antidepressant drugs to children, say they were refused access to unpublished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.
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- Published evidence suggested that the antidepressant
drugs called SSRIs (selective serotonin re-uptake inhibitors) were safe
and effective for children.
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- But when researchers obtained the unpublished evidence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.
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- 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.
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- 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."
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- 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.
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- 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.
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- 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."
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- 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."
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- 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.
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- 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."
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- 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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- © 2004 Independent Digital (UK) Ltd http://news.independent.co.uk/uk/health_medical/story.jsp?story=514317
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