Pharmaceutical companies accused of manipulating drug trials for profit

 By Jeremy Laurance Health Editor

 23 April 2004

 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 might have saved thousands, went unpublished.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 unpublished trials held by the pharmaceutical companies.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 But when researchers obtained the unpublished evidence by contacting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.
> >
> > http://news.independent.co.uk/uk/health_medical/story.jsp?story=514317
>