From: Subject: News Date: Fri, 23 Apr 2004 20:32:53 -0700 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0000_01C42972.278B7D00"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1409 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C42972.278B7D00 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://news.independent.co.uk/uk/health_medical/story.jsp?story=514317 News

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Home > News > UK > Health/Medical

Across the site

The=20 link between industry, authors and their results

Firms=20 become more aggressive as productivity crisis takes its toll =

Leading=20 article: We have a right to know when the drugs don't work =

Editor's Choice

Then there was one
From now, = Neil Hannon is The=20 Divine Comedy

Simon Carr
Our leader will resign in the = summer -=20 you heard it here first, I hope

Kill Bill Vol. 2
For first = time,
Tarantino=20 hits us
where it hurts

Questions please ...
..for Alison = Lapper, the=20 disabled model for Trafalgar Square's statue

Anthony Sampson
We meet the = master anatomist=20 of power

Book Group
Join Independent = forum

Also from this = section

Fall=20 of the sun king: professor is sacked for saying UV rays can = be good=20 for you

The=20 link between industry, authors and their results

Firms=20 become more aggressive as productivity crisis takes its=20 toll

Childhood=20 glandular fever linked to multiple sclerosis

Skin=20 virus 'could be natural cure for acne'

Pharmaceutical companies accused of manipulating = drug=20 trials for profit

By Jeremy Laurance Health Editor

23 April 2004

The multibillion-pound global pharmaceutical industry is = accused today=20 of manipulating the results of drug trials for financial gain and=20 withholding information that could expose patients to the risk of=20 harm.

The stranglehold that the industry exerts over research is = causing=20 increasing alarm in medical circles as evidence emerges of biased = results,=20 under-reporting and selective publication driven by a market worth = more=20 than =A310bn a year in the UK.

In cancer, heart disease, mental health and related fields the = industry=20 has sponsored trials of new drugs which have held out great = promise for=20 patients. But when the same drugs have been tested in independent = trials=20 paid for by non-profit organisations - governments, medical = institutions=20 or charities - they have yielded different results.

Heart drugs prescribed for abnormal heart rhythm introduced in = the late=20 Seventies were estimated to kill more Americans each year by 1990 = than the=20 Vietnam War. Yet early evidence which suggested the drugs were = lethal, and=20 might have saved thousands, went unpublished.

Expensive new cancer drugs introduced in the last decade and = claiming=20 to offer major benefits have increasingly been questioned. = Evidence=20 published in the Journal of the American Medical = Association showed=20 that 38 per cent of independent studies of the drugs reached = unfavourable=20 conclusions about them, compared with just 5 per cent of the = studies=20 funded by the pharmaceutical industry.

In the latest case, researchers commissioned by the National = Institute=20 for Clinical Excellence (Nice) to develop guidelines for = prescribing=20 antidepressant drugs to children, say they were refused access to=20 unpublished trials held by the pharmaceutical companies.

Published evidence suggested that the antidepressant drugs = called SSRIs=20 (selective serotonin re-uptake inhibitors) were safe and effective = for=20 children.

But when researchers obtained the unpublished evidence by = contacting=20 individual researchers who had worked on the trials, a picture = emerged of=20 increased risk of suicidal ideas and attempted suicide. Only one = drug,=20 Prozac, was safe.

Antidepressants, though not recommended for children, were = widely=20 prescribed until last year when the Medicines and Healthcare = Products=20 Regulatory Agency (MHRA) issued a warning to doctors, prohibiting = their=20 use. This followed safety concerns raised by campaigners and taken = up in=20 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=20 recommending use of these drugs for children and young people with = depression. However, our review of combined published and = unpublished data=20 ... suggest that these SSRIs are not efficacious. Moreover a = possible=20 increased risk of suicidal ideation, serious adverse events or = both,=20 although small, cannot be ignored."

Tim Kendall, from the Royal College of Psychiatrists, said the=20 researchers had been "unnerved" by the possibility that Nice could = have=20 issued wrong or harmful advice because it did not have access to = the full=20 data.

The same concerns would apply to advice issued about other = drugs in=20 other specialist areas, he said. Guidelines were being drawn up = for the=20 use of antidepressants in adults based on 1,000 published trials = but it=20 was possible there were tens or hundreds of unpublished trials = they had=20 not seen.

The Lancet says the possibility that the suicide of a = child=20 could be provoked by a supposedly beneficial drug would be a = "catastrophe"=20 and the idea of the drug's use being based on "selective reporting = of=20 favourable research" should be "unimaginable." It says the story = of=20 research into SSRIs in childhood "is one of confusion, = manipulation and=20 institutional failure."

It cites an internal GlaxoSmithKline memo, published in the = Canadian=20 Medical Association Journal last month, referring to a study = of the=20 antidepressant Seroxat (paroxetine) in children. The memo said: = "It would=20 be unacceptable to include a statement that efficacy had not been=20 demonstrated, as this would undermine the profile of = paroxetine."

Billions of pounds are spent on the basis of published = evidence,=20 assembled by organisations such as Nice, The Lancet says. = Global=20 sales of GlaxoSmithKline's Seroxat amounted to $4.97bn last = year.

Andrew Dillon, chief executive of Nice said: "The institute's = ultimate=20 objective is to be given and to be able to use freely all data = relevant to=20 the guidance which it is asked to develop. We continue to work to = that=20 objective."

The Association of the British Pharmaceutical Industry said it = was=20 prevented under Nice's rules from supplying unpublished data for = the=20 preparation of clinical guidelines. But, it has set up a register = of=20 clinical trials, and regulations to be introduced next month under = the=20 European clinical trials directive would make monitoring easier. =

=20

Search = this=20 site:
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