-Caveat Lector-
From
http://www.guardian.co.uk/Print/0,3858,4351264,00.html
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Scandal of scientists who take money for papers ghostwritten by drug
companies
Doctors named as authors may not have seen raw data
Sarah Boseley, health editor
Thursday February 7, 2002
The Guardian
Scientists are accepting large sums of money from drug companies to
put their names to articles endorsing new medicines that they have
not written - a growing practice that some fear is putting scientific
integrity in jeopardy.
Ghostwriting has become widespread in such areas of medicine as
cardiology and psychiatry, where drugs play a major role in
treatment. Senior doctors, inevitably very busy, have become willing
to "author" papers written for them by ghostwriters paid by drug
companies.
Originally, ghostwriting was confined to medical journal supplements sponsored by the
industry, but it can now be found in all the major journals in relevant fields. In
some cases, it is alleged, the scientists named as a
uthors will not have seen the raw data they are writing about - just tables compiled
by company employees.
The doctors, who may also give a talk based on the paper to an audience of other
doctors at a drug company- sponsored symposium, receive substantial sums of money.
Fuller Torrey, executive director of the Stanley Foundati
on Research Programmes in Bethesda, Maryland, found in a survey that British
psychiatrists were being paid around $2,000 (£1,400) a time for symposium talks, plus
airfares and hotel accommodation, while Americans got abou
t $3,000. Some payments ran as high as $5,000 or $10,000.
"Some of us believe that the present system is approaching a high-class form of
professional prostitution," he said.
Robin Murray, head of the division of psychological medicine at the Institute of
Psychiatry in London, is one of those who has become increasingly concerned. "It is
clear that we have a situation where, when an audience i
s listening to a well-known British psychiatrist, you recognise the stage where the
audience is uncertain as to whether the psychiatrist really believes this or is saying
it because they them selves or their department is
getting some financial reward," he said.
"I can think of a well-known British psychiatrist I met and I said, 'How are you?' He
said, 'What day is it? I'm just working out what drug I'm supporting today.'"
Marcia Angell, former editor of the New England Journal of Medicine, wrote a year ago
that when she ran a paper on antidepressant drug treatment, the authors' financial
ties to the manufacturers - which the journal requir
es all contributors to declare - were so extensive that she had to run them on the
website. She decided to commission an editorial about it and spoke to research
psychiatrists, but "we found very few who did not have fina
ncial ties to drug companies that make antidepressants."
She wrote: "Researchers serve as consultants to companies whose products they are
studying, join advisory boards and speakers' bureaus, enter into patent and royalty
arrangements, agree to be the listed authors of article
s ghostwritten by interested companies, promote drugs and devices at company-sponsored
symposiums, and allow themselves to be plied with expensive gifts and trips to
luxurious settings. Many also have equity interest in t
he companies."
In September her journal joined the Lancet and 11 others in denouncing the drug
companies for imposing restrictions on the data to which scientists are given access
in the clinical trials they fund. Some of the journals p
ropose to demand a signed declaration that the papers scientists submit are their own.
The success of Prozac, the antidepressant which became a cult "happy" drug in the
1990s, substantially raised the stakes in psychiatry. Its promotion coincided with the
decline of state funding for research, leaving scien
tists in all areas of medicine dependent on pharmaceutical companies to fund or
commission their work. That in turn gave the industry unprecedented control over data
and ended with research papers increasingly being draft
ed by company employees or commercial agencies.
The responsibility of scientists for the content of their papers takes on serious
significance in the context of court cases in the US, where relatives of people who
killed themselves and murdered others while on SSRIs (s
elective serotonin reuptake inhibitors) - the class of drug to which Prozac belongs -
claimed the drugs were responsible. According to David Healy, a north Wales-based
psychopharmacologist who has given evidence for the f
amilies, the companies have relied on articles apparently authored by scientists who
may in fact have not seen the raw data.
Dr Healy, who had unprecedented access to the data that the companies keep in their
archives, said: "It may well be that 50% of the articles on drugs in the major
journals across all areas of medicine are not written in a
way that the average person in the street expects them to be authored."
He cites the case brought last year against the former SmithKline Beecham (now
GlaxoSmithKline) by relatives of Donald Schell. The court found that the company's
best-selling antidepressant, an SSRI called Seroxat, had ca
used Schell to murder his wife, daughter and granddaughter and commit suicide.
The company's defence was based on scientific papers which analysed the results of
trials comparing Seroxat with a placebo and found there was no increased risk of
suicide for depressed people on Seroxat. But the raw data
probably does not support that, argues Dr Healy. Some of the placebo suicides took
place while patients were withdrawing from an older drug. When the figures are
readjusted without these, he says, they show there is subs
tantially increased risk of suicide on Seroxat.
This raises the question of whether the eminent scientists whose names were on the
papers ever saw the raw data from the trials - or saw only tables compiled by company
employees, he says. David Dunner, a professor at the
University of Washington, who co-authored one of the papers in 1995, admits he did
not see the raw data. "I don't know who saw it. I did not," he said. "My role in the
paper was that the data were presented to us and we
analysed it and wrote it up and wrote references."
His co-author Stuart Montgomery, then of St Mary's hospital medical
school in London, declined to answer calls and emails from the
Guardian. The third name on the paper is that of Geoff Dunbar, a
company employee.
The World Health Organisation has expressed concern about the ties
between industry and researchers. Jonathan Quick, director of
essential drugs and medicines policy, wrote in the latest WHO
Bulletin: "If clinical trials become a commercial venture in which
self-interest overrules public interest and desire overrules science,
then the social contract which allows research on human subjects in
return for medical advances is broken."
Guardian Unlimited © Guardian Newspapers Limited 2002
End<{{{
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