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http://www.guardian.co.uk/Archive/Article/0,4273,4351264,00.html
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
Guardian
Thursday February 7, 2002
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
authors 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 Foundation
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 about
$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 is 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 themselves 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 requires
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 financial
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 articles
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 the 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 propose
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 scientists
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 drafted 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
(selective 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 families, 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 caused
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
substantially 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
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