Medical Science ? or Medical Fraud ???

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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

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 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, land, 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 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 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

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 Kline Beecham

(now GlaxoKline) by relatives of 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. 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 '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. 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. "

EducationGuardian.co.uk © Guardian Newspapers Limited 2002