[Ip-health] Pharma ghost writers

[Sean Flynn]

observer.guardian.co.uk/uk_news/story/0,6903,1101680,00.html

Revealed: how drug firms 'hoodwink' medical journals

Pharmaceutical giants hire ghostwriters to produce
articles - then put doctors' names on them

Antony Barnett, public affairs editor
Sunday December 7, 2003
The Observer

Hundreds of articles in medical journals claiming to
be written by academics or doctors have been penned by
ghostwriters in the pay of drug companies, an Observer
inquiry reveals.

The journals, bibles of the profession, have huge
influence on which drugs doctors prescribe and the
treatment hospitals provide. But The Observer has
uncovered evidence that many articles written by
so-called independent academics may have been penned
by writers working for agencies which receive huge
sums from drug companies to plug their products.

Estimates suggest that almost half of all articles
published in journals are by ghostwriters. While
doctors who have put their names to the papers can be
paid handsomely for 'lending' their reputations, the
ghostwriters remain hidden. They, and the involvement
of the pharmaceutical firms, are rarely revealed.

These papers endorsing certain drugs are paraded in
front of GPs as independent research to persuade them
to prescribe the drugs.

In February the New England Journal of Medicine was
forced to retract an article published last year by
doctors from Imperial College in London and the
National Heart Institute on treating a type of heart
problem. It emerged that several of the listed authors
had little or nothing to do with the research. The
deception was revealed only when German cardiologist
Dr Hubert Seggewiss, one of the eight listed authors,
called the editor of the journal to say he had never
seen any version of the paper.

An article published last February in the Journal of
Alimentary Pharmacology , which specialises in stomach
disorders, involved a medical writer working for drug
giant AstraZeneca - a fact that was not revealed by
the author.

The article, by a German doctor, acknowledged the
'contribution' of Dr Madeline Frame, but did not admit
that she was a senior medical writer for AstraZeneca.
The article essentially supported the use of a drug
called Omeprazole - which is manufactured by
AstraZeneca - for gastric ulcers, despite suggestions
that it gave rise to more adverse reactions than
similar drugs.

Few within the industry are brave enough to break
cover. However, Susanna Rees, an editorial assistant
with a medical writing agency until 2002, was so
concerned about what she witnessed that she posted a
letter on the British Medical Journal website.

'Medical writing agencies go to great lengths to
disguise the fact that the papers they ghostwrite and
submit to journals and conferences are ghostwritten on
behalf of pharmaceutical companies and not by the
named authors,' she wrote. 'There is a relatively high
success rate for ghostwritten submissions - not
outstanding, but consistent.'

Rees said part of her job had been to ensure that any
article that was submitted electronically would give
no clues as to the origin of the research.

'One standard procedure I have used states that before
a paper is submitted to a journal electronically or on
disc, the editorial assistant must open the file
properties of the Word document manuscript and remove
the names of the medical writing agency or agency
ghostwriter or pharmaceutical company and replace
these with the name and institution of the person who
has been invited by the pharmaceutical drug company
(or the agency acting on its behalf) to be named as
lead author, but who may have had no actual input into
the paper,' she wrote.

When contacted, Rees declined to give any details. 'I
signed a confidentiality agreement and am unable to
comment,' she said.

A medical writer who has worked for a number of
agencies did not want to be identified for fear he
would not get any work again.

'It is true that sometimes a drug company will pay a
medical writer to write a review article supporting a
particular drug,' he said. 'This will mean using all
published information to write an article explaining
the benefits of a particular treatment.

'A recognised doctor will then be found to put his or
her name to it and it will be submitted to a journal
without anybody knowing that a ghostwriter or a drug
company is behind it. I agree this is probably
unethical, but all the firms are at it.'

One field where ghostwriting is becoming an increasing
problem is psychiatry.

Dr David Healy, of the University of Wales, was doing
research on the possible dangers of anti-depressants,
when a drug manufacturer's representative emailed him
with an offer of help.

The email, seen by The Observer, said: 'In order to
reduce your workload to a minimum, we have had our
ghostwriter produce a first draft based on your
published work. I attach it here.'

The article was a 12-page review paper ready to be
presented at an forthcoming conference. Healy's name
appeared as the sole author, even though he had never
seen a single word of it before. But he was unhappy
with the glowing review of the drug in question, so he
suggested some changes.

The company replied, saying he had missed some
'commercially important' points. In the end, the
ghostwritten paper appeared at the conference and in a
psychiatric journal in its original form - under
another doctor's name.

Healy says such deception is becoming more frequent.
'I believe 50 per cent of articles on drugs in the
major medical journals are not written in a way that
the average person would expect them to be... the
evidence I have seen would suggest there are grounds
to think a significant proportion of the articles in
journals such as the New England Journal of Medicine,
the British Medical Journal and the Lancet may be
written with help from medical writing agencies,' he
said. 'They are no more than infomercials paid for by
drug firms.'

In the United States a legal case brought against drug
firm Pfizer turned up internal company documents
showing that it employed a New York medical writing
agency. One document analyses articles about the
anti-depressant Zoloft. Some of the articles lacked
only one thing: a doctor's name. In the margin the
agency had put the initials TBD, which Healy assumes
means 'to be determined'.

Dr Richard Smith, editor of the British Journal of
Medicine, admitted ghostwriting was a 'very big
problem' .

'We are being hoodwinked by the drug companies. The
articles come in with doctors' names on them and we
often find some of them have little or no idea about
what they have written,' he said.

'When we find out, we reject the paper, but it is very
difficult. In a sense, we have brought it on ourselves
by insisting that any involvement by a drug company
should be made explicit. They have just found ways to
get round this and go undercover.'