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How drug co PR tactics skew medical journal articles

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How drug companies' PR tactics skew the presentation of medical research

Elliot Ross reveals the secret 'army of hidden scribes' paid by the drug

companies to influence doctors

When doctors are deciding which drug to prescribe a patient, the idea behind

evidence-based medicine is that they inform their thinking by consulting

scientific literature. To a great extent, this means relying on medical

journals.

The trouble is that pharmaceutical companies, who stand to win or lose large

amounts of money depending on the content of journal articles, have taken a firm

grip on what gets written about their drugs. That grip was strong way back in

2004, when The Lancet's chief editor Horton lamented that " journals have

devolved into information laundering operations for the pharmaceutical

industry. " It may be even tighter now.

Drug companies exert this hold on knowledge through publication planning

agencies, an obscure subsection of the pharmaceutical industry that has

ballooned in size in recent years, and is now a key lever in the commercial

machinery that gets drugs sold.

The planning companies are paid to implement high-impact publication strategies

for specific drugs. They target the most influential academics to act as

authors, draft the articles, and ensure that these include clearly-defined

branding messages and appear in the most prestigious journals.

Over the past few months I've tried to find out as much about these companies as

possible. I wanted to know how big this industry is, exactly how it operates,

and how people in the business think about their work. It's a nervous, opaque

industry, but I did find answers to some of my questions.

There are now at least 250 different companies engaged in the business of

planning clinical publications for the pharmaceutical industry, according to the

International Society for Medical Publication Professionals, which said it has

over 1000 individual members.

Many firms are based in the UK and the east coast of the United States in

traditional " pharma " centres like Pennsylvania and New Jersey.

Precise figures are hard to pin down because publication planning is widely

dispersed and is only beginning to be recognized as something like a discrete

profession. These numbers are higher than any previous estimate, yet in truth

the industry is likely to be bigger still.

In selling their services to drug companies, the agencies' explain their work in

frank language. Current Medical Directions, a medical communications company

based in New York, promises to create " scientific content in support of our

clients' messages " . A rival firm from Macclesfield, Complete HealthVizion,

describes what it does as " a fusion of evidence and inspiration. "

Having talked to over a dozen publication planners I found that the standard

approach to article preparation is for planners to work hand-in-glove with drug

companies to create a first draft. " Key messages " laid out by the drug companies

are accommodated to the extent that they can be supported by available data.

Planners combine scientific information about a drug with two kinds of message

that help create a " drug narrative " . " Environmental " messages are intended to

forge the sense of a gap in available medicine within a specific clinical field,

while " product " messages show how the new drug meets this need.

But the issue that dominates industry discussions is authorship.

In a flow-chart drawn up by Crown, publications manager at Merck (the

company that sold the controversial painkiller Vioxx), the determination of

authorship appears as the fourth stage of the article preparation procedure.

That is, only after company employees have presented clinical study data,

discussed the findings, finalised " tactical plans " and identified where the

article should be published.

Perhaps surprisingly to the casual observer, under guidelines tightened up in

recent years by the International Committee of Journal Editors (ICMJE), Crown's

approach, typical among pharmaceutical companies, does not constitute

ghostwriting.

What publication planners understand by the term is precise but it is also quite

distinct from the popular interpretation.

" We've never done ghostwriting, per se, as I'd define it " , says

Romankiewicz, president of Scientific Therapeutics Information, the New Jersey

firm that helped Merck promote Vioxx with a series of positive articles in

medical journals. " We may have written a paper, but the people we work with have

to have some input and approve it. "

The industry has grown despite its prominent involvement in a succession of

medical ghostwriting scandals.

In the early 2000s, court documents released through litigation over

controversial drugs - such as Vioxx and the hormone replacement therapy Prempro

- showed pharmaceutical companies frequently hiring medical communication

agencies to ghostwrite articles and place them in influential medical journals

under the " authorship " of well-known academics paid thousands of pounds for

their endorsement.

The ICMJE tweaks, plus a new willingness to disclose their involvement in the

preparation of articles, has fostered a remarkable confidence among industry

proponents.

" I feel that we're doing something good for mankind in the long-run, " said

Goldin, head of the International Society for Medical Publication

Professionals (ISMPP). " We want to influence healthcare in a very positive,

scientifically sound way. "

" The profession grew out of a marketing umbrella, but has moved under the

science umbrella, " she said.

But without the window of court documents to show how publication planning is

being carried out today, the public simply cannot know if reforms the industry

says it has made are genuine.

Dr Leemon McHenry, a medical ethicist at California State University, says

nothing has changed. " They've just found more clever ways of concealing their

activities. There's a whole army of hidden scribes. It's an epistemological

morass where you can't trust anything. "

Alastair Matheson is a British medical writer who has worked extensively for

medical communication agencies. He dismisses the planners' claims to having

reformed as " bullshit " .

" The new guidelines work very nicely to permit the current system to continue as

it has been " , he said. " The whole thing is a big lie. They are promoting a

product. "

Matheson expects an article he wrote about a new cancer treatment to appear in

print later this year, with an oncologist considered a " key opinion leader "

(KOL) by planners listed as the author in his stead. " You'd do the same thing if

you were selling cornflakes, " Matheson told me. " It's no different. "

And with the industry business model that is all about facilitating the

influence of business over science thriving as it is, it's hard to see when, if

ever, we will again see the thick line one likes to imagine there once was

between the sale of cornflakes and the analysis of medicine. It has all become

rather blurry.

• Elliot Ross is a Fulbright scholar currently based at Columbia University

http://www.guardian.co.uk/science/2011/may/20/drug-companies-ghost-writing-journ\

alism

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