Why the ghostwriters are sending shivers up medical spines

It’s extremely likely that a number of Australian medicos suffered some uncomfortable “there but for the grace of God go I” moments this week.

The immediate cause of their discomfort was the New York Times revelation that Wyeth had paid ghostwriters to produce medical journal articles favourable to its hormone replacement therapy product. Dozens of pages of internal corporate documents revealed the central, previously undisclosed role of Wyeth and its medical writing consultancy DesignWrite in creating articles promoting HRT as far back as 1997.

The documents reportedly show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.

A prominent Australian specialist was one of the doctors named in the NYT article, as I reported in Crikey on Monday.

But it seems a tad unfair to focus on any one individual when it appears that the practice, of authors putting their names to papers prepared or at least drafted by ghostwriters, has been quite widespread.

We gained a glimpse into this shadowy world earlier this year when the Journal of the American Medical Association published a study based on internal Merck documents showing how the company drove academic publications for rofecoxib/Vioxx (which was of course eventually withdrawn from the market because of safety concerns).

The authors concluded that their study: “demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support”.

In the past, medicos and academics could perhaps plead naivity; that they had entered into such arrangements out of good intentions, without understanding the ramifications of their actions.

That time has passed. We now understand so much more about how such practices foster an environment which can be harmful for public health (the history of rofecoxib being just one obvious example).

Those who persist in participating in such practices have no excuses. Not any more. Neither do institutions which allow their academics to persist in such practices.

But that’s just my view.

Here is what some others have to say on the topic:

Dr John Dowden, Editor, Australian Prescriber:

“Authorship is a topic which is never far from the minds of editors of medical journals. It can sometimes be unclear who wrote an article submitted for publication.

In the past, some heads of department added their names to a publication, even though they may have contributed little to the article. Conversely, people who contributed a lot to an article may not appear as authors; they are the ghost writers.

Ghost writing is not a new problem. Ten years ago an article in the Journal of the American Medical Association found that 19% of 809 articles had evidence of ‘honorary’ authorship and 11% had evidence of ghost writing (JAMA. 1998;280:222-224).

The recent legal proceedings surrounding the withdrawn arthritis drug rofecoxib have revealed articles written by employees of the sponsor company which were then attributed to academics. There was evidence of people being paid to put their names to papers which had been prepared by ghost writers. (JAMA. 2008;299:1800-1812)

Academics are not always the best communicators and may need help with their manuscripts. I believe this is acceptable, particularly if the author is trying to write in a foreign language, but this assistance should be disclosed.

Disclosure and integrity are essential components of scientific research. Accepting money to appear as the author of a paper written by somebody else could damage a researcher’s reputation. As the honoraria in the rofecoxib case were only US$750-$2500, it would seem that some do not value their reputation highly.”

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Professor Ian Olver, CEO Cancer Council Australia:

“Transparency of authorship and authors’ affiliations and potential conflicts of interests are important disclosures in judging the subjective content of manuscripts.

Objective endpoints such as survival, even if provided by a pharmaceutical company from trials data, are unlikely to be problematic.

But subjective endpoints or the interpretation of the impact of results as expressed in the discussion or conclusions of a paper are where bias is most likely to occur.

Furthermore in this era of evidence based medicine, a declaration of who designed the trial is important, particularly as scheduling and duration of treatment may be chosen to create evidence around maximising a drug usage.

The case of HRT is a good example where there is great variation in interpretation of the data balancing the increase in likelihood of breast cancer reported with prolonged usage, against the relief of menopausal symptoms which is an immediately beneficial outcome.”