Behind the mask: who really wrote that?

Do published articles about a clinical trial reflect what the original trial protocols set out to do? And are the authors of the published articles the same clinical investigators who conducted the research and designed the trial?

These are intriguing questions that researchers from Denmark, UK and Canada sought to answer in their study, “Ghost Authorship in Industry-Initiated Randomised Trials.”

It is important that the author who has played a substantial role in the research or writing of the article to be disclosed, they said, because authorship “establishes accountability, responsibility and credit for scientific articles.” To not do so can mislead readers and make the potential for manipulated analyses and conclusions much greater, they said.

They first examined all of the published industry-initiated clinical trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg during 1994–1995 and compared their full trial protocols with what was published.

Of the 44 trials they identified, they did not find a single trial protocol or publication “that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis.” In fact, they said, it was unclear if clinicians had even had a role in the protocols or design of the trials.

These researchers defined ghost writing the same as other studies have: if the person who wrote the trial protocol, performed the statistical analysis, or wrote the article did not appear listed among the authors, the study group or committee, or even mentioned in an acknowledgement. By these criteria, they found evidence that 75% of articles had been ghost written. They pointed out that these results differed notably from the rates of 11-13% found in other surveys of ghost writing that had relied on self-reporting.

As an aside, they made another important discovery. Of the total 274 trials approved, only 37% of them were ever begun, completed or made it to print. That might lead us to cautiously ask: What findings were never published that should have been? And when we hear glowing reports about a study that hasn’t been published, could it be because it is so flimsy or flawed it couldn’t withstand peer review?

Some groups have called for establishing protocols for disclosing all parties who’ve been involved in a study, including the roles of medical writers, editors and statisticians but implementing them has proven difficult, they said, in part because of the far-reaching roles and importance of medical writers to industry:

First, legal proceedings and testimonies suggest that it is very common for professional medical writers to compose trial reports, reviews, and other papers for the pharmaceutical industry, but that their role is not revealed. Companies and medical writing agencies may routinely disguise the fact that papers have been ghost-written, including erasing the file history of electronic documents before manuscript submission.

Second, writing agencies have a vested interest in pleasing their clients by writing favourably about the drug in question. Such commercial pressures may explain why conclusions in randomised trials recommended the experimental drug as the drug of choice much more often if the trial was funded by for-profit organisations, even after adjustment for the effect size....

We conclude that ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes.

You bet. Spend any amount of time analyzing research studies, and you realize pretty quickly just how rampant this problem appears. The discrepancy between what a study’s data actually found and what is reported in abstracts, study introductions and conclusions, press releases, and reviews can be day and night. Certainly, there are authors who write carefully and accurately, objectively report a study’s finding, represent its limitations and strengths, and are above reproach. But spin is all too common.

And the pressures placed on health writers and editors in mainstream media to write copy favorable to advertisers or their publication’s mission or culture, or the publisher’s beliefs, with corresponding constraints on what they can write about and what they can say, are more intense than most consumers might guess. For journalists who want to make a name for themselves and get more assignments, they become personally mindful of the need to gain popularity, curry favor and not make enemies in high places. The pressures to go-along-to-get-along can prove irresistible.

And even conflicts of interest among ghost writers and health writers, which can greatly affect the soundness of a report, are rarely disclosed.

Take obesity articles, for example. Few consumers would suspect that journalists for medical and consumer publications are actively solicited and substantially rewarded for writing articles that give the message points the weight loss industry wants. For years, Hoffman LaRoche, Inc. — one of the largest pharmaceutical companies of obesity products, such as Xenical, and a regular sponsor of conferences and publications for the International Obesity Task Force, American Obesity Association and the International Association for the Study of Obesity (IASO) — has given its Roche International Award for Obesity Journalism, to journalists who “demonstrated their expertise and knowledge of overweight and obesity through responsible reporting.” The latest winners each won $14,773.00 (approximate U.S. dollars) for such articles as “Tomorrow, pills will be all you need to lose weight” and “Manifat Destiny.” The Australian branch of IASO has its own ASSO Journalism Award, with a free trip to Europe, for journalists “whose work is judged as having most effectively and accurately communicated the issues surrounding the problem of overweight and obesity, and the extent to which the article is likely to facilitate action on obesity in the wider community.” Award submission guidelines include suggested topics.

If you’ve often wondered why the truth sounds so radically different from everything you read, perhaps this latest study has provided some insights.

© 2007 Sandy Szwarc

* This explains why I may never find a job as a “real” medical or health writer. :)