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Scientific Publishing– Color Me Cynical

When it comes to scientific publishing, I am a true-blue cynic.

Medicine and marketing go hand and hand. Whether reading a published meta-analysis, systematic review or randomized clinical trial, bias is frequently interjected into journal articles because so much money rests on a favorable result appearing in the scientific literature.

The topic of publication bias has been covered extensively in the academic literature. If you want to read up on the topic, I suggest ‘Googling’ articles by Joel Lexchin (York University, Toronto, Ontario, Canada) and/or Lisa Bero at UCSF. Bottom line, if a drug company is in anyway involved in article development or placement, it is likely to color the content.

It’s a well-established fact that randomized clinical trials are likely to favor the sponsor’s products. An article published last year in NEJM reported that 94% of clinical trials published on antidepressants had positive outcomes, in contrast to only 51% of the antidepressant clinical trials reviewed by the FDA, which included both published and unpublished trials. The authors concluded that the high number of studies with positive outcomes reported in the literature was due to publication bias, the fact that clinical trials with favorable results are more likely to be published.

In my experience, several lesser known facets of the business of scientific publishing contribute to this bias:

Reprints

Pharmaceutical companies are the single largest purchasers of clinical reprints. The reprints are handed out to physicians and/or used in sales force training. The sale of reprints, therefore, is a major revenue source for medical publishers. This gives journals a financial incentive to publish studies favorable to the sponsor’s drug, because drug companies are not going to publicize/distribute a reprint of an article that makes their drug look bad. Journals also publish review articles that are authored by drug company employees, articles that often highlight a product feature or provide statistics supporting aggressive treatment of a particular condition. The authorship of these articles appears somewhere in the byline; however, bylines are not included in article citations.

Journal Supplements

Publishers also make money by publishing journal supplements. Journal supplements are special issues sponsored (e.g. paid for) by drug companies.  Although the supplements are supposedly peer-reviewed, supplements are created outside the normal editorial processes for the journal and often favorably highlight a product, procedure or drug class. One good example of this (one that makes me laugh or cry, depending on my mood) is a 2006 American Society of Consultant Pharmacists journal supplement sponsored by Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. Among other things the review states that “atypical antipsychotics can safely reduce caregiver burden and improve symptoms in older adults with behavioral and psychological symptoms of dementia.” Quite funny considering that today atypical antipsychotics have Black Box Warnings stating that elderly people with psychosis related to dementia are at an increased risk of death compared to placebo. Not surprising, that a journal supplement paid for by a company who markets atypicals suggested that giving your senior loved one antipsychotics would make them easier to deal with.

Publication Planning

Did you ever wonder who so many industry-sponsored clinical trials get published in top-notch medical journals? The reason is publication planning, an integral part of every drug company’s marketing strategy.

Publication planning is defined as the “systematic, planned dissemination of key messages and [clinical] data” via scientific journals, symposia, abstracts and educational materials. As part of publication planning, drug companies hire publication planners who decide what key product messages ought to be “inserted” into articles. Publication planners, in turn, hire medical writers who are assigned to the study investigators, working with them to shape, interpret and present the research. Publication planners are also responsible for making sure that the clinical trial or review article is placed in the appropriate journals, presented as posters at national conferences or published as abstracts. More about ghostwriting and publication planning can be found in this article published in PLOS Medicine. Also worth noting is a) many of the communication companies that develop publication plans on behalf of drug companies are owned by medical publishers, and b) the published articles are often used to support claims made in drug company marketing materials.

If you think that I sound like a conspiracist, I understand why. However, I prefer you just color me cynical. In a world where medicine, marketing and scientific publishing are so entangled, it pays to remain skeptical about what you read.

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