Ghostwriting Ban Included in Voluntary Guidelines From Drug Industry GroupOct 1, 2009 | Parker Waichman LLP The drug industry group PhRMA has banned medical ghostwriting. According to The Wall Street Journal, the ban is part of new voluntary clinical trial guidelines that went into effect today. The guidelines were approved by PhRMA's board, which includes officials from most of the big drug companies.
As we’ve reported in the past, ghostwriting involves the act of a drug company producing a journal article aimed at either counteracting criticism of a drug or embellishing its benefits. Usually, a drug maker hires a professional writing company to draft the article, and recruits a physician to sign off as the author. Once the article has been published, drug sales reps often present copies of the piece to physicians as evidence that the drug covered in the article is safe and effective. Critics of the pharmaceutical industry claim ghostwriting is a common practice.
A recent survey published just last month in the Journal of the American Medical Association found that 7.8 percent of 900 research articles, reviews, or editorials that appeared in six general medical journals in 2008 were written by un-credited ghostwriters. So-called “Honorary Authors” were also listed in about 20.6 percent of medical journal articles the researchers reviewed. An Honorary Author is someone credited with an article, but who in reality contributed very little.
Under the new PhRMA guidelines, anyone who makes "substantial contributions” to a study, writes or revises intellectually important parts of a manuscript and has final approval over what is published should be listed as an author, the Journal said. Contributors who don't qualify as authors should be listed in the acknowledgements, and authors "should disclose the identity of the people that provided the assistance and any entity that supported it," the guidelines say.
The new guidelines also urge drug makers to publish “summary results” of all clinical trials of drugs that have been approved for sale, and of drugs that have been dropped from the pipeline, the Journal said. However, experimental drugs are exempt from this guideline. Finally, the Journal reports that the guidelines stipulate that a doctor with an ownership stake in a drug should not participate in clinical trials.
According to the Journal, the new PhRMA guidelines are strictly voluntary because making them mandatory could violate antitrust laws. Time will tell whether pharmaceutical companies will comply.