How much of medical literature is shaped behind the scenes by drug companies?

There are many reports of medical journal articles being researched and written by or on behalf of pharmaceutical companies, and then published under the name ofacademics who had played little role earlier in the research and writing process.

In extreme cases, drug companies pay for trials by contract research organizations (CROs), analyze the data in-house, have professionals write manuscripts, ask academics to serve as authors of those manuscripts, and pay communication companies to shepherd them through publication in the best journals. The resulting articles affect the conclusions found in the medical literature, and are used in promoting drugs to doctors.

For example, as reported in The New York Times [4], an Annals of Internal Medicine article on Merck’s “Advantage” trial of Vioxx omitted some trial participants’ deaths. Distancing himself from the Annals article, author Jeffrey Lisse said in an interview that“Merck designed the trial, paid for the trial, ran the trial…Merck came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at Merck, and then it was sent to me for editing” [4].Ethics?

Drug companies control or shape multiple steps in the research, analysis, writing, and publication of a large proportion of the medical literature, and they do so behind the scenes, according to a policy paper in this week's PLoS Medicine. The paper's author, Sergio Sismondo (Queen's University, Kingston, Canada), who is an expert in the philosophy of science, calls this phenomenon "ghost management."

Such articles are "ghostly" says Dr Sismondo, "because signs of their actual production are largely invisible--academic authors whose names appear at the tops of ghost-managed articles give corporate research a veneer of independence and credibility." Drug companies hire medical education and communication companies (MECCs) to help produce and place company-funded articles in medical journals, says Dr Sismondo.

These articles are "managed," he says, because those MECCs "shape the eventual message conveyed by the article or by a suite of articles." Dr Sismondo looks at one specific example—the published medical literature on the antidepressant drug sertraline. His analysis suggests that between 18% and 40% of the literature on this drug published between 1998 and 2000 was ghost managed by a single MECC acting on behalf of the drug’s manufacturer. Ghost managed studies, says the author, “affect medical opinion, practice and ultimately, patients,” says Dr. Sismondo. “I suspect that most researchers – even those participating in the system – don’t have a good sense of the extent to which this happens.”

(4) Berenson A (2005 April 24) Evidence in Vioxx suits shows intervention by Merck of. cials. The New York Times. Available: http://www.nytimes.com/2005/04/24/business/24drug.html. Accessed 22 August 2007.

Article: Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry?