On August 5, 2009, The New York Times published an article titled "Medical Papers by Ghostwriters Pushed Therapy." Ghostwriting is a pharmaceutical industry practice of contracting with medical communications companies to write medical journal articles and solicit and pay physicians to be authors. The extent of ghostwriting in the medical literature is unknown.

The New York Times article is based on documents involving lawsuits against Wyeth Pharmaceuticals and injuries alleged to have resulted from the use of the company's hormone replace product Premarin.

The court documents provide a detailed account of how Wyeth contracted with a medical communications company to produce 26 scientific papers supporting the use hormone replacement therapy. The medical communications company outlined, drafted, and then solicited physicians to be authors even though many of the physicians contributed little or nothing intellectually to the articles.

The ghostwritten publications were typically review articles according to the court documents.

Ghostwriting is not a new phenomenon. The first large scale revelation about ghostwriting may have involved gabapentin (Neurontin) in which the medical literature was used to promote gabapentin for off-label uses.[1]

This New York Times article again underscores the increasing difficulty faced by the public and health professionals in obtaining independent information about the therapeutic value of pharmaceuticals both in journals and the references that rely exclusively on the published literature.

One strategy that the Center for Drug Information and Research follows is including Food and Drug Administration (FDA) reviews as part of our methodology in assessing the therapeutic value of pharmaceuticals. A recent commentary in the Journal of the American Medical Association concluded that "...reviews are the most complete and accurate syntheses of clinical trial data available-it is time to make better use of them."[2]

[1] Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents. Ann Intern Med 2006; 145(4):284-293.

[2] O'Connor AB. The Need for Improved Access to FDA Reviews. JAMA 2009; 302(2):191-193.

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