WASHINGTON – Senator Chuck Grassley has asked eight leading medical journals to describe their policies and practices regarding ghostwriting.
Grassley said his inquiry is part of his broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals.
"Public dollars and the public trust are at stake in the practice of medicine, and the information that is shared in these journals can influence decisions made by doctors and their patients," Grassley said. "Transparency can do a lot of good in building confidence that there's nothing to hide, and that applies to how expert opinion is presented in public forums like these journals provide."
In December, Grassley wrote to Wyeth and DesignWrite, a medical education and communications company, regarding allegations that Wyeth hired DesignWrite to draft articles promoting the company's hormone therapy products and seek academic investigators to sign on as the primary authors. Previously, Grassley had written to Merck and Scientific Therapeutics Information, a medical publishing company, regarding similar allegations reported in the Journal of the American Medical Association related to articles on Merck's VIOXX studies.
Below is the text of the letter of inquiry that Grassley sent to the American Journal of Medicine, the Annals of Internal Medicine, the Annual Review of Medicine, the Archives of Internal Medicine, Nature Medicine, PLoS Medicine, The Journal of the American Medical Association, and The New England Journal of Medicine.
July 1, 2009
Dear Dr. ________________:
The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs. As a senior member of the United States Senate and as Ranking Member of the Committee, I have a special responsibility to the more than 100 million Americans who receive health care coverage under those programs to ensure that beneficiaries receive drugs and devices that are both safe and effective.
Over the last year, the Committee has been examining a practice used by drug and device companies referred to as "medical ghostwriting." This practice involves payment from these companies to marketing and/or medical education companies to draft review articles, editorials, and/or research papers on the drug or device companies' products. The draft articles, editorials and/or research papers are then presented to prominent doctors and scientists, particularly those affiliated with academic institutions, to sign on as authors, whether or not they are intimately familiar with the underlying data and relevant documentation. It has also been alleged that the listed authors sometimes have minimal or limited input in the development and/or writing of the article. When published, the actual involvement of these listed "authors" is not always clear.
Articles published in medical journals are widely read by practitioners and are relied upon as being objective and scientific in nature. Concerns have been raised, however, that some medical literature may be little more than subtle advertisements rather than independent research. The information in these articles can have a significant impact on doctors' prescribing behavior and, in turn, on the American taxpayer, as the Medicare and Medicaid programs pay billions of dollars for prescription drugs and medical devices. Any attempt to manipulate the scientific literature, which can in turn mislead doctors to prescribe treatments that may be ineffective and/or cause harm to their patients, is very troubling.
As the editor of a major medical journal, you may be able to shed light on the role companies may play in the dissemination of information about their products through medical literature. Accordingly, I would appreciate your response to the following questions:
5. Since 2004, has the journal taken action against any author for failing to disclose the involvement of a third party in the development and/or drafting of a manuscript? If so, please provide details.
Thank you in advance for your assistance and cooperation. I would appreciate your written response by no later than July 22, 2009.
Charles E. Grassley of Iowa
United States Senator
Ranking Member of the Committee on Finance