Healthy Skepticism Library item: 15933
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: media release
Grassley asks top medical journals about ghostwriting
United States Committee on Finance 2009 Jul 2
http://www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=21624
Full text:
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:
1. What is the journal’s position regarding the practice of ghostwriting?
2. Does the journal have any written policies regarding ghostwritten articles? If so, please
provide a copy of those policies.
3. Is an author who submits an article for publication required to disclose to the journal the
direct or indirect involvement of any drug or device company or other third party in the
development and/or writing of the article?
4. What are the journal’s policies or practices regarding public disclosure of the
involvement of any drug or device company or other third party in the development
and/or writing of a journal article, in particular when the listed authors are not affiliated
with the company or third party?
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.
Sincerely,
Charles E. Grassley of Iowa
United States Senator
Ranking Member of the Committee on Finance
