Grassley Asks Top Medical Journals About Ghostwriting
WASHINGTON, July 2, 2009 --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
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