WASHINGTON --- Senator Chuck Grassley has asked leading medical schools to describe their policies on ghostwriting as part of his continuing effort to shed light on financial ties between the pharmaceutical industry and medical professionals.
“I’m interested in transparency, and academic institutions play an important role in establishing adequate and meaningful disclosure. Letting the sun shine in and making information public is basic to building people’s confidence in medical research and the practice of medicine,” Grassley said.
Last July, Grassley wrote to eight leading medical journals to ask the same kinds of questions he’s presented to the medical schools. Prior to that, he asked two major drug companies about allegations that they hired ghostwriters to draft articles promoting company products and seek academics to sign on as primary authors.
Grassley also has conducted oversight and sought disclosure with physicians, continuing medical education and the patient advocacy community. He has worked to expose cases where there was vast disparity between drug-company payments received and reported by leading medical researchers. The National Institutes of Health is working on new disclosure guidelines for federal grant recipients in response to Grassley’s work.
In January, Grassley and Senator Herb Kohl introduced, for the second time, the Physician Payments Sunshine Act. The legislation would require annual public reporting by drug, device and biologic manufacturers of payments made to physicians nationwide. It was included in the health care reform bill passed in October by the Senate Committee on Finance.
Below is the text of the letter of inquiry that Grassley sent to Columbia University, Duke University, Harvard University, Johns Hopkins University, Stanford University, the University of California San Francisco, the University of Pennsylvania, the University of Washington, Washington University in St. Louis, and Stanford University.
November 17, 2009
Lee Goldman, M.D.
Executive Vice President for Health and Biomedical Sciences
and Dean of the Faculties of Health Sciences and Medicine
Columbia University
2960 Broadway
New York, NY 10027
Dear Dean Goldman:
As Ranking Member of the United States Senate Committee on Finance (Committee), I have a responsibility to the more than 100 million Americans who receive health care coverage under the Medicare and Medicaid programs to oversee the proper administration of these programs and safeguard taxpayer dollars authorized by Congress for these programs.
Two years ago, I wrote to you regarding university policies on the reporting of conflicts of interest by members of the faculty, in particular the reporting of payments from drug and device companies. I appreciate your assistance and cooperation with the Committee’s inquiries on that matter. I write today regarding another matter that should be of interest to you and your faculty members.
As you may be aware, the Committee has been examining the practice of “medical ghostwriting” used by drug and device companies. 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. When the article is then published, the participation of the “ghostwriter” may not be revealed. Essentially, the companies are using the reputation of prestigious academic researchers and their institutions to promote the sale of drugs and devices.
Articles published in medical journals are widely read by practitioners and are relied upon as being objective and scientific in nature. 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.
In August, the New York Times cited a few academic institutions that had policies on ghostwriting or were in the process of drafting such policies. However, it also reported that “many universities have been slow to react to evidence about the extent of the practice.” Thus, I am very interested in any information available regarding your university’s policies on the practice.
I have also learned that some experts refer to ghostwriting as a form of plagiarism, and I understand that institutions view charges of plagiarism quite seriously. According to one article that appeared in Inside Higher Ed, some professors even use software to detect if student papers were bought from “paper mills.”[1] Students are disciplined for not acknowledging that a paper they turned in was written by somebody else; but what happens when researchers at the same university publish medical studies without acknowledging that they were written by somebody else? As Stanford law professor, Lawrence Lessig, wrote in a letter to Harper’s in April 2007, “The rules against plagiarism, after all, require only that words borrowed be acknowledged as borrowed.”
To better understand these issues, I would greatly appreciate your response to the following questions and requests for information. Please repeat the enumerated question and follow with the appropriate response and supporting documentation.
1) What is the university’s position on medical ghostwriting and/or the use of third party marketing and/or medical education companies in drafting medical review articles and research papers for faculty?
2) Does the university have any written policies regarding ghostwritten articles? If so, please provide a copy of those policies. Also, please identify the type(s) of information faculty members are required to document and/or report to the university regarding their publication activities. In the event that your institution has made changes to its internal policies and procedures since 2004, I would also greatly appreciate understanding those changes.
3) If the university currently does not have written policies on ghostwritten articles, is the university in the process of developing a policy? If not, why not?
4) Since 2004, has the university received and/or investigated any allegations that a faculty member failed to disclose the involvement of a third party that may be paid by a device or drug company in the development and/or drafting of a manuscript? If so, how many allegations did the university receive and what was the outcome of each investigation? Were any actions taken against the faculty member? If so, please provide details.
5) Please explain the university’s position on plagiarism and its policy on students submitting papers purchased from paper mills or plagiarized in other ways.
6) Since 2004, has the university received and/or investigated any allegations that a student failed to disclose the involvement of a third party in the development and/or drafting of a paper? If so, how many allegations did the university receive and what was the outcome of each investigation? Were any actions taken against the student? If so, please provide details.
Thank you in advance for your input and assistance. I would appreciate your written response by no later than December 8, 2009.
Sincerely,
Chuck Grassley
United States Senator
Ranking Member of the Committee on Finance