Medical ghostwriter
Encyclopedia
The American Medical Writers Association
speaks to the topic as follows:
With medical ghostwriting, professional writers and other parties are paid — commonly (but by no means always) by pharmaceuticals and medical devices manufacturers — to produce manuscripts for conference presentations, scientific publications, explicitly promotional distributions, patient education materials, continuing professional education activities' contents, and other communications. In the pharmaceuticals and medical devices industries, physicians and other scientists are frequently permitted or paid to attach their names to these manuscripts, which are then promulgated at meetings, distributed to patients and caregivers, presented as marketing instruments, or published in textbooks and medical journals. These scientists or physicians may have little involvement in the research or the writing process.
, and the National Institutes of Health
. as well. It is permitted at some institutions, including the University of Washington School of Medicine
, while it is prohibited and considered a particularly pernicious form of plagiarism
at others, such as Tufts University School of Medicine
and the University of Pennsylvania School of Medicine
.
Scandals involving prominent physicians researchers have been reported at over a dozen universities in the United States, however, there have been no reports of any professors being disciplined.. Professor Trudo Lemmens of the University of Toronto School of Law argues that ghostwritten papers help protect companies when they are sued in court.
Professional medical writers
can write papers without being listed as authors of the paper and without being considered ghostwriters, provided their role is acknowledged. The European Medical Writers Association
have published guidelines which aim to ensure professional medical writers carry out this role in an ethical and responsible manner. The use of properly acknowledged medical writers is accepted as legitimate by organisations such as the World Association of Medical Editors and the British Medical Journal. Moreover, professional medical writers' expertise in presenting scientific data may be of benefit in producing better quality papers.
articles, 8% of JAMA
, Lancet
and PLoS Medicine
articles, 5% of Annals of Internal Medicine
articles and 2% of Nature Medicine
were ghost written. Between 1998 and 2005 Wyeth
had 26 papers promoting hormone replacement therapy
(HRT) published in scientific journals.
Previously secret internal Wyeth documents providing evidence of this are viewable on the Drug Industry Document Archive
. It also appears to have occurred in 75% of industry funded trials between 1994 - 1995 approved by the Scientific Ethical Committees for Copenhagen and Frederiksberg.
Of the articles published from 1998 to 2000 regarding sertraline
, between 18% and 40% were ghost written by Pfizer
. A questionnaire using comparable methods in 2005 and 2008 with a 14-28 % response rate found a decrease in number of people who reported ghostwriting among professional medical writers.
Most pharmaceutical companies have in-house publication managers who may either manage the writing of publications on the company's drugs by a team of in-house medical writers or contract them out to medical communication companies or freelance medical writers. Reprints of the articles can be distributed to doctors in their offices or at medical meetings by drug company representatives in lieu of product brochures. This practice might be illegal if it effectively constitutes advertising or advocating use of the drug for non-approved indications or dosages. Payments to medical ghostwriters may be augmented with consulting contracts, paid trips to teach continuing medical education courses, or grants. The academics or doctors are known as "KOLs" ("Key Opinion Leaders") or "TLs" ("Thought Leaders").
The report said, "The Committee was provided with documents from recent lawsuits involving Wyeth’s hormone therapy products. The documents showed that Wyeth hired a medical communications and education company, DesignWrite Inc. (DesignWrite), to draft review articles regarding the breast cancer risk of hormone therapy products and then invited academic researchers to sign on as the primary authors."
American Medical Writers Association
The American Medical Writers Association is the world's leading professional association for medical communicators. AMWA has more than 5,600 members in the United States, Canada, and 26 other countries. AMWA is governed by a board of directors composed of a 14-member executive committee and...
speaks to the topic as follows:
"Ghost authoring" refers to making substantial contributions without being identified as an author. "Guest authoring" refers to being named as an author without having made substantial contributions. "Ghostwriting" refers to assisting in presenting the author's work without being acknowledged. The term "ghostwriting" is often used to encompass all three of these practices.
With medical ghostwriting, professional writers and other parties are paid — commonly (but by no means always) by pharmaceuticals and medical devices manufacturers — to produce manuscripts for conference presentations, scientific publications, explicitly promotional distributions, patient education materials, continuing professional education activities' contents, and other communications. In the pharmaceuticals and medical devices industries, physicians and other scientists are frequently permitted or paid to attach their names to these manuscripts, which are then promulgated at meetings, distributed to patients and caregivers, presented as marketing instruments, or published in textbooks and medical journals. These scientists or physicians may have little involvement in the research or the writing process.
Criticism
Medical ghostwriting has been criticized by a variety of professional organizations representing the drug industry, publishers, and medical societies, and it may violate American laws prohibiting off-label promotion by drug manufacturers as well as anti-kickback provisions within the statutes governing Medicare. Recently, it has attracted scrutiny from the lay press lawmakers the Institute of MedicineInstitute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
, and the National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
. as well. It is permitted at some institutions, including the University of Washington School of Medicine
University of Washington School of Medicine
The University of Washington School of Medicine is a public medical school located in Seattle, Washington.-Overview:UWSOM is a graduate school affiliated with the University of Washington, and is the only medical school in the states of Washington, Wyoming, Alaska, Montana, and Idaho...
, while it is prohibited and considered a particularly pernicious form of plagiarism
Plagiarism
Plagiarism is defined in dictionaries as the "wrongful appropriation," "close imitation," or "purloining and publication" of another author's "language, thoughts, ideas, or expressions," and the representation of them as one's own original work, but the notion remains problematic with nebulous...
at others, such as Tufts University School of Medicine
Tufts University School of Medicine
The Tufts University School of Medicine is one of the eight schools that constitute Tufts University. Located on the university's health sciences campus in the Chinatown district of Boston, Massachusetts, the medical school has clinical affiliations with thousands of doctors and researchers in the...
and the University of Pennsylvania School of Medicine
University of Pennsylvania School of Medicine
The Perelman School of Medicine , formerly the University of Pennsylvania School of Medicine, was founded in 1765, making it the oldest American medical school. As part of the University of Pennsylvania, it is located in the University City section of Philadelphia, Pennsylvania. It is widely...
.
Scandals involving prominent physicians researchers have been reported at over a dozen universities in the United States, however, there have been no reports of any professors being disciplined.. Professor Trudo Lemmens of the University of Toronto School of Law argues that ghostwritten papers help protect companies when they are sued in court.
Professional medical writers
Medical writing
Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research....
can write papers without being listed as authors of the paper and without being considered ghostwriters, provided their role is acknowledged. The European Medical Writers Association
European Medical Writers Association
The European Medical Writers Association was founded in 1989 as a professional organisation for European medical writers, whether working freelance or in-house at pharmaceutical companies or medical communications companies...
have published guidelines which aim to ensure professional medical writers carry out this role in an ethical and responsible manner. The use of properly acknowledged medical writers is accepted as legitimate by organisations such as the World Association of Medical Editors and the British Medical Journal. Moreover, professional medical writers' expertise in presenting scientific data may be of benefit in producing better quality papers.
Prevalence
It is difficult to determine how frequently ghostwriting occurs due to its covert nature. A 2009 New York Times article estimated that 11% of New England Journal of MedicineNew England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
articles, 8% of JAMA
Journal of the American Medical Association
The Journal of the American Medical Association is a weekly, peer-reviewed, medical journal, published by the American Medical Association. Beginning in July 2011, the editor in chief will be Howard C. Bauchner, vice chairman of pediatrics at Boston University’s School of Medicine, replacing ...
, Lancet
The Lancet
The Lancet is a weekly peer-reviewed general medical journal. It is one of the world's best known, oldest, and most respected general medical journals...
and PLoS Medicine
PLoS Medicine
PLoS Medicine is a peer-reviewed medical journal covering the full spectrum of the medical sciences. It began operation on October 19, 2004. It was the second journal of the Public Library of Science , a non-profit open-access publisher. All content in PLoS Medicine is published under the Creative...
articles, 5% of Annals of Internal Medicine
Annals of Internal Medicine
Annals of Internal Medicine is an academic medical journal published by the American College of Physicians . It publishes research articles and reviews in the area of internal medicine. Its current editor is Christine Laine...
articles and 2% of Nature Medicine
Nature Medicine
Nature Medicine is an academic journal publishing research articles, reviews, news and commentaries in the biomedical area, including both basic research and early-phase clinical research. Topics covered include cancer, cardiovascular disease, gene therapy, immunology, vaccines, and neuroscience...
were ghost written. Between 1998 and 2005 Wyeth
Wyeth
Wyeth, formerly one of the companies owned by American Home Products Corporation , was a pharmaceutical company. The company was based in Madison, New Jersey, USA...
had 26 papers promoting hormone replacement therapy
Hormone replacement therapy (menopause)
Hormone replacement therapy is a system of medical treatment for surgically menopausal, perimenopausal and to a lesser extent postmenopausal women...
(HRT) published in scientific journals.
Previously secret internal Wyeth documents providing evidence of this are viewable on the Drug Industry Document Archive
Drug Industry Document Archive
The Drug Industry Document Archive is a digital archive of pharmaceutical industry documents created and maintained by the University of California, San Francisco, Library and Center for Knowledge Management...
. It also appears to have occurred in 75% of industry funded trials between 1994 - 1995 approved by the Scientific Ethical Committees for Copenhagen and Frederiksberg.
Of the articles published from 1998 to 2000 regarding sertraline
Sertraline
Sertraline hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor class. It was introduced to the market by Pfizer in 1991. Sertraline is primarily used to treat major depression in adult outpatients as well as obsessive–compulsive, panic, and social anxiety disorders in...
, between 18% and 40% were ghost written by Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
. A questionnaire using comparable methods in 2005 and 2008 with a 14-28 % response rate found a decrease in number of people who reported ghostwriting among professional medical writers.
Most pharmaceutical companies have in-house publication managers who may either manage the writing of publications on the company's drugs by a team of in-house medical writers or contract them out to medical communication companies or freelance medical writers. Reprints of the articles can be distributed to doctors in their offices or at medical meetings by drug company representatives in lieu of product brochures. This practice might be illegal if it effectively constitutes advertising or advocating use of the drug for non-approved indications or dosages. Payments to medical ghostwriters may be augmented with consulting contracts, paid trips to teach continuing medical education courses, or grants. The academics or doctors are known as "KOLs" ("Key Opinion Leaders") or "TLs" ("Thought Leaders").
Senate Investigation of Medical Ghost Writing
On June 24, 2010, Senator Charles E. Grassley, Ranking Member of the United States Senate Committee on Finance issued a report on medical ghost writing.The report said, "The Committee was provided with documents from recent lawsuits involving Wyeth’s hormone therapy products. The documents showed that Wyeth hired a medical communications and education company, DesignWrite Inc. (DesignWrite), to draft review articles regarding the breast cancer risk of hormone therapy products and then invited academic researchers to sign on as the primary authors."