Corporate-funded medical ghostwriting continues to capture public interest and to concern physicians, patients, Congress, and professional organizations such as the Institute of Medicine.
The Project On Government Oversight has assembled this FAQ to provide a guide for journalists and other interested parties.
What it is
What is corporate-funded medical ghostwriting?
What is the harm in ghostwriting medical articles?
How widespread is ghostwriting?
Is ghostwriting a type of plagiarism?
What does“editorial assistance” mean?
What is “off-label” promotion and how is ghostwriting involved?
Why it happens
Doesn’t peer review prevent ghostwriting?
Don’t universities punish faculty for signing their names to ghostwritten manuscripts?
Who's involved
Which universities and hospitals have been involved in ghostwriting scandals?
Which physicians have been involved in ghostwriting scandals?
Which medical journals have published ghostwritten studies?
Which drugs or devices have been involved in ghostwriting scandals?
Which companies have been caught in ghostwriting scandals?
Viewpoints on ghostwriting
What does the Institute of Medicine say about ghostwriting?
What does the National Institutes of Health say about ghostwriting?
What do universities say about ghostwriting?
What do medical journals say about ghostwriting?
What is corporate-funded medical ghostwriting?
Corporate-funded medical ghostwriting involves a pharmaceutical or medical device company that hires a medical communications company to draft manuscripts, or portions thereof, of research studies, review articles and editorials, supplements, textbooks, and letters to the editor. These ghostwritten manuscripts are approved internally for business objectives and then passed off for signature by prominent academics, who sometimes only ask for minor changes.
What is the harm in ghostwriting medical articles?
Ghostwriting creates an obvious conflict of interest beacause the company is paying for the manuscript—it distorts the medical literature, affecting what prescribers and consumers believe about drugs, devices, and biologics. It also drives up healthcare costs because companies use ghostwritten studies to seek approval for pharmaceuticals and devices and payment from healthcare programs. Companies present ghostwritten studies, reviews, and commentaries to doctors and other prescribers to convince them to use specific drugs and medical devices that may be more costly, and sometimes less safe. These studies are sometimes for off-label conditions.
In court, company lawyers brandish ghostwritten articles as “evidence” to attack independent research and experts who question a product’s safety and effectiveness. Ghostwritten journal articles betray the moral responsibility to patients and the effort to produce a reliable body of medical knowledge essential to evidence-based medicine.
How widespread is ghostwriting?
It’s difficult to estimate the degree of ghostwriting in medicine. After all, this practice is called “ghostwriting” for a reason—it’s supposed to remain hidden.
A study reported in The New York Times found a ghostwriting rate of 7.9 percent in The Journal of the American Medical Association (JAMA), 7.6 percent in The Lancet, 7.6 percent in PLoS Medicine, 4.9 percent in The Annals of Internal Medicine, and 2 percent in Nature Medicine. The highest rate, at 10.9 percent, was in the New England Journal of Medicine.
A study published in PLoS Medicine evaluated policies in the United States and found that only 13 of the country’s top 50 medical schools have policies that specifically prohibit ghostwriting.
In a report on medical ghostwriting by Senator Charles Grassley (R-IA), an anonymous editor of a specialty medical journal said that around one third of the articles submitted to his journal were ghostwritten. The editor added that it was clear that many of the physicians listed as authors “had limited input in the writing of the article….”
An article published in The British Journal of Psychiatry argued that almost 50 percent of publications on drugs that are still on patent are ghostwritten. One prominent academic has posited that in some areas, such as pediatric antidepressant trials, it is known that 100 percent of the articles are ghost- or company-written.
Is ghostwriting illegal?
Medical ghostwriting is not illegal, however, it is considered unethical and could result in a finding of research misconduct by the federal government. In a letter to the Project On Government Oversight, Dr. Francis Collins, director of the NIH, wrote:
[A] case of ghostwriting involving NIH-funded researchers may be appropriate for consideration as a case of plagiarism; i.e., the appropriation of another person's ideas, processes, results, or words without giving appropriate credit; or fabrication, i.e., making up data or results and recording or reporting them. Such a case would be handled by the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS), which investigates research misconduct as defined in the [Public Health Service's] 42 C.F.R. Parts 50 and 93, Policies on Research Misconduct and the Final Rule.
Ghostwriting may be illegal when it is part of other allegations such as fraud, conspiracy to commit fraud, or off-label promotion.
Is ghostwriting a type of plagiarism?
Dr. Francis Collins, director of the NIH, said that ghostwriting can be treated as a case of plagiarism. The University of Pennsylvania said that they treat incidents of ghostwriting as if they are plagiarism.
An article published in Bioethics argues that ghostwriting is a type of plagiarism.
What does “editorial assistance” mean?
"Editorial assistance" often appears in published manuscripts to disclose the work of an outside writer. However, in his report on ghostwriting, Senator Grassley concluded that “the term ‘editorial assistance’ is poorly defined and does not shed light on the specific roles played by a pharmaceutical company or other commercial entities.”
Essentially, the phrase can be and often is code for ghostwriting.
What is “off-label” promotion and how is ghostwriting involved?
The Food and Drug Administration (FDA) approves a drug or medical device product to treat a specific condition. For instance, Paxil was first approved to treat depression. However, once a drug is FDA-approved, doctors can prescribe the drug “off label” to treat other conditions. For instance, a doctor may also choose to prescribe Paxil to treat bipolar disorder, even though this is not FDA-approved.
Companies cannot advertise their products to treat conditions “off label.” However, they regularly promote off-label use with ghostwritten studies that emphasize the benefits of the products. For instance, sales of Neurontin climbed astronomically because the company seeded the scientific literature with ghostwritten studies that found Neurontin could treat a variety of diseases.
Doesn’t peer review prevent ghostwriting?
No. Peer reviewers are not investigators who are trying to ferret out research misconduct. Their job is to check the overall science and confirm that it seems potentially sound. Many ghostwritten articles are published in spite of negative peer reviews. Evidence of ghostwriting normally comes to light years later during litigation against pharmaceutical or medical device companies, when internal company documents become public.
Don’t universities punish faculty for signing their names to ghostwritten manuscripts?
Despite numerous public scandals at multiple institutions, we could find no reports of academic physicians being disciplined for ghostwriting.
For his report on ghostwriting, Senator Grassley asked the top ten medical schools in the United States if they had investigated an incidence of ghostwriting within the prior two years. According to Senator Grassley, only two schools had investigated an incident of ghostwriting—University of California, San Francisco (UCSF) and the University of Washington (UW) Medical School.
UCSF reported that a faculty member submitted a paper in which a ghostwriter had plagiarized another author’s work. The professor retracted his name from the article. UCSF recommended that the university develop resources to educate everyone about the seriousness of the matter, but did not impose sanctions because the faculty member did not know that the article had been plagiarized.
UW Medicine investigated a faculty member in 2005 who failed to disclose involvement of a third party who was paid by a drug company. They concluded that the faculty member made significant intellectual contributions to the work and had a role in writing and reviewing the manuscript. This did not violate university policy, but caused the university to release their Ghost Authorship Policy in 2007.
Which universities and hospitals have been involved in ghostwriting scandals?
Almost across the board, universities and institutions condemn the practice of ghostwriting. However, the practice is quite common. Below are just some of the medical schools and hospitals that have received attention for ghostwriting scandals:
Which medical journals have published ghostwritten studies?
The practice of ghostwriting appears widespread and has most likely affected every medical journal. For example, allegations have been reported for the following journals:
Which drugs or devices have been involved in ghostwriting scandals?
Ghostwriting appears to be pervasive in the pharmaceutical industry. Evidence of ghostwriting has come to light during litigation involving the following drug or medical device products:
Avandia Tylenol Fen-Phen Vagus Nerve Stimulator Menopausal Hormone Therapy Vioxx Neurontin Zoloft Paxil Zyprexa Which companies have been caught in ghostwriting scandals?
Ghostwriting appears to be pervasive in the pharmaceutical industry. Evidence of ghostwriting has come to light during litigation involving the following companies:
Abbott Laboratories Johnson and Johnson Cyberonics Merck EliLilly Pfizer GlaxoSmithKline Wyeth
What does the Institute of Medicine say about ghostwriting?
In 2009, the Institute of Medicine (IOM) released a report on conflict of interest in medicine titled “Conflict of Interest in Medical Research, Education, and Practice.” The report called on academic centers to ban ghostwriting:
Such arrangements (which are essentially gifts) send the wrong message about the values of intellectual independence, professional ethics, accountability, and evidence-based medicine. In the context of research, they raise questions about the objectivity of research reports that other researchers as well as practitioners and developers of practice guidelines rely on.
What does the National Institutes of Health say about ghostwriting?
Dr. Francis Collins, the director of the National Institutes of Health (NIH), was asked about ghostwriting during an interview on C-SPAN. Dr. Collins said:
I was shocked by that revelation—that people would allow their names to be used on articles they did not write, that were written for them, particularly by companies that have something to gain by the way the data is presented….If we want to have the integrity of science preserved, that’s not the way to do it.
What do universities say about ghostwriting?
For his report on ghostwriting, Senator Grassley asked the top ten medical schools in the United States about their policies on ghostwriting. All reported that they do not allow or condone ghostwriting, calling it “unacceptable,” a “violation of university policy,” “inconsistent with principles of sound research and scholarship,” and “contrary to the values and principles of academic medicine.”
The University of Pennsylvania said they consider ghostwriting to be “plagiarism."
Which physicians have been involved in ghostwriting scandals?
Prominent academic physicians at multiple universities have allegedly been involved in ghostwriting. Below are just a few examples:
Dennis Charney, Dean, The Mount Sinai Medical Center Dwight Evans, Professor and Chair, Department of Psychiatry, University of Pennsylvania Steven Haffner, Assistant Professor, Department of Medicine, Baylor College of Medicine Martin Keller, Professor of Psychiatry & Human Behavior, Brown University Marvin A. Konstam, Director, Cardiovascular Center, Tufts University School of Medicine Stan Kutcher, Professor, Department of Psychiatry, Dalhousie University Jeffrey Lisse, Rheumatology Section Chief, The University of Arizona Charles Nemeroff, Chairman, Department of Psychiatry, University of Miami Bruce G. Pollock, Head of the Division of Geriatric Psychiatry, University of Toronto Alan Schatzberg, Professor, Psychiatry and Behavioral Science, Stanford Kimberly Ann Yonkers, Professor of Psychiatry and Obstetrics, Yale School of Medicine What do medical journals say about ghostwriting?
The Journal of the American Medical Association (JAMA) published studies exposing the ghostwriting program used to push sales of Vioxx. In an accompanying opinion, JAMA’s editors excoriated doctors who sign their names to ghostwritten studies and wrote, "Individuals, particularly physicians, who allow themselves to be used in this way, especially for financial gain, manifest a behavior that is unprofessional and demeaning to the medical profession and to scientific research."
PLoS Medicine filed suit with The New York Times to gain access to hundreds of documents showing how companies used ghostwritten materials to convince women to use hormones after menopause. The journal then published an archive of the documents, a study of the documents, and an editorial that stated:
It's time to get serious about tackling ghostwriting. As has been shown in the documents released after the Vioxx scandal, this practice can result in lasting injury and even deaths as a result of prescribers and patients being misinformed about risks. Without action, the practice will undoubtedly continue. How did we get to the point that falsifying the medical literature is acceptable? How did an industry whose products have contributed to astounding advances in global health over the past several decades come to accept such practices as the norm?
Founded in 1981, the Project On Government Oversight (POGO) is a nonpartisan independent watchdog that champions good government reforms. POGO's investigations into corruption, misconduct, and conflicts of interest achieve a more effective, accountable, open, and ethical federal government.
Friday, July 01, 2011
POGO - Frequently Asked Questions about Medical Ghostwriting
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