For the first time, academics at the University of North Carolina School of Medicine will specifically be prohibited from allowing their names to be attached to a murky authorship practice.
A revised conflict of interest policy will officially be released by the school in January and includes a sentence that prohibits ghostwriting, a practice in which a pharmaceutical company asks an academic researcher to be listed as an author of a paper that the companys employees or marketing staff has written.
Ghostwriting is submitting publications written by others in a faculty members name, and UNC will not allow ghostwriting under any circumstances, the clause states, according to Karen McCall, vice president of public affairs at the UNC School of Medicine.
Medical journal ghostwriting has been increasingly met with skepticism because it enables pharmaceutical companies to influence academic publications.
Physicians and others who read medical articles often rely on the articles to make decisions about patient health and safety, U.S. Sen. Chuck Grassley (R-Iowa) said in a statement to Medical Marketing and Media magazine in August. Because of this, its important that all parties contributing financially to the articles be acknowledged so the reader is aware of any commercial or financial interests.
Within the past three years, drug companies Eli Lilly & Company, Merck & Co. and Pfizer Inc., have faced claims that they used deceptive marketing practices, including ghostwriting, to promote their drugs, according to a July 2009 Bloomberg News article.
This is very hard to regulate, said Jeffrey Lacasse, assistant professor at the School of Social Work at Arizona State University.
Lacasse co-authored a study published in the Public Library of Science Medicine journal in February that examined the ghostwriting policies of the nations top 50 academic medical centers as ranked by the U.S. News and World Report in 2009.
Eighty percent of the institutions, including UNC, did not have formal policies that explicitly prohibited the practice, the study found at the time it was released. Lacasse said that he is waiting for more schools to add policies before he updates his study next year.
Our biggest concern is that people may have enacted policies that arent very good policies, he said.
UNC School of Medicines conflict of interest policy, set to be about 70 pages long, contains just one sentence referring to ghostwriting. Lacasse said it was not one of the best policies he had seen because it did not more specifically define the practice or provide examples.
If thats the entire policy, it suggests they dont understand the complexities of it or at least arent choosing to address the complexities, he said.
Lacasse said the ghostwriting policy by Johns Hopkins University School of Medicine is a model. It addresses a type of ghostwriting that occurs when an academic is asked to make minor revisions to an article so that he or she can be listed as an author.
To be an author you need to be a substantive contributor to an article, said Julie Gottlieb, assistant dean for policy coordination at the Johns Hopkins University School of Medicine. We had a committee of senior faculty develop this policy, and I agree. Making minor revisions to an article doesnt justify authorship.
Sherrie Settle, UNC director of pre-award services in the office of sponsored research and the former UNC assistant director for research compliance, worked on the new conflict of interest policy. Settle read Johns Hopkins policy before drafting UNCs, she said, but indicated she stands by the ghostwriting policy drafted by the committee.
Theres really no reason to say any more [ghostwriting is] not allowed, she said.
Eli Lilly and Zyprexa
In 2001 the Food and Drug Administration put a warning on Droperidol, a frequently prescribed antipsychotic for the treatment of schizophrenia, citing that deaths were associated with the drug, according to the FDA Website.
Eli Lilly sought to fill the demand for a new antipsychotic drug by aggressively marketing Zyprexa, one of its own drugs. The company put together a Pre-Launch Feature Outline which detailed steps for drafting an article that showed Zyprexa in a positive light, according to court documents made public in May 2009. The documents are from lawsuits involving Eli Lillys marketing practices. Eli Lilly paid $1.42 billion to the U.S. government and more than 30 states in a January 2009 settlement for deceptive marketing practices, according to the Bloomberg article.
Eli Lillys outline suggested that a key opinion leader, or KOL, should be commissioned to author the article. The company was to execute this either by drafting the full feature for KOL review or by giving the outline to a KOL to develop the feature.
After researching court documents in 2009, Bloomberg News cited a separate research article as an example of how heavily involved pharmaceutical companies can be in academic publications. The 2002 Journal of Clinical Epidemiology article, A retrospective cohort study of diabetes mellitus and antipsychotic treatment in the United States, was co-authored by John Buse, a professor of medicine at the UNC School of Medicine, and others, including an Eli Lilly researcher.
A previous study called The risk of developing diabetes in users of atypical antipsychotics, presented at the American College of Neuropsychopharmacology annual meeting in 2000, suggested that Olanzapine, the generic name for Zyprexa, posed an increased risk for diabetes.
Buse and others wrote their article in response, and it concluded that Olanzapine presented no more of a risk for diabetes than any other antipsychotic drug. Buse, who is listed as the primary author of the paper, was president of the American Diabetes Association at the time.
Bloomberg News examined emails showing that an Eli Lilly official had contacted the journals editor about getting Buses paper published. Suraja Roychowdhury, who was Eli Lillys senior scientific communications coordinator, contacted André Knottnerus, editor of the Journal of Clinical Epidemiology, to ask why there was a delay in publication of Buses article. Knottnerus wrote back in an email, It is a bit strange to be contacted via the Lilly Product team. Dr. Buse [and] co-authors can contact us directly next time.
It is unusual for a commercial product team to follow up on an independent scientists article. Lacasse said.
Contacted about the issues raised by the article, Buse said the paper was not ghostwritten.
When Im working on these papers with the pharmaceutical industry, I dont get paid by the industry to do it, he said, adding thats why he let the Eli Lilly communications department handle the promotion of the paper.
Buse said that he has been asked if he would be listed as an author on a ghostwritten article in the past.
My personal policy has always been that if I would be an author on a paper, I am going to make a substantial contribution to the paper, he said.
Buse, who added he has never been offered money to put his name to an article, said he avoids involvement with the antipsychotic pharmaceutical industry today.
They have this horrendous marketing battle by 10 different companies that are marketing antipsychotic drugs, he said. Various opinion leaders are lying with one drug or another, and in general the literature is filled with bad science and analysis.
The policys effect at UNC
McCall, the medical schools vice president of public affairs, doesnt anticipate that the introduction of the ghostwriting policy will have an impact, because she doesnt think it is a problem at UNCs School of Medicine.
Theyre practices that become unacceptable over time, and everyone is looking at pharmaceutical relationships as one that should be arms length, she said. Once you come to that awareness, then a number of practices that were common suddenly look very strange.
Settle, who was involved in drafting UNCs policy,said she doesnt know whether any UNC faculty members have been involved in medical journal ghostwriting.
Certainly if we had found out we would have been most displeased to find our researchers or clinicians in the media that way, she said. It is the kind of thing that ruins peoples careers.
The new UNC policy does not outline sanctions for faculty members who are found to be participating in the practice, but McCall said anyone found to misrepresent information would be subject to the judgment of supervisors.
Lacasse said he spoke with professors while researching the topic but found no known instance in academia when someone has been subject to disciplinary action for ghostwriting. But an unpublished 2009 study by editors at The Journal of the American Medical Association suggested that it is still a problem. The study used an anonymous online survey to ask 630 authors of journal articles if a ghostwriter had ever contributed to one of their published works.
The study found that, on average, 7.8 percent of their articles, which appeared in six top medical journals, had been ghost authored in 2008.
It always will be this dark figure, this shadowy thing that we cant see very well, Lacasse said. Really strict policies at the academic medical centers thats the only thing I can think of that would change behavior.
Laura Montini, a senior from Ramsey, N.J., is a multimedia journalist for the Reese Felts Digital News Project.