Professionalism/Medical Ghostwriting

Medical ghostwriting is a covert practice among the medical community by which the authors who significantly contribute to medical literature are not given credit, and the authors listed have not substantially contributed to the paper.

Introduction
Medical ghostwriting typically involves the use of hired writers from marketing companies to write research papers based on data provided from pharmaceutical companies. These hired authors are not given actual credit on the paper. Instead, credit is given to a respected researcher or physician in the field who has little or no involvement in the research or writing process. This practice appears to be primarily used by larger pharmaceutical companies seeking to strategically use these published medical papers to promote the use of their products.

The Ghostwriting Culture
Ghostwriting's presence in the medical industry can be largely attributed to an ambivalent culture that does little to prevent it. There are four major participants in the ghostwriting industry. Ghostwriters are the true authors behind many medical research papers. Honorary authors are the medical professionals who sign their name to papers despite having minimal participation in the paper's creation. The pharmaceutical industry hires the ghostwriters and recruits the honorary authors for these papers. And ultimately medical journals receive these papers to be published.

Ghostwriter's Perspective
The ghostwriters often view themselves as someone who is simply helping a researcher get their papers published quickly and in the best journals. One writer remarks, "I believe I provide a service to those who need assistance presenting their findings to the scientific community. If you have a great study but present it badly you won’t be seeing it anytime soon in NEJM." It is also viewed by some as an honorable job because they can write better than researchers and these papers will eventually be used to help people.

Honorary Author's Perspective
Honorary authors are often asked by pharmaceutical companies to simply attach their name to ghostwritten papers, but this is not the only method used. Sometimes these authors are asked to be research consultants, leading to unaware physicians attaching their names to papers they had nothing to do with.

Many honorary authors attach their names to ghostwritten papers for authorship credit. In the research community it is very important to have published papers, and in some cases, researchers have a quota of papers they need to reach. As a result, some researchers are willing to attach their names to papers they had little to do with.

There is also a lack of strict guidelines on how to handle ghost-authorship in many medical research communities. The ultimate effect is a culture that sees ghostwriting as something common, and accepted.


 * “The section on ghostwriting in WAME's code of ethics was "fairly thin and not very explicit," ... it was unclear that it would cover this type of authorship. There wasn't anything that specifically addressed the relationship between pharmaceutical industry's medical-education companies and ghost authorship.” -Martha Gerrity, co-editor of the Journal of General Internal Medicine

Pharmaceutical Company's Perspective
Pharmaceutical companies see research papers not just as a tool to disseminate information, but also as a means to advertise a drug they want to sell on the market. Ghostwriters are told to write in a way that favors the company's product, "My job was to draft a monograph that would profile the product's benefits, one of which, according to the client, was that although the bleeding could be severe, it was at least something that women could anticipate." Pharmaceutical companies also frequently attempt to publish many papers about the same research but with different honorary authors, making the case for using their drug even stronger. See Marketing of pharmaceuticalsfor more information.

Journal's Perspective
Historically journals have been lax on ghostwriting guidelines, partially leading to ghostwriting's current prevalence. Most medical journals lack specific rules on ghostwriting. However, journals are starting to adopt stricter standards for what they allow and what constitutes ghostwriting. "More than 600 biomedical journals have adopted guidelines for responsible and accountable authorship " Journals that do claim to have strict guidelines on authorship place the blame on the authors. The chief editor of PLoS Medicine, Ginny Barbour, claimed, “we are a journal that has very tough policies, very explicit policies on ghostwriting and contributorship, and I feel that we’ve basically been lied to by authors.” In general, journals treat ghostwriting as a problem of the authors rather than a problem with their own standards.

What Makes an Author
The International Committee of Medical Journal Editors (ICMJE) considers authorship based on four criteria: An author should meet all four criteria to have their name placed on the paper, otherwise they should just be acknowledged in the paper. All authors must be able to identify the contributions of each of their co-authors, and should be confident in the integrity of each co-author.
 * Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work
 * Drafting the work or revising it critically for important intellectual content
 * Final approval of the version to be published
 * Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved

Authorship Requirements Among Top Medical Journals
Science requires that all authors of a manuscript are listed, and have seen and approved the manuscript, its content and its submission to the journal. Any changes made must be approved by all authors. Also, authors must be able to explain their contributions to the manuscript. Science also requires that all funding sources and affiliations of the authors are noted so there is no source of bias.

Nature journals do not require all authors to sign the letter of submission. Changes to the author list need to be approved by a letter signed by all authors. In the manuscript, authors need to write a statement outlining the contributions of each author. The senior member of the group needs to accept responsibility for the author's contributions, as well as making sure that the data used is preserved and retrievable.

The New England Journal of Medicine (NEJM) follows the criteria stated by the ICMJE. Authors must sign a statement attesting that they fulfill the requirements. Also, any change in authorship must be approved by all authors.

Comparisons to plagiarism
The concept of ghostwriting is essentially plagiarism. Scientists are putting their name on articles they did not write. If students did this it would be considered plagiarism. However, the comparison isn't black and white. Some ghostwriters participate in the entire writing process, researching, writing and editing the paper. Some will only write while some will solely edit. Some ghostwriters do get acknowledged by the authors while others remain completely anonymous. The comparison comes down to what medical journals consider when proper and legal consent was given to leave the ghostwriters name off the manuscript.

Case Study: Adriane Fugh-Berman
Adriane Fugh-Berman is an Associate Professor of Pharmacology and Physiology at the Georgetown University Medical Center, and an expert of botanical medicine and dietary supplements. In 2004 she was asked by a medical education and communications company to author a review article about the interactions of warfarin, an anticoagulant, with herbs. The invitation mentioned that the study was funded by a drug company, which to Fugh-Berman had no clear link to the drug or herbal products. She asked for more information about the company, and heard nothing back until August 24, 2004 when she received a completed draft of the article with her name on the cover page. The marketing company requested that she review the article and return any comments or changes she wanted to make. She was also informed that the sponsoring company had a drug that would compete with warfarin, and wanted to prime the market for the arrival of their new drug.

The Corporate Coauthor
Fugh-Berman responded to this company's request with an emphatic no, and reminded herself to keep an eye out for this article. However, a few months later the article ended up on her desk again, but this time she was being asked to peer-review it for the Journal of General Internal Medicine. She immediately notified the journal's editors that this article had been ghostwritten, and urged the editors not to publish it. The journal complied, and instead published an article written by Fugh-Berman, The Corporate Coauthor. This article was one of the first exposés on the medical ghostwriting culture. It describes her interactions with the marketing company and exposed the process by which honorary authors are asked to be authors of such papers. Fugh-Berman endorses two methods to combat ghostwriting. First, journals should follow the example of the American Family Physician, which requires authors to fill out a questionnaire with specific situations to determine conflicts of interest. With this system authors have to actively lie to hide an unacknowledged author, "You can lie, but you can't say that you didn't understand the question. And I think that that's important. ... You don't want people deciding for themselves what are relevant conflicts of interest because nobody thinks their conflicts of interest are relevant." Second, Fugh-Berman advocates a public database that contains known conflicts of interest and ethical transgressions of authors. This database could then be used by medical journals when trying to determine if an article is ghostwritten or has a corporate sponsor.

Pharmed Out
In 2006 Adriane Fugh-Berman helped to found an advocacy group called PharmedOut. The mission of this organization is to advance evidence-based prescribing of drugs and to encourage physicians to choose unbiased sources for continued medical education. PharmedOut has published several articles that highlight marketing methods that pharmaceutical companies used to influence prescribing, and hosts an annual concert to discuss the role of the pharmaceutical industry in the medical community.

Woo Suk Hwang
Dr. Woo Suk Hwang, a South Korean scientist was linked to a paper with fraudulent authorship. In the two papers Hwang published in Science it was found that the data had been fabricated and thus the papers were retracted. A coauthor on this paper, Dr. Gerald Schatten, a scientist from the University of Pittsburgh tried to clear his name from this scandal, but was found guilty of "scientific misbehavior." He confirmed that he had helped write the manuscript, but didn't participate in the data collection and was rarely in contact with the other scientists. Investigators concluded that Schatten deserved credit for being an author, however assuming senior authorship was a mistake. By putting his name on this paper, Schatten enhanced his reputation and received substantial personal financial benefit in the short-term. But Schatten neglected his responsibilities of maintaining the integrity of the paper and assuming that all coauthors approved the manuscript for submission, and this came back to hurt him in the long-run.

Theory of Beneficial Skepticism
The Theory of Beneficial Skepticism is the general lesson that Adriane Fugh-Berman can teach about what it means to be a professional. It is impossible to prepare for every situation that will occur in a professional setting. Fugh-Berman had never been asked to be an honorary author before the warfarin-herb case in 2004, so she was not familiar with the methods and motivations of the medical education and communications companies. However, when approached she dealt with the situation as a skeptic. She asked for more information about the drug company and their reason for sponsoring the article, and refused to respond until she received a satisfactory response. Fugh-Berman teaches us that approaching unfamiliar situations with skepticism allows us to discern the underlying motivations of participants and to make informed ethical decisions.