Thursday, December 28, 2006
How Great Researchers Get By-lines, Get Paid, and Get Medicine in Trouble
BY KATE JIRIK

Fraud, plagiarism, intellectual dishonesty: it’s rampant in our society at the moment. Oprah gets conned by James Frey and has to apologize to her viewers. Jack Kelley scams readers of USA Today and Karen Jurgensen, the editor, precipitously retires in response. Jayson Blair fabricates stories for the New York Times and both the executive editor, Howell Raines, and the managing editor, Gerald Boyd, resign. JT Leroy is a total fabrication that takes in thousands. Little, Brown and Company are forced to withdraw Harvard University student Kaavya Viswanathan’s book, How Opal Mehta Got Kissed, Got Wild and Got a Life, over claims of plagiarism.

Thank goodness this type of fraud has not permeated the hallowed halls of academia. No university presidents have been forced to resign or retire because of unethical behavior by their academic researchers. Instead, as in the case of Aubrey Blumsohn, a senior medical professor of Sheffield University in Britain who protested potential fraud, the universities simply offer to pay out hush money to conceal the fraud.

What kind of fraud could possibly involve academic researchers and universities? The answer is the ghostwriting of research articles that appear in reputable medical journals. Let’s be very clear about our definition of ghostwriting. It’s not about substantial editorial assistance for researchers for whom English is not their first language. It’s not about articles that have multiple authors, some of whom worked on only small parts of the research project. It’s also not about honorary authorship, although it is related. Ghostwritten, as defined here, is when an article is written by one person, often someone working directly or indirectly for a pharmaceutical company, and a second person, often a well-known academic researcher, is paid for letting his or her name appear on the by-line, concealing the article’s origin. According to recent studies in JAMA and the British Journal of Psychiatry, somewhere between 11% and 50% of articles on pharmaceuticals that appear in the major medical journals are thought to be ghostwritten.

The people who sell their name are lowly, third-rate researchers, right? Unfortunately, no. They are some of the best and brightest because the pharmaceutical companies want the support of “key opinion leaders.” “Support,” you ask? Surely the articles reflect impartial analyses. Unfortunately, again, this is not an accurate assumption. According to a study in JAMA, the industry sponsored articles report more favorably on a drug than those done by independent researchers by an 8:1 margin. And the ghostwritten articles appear in more prestigious journals and are cited more often by other researchers.

Is it really a problem if some academic researchers sell their names to be the authors of ghostwritten papers? Consider the following. Ghostwritten articles overwhelmingly support the use of the investigational drug. They appear in prominent medical journals with well-known researchers listed as the authors. Drug companies then use reprints of the articles when they market the drugs to prescribing physicians. And prescribing physicians, usually unaware of the industry bias, prescribe the drug for their patients. The issue, as demonstrated in the marketing of Fen-Phen, SSRIs, Neurontin, and Vioxx, is that potentially lethal side effects are either downplayed or frequently ignored altogether. In addition, the sheer quantity of ghostwritten articles ensures that any meta-analysis that is done that might pick up these discrepancies will be skewed in favor of the investigational drug. Is this a problem? Fen-Phen has been withdrawn from the market because of its links to valvular heart disease and pulmonary hypertension. The SSRIs now carry a carry a black box warning because they may increase the risk of suicidal ideation. Court cases are just beginning over Vioxx-linked deaths.

So how does an academic researcher come to sell his/her name as an author? Academic researchers are recruited to sign off on ghostwritten articles. Although the researcher is, in theory, able to make changes in the article, the article is not submitted for publication if those changes are not in keeping with the message the pharmaceutical company wants delivered. The named author, the academician, often is not allowed access to the original data on which the analysis is based. And money most definitely changes hands from the pharmaceutical company, through the medical education company to the academic author. Parke-Davis paid a medical education company $144,000 to produce 12 articles favorable to off-label uses (that is, uses the FDA has not approved) of Neurontin. The medical education company, in turn, paid each “author” $1,000 for signing on as the author. Why would Parke-Davis pay so much? In 2003, Neurontin had $2.7 billion in sales, 80% of which was for off-label use. (An extraordinary collection of materials from the Neurontin litigation has been placed in a searchable on-line database at the University of California at San Francisco.)

It seems a bit far-fetched until you read Adriane Fugh-Berman’s article, The Corporate Coauthor, on how a medical education company attempted to recruit her as an author for a ghostwritten paper. She was approached in the summer of 2004 by a medical education company to author a review article on herb-warfarin interactions. The sponsor of the article was a pharmaceutical company that did not manufacture herbal products or warfarin. On August 24, 2004, she received a completed draft article which included a title along with her name and institution, and suggestions of journals to which it could be submitted. She was asked to submit the article back to the medical education company within one week. The ghostwritten article did not name any pharmaceuticals manufactured by the drug company sponsoring the article; it merely described numerous problems with warfarin. Coincidentally, the pharmaceutical company had developed a competitor to warfarin. Dr. Fugh-Berman refused to sign off as author of this paper. In an odd turn of events, a few months later she was asked to peer-review the ghostwritten article when it was submitted to the Journal of General Internal Medicine by a different researcher.

Let’s look at the issue from another angle. It’s arguable that ghostwriting is plagiarism. Brian Martin, in an often cited article on plagiarism, includes ghostwriting as a form of institutionalized plagiarism. The Office of Research Integrity (ORI) considers plagiarism a major element in scientific misconduct. It defines plagiarism as “the substantial unattributed textual copying of another’s work.” Many universities regard plagiarism as a form of academic misconduct that is subject to disciplinary action. A student found guilty of plagiarism for downloading a paper off the Internet and passing it off as original can receive sanctions ranging up to being suspended from school. Given that many of the so-called authors are academics and hold professorships, it would seem like the same rules should apply. And yet the ORI has not investigated a single case of plagiarism related to ghostwritten articles. A web search failed to turn up even one instance where a university had taken action to discipline an academic researcher for selling his/her name to be the author of a research article. Perhaps if you get paid to put your name on work you haven’t done, it is different from paying someone else for the privilege, although in both cases you claim someone else’s work as your own. Or perhaps the distinction has to do more with power and status--what gets a student a failing grade and what gets a professor a promotion.

But you ask, even given all this, is selling your name to appear as the author of an article you had little to do with actually fraud? Well, according to Special Assistant U.S. Attorney Cathy Young Thomer, yes, it is, “because the writing precedes the author.” The World Association of Medical Editors (WAME) agrees. In their January 2005 listserv discussion on ghostwriting for industry, the practice is condemned as unethical and possibly legally actionable. Larry D. Claxton of the EPA concurs, calling the use of ghostwriters fraudulent behavior and academic dishonesty.

So if it is fraud, why is nothing done about it? Journals often don’t know a paper is ghostwritten. When they do, they just reject the paper; they don’t follow up with the “author’s” university employer, as recommended in WAME’s Publication Ethics Policies for Medical Journals. Academic researchers who reject the opportunity to “author” a ghostwritten article have nowhere to report the incident. Universities assume their researchers are ethical and ignore evidence to the contrary. Pharmaceutical companies have no incentives to stop the practice. It’s a house of cards waiting to topple. The question is, who will take the responsibility to topple it, and what lever will they use?

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