Ghostwriter at work

Clinical and Translation Science Network (CTSciNet) reports on the alarming phenomenon of drug companies placing their ghostwritten articles, under the cover of independent medical researchers’ names, in the medical literature. According to CTSciNet, the trick goes something like this:

When physician Adriane Fugh-Berman of Georgetown University School of Medicine in Washington, D.C., was asked to write a review article on interactions between herbs and warfarin, she said maybe. A clinician and expert on herb-drug interactions, Fugh-Berman thought the information could be useful to clinicians who prescribe warfarin as an anticoagulant.

A few months later, a finished manuscript arrived on her desk. All she needed to do was read and approve it. She was intrigued and more than a little suspicious. She did a little research and learned that the company was working on a related drug that had not yet come up for approval by the U.S. Food and Drug Administration. By planting this paper in the medical literature, the company was preparing for the approval process by highlighting in the medical literature the deficiencies of the best-selling generic that the new drug would compete with.

Fugh-Berman withdrew, but some time later it arrived on her desk again, this time for review. She notified the journal’s editors and urged them to not publish it. Instead of the ghostwritten article, Fugh-Berman published a different article, “The Corporate Coauthor,” which appeared in the same journal — the Journal of General Internal Medicine (JGIM) — in June 2005, alongside comments from the journal’s co-editors and a statement from the World Association of Medical Editors (WAME).

The phenomenon of ghostwriting is rife with moral and ethical complications, and has become fairly common among medical journals. So much so that the issue has created a discussion among peer-review journal editors to create guidelines on dealing with ghostwritten articles. Many — but not all — scientific journals have embraced these guidelines.

CTSciNet’s article outlines some of the fascinating twists and turns of a system vulnerable to exploitation:

“In most cases, [the signing author is] not being paid directly for the article, but they might have other financial arrangements with the company,” Fugh-Berman says. A physician may be paid as a consultant researcher or speaker, for example. “Some of it is just on the physicians’ part,” she says. “But there’s also the fact that this is so common that it’s not considered unusual. There’s no shame attached to it.”

In a recent case documented in court records, the pharmaceutical company Wyeth paid ghostwriters to write dozens of papers on hormone replacement therapy. The company had researchers sign the papers to make it look like they were written independently. Published in medical journals between 1998 and 2005, the articles detailed the benefits of the therapy while minimizing its risks. Fugh-Berman is serving as an expert witness for the plaintiffs in a lawsuit brought by patients against the company.

Fugh-Berman says that, according to court documents, most of Wyeth’s ghostwriters worked at MECs (medical-education companies.) MECs — or more precisely, some of them — often target pre-tenure faculty members who are eager to publish….

Guidelines are emerging as journals try to crack down on the practice. The American Journal of Physicians has created a checklist for contributors regarding conflict of interest.

Fugh-Berman tells CTSciNet, “Creating enforceable, specific publication guidelines prohibiting ghostwriting can be tricky, because researchers may not recognize conflicts of interest obscured by the intermediation of MECs. And the practice of not paying authors helps to maintain a ‘pseudo-academic air’ about the enterprise.”

Martha Gerrity, a clinician-educator and health-services researcher at Oregon Health & Science University in Portland, is quoted as saying, “It’s very well thought out, the use of the medical literature as a marketing tool. But it’s very subtle.” And she goes on to say, “The key is for researchers and institutions to be specific. Saying that people can’t participate in ghostwriting is not useful if people don’t know exactly what ghostwriting is. You have to spell things out so that it mentions the euphemism that industry uses, and that is editorial assistance.”