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Ghostwriting in medicine: Would the real author please step forward?

There’s an expectation that doctors be of high moral character. An article in the April 16 edition of the Journal of the American Medical Association (JAMA) calls that into question. The white coat may have turned a shade of gray.

The article looked at the practice of guest authorship and ghostwriting in producing research papers for medical journals. These journals are the sounding board of medicine: They bring physicians the latest research and drug trial information. They influence the way we practice medicine, and because health care is so expensive, billions of dollars can tumble this way or that depending on what these journals report.

Ghostwriting (big shot signs it, little shot writes it) is not a new phenomenon in medicine, but the JAMA article provided new insight into the practice via documents made public during trials against Merck and its failed arthritis medication Vioxx. Reviewing paper trails on 96 articles published on Vioxx, the authors of the paper found a “systematic strategy to facilitate the publication of guest authored and ghost written medical literature.” In some cases, Merck employees were the true authors, and at other times medical publishing companies wrote up the papers and sent Merck contracts that read “Author(s): TBD.”

No investigator, no paper published
From a practical standpoint, companies like Merck need an external, academically affiliated investigator (typically an MD at a recognized university, medical school, or health center), because their papers won’t get published without one.

What kind of effort does it take for a physician to become primary author on a paper he or she didn’t write? The JAMA article researchers found “scant documentary evidence that the recruited authors were involved in the design or conduct of the study or made substantive contributions to the manuscript beyond minor editing.”

I was surprised to see that the “honorarium” for this kind of authorship was $750 to $2,500. That’s good pay for “minor editing,” but still, it doesn’t seem like a lot to me — not for the deeply credentialed, expert clinicians they’re supposedly looking for.

Dr. John Lesser, director of Cardiac CT and MRI at the Minneapolis Heart Institute, is an active researcher and has published numerous papers. He’s never dabbled in the ghostwriting arts, but he guesses it’s not about the money.

“It’s about getting known. It’s being known. That’s what it’s about.” Lesser told me. “The money is nothing, but if [the paper] makes you known, and you become more important in whatever it is you do — or they now recognize your importance,” Lesser added with a laugh, “then I think that’s the attraction.”

The question of financial relationships
The JAMA article also reveals problems of transparency when it comes to the financial relationship between physicians involved in research and the pharmaceutical industry. In eight percent of the Merck-sponsored clinical trials published on Vioxx, Merck didn’t mention it had funded the study. In half of the review articles produced by Merck and published elsewhere, the company was not clear about its financial sponsorship of the paper or relationship to the author.

It’s a complicated web: Companies need physicians for their clinical expertise and for access to study patients; physicians need companies to help them build a better stethoscope. There are purists in my profession who believe all medical innovation should be done by MD/PhD nuns cloistered away in mountaintop labs — no financial incentives, only the patient in mind. A nice idea, but until we decide to change it, we have the system we’re in.

But for a physician, why does collaboration with a private company always sound like collusion?

Dr. Lesser has some experience with that issue. He’s worked with companies to develop software to improve his “stethoscope,” the cardiac CT scanner. Because of his expertise, Lesser was asked to be part of a physician panel that would publish a paper in a major journal outlining appropriate use of this new technology. In doing so, he disclosed his relationship with the software company.

“I was talking to one of the insurers here about what my thoughts were on what would be appropriate for them to pay for, and the guy wrote me back and said my views were tarnished because of my relationships,” Lesser recalled. “The insurer directly said, ‘We can’t believe anything that you or all the other guys in this article’—which is everyone who knows something about the subject in the U.S. — ‘because look at all your conflicts of interest,’ ” Lesser continued. “Of course the insurer has a major conflict of interest, because if he pays money he has less.”

Disclosure seen as important
Dr. Lesser sees it this way: “There is a value in the connections [between physicians and the industry] and there is also a value in people knowing about it.”

An editorial accompanying the JAMA article concurs. It calls on medical journal editors to be much more stringent in requiring authors to disclose their true involvement, both academically and financially, with the company funding the study.

In the medical community I work within, the malfeasance noted in the JAMA paper seemed to come as no surprise. Shrugs all around. Disappointed but not shocked. Dr. Terry Rosborough, former director of the internal medicine residency program at Abbott Northwestern Hospital commented, “We’re not Dalai Lamas. We weren’t sequestered off at birth to become physicians. We’re normal people and we reflect the values of the culture around us.”

And malfeasance seems to be all the rage. 

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