Ghost Writing: A Created Crisis

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JAMA and the New York Times are creating a crisis, this crisis is worried about who helped who write medical research papers .  New York Times calling ghostwriting practices in medical research unethical are unfounded.   While their biased articles want readers to believe medical research articles “are drafted by drug company-sponsored ghostwriters and then passed off as the work of independent academic authors,” they misstate the facts entirely. Medical research is a multistage process, and what one person may contribute at the very beginning usually tends to be completely different at the end.

In a recent article, they even go as far as saying that “some drug makers have gone to great lengths to turn scientific articles into marketing vehicles for their products.” What they forget to mention of course is just how such drug makers make such great lengths.

Drug makers market their products to inform doctors of new breakthroughs and research that will help treat patients and save lives. As a patient or consumer, wouldn’t you want a drug maker to take such a great length if it could help you?

While recent coverage of ghostwriting has noted that editors of journals are imposing tougher disclosure policies for academic authors by punishing authors who play down extensive contributions by ghostwriters, this practice will only hurt patients. In fact, the suggestion that medical journal’s are already beginning to ‘ghostbust’ is a sign in the wrong direction for research and collaboration. Especially considering the fact some feel that ghostwriting has only become a more serious issue because it has been discovered “in manuscripts about life-and-death products like cancer and hematology drugs.”

Although medical research being published on life-and-death products deserves attention, editors and journals should not be preventing such research based on misinformation about ghostwriting. What is causing media to scapegoat practices such as ghostwriting, which has been around in many forms for many years, is the new push for health care reform. Specifically, the assumption that money can “be saved and medical care improved by relying more heavily on research showing which drugs and procedures are the most effective.”

The media dramatizes such assumptions by making claims that so called ‘experts’ “fear that the comparative effectiveness process could be corrupted if research articles are skewed by the hidden influence of drug or medical device makers.” This fear is problematic for many reasons. First, without the support of industry sponsoring such manuscripts to begin with, important research would never start, let alone be approved to help treat patients. Second, industry sponsorship of research does not constitute a conflict, it represents an investment in science to help patients by working with physicians and medical schools. Lastly, ghostwriting speeds up the process of both research and funding without hurting patients because it allows clinical trials and evidence to be found sooner.

While the International Committee of Medical Journal Editors, defines an author as a person who makes a substantial contribution to developing a study or analyzing its results and in drafting a manuscript, and who approves the final version of an article, this definition is extremely vague. Who is to determine what a ‘substantial contribution’ is? What stage does a contribution begin at during research? Journalists and Congress need to address these concerns before going on a crusade against medical research and industry who are constantly trying to help patients.

Signs of cooperation from industry are already occurring, according to Jeffrey K. Francer, assistant general counsel of the Pharmaceutical Research and Manufacturers of America who said that companies will abide by new standards in October regarding ghostwriting practices. Mr. Francer, also noted that taking any more extreme measures concerning ghostwriting “could be detrimental because they could chill research and chill support for research.”

What everyone seems to forget is that “Ghost Writing” is prevalent in all of science and not just medicine. If the practice is so evil than all the graduate assistants and university researchers should be named authors in papers. If the standard of substantial contribution is held then elected officials should disclose at the beginning of their speeches who wrote their speeches, and begin each constituent letter with Jim from my staff says….. All advertising should include the credits, all corporate brochures the same.

If industry and medical research companies must devote significant resources for disclosing authors, there will be less time to focus on the actual research, and we will miss out on great inventions and innovations. If you gave a patient the option of talking to their physician for fifteen minutes about their health, what do you think they would want to know more: whether the treatment or device they receive will actually work, or whether someone’s name was or was not on an article about that treatment?

Next time President Obama or Senator Baucus or Senator Kohl speak about health care, journalists and the public should be asking who helped them formulate their opinions about health care.

Last time we checked, none of them had medical training, and it’s unlikely that any of their staff do. What is more likely is that their staff has worked for industry or special interest groups, and politicians are concerned about healthcare to win votes.

Journalists need to get their sources straight about a practice they too often value as well, unnamed sources of information. Doctors, industry, and medical research has only advanced and helped keep Americans healthier and longer since the practice of ghostwriting became prevalent. If taking no credit for such breakthroughs has led to such success, then we should respect those men and women who have provided their dedication to making us healthier by letting them spark the ideas for research.

An interesting comment was submitted to Nature on this issue:

'the JAMA author found that commercially funded papers had dropped from 60% to 47% of studies published in JAMA, while increasing slightly at the other two journals. Catherine DeAngelis, editor of JAMA, says the journals overall publication rate, impact factor and advertising sales have not gone down. One possible interpretation, both say, is that companies with something to hide are avoiding JAMA. They are not going to send it to us if there is going to be hanky-panky,says DeAngelis.'

 

Indeed not. And it's also conceivable that the lack of change means that there was little "hanky-panky' before. Only that doesn't fit with the preconceived notion of big pharma manipulating its audiences. Or perhaps it might mean drawing a conclusion not based on evidence. Not very scientific…

To suggest that thousands of scientists, physicians and other professionals in pharma either routinely connive to falsify data, or perhaps sit mute on the sidelines, is insulting. Have transgressions occurred? Indeed. Will they again? Indeed. But as pointed out by Stephen Kessler in his comment, misuse of data occurs in many spheres of science. I neither condone nor encourage such transgressions and they should be exposed for what they are. But to use such transgressions to tar an entire industry is disingenuous.

If one looks at the advisory board for the Vancouver meeting, there is not one single representative from industry or the service organizations that assist in manuscript preparation. Perhaps if the medical publishing industry (and it too is an industry) was prepared to engage with pharma and understand its internal processes, practical progress could be made. In the absence of meaningful dialogue, we get indignant posturing. If the topics for the Vancouver meeting had included a greater emphasis on author training and ethics, perhaps real progress could be made.

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