The Grassley Crusade against Medical Ghostwriting: Let's Not Burn Witches at the Stake

by Rena Steinzor

August 21, 2009

Sen. Charles Grassley (R-IA), of late in the news for his role as power player in the health care debate, has long enjoyed a reputation as a Republican maverick. One reason for that reputation is his highly publicized crusade to improve ethics in the medical profession, specifically with respect to “ghost writing” of medical journal articles. In recent years, it’s become disturbingly common for pharmaceutical companies to hire public relations firms to write summaries of scientific research supporting their products and then pay hefty fees to high-profile academic researchers who sign the drafts and submit them for publication without disclosing their affiliation with their corporate sponsors.

Grassley’s campaign was first featured on the front page of the New York Times in June 2008, with an exposé on a Harvard child psychiatrist who failed to disclose the money he earned from manufacturers of antipsychotic medicines for pushing their use for children. The newspaper has also reported on a spate of ghost-written articles pushing the use of hormone replacement therapy for women. On Wednesday, it was Grassley’s demand that the National Institutes of Health crack down on the practice. Specifically, he wants to know what that august institution plans to do about its own individual researchers, as well as the primary investigators on its grants who have violated “medical ethics.”

Ghost-writing is a troubling practice in the context of academic research, and the failure to disclose such affiliations violates the policies of leading medical journals such as the New England Journal of Medicine, the Lancet, and the Journal of the American Medical Association. Universities should craft policies on the practice and educate their faculty members on its ramifications. Scientists who are careless about what they do and don’t disclose run the risk of compromising their reputations, not least of all with their peers.

But as reported by the media, Grassley’s crusade has taken on characteristics of a witch hunt, especially because the senator, who is himself well-funded by the pharmaceutical industry, seems much more interested in exposing individual scientists who have crossed his line in the sand than criticizing the companies for sponsor the ghost-writing. It’s hard to muster much sympathy for a prominent research scientist who takes millions in payments from drug companies, forgets to mention those affiliations when reporting on supposedly dispassionate research, and then gets challenged by his fellow scientists. But implying that an arm of the federal government should take steps to establish a process for punishing those individuals could degenerate into persecution, especially because analogous efforts to challenge the integrity of individual researchers have such a troubling history.

As my colleagues and I have documented extensively in our book, Rescuing Science from Politics, and elsewhere, the arena of health and safety regulatory science is littered with examples of attacks on individual researchers who discovered bad news about commercially lucrative products like cigarettes, tetraethyl lead (a gasoline additive), thyroid hormone replacements, and atrazine (the leading ingredient in several popular pesticide products). These scientists had trumped-up misconduct charges filed against them, saw their supervisors in academic research institutions harassed for promoting their careers, and spent years of their lives responding to demands that they produce their laboratory notebooks to prove they had not distorted their research. All too often, their universities abandoned them, leaving them to shoulder the daunting costs of securing legal representation and defending their reputations against attacks sponsored by big-monied special interests.

Such witch hunts, mounted by industry representatives who felt threatened by the results of the research, were completely unwarranted. Senator Grassley might or might not agree with that position. Whatever you think of the ends achieved by such attacks, however, the bottom line is that the means to achieve them were essentially the same as the means now under consideration to eradicate medical ghost-writing.

Scientific integrity and independence cannot prosper if the government or, for that matter, the university, focus on the individual, rather than the institutional pressures and powerful commercial interests that produce such behavior. Instead, Congress should consider increasing the nation’s support of university research so that industry funding does not exert such extraordinary power over whether academic scientists live or die professionally. Medical and other scientific journals should extend and toughen their policies on the disclosure of conflicts. They should consider applying a standard of stricter scrutiny to articles that concern products made by companies involved in previous violations of their disclosure rules. Professional organizations that represent research scientists, especially the American Association for the Advancement of Science, should broaden their educational programs on ethical issues. And Senator Grassley should take a more balanced, wise, and fair approach to these issues.

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