An article in the latest issue of PLOS Medicine, The Haunting of Medical Journals: How Ghostwriting Sold “HRT”, details the use of ghostwriting as a marketing tool for pharmaceutical companies. It is a chilling discussion of how at least one pharmaceutical company, Wyeth, used the peer-reviewed literature as a method of distributing marketing messages to physicians.
The author, Adriane J. Fugh-Berman, details a practice that cuts at the heart of science-based medicine – the exploitation and distortion of the literature. The medical profession needs to jealously guard the legitimacy and purity of the peer-review process and the medical scientific literature. I am never one to gratuitously bash “Big Pharma” – this is often used as a method of casually dismissing inconvenient scientific evidence. But at the same time, pharmaceutical companies are in the business of making money. While they are a carefully regulated industry, some in the industry seek ways to skirt around regulations that limit their ability to market their products.
While most physicians consider themselves savvy with respect to pharmaceutical marketing, the story told by Fugh-Berman is one of profound naivete. I guess it should not be a surprise that some academics were bamboozled by expert salespersons who spent a lot of time and effort, apparently, figuring out ways to deceive and manipulate them. But now that the story is out, naivete is no longer an excuse. Here is what happened:
The FDA regulates what pharmaceutical companies can say in their marketing. For example, they are restricted to promoting on-label indications. However, the FDA does not regulate the peer-reviewed literature, and so some pharmaceutical marketers felt that this was a good opportunity to distribute marketing messages outside of FDA control. The primary process was to ghostwrite review articles, commentaries, case series, as well as the occasional primary trial report – and then have “thought leader” physicians sign their name and “author” the article.
This was done under the guise of “editorial assistance,” and “authors” were given the opportunity to edit and make changes to the draft they eventually signed off on. But the entire process was under the careful control and scrutiny of marketers who closely guarded the marketing messages in the paper. These messages included playing up the benefits of a treatment (the paper focuses on hormone replacement therapy), downplaying side effects, criticizing competitors, and promoting off-label use. Review articles are a great place to do this, because there is a great deal of judgment that goes into what to emphasize, and exactly how to present the facts. It is possible to influence opinions in this way without lying, and unless someone was looking for systematic bias it might not be apparent.
Some authors did give significant push-back against this process, but they were “managed.” The ghostwriters also helped to manage the peer-review process, suggesting responses to the editors and reviewers in order to defend core marketing messages.
All of this behavior is documented in 1500 documents revealed in litigation.
The author concludes:
Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.
I completely agree. Reading the description of the ghostwriting process detailed in this paper was beyond disturbing. It gives the image of a callous disregard for the scientific process and a view of physicians and the scientific literature as something to be manipulated.
It is not clear how extensive the practice of ghostwriting is. I have never personally encountered it myself, but this fact is not terribly enlightening. What is clear is that academic institutions and peer-reviewed journals need to take definitive measures to eliminate the practice of ghostwriting articles. The behavior needs to be simply not tolerated. It may also be necessary for the FDA to ban the practice, since it is used as a means to thwart FDA regulations of pharmaceutical marketing.
I do not begrudge the pharmaceutical industry the ability to fairly market their products. But there needs to be an absolute wall of separation between the scientific process and the marketing process, and that means keeping pharmaceutical company ghostwriters out of the scientific literature.