Monday, April 23, 2007

The Haunted Medical Literature: Moffatt and Elliott on Ghost-Writing

We posted quite a bit back in 2005 about ghost-writing (see post here with links backward).

Back then it became evident that a particularly pernicious type of ghost-writing was much more prevalent than anyone seemed to realize.

This sort of ghost-writing has several important elements.
  • Commissioned by Those With Vested Interests - The writing is commissioned by an organization with a vested, usually commercial interest, e.g., a pharmaceutical company.
  • Directed to Support Vested Interests - The ghost-writer, perhaps a free-lancing medical writer or employee of a medical communication company, writes an article meant to support that organization's interest, often by setting the stage for the organization's new products. For example, a pharmaceutical company about to market a new drug may commission articles that makes the condition for which the drug is used seem particularly common or important, or which emphasizes the negative aspects of current treatments.
  • Fronted by an "Expert" - Finally, an expert, often a well-known academic, agrees to become the article's ostensible first author.

Another article in the journal Perspectives in Biology and Medicine's 2007 "medicine and industry" issue addressed the importance of this sort of ghost-writing. [Moffatt B, Elliott C. Ghost marketing: pharmaceutical companies and ghostwritten journal articles. Perspectives Biol Medicine 2007; 50: 18-31.] It made two important assertions.

Ghost-Writing Is Common

Moffatt and Elliott concluded that ghost-writing practice is common, perhaps accounting for as many as 10% of journal articles. Moreover, stealth marketing campaigns that emphasize ghost-writing may create a bolus of articles that may be enough to dominate the literature on particular topics. Moffatt and Elliott summarized some of the known campaigns, including those sponsored by Pfizer Inc to support Zoloft, by Wyeth to support Fen-Phen, and by Parke-Davis (later merged into Pfizer Inc) to support Neurontin. It is particularly worrisome that the clinical literature on a particular topic may be dominated by the products of organized stealth marketing efforts.

Ghost-Writing Is Wrong

The arguments are strong and straight-forward.

First of all, and most importantly, it is harmful to the public health. Although relatively little is known about the details of corporate ghostwriting, the glimpses that we get of it through anonymous surveys and lawsuits suggest that the reason pharmaceutical companies go through the trouble and expense of shaping medical opinion about the safety and efficacy of their products is that it is highly profitable. Marketing campaigns seek to influence the prescribing practices of doctors. Ghostwritten articles may mislead doctors about the actual risks and benefits associated with medical treatments. Medical misinformation of this sort has the risk of harming a large number of people. The potential for harm is amplified by the fact that ghostwritten articles usually bear the name of a highly respected researcher who appears to have no financial stake in the issue at hand.

Second, ghostwritten journal articles always contain undisclosed conflicts of interest. The failure to disclose conflicts occurs on many levels. The "named author" fails to disclose that he or she has received payment for agreeing to publish the paper under his or her name. The MECC fails to disclose that it has received a substantial amount of money to prepare the article and find a 'named author.' And the sponsoring company fails to disclose that it has a direct financial stake in the drug or product in question.
Furthermore, Moffatt and Elliott argue that ghost-writing undermines science.

Ghostwritten articles are useful as marketing tools precisely because they appear to come from a disinterested source. In fact, the entire program of ghostwriting is designed to give articles written by people with a direct financial interest in promoting a product the appearance of disinterestedness.

The harm done by ghostwriting is compounded by the fact that the system of scientific communication is a key aspect of scientific objectivity. One approach to scientific objectivity holds that science is objective because of its procedures. According to this view, the foundation of scientific objectivity rests in the way scientists communicate and contest results. Helen Longino (2001) argues that scientific communities are objective insofar as their communication procedures are open and contestable. But ghostwritten papers conceal the interests of authors and sponsors in a way that makes it difficult to assess and contest the scientific data, which undermines the objectivity of science itself.

Ghost-writing appears to be yet another of the common practices in the contemporary health care arena that ought to create outrage, but have attracted little notice, yet another example of the anechoic effect.

Honest medical scientists ought to be outraged that their field has been contaminated by ghost-written articles meant to sell products. Physicians ought to be even more outraged that the clinical data on which they ought to be basing decisions for individual patients has been likewise contaminated.

WHAT IS TO BE DONE? - Moffatt and Elliott do make some recommendations:

First, universities need to treat the practice of signing on to ghostwritten journal articles as a case of academic misconduct. They need to institute rules to prevent faculty members from lending their names to papers they did not write, and when they discover cases where faculty members have engaged in the practice, they need to have mechanisms in place to sanction them.

Second, lawyers should start naming ghostwriters and sham authors as defendants in litigation against the pharmaceutical industry. As things stand now, only pharmaceutical companies are financially punished for fraud, and since their pockets are so deep, the threat of litigation is not sufficient to deter them from commissioning ghosted articles. But the threat of litigation would probably deter those with more limited financial resources. Litigation could serve as a dramatic way of making ghostwriters, sham authors, and medical communications companies directly culpable for the harm caused by their fraudulent activity.

Third, there needs to be a standing committee, task force, or office with an established institutional home whose job is to gather information about potential cases of ghostwriting, to sanction authors who have been determined to participate in ghostwriting, and to disseminate information about ghostwritten papers to the public. One major difficulty in identifying ghostwritten articles is the fact that journal editors are often reluctant to identify suspected or known ghostwriters publicly. A committee to counter ghostwriting could be housed in a professional body or in a governmental institution, such as the Office of Research Integrity (ORI). Alternatively, it could be hosted in a university or a watchdog organization.

Finally, there needs to be an effective strategy for identifying and discouraging ghostwriting. To achieve this end, we propose an amnesty program where people who report their own involvement in the production of ghostwritten journal articles are offered immunity from sanction in exchange for a detailed description of their involvement. People involved with the production of ghostwritten articles but who have not reported their involvement, on the other hand, would, if discovered, receive sanctions. In the case of academic sham authors, for example, such sanctions might include restrictions on receiving federal funds for research and the forwarding of the academic misconduct case to the university of the researcher in question. The benefit of the amnesty approach is that it would offer incentives for authors to come forward and would identify previously ghostwritten papers, while also discouraging the production of ghostwritten papers in the future.

I would urge practicing physicians and physician-scientists to support these recommendations.

Otherwise, the continued production of ghost-written pseudoevidence will continue to undermine science and delude practitioners.

1 comment:

Anonymous said...

One reoccurring theme in many blogs is the difference between marketing and sales. Marketing, to be brief, is what is our product and who is our potential customer? Sales is the feet on the ground activities needed to inform, create the desire in the customer to purchase, and then act on that desire.

Unfortunately, sales classes are not taught at the college level, and along with this has been the loss of ethical discussion that should accompany these classes. Sales management, and the excesses of salespeople, are never discussed, so there is no limit on the front line people and the only driver is moving more units. This attitude now fills the psyche of many institutions.

The result has been, under the guise of marketing, ghostwriting, skewed data presentations, partial truths, and all of the other excesses we see in today's "marketing plans." The real issue is one of ethics, something business and our academic centers are failing not only their customers, but also the public.

Steve Lucas