August 22, 2009

Medical Research Masking

The NYT has just exposed a disturbing trend: Medical research funded and ghostwritten for pharmaceutical companies to promote their drugs. For example, a for-profit company such a Wyeth offers to write an article, often requiring extensive review of existing literature in a particular area, say, hormone therapy, by sending a query to a professor at a prestigious medical school, such as, say, Columbia. The company also offers to pay the professor for the privilege of having her name on it, say, $25,000. The author merely has to review the article then submit it to a top medical journal without any indication of its true provenance. 

Just such a case was recently exposed from materials in litigation over Wyeth's development and marketing of menopause drugs. Wyeth had also used such practices to promote its diet drug Fen-Phen, subsequently removed from the market after it had been correlated with serious heart-valve damage. As a result, Columbia has drafted new research ethics rules:

"A new policy at Columbia took effect in January. It prohibits medical school faculty, trainees and students from being authors or co-authors of articles written by employees of commercial entities if the author’s name or Columbia title is used without substantive contribution. The policy requires any article written with a for-profit company to include full disclosure of the role of each author, as well as any other industry contribution.

But Dr. Elliott, University of Minnesota bioethicist, said universities should go further than mere disclosure, prohibiting faculty members from working with industry-sponsored writers. Policies asking only for disclosure “allow pharmaceutical companies to launder their marketing messages,” he said."

Unfortunately, Columbia has not been joined by the majority of other medical schools in drafting such a policy, though Duke is a notable exception. I think Professor Elliott has it right here. If the research is good, it should be able to stand on its own merits without having to bear the imprimatur of a professor at a prestigious university--especially of one who did little more than review the article for a hefty sum.

The fact that companies such as Wyeth feel they must cloak their research this way reveals they have something to hide. Of course if the research is sound then perhaps (as they would surely argue) they are merely the victims of prejudice as any article explicitly authored by Wyeth would likely be subject to greater scrutiny by medical journals and practitioners themselves. But their status as for-profit companies marketing a product should indeed make us more skeptical of any research they promote. As I see it, there are two main reasons why this practice is unethical:

1. It creates a conflict of interest between the professor's civic duty and the economic interest in selling a product. As such, it blurs marketing and medicine.

2. Ghostwriting is essentially a form of plagiarism in which one passes off the work of another as one's own. While it doesn't exactly rob any single author (since they are payed for their services) it keeps us from ever tracing them--and institutions such as Wyeth--as the actual origins of the research in question. As a result, it's like robbing intellectual history itself.

It's easy to understand why so few medical schools have adopted reformist policies on this problem. They, like their professors, are in a race to maintain prestige. And having their name on more articles in more places maintains that prestige. The same goes for the journals themselves, which seek to publish work by prestigious academics. It's a bit like the classic case of hockey helmets in the NHL. Before they were required, most players didn't want to wear them since they presented a competitive disadvantage by reducing visibility and maneuverability against players not wearing them. But players were usually in favor of making helmets mandatory, which eventually occurred.

Because of this game-theoretical problem, government regulation may very well need to be applied to effect real and lasting change in the medical industry, as U.S. Senator Charles Grassley has argued.