Tuesday, December 13, 2005

Ghost Story

There is a fascinating story in today's Wall Street Journal regarding the dreadful practice of medical research ghostwriting (the article is available on-line only for subscribers, but there is a helpful, free pop-up feature illustrating the problem). This story reveals what happens when you define deviancy downwards: what once were vices, or even crimes, become common habits.

Scientific ethics have traditionally insisted that the writers of an article be intimately associated with the research for that article: otherwise, slipshod work can go undetected. Scientific ethics have also traditionally insisted that possible conflicts-of-interest be fully revealed, at the very least, and certainly avoided if possible, to preserve one's all-important reputation for good work. Traditionally, scientific ghostwriting has been absolutely, unequivocally unethical.

Nevertheless, there is a temptation to engage ghostwriters, because writing is so time-consuming. Squeaky wheels get the grease, as they say! Pressed for time? Poor researcher! Let *us* at Smith/Merck/Glaxo/Kline do the work!

The practice of medical research ghostwriting is going to allow a series of avoidable disasters to happen. Ghostwriters, in the pay of drug companies, can write up medical research on behalf of harried medical researchers, who then check off on the work, in order to catapult (what can amount to inflated) drug company propaganda into the top-tier medical journals. The researcher gets another paper to pad their curriculum vitae, and the drug companies move the onerous drug approval process that much further along, for an eventual payoff when the drug enters the market.

I always wondered how the top medical researchers got so many papers published: their output is much higher than most scientific research fields. I thought it was because they had labs full of post-docs and graduate students hard at work, but apparently it isn't even that anymore. There is an entire group of poorly-acknowledged ghostwriters hard at work as well.

Merck's trouble with Vioxx is a perfect illustration. Someone at Merck withheld late-arriving information from the rent-a-doc at the University of Arizona whose name they were using to help promote Vioxx in the medical literature. The researcher may not have even known his reputation was in the process of being tarnished, but he should have been more wary! (The researcher says he actually had very little to do with the article - AT ALL!!!)

The Merck folks did not misconstrue data so much as they omitted data. That should still count as unethical. After all, if you were hastily trying to cross the street, and I *forgot* to tell you about the approaching traffic you failed to see (but that I did), I should share blame for the ensuing accident.

The entire enterprise of medical research has become a house of cards!

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