Saturday, April 19, 2008

Ghosts in the Medicine Cabinet

Just this past Tuesday, I wrote about the federal government's efforts to enforce a policy of pre-emption, which would render moot any attempt to sue the manufacturer of a drug which had been approved by the FDA.

One of the key points I tried to emphasize was that a policy of pre-emption is implicitly reliant upon the presumption that the FDA's rulings are based on a sufficient volume of and intellectually honest array of facts regarding those drugs. I didn't expect a significant payoff to that theme so quickly, but then came this article in Wednesday's New York Times.

The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.

The article, based on documents unearthed in lawsuits over the pain drug Vioxx, provides a rare, detailed look in the industry practice of ghostwriting medical research studies that are then published in academic journals.

The report the article refers to is Guest Authorship and Ghostwriting in Publications Related to Rofecoxib, which appeared in the Journal for the American Medical Association. (Rofecoxib is the generic name for Vioxx)

Thus, as the Bush administration pushes hard for pre-emption in the pharmaceutical industry, information proving the policy's reliance on demonstrably false and potentially fatal tenets abound. From Johnson & Johnson's withholding of evidence as to the true levels of estrogen in its Ortho Evra birth control patch to an even more egregious policy of ghostwriting at Merck, the level of scientific dishonesty implicit in these revelations is astounding.

But this is more than a case of intellectually dishonest research practices. The failure to adhere to generally accepted rules governing scientific research--adherence to the Scientific Method, peer review, etc.--goes hand-in-hand with the argument against pre-emption.

If the FDA were accepted as the sole and unmutable authority governing the pharmaceutical industry, it would be imperative to prove that the rulings made by that agency were based on sound scientific judgment. Yet every day that goes by brings more evidence to the contrary.

Americans place an enormous amount of faith in the pharmaceutical industry and the FDA. That faith must be backed by an equally-large investment from the industry in scientifically and intellectually honest research practices. That it has not illustrated such a commitment is overwhelmingly evident by recent revelations. To back up that lack of commitment with a promise not to prosecute--or allow civil retribution of any kind--those dishonest practices would be a monumental failure of the FDA's responsibility to the American public.

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