December 17, 2007

Dr. Scott Gottlieb, a senior fellow at the American Enterprise Institute, has a terrific op-ed in the Wall Stree Journal today explaining why government lawsuits against pharmaceutical companies for their communication of "off-label" drug uses to doctors actually hurt patients:

The Justice Department rarely alleges in these cases that the scientific information is false or misleading, only that a firm can be "ahead of the science" in sharing with doctors information about emerging uses of medicines, even when those new uses quickly become the mainstay of care. Underlying this, of course, is a nagging presumption that doctors can't be trusted to weigh for themselves this sort of medical information, and thus need the FDA's supervision.

This might be more tolerable in a world where the FDA rapidly adjudicates study results to decide what belongs in and out of drug labels. In reality, the FDA reserves 10 months to consider supplemental uses for marketed drugs, and the entire process usually is much longer. In many cases, doctors don't easily learn about these new drug uses, or get targeted education on prescribing, without the role of the drug firm that is the only deep-pocketed actor with an incentive to share this kind of information.

This chilling of commercial speech is particularly harmful for cancer patients, because upwards of 50% of all cancer treatments are used off-label. The solution Scott suggests - "that [federal prosecutors] merely check with a public health authority like the National Institutes of Health to see if a certain "off-label" use falls within the scope of appropriate medical care" before launching a lawsuit - is eminently sensible.

Let's hope that someone at the DOJ is listening.

Posted by Paul Howard at December 17, 2007 09:59 AM

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