the FDA's War on Drugs

Excerpts from a long article by Dr. Scott Gottlieb, former FDA deputy commissioner, in the WSJ...

Gottlieb opens with an example:

In December 2005, Eli Lilly pled guilty to a criminal indictment from the Justice Department and paid $36 million in fines and "disgorgement" of its ill-gotten gains. The company's crime was mounting a concerted effort to inform doctors that, according to leading medical authorities, the firm's estrogen-modulating drug Evista substantially reduced the risk of invasive breast cancer in postmenopausal women.

The finding came from a series of landmark national studies, some eventually touted by government research. So why the criminal charge?

At the time Eli Lilly was conveying the cancer information to doctors, the Food and Drug Administration (FDA) had approved Evista for treating osteoporosis, not preventing cancer. Only this past September--eight years after the first significant cancer prevention results were published--did the FDA approve Evista for use against breast cancer, turning Eli Lilly's crime, by some measures, into a public service.

For patients and doctors who rely on the latest clinical information to make hard decisions, no relevant scientific discovery took place between the medical findings, the legal prosecution, and the FDA's approval of those same results.

Why the problems?

In fast-moving fields like cancer, in which doctors tailor treatments based on evidence that is constantly evolving, two years can be an eternity to learn about important science. For some patients, that interval can be fatal....

This month, Representative Henry Waxman (D-Calif.) took umbrage at a copy of a draft FDA guidance (he leaked it himself), saying that, as a public health matter, the FDA found it appropriate for drug firms to share study reprints from peer-reviewed medical journals. Drug firms are personae non gratae in Washington, a result of the industry's own excesses but also of a lot of political targeting. The result is an anything-that-bashes-pharma-goes mentality in policymaking.

Drug firms tend to settle these cases. Firms have good reason to cut a deal: if they fight and lose in court, they can be banned from doing any business with government programs like Medicare. At one time, prosecutions were aimed at a handful of bad actors that encouraged prescriptions for purposes far outside popular medical practice. But like a lot of government efforts, the scope of these prosecutions expanded to encompass a much broader slice of medical activity.

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 information with doctors 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 cannot 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 ten months to consider supplemental uses for marketed drugs, and the entire process usually is much longer....

It is true that some off-label drug use is based on very unsettled science and has more risks. But medicine--and not just cancer care--involves lots of hard choices. And the more serious the disorder, often the more likely it is that for every right and wrong treatment choice there are many other practical decisions painted in shades of gray. Efforts to confine patients and doctors to FDA-approved uses have their own health consequences, raising the question: just who is in the best position to make these hard choices?...

And finally, the (Congressional) politics of all this:

This month, Representative Henry Waxman (D-Calif.) took umbrage at a copy of a draft FDA guidance (he leaked it himself), saying that, as a public health matter, the FDA found it appropriate for drug firms to share study reprints from peer-reviewed medical journals. Drug firms are personae non gratae in Washington, a result of the industry's own excesses but also of a lot of political targeting. The result is an anything-that-bashes-pharma-goes mentality in policymaking.

Politicians wage broad wars on medicine to claim thin strips of ideological terrain. This would be good political theater if there were not so many human victims.