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01-22550 gottlieb

January 2008
Stop the War on Drugs
By Scott Gottlieb, M.D.

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 aconcerted effort to inform doctors that, according to leading medical authorities, the firm’s estrogen-mod-ulating drug Evista substantially reduced the risk of invasive breast cancer in postmenopausal women. On the Issues
The finding came from a series of landmark are sharing is part of educational meetings, peer- national studies, some eventually touted by gov- reviewed journal articles, or treatment guidelines ernment research. So why the criminal charge? issued by medical-specialty societies and govern- At the time Eli Lilly was conveying the cancer information to doctors, the Food and Drug The prosecutions are aimed at recouping federal Administration (FDA) had approved Evista for money. The argument is that the medical commu- treating osteoporosis, not preventing cancer.
nity is goaded by the drug companies into filing Only this past September—eight years after the “false claims” with the government, and hospitals first significant cancer prevention results were and health plans charge Medicare and Medicaid published—did the FDA approve Evista for use for drugs used for unapproved indications.
against breast cancer, turning Eli Lilly’s crime, by Drug firms tend to settle these cases. Firms some measures, into a public service.
have good reason to cut a deal: if they fight and For patients and doctors who rely on the latest lose in court, they can be banned from doing any clinical information to make hard decisions, no business with government programs like Medicare.
relevant scientific discovery took place between At one time, prosecutions were aimed at a hand- the medical findings, the legal prosecution, and ful of bad actors that encouraged prescriptions for the FDA’s approval of those same results. In fast- purposes far outside popular medical practice. But moving fields like cancer, in which doctors tailor like a lot of government efforts, the scope of these treatments based on evidence that is constantly prosecutions expanded to encompass a much evolving, two years can be an eternity to learn about important science. For some patients, that The Justice Department rarely alleges in these cases that the scientific information is false or At issue is what is referred to as “off-label misleading, only that a firm can be “ahead of the promotion”—allegations that drug companies science” in sharing information with doctors encourage doctors to use medicines for purposes about emerging uses of medicines, even when not yet approved by the FDA. These charges are those new uses quickly become the mainstay of applied even when the information drug firms care. Underlying this, of course, is a nagging pre-sumption that doctors cannot be trusted to weigh Scott Gottlieb, M.D., is a resident fellow at AEI. A for themselves this sort of medical information version of this article appeared in the Wall Street Journalon December 17, 2007.
and thus need the FDA’s supervision.
1150 Seventeenth Street, N.W., Washington, D.C. 20036 This might be more tolerable in a world where the question: just who is in the best position to make these FDA rapidly adjudicates study results to decide what belongs in and out of drug labels. In reality, the FDA The travails of another Genentech drug, the breast reserves ten months to consider supplemental uses for cancer medicine Herceptin, demonstrate the health con- marketed drugs, and the entire process usually is much sequences of these prosecutions. Herceptin was widely longer. In many cases, doctors do not easily learn about used in advanced breast cancers for years, and recently these new drug uses or get targeted education on pre- it was found to cut recurrence by about half in some scribing without the help of the drug firm, which is the patients with earlier-stage tumors. The results were first only deep-pocketed actor with an incentive to share published early in 2005, and the new use was approved by the FDA in late 2006. The wider use of Herceptinwill save lives, but doctors did not embrace it right away.
Herceptin prescriptions spiked when the study was first published in the New England Journal of Medicine, only to tail off before spiking again at the time of FDAapproval. Those early adopters were probably familiar with the drug and the findings, perhaps through practic- ing in busy academic centers. Some of the late adoptersmight have been reluctant to take up the new use with- half of cancer medicine is practiced.
out the benefit of targeted education. You can bet thatfolks at Genentech, living under the thumb of the The Philadelphia U.S. attorney’s office has conducted Philadelphia U.S. attorney, were not about to talk up the a multiyear investigation into the biotech company Genentech. They are alleging that meetings the company The use of Herceptin in early-stage breast cancers sponsored for oncologists in the 1990s were illegal— was roughly half what you would expect for the almost because Genentech shared information about unapproved two years between publication of the study’s findings uses for its drug Rituxan, used largely in the treatment and the FDA nod. It is hard to deny that some of those of lymphoma. Nevermind that the forms of lymphoma Herceptin-eligible women who did not get the drug are for which Rituxan was to be used were largely fatal; that some of those uses are now approved by the FDA; and Attorney General Michael Mukasey could add to the that the education was based on findings from large staff manual for his attorneys a requirement that they studies, including one supported by the government. In merely check with a public health authority like the fact, if you queried the National Cancer Institute’s National Institutes of Health to see if a certain off-label website—even at the time when Genentech allegedly use falls within the scope of appropriate medical care engaged in the illegal educational activity—for advice before waging a legal war. Even that may be a hard sell on the best treatments for some of these same forms of in Washington, where prosecutions are pursued on the lymphoma, the search returned “Rituxan.” basis of how much money they can recoup.
“Off-label” is now a dirty term in the conventional lexicon, made synonymous with lawbreaking as a result (D-Calif.) took umbrage at a copy of a draft FDA guid- of these prosecutions, even though it describes the way ance (he leaked it himself), saying that, as a public more than half of cancer medicine is practiced. It is true health matter, the FDA found it appropriate for drug that some off-label drug use is based on very unsettled firms to share study reprints from peer-reviewed medical science and has more risks. But medicine—and not just journals. Drug firms are personae non gratae in Washing- cancer care—involves lots of hard choices. And the ton, a result of the industry’s own excesses but also of a more serious the disorder, often the more likely it is that lot of political targeting. The result is an anything-that- for every right and wrong treatment choice there are bashes-pharma-goes mentality in policymaking.
many other practical decisions painted in shades of gray.
Politicians wage broad wars on medicine to claim thin Efforts to confine patients and doctors to FDA-approved strips of ideological terrain. This would be good political uses have their own health consequences, raising the theater if there were not so many human victims.


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