Magazine January 27, 2014, Issue

Let My Patients Go

The Cure in the Code: How 20th-Century Law Is Undermining 21st-Century Medicine, by Peter W. Huber (Basic, 304 pp., $28.99)

As statements of qualified praise go, “writes well for a lawyer” is a cousin of “doesn’t sweat much for a fat chick” — it does not rise even to the level of a vacant superlative such as WFB’s “tallest building in Wichita, Kansas.” Better to say that Peter W. Huber writes well — exceedingly well — and is a lawyer. He is much more than that: a former MIT professor, a contributor to publications as diverse as National Review and Wired, a Manhattan Institute fellow, and one of the few men walking the Earth who could write a book about FDA reform that is not only profitable but pleasurable to read.

The book is exciting, in that it suggests possibilities for significant improvements in our ability to treat terrifying diseases in the near future; but it is also depressing, because its sophisticated analysis — in flying so far above the regulation–deregulation and government–market binaries that dominate so many of our policy debates — cannot help but draw one’s attention to the intellectual poverty of Washington’s practically pre-Copernican approach to important policy decisions.

The Cure in the Code begins with a brief and bracing discussion of large-scale public-health efforts in the recent past, and is hindered by no libertarian scruple regarding the successes of what Huber accurately describes as socialized medicine:

America underwrote much of the global war on smallpox and helped save hundreds of millions of lives worldwide, and because we no longer have to protect ourselves against smallpox, Americans today save as much every month in direct and indirect societal costs as their grandparents spent on the entire smallpox campaign. According to estimates made in 1994, every dollar spent on polio vaccine saved about five times as much in such costs. The measles immunization payoff was 13 to one. . . . Socialized medicine’s hundred-year war against germs did far more to improve human health and extend life expectancy than all the rest of medicine developed before or since.

The problem for policymakers today, he argues, is that “the medical future looks nothing like the medical past — the diseases are different, and so are the cures.” For very complex diseases such as cancer, the idea of a “cure” is itself problematic: Better to speak of cures in the plural, because every cancer, like every cancer patient, is unique, and the frontiers of molecular medicine have in many cases reached the point where the question no longer is “Does it work?” but “Does it work — for him?” With that in mind, Huber goes about exploring the shortcomings in public institutions, especially in law and in the regulations administered by the FDA and related agencies, and constructs a multifaceted argument that, while medical science is always by necessity a work in progress, our ability to treat diseases and to ameliorate their symptoms is now constrained much more severely by the limitations of politics than by the limitations of science.

Though never shrill, Huber is absolutely damning on the subject of the FDA, arguing that its methods are not only cumbrous and counterproductive but ultimately unethical. Forcing researchers to follow outmoded blind-trial protocols when there is available a superior alternative — the adaptive protocol, under which large databases of molecular-level information are constantly updated to provide a learn-as-you-go research method — means that many potential treatments go undiscovered or unapproved, for example those that provide significant results but only for a relatively small number of patients. Worse, it means that large numbers of patients are needlessly denied potentially life-saving treatment because they are administered placebos in order to satisfy the demands of the double-blind model.

The villain of the piece is what Huber describes as the FDA’s “thalidomide brain.” Regulatory agencies are slow to adapt to new scientific realities in part because they do not understand those new realities; but they are also hobbled by wrong lessons learned from the past. Frances Oldham Kelsey, the FDA functionary who blocked the official licensing of thalidomide in the U.S. market, is to this day a name to conjure with among regulators, and she was awarded the nation’s highest civilian honor by President Kennedy for her role in preventing official approval of the drug. The episode is a telling one: Kelsey seems to have been more or less in the dark about the specific consequences of thalidomide — she merely thought its makers were making suspiciously extravagant claims, and judged them to be shifty. More significant, her resistance to licensing the drug did not keep it from being distributed to patients, or keep those patients from suffering its ill effects; she did, however, spare the FDA the embarrassment of having given its imprimatur to thalidomide, and allow it to absolve itself of any responsibility for the drug’s horrific consequences.

#page#That lesson of bureaucratic self-protection has not been lost on the FDA, as Huber notes:

By late 2010 . . . minor deviations in testing protocols were being cited as reasons for rejecting very promising results, some involving drugs for deadly diseases for which there is no other good treatment. In 2010, for example, the FDA rejected the only medication able to treat a rare, fatal lung cancer (idiopathic pulmonary fibrosis) because the drug — which had already been licensed in Japan and was about to be licensed in Europe — had completed only one of the two large studies required by the FDA. The fraction of cancer drugs granted accelerated approval had been cut in half.

Huber lays out a fairly specific policy agenda, not only for reforming the FDA and our drug-licensing practices but also for helping to ensure that the economics of cutting-edge medical research will work toward the benefit of patients. Among his prescriptions is liberalizing the flow of information between drug manufacturers and health-care providers: Under current rules, drug companies are in many cases effectively silenced when it comes to discussing possible off-label uses of their drugs — not because their claims are not backed up by solid research, but because of innocent practices that Washington insists on calling “fraud.” Under the False Claims Act, the federal government holds that encouraging off-label prescriptions is equivalent to encouraging fraud against the federal government. “As Washington sees it,” Huber writes,

scientific truth is irrelevant in the economic fraud cases. So are the prescribing doctor’s medical judgment and the patient’s informed choice. The fraud lies in extracting money from Washington by saying things to others that Washington hasn’t certified to be true, at a time and in a manner that Washington hasn’t certified to be good. Pfizer may be sued or prosecuted if it breathes an unapproved word about Viagra to any pediatrician who prescribes the drug to infants [as a treatment for premature babies with breathing problems] and then bills the government. Even if every word breathed has an anchor in rock-solid science. Even if, by the time Pfizer gets hauled into court, the FDA itself has reviewed the science, accepted it, and approved Baby Viagra.

If there is a shortcoming in Huber’s critique, it is his implicit belief that legal and political institutions can be managed dispassionately, in a manner consistent with pure science. This is a blind spot analogous to the FDA’s “thalidomide brain,” and a few of Huber’s own anecdotes illustrate this. Our culture limits the ability of our democratic institutions to approach many of our medical challenges in even a roughly rational way. The name of Oprah Winfrey crops up more often than one would expect from such a serious book, but her impact, and the impact of those who share her style of emotion-driven analysis, is not trivial. Huber cites Winfrey’s role in distorting the public’s understanding of the AIDS epidemic — in 1987, she passed on to millions of viewers the prediction that 20 percent of heterosexuals would die of AIDS in the ensuing three years — and her spreading of destructive anti-vaccine junk science. (Oprah’s love affair with junk science has moved on to such voguish concerns as GMO food.)

Science in fact matters very little to federal health-care commissars: Under the Affordable Care Act, the federal government has positioned itself to begin subsidizing such scientifically unsupported hokum as chiropractic, acupuncture, herbal medicine, and the like. Huber’s approach would put more decisions in the hands of relatively competent authorities with local knowledge and more intelligently aligned incentives, but in the case of the FDA, as in the case of many similar agencies, the people are the regulators’ problem as much as the regulators are the people’s problem. The political incentives the FDA responds to have as much to do with Oprah as they do with what happens in Congress — possibly more.

The book is sprinkled liberally with sentences that are thought-provoking gems, each worthy of an essay of its own: “Saquinavir doesn’t care a fig about sexual orientation; it hates HIV protease and nothing else”; “Pound for pound, bacteria, viruses, and other microbes contain far more intelligence than we do”; “[Maurice] Hilleman saved lives by the carton, at grocery-store prices — acres of cartons, hundreds of millions of warm eggs replicating his genius around the world”; “We don’t choose Cherry Garcia; it chooses us.” Huber occasionally goes farther down these rabbit holes than is absolutely necessary, but it is a pleasure to follow him.

I used to suggest a year-long project to my writing students: Read T. S. Eliot’s “The Waste Land,” and then read (or at least read from) all of the works referred to in the poem: the Bible, the Upanishads, The Divine Comedy, Donne’s Devotions, The Golden Bough, From Ritual to Romance, Prothalamion, the poems of Gérard de Nerval, etc. One might undertake a similar project with Huber’s book. It is not absolutely essential that one know all about the possible role of tumors in the famous Hatfield–McCoy feud, or possess an understanding of Bayes’s theorem, or know the saga of BioThrax, to appreciate all that Huber has to offer in this very rich book, but it would be a shame to fail to make use of the selections of such a wide-ranging and insightful mind.

But start with The Cure in the Code.

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