Peter Huber’s The Cure in the Code is likely the best nonfiction book in years if quality is measured by the potential to improve important social policy. Huber compellingly shows how twenty-first century medicine can lengthen life and improve its quality, if only we can get rid of the twentieth century mindset of government control at the FDA and in the Obama administration. Huber does not write as a political polemicist, but as scientist, demonstrating that the model of medical treatment and discovery on which current law rests does not comport with the revolutionary nature of modern molecular and genomic medicine.
Huber concedes that, at one time, a more collectivized medicine made some sense. Early in the last century, highly contagious infectious diseases imposed substantial risks to society as a whole. Government was then right to impose a centralized regime that could order improvements in drinking water and insist on universal vaccinations. For such diseases, the FDA’s method for testing efficacy through randomized trials also worked, because generally the drugs for infectious diseases focused on stopping microbial invaders and worked the same in everyone’s body.
But in the West, infectious diseases are now largely contained. Increasing longevity now requires progress against diseases generated in large measure by our own bodies, like cancer, heart problems, and neurological disorders. Fortunately, science, with the help of genomics, can conquer these diseases by diagnosing and fixing their causes at a molecular level. But the cures for what the lay public understands to be a single disease, like breast cancer, will often differ radically depending on the patient and perhaps even her personal environmental history.
Huber explains why the new science of personalized medicine requires a revolution in government health care policy. The FDA’s traditional trials will miss many life-saving treatments if different drugs or combinations of drugs work only in small numbers of people. In addition, molecular and genomic science today is always adding to general medical knowledge not linked to any particular drug. As a result, the FDA should shift from “frequentist” to Bayesian probability analysis and legalize drugs that can be justified by combining this general information with an understanding of how the drug works. To be sure, this process will require the kind of risk-adjusted judgments bureaucrats like to avoid, but the alternative is to keep patients from enjoying the benefits of the scientific frontier.
Molecular and genomic medicine also means that further medical progress requires unlocking information about the distinctive biological makeups of patients themselves. But Huber points out that federal law places many barriers not only between patients and drug companies, but between doctors and those companies.
Finally, with its top-down enthusiasm for determining the best general practices for patients, Obamacare is also out of step with an ever-more personalized medicine. The treatment that is generally effective for many may well not be effective on you, but general rules—the stuff of law—will crowd out the individualized treatment—the stuff of new medicine. And centralizing health care policy in the federal government will discourage drug companies from investing even in this new golden age, because they may fear that the government will use its power to prevent them from getting a market return on their investment. And when they do get drugs to market, political demagogues will be aided and abetted in expropriating their profits, because drugs targeted at a few people will often require high individual prices to pay for the high cost of research.
Huber’s solution is more freedom in health care policy—more freedom for doctors and patients to collaborate with one another, more freedom for the seriously ill to take risks that to choose cures that will advance medical knowledge, and more freedom for the wealthy to spend money on cutting-edge treatment that ultimately redounds to everyone’s benefit. In medicine today, information is power and there is no better device than the market for gathering dispersed bits of information, bringing them together, and making new knowledge available in usable form as fast as possible. If the next President has any sense, he or she will make Huber his medical czar so he can euthanize the monster of current federal health regulation.