Tuesday, October 21, 2014

Huber on the Personalized Medicine Revolution—and the Government Roadblocks

The convergence of two technological revolutions—biochemical and digital—has given rise to personalized medicine, which allows drug treatments to be tailored to the individual’s own unique genetic profile.

But the enormous promise this dual revolution holds for human health is threatened by antiquated laws and regulations, particularly the federal Food and Drug Administration. So observes Peter W. Huber in his book The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine.

Huber is a senior fellow at the Manhattan Institute for Policy Research, and his book is a fascinating read. He gives us an in-depth look at the modern drug science he dubs “intelligent design.” Huber observes:

In the last three decades, biochemists have made the transition from blind guesswork to the systematic design of precisely targeted drugs [which, in turn, has] transformed molecular medicine into an applied science anchored in immaterial code of almost limitless power and plummeting cost. [P. 23]

For example, scientists using powerful computers can now peer into the genetic makeup of individual patients to identify “biomarkers”—genetic traits that enable scientists to determine which particular drugs work for which individual patients.

But the FDA’s standard drug approval protocols, rigidly geared to one-size-fits-all “crowd” treatments for what Huber calls the “legacy germs”—infectious diseases like smallpox, cholera, and polio which earlier medicine was mainly concerned with—doesn’t jibe with the new sciences. The result: Countless valuable drugs go unlicensed or are severely restricted in their usage.

Huber also shows:

  • How low-cost “sniffers” can allow doctors and patients to monitor the individual’s own unique genetic profile, enabling them to get ahead of developing or potential health problems through lifestyle changes and/or targeted drugs—but which authorities are loath to allow. (20)

  • How Washington’s obsession with short-term cost control creates a bias against high-priced, cutting edge drugs, harming medicine’s advance and hampering the long-term drop in healthcare costs.

  • How overbearing government controls crippled the antibiotic and vaccine markets, putting us at risk of mutating germs and bioterror—and the lessons we should draw from that.

  • How temporary deregulation by a reluctant FDA helped spur rapid advances against the HIV epidemic—and the lessons we should draw from that.

  • How statist governments’ “omnipotent buyer”—or monopsony—status in the drug market can and does devalue intellectual property rights, thus repelling new private capital and deterring innovation.

  • How anti-discrimination laws and obsessions hamper the development of personalized medicine and markets.

  • How a free market enables the rich to subsidize the poor without taxes or other rights-violating policies, or stifling innovation and investment.

  • How leftists get away with the claim that socialized nations deliver cheaper care, and why that claim is nonsense. [p. 230]

There’s more. Huber’s interesting book is rich in history, facts, insight, and policy prescriptions covering the science, economics, and regulation of modern drug development. He systematically pulls it all together into a convincing call for—if not a fully free healthcare market—at least a much freer one.

From this layman’s perspective, The Cure in the Code is not only a valuable addition to the intellectual arsenal of anyone concerned about freedom and individual rights in healthcare, but also of interest to anyone—rich or poor, of whatever political persuasion—who values a future of quality, ever-more-affordable healthcare.

Related Reading:

Close the FDA’s “Loopholes” of Statism, not Freedom

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