The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine

Description

Never before have two revolutions with so much potential to save and prolong human life occurred simultaneously. The converging, synergistic power of the biochemical and digital revolutions now allows us to read every letter of life's code, create precisely targeted drugs to control it, and tailor their use to individual patients. Cancer, diabetes, Alzheimer's and countless other killers can be vanquished,if we make full use of the tools of modern drug design and allow doctors the use of modern data gathering and analytical tools when prescribing drugs to their patients.But Washington stands in the way, clinging to outdated drug-approval protocols developed decades ago during medicine's long battle with the infectious epidemics of the past. Peter Huber, an expert in science, technology, and public policy, demonstrates why Washington's one-size-fits-all drug policies can't deal with diseases rooted in the complex molecular diversity of human bodies. Washington is ill-equipped to handle the torrents of data that now propel the advance of molecular medicine and is reluctant to embrace the statistical methods of the digital age that can. Obsolete economic policies, often rationalized as cost-saving measures, stifle innovation and suppress investment in the medicine that can provide the best cures at the lowest cost.In the 1980s, an AIDS diagnosis was a death sentence, until the FDA loosened its throttling grip and began streamlining and accelerating approval of life-saving drugs. The Cure in the Code shows patients, doctors, investors, and policy makers what we must now do to capture the full life-saving and cost-saving potential of the revolution in molecular medicine. America has to choose. At stake for America is the power to lead the world in mastering the most free, fecund, competitive, dynamic, and intelligent natural resource on the planet,the molecular code that spawns human life and controls our health.

Peter Huber is a senior fellow at the Manhattan Institute, where he specializes in issues of drug development, energy, technology, and the law, and is also a partner at the law firm of Kellogg, Huber, Hansen, Todd, Evans & Figel. He lives in Hanover, New Hampshire.

"[An] urgent, compelling account of how 21st-century medicine is being hampered by a regulatory regime built for the science of the 20th century." --Wall Street Journal "[An] exciting and authoritative review of accelerating advances in personalized medicine." --Barron's "Spotlighting an area where federal laws and regulations lag far behind technological innovation, the author, a Manhattan Institute senior fellow, maintains that medicine's rapidly developing capacity to decode individual human genomes and tailor patients' treatments accordingly -- as with breast cancer -- is being hindered by...'outdated drug-approval protocols developed decades ago during medicine's long battle with the infectious epidemics of the past.'" --Pittsburgh Tribune-Review "A must read for physicians, patients, biotech investors, and healthcare politicians, The Cure in the Code is the most important policy book of the decade, and it could only have been written by Peter Huber, a polymathic master of both the deadly menace and huge promise of bioscience, and scathing critic of the blindness of healthcare bureaucracy." --George Gilder, author of Knowledge and Power: The Information Theory of Capitalism "A thoughtful and compelling account of how the federal government's current regulatory science is not only outdated, but risks hampering scientific efforts to combat diseases at the molecular level. Marshaling insights from medicine, law, and economics, Huber makes an urgent case for how to improve the drug and therapy regulatory system to better equip physicians with innovative treatments that meet critical patient needs." --Tom Coburn, M.D., United States Senator from Oklahoma "[Huber is] 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 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 book is sprinkled liberally with sentences that are thought-provoking gems, each worthy of an essay of its own... [A] very rich book." --National Review "Our ability to read the genetic code heralds a transformation of modern medicine. Yet many potential medical miracles remain throttled...[Huber's] ardor for invigorating pharmaceutical progress is apparent on every page." --Booklist "Intriguing." --Kirkus Reviews "A provocative, optimistic look at modern medicine... Huber's challenge is sure to spark controversy as the U.S. adapts to the Affordable Care Act." --Publishers Weekly