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

by Peter W Huber

Overview

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But Washington stands in the way, clinging to outdated drug-approval protocols developed decades ago during medicine's long battle with the infectious epidemics of the past.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.

Product Details

ISBN-13:	9780465050680
Publisher:	Basic Books
Publication date:	11/12/2013
Pages:	304
Product dimensions:	6.52(w) x 9.54(h) x 1.05(d)

About the Author

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.

Table of Contents

Wetware ix

Part 1 Coming Apart

1 The Triumph-and Limits-of Socialized Medicine 3

2 Sniffers 13

3 Intelligent Design 23

4 Coming Apart 35

5 Reassembling the Pieces: Part 1 49

Part 2 Scientific Medicine

6 The Social Contract 63

7 A Virus Like Us 79

8 Drug Science from the Bottom Up 93

9 The Fading Myth of the FDA's "Gold Standard" 103

10 Adaptive Trials 115

11 Reassembling the Pieces: Part 2 125

Part 3 The Falling Cost of Health Care

12 Anthraxing Wall Street 137

13 Dollar Doctor Science 147

14 The Rising Cost of Helpless Care 159

15 The Falling Cost of Health Care 171

16 Reassembling the Pieces: Part 3 181

Part 4 The Culture of Life

17 Dying Alone 197

18 The Right to Sniff 209

19 The End of Socialized Medicine 217

20 The Culture of Life 227

Acknowledgments 237

Notes 239

Index 267

Editorial Reviews

09/09/2013
Digital and biochemical revolutions have made it possible to decode what ails us and help determine the remedy—if only Washington and the FDA would get out of the way—argues Huber, a lawyer and senior fellow at the Manhattan Institute, in this provocative, optimistic look at modern medicine. He envisions a free-market ideology for drug development and usage that, thanks to digital technology, will cheaply design new drugs and predict how well they perform and on whom. But Huber, who popularized the term “junk science” with his 1991 book Galileo’s Revenge: Junk Science in the Courtroom, believes Washington nudges doctors away from the Hippocratic oath to “prescribe regimens for the good of my patients” and toward “veterinarian ethics—the sick dog’s treatment is determined by the master’s willingness to pay.” There’s no middle ground in the war between the 20th and 21st century medicine, Huber believes—we must choose between medicine that deals with “biochemical reality” or is “favored by crowd doctors” who “cling to the view that if they scrutinize, track, certify, and choreograph things just right, they can deliver better medicine to all from afar.” Huber’s challenge is sure to spark controversy as the U.S. adapts to the Affordable Care Act. (Nov.)

Publishers Weekly

“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

“[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

From the Publisher

2013-10-01
Legal expert Huber (The Bottomless Well: The Twilight of Fuel, the Virtue of Waste, and Why We Will Never Run Out of Energy, 2006, etc.) contends that government intervention in the science and practice of medicine is impeding progress. The author claims that the advancement of molecular biology--the ability to decipher the genetic codes of bacteria and viruses, as well as of their human victims--allows for the practice of a new kind of individualized medicine. Cheap home-diagnostic test devices now allow patients to collect their own medical information just as diabetics routinely regulate their own insulin dosages. In the not-too-distant future, it should be possible to develop specifically tailored medical protocols based on an individual's unique genome. "[M]agic-bullet science," writes the author, can become a reality if regulatory agencies do not interfere and people are allowed to take active control of their personal treatments. Huber makes the point that the kind of broad-based, double-blind experiments currently required before a drug can be marketed will become obsolete as risk factors for particular treatments can be individualized on the basis of genetic information. He predicts a future in which "the power to read biochemical text" will be democratized and information will be deposited on the digital cloud. Patients will be directly connected "with the biochemists and doctors who design clever fixes and patches and find new ways to use them as well." Huber, an opponent of Obamacare, suggests that past public policy initiatives regarding vaccination and sanitation have served their purposes and that "collective solutions" to medical issues are becoming counterproductive. The "triumphs of socialized medicine are behind us now," he writes. Huber's political polemics detract somewhat from an otherwise intriguing discussion.

Kirkus Reviews