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The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine
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 But Washington stands in the way, clinging to outdated drug-approval protocols developed decades ago during medicine's long battle with the infectious epidemics of the past.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.
306 pages, Kindle Edition
First published November 12, 2013
11 people are currently reading
156 people want to read
About the author
Peter W. Huber
21 books6 followersPeter William Huber earned a law degree from Harvard University in 1982, and a doctorate in mechanical engineering from Massachusetts Institute of Technology. He is a partner at the law firm of Kellogg, Huber, Hansen, Todd, Evans & Figel, an author who writes on drug development, energy, technology, and the law and a senior fellow at the Manhattan Institute.
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Displaying 1 - 8 of 8 reviews
January 14, 2015
Good book, with some good topics that are brought up. Just wish book was a little easier to read and more clearly written.
December 10, 2018
An interesting take on the pharmacy industry, the FDA approval process and how to best design laws for the future of pharmacy.
September 25, 2015
Occasionally, I come across a book that I can't but help to classify as a must-read, whatever drawbacks it might have. This is one such book (and, fortunately, its drawbacks are minimal).
First and foremost, Peter Huber's The Cure in the Code is a damning analysis of the ability of the FDA's current regulatory system to keep up with advances in medical science. Or, as Huber so pithily puts it, germs don't "have to be smarter than our scientists anymore, just faster than our lawyers." Huber provides a detailed account of the many ways that our current regulatory system has become too sclerotic and obese to deal with the many diseases that are too complex and too linked to individual genetics to be treated with the sort of one-size-fits-all cures and vaccines that dealt with bacterial infections and viruses in the past. Huber also takes the regulatory system to task for consistently interfering with the ability of Americans to make use of diagnostic information that could lead them to make more informed lifestyle decisions even as society in general becomes more accepting of behaviors which could increase their medical risks.
Huber's closing arguments attempt to sound the death knell for "socialized medicine." And, while I am not convinced that he has made the case for ending all government involvement in health care, I do find his argument for a much more limited government role in health care to be well-reasoned and compelling.
The Cure in the Code will be particularly appealing to those with an interest in advances in medical science and policy-making as it relates to health care. It is accessible to a general audience, however, and sheds some much needed light on an area of policy that too often is dominated by a narrow debate about single-payer vs. free-market systems. But, as Huber, so convincingly argues, the current regulatory system does much to harm a patient before that patient even sets foot in a hospital or doctor's office.
First and foremost, Peter Huber's The Cure in the Code is a damning analysis of the ability of the FDA's current regulatory system to keep up with advances in medical science. Or, as Huber so pithily puts it, germs don't "have to be smarter than our scientists anymore, just faster than our lawyers." Huber provides a detailed account of the many ways that our current regulatory system has become too sclerotic and obese to deal with the many diseases that are too complex and too linked to individual genetics to be treated with the sort of one-size-fits-all cures and vaccines that dealt with bacterial infections and viruses in the past. Huber also takes the regulatory system to task for consistently interfering with the ability of Americans to make use of diagnostic information that could lead them to make more informed lifestyle decisions even as society in general becomes more accepting of behaviors which could increase their medical risks.
Huber's closing arguments attempt to sound the death knell for "socialized medicine." And, while I am not convinced that he has made the case for ending all government involvement in health care, I do find his argument for a much more limited government role in health care to be well-reasoned and compelling.
The Cure in the Code will be particularly appealing to those with an interest in advances in medical science and policy-making as it relates to health care. It is accessible to a general audience, however, and sheds some much needed light on an area of policy that too often is dominated by a narrow debate about single-payer vs. free-market systems. But, as Huber, so convincingly argues, the current regulatory system does much to harm a patient before that patient even sets foot in a hospital or doctor's office.
October 7, 2015
A really interesting take on cancer. I think the strength of the author is his ignorance on the subject - and I mean that as a compliment. Whereas other cancer books are written by doctors and have a one sided approach, Mr. Huber's has more of a laymen s approach.
He talks about how the dinosaurs had cancer, how some researchers don't even call it a disease but rather a phanomon that happens as you age, like balding or wrinkly skin. Cancer is nothing more than cellular mutations that happen to be competative advantages in your body and therefore grow without being killed by white blood cells. We were taught that life on earth would not exist without mutations that cause populations to evolve. As one ages and cells replicate, cancer is inevitable. Think of it like buying a lottery ticket everyday for the rest of your life. If you live to be 10,000 years old you have a pretty good chance of winning. Same with cellular mitosis mutations that happen to be survivors.
He mentions that obesity and smoking are the two cancer causers. Everything else is just tiny little things. Cell phones, drinking, working near power lines, all of them have a tiny tiny effect. He even challenges the notion that antioxidents prevent that much cancer and argues that they help because they often take up valuable real estate that burgers and fries might occupy. Take that POM!
Looking at cancer from an outside the cancer establishment point of view is a valuable part of the process and I'm glad I read this book.
He talks about how the dinosaurs had cancer, how some researchers don't even call it a disease but rather a phanomon that happens as you age, like balding or wrinkly skin. Cancer is nothing more than cellular mutations that happen to be competative advantages in your body and therefore grow without being killed by white blood cells. We were taught that life on earth would not exist without mutations that cause populations to evolve. As one ages and cells replicate, cancer is inevitable. Think of it like buying a lottery ticket everyday for the rest of your life. If you live to be 10,000 years old you have a pretty good chance of winning. Same with cellular mitosis mutations that happen to be survivors.
He mentions that obesity and smoking are the two cancer causers. Everything else is just tiny little things. Cell phones, drinking, working near power lines, all of them have a tiny tiny effect. He even challenges the notion that antioxidents prevent that much cancer and argues that they help because they often take up valuable real estate that burgers and fries might occupy. Take that POM!
Looking at cancer from an outside the cancer establishment point of view is a valuable part of the process and I'm glad I read this book.
March 29, 2015
Maybe 2.5 stars.
This is a pretty good general overview of the interaction between pharmaceutical companies and the regulatory environment they find themselves in (basically, what I gleaned from it, is that it's a clusterfuck of stringent FDA trial scripts and regulations that, at worst, incentivize companies to abandon their drugs), along with some history of the progression of modern medicine and interesting chemical/biological tidbits.
But, it seems that Huber is more of an academic idealist type; he advocates free market type policies that will supposedly propagate personalized molecular medicine, as opposed to the current crowd-based "one size fits all" paradigm, as well as emphasizing the benefits of doctors prescribing off-label drugs. He doesn't ever, from what I recall, take into consideration corruption at any level, from the drug company's PR guy to the company CEOs/lobbyists festering in the FDA.
That's really my main gripe with this book, it's too idealistic, too founded in unsteady assumptions of morality and efficacy of markets and companies.
Also, he has a neat writing style, albeit a bit dry and redundant at times.
This is a pretty good general overview of the interaction between pharmaceutical companies and the regulatory environment they find themselves in (basically, what I gleaned from it, is that it's a clusterfuck of stringent FDA trial scripts and regulations that, at worst, incentivize companies to abandon their drugs), along with some history of the progression of modern medicine and interesting chemical/biological tidbits.
But, it seems that Huber is more of an academic idealist type; he advocates free market type policies that will supposedly propagate personalized molecular medicine, as opposed to the current crowd-based "one size fits all" paradigm, as well as emphasizing the benefits of doctors prescribing off-label drugs. He doesn't ever, from what I recall, take into consideration corruption at any level, from the drug company's PR guy to the company CEOs/lobbyists festering in the FDA.
That's really my main gripe with this book, it's too idealistic, too founded in unsteady assumptions of morality and efficacy of markets and companies.
Also, he has a neat writing style, albeit a bit dry and redundant at times.
January 6, 2017
While this is a good book, it could have been a lot better. I felt a lot of the information and ideas were redundant. Key take away of the book: cure is indeed in the molecular code and FDA should ask for bayesian statistics for approving new drugs rather than using conventional approach of statistical significance. Peter Huber has given ample illustrations to justify each takeaway. The book seemed to make a strong case for future policy direction.
February 7, 2016
A VERY heady read. Took me nearly a month to complete. Full of a lot of hard science vocabulary. However, it's definitely one of my most influential books on my bookshelf.
July 2, 2016
If blind doctors keep treating the crowd assembled for the regulatory organs' benefit, they will lose the molecular science in the crowd. The drug won't get licensed and the disease won't get cured.
Displaying 1 - 8 of 8 reviews