Singularity Health Law Blog

Peter W. Huber. The Cure in the Code.

Book Review: Peter W. Huber. The Cure in the Code: How 20th Century Law is undermining 21st Century Medicine.Basic Books (Nov. 2013).

Mr. Huber provides an intense guide to the exploding scientific developments in molecular medicine and the legal and regulatory impediments that threaten to cripple its promise of cheaper and more effective medicine through individualized treatment applications. Modern molecular and genomic advances in medicine, coupled with the exponential increases in computing power and attendant increase in algorithmic data analysis capability opens up the potential for great leaps in medical knowledge and treatment effectiveness.

Standing in the way, however, is the federal Food and Drug Administration with an antiquated system of approvals for new developments in medicine. Mr. Huber argues that the gold standard for FDA approval, the double blind based studies of broad effectiveness against a placebo, are too expensive, too time consuming, too unethical and too narrow. They are too narrow in the sense that they are too broad, requiring a demonstration of effectiveness in a large population, dealing with a specific medical issue, without focusing on the drugs applicability to specific molecular potential in individual cases.

The author refers to this as the “old magic bullet” model, with a single simple cause directly linked to a single effect. He asserts,

 

[A] high level of complex and statistically elusive biochemical diversity likewise makes it impossible to judge a drug’s efficacy or most of its potential side effects using a conventional, one dimensional statistical analysis of data in biochemically indiscriminate Trials.

 

Mr. Huber notes that the FDA relaxed the reins somewhat in dealing with the multi-virus issues inherent in HIV treatment, speeding drugs to market like AZT and the creation of “drug cocktails” for attacking the virus, when one drug alone was insufficient.  Since then, the FDA has retreated to a more regressive pattern of focus on testing large scale applications of individual drugs to broad populations rather than providing support for wider experimentation by doctors and patients based upon biomarkers and molecular diversity to generate the type of success and failure information that can provide meaningful advances in medical knowledge. The answer he suggests requires a radical reorientation of the FDA, with the focus of Baysean statistical analysis on a broad range of evidence.

 

WHEN WILL COMPUTERS THINK?

The Obama Administration recently announced the formation of the “Brain Activity Map Project” to be funded by the National Institutes of Health and other public and private foundations and organizations to undertake a ten year study of the human brain. The effort, which is similar to the organized effort to map the human genome is expected to cost at least 300 million dollars a year over the ten years. It is anticipated by scientists that it will be much for complex and difficult to undertake than the genome project. The hope is to develop a complete model of brain activity and the process of neuron firings that lead to cognition.

 

TROUBLING U.S. HEALTH CARE STATS.

The Institute of Medicine and the National Research Counsel announced the pre-publication release of their report on their recent comparison of health care data between the U.S. and 16 other countries which crosses all age categories. The other countries include Canada, Japan, Australia, Germany, Austria, Denmark, Finland, Norway, Portugal, Sweden, Switzerland, the Netherlands, the United Kingdom and Spain. This is a fascinating read entitled U.S. Health in International Perspective: Shorter Lives, Poorer Health is currently available to read on line for free at the National Academies Press website. The U.S. generally finished near the bottom in most categories for the population under the age of 75.  Our post 75 population, outscores their peers elsewhere. 

SHAM PEER REVIEW BOOK INTERVIEW: Greg Piche´

Those that are interested can find an interview of the author of Sham Peer Review by the Denver Press Club at the following link.

http://denver.granicus.com/MediaPlayer.php?view_id=96&clip_id=5585

WHAT HEALTH INSURANCE COMPANIES DO FOR US.

The writer and curmudgeon Ambrose Bierce once described a banker as a person who wants to sell you an umbrella on a sunny day.  A former judge and friend recently described an insurance company in similar terms as selling you coverage for everything except loss. One of the strange anomaly's of health insurance companies is that they make their money by not providing you the coverage you think that you are paying for. Health insurance companies have grown so big and powerful that in about half of the states there is little or no competition beyond two major providers. They make billions of dollars a year, but they do little for the price beyond providing a largely unnecessary financial load on the most expensive health care system by half in the world.

 

HEALTH MANDATE, RON PAUL AND THE COLLAPSE OF COMMUNITY VALUES.

The Republican Candidate’s debate last week with all of the emphasis on who is and will be the darling of the Tea Party graphically underscored the American value creep of the past four decades away from what used to be community responsibility. Rep. Paul, a physician, continues to rail against the “individual mandate” in the Health Reform legislation enacted by Congress and signed by Mr. Obama in 2009.  He views it as a slap in the face of individual rights, because it curtails personal freedom by removing the personal freedom to choose to remain uninsured, whatever the consequences.  Moderator, Wolf Blitzer, posed the question to him that if a healthy 30 year old chose not to obtain insurance but was suddenly confronted with an unexpected need for medical assistance, should be be denied treatment?  

 

BOOK REVIEW: SMART MEDICINE BY WILLIAM HANSON, M.D.

Smart Medicine: How the Changing Role of Doctors Will Revolutionize Health Care is a book soon to be published by Palgrave Macmillan is an entertaining mix of the history of medicine and promise of medical technology in the future. The history takes us through the early colonial feuds of Drs. John Morgan and William Shippen, Jr.in Philadelphia to an interesting chapter about how George Washington was killed by his doctors. Lincoln’s physicians do not show well either, but he probably would have died anyway.  There are of course other candidates for this presidential distinction such as Zachary Taylor, but enough said.

BOOK REVIEW: TYPOGRAPHY FOR LAWYERS by Matthew Butterick, Jones McClure Publishing, Houston, Tx (2010).

Forget the narrow title of this wonderful little volume. This is a treasure for anybody who creates documents on computer. I confess to be one of those people who have always defaulted to the banal Times New Roman fonts and 12 point type on every document that I produce. I also admit that I have placed two spaces between sentences in most of my professional documents.  (This is a no no under the rules of typography. )This small and stimulating book is liberating. It belongs on everyone’s shelf who cares about the art of presentation of words on a page. It expands the knowledge of options available in the selection of fonts, white spaces, and formatting in documents produced by Apple Pages and Microsoft Word. It is both expanding and liberating.  It belongs on the shelf of anyone who cares about written presentation along with Strunk and White, and their iconic Elements of Style.

 

THE END OF MEDICINE: How Silicon Valley (and Naked Mice) Will Reboot Your Doctor by Andy Kessler, Collins 2007.

    Andy Kessler is an irreverent, flip and highly readable writer who poses an interesting single question and than doggedly pursues an answer, with a lot of biting asides to entertain the reader. The question is, given the exponential decline in cost of technology in Silicon Valley and its exponential increase in power and effectiveness, why hasn’t medical technology turned over the same returns to deliver more effective health care at a cheaper cost. There are a number of reasons including the inherent slowness of the treatment and study process, the FDA, entrenched economic interests and the focus on treatment rather than prevention.

    

THE SINGULARITY IS NEAR: When Humans Transcend Biology. by Ray Kurzweil, Viking Press, 2005.

    Recent developments in brain scanning through technological refinements of SPECT, fMRI and PET scans that monitor water, blood and/or glucose movement in the human brain to observe actual brain functioning as opposed to structure are providing a wealth of new information concerning its organization, complexity and integration.  Ray Kurzweil believes that exponential improvements in the temporal, spatial resolution and bandwidth of the human brain which is doubling each year, will successfully enable us to reverse engineer the human brains principals of operation  in the first half of this century.  This will result in that he calls the “Singularity” where machine based intelligence surpasses that of all humans combined, creating a disruptive transformation in human capability.  This capability he believes will be a billion times more powerful that all of human intelligence today.

Within several decades information based technologies will encompass all human knowledge and proficiency, ultimately including the pattern recognition powers, problem solving skills, and emotional and moral intelligence of the brain itself.