Holland & Hart Healthcare Law Blog

OKLAHOMA FEDERAL JUDGE AUTHORIZES SUBSTITUTE USE OF NEMBUTOL TO AID IN EXECUTIONS.

 

There has been a shortage of thiopetal sodium recently, the anesthetic of choice in executions by lethal injections, which has temporarily halted executions in a number of jurisdictions that unlike, Texas,  have not stocked up on the drug. The manufacturer of the drug Hospira, Inc. of Illinois has indicated that it has had manufacturing issues with the drug and replacement supplies would not be available until early 2011.  Hospira, which markets its drugs, under the tag line of “Advancing Wellness” has indicated that it does not favor the “off-label” use of its drug in state sponsored executions. Death penalty opponents have been objecting to the substitution of other drugs because of the potential for pain and suffering by the prisoner in potential violation of the Eighth Amendment prohibition against cruel and unusual punishment.

 

THE PROMISE AND PERIL OF EVIDENCE BASED CLINICAL STANDARDS.

 

A key component of the governments efforts to bend the cost curve for health care is the use of technology and new health delivery structures to introduce “evidence based” clinical standards for the treatment of patients.  Technology will be useful in determining the most clinical effective modalities of treatment and in monitoring the implementation of the guidelines across the spectrum of health car providers. It is an idea that on the surface makes a great deal of sense.  Providers should be held accountable to implement those methods of treatment that have shown themselves to be the most effective and cost efficient in the treatment of chronic disease disease syndromes.

 

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.

NEW MEXICO BODY PARTS CAPER.

It came up “heads” when an employee at a medical waste disposal facility called Stericycle in Kansas noticed a partially burned head and torso at disposal site.  Stericycle normally disposes of dead tissue, but this was more like raisins in the oatmeal and he quickly perceived something was wrong.  Further investigation led to the discovery of 6 additional roughly severed heads and a number of torsos in a truck outside of the facility. Shades of Alistair Cook! Cook you will remember as the genial host of Masterpiece Theater on PBS whose body was dismembered and proliferated by a gang of New Jersey body snatchers a couple of years ago.

MARKET DRIVEN HEALTH CARE IN 2057: The Movie

How about a popular movie on market based health care reform?  There is actually one out there although it hasn’t yet penetrated the cloud over the current health care debate, and surprisingly didn’t score well in the box office count over the weekend.  On the first day after the House passage of the Obama Administration’e Health Care Reform Bill as approved by the Senate and following passage by the house of a bill to amend it, it might be interesting to review a future that is at least equally as bleak as the “Tea Party”  people and their surrogates have been painting the likely affects of health care reform.  The movie presents a society in which high pressure sales people use guilt, guile and outright fraud to coerce people to purchase very very expensive electronic organ replacement devices such as hearts, kidneys. livers, eyes, knees,, etc. (called “artiforgs” ) The artiforgs can provide an electronic read out to various patrolling repossession gleaners, the status of their credit accounts.

DSM –V: THE NEXT FRONTIER OF MENTAL ILLNESS (IF IT IS ILLNESS).

There is much anticipation over the soon to be released new edition of the Diagnostic and Statistical Manuel of Mental Disorders  (DSM –V) by the American Psychiatric Association (“APA.)  It is due in 2012. There are many interests involved in the development and recognition of categories of mental disorders. (There is still controversy over whether there is mental “illness,” but there is more congruence over the existence of “disorders.”  The late poet, Theodore Roethke, once wrote, “What is mental illness, but nobility of soul at odds with circumstance?”  The APA, the psychiatric profession, the pharmaceutical industry and other groups have a much bigger and more complex investment in the definition of categories of mental illness.

THE “AVIATION” MODEL IN HEALTHCARE AND AIR FRANCE FLIGHT 447

 In the 1980s the Commercial Aviation Safety Team (“CAST”) determined that eighty five percent of aviation accidents and fifty two percent  of all fatal aviation accidents were the result of cognitive error by pilots. CAST pushed for the use of systems, checklists and foolproof communication systems to reduce the human element in aviation. The result was a fifty percent decrease in aviation accidents. The success of the systems method in aviation led healthcare safety advocates to campaign for the application of the systems model to tamp down the impact of human frailty on adverse healthcare outcomes. The systems model is now a fact of life in high risk medical procedure, pharmaceutical administration and other healthcare delivery modalities.

 You can see it in the operating room when a nurse paints a sign “the other leg” on your healthy limb or where two nurses must sign off on a prescribed medication. The interest in the systems application to quality improvement continues unabated. See Kahn, et al. , “To Err Is Human: Building A Safer Healthcare System.” National Academy  Press. Washington, D.C. (2000); Stripe, et al. “Aviation Model Cognitive Risk Factors applied To Medical Malpractice Cases.” (JABFM.org.);Inglehart & Fleming, “New Patient Safety Uses Aviation System Model.” Health Affairs Blog, April 13, 2009.

 Since the 1980s and the onset of the digital age the aviation model morphed into a much more pervasive systems intervention through the surge in computer driven maintenance and operational applications, not unlike parallel developments in healthcare. The crash of Air France Flight 447 A330 Airbus over the Atlantic Ocean on May 31, 2009 thrust to the fore two separate, but related computer systems driving  both airplanes and healthcare, albeit to differing degrees. The Airbus utilized the Aircraft Communication Addressing and Reporting System (“ACARS”). The onboard computers sent ten automatic maintenance messages to Paris indicating failures in the plane’s electrical systems and decompression of air in the plane’s fuselage.

 The current proliferation of medical devices with direct internet monitoring and reporting capacity provide the potential and fact of real time reporting of human body systemic failure to medical record repositories. The healthcare mimicry of aircraft maintenance information technology is upon us and we will likely embrace the use of “wearable” computers with growing fervor in the future.

Despite the apparent differences between healthcare and aviation, the information exchange paradigm used to insure quality in the aviation industry can be implemented to reduce the impact of the aforementioned system errors in health care delivery system (sic).

Martin, Lance, “Reducing Medical Errors Using an Aircraft Maintenance Information Technology (IT) System Model,” Dartmouth undergraduate Journal of Science. Dujs.dartmouth.edu/2004s/healthcareit.pdf.

 Despite Mr. Martin’s optimism and enthusiasm there appears to two principal kinks in both the aviation and healthcare systems that need to be addressed. The first relates to the information systems. There is no question that computer monitoring systems can generate a great deal of useful data. The critical question is how to sort and present the data in a format and application that can realistically serve the needs of pilots and practitioners. There needs to be assurance that the data is correct and not affected by defective “pitot tubes” or other malfunctions and a means to sift and prioritize mountains of data so as to provide real time, meaningful input to those sitting at the controls.

 The second concern relates to the ultimate control of the mission. The Airbus A330 contains the latest in fly-by-wire technology that substantially limits the operational control of the aircraft by the pilots. This is an exclusively electric system, without manual or hydraulic features. There is a debate ensuing in the blogosphere as to the degree of control, if any can be wrested from the computers by Airbus pilots in the event of an emergency. (Think of HAL in 2010:A Space Odyssey. That would be next year.)  The issue is at what point should human beings be able to reassert control from computer systems, particularly where onboard computers are juggling conflicting information from various sensors?

 Did the computers aboard Flight 447 malfunction causing a crash or did a last ditch effort by the pilots to regain control interfere with the failsafe functioning the planes systems? Was it a combination of both or an unremediable "act of God?" We may never know the answer.

Remember, more often than not, an airliner goes down at the end of a long chain of unrelated, seemingly innocuous decisions, malfunctions, mistakes and external factors. Remove any single link (or even change their sequence) and you have an on time arrival. Miles O’Brien Uplinks, June 19, 2009. trueslant.com/milesobrien/2009/06/10the-paradox-of-simplicity/.

 In the future computer systems will have an ever increasing role in healthcare decision making and treatment as the incorporation of artificial intelligence applications into electronic medical records provides a whole new platform and paradigm for healthcare delivery. The healthcare industry will eventually face the conundrum of when and under what circumstances a physician will need to regain control over the treatment process. The crash landing of U.S. Airways Flight 1549 in the Hudson River earlier this year underscores some legitimate concerns to keep in mind. That crash also involved an Airbus with a similar air flight control system, which may have unnecessarily shut down the plane’s engines after the bird strike, causing the plane to lose all thrust. There may come a time when we need a doctor with the nerve, experience and professionalism of a Chesley B. “Sully” Sullenberger, III to seize the controls and manage a life threatening emergency.

INTERNET MEDICINE PART II: PHYSICIAN CHAT ROOMS

One of the growing phenomena related to the practice of medicine and the internet is the introduction of physician chat rooms in real time on the web. In new forums like Sermo, approximately 90.000 physicians can currently log on line and discuss clinical issues in real time and obtain broad based input and support and advice from other physicians with respect to clinical issues. This is a form of social networking for physicians. Among the potential benefits of the forum is the ability to compare notes and to alert others to sudden distortions in the health of local populations due to flu or other causes, and the sharing of what works and doesn’t work in clinical practice. 

Stem Cell Research on Again, Time to Celebrate [Guest Editorial]

Among many other things that the Obama administration addresses --one of the most important far reaching actions in my opinion is the go-ahead to stem cell research. This was important scientific research that can help prevent diseases and in the development of better medicine to give a second chance at life to millions of human beings alive today.