Holland & Hart Healthcare Law Blog

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 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.

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.

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.

FDA Review to “Pre-Empt” State Pharmaceutical Litigation?

The United States Supreme Court will soon decide whether state tort actions against drug companies will be "pre-empted" by the FDA’s pre-market regulation of new drug products. The case, Wyeth v. Levine, arose out of a Vermont action by a musician, Diane Levine, who was injected with Wyeth’s anti-nausea drug, Phenergan during hospital treatment for migraine headaches. The drug was mistakenly injected into Ms. Levine’s artery resulting in the necessary amputation of her right arm. Many observers believe the Supreme Court will follow the logic of its recent decision in Riegel v. Medtronic, to pre-empt state law tort actions against drug companies where the drug has received FDA approval.

The FDA does not itself test new drugs, but rather relies on reported results of pre-market studies performed by the drug companies themselves. It may not surprise anybody to learn that these self-reports are not always complete and candid. Further, an overextended and underfunded FDA is not always on top of its game in investigating weaknesses in the studies presented to it.

Stroke, tPA & Statistical Chance

A healthy dose of fatalism should accompany any patient experiencing the symptoms of stroke when presenting at an emergency room for treatment. Assuming the facility is not a stroke center, with enhanced diagnosis resources and treatment options for combating the effects of ischemic stroke, one’s prospects for full or partial recovery could well depend upon the confidence in and willingness of the E.R. physician to administer tissue plasminogen activator or "tPA," a thrombolytic agent, capable of recanalizing a passage through an arterial clot in the brain tissue.

Although the use of tPA is recommended by the American Heart Association as a first line treatment for ischemic stroke the use of the drug is controversial because of significant risk of inducing intracranial hemorrhage and other organic damage in a small but significant number of patients.

Ketek Attack At FDA.

In the April 19, 2007 edition of The New England Journal of Medicine, David B. Ross, M.D., Ph.D.,, a clinical assistant professor at George Washington University School of Medicine and Health Sciences took the FDA to task for its approval of Ketek, a ketolide antibiotic manufactured by Sanofi-Adventis, for use in respiratory tract infections.  The drug underwent three rounds of review by the FDA and followed an unusual structure of review and approval that may suggest outside interference in the process.

Second Circuit Finds 1986 HHS Rule Excluding Medical Coverage for Surgical Transplantation of Experimental Medical Devices Arbitrary and Capricious.

In Yale-New Haven Hospital, et al. v. Michael O. Leavitt, U.S. Department of Health and Human Services, ___ F.3d___, 2006 WL 3317691 (2nd Cir. 2006), Yale-New Haven Hospital and 48 implantees of cardiovascular-defibrillator devices ("ICDs"), sued to recover H.H.S.’s set-off recoupment of $1,500,000.00 in payments for the ICDs implanted in 1994 and 1995. The case turned on the validity of an "interpretive" rule promulgated by HHS in the 1986 Medical Reimbursement Manual. The provision directed all fiscal intermediaries to reject any and all claims for medical devices that had not received pre-approval by the FDA.