SHAM PEER REVIEW: THE POWER OF IMMUNTY AND THE ABUSE OF TRUST BY Gregory R Piche' is now available free by email to any of the readers of this blog. Simply provide your name, address and email address and it will be sent to you.
Fueled to a large extent by the survival of the Affordable care Act in two United States Supreme Court challenges, and countless Congressional votes, the health insurance industry is set to further consolidate the major health insurance players from five to three as Anthem proposes to acquire Cigna for $48.3 billion dollars and Aetna seeks to acquire Humana for a mere $37 billion dollars. The argument is being made that consolidation in the health care insurance industry will help reduce costs and it is likely that it will.
CMS indicates that it is again considering compensating physicians for discussions and advice with patients concerning end of life decisions. The American Medical Association requested consideration of the issue last fall.
The Affordable Care Act as adopted contains 906 pages. It is a complex statute made necessarily so by industry and congressional efforts to block provisions that would have simplified it such as a move to a single payer option. To satisfy all of the various stakeholders including insurance and pharmaceutical companies and their minions, it became strategically necessary to make complex what would otherwise be simple by creating a system of state insurance exchanges and low income subsidies to increase enrollment.
The case of King v. Burwell pending in the Supreme Court of the United States is an effort to scuttle the Act by focusing on four words out of the 906 pages. Part of the changes to the tax code contained in the Act provides for a calculation of a tax credit that depends upon the number of months that the taxpayer has been enrolled in a health insurance plan purchased on an insurance exchange “established by the State.”
States, under the Act have the option to establish their own exchange or to rely on exchanges set up by the federal government. 34 states have opted to use the federal exchanges.
The argument goes that if a state fails to set up its own exchange and relies on the federal default exchange those states have not utilized an exchange established by the State and therefore there can be no tax credits provided for those subsidized insureds living in the 34 federal option states. If successful, the plaintiffs in King will have engineered the loss of $29 Billion dollars in tax credits in those states impacting primarily poor and middle income people on subsidies.
Interestingly, the proponents of the abrogation of the Act provide no specific alternatives for the federal government to deal with what appears likely to be the largest public service and human suffering disaster since Katrina. In order for the Supreme Court to kill the Act on these grounds it would need to abandon any semblance of judicial restrain and proceed on strictly political grounds. The country be damned.
Federal exchanges adopted by a state in lieu of one created by the state is one established by the state in the context of the Act as a whole.
Eight out of ten members of the North Carolina Board of Dental Examiners are active dental practitioners. The Board issued cease and desist orders to commercial teeth whitening enterprises, asserting that they were unlawfully engaged in the practice of dentistry. The FTC brought an enforcement action against the Board for anticompetitive conduct in using the state regulatory power to manipulate and control the commercial market for teeth whitening services in North Carolina.
The Supreme Court, this week, affirmed the findings of an administrative law judge and the FTC that the Board’s conduct was not immune from antitrust liability under the “state action immunity” doctrine. Federal antitrust law, as a matter of comity, exempts state sovereign acts which have anticompetitive effects from antitrust liability where the actions are a matter of clearly articulated state policy.
Justice Kennedy, in a six to three opinion, stated that even if the Board, made of competitors, could be reasonably perceived as an arm of the State of North Carolina, when it undertakes to manipulate or control a commercial market under color and protection of state law, it must operate under a well articulated state policy and must be actively supervised by the state in its regulatory actions.
The teeth whitening industry is not one that inherently required the active supervision of the Board. No active supervision was present. No immunity for its actions exists. Sic Semper Tyrranis.
In the “ I am not making this up” category, a Delaware Jury convicted Melvin Morse, M.D., a pediatrician and noted authority on childhood near death experiences of water boarding his 11 year old step daughter as a form of discipline and punishment. He was charged by authorities with endangerment and assault after the girl ran away from home and reported on Morse’s behavior. His lawyers argued that he was merely washing her hair in a manner that she didn’t like.
Robin Cook and Eric Topol had an interesting article in the Wall Street Journal today entitled “How Digital Medicine Will Soon Save Your Life.” They predict that digital medicine will arrive soon with “force of a hurricane. The promise of individualized “tailored” medicine’s advance with the prospect of cheap gene decoding, nanotechnology and smart phone’s playing the role of physician avatars, silently monitoring our body chemistry and organ functioning is certainly appealing and probably within the realm of near realization. They note the recent FDA approval of VISI, a device that monitors heart electricity, respiratory rate, blood oxygen, and blood pressure without a cuff and transmits the data to a medical office. They predict that the advent of digital medicine will democratize medicine permitting patients to own or control their medical data which they can transmit over the web. They see this as a shift away from the “medical - industrial complex.”
The authors see problems and unanticipated problems related to privacy, misuse of information and patients being overwhelmed by the information available to them. They suggest that the FDA will have to play a major role to ameliorate those issues. This is somewhat funny. The reality is that if the FDA plays a major role in this futuristic model it is far more likely to be the problem than the solution. It still clings to the 19th Century approach to approval of medicines that work for the majority, but not all of the public and to obstruct the access to drugs that work for a minority of patients, with appropriate molecular structures, but not for the majority. To reach the great advances and lower costs that the author’s envision there will need to be a hurricane running through the FDA.
To my sorrow I never met Nelson Mandela, but in a visit to his modest home on Vilakazi Street in Soweto in the 1990s there were a number of artifacts remaining that voiced much about the man. The one bedroom brick home was small with a brick wall between the kitchen in the rear and the living room in the front. The living room was a dangerous place. One can still see the ridge of higher ground blocks away where state security service officers regularly fired high power rifles into their living room. (The outside bricks are still chipped from target practice.) The Mandelas were forced to sleep on the kitchen floor in the back of the house in order to assure that they would wake up in the morning.
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.
In July, 2012, Rosemary N, Collyer, a United States District Court Judge for the District of Columbia, ruled that autologous stem cells re-injected into a person’ body following a acculturation of the cells with the use of another drug product shipped in interstate commerce is a “drug” subject to regulation by the U.S, Food and Drug Administration. The purpose of the re-injection is to stimulate the regrowth of bone, cartilage and other human tissue to regenerate them in lieu of joint transplants and other orthopedic surgical procedures.