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.
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.
Late last month in St. Charles, Missouri, a 34 year old man named Sydney Levin, on probation for illegal substance possession and felony stealing, was discovered using a prosthetic product known as the Whizzinator to pass synthetic medical grade urine in lieu of his own. He was charged with possessing a “forging instrument” and released on a $25,000. bond. The Whizzinator contains an artificial penis connected to a 4 oz. bag to contain the synthetic urine. There are heating elements in the apparatus that elevate the temperature to human body levels. The device comes in three colors, white, black and brown. The product is advertised at $149.95 plus shipping and handling. Rapid Clean Clean Pee is advertised at $15.95 a pack.
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.
The United States Supreme Court will decide the question of whether genes are patentable in the coming term. The decisions has broad implications for the biotechnology industry, for researchers and for patients. The case at hand is Association for Molecular Pathology v. Myriad Genetics, Inc. originally filed in the U.S. District Court for the Southern District of New York by the ACLU and the Public Patent Foundation. The object of the case is to challenge a number of patents granted to Myriad, a Utah biotechnology company, by the U.S. Patent and Trademark Office. The patents granted were on DNA isolated from two human genes that increase the risk to women for breast and ovarian cancer.
First, there was blackmail, then there was greenmail, and now there is "Waxmail", a new form of extorted payments arising from the dark corners created by the Hatch-Waxman Act also known as the Drug Price Competition and Patent Term Restoration Act. The original purpose of H-W was to provide incentive for generic drug manufacturers to challenge weak patent claims by pharmaceutical companies by providing an exclusive 180 day right of challenge to the first generic company to raise a challenge to a pharmaceutical patent prior to its expiration. As an unintended consequence of the Act, generic companies are settling their patent suits for multi-million dollar payments that provide that the generic companies will sit on their generic products without bringing them to market for an agreed upon period of time. These are called "reverse payment" agreements. Most federal courts of Appeal to have reviewed these agreements have found them not to constitute violations of the Federal Trade Commission Act, contra to the position taken by the FTC, as long as the time of deference did not extend beyond the scope of the face of the patent.
One of the “advantages“of computerized medical records is the easy ability in some programs to develop templates for the development of physician history and physicals and other documentation requirements for billing Medicare and other third party payors for services provided or in some cases not provided in order to increase payments. According to a recent article in the New York Times there has been a substantial increase in Medicare payments as the result of computer based upcoding of Medicare payment requests due to the cut and paste of various unrelated medical records to develop documentary support for higher levels of reimbursement.
Modern biotechnology now makes possible issues that were not contemplated by Congress in the adoption of the Social Security Act. One of those issues is whether a child conceived by artificial insemination a year after her father’s death is a “child” of her father entitled to survivor benefits under the Social Security Act. The 9th U.S. Circuit Court of appeals earlier ruled “yes.” In the recent ruling in Beeler v. Astrue, the 8th U.S. Circuit Court of Appeals ruled “no”, overturning a lower, trial court decisions and affirming the final decision of the Commissioner of Social Security.
It seems counterintuitive and contrary to the overwhelming majority of articles and studies, but the New York Times today reported on a study recently appearing in Health Affairs that suggested that the switch to electronic medical records resulted in a 40 percent increase in tests, most of the MRI and CAT scan variety. The study, based upon the analysis of a 2008 survey by the National Center for Health Statistics, performed for an entirely different purpose, and has questionable design. The study followed 28,888 patient visits and 1100 physicians and claims to have a more National perspective. The authors of the study suggest that most earlier studies are based upon statistical models of expected savings like those undertaken by the RAND Corporation and the study of flagship integrated systems like Kaiser, rather than on national utilization data.
Yesterday, a panel of the federal 9th Circuit Court of Appeals considered a challenge to the constitutionality of the National Organ Transplant Act (the “Act”) as it relates to restricting compensation to bone marrow cell donors whose cells are extracted through apherisis. The Act prohibits the compensation of donors of body organs including specifically, bone marrow, but permits compensation for blood, sperm, and eggs. In Flynn et al v. Eric Holder, No. 10-55643 (9th Cir. 2011), the Plaintiffs, who included a variety of persons and entities adversely affected by the difficulty of obtaining donations of bone marrow, argued that there was no rational basis for distinguishing between the donation of blood plasma and the donation of hematopoietic stem cells which are excreted from the bone marrow itself into the blood stream in thus implicating the “equal protection clause” of the Constitution.