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.
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.
Last year California Governor Jerry Brown signed into law California SB 1172, which makes it illegal to provide “conversion” or “reparative” therapy to homosexuals under the age of 18 in the state. The issue is whether this an unremarkable and rational exercise of the police power of the state or an infringement of First Amendment rights. Supporters of the bill assert that the “antigay” therapy is worthless pseudoscience and has the potential of harming young homosexuals who are struggling with identity and self worth issues. They claim that homosexuality is not a disease or an assumed condition, but an intrinsic or genetic positioning on a natural scale of human sexuality.
The United States Supreme Court, in a unanimous opinion written Justice Sotomayor, overturned an Eleventh Circuit Court of Appeals and Georgia District Court finding “state action” antitrust immunity in the case of FTC v. Phoebe Putney Health System, Inc. et al, No. 11-1160. Had they ruled otherwise there would have opened a huge whole in the FTC’s ability to regulate anticompetitive conduct by state sub-entities under a general grant of state authority. Georgia like many states has a hospital authorities law that permits counties and or municipalities to create quasi governmental entities with broad grants of powers to operate health care facilities.
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.
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.
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.
160 Common U.S. Food and Drug Administration (“FDA”) approved drugs which are used for “off label” purposes represent approximately 21 percent of all prescriptions in the United states. Physicians may prescribe FDA approved drugs for any therapeutic use that is appropriate in their medical judgment. The FDA, however, prohibits pharmaceutical companies and their employees from promoting the use of FDA approved drugs for “off label” use. Although there is no express prohibition in the Food Drug and Cosmetic Act or its regulations prohibiting the promotion of drugs for off label use, the government uses a criminal statute which prohibits the introduction of “misbranded” drugs into interstate commerce ( 21 U.S.C. 331(a) and 333(a)(1) to prosecute pharmaceutical companies, their employees and sometimes physicians who are “promoting” the off-label use of drugs.
On November 30, 2012, Judge Greg Costa of the U.S. District Court for the Southern District of Texas, on remand from the 5th Circuit Court of Appeals, allowed three Indian cardiologists to move forward with their discrimination claim against David P. Brown, the administrator of Citizen’s Medical Center, finding that under the McDonnell Douglas shifting burden framework, the plaintiff’s had met their burden of showing a prima facie case of discrimination through circumstantial evidence on 4 out of 8 adverse employment actions alleged by the plaintiffs and that the justifications offered by the defendant were pre-textual.
More and more physicians who used to accept on call duty at a hospital as part of their obligations of being part of the medical staff are insisting on receiving some form of remuneration for the inconvenience. On October 30, 2012 the Office of Inspector General of HHS posted an advisory opinion No. 12-15 approving a hospital’s plan to pay for on-call services of physicians on its medical staff. These are for consulting physicians, not those physicians called on a regular basis to assist the ER, like intensivists, hospitalists, interventional cardiologists, etc. The concern of the OIG was the likely implication of the federal antikickback statute. The personal services and management contracts safe harbor at 42 CFR Section 1001.952(d) doesn’t apply because it requires the aggregate amount of compensation to be identified in advance.
