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.
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.
Jennie Linn McCormack of Pocatello, Idaho has a messy life. She is the single mother of three children living on a $250.00 per month child support payment for one of her children. She is unemployed, poverty stricken and desperate. Adding to her troubles she became pregnant again and the father is now serving time in prison for robbery.
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.
Is your surgeon twittering on-line during your surgery or ordering golf shoes from Amazon.com? When you look up at your surgeon just before you slip under anesthesia you might want to check out whether he has a blue tooth device in his ear. According to an article in the New York Times on December 15, 2011 it is not that unusual for surgeons, nurses and technicians in an operating room to be accessing the internet and texting, checking emails and chatting away with relatives during surgical procedures.
There are a number of “silencer” contracts that have been marketed to dental and medical professionals as a means of keeping bad reviews from patients off of the internet. Typically these agreements provide that in exchange for maintaining the confidentiality of the patient’s medical records the patient agrees not to make any critical reviews of the professional services received on the internet. These agreements also sometimes provide that the patient assigns his or her future intellectual property rights in reviews of the professional to the professional so that the professional can require web sites to “take down” adverse reviews.
