David Eckert, from Hidalgo County, New Mexico, was subjected to numerous, highly invasive procedures, because police suspected him of hiding drugs in his rectum. Mr. Eckert had been convicted of methamphetamine possession in 2008, and the police suspected his continued involvement with drugs. However, the officers who searched both Mr. Eckert’s person and his vehicle, after pulling him over for a traffic violation, found neither drugs, nor weapons. One officer indicated that Mr. Eckert held himself in an “erect” position, and “kept his legs together,” which led the officers to assume that Mr. Eckert held drugs within him.
After a local hospital refused forcibly to search Mr. Eckert, he was transported to the Gila Regional Medical Center (GRMC), 50 miles away. At GRMC, Mr. Eckert was subjected to two rectal exams, three enemas, forced bowel movements in front of officers and nurses, x-rays, and a colonoscopy performed under anesthesia. However, each search was fruitless. Mr. Eckert received a bill from the hospital for $6,000. Mr. Eckert filed suit against the hospital, and the parties settled for $1.6 million.
Pharmaceutical company, Berg, has partnered with the Icahn School of Medicine at Mount Sinai (Icahn), in order to implement a “data driven, biological research approach” to medicine, which they claim could change the face of health care. Berg and Icahn will use Berg’s Interrogative Biology platform to analyze biological data from human beings. The Interrogative Biology platform combines a patient’s biological data with his clinical and demographic data in order to create a biomarker library. A biomarker is a quantifiable substance in an organism that predicts disease or infection.
The biomarker library is intended to allow the partners to detect disease patterns in a given population. The identification of disease patterns would help doctors, insurance companies and government agencies identify the most efficacious diagnostics and treatments for patients.
Recently, Myriad, a biotechnology company located in Utah, filed patent infringement claims against three companies: Ambry Genetics; Gene by Gene; and Quest Diagnostics. Myriad developed a genetic test (BRCA test) that assesses a woman’s risk for developing hereditary breast and ovarian cancers. Until June, 2013, Myriad held gene patents that allowed it to maintain a monopoly over BRCA testing. For the fiscal year ending June 30, approximately 85% of Myriad’s profits, which totaled over $613.2 million, derived from BRCA testing. However, in June the Supreme Court determined that some of Myriad’s patents were invalid, and paved the way for other companies to enter the market.
Two closely held corporations, Ambry Genetics and Gene by Gene, were the first companies to announce their plans to sell BRCA tests. Myriad filed suit against them both. Most recently, the largest operator of laboratories in the U.S., Quest Diagnostics (Quest), announced its plan to enter the market. On October 10, Quest filed suit against Myriad in federal court in Santa Ana, California, in anticipation of a patent infringement suit against it by Myriad, based on Myriad’s litigious history. Myriad filed suit against Quest on October 22. All three companies plan to sell the tests at a lower price than Myriad’s.
Read more here. For more on the Supreme Court’s decision in June, 2013, click here.
On September 27, 2013 the National Institute of Health (NIH) announced that it is seeking public comment on draft proposals regarding how researchers should share data from genomic research projects. The goals of the proposal are: to protect the privacy of participants in human subject research; to protect intellectual property rights; and to promote data-sharing in order to advance genomic research. Under the proposal researchers would be able to combine data from various projects, which would enhance the value of the scientific data collected. The public may submit comments to the NIH until November 20, 2013.
Professor of biomedical sciences at Yale University, James Rothman, professor of molecular and cellular biology at the University of California, Berkeley, Randy Schekman and physiology professor at Stanford, Thomas C. Suedhof have been granted a $1.25 million dollar prize by the Nobel Assembly. The three individuals will share the prize for their research which “revealed the exquisitely precise control system for the transport and delivery of cellular cargo.” The discoveries have led to better ways to diagnose patients, because disturbances in the transport system contribute to dangerous medical conditions, such as diabetes, neurological diseases and immunological disorders.
The National Institute of Health (NIH) will grant twenty-five million dollars, over the next five years, in order to examine health, privacy, economics, interpersonal issues and newborn genomic screening. The NIH will take DNA samples from newborns, from four U.S. cities; however, many of the parents and children involved will have no notice that their DNA is being studied.
The goal of the NIH is to discover whether it is economically feasible to obtain every newborn’s DNA for analysis purposes. Currently, newborns are screened for twenty-six manageable, or even preventable, conditions or diseases. The current screening costs approximately one-hundred dollars; however the new genomic screening costs approximately five-thousand dollars. In addition, some are concerned that, if genomic screening proves successful, many parents may limit their children’s activities in order to protect them from disorders that may never develop.
China’s State Administration for Industry and Commerce (SAIC) is increasing its investigatory efforts into the Chinese pharmaceutical industry and medical services sector. The SAIC is focusing on the price of medicine, and whether companies are in violation of anti-trust legislation. The SAIC will severely punish those engaged in acts of bribery in the bidding process for pharmaceuticals and medical services because bribery inflates prices artificially and hurts consumers.
The PPACA incorporates mechanisms intended to protect consumers from insurance company abuses. One such mechanism limits patients’ out-of-pocket (OOP) spending for major medical coverage. However, as posted on the Department of Labor’s website, the cap on OOP expenses for consumers will not go into effect until 2015. Some claim that the delay is meant to help businesses and consumers adapt to the PPACA, while others claim that the Administration is catering to employers and businesses at the expense of consumers.
The UK seeks to use data to personalize care for cancer patients by setting up the world’s largest single cancer database, which will contain detailed medical information for the 350,000 types of cancer diagnosed across its population. The government maintains that the database will deliver “real-time” data on cancer patients to researchers and clinicians. The instant dispatch of information will give cancer specialists access to information on how varieties of tumors respond to treatment, as well as other detailed clinical information that will help physicians individualize cancer treatments.
The database will also include historical cancer records from the last 30 years, which includes upwards of 11 million records. The combined registry is the result of a five-year project to merge England’s cancer registries into one registry that is centrally managed and subject to the same processes and standards.
Justice Thomas wrote for the Court in a unanimous ruling, issued on June 13, 2013, that human genes isolated by scientists are not patentable. The American Civil Liberties Union (ACLU) brought suit in 2009 against Myriad Genetics, Inc., which held a patent on genes (BRCA1 and BRCA 2) that are known to detect breast cancer. As a result of the patent, Myriad held a virtual monopoly over predictive testing for breast and ovarian cancer, to the detriment of women worried that they were at risk. Any other company was barred from examining a woman’s BRACA1 and BRACA2 genes, and Myriad charged upwards of approximately $3,000 per diagnostic test.
The ACLU claimed that the Myriad patents were overbroad and barred scientists from examining the genes, thereby implicating the First Amendment. However the central issue was whether the patents were merely abstract ideas that a person’s risk of cancer could increase depending upon how nature made the genes, or rather patentable, human-made inventions. The Court held that isolated human genes are products of nature, and merely locating and isolating them is far removed from creating the genes or altering genetic information within the genes. However, the Court held that synthetic DNA, otherwise known as complementary DNA or cDNA, is patentable as a human invention.
Biotech business interests are implicated in this decision, and there is a split in predictions about the effect this will have on innovation. Some predict that the decision will chill research and development because the monetary incentive is no longer present. However others predict that companies will still profit from their innovations. Justice Thomas wrote that companies may patent the method of isolating a gene, but that Myriad was unable to do so because geneticists were already well-aware of its process for isolating BRCA1 and BRCA2.
To read more click here and here. Read the Supreme Court ruling here.