Friday, August 24, 2012
Michael Bailit et al, Shared-Savings Payment Arrangements in Health Care: Six Case Studies, Commonwealth Fund
Michelle M. Mello et al, Ethical Considerations in Studying Drug Safety — The Institute of Medicine Report, NEJM
Thursday, August 23, 2012
Having just completed the first week of classes, I am enjoying the energy that the return of students brings to the building. But, I am also remembering how hard it is to introduce students to the healthcare system (non-system, really). For those who also feel challenged by the introductory phase of health law classes, here's something that may help: the New England Journal of Medicine has posted a 45 minute documentary entitled Getting Better regarding the ways in which the American healthcare system has changed over the last 200 years. NEJM's description:
Getting Better is a 45-minute documentary video that tells three remarkable stories of medical progress — in surgery, leukemia, and HIV/AIDS. Atul Gawande, Vincent DeVita,
Tony Fauci, Paul Farmer, and other prominent experts explore research, clinical
practice, and patient care, and how health care has continued to get better
over the past 200 years.
The first third of the video, narrated by Dr. Atul Gawande, is a particularly nice snapshot of the sea changes in medicine and surgery that have occurred within the last 200 years. Publication of scientific findings probably plays a larger role in the story line than is necessary, but it is good to be reminded of the advances that have occurred so recently and that were true game changers (such as aseptic surgery).
Wednesday, August 22, 2012
Yesterday a three judge panel of the DC Circuit struck down the EPA's Cross-State Air Pollution Rule, known as the “Good Neighbor Rule,” which required utilities in 28 states and the District of Columbia to install new pollution controls. The basis of the ruling was that the agency overstepped its authority by issuing standards before states had a chance to develop their own. The panel also concluded that the emissions reductions were greater than necessary.
The panel in essence substituted their judgment on whether the restrictions were excessive, ignoring their responsibility to grant the agency due deference. This calls into question the court's political objectivity. Indeed, articles reporting on the decision in the L.A. Times, CNN, and the Washington Post implied there may be some political views at play by pointing out that the deciding votes in the 2-1 decision were Bush era appointees. Indeed, a Reuters article commented that The ruling “will likely be cheered by Republicans, who have made the EPA and President Barack Obama's environmental policies a main campaign theme ahead of November elections.” The emissions reductions were estimated to prevent 13,000 to 34,000 premature deaths each year. For an overview on the history and purpose of the rule, click here.
Herewith my update on the Myriad gene patent case.
In response to the Supreme Court's remand in light of the Mayo v. Prometheus decision (132 S.Ct. 1289 (2012)), the Federal Circuit held oral argument on July 20 and issued its decision on August 16, 2012, Ass'n for Molecular Pathology v. United States PTO, 2012 U.S. App. LEXIS 17679 (August 16, 2012). At issue were fifteen composition and method patent claims held by Myriad with respect to the BRCA1 and BRCA2 genes, genes implicated in breast cancer. The district court had held the claims invalid under section 101 of the Patent Act as patent-ineligible products of nature or scientific laws. The Supreme Court's remand had asked the Federal Circuit to reconsider its reversal of the district court in light of Mayo.
In its most recent decision, the Federal Circuit largely reaffirmed its earlier analysis. One type of patent at issue was Myriad's composition claims to isolated DNA molecules. The Federal Circuit's earlier decision had concluded that Myriad's composition claims were valid, Association for Molecular Pathology v. United States PTO, 653 F.3d 1329 (2011). In the new judgment of the Federal Circuit, Mayo did not question composition patents generally; the question for resolution was whether the Myriad patents claimed patent-ineligible products of nature. The Federal Circuit held that they did not, that although they were made from biological materials they were non-naturally occurring and man-made. Nor are they laws of nature. In reaching this conclusion, the Federal Circuit reasoned that the isolated genes were not merely "purified" versions of natural substances, but "distinct chemical entities." The Federal Circuit rejected the government's suggested "magic microscope" test under which if an imaginary microscope could focus on the claimed isolated bit of DNA, it was not patent eligible. Instead, relying on Charkrabarty, it analyzed whether the isolated molecules were "markedly different" from what is found in nature. Whether chemical entities that convey genetic information warrant special treatment under the patent law, the court said, was a question for the legislature, not for the courts under the current statutory regime.
One set of Myriad's method patent claims consisted of analyzing and comparing DNA sequences. For these patents, the analytic question is whether these patents merely state scientific laws and thus are ineligible for patenting. The Federal Circuit had earlier concluded that these patent claims were invalid and this decision also did not change. These were patents consisting of comparing one sequence to another and merely reflected abstract mental processes and thus were ineligible. However, the Federal Circuit continued to hold that a different type of method claim, that of screening potential cancer therapeutics through changes in cell growth rates of transformed cells, was patentable. The Federal Circuit's reasoning was that this patent used "transformed" cells with "enhanced function and utility" to draw the therapeutic conclusion and hence did not simply apply a law of nature.
For anyone not thoroughly worried by Maryn McKenna's book Superbug: The Fatal Menace of MRSA, there's a Klebsiella story in the Wall Street Journal that will scare even the most fearless hospital-goer:
An outbreak of antibiotic-resistant bacteria raced through a top research hospital at the National Institutes of Health last summer, killing six patients and possibly contributing to the deaths of five others, researchers reported today. . . . The outbreak began in June of 2011, when a 43-year-old female patient with a history of multiple drug-resistant infections was transferred from a New York City hospital.
Although the patient was admitted into an isolation area, a Klebsiella pneumonia infection she had brought with her into the hospital soon leapt to at least three other patients. The NIH did not identify the New York hospital. The outbreak was brought under control by the end of the year. . . . [The story] underscores how health-care facilities are responsible for outbreaks, a broad problem that experts say leaves as many as 100,000 Americans dead each year. . . .
Hospitals have resisted efforts to require mandatory reporting of infection rates, in part because of the longstanding difficulties of establishing whether patients arrive with infections. An article in the Journal for Healthcare Quality earlier this year said 21 states have adopted public reporting requirements for hospital infections.
One of my students wrote an excellent paper calling for "universal screening for MRSA ... to be done for all hospital admissions in order to treat MRSA in hospitals and decrease the rate of MRSA within the community." Other steps are also necessary in relation to microbial infections. One wonders what it will take so see far more serious and coordinated responses to the threat. Kevin Outterson has written several excellent articles on growing antibiotic resistance, noting that antibiotics are uniquely susceptible to losing power due to overuse--but even a legal category for antibiotics as a whole could be overbroad, because of the unique properties of each microbe. I hope that scholarship like his helps inform a broader public policy response to this latent crisis.
SIU is seeking to fill its Garwin Distinguished Professorship, here.
The Southern Illinois University School of Law is seeking nominations and applications for the Garwin Distinguished Professor of Law and Medicine for the 2013-14 academic year. Established in 1996, the Garwin Professorship is funded in part by a grant from the Garwin Family Foundation which was established in 1993 for the purposes of fostering education and academic research. Support for the position includes a competitive salary, benefits, travel allowance, housing for one year, and a research assistant.
Great opportunity to spend time with a very collegial group! [NPT]
Tuesday, August 21, 2012
Monday, August 20, 2012
People with health care insurance have better health than people who do not, but questions persist whether the better health reflects access to coverage or other factors that correlate with insurance coverage. In a recent study comparing three states that substantially expanded adult Medicaid eligibility with neighboring states that did not implement expansions, researchers found that the Medicaid expansions were associated with a reduction in death rates (as previously discussed on this blog). However, other studies have not demonstrated much benefit from access to coverage. In a study reported in the current issue of the Journal of the American Geriatrics Society, researchers did not find reductions in deaths from any cause or in hospitalizations for cardiovascular disease for persons who received financial assistance to cover the "doughnut" hole in Medicare's prescription drug program. As data come in from the Oregon lottery for access to Medicaid, we will be in a better position to assess the benefits for health from access to health care coverage.