Friday, July 27, 2012
Here in West Texas, we are less than three weeks away from the start of school! Target overflows with notebooks and pencils. So I am giving considerable thought to how and what I will be teaching. It’s in that context that I read that, my alma mater has made something of a splash by announcing that it’s offering a Ph.D. in Law which is intended “to prepare students who have earned a J.D. degree from an American law school to enter careers in legal scholarship prepare future law professors.” Dean Robert Post explained further that the degree was necessary because, ““It’s becoming increasingly hard to transition directly from law practice to teaching” because “candidates are now expected to present a relatively mature scholarly profile; they need a defined research agenda and a substantial portfolio of writing.”
Given the near frenzy of criticism directed at law schools for not teaching skills, and in general for being a scam, that seems to be very poor timing. And certainly there’s been plenty of criticism of the new degree. But it’s also an opportunity to stop and reflect. What skills do you need to be a law professor and in particular, a health law professor? Health Law, as we all know, is an extremely big tent including, among other areas of practice transactional, regulatory, personal injury, patent, constitutional, labor, disability, tax etc. It seems unlikely that any one person could have an expertise in all of these subject areas, let alone the practice skills that go with it. So every one of us is probably at some point teaching something we have never seen in practice.
As I’ve written before, this is one of the big differences between law school and medical school. Pretty much, medical students are taught by people who know how to do what they’re teaching.
Richard Kaplan, Top Ten Myths of Medicare, SSRN
Abigail R. Moncrieff, Understanding the Failure of Health-Care Exceptionalism in the Supreme Court's Obamacare Decision, SSRN/CHEST
Karen Davis et al, Medicare Beneficiaries Less Likely To Experience Cost- And Access-Related Problems Than Adults With Private Coverage, Health Affairs
Tim Jost & Sara Rosenbaum, The Supreme Court and the Future of Medicaid, NEJM
Thursday, July 26, 2012
A study was just published in the New England Journal of Medicine that found Medicaid coverage lowers death rates. The researchers, from Harvard's School of Public Health, studied three states that had expanded Medicaid coverage to poor adults who, until the ACA, were an optional coverage category for the states. Comparing these states to those without such Medicaid expansions, the study found:
Medicaid expansions were associated with a significant reduction in adjusted all-cause mortality (by 19.6 deaths per 100,000 adults, for a relative reduction of 6.1%; P=0.001). Mortality reductions were greatest among older adults, nonwhites, and residents of poorer counties. Expansions increased Medicaid coverage (by 2.2 percentage points, for a relative increase of 24.7%; P=0.01), decreased rates of uninsurance (by 3.2 percentage points, for a relative reduction of 14.7%; P<0.001), decreased rates of delayed care because of costs (by 2.9 percentage points, for a relative reduction of 21.3%; P=0.002), and increased rates of self-reported health status of “excellent” or “very good” (by 2.2 percentage points, for a relative increase of 3.4%; P=0.04).
In other words, much like the study in Orgeon, these researchers found that Medicaid improves health -- important information for governors considering their "options". (Governor Perry? Governor Scott? Where are you going?)
Wednesday, July 25, 2012
Don Lee reporting for the LA Times, here, on the growth of clinical outsourcing. "In one of its recent efforts, WellPoint laid off pre-service nurses in Colorado and Nevada so the work could be done in Manila, according to a Labor Department filing by a WellPoint human resource manager in Denver… WellPoint's offshoring covers a wide range of departments and tasks involving claims, enrollment, billing, post-service clinical claims review, utilization management and pre-service nursing…" [NPT]
I can't resist a second post today. A bipartisan group of Congressional representatives have just sent letters to nine major data brokers: Acxiom, Epsilon (Alliance Data Systems), Equifax, Experian, Harte-Hanks, Intelius, Fair Isaac, Merkle, and Meredith Corp.
The letters seek information concerning the brokers' data gathering activity. Information requested includes entities providing data (including sources of health data), types of data items collected, and products or services offered by the brokers to third parties using consumer data. The representatives also want to know whether consumers have access to the information and whether they can request correction or deletion. Companies' replies are due by August 15, and it will be fascinating to see what they say.
Copies of the letters can be found on Representative Markey's website, http://markey.house.gov/content/letters-major-data-brokers.
Myriad Genetics holds a number of patents on two genes implicated causally in breast cancer, BRCA1 and BRCA2. In 2009, scientific organizations devoted to genetics and pathology, genetics researchers, clinicians, genetics counselors, patients, and breast cancer and civil liberties advocacy groups filed a complaint seeking to have the patents declared invalid. In addition to Myriad, defendants in the suit are the US Patent and Trademark Office (USPTO) and the University of Utah Research Foundation (in this spirit of full disclosure, I teach at Utah and have colleagues who have appeared as amici in the case but otherwise have no relationships with Myriad). The patients claimed that the patents harmed them medically, as they were unable to obtain testing because of its high cost. Plaintiffs also contended that Myriad's test did not include additional variants of these genes that might be clinically relevant for them. Clinicians contended that they were unable to offer testing that differed from Myriad's, except under license from Myriad. The researchers claimed that Myriad had withheld scientifically important information and that they were unable to engage in research that could develop further understanding of the etiology of breast cancer and testing for it.
Central to the case is whether the patents come within the "law" or "product" of "nature" exception to 35 USC 101, or whether the DNA Myriad had "isolated" is a patentable discovery. The district court held that the patents were invalid and granted summary judgment for the plaintiffs, Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F. Supp.2d 181 (S.D.N.Y.2010). On the merits of the patent claims, the U.S. Court of Appeals for the Federal Circuit affirmed in part and reversed in part. Myriad's patents on methods for comparing DNA sequences were held invalid as covering only an abstract analytic method. Myriad's other patents, on the "isolated" DNA molecules were held valid, as the molecules in the judgment of the court do not exist in nature. Finally, the Federal Circuit concluded that Myriad's method claim for screening potential cancer therapeutics through changes in cell growth rates was not a law of nature and was thus patent eligible, Association for Molecular Pathology v. US Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011).
In March, 2012, the US Supreme Court decided the Prometheus Labs case, invalidating a patent on a process for determining the proper dosage of thiopurine drugs in treating autoimmune disease, Mayo Collaborative Services v. Prometheus Labs, Inc, 132 S.Ct. 1289 (2012). The goal of the Prometheus test was to tell physicians how to adjust dosages so that they would be at a level high enough to be therapeutic but without causing patients harm. The test did this by measuring metabolites in the patient's blood. In invalidating the patents, the Court concluded that the algorithm for adjusting dosage merely stated known laws of nature and did not add anything inventive to the application of these laws.
Six days later, the Court granted cert. in the Myriad case, vacated the decision of the Federal Circuit, and remanded for further consideration in light of Prometheus Labs., Association for Molecular Pathology v. Myriad Genetics, 132 S.Ct. 1794 (2012).
This past Friday, the case was re-argued in the Federal Circuit, before the same panel that upheld the Myriad patent (it was a 2-1 decision). According to the Bloomberg News report of the oral argument, http://www.businessweek.com/news/2012-07-20/myriad-defends-patent-claims-on-genetic-material-in-court-case#p1, at issue were patents concerning the isolated DNA molecule. Lawyers from the ACLU argued for the plaintiffs, contending that the patents come under the law or product of nature exception as understood in Prometheus. The Department of Justice also argued for the invalidity of the patents, analogizing the DNA extraction to taking coal from the ground. Myriad argued that the patent claims refer to human-made compositions, not natural products. Circuit Judge Bryson (the judge in the minority in the original panel decision) reportedly analogized the molecule to a piece of marble with the non-essential bits chopped away, like Michelangelo's David. As Circuit Judge Moore, noted, there's lots of money at stake in the decision--as well as important consequences for genetics research, clinicians, and patients.
In subsequent posts, I'll note updates to the case as they occur.
Tuesday, July 24, 2012
The Congressional Budget Office today released two reports on the post-SCOTUS world of the Affordable Care Act. First, the CBO estimates the effect of the Court's ruling that makes the Medicaid expansion a state option. The estimate, here, is that for the period 2012–2022 this will reduce spending by $84 billion though with the cost of an additional 3 million uninsured. The second report assesses the impact of H.R. 6079 (the Repeal of Obamacare Act). The CBO estimates, here, a net increase in federal budget deficits of $109 billion for the period 2013–2022. [NPT]
Monday, July 23, 2012
As debris from the March 2011Japanese tsunami washes ashore in Alaska and other West Coast states, it is worth reflecting on the toll it took on lives. It relates to the "clean" energy debate - nuclear power is being touted as the low carbon footprint alternative to coal fired power plants. However, all costs need to be assessed, including the risks of major accidents.
A Stanford University study released last month revealed that the radiation toll from the Fukushima Daiichi nuclear accident could eventually result in anywhere from 15 to 1,300 deaths. Reports of radiation exposure could be underestimated though. On Sunday, the Washington Post reported that workers at the stricken Fukushima nuclear power plant may have placed lead around radiation detection devices in order to stay under a safety threshold for exposure. Disturbing, since current exposure rates affects the predictions of long-term effects.
A Wall Street Journal report commented that the human deaths resulting from Fukushima are probably far lower than those at Chernobyl, since about 80% of the radioactivity was blown towards the ocean. At Chernobyl, most of the radioactivity settled over land and the amount released was far greater.
If 80% of the radiation went out to sea, the amount absorbed into marine plants that eventually make their way into fish and the human food chain is a concern. In Chernobyl, children were affected long after the accident from drinking milk from cows that fed on grass near the plant. These cows could have been prevented from grazing in the areas near the plant, but obviously the same cannot be said for fish feeding near the Japanese site. Hopefully there will be monitoring of cancers and thyroid disease throughout the Pacific rim, so the true costs of poorly sited nuclear power plants can be assessed accurately.