Special guest post by Nicholas J. Diamond
The Hill is abuzz with talk over the Syrian refugee crisis and whether refugees should be allowed to resettle in the U.S. A group of former national security experts from both Republican and Democrat administrations recently urged Congress to allow refugee resettlement in the U.S. In contrast, Texas recently filed a lawsuit against the Federal government in an effort to prevent the arrival of a family of Syrian refugees scheduled to arrive in Dallas.
But the political buzz has been ignoring a significant fact. The refugee crisis is not just a political matter. It also poses serious health risks for the refugees themselves.
Let’s start with physical health. While migration in general introduces various health risks, forced migrations like the Syrian refugee crisis create particularly acute concerns. A forced migration tends to impact large numbers of people—an estimated 9 million Syrians have fled their homes since 2011. The rapid movement of this many people causes massive disruptions in all aspects of life, including the availability of food and potable water, basic health services, shelter, and proper sanitation, to name just a few. Continue reading
There is plenty to say about the proposed changes to the Common Rule that the Office of Human Research Protections announced in September. But it’s striking to consider what is left unsaid—that the regulations will need to be revised again in the near future.
When the final revisions are published (in late 2016, so they say), the rules should include a plan to revise again in ten years. This plan is already in place in for a few areas covered in the proposed revisions, but it is imperative that OHRP extend this requirement to the entire new rule.
By Nicolas Terry
This week we interviewed Anna Laakmann, Associate Professor of Law at Lewis & Clark Law School. Anna’s teaching and scholarship focus on biomedical innovation policy. Before she entered the legal academy, Laakmann was manager of technology development and commercialization at a medical research institute outside Philadelphia, where she evaluated the patentability and commercial potential of scientific discoveries, managed patent prosecution, and negotiated license agreements with biopharmaceutical companies.
Nic and Frank led off with discussion of the LabMD appeal, an NPR story on the NPRM (see Episode 32), and an opinion on the disposition of frozen embryos–a topic of some interest to bioethics scholars.
Anna then led the discussion of her work on regulatory property and liability for clinical innovation. Listeners interested in the coordination of conflicting sets of laws regulating innovation may also find the work of scholars at the two “Innovation Law Beyond IP” conferences at Yale of interest.
The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw
Most readers of this blog will be familiar with the story of Sovaldi (sofosbuvir), a breakthrough treatment for Hepatitis C. Sovaldi is a transformative cure for a devastating disease, but priced at $84,000 per 12-week course, it has distressed insurance budgets (particularly Medicaid) and in many instances, led to rationing of access. As a result, there has been much debate about the appropriate price for such a valuable treatment.
Many have made the case that $84,000 is a pretty good value proposition compared with the ongoing expenses of living with Hepatitis C, or the cost of a liver transplant. Indeed, most of the people whose opinions I admire are willing to accept the $1,000 per-pill price tag (pills cost about $1/ea. to make) as a reward for innovation and incentive for R&D.
Even though I can accept the merits of these arguments, I find that I still cannot shake a visceral sense of injustice. I’m glad Sovaldi exists. I don’t mind that Gilead is making money. And yet, the situation feels profoundly unfair. It took me a long time to figure out why. Continue reading
Our colleagues at PRIM&R are hosting a series on “Unpacking the NPRM.” Check it out at their blog Ampersand, or by clicking on the links below!
- December 2, 2015: Unpacking the NPRM: Single IRB Review and Continuing Review, Elisa A. Hurley
- November 24, 2015: Unpacking the NPRM: Informed Consent, Elisa A. Hurley
- November 17, 2015: Unpacking the NPRM: Biospecimens Research and Broad Consent, Elisa A. Hurley
- October 29, 2015: Unpacking the NPRM: Expanding Exemptions, Elisa A. Hurley and Avery Avrakotos
- October 13, 2015: Unpacking the NPRM: A New Category of Exclusions, Elisa N. Hurley and Avery Avrakotos
By Dalia Deak
Last week, Pfizer and Allergan announced a $155B merger that has the health care and policy world talking. The contours of the deal—in particular, where the new company will be based and the implications it has for the company’s tax rate— have raised important questions.
Pfizer is a company with a long history in the United States that dates back to the mid-1800s when it sold antiparisitics and then painkillers during the Civil War. In the modern era, Pfizer is perhaps best known for blockbusters drugs like Viagra and Lipitor. Yet, expiring exclusivities and patent protections have threatened to knock the drugmaker from its No.1 spot. In January of this year, revenues were higher than expected but still down 3% year-over-year, with a forecasted decline in sales from $49.6B in 2014 to between $44.5B and $46.5B expected in 2015. Without blockbusters to replace Lipitor and Celebrex in particular (which fell 6% and 31% respectively), the company has been looking for a deal, even trying to push through a $118B acquisition of UK-based Astrazeneca in 2013, though that deal ultimately failed.
by Norman L. Cantor
I am obsessed with avoiding severe dementia. As a person who has always valued intellectual function, the prospect of lingering in a dysfunctional cognitive state is distasteful — an intolerable indignity. For me, such mental debilitation soils the remembrances to be left with my survivors and undermines the life narrative as a vibrant, thinking, and articulate figure that I assiduously cultivated. (Burdening others is also a distasteful prospect, but it is the vision of intolerable indignity that drives my planning of how to respond to a diagnosis of progressive dementia such as Alzheimers).
My initial plan was to engineer my own demise while still competent to do so. My sketch of methodologies and my preferred course (stopping eating and drinking) appear at: http://blogs.law.harvard.edu/billofhealth/2015/04/16/my-plan-to-avoid-the-ravages-of-extreme-dementia/. The obvious hazard in that plan is cutting short a still vibrant and satisfactory existence.
An alternative strategy would be to allow myself to decline into incompetency, but beforehand to dictate, in an advance directive, rejection of future life-sustaining medical interventions. This strategy would probably work as applied to serious maladies such as kidney disease, lethal cancer, or congestive heart failure. The disturbing issue then becomes timing. The onset of such serious maladies is fortuitous and years of lingering in dementia might precede my demise.
A further alternative would be to seek to accelerate my post-competence demise by declining not only major medical interventions such as mechanical respirators or dialysis, but also more simplistic items like antibiotics, antiarrhythmics, and artificial nutrition and hydration. My envisioned scenario is that infection would occur early (via urinary tract, skin, or pneumonia) and that this condition, left untreated, would precipitate my death. (My advance instructions would allow palliative but not curative measures.)
As part of the Regulatory Science series at University of Arizona:
Health Law and Health Policy: A Frictional Account
William M. Sage, MD, JD, University of Texas
Today 12/2 — Noon (AZ Time) / 2pm Eastern / 11am Pacific
The talk will be webcast live, and available as an archive:
Participants in the live webcast will have the opportunity submit questions and comments. Please do!
By Matt Ryan
Following the Supreme Court’s decision in NFIB v. Sebelius, states have had the option whether to expand Medicaid or not. As of this writing, 30 states and the District of Columbia have expanded Medicaid. Kentucky was the only Southern state that decided to expand Medicaid and run their own exchange. The decision brought great success. Under Democratic Governor Steve Beshear, Kentucky saw their uninsured population drop by 10.6% from 2013 to 2014. As Governor Beshear put it, Kentucky was the “poster-child for the implementation of the ACA.”
Last month, Kentucky elected Matt Bevin governor. Mr. Bevin, a Republican, had promised to dismantle Medicaid and the insurance exchange. When asked about Medicaid early in his campaign, Mr. Bevin responded, “No question about it. I would reverse that immediately.” Many feared that Mr. Bevin’s election put Medicaid in critical condition. But since his election, Mr. Bevin has shifted his position.