By Arielle Lusardi
As state medical marijuana laws proliferate throughout the country, companies are trying to secure their own piece of the action. In July 2014, a San Francisco-based start-up company, called Eaze, launched a mobile application that facilitates the delivery of medical marijuana in California. Read More
The Petrie-Flom Center is leading the Law and Ethics Initiative of the Football Players Health Study at Harvard University. Two new videos explain our involvement, and what the study is all about.
By Holly Jones, BA, JD candidate
How can the federal government ensure consumer safety in an industry that distributes a substance the federal government classifies as an illegal drug? The federal government effectively banned the use of marijuana nationwide with the Controlled Substance Act of 1970, classifying marijuana as a Schedule I substance according. Regardless of this federal prohibition, 23 states and Washington, DC have legalized marijuana for medical use. A lack of federal legalization allows states to independently enact their own distinct medical marijuana laws.
In a dataset released yesterday on LawAtlas.org, the distinctions become clear — there are currently 24 variations of medical marijuana program product safety guidelines in the United States, some of which bear little, if any, resemblance to one another. While some states, like Connecticut and Massachusetts, provide incredibly comprehensive guidelines for their medical marijuana programs, others provide skeletal legislation and instead grant a great deal of autonomy to local jurisdictions.
While variation may allow researchers to more effectively evaluate the approaches, from a patient-safety perspective, uniformity has its advantages. Read More
By Emily Largent
The Kaiser Family Foundation (KFF) recently conducted a survey of gay and bisexual men in the U.S. focusing on attitudes, knowledge, and experiences with HIV/AIDS. The survey results, released Thursday, can be found here. I was most interested in the finding that only a quarter of those surveyed know about PrEP (pre-exposure prophylaxis).
PrEP (brand name Truvada) is a combination of two medicines (tenofovir and emtricitabine) that has, if taken consistently, been shown to reduce the risk of HIV infection in people who are high risk by up to 92%. The FDA approved an indication for the use of Truvada “in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk” in 2012. The U.S. Public Health Service released the first comprehensive clinical practice guidelines in May of this year. Read More
The Health Affairs blog recently published an important write-up of the status of safety net ACOs. Therein, authors James Maxwell, Michael Bailit, Rachel Toby and Christine Barron offer five “key observations regarding emerging safety-net ACOs and suggest broad policy implications” which are drawn from what appears to be a fairly extensive research project including “site visits and telephone interviews with 66 safety-net ACO leaders and state officials conducted over the last two years in 14 states.” Generally, they leave the reader with an optimistic impression of safety-net ACOs efforts to achieve population health – which contrasts with my previous post on Bill of Health.
In short, the authors offer the following observations:
The entirety of the post is well-written and I encourage folks to check it out for themselves. My concerns about the ACO model do still largely hold, however. While the authors of this blog highlight four states (MA, OR, AL and MN) with policies on the books to encourage creativity in safety-net ACO design, that leaves 46 others without such supportive legislation. In short, I think we are still working at the margins here. Moreover, I worry that the authors have chosen a definition of ACO that goes well beyond what CMS considers to be an ACO and in so doing have spotlighted “bright lights” of the health care delivery landscape that may not have the metrics and results to support their claims at innovation. The authors offer us little information about what kind of improvements either in quality of care or health outcomes these safety-net ACOs have been able to achieve. (Meanwhile, CMS recently released the latest quality metrics on the Pioneer and Shared Savings ACOs they sanction and monitor.)
The bottom line is this: safety-net ACOs, like all ACOs, certainly hold promise. The question is whether we will translate this promise into systems-level change.
[View the original posting here.]
Creighton University School of Law invites applications for a lateral tenured or tenure-track professor in health care law to join our faculty in Fall 2015. Applicants should have significant academic or practice experience in the business side of health care (e.g., the financing and regulation of health care, including but not limited to the Affordable Care Act). Creighton University has seven health care schools on its campus, as well as a College of Arts and Sciences and a College of Business, and the Law School is particularly interested in establishing interdisciplinary programs with those schools for non-JD as well as JD students. Candidates with experience in developing such programs are especially encouraged to apply. Candidates should have excellent academic credentials and a proven record of (or demonstrated potential for) outstanding classroom teaching and scholarship.
Applicants should apply online to Eric Pearson, Chair of the Faculty Appointment Committee, Creighton University School of Law. Please include:
Robin Pierce, JD, PhD, contributes to the HealthLawProf Blog, and is joining Bill of Health as a regular contributor.
Robin is Senior Law Associate with the Petrie-Flom Center for Health Law and Policy, Biotechnology and Bioethics at Harvard Law School. She was formerly on the faculty of Technische Universiteit Delft in The Netherlands where her work focused on the legal, ethical, and policy implications of advances in biotechnology, including policy issues in the integration of nanotechnology in health care, regulatory, policy, and ethical issues in governance of synthetic biology, and policy, legal, and ethical issues arising from advances in Alzheimer’s disease research, and neuroscience, in general. In 2014 Dr. Pierce was appointed Associate Editor for Science and Genetics with the Journal of Bioethical Inquiry. In 2010 she was appointed Programme Leader for the Kluyver Center program on Society and Genomics in The Netherlands. She has taught across disciplines including such courses as Remedies (law), Social Issues in Biology, Ethic, Legal, and Social Issues in the Life Sciences, Public Health Ethics, and the Development of Legal and Political Institutions.
Representative Publications: Read More
Download the Paper: Solving the Problem of New Uses by Creating Incentives for Private Industry to Repurpose Off-Patent Drugs
Benjamin N. Roin is Assistant Professor of Technological Innovation, Entrepreneurship, and Strategic Management at the MIT Sloan School of Management and an associate member of the Broad Institute of MIT and Harvard. From 2010 to 2014, as a faculty member at Harvard Law School, Ben was Faculty Co-Director of the Petrie-Flom Center. Ben’s work focuses on entrepreneurship, intellectual property, and innovation policy. His primary areas of research are patent law and biopharmaceutical innovation.
By Kate Greenwood
[Cross-posted at Health Reform Watch]
Given the health law and policy topics that are this blog’s usual fare, some of you may have missed the fact that earlier this month the eighty-eighth annual Miss America pageant was held here in New Jersey, at Boardwalk Hall in Atlantic City. And you may have also missed it (I did) when, this past July, Miss Idaho, Sierra Sandison, a Type 1 diabetic, became a social and traditional media sensation after she competed in the swimsuit competition with her insulin pump clipped to her bikini bottom, visible for all to see. Sandison started a hashtag, #showmeyourpump, inspiring Type 1 diabetics from around the world to post photos of themselves with their pumps.
Although Sandison was the first contestant to compete in the Miss America pageant with her pump visible, she is not the first contestant with Type 1 diabetes, or the first to rely on a pump. In 1998, both Deana Herrerra, Miss New York, and Nicole Johnson, Miss Virginia, had the disease, and both relied on pumps to control it. Johnson went on to be crowned Miss America 1999, with a platform of diabetes awareness. Johnson explained to the Philadelphia Inquirer that, before getting the pump, “‘I stuck myself four or five times a day. I was getting scar tissue. I was feeling depressed, and I thought, `I’m never going to have an iota of freedom.'” Since getting the pump, Johnson said, “‘Now, I control the diabetes.”’
Sierra Sandison’s decision to wear her diabetes pump on her hip both contributed to and was the result of a trend toward greater acceptance of medical devices and our need for them. (As Miriam Tucker reported at NPR, “Amputees are increasingly using visible prostheses rather than covering them up. And the ostomy community has its own version of the ‘show me’ campaign.”) Nicole Johnson told Tucker that “‘Our culture seems to be more accepting today, as opposed to when I was diagnosed in 1993.'”
Perhaps unsurprisingly, the increase in acceptance has not translated into easy or uniform access to the medical devices that help diabetics manage their disease, including insulin pumps, insulin pens, and continuous glucose monitors. Read More
[Cross-posted at HealthLawProfs blog.]
Under HIPAA, patients’ spouses and other family members have certain rights to access health information. In an important guidance document in the wake of United States v. Windsor, the Office for Civil Rights (OCR) at HHS has clarified that “spouse” under HIPAA refers to legally married same-sex spouses, even if the individual is receiving services in a jurisdiction not recognizing same-sex marriage. Read More
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