The Father of Sunshine

Paul Thacker

Over at our sister blog for the Safra Center’s Institutional Corruption Lab, Paul Thacker has a great post about how the Physician’s Payments Sunshine Act came to exist.  The new database created by the Act is just now going live, and its a good time to reflect on how we got here. Thacker was a staffer for Senator Chuck Grassley, and from that vantage, has rare insight into how the bill was conceived and how initial objections of Big Pharma were overcome.  Thacker also outlines several complementary efforts, including pressure to reform NIH policies around conflicts of interest.  That proposal went all the way to the White House, where it was gutted.  Worth reading.

Colorado Personhood Version 4.0

By Jonathan F. Will
[Cross-posted at Hamilton and Griffin on Rights.]

This November citizens of Colorado will have an opportunity to vote on a proposed amendment (Amendment 67) to their state constitution that would define the words “person” and “child” in the Colorado Criminal Code and Colorado Wrongful Death Act to include “unborn human beings.”  Similar personhood measures were rejected by a margin of 3-to-1 by Colorado citizens in 2008 and 2010, and a proposal in 2012 failed to receive the requisite signatures to get on the ballot.  Is this version 4.0 all that different?

A New Strategy

In short, the language is different, but not in ways that ought to matter for those concerned about the implications for reproductive rights.  I was initially surprised that a fourth personhood proposal was able to secure enough signatures to get on the ballot when the third measure was not.  After speaking with a reporter from Colorado, it became clear that the strategy this time around was very different.

This most recent personhood effort rode the wave of momentum generated by the 2012 story of a Colorado woman, hit by a drunk driver, who lost her pregnancy in the eighth month of gestation (a boy she had named Brady).  At that time, Colorado did not have a law on the books that permitted the drunk driver to be prosecuted for the death of the fetus.  Amendment 67, advertised as “The Brady Amendment” was offered as a solution, and there was no trouble generating over 100,000 signatures.  Even without Amendment 67, Colorado has since passed a Crimes Against Pregnant Women Act, which criminalizes (with varying degrees of punishment) the termination of a woman’s pregnancy without her consent.  This new law does not define the fetus as a person, expressly permits women to choose to have abortions, and certainly is not considered to go far enough for those in favor of sweeping personhood measures.  Amendment 67 was thus still viewed to be necessary by some. Continue reading

Vaccination Policy and Public Trust

By Kelsey Berry

The conflict between a physician’s dual roles as an agent of population health and an agent of his or her patient is exemplified in the classical debate about ethical vaccination policy. Whereas studies have demonstrated the role of vaccination in protecting public health at negligible risk to individuals, “vaccine hesitancy” and non-acceptance among parents has increasingly contributed to vaccination delay and refusal. Recent domestic measles outbreaks and increased numbers of reported infections in 2011 and 2013 gesture to the public health impacts of even small decrements in uptake, especially in a globalized setting where the infection can travel easily.[1]

The FORUM at Harvard School of Public Health recently hosted an event on vaccination, exploring through an expert panel the drivers of public perception about vaccination and ways of restoring public trust in vaccination. Panelists discussed the need for research into the values and concerns of those who exhibit vaccine hesitancy, and development of effective modes of communication, tailored to individuals’ concerns, that will allow trained physicians to effectively guide choice. Notably, the clinical encounter was brought up several times as fertile ground for both reestablishing trust and promoting vaccine uptake effectively.

Reestablishing public trust in public health interventions may be key to avoiding conflicts between physicians’ duties to both population health and patients/guardians. If the patient/guardian ultimately expresses support for vaccination, as a result of persuasive information supplied by the physician, the conflict seems to disappear. However, what about the case in which a patient expresses support for vaccination as a policy, but does not support the use of vaccination in the case of his or her own child (assuming for simplicity that there are no medical contraindications to vaccination in this child’s case)? This scenario brings out a possible duality in the held views of patient/guardians. There seem to be two competing views within one patient/guardian: first, the view that we as a society should promote population health through vaccination, and second the view that one’s own person/child should be exempt from vaccination. Continue reading

Medical Marijuana Delivery May Not Be As “Eazy” As It Seems

By Arielle Lusardi, BA, JD/MPH (’17)

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. Continue reading

Being Blunt About Product Safety: The problems with the lack of uniformity in medical marijuana laws

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. Continue reading

A Lack of Pep for PrEP

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. Continue reading

How much promise do safety-net ACOs really hold?

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:

  1. State policy is a key factor in the formation of safety-net ACOs.
  2. Both health policy experts and those involved in forming ACOs consider health homes, high-cost case management, and integrated behavioral health to be priority delivery system transformations for ACOs in the safety-net.
  3. It takes money to save money: upfront capital and financial flexibility are required for investment in delivery system transformations.
  4. Safety-net ACOs are adopting payment and delivery system transformations incrementally.
  5. Building on a long-standing recognition of how non-medical factors impact health outcomes and utilization, safety-net ACOs are addressing social determinants of health through community partnerships.

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.

Introducing Robin Pierce

Pierce_peopleRobin 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:  Continue reading

Lessons from Miss Idaho: Greater Acceptance of (but Not Necessarily Greater Access to) Diabetes Devices

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. Continue reading

HHS Issues Guidance on Same Sex Spouses and HIPAA

[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.  Continue reading

Lost Chances to Recover: An Elaboration

By Alex Stein

An important development of the lost-chance doctrine recently took place in Rash v. Providence Health & Services, — P.3d —- (Wash.App.Div.3 2014).

An 82-year old patient with a critical heart condition was hospitalized to undergo surgery. The patient’s heart condition made her death inevitable, but she managed to prolong her life with the help of medications. The hospital negligently failed to give the patient blood pressure medications. As a result, the patient suffered a series of strokes from which she died. The hospital’s negligence thus accelerated the patient’s demise.

The patient’s heirs sued the hospital for medical malpractice. The patient’s preexisting condition doomed the plaintiffs’ claim that the hospital’s negligence was the but-for cause of her death. The plaintiffs consequently demanded compensation for the lost chance of  better outcome, pursuant to Herskovits v. Grp. Health Coop. of Puget Sound, 664 P.2d 474 (Wash. 1983); and Mohr, 262 P.3d 490 (Wash. 2011). Continue reading

Worth Reading This Week

By Nicolas Terry

bioIP Workshop – Deadline for Abstracts Approaching

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioIP), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson,   Posted in Call for Abstracts, Kevin Outterson | Tagged , | Leave a reply

So Much, But Yet Not Enough—The Administration’s Plan to Combat Antibiotic Resistance

By Diana R. H. Winters
[Cross-posted at HealthLawProf blog.]

Yesterday was a big day in the fight against antibiotic resistance. The White House released an Executive Order and a National Strategy document on Combating Antibiotic-Resistant Bacteria, the President’s Council of Advisors on Science and Technology (PCAST) released a report on antibiotic resistance, and the National Institutes of Health and the Biomedical Advanced Research and Development Authority announced a $20 million prize for developing tests to identify highly resistant infections. Kevin Outterson at The Incidental Economist, Food Safety News, and the New York Times provide a good summary of these developments.

It is clear that the administration recognizes the grave threat posed by antibiotic resistance and that it intends to make combating this danger a national priority. Its approach is broad—the National Strategy includes a “Guiding Principle” that “[d]etecting and controlling antibiotic resistance requires the adoption of a ‘One-Health’ approach to disease surveillance that recognizes that resistance can arise in humans, animals, and the environment,” and the strategy pays much attention to the role of antibiotics in food production. One main objective of the strategy is to eliminate the use of medically important antibiotics at subtherapeutic levels for growth promotion (the practice of feeding animals antibiotics to make them fatter, not to make them well).

But in regards to the use of antibiotics for growth promotion in animals, the strategy does not provide the tools, or even the rhetoric, to support meaningful movement towards decreasing their use. The strategy calls for FDA to implement Guidance #213, to enhance its data collection capabilities, and to increase educational outreach on the appropriate use of antibiotics. Guidance #213, issued in December 2013, is intended to provide drug sponsors with information as to how they can “modify the use conditions” of medically important antimicrobial drug products to limit use to that “necessary for assuring animal health,” and only under veterinary supervision. Not only do guidance documents not establish legally enforceable duties, the recommendations in Guidance #213 are characterized as voluntary. FDA, moreover, has known the dangers of using antibiotics in animal feed at subtherapeutic levels for four decades, and has been sitting on the information. Swift and strong action is needed now.

Continue reading

House Hearing on Regulation of Laboratory-Developed Tests Displays More Consensus Than Disagreement

The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative. The hearing, which can be viewed online (here and here), featured representatives from the FDA, industry, and research organizations. And although the various panelists offered differing views on the propriety of the FDA’s decision to begin exercising its regulatory authority over LDTs, there seemed to be more agreement than disagreement among the panelists.

Most interestingly, as Representative Henry Waxman pointed out toward the end of the hearing, “[no]body on the panel [is] arguing that there shouldn’t be a very careful scrutiny of these tests. It seems like the question is who should do it: CLIA or the FDA.” Representative Waxman’s subsequent colloquy with Harvard Medical School Professor Christopher Newton-Cheh on this point particularly helped to differentiate the historical roles of CMS and the FDA in this space. But even those panelists who opposed the FDA’s involvement seemed supportive of expanding CMS’ authority under CLIA to conduct clinical validity analyses. (Anyone interested in the administrative law aspects of this issue should know that problems of shared regulatory jurisdiction have recently received increased scholarly attention, with Jody Freeman and Jim Rossi providing a particularly thorough treatment of the issue in their recent article, Agency Coordination in Shared Regulatory Space.)  Continue reading

Research Assistant III: Work with Professors Eyal, Hammitt, Freedberg, Kuritzkes, and collaborators on HIV cure studies’ risks, risk perceptions, and ethics

The research assistant will work with the principal investigator Nir Eyal and collaborators from the Harvard TH Chan School of Public Health, Duke University, Massachusetts General Hospital, and the Brigham and Women’s Hospital as well as the ACTG HIV trial site network. The multidisciplinary team uses methods of clinical epidemiology, economics, simulation modeling, and normative theory to predict risks in early-phase HIV cure studies, assess how much likely candidates for participation understand those risks, and make ethical recommendations on the conduct of HIV cure studies.

The research assistant will help prepare, conduct and analyze a pilot survey expected to take place in a US site of the AIDS Clinical Trials Group (ACTG). The survey will assess perceptions of HIV cure and of cure study risks. The research assistant will also promote other research and grant-related activities, through literature reviews and assistance in the preparation of abstract, poster, and manuscripts for publication, grant applications, a simple project website (using Harvard’s user-friendly OpenScholar platform), and slides for lectures and seminars. The research assistant will be in touch with top researchers in HIV cure, medical decision making, and ethics from around the country, to facilitate our meetings, a workshop, and regular conversations to plan the research and debate ethical issues around early-phase HIV cure studies.

For the full job ad:
https://jobs.brassring.com/1033/asp/tg/cim_jobdetail.asp?partnerID=25240&siteID=5341&AReq=33776BR

Live Blogging: Post-Trial Responsibilities Conference, Session 2

By Zachary Shapiro

Hello from the Post-Trial Responsibilities conference! I will be live blogging session 2: where speakers will be providing important perspectives on PTA. Barbra Bierer is monitoring the discussion.

We started with Richard Klein calling in from FDA:

Richard is talking about post-trial responsibilities. He points out that there is a justice issue here with ensuring access to health care and up to date interventions. He points out that while the FDA can encourage Post-Trial Access (PTA), it has no authority to require or ensure it. He points to moral authority, rather than legal. Foreign trials, however, are a different story, as the FDA has sway over protocol applications that are submitted in the US. Richard begins highlighting some specific considerations for protocol drafters and IRBs: particularly focusing on determining monitoring plans, as well as figuring out financial responsibilities for the provision of PTA.

He moves on to highlight that there is more of a moral obligation than a legal obligation. FDA is supportive of the provision of PTA. He believes that enthusiasm must be tempered, as there are situations when PTA is not appropriate. These include studies that have significant safety concerns, studies of bio-markers as well as validation studies that do not specifically examine safety and effectiveness. There are also situations where PTA is simply not feasible, particularly if additional drugs do not exist (one thinks of the recent Ebola treatment), if there is insufficient safety data, or if there is no practical capacity or resources to provide safety monitoring. We must also be aware of financial limitations, especially for start-up biotech firms that might not have deep pockets. Continue reading