mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

by Dan Vorhaus and Phil Ross (cross-posted from Genomics Law Report)

For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.

As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:

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Rationing Legal Services: Can Bioethics Help? My new article forthcoming in the Journal of Legal Analysis

There is a deepening crisis in the funding of legal services in the United States. The House of Representatives has proposed cutting the budget of the Legal Services Corporation (LSC), one of the main funders of legal assistance to America’s poor, to an all time low in inflation-adjusted terms. Other sources of funding, such as Interest on Lawyers Trust Account (IOLTA) are also way down due to low interest rates. More than 135 state and local organizations providing LSC assistance are now in a precarious position. The community was already decimated by the last round of cuts in January 2011, that led to the laying off of 1,226 lawyers and support staff at LSC-funded organizations, and 81,000 fewer low-income Americans receiving aid. This is all occurring at a time of extremely high unemployment and state budget cuts in services supporting low-income people, meaning demand for many of these services is going up.

The deepening crisis in funding of legal services only makes more pressing and manifest a sad reality: There is and always will be persistent scarcity in the availability of both criminal and civil legal assistance. Given this persistent scarcity, this Article will focus on how existing Legal Service Providers (LSPs), both civil and criminal, should ration their services when they cannot help everyone. To illustrate the difficulty these issues involve, consider two types of LSPs, the Public Defender Service and Connecticut Legal Services, that I discuss in greater depth below. Should the Public Defender Service favor offenders under the age of 25 instead of those older than 55? Should other public defenders offices with death eligible offenses favor those facing the death penalty over those facing life sentences? How should Connecticut Legal Services prioritize its civil cases and clients? Should it favor clients with cases better suited for impact litigation over those that fall in the direct service category? Should either institution prioritize those with the most need? Or, should they allocate by lottery?

These are but a small number of the difficult questions faced by those who have to ration legal services. Very little has been said as to what principles should govern the rationing of legal services. This is surprising given that civil and criminal LSPs are often funded through a mixture of government funding and charitable support in such a way that they should be answerable on questions of justice, and because their decisions whether or not to support a client is likely to have significant effects on that person’s life prospects. Thus, it seems as though the rationing decisions of LSPs deserve significant ethical scrutiny.

In my new article Rationing Legal Services, forthcoming in the peer-reviewed Journal of Legal Analysis (and available for free download in draft form now), I seek to remedy this deficit in the existing literature by engaging in a comprehensive analysis of how LSPs should allocate their resources given the reality of persistent scarcity. Luckily, this work does not have to begin at square one. There is a developed literature in bioethics on the allocation of persistently scarce medical goods (such as organs, ICU beds, and vaccine doses) that I use to illuminate the problems facing LSPs and the potential rationing principles they might adopt.

First Amendment & Pharma: Taking Freedom of Information Seriously

By Frank Pasquale

Back in 2011, the AJLM had a symposium issue anticipating major issues in 1st Amendment limits on FDA restrictions on off-label marketing. It was a prescient move, as Prof. Robertson’s post shows. Just as it did in Sorrell, the Second Circuit is using free speech jurisprudence to significantly expand pharmaceutical companies’ freedom of action to promote drugs:

The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomniafibromyalgia and other conditions. . . .

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Court Says Off-Label Promotion is Legal, and the Difference Between Warrant and Truth

By Christopher Robertson

Invoking the First Amendment protection of speech, the Second Circuit today reversed a criminal conviction for a drug salesman’s promotion of a drug beyond its FDA-approved uses.  The case in U.S. v. Caronia; the opinion is here, and here’s the Reuters story.

In First Amendment cases like Western States Medical Center and Sorrell v. IMS, the Supreme Court has been nibbling around the edges of the FDA’s regulatory regime, but nobody — not the industry, the FDA, or the Supreme Court — has seemed eager to really take it on directly.  For decades the FDA has relied on the regulation of speech as a primary tool.  Those regs turn on the distinction between drugs’ on-label uses (for which companies can promote) and off-label uses (for which companies are not allowed to promote, since the companies have declined to prove to the FDA that the drug is safe and effective for those uses).  Physicians are free, however, to use drugs off-label, so the crux of the FDA regulation really is about whether the company can talk about (promote) a transaction that is otherwise perfectly legal.  With Caronia, the Second Circuit is striking right at the heart of this regulatory regime.

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The Capacity of Surrogate Decision-Makers

During my many years in healthcare as a clinician, researcher and hospital ethics consultant, I am dismayed by how little relative attention is given to ensuring that surrogate decision-makers (or “proxies”) have the “capacity” to make sound medical decisions for adult patients without decision-making capacity. Some attention has been given to this in the literature, but not a lot. And, practically, it is routine in most clinical situations to defer to a proxy without much assessment of his/her capabilities.

For example, it has been demonstrated through many empirical studies that family members experience high distress when loved ones are admitted to ICUs, quite understandably — many families experience such high distress that decision-making abilities can be compromised. Others, even if distress is well-managed, are simply not aware of the patients’ previously stated wishes, to enable them to make decisions based upon substituted judgment. And, still others may not know enough of the medical situation to make good decisions based upon the patient’s best interests. Then, sadly, we also have a portion of proxies who may not want to keep the best interests of the patient at heart — in fact, I have done research among people with cancer who are also suffering from domestic violence from their primary caregiver (and presumed proxy). In these situations, the proxy may actually want to cause harm to the patient. Or, another example is when the harm may not be intended, but the proxy makes decisions based upon their own needs. An example is a proxy who chooses to keep a person in a terminal condition on life-support for their own financial gain (for pension checks to keep coming, for example).

We need to pay more attention to the capabilities of health care proxies. For example, in addition to encouraging clinicians to assess patients’ decision-making capabilities, clinicians should also be assessing the proxies’ decision-making abilities – early in the process. However, to my knowledge, there are no clear methods, guidelines, policies or laws “removing” established proxies from their posts as decision-makers (aside from taking the person to court, which is often impractical), when their judgment seems compromised. Clinicians are often left without guidance. Perhaps folks in clinical bioethics can help establish some clear standards for proxy decision-making, which might serve as a guide for clinicians, but also for future policy development. Just some initial thoughts…

What’s In a Name?

by Suzanne M. Rivera, Ph.D.

In regulatory and research ethics circles, it is fairly common to hear people say they prefer the term “research participant” to “research subject” because they feel it’s more respectful.  They think the word “subject” is demeaning.  I respectfully disagree.  I think it’s honest.

The federal agencies that oversee human research use both terms as though they are interchangeable.  The National Institutes of Health (NIH), for example, has a policy called, “Required Education in the Protection of Research Participants” which compels training for “individuals involved in the design and/or conduct NIH funded human subjects research.”

Of course, some research subjects are willing and active participants, but many are not.  The truth is that many people are studied without their consent or even knowledge.  In compliance with federal regulations, and under the watchful eye of ethics committees called Institutional Review Boards (IRBs), millions of medical records, biological specimens, and other sources of data (like court records, purchasing patterns, and web searching cookies) are mined by researchers every day.  You and I don’t participate in those studies.  They are done to us.  To the extent these studies are done with integrity, I don’t object.  But let’s not pretend we are participants. Read More

Upcoming Discussion: “The Objectivity of Ethics and the Unity of Practical Reason”

Katarzyna de Lazari-Radek and Peter Singer have an interesting new article in the most recent issue of Ethics on “The Objectivity of Ethics and the Unity of Practical Reason.”

Abstract:

Evolutionary accounts of the origins of human morality may lead us to doubt the truth of our moral judgments. Sidgwick tried to vindicate ethics from this kind of external attack. However, he ended The Methods in despair over another problem—an apparent conflict between rational egoism and universal benevolence, which he called the “dualism of practical reason.” Drawing on Sidgwick, we show that one way of defending objectivity in ethics against Sharon Street’s recent evolutionary critique also puts us in a position to support a bold claim: the dualism of practical reason can be resolved in favor of impartiality.

On Monday, PEA Soup will begin a discussion on this article, led by Roger Crisp.  I hope to see you there! -YK

Twitter Round-Up (11/25-12/1)

By Casey Thomson

From policy adoption at the federal level to debate over the health concerns of political figures, this week’s round-up focuses largely on the news for bioethics and health law in the realm of politics.

  • Dan Vorhaus (@genomicslawyer) posted a feature on the history of gene patent litigation and implications for next-generation sequencing technologies. (11/26)  He also included a link summarizing key information on H.R.6118, newly passed in the House and Senate and now being presented to the President. Otherwise known as the Taking Essential Steps for Testing (TEST) Act 2012, the bill gives the Centers for Medicare and Medicaid Services (CMS) “greater flexibility in enforcing CLIA [Clinical Laboratory Improvement Amendments] proficiency testing violations” (as noted by Vorhaus). (11/26)
  • Daniel Goldberg (@prof_goldberg) included a post on the inequality in self-rated health as considered by gender. The study, done in Spain, found that females’ lower sense of self-rated health is a reflection of the higher burden of disease in women, and encouraged systems of health to reconsider the approach towards afflictions with lesser impact on mortality that are possibly receiving less attention than is deserved. (11/26)
  • Daniel Goldberg (@prof_goldberg) additionally included a report on the problems parents with disabilities are facing in terms of retaining (or even gaining) their right to be a parent. Such bias against parents, the article notes, may not recognize that ensuring essential support may be all that is needed to discourage problems or eradicate risks for the majority of cases. (11/26)
  • Frank Pasquale (@FrankPasquale) linked to a blog post on the recent protests by AIDS activists in the office of House Speaker John Boehner. The protesters, stripped naked in order to reveal the painted “AIDS Cuts Kill” written on their chests, were there to protest the possible cuts to HIV/AIDS program funding that may follow a fiscal cliff deal.  (11/28)
  • Arthur Caplan (@ArthurCaplan) featured his talk with Boston Public Radio on the fine line politicians must walk when balancing their struggle with a health crisis along with the responsibilities of being a public official. The recent health concerns facing Boston’s Mayor Thomas Menino served as inspiration for this discussion. (11/28)
  • Frank Pasquale (@FrankPasquale) added a news article detailing the recent speech made by principal deputy national coordinator David Muntz of HHS’ Office of the National Coordinator for Health Information Technology. Muntz, in addition to discussing the need to better incorporate technology for fostering stronger communication between patient and doctor, mentioned some striking statistics: “only 15% of patients have renewed a prescription online,” while “just 10% have a personal health record.” (11/29)
  • Arthur Caplan (@ArthurCaplan) posted a link to a new feature on concierge medicine, where appointments can be paid for solely through cash and not through insurance. While previously considered an option only for the rich, concierge medicine has possible implications for the greater body of patients: as the article noted, it may become a more viable option especially as threats of regulation and backlash in a doctor shortage encourage traditionally high-priced firms to backtrack. (11/29)
  • Arthur Caplan (@ArthurCaplan) also shared a video by Canadian comedian Rick Mercer on getting flu shots. (12/1)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Petrie-Flom Interns’ Weekly Round-up: Nov 17-Nov 30

By Kathy Wang and Hyeongsu Park