Google, Whole Foods, and … Big Pharma?

Nadia Sawicki Leave a comment

By Nadia N. Sawicki

Google’s informal corporate slogan is “Don’t be evil.”  Whole Foods is a Fortune 500 company with a net revenue of 10 billion dollar that prides itself on a commitment to social responsibility.  Both companies have pledged to do long-term good in the world, even at the expense of short-term gains, and both are wildly successful.

If corporations can be profitable as a result of their commitments to social justice and corporate ethics, why can’t this doctrine be extended to the pharmaceutical industry?  Someday, a company called GoodPharma might reach the Fortune 500 on the basis of a pledge to improve access to medicine, conduct international research trials in accordance with the highest standards of research ethics, engage in research on orphan diseases, publish negative research findings, promptly report information about adverse effects, and generally act as a model for ethical industry practices.  If this business model hasn’t been explored, it should be.

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Study Reveals Complexities of Disclosing and Compensating for Medical Mistakes

I. Glenn Cohen Leave a comment

[Editor’s Note, I am guest posting this on behalf of my wonderful colleague Michelle Mello, at the Harvard School of Public Health]

Gridlock in many state legislatures over proposals to reform medical liability by capping noneconomic damages—and growing recognition that caps have only modest success in addressing the problems with the malpractice system—have led  health care providers and other stakeholders across the country to think hard about alternative approaches.  Alternatives that don’t require the passage of legislation are especially appealing.  Attention has focused in the last couple of years on a promising approach pioneered by a handful of hospital systems, including the University of Michigan Health System: “disclosure-and-resolution” programs, or DRPs.  In DRPs, healthcare facilities and their malpractice insurers disclose unanticipated care outcomes to patients and their families; investigate and explain what caused them; apologize; and, where appropriate, offer compensation without waiting for the patient to sue.

Early adopters of this approach report remarkable success in reducing liability costs and believe they have markedly improved patients’ experience following a medical injury.  But they can’t tell how much of the benefit is attributable to disclosing errors and apologizing, versus offering compensation.  Is it the honesty and empathy, or the money, that matters?  And if it’s the money, how much is enough to get the outcomes healthcare providers want: reduced frequency of malpractice claims, lower defense and indemnity costs, quicker disposition, improvements in staff reporting of unanticipated care outcomes, and a clinical culture that supports open communication with patients?

A new study that I published with my colleagues, Lindsey Murtagh, Penny Andrew, and Tom Gallagher, in Health Affairs this week begins to answer these questions.  We used an experimental survey design to investigate the relative effects of disclosure, explanation, and apology on the one hand, and different kinds of compensation offers on the other, on people’s responses to learning that they were the victim of a medical error.  We fielded an online survey in which 2,112 American adults randomly received one of 16 vignettes in which they were informed of a medical error.  In all vignettes, a physician and administrator explained how the error occurred, took full responsibility, and apologized.  Some vignettes also included an offer of compensation—either waiver of medical bills, limited reimbursement of out-of-pocket expenses, or full compensation—while others included no compensation offer.  Respondents answered several questions about how they would react to the disclosure.  The survey sample was drawn from KnowledgePanel, a standing, probability-based panel of U.S. adults maintained by GfK (formerly Knowledge Networks).  The survey response rate was 65%.

What did we find?

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

The Petrie-Flom Center Staff Leave a comment

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

I. Glenn Cohen Leave a comment

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

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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 insomnia, fibromyalgia and other conditions. . . .

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

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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

srose Leave a comment

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?

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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”

ykuo Leave a comment

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