Of Morals and Smartphones

By Emily Largent

Although many lament that the ubiquity of smartphones has contributed to a recent decline in etiquette, a study published this week in Science suggests that smartphones’ ubiquity may make them a valuable–if surprising–tool for studying modern morality.

Most moral judgment experiments are lab-based and driven by hypotheticals. By contrast, this was a field experiment that focused on the moral judgments people make in their daily lives. The authors recruited 1,252 adults from the U.S. and Canada. Participants were contacted via text message five times each day over a three-day period. Each time, they were asked “whether they committed, were the target of, witnessed, or learned about a moral or immoral act within the past hour.” For each moral or immoral event, participants described via text what the event was about; provided situational context; and provided information about nine moral emotions (e.g., guilt and disgust). Political ideology and religiosity were assessed during an intake survey.

Participants reported a moral or immoral event on 28.9% of responses (n = 3,828). Moral and immoral events had similar overall frequencies.  The authors found political ideology was reliably associated with the types of moral problems people identified.  Liberals mentioned events related to Fairness/Unfairness, Liberty/Oppression, and Honesty/Dishonesty more frequently than did conservatives.  By contrast, conservatives were more likely to mention events related to Loyalty/Disloyalty, Authority/Subversion, and Sanctity/Degradation.  Continue reading

What Is (or Isn’t) a Public Health “Emergency”?

In this week’s issue of New England Journal of Medicine, Michelle Mello, Wendy Parmet, and I write about what constitutes — or should constitute — a “public health emergency”. The law provides for emergency declarations, which suspend ordinary legal standards and processes in order to avoid catastrophe, on many levels (international, federal, state, local) and in public health or more general contexts. We focus our discussion at the state level, using Governor Deval Patrick’s declaration of the opioid-addiction crisis as a public health emergency as an opportunity to explore the appropriate parameters of these powers. My co-authors and I don’t debate the public health significance of opioid addiction in the Commonwealth, nor the specific measures ordered pursuant to this declaration. We do question the expanding use of public health emergency powers beyond the traditional arenas of infectious disease outbreaks, natural disasters, and acts of bioterrorism into new territories, such as injuries and chronic disease.

State laws provide governors and their top health officers with considerable latitude in declaring public health emergencies. But the powers available upon such declarations are extraordinary and should be wielded with care. My co-authors and I identify three key criteria that seem to be enshrined in the spirit of public health emergency laws: “the situation is exigent, the anticipated or potential harm is calamitous, and the harm cannot be avoided through ordinary procedures.” In the absence of these criteria, the invocation of such emergencies may raise heightened concerns — for instance, if ensuing orders involve serious infringements on individual and private business rights — and could result in a loss of public trust in health officials and legitimacy in public health laws. We caution against setting such troubling precedent.

Read more in our Perspective, entitled “What Is a Public Health “Emergency”?“.

Petrie-Flom Center Executive Director Appointed to SACHRP

Holly Fernandez Lynch, J.D., M.Bioethics, Executive Director of the Petrie-Flom Center at Harvard Law School, has been appointed by Secretary of Health and Human Services Sylvia Burwell to a four-year term as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP).  SACHRP is a Federal Advisory Committee charged with providing expert advice and recommendations to the Secretary on issues and topics pertaining to the protection of human research subjects. To date, SACHRP has focused its attention on areas such as research involving children, prisoners, and individuals with impaired decision-making capacity; informed consent and the use of biospecimens; harmonization of human subjects regulations and guidance; the reduction of regulatory burden; the HIPAA Privacy Rule; community-engaged research, and accreditation.  Continue reading

Can Someone’s Sex be Situational?

by Vadim Shteyler

Dutee Chand’s career was rising quickly—in 2012 she was the Under-18 Indian National Champion for the 100-meter race. In 2013, she became National Champion in the 100 and 200-meter races as well as the first Indian to reach the final at the World Youth Championships. However, on July 15, 2014, her career was placed abruptly on hold when she was banned from all national and international competitions as a female competitor. Testing revealed that she had hyperandrogenism, that is her body naturally produced elevated levels of the male hormone, testosterone.

In April 2011, the International Olympic Committee (IOC) and the International Association of Athletics Federations (IAAF) had instituted policies banning all athletes with testosterone levels at or above the lower limit for males from competing in the female category. The policy allows women to requalify if they are shown to be resistant to the effects of testosterone or if they undergo one of a number of medical interventions to decrease their testosterone levels. This policy was a change from the extensive medical and psychological testing used for sex verification. (Read more about Caster Semenya, whose experiences catalyzed the policy change.)

Supporters of the new policy argued that a male competing among females has unfair advantage and, as such, furthers his career undeservingly and wins medals for his country unjustly. If increased testosterone levels largely contribute to the better athletic performance of males, then athletes with male-range testosterone should be banned from female competitions. Further, the IAAF cutoff for female testosterone levels is greater than 10 times the mean for average women, ensuring that the vast majority of women, even those with elevated testosterone, would not be disqualified based on these criteria. (Read more in The Journal of Sex Research.)  Continue reading

Questioning Quorn

By Diana R. H. Winters
[Cross-posted on HealthLawProfBlog.]

There was an article a couple of weeks ago in the New York Times about “engineered foods,” and how “a handful of high-tech start-ups are out to revolutionize the food system by engineering ‘meat’ and ‘eggs’ from pulverized plant compounds or cultured snippets of animal tissue.”   The author discussed some of the business models, interviewed some of the entrepreneurs, and contemplated some of the implications of “Food 2.0.” The concerns she noted involved the nutritional impact of these foods, and the possibility of resource-intensive production.

But what sort of screening will these food products go through before they enter the food supply? How will FDA vet these new foodstuffs for toxicity or allergenic properties? It won’t. Manufacturers can self-affirm that food products are safe, based on their own studies, and market them on that basis with no prior FDA approval. This is the GRAS (generally recognized as safe) route to marketability. A manufacturer could also choose to submit to the formal food additive approval process, which is extremely time-consuming, but considering the breadth of the GRAS exception, they probably won’t. Many more GRAS notifications are filed per year than food additive petitions.  Continue reading

Discrimination on the Basis of Health Status in Health Insurance: “Market-Norm or Necessity”?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

In recent months, advocates have alleged that discrimination on the basis of health status in health insurance continues, notwithstanding the Affordable Care Act’s attempts to level the playing field for people with chronic health conditions. How the government and industry should respond to the allegations is not clear, however, in part because what constitutes “discrimination” is not clear in this context. As Jessica Roberts has noted, there is an “intrinsic tension between an antidiscrimination framework and the practices of the private, for-profit health-insurance industry.” This tension makes it difficult to pinpoint where permissible cost-consciousness ends and impermissible discrimination begins.

As has been widely reported, at the end of May, the National Health Law Program, along with the Tampa-based organization The AIDS Institute, filed an administrative complaint with the United States Department of Health and Human Services’ Office of Civil Rights in which they allege that four qualified health plans offered through the federally-facilitated marketplace in Florida discriminate by “charg[ing] inordinately high co-payments and co-insurance for medications used in the treatment of HIV and AIDS.” The complainants go on to allege that because “[o]ther issuers vary tiering or place HIV drugs on more affordable tiers,” “the practice of placing all anti-retrovirals on the highest tier is not a market-norm or necessity.”

The complaint’s emphasis on whether the plans’ actions reflect a “market-norm or necessity” tracks the Centers for Medicare & Medicaid Services’ 2015 Letter to Issuers in the Federally-Facilitated Marketplaces, in which CMS writes that “to ensure nondiscrimination in [qualified health plan ("QHP")] benefit design, CMS will perform an outlier analysis on QHP cost sharing (e.g., co-payments and co-insurance) as part of the QHP certification application process.” CMS goes on to specify that, with regard to prescription drugs, a plan will be considered an “outlier” if it has “an unusually large number of drugs subject to prior authorization and/or step therapy requirements in a particular category and class.”

As Sarah Rosenbaum has noted, “CMS does not provide a review methodology or define what is ‘unusually large’.” Even if it had, what if subjecting a large number of drugs to prior authorization or step therapy requirements did not make a plan unusual? Would that mean that doing so was not “discrimination”? Continue reading

What’s to become of population health?

When the accountable care organization (ACO) model was initially conceptualized, many in the health policy world hoped it could provide a platform for real transformation of US health care.

Among the ACO model’s most promising innovations was its explicit orientation towards achieving “the Triple Aim.” First articulated by Don Berwick and the Institute for Healthcare Improvement (IHI), the Triple Aim is a strategy for optimizing the health care delivery system and achieving the best of all worlds. It outlines three goals: high quality health care, lower costs, and population health. The Center for Medicare and Medicaid Services adopted this goal and still describes a version of the Triple Aim on its webpage titled “Innovation.”

Continue reading

Post-Trial Access and Responsibilities (and Upcoming Conference, Sept. 18 at HLS)

By Zachary Shapiro

Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is widely available or approved for the market (or maybe longer/in other circumstances). At issue is the question of the commitment a clinical trial sponsor owes the participants of their trial (and maybe others) in the period after a clinical trial phase, but before market approval of the tested pharmaceutical (or maybe longer).

While the provision of Post-Trial Access may seem to be an ethical “no-brainer,” there are numerous variables that make the decision of whether to provide PTA difficult. One major question is whether all arms of the trial deserve access to the therapy, even those who were on placebo or in the control arm. If the therapy tested shows less efficacy than a more or less expensive treatment modality, is there a responsibility to provide the more effective treatment, regardless of the cost? What if said therapy is far beyond the standard of care for the condition in the particular country where the trial took place? Furthermore, how long do PTA obligations extend? While the simple answer is that they end after market approval, the truth is that many drugs have long approval processes, with complicating factors that can result in significant delays. This is an even more difficult question if the trial is a multi-regional study, and takes place in a country where the sponsor does not intend to market the product.

The question of how to provide PTA also poses logistical issues, as many sponsor sites close after a clinical trial is finished. This can make provision of post-trial access extremely expensive, and perhaps unduly burdensome, especially if the trial is sponsored by a biotech start-up without the deep pockets of a large pharmaceutical company. These costs can skyrocket depending on whether we believe the sponsor should be responsible for costs that might result from improper use of the therapy, or failure of the participants to comply with proper treatment. Continue reading

Asking the Right Right Question About Football – Why do Some NFL Players Abuse Their Partners?

The national press is buzzing after TMZ released a video of Baltimore Ravens running back Ray Rice’s barbaric assault of his then-fiancee, Janay Rice.  Much of the spotlight of the coverage shined on the NFL’s handling of the abuse, and perhaps even more time was spent yesterday questioning Ms. Rice’s decision to stay in her relationship with her husband.  These are certainly valid questions to ask, and there is something to be said about the raised “awareness” of domestic violence in the aftermath of its players deplorable acts of violence.  I would argue the discussion has been more valuable than any awareness raised by NFL teams wearing pink during breast cancer awareness month.

If we want to best-capitalize on the awareness raised by these acts of violence, however, the conversation needs to shift from harm reduction (“why did she stay?”) to harm prevention.  To illustrate: when faced with the prevalence of lung cancer, do we ask “Why does the cancer patient continue to smoke?”  Yes, to some extent, we do, but we first addressed the causal inquiry, “What causes cancer?”, and in order to prevent the next generation from becoming addicted to nicotine, millions have been invested and continue to be invested in educating the public (and particularly youth) about the harms of tobacco use, and legislative action has been taken to prevent the harms caused by tobacco use.

Domestic violence (or intimate partner violence), like lung cancer, is a public health issue.  This is not a novel or controversial statement.  According to a 2010 CDC report, one in four women and one in seven men have experienced severe physical violence by an intimate partner, and according to a 2003 report, the national costs of health services for intimate partner rape, physical assault, and stalking is nearly $4.1 billion.  The CDC’s website states:  “The goal is to stop IPV [intimate partner violence] before it begins. There is a lot to learn about how to prevent IPV.”

It is time that the health care community take the CDC’s statement seriously and work collaboratively across law, public health, and medicine to research, propose, and implement innovative solutions to this perpetual epidemic, that costs thousands of lives in the United States each year.  Unlike some other organizations aimed at addressing public health issues, organizations whose goal is to prevent domestic violence are often grossly under-funded.  Perhaps the most apropos inquiry or statement to put to the NFL, the NFL Player’s Union, or other public health institutions that agree that domestic violence prevention is important is one capture by a classic football film: “SHOW ME THE MONEY.”

[Ed. Note: This post reflects the author's views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

10/8/14: A Conversation with Jim Doyle

A Conversation with Jim Doyle
October 8, 2014 12:00 PM – 1:00 PM
Wasserstein Hall, Room 2012, 1585 Massachusetts Ave.

JimDoyleJoin the Harvard Health Law Society for a lunch talk with former Attorney General and Governor of Wisconsin Jim Doyle. Come hear about the former governor’s experiences tackling public health issues through state politics and join us for a Q&A session about health policy, health law careers, and politics. Governor Jim Doyle served as the 44th governor of Wisconsin and is recognized as a national leader in health care, energy, biotechnology, and many other areas. He has worked closely with the White House, high-ranking officials, and other governors. He currently serves as counsel for Foley & Lardner and is teaching a class at the Harvard School of Public Health this fall entitled “Health Policy, Leadership, and Politics at the State.”

Co-sponsored by the Center for Health Law Policy and Innovation and the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics.

9/30/14: A Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.

Asking the Right Question about Football

By David Orentlicher
[Cross-posted at HealthLawProf Blog and orentlicher.tumblr.com.]

In his New York Times op-ed today, former Denver tight end Nate Jackson explains why the NFL should prefer that its players use marijuana to medicate their pain rather than to rely on prescription drugs that can have serious side effects and promote dangerous addictions. Jackson explains quite effectively why he needed marijuana during his six-year career:

I broke my tibia, dislocated my shoulder, separated both shoulders, tore my groin off the bone once and my hamstring off the bone twice, broke fingers and ribs, tore my medial collateral ligament, suffered brain trauma, etc. Most players have similar medical charts. And every one of them needs the medicine.

But to ask whether players should use marijuana or legal drugs to treat their pain is to ask the wrong question. As I write in a forthcoming symposium on concussion in sports in the Journal of Law, Medicine & Ethics, Continue reading

Medical Malpractice in Reproductive-Choice Procedures

By Alex Stein

Malpractice suits filed in connection with reproductive-choice procedures often present unique problems. The suit filed by Jami Conner against her former gynecologist, Dr. Bryan Hodges, is a case in point. The plaintiff, a mother of two children, decided that she did not want to have more children. To avoid future pregnancy, she asked the defendant to perform bilateral ligation of her tubes and the defendant granted her wish. Two and a half years later, however, the plaintiff discovered that she was pregnant again. Her suit against the defendant promptly followed that discovery. Continue reading

To Watch: Rural Enrollment on Exchanges

As we gear up for a second year of exchange marketplace enrollment, one issue to keep an eye on is the success we have at getting people who live in rural areas onto the healthcare rolls.  As pointed out in today’s Kaiser Health News write-up (here), there is potential for the ACA to increase rural health disparities, even while it gets more people insured, because many of the efforts to encourage enrollment–think navigators, enrollment centers, advertising, and outreach–just work better in urban areas.  For some reading on this issue, see the Kaiser Family Foundation’s posting here, the HHS’s Health Resources and Services Administration’s report here, and the Rural Health Foundation’s roundup here.

Worth Reading This Week

By Nicolas Terry

Harvard Effective Altruism: an event today, Michael Kremer on Sept. 10, and a fellowship opportunity

A message from Harvard Effective Altruism:

On Saturday, Sept. 6 at 3pm in Sever 111, we are holding a giving game / donation discussion and an information session for Harvard students interested in our organization. We’ll explain what effective altruism is and what HCEA does here on campus. If you’re new to HCEA, you should definitely check it out!

Wednesday, Sept. 10 at 4:30pm in Science Center Hall A: Prof. Michael Kremer – a development economist at Harvard – will give a talk entitled “How can individuals reduce global poverty?” He’ll discuss the ways that individuals can use both their money and their careers to contribute to poverty reduction and international development.

All semester long! HCEA is hosting its third Philanthropy Fellowship program for Harvard undergrads and graduate students. Fellows will attend talks from speakers like Harvard professor Steven Pinker, Rob Mather of the Against Malaria Foundation, and Center for Applied Rationality president Julia Galef; learn about effective altruism at weekly dinners with other fellows and speakers; get to know likeminded students at discussions and social events; and fundraise for effective charities! You can find more information and apply on our website before 11:59pm on Sunday, Sept. 14th.

We hope to see soon! Altruistically yours,
Ales and John

Ebola and the Return of Quarantine

[Ed. Note: Cross-posted from HealthLawProf Blog.]

Last month’s riots in an Ebola-infected slum in Monrovia, Liberia demonstrated anew the perils of relying on quarantine, and similar highly coercive public health laws, to contain highly contagious diseases.

At first blush, Ebola viral disease (EVD) is exactly the type of disease for which broad quarantines (more precisely, sanitary cordons) would seem appropriate. Transmitted through direct contact with the bodily fluids of an infected person, EVD can spread rapidly through a community, as it has done in several West African nations. Although experimental treatments and vaccines offer promise for the future, they have not yet been shown to be effective in humans; nor are they readily available. As a result, health officials are forced to rely on tried and true public health strategies, such as identifying cases, isolating and treating them with strict infection control measures, and monitoring their contacts. Needless to say, doing so is very challenging and very expensive, especially in highly urbanized areas, with weak health systems.

Given the challenges, health officials and government leaders are often tempted to call in the troops, and rely on more heavy-handed measures, such as imposing sanitary cordons around whole towns or neighborhoods, quarantining those who have had contact with patients, and restricting travel into and out of affected regions. Although the impetus for these measures is understandable given the magnitude of the EVD threat, history suggests that such highly coercive tactics frequently backfire. Like the military-style show of force employed by the police department in Ferguson, Missouri earlier this summer, highly coercive public health measures can undermine the public’s trust in authorities. Thus, rather than reduce travel, identify contacts, and come forward if they show symptoms, individuals are more apt to try to leave affected areas and avoid the health care system. Or they riot, as they did in Monrovia and China during the SARS outbreak. In any case, the problem is made worse not better. Continue reading

8 Facts (and some pretty graphs) that explain what’s wrong with American Healthcare

This single webpage (Vox) covers about 80% of what I try to convey during the first day of my health law class.  And the page does it with some nice graphics, which are worth stealing (ahem, “fair using” for educational purposes).  While nothing will be new to health policy scholars, it is a nice synthesis.  Highly recommended.