Ebola and Cognitive Bias

In the wake of another health care worker contracting Ebola, alarm bells are ringing. Last week, President Obama abruptly cancelled a campaign stop to Rhode Island to hold press conferences where he promised that federal authorities are “taking this very seriously at the highest levels of government.” Despite Obama’s assurances that the dangers associated with the disease spreading in the US are extremely low, other political camps are less convinced. Mitt Romney, the former Governor of Massachusetts, urged officials to close US borders to countries experiencing Ebola outbreaks, basically quarantining West Africa from travel to the United States.

In light of the hysteria surrounding Ebola and not Enterovirus, it’s worth thinking about our national response. Enterovirus has already claimed more lives in the US than Ebola. Think about this, the CDC warns that enteroviruses are highly contagious and already more than 500 patients have been diagnosed across 43 states in the past couple months. Yet, there has been no national outcry or demands to quarantine states, cities, local communities, or hospitals where patients were treated. Why?

Unlike the enterovirus, the face of Ebola is decidedly immigrant or “outsider.” It’s origins are Africa.  Could these factors have contributed to Thomas Eric Duncan’s initial treatment at a Texas hospital and the inaccurate media accounts shortly following his diagnosis? Studies show how cognitive or implicit biases may have much to do with how we treat patients.  Continue reading

More Democracy in Hospital Management

by Vadim Shteyler

Interdisciplinary collaboration between all healthcare professionals involved in an individual patient’s care has been increasingly recognized as vital for providing high quality medical care. However, when it comes to hospital management, decisions affecting daily workflow are still largely made by physicians.

The movement towards an inter-professional team approach of providing medical care is still new but gaining widespread support. To characterize the disconnect between the presence of inter-professional collaboration in medical care, but its absence in healthcare management, it is valuable to understand the rationale for inter-professional teams in healthcare.  Continue reading

New Website: The Football Players Health Study at Harvard University

FPHS Logo

We are pleased to announce that a new website has been launched for The Football Players Health Study at Harvard University. Take a look to learn more about the project, the study team, and what we have in store with the goal of improving the health and wellbeing of professional football players. You can also find out more about the Petrie-Flom Center’s involvement, and in particular our Law and Ethics Initiative, here

Prop. 46: Lawyers v. Doctors

By Emily Largent

California Proposition 46, the Medical Malpractice Lawsuits Cap and Drug Testing Doctors Initiative, is on the November 4, 2014 ballot.  If approved by voters, the initiative would: increase the state’s cap on non-economic damages that can be assessed in medical negligence lawsuits; require hospitals to test certain physicians for drugs and alcohol; and require healthcare providers to check a statewide prescription drug database before prescribing or dispensing certain drugs to a patient for the first time.

The  debate over Proposition 46 has been framed as a battle between doctors and lawyers.  See also here or here.  It’s not hard to see why.  Attorneys have contributed the vast majority of the “yes” campaign‘s $9 million fund.  By contrast, nearly three-fourths of the “no” campaign‘s $57 million has come from six insurance companies; other big backers include the state medical and dental associations.  (It is the most expensive campaign in California this year.)  While the two sides have made a variety of arguments for and against Proposition 46′s various provisions, I want to focus on the putative costs and cost-savings:

First, Proposition 46 would increase California’s current $250,000 limit on non-economic awards (which dates to the Medical Injury Compensation Reform Act of 1975) to $1.1 million, and provide for annual adjustment for inflation going forward. The non-partisan Legislative Analyst’s Office estimates that increased state and local government health care costs from raising the cap likely range from the tens of millions of dollars to several hundred million dollars annually.  On the other hand, a RAND study of EDs in three states with strict malpractice limits found the caps had little effect on the cost of care.  Continue reading

Savior Siblings in the United States

By Zachary Shapiro

With the emergence of new techniques in the field of reproductive technology, applications arise that seem more the realm of science fiction than reality. While many have considered stem cells to be the next frontier of modern medicine, reproductive technology may offer hope to many individuals suffering with rare and unique genetic diseases.

The term “savior siblings” refers to the use of pre-implantation genetic diagnosis (PGD) and other forms of in-vitro fertilization (IVF) in order to create a sibling for the purpose of providing biological material (bone marrow, blood, etc.) that can help treat or cure an existing terminally ill child. It is estimated that up to one percent of PGD in the United States is used to create children that are tissue matches for their siblings. See here.

There has been little meaningful discussion about savior siblings in bioethical or legal circles, and there is no formal regulation governing their use or creation in the United States. This stands in stark contrast to other countries, particularly England, France, and Australia, where a regulatory framework for the use of savior siblings has arisen along with debate over their acceptability. These countries are already discussing how to ethically deal with this extremely complicated issue.  Continue reading

Upcoming Event: Law and Ethics of Non-Invasive Prenatal Testing

DNA_3helixesThe Law and Ethics of Non-Invasive Prenatal Testing

November 6, 2014 12:00 PM

Harvard Law School
Wasserstein Hall, Room 3018
Cambridge, MA 02138 [Map]

See the list of panelists here.

The Petrie-Flom Center will host a discussion of the issues surrounding noninvasive prenatal testing (NIPT), a screening method for detecting certain specific chromosomal abnormalities, as well as sex, in utero.  NIPT may help mothers avoid other tests that could put their pregnancies at risk, but the ability to detect substantial information about a developing fetus with such ease raises a wide range of important ethical and legal issues.  Our discussion will cover background on the technology, what makes NIPT unique, issues with global dissemination, eugenics concerns and legislative responses.

This event is supported by the Oswald DeN. Cammann Fund.

Upcoming Event: Global Reproduction

pregnant_bellyGlobal Reproduction: Health, Law, and Human Rights in Surrogacy and Egg Donation
November 5, 2014, 5:00 PM – 7:00 PM
Wasserstein Hall, Room 1010, Harvard Law School

Please join us for a screening of the documentary Can We See the Baby Bump, Please?, followed by a panel discussion of the legal and human rights issues surrounding surrogacy and egg donation in a global context.

The film screening will begin at 5PM; the panel discussion will begin at 6PM.  Feel free to join for one or both segments. The panelists are:

We encourage attendees to read Risk Disclosure and the Recruitment of Oocyte Donors: Are Advertisers Telling the Full Story? prior to the event.

Co-sponsored by Our Bodies, Ourselves and the South Asia Institute at Harvard University, with support by the Oswald DeN. Cammann Fund.

This Friday: Transparency in the Global Food System

groceries_aisleTransparency in the Global Food System: How Much Information and to What Ends?

October 24-25, 2014

UCLA Faculty Center
480 Charles Young Drive
Los Angeles, CA

Every day brings increasing media coverage, intensified citizen concern and political focus to the problems of our food system, accompanied by a building consensus on the need to address the known challenges.  But, the factors shaping our current food system and their implications are often opaque and difficult to analyze, due to both the complexity and lack of transparency in our system. This conference will examine these issues: the meaning of transparency in food law and policy, how consumers use and misuse information about the food system, and the limits of information as a policy tool.

Dr. David A. Kessler, former Commissioner of the United States Food and Drug Administration and currently a Professor at the University of California, San Francisco Medical School, will deliver the conference keynote address on October 24th. In addition, as part of UCLA Food Day events, a screening and panel discussion of the documentary Food Chains will be held in the evening following the conference.  Closing the event, an academic workshop will be held on Saturday, October 25th to discuss the future of food law teaching and scholarship.

For the full conference agenda and registration, click here Continue reading

Another Blow to Nursing Home Arbitration Agreements

By Alex Stein

Most, if not all, nursing homes have their residents sign an agreement to arbitrate any dispute or disagreement arising out of or in connection with the care rendered to the resident by the nursing home, including claims by the resident involving, and/or arising out of conduct committed by the nursing home and/or its agents, employees, or others for whom and/or which the nursing home is, may be, or is asserted to be, legally responsible. Such agreements also stipulate that they will apply to and bind any and all persons and/or entities who and/or which may assert a claim on behalf of, or derived through, the resident, including, without limitation, the resident’s legal representative, guardians, heirs, executors, administrators, estate(s), successors and assigns.

Ostensibly, such agreements compel arbitration on the resident’s survivors who claim that the resident died prematurely as a result of the nursing home’s neglect. The Federal Arbitration Act (FAA), as interpreted in AT&T Mobility LLC v. Concepcion, 131 S. Ct. 1740 (2011), seems to support this observation. This Act requires state and federal courts to enforce arbitration agreements similarly to other contracts. Pursuant to this Act, when a resident’s survivor files a wrongful death suit against the nursing home, the court must stay the proceeding and direct the parties to arbitration.

However, a recent decision of the Oklahoma Supreme Court, Boler v. Security Health Care, L.L.C., — P.3d —- (Okla. 2014), has shown that this appearance is misleading.  Continue reading

Tomorrow: “Human Subjects Research Regulation” Book Launch

Human_Subjects_Research_slideBook Launch: “Human Subjects Research Regulation: Perspectives on the Future”

Wednesday, October 22, 2014 12:00 PM – 1:00 PM

Harvard Law School Library, Langdell Hall 4th Floor, Caspersen Room, 1557 Massachusetts Ave.

This event is free and open to the public. Lunch will be served. For a list of our panelists, please visit our website.

MIT Press recently published Human Subjects Research Regulation: Perspectives on the Future (2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch. This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

Please join us for a discussion of the book, pending efforts to amend federal research regulations, and some of the biggest unresolved questions in this space.

This event is co-sponsored with the Harvard Law School Library

Ebola? No, It’s Our Health Care System

By Nicolas Terry

The enormity of the tragedy in West Africa remains hard to appreciate even as Ebola begins to migrate into developed countries. In the U.S. mindless panic stoked by the 24 hour news cycle and fear-mongering politicians are not the only familiar phenomena. In important ways our “Ebola crisis” is only tangentially related to a malicious virus and has much more to do with the state of our health care system. Consider the following “Ebola issues”

  1. Ebola has been marked by uncertainty as to federal and state responsibilities for infectious disease policy, prevention and reaction. Sadly, first impressions have been confirmed by the appointment of an Ebola “czar”, a sure sign that various branches of government have not been playing well together. Such regulatory fragmentation and lack of coordination is not new. Health care is our most regulated industry emanating from a bewildering array of legislation and regulation enforced by innumerable and frequently dysfunctional federal and state agencies.
  2. That lack of coordination has been replicated at the local level between agencies and healthcare institutions and between multiple institutions. Regional or local planning appears to be missing or only reactive. In a post-Katrina, post-swine flu world it seems extraordinary that there were not cogent plans waiting to be executed. Of course “There are only four in the U.S. with special isolation units designed to contain biohazards like Ebola” but why weren’t there plans to utilize them? Even now how many localities have a plan to handle, say, a major outbreak by using a centralized, tertiary care facility? Continue reading

Should Foreigners Be Allowed to Be Listed for U.S. Organs and Other Questions about Organs Without Borders

I have a new paper in a theme issue of Law and Contemporary Problems (one of two, I’ll post the second as well when it is available) titled Organs Without Borders? Allocating Transplant Organs, Foreigners, and the Importance of the Nation State (?) This paper is related to but separate from my work on medical tourism, which has dealt among other things with “transplant tourism,” such as traveling abroad to buy a kidney.  In this work I deal with the legally sanctioned distribution of organs. It will surprise many that in the U.S. a non-resident and non-citizen may be listed on the wait list for an organ for transplantation and if he or she is so listed he or she must, as a matter of law, be given the exact same priority as a similarly situated U.S. citizen-resident. Is that policy just or unjust. These are among the topics I tackle in this article. Here is the full abstract:

Most of the discussion of market or non-market forms of allocating and procuring organs takes as its unit of analysis the nation state, or, less commonly a particular state or province, and asks what should the system look like as to this unit. In this article, the second of two articles I contribute to this issue of Law and Contemporary Problems, I want to expand the viewfinder and examine an issue that has received peculiarly little attention in the scholarly and policy discourse: the desirability of treating the nation state (or its subdivisions) as the right level of distribution for organs, whether through market systems or non-market allocation systems. I will show that when we flirt with using a more global viewfinder, a series of difficult (and thus far largely unexplored) ethical and regulatory questions arise relating the inclusion of “outsiders.” At the very end of this article I explore what relevance this analysis may have to allocation within the nation-state as well.A large number of questions could be discussed under this title, but for this article I largely limit myself to two related questions. For both I will use the U.S. as the “home country” for rhetorical clarity, but the basic issues are the same for any home country. The first issue is: Should the U.S. allow “foreigners” to be on the list of those eligible to receive organs in the U.S. when they become available, and, if so, at what level of priority? Surprisingly the current law allows them to be listed to receive organs and if they are so listed it prohibits any discrimination against them for priority based on their being foreign. Second: should the U.S. maintain its own organ distribution network that is limited to the nation state instead of participating in a more globalized system? I should emphasize that my interest here is organs that come to recipients through typical government-run (or at least government-approved) organ allocation systems rather than foreigners who come to U.S. centers and bring their own living donor.

I first describe the two issues and then offer a normative analysis of each. This cluster of issues applies equally to the current U.S. distribution system with its hostility to markets and any of the potential alterations discussed in other articles in this issue of Law and Contemporary Problems.  Continue reading

Upcoming Medicare Forum on Appeals Backlog, Posts

Next week (on October 29) Medicare’s Office of Medicare Hearings and Appeals (OMHA) is holding another appellant forum to discuss the ongoing backlog of Medicare claims waiting for a hearing.  In one sense, a lot has happened since the last forum in February (I covered that here): OMHA announced pilot projects to try statistical sampling and facilitated settlement in some cases (see here and here); CMS (effectively the “defendant” for settlement purposes in these appeals; functionally independent from OMHA) announced a willingness to settle a subset of pending inpatient hospital billing claims for 68 cents on the dollar (see Nick Bagley’s post at the incidental economist); the backlog came up at a couple congressional hearings; and two lawsuits were filed to challenge it, one by providers (see here) and another by beneficiaries (see here).

In another sense, not that much has happened. Unless Thursday’s forum brings big news—and I know that OMHA and CMS have been working hard on reforms so perhaps it will—there is still a big backlog of Medicare appeals, there is still not a resource fix in sight, and the influx of Medicare appeals seems to still far outstrip OMHA’s capacity to hold hearings.

In advance of the forum, I’m planning a series of posts offering my thoughts, such as they are, on where we are and where we are going. I invite anyone who disagrees or thinks I’ve gotten something wrong to post their own views in the comments. Or you can email me and I will look into sharing your thoughts as an independent posting. You can get all my posts on this subject, including new ones as they come in, by clicking here.

A caveat: I’m approaching these as blog posts—trying to get my educated thoughts based on everything I have read out in a timely way—but I might be missing something. If the upcoming forum or comments reveal that I am–I won’t be there in person but will be watching remotely–I will either post a general update or go add particular updates in the text of my posts as necessary.

And a disclosure: I’ve said this before but want to do it once more again before pontificating—I worked in government until a little over a year ago, so my views on these matters may be biased. (And of course I will not discuss anything I worked on.)  But I’ve done my best to be objective.

Harvard Effective Altruism: George Church this Monday

From Harvard College Effective Altruism:

The Risks of Biotechnology, with George Church
Monday, Oct. 20, 5.30pm, Sever 102

Genetic manipulations can reintroduce extinct viruses or create viruses much deadlier than ever before. What are the dangers associated with biotechnology? Can a mistake in a lab lead to a global pandemic? Can this technology be used by terrorists? What would be the implications? And is humanity doing enough to avoid these threats?

George Church, Professor of Genetics at Harvard Medical School and the world’s leading expert on synthetic biology and security will share his insights on these issues.

George Church event_Harvard Effective Altruism

Egg Freezing and Women’s Decision Making

By David Orentlicher
[Cross-posted at Health Law Profs and PrawfsBlawg.]

The announcement by Apple and Facebook that they will cover the costs of egg freezing predictably provoked some controversy—predictably because it involves reproduction and also because too many people do not trust women to make reproductive decisions.

Interestingly, the challenge to women’s autonomy can come from both sides of the political spectrum, as has happened with several assisted reproductive technologies. Scholars on the left criticized surrogate motherhood on the ground that surrogates were exploited by the couple intending to raise the child, and other new reproductive technologies are criticized on the grounds that women will feel obligated to use them rather than free to use them. Indeed, this concern about coercion drives some of the objections to egg freezing.  Continue reading