10/6/14: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Wasserstein Hall, Milstein East B, Harvard Law School, 1585 Massachusetts Ave.

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

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

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

Sunstein Keynote at Petrie-Flom Annual Conference featured in Harvard Law Today

sunstein-atlanticHarvard Law Today has posted a feature on Cass Sunstein’s keynote address at the 2014 Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy.” Sunstein, who is the Robert Walmsley University Professor at Harvard Law School and the co-author of Nudge: Improving Decisions About Health, Wealth, and Happiness, addressed the opening day of the conference on May 2, 2014, on the subject of “Choosing Not to Choose.”

Full video of the conference will be available soon via the Petrie-Flom Center’s website. In the meantime, you can read about and view Sunstein’s keynote address here.

DUE 6/3: Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:  Continue reading

Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation





The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:

  • Stem cell therapies
  • Nanotechnologies
  • Genetic (and biomarker) tests
  • Gene therapies
  • Personalized medicine
  • Comparative efficacy research
  • Drug resistant pathogens
  • Globalized markets
  • Tobacco
  • GMO
  • Bioterrorism countermeasures
  • Mobile health technologies
  • Health IT
  • Drug shortages
  • Other related topics

Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at dsr@fdli.org by Tuesday, June 3, 2014. Questions should also be directed to Davina Rosen Marano.

We will notify selected participants by the end of June.  Selected participants will present at the symposium, and will be expected to submit a completed article by December 15, 2014 (after the event) to be considered for publication in a 2015 issue of FDLI’s Food and Drug Law Journal (FDLJ).  Publication decisions will be made based on usual FDLJ standards.

#BELHP2014 7: Defaults in Health Care

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Our esteemed moderator Gregory Kurfman of the New England Journal of Medicine oversaw a session that dug deep into how defaults work and why. The result was a better understanding of the regulatory tool most associated with soft paternalism, but doubt about whether its operation in healthcare is as libertarian or asymmetrically paternalistic as advertised.

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#BELHP2014 Panel 1, The Ethics of Nudges in Health Care

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is the first installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

The panel on the Ethics of Nudges in Health Care was comprised of:

  • Yashar Saghai, Post-Doctoral Fellow and Director of Global Food Ethics, John Hopkins University
  • Jennifer Blumenthal-Barby, Assistant Professor, Baylor College of Medicine, presenting with Zainab Shipchandler and Julika Kaplan, Rice University
  • Nir Eyal, Associate Professor at Harvard Medical School
  • Jonathan Gingerich, Ph.D. student, Department of Philosophy, UCLA

Yashar Saghai’s presentation, titled Public Health Nudges and the Principle of the Least Restrictive Alternative, argued against the notion that policies or interventions that impose fewer restrictions on individual choice should always be preferred over more restrictive options. More on this topic in Saghai’s 2012 BMJ article “Salvaging the Concept of Nudge.”

Jennifer Blumenthal-Barby and student collaborators Zainab Shipchandler and Julika Kaplan asked whether incentives in global health studies should be viewed as nudges and what are the potential ethical implications. In their presentation, titled Incentives as Nudges for Childhood Vaccination in Rural India, they showed evidence that suggests food incentives to participate in vaccine programs could function as nudges that influence individual’s behavior in a wider range of healthcare related ways, beyond simply increasing participation in the vaccine program.

Nir Eyal explored potential arguments for When nudging is just fine, and why? Eyal started with the observation that nudges can cause large modifications in individual behavior despite being very easily resistible, and canvassed several related ideas about the appeal of nudges, finding problematic counterarguments to most of these prima facie claims. He concluded by suggesting that nudges could be viewed as morally acceptable ways of manipulating people into behaving in ways that are better for them without transgressing on any fundamental liberties.

Jonathan Gingerich argued that the ethical acceptability of nudges should be put into question when they prevent democratic deliberation on important issues. In his presentation, The Political Morality of Nudges, Gingerich presented several examples of how interventions that claim to improve social welfare through nudges could in fact prevent broader substantive deliberation over important political issues for which we generally require democratic decision making.

Potato Chips and Choice Architecture

By Nathaniel Counts

If, out of concern for public health, the government banned potato chips today, a lot of people would get very angry.  Only some of these people would be angry because they missed potato chips.  For most it would be the principle of the thing – the government should not interfere with our autonomy to eat whatever we want, as long as it does not harm others, and some days this will include potato chips.  I would posit that the autonomy at issue here is a narrow understanding of autonomy, and one that we should be suspicious of.

Imagine yourself in the biggest Costco in the world.  It has every food in existence and they are all placed equidistant from you, and you may survey the scene and choose whatever food you most desire and then eat it.  This would be true autonomy.  The world we live in, however, is deeply constrained and we should question how meaningful our autonomy is.

In reality, every time someone who came to the Costco before you made a purchase, the store owners moved the product a little bit closer to you, and manufacturers began shipping more variants of it.  The decisions that determined the composition of your commercial world were made over hundreds of years by individuals with no understanding of health – diet and exercise, hypertension and heat disease all being foreign concepts until recently.  Today potato chips, in all their variety, take up quite a lot of shelf space, and healthful foods are hard to come by.

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2/3 Petrie-Flom Health Law Workshop: Paper Now Available

Kevin Outterson will join us on Monday, February 3, for the first spring meeting of the Petrie-Flom Center’s Health Law Policy Workshop. He is a Professor of Law and Professor of Health Law, Bioethics, and Human Rights at Boston University. Professor Outterson teaches health law and corporate law, and his interests include global pharmaceutical markets, finance and organization of health care systems, antimicrobial resistance, poverty tourism, and health disparities. He serves as the editor-in-chief of the Journal of Law, Medicine & Ethics, the faculty co-advisor to the American Journal of Law & Medicine, the immediate past chair of the Section on Law, Medicine & Health Care of the AALS, and a member of the Board of the American Society of Law, Medicine & Ethics. Before teaching, Professor Outterson was a partner at two major U.S. law firms.

His research work focuses on the organization and finance of the health sector. Areas of specialization include global pharmaceutical markets, particularly antibiotics and other antimicrobials that can degrade in usefulness over time through resistance.

On Monday, Professor Outterson will discuss his paper “New Business Models for Sustainable Antiobiotics.” For more information on the Health Law Workshop, including meeting time and location, and to download the paper, please visit our website.

Encouraging Innovation in Chronic Care Management

By Michael Young

The growing burden of managing chronic illness has long been a critical issue for policy makers and clinicians seeking to improve the quality, cost and efficiency of healthcare systems in the United States. According to the Institute of Medicine, the costs of treating and managing the segment of the population living with chronic illnesses currently represents nearly $1.5 trillion of the over $2 trillion in annual healthcare spending in the U.S.  Over 90% of Medicare costs are allocated to beneficiaries living with two or more chronic conditions, with close to 50% of spending on individuals living with 6 or more chronic conditions (approximately 14% of beneficiaries).  The immense share of healthcare spending attributable to chronic illness is expected to climb as the population ages. 

Earlier this month, a bipartisan bill entitled the Better Care, Lower Cost Act was introduced in Congress which aims to address the complex issues involved in chronic care management.  The legislation outlines three key innovations toward this end.

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Managed Care for Mental Health

By Nathaniel Counts

Managed care and integration of primary care and mental health services are major foci of the Affordable Care Act, especially as more practices are encouraged to become Patient-Centered Medical Homes.  In managed care, vitals are used to track progress, and case managers can look over an individual’s blood pressure, weight, and blood-sugar levels to work with service providers and patients to ensure best outcomes.  If an individual is receiving mental health services, then the providers will share information about the patient’s current needs in both physical and mental health.  If the individual is not referred to or does not seek out mental health services, then there is no mental health component to manage.

Meanwhile in Massachusetts, every pediatrician is mandated to offer CANS (Child and Adolescent Needs and Strengths), a lengthy evaluation form that asks a patient (aged 5 to 20 for the link above) to evaluate their own life and mental health on sets of 0-3 scales.  CANS is used to monitor children’s mental wellbeing and identify potential problematic areas, including whether a mental health referral for serious emotional disturbance is necessary.  To the best of my knowledge, this information is not stored and used as an indicator for managed care, as blood pressure and weight are. Continue reading

New Blog, “ACA Death Spiral,” by Houston Law’s Seth Chandler

In case the title of the blog doesn’t make its thrust clear, here’s a snippet from Seth’s opening post:

This blog is going to chronicle what I believe will be the implosion of the Affordable Care Act.  I do not believe the Exchange based system of providing health insurance without medical underwriting is likely to work or that, if it does, it will not need far more massive propping up from federal taxes than is conventionally recognized. We’ll be looking at current events, the history of the Act, important court cases, and regulatory developments. Our tools will be a careful review of primary documents, some graphical and mathematical analyses, and references to important and insightful articles written by others.

Also, there is more to the Affordable Care Act than the Exchanges.  There is more than the individual mandate. There is the employer mandate, the complex systems of federal reinsurance needed to backstop the Act, the reintroduction of medical underwriting under the “wellness label” and so much more.  We’ll try as time permits to take a look at developments in these important areas too.

Seth — who is an insurance law expert — notes the “need for some hard and at least somewhat scientific look at what is going on.” So far, since beginning the blog some 48 hours ago, he has tackled the Upton Bill intended to address the “if you like your health care plan you can keep it” issue (which passed the House this afternoon with the help of 39 Democrats and now heads to the Senate); yesterday’s announced “Obamafix,” intended to address the same issue; whether the ACA’s little-known reinsurance and risk adjustment provisions could make exchanges more resilient to the underenrollment that many, including Seth, anticipate; and five questions journalists should be asking about the ACA (hint: fewer questions about how the rollout is likely to affect the careers of pols; more questions about the winners and losers under the ACA among the rest of us).

Welcome to the blawgosphere, Seth.

[Cross-posted at The Faculty Lounge]

Video Now Available: Tulsa Law Review Symposium Honoring Einer Elhauge

On Friday, October 4, the Tulsa Law Review hosted a symposium titled “Health Law Policy: Legal Issues in the Evolving Healthcare Market” honoring the work of Petrie-Flom Center Founding Director Einer ElhaugeI. Glenn Cohen, current Faculty Co-Director of the Petrie-Flom Center, and Christopher T. Robertson, Visiting Professor at Harvard Law School and former Petrie-Flom Academic Fellow spoke at the event.

For more information, including a link to the event videos, click here.

Another Wrinkle in Exchange Rollout? Private Sites Attempting to Lure Shoppers Looking for Exchanges

Yesterday saw two reports—perhaps the first of many—discussing the emergence of an additional wrinkle in the rollout of the health exchanges: private websites attempting to lure shoppers away from the government exchanges with websites that look and sound like the real thing.

According to an article posted by WMUR New Hampshire, the state insurance commissioner has issued a cease-and-desist letter to the owner of one website, newhampshirehealthexchange.com, that is allegedly trying to take advantage of shoppers hoping to acquire insurance through the real exchange.  New Hampshire’s not the only state dealing with this sort of issue.

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Call for Papers on “Buying and Selling Health Care”

The Journal of Law, Medicine & Ethics plans to publish a symposium issue in Winter 2014 exploring ethical, legal, and clinical issues triggered by the increasing commercialization of health care in the United States. The symposium will address a variety of dynamics present in this quintessentially American medical marketplace, with a particular focus on how commercialism impacts practitioners, patients, and policy makers at all levels.

Papers from any perspective or disciplinary background and concerning any aspect of the “buying and selling of health care” are welcome.

Deadlines and submission instructions below the fold.

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HHS Proposes Rule to Amend NOTA, Nullify Flynn v. Holder

On October 2, in the midst of the government shutdown—either HHS somehow managed to convince itself that the rule was “necessary for the protection of life” or, more likely, it had already been scheduled for printing—HHS quietly published a Notice of Proposed Rulemaking. The proposed rule would effectively moot the recent Ninth Circuit case of Flynn v. Holder by criminalizing the compensation of bone marrow donors, even when the life-saving stem cells are extracted through a newer, minimal risk procedure. In this post, I’ll explain the medicine, the Ninth Circuit’s decision, and what HHS proposes to do in response. In my next post, I’ll have some reaction to HHS’s policy arguments, about which I’m skeptical, and perhaps a few thoughts about where plaintiffs might go from here.

Section 301 of the National Organ Transplant Act (NOTA) of 1984 criminalizes the transfer of “human organs” for “valuable consideration.” Reimbursement of reasonable out-of-pocket expenses associated with travel and lost wages are okay—as are, since the 2008 amendment of NOTA, paired living donor chains—but any other “valuable consideration” that might incentivize sources of organs is not. Under NOTA, as amended,

‘human organ’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation

(emphases added). HHS has since added to this list “intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.”

So-called “bone marrow transplants”—in reality, infusions of hematopoietic (blood) stem cells (HSCs)—are often life-saving procedures for those with, for example, leukemia or aplastic anemia. (See these sobering statistics compiled by the Institute for Justice, which represented the plaintiffs in Flynn.) When NOTA was passed, the only way to obtain HSCs was through bone marrow aspiration using a long needle thick enough to suck liquid marrow directly from the donor’s pelvic bone. HSCs are then harvested from the marrow. The procedure is done under general anesthesia and so the donor is subject to the usual risks of anesthesia. Although the donor can return to usual activities in two to seven days, discomfort may linger for up to two weeks. Continue reading

The Spillover Effect of Medicare FFS on MA Negotiations

By Jeremy Kreisberg

The Congressional Budget Office (CBO) recently released an assessment of two illustrative versions of premium support for Medicare.  The report is interesting for many reasons, but I want to focus on one issue that Austin Frakt at The Incidental Economist raised.

Among the assumptions in the report, CBO “estimate[d] that in most counties the percentage of beneficiaries enrolled in the [Medicare Fee-For-Service (FFS)] program would decline once either premium support option took effect. . . . [T]he reduced market share of the FFS program would tend to boost the rates that private insurers paid to health care providers and thereby lead them to raise their bids” (pg. 39).

In a very thoughtful post, Professor Frakt questioned this assumption:

I read the details in the report that follow, but they didn’t help me with my fundamental objection. There’s a lot of verbiage about the (non-Medicare Advantage (MA)) commercial market paying higher prices than MA or FFS. The idea seems to be that Medicare private plans would tend to resemble the commercial market, if not for FFS. Hence, prices would go up if FFS became less of a threat, as it would under premium support.

This may be true, but not enough was said about why. The commercial market and the Medicare one serve different consumers, are challenged by different competitors, and are constrained by different regulations. They are different markets. Why should prices in one have any relation to those in the other?

I agree with Professor Frakt that there is no easy answer here, but I’m a bit more confident that CBO has a sound theoretical justification for its assumption.  After the jump, I’ll explain what I perceive as CBO’s theoretical justification, and I’ll note one interesting application of CBO’s reasoning to another controversial policy proposal.

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Anonymity is Not Privacy (and Why it Matters)

Anonymity is not just an aspect of privacy and recognizing their difference reveals a powerful and poorly understood set of legal tools for facilitating and controlling the production of public goods.  This is the central claim of my newest article (SSRN draft available here).

Three examples illustrate the scope of the under-explored ways in which anonymity is currently used in our law.

  • The first is from June 1997, when many residents in the Boston neighborhood of Allston learned to their anger that Harvard University had spent the previous 8 years secretly acquiring over 50 acres of Allston real estate.  It did so using buying agents, which can generally protect their principal’s anonymity—even by falsely stating that they are not agents.
  • The second is from Election Day 2012, when many voters who had shared photos of their completed ballots on Facebook and Twitter learned, to their surprise, that they had violated their states’ elections laws in doing so.   They did not know that anonymity in voting was not just a right, but also a requirement.
  • The third is from a 2006 lawsuit over the control of thousands of tissue samples being used in research at Washington University.  When many of the research participants sought to withdraw their tissue from future research, in response to what they saw as a breach of their consent, they were shocked to learn that the university could refuse and extinguish their rights of withdrawal by anonymizing their tissue samples.

These varied uses of anonymity in our law—as a right when purchasing land, a requirement in voting, and a trigger than extinguishes rights in biomedical research—may appear to be unrelated.  But I argue that they are in fact all part of a cohesive and previously unrecognized class of rules that use anonymity not to protect privacy, but rather to incentivize or control the production and circulation of information and other socially desirable goods. Continue reading

Racism in Transplant Denial? Or Too Few Hearts To Go Around?

Anthony Stokes, a fifteen year old kid from Decatur County, Georgia, is expected to die in a matter of months, according to his doctors at the Children’s Healthcare of Atlanta.  Maybe, they say, he will live for six months.  Who knows?  Anthony suffers from an enlarged, increasingly less functional heart.  His condition is not unusual, and a reasonably effective cure is at hand: a heart transplant. (Learn more about Anthony’s story here.)

However, Anthony has become the latest victim of a dysfunctional U.S. transplantation system, which tempts Americans with a transplant waiting list, but kicks them off if they become too sick or too old.  The problem is that there are too few organs to meet demand, and this perennial problem receives far too little attention from Congress.  Indeed, the U.S. transplantation list, coordinated by the United Network for Organ Sharing, UNOS, (a private organization that coordinates significant aspects of the U.S. transplant system) is so overcrowded that patients increasingly turn to black markets in India, China, Pakistan, South Africa, and other countries if they hope to survive.  (Learn more about that here.) Congressional hearings document Chinese prisoners dying and shortly thereafter Americans receiving organs.

Anthony’s family and some local organizations claim that racism is behind doctors refusing to place the boy on the transplant list.  Anthony is African American.  They ask, what is the harm in letting him on the list?

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