The Faculty Lounge

CFP: Jaharis Health Law Symposium

The DePaul Journal of Health Care Law, Mary and Michael Jaharis Health Law Institute, and Center for Intellectual Property Law & Information Technology (CIPLIT®) are excited to announce a Call for Papers in connection with the 2022 Jaharis Health Law Symposium.

This year’s topic, “Antitrust and Access to Care: Lessons from Market Consolidation and a Public Health Crisis,” will explore how consolidation across health care markets has impacted access to care. Prominent legal scholars, antitrust enforcers and expert practitioners will address a range of questions through four separate panels focusing on health insurance, pharmaceutical, hospital and digital health markets.

Three papers will be selected from the submissions. Each selected author will receive a $500 honorarium and their article (of approximately 10,000 words) will be published in the Symposium issue of the DePaul Journal of Health Care Law. Full article drafts will be due by June 1, 2022.

We are open to a wide range of topics consistent with the Symposium theme but are particularly interested in papers from scholars with diverse experiences and backgrounds researching health insurance or pharmaceutical markets, as well as papers from junior scholars.

The Symposium will be held both in-person and remotely at DePaul College of Law in Chicago on March 10, 2022. Presenters able to appear in person will receive reimbursement for reasonable travel expenses.

Please submit an abstract of no more than 500 words to [email protected] by January 15, 2022, with the subject line “Jaharis Symposium: Call for Papers.” You also may submit an optional statement of no more than 500 words describing how your selection would enhance the diversity of the Symposium.

Paying Bone Marrow Donors Is Not Unethical

So says me and nearly two dozen others who work on questions of medical ethics, in a recent letter to The Department of Health and Human Services in response to an NPRM designed to reverse the decision in Flynn v. Holder.

Fellow Lounger Michelle Meyer and I have both written here a couple of times about current debates surrounding compensating bone marrow donors, as well as Flynn v. Holder (the 9^th Cir. case holding that bone marrow donors could be legally compensated for peripheral blood stem cells obtained through apheresis, and the HHS proposed rule that would overturn that ruling.

Now, a group of researchers (including myself and Michelle) have signed onto a letter in opposition to the proposed HHS rule. From the letter:

This Rule would effectively reverse the decision in Flynn v. Holder before the U.S. District Court of Appeals for the Ninth Circuit.1 That decision holds that compensating donors of hematopoietic stem/progenitor cells (hereafter: “hematopoietic cells”) through a procedure called apheresis was not contrary to the National Organ Transplant Act.

We oppose the Rule. We maintain that the ethical arguments against a compensatory model for hematopoietic cell donation through apheresis (hereafter: “the compensatory model”) fail. We further maintain that significant ethical considerations speak in favor of the compensatory model, and therefore against the Rule.

Below, we respond to the ethical arguments offered in favor of the Rule: that the compensatory model would result in wrongful exploitation (§2); that the compensatory model would promote the view that human beings, their bodies, or subparts thereof, are mere commodities (§3); and that the compensatory model would incentivize donation for personal gain over donation from altruistic motives (§4). Given the ethical importance of avoiding preventable death and the strong likelihood that the compensatory model would help avoid preventable death, as well as the ethical importance of free choice, we conclude that the Rule is unethical (§1).

Read the whole thing here.

Related Posts:

On To Bone Marrow

Flynn v. Holder – The Fight Continues

Flynn V. Holder Rehearing Denied

Cohen on Flynn v. Holder

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

Call for Abstracts: Transparency in Health & Health Care: Legal & Ethical Possibilities & Limits?

My former colleagues at Harvard Law's Petrie-Flom Center have asked me to post the following.

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: “Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.”

Conference Description

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model.  Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more.  Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain.  For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Information about the call for abstracts after the jump...

 

The Future of Health Law and Policy: Petrie-Flom Center 10th Anniversary Conference

On March 29, current affiliates and alums (including myself) of Harvard Law's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics will converge on Cambridge for a day-long conference to discuss current and future directions in these areas. The conference features panels on Health Care Coverage, Costs, and Fragmentation; Law and Bioethics; Health Innovation Policy and Regulating Novel Technology; and Empirical Health Law, as well as a keynote address by Health Affairs Editor-in-Chief Alan Weil. The event is free and open to the public, but seating is limited and registration is required. Hope to see some TFL readers there.

The Law School Industry - Veteran Emphasis in US Based Law Schools

This analysis provides an excel based study of how the law school industry approaches military veterans, especially who are students at the school but also more broadly. The title is, Veteran Emphasis in US Oriented Law Schools: Part 1, as we will be continuing with this study to contact every entry to develop a better understanding of current challenges, developing practices, and new innovations (note: you will have to download the document for it to view correctly as in excel format).

The information is organized alphabetically by state, and within each state by law school, and includes website links and contact details. A number of factors were taking into account, including law reviews, clinics and externships, associations and organizations, classes, and other miscellaneous innovations. The 'classes' data is somewhat fuzzy as we did not develop a clear metric about what counted as a veteran oriented class and instead went for classes that would be specifically of a military nature. The 'miscellaneous' factor includes a number of interesting innovations, which might be better located under a different classification but we've situated together - e.g., Yellow Ribbon Programs, Outreach Centers, Recruitment Innovations.

A surface read of the information reveals some potentially interesting takeaways. First, while there are considerable number of 'military' or 'national security' law school courses (approximately 120), there are less than 10 classes specifically addressing veteran law (and only one LLM). Second, there are approximately 30 Veteran clinics at US law schools, and while about 115 organizations, only a little more than 1/2 that are specifically focused on veterans (e.g., many instead are more generalist, such as Military Justice Society). Third, there is a significant need for law journals specifically dedicated to veteran conditions (this is not to say there are not special issues or articles that come up in other contexts or other non-scholarship networks). Fourth, while many states will have law schools that offer some focus on veterans, often the emphasis is a more generalist class or a student society. In fact, a number of states have no emphasis on veterans in regards to any of the dynamics (e.g., Montana, Nevada, New Hampshire, Oklahoma, Oregon). Other states only offer some class, but do not offer any additional emphasis or support (e.g., Indiana). Other states have very strong innovations at play (e.g., California, Florida, Michigan, New York, Ohio). There is so much more to be studied here, but we hope this provides some useful information for those interested to better address veteran considerations. At the very least, there seems to be considerable energy at the student level to create community, which may be a valuable resource for future innovations. The relative lack of clinics and more over explicit information on law school websites suggests that this may be an area for more institutionalized veteran-oriented support, and which might also be a valuable opportunity for building a niche market for student recruitment and career placement.

This part of the study was completed with Mr. James Russell Dumas, and with helpful input from Prof. Evan Seamone, Prof Richard Meyer, and a number of MC School of Law veterans. Moving forward with the studies will be in collaboration with Prof. Evan Seamone.

How Should We Think About Whether To Donate Our Leftover, Non-Identified Tissue to Research?

Proposed changes to the federal Common Rule that governs most human subjects research would ask patients for the first time to decide whether to allow their non-identified, leftover tissue to be used for research or thrown away. For that choice to be meaningful, the public needs to be aware of the nature, risks, and benefits of biospecimens research, and of what the proposed changes will—and will not—do. In my latest Forbes essay, "No, Donating Your Leftover Tissue To Research Is Not Like Letting Someone Rifle Through Your Phone," I consider the power of analogies and other reflections on a recent New York Times op-ed on these proposed changes by Rebecca Skloot, author of The Immortal Life of Henrietta Lacks.

Medical Research Subjects: Guinea Pigs, Laborers, Or Altruists?

Cari Romm has a great article in The Atlantic, The Life of a Professional Guinea Pig: What It’s Like To Earn A Living As A Research Subject In Clinical Trials.  (HT: Jamie Boyle)

I’ve blogged before about my course on Taboo Trades & Forbidden Markets (see here for course resources, including reading lists, blog posts, and the like) and for the past several years have included readings about the market for professional research subjects. Last year, for example, I assigned this New Yorker article, Guinea Pigging, by Carl Elliott, together with More Money, More Problems? Can High Pay be Coercive and Repugnant?, by Sandro Ambuehl, Muriel Niederle, and Alvin E. Roth, and Martha Nussbaum’s, Taking Money For Bodily Services, in SEX AND SOCIAL JUSTICE.

I’ll certainly be adding Romm’s article into the mix in future years.  The piece hits on two points that I have tried to make in various works on taboo trades, particularly human egg markets.  The first is that attempts to keep payments low, out of coercion or other fears, does not necessarily result in altruistic donors. Instead, the result is often that donors with higher opportunity costs and better income opportunities exit the market, leaving behind “donors” who are poorer, potentially less educated, and more in need of money to meet basic needs. In other words, precisely the donors least likely to thoughtfully weigh the risks of donation against the monetary benefits and most likely to succumb to the “coercive” effects of money, because they have fewer income opportunities from which to choose. Second, pretending that donors are altruists, rather than sellers or wage earners, deprives them of legal protections and, sometimes, legal obligations.   

I discuss both of these issues in a recent article in the Journal of Applied Philosophy (the article is gated, but you can access an earlier draft on SSRN).  As I state there:

The provision of human oocytes for third party reproduction (“egg donation”) has long been contested territory, sitting uncomfortably between the world of gift exchange and its crass cousin, the marketplace. . . . 

[Yet] egg donation is a thriving and profitable industry, a substantial source of income for many young women, and the most important purchase that intended parents will ever make. In other words, it is a market, and well-established social policies seek to address a variety of concerns with respect to all markets. Among other goals, the legal regime governing markets seeks to control collusive economic activity and rationally tax income-generating activities. Those goals are in direct conflict with the [litigation discussed here, namely collusive price controls and challenges to ambiguous and inconsistent tax policies]. . . .

Together, these cases demonstrate the difficulty of achieving in practice what has seemed so appealing to many in the abstract – a mechanism that harnesses the market’s incentivizing forces while at the same time preserving ideals of reproduction and parenthood as outside of the marketplace. . . . A close examination of these cases also provides lessons on the dangers of romanticizing what is, for better or worse, a highly profitable and robust industry. 

The Atlantic, quoting Carl Elliot, sums up these issues well in the context of medical research subjects:

“Under the basic ethics guidelines … research subjects are treated as if they are altruistic volunteers,” he [Carl Elliot] told me. The issue of payment for research participation is an especially complicated one, and the pretense of altruism acts as a hedge against accusations of unethical behavior. “You have to ask: Who has a month or three weeks to just check in to a trial site or live there for that amount of time?” he said. “Homeless people, undocumented people, people who are either temporarily or long-term unemployed, people who are out of jail who can’t get regular work.” Paying members of vulnerable groups to put experimental drugs in their bodies can seem dangerously close to coercion.

But treating money as an afterthought rather than the main motivator also means that guinea pigs aren’t considered employees. “It’s work, but it offers none of the protections of work,” Elliott said. “You don’t have the right to minimum wage, you don’t have the right to unionize, you don’t have disability payments, you don’t even have regular health and safety inspections.”

Read the full Atlantic article here. And definitely read my full article on egg donation here. :-)

The Law School Industry - Institutional Considerations for Military Veterans

From movies to policy debates, veterans are a perennial image in the American psyche. At the law school, the most notable presence of the military are recruiting officers (e.g., JAG), and to a lesser extent, student organizations (e.g., student veterans organizations, military justice societies) and the occasional veteran clinic. There is, however, no comprehensive in-depth study of how law schools accommodate veterans or how various institutional platforms operate (in the next few months, I will post an excel-based study mapping all these initiatives at law schools with some brief comments). While researching this topic and speaking with student veteran groups, military personnel and therapists, certain themes have emerged that might provide law school administrations with some guide for developing 'best practices' towards students serving or having served in the military. 

The core challenge seems to be that there tends to be a lack of awareness by law school admission offices about the psychological and social challenges that veterans face, in civilian life or at school in particular. Below is a brief list of some common blind spots and potential reforms.

Common Rule NPRM Finally Out (& the Ethics of Cause Lawyers Advising Clients to Disobey Preliminary Injunctions)

I'd begun a blog post about claims (see Mark Joseph Stern in Slate and Howard Wasserman at Prawfs) that the cause lawyers representing Rowan County, KY County Clerk Kim Davis acted unethically by "advis[ing] her," according to Stern, to disobey a court order preliminarily enjoining her practice of allowing her office to issue no marriage licenses to either same-sex or opposite-sex couples, thereby putting her at (considerable) risk of contempt (that show cause hearing, in which the ACLU has requested fines but not jail time, is scheduled for tomorrow). My quick and dirty take is that unless one is prepared to say that disobeying a preliminary injunction and accepting one's lumps in the form of fines and/or jail time is itself per se wrong and outside the bounds of legal ethics, such that advising a client to defy an injunction is no different than advising them to, say, lie on the stand (which doesn't seem to be the view that either Stern or Wasserman takes), then I tend to think that the legal and other risks (financial, emotional, reputational, etc.) of this strategy compared to her alternatives is something that should be subject to (to draw an analogy to medical ethics) shared decision-making between professional and client.

A cause lawyer should, of course, bend over backwards to ensure that her client understands all of her options and the likely consequences of each, especially when presenting options that align with the lawyer's cause and/or pocketbook. (I can't tell from Stern's bare assertion that Liberty Counsel "advised her to disobey the ruling" whether such a conversation took place or not.) But it's not obvious to me that including disobey-and-risk-the consequences among those alternatives is per se unethical. Indeed, one could make the case that deliberately withholding that possibility from the client out of concern that it is "too risky" is itself unethical in its paternalism. Nor was it unethical of the ACLU cause lawyers representing the couples in this suit to "advise them" to continue to litigate in order to establish a legal precedent that will mostly benefit others (and give the ACLU a very public win), despite the fact that the couples could instead drive 30 minutes to an adjacent county and start married life significantly sooner—provided that the plaintiffs were adequately informed of their options.

Yes, plaintiffs' sacrifice in this case is much more likely to be rewarded by a legal victory than is the defendant's, but legal (and medical) outcomes are not laypersons' only or necessarily most important measures of success, even if that is what lawyers (and doctors) tend to focus on. Some patients can and do reasonably value their ability to converse with lucidity over their ability to be free from pain, their ability to die a death they deem dignified over additional days, weeks, or even months of life, and so on. Who is the professional to say that a fine of $X, jail time of Y days, or a delay in legally recognized marriage (with its attendant benefits) of Z weeks or months is "too risky" or "not worth" the anticipated benefits, whether medical/legal or otherwise? These trade-offs, after all, are not primarily or ultimately professional judgments, even though professional expertise appropriately feeds into them. Or so I've previously argued in the context of cause lawyering.

But that will have to be my only comment on that topic, because after more than four years, sixteen federal agencies and departments have finally released their Notice of Proposed Rulemaking, suggesting numerous and significant changes to the Common Rule (the federal regulations that govern IRBs and much human subjects research).

It is 519 pages long.

I hope to have some quick thoughts at some point relatively soon. In the meantime, here is the tl;dr version of the NPRM, highlighting its major proposed changes (this also appears at pp. 21-26 of the NPRM):

Interpreting Fiorina's Comments on Vaccination Law

I've started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She's Right, analyzes GOP presidential candidate Carly Fiorina's recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina's remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others' views, especially on contentious issues like vaccination.

Boni-Saenz on Sexuality and Incapacity

Alexander Boni-Saenz of Chicago-Kent Law School has posted "Sexuality and Incapacity," which is forthcoming in the Ohio State Law Journal, on ssrn.  Cribbing now from his abstract:

Sexual incapacity doctrines are perhaps the most important form of sexual regulation, as they control access to sex by designating who is legally capable of consenting to sex. Most states have adopted sexual incapacity tests for adults that focus narrowly on assessing an individual’s cognitive abilities. These tests serve an important protective function for people with temporary cognitive impairments, such as those rendered incapable due to alcohol or drugs. However, this comes at the cost of barring many people with persistent cognitive impairments, such as Down Syndrome or Alzheimer’s Disease, from any sexual activity. This is despite the fact that they still have sexual desires and are able to engage in sexual decision-making with support from caregiving networks. The central claim of this Article is that sexual incapacity doctrine should grant legal capacity to adults with persistent cognitive impairments if they are embedded in an adequate decision-making support network. In other words, the right to sexual expression should not be withheld due to cognitive impairment alone. To justify this claim, the Article provides a theory of sexual incapacity doctrine that is grounded in the practice of supported decision-making and the normative foundations of sexual capability and relational autonomy. The Article then sets forth a novel test for sexual consent capacity: cognition-plus. This test focuses on gauging the capacity for volition, assessing the mental capacity of the individual to understand the nature and consequences of the sexual decision, and evaluating the adequacy of the decision-making support system using principles of fiduciary law. The Article concludes by applying the cognition-plus test to the case of older adults with dementia, a group of increasing importance with the aging of the population.

I enjoyed hearing an earlier version of this last year.  It touches on a lot of fields.  Faculty lounge readers who work in elder law, trusts and estates, health law, or sexuality will, I think, be particularly interested in this.

The Ethics of Punking the Diet-Research Media Complex (and Millions of Readers)

A remarkable new “sting” of the "diet research-media complex" was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.

Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn't have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.

But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being.

They wrote up the results, submitted the manuscript to twenty predatory journals known to publish basically anything for a price, picked one of the “multiple” ones that accepted it, and wrote a check. (The journal that published the paper now says it did so “by mistake” and has removed it from its website, but you can read it here.) Then they cooked up a press release, sent it out to numerous journalists and media outlets, and waited. Several (of various quality, focus, and circulation) took the bait and passed on to their readers the good news that adding chocolate to a "strict" low-carb diet would "accelerate weight loss." As Bohannon brags:

It made the front page of Bild, Europe’s largest daily newspaper, just beneath their update about the Germanwings crash. From there, it ricocheted around the internet and beyond, making news in more than 20 countries and half a dozen languages. It was discussed on television news shows. It appeared in glossy print, most recently in the June issue of Shape magazine (“Why You Must Eat Chocolate Daily”, page 128).

Then, yesterday, Bohannon exposed his own “con” in io9, an online science and technology magazine, under a headline that blared: I Fooled Millions Into Thinking Chocolate Helps Weight Loss.

Was the sting ethical?

Two Cheers for Corporate Experimentation

I have a new law review article out, Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Innovation, arising out of last year's terrific Silicon Flatirons annual tech/privacy conference at Colorado Law, the theme of which was "When Companies Study Their Customers."

This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).

Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Here is how the abstract begins:

“Practitioners”—whether business managers, lawmakers, clinicians, or other actors—are constantly innovating, in the broad sense of introducing new products, services, policies, or practices. In some cases (e.g., new drugs and medical devices), we’ve decided that the risks of such innovations require that they be carefully introduced into small populations, and their safety and efficacy measured, before they’re introduced into the general population. But for the vast majority of innovations, ex ante regulation requiring evidence of safety and efficacy neither does—nor feasibly could—exist. In these cases, how should practitioners responsibly innovate?

My short answer to this question is that responsible innovators should inculcate a culture of continuous testing of their products, services, policies, and practices, and that it is a kind of moral-cognitive mistake (which I dub the "A/B illusion") for the rest of us to respond to these laudable (and sometimes morally obligatory) experimental efforts by viewing it as more morally suspicious for innovators to randomize users to one of two (or more) conditions than to simply roll out one of those conditions, untested, for everybody. The long answer, of course, is in the article. (The full abstract, incidentally, explains the relevance of the image that accompanies this post.)

Thanks to Paul Ohm and conference co-sponsor Ryan Calo for inviting me to participate, to the editors of the Colorado Technology Law Journal, and to James Grimmelmann for being a worthy interlocutor over the past almost-year and for generously unfailingly tweeting my work on Facebook despite our sometimes divergent perspectives. James's contribution to the symposium issue is here; I don't know how many other conference participants chose to write, but issue 13.2 will appear fully online here at some point.

If you would rather hear, than read, me drone on about the Facebook and OkCupid experiments (and some other recent digital research, including Apple's ResearchKit and the University of Michigan's Facebook app-based GWAS, "Genes for Good," as well as learning healthcare systems and the future of human subjects research) you may do so by listening to episode 9 of Nic Terry's and Frank Pasquale terrific new weekly podcast, This Week in Health Law.

Call for Abstracts: Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products

At the request of the organizers, I'm passing on the following:

The Food and Drug Law Journal is pleased to announce a forthcoming symposium—Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products—to be held at the Georgetown University Law Center (GULC) on Friday, October 30, 2015, and co-sponsored by the Food and Drug Law Institute and GULC's O’Neill Institute for National and Global Health Law.

The deadline for submitting abstracts is June 1, 2015. Download more information about the symposium here.

Reverse Transplant Tourism

I promised that I would talk some more about the articles in the Law & Contemporary Problems volume, Organs & Inducements, that was just published.  So today I’d like to talk about my article with Mike Rees, Reverse Transplant Tourism. 

The short version is that Reverse Transplant Tourism (“RTT”) is a new form of cross-border kidney paired donation. Such kidney exchanges, in which patients with willing but incompatible living kidney donors exchange their donors’ kidneys, have already become common in the United States.  But RTT takes the standard kidney exchange a step further, by expanding it to poor patients outside of the United States who have a willing donor, but who are not able to afford a transplant. 

We label the procedure “reverse transplant tourism” for a few reasons, intending a play on words. One meaning is literal – in transplant tourism, patients from rich countries typically travel to poorer ones seeking a donor willing to trade a kidney for cash payments.  Under RTT, patients from poor countries travel to rich ones, in order to obtain a transplant that could not be performed in their home country, due to their poverty and the limitations of their national healthcare system.  In addition, RTT could “reverse” many of the negative effects of illegal transplant tourism by avoiding its organ-deficit problem (rather than a net outflow of kidneys from the developing to developed world, RTT matches kidney inflows to outflows) and by building on the system of protections for donors and recipients already present in the U.S transplant system.  In the process, RTT helps an ailing American patient whose willing donor is biologically incompatible. 

To illustrate, let’s begin with the common kidney swap. Suppose that Amanda wants to donate a kidney to Bob but is unable to do so, either because their blood types do not match or because there is some other incompatibility. Another pair, Carlos and Diana, faces the same problem. However, Carlos is compatible with Bob, and Amanda is compatible with Diana. By swapping, as illustrated in figure 1, the kidney swap enables two transplants, providing both Bob and Diana with a compatible kidney. Although kidney exchange began with this type of two-pair exchange, longer exchanges and chains of transplants have recently come to dominate. 

Imagine now, however, that Carlos and Diana, rather than facing biological incompatibility, face a different problem: They are poor and live in a country where poverty is a barrier to transplantation – let’s assume Mexico, which does not pay for all of the necessary costs of transplantation. As illustrated in figure 2, RTT can help both Bob and Diana, allowing each to receive a kidney that they otherwise could not—in Bob’s case because of his biological incompatibility with Amanda, and in Diana’s case because of her poverty and lack of adequate health care coverage. 

Because transplantation is much less expensive than dialysis, RTT both saves money and transplants two patients who otherwise could not obtain one – in one case because of biological incompatibility and, in the other, due to lack of access to health care coverage. 

In my next post, I’ll provide some more details regarding RTT, explain why it ultimately saves money, and discuss the applicability of NOTA. In the meantime, you can read the full paper here.

Related Posts:

Reverse Transplant Tourism Goes Live!!

RTT Conclusion

Reverse Transplant Tourism (cont.)

Reverse Transplant Tourism

Organs & Inducements

The latest issue of Law & Contemporary Problems is now out and you can access all of the articles in the volume online (see the embedded webpage below, or go here).  This issue, edited by Phil Cook and me, features articles from law, medicine, economics, and more.  Each paper addresses the ethics, laws, and other issues relating to inducements for organ donation.  I'll be back with more to say about specific papers in the volume, but in the meantime, there are very few other sources that tackle this question so specifically or in such depth.  Prior posts on the Organs & Inducements symposium are here and here.

Will the Real Evidence-Based Ebola Policy Please Stand Up? Seven Takeaways From Maine DHHS v. Hickox

UPDATES (11/9/14): NPR reports that Hickox's boyfriend  has withdrawn from nursing school and that the two will move out of the state after Nov. 10. Alas, in so reporting, NPR claims that Maine had "sought a court order to require [Hickox] to stay indoors." Apparently NPR doesn't read TFL (or court petitions). Meanwhile, I found this recent JAMA news report about what we do and don't know about Ebola enlightening. Both links via Ross Silverman on Twitter (@phlu). Finally, thanks to Christian Turner for plugging the post on the latest episode of the always interesting Oral Argument podcast.

The case I mentioned in my last post, Maine Department of Health and Human Services v. Kaci Hickox is no more. Hickox and public health officials agreed to stipulate to a final court order imposing on Hickox the terms that the court had imposed on her in an earlier, temporary order. Until Nov. 10, when the 21-day incubation period for Ebola ends, Hickox will submit to "direct active monitoring" and coordinate her travel with Maine public health authorities to ensure that such monitoring occurs uninterrupted. She has since said that she will not venture into town or other public places, although she is free to do so.

Below is a detailed account of the case, which suggests the following lessons:

1. As Hickox herself described it, the result of her case is a “compromise,” reflecting neither what Hickox nor what Maine initially wanted.
2. That compromise was achieved by the parties availing themselves of the legal process, not through Hickox’s civil disobedience.
3. The compromise is not easily described, as it has been, as a victory of science-based federal policy over fear-based state demagoguery. By the time the parties got to court, and perhaps even before then, what Maine requested was consistent with U.S. CDC Guidance, albeit a strict application of it. What Hickox had initially offered to do, by contrast, fell below even the most relaxed application of those guidelines, although by the time the parties reached court, she had agreed to comply with that minimum.
4. The compromise applies only to Hickox, and was based on a stipulation by the parties to agree to the terms that the court had temporarily imposed after reviewing a limited evidentiary record. Additional evidence and legal arguments that the state might have raised in the now-cancelled two-day hearing could have resulted in a different outcome.
5. A substantially different outcome, however, would have been unlikely under Maine’s public health statute. Indeed, it is not clear that Maine’s public health statute allows public health authorities to compel asymptomatic people at-risk of developing Ebola to do anything, including comply with minimum CDC recommendations.
6. “Quarantine” is a charged, but ambiguous, term. It allows us to talk past one another, to shorthand and needlessly politicize a much-needed debate about appropriate policy, and to miss the fact that the CDC Guidance in some cases recommends what could be fairly described as a "quarantine" for people like Hickox and requires it for asymptomatic people with stronger exposure to Ebola (but who are still probably less likely to get sick than not).
7. It’s not clear who has bragging rights to Ebola policy "grounded in science," or what that policy looks like.

Above the (Public Health) Law: Healthcare Worker Deception & Disobedience in a Time of Distrust

Addendum and updates (latest: 4 pm, 10/31) added below

 

A physician shall . . . be honest in all professional interactions, and strive to report physicians . . . engaging in fraud or deception, to appropriate entities.

 

—AMA Principles of Medical Ethics

 

 

This is a troubling series of news reports about deception and defiance on the part of some healthcare workers (HCWs) in response to what they believe to be unscientific, unfair, and unconstitutional public health measures:

(1) Ebola Aide Doc: I'm Not Telling My Team To Tell The Truth

Gavin Macgregor-Skinner, an epidemiologist and Global Projects Manager for the Elizabeth R. Griffin Foundation, who has led teams of doctors to treat Ebola in West Africa, reported that he "can't tell them [his doctors] to tell the truth [to U.S. officials]" on Monday's "CNN Newsroom."

“At the moment these people are so valuable . . . I have to ensure they come back here, they get the rest needed. I can't tell them to tell the truth at the moment because we're seeing so much irrational behavior,” he stated. “I've come back numerous times between the U.S. and West Africa. If I come back now and say ‘I've been in contact with Ebola patients,’ I'm going to be locked in my house for 21 days,” Macgregor-Skinner said as his reason for not being truthful with officials, he added, “when I'm back here in the US, I am visiting US hospitals everyday helping them get prepared for Ebola. You take me out for three weeks, who’s going to replace me and help now US hospitals get ready? Those gaps can't be filled.” 

He argued that teams of doctors and nurses could be trusted with the responsibility of monitoring themselves, stating, “When I bring my team back we are talking each day on video conferencing, FaceTime, Skype, text messaging, supporting each other. As soon as I feel sick I’m going to stay at home and call for help, but I’m not going to go to a Redskins game here in Washington D.C. That's irresponsible, but I need to get back to these hospitals and help them be prepared.

UPDATE: Here is the CNN video of his remarks.

(2) Ebola Doctor 'Lied' About NYC Travels

The city’s first Ebola patient initially lied to authorities about his travels around the city following his return from treating disease victims in Africa, law-enforcement sources said. Dr. Craig Spencer at first told officials that he isolated himself in his Harlem apartment — and didn’t admit he rode the subways, dined out and went bowling until cops looked at his MetroCard the sources said. “He told the authorities that he self-quarantined. Detectives then reviewed his credit-card statement and MetroCard and found that he went over here, over there, up and down and all around,” a source said. Spencer finally ’fessed up when a cop “got on the phone and had to relay questions to him through the Health Department,” a source said. Officials then retraced Spencer’s steps, which included dining at The Meatball Shop in Greenwich Village and bowling at The Gutter in Brooklyn.

 

UPDATE 11PM, 10/30: A spokesperson for the NYC healh department has now disputed the above story, which cites anonymous police officer sources, in a statement provided to CNBC. The spokesperson said: "Dr. Spencer cooperated fully with the Health Department to establish a timeline of his movements in the days following his return to New York from Guinea, providing his MetroCard, credit cards and cellphone." . . . When CNBC asked again if Spencer had at first lied to authorities or otherwise mislead them about his movements in the city, Lewin replied: "Please refer to the statement I just sent. As this states, Dr. Spencer cooperated fully with the Health Department."

(3) Ebola nurse in Maine rejects home quarantine rules [the WaPo headline better captures the gist: After fight with Chris Christie, nurse Kaci Hickox will defy Ebola quarantine in Maine]

Kaci Hickox, the Ebola nurse who was forcibly held in an isolation tent in New Jersey for three days, says she will not obey instructions to remain at home in Maine for 21 days. "I don't plan on sticking to the guidelines," Hickox tells TODAY's Matt Lauer. "I am not going to sit around and be bullied by politicians and forced to stay in my home when I am not a risk to the American public."

Maine health officials have said they expect her to agree to be quarantined at her home for a 21-day period. The Bangor Daily News reports. But Hickox, who agreed to stay home for two days, tells TODAY she will pursue legal action if Maine forces her into continued isolation. "If the restrictions placed on me by the state of Maine are not lifted by Thursday morning, I will go to court to fight for my freedom," she says.

On the evolving Hickox situation, it's unclear whether — as Hickox herself has suggested — she is already under a mandatory home quarantine order, which she is threatening to defy by leaving her house on Thursday morning and (unless it's been lifted) suing, or whether — as her attorneys say — she is currently under no such quarantine order and is free to leave her house at any time (but is choosing to rest for a couple of days). In any case, Maine has clearly said that it is prepared to get a court order to enforce (or impose) a quarantine order.

 

More after the jump...

 

Happy Birthday NOTA! (Now Go Away)

 

Yesterday marks the thirtieth anniversary since passage of the National Organ Transplant Act (NOTA) and, as noted by Eric Posner over at Slate, no one is celebrating. Instead, the growing gap between kidney need and supply, documented by Phil Cook and mehere and depicted in the figure above right, has prompted increasing calls for changes to NOTA’s ban against valuable consideration in exchange for a human organ. Once the province of a small number of “kooky” academics, today even many transplant professionals join the call for reform. Recently, for example, the President of the American Society for Transplantation called on the association to consider “incentives, including but not limited to financial ones,” for organ donation and a widely-circulated letter from bioethicists and health experts to President Obama and other top government officials calls for pilot studies of benefits to organ donors.

On this anniversary of the statute, it’s worth revisiting NOTA’s legislative history (which I discuss in more detail here). Although NOTA is today most often discussed in connection with its prohibition of “valuable consideration,” it is important to remember that such a ban was not the central purpose of the statute, and was added to the statute relatively late. Original drafts of NOTA addressed only the development of a national organ procurement and distribution system. The prohibition on compensated organ donation was added later, in response to a Washington Postarticle about the plans of H. Barry Jacobs, a Virginia physician whose medical license had previously been revoked for Medicare fraud, to establish a for-profit organ brokerage.

Perhaps because the “valuable consideration” language was a late addition to the statute in response to a specific concern, NOTA’s legislative history addresses the term “valuable consideration” only with respect to that concern, and does not provide much insight into the term’s breadth beyond the commercial exchange context. Indeed, a careful reading of the legislative history of NOTA suggests that Congress paid little, if any, attention to the possible meanings of and ambiguities in the phrase “valuable consideration.”

This apparent lack of Congressional attention to statutory language that, while of little import at the time, has assumed great significance in the face of the persistent kidney shortage, matters a great deal. Concerns about running afoul of NOTA regularly impede innovations designed to address the kidney shortage, despite the lack of a clear congressional intent to prohibit these transactions. For example fears of violating NOTA put a halt to Pennsylvania’s planned pilot program to reimburse funeral expenses and have caused uncertainty about the validity of specific practices, such as kidney swaps, that bear little resemblance to the commercial transactions Congress appeared to have in mind when passing the statute.

In short, a vast academic literature addresses “valuable consideration” under NOTA. Commentators debate the meaning of the term and what Congress must have intended with this ambiguous language. But my analysis suggests that Congress, in passing NOTA, only considered the term “valuable consideration” in the context of a very specific and immediately salient threat involving for-profit, commercial exchanges.

Congress could give us all a nice NOTA birthday gift by amending the statute to specifically permit the types of innovations currently being proposed from a number of NOTA critics, none of which involve the type of profit-seeking kidney brokers that originally prompted the “valuable consideration” ban. Barring that, as I previously discuss in this earlier series of posts, uncertainty regarding NOTA’s scope is likely to continue to impede innovation, exacerbate the kidney shortage, and produce unnecessarily high rates of death and disability from kidney failure.

In “celebration” of the anniversary, I plan to be back this week with a few more NOTA-related posts.

Facebook Rumored To Be Planning Foray Into the Online Health Space

Image: Flikr

I know, I know. You're tired of hearing me drone on about Facebook. I'm tired of hearing me talk about Facebook, too. But this is actually a different Facebook controversy.

Reuters broke the story on Friday, citing anonymous sources:

The company is exploring creating online "support communities" that would connect Facebook users suffering from various ailments. . . . Recently, Facebook executives have come to realize that healthcare might work as a tool to increase engagement with the site. One catalyst: the unexpected success of Facebook's "organ-donor status initiative," introduced in 2012. The day that Facebook altered profile pages to allow members to specify their organ donor-status, 13,054 people registered to be organ donors online in the United States, a 21 fold increase over the daily average of 616 registrations . . . . Separately, Facebook product teams noticed that people with chronic ailments such as diabetes would search the social networking site for advice, said one former Facebook insider. In addition, the proliferation of patient networks such as PatientsLikeMe demonstrate that people are increasingly comfortable sharing symptoms and treatment experiences online. . . . Facebook may already have a few ideas to alleviate privacy concerns around its health initiatives. The company is considering rolling out its first health application quietly and under a different name, a source said.

I'm quoted in this International Business Times article about Facebook's rumored plans. What follows is the full statement I provided to the reporter (links added). (I love it when a journalist will let me email my thoughts to him or her; I can better control what I say and after they use one or two sentences, the rest becomes an instant blog post.)

It's hard to comment too much, since the details are at this point so vague. But here are some thoughts. There's nothing inherently wrong with creating free online fora centered around particular medical conditions, including very serious ones, inviting patients suffering from those conditions to share their experiences with each other, and conducting research on and even selling that data to third parties. That's exactly the model that PatientsLikeMe uses. That patient network was created by the brothers and friend of a man with ALS and it has proved critical for many patients suffering from some 1500 diseases and critical for science. The Personal Genome Project, begun by Harvard geneticist George Church and now with additional university sites in Canada and the UK, is similar. [Disclosure: I'm a PGP research subject through which I have published by whole genome sequence and sensitive medical data online. I have not identified my PGP profile by name, although genomic data is inherently re-identifiable and PGP subjects were the target of a pair of re-identification attacks by privacy scholars last year. I'm also a member of the board of directors of PersonalGenomes.org, the nonprofit created to support the PGP and similar initiatives.]

Openly sharing such sensitive information online is the last thing many people would want to do, and it's not for everybody. But there are lots of reasons why many benefit from such fora. Connecting with others who share and can understand your experience can be psychologically critical, and for some ill people, such as those with limited mobility or rare conditions, an online forum may be the only feasible way of achieving this benefit. Such online fora needn't be open to researchers and others, but again, many patients prefer to openly share their experiences. Privacy can be important, but secrecy can also take a toll, especially for those with stigmatized conditions. Sharing patient data as widely as possible is the best way to accelerate research into those conditions, and many patients feel that playing even a modest role in accelerating research is empowering.

Notwithstanding the benefits for many patients, and for science, of data sharing, people have very different preferences about sharing their personal information. It's essential that Facebook — like PatientsLikeMe and the PGP — be absolutely transparent about who will have access to the data users provide (just other forum members? a user's entire Facebook network? third parties to whom Facebook sells the data? everyone with an Internet connection?), how user data will be used (to conduct research? to target ads to patients?), and whether users will be identified with their data (will they be permitted to post anonymously or pseudonymously, and if so, will Facebook ever attempt to re-identify users and how will it react if third parties attempt to do so?). Facebook should also be very clear about the risks of sharing potentially identifying data online and of following any medical advice offered by fellow users.

If true, it's troubling that Facebook is considering initially launching its health application under a different name, presumably in order to conceal its connection to Facebook and what many view as its checkered history of privacy practices. Individuals have the right to decide how open they want to be with their personal information, and they also have the right to decide for themselves whether Facebook can be trusted to stick to whatever terms it offers the users of its health application.

Fall Facebook/OKCupid & the Future of Research Tour

I’m participating in several public events this fall pertaining to research ethics and regulation, most of them arising out of my recent work (in Wired and in Nature and elsewhere) on how to think about corporations conducting behavioral testing (in collaboration with academic researchers or not) on users and their online environments (think the recent Facebook and OKCupid experiments). These issues raise legal and ethical questions at the intersection of research, business, informational privacy, and innovation policy, and the mix of speakers in most of these events reflect that.

The first, and most accessible, is a “tweet chat” today, from 1-2 p.m. EST, on “Research Ethics in a Modern World.” It’s being sponsored by the Milken Institute’s FasterCures, “an action tank driven by a singular goal — to save lives by speeding up and improving the medical research system.” Other participants are Susannah Fox (RWJF's first Entrepreneur in Residence), John Wilbanks (a very interesting guy whose work, largely on empowering patients and research participants to share their data in ways that are consistent with their values, and bio defy concise description), and Margaret Anderson (FasterCures’s Executive Director).

Likely discussion topics include the impact of social media on research and research ethics; the ethics of A/B testing and similar behavioral testing of user environments (i.e., websites) by corporations, and who should be empowered to conduct research risk-benefit analysis (patients/participants? scientists? legal systems?). You don’t need to have a Twitter account to read the conversation, either as it unfolds in real time or at any time thereafter. Just point your web browser to this URL. But to ask a question or otherwise participate in the discussion (which is encouraged!), you do need a Twitter account.

On October 22, I’ll be at Harvard Law participating in a panel discussion of the Petrie-Flom Center’s latest anthology, “Human Subjects Research Regulation: Perspectives on the Future,” with Glenn Cohen, Holly Fernandez Lynch, and Barbara Bierer.

On December 4, I’ll be at Colorado Law participating in a day-long conference, “When Companies Study Their Customers: The Changing Face of Science, Research, and Ethics,” sponsored by the Silicon Flatirons Center for Law, Technology, and Entrepreneurship and the Tech Policy Lab at the University of Washington. Other participants include law profs Paul Ohm, Ryan Calo, and James Grimmelman, Princeton Center for Internet Technology Policy Director Edward Felten, FTC Commissioner Julie Brill, and UT-Austin psychologist Tal Yarkoni.

On December 5, I’ll be in Baltimore participating in a Meet the Authors lunch event at the annual PRIM&R conference with the editors and several other contributors to the aforementioned book.

And on December 6, I’ll be participating in a PRIM&R session on “Manipulating Emotions on the Internet: The Cases of Facebook, OkCupid,” with OHRP Director Jerry Menikoff, privacy and Internet research ethics scholar Michael Zimmer, and Berkeley Director of Research Subject Protection Rebecca Armstrong.

On April 13, I’ll be giving a seminar at Wharton in the Legal Studies and Business Ethics Speaker Series, in which I may present something related to these themes.

Many thanks to the organizers for including me in these very interesting events (interesting least of all due to my inclusion, needless to say), and I hope to see some readers at some of them.