Category: Bioethics

After Makena: Could a Risk Corridors Approach Balance Incentives and Access?

The past few weeks have been worrying ones for expectant mothers who wanted a hormonal treatment designed to stop preterm births. As Rob Stein of the WaPo explains,

A form of progesterone known as 17P was used for years to reduce the risk of preterm birth. . . Because no companies marketed the drug, women obtained it cheaply from “compounding” pharmacies, which produced individual batches for them [at about $20 each]. Doctors and regulators had long worried about the purity and consistency of the drug and were pleased when KV won FDA’s imprimatur for a well-studied version, which the company is selling as Makena.

The list price for the drug, Makena, turned out to be a stunning $1,500 per dose. That’s for a drug that must be injected every week for about 20 weeks, meaning it will cost about $30,000 per at-risk pregnancy. . . . The approval of Makena gave the company seven years of exclusive rights, and KV immediately fired off letters to compounding pharmacies, warning that they could no longer sell their versions of drug.

A day after Stein’s article appeared, the FDA made it clear that it “does not intend to take enforcement action against pharmacies that compound” 17P, “in order to support access to this important drug, at this time and under this unique situation.”

This is a fascinating, and in some ways troubling, response to the accusations of price-gouging by KV. Nonenforcement here has some eerie parallels to the epidemic of waivers now undermining the implementation of the ACA.

Compounding pharmacists had already averred that “many of [KV’s] assertions that the compounding of an FDA approved product is prohibited are not supported by the legal citations it references.” Though the FDA’s letter preserves access to 17P for now, that access could be revoked at any time. As the FDA states on its website:
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Indian Supreme Court on Withdrawal of Life Support

There is a fascinating recent decision from the Indian Supreme Court on the Shanbaug case, regarding a woman who has been in a persistent vegetative state (PVS) for over 37 years. A petitioner who had written a book on Shanbaug argued for a withdrawal of life support. Shanbaug had no family to intervene, but hospital staff resisted, and the Court ultimately sided with them. While unflinchingly examining the dehumanizing aspects of PVS, the Court offers a remarkable affirmation of the good will of the staff who have taken care of Shanbaug:

[I]t is evident that the KEM Hospital staff right from the Dean, including the present Dean Dr. Sanjay Oak and down to the staff nurses and para-medical staff have been looking after Aruna for 38 years day and night. What they have done is simply marvelous. They feed Aruna, wash her, bathe her, cut her nails, and generally take care of her, and they have been doing this not on a few occasions but day and night, year after year. The whole country must learn the meaning of dedication and sacrifice from the KEM hospital staff. In 38 years Aruna has not developed one bed sore. It is thus obvious that the KEM hospital staff has developed an emotional bonding and attachment to Aruna Shanbaug, and in a sense they are her real family today.

After a scholarly survey of many countries and U.S. states’ laws on withdrawal of life support, the Court concludes:

A decision has to be taken to discontinue life support either by the parents or the spouse or other close relatives, or in the absence of any of them, such a decision can be taken even by a person or a body of persons acting as a next friend. It can also be taken by the doctors attending the patient. However, the decision should be taken bona fide in the best interest of the patient. . . .

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On the Colloquy: The Credit Crisis, Refusal-to-Deal, Procreation & the Constitution, and Open Records vs. Death-Related Privacy Rights


This summer started off with a three part series from Professor Olufunmilayo B. Arewa looking at the credit crisis and possible changes that would focus on averting future market failures, rather than continuing to create regulations that only address past ones.  Part I of Prof. Arewa’s looks at the failure of risk management within the financial industry.  Part II analyzes the regulatory failures that contributed to the credit crisis as well as potential reforms.  Part III concludes by addressing recent legislation and whether it will actually help solve these very real problems.

Next, Professors Alan Devlin and Michael Jacobs take on an issue at the “heart of a highly divisive, international debate over the proper application of antitrust laws” – what should be done when a dominant firm refuses to share its intellectual property, even at monopoly prices.

Professor Carter Dillard then discussed the circumstances in which it may be morally permissible, and possibly even legally permissible, for a state to intervene and prohibit procreation.

Rounding out the summer was Professor Clay Calvert’s article looking at journalists’ use of open record laws and death-related privacy rights.  Calvert questions whether journalists have a responsibility beyond simply reporting dying words and graphic images.  He concludes that, at the very least, journalists should listen to the impact their reporting has on surviving family members.


Why Don’t You Need IRB Approval to Talk About People in Cases?

Legal archaeology is a term sometimes used to refer to scholarship that brings a rich context to famous cases.   If you were a legal researcher seeking to enrich a modern classic – e.g., Pepsico [contracts], Lawrence [con law], Liebeck [torts], Twombly [civ pro] – you might proceed by interviewing the parties and their attorneys, examining prior and related cases, and boning up on the briefs and exhibits.  It seems pretty clear to me that before undertaking such research, a prudent professor would check in with their IRB.  The interviewing of the parties and their attorneys in particular doesn’t appear to be clearly covered by any exemption, and I imagine that at least expedited review would be indicated.

But how about simply writing about living parties – or judges – in modern cases? It would seem inconceivable to go to the IRB before writing about, say, Yaser Hamdi.  Well, you never know how your local IRB will deal with novelty.  So let’s go back to the basics.   Is this research under Section 46.102? Arguably: it is a “systemic investigation . . . designed to contribute to generalizable knowledge.”  Is it research regarding human subjects? Well, under 46.102(f), human subjects are people you collect data from through actual contact or those who you collect data that is otherwise private.   Private information “includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).”  Are their facts about behavior disclosed in judicial opinions which fit this definition?  I can think of many: disclosure of facts from police reports, medical records, taxes, etc.  Indeed, most opinions disclose facts about individuals that they’d never, ever, want told to the public, and were forced to disclose only through contentious discovery.  Quite often, the discovery contained stipulations of confidentiality that bind the parties, but not the court.

Nevertheless, it’s clear that writing about such personal facts in released opinions is in fact exempt from IRB review, since a judicial opinion is, under 46.101(b)(4), a public record.  So you might think that this entire exercise is academic.  And for some IRBs, it would be.  But most IRBs would take the position – if asked – that researchers must submit an application to them, so that the board can evaluate the claim for exemption.  This is a slam dunk case for exemption, but that doesn’t mean that the professor gets to decide for herself that no application is necessary.  Of course, I’ve never heard of a law professor submitting to an IRB before writing an article about a recent case of interest, even when discussing the most personal facts relating to the parties or the judge. In fact, some articles about particular judges  have created political scandals of some note.  Unless I’m mistaken about any of the previous analysis, I think that means that most law professors, some of the time, are not in technical compliance with a set of (very silly and possibly unconstitutional as applied) regulations.  Ironically, it is probably constitutional law professors, who write about recent cases involving individual parties most often,  who are the prime violators.  If your law school has not reached a general understanding with your local IRB about how to proceed, it should.



Is There a Constitutionally Protected Right to Use Reproductive Technologies?

A few months back Jessie Hill had a blog post entitled “My so-called right to procreate” asking about the scope of procreative liberty protected by the Constitution.  I wrote about this issue in passing in a paper devoted to the opposite question, whether the constitution protect a right NOT to procreate (or what I prefer to think of as rights not to procreate, separable sticks in a bundle encompassing the right not to be a legal, gestational, or genetic parent – indeed as I pointed out there, I think the right to procreate should be similarly unbundled).  In a new paper entitled Well, What About the Children?: Best Interests Reasoning, the New Eugenics, and the Regulation of Reproduction, as part of a larger project on the justifications for the regulation of reproduction I briefly address a slightly narrower issue than the one in Jessie’s post, whether there is a negative liberty fundamental right to non-interference with reproductive technology use.  I thought I would set out and expand on that discussion here and see what other readers thought.

My own view is that the constitutional status of state interventions preventing access to reproductive technologies (either directly, e.g., prohibitions on access to reproductive technology for women over age 50 or through regulation, or indirectly, e.g., parental fitness screening for surrogacy users) is deeply under-determined by the existing doctrine.  The only U.S. Supreme Court decision to consider whether there is a fundamental right to become a genetic parent, Skinner v. Oklahoma, 316 U.S. 535, 536-39 (1942) (finding a fundamental right that was violated by physical sterilization of individuals convicted three or more times of crimes of moral turpitude but not embezzlement) is subject to a myriad of possible interpretations especially as applied to reproductive technologies.

Here are a few:

Skinner protects as a fundamental right any use of reproductive technologies that simulates that which would be achievable by coital reproduction in the fertile individual (not, therefore, something like genetic engineering). John Robertson is the person I most closely associate with this view (although his view has considerably more nuance that I can get across here).

On the other extreme, one might argue that because Skinner itself was premised on an Equal Protection claim not a substantive Due Process one and thus there is no substantive Due Process right to Procreate at all. Cf. VICTORIA F. NOURSE, IN RECKLESS HANDS: SKINNER V. OKLAHOMA AND THE NEAR-TRIUMPH OF AMERICAN EUGENICS 165 (2008) (concluding that “both liberals and conservatives have made a mistake” in their reading of Skinner because the case was “neither argued nor decided as a case about rights in the sense that we use the term ‘fundamental right’ today).” That said, over the years the Court has lumped Skinner in with its substantive Due Process jurisprudence so often that the time may have passed for hewing to this distinction.

In between there are several other positions:

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Clarifying Commodification

I’ve found both in published work and in classroom and workshop discourse that people often mean different things when they talk about commodification concerns as an argument for blocked exchanges – e.g., forbidding the sale of kidneys from live donors, prostitution, the sale of surrogacy services, etc.

I thought it might be useful to try and sort out some of these different meanings (for those looking for a more formal discussion with citations, this old paper of mine may be useful). This is my own classification (though it builds off work by my colleague Michael Sandel among others). I will be interested to see if others think one should add to or reformulate the taxonomy.  It is also worth emphasizing at the threshold that while money is the focus of most anti-commodificationist arguments that for each version barter can also give rise to the same objections.

At the top-level we can divide commodification into three large categories (the 3 C’s if you will): Coercion, Corruption, and Crowding-Out. For the purposes of this post my goal is not to evaluate these arguments, just to parse them better.

(1) Coercion:

(a) Voluntariness. This concern, also known as exploitation, is framed as concern about the voluntariness of the transaction in a way that demands more than minimal notions of consent.  It is the fear that only the poor will sell organs or that only destitute women will consent to act as commercial surrogates, and argues for blocking the exchange to protect those populations. It thus depends on some empirical facts about the population the argument seeks to protect; one occasionally seeks proposals to limit organ or surrogacy services sales to people above a certain income bracket to blunt the concern.  It also depends on views about the validity of blocking an exchange due to these somewhat paternalistic concerns.  Thus, sometimes it is argued that it is hypocritical to block an exchange preventing a badly-off person from improving their station in life unless we are also committed to a redistributive plan that makes them as well-off as they would be if the exchange was permitted.   It is important to understand that this objection is not focused on a claim that the buyer and seller are giving up unequally (in amount, see below regarding mismatches of type) valued things, the “raw deal” problem that parallels one strand of substantive unconscionability doctrine in contracts; instead, it is about the seller’s poverty and their susceptibility towards “an offer you can’t refuse” even if the good is valued fairly.  While one solution to some forms of unconscionability may be to re-write the terms to be more favorable to the seller, adding extra compensation here would worsen not improve the exchange from the point of view of this objection.

(b) Access: Somewhat less frequently the objection is made almost in reverse. While the voluntariness version treats the exchange as representing a “bad” that the poorer party in the exchange suffers in one respect involuntarily, the access variant instead views the exchange as representing a “good” that only the better-off party has access to because of the existence of the market.  For example, the sale of “premium” eggs is something only the wealthy will have access to, or the during Civil War the practice of commutation where one could pay three hundred dollars to avoid serving in the draft was only available to wealthier stratas of society. This objection also depends on notions of background unjust inequalities in resource distribution to get going.

Price caps may be a partial solution to either form of the coercion objection because they will lower the price to make it not-so-attractive as to make us question voluntariness (the “offer you can’t refuse”) and also move the purchase of the good into the range of access for more of the population.  It is only a partial solution because it usually results in shortages.  One could also imagine “mixed” systems that do better at addressing one concern than the other — so the state could be the only permitted buyer of organs and then distribute them through the current transplant system rather than willingness to pay — this would go a long way to blunting the access concern, but not necessarily the voluntariness one (and indeed might make the corruption objection below even worse).

(2) Corruption: A second version of the objection is that a market exchange “corrupts,” “taints,” or “denigrates” the things being exchanged — for instance, the argument that prostitution devalues women’s bodies by attaching a price tag to their sexuality.  Cass Sunstein offers a good starting formulation of the corruption argument: an exchange is corrupting when “the relevant goods cannot be aligned along a single metric without doing violence to our considered judgments about how these goods are best characterized.”  Incommensurability and Kinds of Valuation: Some Applications in Law, in INCOMMENSURABILITY, INCOMPARABILITY, AND PRACTICAL REASON 234, 238 (Ruth Chang ed., 1997).  More specifically, one might suggest that there are various “spheres” (sometimes called “modes”) of valuation, and an exchange is corrupting when it ignores the differences between these spheres of valuation and forces us to value all goods in the same way.  For example, exchanging children for money corrupts the value of children because money and children belong in different spheres of valuation.

As I have described in depth, that requires both a theory of sphere differentiation and a theory of what it is about exchanges that “does violence,” neither of which are that easy to articulate.  For present purposes, though, I want to merely distinguish versions of the argument along two dimensions.

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Flynn v. Holder, Markets for Bone Marrow, and Abigal Alliance

Over the summer at the annual health law professors’ conference organized by ASLME, I saw a wonderful presentation on Flynn v. Holder from John Robertson, which I think John will be publishing soon. The case is a challenge to the National Organ Transplant Act (NOTA) of 1984’s ban on selling bone marrow filed in the U.S. District Court, Central District of California, and you can view the complaint here.

My main interest in the case is how it will compare to Abigail Alliance v. Eschenbach, a case I helped litigate at the D.C. Circuit en banc stage when I was at the DOJ. Abigail Alliance involved a challenge by terminally ill patients to have access to drugs that had cleared Phase 1 Clinical Testing but had not gone further in the testing process.  There, the plaintiffs succeeded in getting a panel of the D.C. Circuit to to hold that a fundamental right of theirs was being violated by the FDA policy, with a remand for consideration of whether the government could make its showing on strict scrutiny. On rehearing en banc, however, the full D.C. Circuit reversed gears finding no fundamental right (there was no serious argument in the case that the government would not prevail on rational basis review).

In many ways, Flynn is a beautifully set up test case. The primary plaintiff is very sympathetic — a “single mother of five with three daughters who suffer from a deadly bone marrow disease.” Because bone marrow is renewable, and many other renewable “organs” (think sperm and egg) explicitly fall outside of NOTA’s prohibition, there is an air of arbitrariness here. The plaintiffs do not want to buy bone marrow in crass commercial terms, but instead to “create a pilot program that would encourage more bone marrow donations by offering nominal compensation—such as a scholarship or housing allowance.” While I do not think this fact actually allows us to avoid the the corruption form of the anti-commodificationist argument (I may blog more on that topic soon), on a superficial level it does seem to reduce the strength of at least one talking point. The fact that we already tolerate altruistic bone marrow donation suggests that the risk-prevention rationale that was central in Abigail Alliance faces some problems here. Indeed as I , Lori Andrews, and others have argued in the context of reproductive services, in some ways the “coercion” or “exploitation” concerns that are sometimes raised in anti-commodificationist arguments may be more worrisome in the altruistic and familial setting than in arm’s length market arrangements. The case also seems to compare favorably on crowding-out concerns. Although the Abigail Alliance court did not reach the issue (because whether a fundamental right was present dominated the analysis) the government offered a somewhat attenuated crowding out argument: that the availability of experimental drugs outside of clinical trials would reduce the enrollment in clinical trials, and therefore slow either approval of these drugs (and widespread availability) or a demonstration that they were unsafe or ineffective. Though attenuated, this was a concern that many took quite seriously in the run-up and aftermath of the case.  Here, by contrast, I think the crowding out argument is more straightforward and is similar to one that people associate with Richard Titmuss’ work as to blood sale, that adding commercial elements will drive altruistic donation out of the market. To be sure that is an empirical claim, but one that seems less plausible to me than the parallel claim in Abigail Alliance, and I think here again the charitable/foundation approach may blunt some concerns about the transformation of the social meaning of bone marrow donation.

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Mechanical Turk, Research Ethics, and Research Assistants

A recent faculty workshop by my witty and brilliant colleague Jonathan Zittrain on “ubiquitous human computing,” (this youtube video captures in a different form what he was talking about ), prompted me to thinking about some ways in which platforms like Amazon’s Mechanical Turk, interface with university research and research ethics in interesting ways.

For those unfamiliar, Mechanical Turk allows you to farm out a variety of small tasks (label this image, enter date of this .pdf to a spreadsheet, take a photo of yourself with the sign “will turk for food,” etc) at a price per unit you set. Millions of anonymous users can then do the task for you and collect the bounty, a form of microwork.

As Jonathan detailed, this raises a host of fascinating issues, but I want to focus on two that are closer to bioethics.

First, I have begun to see some legal academics recruiting populations for experimental work using Mechanical Turk, and there is an emerging literature on the pros and cons of subject recruitment from these populations. Are Mechanical Turkers “research subjects” within the legal (primarily the Common Rule if one receives federal funding) or broader ethical sense of the term? Should they be? Take as a tangible example the implicit bias research of the kind Mahzarin R. Banarji has made famous, and imagine it was done over something like Mechanical Turk. How (if at all) should the anonymity of the subject, the lack of subject-experimenter relationship of any sort, the piecemeal nature of the task, etc, change the way an institutional review board reviews the research? It is a mantra in the research ethics community that informed consent is supposed to be a “process” not a document, but how can that process take place in this anonymous static cyberspace environment?

Second, consider research assistance.

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Nobody Expects the Singularity

“I don’t want to achieve immortality through my work,’ Woody Allen said, “I want to achieve it through not dying.” The “Singularity University” is attracting Silicon Valley glitterati who think along the same lines:

[T]he Singularity — a time, possibly just a couple decades from now, when a superior intelligence will dominate and life will take on an altered form that we can’t predict or comprehend in our current, limited state . . . [will lead to a world where] human beings and machines . . . so effortlessly and elegantly merge that poor health, the ravages of old age and even death itself will all be things of the past.

Some of Silicon Valley’s smartest and wealthiest people have embraced the Singularity. They believe that technology may be the only way to solve the world’s ills, while also allowing people to seize control of the evolutionary process. For those who haven’t noticed, the Valley’s most-celebrated company — Google — works daily on building a giant brain that harnesses the thinking power of humans in order to surpass the thinking power of humans.

Ezra Klein skewers the techno-utopianism, toying with the idea that we may well be robotized before we get electronic medical records:

Right now, one of the top stories on the New York Times site is about how human beings are going to become people-computer hybrids and live forever and that vision actually seems semi-plausible until you realize that all the information about the operation to download your memories into a Macintosh will probably be kept in a manila folder in a large filing cabinet, and then it doesn’t seem so likely.

But Klein neglects the trends toward tiering in the medical system, which may well continue forking into “upper decks” where anything is possible and nether realms of penury. As Andrew Orlowski comments, “The Singularity is . . . . rich people building a lifeboat and getting off the ship.” I think that progress in bioethics depends on a rejection of that kind of thinking in favor of a more solidaristic orientation toward the needs of the worst off. As I stated in 2002,

We are all disturbed by hypothetical dystopias like Huxley’s Brave New World. But their most important flaws – the inequality, degradation, and moral irresponsibility of their inhabitants – are already apparent in [some aspects of life in the] world’s wealthiest nations[, which] spend hundreds of millions of dollars on elaborate technologies of life-extension, while contributing much less to efforts to assure basic medical care to the poorest. Public debate on regenerative medicine must acknowledge this inequality. Societies and individuals can invest in it in good conscience only if they are seriously committed to extending extant medicine to all.

If “Singularity University” turns out to be a prime philanthropic initiative of the Google guys, while the Bill and Melinda Gates Foundation sticks to “progress in fighting hunger and poverty,” I know which tech company I’ll be rooting for.


Milgram on T.V.

At least Milgram Wasn't Doing It For Profit

From the hyper-civilized French comes a new game show:

Game show contestants turn torturers in a new psychological experiment for French television, zapping a man with electricity until he cries for mercy — then zapping him again until he seems to drop dead.

“The Game of Death” has all the trappings of a traditional television quiz show, with a roaring crowd and a glamorous and well-known hostess urging the players on under gaudy studio lights.

But the contestants did not know they were taking part in an experiment to find out whether television could push them to outrageous lengths, and which has prompted comparisons with the atrocities of Nazi Germany.

The better analogy is Stanley Milgram’s Yale experiments, which were the direct inspiration for this show.  Though the article blames television’s “absolutely terrifying power” to compel obedience here, I think the result can be explained much more simply as depending on the power of authority itself.

Maybe we need an IRB for reality show producers.