Archive for the ‘Bioethics’ Category
Neuroscience at Trial: Society for Neuroethics Convenes Panel of Front-Line Practitioners
posted by Amanda Pustilnik
Is psychopathy a birth defect that should exclude a convicted serial killer and rapist from the death penalty? Are the results of fMRI lie-detection tests reliable enough to be admitted in court? And if a giant brain tumor suddenly turns a law-abiding professional into a hypersexual who indiscriminately solicits females from ages 8 to 80, is he criminally responsible for his conduct? These were the questions on the table when the International Neuroethics Society convened a fascinating panel last week at the Carnegie Institution for Science last week on the uses of neuroscience evidence in criminal and civil trials.
Moderated and organized by Hank Greely of Stanford Law School, the panel brought together:
- Steven Greenberg, whose efforts to introduce neuroscience on psychopathic disorder (psychopathy) in capital sentencing in Illinois of Brian Dugan has garnered attention from Nature to The Chicago Tribune;
- Houston Gordon (an old-school trial attorney successful enough not to need his own website, hence no hyperlink), who has made the most assertive arguments so far to admit fMRI lie-detection evidence in a civil case, United States v. Semrau, and
- Russell Swerdlow, a research and clinical professor of neurology (and three other sciences!). Swerdlow’s brilliant diagnostic work detected the tumor in the newly-hypersexual patient, whom others had dismissed as a creep and a criminal.
In three upcoming short posts, I will feature the comments of each of these panelists and present for you, dear reader, some of the thornier issues raised by their talks. These cases have been reported on in publications ranging from the Archives of Neurology to USA Today, but Concurring Opinions brings to you, direct and uncensored, the statements of the lawyers and scientists who made these cases happen … Can I say “stay tuned” on a blog?
November 20, 2011 at 12:39 pm
Tags: law & neuroscience, neuroethics
Posted in: Bioethics, Capital Punishment, Criminal Law, Evidence Law, Health Law, Psychology and Behavior, Uncategorized
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Auditing Studies of Anti-Depressants
posted by Frank Pasquale
Marcia Angell has kicked off another set of controversies for the pharmaceutical sector in two recent review essays in the New York Review of Books. She favorably reviews meta-research that calls into question the effectiveness of many antidepressant drugs:
Kirsch and his colleagues used the Freedom of Information Act to obtain FDA reviews of all placebo-controlled clinical trials, whether positive or negative, submitted for the initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. . . .Altogether, there were forty-two trials of the six drugs. Most of them were negative. Overall, placebos were 82 percent as effective as the drugs, as measured by the Hamilton Depression Scale (HAM-D), a widely used score of symptoms of depression. The average difference between drug and placebo was only 1.8 points on the HAM-D, a difference that, while statistically significant, was clinically meaningless. The results were much the same for all six drugs: they were all equally unimpressive. Yet because the positive studies were extensively publicized, while the negative ones were hidden, the public and the medical profession came to believe that these drugs were highly effective antidepressants.
Angell discusses other research that indicates that placebos can often be nearly as effective as drugs for conditions like depression. Psychiatrist Peter Kramer, a long-time advocate of anti-depressant therapy, responded to her last Sunday. He admits that “placebo responses . . . have been steadily on the rise” in FDA data; “in some studies, 40 percent of subjects not receiving medication get better.” But he believes that is only because the studies focus on the mildly depressed:
The problem is so big that entrepreneurs have founded businesses promising to identify genuinely ill research subjects. The companies use video links to screen patients at central locations where (contrary to the practice at centers where trials are run) reviewers have no incentives for enrolling subjects. In early comparisons, off-site raters rejected about 40 percent of subjects who had been accepted locally — on the ground that those subjects did not have severe enough symptoms to qualify for treatment. If this result is typical, many subjects labeled mildly depressed in the F.D.A. data don’t have depression and might well respond to placebos as readily as to antidepressants.
Yves Smith finds Kramer’s response unconvincing:
The research is clear: the efficacy of antidepressants is (contrary to what [Kramer's] article suggests) lower than most drugs (70% is a typical efficacy rate; for antidepressants, it’s about 50%. The placebo rate is 20% to 30% for antidepressants). And since most antidepressants produce side effects, patients in trials can often guess successfully as to whether they are getting real drugs. If a placebo is chosen that produces a symptom, say dry mouth, the efficacy of antidepressants v. placebos is almost indistinguishable. The argument made in [Kramer's] article to try to deal with this inconvenient fact, that many of the people chosen for clinical trials really weren’t depressed (thus contending that the placebo effect was simply bad sampling) is utter[ly wrong]. You’d see the mildly/short-term depressed people getting both placebos and real drugs. You would therefore expect to see the efficacy rate of both the placebo and the real drug boosted by the inclusion of people who just happened to get better anyhow.
Felix Salmon also challenges Kramer’s logic:
[Kramer's view is that] lots of people were diagnosed with depression and put onto a trial of antidepressant drugs, even when they were perfectly healthy. Which sounds very much like the kind of thing that Angell is complaining about: the way in which, for instance, the number of children so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) was 35 times higher in 2007 than it was in 1987. And it’s getting worse: the editors of DSM-V, to be published in 2013, have written that “in primary care settings, approximately 30 percent to 50 percent of patients have prominent mental health symptoms or identifiable mental disorders, which have significant adverse consequences if left untreated.”
Those who would defend psychopharmacology, then, seem to want to have their cake and eat it: on the one hand it seems that serious mental health disorders have reached pandemic proportions, but on the other hand we’re told that a lot of people diagnosed with those disorders never really had them in the first place.
That is a very challenging point for the industry to consider as it responds to concerns like Angell’s. The diagnosis of mental illness will always have ineradicably economic dimensions and politically contestable aims. But doctors and researchers should insulate professional expertise and the interpretation of maladies as much as possible from inappropriate pressures.
How can they maintain that kind of independent clinical judgment? I think one key is to assure that data from all trials is open to all researchers. Consider, for instance, these findings from a NEJM study on “selective publication:”
We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. . . . Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall. (emphasis added).
Melander, et al. also worried (in 2003) that, since “The degree of multiple publication, selective publication, and selective reporting differed between products,” “any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.” Without clearer “best practices” for data publication, clinical judgment may be impaired.
Full disclosure of study funding should also be mandatory and conspicuous, wherever results are published. Ernest R. House has reported that, “In a study of 370 ‘randomized’ drug trials, studies recommended the experimental drug as the ‘treatment of choice’ in 51% of trials sponsored by for-profit organizations compared to 16% sponsored by nonprofits.” The commodification of research has made it too easy to manipulate results, as Bartlett & Steele have argued:
One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.” Rescue countries came to the aid of Ketek, the first of a new generation of widely heralded antibiotics to treat respiratory-tract infections. Ketek was developed in the 1990s by Aventis Pharmaceuticals, now Sanofi-Aventis. In 2004 . . . the F.D.A. certified Ketek as safe and effective. The F.D.A.’s decision was based heavily on the results of studies in Hungary, Morocco, Tunisia, and Turkey.
The approval came less than one month after a researcher in the United States was sentenced to 57 months in prison for falsifying her own Ketek data. . . . As the months ticked by, and the number of people taking the drug climbed steadily, the F.D.A. began to get reports of adverse reactions, including serious liver damage that sometimes led to death. . . . [C]ritics were especially concerned about an ongoing trial in which 4,000 infants and children, some as young as six months, were recruited in more than a dozen countries for an experiment to assess Ketek’s effectiveness in treating ear infections and tonsillitis. The trial had been sanctioned over the objections of the F.D.A.’s own reviewers. . . . In 2006, after inquiries from Congress, the F.D.A. asked Sanofi-Aventis to halt the trial. Less than a year later, one day before the start of a congressional hearing on the F.D.A.’s approval of the drug, the agency suddenly slapped a so-called black-box warning on the label of Ketek, restricting its use. (A black-box warning is the most serious step the F.D.A. can take short of removing a drug from the market.) By then the F.D.A. had received 93 reports of severe adverse reactions to Ketek, resulting in 12 deaths.
The great anti-depressant debate is part of a much larger “re-think” of the validity of data. Medical claims can spread virally without much evidence. According to a notable meta-researcher, “much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong.” The “decline effect” dogs science generally. Statisticians are also debunking ballyhooed efforts to target cancer treatments.
Max Weber once said that “radical doubt is the father of knowledge.” Perhaps DSM-VI will include a diagnosis for such debilitating skepticism. But I think there’s much to be learned from an insistence that true science is open, inspectable, and replicable. Harvard’s program on “Digital Scholarship” and the Yale Roundtable on Data and Code Sharing* have taken up this cause, as has the work of Victoria Stodden.
We often hear that the academic sector has to become more “corporate” if it is to survive and thrive. At least when it comes to health data, the reverse is true: corporations must become much more open about the sources and limits of the studies they conduct. We can’t resolve the “great anti-depressant debate,” or prevent future questioning of pharma’s bona fides, without such commitments.
*In the spirit of full disclosure: I did participate in this roundtable.
X-Posted: Health Law Profs Blog.
July 14, 2011 at 3:56 pm
Posted in: Bioethics, Culture, Health Law, Law and Psychology, Philosophy of Social Science, Technology
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Rethinking Sorrell v. IMS Health: Privacy as a First Amendment Value
posted by Frank Pasquale
The Supreme Court will soon hear oral arguments in Sorrell v. IMS Health. The case pits medical data giant IMS Health (and some other plaintiffs) against the state of Vermont, which restricted the distribution of certain “physician-identified” medical data if the doctors who generated the data failed to affirmatively permit its distribution.* I have contributed to an amicus brief submitted on behalf of the New England Journal of Medicine regarding the case, and I agree with the views expressed by brief co-author David Orentlicher in his excellent article Prescription Data Mining and the Protection of Patients’ Interests. I think he, Sean Flynn, and Kevin Outterson have, in various venues, made a compelling case for Vermont’s restrictions. But I think it is easy to “miss the forest for the trees” in this complex case, and want to make some points below about its stakes.**
Privacy Promotes Freedom of Expression
Privacy has repeatedly been subordinated to other, competing values. Priscilla Regan chronicles how efficiency has trumped privacy in U.S. legislative contexts. In campaign finance and citizen petition cases, democracy has trumped the right of donors and signers to keep their identities secret. Numerous tech law commentators chronicle a tension between privacy and innovation. And now Sorrell is billed as a case pitting privacy against the First Amendment.
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April 25, 2011 at 10:37 pm
Posted in: Bioethics, First Amendment, Health Law, Privacy, Privacy (Medical), Supreme Court, Technology
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After Makena: Could a Risk Corridors Approach Balance Incentives and Access?
posted by Frank Pasquale
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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April 3, 2011 at 9:59 am
Posted in: Bioethics, Health Law, Insurance Law, Intellectual Property
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Indian Supreme Court on Withdrawal of Life Support
posted by Frank Pasquale
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. . . .
March 7, 2011 at 9:45 am
Posted in: Bioethics, Health Law
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On the Colloquy: The Credit Crisis, Refusal-to-Deal, Procreation & the Constitution, and Open Records vs. Death-Related Privacy Rights
posted by Northwestern University Law Review
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.
September 5, 2010 at 1:15 pm
Tags: Antitrust, Constitutional Law, copyright, discrimination, financial crisis, free speech, Intellectual Property, Privacy, trademark
Posted in: Antitrust, Bioethics, Civil Rights, Constitutional Law, Corporate Finance, First Amendment, Intellectual Property, Privacy, Securities, Securities Regulation
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Why Don’t You Need IRB Approval to Talk About People in Cases?
posted by Dave Hoffman
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.
Thoughts?
September 1, 2010 at 3:04 pm
Posted in: Administrative Law, Bioethics, Constitutional Law, Empirical Analysis of Law, Law School (Scholarship)
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Is There a Constitutionally Protected Right to Use Reproductive Technologies?
posted by Glenn Cohen
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:
August 24, 2010 at 9:38 am
Posted in: Bioethics, Civil Rights, Constitutional Law, Family Law, Health Law, Jurisprudence, Uncategorized
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Clarifying Commodification
posted by Glenn Cohen
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.
August 17, 2010 at 8:53 am
Posted in: Bioethics, Culture, Family Law, Feminism and Gender, Health Law, Jurisprudence, Law and Humanities, Law and Inequality, Legal Theory, Uncategorized
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Flynn v. Holder, Markets for Bone Marrow, and Abigal Alliance
posted by Glenn Cohen
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.
August 9, 2010 at 10:00 am
Posted in: Bioethics, Civil Rights, Consumer Protection Law, Health Law, Law Practice, Property Law
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Mechanical Turk, Research Ethics, and Research Assistants
posted by Glenn Cohen
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.
August 3, 2010 at 9:49 am
Posted in: Amazon, Anonymity, Bioethics, Bright Ideas, Google & Search Engines, Law and Psychology, Law School, Law School (Scholarship), Technology, Web 2.0
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Nobody Expects the Singularity
posted by Frank Pasquale
“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.
June 16, 2010 at 12:05 am
Posted in: Bioethics, Culture, Current Events, Law and Inequality, Technology, Weird
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Milgram on T.V.
posted by Dave Hoffman
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.
March 17, 2010 at 7:07 am
Posted in: Behavioral Law and Economics, Bioethics, Current Events, Empirical Analysis of Law, Law and Psychology
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Health care systems kill people. So what?
posted by Nate Oman
As the debate over health care reform slogs on, a particular kind of argument has become quite familiar. It goes something like this:
Health care system X is a bad system because it kills people.
In support of this assertion, we are then treated to a set of anecdotes about how this or that person died as a result of this or that health care system break down. Hence, we see critics of Obama’s proposals trotting out horror stories about how NHS bureaucracy resulted in the death of this or that Briton’s loved ones. Likewise, we see supporters of health care reform unearthing heartbreaking stories of how the American patchwork of private insurance and Medicare or Medicaid killed off dad or mom. My question is, “So what?” Read the rest of this post »
September 15, 2009 at 7:48 am
Posted in: Bioethics, Health Law, Tort Law
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Health Tech: CNET Shadows The Economist
posted by Deven Desai
Teaching Information Privacy is simply fantastic. The law and issues force students to consider torts, contracts, criminal procedure, constitutional law, and more. The health and genetic privacy material alone could easily be a course unto itself. Health care has been a major policy matter for more than a decade, and yet, it has not suffered the usual let’s move on to the next hot topic pattern that specific health matters such as HIV/AIDS and more recently H1N1. One area that is coming is so-called e-health. CNET is hosting a three day series on “Your e-health future.” The series looks at digital health records, Microsoft and Google’s forays into the sector, some fundamentals about e-health, stimulus, and so on. I plan on reading the different parts but based on the bits I’ve scanned, it is a little thin. In contrast, The Economist’s special report “Medicine Goes Digital” from April was stimulating and informative. I highly recommend the series of articles. The basic premise, “The convergence of biology and engineering is turning health care into an information industry,” relates to something I have been working on for a while: the way in which the merging of humans and machines (some call this possibility the singularity) poses problems that relate to intellectual property and privacy in much the same way being online did and continues to pose problems. These changes are coming. The question, and my hope, is that for once the law will be ahead of the curve as technology foments a fundamental change in the way we live.
Image: “Fieldbook of medicine (1517). Treatment of a skull injury. Wood cut work attributed to Hans Wechtlin.”
Source: Wikicommons
License: Public Domain
May 19, 2009 at 9:47 pm
Posted in: Bioethics, Health Law, Privacy, Privacy (Medical)
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What’s in a Name, Part 2: Consider “half-siblings”
posted by Naomi Cahn
Ryan Kramer graduated from Colorado University’s aerospace engineering program on Friday, a program that is so tough that only about 50% of those who begin ultimately finish it. Before he starts his master’s degree in engineering management at USC this fall, one of his big summer plans is to meet two of his half-siblings; he has at least five others.
I’ve met Ryan once, and was incredibly impressed with him – I’m not surprised that he was able to complete his competitive college program nor that he is seeking out half-siblings and the man who anonymously provided the sperm that enabled Ryan to exist. Ryan and I met at a conference on establishing a national donor gamete databank. Ryan and his mother, Wendy Kramer, have started the enormously successful Donor Sibling Registry, which is now responsible for connecting more than 6000 people with others who share some of the same genetic origins (disclosure: I have just become a board member of the DSR).
Donor-conceived offspring often – although not always – regret their lack of connection with their entire biological heritage. They want to know more about the often anonymous individual[s] who helped create them. As the secrecy around using “donor” sperm and eggs dissolves – in the past, parents frequently did not tell their children that they had been created by donor gametes — offspring and their parents are increasingly trying to get additional information and are advocating for disclosure of “donor” identities. Many have begun to use the internet to create an extended family that includes others who have used the same donor. Almost 150,000 people visited the DSR website in 2008, and more than 24,000 people have registered on it. It maintains an extremely active blog and message group.
The language in the donor world shows how these families are constructed. Offspring who share the same donor are typically labelled “half-siblings. “Accidental incest” is a concern. The word “donor” is itself a misnomer; gametes are typically sold rather than provided altrustically. Read the rest of this post »
May 10, 2009 at 2:30 pm
Posted in: Bioethics, Family Law, Feminism and Gender
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What’s in a Name? Consider “Embryos”
posted by Naomi Cahn
Dan first asked me to blog a few months ago, around the time my book, Test Tube Families: Why the Fertility Market Needs Legal Regulation, was hitting the market. Since then, we’ve had Nadya Suleman’s octuplets, President Obama’s lifting of the federal stem cell research ban (although this may only apply to embryos resulting from fertility efforts), and proposed new legislation in Georgia that would allow for embryos to be “adopted.” These events in reproductive technology are neither as newsworthy nor as profoundly disturbing as the torture memos or bailing out Wall Street — or, potentially, as swine flu. They are, nonetheless, critical to the cultural conflict over abortion, family formation, and gender roles.
Consider the proposed Georgia law, and almost copycat-like, legislation in Tennesse. The “Option of Adoption Act” is a Georgia bill that is now sitting on the desk of Ga.. Governor Sonny Perdue. This is the same Republican governor who filed his own brief in Northwest Austin Municipal Utility District v. Holder (the Voting Rights Case that the Supreme Court heard last week), arguing – among other things — that electing a black president indicates no further need for the type of scrutiny Georgia receives under Section 5; the Georgia attorney general had, apparently, refused to file such a brief. Anyway, the Option of Adoption Act, which was introduced in the Georgia legislature by an anti-abortion state representative, sets out methods through which people who create an embryo (when someone undergoes a cycle of in vitro fertilization, there are often embryos left over that ) can donate any leftovers to someone else. There may be up to half a million frozen embryos in the United States, although many of them are incapable of becoming viable fetuses. In Georgia, if the legislation becomes law, the recipients of any embryo transfer can then choose to petition a court for recognition that they are the legal parents of any child born to them.
.One of the bill’s advocates, Daniel Becker, the President of Georgia Right to Life, trumpeted that, “’This bill is monumental in that it establishes the adoption of embryos as children for adoption purposes.’” Indeed, there have even been claims that an embryo exchange should be the basis for eligibility under the federal adoption tax credit. As Sarah Lawsky and I painstaking show in Embryo Exchanges and Adoption Tax Credits, use of someone else’s embryo is not an adoption. Calling embryos “children” is problematic for a number of reasons.
May 4, 2009 at 7:00 am
Posted in: Bioethics, Family Law, Feminism and Gender
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Neurocosmetics as Faulty Data
posted by Frank Pasquale
Edge, a fascinating online salon/magazine, asked 151 luminaries “What Will Change Everything“? I’ve picked through the 107,000 words of responses over the past few weeks; many are thought-provoking.
For example, Marcel Kinsborne predicts a growing market for “neurocosmetics” which translate the benefits of cosmetic surgery to the social world:
[D]eep brain stimulation will be used to modify personality so as to optimize professional and social opportunity, within my lifetime. Ethicists will deplore this, and so they should. But it will happen nonetheless, and it will change how humans experience the world and how they relate to each other in as yet unimagined ways. . . . We read so much into a face — but what if it is not the person’s “real” face? Does anyone care, or even remember the previous appearance? So it will be with neurocosmetics.
Consider an arms race in affability, a competition based not on concealing real feelings, but on feelings engineered to be real. Consider a society of homogenized good will, making regular visits to [a] provider who advertises superior electrode placement? Switching a personality on and then off, when it becomes boring? . . .
We take ourselves to be durable minds in stable bodies. But this reassuring self-concept will turn out to be yet another of our so human egocentric delusions. Do we, strictly speaking, own stable identities? When it sinks in that the continuity of our experience of the world and our self is at the whim of an electrical current, then our fantasies of permanence will have yielded to the reality of our fragile and ephemeral identities.
It’s one thing to read these imaginings in the fiction of a Houllebecq, Franzen, or Foster Wallace; it’s quite another to see them predicted by a Professor of Psychology at the New School for Social Research. I have also predicted an arms race in the use of personality optimizing drugs, but I believe such an arms race would defeat, rather than reveal, humanity’s true nature. My difference with Kinsborne suggests a technophilic bias at the heart of Edge’s inquiry: an implicit belief that certain technologies will inevitably change us, rather than being changed or stopped by us.
January 24, 2009 at 11:03 pm
Posted in: Bioethics
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Towards Responsible Use of Cognition-Dulling Drugs
posted by Frank Pasquale
In a recent editorial in Nature entitled Towards responsible use of cognitive-enhancing drugs by the healthy, distinguished contributors have endorsed a “presumption that mentally competent adults should be able to engage in cognitive enhancement using drugs.” Against various Luddites who worry about the rat races such drug use could spark, the editorialists argue that cognitive enhancement is here to stay: “From assembly line workers to surgeons, many different kinds of employee may benefit from enhancement and want access to it, yet they may also need protection from the pressure to enhance.” Instead of the regulation encouraged by Francis Fukuyama, they would have us rely on robust professional standards to guide “appropriate prescribing of cognitive enhancers.”
The most promising aspect of the editorial is the thin and unspecified concept of enhancement that it endorses. As Carl Elliott notes, relentless focus on well-defined tasks can offer a real competitive edge in today’s economy:
Employees who cannot rely on job security often feel as if they are constantly required to prove their value to their employers. Many of these same employees spend most of their time sitting in front of a computer screen performing repetitive tasks that require sustained attention and concentration.
Of course, many in this group may experience moments of imagination or reverie positively, as exemplary thought rather than distracting consolation. For those individuals, the next goal of an autonomy-enhancing bioethics should be the development and widespread use of cognition-dulling drugs, which serve to blot out all awareness except of the task at hand. Cures for resentment, envy, or union-organizing may also serve to enhance workplace efficiency.
Bioconservatives may fear that cognition-dulling drugs presage a Brave New World–particularly Aldous Huxley’s futuristic vision of certain fetuses being routinely exposed to alcohol in order to ease their acceptance of low-caste membership. They tend to forget Huxley’s counter-image of a progressively technologized paradise, in Island, which “answers the authoritarian monoculture of Brave New World point by point”:
Biotechnology is present, but as a kind of ecologically wise agricultural system. . . . The nuclear family has been abolished . . . but only to increase human attachment among all its inhabitants . . . The novel . . . ends, exactly as it began, with the island’s mynah birds repeating the mantra they have been trained to mimic over and over again: “Attention.”
Like the happy inhabitants of Huxley’s Island, both cognition-enhancers and cognition-dullers can work together peaceably in a mutualism that discourages conflict.
Fortunately, the Nature editorialists appear in principle open to cognition-dulling methods, endorsing a nuanced and contextualized response:
Appropriate policy should prohibit coercion except in specific circumstances for specific occupations, justified by substantial gains in safety. It should also discourage indirect coercion. Employers, schools or governments should not generally require the use of cognitive enhancements. If particular enhancements are shown to be sufficiently safe and effective, this position might be revisited for those interventions.
The key then is to carefully consider how best to develop a pharmacopeia that safely and effectively cures tendencies to insubordination, daydreaming, dissatisfaction, and other inefficient habits.
January 4, 2009 at 10:22 am
Posted in: Bioethics
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Surgical Strike on Social Suffering
posted by Frank Pasquale
The recent face transplant at the Cleveland Clinic raises some fascinating issues about the nature of personal identity and cutting edge medicine. A failing face transplant might create agonizing medical problems for the recipient, leading some to suggest that death-accelerating drugs should be available in that case. Current organ donation cards do not specify whether they authorize a face donation. The family of the face donor might find the transplant recipient’s new face uncannily like that of the relative they recently lost. Finally, there is the question of the cruelty of a society that made the transplant so pressing in the first place:
She “was called names and was humiliated,” Siemionow [the doctor who led the transplantation team] told reporters yesterday. . . . Eric Kodish, the Cleveland Clinic’s chief ethicist, added, “Human beings are inherently social creatures. A person who has sustained trauma or other devastation to the face is generally isolated and suffers tremendously.” He concluded: “The relief of suffering is at the core of medical ethics and provides abundant moral justification for this procedure.”
Yes, suffering cries out for relief. But when the suffering is social and the relief is surgical, where are we going? We’re drifting from a standard of necessity rooted in you to a standard—”socially crippled”—that’s dictated by others. And instead of changing them, we’re changing and endangering you. The Cleveland doctors say their patient consented freely. They asked her, for example, whether it was she or her family who wanted the transplant. But how free can your choice be when the reason you want it is to escape humiliation?
As Will Saletan concludes, “I feel for the Cleveland patient. I hope her new face ends her suffering. I just don’t want to end up killing her—and calling that her choice—because we made her life hell.”
As the cosmetic surgery boom abates in South Korea, it’s important to think of all the smaller ways in which competitive pressures and fear of lesser humiliations drive demand for these procedures. The greater the humiliation in store for the unattractive, the more this “luxury” becomes a necessity.
January 4, 2009 at 8:44 am
Posted in: Bioethics
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