Moderated and organized by Hank Greely of Stanford Law School, the panel brought together:

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 [...]]]> 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.

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 [...]]]> 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:

FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct. In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.

Moreover, the problem persists for at least one other drug, colchicine. As Arthur Allen explains at Slate,

The colchicine and [17P] stories have their roots in the FDA’s historically complex relationship with the drug industry. Since 1962, the agency has required that all new drugs be proven safe and efficacious before hitting the market. Many drugs marketed before 1962, however, remain on sale without having been formally approved by the FDA and are technically illegal. In 2006, the FDA launched the Unapproved Drugs Initiative, aimed at getting rid of as many of these drugs as possible. . . .

The FDA campaign has two approaches. In some cases, the agency simply warns companies to stop producing and shipping unlicensed drugs by a given date. In other cases the FDA warns a group of companies producing a particular class of drug, notifying them that it plans to crack down on their unapproved substances. The idea here is to give the companies an opportunity to submit their drugs to the rigorous testing required for FDA approval. This is what happened with . . . at least 86 newly approved drugs. The problem is that after submitting such drugs to expensive testing, drug makers typically jack up the prices, in a position to do so under congressional patent incentives aimed at producing innovative drug research. The FDA has no say in how a drug is priced.

As the Post notes, KV says it “is spending more than $200 million to develop the drug and conduct follow-up studies that the Food and Drug Administration demands.” Had it kept its pricing power, it was estimated that Makena would cost the US health care system $4 billion per year. Assuming that 3/4 of that would be revenue to Makena, and it lasted for the full 7 years of exclusivity, that would be a $21 billion return on a $0.2 billion investment. That seems excessive, especially given that KV didn’t develop the drug. On the other hand, if the Makena price were to be reduced one hundredfold, that’s a $0.21 billion return on a $0.2 billion investment. Unless we hit some serious deflation, that doesn’t cover the time value of the money invested in studies and development.

Are there any better models here? Stein’s story says that “experts said the FTC could sue KV if it concludes the company is illegally impairing competition,” but I don’t see the theory there. The FTC has lamented post-merger price hikes for life sustaining drugs (see FTC v. Lundbeck), but has precious little authority over price hikes here. Perhaps liberal constitutional law professors could fuse the “medical self-defense” theory of Eugene Volokh with the expansive Yoo/Vermeule/Posner theories of executive power, and find inherent executive authority here to save preemies? Probably not; the current Supreme Court is only receptive to creative con law from one side of the political spectrum.

Another idea is for legislation to create “risk corridors” for researchers who engage in the FDA’s Unapproved Drugs program, as CMS has for prescription drug insurance plans in Medicare Part D. As Kip Piper explains,

Using a system of risk corridors that compares actual incurred drug benefit costs to estimated costs submitted in bids, Medicare limits the profits and losses of Part D drug plans. Specifically, if a Medicare drug plan’s actual benefit costs exceed expected (bid) levels by a sufficient degree, the plan will receive an additional federal payment to cover a portion of the loss. However, if a drug plan’s actual spending falls sufficiently below projections, the plan must share some of the profit with the feds. Risk corridors apply to actual and expected drug benefits costs but exclude plan administrative costs and federal reinsurance payments.

Unfortunately, estimates of the value of testing unapproved drugs vary widely. The FDA’s director of the FDA’s Office of New Drugs and Labeling Compliance insists on the importance of these programs. But, looking specifically at colchicine, an Austin rheumatologist said “Doing one trial in patients and a few drug interaction studies doesn’t justify marketing exclusivity and a 50-fold increase in price.” As Allen puts it, we need “legislative remedies to improve the drug supply without costing the public an arm and a leg.”

In health care finance, the “cost-shift” hydraulic is a familiar model. When policymakers cut reimbursements for, say, Medicare or Medicaid, providers still have the same income target, and respond by raising prices for the privately insured. One scholar estimated that the privately insured pay over 120% of costs, while Medicare payments are between 95 and 99%. We might think of pharmaceutical patents as another manifestation of “cost-shifting,” from the future (which will enjoy drugs in the public domain) to the present (which must pay the monopolist’s price). Other forms of exclusivity can also lead to that type of cost-shift, as the Makena controversy makes clear. Perhaps the people most benefited by a regime of pharmacovigilance and evidence-based medicine should be asked to pay something for that new reassurance. But they shouldn’t be price gouged. A risk corridors approach might better balance patients’ interests in research on, and reasonable prices for, unapproved drugs.

X-Posted: Health Reform Watch.

[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 [...]]]> 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. . . .

In our opinion, if we leave it solely to the patient’s relatives or to the doctors or next friend to decide whether to withdraw the life support of an incompetent person there is always a risk in our country that this may be misused by some unscrupulous persons who wish to inherit or otherwise grab the property of the patient. Considering the low ethical levels prevailing in our society today and the rampant commercialization and corruption, we cannot rule out the possibility that unscrupulous persons with the help of some unscrupulous doctors may fabricate material to show that it is a terminal case with no chance of recovery. There are doctors and doctors.

While many doctors are upright, there are others who can do anything for money (see George Bernard Shaw’s play ‘The Doctors Dilemma’). The commercialization of our society has crossed all limits. Hence we have to guard against the potential of misuse (see Robin Cook’s novel ‘Coma’). In our opinion, while giving great weight to the wishes of the parents, spouse, or other close relatives or next friend of the incompetent patient and also giving due weight to the opinion of the attending doctors, we cannot leave it entirely to their discretion whether to discontinue the life support or not. We agree with the decision of the Lord Keith in Airedale’s case (supra) that the approval of the High Court should be taken in this connection. This is in the interest of the protection of the patient, protection of the doctors, relative and next friend, and for reassurance of the patient’s family as well as the public. This is also in consonance with the doctrine of parens patriae which is a well known principle of law.

I am no expert in this area of law, but I thought the Court’s opinion very interesting and worth recommending as a survey of global views on the topic and a careful consideration of a particular case.

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 [...]]]>

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.

But how about simply writing about living parties [...]]]> 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?

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 [...]]]> 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.

(a) Intrinsic vs. Consequentialist: One variant of the argument is “intrinsic”; for example, the statement “prostitution devalues women’s sexuality” is a proposition about an inherent incompatibility between an object and a mode of valuation.  A different variant of this argument is what might be called the “consequentialist” corruption argument, for example that allowing the sale of babies WILL cause us to change the way we value children in our society in a way that will produce deleterious consequences.  Although the two are often used interchangeably, these two versions are quite different.  The consequentialist but not the intrinsic version heavily depends on empirical premises about how likely experience-modification (to use a term of Scott Altman’s) will occur, and the possibility that legal or cultural interventions might prevent it.  When the corruption objection takes its intrinsic form, by contrast, such policy solutions are inapposite because whatever one does to mitigate the bad consequences of the exchange, even if the exchange is made in secret or is not widespread, the exchange still denigrates the good.  It is as if the evil that the objection pushes against occurs and is consummated in the moment of exchange, irrespective of the consequences that follow.

(b) Conventionalist vs. Essentialist: Particularly within the intrinsic version of corruption argument (but also on the consequentialist version) the departure point is that there is an exchange between goods in two modes of valuation that does violence to the way we think the goods are properly valued.   Thus, we need a method for determining how goods are properly valued.  There are roughly two large camps – conventionalist and essentialist.  Conventionalists believe that the proper sphere of valuation depends on prevailing societal norms of a particular group, at a particular time.  Michael Walzer’s approach in Spheres of Justice is emblematic.  Herodotus has a famous passage in the Histories along these lines

“During [King] Darius’ reign, he invited some Greeks who were present to a conference, and asked them how much money it would take for them to be prepared to eat the corpses of their fathers; they replied that they would not do that for any amount of money. Next, Darius summoned some members of the Indian tribe known as Callatiae, who eat their parents, and asked them in the presence of the Greeks . . . how much money it would take for them to be willing to cremate their fathers’ corpses; they cried out in horror and told him not to say such appalling things. . . . [C]ustom is king of all.” HERODOTUS, THE HISTORIES bk. III, ch. 38, at 185–86 (Robin Waterfield trans., 1998).

The approach faces interesting questions regarding exchanges between societies, concerns about whether some of these norms (e.g., regarding women’s sexuality) stem from prior relationships of subordination, and the possibility that we can “re-educate” norms to avoid these kinds of conflicts.

By contrast, on the essentialist view, one looks to the timeless essence or nature of a good to determine how to value it, as well as which exchanges accord with that mode of valuation.  This is no easy task, especially when one recognizes that not only the exchange of money but barter can produce problematically corrupting exchanges.  If the problem is the exchange of things that have radically different spheres (not amounts) of valuation, then the philosophical battleground will be in defining how wide the various spheres are and the extent to which they overlap in a way that convincingly follows from the essence of the good itself.

(3) Crowding-Out: This theory, associated with Titmuss’ work on the blood supply, suggests that when markets enter the domain they push out altruistic giving.  The next step of the argument usually suggests that the result is less supply of the good in question (i.e., fewer people donate blood in regimes where sale is allowed), or at least that there results a diminution in supply of quality versions of the good – one claim associated with Titmuss’ argument was that blood sale regimes caused individuals to fake their health status and that bad blood entered the system as a result, although this critique is contingent on a lack of effective means of screening.  When the claim is instead that the market merely pushes away altruistic conceptions of the good, I think that is more properly described as the corruption argument above.

Again, I’d welcome comments on the taxonomy.

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 [...]]]> 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.

While many of these points are not directly relevant to the substantive due process classification as a fundamental right, they are certainly relevant to the system design/policy question, they will make it easier for the court to side with the plaintiffs, and they may become to the analysis under strict scrutiny if the court determines that standard applies. Perhaps cutting the other way is that unlike in Abigail Alliance here allowing the ‘purchase’ introduces risk to a new person (the bone marrow donor who would not have donated but for the new incentive), so it is not merely a right to do what one wants with one’s body, but instead involves the bodies of others, although that distinction does not strike me as particularly important.

On a more doctrinal level, I think this will be a much harder case for the government to win than Abigail Alliance. While in Abigail Alliance we successfully argued that the history of regulating drugs to protect the patient went back to colonial America and thus the opposite right was hard to establish under the Glucksberg framework, here NOTA is of fairly recent vintage and (also unlike Glucskberg) there is no deeply entrenched negation of the right. For most of the levels of briefings all sides in Abigail Alliance as well as the court treated the case as though the Glucksberg’s “Due Process Traditionalist” approach governed, rather than a more intimacy-based view associated with the “mysteries-of-life” passage from Casey. It will be interesting whether the Flynn court also focuses exclusively on Glucksberg, considers both approaches, or (though unlikely) focuses on the intimacy approach.

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 [...]]]> 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.

I often have my R.A.’s read over papers before I send them out to hunt for typos (alongside more substantive tasks I give them). Imagine that tomorrow I decided (imagine a shrinking research budget due to times of fiscal austerity) to farm the typo-hunt off to Mechanical Turk because I could get results faster and at one tenth the price, since there were individuals in destitute circumstances willing to do it at a rate far below that I pay my (wonderful, in case they are reading) R.A.’s. Even if the accuracy of the Turkers was individually less good, it seems plausible that having four of them pour over each page might be better and still cheaper than using R.A.’s to do it. Lest you think this only an interesting hypothetical, consider Samasource, whose mission statement suggests it “enables marginalized people, from refugees in Kenya to women in rural Pakistan, to receive life-changing work opportunities via the Internet” in just this way.

Would I have violated any rules at your university? Have I done something wrong? Perhaps I have deprived Harvard students of the opportunity to work closely with a faculty member (although on typo hunting?) Am I problematically circumventing Harvard’s minimum wage for R.A. work? Am I exploiting these Kenyan refugees or rural Pakistani women or instead giving them “life-changing work opportunities via the Internet?”

I’d be curious to hear the thoughts of any readers, as well as any reports on whether your institution has a policy on this subject.

[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 [...]]]> “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.

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 [...]]]>

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.

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, [...]]]> 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?”

My point in this post is not to argue the merits of this or that proposal.  I’ve got opinions on those things, but I’ll save them for another time.  Nor do I want to create some kind of equivalence between all health care systems.  America’s strikes me as exceptionally expensive and inefficient.  Rather, I want to make a much simpler point:

All health care systems kill people.  All of them.

They do this for three reasons.  First, death is not ultimately preventable.  We all die, although in the United States in particular we seem loath to acknowledge this fact let alone let it influence how we think about health care spending.  Second, and perhaps more importantly for our purposes, things always breakdown.  Even a system designed by smart people of good will will, for time to time, go horribly wrong and do something stupid.  Unfortunately, this holds true in health care, where the stakes are high, and the forces of entropy and stupidity can kill.  Finally, nobody has ever been willing to spend infinite resources to eliminate every preventable death.  Every day we all engage in behavior that creates some non-trivial likelihood of death because the costs of doing otherwise are prohibitively high.  Using automobiles is an obvious example, but a moments reflection will multiply them.  The unvarnished truth is that we necessarily are willing to let people die preventable deaths.

As a result, I find myself unmoved by the stories of grandma killed off by the NHS or dad left to die by an insurance company. Health care systems kill people.  So what? Can we start having a real discussion?

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 [...]]]> 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.  

  Biological connection is, of course, only one of the many methods of forming a family. Yet the genetic ties between their children cause many women to feel strong family-like connections to each other.  Consider Gwenyth Jackaway, who, according to a story in O Magazine  searched for genetic relatives for her son, Dylan, because she wanted him to be “part of a larger community,” and refers to the other children she found as “Dylan’s siblings.” Then there’s Mike Rubino, who was Donor 929 at California Cryobank. He was inspired to find what happened to the sperm he had provided to the Cryobank, and, through the DSR, discovered that Rachael McGhee had written a thank you message to Donor 929. McGhee had given birth to 2 children using sperm from Donor 929, and, on Father’s Day, she’d remind the children to think about their donor and send him hugs. Rubino and McGhee, along with her 2 children, ultimately spent a week together, getting to know one another.
For Ryan, finding his donor led to a feeling of “‘immediate peacefulness,’” his mother explained to the Denver Post. As I have argued in the context of both adoption and the donor world,  the United States should establish a national donor gamete registry, similar to that in place in numerous other countries such as Great Britain. The registry should keep track of children both through donor egg, embryo, and sperm, including the identities of the gamete providers. Federal law already requires that fertility clinics provide information on the number of children born through donor eggs and embryos, although the procedures for collecting this additional information are not in place and would take some time to develop. Participation in such a registry would be mandatory for anyone involved in supplying donor gametes. When donor-conceived offspring reach a certain age, they should be able to receive identifying information about their donor (the donor could file a statement indicating his/her lack of interest in being contacted). While mandatory limits on donor anonymity constitute a radical change in existing practices, there are multiple reasons supporting this change – including a goal of helping other offspring find the “immediate peacefulness” that Ryan found.

Consider the proposed Georgia law, and almost copycat-like, [...]]]> 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.

First, and most clearly, it is part of a right to life agenda designed, ultimately, to overturn Roe. In the short term, this is an effort to continue to control the rhetoric around abortion and to continue to make inroads through the political process on women’s right to choose. And, it is factually inaccurate. Not only is the terminology politically motivated, but also the legal procedures for donating an embryo are quite different from the legal procedures for an adoption.

Second, labeling an embryo a “child” may lead to questions about how to think about egg and sperm that are “donated” by one person to another. (Here again the language is tricky: egg and sperm are usually not donated but are — as many other wonderful colleagues have noted — sold. Stay tuned for a potential blog post about this.) If there are to be questions raised about the fertility industry, however, the questions should relate to better regulation without allowing right to life advocates to take over the discourse. For more on this, see Jennifer Collins’s recent post.

Finally, there are numerous options for thinking about what to do about the problem of leftover embryos. Many people don’t like the idea that their embryos will become someone else’s children, or they want to keep these embryos in storage for future family-building; others want to dispose of them entirely; some want to donate them for research; and then there’s the group who wants to help others family-build. If we think of embryos as “children,” however, we may limit people’s choices on what to do with their leftover embryos, and we may also get close, again, to shutting down federal funding for stem cell research. . No good outcomes here – unless we think of embryos as embryos.

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 [...]]]> 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.

We need to understand that it’s a conception of the self that is driving the acceptance of new technologies of self-alteration here, rather than vice versa. Consider eHarmony consultant Helen Fisher’s acceptance of the arms arms race metaphor in the same issue of Edge:

As scientists learn more about the chemistry of trust, empathy, forgiveness, generosity, disgust, calm, love, belief, wanting and myriad other complex emotions, motivations and cognitions, even more of us will begin to use this new arsenal of weapons to manipulate ourselves and others. And as more people around the world use these hidden persuaders, one by one we may subtly change everything. [emphasis added]

It’s easy to see where that arms race leads. Perhaps at some point we’ll all end up like those apostles of reductionist philosophy Patricia and Paul Churchland, who, rather than acting out, expressing, or displaying emotions, appear to prefer to refer to their supposed chemical determinants:

One afternoon recently, Paul says, he was home making dinner when Pat burst in the door, having come straight from a frustrating faculty meeting. “She said, ‘Paul, don’t speak to me, my serotonin levels have hit bottom, my brain is awash in glucocorticoids, my blood vessels are full of adrenaline, and if it weren’t for my endogenous opiates I’d have driven the car into a tree on the way home. My dopamine levels need lifting. Pour me a Chardonnay, and I’ll be down in a minute’.”

Nicholas Carr has noted that “institutionally supported programs of brain enhancement [may] impose on us, intentionally or not, a particular ideal of mental function.” Fisher, Kinsborne, and the Churchlands suggest the metaphysical foundations of self-mechanization. It’s a vision of the self as “multiple input-multiple output transducer,” which, as I said in this article, follows a long line of reducing “soul to self, self to mind, and mind to brain.” This last step of understanding what the brain is as what it does is a functionalism that begs the question Bourne used to put to Dewey: what exactly is the point of this pragmatic deflation of our self-understanding?

In a recent series of posts at PopMatters, Rob Horning has explored the psychology of consumerism, a condition we are endlessly told by elites to consider the linchpin of global development, economic growth, and domestic order.

[Harry Frankfurt] calls attention to “second-order desires”, or the desires we have about our primary desires. These are what we want to want and, according to Frankfurt, make up the substance of our will . . . . [W]e often have multiple sets of preferences simultaneously, which foils the more simplistic models of neoclassical economics with regard to consumer demand. . . .

The persuasion industry is seeking always to confuse the communication between our first- and second-order desires; it’s seeking to short circuit the way we negotiate between the many things we can conceive of wanting to come up with a positive will to want certain particular things at certain moments. It seeks to make us more impulsive at the very least; at worst it wants to supplant our innate will with something prefabricated that will orient us toward consumer goods rather than desires that are able to be fulfilled outside the market.

The neurocosmetics forecast in Edge have the same place in the social world that marketing has in the worlds of goods and services. For example, the complex mixture of ennui, detachment, skepticism, and embers of warmth in office life limned in Joshua Ferris’s And Then We Came to the End could be flattened into the glad-handing grin of an unalloyed will-to-succeed. Horning suggests that “consumerism makes the will and ability to concentrate seem a detriment to ourselves:”

Dilettantism is a perfectly rational response to the hyperaccessibility of stuff available to us in the market, all of which imposes on us time constraints where there was once material scarcity. These time constraints become more itchy the more we recognize how much we are missing out on (thanks to ever more invasive marketing efforts, often blended in to the substance of the material we are gathering for self-realization).

Similarly, neurocosmetics promises to relieve the mental effort of crafting a genuine response to events from the welter of conflicting emotions they generate, leaving only the feeling induced by drugs.

In a world of neurocosmetics, emotions lose their world-disclosive potential and moral force. Rather than guiding our choices, they are themselves one among many choices. The industrial possibilities are endless, and I’m sure some rigorous cost-benefit analyses will prove the new soma’s indispensability to such varied crises as aging, unemployment, and gender imbalances.

I shudder at such a world, but I doubt economic analysis can provide any basis for rejecting it. Neurocosmetics and consumerism are but two facets of the individualist, subjectivist, economic functionalism that’s become our default language for judging states of the world.

If I were asked to participate in Edge’s salon, I think I’d flip the question and ask “what kind of common moral language do we need to stop random technological developments from changing everything?” Philosophers like Langdon Winner and Albert Borgmann have started answering that question as they consider technology and the character of contemporary life. Borgmann notes that “simulations of reality can lead to disastrous decisions when assumptions or data are faulty.” Perhaps we should start thinking of neurocosmetics as a faulty source of emotional data about our responses to the world around us.

The most promising aspect of the editorial is the [...]]]> 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.

[For my real views on the subject, please see this and this. Ellen Gibson at Businessweek gets my prize for best reporting on the editorial, by raising these issues:

Dr. Anjan Chatterjee, a neurologist at the University of Pennsylvania Hospital, raises [a] red flag. Creative insights often arise when the mind is allowed to wander, he says. If drugs that sharpen concentration become widespread in the workplace, they may nurture “a bunch of automatons that are very good at implementing things but have nothing to implement.”

As Martha Nussbaum has observed in another context, “I’m getting more and more worried that we’re going to have nations of docile engineers who won’t know how to examine the claims of a political leader”–or to cease concentrating on the problems in front of them to think about the bigger picture. We might also worry about a competitive academic environment driving the endorsement of attention-grabbing policies without adequate attention to the social consequences of such policies.]

She “was called names and was humiliated,” Siemionow [the doctor who led the transplantation team] told reporters yesterday. [...]]]> 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.