As discussed in other posts, HHS has issued a Notice of Proposed Rule Making (NPRM) with significant changes to the U.S. regulation of human subjects research. Bill of Health will be hosting a mini-symposium on the topic getting some of the most important thinkers about human subjects research to weigh in on the NPRM and what it means for the field. Watch this space for more over the coming days and weeks.
As Michelle noted, the Notice of Proposed Rule Making (NPRM) on human subjects research is out after a long delay. For my (and many Bill of Health bloggers’) view about its predecessor ANPRM, you can check out our 2014 book, Human Subjects Research Regulation: Perspectives on the Future.
Here is HHS’s own summary of what has changed and what it thinks is most important:
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register. The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015. There are plans to release several webinars that will explain the changes proposed in the NPRM, and a town hall meeting is planned to be held in Washington, D.C. in October. Continue reading
On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Times raising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.
Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.
Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].
Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.
The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.
Here is what FDA said with my analysis in bold:
Talking Points today reports that Presidential Nominee Gov. Scott Walker has said he would pass a 20-week abortion ban without an exception for rape and incest. “In this case, again, it’s an unborn life, it’s an unborn child and that’s why we feel strongly about it,” Walker said. “I’m prepared to sign it either way that they send it to us.” I have elsewhere explained why I think 20-week bans, premised on fetal pain, are misguided and constitutionally dubious.
But I am an equally opportunity, intellectual, so here I want to defend Scott Walker. As I note in my recently published paper “Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?” in the Journal of Law, Medicine, and Ethics those who are pro-life have compelling reasons not to recognize an exception for rape and incest. Indeed, it is Pro-Life views that make exceptions for these two kinds of abortions that are in need of justification. The paper also explains some fears from the Pro-Choice perspective about attacking the failure to recognize these exceptions with a vengeance, given the view of women’s sexuality and manichean madonna/whore dyad such an approach expresses. Here is the abstract:
There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot” to the center and get away from the statements of those like Todd Akin who made comments about how in cases of “legitimate rape,” the victims’ bodies “have ways to try and shut that whole thing down.” The way Romney did his pivot was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy among those who oppose abortion.
Abortion should be criminalized, yes, but with these exceptions carved out. Continue reading
Last week, the Food and Drug Administration released highly anticipated draft recommendations that would allow gay men to donate blood after one year of celibacy. While an improvement from the current, highly criticized lifetime ban, the new policy, which was announced in December, still caters to fear and stigma rather than science. It should be reconsidered. […]
Read the full article here.
Given that it was the subject of my first ever blog post on Bill of Health, I am very pleased to share my new paper: “Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?” which has just been published in the Journal of Law, Medicine, and Ethics (it is behind a paywall, but there is a version they have allowed me to post on SSRN that has all the text but not the formatting that can be freely downloaded).
This paper is likely to piss off people both on the Left and the Right of the abortion issue, which I think of as a feature not a bug ;), but in any event I hope will prompt a good conversation. Here is the abstract:
There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot” to the center and get away from the statements of those like Todd Akin who made comments about how in cases of “legitimate rape,” the victims’ bodies “have ways to try and shut that whole thing down.” The way Romney did his pivot was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy among those who oppose abortion. Continue reading
When I was young I wanted to be Alan Wertheimer. When I first read him as an undergrad in courses in ethics and in law and philosophy he was one of the twentieth century writers in the field I most admired (along with Bernard Williams, Joel Feinberg, and a few other august names). His clarity, his insight, and his thinking on topics like exploitation and coercion served to me as a model for what I wanted to do with my life.
Thus it was a true honor to, like Emily, get to know him personally over the last few years. To all the superlatives about him that jump out from the page I can add that in real life he was a real mentsch, an amazing reader and mentor, who I will miss very much.
What is perhaps most impressive about Alan is that he was not only a consummate philosopher’s philosopher, but also a lawyer’s philosopher. A quick search I did for his work in the secondary sources database in Westlaw show 442 separate law papers citing to his work. He has had a significant impact on not only bioethics, but contracts, law and sexuality, constitutional law, and the legal profession. Indeed, as a parting salute to this great thinker let me highlight one of his papers that never achieved the recognition I think it deserved (it inspired some of my own writing): The Equalization of Legal Resources from 1988 in Philosophy and Public Affairs.
Goodbye Alan, you will be missed, but very much remembered.
The German Supreme Court ruled on Wednesday that children of any age (one of the children in this case was 12!) had the right to access the identifying information of their anonymous sperm donor, a major step towards ending sperm donor anonymity in the country. The court rejected the notion of a minimum age on behalf of children, but did require that it be shown that the child requested the information. News reports also suggested that the court indicated that “the private life of the donor must be taken into account,” but not reading German I can’t confirm what the Court meant in this regard (though I suspect the Court was being itself somewhat vague and uncertain). It has been estimated that there are currently 100,000 German citizens fathered by sperm donors with an additional 1,500 to 5,000 born each year.
There is a definite trend in rejecting sperm donor anonymity across the world that continues to gain steam. For reasons I have expounded elsewhere, I think the argument for ending anonymity, and its reliance on best interests of the resulting child reasoning, is problematic. But in other work I have also examined whether increasing compensation for sperm donation may increase the number of men willing to be non-anonymous donors.
(H/T Pablo De Lora)
By I. Glenn Cohen
Many people – non-philosophers especially, but some philosophers as well – loosely use the term “commodification” as an objection to a “taboo trade”. By “taboo trade” I mean the sale of a good or service such as an organ, sperm, egg, surrogacy, prostitution, etc.
This is unhelpful since it means that people often talk past each other and substitute rhetoric for reason.
In my own work I have tried to disentangle various separate objections falling within this family. This is also important in determining what, if any, form of regulation might help combat or minimize the ethical concern. It is also important because it helps us see that some forms of regulation might improve matters as to one of the ethical objections while at the same time worsen matters as to another one of the ethical objections.
For this blog post I wanted to share my taxonomy of ethical objections drawn from a recent paper I did on objections to buying and selling organs and the potential ways various regulatory tools can and cannot be used to deal with them: Regulating the Organ Market: Normative Foundations for Market Regulation, 77 Law and Contemporary Problems (forthcoming Nov 2014) In the paper itself it is set out more formally with supporting citations, here I present just excerpts more informally.
While I illustrate the taxonomy of arguments using the buying and selling of organs, in fact the same categories can be used for any taboo trade (prostitution, selling eggs, commercial surrogacy, etc):
The basic idea behind what I have elsewhere called the “corruption” argument is that allowing a practice to go forward will do violence to or denigrate our views of how goods are properly valued. This argument is sometimes labeled the “commodification” argument, but because that term is also used in a way that encompasses some of the other arguments I discuss below, I prefer the more specific label of “corruption.” The American Medical Association, among others, has voiced this kind of objection in the domestic organ-sale context, suggesting paying kidney donors would “dehumanize society by viewing human beings and their parts as mere commodities.”
We can distinguish two subcategories of this objection, which I have elsewhere called “consequentialist” and “intrinsic” corruption. “Consequentialist corruption” justifies intervention to prevent changes to our attitudes or sensibilities that will occur if the practice is allowed —for example, that we will “regard each other as objects with prices rather than as persons.” This concern is contingent and to be successful must rely on empirical evidence, in that it depends on whether attitudes actually change. By contrast, “intrinsic corruption” is an objection that focuses on the “inherent incompatibility between an object and a mode of valuation.” The wrongfulness of the action is completed at the moment of purchase irrespective of what follows; the intrinsic version of the objection obtains even if the act remains secret or has zero effect on anyone’s attitudes.
2. Crowding Out Continue reading
I have a new paper in a theme issue of Law and Contemporary Problems (one of two, I’ll post the second as well when it is available) titled Organs Without Borders? Allocating Transplant Organs, Foreigners, and the Importance of the Nation State (?) This paper is related to but separate from my work on medical tourism, which has dealt among other things with “transplant tourism,” such as traveling abroad to buy a kidney. In this work I deal with the legally sanctioned distribution of organs. It will surprise many that in the U.S. a non-resident and non-citizen may be listed on the wait list for an organ for transplantation and if he or she is so listed he or she must, as a matter of law, be given the exact same priority as a similarly situated U.S. citizen-resident. Is that policy just or unjust. These are among the topics I tackle in this article. Here is the full abstract:
Most of the discussion of market or non-market forms of allocating and procuring organs takes as its unit of analysis the nation state, or, less commonly a particular state or province, and asks what should the system look like as to this unit. In this article, the second of two articles I contribute to this issue of Law and Contemporary Problems, I want to expand the viewfinder and examine an issue that has received peculiarly little attention in the scholarly and policy discourse: the desirability of treating the nation state (or its subdivisions) as the right level of distribution for organs, whether through market systems or non-market allocation systems. I will show that when we flirt with using a more global viewfinder, a series of difficult (and thus far largely unexplored) ethical and regulatory questions arise relating the inclusion of “outsiders.” At the very end of this article I explore what relevance this analysis may have to allocation within the nation-state as well.A large number of questions could be discussed under this title, but for this article I largely limit myself to two related questions. For both I will use the U.S. as the “home country” for rhetorical clarity, but the basic issues are the same for any home country. The first issue is: Should the U.S. allow “foreigners” to be on the list of those eligible to receive organs in the U.S. when they become available, and, if so, at what level of priority? Surprisingly the current law allows them to be listed to receive organs and if they are so listed it prohibits any discrimination against them for priority based on their being foreign. Second: should the U.S. maintain its own organ distribution network that is limited to the nation state instead of participating in a more globalized system? I should emphasize that my interest here is organs that come to recipients through typical government-run (or at least government-approved) organ allocation systems rather than foreigners who come to U.S. centers and bring their own living donor.
I first describe the two issues and then offer a normative analysis of each. This cluster of issues applies equally to the current U.S. distribution system with its hostility to markets and any of the potential alterations discussed in other articles in this issue of Law and Contemporary Problems. Continue reading
Ed Note: Guest post by Jonathan F. Will
On July 29, 2014 a panel of the 5th Circuit struck down a Mississippi statute that would have effectively closed the only remaining abortion clinic in the state. Just four months ago a different panel of the 5th Circuit upheld a nearly identical statute enacted in Texas. Both statutes require physicians performing abortions to have admitting privileges in local hospitals.
The differing results are unremarkable because both the purpose and effects prongs of Casey’s undue burden analysis are necessarily fact driven. But there are some open questions worth highlighting from the decisions. The Mississippi law raises a matter of first impression. Namely, of what relevance is it, if any, that Mississippi women would have to cross state lines to obtain an abortion if the law was upheld? After all, even if the last abortion clinic closed, Mississippi women would have a shorter distance to travel to obtain such services than some Texas women now have because of the other 5th Circuit decision.
In striking down the Mississippi law, the 5th Circuit cited an Equal Protection case from the 1930s involving racial discrimination, and suggested (at least in part) that Mississippi cannot “lean on its sovereign neighbors to provide protection of its citizens’ federal constitutional rights.” The idea being that if a state cannot rely on a sister state to provide education for minorities, a state likewise should not be permitted to rely on a sister state to provide abortion services. Regardless of my feelings about the outcome of the case, I have to agree with the dissenting opinion of Judge Garza that this analogy doesn’t work very well.
Should litigants in products liability or other litigation be able to subpoena data from clinical trials to help prove their case? Does it matter whether the clinical trial is ongoing, finished recruiting but still analyzing data, or published? Michelle Mello and I have an invited commentary on this issue in JAMA Internal Medicine “Clinical Trials and the Right to Remain Silent” with our analysis and recommendations. We are discussing a real case from Yale where a subpoena was sought for data from a placebo-controlled trial of pioglitazone conducted there, where the person seeking the data had sued the manufacturer and believed she had been injured by pioglitazone but was not a clinical trial participant. In the same issue of JAMA IM, Yale gives its own account about how it handled the case here. Dr. Kernan (the investigator) and I also have a nice interview podcast on the issue.
I have a new article in JAMA this week, “Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men,” co-authored with my former student Jeremy Feigenbaum and my frequent co-author Dr. Eli Adashi (former Dean of Medicine at Brown). In the article we show that FDA’s current policy is morally, ethically, and legally problematic. We are out of step with our peer countries (including the UK, Canada, South Africa) who do delay when men who have sex with men can give blood but not for a lifetime, the way the U.S. does. It is remarkable that if you have sex with a female prostitute or a woman who is HIV+ you face only a 12-month deferral in the U.S. but if you have had sex with a man, just once, ever, no matter his HIV status you face a lifetime delay.
We are in a world where the Defense of Marriage Act was struck down as unconstitutional, where Don’t Ask Don’t Tell has been struck down so that gay men and lesbians can proudly serve their country and shed blood (their own, others) on the battlefield. It is time to change a 30-yr old policy prohibiting them giving blood. What’s more, given the the Windsor decision and the recent Ninth Circuit application of heightened scrutiny to the exclusion of gay jurors for jury duty, we think there are serious constitutional questions about FDA’s policy as well.
My preferred approach, and the one I think FDA should move towards, is the Italian “test and assess” which has no blanket classification of MSM but instead does individualized risk assessment. As we describe in our paper thus far has not increased the risk of HIV+ blood making its way into the blood supply.
The Williams Institute in 2010 estimated that 6% of men had at least once had sex with another man, meaning there are potentially 7.2 million men who could become blood donors but are excluded by FDA’s rule. We owe it not only to these men, but also to all those who could benefit from their blood donations to revisit this rule.
My good friends and co-authors at Simon Fraser University have a nice new website aimed at Canadians (though useful for people from all countries) considering using medical tourism about what to think about, questions to ask, steps to take, etc (Full Disclosure: I participated in a feedback session on the website). Here is a story about the website in the National Post, and here is the website itself.
Update: The Moore Foundation has generously paid to make my article available as open access on their website here. Today I am speaking at Health Affairs’ “Using Big Data to Transform Health Care” in DC, that will also launch its new issue devoted to the topic. I have a co-authored paper in the volume entitled “The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care” that has just been released. Ironically the article is behind a paywall (while data wants to be free, I guess big data is different!) Here is the abstract.
Predictive analytics, or the use of electronic algorithms to forecast future events in real time, makes it possible to harness the power of big data to improve the health of patients and lower the cost of health care. However, this opportunity raises policy, ethical, and legal challenges. In this article we analyze the major challenges to implementing predictive analytics in health care settings and make broad recommendations for overcoming challenges raised in the four phases of the life cycle of a predictive analytics model: acquiring data to build the model, building and validating it, testing it in real-world settings, and disseminating and using it more broadly. For instance, we recommend that model developers implement governance structures that include patients and other stakeholders starting in the earliest phases of development. In addition, developers should be allowed to use already collected patient data without explicit consent, provided that they comply with federal regulations regarding research on human subjects and the privacy of health information.
I will also have a related paper on mobile health coming out later this summer that I will blog about when it comes out…
Yesterday JAMA published a new perspective I co-wrote with Bob Truog and Mark Rockoff “Physicians, Medical Ethics, and Execution by Lethal Injection“. In that article we make the case that the recommendations coming out of the Oklahoma botched lethal injection executions to require physician involvement would force physicians into an untenable medical ethical position. We also argue that it supports a kind of kabuki theater of medicalization, where execution becomes normalized.
Now comes a news report of a Utah lawmaker pushing to give those set to be executed the option of firing squad which he views as more humane than lethal injection. Many people will no doubt recoil at this notion. But here is my intentionally provocative question (and this is on my behalf not my co-authors): If you are in favor of capital punishment, wouldn’t a single close range shot to the head as a form of execution be, in some ways, more defensible than lethal injection? If you recoil at the notion of this being a way of doing execution, have you perhaps fallen for the kabuki theater of medicalization? Why not choose a method of execution that is more honest about the gravity (and perhaps the horror) of what we are doing rather than present something as somewhere on a continuum with sedation?
[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.” This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]
Christopher Robertson is moderating this session.
This session was kicked off by Matthew Lawrence, a Fellow at the Petrie-Flom Center, on “Rationing Justice by Default”. His paper departs from the fact of a huge backlog in Medicare appeals. The question is, if procedural justice is scarce, how do you ration it? Trim procedural protections for everyone? Limit access by a filing fee? Quadruple funding? Lawrence proposes a better alternative: Give full procedural protection to some and none to the rest based on the value that claimants get by from procedure claim, which is heterogeneous. You can then sort the cases via choice architecture. Many Medicare appeals are by large repeat players like the Scooter Store. Beneficiaries appealing is very small. The reasons why we give process lines up quite well to identity of appellant. Fairness, dignity/autonomy, normative legitimacy. The first two of the three probably apply less to the Scooter Store, whose interest is primarily financial. How do you sort? The classical solutions would include: (1) Treating providers differently – but that would discourage assignment, results in inequality, and would be over and under inclusive. (2) Fee for hearing – but leads to externalities since there are public values of process, there are behavioral biases that lead to undervalue process, and perhaps it normatively should be free. His preferred approach: sort with default rule. Maximize the stickiness. Give incentives for sophisticated party to opt into efficiency track. He explained this approach and then considered a set of objections.
[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.” This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]
This panel, moderated by Dr. Neel Shah concerned motivational crowding out.
The first paper, presented by Aditi Sen, was a paper co-authored with Huffman, Lowenstein, Asch, Kullgren, and Volp. The paper examined motivational crowding out from incentive payments in the weight loss context. They measured motivation via a survey administered before and after the introduction of financial incentives in two weight loss field experiments and found no evidence that intrinsic motivation fell when participants were given financial incentives as compared to controls.
The second paper, by Kristen Underhill, went deep into the theory of motivational crowding out. The article reviews the existing literature and shows how sloppily the notion of crowding out is used. She offers 9 different dynamics of crowding out and discusses which have been validated when. She then offers a framework for thinking about when regulatory interventions are justified focused on autonomoy, behavioral outcomes, and the principal and beneficiary of the incentive scheme. The goal of the project was to offer “incentive architecture” techniques for regulators and guidance as to when they are appropriate.
The audience questions include: in what contexts do crowding out occur or not and how woudl we predict? Tax incentives as an example of the relevant incentives? Does motivational crowding out varies with SES? Do the empirical results apply more to moralized behavior like smoking and weight loss than others, and other topics?
I am at a fantastic event at Yale I co-organized on Intersections in Reproduction: Perspectives on Abortion, Assisted Reproductive Technologies, and Judicial Review with some amazing scholars present and excellent papers being presented. Like many people who have thought about sex selection, I would have imagined I have thought through most of the issues from most perspectives. What I love about these gatherings is that they always prove me wrong.
Today two very interesting questions were raised about a common argument raised about sex selection, the risk that it will result in unbalanced sex ratios. Our discussion, I would say, “queered” the typical claim in two interesting ways, and I am curious what others think (to be clear these were my thoughts on questions raised, not putting words in their mouths).
[Note: This post is meant to be provocative and press a public policy question in the most thought-provoking way possible. Losing a loved one is among the most heart-wrenching experiences in a life time and my heart goes out to all those with loved ones on the flight waiting for answers. But one of the major points of this post is to highlight our tendency to spend more on identified lives not statistical ones for just these kinds of reasons and ask if it is justified.]
The search for Malaysia Airlines Flight MH370 is likely run to “Hundreds of Millions of Dollars” according to the most recent estimate from ABC News. This is based on extrapolation of the difficulties involved and the experience of searching for Air France 447 which cost 50 million USD. Let’s take a conservative estimate of 100 million USD to find the plane, probably on the low end. Let us put aside the possibility that even with that expenditure the plane will never be found, again an assumption that counts against the argument I will be making. This is 100 million dollars spent, roughly speaking, on “helping.” It is very unlikely that there are any survivors, so I don’t think this can reasonably be thought of as “life-saving” (I will assume it is not, but if it were that wouldn’t make that much of a difference in the argument I will offer though it will require confronting the question of Should the Numbers Count for life saving?).
Instead the money is being spent (1) to satisfy the somewhat diffuse curiosity/grief of those who have watched this in the media, (2) to give answers to the very deep need for closure of the loved ones of those flying on these planes, and (3) to learn about what went wrong and potentially determine whether there is a systemic problem with these planes that might affect other planes.
All of those are worthy goals. But are they worth 100 million USD? In the category of “helping” or “life-saving” what else could we do with the money? Let me draw on one estimate mentioned by Ezra Klein in the WaPo and Don Taylor at the Incidental Economist from a paper by Tammy Tengs “Five Hundred Life Saving Interventions and Their Cost Effectiveness“
I chose the cheapest intervention, influenza vaccines for children age 5+ which is estimated to cost $1,300/life year saved in 1993 dollars. I then updated that to 2013 dollars with a conversion calculator to generate a cost of 1915.89 USD per life year saved (it may also be that this intervention is now cheaper than it was at the time of Teng’s paper). I then divided 100 million dollars by that number to get my 52,192 life years saved for children estimate. That is fairly back of the envelope and there are lots of tweaks you would do to get a more exact figure, but it is close enough to make the point: Why are we spending so much on Malaysia Airlines search when we could be saving so many lives?