Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate

This new post by I. Glenn Cohen appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

In 2013 the Center for Medical Progress appeared to have secured tax-exempt status for a fake company it set up called Biomax Procurement Services. The company’s “representatives” contacted the non-profit women’s health provider Planned Parenthood staffers and led them into conversations that were secretly recorded. The result, according to their website (as reported by CNN), was “a 30-month-long investigative journalism study by The Center for Medical Progress, documenting how Planned Parenthood sells the body parts of aborted babies.”

The videos were edited down and released slowly in a way designed to paint Planned Parenthood in the worst light. While some have called it a “hoax,” that’s not a word I would use in this case. When I think of great journalistic hoaxes I think of Orson Welles’s War of the Worlds (though more recent historical work suggests that the panic it caused may have been mythological). Instead what happened here, I want to suggest, is what I will call a “manufactured controversy.” [..]

Read the full post here.

Some Very Preliminary Thoughts on Whole Women’s Health v. Hellerstedt (Texas Abortion Case) Argument

By I. Glenn Cohen

It is always dangerous to try to glean too much from oral argument, and I have only read the transcript (no recording yet) of today’s argument in Whole Women’s Health v. Hellerstedt, and finally I filed a brief in this case on the side of the law’s challengers so I may be suffering from some motivated reasoning. But with all those caveats, here goes:

Justice Scalia’s passing seems to have radically transformed this oral argument and likely this case. The 3 firm anti-abortion votes on the court (Alito and Roberts from their questions and earlier positions, Thomas we can infer from his earlier positions) left over after Justice Scalia’s passing seemed very much to be playing a defensive game. Many of their questions were aimed at convincing others on the Court (especially Justice Kennedy, the swing voter on these matters) to remand the case back to the lower court, much more so than focusing on giving Texas an outright win.

Appellant’s Counsel Toti’s argument barely was able to get to the merits questions in the case. Instead Justices Roberts, Alito, sometimes joined by Kennedy in these questions, repeatedly asked about evidence in the record on when various clinics closed, re-opened, and what evidence there was for the reason behind it. Toti tried to make use of the timing to her advantage as did the Justices more supportive of her side, but there was a lot of push on why this element of the record was not better developed. She was also repeatedly asked questions regarding the evidence on the capacity of remaining clinics to absorb extra patients needing abortions and what was developed in the record.

The same was true to a lesser extent in Appellee’s Counsel Keller’s argument. Justice Kennedy in particular focused on a line of questioning at page 44 of the argument that may also be significant in terms of remanding the case without resolving it:

“But I thought an underlying theme, or at least an underlying factual demonstration, is that this law has really increased the number of surgical procedures as opposed to medical procedures, and that this may not be medically wise?” Continue reading

Does the NAM Recommendation of Sex Selection for Mitochondrial Replacement Therapy Violate the Equal Protection Clause (Part III on my take on the NAM report)

As I said in one of my earlier posts today one of the most interesting parts of the NAM report on mitochondrial replacement therapy was its recommendation that only male embryos be implanted and not female ones. The argument is that this will eliminate the risks of germ-line transmission of anything untoward. I will leave it to others more versed in the risk factors to discuss whether this is an over-reaction (the UK did not adopt this in their recommendation) or reasonable. In the last post I discussed why politically/ethically this may get them in some hot water, but here  I want to raise a different question. Would such a recommendation be unconstitutional?

If FDA were to adopt this rule it would clearly be state action. It seems to be a state-law that favors one gender (males) over another (females) in that only males can be produced in this way. If that is right, under existing Supreme Court precedent it would be judged under “intermediate scrutiny.” To pass intermediate scrutiny, the challenged law must further an important government interest by means that are substantially related to that interest. Would this rule satisfy that test? Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part II My First Take)

By I. Glenn Cohen

My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Continue reading

Identified versus Statistical Lives at the Movies

Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.

sq_martianFirst, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Continue reading

Mini-Symposium: The NPRM and the Future of Human Subjects Research Regulation

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.

NPRM Summary from HHS

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

FDA’s Non-Response Response to My New York Times Op-Ed on Gay Blood Ban

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.

Well FDA responded…sort of … through a NY TImes Letter To the Editor.

Here is what FDA said with my analysis in bold:

Continue reading

Defending Scott Walker on Not Exempting Abortions for Rape and Incest

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

Faculty Director I. Glenn Cohen: New Blood-Donor Policy, Same Gay Stigma

Faculty Director I. Glenn Cohen has co-authored a new Op-Ed in the New York Times:

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.

Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?

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

Remembering Alan Wertheimer: Not Only a Philosopher’s Philosopher but a Lawyer’s Philosopher

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.

German Supreme Court: Children of Any Age Have Right to Access the Identity of Their Anonymous Sperm Donor

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)

 

What’s Wrong with Selling Organs (and a Taxonomy of Taboo Trade/Commodification Objections)

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):

1. Corruption

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

Should Foreigners Be Allowed to Be Listed for U.S. Organs and Other Questions about Organs Without Borders

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

MS Admitting Privilege Law Struck Down by 5th Circuit

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.

Continue reading

When Should you Be Able to Subpoena Clinical Trial Data? “Clinical Trials and the Right to Remain Silent” in JAMA Internal Medicine

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

When you Can Shed Blood for your Country but not Donate it

Portsmouth, Va. (Jan. 5, 2005) - A hospital corpsman assigned to USS Bataan (LHD 5), donates a pint of blood during the blood drive held by the Blood Donor Team. The Blood Donor Team stationed at Portsmouth Naval Hospital visits multiple commands throughout the area in efforts to boost the blood supply for the U.S. Armed Forces around the world. U.S. Navy photo by Photographer’s Mate 3rd Class Jeremy L. Grisham (Image from Wikimedia Commons).

A hospital corpsman donates a pint of blood. U.S. Navy photo by Photographer’s Mate 3rd Class Jeremy L. Grisham (Image from Wikimedia Commons).

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.

New Medical Tourism Website with Info for Patients

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.