Fall Facebook/OKCupid and Future of Research Tour

Sept. 18 Tweet ChatI’m participating in several public events this fall pertaining to research ethics and regulation, most of them arising out of my recent work (in Wired and in Nature and elsewhere) on how to think about corporations conducting behavioral testing (in collaboration with academic researchers or not) on users and their online environments (think the recent Facebook and OKCupid experiments). These issues raise legal and ethical questions at the intersection of research, business, informational privacy, and innovation policy, and the mix of speakers in most of these events reflect that.

The first, and most accessible, is a “tweet chat” today, from 1-2 p.m. EST, on “Research Ethics in a Modern World.” It’s being sponsored by the Milken Institute’s FasterCures, “an action tank driven by a singular goal — to save lives by speeding up and improving the medical research system.” Other participants are Susannah Fox (RWJF’s first Entrepreneur in Residence), John Wilbanks (a very interesting guy whose work, largely on empowering patients and research participants to share their data in ways that are consistent with their values, and bio defy concise description), and Margaret Anderson (FasterCures’s Executive Director).

Likely discussion topics include the impact of social media on research and research ethics; the ethics of A/B testing and similar behavioral testing of user environments (i.e., websites) by corporations, and who should be empowered to conduct research risk-benefit analysis (patients/participants? scientists? legal systems?). You don’t need to have a Twitter account to read the conversation, either as it unfolds in real time or at any time thereafter. Just point your web browser to this URL. But to ask a question or otherwise participate in the discussion (which is encouraged!), you do need a Twitter account.

On October 22, I’ll be at Harvard Law participating in a panel discussion of the Petrie-Flom Center’s latest anthology, “Human Subjects Research Regulation: Perspectives on the Future,” with Glenn Cohen, Holly Fernandez Lynch, and Barbara Bierer.

On December 4, I’ll be at Colorado Law participating in a day-long conference, “When Companies Study Their Customers: The Changing Face of Science, Research, and Ethics,” sponsored by the Silicon Flatirons Center for Law, Technology, and Entrepreneurship and the Tech Policy Lab at the University of Washington. Other participants include law profs Paul Ohm, Ryan Calo, and James Grimmelman, Princeton Center for Internet Technology Policy Director Edward Felten, FTC Commissioner Julie Brill, and UT-Austin psychologist Tal Yarkoni.

On December 5, I’ll be in Baltimore participating in a Meet the Authors lunch event at the annual PRIM&R conference with the editors and several other contributors to the aforementioned book.

And on December 6, I’ll be participating in a PRIM&R session on “Manipulating Emotions on the Internet: The Cases of Facebook, OkCupid,” with OHRP Director Jerry Menikoff, privacy and Internet research ethics scholar Michael Zimmer, and Berkeley Director of Research Subject Protection Rebecca Armstrong.

On April 13, I’ll be giving a seminar at Wharton in the Legal Studies and Business Ethics Speaker Series, in which I may present something related to these themes.

Many thanks to the organizers for including me in these very interesting events (interesting least of all due to my inclusion, needless to say), and I hope to see some readers at some of them.

The Expressive Dimension of Donor Deferral

By Dov Fox

The Guardian and L.A. Times are the latest major news organizations to decry trans-Atlantic restrictions on blood donation by men who have sex with men (MSM). The case against such categorical bans has been reignited by an influential piece that Bill of Health editor Glenn Cohen recently published with co-authors Jeremy Feigenbaum and Eli Adashi in the Journal of the American Medical Association. Cohen, Feigenbaum, and Adashi make a powerful case why sexual orientation should be just one component among others used to assess the risk that blood donors might spread HIV.[i]

But their argument elides exactly what is—and isn’t—wrong with excluding men who have sex with men from donating blood. At times they suggest the longstanding U.S. ban reflects “outdated homophobic perceptions.” Yet they acknowledge that it was “well-intentioned and guided by a need to protect the integrity of the national blood supply.” Indeed, the Food and Drug Administration that enacted the lifetime MSM ban solicited guidance from the National Gay Task Force whose recommendations were adopted into Red Cross blood collection procedures.[ii] It’s unlikely the policy was motivated by animus as opposed to concern for public health.

Elsewhere, the authors imply the policy’s chief offense is that it deprives MSM of a crucial “civic opportunity.” But giving blood, even if it shares the life-saving potential of military service and registration as an organ donor, is not typically regarded as a duty of citizenship tantamount to voting or jury service.[iii] So it’s not its effects on those it excludes that makes the donor ban so bad.

The best reason to let low-risk gay men give blood lies in the demeaning message that excluding them expresses, what I’ve called the expressive dimension of donor deferralContinue 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.

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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.

Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

Human Subjects Research Regulations Book CoverThe Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch.  This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

The book is currently available from MIT Press and Amazon, in hardcover and paperback.  We will be hosting a book discussion at Harvard Law School on October 22, and in Baltimore on December 5 at Public Responsibility in Medicine and Research (PRIMR)’s annual Advancing Ethical Research Conference.  Details will be announced shortly.

 From the book jacket:

 The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.

After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.

Contributors
 Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf

For a more information, including the full table of contents, check out the book on the MIT Press website

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.

Big Data, Predictive Analytics, Health Care, Law, and Ethics

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…

Religious Freedom and Access to Health Care

SCOTUSfrontCheck out the “hot off the press” New England Journal of Medicine Perspectives piece “When Religious Freedom Clashes with Access to Care” by Petrie-Flom Faculty Director I. Glenn Cohen, Executive Director Holly Fernandez Lynch, and NEJM Executive Editor (and PFC Faculty Affiliate), Gregory Curfman.  We review the legal background for SCOTUS’ Hobby Lobby decision, summarize the majority and dissenting opinions, and clarify some key implications of the case, including further problematization of the employer-based health insurance system, reduced likelihood of future attempts to offer religious exemptions to health care mandates, and expanded religious challenges in the health care space.  We close by noting that although the public’s ire and praise has been directed at the Justices, they were applying Congress’ statute – and Congress could (but is very unlikely to) amend the Religious Freedom Restoration Act to be less stringent, or otherwise intervene to ensure that women have affordable access to contraceptive services regardless of their employer’s beliefs.

Take a look and let us know what you think!

Using Big Data To Transform Care: A Briefing on the July 2014 Special Issue of Health Affairs

HealthAffairsJournal

Register online now!

The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless.  The July 2014 issue of Health Affairs, “Using Big Data To Transform Care,” examines this new era for research and patient care from every angle.

You are invited to join Health Affairs Editor-in-Chief Alan Weil on Wednesday, July 9, for an event at the National Press Club, when the issue will be unveiled and authors will present their work.  Panels will cover:

  • Using Big Data At The Point Of Care
  • Research Issues
  • The Role Of The Federal Government
  • Obstacles/Challenges Of Using Big Data

Among the confirmed speakers are:  Continue reading

I. Glenn Cohen Discusses Ethics of Medical Personnel Involvement in Executions

cohen_talking_peoplePetrie-Flom Faculty Director I. Glenn Cohen appeared on The Rachel Maddow Show last night to discuss his recent opinion piece in JAMA, coauthored with Robert D. Truog and Mark A. Rockoff (both of Harvard Medical School), on “Physicians, Medical Ethics, and Execution by Lethal Injection.” In the piece, Cohen et al. argue that medical specialty boards should withdraw board certification from members who participate in executions.

From the interview:

…we think it [execution] is totally incompatible with the role of the doctor. A doctor is about healing. A doctor is about soothing pain. A doctor is not meant to be conscripted by the state to make what is the involuntary killing of another person look as though it’s a medical procedure, like getting your teeth pulled or putting your dog to sleep. It’s kabuki theater, Rachel, and we think doctors should stand up. Whatever your position is on capital punishment, it’s wrong to make this procedure look like medicine. That’s not what it is. [...]

Watch the full interview.

Doctors, Lethal Injection, and Firing Squads

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?

New op-ed on doctors and the death penalty, coauthored by I. Glenn Cohen

Petrie-Flom Faculty Director I. Glenn Cohen has coauthored a new opinion piece now available through JAMA, “Physicians, Medical Ethics, and Execution by Lethal Injection.” From the article:

In the wake of the recent botched execution by lethal injection in Oklahoma, however, a group of eminent legal professionals known as the Death Penalty Committee of The Constitution Project has published a sweeping set of 39 recommendations that not only tinker with, but hope to fix, the multitude of problems that affect this method of capital punishment.

Many of the recommendations this committee makes with regard to legal and administrative reforms appear worthwhile and reasonable. Their final recommendation, however, concerns the role of the medical profession in performing lethal injection. It states: “Jurisdictions should ensure that qualified medical personnel are present at executions and responsible for all medically-related elements of executions.”

In particular, the recommendation specifies that “Execution team members…are licensed, practicing doctors, nurses or emergency medical technicians who are responsible for performing functions in their day-to-day practice that are similar to those they will perform at the execution.” Regardless of this committee’s recommendations, physician participation in capital punishment is an ethical dilemma that the profession of medicine must address.

Read the full article.

Michael Jackson and Emotional Damages

by Dov Fox

You know the King of Pop died in 2009 while rehearsing for a comeback tour in London. Here’s a twist you may not have heard about: Michael Jackson fan club members sued Conrad Murray, the doctor who administered the lethal overdose of anesthesia. And the celebrity enthusiasts won. A French court recently awarded five of the grieving fans economic damages (albeit just a euro each) to compensate for their emotional suffering.

The case highlights a neglected problem in our own law, not just medical malpractice, but constitutional and common law too. It’s this: Supreme Court rules and policies about harm, compulsion, and intentionality rely on the flawed assumption that operations of the mind are meaningfully distinct from those of the body. In our new essay on Dualism and Doctrine, Alex Stein and I (1) demonstrate just how this fiction distorts the law, (2) argue that the reasons for its persistence cannot save it, and (3) identify the ways in which courts should uproot dualism’s pernicious influence on our legal system. Continue reading

#BELHP2014 Panel 2, Potential Problems and Limits of Nudges in Health Care

[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.]

By Matthew L Baum

In this next installment of today’s live-blogging of the conference (and with all of the caveats of live-blogging mentioned by my colleagues and my apologies for any errors or misrepresentations) we have Professors David Hyman (DH), Mark White (MW) and Andrea Freeman (AF) in a panel moderated by Glenn Cohen (GC) on the “Potential Problems and Limits of Nudges in Health Care”.

The panel began with DH, H. Ross & Helen Workman Chair in Law and Director of the Epstein Program in Health Law and Policy, University of Illinois College of Law, and a talk entitled, “what can PPACA teach us about behavioral law and economics” (Patient Protection and Affordable Care Act). DH began with the observation that nudges often work quite well… “unless they don’t”. While many nudges are “sticky”, i.e. they influence behavior in the way they were intended, others are “slippery”, i.e. they fail to influence behavior in the way they were intended. His talk set out to illustrate the phenomenon, and to pose two questions. The first was an empirical question: what makes a nudge sticky vs slippery? The second was philosophical: is it meaningful to talk about a “failed nudge” or when we do, do we really just mean failed marketing? He focused on an analysis of PPACA as a case study.

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New Joint Project on Law and Applied Neuroscience

The MGH Center for Law, Brain and Behavior and Harvard Law School’s Petrie-Flom Center announce joint “Project on Law and Applied Neuroscience” for 2014-2016

The MGH Center for Law, Brain and Behavior and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will collaborate on a joint venture – the Project on Law and Applied Neuroscience – beginning in Fall 2014. The collaboration will include a Senior Fellow in residence, public symposia, and an HLS Law and Neuroscience Seminar.

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Sex Selection or Gender Selection? Queering the Ratio Question

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).

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CONFERENCE – CLASHING RIGHTS & REPRODUCTIVE AUTONOMY

Join us at Northeastern University School of Law at 1 p.m. on April 25, 2014 as leading academics and practitioners discuss the tensions between free speech and reproductive rights.

For more information, see http://www.northeastern.edu/law/academics/institutes/health-law/events/clashing-rights/

Twitter Round Up

This week’s twitter round up features a variety of topics from our contributors, from discussions about health care spending and the Affordable Care Act to articles about environmental poisoning of soldiers in Iraq.

  • Amitabh Chandra tweeted that “Healthcare spending growth hits a 10yr high… so much for ‘ACA is bending the cost curve’” and shared an article from USA Today.
  • Frank Pasquale shared a blog entry by Larry Backer about Pennsylvania State University students’ worries about the rise of health care costs.
  • I. Glenn Cohen shared a link to an article in The New York Times entitled “‘Environmental Poisoning’ of Iraq Is Claimed” and states that many veterans suffer from environmental poisoning while the “IOM [is] not sure.”
  • Kate Greenwood retweeted Austin Frakt and an article from The Incidental Economist about the negative impact of the insurance market before the implementation of the Affordable Care Act on entrepreneurship.
  • Stephen Latham tweeted a link to his blog reporting on the recent announcement of the Public Health Committee of the Connecticut Legislature that it does not plan to vote on a bill addressing “Aid-In-Dying” or physician-assisted suicide despite “61% public support for the bill.”