Tobacco and Dietary Supplements – The Role of the FDA

By Joanna Sax

Thank you for inviting me to blog.  Later this week, I’ll be attending Harvard Law School’s Petrie-Flom Annual Conference on the FDA in the 21st Century.  My paper/presentation addresses the role of the FDA in the regulation of dietary supplements.  By way of preview, my paper compares similarities between the dietary supplement industry and tobacco.  Both industries have successfully avoided heavy regulation by the FDA. 

A tension exists between the personal choice/autonomy to use a variety of dietary supplements with the actual or potential health danger.  With the current light-handed regulation, costs for dietary supplements are much lower than they would be if they had to be approved by the FDA prior to market.  Some consumers believe that if a product says it is ‘natural’ then it must be safe.  This, however, is not necessarily true.  Would you eat any wild plant or mushroom just because it is natural?  I hope not.  In recent years, a number of adverse events, including death, have been shown to be correlated or caused by use of dietary supplements. 

It seems that some of the tactics employed by the tobacco industry to avoid regulation are similar to tactics employed by the dietary supplement industry.  My paper/presentation addresses what lessons we can learn from the tobacco industry to analyze if the FDA should be granted the authority to increase the regulation of the dietary supplement industry.  I hope to see you all in Boston.

Introducing Joanna Sax

We’re excited to introduce and welcome Joanna Sax as a guest blogger for the month of May.

Joanna is an Associate Professor of Law at California Western School of Law.  She teaches Contracts, Trusts & Estates and a seminar entitled Law, Science & Medicine.  Her main area of research is biomedical policy; specifically, how to create incentives to advance scientific research and protect scientific integrity.  In this area, Joanna has recently focused on issues such as financial conflicts of interest and the relationship of politics and science.  Another area of interest is FDA regulation; Joanna will be presenting at the upcoming conference on the FDA in the 21st Century hosted by Petrie-Flom.  Prior to focusing her research interests on the intersection of law and science, she was a molecular biologist and spent years researching cancer.

Joanna attended the University of Wisconsin – Madison, where she earned a B.S.  After undergraduate school, she was a pre-doctoral fellow at the National Cancer Institute.  In 1999, following her fellowship, she began a PhD program in Cell and Molecular Biology at the University of Pennsylvania School of Medicine.  In 2003, after earning a PhD, she entered law school at the University of Pennsylvania.  After law school, she spent 2 and a half years as an attorney at Morgan, Lewis & Bockius, LLP.  In 2009, Joanna joined the faculty at California Western School of Law.

Some of Joanna’s recent publications include:

Welcome, Joanna!

Blackjack and Cognitive Enhancement

Blackjack players who “count cards” keep track of cards that have already been played and use this knowledge to turn the probability of winning in their favor. Though many casinos eject card counters or otherwise make their task more difficult, card counting is perfectly legal. So long as card counters rely on their own memory and computational skills, they have violated no laws and can make sizable profits.

By contrast, if players use a device to count cards, like a smartphone, they have committed a serious crime. For example, several iPhone apps helps players count cards and at least one has a “stealth mode” that lets users surreptitiously enter data and receive feedback. In response, the Nevada Gaming Control Board issued an open letter reminding the public that using such an app when betting at blackjack violates the state’s antidevice statute which provides for up to 6 years imprisonment for a first offense. Somehow using a device to augment our abilities to remember and to calculate turns a perfectly legal activity into an offense with a very serious penalty.

The fact that we do not criminalize natural, unassisted card counting raises interesting questions of criminal and constitutional law: Could we criminalize natural card counting without violating fundamental principles that protect thought privacy? (Email me for a manuscript on that question.) In this recently published paper, however, I focus on a puzzle about technological enhancement. Namely, can we justify criminalizing device-assisted card counting but not unassisted card counting?

The importance of the question extends beyond the world of blackjack and casino gaming because it appears, at least superficially, that antidevice statutes criminalize a kind of technological enhancement. Some ethicists distinguish therapies that seek to return us to normal, healthy functioning from enhancements that promise to give us extraordinary abilities. People are often much more comfortable with therapies (e.g., drugs or devices to treat attention deficit disorder) than with enhancements (e.g., drugs or devices to give us better-than-normal concentration).

As a historical matter, casinos lobbied for antidevices statutes in the 1980s to protect their revenue as computers were becoming more popular and accessible. I focus on a deeper question: Is there any moral justification for permitting an activity, like card counting, when it uses only our natural abilities but severely punishing the activity when it is technologically enhanced? I consider a couple of possible justifications for the differential treatment and suggest that both are lacking.

[Adapted from Criminalizing Card Counting at the Blackjack Table; Originally posted at Prawfsblawg]

May 22 (note new date): Dan Brock delivering the Gay Lecture on “The Future of Bioethics”

Please join the Division of Medical Ethics for:

The 2013 George W. Gay Lecture in Medical Ethics

Dan W. Brock, PhD
Frances Glessner Lee Professor of Medical Ethics, Department of Global Health and Social Medicine, HMS

“The Future of Bioethics”
Wednesday, May 22, 2013 (note new date)
4:00 PM

Harvard Medical School, Tosteson Medical Education Center

Carl W. Walter Amphitheater
260 Longwood Avenue, Boston

Please pass this invitation along to other interested friends and colleagues.

The George W. Gay Lecture is the oldest endowed lectureship at Harvard Medical School, and quite possibly the oldest medical ethics lectureship in the United States. The lectureship was established in 1917 by a $1,000 gift from Dr. George Washington Gay, an 1868 graduate of HMS. Since its inception, many of the nation’s most influential physicians, scientists, researchers and social observers, including Erich Fromm, Felix Frankfurter, Margaret Mead, Elizabeth Kübler Ross, E.O. Wilson, and Joshua Lederberg have given the Gay Lecture. Elie Wiesel, Marian Wright Edelman, Paul Krugman, Nicholas Kristof and Donald Berwick have given recent Gay Lectures.


The High Price of Drugs – and Why Doctors Should Care

By Ryan Abbott

A few days ago, a group of more than 100 experts in chronic myeloid leukemia (CML) published an article in the medical journal Blood to draw attention to the prices of anti-cancer drugs and the effects of these prices on individual patients.

The authors note that three new drugs were approved by the FDA for CML in 2012, all of which were priced at “astronomical levels.” Of the 12 anti-cancer drugs approved by the FDA last year, 11 were priced above $100,000. This represents a doubling of prices from a decade ago. The authors claim that these prices “are too high, unsustainable, may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national healthcare systems.”

The cost of medicines is a controversial issue. Proponents of allowing the pharmaceutical industry to set its own prices argue that high prices are needed to incentivize new drug development. According to PhRMA, the cost of new drug approval is around $1.2 billion, although some independent experts put that price as low as $75 million. Yet, whatever the benefits of high prices, it is clear that high prices create a barrier to patient access to medicines.

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More on NSF and NIH Funding

By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been.  It seems to reflect a terrible paradox:  on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.


Petrie-Flom Interns’ Weekly Round-Up: 4/20-4/26

By Hyeongsu Park and Kathy Wang

  • Harvard University announced on Wednesday that it would shut down its primate research center over the next two years. The facility has been cited for animal welfare violations, but the university said that it was closing the research center due to a tough economic climate.
  • After a federal judge recently ordered the Food and Drug Administration to make the morning-after pill available to women of all ages without a prescription, a New York Times article discusses a broader issue that follows: whether birth-control pills should require a doctor’s prescription. Various groups, gynecologists, and politicians are sharply divided on this issue. The author discusses procedural hurdles and safety issues around making the morning-after pills over-the-counter drugs.
  • Utah recently became the first state to explicitly permit general prisoners (not death-row inmates) to donate their organs if they die while incarcerated. The New York Times introduces discussions among various academic and health professionals regarding the law allowing prisoners to become organ donors.
  • After Colorado voters approved a measure in November legalizing small amounts of marijuana for recreational use, Colorado legislators will discuss taxes on marijuana and the plan to use the tax revenues this week. The legislators are considering excise and sales taxes on marijuana of up to 30 percent combined. The goal is to set taxes high enough to finance the administration of new laws, but not so high that customers are driven back to the black market.
  • A group of Texas optometrists is lobbying the State Legislature for more power to negotiate contracts with health insurance companies, and the measure they support could hit consumers’ wallets.
  • British antitrust authorities accused the pharmaceutical giant GlaxoSmithKline of paying three rivals to delay the introduction of a generic version of antidepressant drug.
  • A Pennsylvania judge on Tuesday threw out three of seven murder charges against Dr. Kermit Gosnell, who was charged with killing viable fetuses while performing abortions.

Replies to the Organ Conscription Trolley Problem

Yesterday, I argued for more aggressive efforts to boost the supply of cadaveric organs available for transplant: If an out-of-control trolley were heading toward a living person strapped to the tracks, we surely ought to divert it to another track, even if doing so will crush a corpse along the alternate path. If we are permitted to crush a corpse when it’s the only way to save a life, even if the family of the deceased doesn’t want us to, then we can recover organs from the deceased when the invasion is fairly minimal (it won’t interfere with burial) and the gains are not one life but several. I emphasized an important qualification, however: we are not permitted to just take organs when we can obtain consent with less invasive approaches, like offering financial or priority incentives.

Commenter SG raised questions about whether trolley problems do a good job of testing our intuitions. There is certainly a lively debate about the reliability of trolley problem intuitions and the reliability of moral intuitions more generally. Despite pitfalls, I believe trolley problems can help us abstract away  morally irrelevant considerations. A family considering donation, for example, doesn’t know whose lives are in the balance. But we know that as a matter of policy, many lives end prematurely because lifesaving organs are wasted. Therefore, the trolley problem I posed helps us removes distractions and confront the loss of life more directly.

Commenter Mitch proposed a variation: Suppose the deceased on the alternate track is your recently-deceased loved one.  I have two replies: First, we need not frame the problem that way in order to draw conclusions about organ donation policy. The destruction of the corpse will be very upsetting to the family, but when we decide public policy, we typically abstract away from who our particular loved ones are. It would bias my hypothetical to stipulate that the living person is your relative, and it would bias the opposite way to assume the deceased was.

Second, even if the trolley problem were posed in this  fashion, you should still flip the switch if it’s the only way to save a living human. (Perhaps families should be excused from blame given that they must  decide under pressure while grieving, but that’s another matter). Interestingly, medical examiners frequently conduct autopsies in which consent is irrelevant. Some of these investigations may save lives by preventing murders. But organ donation is plausibly much more lifesaving than medical investigation.

One last point: It’s easy to think that our choices are to give up our organs or have them stay intact forever. Perhaps mandatory autopsies are viewed as different than conscripted donation because autopsies do not involve a prolonged “using” of someone’s organs. But the “using” happens either way. Your organs can be taken over by bacteria and insects or they can go to save living people. If we were better able to come to terms with such unpleasant facts, we’d more effectively save and heal the living.

[Originally posted to Prawfsblawg]

A Tale of Two Polities

By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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The Organ Conscription Trolley Problem

Yesterday, Glenn discussed paying people to donate nonessential organs while they are alive. I will argue that we ought to more aggressively incentivize organ donations from the recently deceased.

Imagine that an out-of-control trolley is heading toward an innocent person who is for some reason strapped to the trolley tracks. You happen to be standing near a switch that can divert the trolley to a different track and represents the only available means of saving the person. Here’s where this trolley problem gets much easier than others you’ve seen: If you divert the trolley, it will unavoidably crush the body of an already-deceased person who is strapped for some reason to the diversion track. Are you morally permitted to flip the switch to save a life when doing so will crush a deceased person? Clearly you are. Indeed, you are morally obligated to do so.

What if the family of the deceased is standing nearby and urges you not to, pleading that if their loved one’s remains are crushed, it will interfere with his religious preferences about burial? No matter how much it upsets the family and would have upset the deceased, you are  permitted to divert. Now what if diverting  would save not one life but six or seven? And what if the trolley wouldn’t crush the deceased beyond recognition but would merely cause some internal change that would be invisible at burial? Surely the answers only become easier.

If you’ve answered as I have, we should be permitted to take the organs from the recently deceased when doing so represents the only way of saving the six or more people who need those organs to survive. Does this mean we should implement a routine salvage program where people must donate if they die with organs available for transplantation? Not necessarily. There may be financial or priority incentives that will induce sufficent donation such that we don’t have to go so far as to conscript lifesaving organs. But our current practices cause far to much unnecessary death and misery. See here and here for more. [Originally posted at Prawfs]

Impact of the “Lander Brief” in the Myriad Case – and an answer to Justice Alito’s Question

 [Cross posted at]

The Supreme Court heard oral arguments on April 15 in Association of Molecular Pathology et al. v Myriad, concerning whether human genes are patent-eligible subject matter. The case focused on Myriad’s patents on two genes, BRCA1 and BRCA2, involved in early-onset breast cancer.

Surprisingly, many of the Court’s questions for Myriad’s counsel focused on what Justice Breyer dubbed the “Lander Brief” – an amicus filed on behalf of neither party by one of the country’s leading scientists, Dr. Eric Lander. (Lander was one of the leaders of the Human Genome Project and co-chair’s the Presidents Council of Advisors on Science and Technology.) [Full Disclosure: I am one of the authors of this brief.] Justices Breyer, Ginsburg and Alito referred to the brief by name, and several other Justices were clearly influenced by the information in the brief.

I believe that the “Lander brief” was a hot topic of conversation because the Justices realized that it was central to applying the Court’s product-of-nature doctrine to DNA. Importantly, the brief demolished the scientific foundation of the Federal Circuit decision on appeal. The Federal Circuit panel held that human chromosomes are not patent-eligible because they are products of nature, but a majority found that “isolated DNA” fragments of human chromosomes (such as pieces of the breast cancer genes) are patent-eligible. The Federal Circuit’s distinction rested on its assumption that (unlike whole chromosomes) isolated DNA fragments do not themselves occur in nature, but instead only exist by virtue of the hand of man. Continue reading

Post-doc/Instructor Positions in Medical Ethics at NYULMC

The Division of Medical Ethics at the NYU Langone medical Center seeks to recruit two persons either as post-docs or instructors.

Applicants must demonstrate an excellent record of quality scholarship and teaching, and must have a PhD, JD, or MD. Successful applicants will be expected to demonstrate a strong scholarly career track in a sub-field of medical ethics/bioethics. The Division is especially interested in persons with research interests in neuroethics, reproductive technologies and ethics, public health ethics, transplantation ethics and mental health ethics. Continue reading

Department of Social Science, Medicine & Health, King’s College London: POSTGRADUATE BURSARIES 2013-14

The Department of Social Science, Health & Medicine invites applications from candidates wishing to pursue Masters programmes, starting from September 2013:


The MA in Bioethics & Society is a new postgraduate programme that is jointly taught with the Centre of Medical Law and Ethics at King’s. The programme gives particular emphasis to addressing bioethical questions in ways that integrate conceptual and normative analysis with empirical research. Students will also study the history and sociology of bioethics and have the opportunity to obtain training in empirical research methods.


This interdisciplinary and novel Master’s programme is designed to develop a new generation of thinkers and policy makers that have high level skills in the critical analysis of the social and political determinants of health and its inequalities in a global context as well as abilities to identify and provide normative arguments about the underlying ethical frameworks and conflicts.  The programme includes two core modules including Critical Global Health and Global Health Ethics as well as a dissertation.

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Transplant Tourism: Hard Questions Posed by the International and Illicit Market for Kidneys, New Article I Wrote

[Cross-Posted at Prawfsblawg]

The Journal of Law, Medicine, and Ethics has just published an article by me on transplant tourism, that discusses the burgeoning international market for buying and selling kidneys. I review the existing data from Pakistan, Bangladesh, and India, which is pretty deplorable. As I show the vast majority of these sellers are poor and using the money (which is a significnat sum in terms of what they earn, even though in the end only 2/3 is paid) to try to buy themselves out of bonded labor, pay off familial debts, or try to mount a dowry. Many are misinformed or decieved about the health consequences for them and the needs of the person who will receive their kidney. Once they have agreed to sell they are often pressured not to renege. They are often released too soon post-transplant compared to what is optimal for a transplant, and their self-reported health post-transplant is worse. Many experience significant social stigma as a “kidney man” (or woman)and the 20-inch scar (the more expensive way of doing the procedure would reduce the scar size) marks them for life and makes it difficult for them to marry. Most express significant regret and would advise others not to undertake the operation.

Despite these grave facts, as I argue in the paper (and in greater depth for many of these arguments in the chapter on transplant tourism in my new book on medical tourism under contract at Oxford University Press), many of the traditional justifications from the anti-commodification literature — arguments relating to corruption, crowding out, coercion, and exploitation — do not make a convincing case in favor of criminalization. If a ban is justified, I argue the strongest arguments are actually about defects in consent and justified paternalism, on the assumption that criminal prohibition is a second best regulation in the face of the impossibility of a more thoroughly regulated market.

I then examine what means might be used to try to crack down on the market if we concluded we should. I evaluate possibilities including extraterritorial criminalization, professional self-regulation, home country insurance reimbursement reform, international criminal law, and of course better organ retrieval in the patient’s home country.

I will keep writing on this topic, including for my new book, so even though this paper is done feel free to email me your thoughts.

While We Sleep?

By Scott Burris

Nothing threatens a know-nothing more than the prospect of someone knowing something. Hence there has been increasing pressure on and from some in Congress to reduce government funding of social science research.  I hope every reader of this blog is aware that an appropriations rider added by Tom Coburn has drastically restricted NSF funding of political science research. That’s an ugly development, on par with the scandalous cuts to CDC that put paid to its gun research agenda years ago.

But the big funder of social and behavioral research in health is the NIH. In the past two weeks, I have heard via two different insiders that the agency is under pressure to significantly cut back on social and behavioral research, at least research with any important links to public policy. Now it is true that NIH does far too little policy-relevant research as it stands, but many fine researchers do important work related to law and policy with NIH support, and the important influence of law on health means we need more, not fewer, NIH-supported careers.

So I am hoping I am getting false information. What are you hearing?

Call for Applications: Student Internship Program

The Petrie-Flom Center for Health Law Policy,
Biotechnology, and Bioethics at Harvard Law School
Call for Applications
Student Internship Program


The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the upcoming academic year beginning in September 2013.   Full-year availability is preferred, but single-term internships will be considered on an individual basis; please indicate your preference in your application materials. We are not currently accepting applications for Summer 2013, but may consider extension through Summer 2014 if there is mutual interest.

Who is eligible?

Harvard undergraduate and graduate students with an interest in the Center’s work are eligible to apply. More information about the Center is available here. The internship is open to students in all disciplines, but we particularly welcome applications from students studying health policy, philosophy, bioethics, law, medicine, business economics, and the sciences.  We are also interested in receiving applications from students interested in technology and communications, as we plan to substantially update and expand our Internet presence and social media strategy.

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Organ Donation Euthanasia

ELPAT (Ethical, Legal and Psycho-social aspects of Transplantation) is a division of the European Society of Organ Transplantation (ESOT). During the last weekend, the third ELPAT Conference has been held in Rotterdam. It has been a fascinating meeting that has gathered a group of prestigious scholars from many countries around the world to debate several ethical and legal topics involved in transplantation. Glenn Cohen has been one of the key speakers, along with Robert Truog, Alex Capron, Jennifer Radcliffe Richards and many others.

One of the issues which has been hotly debated is “organ donation euthanasia”, a practice that is currently being developed, albeit still marginally, in Belgium, where, as you know, euthanasia is legal since 2002. The issue which intrigued me more is the possibility of adding those organs to the common European pool for their eventual transplantation in a patient from a country in which euthanasia is still forbidden. In a way, our reluctance to such scenario seems to be analogous to the use of organs from executed prisoners. There are even more perplexing alternatives. As is well known, many British citizens travel abroad in order to get euthanasia (Switzerland is the main destination but also The Netherlands and Belgium). Should they also become eligible donors, would it be possible for British citizens to receive the organs? How can we handle that with the allegedly criminal behavior of the travel companions of the “suicide tourist”?

Euthanasia is not permitted in the US, although some States have enacted “aid in dying” statutes. I was wondering, first, if it might be possible in those States to be an “aided in dying organ donor”. What happens if the person who is prescribed the lethal dose requests it? Is it possible to arrange things in such a way that that request is feasible and honored (maybe the individual ingests the pills in an ICU)? Secondly, what about the organs? Should they remain in the State in which aid in dying has been legalized? What do you think?

Call for Proposals: Frontiers of Informed Consent

3rd Annual Workshop in Applied Ethics

Northeastern University, Boston, MA, September 27-29, 2013 

Informed, autonomous consent is widely considered to be central to the ethics of human subjects research. However, it remains both conceptually and practically underspecified. A conceptually clear account of informed consent that is appropriate to the broad array of human subjects research, from medical to social science, has been elusive. Moreover, it has proven to be difficult to operationalize informed consent in practice. These challenges to the ethics of informed consent have been compounded by the globalization of research and rapid technological developments.

This interdisciplinary workshop will bring together practitioners and theorists at the leading edge of the ethics of informed consent to share their research and discuss the future of informed consent. The workshop is designed to be highly interactive, and to provide speakers with constructive feedback from colleagues working on related issues.

We invite the submission of abstracts (no more than 750 words) from researchers working on the theoretical and practical challenges of informed consent. Possible topics include, but are not limited to, the following:

  • Conducting research on vulnerable populations
  • Conducting cross-cultural research
  • Conducting research in virtual environments
  • Informed consent and incidental health findings (MRI, genetic)
  • Community health research
  • Community-based participatory research and its challenges to traditional informed consent
  • Community research boards
  • Ethical issues in reporting data to participants
  • When IRBs confuse human subjects protection with research design
  • Genetic testing outside institutional contexts (e.g. mail order)
  • Theories/definitions of informed consent
  • Alternatives to informed consent for human subjects research
  • Theoretical/definitional work on informed consent and its role in human subjects research
  • Informed consent, parental/guardian responsibilities, and minors
  • Extending informed consent to nonhuman research subjects

Please email submissions (and questions) to Ronald Sandler (

The abstract submission deadline is May 1st, 2013. Abstracts will be reviewed by a program committee. Those selected for the program will be asked to submit completed papers one month prior to the workshop, and papers will be made available on the workshop website.  Papers can be of any length, but speakers will be limited to twenty-five minutes to present their ideas, followed by thirty minutes of discussion. For more information about the workshop go to This workshop is sponsored by Northeastern’s Ethics Institute, Social Science Environmental Health Research Institute, and Department of Philosophy and Religion.