While Iceland’s detailed genealogical records enable the widespread use of estimated data in Iceland, a large enough U.S. database could be used to make similar inferences about individuals here. While the U.S. lacks a national database similar to Iceland’s, private companies such as 23andme and Ancestry.com have created rough gene maps of several million people, and the National Institutes of Health plans to spend millions of dollars in the coming years sequencing full genome data on tens of thousands of people. These databases could allow the development of estimated data on countless U.S. citizens.

DeCODE plans to use its estimated data for an even bolder new study in Iceland. Having imputed the genotypes of close relatives of volunteers whose DNA had been fully catalogued, deCODE intends to collaborate with Iceland’s National Hospital to link these relatives, without their informed consent, to some of their hospital records, such a surgery codes and prescriptions. When the Icelandic Data Protection Authority (DPA) nixed deCODE’s initial plan, deCODE agreed that it will generate for only a brief period a genetic imputation for those who have not consented, and then delete that imputation from the database. The only accessible data would be statistical results, which would not be traceable to individuals.

Are the individuals from whom estimated data is gathered entitled to informed consent, given that their data will be used for research, even if the data is putatively unidentifiable? In the U.S., consideration of this question must take into account not only the need for privacy enshrined in the federal law of informed consent, but also the right of autonomy, which empowers individuals to decline to participate in research. Although estimated DNA sequences, unlike directly measured sequences, are not very accurate at the individual level, but rather at the group level, individuals may nevertheless object to research participation for moral, ethical, and other reasons. A competing principle, however, is beneficence, and any impediment to deCODE using its estimated data can represent a lost opportunity for the complex disease genetics community.

The solution deCODE proposed to the DPA, to delete the individual-level imputation, is premised upon the idea that individuals whose data have been de-identified do not face a serious risk of re-identification, a notion that has been called into question. Indeed, it is the risk of re-identification that animates the September 8, 2015 Notice of Proposed Rulemaking (NPRM) published by the U.S. Department of Health and Human Services in the Federal Register, which proposes a change to the Common Rule, the federal policy for protecting human research subjects. While the NPRM does not address the need for informed consent for estimated data, dealing instead with biospecimens and personal information, it does cast significant doubt on the ability to achieve de-identification of biospecimens and personal information gathered for research purposes.

The NPRM would treat biospecimens as intrinsically identifiable because of the information imbedded in them, and would therefore require informed consent for research using all existing biospecimens, whether clinical or from prior research, even those that have been stripped of identifiers. Currently, U.S. law does not require informed consent for de-identified biospecimens and personal information. This rule change would apply prospectively to biospecimens collected after the effective date of the new rules.

Clearly, the NPRM contemplates that the use of even de-identified biospecimens raises privacy concerns, given researchers’ ability to extract identifying information from them. A broad reading of the NPRM would suggest that the use of estimated data to extrapolate information about individuals gives rise to the need for informed consent, so as to protect the privacy of those who have not expressly agreed to participate in research. The 2014 NIH Genomic Data Sharing Policy (GDS) goes even further than the NPRM by protecting genomic data itself, stating the expectation that investigators will obtain obtain consent for genomic and phenotypic data to be used in future research, even if the source of the data itself is not identified.

The NPRM and NIH GDS comport with public opinion, according to survey data indicating that the public does not recognize the regulatory distinction between identifiable and nonidentified samples and information. When asked how important it is for them to be informed that research would be performed on their samples, 72 percent of respondents in one survey stated that it was moderately to very important for them to be informed that research would be performed on their samples when the data was anonymous, versus 81 percent who felt that it was moderately to very important for them to be informed that research would be performed on their samples when the data was identifiable. Of those who wanted to be informed about either or both scenarios, as many as 57 percent would require their permission to be sought before their samples were used.

Even absent concern about re-identification, individuals sometimes decline on ethical, religious, or other personal grounds to participate in certain controversial forms of research, such as somatic nuclear cell transfer, stem cell research, and germ-line gene therapy. In addition, they may object to commercial exploitation of discoveries developed through the use of their non-identified data.  Finally, public trust and participation in research is enhanced when potential research subjects feel secure in knowing they will be consulted before their biospecimens and information are used.

Should the NPRM be implemented, it is hard to argue that there is any meaningful distinction between nonidentified data and estimated data in terms of the need for informed consent. Neither kind of data requires any direct interaction with the individual about whom data is gathered.  Both are subject to re-identification. The primary difference is that estimated data are not accurate at the individual level, but only at the group level. While this fact may adequately address the privacy issue, it does not resolve the matter of autonomy. For this reason, individuals are entitled to informed consent for the use of their nonidentified and estimated data alike. The Common Rule clearly supports informed consent for individuals involved in biomedical research, particularly when they have a reasonable expectation of privacy regarding the tools used to estimate their data, namely their medical and hospital records.

Donna M. Gitter is a professor of law at Baruch College, City University of New York, in New York, NY. This commentary is based on a presentation she gave at The Petrie-Flom Center’s 2016 Annual Conference: Big Data, Health Law, and Bioethics.

In the March-April issue of the Hastings Center Report, anthropologist Mara Buchbinder, who is on the faculty of the Center for Bioethics at the University of North Carolina at Chapel Hill, and several colleagues report on interviews they conducted with North Carolina practitioners who work within the confines of the state’s 2011 Woman’s Right to Know (WRTK) Act, which requires providers to pair counseling with state-mandated content with a 24-hour waiting period between consultation and abortion provision. They found that many abortion providers, rather than refusing to abide by the parts of the law that they disagree with (which could result in the loss of their licenses, which would further limit access to abortion care), aim instead to “conscientiously comply.” They follow the law, but find ways to distance themselves from its objectionable requirements, instead deploying it in ways that build trust and rapport with their patients. Some do so by sharing their personal stances on the law, providing patients with an opening to share their own frustrations. Others contextualize parts of the required information, such as the risks of an early-term abortion, by emphasizing the fact that the risks of a full-term pregnancy are comparatively far greater. Several physicians the researchers interviewed make it a point to do the counseling themselves, and they found that an unexpected benefit of the law is the additional patient contact it occasions. Ultimately, Buchbinder and her colleagues “challenge the stark dichotomy between conscientious refusal and morally compromised care.”

I asked Buchbinder a few questions about the genesis of the project, the further implications of her research, and other applications of the conscience compliance framework. 

Can you talk a little bit about how you and your collaborators came to the research that led to the piece in the Report? What interested you in the particular issues you raise and the case studies you used? 

A big motivator for us in conducting this study was that, despite a robust literature on the impact of abortion legislation on patients, there had been relatively little research focusing on providers’ experiences practicing under new regulations. There are a few reasons for this, which we’ve written about elsewhere. One is that the Supreme Court’s 1992 decision in Planned Parenthood v. Casey has directed abortion rights advocates toward establishing an "undue burden" on women when mounting challenges to restrictive laws. There are also sociopolitical reasons having to do with the heavily stigmatized nature of abortion work; it’s much easier to invoke public sympathy for women seeking abortion than for abortion providers. So we felt that this was a missing piece of the conversation on the societal impact of abortion legislation. 

How did your interview subjects respond to the kind of research that you were doing? 

I was really impressed with how receptive, welcoming, and trusting they were. We were able to get providers from 8 out of 11 clinics in the state to speak with us about their work, which is rather remarkable considering that abortion providers are by necessity trained to be suspicious of outsiders who want to come spend time in their clinics. Participants were really happy to carve out some time to think and speak about these issues. Abortion work can be really isolating because of occupational stigma and threats to personal safety. Many providers commented on how nice it was for them to reflect on their experience. 

Do you foresee lawmakers recognizing that physicians are deploying the WRTK act in the way that you’ve outlined—using the practice of conscientious compliance to help foster rapport with their patients, while making clear that parts of it are legally required but medically objectionable—and in turn amending their laws to somehow prevent it?

This is an important question, and one that several anonymous reviewers have raised in response to my journal articles based on this research. My first response is that I think that lawmakers in states where abortion is heavily regulated are more focused on creating access barriers via mandatory waiting periods, admitting-privileges requirements, and holding abortion clinics to ambulatory surgical center standards than they are on abortion counseling per se. In North Carolina, for example, we have seen the mandatory waiting period jump from 24 to 72 hours during the course of this research. Of course, it is possible that lawmakers could seek to tighten regulations to prevent the kind of conscientious compliance that we observed—for example, by requiring that providers read from a state-authored script verbatim. However, I think that providers will always innovate “workarounds” (as Nancy Berlinger has aptly put it in her recent book) for mitigating the moral distress produced by such restrictions. And some of those workarounds—like a provider prefacing what she is legally mandated to say with her own comments—are more likely to fall within the confines of constitutionally protected speech. To a certain extent, then, I think that patient-provider interactions are more impervious to legislative interference than other forms of abortion regulation. 

Do you see a way of rolling back the kind of abortion legislation that produces moral distress in practitioners? Will there simply need to be more and more robust reframing of conscientious compliance–or perhaps outright refusal–in order to provide adequate care?

I think that’s tough to say. Certainly, the Supreme Court’s decision regarding Texas’s HB-2 (which requires abortion providers to have admitting privileges at nearby hospitals and requires clinics to meet the standards of ambulatory surgical centers) is likely to have an impact on abortion legislation nationwide. But such restrictions offer fewer opportunities to work within the confines of the law: if the Supreme Court sides with the state of Texas, many clinics in the state will be forced to shut down, rendering conscientious compliance moot. 

In terms of what happens next for me personally, I’ve begun a new project looking at the social and ethical implications of physician aid-in-dying in the United States, in which I’m using Vermont’s Patient Choice and Control at the End of Life Act (Act 39) as a case study. One thing that I will be interested in exploring in the context of that project is whether end-of-life care and physician aid-in-dying raise possibilities for conscientious compliance despite moral objection. I mention this in part to highlight that there are multiple areas of bioethical inquiry that might benefit from a more robust and broader framing of the concept of conscience. So there is also the “what’s next” for bioethical theory, alongside practical concerns. 

I’m glad that you mentioned where you’re going next—intuitively, conscientious compliance seems like a fruitful way to frame understanding of, and decisions within, a wide variety of settings. Could you expand a bit more upon how you see it working in your Vermont case study or any other arenas?

One area where I can imagine the concept of conscientious compliance being invoked with respect to Vermont’s Act 39 concerns a clause of the law that suggests that physicians might have an affirmative duty to inform terminally ill patients about their ability to pursue aid-in-dying under the law. (I say, “might,” because there is some ambiguity in the way the law is written, leaving this somewhat open to interpretation.) This has raised concerns for some physicians, who think that initiating the topic of assisted death (as opposed to waiting for a patient to initiate it) violates medical ethics and best clinical practices. I think that there are potentially valid ethical concerns here, but I also think that a conscientious compliance framework can help us to imagine ways of responding to such a mandate and informing patients about the law without compromising one’s commitment to conscientious, compassionate care. 

Elizabeth Dietz is a project manager and research assistant at The Hastings Center.

Health care providers in the United States are bound by the Hippocratic Oath, medical ethics, respect for human rights, international declarations, Geneva Conventions, the Nuremburg Code, and the United Nations Universal Declaration of Human Rights. The Declaration of Human Rights states, “No one shall be subjected to torture or to cruel, inhuman, or degrading treatment or punishment.” Medical ethics embodies these historical documents and calls upon health care providers to do no harm to patients, obtain their consent, not violate their bodily integrity, and recognize their vulnerability. These principles apply to patients in civilian or military settings including the care of detainees and prisoners.

After 9/11, conflicts arose between these ethical standards and the duties of health care personnel. These conflicts needed to be settled within a framework that respects the codes of ethical and professional conduct. The DHB report is a response to that overwhelming need. 

Senator Diane Feinstein, vice chair of the Senate Intelligence Committee, has written to Secretary of Defense Ashton Carter urging the adoption of the recommendations. Support has also come from prominent bioethicists and human rights advocates. The World Medical Association, American Medical Association, American Nurses Association, and the American Psychiatric Association (APA) are among the many groups that have condemned the participation of health care providers in interrogation, torture, or force-feeding.

The urgency of the adoption and promulgation of the report before the end of the current administration’s term is essential. Our military health care personnel face numerous challenges, working under the most difficult conditions, as they care for combatants, prisoners, and detainees.  Complying with the ethical standards of the profession, as well as the oath of office to obey lawful orders, can present challenges under trying circumstances. These physicians, nurses, psychologists, psychiatrists, medics, and allied health professionals balance what can be conflicting demands of professional and military standards with potentially grave consequences to their careers and lives.

Currently, health care providers have few choices when faced with moral dilemmas arising from their participation in these duties. They can obey orders that would be considered unethical by universally accepted standards (as well as those standards set forth by their professional organizations) or face the consequences:  administrative hearings or court marshals which could result in dismissal, imprisonment, or dishonorable discharge. These health care providers can also suffer a loss of career with substantial financial and social ramifications should they choose to resist such participation. Psychological injuries can also result from participation in activities that one deems to be immoral.

The DHB report, issued a year ago, addresses these concerns with 16 recommendations. Three of them are broad, far-reaching statements that are intended to alleviate some of the moral strain on these personnel.

Recommendation 2, states, “Throughout its policies, guidance, and instructions, DoD must ensure that the military health care professional’s first obligation is to the patient.”  The recommendation preserves the autonomy of health care providers in their treatment of patients regardless of whether the patients are service personnel, detainees, or prisoners.

Recommendation 3 reads, in part, that the Department of Defense “should excuse health care professionals from performing medical procedures that violate their professional code of ethics” and “the core tenets of their religious or moral beliefs.”

Recommendation 7 states, “DoD should provide military health care professionals with privileges similar to those of Chaplains and Judge Advocates regarding their independence and obligation to protect privacy and confidentiality while meeting the requirements of line commanders.”

Additional recommendations include the establishment of a Department of Defense infrastructure for training and education as well as consultation on military medical ethics.

Long before the DHB report was issued, a Navy nurse (a lieutenant with 18 years in the Navy) on duty at Guantanamo Bay prison refused to participate in force feeding of detainees. The nurse faced an administrative hearing and a possible dishonorable discharge. If the DHB recommendations had been in place, the nurse would have been excused from performing the procedure. After the DHB issued the report, the Navy nurse was returned to duty without further action.

Health care professionals should have the freedom to follow their conscience and their professional association’s code of ethics during their service in the military. The DHB report will not only ensure the moral comfort of our medical service personnel, it also stands as a moral document that can frame our moral intent as we go forward into turbulent times.

Adil Shamoo, PhD, a biochemistry professor at the University of Maryland's School of Medicine, is the chair of the Defense Health Board's medical ethics subcommittee, which wrote “Ethical Guidelines and Practices for U.S. Military Medical Professionals,” the report approved by DHB. The views expressed here are solely those of the author and do not represent those of the DHB, medical ethics subcommittee, or any of its members.

In fact, a lot of gender policing already goes on in public restrooms. Both men and women face hostility when they don’t seem qualified to use a particular lavatory because of their appearance. “Excuse me,” the gender police will say, “but this is a ladies’ room” or “the men’s room,” as the case may be. Sometimes, the remarks are cruder, more direct, or laced with threats, but states considering restroom and locker room restrictions are not usually worried about protecting people with atypical gender expression. They worry more about danger at the hands of those people, or at least they say they do.

These legal efforts involve no small amount of posturing. Even the states moving to restrict access to rest rooms and locker rooms acknowledge the need for fluidity in sex classifications. They admit as much when they allow people to change the classification of sex assigned to them at birth. There’s a social contradiction in both permitting this kind of change and also obstructing its effects. In effect these states are saying, “Yes, you may change your sex as known to the state. Just follow certain rules, such as giving us a physician’s report, and we’ll make those changes in your records. Once that’s done, you may be known as male where you were formerly known as female or be known as female where you were formerly known as male. However, you may not restrooms consistent with that new designation.”

These legislative efforts have not gone forward without resistance. These laws – and North Carolina’s additional restrictions against gay, lesbian, and transgender antidiscrimination protections – have prompted certain businesses and musicians to boycott the state. President Obama has criticized the laws. In defending the restroom restrictions against this criticism, some conservatives say they want to protect the public from voyeurism and, worse, sexual assault. For example, some politicians have said that transgender women are really men parading into women’s spaces. Posing as “women,” the argument goes, these sexual changelings catch actual women off guard, opening them to the dangers of sexual leering and sexual assault. As long ago as 1979, Janice Raymond raised this worry, among others, against sexual reassignment: She argued that males would intrude into women’s space by disguising themselves as women, simultaneously trivializing women’s bodies and endangering them. This stance now proves itself the last redoubt against transgender identities, and its offer of protection is emotionally powerful, if we imagine transgender women as men in disguise, with all the power differentials between men and women left intact. Even if some women might be able to defend themselves against “women” whose true nature is cloaked from view, children and adolescents won’t be able to do so equally well, and more’s the horror, or so the argument goes.

But there is more to the story when it comes to identifying stealth predators. If transgender people put the public at risk in restrooms and locker rooms, so do gay men and lesbians, at least according to expressed concerns about stalking and sexual predation. In the same way that not all transgender people are identifiable as such, not all gay men and lesbians are identifiable even to those people who imagine themselves experts at “gaydar.” Some transgender people fly below the social radar, as do many gay men and lesbians. For this reason, anyone entering a public restroom or locker room cannot know for sure that transgender people, gay men, or lesbians are not already there alongside them. This uncertainty is exactly what hones the anti-gay and anti-lesbian edge in bills ostensibly aimed at transgender people.

Legislators know that gay men and lesbians are in public restrooms, and they also know that the same malevolence they attribute to transgender people can be attributed to gay men and lesbians, too, pretty much without permutation, leaving every gay man and lesbian under sexual suspicion. It is not a coincidence that some violence perpetrated against gay men and lesbians in certain public venues is justified as self-defense, as protection from unwanted sexual interest and behavior. The logic by which legislators want to keep rest rooms free from transgender people also commits them to keeping those same places free from gay and lesbian people too.

Why these legislative efforts to cordon off restrooms now? Are assaults by transgender men and women on the rise in locker rooms? Or are they more about symbolism and the assertion of gender values in the face of social change? These efforts seem to me to be an indulgence in gender nostalgia, an expression of longing for an imagined past in which men and women lived without any traits that threw expected gender roles into question. Even so, checking birth certificates at the lavatory door won’t go very far in blunting the widespread social change that has unfolded – that should continue to unfold – in the wake of attention to human variation in anatomy, genetics, sexual orientation, gender identity, and social roles.

For example, in 2013 the American Psychiatric Association set aside its diagnosis of “gender identity disorder” in favor of “gender dysphoria,” a shift that normalized cross-sex identities by focusing clinical attention on the discomfort of gender nonconformity rather than on the nonconformity itself. With the 2015 Supreme Court decision in Obergefell v. Hodges, the U.S. government withdrew from making the social good of marriage available according to the sex of the parties involved.

It is hard to imagine turning back the clock on this social development even if the occasional county clerk or attorney general moves to obstruct same-sex marriage licenses. Public restrooms and locker rooms have flared up, however, as a focus for debate about access to social goods according to one’s sex as known to the state. As a matter of sexual logic, though, we have already had and settled this kind of debate: If gay men and lesbians are trustworthy enough for public rest rooms and locker rooms, then so are transgender men and women. 

Timothy F. Murphy is professor of philosophy in the biomedical sciences at the University of Illinois College of Medicine and visiting associate dean for academic affairs at the University of Illinois at Chicago Honors College.

In part, the disagreement rests on factual questions regarding the reliability of PGS screening. Dr. Norbert Gleicher questions “whether a biopsy that examines five to ten random cells from the outer shell of a 200-cell embryo can reliably represent the inner cell mass, the crucial core from which the fetus develops.” He reports three normal births after the transfer of mosaic embryos. But Dr. Mark Sauer responds that such a small sample of healthy babies does not warrant a change in the standard practice not to implant mosaic embryos, especially since problems may show up later in childhood or adulthood.

If the only risk is that the embryo won’t implant, and the woman will miscarry, it seems reasonable to allow infertility patients to decide whether to take that risk. But what if there is a serious risk that the child will have developmental defects? Is that a risk that prospective parents should be able to take? Should physicians accede to such a request?

The question is complicated by the fact that, quite apart from the factual issues about the reliability of PGS, there’s another deeper, conceptual question: May prospective parents take risks with the health of their future child if there is no other way that the child can be born? As one couple put it in the New York Times article, “Had we not used that embryo, it either would have been discarded or donated to science. The boy we have now wouldn’t have been.” In this case, the boy turned out to be a happy, healthy child, but what if he had been born with a serious disability? Could they justify their decision to use a mosaic embryo?

Law professor John Robertson, a prominent defender of procreative liberty, is opposed to most restrictions on reproductive technologies or arrangements. He argues that it is illogical to attempt to protect children by preventing them from being born as long as their lives can reasonably be expected to be worth living. Moreover, most people with disabilities, even serious ones, do have lives worth living. This suggests that the prospective parents should be able to make the decision to use a mosaic embryo, since even if the child has a significant disability, he or she will have a life worth living. In addition, preventing them from using the embryo restricts their procreative liberty, preventing them from having a genetically related child.

 In my view, this places too much weight on procreative liberty and too little on procreative responsibility.  Procreative responsibility means thinking about the kind of life one’s child is likely to have. Reasonable people can disagree about the bounds of procreative responsibility, but what they may not do is say that it doesn’t matter what the child’s life will be like, if he or she has no other way of getting born. After all, no child suffers or is made miserable by not being born.

Admittedly, the couple will suffer if they cannot have a child. However, they do have other alternatives. They could undergo another round of IVF, if that might result in normal embryos. Or they could forego having a genetically related child and use gamete donation. Adoption is another way for people to build families. I do not discount the cost to them of these alternatives, and support policies that minimize the costs (such as having IVF covered by insurance), but people may be required to accept some burdens to avoid having children who will be significantly disadvantaged.

If PGS is reliable, the practice not to  transfer mosaic embryos is a reasonable one. But do we really know that PGS is reliable for mosaic embryos? Many fertility doctors report that when they choose between embryos for implantation, they do it impressionistically. They pick embryos that “look healthy” or “look normal.” More research is needed to improve techniques for determining embryo viability and avoiding defects in born children. This is thwarted by the policy in the U.S. that forbids federal funding for research that uses embryos.  Ending that policy would be beneficial for many couples struggling with infertility, not simply the ones who have only one mosaic embryo.

Procreative responsibility requires prospective parents, and the doctors who help them become pregnant, to think seriously about the welfare of their future children. They should avoid bringing into the world children who will have significant medical problems, if they can become parents by having other children who will not have such problems.

Bonnie Steinbock, a Hastings Center Fellow, is a professor of bioethics at Clarkson University and Icahn School of Medicine at Mount Sinai. 

Under the bill, patients are eligible for medical aid in dying if they are at least 18 years old, have a grievous and irremediable medical condition, and have made an informed and voluntary request. To prevent Canada from becoming a destination for medical tourism, patients must also qualify for government funded health care. 

The bill states that patients have a “grievous and irremediable” illness if they have a serious and incurable illness, disease, or disability and they are in an advanced state of irreversible decline. The serious and incurable ailment or state of decline causes enduring physical or intolerable psychological suffering that cannot be relieved by means that are acceptable to the patients. Further, their natural death is “reasonably foreseeable,” but without an estimate of the time remaining.

The bill proposes safeguards, which include having two practitioners, who can be physicians or nurse practitioners, serve as gatekeepers. They would assure, for example, that a patient is eligible for medical assistance in dying; that the patient is competent and informed and has voluntarily made a request in writing; that the request was witnessed by two people; and that the patient has been informed that he or she has may withdraw consent at any time.  

Despite these safeguards, the bill has many critics. Some religious leaders have denounced it for legalizing assisted dying. I believe that the bill is unconstitutional because it narrows the class of people whom the Supreme Court held are eligible for medical aid in dying.

The Supreme Court in the Carter decision unanimously decided in February 2015 that, to be eligible for aid in dying, persons must be competent, consenting adults who are experiencing enduring and intolerable suffering caused by a grievous and irremediable illness, disease or disability, the treatment for which (if any) is unacceptable to them. The Canadian justice department conceded that “The Court's declaration did not indicate that the person must be at the end of life, have a terminal diagnosis or be at an advanced stage of decline.”  And yet the Government’s bill appears to prevent people from accessing medical aid in dying based on these criteria. 

This situation is ironic. The Carter case was named for the first plaintiff in the constitutional litigation launched in 2011: the family of Kay Carter. Mrs. Carter travelled to the Dignitas Clinic in Switzerland to end her life because she was experiencing enduring and intolerable suffering from spinal stenosis, which was unlikely to be the cause of her death. Even though Kay Carter’s family won in court, she might not to have qualified for medical aid in dying under the government’s bill because the spinal stenosis was not life-threatening. The justice minister responded that indeed Kay Carter would have been eligible because her medical condition was advanced and she was suffering. 

The debate about the late Kay Carter’s eligibility highlights the ambiguity of the bill’s provisions. The requirement that a natural death is “reasonably foreseeable” is unclear; as one lawyer remarked, “Everyone’s death is reasonably foreseeable.”  Likewise, the requirement that the patient be in “an advanced state of irreversible decline in capability” might be interpreted to mean that the illness causing the suffering must be a terminal illness.

The justice minister is quoted as saying that “the legislation allows medical practitioners a degree of flexibility in deciding whether an individual patient qualifies,” affirming that the bill places discretion in the hands of practitioners as opposed to patients. 

Critics have expressed concerns that the bill does not provide exemption from criminal liability to social workers and nurses with whom patients might wish to discuss medical aid in dying before they formally consent. It also excludes people whose enduring suffering is caused only by mental illness, those who would like to state their wishes in an advance directive to be acted upon when they lose capacity, and mature minors. Moreover, in Canadian rural and remote communities, patients can be “very lucky to have one practitioner,” making the two-practitioner requirement unrealistic, especially when a practitioner may object to performing medical assistance in dying.

The Carter decision and the proposed legislation fundamentally differ in their focus. The judicial decision decried the fact that the criminal law put a small class of people in Canada to the “cruel choice” of “a life of severe and intolerable suffering” until they die of natural causes or of ending their lives “prematurely, often by violent or dangerous means.”  By contrast, the bill seems focused on the political and bureaucratic challenges of passing a contentious bill in both houses of Parliament by June 6, 2016.  On that date, the criminal law preventing assistance in dying expires. Physicians then may lawfully provide such assistance to the broader group of patients specified by the Supreme Court. However, many physicians might choose not to provide it at all, fearing criminal sanctions in the absence of Parliamentary rules.

Juliet Guichon is an assistant professor in the Cumming School of Medicine, University of Calgary; @JulietGuichon.

Massachusetts is not the only state considering a transparency bill.  At least ten other states, including California, North Carolina, Oregon, and Virginia have all drafted bills that would advance similar goals.  These bills do differ in their details.  As just one example, each state would require disclosure from a different set of drugs and companies.  Massachusetts would only require disclosure of costs and pricing for the top twenty selling drugs in the state (where the list is based around a set of criteria including but not limited to cost), California, Oregon, and Virginia would require disclosure for any drug whose wholesale cost is $10,000 or more per year (in California, this includes over 900 drugs), and North Carolina’s bill is framed around classes of drugs, rather than prices.

It is no accident that these bills have been developed in the wake of Martin Shkreli, Valeant Pharmaceuticals, and other drug pricing scandals.  Patients and policymakers are seizing this moment to take action against the drug industry.  Forcing companies to disclose their R&D costs, advertising costs, and pricing practices is seen as a step in the right direction against these secretive companies.  In this blog post, I want to focus on just one of many interesting issues raised by these bills: what and who are they useful for, and how can we target the required disclosures to best achieve those ends?  More specifically, I’m not interested in transparency for transparency’s sake.  Disclosure rules (like nutrition labels, for instance) can and should be used to help people make better decisions than they would’ve otherwise made.

 It’s not about patients: Interestingly, these transparency bills are seemingly not designed to help patients themselves, unlike many other transparency rules in the health care context.  The idea is not to create a public database that enables consumers to price shop for health care services (Massachusetts and other states already have such tools).  Indeed, much of the information proposed to be collected is either not clearly relevant for patients seeking to lower their own costs (R&D expenditures, advertising costs) or will be held back by the state government as proprietary information (price charged to different insurers), although details on this latter point have yet to be worked out in most states.

 It’s not about direct price regulation (yet): One common argument made in support of these bills is that they will enable states to control the price of these drugs.  At least in the case of Massachusetts, the bill’s sponsor has explicitly disavowed this argument, stating at the hearing that “we’re not trying to regulate prices.”  The idea instead is something like, more transparency will promote competition, which will then lead to lower prices.  Perhaps, but I’m not optimistic, given that more transparency in the context of health care services has often led to an increase in average costs, not a decrease.  These bills may well be precursors to bills that address drug prices directly, but they do not themselves do so.

 It’s about gathering data: And so we come to what I think is and should be the goal of these bills: to gather data about drug R&D costs, advertising costs, and pricing that policymakers and researchers can use to make sensible choices about how to regulate pharmaceuticals, for the benefit of both patients and drug companies.  As such, it is important to think about what types of data would be useful for solving problems (or identifying them) in drug pricing and innovation policy, and how we can use these bills to give us information that we don’t already have.  At least some of the data these bills seek to collect (such as amount spent on advertising) is already publicly reported in some form. We should take care to specify that the information requested by these bills would be different and more useful, such as if it were broken down in a more granular way, by drug and by outlet.

 Data can serve a range of purposes:  Policymakers and researchers can use the information generated by these bills to enable evidence-based policymaking along a range of dimensions.  Boston University law professor Kevin Outterson, a leading expert in incentives to develop new antibiotics, testified that such data would be useful as governments seek to estimate the risks and costs of developing new antibiotics, in service of supporting alternative innovation incentives.  Jamie Love, the Director of Knowledge Ecology International, has written persuasively that detailed information about clinical trial costs, broken down by drug, phase, and patient, could enable policymakers to analyze intelligently incentives designed to develop new uses for old drugs, or to test drugs on new populations.  Interestingly, these arguments may support even broader data collection than the states have proposed.  That is, collecting data on only the top twenty drugs that have come to market gives us no information about the drugs that have failed, or most drugs that are only barely recouping their input costs.

In my own view, it’s not obvious that the data generated by these bills could or would be used to take action against pharmaceutical companies directly.  After the last several months, the public already knows that many companies charge high prices for drugs, that prices are based less on input costs and more on what the market will bear, that companies increasingly in-license drugs rather than developing them entirely in-house, that they spend large amounts on advertising and lobbying, etc.  On these metrics, companies will not be telling the public things they don’t already know on some level.  But the value of the data to enable policymaking on alternative incentives for innovation, or even to promote incentives that directly support pharmaceutical companies themselves, is real – and policymakers ought to think carefully about how best to use these transparency bills to support these efforts.

[Author's note: The link above to the text of the MA bill does not link to the most recent version, which was discussed at the hearing on Monday. If anyone knows whether and where the most recent version is located online, I would be happy to update the link! Relatedly, I did not discuss the price cap element of the original bill in this blog post in part because that element has been limited significantly in the new version.]

 Rachel Sachs JD, is an academic fellow at the Petrie-Flom Center at Harvard Law School.This post originally appeared in  Bill of Health, the Petrie-Flom blog. 

But the decision to accept, and then kill, the documentary raises important questions that shouldn’t be put to rest just because the film has been. The episode invites us to consider how directors can and should choose to represent a point of view, and challenges us to reevaluate preconceptions (and misconceptions) about what the word “documentary” means as a form of nonfiction storytelling.

To explore the complex issues surrounding documentary ethics, I interviewed seasoned filmmakers and producers, in addition to scholars conversant in vaccine science and politics, about what happened with Vaxxed—and what can and should be learned from the whole messy affair.  

This story has presumably captured public attention not only because it involved a famous film festival flip-flopping, but because it speaks to ethical dilemmas that aren’t so easy to unpack.

The Power of Point of View

The man behind Vaxxed is, not surprisingly, the source of much of the controversy surrounding it. When a network of first responders mobilized against Tribeca’s programming decision, it was out of concern that Vaxxed left unacknowledged the polarizing and deceptive biases of its director, Andrew Wakefield. His is not a common household name, but, for vaccine advocates and bioethicists, it’s an unsavory one.

Nancy Berlinger, an ethicist at The Hastings Center who has written on vaccine exemptions, explained why the unusual director matters in this case:

“Andrew Wakefield lost his license to practice medicine in the UK after a 1998 article he published in The Lancet—which suggested a connection between vaccination and the development of autism—was discredited and retracted. The film is directed by him. It’s very much his product. In filmmaking, the director’s vision is important, and presumably this was not about the phenomenon of parents refusing to vaccinate their children, but instead his take on it.”

Berlinger explained that the scientific community lambasted the festival for giving credence to junk science by programming this film. Which begs the question: Is it possible or desirable to create a documentary film without “a take,” or a point of view?

Many filmmakers argue that it’s impossible to present a documentary without the perspectives of a director. Gordon Quinn, artistic director and co-founder of the Chicago-based production company Kartemquin Films, known for its modern classic Hoop Dreams, genially scoffed when I asked him if filmmakers aspired to be objective. “No one ever claimed we were objective—that’s absurd,” he said. “There are filmmakers who are very fly-on-the-wall, but the reality is you have to point the camera one way and not another. If you’re standing behind the police line or if you’re standing on the side of demonstrators looking at the police, it’s a different story.”

Stanford University professor and filmmaker Jan Krawitz also acknowledged that she, and every filmmaker, necessarily brings their own viewpoints to bear on what they direct. Krawitz directed Perfect Strangers, a 2013 film that followed the story of a single kidney donor to explore the philosophical themes that shape understandings of non-directed living organ donation, such as compassion, altruism, and second chances. “I felt responsible to tell (my character) Ellie’s story eloquently and accurately, but the film is necessarily different from a film that she might have made herself,” Krawitz pointed out.

But here’s the thing: As Krawitz puts it, having a point of view is a good thing—as long as it’s not pretending to be anything more than that. “I would argue that an independent documentary filmmaker presents a perspective that can and should have a point of view as long as it doesn’t masquerade as some sort of ‘objective truth,’ which ultimately is elusive,” she said in an email.

This was the problem with how Wakefield and Tribeca framed Vaxxed: Its promotion relied on camouflaging bias, presenting the film as a detached account of medical history, when it very much was not.  

Which raises a secondary question: If a documentary filmmaker has a responsibility to present their bias . . . what’s the ethical way to go about doing that?

Why Transparency Matters

Polemicist filmmakers, like Michael Moore (Where to Invade Next), are careful to acknowledge their ideological points of view from the start. “There are many examples of partisan films in which the filmmaker is a participant, but they are generally foregrounded as such,” Krawitz said. “The films of Michael Moore or Laura Poitras come to mind. With both of these filmmakers, the audience is invited to share the subjectivity of the filmmaker, and there is no attempt to conceal the director’s bias.”

There was no such transparency in how Vaxxed promoted itself, and, for that reason, some filmmakers hesitate to categorize it as a polemic. For example, the film’s trailer features Wakefield as a coiffed, on-screen expert interpreting an allegedly deceitful CDC graph and concluding, “Wow, the CDC had known all along there was this MMR-autism risk.” (“MMR” refers to the measles, mumps, rubella vaccine.) Reassuring professional honorifics, “Andrew Wakefield, MB, BS Gastroenterologist,” flash alongside his name as he pontificates.

This is a misleading way to introduce someone banned from practicing medicine in Britain for unethical conduct, including conducting unnecessary medical procedures on children, no? The trailer represents Wakefield’s viewpoint as what concretely happened, and his affiliates as whistleblowers. However, there are many reasons to think his viewpoint is not accurate or truthful.

Tribeca Film Festival has also been criticized for editorializing and concealing the blemishes on Wakefield’s professional record. These actions had the effect of looking like an intentional omission that obscured the director’s point of view in Vaxxed.

When it announced the programming, the festival failed to mention that Wakefield was stripped of his medical license and had his 1998 Lancet article retracted. Perplexingly, the online 2016 film guide celebrated his research study as something that would “catapult Wakefield into becoming one of the most controversial figures in the history of medicine.”

This is a strange way to dress up the fact that the medical community excommunicated Wakefield from its ranks after he committed scientific fraud. Tribeca’s description of the film—now removed from the site, but available here—also failed to transparently recognize the position of Wakefield as someone with a great deal of skin in this game, as someone disgraced by the scientific community and presumably looking to have his name cleared.

Filmmaker Dan Rybicky (Almost There) imagined different scenarios in which it might have been okay to screen a movie like Vaxxed:

“While many documentaries have chosen to present only one side of a story (Michael Moore’s films come to mind), I think the bigger concern here is that the Tribeca Film Festival did not provide enough context about this particular documentary in their description of it on their website. If they had—and if they had maybe included in this year’s program another autism documentary which presents the other side of the story (if one exists)—I think Vaxxed could have remained in the festival. In a way, I wish it had, because the post-screening dialogue would have been extremely compelling and possibly revelatory.”

“Providing different perspectives to a story and its characters allows audiences to make up their own minds about who and what to believe,” Rybicky added.

Polemics aren’t necessarily dimensional in this way, but they differ from propaganda by foregrounding biases as such, while still remaining unapologetically partisan.

The Truth-Telling Burden

Filmmakers and ethicists generally agree that filmmakers have an obligation to present information that, if not objectively “true,” is at least honest in intent. But this, too, is a complicated notion.

“The responsibility that the filmmaker has is to be truthful to their vision of the world and not to intentionally misrepresent,” said Justin Schein, director and co-founder of Shadowbox Films. But intent is the operative word here, because, even if Wakefield’s film misleads people, it’s not clear that he means to mislead. He could honestly believe in his version of events, that the CDC knowingly covered up a vaccine-autism link and harmed innocent children.

“Of course, my entire conception of reality could be false in some fundamental way, and if so, all of my efforts to ‘honor the truth’ will obviously fail, even if I try to be an ethical person,” said Penny Lane (NUTS!), a filmmaker who recently published an open letter about Vaxxed to Tribeca Film Festival. She continued:

“I can only honor the truth to the extent to which I can know and understand it. Perhaps an ethicist would have to weigh in on this: If I intend to tell the truth, but fail to do so due to an inability to locate and/or recognize the truth, am I behaving ethically? I have absolutely no idea whether Andrew Wakefield believes his own bullshit, and therefore I haven’t a clue if when he made Vaxxed, he did his best to honor the truth as he understands it, or if he is just a plain old liar.”

Whether Wakefield believes his unbelievable version of medical history is an insoluble, albeit fascinating, question. A more gratifying thought experiment might be: How should a film representing vaccine politics, with a director as entangled in those politics as Wakefield is, disclose its entanglements? This is a question documentary filmmakers face constantly, often in the midst of production.

In his recent film, Left on Purpose, Justin Schein becomes involved in an impossible ethical dilemma while documenting the past and present of the aging peace activist Mayer Vishner. Schein made the artistic choice to incorporate that entanglement in the film for the sake of accuracy and transparency.

“I have come to believe that when the ethical challenges of making the film dramatically impact the course of events that it must be acknowledged in the film—otherwise the film will lose credibility in the eyes of the viewer,” Schein said in an email. Similarly, in his film Almost There, Dan Rybicky made a conscious choice to go in front of the camera after learning something surprising about his subject’s past, something that threatens and changes their relationship.

“This is one way in which I tried to remain honest and authentic about my motivation for being involved in the story I was telling,” Rybicky said in an email.

In addition to the burden of honesty placed on the filmmaker, it’s important to consider the responsibilities that festivals and viewers have to be ethical.

“I believe that part of the responsibility of a good festival is to help educate the viewer. This is done by showing films that question the illusions of film and discussing how the films are made,” said Justin Schein.

As Emmy Award-winning documentary producer Marilyn Ness (Cameraperson and Trapped) put it in an email:

“Of course, filmmakers and anyone else may have different truths—even discredited ones—like what was put forward in Vaxxed. But then I think the onus is on the distributors, whether it be festivals, broadcasters, or streaming distributors, not to make all ‘truths’ equal. Audiences come to festivals or broadcasts or Netflix because they believe there has been some vetting and some consideration around documentary vs. reality vs. something else. For documentaries to retain their pride of place and their earned right of trust, everyone up and down the line, from filmmakers to distributors, needs to uphold some basic presumptions of truth in the films they champion.”

Nonfiction producer Heidi Reinberg suggested that part of the problem might lie with misconceptions about what “nonfiction” means to viewers. “We live in an age where a large percentage of people feel like if a nonfiction film exists, what’s in it must be true,” she said. “We have access to more media and more information than ever before, and yet people will spread a three-minute video around or a picture that they know to be Photoshopped because it supports their own viewpoint.”

Digital-age gluts of information and misinformation propel the endurance of the anti-vax phenomenon, too. “The Internet and the media continue to imply a connection between vaccines and autism, which fuels public fears,” said Lawrence Gostin, director of the World Health Organization Collaborating Center on Public Health Law & Human Rights and Georgetown Law professor.

The endurance of anti-vax messages isn’t unique, given that other phenomena in health and medicine persist despite best evidence to the contrary. “There are others, such as genetically modified foods and climate change deniers. I think GMO foods is among the biggest and most overblown fears,” he said in an email.

The festival programmers may have prioritized the allure of controversy in selecting Vaxxed. The takeaway might be that such thinking misfires as often as it provokes thought, sometimes at great cost.

Heidi Reinberg offered a poignant and timely metaphor that best analogizes the unintended side effect of pulling Vaxxed from the festival:

“That film is the Donald Trump of nonfiction films—the maker is bucking the establishment, and the ensuing controversy is giving Vaxxed a whole lot more free publicity than it ever would have garnered on its own.”

Nonetheless, now that some of the sensationalist noise has quieted, something must be said for the emergence of a productive conversation about the intractable things filmmakers feel they owe their subjects and audiences. This is part of the disciplinary trend that Gordon Quinn and others have seen, as we move toward more open discussions of ethics in documentary filmmaking.

“We’ve struggled and talked about these issues all the time—we just didn’t name it ethics,” said Gordon Quinn about the discrete choices involved in realizing artistic vision. “But that’s what we all do.”

Chelsea Jack is a project manager and research assistant at The Hastings Center. A version of this post originally appeared in The Establishment.

I could serve as a geriatric poster-child for my age: some Parkinson’s disease, fairly advanced emphysema, arthritis, moderately severe asthma, and elevated but controlled high blood pressure—a typical potpourri of those chronic diseases that now mark the elderly. I call this the great trade-off. Earlier generations lived shorter lives and had faster deaths. We now live longer but medical advances typically give us a slower death from those diseases.

I did over time answer the question of how long I should want to live. First, to live long enough to do most of those things that life makes possible: to become educated, have a satisfying career, see a bit of the world, develop a circle of friends, and to marry and raise a family. I have now done all those things, well and fully (if not always perfectly).  Second, I want to die at a stage in life when those in my family and community see no significant social loss to society in my death even though (I hope) they will personally miss me.

 It was once acceptable to say, with few tears, that “he died a natural death.” But now that death has been medicalized, a specific disease that caused the death is required.  My views on a long life are not notably idiosyncratic. Two American public opinion surveys found that 90 is taken to be a long enough life, for Germans it is 85, and for Australians 80. Hardly anyone wanted to live beyond 100. While some might say that life itself is an intrinsic good–and the more of it the better–others have contended that it is the reality of our finitude that forces us to shape a meaningful life. That is my own bias.

But apart from what you and I might find acceptable for our individual lives it is no less necessary to ask: would a significant increase in average life expectancy–say, well over 100 and as long as 120 or 150–benefit us as a human community? I can’t imagine how it could be a benefit, but I can imagine the damage a pursuit of that goal could bring. A number of wealthy Silicon Valley entrepreneurs and innovation-driven scientists seem to want just that. Or do they? A parallel and often overlapping effort–supported by prominent geriatric and medical researchers–is the goal of compressing morbidity; that is, a long, healthy life followed by a quick death. They concede that the compression goal would likely increase life expectancy, but that is not their intention.

Another research group, Calico, in Silicon Valley, enthusiastically seeks both compression and increased longevity. That group worries me the most. Consider that even now there is in the U.S. a looming long-term problem with our aging society, living to an average of 79. By 2050, just as the millennials will be coming in to middle age, 20 percent of the population will be over 65, with 400,000 over 100.  Yet even now a large and growing proportion of the elderly are going into old age without adequate savings and pension plans–and often devastating medical costs beyond their Medicare coverage. The Social Security and Medicare programs will have to be significantly ramped up. Whatever their health care system, every developed country faces a similar problem.

The poor countries face far greater pressure. Some 60 percent of their deaths now come from aging populations and the same chronic diseases that afflict the rich countries. They neither have, nor are likely to have in the foreseeable future, the kind of high-tech medicine and social security systems we lavish on our elderly. Their care will fall heavily on their families and children. Global life expectancy is 69 compared with 79 in the U.S. (and 84 in Japan, the country with the highest life expectancy), but the poor countries are rapidly catching up. It is reasonable for poor countries to try to catch up with us, but that’s all they need.  

We don’t need to live longer either. Although our country has many needs, I have heard no one contend that we could collectively solve them better if we could just live longer. For that matter, I never heard it said of my parent’s generation, mainly dying in their 60s and 70s. Evolution, replacing the young with the old, knows what it is doing. Smart scientists and Silicon Valley entrepreneurs would do well to exercise some of their innovative imaginations on the problems that already plague our present life spans, particularly those of poor countries. I wish them well in the search for a compression of morbidity, even though I will be long gone before it ever happens. 

Daniel Callahan is the cofounder of The Hastings Center and author of The Five Horsemen of the Modern World: Climate, Food, Water, Chronic Illness, and Obesity, to be published next month by Columbia University Press.

The “emergency” that prompted the session was the February 22 passage of a transgender-inclusive antidiscrimination bill in the city of Charlotte. North Carolina Governor Pat McCrory wrote on Twitter that he “signed bipartisan legislation to stop the breach of basic privacy and etiquette, [and] ensure privacy in bathrooms and locker rooms.”  But the law invades the privacy it purports to protect. Rooted in the specter of men masquerading as women to enter and commit violent crime in women’s bathrooms, it instantiates surveillance over the genitalia of anyone using public restrooms who is not stereotypically masculine or feminine. Furthermore, the measure (which is part of broader legislation dealing with the relationship of local and state laws) bars local policy-makers from enacting municipal antidiscrimination laws that conflict with these new state-level restrictions.

HB 2 should incite the worry, and the anger, of bioethicists on several fronts. It is unclear how transgender people could even comply with the letter of the law, let alone its spirit. When transgender men who are read as men – but whose birth certificates say “female”–- are compelled to use the women’s restroom, this creates precisely the “problem,”- i.e., the idea of men invading a women’s only space, that the law purports to protect against. The law’s defenders have invented an imaginary threat to shore up support for the legislation, insisting that women are endangered if transgender women, who are routinely misgendered as “men” in this rhetoric, are allowed to share these spaces. While a 2013 survey by the Williams Institute of UCLA School of Law found that “roughly 70% of trans people have reported being denied entrance, assaulted or harassed while trying to use a restroom,” there is no evidence of violence perpetrated by transgender people in restrooms.

In fact, it is transgender women who are at the greatest risk of violence under this new law. And for those people whose gender is not precisely binary – transgender people who don’t want to be or aren’t able to be consistently read as male or female, as well as gender-nonconforming men and women – this law enacts a harm without providing a protection. These are people who are already often looked at mistrustfully when they use the bathroom, who are asked if they belong, regardless of what restroom they are using. “Bathroom bills” do not prohibit these people from using the restroom. But a substantial practical effect of them is to encourage – require, even – interrogation of their gender, which is a practice that should be quelled. This law transforms a “breach of basic privacy and etiquette” – not the one that Governor McCrory claims to be preventing, but the one that actually happens – from harmful individual actions into legislative mandate.

For bioethicists, this law raises important questions about the relevance of gender and personal health information to the state. HB 2 states that “Public agencies shall require every multiple occupancy bathroom or changing facility to be designated for and only used by persons based on their biological sex,” and defines biological sex as “The physical condition of being male or female, which is stated on a person's birth certificate.” It presupposes that someone will enforce this law, presumably using information from a birth certificate as verification of gender. Will it be acceptable to produce this after relieving one’s self, or will such a document be required for entry? Will a driver’s license suffice, or will transgender citizens need to start carrying their birth certificates in their wallets? Will paranoid parents be empowered to confirm the genitalia of their fellow PTA meeting attendees?

What are the ethical consequences of the state’s right to determine the gender of its citizens?

These are not hypothetical questions. “Biological gender” in the North Carolina statute is determined based on a person’s birth certificate. North Carolina allows changes to gender markers on birth certificates if a person has undergone surgical gender confirmation. Therefore, North Carolina already has laws in place that govern a person’s legal gender, and HB 2 is subject to the provisions of those laws. Consequently, HB 2 solidifies relationship between legal rights, lived experience, and medical interventions into gender. But should surgery – personal health information – be a matter of state record, such that access to public services can be contingent on it? Transgender people are going to have to use bathrooms, and the ones who can do so legally and safely in a public restroom are limited by this law to those whose birth certificates match their gender presentation. Since the only way to achieve that is through expensive surgical means, this policy, in effect, requires surgical and legal intervention in exchange for access to public services. It is important to note, as well, that this law also homogenizes the minimum wage across the state, preventing municipalities from raising it above $7.25. This at the very least has the potential to make the health interventions the state now requires even less accessible to those people who would need them. 

This law has prompted a national conversation about of a series of applied and interdisciplinary ethical questions, as evidenced by both local and national efforts to repeal it. Restrooms have long been uncomfortable and dangerous spaces for transgender and gender-nonconforming people, especially if they are not read as discernibly male or female. But in addition to, or perhaps because of, the threat of violence in bathrooms, some transgender people do long-term damage to their bodies by avoiding gendered restrooms and being unable to find “safe” or gender-neutral ones. The question of how to best ensure access to safe public restroom facilities was already an important infrastructural concern for transgender people and their allies. But “bathroom bills” approach the issue of safe bathrooms for all people by further limiting access for transgender people, rather than ensuring it for all.

The swift and forceful condemnation of these bills by transgender people and their allies highlights not only the need for bathroom access, but the fact that it has never been a guarantee for transgender people. Bioethicists should take up this issue, connecting it with related questions of access to public facilities, the ethical considerations of limiting that access, and the feasibility of enacting meaningful solutions in public spaces constrained by taxpayer dollars. Most importantly, these conversations must center around the health and safety of all, and not attempt to implement solutions that further harm transgender and gender nonconforming people.

Elizabeth Dietz is a project manager and research assistant at The Hastings Center.

In February, our team held six workshops with Singaporean health care professionals to discuss the cases we’d developed, based on discussions during earlier visits, to illustrate common ethical challenges in the care of aging, often frail or chronically ill people in Singapore. Piloting workshops is always exciting, because we get to see what real people make of our fictional characters and situations. Do they seem “realistic” as well as “typical”?

One case is structured as a dialogue between an elderly woman determined to live independently despite deteriorating health and a case worker who is trying to figure out whether he should support his client’s choices or try to change her behavior. This case prompted participants in several workshops to ask the same question: What language are these people speaking? The characters’ names were Chinese – but would a young case worker speak the same dialect as a client who is 50 or 60 years his senior? Or should we imagine that the elderly woman had attended English schools as a child and was accustomed to speaking British-influenced English? Or did they both speak Singlish? Would the case worker call his client “ah po” (Grandma)? Or “Auntie,” the Singlish equivalent for addressing an elder in a friendly yet respectful way?

As we worked with our local colleagues to fine-tune the case narratives and get small, meaningful, local details right, we gained fresh insights into how members of different health care professions perceived our project’s goal. The first edition of the Singapore Casebook focused on medical decision-making and on doctors as moral agents. The second edition, with its broader focus on ethical challenges arising in an aging society, explores situations that involve illness and aging, therefore health, but not necessarily health care.

 In Singapore, engagement with the ethical challenges of care and care work– arising for leaders and staff in community-based organizations or in collaborations with health care professionals, families, and foreign domestic workers– is new.  Singapore is home to many pilot programs in health care delivery for its aging population, but resources remain centered in hospitals or are allotted through care transitions originating in the hospital. The ethics of providing and receiving care “in the community” – to a frail or chronically ill person living at home, in a family member’s home, or in a nursing home – is a new area for bioethics here. Case-based ethics education, as a way of reflecting on and strengthening practice, is more familiar to physicians than to social workers and nurses, and may be unfamiliar to case workers, program administrators, and others. As our focus broadens from clinical and professional ethics, to organizational and social ethics, we ourselves are reflecting on how to adapt teaching and learning tools so they are useful and appealing to broader audiences.

This project is also raising intriguing questions about how to use realistic fictional narratives to help people new to ethics see and reflect on the moral dimensions of their daily work. For example, at what point does a person, by accepting a neighborly offer of help, become a client receiving “community care,” and object of scrutiny? As we imagined that fictional, realistic encounter between an old lady who is trying to live her life and an earnest, imperfect young case worker who is trying to do the right thing, we first had to imagine how these two people found each other. The “bedside” encounter is easy to see. Imagining the effort to keep things as they have been at home, as an aging person’s health changes, as a caregiver’s patience frays, is more difficult.  Considering how and why to support ethics teaching and learning in the community, close to the lives of aging people, is an ongoing question for our project team, and for health care ethics in aging societies.

Nancy Berlinger is a research scholar at The Hastings Center. Michael K. Gusmano is a research scholar at The Hastings Center and an associate professor of health policy in Rutgers University School of Public Health. Jacqueline Chin is an associate professor at the Centre for Biomedical Ethics of the Yong Loo Lin Medical School at the National University of Singapore. Michael Dunn is director of undergraduate medical ethics and law education at the Ethox Centre of the University of Oxford. The Singapore Casebook Project: Care Transitions is directed by Jacqueline Chin and is funded by the Lien Foundation.

A telling place to begin that story is with China’s decision last year to eliminate its one-child limit, rescinding a policy put in place with much criticism in 1980. The initial motive of the policy was to slow or stop the rapid population growth in China, seen as a threat to its goal of eliminating poverty and endangering its fast-rising economic growth. Reduction of population growth, led by the U.N. and various NGOs—and popularized by Paul Ehrlich’s book The Population Bomb–had been an international movement in the 1960s and 1970s. Initially it was heavily focused on developing countries with very high birthrates and pervasive poverty, but it was gradually picked up by environmentalists as well for two reasons. One of them was anxiety about the projected future number of people on earth, dangerously straining natural resources. The other was the disproportionate climate harm done by heavily industrialized affluent countries even with much lower population growth.

With the exception of sub-Saharan Africa and Southeast Asia—where family sizes still remain in the six-to-eight children range–rising affluence, women’s education, and effective family planning programs brought about a significant decline of global birth rates. Not foreseen by the Chinese or others, however, was the possibility that too-low birthrates could threaten economic welfare, leading to depopulation and a declining number of young workers to support a growing number of the elderly. That perception began gradually to emerge in the 1970s and 1980s in developed countries. The success of effective family planning policies and the rising number of working women stimulated that shifting perspective. What came to be known as “low birthrates,” a total fertility rate  (TFR) of, on average 1.5-to-1.8 children per woman, and “low-low” birthrates below 1.5, induced second thoughts, which became common by the 1990s. 

Some 32 developed countries have put in place policies to raise birthrates, up from eight in 1986. That has turned out to be more difficult than expected. Many Chinese do not want a second child, and Japan, with the lowest of all birthrates, (1.4 TFR), has made little progress in its efforts to increase procreation. For the past five years there have been more deaths than births in Japan. Other countries trying to turn the tide have not made much progress. In any case, none of the countries seeking to raise birthrates aim to return to earlier excessively high birthrates.

More recently coming to the fore, however, is the great shift in aging that has accompanied population growth.  What came to be called the dependency ratio–the imbalance of productive young workers and more dependent retired–began to loom large toward the end of the twentieth century. Rapidly rising elder health care costs in developed countries as well as generous retirement policies came to be a black cloud on the horizon. Less expected was the proportionate rise in the number of elderly in developing countries. Coming to be called “age compression,” it emerged much faster than it had in rich countries. By 2012 the global ratio of young to old saw the number of those over 60 to be greater than those under 5 for the first time in history.

Some 12 percent of the world’s population is over 60 and it is projected to rise to 22 percent by 2050. Between 2010 and 2050 a 250 percent increase in the number of people in this age group is expected in developing countries, compared with a 71 percent increase in developed countries. In 2010 there were an estimated 524 million people in the world over the age of 65, but that group is projected to grow to 1.5 billion by 2050. Few developing countries are prepared for that change. They already lack good health care for the needs of the young much less for what will be the much greater needs of the old. Government and industry pension and retirement programs are virtually nonexistent. The movement of the young to cities—now holding 50 percent of the world’s population--where jobs are available is leaving millions of the rural old without traditional family care.

There is growing uneasiness even in developed countries. In 1965 in OECD (Organization for Economic Cooperation and Development) countries there were 14 people over age 65 for every 100 younger workers; now there are 28. Whether future population growth will keep that already low ratio from going higher is unpredictable. Nor is the U.S. any better off. The growth rate of the U.S. Medicare program for the elderly is at present slowing down from earlier fast annual cost increases–most likely due to the most recent  recession and some successful cost-control efforts—but it is expected to rise again in future decades as the retirement of the baby boom generation picks up speed. While their proportion in relation to those over 65 is small there are now about 72,000 people age 100 and older, up from 50,000 in 2000. What was rare and worth a special obituary 40 to 50 years ago is now commonplace.

Generally overlooked, however, is the financial status of the elderly. Right off top, some 18 percent of a retirees’ Social Security income is spent on the copayments and deductibles of their Medicare health coverage.  But the worst costs of retirement—home and nursing home care, daily needs for food and shelter–cannot, for most, be covered by Social Security alone. They will need the help of income from pension plans, for people lucky enough to have them (and fewer than 50 percent of today’s retirees do, and personal savings. Baby boomers have been notoriously poor savers, accumulating on average only $30,000 in cash. Short of greatly increased Social Security coverage and relief from health care costs over and above the present Medicare coverage, a fair number will live below the poverty line.            

There is another twist to the population and aging story. Old age is now increasingly accompanied by lethal, disabling, and expensive chronic diseases—notably cancer, heart disease, type 2 diabetes, and emphysema, and with Alzheimer’s catching up. Those diseases now plague all rich countries. The marvel of more people living into their 80s, 90s, and 100s obscures the cost to the health care and retirement programs that accompany it. Most notably, developing countries have joined that once exclusive club. Where infectious diseases were once the leading killers in poor countries (and malaria still is), 60 percent of deaths are now due to chronic diseases.  

An aggravating feature of what might be called the aging/chronic illness syndrome is that much, though hardly all, of the challenge of chronic illness is that its causes are heavily traceable to lifestyle behavior. Bad diets and consequent obesity and heart disease, smoking, excessive alcohol consumption, and lack of exercise all play a significant role. That distressing feature is particularly apparent of late in poor countries, where they appear some 10 years earlier than in rich countries.  Strategies of prevention are obviously called for, but not easy to put in place. If many people everywhere are not happy to pay high taxes or accept heavy regulation to deal with global warming (and even when they concede the threats), they are even less prone to have government regulate what they do with and to their bodies.  

There are many good things going on in coping with population growth, aging, and chronic illness. But all in all we are with the good of the body at the stage that the reduction of global warming and the good of the planet were 30 years or so ago: plenty of scattered ideas, and signs of progress here and there, but little overall policy coherence. What made the greatest difference with global warming was the establishment by the U.N. of the Intergovernmental Panel on Climate Control in 1988 (IPCC) to coordinate scientific research and information, and then, in 1992, the U.N. Framework Convention on Climate Change (UNFCC) to reach policy agreement. A comparable U.N. organization to encompass population growth, aging, and chronic illness would be timely and helpful.  

Daniel Callahan is President Emeritus of The Hastings Center and author of the forthcoming book,The Five Horsemen of The Modern World: Climate, Food, Water, Chronic Illness, and Obesity (Columbia University Press).

Charles Dupras joins the conversation on Bioethics Forum to say more about an article, “Epigenetics in the Neoliberal ‘Regime of Truth,’” that he co-wrote with Vardit Ravitsky in the January - February issue of the Hastings Center Report. I asked Dupras to explain what we gain from the biopolitical perspective they offer on the translation of epigenetic knowledge.  Dupras is a PhD candidate in bioethics at the University of Montreal. Ravitsky teaches in the bioethics program at the University of Montreal and directs the Ethics and Health Branch of the Center for Research in Ethics.

Epigenetics refers to molecular mechanisms that influence the expression of genes, sometimes activating genes and sometimes silencing them. Part of what’s fascinating about these mechanisms is that they can occur in response to social and environmental factors. But they can also be heritable: a gene silenced in a parent may remain silenced in the person’s child. For this reason, epigenetics bridges the gap between individuals’ genetics and their environment.

“Epigenetics could provide the missing molecular evidence of the importance of using public policy to reduce the incidence and prevalence of common diseases,” Dupras and Ravitsky write. However, they caution against the risk that a “clinical translation” will garner more attention and public resources than a “policy translation” of epigenetic knowledge.

Epigenetics has the potential to mobilize political will toward remedying social inequities resulting in common public health problems, but Dupras and Ravitsky worry about two sociological trends that might impede the policy translation of epigenetics: molecularization and biomedicalization.

As personalized medicine has gained more traction, knowledge about health risks and health has increasingly been talked about in terms of individual genetic susceptibility (molecularization) and precise clinical interventions (biomedicalization). Can this shift in perspective directed at the individual impede the translation of epigenetic knowledge into public health strategies? Dupras and Ravitsky are interested in how this scientific knowledge gets translated in a “neoliberal” biopolitical context. Taking a leaf from medical anthropologist Margaret Lock, Dupras explains that they wrote this article to caution against a return to biological reductionism with epigenetics.

Q:  What do you consider to be the most important ideas and arguments in your article?

There is scientific evidence of how social disparities and harmful environments impact health, but scientific evidence is not the only factor. To develop and adopt wise policies, we also need political will and social engagement.

There are many pressures on our politicians. They want to do the right thing, to listen to evidence, but they also want to be (re)elected. This creates a reality where political will can be influenced by what we call the “biopolitical context,” by broader social trends. That’s why we claim that the biopolitical landscape can influence what public policies are adopted.

In the U.S., as well as elsewhere in the world, there is a strong emphasis today on personalized or precision medicine. This results from a biopolitical context that favors individual and technological solutions to health problems. There is also an emerging acknowledgement of social determinants of health and the importance of the environment.  So, these two trends can create a tension when it comes to choosing how to implement new scientific knowledge. Our main point in this piece is that we should acknowledge the socio-political context and not be completely seduced by one paradigm, but rather find a good balance and translate new knowledge in socially responsible ways. 

Q: When you write about the future of epigenetics, you seem to be creating a relationship of opposition between “clinical translation” and “policy translation.” Are these two forms of knowledge translation really oppositional, or are they complementary?

They are complementary approaches. One is more preventative–more upstream. The other, like emergency medicine, is also necessary, but it is downstream. It is about solving problems that have already occurred. So they are complementary across time.

They are also complementary because one addresses the population and the other tackles the individual. Policy translations reflect how we use epidemiological data to implement public health strategies. Clinical translations reflect how we want our doctors to care for individual patients.

In our article, we advocate for a balance between these two approaches. We suggest that in our current biopolitical context we are probably heading too much in the individualized biomedical direction and not enough toward population-level and preventive strategies.

Q: I wonder if your paper overstates the influence of “molecularization” on Western biopolitics. You caution against the dangers of internalizing problems that have a much larger scope, and you argue that this kind of myopia might lead us to disregard some of the most important issues of our time, like social justice, biodiversity, and the protection of ecosystems. But in the U.S. social determinants of health, environmentalism, and social justice are ideas enjoying immense popularity. Are you saying that epigenetics represents a novel threat to the gains that have been made toward recognizing the social determinants of health?

Yes, precisely. We are concerned that epigenetics may create an even stronger emphasis on individual interventions–to the detriment of social ones–if only its clinical translation resonates with the current biopolitical context.

We agree with anthropologist Jörg Niewöhner and sociologist Hannah Landecker that there is something new about the kind of “molecularization” that epigenetics is bringing to the table. In comparison with genetics, epigenetics allows us to bridge the internal body with the external environment. It is a kind of molecularization that opens our eyes to that bridge and most importantly to the influence of the social environment on health. In another article in the journal Bioethics, we argued that, at first glance, epigenetics is indeed a convincing way to promote the collective management of social determinants of health. However, in this article we are asking further: is this really going to happen? We want to explore the possible sociopolitical and economic barriers to such a translation of epigenetics.

Epigenetics changes the vocabulary of discussions about complex issues such as the protection of ecosystems and social justice. We can be discussing the external environment and then shift the discussion toward molecules and what happens inside the body. It’s a shift in what we look at and what we value as important. We need to be aware of that.

Q: “Neoliberal” has become a buzzword in particular academic disciplines, particularly the social sciences and philosophy, but its ubiquity makes me skeptical of its utility. Why is “neoliberal” a helpful descriptive concept in conversations about how epigenetic knowledge might get translated?

We had long discussions about how we were going to name this “regime of truth” (to use Foucault’s term), because it was not self-evident. We are trying to get at the interplay between the influence of society on science and the influence of science on society. We describe four “pathways of thinking”: internalization, isolation, commodification, and technologization. These are all clinical features of epigenetics. But we tried to connect them with broader social trends, with political agendas.

We thought that the term “neoliberalism” best reflects these four processes. It accounts for the focus on the individual and the fact that we can commodify and then commercialize the epigenome. These focuses – on the internalized and the isolated – fit patterns emerging from liberal individualism and economic liberalism.

In short, we wanted to explore why the clinical translation is so dominant in our societies, why clinical approaches are being pushed forward more than the public health ones.

Q: What do you mean when you say “regime of truth,” and why is it important for understanding how epigenetic knowledge gets translated?

We used the concept as a framework (as suggested by sociologist Thomas Lemke) to help us identify what kind of knowledge is perceived as convincing in contemporary societies. Is it, for instance, social theories? Epidemiological data? Molecular mechanistic explanations? In other words, is there a category of scientific evidence that weighs more than others, and, therefore, has more influence on collective/political decision-making? We suggest that molecular-level arguments have this special power in today’s society. We use the term neoliberal regime of truth to name the biopolitical context in which molecular-scale arguments acquire this special power.

Q: Do your observations about neoliberal pressures on the translation of epigenetic knowledge make you pessimistic about the future?

As opposed to being pessimistic, we are critical of a possible future. We can’t predict how epigenetics will be used. But it’s important to remember that social movements are not monolithic and rarely go in one single direction. There is usually tension and dialogue between various actors.

In the recent past, neoliberal forces have influenced the market economy, and this had a variety of social and political outcomes. In this article we caution about the impact these forces might have on how we choose to implement the very promising tools epigenetics research is giving us. We want to put environmental concerns and the reduction of socioeconomic disparities on the table, because they are really important.

Epigenetics is a perfect case study for knowledge translation because it sort of sits between the policy and the clinical approaches. We present these two complementary ways of translating knowledge to show that what determines which road we will take is not just scientific evidence, but also social trends and political will.

Chelsea Jack is a project manager and research assistant at The Hastings Center. This is the first post in a series of conversations with authors of articles in the Hastings Center Report in which they expand upon topical issues of public interest.

On February 25, the Special Joint Committee on Physician-Assisted Dying, a federal parliamentary committee created especially to address the issue, released a report that marks a turning point. If implemented in legislation, the report would make medically assisted euthanasia and suicide available to a broad range of suffering people in Canada: those with serious and irremediable illness, including psychological illness; those who expressed a wish for such assistance prior to losing competence; and possibly competent minors. The committee also recommended that all publicly funded health care institutions—including those with religious affiliation—be required to participate.

This latest Canadian move toward legalized medical aid in dying originated in June 2011, when a small group of people filed a Statement of Claim in the British Columbia Supreme Court in Vancouver. They argued that the Canadian Criminal Code sections, which make it illegal for physicians to help consenting grievously and irremediably ill adults to die, violated their constitutional rights under the Canadian Charter of Rights and Freedoms to “life, liberty and security of the person” and to “equality.” Gloria Taylor, a 64-year-old plaintiff with amyotrophic lateral sclerosis, testified that she did not want to suffer a death that is “slow, difficult, unpleasant, painful, undignified, and inconsistent with the values and principles I have tried to live by.”

At trial, the plaintiffs won. The trial judge’s carefully reasoned 400-page decision, released in 2012, rejected the government arguments that there was a “bright line distinction” between letting die and assisting in suicide or actually killing, and that judicial disregard of the alleged distinction would create a slippery slope leading inevitably to wrongful homicide. The trial judge accepted the evidence of several ethicists who testified that there is no ethical distinction between physician-assisted death and other end-of-life practices such as withholding or withdrawing life-sustaining treatment when death is likely to result. The trial judge concluded, based on extensive evidence, that “the risks inherent in permitting physician-assisted death can be identified and very substantially minimized through a carefully designed system imposing stringent limits that are scrupulously monitored and enforced.”

The governments appealed to the British Columbia Court of Appeal, where the plaintiffs lost in 2013 because the Supreme Court of Canada had decided 20 years earlier that a sufferer of ALS, Sue Rodriguez, had no legal right to physician assistance in dying.

In January 2014, the Supreme Court of Canada agreed to hear a further appeal. Later that year, an opinion poll revealed that 84 percent of 2,500 Canadians surveyed said they agreed that "a doctor should be able to help someone end their life if the person is a competent adult who is terminally ill, suffering unbearably and repeatedly asks for assistance to die."

Nevertheless, it was with some surprise that Canadians received the news on February 6, 2015, that the Supreme Court of Canada had ruled unanimously in favor of the plaintiffs. The court decided that a carefully designed and monitored system of safeguards could both protect the vulnerable and honor the rights of a small class of people to “life, liberty and security of the person.” The court held that the class consists of competent adults who clearly consent to the termination of life and have a grievous and irremediable illness, disease, or disability that causes enduring suffering that is intolerable to the individual.

Because it is the role of the elected branch of government to design a system of safeguards and access, the Supreme Court gave federal and provincial/territorial lawmakers 12 months “to respond, should they so choose, by enacting legislation consistent with the constitutional parameters set out in these reasons.”

Creating law about medical assistance in dying is, perhaps, more complicated in Canada than many other jurisdictions because the subject matter affects two levels of government. The federal government exercises criminal law-making power while the provinces and territories oversee health services and the governance of health professions. 

Many hoped that the federal government would lead by amending the Criminal Code to clarify issues related to eligibility, access, and safeguards, but last October the Conservative government was defeated in a general election without having proposed changes to it. The new Liberal government took office on November 5, 2015 and soon asked the Supreme Court of Canada for a six-month extension. The Court granted a four-month extension, to June 6, 2016. In the interim, the Court permitted eligible Canadians to apply to a superior court for physician assistance in dying. Quebec, which had initiated the process of making assistance in dying legal in 2009, legalized it in December for terminally ill competent adults.

The new report by the Special Joint Committee on Physician-Assisted Dying has been hailed as “brave, expansive and patient-centered” and denounced as “a near-worst case scenario.” Four opposition Conservative Members of the Commons wrote a dissenting report that decried the expansive nature of the majority report and argued for a greater focus on vulnerability.

The report is consistent with the Supreme Court’s decision in stating that those eligible are competent adults with grievous and irremediable illness who are experiencing intolerable suffering (from a physical or psychological condition), not just those who are terminally ill. The report expanded upon the court’s decision by proposing that people diagnosed with a condition likely to affect their competence may request assistance in dying in an advance directive. The report described a difference of opinion on whether mature minors should have access to assisted dying and, therefore, recommended deferring the decision for up to three years. During that period, the report recommended that the Canadian government facilitate a study of the moral, medical, and legal issues involved to help inform the policy on mature minors. To avoid making Canada a destination for people seeking assistance in dying, the report recommended that the service be available only to insured persons eligible for publicly funded health care services in Canada.

The report also recommended cooperation among governments to ensure that there are few barriers to access. It proposed that physicians who object to providing assistance in dying make a referral to other physicians; all publicly funded health care institutions offer the procedure; the length of the period of reflection be sensitive to the patient’s condition and disease progression; and that the patient not be required to seek approval from any board or agency. Acknowledging the role that health care providers other than physicians play in assisted dying and that medical care by physicians can be scarce in rural and remote Canadian communities, the report recommended that freedom from criminal sanction be granted to these officials: physicians, nurse practitioners, registered nurses acting under a physician’s direction, and pharmacists and other health care professionals who provide ancillary services. Because of this recommendation, the report uses the terminology medical assistance in dying (MAID).

To provide safeguards, the report recommended that, wherever possible, the request for MAID be in writing and witnessed by two people, and that two physicians ensure that the requesting patient meets the eligibility criteria. It also recommended that physicians who assess capacity should pay particular attention to patient vulnerability in end-of-life circumstances. For example vulnerability might arise from socio-economic circumstances such as the expense to an individual or family for care or, especially in the elderly, from social isolation.

To oversee the practice of MAID, the report recommended cooperation among governments in creating and analyzing MAID cases, and that Parliament review the applicable federal legislation every four years. It also made recommendations to ensure appropriate end-of-life practices for indigenous peoples, a national palliative care plan, mental health supports and services, and better care for people with dementia and their families.

The minority report denounced the majority report for failing to strike the correct balance between respecting individual autonomy and protecting “vulnerable Canadians” and for expanding upon the Carter decision. The minority would have required psychiatric assessment of mentally ill patients, prevented access to people who do not have capacity and to minors, and offered greater protection for physicians’ conscience rights as well as for church-affiliated public health care institutions.

Neither the majority nor the minority reports used the words “coroner” or “medical examiners.” These government officers are death experts. Daily, in provinces and territories, they accurately report and monitor all non-natural, including suspected death by drug toxicity (which would include MAID), and many natural deaths. Explicit reference to coroners and medical examiners would have relieved concern that these government officers might not be consulted. This is a significant flaw in a report that, on balance, focuses on assisting the most vulnerable in Canada.

Politics will determine what parts of the Parliamentary committee report become law. Although the party that brought the Canadian Charter of Rights and Freedoms into the Constitution now has a majority of members in the House of Commons, the Prime Minister might not require Liberal Party members to vote along party lines on this Charter issue. 

The issue of assisted dying will continue to be a keen focus of Canadian public, media, and political attention as the huge demographic born between 1946 and 1964 marches toward the inevitable. Canada’s Supreme Court ruling means that eligible Canadians may soon legally choose the time and circumstances of their death.

If Canadian governments collaborate to implement the report’s majority recommendations and seek advice and direction from coroners and medical examiners, then Canada will have law concerning medical assistance in dying that aims bravely to address intolerable suffering of eligible individuals.

Juliet Guichon, Christopher Doig and Ian Mitchell are faculty members in the Cumming School of Medicine, University of Calgary; Pauline Alakija is a forensic pathologist and clinical professor at the University of Alberta medical school; Pascal Thibeault is a University of Toronto law graduate student and graduate of the Yale Sherwin B. Nuland Summer Institute in Bioethics.  This post has been updated.

Our genomic sequence constitutes the most sensitive and personal of information: uniquely identifying us, revealing our propensity to develop certain diseases and conditions, and exposing familial connections of close genetic relatives. In recent years, Big Data has taken firm hold in numerous sectors, revolutionizing the volume and velocity at which businesses can collect, curate, and use digital information. Consumers can track what they eat, their fertility, whether they are exercising, and how much they are sleeping. Combining these pieces of data with genomic and health information such as family history, health conditions, disease state, and demographic information constitutes a gold mine for scientific research.

 23andMe capitalized on the quantified self movement and consumers’ effusive willingness to collect and share personal data, transforming it into a highly profitable venture. Within the past year, 23andMe rapidly reinvigorated its business model, introducing Food and Drug Administration-compliant Carrier Screening Reports as part of its new Personal Genome Service, introduced on online recruitment platform for disease specific research cohorts, and publicized multimillion dollar partnerships with pharmaceutical giants such as Genentech.

In numerous media interviews, 23andMe CEO and cofounder Anne Wojcicki beams with positivity about how this model will revolutionize health care; empowering consumers with an awareness of the secrets of their genome while accelerating the speed of research and drug discovery. As one article in the San Francisco Chronicle characterized it, “23andMe wants to do for health what Google has done for the search: make massive quantities of information digital, accessible, and personal.” 23andMe made this vision a reality by digitalizing and compiling genotypic-phenotypic data into a searchable format for interested investigators to run queries in its Research Portal, an online searchable database of over genotyped individuals with more than 225 million phenotypic data points, including demographic, clinical information, and family history.

An exciting prospect for research scientists, but also attractive to many other business as well. The sheer amount of information 23andMe’s database makes it appealing to a number of external parties, including data brokers, the pharmaceutical industry, employers, health insurers, and law enforcement. Entities may want to use the data for predictive modeling and draw inferences to market a product, decide suitability for employment, deny life insurance coverage, or target suspects pursuant to a criminal investigation. These uses of the data pose significant informational risks: shame, embarrassment, discrimination, or being subjected to law enforcement investigations. Perhaps surprisingly, many of these secondary uses of the data are currently permitted by law.

Just how much information does 23andMe collect? Much more than consumers may imagine unless they read the fine print. Purchasing the test and submitting DNA creates a potentially indelible electronic record of your genomic sequence in 23andMe’s database, along with a composite mosaic of additional health, lifestyle, and consumer-generated personal details. In addition to the information the consumer actively sends, 23andMe employs numerous techniques to collect and track additional details through social media, web beacons, and consumer IP addresses such as compiling personal photos, place of employment, a record of every website the consumer clicks on, and real time tracking of the consumer’s location. 23andMe uses this data internally for marketing purposes and shares the data for research if the consumer provides consent.

But the fine print also contains a provision that permits 23andMe to unilaterally modify its privacy policy at any time, effectively changing current promised limitations. Wojcicki’s positive intentions aside, she is not the sole party controlling the data. If 23andMe follows in Google’s footsteps, then the private information may not stay private. Indeed, Google Ventures managing partner Bill Maris (a financial supporter of 23andMe) has dismissively challenged, “What are you worried about? Your genome isn’t really secret.” If 23andMe modifies its policy to widely sell consumer data without consent, the lightning nature of electronic data sharing means Pandora’s Box is open.

How is this possible? In addition to expediting the process for research, 23andMe also challenged the traditional regulatory and ethical requirements that ordinarily correspond to collecting and disseminating private genomic and health information. The massive paradigm shift to collecting genomic and health information in the commercial arena, as opposed to the health care setting, means the transaction may occur outside the scope of regulatory structures designed to ensure informed consent when subjects provide DNA and to protect health data privacy.

 The HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule does not apply to consumer curation of health data or any associated protections related to privacy, security, or minimizing access. Similarly, unless a commercial entity conducts research that is supported by a federal department or agency, such as NIH funding, regulations set forth in the Common Rule will not govern that entity’s practice. Even though 23andMe receives NIH funding, 23andMe currently asserts that its data-mining analysis does not constitute research on human subjects under the current version of the Common Rule because it de-identifies the data. This stance is significant because it means 23andMe believes any consent it obtains to retain, use, and share consumer data is not necessary for regulatory compliance, but rather constitutes a transactional courtesy.

The traditional informed consent dialogue intended as a means to convey risks and benefits shifts dramatically when the consent process occurs online via consumer interaction with a website clickwrap interface rather than a physical contact person from the research team. Clicking through to purchase the test constitutes an entangled package consisting of a service, agreeing to receive medical information, and research. Recent litigation over 23andMe’s model of presenting its terms reiterates that just because you don’t read the fine print does not mean you can claim those terms are unfair and erase your decision.

Consumers may be blinded by the genomic technological imperative to know and widely share their genetic profile or assuaged by notions of altruism highlighting their contribution to important scientific research. They may bypass reading the fine print, or alternatively, they may not fully appreciate the implications of the transaction. Read the policies closely, and read them carefully, to assess whether the benefits outweigh such looming informational risks.

Katherine Drabiak,JD, is an assistant professor in the Department of Health Policy & Management, Department of Global Health, at the University of South Florida College of Public Health.

Given these concerns, in 2003 the Accreditation Council for Graduate Medical Education (ACGME), the private accrediting organization that oversees American graduate medical education programs, imposed limits for the first time on resident physician work hours. One key requirement was that resident physicians’ work shifts be limited to no more than 30 hours of continuous patient care duty. However, many patient safety advocates argued that the 2003 ACGME requirements fell short in preventing fatigue-related harms to both resident physicians and their patients.

In 2008, at the request of Congress, the Institute of Medicine (IOM) published a report outlining the increased risks of work shifts up to 30 hours in duration for trainees–including increased risks of motor vehicle accidents, exposure to blood-borne pathogens (for example, from needle sticks), and depression—and the risks to their patients as a result of medical errors. The IOM report recommended that trainee work shifts, regardless of level of training, be limited to no more than 16 consecutive hours of patient care duty, after which a protected sleep period of at least five hours was recommended. As a result, in 2011 the ACGME imposed additional restrictions to limit trainee duty hours. According to the current requirements, first-year trainees are limited to performing no more than 16 continuous duty hours; upper level residents are limited to 28-hour shifts, during which “strategic napping” is encouraged. To comply with these duty hour restrictions, many programs had to adopt new models to provide patient care, with shifts requiring multiple handovers of patient care between trainees.      

There has been increasing concern that the duty hour restrictions have adversely affected the educational experience of trainees by limiting the continuity of care they provide, and that they introduced a different source of medical errors due to the handovers of care. There has not been consistent evidence that shorter continuous duty hours for trainees translates into safer patient care by reducing fatigue, yet there is rising concern that shorter shifts are compromising the trainees’ educational experience. As a result, there has been interest in comparing patient outcomes and resident satisfaction resulting from the two different approaches to scheduling trainees’ duty hours.

The FIRST trial has attempted to provide this comparison. The trial was conducted at 117 general surgery residency programs across the country. Each participating residency program, and by extension the trainees in the program, was randomly assigned to either the control arm that conformed to the current duty hour restrictions as imposed by the ACGME or to an experimental arm that allowed a flexible duty hour schedule, permitting shifts of unlimited duration. As such, the surgical patients of participating hospitals were also randomly assigned to be cared for by resident physicians of varying duty hour schedules.

The ACGME provided funding for the study and granted a waiver to all participating programs assigned to the experimental arm, allowing flexible schedules that did not comply with the current ACGME limits on consecutive work hours; programs in the experimental arm were still required to adhere to a maximum duty limit of 80 hours per week, averaged over a four-week period. The study groups were compared with respect to patient outcomes, including the rates of 30-day postoperative death or serious illness, and resident outcomes, namely a self-reported level of satisfaction with the overall quality of resident education and well-being.

The FIRST trial has been criticized as unethical by the advocacy group Public Citizen, the American Medical Student Association (AMSA), and the Committee of Interns and Residents/SEIU Healthcare for inadequate protection of the human subjects involved in the study. The protections of the Common Rule require that risks to human research subjects are minimized; that the potential benefits to the subjects, if any, and of the knowledge expected to be gained by the study outweigh the risks posed to the research subjects; and that subjects provide informed consent prior to participation. In the case of the FIRST trial, however, the institutional review board (IRB) office of the lead institution, Northwestern University, determined that the trial was not human subjects research. The lead investigators therefore advised participating institutions, “we do not believe local IRB approvals are needed. . .” Thus, the standard protections for human subjects participating in research were not extended at some, and perhaps all, participating institutions (information that has not been made public). Herein lies a first-rate oversight and regulatory failure.

The investigators have claimed in their IRB form for determining whether a project involves human subjects research that “the project is limited to the use of existing and/or prospectively collected coded private information . . .” and that “the private information . . . were/are not collected specifically for the currently proposed research project through an interaction or intervention with living individuals.” The investigators adhere to the position that since the intervention occurred at the level of the residency program, and the outcomes data collected was confined to mining a de-identified, validated database of surgical outcomes and the anonymous responses of a nationally administered resident survey, that no interaction or intervention with individuals occurred. It is an intriguing premise, but flawed in the dehumanization of the subjects randomized by their association with the program.

 The practice environment for the 4,330 residents and the care environment for the 138,691 patients involved were most certainly manipulated for research purposes; therefore the residents and patients were subject to the intervention of a systematic investigation and, in fact, were human subjects. While the study was not funded by federal entities, as Public Citizen’s Michael Carome describes, “the FIRST trial almost certainly was conducted at institutions that extend their OHRP-approved Federalwide Assurances (FWAs) to all research, regardless of funding.” The subjects of the trial therefore should have been protected under the Common Rule.

Public Citizen and AMSA contend that in assigning trainees to flexible duty hour schedules that were allowed to approximate “the old way” of 28-plus hours of continuous duty, the FIRST trial placed the trainees, particularly first-year residents in the intervention arm, at an unacceptable increased risk of motor vehicle accidents, occupational injury, and depression. Because the investigators were tracking patient safety outcomes, it can be assumed that the flexible-duty hours intervention had the potential to pose more than minimal risk to patient subjects. Yet the subjects of the trial, including both trainees and their patients whose outcomes were tracked, were not provided the opportunity to consent or withdraw from the study due to the “cluster randomization” procedure affecting all of the trainees and patients within a particular center.

In the ongoing iCOMPARE study, a similarly designed trial investigating flexible duty hours among internal medicine residency programs, the designated lead IRB at the University of Pennsylvania recognized the study as human subjects research, but determined that informed consent of both resident and patient subjects could be waived. The Penn IRB found that “iCOMPARE could not practicably be carried out without the waiver . . .” given the cluster randomization design. As with the FIRST trial, Public Citizen and AMSA have criticized iCOMPARE as unethical due to the risks posed to the subjects, and also have alleged inappropriate application of the waiver of informed consent requirements.

The FIRST trial investigators were transparent in their expectation (see “expected results”) that the study would demonstrate no difference in outcome between groups, and thus provide support for a movement to return to more flexible duty hour schedules with longer shifts. The investigators’ agenda, however, may have compromised the scientific validity of the study. The design of the intervention arm allowed for significant variability in implementing the experimental schedule, even allowing the “intervention group” to structure a schedule similar to the control group’s ACGME compliant schedule, and thus reducing the probability of finding a difference between groups. Indeed, the “Flexible-Policy Group” in the trial is reported to be “100% adherent” to the policy of allowing interns’ duty hours to exceed 16 hours, however no data regarding the actual length of time residents worked is provided. The questionable study design, lack of informed consent process, and exposure of subjects to increased personal risk are all problematic from an ethical perspective.

I imagine that institutions justified their participation in the FIRST trial without IRB approval by invoking what I shall call a “regulatory misconception.” Graduate medical education trainees are an inherently vulnerable population, with limited autonomy under the best of conditions. Trainees must conform to the standards of the program in which they are enrolled. They often have little to no control over their schedules or prescribed curriculum, which are regulated and standardized by the ACGME. Thus, when the ACGME waived the typical duty hour restrictions and provided funding for the trial, there was an appearance of a regulatory approval by the body whose primary role is “assessing and advancing the quality of residents’ education” (ACGME mission statement), despite the lack of regulatory approval by a body providing research oversight.

 The FIRST trial attempted to answer an important question. With a paucity of evidence that duty hour restrictions have improved patient care, and with continued concern that the educational environment has been harmed by the same restrictions, the educational community needs a rigorous investigation of different paradigms to maximize both resident education and patient safety. It is only through high quality, evidence based research that we can move forward with meaningful educational reform. But we must recognize such research endeavors as human subjects research, and in so doing, promote the safety and autonomy of the subjects. The FIRST trial failed in this regard and we must not allow it to set a dangerous precedent of regulatory failure for research within medical education. We owe this to our trainees, our profession, and above all, to the patients we serve.

Nicole Chiota-McCollum, MD, is a vascular neurology fellow at the University of Virginia.

In Flint, home to an estimated 1,000 undocumented immigrants, reporters from Michigan Radio and Think Progress  have described the challenges of getting clean water and timely, accurate information to this Spanish-speaking population.  People who don’t answer a knock on the door can’t receive supplies and information being provided in that way by the National Guard. People who fear engaging with authorities or who cannot provide ID will have great difficulty obtaining supplies and information that requires going to a public place (and showing ID). People who lack reliable sources of information in their own language will rely on word of mouth, or conclude that there is no problem.

Door to door canvassing coordinated by a community-based Hispanic/Latino organization found that in late January most immigrants still had no idea that they should not drink the water: the message known to the nation simply had not reached them. This low-income population’s underlying lack of access to health care and the means to pay for health care are other foreseeable challenges to identifying, testing, and providing ongoing health care to infants and children who may have been exposed to high levels of lead. Even when U.S.- born children are eligible for public insurance, children whose parents are undocumented tend to be less likely to be enrolled in insurance or to receive primary health care, compared to children whose parents are citizens or legal residents.

One of the many lessons of the failure of public officials to protect the people of Flint is that public health and population health is affected by immigration policy, which itself does not seem to be about health. Because undocumented immigrants are part of this nation and its economy, and live in every state and in urban, suburban, and rural communities, public health planning and emergency response systems should always account for this population, which may be reluctant to call attention to itself, or unaware that a crisis is unfolding.

Nancy Berlinger is a research scholar at The Hastings Center, where she codirects the Undocumented Patients project. Caroline Rath is a physician assistant and public health consultant who has worked with immigrant populations in New York City and the Arizona/Mexico border region; in 2013, she completed an internship with the Undocumented Patients project as part of her MPH degree from the City University of New York.

But the CDC’s graphic is not about fetal health: it highlights the risks of excessive drinking for women. The reason it does this is simple: since, according to the new recommendations, any amount of alcohol can harm even the least developed fetuses, and women often do not know that they are pregnant for several weeks after their first missed period, it follows that any woman who might become pregnant (to the CDC, that means any sexually active woman not on birth control) should abstain from alcohol.

The logical train that gets you from “alcohol is bad for fetuses” (which – let me be clear – nobody is questioning) to “sexually active women not on birth control should not drink” is more of a logical rollercoaster, but it’s worth the ride. It rests on a series of flawed assumptions, each with damning implications. It’s worth noting that these assumptions come through much more in the graphic than in the report itself. But the graphic is the way that the CDC has chosen to convey these findings; therefore, it’s neither pedantic nor petty to take exception with it.

The first assumption that it makes is that “women” equals heterosexual cisgender women. Now, you might say, hold on a second – I know that “women” includes queer ladies and transgender ladies, and that many agender folks have uteruses. But isn’t that splitting hairs when the important thing is to tell women who might unknowingly be pregnant that alcohol could harm their fetuses? I might agree if the CDC had not couched its treatise on fetal alcohol syndrome prevention under the banner of “Drinking too much can have many risks for women.” The CDC is addressing all women (or does it mean all people with uteruses?)  – and seriously missing some of them.

The second assumption is an even more bizarre one, and involves what the CDC seems to understand to be women’s relationship to pregnancy. By telling women that they should not drink unless they are on birth control, the CDC is targeting its message to those women who do not want to become pregnant (they would, presumably, be the ones going on birth control in order to drink under their guidelines). The CDC makes this case by, in part, elucidating the risks that alcohol poses to the fetus – miscarriage, stillbirth, fetal alcohol syndrome, etc. But in the context of a pamphlet that outlines the risks of excessive drinking to a woman’s health, why frame the harms in terms of the risks posed to an unborn – and unwanted – child? Is the CDC saying that even women who are not ready to have a baby should prepare for the possibility, if they are not using birth control perfectly (or it fails), of both becoming pregnant and deciding to keep the baby? That is the only case I can come up with in which these recommendations are really valid. But the graphic is saying so much more than that.

The graphic highlights the dangers of excessive alcohol consumption for women. But excessive drinking is bad for people, full stop. The CDC wouldn’t find itself embroiled in controversy for enumerating the many ailments that excessive drinking can foist upon humans. And if what the CDC means to do is to publicize the dangers that alcohol – any alcohol – can pose for unborn children, then it should have done just that, rather than layer those warnings within broader grandstanding about women’s health. What the CDC has done, instead, is to characterize women as vessels for children who, once burdened thusly, defer their health responsibility to their fetuses. It fails to account for the other options that women have during unwanted pregnancy, for one, but more importantly, as was pointed out in the New York Times, defers the crux of the problem from birth control – something that can and should involve all parties engaged in potentially babymaking sex, and genuinely does merit more public education – back to the women’s autonomous behavior.

This brings me to the final, and in my view, most critical, misplaced assumption. Drinking too much for “any woman,” according to the CDC, can have the following risks: injuries/violence, heart disease, cancer, sexually transmitted diseases, fertility problems, and unintended pregnancy. In a pointed op-ed in the Washington Post, Alexandra Petri does an excellent job of pointing out the preposterousness of such a list. “Who knew that drinking alcohol could give ‘any woman’ a sexually transmitted disease,” she asks. “That’s the last time I drink merlot alone in my apartment. I don’t want herpes. Furthermore, I had no idea that drinking eight beverages a week could result in a baby. I always thought, somehow, that there were other activities involved. But the CDC knows best.”

What the CDC is saying is an echo of what women and girls have always heard: Drinking too much can make it so that you cannot fend off unwanted sexual advances, so that you are the target of other people’s violence, so that you can’t protect yourself adequately from someone else giving you an STD, so that someone might get you pregnant. This list assumes that women are responsible for – and responsible for preventing – the actions of others.  As Petri points out, none of these things can actually happen to women drinking alone: thus, none of them are specifically risks of alcohol consumption. Perhaps they are the risks of being a woman in a world in which these things happen, or the risks of sex with a deceitful partner, or the risks of sex itself, but each of these bad outcomes requires at least the involvement and at most the evildoing of another party.  

This graphic is a publication that shouldn’t merit further consideration as a policy recommendation. It’s poorly designed, and I’d imagine that as I write this, the CDC is trying as hard as it can to backtrack away from it. But it deserves the press that it’s getting as a rhetorical devise, and the ridicule that it’s received, for the simple reason that what the CDC says matters. It is one of the most influential health organizations in the world. It is where regular people turn to understand what to feed their children, to figure out if their vacation will put them at risk, and how to fight off the flu. And so when it tells women what to do with their bodies – because that’s how it’s being interpreted, even if that’s not what the CDC meant – people notice. And so it matters when what it publishes legitimates generations of taking the easy way out of solving real problems of violence against women, poor sexual health education, and unwanted pregnancy: the same logic that connects revealing clothing or friendly interest to women being assaulted undergirds the assertion that injuries, violence, and STDs are risks of excessive drinking for women.

Elizabeth Dietz is a research assistant at The Hastings Center.

It’s not surprising that this came up for the first time in New Hampshire, which borders Vermont, whose Oregon-type provision for physician-assisted dying has been in place since 2013, and Massachusetts, where similar legislation is pending after a ballot measure was narrowly defeated in 2012.  Kinhan has written about his support for pending legislation in New Hampshire that would commission a study of the issue.

Clinton’s response was far from a polished sound bite, but the transcript suggests that she views aid-in-dying as a question of public importance, one that people “deserve to understand” whether or not it is an option they would choose for themselves. She concluded her remarks in a way that those who follow this complex issue will recognize as thoughtful – interdisciplinary, cross-cultural, and attentive to evidence, experience, and diverse moral perspectives:

"So I don't have any easy or glib answer for you.  I think I would want to really immerse myself in the -- the -- the ethical writings, the health writings, the scientific writings, the religious writings.  I know some other countries, the Netherlands and others, have a quite open approach.  I'd like to know what their experience has been. Because we - we have to be sure that nobody is coerced, nobody is under duress. And that is a difficult line to draw." 

The headline of the Washington Post article said that Clinton was “stumped” by Kinhan’s question. It was an odd word choice. Ethical issues of public importance, with complex legal, medical, and social dimensions, rarely have easy answers. Kinhan himself told the Post that, “I was pleased she was being open and frank . . . I respected that.”

Nancy Berlinger is a Hastings Center scholar. Her most recent book is Are Workarounds Ethical? Managing Moral Problems in Health Care (Oxford University Press 2016). She is the lead author of The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care Near the End of Life: Revised and Expanded Second Edition (Oxford University Press 2013.

The World Health Organization will hold an emergency committee meeting on the pandemic reemergence of Zika virus and the explosive increase in reported cases of congenital microcephaly in Brazil possibly linked to Zika on February 1. The virus is a mosquito-borne infection in the same family as West Nile and dengue. Until 2015, Zika had rarely appeared in the Western hemisphere. The WHO will decide whether the pandemic should be considered a public health emergency of international concern. Hastings Center Fellow Lawrence Gostin and Daniel Lucey suggested that “the very process of convening the committee [will] catalyze international attention, funding, and research.”

Much of the fear and uncertainty around Zika stems from a suspected association between pregnant women infected with Zika and risk of their babies being born with microcephaly, a birth defect characterized by an abnormally small head and brain damage. But much remains unknown about transmission and diagnosis. Christian Pettker, chief of obstetrics at the Yale School of Medicine, wrote in the New York Times, “Fear of these unknowns explains the severity of some of the responses from the medical community,” like telling women in areas with active Zika transmission to avoid pregnancy.

In a December 2015 article in the South African Medical Journal, Solomon Benatar, a bioethicist at the University of Cape Town and a Hastings Center Fellow, reviewed the ethical challenges presented by the 2014-2015 Ebola outbreaks in West Africa and offered lessons for future public health emergencies. Benatar’s account of the “interpersonal, public health and global” levels of ethical challenges offers a helpful framework for understanding what is at stake in the Zika pandemic and concerning other zoonotic (animal to human) diseases.

Interpersonal professional ethics demands engaging with questions about where and how experimental Zika vaccines will be developed, tested, and deployed. The Brazilian government and the National Institute of Allergy and Infectious Disease (NIAID) in the US have begun directing funds toward developing a vaccine. Zika vaccine candidates and public health interventions aim to benefit countries in the global South, where the virus is currently spreading. It seems to make sense to test drugs on consenting research participants in afflicted areas within this region. However, clinical research participants from middle- and low-income countries can be vulnerable to exploitation.  

Notorious examples of this include the unethical placebo controls in AZT trials in Africa aimed at preventing mother-to-child transmission of HIV. Similarly, particular communities in Central and South America may recall being medically experimented on as part of research efforts supported by the US, e.g. the Guatemalan syphilis study and the Norplant study in Brazil. Hastings Center Fellow Ezekiel Emanuel et al have suggested that clinical research in middle- and low-income countries has historically created a greater risk of exploitation: “individuals or communities in developing countries assume the risks of research, but most of the benefits may accrue to people in developed countries.”

However, experts estimate that a Zika vaccine is possibly 3 to 10 years away. Right now health advisories from particular countries in Central and South America include aggressive mosquito control, travel postponement for pregnant women – and even that women delay their pregnancies. Monica Roa, programs director of Women's Link Worldwide, an organization devoted to the human rights of women and girls, said on NPR that this last recommendation as “naïve and ineffective.”

As Benatar suggests, the field of public health ethics is not fully developed yet, but it asks questions related to the role of national governments, trust in those governments, and the strength and preparedness of local health systems. What additional responsibilities fall upon affected states – some of which, like Ecuador, limit access to contraception and ban abortion – to supplement these recommendations with informative public health campaigns? What additional responsibilities fall upon states to shore up the preparedness of health systems that might have to care for babies born with microcephaly and their families?

A WIRED article points out that elective abortion is illegal in Brazil, where increases in the Zika infection and congenital microcephaly have been most pronounced. Abortion is only permitted in Brazil to terminate a pregnancy resulting from rape, to save a pregnant woman’s life, or to prevent anencephaly or other malformations “incompatible with extrauterine life.” Roa suggests, “In the countries where the law doesn't allow for [abortion], I think the debate [about reproductive rights] should be on the table and discussed in the context [of Zika virus infections].”

While public health ethics allows us to examine possible future directions for the responsible management of this pandemic, global health ethics asks, “How did we get here? What social and economic imbalances of power led to this outcome?”

Along these lines, Amy Vittor, an assistant professor in medicine at the University of Florida’s Emerging Pathogens Institute, wrote in The New York Times, “Indeed, the outbreak is a symptom of a larger problem that has gone unaddressed for the world’s poor. Lack of running water and waste management, in conjunction with urban crowding and poor housing, has given rise to the perfect set of conditions for the transmission of such mosquito-borne viruses. Mosquito control measures and heightened surveillance are absolutely critical in the immediate response, but to address the underlying conditions that give rise to epidemics such as Zika, we must address urban poverty.” 

Wearable devices, social media platforms, and smartphone apps are increasingly being seen as new data sources, capable of capturing complex and continuous personal health information that is relevant to understanding health and disease (see for example here, here and here). This trend has opened the way for major consumer tech companies, which have had little interest in health care in the past, to enter the space of medical research. From Apple’s ResearchKit, which allows researchers to carry out medical studies on iPhones, and the company’s reported forays into DNA collection, to Google’s Baseline Study, which aims to paint a picture of “what it means to be healthy” based on data collected on its devices, and Google Genomics, a cloud service for genomes, Silicon Valley is intent on revolutionizing medicine.

Indeed, in comparison to the new methods of acquiring and managing data that these technologies enable, traditional research models like the randomized control trial feel painfully slow and restricted to small populations, while the computer capacities of universities and hospitals seem antiquated. In the terms we have become accustomed to hearing from Silicon Valley, medical research appears ripe for disruption. As the call for essays and some commentators have pointed out (here and here), however, disruptive innovation in the medical field raises a number of ethical issues that it would be important to think through before the revolution goes forward.

These ethical issues can be grouped into three types, those pertaining to: 1) research ethics, 2) privacy and data protection, and 3) new power asymmetries that can affect future research agendas.  

Conducting research via a smartphone, which collects data through its various sensors, through surveys, or by pulling data from other apps and wearables, poses a number of questions that stem precisely from the less rigorous nature of digital data collection that is promoted as its biggest advantage. Researchers have voiced concerns, for example, about the quality of self-reported data and the possible burden of an overload of “dirty” data (apps do not know if participants are who they say they are, or if they actually have the condition being researched), while the question of the accuracy of wearables and tracking devices is ongoing.

Informed consent in the digital context is another point of contention. Digital consent differs from traditional means of consent in that participants do not benefit from a face-to-face encounter with researchers during which they can raise questions. With ResearchKit studies, participants are shown images and sometimes short videos that help them understand how the study will run, and then they are quizzed about the material in a “yes” or “no” manner. But there is no possibility to ask for further clarification. However, some researchers view digital consent as one of the more exciting aspects of the ResearchKit, allowing participants to read and give consent at their own pace, in their own home.

Another area of concern involves new types of population bias that may be inherent to research enabled by mobile technologies. ResearchKit in particular has come under such criticism. The large majority of smartphone users worldwide do not use iPhones, but iPhone users tend to be younger, better educated, and wealthier than other smartphone users. As this piece points out, ResearchKit users will skew towards a demographic that is quite different than the one typically affected by the main diseases that the first ResearchKit apps are studying, such as cardiovascular disease and diabetes.

One of the most pressing concerns, of course, is privacy. Health-related consumer apps occupy an ambiguous space between the highly regulated medical domain and less regulated consumer market, and privacy rules for health information do not necessarily apply to consumer apps. This data can be – and typically is – shared and sold in ways that users are not aware of. Apple does require that apps created using the ResearchKit have an IRB approval, and has stated that it will not see data collected via the ResearchKit, which should be de-identified. Currently, for example, some of the institutions using ResearchKit are working with Sage Bionetworks, which receives and anonymizes data before it is sent to researchers. But a number of studies have now demonstrated that anonymization can no longer be guaranteed (see here and here), and as health data becomes increasingly valuable, the incentives to hack, steal, and sell it will grow.

Furthermore, the privacy policies of all the apps, activity trackers, and smart scales that Apple’s HealthKit and Google Fit connect with in order to collect data are also at play here. Apple saying it won’t look at this data is one thing, but it’s difficult to imagine Google or Facebook making this claim, given that the revenue of these companies depends on the collection of personal data. Anonymization often clashes with financial interests. Google Fit, for example, could be an additional means for Google to tap into specific health-related data to sell to pharmaceutical advertisers.

The implications for research ethics and privacy that these new data collection and research approaches entail are complex and require careful reflection. But insofar as the devices and services that generate, store, and in some cases analyze these data are owned by commercial entities that are outside traditional health care and research, we also should be attentive to  new power asymmetries that may emerge in this space, and their implications for the shaping of future research agendas.

Much of the enthusiasm surrounding research using data generated from social media and mobile technology stems from the easy access to large data sets. But if for-profit companies become mediators, gatekeepers, or proprietors of data sets that are to some extent considered a public good, the question of who gets access, for what purposes and at what cost needs to be considered. Companies could restrict access to data sets either to their own researchers (Google and Apple are recruiting, see here and here or to researchers from institutions that pay the right price. This may create a new kind of digital divide between big data “haves” and “have-nots,” based on access to and control over new technological infrastructures, databases, and forms of expertise, as a number of social scientists have begun pointing out.

We may also question the nature of the new research partnerships being struck between research institutes and tech corporations. Terminology can be telling: the announcement on Duke’s website of its collaboration with Google on the Baseline Study read, “Duke and Stanford to Assist Google X” – not the other way around. As philosophers and sociologists of science have argued, who asks questions in science determines which questions get asked. In this context, we might expect to find new biases in the types of research that emerge.

If new ways of generating large datasets and new methods for analyzing them can propel health care and medical research into the future, as some commentators maintain, then what is at stake here is the question of who will be in control of future research agendas. In light of the implications for research ethics and privacy touched upon here, we need to carefully reflect on how disruption is being carried out, but also on who should be driving it.

Tamar Sharon is an assistant professor of philosophy of technology at Maastricht University, NL, and a member of the Data and Information Technologies in Health and Medicine Lab, King’s College London.

Last June, the direct-to-consumer genetic testing company 23andMe announced that it had reached the milestone of 1,000,000 genotyped costumers. While the company celebrated this milestone as a “turning point” in genetic testing, we believe it is in fact cause for concern. Our concern is that the growing importance of 23andMe’s database as a resource for research – and recently also a recipient of public funding – will aggravate existing biases in disease research, leading to impoverished knowledge and exacerbated inequalities.

For over a decade, studies have drawn attention to the stark underrepresentation of people of non-European descent in genomic research. Some authors have also criticized the lack of a systematic effort to remedy this. Although several initiatives have attempted to increase population diversity in research-oriented genomic databases, the number of genotyped participants resulting from these programs is still relatively small. The Exome Aggregation Consortium (ExAC), which some geneticists consider to be one of the most useful resources ever for variant assessment thanks to the wide range of ethnic groups represented, currently holds genetic data from around 90,000 people. Moreover, attempts to aggregate datasets from different provenance, as ExAC has done, come with its lot of thorny challenges. One is the amount of labor that is needed to ensure the compatibility of different datasets with a common data model before they can be combined. ExAC has struggled with this, and sometimes the obstacles faced by projects to “scale up” and integrate existing datasets are so high that it seems more effective to build new databases from scratch.

 Against this backdrop, the idea that the underrepresentation of certain ethnic groups in large datasets can be fixed by integrating dispersed small datasets together appears unrealistic, and thus the fact that 23andMe owns the world's largest health DNA database (aside from forensic DNA collections) makes the issue of representation of genotyped participants especially critical.

How diverse is the population in the 23andMe database? Little information is available on the demographics of users of DTC personal genomic testing. We are aware of four surveys, all U.S.-based, conducted from 2011 to 2015: see here, here, here, and here. Although the later studies better represent ethnic minorities and socio-economic background, the findings are overall consistent: white, educated, and affluent groups seem to be starkly overrepresented among the users of DTC personal genomic tests.

Expanding privately owned datasets is likely to exacerbate health and health-research disparities. This, in turn, may skew research towards those conditions that affect educated, wealthy, white people, either because they can be more easily studied or because the company and its investors are most interested in developing therapies for people who can afford to pay for them.

Beyond exacerbating health and health-research disparities, expanding privately owned datasets may also represent an impoverishment of data and knowledge that contrasts starkly with the promises of data abundance and unbiased research that accompany data-driven genomics. Every instance of data gathering, coding, exchange, and analysis requires researchers to make methodological decisions that depend on their interests, resources, and access to relevant groups. If the datasets required to pursue a specific research question are not there and no resources are available to gather them, then this question will not be answered. This is a moral issue as well as a scientific one.

Issues of representation are not limited to problems of external validity and social utility of research, but include disempowering effects in research agenda-setting for disadvantaged groups. Paradoxically, even some participatory features of genomics and ancestry companies could exacerbate the issue of representation. For example, 23andMe encourages customers to suggest new research questions and projects, and upload information on phenotypes and lifestyles. However, if such customers disproportionately represent certain segments of the population that already have “voices” in research agenda-setting, even promising developments of medical research towards more participatory models can go astray.

It might be objected that these considerations of, broadly speaking, social justice in research do not apply to the private sector. There is indeed a difference in the extent of the obligations the public and private sectors have with respect to issues of social justice. It is the former that is in charge of providing social goods. However, the public sector often fulfills its duties with regard to social justice by guiding and regulating the behavior of the private sector, and especially so when it has been decided that a particular good – in this case genomic datasets for research – is to be produced by private companies. This is the case as public money is directly channeled into the expansion and use of privately held databases. Though a $1.4 million grant by the National Institutes of Health to 23andMe  is not be high in comparison to the total NIH funding for genomic research, it has a symbolic value. It legitimizes this type of approach to building genomic databases, even as the NIH openly complains about the cost of supporting biology databases and the NIH genome institute (NHGRI) announces its plans to scale back support of  genomic (and other “omic”) databases.

The expansion of datasets collected by private companies poses other moral and organizational questions. In contrast to public biobanks where information on demographic features of samples is not proprietary and can be accessed by researchers and sometimes also by the public, at the moment private companies have no accountability in this regard.  If these private enterprises are to receive public funding, they should submit themselves to public governance with regard to key strategic questions.

Today, through the sheer weight of numbers, private companies dominate the sector of genomic datasets and personalized medicine. Given their remit and their commercial strategy, we should think about ways to improve on recruiting strategies for DTC companies, nudge their R&D departments towards studying these issues, and make public funding conditional to the disclosure of demographic information and the enactment of mechanisms of oversight. We should strive to prevent data abundance from impoverishing genomic research and exacerbating current inequalities in the allocation of research resources.

Less than two decades ago, a publicly vocal, and at times bitter, race took place over sequencing the whole human genome. At stake, was the disputed question of whether the human genome sequence should be public knowledge or could be privatized towards commercial ends. Should the fact that today, the largest DNA database is held by a private company not make us pause and reflect?

The authors are with the Data and Information Technologies in Health and Medicine Lab,Department of Social Science, Health and Medicine, King’s College London.

Texas and other states have argued that they will suffer injury due to the consequences of the executive action on state expenditures. Texas, for example, has restricted drivers’ licenses to immigrants who are “lawfully present.” According to an August 2015 report from the Pew Charitable Trusts, 10 states plus the District of Columbia issue drivers’ licenses to qualified drivers without restrictions based on immigration status; most states exclude undocumented immigrants. Because the process of enrollment in a federal program such as DAPA or DACA involves a determination that an individual is lawfully present, increasing the number of immigrants who are lawfully present also increases the number of people who may be eligible for drivers’ licenses.

What’s the connection to health care access?  For an undocumented immigrant, the process of securing relief from deportation by securing “deferred action” status through a mechanism such as DACA or DAPA involves being designated by the federal immigration system as Permanently Residing under Color of Law (PRUCOL). A person designated as PRUCOL is known to the immigration system and is unlikely to be deported. While undocumented immigrants are ineligible under federal law for a range of federally-funded benefits, it is up to each state to decide which state-funded benefits are available to this population. Some states have long used PRUCOL as a threshold for providing some benefits to undocumented immigrants. Notably, New York and Massachusetts permit state residents who are PRUCOL to apply for Medicaid.

The 2012 executive action that created DACA also created a large new PRUCOL population, raising fresh state-level questions about health care access.  If some undocumented immigrants were now eligible for state-issued driver’s licenses, why not also state-funded health insurance? In 2013, California answered this question by extending Medi-Cal  to income-eligible residents enrolled In DACA.  If the 2014 executive action is upheld by the Supreme Court (look for arguments in April and a decision in June) and implemented in the last months of the Obama administration, many more undocumented immigrants could secure public health insurance in these three large states.

Nancy Berlinger is a research scholar at The Hastings Center and the co-director of the Center’s Undocumented Patients project.

I said that in focusing on abstract science and policy arguments against right to try laws, experts (and here I meant to include ethics experts) have neglected the power of stories.

Patients’ stories are the currency of right to try advocates. But the stories advocates tell fail to convey the full range of patient experiences with relatively untested drugs. In my view, right to try critics would be more persuasive if they told patients’ stories, too. Legislators and the public should hear stories about the burdens and disappointment that can follow a resort to last-chance drugs. I referred to one such story in my column and describe more of them in a June 2015 Texas Law Review article, “The Right to Try Investigational Drugs: Science and Stories in the Access Debate.”

Twenty-four states in the nation have right to try laws. I congratulate Kearns and Caplan on persuading New York and Connecticut legislators to take a careful look at right to try proposals in their states. Adding patient stories to the discussion could help right to try critics accelerate this trend. 

Rebecca Dresser is a professor at Washington University in St. Louis and the author of When Science Offers Salvation: Patient Advocacy and Research Ethics.

Rebecca Dresser offers a much-needed and timely review of the current right to try movement in “‘Right to Try’ Laws: The Gap between Experts and Advocates” She raises several important points often overlooked in the rush by policy-makers and the public to help terminally ill patients.

First, Dresser highlights the fact that the laws do not actually reduce the Food and Drug Administration’s involvement in the approval process for unapproved therapies. And she writes that, in any case, experts and scientists (and, we would add, ethicists) see little benefit from loosening FDA restrictions. She also notes that pharmaceutical companies’ preapproval access programs are inadequate to meet patient demand. More important is her observation that patients facing death may overestimate how much an unapproved drug might help them while failing to grasp the very real harm it can cause.

But the most important point Dresser raises is that right to try laws do not obligate manufacturers to grant access to the drugs being sought. Not one of the now 24 state laws on the books compels manufacturers to act. Yet article after article—by patients and advocacy groups, by editorial and opinion writers, on social and in mainstream media—hails such laws as last-chance lifelines for very sick people who have exhausted all other treatment options. As Dresser points out, lawmakers can make political hay out of these bills. (After all, there’s nothing to lose and plenty to gain politically from giving the impression of rescuing the desperately ill.) This hollow promise made by the right to try movement—feel-good legislation that terminally ill patients are only too eager to believe—is a chief reason that ethicists oppose the laws.

We do, however, take issue with Dresser in some places. The first is with her contention that commentary on right to try legislation has tended to focus on abstract scientific and policy considerations. In response, we would direct her to the website of the New York University Langone Medical Center Working Group on Compassionate Use and Pre-Approval Access, of which we are both members, and Caplan a founder. There she’ll find dozens of articles, by group members and others, on right to try legislation. Some appeared in peer-reviewed journals, but many others were in mainstream outlets (in national and local newspapers and on network news, patient advocacy, and health care websites). Contrary to what Dresser suggested, we clearly and, we believe, convincingly argue against access to unapproved drugs until ethical safeguards are put in place. The articles are easy to follow; writing them to be so is not that hard to do, because the laws are unethical as written: they can lead to increased suffering in already-suffering patients, and they hold out false hope. Those aren’t complex objections, and they aren’t difficult to articulate plainly. And, of course, many, if not most, of the articles emphasize the “negative impact liberal access [to unapproved therapies] can have on individual patients,” which Dresser felt was lacking in the literature.

Finally, Dresser complains that opponents to right to try legislation haven’t engaged policy-makers “much.” Members of our group have written many opinion pieces on the laws. Recently, we contributed op-eds to the major daily newspapers of Hartford, Connecticut, and Albany, New York. We submitted them there precisely because legislation was under consideration in both of those capitals’ statehouses.

The Hartford article discussed the illusion of hope right to try laws holds out, and the Albany piece focused on the fact that many of the laws and bills stipulate that hospice care may be withdrawn if patients do get access to the drugs sought–again, hardly abstract or policy-oriented concepts.

After those op-eds ran, the working group discussed the ethical concerns they raised with legislators from Connecticut and New York. Both states decided not to pursue the bills further during their current legislative sessions (which have since ended), and the lawmakers indicated that they would be amenable to addressing ethical concerns if the bills are reintroduced in a subsequent session. This may not count as “much” engagement with policy-makers. Yet we consider it to be an encouraging trend that signals that some lawmakers are interested in the smaller, often unethical details of the bills’ texts.

We agree with Dresser that the public and policy-makers need to hear more about how right to try laws dangle the illusion of hope in front of vulnerable patients and about the harm that unapproved drugs can cause. And we agree that this is an area where bioethics has a key role to play. 

Lisa Kearns, MS, MA, is a research associate at NYU Langone Medical Center’s Division of Medical Ethics. She is a member of the NYU Langone Medical Center Working Group on Compassionate Use and Pre-Approval Access. Arthur Caplan, PhD, is the founder and director of the NYU Langone Medical Center’s Division of Medical Ethics and a founding member of the NYU Langone Medical Center Working Group on Compassionate Use and Pre-Approval Access.