I recently saw someone walk into a signpost (amazingly, one that signalled ‘caution pedestrians’); by the angle and magnitude that his body rebounded, I estimated that this probably really hurt. What I had witnessed was a danger of walking under the influence of a smart phone. Because this man lacked the ability to tweet and simultaneously attend to and process the peripheral visual information that would enable him to avoid posts, the sidewalk was a dangerous place. If only there existed some way to enhance this cognitive ability, the sidewalks would be safer for multi-taskers (though less entertaining for bystanders).
In a public event on neurogaming held last Friday as part of the annual meeting of the International Society for Neuroethics, Adam Gazzaley from UCSF described a method that may lead to just the type of cognitive enhancement this man needed. In a recent paper published in nature, his team showed that sustained training at a game called NeuroRacer can effectively enhance the ability of elderly individuals to attend to and process peripheral visual information. While this game has a way to go before it can improve pedestrian safety, it does raise interesting questions about the future of our regulations surrounding distracted driving, e.g., driving while texting. In many jurisdictions, we prohibit texting while driving, and a California court recently ruled to extend these regulations to prohibit certain instances of driving under the influence of smart phones (i.e. smart driving).
But if individuals were to train on a descendant of NeuroRacer and improve their ability to visually multitask, should we give them a permit to text while driving?
“Examining the intersection of law and health care, biotech & bioethics”
- the subtitle of the Bill of Health blog.
I approach this intersection like many of my fellow students: outfitted with the tools and spectacles of a specific discipline. Whether that is health law, policy, medicine, engineering, philosophy, genetics, or cognitive science, none of us have had the ideal education that would enable not only an approach, but an inhabitation of this intersection.
What would that ideal education be? To consider the ideal education for a citizen, Rousseau conducts an elaborate thought experiment giving that education to a fictional young boy named Emile (hence the title of the work: Emile, or On Education). Let us begin a similar experiment to consider the ideal education for someone to inhabit the intersection of law and health care, biotech & bioethics.
The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation. And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human research studies. Under its list of Frequently Asked Questions (FAQ) related to informed consent, there is a question (7) which reads, “When does compensating subjects undermine informed consent or parental permission?” (http://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).
Aside from the fact that it’s still a very leading question (asking “when does it?” implies that, in fact, it does…), the new answer provided by OHRP clarifies that compensation in and of itself is not necessarily coercive or a source of undue influence. It says that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for some individuals agreeing to participate in research.
In general, the panel rightly pointed out practical limitations of these technologies. Panelist Nancy Kanwisher highlighted, for example, that research on lie-detection is done in a controlled, non-threatening environment from which we may be unable to generalize to criminal courts where the stakes are high.
While I was sympathetic to most of this discussion, I was puzzled by one point that the panel raised several times: the problematic nature of applying data based on a group of people to say something about an individual (e.g., this particular defendant). To present a simplified example: even if we could rigorously show a measurable difference in brain activity between a group of people who told a lie in the imager and a group of people who told the truth, we cannot conclude that an individual is lying if he shows an activity pattern similar to the liars. Since the justice system makes decisions on individuals, therefore, use of group data is problematic.
To me, this categorical objection to group data seems a bit odd, and this is why: I can’t see how group data is conceptually different from ordinary circumstantial evidence. Continue reading →
It astonishes me how many people do not realize the controversial nature of “brain death” and the fact that it is not the same as death. There is a substantial body of literature showing that brain death is not the equivalent of death. The President’s Council on Bioethics issued a white paper in 2008 acknowledging the deficiencies with our current approaches to determining death. The literature on the topic is fascinating—some brain dead individuals have gestated babies successfully to viability and gone through puberty. Many brain dead individuals can heal wounds, regulate their body temperatures, and persist on ventilators for many years. (If you are unfamiliar with this literature and want to read further, see the citations provided below.)
Frank Miller and I have argued that best the way to think about the status quo is that brain death is a status legal fiction, much like the legal construct that a corporation is a person. A corporation is similar enough to a person that it is convenient to treat corporations as persons under the law, rather than writing an entirely new body of law meant to apply to corporations alone. We have argued that brain death is similar to death—Frank Miller and Bob Truog express this by saying that a person who is brain dead is “as good as dead.” For this reason, we can ethically and legally treat the two states in the same way for the purposes of determining death and allowing vital organ transplantation.
There are many open and interesting questions about brain death that I will be exploring on this blog for the next few weeks. Michael Nair-Collins has a recent article in the Kennedy Institute of Ethics Journal that argues that the current approach to determining death in the U.S. is paternalistic and, presumably, unjustified. He cites as evidence the kinds of information that are shared with people deciding whether to become organ donors. But is this true, or is there evidence that the public is able to distinguish between brain death and death? Kenneth Kasper, Frank Miller, and I are investigating this at the moment, and we are finding some surprising answers in the literature. Continue reading →
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell  came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.
Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells. ASCs are found throughout the body. Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells. It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.
A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices. Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells? In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.
Are you interested in foreign aid, global development, medicine? Want to know how philanthropy and charitable giving can do the most good?
Aid Works(On Average) - By Toby Ord
Tuesday, March 26th; Emerson Hall 108; 8 PM
There is considerable controversy about whether foreign aid helps poor countries, with several prominent critics arguing that it doesn’t. Dr. Ord shows that these critics have only reached this conclusion because they have failed to count the biggest successes of aid, such as the eradication of smallpox, which have been in the sphere of global health rather than economic growth. These health successes have often been neglected in analysis of aid because they have only made up a small proportion of aid spending. When we look at the impact of this spending, though, we see that it the big wins have been so utterly vast that they more than justify all aid spending to date.
The principle of justice articulated in The Belmont Report requires equitable selection of human research subjects. Equitable in this context means that the risks and benefits of the study are distributed fairly. Fairness has two components: 1) avoiding exploitation of the vulnerable (e.g. preying upon a poor, uneducated population) and 2) avoiding the unjustified exclusion of any population ( whether out of bigotry, laziness or convenience).
Recruitment strategies invariably shape the selection of research subjects and the extent to which a pool of participants really represents a cross-section of society. Institutional Review Boards (IRBs) are charged with evaluating whether study recruitment plans and materials used to obtain informed consent are easily understood and free of misleading information. This is relatively straightforward when researchers, IRB members, and study subjects all speak the same language. But when studies are done in geographical areas that include numerous cultural and language communities, it can be quite tricky.
One of the barriers that prevents people from enrolling in (or even knowing about) studies is a lack of awareness and planning by researchers to address language differences. The human research protection regulations at 45 CFR Part 46.116 require that informed consent information must be provided to research participants (or their representatives) in language understandable to them. IRBs are supposed to be vigilant about this and require investigators to obtain translated Informed Consent Documents (ICDs) for use with non-English speaking research subjects. But researchers commonly balk at this expectation, saying it’s unreasonable. (A disproportionate number of objections have been raised to me thusly, “And what am I supposed to do if someone shows up speaking only Swahili?!”) Continue reading →
The George W. Gay Lecture is the oldest endowed lectureship at Harvard Medical School, and quite possibly the oldest medical ethics lectureship in the United States. The lectureship was established in 1917 by a $1,000 gift from Dr. George Washington Gay, an 1868 graduate of HMS. Since its inception, many of the nation’s most influential physicians, scientists, researchers and social observers, including Erich Fromm, Felix Frankfurter, Margaret Mead, Elizabeth Kübler Ross, E.O. Wilson, and Joshua Lederberg have given the Gay Lecture. Elie Wiesel, Marian Wright Edelman, Paul Krugman, Nicholas Kristof and Donald Berwick have given recent Gay Lectures.
[Disclaimer: I am not involved in this, and the views expressed here are entirely my own.]
Concussions and Performance Enhancing Drugs (PEDs) have been the dominant subject of concern in the sports world recently, and for good reason, but I would like to highlight an often overlooked and more general problem. Our athletes are rewarded for pushing their bodies to the brink to accomplish majestic feats, requiring physical perfection. We laud playing through injuries to succeed at the pinnacle of sport, or recovering from injuries at super human speeds, only to return those bodies to the brutal punishment of competition. With these pressures, Concussions and PEDs can be viewed as mere symptoms of a culture that runs from the fans to the teams to the players themselves, asking them to sacrifice their bodies, sometimes, to the detriment of their long-term health. In this new age of awareness about player health, we should be asking: Are athletes making properly informed rational choices about their health? Or are there situations where neither the players nor their teams are properly incentivized to protect long-term player health due to the culture described above?
For some time, animal rights activists in the US and abroad have been trying to pressure commercial airlines out of their long-standing practice of transporting research animals. Last week, a coalition of more than 150 leading research organizations and institutions sent a letter to the CEOs of the targeted airlines, urging them to continue transporting animals needed for research purposes. A copy of the coalition joint letter is available here.
The basic thrust of the letter can be summarized by this passage: “Your company’s commitment to transporting laboratory animals is crucial to finding treatments and cures for diseases afflicting millions of people worldwide. We ask that you continue transporting research animals, allowing lifesaving research around the world to progress.” Continue reading →
While attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R) last month in San Diego, I had the opportunity to hear a talk by Dr. John Ioannidis, in which he debunked commonly accepted scientific “truths.” Calling upon his own work, which is focused on looking critically at published studies to examine the strength of their claims (see his heavily downloaded 2005 paper “Why Most Published Research Findings Are False”), Ioannidis raised important questions for those of us who think about research ethics, and who oversee and manage the research conducted at universities and scientific institutes across the country.
Ioannidis persuasively argued that our system for publishing only studies with statistically significant positive findings has resulted in a bizarre kind of reality where virtually no studies are ever reported that found “negative” results. Negative results are suppressed because nobody is interested in publishing them. Editors and reviewers have a major role in this problem; they choose not to publish studies that are not “sexy.” This artificially inflates the proportion of observed “positive” results and influences the likelihood a scientist will even write up a journal article because she knows what it takes to get published.
But isn’t there an ethical obligation to publish so-called negative results? In human research, people give their time and undergo risks for the conduct of a study. Their sacrifices are not meaningful if the results are never shared. Furthermore, negative results tell us something important. And if they are not published, some other research team somewhere else may unknowingly repeat a study, putting a new batch of subjects at risk, to investigate a question for which the answer is already known. Finally, to the extent a study is conducted using taxpayer dollars, the data derived should be considered community property, and there are opportunity costs associated with unnecessarily repetitive work. Continue reading →
With an approved constitution, elected officials and now, recognition from all three divisions of the American Philosophical Association (APA), a new society is finally official. The Society for Philosophy and Disability, or SPD, will hold its first two sessions at the February 2013 Central APA meeting in New Orleans.
SPD is a non-profit educational organization dedicated to furthering research and teaching on philosophical issues related to disability and to promoting inclusiveness and support for people with disabilities in philosophical education and in the profession of philosophy. SPD aims to provide a forum for philosophical discussion of disability by arranging meetings, maintaining an online presence, and organizing academic projects.
Adam Cureton, President of the Society, invites everyone to join SPD, which they can do on the Society website. You are also welcome to invite colleagues or students who are interested in philosophy and disability to join us.
A special issue published this month by the Journal of Philosophy & Technology features a collection of articles discussing evolution, genetic engineering, and human enhancement. Recent years have seen a rapidly expanding variety of approaches to exploring the normativity of human enhancement, by philosophers, bioethicists, physicians, and biologists. The articles in this special issue largely focus on the question: how can evolution and aetiological teleology inform biological ethics and theories of human enhancement?
For a separate collection of articles discussing the ethics of human enhancement from the perspective of the physician-patient relationship, see this special issue by the American Journal of Bioethics, published approximately a year ago.
How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today. Beginning at the start of the epidemic, when little was known about the HIV virus and even hospitals were refusing to treat AIDS patients out of fear of contagion, the film follows a group of leaders in the groups ACT-UP and TAG. Using existing footage interspersed with current-day interviews, it tells the story of how patients and concerned allies pushed the research community to find a way to treat what was then a lethal disease.
The film’s portrayal of the U.S. Government, specifically then-President George H. W. Bush and high ranking officials in the Food and Drug Administration, is damning. As hundreds of thousands of people became infected with HIV and the death toll rose, prejudice against marginalized groups (especially gay men, IV drug users) contributed to a lack of urgency about the need to learn how stop the spread of the virus and how to treat the opportunistic infections that killed people with full-blown AIDS. In contrast, footage of demonstrations, meetings, and conferences highlights the courage of the activists who risked and endured discrimination, beatings and arrests to bring attention to the need for more research.
But How to Survive a Plague is more than a documentary about the power people have to make change when they join together to demand action. It also is a provocative commentary about unintended consequences. I saw the film while attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R). In that context, I was especially interested in the way How to Survive a Plague highlights an interesting ethical issue in clinical research. Namely, the problem of protecting people so much from research risks that the protection itself causes harm. Continue reading →
In regulatory and research ethics circles, it is fairly common to hear people say they prefer the term “research participant” to “research subject” because they feel it’s more respectful. They think the word “subject” is demeaning. I respectfully disagree. I think it’s honest.
Of course, some research subjects are willing and active participants, but many are not. The truth is that many people are studied without their consent or even knowledge. In compliance with federal regulations, and under the watchful eye of ethics committees called Institutional Review Boards (IRBs), millions of medical records, biological specimens, and other sources of data (like court records, purchasing patterns, and web searching cookies) are mined by researchers every day. You and I don’t participate in those studies. They are done to us. To the extent these studies are done with integrity, I don’t object. But let’s not pretend we are participants. Continue reading →
Former Penn State football coach Jerry Sandusky was recently sentenced to 30 to 60 years in prison for serial child sex abuse. Sandusky had faced as great as a 400-year potential sentence during trial, but even the 30 year minimum term will likely exceed his natural lifespan all the same: at 68-years-old, Sandusky will probably die in prison long before serving his time. If he lives to the average life expectancy of 75, he will have served only a quarter of his minimum sentence. In light of the vileness and severity of his crimes, Sandusky’s death may leave many victims and observers feeling that death provided an early exit from deserved punishment.
Curiously enough, Sandusky’s former employer patented and licensed a telomerase reporter system capable of monitoring the regulation of telomere maintenance. Telomeres are microcellular regions that protect against gene degradation and promote cell longevity. The maintenance (or lengthening) of telomeres through telomerase therapy is an exciting subfield of life-extension therapy that may radically lengthen human lifespans in future.
The arguments for and against this and other forms of human enhancement technology are fairly well combed-over in popular discourse: it’s unnatural; it’s sinful; it’s unfair; it’s arrogant. On the other hand, this and other subfields of gerontology profess some noble goals: to improve the ratio of “good years” with years of morbidity; to deliver unto humans a “gift” of possibly unlimited life. But what if we inverted the concept of life extension therapy as a “gift,” and could administer it to criminals like Jerry Sandusky, in order to extend their remaining life up to the end of their sentence? Telomerase therapy may be a continual treatment; it could conceivably even be withdrawn to give the old man just enough “life” to watch the clock on his last day. Continue reading →
As the New York Times reports (quoting me on the ethics), some American IVF clinics are now running raffles where the prize is IVF services. The contests give clinics publicity and sometimes serve charitable causes. Are IVF raffles unethical? Should we ban them?
Gambles and contests over the ability to have babies represent a new level of commodification—if you will, a new frontier. But they are not always unethical. Clinics do not owe infertile couples free access to IVF services. In some cases, the state and insurers don’t owe it to them either—legally or morally. IVF is expensive and some medical services are needed even more badly. Uninterested couples can avoid these raffles. What these raffles do is to give infertile couples opportunities that they would lack otherwise for obtaining an important benefit, opportunities that go beyond what clinics owe them. Lotteries, in particular, are not necessarily unfair means of distributing resources. Some philosophers deem them very fair. Even when couples with means can buy several raffle tickets, impoverished couples still get better chance of IVF access than under the current system. Money speaks, but it speaks less vocally than in much of American healthcare. In this respect, these raffles are a good parody of our unjust system.
These contests are games. Conservatives worry that they take infertility or the beginnings of human life too lightly. But light-heartedness could be a good thing in this area. It might reduce the anxiety and the stigma that too often accompany infertility treatment. Associating the conception of new human life with fun? Traditional procreation can do that, too!
In short, not everything that’s odd is unethical. Notwithstanding initial “yuck” feelings, raffles for IVF access are not always morally wrong. It would have been morally more ideal if clinics offered free IVF services to everyone, or prioritized the neediest and the underserved, or gave rich and poor equal chance. But acting less than ideally is not doing wrong. Continue reading →
While it is important for people to express their wishes about end-of-life care in advance, a court case in Hawaii reminds us that advance directives do not always ensure that patient’s wishes will be followed. Karen Okada wrote a living will, which the hospital ethics committee found to express a desire not to have a feeding tube in her current condition. A family member has objected, on the basis that he is acting in accordance with his authority as an appointed surrogate. Unfortunately, patients’ preferences can be frustrated by their families or their health care providers.