Thinking about brain death

By Seema Shah

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. Read More

Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H.

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 [1] 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.[2]

Read More

Harvard HIP (High Impact Philanthropy): Toby Ord speaking tonight

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.

Dr. Toby Ord is a philosopher at the University of Oxford and a research associate at the Uehiro Center for Practical Ethics and the Future of Humanity Institute. He is also the founder and director of Giving What We Can, an international society dedicated to eliminating poverty in the developing world.

Join Dr. Ord tonight, March 26, at 8 PM for a talk and discussion of the effectiveness of foreign aid. Refreshments will be provided, and a reception will follow.

Planning to come? Please RSVP on Facebook to help us plan refreshments.

You Talkin’ to Me?

by Suzanne M. Rivera, Ph.D.

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?!”) Read More

Apr 4: Dan Brock delivering the Gay Lecture on “The Future of Bioethics”

Please join the Division of Medical Ethics for:

The 2013 George W. Gay Lecture in Medical Ethics

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

“The Future of Bioethics”
Thursday, April 4, 2013
4:00 PM

Harvard Medical School

Tosteson Medical Education Center

Carl W. Walter Amphitheater
260 Longwood Avenue, Boston

Please pass this invitation along to other interested friends and colleagues.
RSVP to DME@hms.harvard.edu.

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.

Professional Athletes and Personal Responsibility for Health

[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.[1]  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?

Some recent stories have exemplified the culture:

Read More

Humane Transport of Research Animals

by Suzanne M. Rivera, Ph.D.

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 letter initiative was organized by the National Association for Biomedical Research (NABR), and had the strong support of the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), the American Association for Laboratory Animal Science (AAALAS), and Research!America, to name a few.

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.” Read More

Accentuate the Negative

by Suzanne M. Rivera, Ph.D.

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.  Read More

The Society for Philosophy and Disability Is Official

By Nir Eyal

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.