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.

Special issue in the Journal of Philosophy & Technology on evolution, genetic engineering, and human enhancement

By Yu-Chi Lyra Kuo

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.

Happy reading, and happy holidays! ~YK

Film Review: How to Survive a Plague

By Suzanne M. Rivera

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. Read More

What’s In a Name?

by Suzanne M. Rivera, Ph.D.

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.

The federal agencies that oversee human research use both terms as though they are interchangeable.  The National Institutes of Health (NIH), for example, has a policy called, “Required Education in the Protection of Research Participants” which compels training for “individuals involved in the design and/or conduct NIH funded human subjects research.”

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. Read More

Life Extension: Forcing Criminals to Serve Their Time? (Part I)

By Yu-Chi Kuo

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.
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Raffles for IVF Access?

By Nir Eyal

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. Read More

The Limits of Advance Directives

By David Orentlicher

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.

[Cross-posted from HealthLawProf Blog]

Reporting Information about Clinical Trial Data: Passing the Torch from HHS to the FDA

By Leslie Francis

In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements.

A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The articles can be found here and are very much worth reading).

A posting Sept. 26 in the Federal Register indicates that the Secretary of HHS has delegated authority to to oversee the reporting process to the FDA.  Whether this signals improved monitoring of clinical trial data submissions remains to be seen.  One can only hope.