The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part I: What are the legal implications?

Last week I blogged about recent publications concerning the global battle against anti-microbial resistance (AMR). I did not mention a recent paper published in the June 2014 issue of Nature, which describes how European and U.S. researchers and authorities are increasingly considering clinical research in unconventional areas to fight AMR. The news-report “Phage therapy gets revitalized” by Sara Reardon concentrates on the use of viruses (bacteriophages) to battle bacteria. The idea is not new, but apart from some applications in the former Soviet Union, it never was established as a major research area elsewhere. In particular the paper examines the European Phagoburn project, which is the first large, multi-centre clinical trial of phage therapy for human infections, funded by the European Commission. It involves a phase I-II trial of using viruses for the treatment of bacterial infection following burns. The European Union (EU) is contributing €3.8 million (US$5.2 million) to the Phagoburn study demonstrating that it is taking the approach seriously. Meanwhile, the US National Institute of Allergy and Infectious Diseases announced in March 2014  that it regards phage therapy as one of seven key areas in its strategy to fight antibiotic resistance.

So far Western practice has concentrated on treating complex or unidentified infections with broad-spectrum antibiotics. These antibiotics would typically eliminate multiple types of bacteria, including those who have beneficial effects to the human organism. Despite resulting in direct negative consequences for patients, e.g. gastrointestinal disorders, these “atomic bomb” approaches can result in biological niches where resistant “bad bugs” can prosper. This is the reason why scientists are turning towards more targeted approaches. This is where phage therapy comes into play. Like “guided missiles”, phage-therapy has the ability to kill just species of bacteria or strain. Quoting the US virologist Ryland Young and the head of the scientific council at the Eliava Institute in Tblisi (Georgia), Mzia Kutateladze, the Nature report explains how nature offers an almost unlimited source of different phages and that so far no identical phages have ever been found. For this reason it is fairly simple to identify a particular phage for a bacterial target. If the bacterium should become resistant against that particular phage, researchers would modify the viral cocktails that are used for treatment by adding or substituting phages. At the Eliava Institute such updates occur – according to the report – approximately every 8 months and the scientists would not be fully aware of the precise combination of phages in the cocktail.

In light of these advantages the recent interest of US and EU stakeholders in phage therapy comes as no surprise. However, the scientific and legal challenges confronting these projects are complex. After all we are talking about viruses here, which triggers alarm bells with regard to public perception, safety concerns, and the regulation of relevant research. It also appears questionable if – or under what circumstances – regulatory authorities would be willing to grant market approval for such a rapidly changing product like in the case of e.g. influenza vaccines. Another significant problem for the development of new phage therapies, also addressed in the paper, lies in the reluctance of pharmaceutical companies to invest into the field. The potential obstacles for more private involvement in phage therapy are many and range from considerable risks of failure, reputational damage, and unforeseeable side-effects to insufficient certainty with regard to intellectual property protection and guarantees of a profit.

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Liveblog of 4/2 panel on Hot Topics in European Bio-Patent Law, Part I

I’ll be liveblogging today’s panel on Hot Topics in European Bio-Patent Law (co-sponsored by the Broad Institute), with several guest speakers from the European Patent Office (EPO).

Ben Roin, Heiken Assistant Professor of Patent Law here at HLS, is moderating.  Speakers will be Dr. Aliki Nichogiannopoulou on stem cells, and Dr. Anja Schmitt on gene patents, Dr. Maiake van der Kooij, all of the EPO, followed by Tom Kowalski of VedderPrice.

Dr. Nichogiannopolou begins by talking about stem cells, and opens with a few background points about the EPO.  The agency has its own implementing legislation separate from the EU, and includes 38 member states – 10 more than the EU itself, including industry-important Switzerland.  The EPO supports innovation, competitiveness, and economic growth for the benefits of European citizens, and has the mandate to grant European patents for inventions. Continue reading

TOMORROW: panel discussion, Current Legal Issues in HIV/AIDS Work

Current Legal Issues in HIV/AIDS Work

Thursday, March 27, 2014, 12:00pm

Wasserstein Hall 1019, Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

More than 30 years have passed since AIDS first appeared in the United States. Today the CDC estimates that 1.1 million Americans are living with HIV/AIDS, and each year 50,000 Americans are newly diagnosed. Despite great strides in education, awareness, prevention, and treatment, people affected by HIV/AIDS still face significant discrimination, including unequal treatment under the law. This panel will explore some of the legal barriers faced by people living with HIV/AIDS in the United States, including FDA’s ban on men who have sex with men donating blood and laws criminalizing HIV transmission. Panelists include:

  • Felix Lopez, Director of the Legal Department, GMHC
  • Jason Cianciotto, Director of the Public Policy Department, GMHC
  • I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
  • Moderator: Aziza Ahmed, Visiting Scholar, Petrie-Flom Center; Associate Professor of Law, Northeastern University School of Law

This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

This event is cosponsored by Gay Men’s Health Crisis (GMHC). Founded in New York in 1981, GMHC is one of the world’s first and leading providers of HIV/AIDS prevention, care, and advocacy. 

3/27: panel discussion on Current Legal Issues in HIV/AIDS Work

Current Legal Issues in HIV/AIDS Work

Thursday, March 27, 2014, 12:00pm

Wasserstein Hall 1019, Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

More than 30 years have passed since AIDS first appeared in the United States. Today the CDC estimates that 1.1 million Americans are living with HIV/AIDS, and each year 50,000 Americans are newly diagnosed. Despite great strides in education, awareness, prevention, and treatment, people affected by HIV/AIDS still face significant discrimination, including unequal treatment under the law. This panel will explore some of the legal barriers faced by people living with HIV/AIDS in the United States, including FDA’s ban on men who have sex with men donating blood and laws criminalizing HIV transmission. Panelists include:

  • Felix Lopez, Director of the Legal Department, GMHC
  • Jason Cianciotto, Director of the Public Policy Department, GMHC
  • I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
  • Moderator: Aziza Ahmed, Visiting Scholar, Petrie-Flom Center; Associate Professor of Law, Northeastern University School of Law

This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

This event is cosponsored by Gay Men’s Health Crisis (GMHC). Founded in New York in 1981, GMHC is one of the world’s first and leading providers of HIV/AIDS prevention, care, and advocacy. 

More on taxing egg “donation” payments

Dov Fox had a terrific post about taxes on compensation for those who donate eggs and sperm a few weeks ago in reaction to Perez v. Commissioner.  I don’t have any particularly new thoughts on this area, but for those of you who haven’t already seen it, I wanted to share the excellent mini-symposium that recently concluded over on the Faculty Lounge on this topic.  Kim Krawiec organized, and there’s a series of great posts by several scholars, pointing out, among other things, the strangeness of the fact that there’s still quite a lot of uncertainty about these issues, even though they’ve been around for a while and are not particularly rare.  In any case, it’s very much worth reading, even for those who aren’t normally tax wonks.

Inaugural Issue of the new Journal of Law and the Biosciences Now Online (Free Access)

I am very pleased to announce the the first-ever issue of The Journal of Law and the Biosciences is now online. I serve as one of three Editors In Chief (along with Nita Farahany and Hank Greely). The journal is a co-production of Harvard, Duke, and Stanford Law schools and Oxford University Press and is the first peer-reviewed journal of its kind.

Here is the table of contents for the first issue:

Edward S. Dove, Bartha M. Knoppers, and Ma’n H. Zawati, Towards an ethics safe harbor for global biomedical research, J Law Biosci (March 2014) 1 (1): 3-51 doi:10.1093/jlb/lst002

Rebecca Dresser, Public preferences and the challenge to genetic research policy, J Law Biosci (March 2014) 1 (1): 52-67 doi:10.1093/jlb/lst001

Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy, and Julian Savulescu, The regulation of cognitive enhancement devices: extending the medical model, J Law Biosci (March 2014) 1 (1): 68-93 doi:10.1093/jlb/lst003

Timothy Caulfield, Sarah Burningham, Yann Joly, Zubin Master, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, Amy McGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, Helen Wallace, and Ma’n H. Zawati, A review of the key issues associated with the commercialization of biobanks, J Law Biosci (March 2014) 1 (1): 94-110 doi:10.1093/jlb/lst004

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FDA, Mitochondrial Manipulation, Three Parent Children, and the NY Times

In yesterday’s NY Times Op-Ed page Marcy Darnovsky writes about FDA’s consideration of mitochondrial manipulation therapies later this week. As she describes it:

The F.D.A. calls them mitochondrial manipulation technologies. The procedures involve removing the nuclear material either from the egg or embryo of a woman with inheritable mitochondrial disease and inserting it into a healthy egg or embryo of a donor whose own nuclear material has been discarded. Any offspring would carry genetic material from three people — the nuclear DNA of the mother and father, and the mitochondrial DNA of the donor. 

As she writes in her opinion:

Some media accounts about these techniques have misleadingly referred to “saving lives,” as if they were aimed at people who are sick and suffering. Others have failed to note how very few women would be candidates for even considering them. And they could turn to safer and simpler alternatives. An affected woman could adopt or use in vitro fertilization with another woman’s eggs. Of course, the resulting child would not be genetically related to her, but neither would the child be put at grave risk by an extreme procedure.

The F.D.A. advisory panel says that its meeting will consider only scientific aspects of mitochondrial manipulation and that any “ethical and social policy issues” are outside its scope. But those are precisely the issues that we must address. Simply being able to do something doesn’t mean we should do it.

That conclusion is a bit pat, though I don’t fault her too much given how tight op-ed word limits are, and maybe a tad reactionary. I do think she raises an interesting point about how this is not saving lives, though I think so for different reasons.

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Can you be taxed for selling your eggs?

Dov Fox

Those who deal in alternative ways of making families use euphemisms that obscure the market mechanisms at work when individuals ‘‘donate’’ their eggs or sperm, couples ‘‘contribute’’ their embryos, surrogates ‘‘offer’’ their wombs, and orphans are ‘‘matched’’ to adoptive parents. Make no mistake, family formation is big business. The question of first impression before a San Diego Tax Court judge is whether that business is taxable.

Nichelle Perez, like almost 17,000 other women every year in the U.S. alone, received payment (in her case $20,000) for providing her eggs to the infertile through an invasive and risky process of ‘‘superovulation.’’ When the IRS sought to tax that payment as business earnings from self-employment, Perez objected that it ought to be exempted, lest she ‘‘be[] penalized for doing something good for another person.”

Should the sale of eggs that have grown inside a woman’s body be taxed like property that’s subject to a long-term capital gain? Or does the pain and suffering that the transaction involves make it more like a settlement from a personal-injury lawsuit? Does the answer turn on the legal (or moral) status of human eggs? Or on whether the conditions under which a woman agrees to their extraction are meaningfully ‘‘voluntary’’?

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Book Review published on SSRN

Three weeks ago I blogged about my recent review of  “Pharmaceutical Innovation, Competition and Patent Law – a Trilateral Perspective” (Edward Elgar 2013). The full review, which is forthcoming in a spring issue of European Competition Law Review (Sweet Maxwell), is now available at SSRN: http://ssrn.com/abstract=2396804.

DC Circuit Upholds FDA Authority Over Stem Cells

Earlier this week, the D.C. Circuit upheld the FDA’s authority to regulate stem cells (for a good news report see here). The company in question, Regenerative Sciences, had received a warning letter from FDA, which the company challenged claiming that its use of stem cells as therapy was not prohibited by existing federal law and that the FDA lacked authority to regulate it. They lost before the district court and appealed to the D.C. Circuit.

In a unanimous decision (by judge Griffith for himself, Judge Srinivasan and Edwards) the D.C. Circuit affirmed this decision. Here are some key passages: Continue reading

Paper on “Legal aspects of biobanking as key issues for personalized medicine & translational exploitation”

I am pleased to announce that my co-author Professor Jens Schovsbo from the University of Copenhagen and I completed a paper addressing “Legal aspects of biobanking as key issues for personalized medicine & translational exploitation”.

This perspective article, which has been written upon request by the medical journal “Personalized Medicine”, deals with the legal aspects of biobanking and points towards the concerns, interest, and choices that should be considered when establishing and operating a biobank. It focuses on public biobanks in a university setting and the specific challenges posed by PM with a special focus on publicly funded biobanks, commercialization issues and the involvement of industry.

To this end we start out by briefly discussing differing definitions of the term biobank and highlighting the particular significance of biobanks for the development of PM and translational innovation. The next part describes the inherently complex, dynamic and heterogeneous environment in which legal challenges to biobanking and the regulation of biomedicine must be considered. Based on our finding we then sketch out more specific legal problems that might occur throughout the various chronological stages of biobanking regarding consent obligations and intellectual property rights (IPR). After this we use an on-going interdisciplinary research project based at the University of Copenhagen (UCPH) to illustrate how the legal and ethical challenges might be dealt with analytically and in a practical way that reflects the concerns and interest of stakeholders in biobanking and results in a transparent, legally and ethically robust system. In our closing remarks we make recommendations on how to improve the legal framework for biobanking and in particular for the challenges posed by PM.

We conclude that any decisions as to the design of the regulatory environment should follow a process that takes account of the values, hopes and concerns of all stakeholders involved. In particular, we stress the importance of a careful planning of consent obligations combining traditional legal methods with an adequate institutional set up. In order to enhance the translational exploitation of biobanks, we further emphasize the pressing need to carefully consider a great variety of strategies and policy choices relating to intellectual property rights (IPRs).

We will publish the paper on SSRN as soon as we receive the approval by “Personalized Medicine”. I’ll keep you posted.

UPDATE: The full paper is now available here.

My Comments on HHS’s Proposed Rule Criminalizing Trade in Blood Stem Cells

Professor Nalini Ambady (1959-2013)

Professor Nalini Ambady (1959-2013)

Bonjour de Toulouse, where I’m visiting this month at the Institute for Advanced Study (IAST), which is hosted by the Université de Toulouse Capitole and physically (and in many senses conceptually) situated inside the Toulouse School of Economics. That setting is a particularly good one for this post on markets in human tissue.

In early October, I wrote about a rule that the Department of Health and Human Services has proposed that would amend the National Organ Transplant Act (NOTA) to criminalize compensation for providing peripheral blood stem cells (PBSCs) given through apheresis. Compensating those who allow their bone marrow to be aspirated — the other major source of hematopoietic stem cells (HSCs) — is already explicitly criminalized under the statute. At the end of the post, I promised to follow up with a second post on why I’m skeptical about this rule, as a matter of policy. This is that post.

But before discussing appropriate policy for addressing the problem of the 3,000 Americans who die each year for want of a bone marrow transplant, and for reasons I’ll explain near the end of my post, I want to say something about one particular person: Professor Nalini Ambady, a Stanford social psychologist who, about one year ago, began an international search for a compatible, willing HSC donor to treat her leukemia.

Because she is South Asian, and because few Asians and other racial and ethnic minorities are listed in the U.S. bone marrow registry — South Asians comprise only 2% of the U.S. registry — she had a difficult time finding a match. She nevertheless found 12 potential matches in the U.S. bone marrow registry, and apparently at one point had scheduled the transplant. In the end, however, half were ruled out as imperfect matches — and each of the remaining six matches declined to donate.

Having exhausted the U.S. registry, Ambady and her supporters sought a match in South Asia registries — but even fewer people are registered in that region than in the U.S. Of India’s 1.2 billion people, for example, only about 45,000 are registered. Nevertheless, a potential thirteenth match was found in an Indian registry. He matched at least 6 of 10 HLA markers; he would need a blood test to determine whether he was a complete match. Unfortunately, after a worrisome week of silence about whether he was indeed a complete match, Ambady and her family learned that the potential donor had backed out.

And then a potential fourteenth match:

Weeks later, it happened with another potential match for Nalini, this time an 8/10 and so an even likelier match. This man wanted to watch someone else donate their bone marrow before making up his mind. A registry chief actually arranged this for him in early May. Somehow, it wasn’t persuasive enough. He, too, decided not to donate.

Professor Ambady died on October 28 after eight compatible or potentially compatible registered donors ultimately declined to donate.

Apparently, declining to donate after agreeing to be listed in a registry and being found to be a match is quite common. According to one registry chief, the attrition rate is 50% in the U.S., Europe, and India. Would a financial incentive have tipped any of these vaccillating prospective donors towards a decision to donate? Although we can’t say, this is an eminently answerable question. Unfortunately, the Department seems uninterested in learning whether a compensation scheme would save lives — or have ill or counterproductive effects — or not.

In its Notice, the Department lists the following policy reasons for expanding NOTA’s list of “organs,” the exchange of which for valuable consideration is prohibited, to include PBSCs: (1) preventing commodification; (2) curbing opportunities for coercion of PBSC providers and (3) exploitation of PBSC recipients; (4) encouraging altruistic donations, and (5) decreasing the likelihood of disease transmission resulting from paid donations. My responses to these arguments are after the jump. I end with some thoughts about alternative policy tools for increasing the supply of PBSCs in the absence of a legal compensation scheme.

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DUE MONDAY: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference

The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:

  • Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions?  What is a “best” decision, i.e., whose perspective should be paramount?
  • What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
  • Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
  • What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa?  Where should the nudges push?
  • Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture?  When nudges are not plausible, what is the best way to overcome bounded rationality?
  • When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
  • How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
  • What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?

Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.

Calls for abstracts are due by December 2, 2013.

For a full conference description, including the call for abstracts and registration information, please visit our website.

DUE IN ONE WEEK: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference

The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:

  • Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions?  What is a “best” decision, i.e., whose perspective should be paramount?
  • What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
  • Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
  • What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa?  Where should the nudges push?
  • Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture?  When nudges are not plausible, what is the best way to overcome bounded rationality?
  • When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
  • How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
  • What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?

Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.

Abstracts are due by December 2, 2013.

For a full conference description, including the call for abstracts and registration information, please visit our website.

Going On Now: IOM Stem Cell Therapies Workshop

The IOM is hosting a workshop *right now* on Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings.  You can sign up via a quick online form, and they’ll immediately send you a link to the live webcast (agenda here), which will hopefully be archived.  Our own Glenn Cohen is slated to discuss stem cell medical tourism at 1:15 this afternoon.

Here’s the description from the IOM site:

Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and conditions such as Parkinson’s disease, diabetes, and spinal cord injury. Currently, however, the evidence base to support the medical use of stem cells is still limited, with few clinical applications shown to be safe and effective. Despite the preliminary nature of clinical evidence, consumer demand for treatments using stem cells has risen, fueled by direct-to-consumer advertising of stem cell-based treatments. Clinics have been established throughout the world, both in newly industrialized nations such as China, India, and Mexico, as well as developed countries such as the United States and within Europe, that offer “stem cell therapies” for a wide range of diseases and conditions. Often provided at great expense and often promoted as established and effective, these treatments have generally not received stringent regulatory oversight, have not been tested through rigorous trials to determine safety and likely benefit, and the claims remain largely unsubstantiated by medical science. Complications from treatments have ranged from tumor formation to the death of patients. Some feel that the false claims and potential for harm to patients could significantly damage the real potential of research to produce valid stem cell therapies.

The Institute of Medicine and the National Academy of Sciences will co-host a workshop with the International Society for Stem Cell Research that will take a critical look at the practice of unproven stem cell treatments. Speakers will examine the evidence base of unsubstantiated treatment offerings and the associated research and clinical risks and concerns. Discussions will delve into legal hurdles for establishing standards and criteria to govern stem cell trials and treatments and explore a range of potential solutions for assuring the quality of unregulated therapies.

Caplan on Organs and Inmates

By Art Caplan

Are we ever capable of laying a stupid idea to rest in America?  Apparently not.  The latest tempest in the ever-resurrecting world of solutions to the shortage of organs is donation by executed prisoners.  The Governor of Ohio held up a plan to execute a man on death row when he requested that his organs be donated to his mother and sister each of whom have serious health problems.

According to the AP,

“Ohio Governor John Kasich on Wednesday stayed the execution of convicted killer Ronald Phillips to assess whether Phillips’s non-vital organs or tissues can be donated to his mother or possibly others. Phillips, 40, was scheduled to be executed Thursday for the 1993 murder of 3-year-old Sheila Marie Evans.

“I realize this is a bit of uncharted territory for Ohio, but if another life can be saved by his willingness to donate his organs and tissues, then we should allow for that to happen,” Kasich said in a statement.”

The Governor need not have bothered.  What child rapist and murderer Ron Phillips had in mind was donating his heart and kidneys to his family.  He has shown no interest in helping anyone else nor did he ever mention tissue donation.

Moreover, getting organs from an executed prisoner is both impractical and immoral.

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House and Senate Pass Bill Allowing HIV+ People to Donate Organs

In a week where most of the health law news has been, shall we say, less than hopeful for those of us who like the idea of robust health insurance expansion, as the Washington Blade reports there was one bright spot for progressive health policy: The House and Senate passed the HOPE (HIV Organ Policy Equity Act) which, if signed by the president, will authorize the HHS Secretary and OPTN to investigate and (if the research supports it) allow HIV+ individuals to donate organs to HIV+ individuals. You can read the full text here. The most relevant paragraph is

Clarification

In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement and Transplantation Network may adopt and use such standards with respect to organs infected with human immunodeficiency virus (in this paragraph referred to as HIV), provided that any such standards ensure that organs infected with HIV may be transplanted only into individuals who—(A) are infected with HIV before receiving such organ; and(B) (i)are participating in clinical research approved by an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of section 377E; or (ii) if the Secretary has determined under section 377E(c) that participation in such clinical research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the standards and regulations under section 377E(c).

A few quick reactions: (1) What fascinating co-sponsors across the aisle: Sens. Barbara Boxer (D-Calif.) along with Tammy Baldwin (D-Wis.), Tom Coburn (R-Okla.) and Rand Paul (R-Ky.) as original co-sponsors. In the House, Reps. Lois Capps (D-Calif.) was lead sponsor and Andy Harris (R-Md.) was an original co-sponsor. (2) This is a good step forward, but one wonders whether limiting the potential recipients to HIV+ folks is itself wise. I can easily imagine cirucmstances where an individual who faces death would prefer an HIV+ organ even if it will carry with it a significant chance of HIV infection. Perhaps I don’t know enough about the immunology here and there is something I am missing (and commentators please help educate me and other readers). One might indeed wonder if, in some weird way, the bill now creates a disability discrimination (I say that because the Supreme Court has in its jurisprudence treated HIV as capable of causing a major life impairment under the Americans with Disabilities Act) in favor of those with HIV, because only they are potentially eligible for a certain pool of organs that may become available. That’s probably not actionable (as I understand it the ADA does not protect non-disabled people from discrimination in favor of the disabled), but it is at least quite curious. (3) Is this a portent of things to come from the administration? Relaxation of the much-reviled ban on gay men donating blood? Or will this “win” for the community (and to be clear the HIV+ community and the gay community are by no means isomorphic) going to sop some of the pressure on the blood ban?

PRIM&R 2013 Advancing Ethical Research conference report: Who is responsible for the body?

By Lauren A. Taylor, Coordinator for Health and Religion in the Global Context, Harvard Divinity School and co-author of The American Health Care Paradox: Why Spending More Is Getting Us Less(PublicAffairs, 2013).

Who is responsible for the stewardship of the body? What about the body’s tissue? Or its blood? While many people suggest that each individual owns their own bodies, these questions can become considerably more complicated when viewed through the lens of a bio-banking effort. When blood and tissues are “inside” or “part of” our body, it may appear clear, but once removed from the larger whole, the question of ownership can become substantially more challenging. One of Wednesday’s pre-conference programs explored these issues in considerable depth, featuring perspectives from a range of relevant actors.

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PRIM&R 2013 Advancing Ethical Research conference report: Pluripotent Stem Cell Research: Let’s Discuss Informed Consent Lunch

By Melissa LopesFellow, Division of Medical Ethics, Harvard Medical School and Director of Research Policy and Compliance, Office of the Vice Provost for Research, Harvard University

The DISCUSS project is designed to develop consensus recommendations for the use of stored biospecimens (originally consented for research) to:

  • derive iPSC lines and
  • deposit the derived lines in a cell bank or repository for widespread distribution.

The project represents a formal collaboration of NIH, CIRM and the International Stem Cell Forum. The broadly stated aim of this collaboration is to evaluate consent protocols and ethical requirements in support of ongoing collaborations and the exchange of research materials.

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