Month: April 2015

Ethics for CRISPR and the Big Leap Forward

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By Kelsey Berry

This week, a research group in China published a paper describing a significant step forward in one application of the genome editing technique CRISPR: they used it to modify the genome of non-viable human embryos. Now, the scientific community finds itself grasping for ethical and legal foundations in order to evaluate the implications of this work and its possible extensions. Bioethicists and philosophers have been laying these foundations for years. Yet, the key problem, as always, is in translation: as we shift from science fiction to scientific reality, the robust and rigorous literature on the ethics of human population enhancement must find its way to usefully inform the policy debate and scientific practice. Translation between these camps can be thorny, but it must start with convergence on the issues at stake. Here’s a quick primer on the issue:

The spark: A team out of Sun Yat-sen University in Guangzhou led by Junjiu Huang used the CRISPR technique in non-viable human embryos to modify the gene responsible for a potentially fatal blood disorder. Leading journals Science and Nature denied the group publication on ethical grounds; the paper can be found in Protein & Cell. This is the first time that the CRISPR technique has been used to modify the human germline; however, the team specifically selected non-viable embryos in which to conduct the experiment in order to side step some of the most pressing ethical concerns.

The technology: CRISPR, which stands for “clustered regularly interspaced short palindromic repeats” refers to DNA loci that contain repeated base sequences, separated by other sequences called spacers. These spacers are like memories from previous exposure to a virus, and they tell the biological system which invaders to look out for and destroy – a key part of an adaptive immune system. In 2012, a team led by Doudna and Charpentier showed that CRISPRs could also be used to zero in on DNA sequences of their choosing simply by introducing synthetic guide RNA that matched the DNA sequence they wished to target. The CRISPR system would then slice up the targeted DNA sequence, either knocking out a gene entirely or allowing researchers to insert a “patch,” which if incorporated into the DNA sequence would modify the target gene. Since 2012 this technique has been shown to work in several organisms, including in human cells.

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The Place of Human Rights in Global Health Policy

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Guest Post by Professor John Tasioulas

The international community is currently in the process of formulating the Sustainable Development Goals that will guide the post-2015 development agenda. Many UN bodies, NGOs, governments and members of civil society have in the past stressed the vital need to embed the SDGs in a human rights framework. However, in July 2014,  the UN’s Open Working Group on Sustainable Developments Goals, of which UK Prime Minister David Cameron is co-chair, issued an outcome document that largely shunned use of the words ‘human rights’.  Some have interpreted this as a major set-back for the role of human rights in the post-2015 development agenda. Indeed, one distinguished human rights lawyer, speaking at the Harvard Human Rights Program’s recent 30th anniversary event, was moved regretfully to announce that human rights are now out of fashion. The absence of any serious engagement with human rights in the outcome document is disturbing and highlights the urgent need to clarify the role that human rights should play in the development agenda.

In an article published in the Lancet, Effy Vayena and I focus specifically on the place of human rights in global health policy. Understanding human rights in the first instance as universal moral rights, we argue for two main propositions. First, global health policy needs to attend to more than just human rights, vitally important though such rights are. For example, it needs to encourage compliance with duties people have to themselves (e.g. to maintain a healthy diet and exercise regimen) and to foster health-related common goods (e.g. a compassionate culture of organ donation or participation in clinical trials). Human rights do not all by themselves exhaust the values that should guide global health policy.

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Medicare’s Costly Drug Problem

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By Zack Buck

Last week, Dr. Salomon Melgen, an ophthalmologist who practices in North Palm Beach, Florida, was indicted on Medicare fraud charges. Melgen was charged with a variety of crimes, with prosecutors alleging he falsely diagnosed patients and falsified their files. Melgen’s name may be familiar. Last year, he was reported to be the provider with the highest total of Medicare Part B reimbursements in 2012, reportedly reimbursed by Medicare for more than $20 million, a substantial percentage of which was directly based upon his prescriptions for, and administration of, the drug Lucentis.

But the allegations against Melgen highlight a deeper challenge facing Medicare.

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‘The Week in Health Law’ Podcast

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By Nicolas Terry

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This week we are joined by Michelle Meyer, Professor and Director of Bioethics Policy in the Union Graduate College–Icahn School of Medicine at Mount Sinai Bioethics Program. We primarily discussed the ethics of digital experimentation and e-Research, with an eye to controversies over Facebook and OkCupid and the launch of innovative research platforms such as ResearchKit.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Bioethicists Art Caplan & Tom Mayo: Lawmakers have no business legislating end-of-life decisions

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A new piece by contributor Art Caplan along with Tom Mayo in The Dallas Morning News:

This week, the Texas Legislature considered restoring to pregnant women a right every other adult Texan already enjoys: the right to make health-care treatment decisions in an advance directive or through the next-of-kin who speaks for them.

House Bill 3183 would eliminate all vestiges of the “pregnancy exclusion” from Texas’ Advance Directives Act. If it passes, the bill would remove the basis on which a Fort Worth hospital in 2013 kept brain-dead and pregnant Marlise Muñoz on life support for two months. This was done despite her husband’s insistence that his wife would not want to be hooked up to machines under those circumstances.

Eventually, a trial court agreed with her husband and declared that the pregnancy exclusion and the entire Advance Directives Act did not apply to a patient once she had died. That was only after Marlise Muñoz’s family had to endure the unimaginable pain of watching her corpse deteriorate before their eyes. Little wonder that they support “Marlise’s Law” and were in Austin to testify in support of the bill. […]

Read the full article here.

Think Tanks on Prescription Drug Coverage – Missed Opportunity

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By Lydia Stewart Ferreira

Two Canadian think tanks – the C.D. Howe Institute and the Institute for Research on Public Policy – recently issued contradicting reports on whether prescription drug plans should be age-based or income-based.

As background, medications prescribed outside a Canadian hospital setting are not covered by Canada’s medicare system. They are financed through a patchwork of private and public drug insurance plans that only provide coverage for select populations. For example, up until the late 1990s, people 65 and older received universal, public drug coverage in most provinces. But with population aging, the public liability associated with age entitlements has become a major concern for governments. Four Canadian provinces have discontinued their age-based programs, which covered most of the cost of medications for seniors, and replaced them with income-based programs, which protect all residents against catastrophic drug costs. Other provinces have started to move or are considering moving in this direction.

The C.D. Howe Institute think tank concluded that provincial drug plan benefits based on age are ‘outdated’ and drug plan benefits should be based on income instead. “[I]ncome-based plans are a better alternative for cash-constrained provinces and offer more equitable access to public benefits.”

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Larissa

Larissa MacFarquhar has been a staff writer at The New Yorker since 1998. Her subjects have included John Ashbery and Edward Albee, among many others. Before joining the magazine, she was a senior editor at Lingua Franca and an advisory editor at The Paris Review. She is working on a book about extremely ethical lives.

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Harvard U Effective Altruism presents: Derek Parfit discusses altruistic giving

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When: Tuesday, April 21, 6:00pm Where: Harvard campus, Science Center E

Oxford and Harvard philosopher Derek Parfit is described by Encyclopaedia Britannica as “the most important moral philosopher of the 20th and early 21st centuries”.  The New Yorker called his books “the most important works to be written in the field in more than a century.”  He will be discussing personal identity, future generations, ethics  and Effective Altruism in a fireside chat moderated by ethicist Nir Eyal, Associate Professor of Global Health and Population at the Harvard T.H. Chan School of Public Health.

This event is co-sponsored by Harvard University Effective Altruism (HUEA) and Harvard College Effective Altruism (HCEA), and is open to the public.

Bioethicist Art Caplan: Actress Sofia Vergara Can’t Destroy Her Embryos

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A new piece by contributor Art Caplan on NBC News:

Nick Loeb and Sofia Vergara once were a huge item. Today, they are back in the tabloid press because of a dispute over frozen, human embryos.

The 42-year-old actress and star of “Modern Family,” one of the top-earning women in Hollywood, announced her engagement to the wealthy, 40-year old businessman in 2012. Last May, Vergara announced they had split amid a host of abuse allegations.

Their squabble now has grown to include Loeb suing Vergara in California to prevent her from destroying two frozen female embryos, which court documents say they created using in vitro fertilization in November 2013. […]

Read the full article here.