TOMORROW: Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

This event is free and open to the public. Lunch will be served.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

RESCHEDULED: 4/11, Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

This event is free and open to the public. Lunch will be served.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

CANCELED: 3/3 Panel on Presidential Commission for Study of Bioethical Issues

UPDATE, 3/1: DUE TO THE STORM THAT IS CURRENTLY AFFECTING THE EAST COAST, OUR SPEAKER MICHELLE GROMAN HAS HAD TO CANCEL HER TRAVEL FOR MONDAY, 3/3. THE EVENT WILL BE RESCHEDULED FOR LATER IN THE SPRING.

CANCELED: Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

TO BE RESCHEDULED

Austin Hall West (111), Harvard Law School

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

This event is free and open to the public. Lunch will be served.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

A solution to the contraceptives coverage mess?

While prepping for a guest lecture on the contraceptives coverage mandate currently before SCOTUS, I had the opportunity today to review the merits briefs filed in the Hobby Lobby case.  I think both petitioners and respondents put out their absolute strongest arguments, as one would expect at this highest level of review.  The government asserts a fairly convincing case that for-profit corporations were not meant to be covered by the Religious Freedom Restoration Act (RFRA) and that individual shareholders are not burdened by the mandate, and the respondents convincingly argue that RFRA does indeed apply and the numerous exemptions already offered by the government have eviscerated any claim that refusing religious exemptions to for-profit corporations is necessary to achieve a compelling government interest.

The respondents, Hobby Lobby and its family owners, articulate a variety of less restrictive alternative methods to achieve the government’s interest in promoting public health and gender equality, including having the government provide free access to contraceptives rather than demanding that employers do so. Interestingly, however, the respondents do not suggest simply extending the existing accommodation available to religious non-profits to for-profit corporations with religious objections.  This accommodation allows a religious non-profit that objects to contraceptives to sidestep the mandate, instead requiring that its insurance company exclude contraceptives from the employer’s plan and itself bear responsibility to provide preventive services without cost-sharing.   The rationale is that it should be at least cost-neutral for insurance companies to provide this coverage, on the grounds that preventing pregnancy is cheaper than covering new dependents.  (And for self-insured plans, there is a similar approach by which third party administrators bear the burden, and are compensated via adjustments to Exchange user fees.)

I can’t be certain why the respondents omitted this obvious alternative, but one possibility has to do with the fact that the accommodation is currently being challenged (e.g., by the Little Sisters of the Poor) as insufficient because objecting employers argue that they are still being required to facilitate access to objectionable services, even if they do not have to pay for them.

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TOMORROW: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

1/31: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

ICYMI: Bi-weekly Petrie-Flom Center Newsletter, 1/10/14

The latest edition of the Petrie-Flom Center’s bi-weekly e-newsletter is now available. Check it out for news and announcements from the Center, new scholarship from our affiliates, updates on upcoming events, and job and fellowship opportunities in health law and bioethics!

Peter Singer on BatKid

This is worth a read, and, in my opinion, absolutely right.  The discussion is relevant to broader questions of identified v. statistical lives, as well as “choice architecture” questions about how charities ought to seek out donations.  Take a look:

Heartwarming causes are nice, but let’s give to charity with our heads

Full disclosure: Several years ago my family took advantage of a Make-A-Wish trip resulting from my younger brother’s leukemia.  He is now a thriving adult and doing great, and the experience was incredible, especially for those families with children facing terminal diagnoses.  But the fact remains that this really has to be seen as a “luxury” charity – and when faced with a stark side-by-side choice of where the dollars could be spent, Peter’s analysis nails it.

1/31: Second Annual Health Law Year in P/Review conference

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

Petrie-Flom to launch new Ethics and Law Initiative

The Petrie-Flom Center is pleased to announce the launch of its new initiative in Ethics and Law. The initiative will be part of the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center. For more information, check out the full press release.

SCOTUS and the Contraceptives Coverage Mandate

As everyone and their brother expected, SCOTUS has just decided to take up two cases challenging the contraceptives coverage mandate: Hobby Lobby, in which the 10th Circuit ruled in favor of the religiously-objecting (but secular, for-profit) employer, and Conestoga, in which the 3rd Circuit went the other direction, maintaining that “for-profit, secular corporations cannot engage in religious exercise.”

I think the First Amendment piece of this is pretty much open-and-shut: the requirement that employers offer health plans that provide contraceptives coverage free of charge is pretty clearly neutral and generally applicable.  Arguments around the Religious Freedom Restoration Act are much more interesting.  For our non-lawyer readers, the basic idea behind RFRA is that the federal government may not (1) substantially burden the right to free exercise of religion, unless it does so (a) in furtherance of a compelling interest, and (2) using the least restrictive means.  This is a high hurdle, otherwise known as strict scrutiny.

You can see several clear decision points under the RFRA analysis, and pretty much any one of them could go either way:

Do for-profit corporations have a right to free exercise?

As a threshold matter, RFRA offers protection only to those entities with free exercise rights.  Citizens United tells us that “corporations are people, my friend.”  So if that analysis applies to both the First Amendment’s free speech rights and free exercise rights, then corporations can at least pass go.  On the other hand, some courts have maintained that religion can only be exercised by individuals or religious organizations, such that RFRA would not apply to secular, for-profit corporations.

Does the contraceptives mandate impose a substantial burden? 

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Live Blogging: The Globalization of Health Care, Legal and Ethical Issues

By Holly Fernandez Lynch

This afternoon the Petrie-Flom Center co-hosted a panel discussion (with the HLS Library and the Harvard Global Health Institute) of Glenn Cohen‘s new edited volume out from Oxford University Press, The Globalization of Health Care: Legal and Ethical Issues.  Panelists were Professor Cohen, Sue Goldie, and Neel Shah; Einer Elhauge served as moderator.  This isn’t quite *live* blogging because the event just finished, but here were some of the highlights:

  • Professor Cohen began by describing the book and its contents, noting the theme that health care is becoming global – just like everything else.  The book is broken up into five sections:
    1. Medical Tourism: This is the phenomenon of patients traveling abroad for the primary purpose of getting care, in order to save on costs or to access procedures and technologies that are not available in their home country. The number of medical tourists is high (for example in 2010, nearly a million Californian’s traveled to Mexico for care), as are the profits (it’s been estimated that India’s revenues from medical tourism are around $2.2B annually).  This section of the book addresses a variety of related issues, including lessons about accreditation and safety for medical tourists, insurance coverage and encouragement for services abroad (and travel costs), media coverage of medical tourism, distributional justice issues in terms of diverting access to care for local patients, and legal questions related to tourism for services that may be illegal in a patient’s home country. Continue reading

Bill of Health Celebrates 1 Year in the Blogosphere

Our baby is 1!  In September 2012, we launched Bill of Health with the goal of becoming your go-to place for news, commentary, scholarship, and debate in the fields of health law policy, biotechnology, and bioethics.  We rounded up authors from Cambridge to Spain, from seasoned academics and practitioners in law and medicine to students who were themselves interested in learning more. And then we set them loose on this blog.  The results have been tremendous (if we do say so ourselves)!

In the past year, we’ve seen excellent analysis of nearly every corner of our fields, from the Affordable Care Act – of course – to conscientious objection, human subjects research, end-of-life care, organ donation, genetics, gene patents, medical tourism, conflicts of interest, disability, enhancement, health care finance, GMO foods, health IT, global health, privacy, obesity, personal responsibility, public health, vaccines, reproductive technology, and more.  We even hosted our first online symposium, involving the foremost experts on the law, ethics, and science of re-identification demonstrations.  Our posts have been picked up regularly by other blogs, academic outlets, and business journals, and in the past year, more than 80,000 unique visitors have come by to check us out from all over the world.

So we’re feeling pretty proud!  Thanks to all of our fantastic contributors and to you – our readers – for making Bill of Health such a big success.  This year, we want to get you even more involved by fostering a strong community of commenters.  Make your voice heard and let’s extend the debate.  And of course, be sure to get in touch with us if you have any suggestions or ideas for how to make Bill of Health even better going forward.

Here’s to another great year!

- Holly Fernandez Lynch and Glenn Cohen, eds.

Fertility and Divorce

In case you missed it, NYT had an interesting Op-Ed on Friday that addressed the inclusion of money for fertility treatments in divorce settlements – and made some suggestions about how to address fertility issues in prenups. Take a look here.

As prices drop, I wonder if/when it will become commonplace for women to start banking some “just in case” eggs in their early twenties as a matter of course. Some eager-to-be grandparents have already started the trend.

More Commentary on Why Patients May Be Discriminated Against

Given my recent piece in the New England Journal on discrimination against patients, particularly obese patients in the context of the Americans with Disabilities Act, I found this NY Times story particularly interesting: Disability and Discrimination at the Doctor’s Office. The Times story focuses on patients who are disabled in more traditional ways, but indicates that the main culprit behind the medical discrimination they may experience is not animus, but rather lack of proper equipment, which can be quite expensive.  Luckily, there may be hope on the horizon, thanks to the ACA.

Tough Advice to Swallow from the NYT Ethicist

Take a look at the answer this physician received about breaking his promise of confidentiality to a patient.  The New York Times’ Ethicist describes this as a modern problem, but it seems to me this is age-old.  And although the confession was not medical, the nature of the doctor-patient relationship and the historical trust it has cultivated can’t be ignored.  The Ethicist says he expects vehement disagreement, and that’s one thing he’s right about for sure.

Live Blogging FDA in the 21st Century Conference, Panel 9 – Addressing the Challenges of and Harnessing New Technologies

Last but not least!  Our final conference panel focused on “Addressing the Challenges of and Harnessing New Technologies,” and was moderated by Fran Miller.

We heard first from Margaret Riley on “Twenty-First Century Technology with Twentieth Century Baggage: FDA Regulation of Regenerative Medicine.”  Riley explained that regenerative medicine (i.e., the use of pluripotent stem cells) has the potential to cure disease, injury, and even remedy organ shortages.  Of course, it is a hugely political issue and the debate is emotional, value-laden, and not necessarily logical.  As a result, the legislation/regulation that results in this area may be far from ideal.

Focusing on FDA specifically, Riley explained that the agency’s approach to stem cell regulation is rooted in its regulation of gene therapy and tissue products, as initiated in the 1990s.  FDA’s regulation of autologous stem cell therapies – in which a person’s own cells are removed, manipulated, and reintroduced – as a drug was recently upheld by the District Court of DC (US v. Regenerative Sciences, 878 F. Supp. 2d 248 (DDC 2012)), but is now on appeal to the DC Circuit. Riley is not sure what the outcome will be on appeal, but noted that getting BLA’s approved on a doctor-by-doctor basis will be very difficult and likely impossible.  One possible outcome of FDA regulation is likely to be off-shoring and stem cell tourism; ironically, strict regulation may end up not protecting patients, who will end up going abroad.

Next up was Nathan Cortez, who asked “Is the FDA Equipped to Regulate Mobile Health Devices?”

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Live Blogging FDA in the 21st Century Conference, Plenary 3: Susan Winckler, President and CEO of FDLI

[Posted on behalf of Holly Fernandez Lynch, Executive Director, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]

For the last plenary session of the conference, we heard from Susan Winckler, President and CEO of the Food and Drug Law Institute, who discussed “Other Influencers of Food and Drug Law” – namely the media and Congress.

Susan began by contrasting media past and present – from newspapers, radios, and TV news, today the agency has to contend with the range of issues and challenges associated with social media.  There has been a shift from dealing with a defined press corps focused (and expert) on FDA to a “media of the masses,” which requires some level of training and background on the agency’s mission and intricacies.  The agency can now also speak directly to the public, and be more proactive, without the filter of reporters and news media editors.

Associated with this media shift, Susan identified several new realities and challenges:

  • How to explain complex scientific and legal issues in 140 character tweets?
  • How to speak with “one voice” despite the fact that every agency employee now has a media outlet?
  • How to address the expectation that FDA make declarations in real time, giving immediate responses to new developments? 
Susan then moved on to discuss the various ways in which congress engages with and influences the agency, beyond amending the FDCA:

Live Blogging from FDA in the 21st Century Conference, Panel 4: Timing Is Everything

Another great conference session this afternoon: “Timing Is Everything: Balancing Access and Uncertainty.”  This one was moderated by Jeff Skopek, with presentations by Shannon Gibson, Trudo Lemmens, and Efthimios Parasidis.

First, we heard from Gibson and Lemmens on “Overcoming ‘Premarket Syndrome,’” AKA the various problems associated with relying solely on premarket data for safety and efficacy determinations.  These problems include the fact that industry studies have been shown to be more likely to be biased in favor of demonstrating a positive result, and premarket studies also cannot really demonstrate how a product will be used in clinical practice.  Moreover, for niche market drugs (e.g., those for orphan indications or pharmacogenomics), which are becoming more and more popular, there are fewer patients available to serve as clinical trial subjects, thereby inherently limiting the data that may be generated prior to approval and increasing uncertainty around safety and effectiveness.

So what should we do? Develop an improved post-market research agenda, say Gibson and Lemmens, and explore “adaptive licensing,” by which they mean rendering regulatory decisions based on the entire body of evidence collected throughout a product’s life cycle.   They argue that drug access decisions should not be binary, but instead, should be incremental and continually reassessed based on new data, including data that becomes available after a drug has been initially made available to patients. They closed by pointing out the importance of data transparency at all points in drug regulation.

Next, we heard from Efthimios Parasidis on “Innovative Regulating as a Public Health Imperative.”  Parasidis focused on the ways in which FDA can leverage its existing post-market regulatory authorities granted under the Food and Drug Administration Amendments Act of 2007, including requiring post-market studies and imposing Risk Evaluation and Mitigation Strategy requirements (REMS).

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