Little Sisters: Cato Institute Targets the Affordable Care Act—Yet Again

By Gregory M. Lipper

Fresh off its unsuccessful attempt to gut the Affordable Care Act in King v. Burwell, the Cato Institute is back for more. This time, Cato has filed an amicus brief in support of Supreme Court review in Little Sisters of the Poor Home for the Aged v. Burwell. This is one of the many, many (many) challenges brought under the Religious Freedom Restoration Act (RFRA) by nonprofit organizations to an accommodation, offered by the Department of Health and Human Services (HHS), exempting religious nonprofits from providing contraceptive coverage to their employees. To take advantage of the accommodation, nonprofits need only provide written notice to the government of their objection and the name of their insurance provider or plan administrator. At that point, the government arranges for the nonprofit organization’s insurance company or plan administrator to provide the coverage at no cost to the nonprofit or its employees.

These RFRA challenges to the nonprofit accommodation have been rejected by all seven federal appeals courts to address them. But in this brief backing the challenge by Little Sisters, Cato asks the Supreme Court to dodge the RFRA question entirely, claiming that the case “can be resolved without further engaging in the delicate analysis required by the Religious Freedom Restoration Act.” Instead, Cato makes the following argument: (1) in light of King v. Burwell’s statements about agency deference, HHS had no authority to offer religious accommodations to its own regulations implementing the Affordable Care Act, and (2) without a religious accommodation, the contraceptive coverage requirement is unenforceable against nonprofit organizations with religious objections.

Cato seeks—in the name of religious liberty!—to prevent regulatory agencies from granting accommodations to entities with religious objections to regulations, and then argues that the absence of religious accommodation makes the underlying regulations unenforceable against religious objectors. Cato’s curious argument suffers from two serious flaws.

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DCIS Study Amplifies Questions and Demand for Answers

By Dalia Deak

This week, a JAMA Oncology article made a splash when it intensified discussion around what ductal carcinoma in situ (DCIS) should be considered – cancer, precursor, or risk factor – and whether current treatment approaches have been effective. The New York Times, The Guardian, and others have picked up the story, and readers have reacted extensively, only amplifying a demand for answers to questions raised.

Often called Stage 0 breast cancer, DCIS is considered to be abnormal cells that are confined inside the milk ducts and, as such, are not considered invasive. Because of the increased risk associated with DCIS, many women who are found to have DCIS (a growing number considering the frequency of and improvements in mammography) undergo lumpectomies or mastectomies often accompanied by radiation therapy. Continue reading

Call for Abstracts! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and Bioethics.”  This year’s conference is organized in collaboration with the Berkman Center for Internet and Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.

Conference Description

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data). Continue reading

NOW AVAILABLE: FDA in the 21st Century: Get 30% Off When You Order through the Press!

lync17118_frontJust out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen, stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

Use promo code FDA21 and save 30% if you order now at the Columbia University Press website!

And join us at Harvard Law School on October 28 for a book launch and panel discussion featuring editors Holly Fernandez Lynch and Glenn Cohen!

Journal of Law and the Biosciences: Call for Harvard Student Submissions

JLB coverThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish the Journal of Law and Biosciences  (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a Notes & Developments section, comprised  of  brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students to contribute papers to be published in JLB’s Notes & Developments section in early 2016. In previous years, Notes & Developments have been generated from scratch specifically for JLB, based on selection from submitted proposals. This year, we are taking a different approach by publishing already complete (or to-be-completed by the deadline) original student papers (such as student notes, course papers, etc.) written by graduate students from any Harvard school.  Notes & Developments are limited to 5000 words, including footnotes and references,  and  should  be  on  a  topic  of  relevance  to  law  and  the  biosciences,  in particular a topic of relatively recent concern, controversy, or change. They should focus on  describing  the  issue  at  hand,  explaining  why  it  is  relevant to scholars and practitioners, and providing analysis and questions for further consideration.

Interested students should submit their papers and CVs for consideration no later than September 7, 2015 (earlier  is  welcome). Up to four papers will be selected for publication in the New Developments section of JLB. Applicants will be notified by the end of September. Selected students will receive comments on their papers by the end of October, and will also be responsible for providing comments to the other selected students. Revisions will be due by the end of November, and final submissions to JLB will be due by the end of December 2015.

Please send all application materials, and direct all questions, to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey

By Robert Field

What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.”

Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical officer at the Food and Drug Administration (FDA). She saved thousands of lives and prevented untold suffering by using techniques that earn bureaucrats a bad name, delay and obstruction, to keep the drug thalidomide from reaching the market in the United States in 1961.

Thalidomide is a sedative that had been approved for sale in Europe four years earlier and was prescribed for morning sickness during pregnancy. The American manufacturer, Richardson-Merrell, saw a large potential market in the United States. However, Dr. Kelsey, who was assigned to review its application for marketing approval, was troubled by questionable safety data. The law in effect in 1961 required that she issue a decision within 60 days, but she was able to buy more time by asking for additional information.

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Interpreting Fiorina’s Comments on Vaccination Law

I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.

Pain-o-meters: How – and Why – Should We Develop Them?

By Karen Davis

The prevalence of chronic pain is staggering.  The Institute of Medicine reported in 2011 that 100 million Americans suffer from chronic pain – more than those with heart disease, cancer and diabetes combined.  The report also highlights that the annual costs for medical care, lost wages and productivity is more than $600B.  These enormous personal and societal costs of chronic pain has driven an effort to “prove” if and how much pain an individual is suffering from for health care providers, insurance companies and legal actors.  This is challenging because pain is a personal and subjective experience.  Ideally, self report would be sufficient to establish the “ground truth” of the pain experience.

However, some are not able to provide self reports accurately, and the potential financial gain associated with claims of pain has tarnished the perceived authenticity of subjective reports.  This has led some to develop brain imaging-based tests of pain – a so-called “painometer.”  Yet, current technologies are simply not able to determine whether or not someone has chronic pain.  Here, I consider specifically how we could develop a brain-imaging based painometer – and whether we would want to do so.  As we ask: “Can we do it?,” we should always ask, “Is this the right thing to do?”

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Bioethicist Art Caplan: Why Jim Carrey is Wrong About Vaccines

A new opinion piece by contributor Art Caplan on NBC News:

California has decided one large epidemic scare is enough. After the frightening outbreak of measles that started at Disneyland and sickened 147 people, Californians rejected the irrationality of anti-vaccine zealots and decided to restrict parents’ ability to exempt their children from school vaccinations.

The new law signed by Governor Jerry Brown throws out religious and philosophical reasons to exempt. Only health concerns will be permitted and those must be verified by a physician. If you simply don’t want to vaccinate your kids, you will have to home school.

The new law is all to the good. No major religions have heartburn over vaccination. Most see it as an obligation in order to help the community. And philosophical exemptions were nothing but an open door for those who are ill-informed, addicted to misinformation on the internet or just plain selfish. […]

Read the full article here.

The ACA Survives — But With A Note Of Caution For The Future?

Academic Fellow Rachel Sachs has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision in King v. Burwell. From the piece: 

Chief Justice Roberts has once again saved a core provision of the Affordable Care Act (ACA). In King v Burwell, a majority of six Justices upheld the validity of an Internal Revenue Service (IRS) rule interpreting the text of the ACA to permit tax credits to be distributed through both state and federal insurance exchanges. As a result, the millions of Americans receiving subsidies through federally established exchanges in the states that have not chosen to establish their own exchanges will continue to receive them.

Much of the briefing and argument in King involved the legal principle known as Chevron deference, in which courts generally defer to agencies’ reasonable interpretations of statutes if the statutory language is ambiguous. In this case, the government first argued that the statutory language clearly permitted tax credits to be made available on federally established exchanges. But even if the statute was ambiguous, it contended, Chevron counseled deference to the IRS’ reasonable interpretation of the statute.

Read the full piece on the Health Affairs Blog!

Happy about the Supreme Court’s ACA decision? Thank a law professor

By Rachel Sachs

[Originally published on The Conversation].

The core of the Affordable Care Act (ACA) has now survived its second trip to the Supreme Court.

Chief Justice John Roberts wrote for the majority in King v Burwell, holding that the federal government may provide subsidies for citizens to purchase health insurance on exchanges that were established by the federal government, rather than by their own state.

A ruling for the challengers (the “King” in King v Burwell) would not only have stopped the flow of subsidies to 6.4 million people currently receiving them, but it would also have disrupted the functioning of the individual insurance markets in the 34 states that have not established their own exchanges. Continue reading

Health Law Year in P/Review: Until Next Year

This new post by Holly F. Lynch, I. Glenn Cohen, and Gregory Curfman appears on the Health Affairs Blog as the final entry in a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

It’s been our great pleasure to collaborate with the Health Affairs Blog on this series stemming from theThird Annual Health Law Year in P/Review symposium at Harvard Law School. This annual event takes a look back over the prior year and previews the year to come with regard to hot topics in health law.

After the symposium, we asked our speakers to keep the conversation going online by expanding on their topics from different angles or by honing in on particularly intriguing features. These pieces were published on the Health Affairs Blog through the spring and into summer.

We heard more from Kevin Outterson on how to promote innovation in the development of new antibiotics, from Rachel Sachs on whether the Food and Drug Administration’s proposal to regulate laboratory-developed tests will really stifle innovation, and from Claire Laporte on the impact of recent Supreme Court decisions on bio-IP.

George Annas weighed in on the Ebola outbreak, which has already almost faded from public consciousness but offers important public health lessons, while Wendy Parmet and Andrew Sussman tackled important developments in tobacco control. […]

Read the full post here.

The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Continue reading

How law professors helped the Supreme Court understand the Affordable Care Act

By Rachel Sachs

[Originally published on The Conversation].

In March, the Supreme Court heard oral arguments in King v Burwell, a case that could broadly impact the functioning of the Affordable Care Act (ACA). The central question in King v Burwell is whether the federal government may provide subsidies for citizens to purchase health insurance on exchanges that were established by the federal government, rather than by their own state. If the court rules for the government, these subsidies will remain in place. If the court rules against the government, subsidies may no longer be provided to people living in states that have not established their own exchanges.

A decision is expected by the end of June, and a ruling against the government could harm not only the 6.4 million people receiving these subsidies, but also the individual insurance markets in the 34 states that have not established their own exchanges. These markets would likely descend into an actuarial “death spiral,” in which healthier people exit the market in cycles, leaving sicker patients to pay ever-higher premiums. Continue reading

Marriage Equality, Health, and Life Extension

Health care analysts have long studied the effects of relationships on health, e.g., married men live longer than unmarried.   Professor Debra Umberson, a sociologist at the University of Texas Sociology Department has researched deeply into these issues.  She opened my eyes recently with insights as to how denial of marriage equality is a public health hazard because of the beneficial effects of marriage on health and life extension.

Here is a link to her Huff Post essay on this topic and a word version of the same:

http://sites.la.utexas.edu/mharp/2015/06/09/one-benefit-to-same-sex-marriage-that-nobody-is-talking-about/

 In Sickness As In Health

As the U.S. Supreme Court decides whether the Constitution requires recognition of same-sex marriage, many have speculated about the real-world consequences of marriage equality.  On at least one front the answer is clear.  Extending marriage rights to same-sex couples will improve the nation’s health. Continue reading

FDA’s Non-Response Response to My New York Times Op-Ed on Gay Blood Ban

On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Times raising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.

Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.

Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].

Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.

The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.

Well FDA responded…sort of … through a NY TImes Letter To the Editor.

Here is what FDA said with my analysis in bold:

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Who needs to be involved in creating community health?

A slew of organizations, including most notably the Robert Wood Johnson Foundation, are talking about creating a “culture of health” as a new way forward in US health policy. The underlying thinking assumes that legislative fixes, including the Affordable Care Act, will continue to be vehemently fought if attitudes towards health do not in some ways fundamentally change. Inherent in the idea of building a culture is incorporating unconventional actors and voices into discussions about how to improve outcomes at a local level. This has led public health strategists to ask new questions about who to involve in community health building efforts with an eye towards employers, small businesses, social service organizations and community institutions.

With this in mind, I recently spoke with Peter Doliber, Executive Director of the Alliance of Massachusetts YMCA about how he sees the Ys fitting into a plan to create health. His background is in public health and hospital administration, having worked in a range of communities to develop programs that increase access to health care, improve health outcomes and create a return on investment. Here’s an abbreviated version of our conversation.

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Fundraising and the Delayed Kidney Transplantation: A Loophole in the Ban against Commercialization?

In April, a kidney donation from an unrelated living donor was put on hold in South Portland, Maine. The reason was unusual: the generosity of the community.  In response to an online fundraising for the donor, 768 people contributed over $49,000—well beyond what can reasonably be called “compensation.” The hospital thus had to ask the question: Is the donation procedure in conflict with the law now that the donor stands to profit from it? After initial media coverage, there was no further news about this case. On Monday, however, it was announced on the fundraising page that the transplant is back on track and due to happen in two weeks. Does that mean that we now have a loophole in the ban against commercialization of organs?

The case is unprecedented. There are and have been other online fundraisers to compensate donors. But this is the first time that the unpredictable powers of the internet kicked in (remember the guy who raised $55,000 to make a potato salad?). The law prohibits any monetary payments to organ donors. The situation poses two questions: What should be done in this particular case, and how should fundraising for organ donors be regulated going forward?

It appears that the first question was somehow resolved even though we don’t know how: Did the hospital decide it was not a problem after all, or did the donor agree with the hospital’s reported initial suggestion of donating the “excess” money to some other organization? In either case, what follows remains problematic.

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The Ethics of Punking the Diet-Research Media Complex (and Millions of Readers)

ScaleA remarkable new “sting” of the “diet research-media complex” was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.

Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn’t have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.

But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being. Continue reading

Faculty Director I. Glenn Cohen: New Blood-Donor Policy, Same Gay Stigma

Faculty Director I. Glenn Cohen has co-authored a new Op-Ed in the New York Times:

Last week, the Food and Drug Administration released highly anticipated draft recommendations that would allow gay men to donate blood after one year of celibacy. While an improvement from the current, highly criticized lifetime ban, the new policy, which was announced in December, still caters to fear and stigma rather than science. It should be reconsidered. […]

Read the full article here.