REGISTER NOW! Specimen Science: Ethics and Policy Implications Symposium, with NEW Lunchtime Talk on “Biospecimens and the NPRM”

testtube_hand_bw_slideSpecimen Science: Ethics and Policy Implications
NEW Lunchtime Talk on “Biospecimens & the NPRM”
Monday,  November 16, 2015, 8:00 AM – 5:00 PM
8-11:45am: Austin Hall North (100);
11:45am-5:30pm, Langdell Hall South, Room 272

Harvard Law School, Cambridge, MA [Map]

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data.   However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others.  Conference papers eventually will be published as an edited volume with a major academic press.


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‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we interviewed Kirk J. Nahra, Partner at Wiley Rein. As his firm website notes, he “was named as the Co-Chair of the Confidentiality, Privacy, and Security Workgroup, a panel of government and private sector privacy and security experts advising the American Health Information Community (AHIC) on privacy and security issues arising from health information technology,” and has also “been named an expert practitioner by the Guide to the Leading US Healthcare Lawyers, a leading health care lawyer by The Best Lawyers in America directory and one of the leading privacy “hired guns” by Computerworld.” We discussed HITECH, HIPAA, health data outside the HIPAA zone, and the future of health privacy. We also briefly mentioned emerging threats to the US/EU Safe Harbor framework.

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 RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

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

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we discussed Medicare payment policies, the social determinants of health, and changing delivery models with Professor Jessica Lind Mantel, Assistant Professor & Co-Director of the Health Law & Policy Institute at the University of Houston Law Center. Some of Professor Mantel’s many excellent articles on health law & policy are available here.

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 RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

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

NPRM Symposium: More Resources, Now from OHRP

The Office for Human Research Protections (HHS) has released a series of 6 webinars to help the public better understand the goals and impact of the NPRM.  Happy viewing:

  1. Overview of the NPRM (approx. 34 mins.), Jerry Menikoff, Director, OHRP
  2. Exclusions and Exemptions (approx. 30 mins.), Jerry Menikoff, Director, OHRP
  3. Informed Consent (approx. 28 mins.), Jerry Menikoff, Director, OHRP
  4. IRB Review and Operations (approx. 18 mins.), Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
  5. Research with Biospecimens (approx. 22 mins.), Julie Kaneshiro, Deputy Director, OHRP
  6. Secondary Research Use of Data (approx. 21 mins.), Ivor Pritchard, Senior Advisor to the Director, OHRP

Research Ethics Extravaganza: New Draft CIOMS Guidelines

As if the proposed revisions to the Common Rule weren’t enough to process, the Council for International Organizations of Medical Sciences (CIOMS) just released its proposed changes to the current CIOMS Ethical Guidelines for Biomedical Research (last revised in 2002).  CIOMS invites public comments until March 1, 2016, at which point the CIOMS Working Group will process and review them and submit the final document to the CIOMS Executive Committee for approval.

According to CIOMS, most guidelines have been substantially revised in this draft, several have been merged, and new guidelines have been added.  The proposal also merges the guidelines for biomedical research with those for epidemiological research, and the scope has been broadened from biomedical research to health-related research with humans.

A busy and exciting time in research ethics!

NPRM Symposium: Resources from PRIM&R

Our colleagues at PRIM&R (Public Responsibility in Medicine & Research) have compiled several resources to help those interested in the proposed changes to the Federal Policy for the Protection of Human Subjects, or the Common Rule.  These include an NPRM Resources page, with a chart comparing the current Common Rule with the proposed changes by section, and other materials.  PRIM&R has also recently released a freely available (till December 11, when it becomes available only to members) annotated version of the current Common Rule, which provides the regulatory text, hyperlinked to further information in the form of guidance, frequently asked questions, and regulatory resources from the Office for Human Research Protections.

PRIM&R will be blogging about the NPRM in the coming weeks, and we will cross-post here.  Stay tuned.

NPRM Symposium: Helpful Resources to Understand What the NPRM Proposes to Change

For those trying to make sense of the NPRM, the Academic and Clinical Research Group at Verrill Dana has issued two very helpful resources: 

  1. A redline of HHS’s current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the proposed regulations in the NPRM.
  2. Several decision charts walking through the following issues: 
  • the scope of covered human subject research and clinical trials,
  • the key definitions of “human subject” and “research,”
  • the exclusions (and conditions for exclusion) from the proposed regulations, and
  • the exemptions (and associated requirements) from the proposed regulations.

For those interested, the firm’s full client advisories on the NPRM are available here

[Posted with Verrill Dana’s permission]

Presidential Campaigns Focus on Drug Costs

By Katherine Kwong

Drug prices have become a hot topic on the presidential campaign trail following recent stories such as the sudden spike in price from $13.50 to $750 for the parasitic infection treatment Daraprim. This story is the latest example of a growing number of complaints about steep increases and high prices for many drugs, including those used to treat multiple sclerosis and cancer, as well as commonly-used generic drugs used to treat everything from high cholesterol to bacterial infections.

In contrast with the Republican presidential candidates, who have generally not supported additional government regulation of drug pricing, Democratic presidential candidates responded to the Daraprim story by urging greater government action to lower drug costs.

Hillary Clinton cited Daraprim as an example when unveiling a proposal to cap drug costs to $250 per month, require pharmaceutical companies to spend a minimum amount on research and development, and allow Medicare to negotiate drug prices. She would also end tax credits for drug advertising to consumers and allow the importation of drugs from other countries.

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TOMORROW (9/30): Non-Human Primates in Research – Legal and Ethical Considerations


Non-Human Primates in Research: Legal and Ethical Considerations
September 30, 2015, 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]


Please join us for a discussion of critical legal, ethical, scientific, and social issues raised by research involving non-human primates, and the research centers that house them.  What does the current regulatory structure require and permit, what gaps exist, what enforcement problems have arisen, and how are they being addressed at Harvard and elsewhere?  How should scientific and medical interests be balanced against the interests of the animals, and how might the ethical and/or regulatory analysis differ depending on the type of primate involved?  What trends are emerging with regard to funding, scientific approaches, and public opinion?  Our panelists will address these questions and others in the course of a lively debate.

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Worth Reading This Week

By Nicolas Terry

Medicaid Is Not a Welfare Program

Medicaid is often thought of as a welfare program because of the essential role it plays in providing health insurance for low-income people. However, looks can be deceiving. In terms of scale and scope, Medicaid is rapidly becoming a powerhouse player in health care.

Medicaid enrollment is booming as a result of the Affordable Care Act (ACA): nearly 72 million people are enrolled in Medicaid and the Children’s Health Insurance Program (CHIP). To put this in perspective, about 55 million people are enrolled in Medicare and about 64 million in the UK’s NHS. Medicaid enrollment is likely to continue rising as more states contemplate expansion. As of this month, 30 states and the District of Columbia have expanded Medicaid under the ACA.

Size isn’t the only way Medicaid is changing. Unlike Medicare, Medicaid is a joint state and federal program, which means that states have a lot of latitude to innovate with both delivery and payment. The ACA has enhanced opportunity for reform through planned initiatives like the Center for Medicare and Medicaid Innovation (CMMI), and unexpected pathways, like negotiations around Medicaid expansion – these have yielded some of the most radical departures from the traditional public program paradigm, even in states that have not sought a “private option

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Job Opportunity: Legal Research Associate

Come join our team!

The Public Health Law Research program is hiring legal research associates to work on our policy surveillance project. The legal research associate will conduct legal research using Lexis and Westlaw, build historical law using HeinOnline, and conceptualize legal domains for empirical research. The associate will also code law for the creation of quantitative legal datasets at, and write legal briefs and other materials for

Learn more and apply today!

Assisted Suicide and Lethal Injection: FDA’s Regulatory Dilemma?

Two weeks ago, California’s legislature approved a bill that would make California the fifth, and largest state to approve assisted suicide. If Governor Jerry Brown signs the bill, California would join Oregon, Washington, Montana, and Vermont in permitting physicians to prescribe life-ending medications. California was one of 36 states that considered assisted suicide legislation this year. Though none of the bills have become law, the assisted suicide, or “Death with Dignity” movement seems to be gaining strength.

If assisted suicide becomes legal in California, whether and how patients will have access to assisted suicide is a different matter. Secobarbitol and pentobarbital are the most commonly used medications in assisted suicide. Pentobarbital, the cheaper of the two options and the preferred drug of choice, is facing a drug shortage. Pentobarbital is also used in capital punishment, and U.S. suppliers have stopped producing the drug because the suppliers did not want to be associated with lethal injection. The drug shortage has left some patients considering assisted suicide to go through back alleyways to obtain pentobarbital.

Indeed, the Death with Dignity movement is facing many of the same issues that state corrections agencies are facing in obtaining access to lethal drugs. None of the drugs used for assisted suicide or lethal injection are FDA-approved for a lethal purpose. Both groups have faced challenges in importing the drugs from other countries because FDA cannot accepting an imported drug if it appears to violate Food Drug and Cosmetic Act. Both groups have, in some cases, resorted to compounding pharmacies to manufacture lethal drugs from raw materials.

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What’s the Difference Between Anorexia Nervosa and Hunger Strike?

My last post presented the debate over force feeding hunger striking prisoners in Israel. This post will discuss another group subjected to the dramatic means of force feeding in extreme circumstances, Anorexia Nervosa patients (AN).

Although ethical justifications for force-feeding are similar for both Anorexics and Hunger strikers (save life), the legal framework is completely different in each context. Whereas hunger striking prisoners were dealt with via ad-hoc legislation meant to answer national security threats, AN patients are handled within the framework of mental health law.  In the U.S., compulsory hospitalization of mental patients occurs through the state’s Civil Commitment Laws, which require dangerousness resulting from a mental illness to be evaluated by a psychiatrist.

Is the different legal attitude justified? How is it that the same act performed by prisoners is viewed as a political assertion but when done predominantly by adolescent middle-upper class girls, it is considered mental illness?

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Generic Drug Price Increases: Implications for Medicaid

The internet (not just the health policy part of the internet!) is fascinated by today’s New York Times story about dramatic recent increases in the costs of many decades-old drugs.  The story focuses on the case of Daraprim, the standard of care for treating the parasitic infection toxoplasmosis.  Daraprim was recently acquired by a start-up, which then raised the drug’s price from $13.50 a pill to $750 a pill.  Daraprim has been around for decades, and as the story notes, it’s just one of many recent examples of dramatic price increases for generic drugs, often after their acquisition by other companies (as in this case).

The article raises an enormous number of issues of interest to intellectual property and health policy scholars, both explicitly and implicitly, and other commentators have begun to canvass them.  But I want to spend the rest of this blog post unpacking a single point made in the article, because it actually contains an enormous amount of complexity.  As the author notes, “[the company’s] price increase could bring sales to tens or even hundreds of millions of dollars a year if use remains constant. Medicaid and certain hospitals will be able to get the drug inexpensively under federal rules for discounts and rebates. But private insurers, Medicare and hospitalized patients would have to pay an amount closer to the list price.”

The author is right that there’s one sense in which Medicaid and entities eligible for the 340B program (I assume this is what the author is referring to when he says “certain hospitals”) will be able to obtain this drug “inexpensively” – but there’s another sense in which they won’t be able to.

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Texas, Abortion, and the Supreme Court – Part II

[cross-posted at Prawfsblawg]

By Jessie Hill

In this second post on the certiorari petition in Whole Women’s Health v. Cole, I want to consider the likelihood that the Supreme Court will take this case, and if it does, what it is likely to do with it.

I think it’s a very good bet that the Supreme Court will decide to hear this case this Term, perhaps in conjunction with one of the other cases that deals with admitting privileges laws – either Currier v. Jackson Women’s Health Organization, another admitting privileges case, in which the Fifth Circuit actually enjoined an admitting-privileges requirement that would have shut down the last remaining abortion clinic in Mississippi, or Planned Parenthood v. Van Hollen, in which the Seventh Circuit enjoined an admitting-privileges law. However, both of those cases are still at the preliminary-injunction stage, unlike Whole Women’s Health, which was rushed to trial on an expedited schedule. Still, SCOTUS has been holding onto the petition in Jackson Women’s Health Organization since the spring and may well decide to consolidate it with Whole Women’s Health. (No petition has yet been filed in Van Hollen, as that case is back in front of the district court and scheduled for trial.)

There are a lot of reasons for the Court to grant cert in at least one of these cases.

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Bioethicist Art Caplan: Science Anyone?

Bill of Health Contributor Arthur Caplan has a new piece up on From the piece:

Plenty of pundits are analyzing the Wednesday night GOP debate in terms of who won and who lost. They are missing the point. There was a huge loser in the back and forth among the contenders—the public health of the American people. Why?–the resurrection in the debate of the heinous canard that vaccination causes autism.

Donald Trump led the assault on the health of our children by proclaiming that “”We’ve had so many instances … a child went to have the vaccine, got very, very sick, and now is autistic.” Really? Donald produce your evidence or get your racist, misogynist, birther, comb-over tushy out of the race. There is no evidence that vaccines cause autism. None. No one should tolerate outright lying that puts vulnerable kids at risk from a would-be President. So Donald show us your proof or leave Americas kids alone. […]

Read more here.

‘The Week in Health Law’ Podcast

By Nicolas Terry

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How many podcasts discuss a Kardashian, drug pricing, and readmission penalties-all in the same episode? We welcome guest Aaron Kesselheim, from Harvard Medical School, and the Department of Health Policy and Management at Harvard’s T.H. Chan School of Public Health. Aaron is a prolific and insightful scholar whose work has influenced policy makers globally.

To start the packed show, Nic and Frank discussed a new study of ACOs, proposed budget cuts for AHRQ, worry over unintended consequences of readmission penalties, and EHR gag clauses (and developer codes of conduct). With Aaron’s help we discussed Kim Kardashian’s FDA feud over stealth marketing of an anti-nausea drug, the FDA guidance on limited character social media marketing, the nomination of the new FDA Commissioner, and how we could tackle high drug prices using Sovaldi as an example.

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 RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

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

A Circuit Split on Contraceptives Coverage

Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate.  Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.

First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.

Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met.  So far, so good.  But that’s the end of my agreement.

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