Category: Health Law Policy

‘The Week in Health Law’ Podcast

Nicolas P. Terry Leave a comment

By Nicolas Terry

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This week we are joined by Bill of Health’s own Glenn Cohen, HLS Professor of Law and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics. We discuss surrogacy arbitrage, MRT, CASPR DNA editing and “Uber” elder care.

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

Bioethicist Art Caplan: Rein It In, Dr. Oz

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A new piece by contributor Art Caplan on Medscape [Note: free registration required]:

Dr Mehmet Oz is in trouble again. He was accused by 10 physicians in a letter of promoting quackery. They demanded that Columbia University Medical Center fire Dr Oz. Now, I can say with some authority that as “America’s Doctor”—the person who, for many Americans, is the voice of medicine—he is not going to be fired. His show is not going to end. That isn’t going to happen.

Dr Oz has evoked this response from these 10 physicians because he continues to push the border of legitimacy on his shows with respect to touting things for which there isn’t much evidence. And that is a problem. Many doctors tell me that when Dr Oz endorses something—green coffee beans, some neti pot to cure the common cold—whatever it is, they are going to be asked about it, and their patients run out and buy it. He has enormous power when it comes to the platform he has built. And let’s face it: He is an effective communicator. His show is fun to watch. I understand why the American people are paying attention to Dr Oz. […]

Read the full article here.

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of April. The selections feature topics ranging from the effect of direct-to-consumer advertising on asthma medication sales, to the impact of FDA approval of Colrys on patient initiation of and spending on colchicine products, to the reasons why certain new drugs required multiple review cycles.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, Korngiebel D, James C, Kuwana E, Gallagher TH, Diekema D, Capron AM, Joffe S, Wilfond BS. Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med. 2015 Apr 14. [Epub ahead of print]
  2. Daubresse M, Hutfless S, Kim Y, Kornfield R, Qato DM, Huang J, Miller K, Emery SL, Alexander GC. Effect of Direct-to-Consumer Advertising on Asthma Medication Sales and Healthcare Utilization. Am J Respir Crit Care Med. 2015 Apr 16. [Epub ahead of print]
  3. Goldacre B. How to get all trials reported: audit, better data, and individual accountability. PLoS Med. 2015 Apr 14;12(4):e1001821.
  4. Kesselheim AS, Franklin JM, Kim SC, Seeger JD, Solomon DH. Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population. J Gen Intern Med. 2015 Apr 9. [Epub ahead of print]
  5. Light DW, Lexchin J. Why do cancer drugs get such an easy ride? 2015 Apr 23;350:h2068.
  6. McClellan MB, Daniel GW, Dickson D, Perlmutter J, Berger DP, Miller V, Nussbaum S, Malin J, Romine MH, Schilsky RL. Improving evidence developed from population-level experience with targeted agents. Clin Pharmacol Ther. 2015 May;97(5):478-87. Epub 2015 Apr 3.
  7. Ross JS, Dzara K, Downing NS. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs. Health Aff (Millwood). 2015 Apr 1;34(4):681-88.

TWO EVENTS THIS WEEK (5/7-5/9): “After Hobby Lobby: What Is Caesar’s, What Is God’s?” & “Law, Religion, and Health in America”

The Petrie-Flom Center Staff Leave a comment

Pre-Conference Session

Hobby_Lobby_slide_270_174_85“After Hobby Lobby: What Is Caesar’s, What Is God’s?”
May 7, 2015, 4:00 – 6:00 PM
Wasserstein Hall, Milstein East BC
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

As prelude to the 2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,” please join us for a pre-conference session examining the role of religion in the American public sphere. Our expert panel will discuss the nature of conscience and conscientious objection, religious freedom, and religious accommodation from philosophical, theological, historical, legal, and political perspectives.

Panelists:

  • J. Dionne, Jr., Columnist, The Washington Post; Senior Fellow, The Brookings Institution
  • Diane L. Moore, Senior Lecturer on Religious Studies and Education and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School
  • Charles Fried, Beneficial Professor of Law, Harvard Law School
  • Frank Wolf, Representative, Virginia’s 10th Congressional District, U.S. House of Representatives, 1981-2015 (retired)
  • Moderator: Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • Moderator:  Glenn Cohen, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center

The panel will be followed by a light reception at 6 PM.

This event is free and open to the public, but seating is limited. Register online!

 Full Conference:
stethoscope_bible_slide“Law, Religion, and Health in America”
May 8-9, 2015
Wasserstein Hall
Milstein East ABC
Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated.  Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience. 

This conference will identify the various ways in which law intersects with religion and health care in the United States, understand the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

Highlights:

Keynote Lecture: Religious Liberty, Health Care, and the Culture Wars

 Plenary Session: The Contraceptives Coverage Mandate Litigation

The conference is free and open to the public, but seating is limited. View the full agenda and register online!

The pre-conference session is co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb, Jr. Initiative on Religious Freedom and Its Implications at the Center for American Political Studies at Harvard University.

The 2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,“ is supported by the Oswald DeN. Cammann Fund.

May 7: Identified Versus Statistical Lives – Book Talk & Discussion

The Petrie-Flom Center Staff Leave a comment

Identified Versus Statistical Lives – Book talk and discussion, featuring co-editors I. Glenn Cohen (Faculty Director), Nir Eyal, and Norman Daniels

Cohen_Identified_LivesThursday, May 7, 12:30 – 1:30 PM
Harvard Chan School of Public Health
Building 1, Room 1208
677 Huntington Avenue
Boston, MA  [Map]

The essays in Identified versus Statistical Lives: An Interdisciplinary Approach address the identified lives effect, namely, the greater human proclivity to assist persons and groups identified as at high risk of great harm than ones who will (or already) suffer similar harm, yet remain unidentified. Because of this effect we often allocate resources reactively rather than proactively, prioritizing treatment over prevention. The practical and the ethical questions this raises extend to almost every aspect of human life and health policy. The book discusses the psychology of the identified lives effect, pits thinkers who deem it to reflect an irrational aspect of our thinking against ones who deem it to be rational, and explores practical questions ranging from environmental health to “treatment as prevention” for HIV/AIDS.

Read the front matter of the book online!

To Spur Medical Innovation, Make Corporate Cheaters Pay

Ameet Sarpatwari 3 Comments

By Aaron S. Kesselheim and Ameet Sarpatwari 

Cross posted from Health Affairs Blog

The past decade has seen a relatively constant rate of newly approved drugs every year. The number has even jumped in the past few years. Yet, despite such encouraging trends, we are actually facing a crisis in drug innovation today. That is because many of these new products do not offer substantial improvements over already available alternatives.

At the same time, novel and effective treatments for many diseases—both rare and common—remain elusive. For example, there is widespread concern over the lack of development of new antibiotics aimed at multidrug-resistant infections. Therapeutic innovation for central nervous system disorders such as dementia and psychoses, which affect almost 100 million Americans, has likewise stagnated.

In this climate, pharmaceutical manufacturers have nonetheless continued to thrive. The top eleven drug manufacturers made $711 billion from 2003 to 2012, including $68 billion in 2012 alone, translating to an industry profit margin on par with the banking sector.

Read More

New Discussion Draft of 21st Century Cures Act Released

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By Rachel Sachs

Yesterday, a new discussion draft of the 21st Century Cures Act was released, just in time for today’s hearing on the draft before the House Energy and Commerce Committee.  At just 200 pages (although with some sections still “to be supplied”), this version is just half the size of the previous draft.  As such, it is perhaps more notable for what it took out of the original draft than for what it added in.  I haven’t had time to digest fully all of the cuts just yet, but in advance of the hearing this morning I wanted to highlight two significant deletions from the first draft and one potentially significant addition.

First, when I blogged in February about the first draft of the Act, I expressed excitement over the idea of a Medical Product Innovation Advisory Commission.  The Commission would have had the ability to oversee the way in which agencies like the NIH, FDA, and CMS all interact with each other to affect the development and dissemination of medical products.  A significant portion of my scholarship focuses on precisely these ideas, and I was hopeful that the Commission would make it into the second draft.  Alas, it did not.

Second, the first draft of the Act contained a series of very controversial exclusivity provisions.  Chief among them may have been the draft provision giving “dormant therapies” (essentially, new drugs for unmet medical needs) the option of 15 years of exclusivity.  Alexander Gaffney’s Regulatory Explainer on the first draft provides a helpful overview, for those who are interested in learning more about this provision.  But interestingly, this and other provisions relating to increased exclusivity are gone from the new draft.  Now, it is possible that some of this language will reappear later, especially as the section of the draft relating to “Repurposing Drugs for Serious and Life-Threatening Diseases and Conditions” has yet to be supplied.  But in the first draft of the document, the sections for “Repurposing Drugs” and “Dormant Therapies” were separate, so it is not clear that this is likely to happen.

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Exploring The Significant State-To-State Variation In Marketplace Enrollment

The Petrie-Flom Center Staff Leave a comment

This new post by the Petrie-Flom Center’s Academic Fellow Matthew J. B. Lawrence appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

What role did geography, advertising, community, Navigators, and the controversy surrounding the Affordable Care Act (ACA) play in consumers’ decisions whether to purchase health insurance in the individual marketplaces? The percentage of potential exchange marketplace enrollees who actually made use of the marketplace to purchase insurance varied widely from state to state for 2014 and 2015.

As of February 22, 2015, for example, there were eight states with enrollment at 50 percent or greater and eight states with enrollment at 25 percent or lower. (Per the Kaiser Family Foundation, the top eight were Vermont, Florida, Maine, DC, Delaware, Pennsylvania, New Hampshire, and North Carolina. The bottom eight were Colorado, Ohio, Alaska, Hawaii, North Dakota, Minnesota, South Dakota, and Iowa).

It would be an interesting and challenging task to explain this variation empirically. Generating reliable statistical inferences from inter-state comparisons is notoriously difficult, and the variables at play here range from the easily measured (percent of population eligible for subsidies, navigator grant amounts, number of participating insurers, premiums) to the not-so-easily measured (enthusiasm for Obamacare, efficacy of state or federal outreach efforts, geography, education, availability and usefulness of charity care and emergency Medicaid, functionality of state exchange website, population health, availability of health services). […]

Read the full post here.

‘The Week in Health Law’ Podcast

Nicolas P. Terry Leave a comment

By Nicolas Terry

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This week we are joined by Nathan Cortez, Associate Dean for Research and the Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies at SMU-Dedman School of Law. We discuss wearables & mHealth  and their regulation by FDA, FTC, & HHS-OCR.

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

Athlete concussion under-reporting and pressure from stakeholders

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By: Christine Baugh

As concussions are increasingly seen as a public health problem, under-reporting and under-diagnosis of concussion is recognized as one barrier to improving the safety of sports participation. A number of studies have previously characterized the extent of under-reporting of concussions among athletes, particularly at the collegiate level. Furthermore, existing research has examined the applicability of theories of behavior change to concussion reporting and created relevant frameworks for examination. Although a growing body of evidence suggests that reporting (or not reporting) a concussion is a decision actively made by the athlete weighing relevant factors, the extent to which interpersonal, intrapersonal, environmental, or policy factors influence athletes’ decisions about whether or not to report a concussion is not fully understood.

A recent study, on which I am a co-author, titled “Concussion under-reporting and pressure from coaches, teammates, fans, and parents,” published in Social Science and Medicine aimed to understand one possible contributory factor to athlete under-report of concussion: pressure on athletes from relevant stakeholders. (Abstract available here.) The survey-based study queried a sample of 328 athletes from 19 contact or collision sports teams (notably excluding football and hockey teams) at 4 colleges in the northeast region of the United States. Among other things, the study asked athletes whether they experienced pressure to return to play after a head impact, specifically asking about pressure from coaches, teammates, parents, and fans. Read More