Post-Trial Access and Responsibilities (and Upcoming Conference, Sept. 18 at HLS)

By Zachary Shapiro

Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is widely available or approved for the market (or maybe longer/in other circumstances). At issue is the question of the commitment a clinical trial sponsor owes the participants of their trial (and maybe others) in the period after a clinical trial phase, but before market approval of the tested pharmaceutical (or maybe longer).

While the provision of Post-Trial Access may seem to be an ethical “no-brainer,” there are numerous variables that make the decision of whether to provide PTA difficult. One major question is whether all arms of the trial deserve access to the therapy, even those who were on placebo or in the control arm. If the therapy tested shows less efficacy than a more or less expensive treatment modality, is there a responsibility to provide the more effective treatment, regardless of the cost? What if said therapy is far beyond the standard of care for the condition in the particular country where the trial took place? Furthermore, how long do PTA obligations extend? While the simple answer is that they end after market approval, the truth is that many drugs have long approval processes, with complicating factors that can result in significant delays. This is an even more difficult question if the trial is a multi-regional study, and takes place in a country where the sponsor does not intend to market the product.

The question of how to provide PTA also poses logistical issues, as many sponsor sites close after a clinical trial is finished. This can make provision of post-trial access extremely expensive, and perhaps unduly burdensome, especially if the trial is sponsored by a biotech start-up without the deep pockets of a large pharmaceutical company. These costs can skyrocket depending on whether we believe the sponsor should be responsible for costs that might result from improper use of the therapy, or failure of the participants to comply with proper treatment. Continue reading

Introducing the 2014-2015 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2014-2015 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.

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Open Clinical Ethics Positions at Boston Children’s Hospital

Interested candidates should apply at www.childrenshospital.jobs.

Temporary Clinical Ethicist

The Clinical Ethicist provides formal and informal ethics consultations and collaborates with clinical teams, patients and families, managers, and consultants to address ethical issues in pediatric health care and research. Documents ethics activities. May participate in clinical ethics rounds and other educational activities.

Requires working knowledge of theories, principles and concepts typically acquired through completion of a graduate degree in ethics, bioethics, or moral philosophy; a working knowledge of health care and hospitals or clinical degree in a health professional field; and extensive experience in clinical bioethics, preferably in hospital or health delivery systems. Work requires excellent interpersonal, organizational, oral and written communication skills in order to mediate moral disagreements or concerns and develop consensus, compromises, or other ethically acceptable resolutions. Work requires sensitivity in speaking with parents, patients, staff and others in stressful circumstances, in discussing ethical decisions regarding life support, dying and death, disclosure of bad news, participation in research, organ donation and transplantation, and other potential conflicts of interest and values. Work requires demonstrated ability in multidisciplinary collaboration and the ability to initiate, prioritize, and manage multiple projects, working across multiple departmental lines of authority and accountability and under pressure to meet deadlines.

Clinical Ethicist

Provides formal and informal ethics consultations.  Organizes and participates in clinical ethics rounds, and collaborates with clinical teams, patients and families, to address ethical issues in pediatric health care and research. Develops ethics resources and education and serves as a facilitator for change directed toward strengthening the Hospital staff’s sense of moral responsibility and moral community.

Work requires at least 5 years clinical inpatient experience in a staff physician or nursing role with substantial prior ethics education and experience derived from completion of an ethics fellowship or other advanced ethics training and/or significant ethics consultation experience.  Preference for a clinical degree in a health professional field and graduate level preparation in this discipline, clinical ethics fellowship completion, graduate degree in bioethics or related field, a strong understanding of acute care pediatric health care, and five or more years of experience in clinical bioethics, preferably in a pediatric hospital or health delivery system. Significant focus on inpatient pediatric ethics consultations with active collaboration with nursing, social work, medical staff, and other internal and external individuals and groups.

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See and Share Job and Fellowship Opportunities on the Petrie-Flom Website

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Looking for new opportunities in the fields of health law, policy, and bioethics? Look no further!

This spring, we’ve added a new opportunities section to the resources on the new Petrie-Flom website. This page features opportunities in health law and bioethics including jobs, fellowships, graduate programs, seminars, calls for abstracts and submissions—and more! These opportunities are updated in real time, full posts remain active on the website until their deadline passes, and past posts are visible in our opportunities archive.

If you have opportunities that you would like to share with the Petrie-Flom community via our website and/or our biweekly e-newsletter, please contact us at petrie-flom@law.harvard.edu.

New Joint Project on Law and Applied Neuroscience

The MGH Center for Law, Brain and Behavior and Harvard Law School’s Petrie-Flom Center announce joint “Project on Law and Applied Neuroscience” for 2014-2016

The MGH Center for Law, Brain and Behavior and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will collaborate on a joint venture – the Project on Law and Applied Neuroscience – beginning in Fall 2014. The collaboration will include a Senior Fellow in residence, public symposia, and an HLS Law and Neuroscience Seminar.

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American, Georgetown, and Hamline Law Offer Summer 2014 Health Law Courses

American University Washington College of Law’s seventh annual Health Law & Policy Summer Institute will run from June 16 to June 28. The Institute’s flexible schedule includes day, evening, and online courses focusing on: (1) pharmaceutical law, (2) bioethics, (3) health care fraud and compliance, and (4) the economics of health care reform.

The O’Neill Institute for National and Global Health Law at Georgetown University is pleased to present two programs this summer: (1) Emerging Issues in Food and Drug Law and (2) U.S. Health Reform – The Affordable Care Act.  Now in its third year, the Summer Programs will convene leading practitioners, policymakers, advocates and academics in global food and drug law and US health reform for a series of interactive lectures, panel discussions, and case studies.  Held during consecutive weeks, July 14-18 (Emerging Issues in Food and Drug Law) and July 21-25 (US Health Reform – The Affordable Care Act), interested participants may attend one or both programs.  Additional details, including schedule, speakers, online application, and program fees may be found here.  Questions may be directed to oneillsummer@law.georgetown.edu.

The Hamline University School of Law Health Law Institute is pleased to offer a variety of condensed health law courses taught by academic and industry experts in Saint Paul, MN. Courses include: (1) Health Care Compliance Institute, (2) Biotechnology Policy, (3) Elder Law, and (4) Health Care Fraud and Abuse. Courses will run from May 27th through June 28th. Additional information, including the application and course descriptions can be found here.

 

Ten Faculty Fellowships Awarded to Promote Public Health Law Education

Official Press Release:

Atlanta – Georgia State University College of Law and its Center for Law Health & Society have selected 10 faculty fellows to participate in the Future of Public Health Law Education: Faculty Fellowship Program. The program is funded by the Robert Wood Johnson Foundation to foster innovations and build a learning community among those who teach public health law at professional and graduate schools. For more information, visit law.gsu.edu/phlfellowship.

The fellows, chosen from across the country, will develop interdisciplinary courses and programs in public health law at their respective universities during the fellowship year. Their projects will strengthen interdisciplinary education in public health law and promote collaborations with public health agencies and organizations in the fellows’ communities.

The fellows are:

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Max Mehlman: 2014 McDonald Merrill Ketcham Awardee for Excellence in Law & Medicine

By Nicolas Terry Cross-posted from HealthLawProf Blog

The Hall Center for Law and Health at Indiana University McKinney School of Law is proud to welcome Professor Maxwell Mehlman to receive the McDonald Merrill Ketcham Award for Excellence in Law & Medicine for 2014. For more details please see here.

Professor Mehlman serves as Distinguished University Professor, Petersilge Prof. of Law and Director of the Law-Medicine Center, Case Western Reserve School of Law, and Professor of Biomedical Ethics, Case Western Reserve School of Medicine. His lecture is entitled “Are Physicians Fiduciaries for Their Patients?” Professor Mehlman will then join a panel discussion on the topic. The panelists are Mary Ott, M.D., M.A., Associate Professor of Pediatrics, Indiana University School of Medicine, Joshua Perry, J.D., M.T.S., Assistant Professor of Business Law and Ethics and a Life Sciences Research Fellow, Indiana University Kelley School of Business (Bloomington) and Mark Rothstein, J.D., Herbert F. Boehl Chair of Law and Medicine, University of Louisville Louis D. Brandeis School of Law, and Director of the Institute for Bioethics, Health Policy, and Law, University of Louisville School of Medicine.

International Aid, Public Health, and Corruption

My wonderful HLS colleague Matthew Stephenson has just launched the Global Anticorruption Blog (GAB). As it happens, his first two posts may be of interest to BOH readers, especially those  may be of interest to readers interested in international aid for public health projects, of the sort supported by the Gates Foundation.  The first post argues that the extent of corruption in these projects is much larger than the Gates Foundation and others acknowledge.  The second post contends that one reason for lowballing of corruption estimates is political: these projects depend substantially on public funding, and political support for health aid may be undercut by candid assessments of the extent of the corruption and fraud problems. Both the posts and the blog are well worth a read.

A New Way to Keep Up with New PHLR

This week, PHLR launched its SciVal Experts PHLR Community website.  The core of the site is publications and other information for 300 leading public health law researchers doing empirical evaluations of the impact of laws and legal practices on health. The SciVal system allows visitors to find experts by topic, to trace their institutional and individual networks, and to find the latest publications in the field.

We encourage you to visit the site and explore for yourself, but we’ll also begin periodically sharing batches of publications on this blog.

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Announcing the New Journal of Law and Biosciences

The Petrie-Flom Center and Harvard Law School are delighted to announce our partnership with Duke University, Stanford University, and Oxford University Press to launch a new peer-reviewed, open access, online journal in 2014: Journal of Law and the Biosciences (JLB).

JLB will become the preeminent outlet to publish cutting-edge scholarship wherever law and the biosciences intersect. The journal will take a broad and interdisciplinary view of these areas, publishing articles on topics generally considered part of bioethics or neuroethics, such as the ethical, legal, and social implications of reproductive technologies, genetics, stem cell research, neuroscience, or human biological enhancement.  At the same time, JLB will be a home for work that speaks directly to legal issues where the biosciences can be involved, such as food and drug regulation, biosciences patent law, scientific evidence, and criminal responsibility.

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Beyond Roe: Reproductive Justice in A Changing World

Blogging highlights from Rutgers-Camden (conference coordinated by Professor Kimberly Mutcherson)

A few blog highlights from the Beyond Roe conference at Rutgers-Camden:

Excellent Keynote remarks presented by Byllye Avery, founder of Black Women’s Health Imperative and MacArthur Foundation Fellowship (aka Genius Award). Dr. Avery urges a close examination of the states challenging reproductive access.  She explains a link between former slave states as the new battlefront in reproductive equality…

June Carbone gives a provocative preview of her forthcoming book with Naomi Cahn: The Marriage Market

Dazon Dixon Diallo, President of Sister Love, Inc-presents new empirical data on race, youth, and reproductive decision-making and African American youths’ perspectives on abortion.

Young scholars to watch out for:

Aziza Ahmed, Assistant Professor at Northeastern School of Law presents a project on Scientific Expertise in Abortion Jurisprudence.

Lisa Kelly, SJD candidate at Harvard Law School gives an enlightening talk on Transnational abortion rights and the litigation emerging in Latin American countries.

Terrific project on the rise by Grace Howard, a PhD student at Rutgers University who presented a talk: When the Crime is Birth: “Meth Babies” and the Limits of Pure White

The Petrie-Flom Center Unveils New Website

The Petrie-Flom Center is proud to announce our new website:  http://petrieflom.law.harvard.edu/. The site continues to provide key information about the Center, our fellows, and events, but it is now poised to become the go-to place for news, scholarship, and other information on health law policy, biotechnology, and bioethics.

Please stop by and take a look at some of the great new features:

  • Our front page now highlights key national and international news stories in our fields, as well as news and scholarly announcements regarding our affiliates, recent blog posts from here at Bill of Health, and an at-a-glance view of our upcoming events.
  • At our new events page, you can view – and share – all upcoming events, or sort items by type: lectures/panels, conferences, and workshops. You can also view an archive of our previous events (which is still in development) and watch event videos as they become available.
  • We have added a resources page, where you can find primers on key topics in health law policy, biotechnology, and bioethics, including the Affordable Care Act, conflicts of interest, conscience, human subjects research, gene patenting, reproductive rights, vaccines, and more. You can also head to this page to find scholarship and media commentary from our affiliates.
  • For students, there are now pages (also in development) collating curricular resources and programs at Harvard and elsewhere.
  • The new site allows us to tag items by subject, which will making searching for what you’re interested in easier and more informative. Scroll down to the footer to see popular tags.
  • Finally, check back soon for a new “Opportunities” tab, where we’ll highlight jobs, fellowships, and other items of interest in the fields of health law policy, biotechnology, and bioethics from beyond the Petrie-Flom Center.

As we launch the new site, there are sure to be a few kinks. Please let us know if you find something that isn’t working quite as it should, or if you need help locating something from our old webpage.

We’d love to hear your feedback! In particular, if you have ideas for our key topics initiative, or another resource that ought to be included under the For Students tab, please let us know.

You can also follow us on Twitter and like us on Facebook to stay up-to-date on PFC news and announcements.

2014 Health Law Student Scholarships for Healthcare Compliance Certification Program at Seton Hall

Healthcare Compliance Certification Program 

2014 Health Law Student Scholarships

Seton Hall University School of Law 

Center for Health & Pharmaceutical Law & Policy 

The Healthcare Compliance Certification Program is a multi-day educational program that addresses the myriad of legal and compliance issues faced by the pharmaceutical and medical device industries.

Purpose: This award recognizes promising health law students with an aptitude for and commitment to a career in health law with a focus on the legal and compliance issues within the pharmaceutical, biotech, and medical technology industries.

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Health Law Chair Position at Loyola University Chicago

Nadia N. Sawicki

I’m pleased to announce that Loyola University Chicago School of Law is seeking to fill the recently created Bernard J. Beazley Chair in Health Law and Policy.  My colleagues and I at the the Beazley Institute for Health Law and Policy are excited for the opportunity to welcome a distinguished scholar of health law into the Loyola community.

Inquiries should be directed to Prof. Spencer Weber Waller, the chair of the search committee, at  swalle1 at luc.edu. Interested candidates should submit an application at www.careers.luc.edu.

Additional details about the position are below the fold. Continue reading