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Webcasts of Previous Events
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Revising the Requirement of Informed Consent in an Era of Privatization and Managed Care |
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A discussion with Daniel Sperling, Petrie-Flom Center Short-Term Visiting Fellow and Senior Lecturer in Bioethics, Health Law, and Health Policy, The Federmann School of Public Policy & Government and Braun School of Public Health & Community Medicine, The Hebrew University of Jerusalem. Dr. Sperling presented his research project with a response from HLS Professor and Petrie-Flom Faculty Co-Director, I. Glenn Cohen |
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Personalized Medicine Patenting |
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Pharmaceutical researchers pursue medical treatment and diagnostic methods to target diseases specific to certain demographic groups. Such pursuit is often motivated by commercialization through patenting. Are these research innovations a solution to orphan diseases? Or do they foster a culture of niche, designer medicine? This lecture, based on the recently published book "Identity, Invention, and the Culture of Personalized Medicine Patenting" (Cambridge 2012), by Professor Shubha Ghosh of the University of Wisconsin Law School, examined these questions through discussion of BiDil, the first drug FDA approved specifically for the African-American population; Myriad's patented diagnostic method for identifying breast cancer in Ashkenazi Jewish women; Prometheus' patent for treating Crohn's Disease (invalidated by the Supreme Court in 2012 in an infringement suit by Prometheus against the Mayo Clinic); and other provocative examples at the intersection of patent and health law. Professor Benjamin Roin, Heiken Assistant Professor in Patent Law at Harvard and Petrie-Flom Center Faculty co-Director, served as discussant.
View the presentation slides. |
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Rethinking Personhood: Fetuses, Animals, and Robots |
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Are there entities that we do not (or would not) recognize as persons but should, or entities that we do (or would) recognize as persons but should not? Should fetuses, animals, or artificial intelligences have rights? On what grounds should we recognize the moral and legal standing of others? Our panel discussion on these and related questions with leading experts looked to entities whose status is unclear or contested in order to rethink the nature of moral and legal personhood. I. Glenn Cohen, Alice Crary, and Lawrence B. Solum served as panelists, with Jeffrey M. Skopek moderating. |
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Charles Fried on Evidence as a Public Good |
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We hear a lot about the conflict between use of an individual's information for the public good and that individual's privacy concerns. In this talk organized by PFC Academic Fellow Michelle Meyer, Charles Fried, Beneficial Professor of Law at Harvard, examined the deeper conflict that arises when an individual is used to generate information-public or private-in the first place. Professor Fried revisited some of the foundational questions that animated his groundbreaking 1974 book, Medical Experimentation: Personal Integrity and Social Policy. |
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Compliance with and Enforcement of US Healthcare Laws: Evolution of Modern Life Sciences Compliance Programs |
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There have been a number of recent prosecutions of life sciences companies under the Food, Drug, and Cosmetic Act and the qui tam whistleblower provisions of the False Claims Act. Allegations include things like unlawful promotion, failure to report safety data, and false price reporting practices, resulting in massive settlements, some in the billion dollar range. Understandably, compliance has become a top priority for life sciences companies, which typically have dedicated compliance programs in place with ever more sophisticated internal programs for educating employees, preventing wrongful conduct, detecting and deterring violations, and ensuring prompt remedial action. Our panel discussion heard from some of the leading experts from the government, life sciences industry, private bar, and academia, including: Mary Riordan, James Sheehan, Paul Kalb, Kathleen Boozang, and was moderated by Kris Curry. |
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Health Law Year in P/Review |
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2012 was an historic year for health law, with the Supreme Court issuing the final word on the constitutionality of the Affordable Care Act alongside a host of other critical developments. 2013 promises to continue the trend, with a number of other important topics on the horizon, from employer coverage of contraceptives to gene patenting and more. The Petrie-Flom Center and New England Journal of Medicine held the inaugural Health Law Year in P/Review event, bringing together leading experts to review some of the most important changes in the health law landscape over the past year, their implications for the future, and a preview of what is to come. Speakers included: Einer Elhauge, Jonathan Gruber, I. Glenn Cohen, Holly Fernandez Lynch, Wendy Parmet, Renee Landers, Aaron Kesselheim, Kevin Outterson, Kristin Madison with remarks from Dean Martha Minow. |
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Food & Drug Law: Past, Present & Future
Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS |
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Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specializing in Food and Drug Law, for more than five decades. He has represented clients in administrative, legislative, executive, and judicial settings. He began his law practice with the firm in 1960 and is now Senior Counsel; between 1971 to 1975, he was Chief Counsel for the Food and Drug Administration. The Best Lawyers in America selected Mr. Hutt as the 2013 FDA Lawyer of the Year for Washington, DC. Since 1994, Mr. Hutt has taught Food and Drug Law during Winter Term at Harvard Law School, covering all aspects of government regulation of food and drugs from ancient times to present. Speakers included: Martha Minow, HLS Dean, I. Glenn Cohen, Theodore Ruger, and Lewis Grossman. |
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Stem Cell Therapy and Medical Tourism: Of Promise and Peril? |
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Experimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide. Despite this progress, the overwhelming majority of clinical problems for which stem cell-based intervention offers hope remain therapeutically unproven, and a major gap exists between current public understanding and the availability of innovative therapies. This event featured a distinguished panel of speakers addressing various aspects of medical tourism for stem cell therapy. Presentations covered the state of stem cell science, historical context and comparisons related to earlier instances of medical utopianism, empirical data on the nature of stem cell tourism, how to address patient hopes in the realm of unproven therapies, and special issues related to stem cell tourism by parents for their children. Speakers included: M. William Lensch, Brock Reeve, George Q. Daley, Jill Lepore, Tim Caulfield, Insoo Hyun, I. Glenn Cohen |
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Advances in HIV Prevention: Legal, Clinical, and Public Health Issues |
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In conjunction with the Center for Health Law and Policy Innovation at Harvard Law School and the Fenway Institute, the Center held a panel discussing the advances in the fight against HIV created by the availability of new home self-tests and newly approved drugs for pre-exposure prophylaxis. The panel addressed the legal, clinical, and public health issues raised by these advances, as well as the history of HIV surveillance, treatment, and prevention in the U.S. Panelists included Robert Greenwald, Douglas A. Michels, David Piontkowsky, Kenneth H. Mayer and Mark Barnes. |
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The Guatemala STD Inoculation Studies: What Should We Do Now? |
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The Center hosted a panel with the Human Rights Program at Harvard Law School to discuss appropriate next steps to address the recently uncovered Guatemala STD Inoculation Studies, as well as concerns about the government immunities included in modern public health laws. In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to and infecting them with a number of STDs without their consent. The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby. The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed and efforts to directly compensate the victims have not been forthcoming. Panelists discussed what could and should happen now for the Guatemalan victims, as well as some potential legal reforms. Panelists: Holly Fernandez Lynch, Susan Reverby, I. Glenn Cohen, Wendy Parmet, and Fernando Delgado.
Professor Reverby's PowerPoint Presentation |
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Open Access to Health Research: Future Directions for the NIH Public Access Policy |
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In recognition of Open Access Week 2012, the Petrie-Flom Center co-hosted a panel of experts to explore the challenges and opportunities for increasing NIH Public Access Policy compliance and open access efforts at Harvard. The discussion was moderated by Scott Lapinski and June Casey. Panelists: Peter Suber, Amy Brand, Winston Hide, and Patrick Taylor. |
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Obamacare on Trial - a booktalk with Einer Elhauge |
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The panel discussion on Einer Elhauge’s new book, Obamacare on Trial, was held on November 1, 2012 and was the Harvard Law School Library’s first book event for fall 2012. Panelists include Einer Elhauge and I. Glenn Cohen of Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Sanford Levinson of the University of Texas at Austin Law School, Abigail Moncrieff of Boston University School of Law, and John McDonough of the Harvard School for Public Health. |
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Patients with Passports: Medical Tourism, Law and Ethics |
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Given as a presentation of the 2012-2013 Radcliffe Fellows Series, Petrie-Flom Faculty co-Director I. Glenn Cohen discussed the growing phenomenon of medical tourism, the practice of citizens of one country traveling to seek medical care in another country. His lecture discussed the emerging legal and ethical issues brought up by the many varieties of medical tourism—for services that are legal in the destination and home country, for services that are illegal in the home country but legal in the destination country, and for services that are illegal in both places. (Listen to the presentation here) |
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The Expanded Medicaid Mandate Under the Affordable Care Act |
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Continuing our investigation of health care reform, we are hosting a jointly-run event with Vanderbilt University Law School and our colleague James Blumstein, University Professor of Constitutional Law and Health Law & Policy addressing constitutional issues related to the expanded Medicaid component of the Affordable Care Act and whether the changes violate notions of cooperative federalism.
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Is the Obama Health Care Reform Constitutional?
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America's most significant health care reform initiative in over 50 years, and the centerpiece of President Obama's domestic policy agenda, has been challenged in federal courts across the country. At the date of this panel, two district courts had pronounced the measure (at least in part) unconstitutional focusing on its individual mandate, while two courts had upheld the measure. Appeals were pending before the Circuit courts, and with more litigation on the way the question may end up before the U.S. Supreme Court. Is the reform constitutional? How is the Supreme Court likely to rule? This panel, involving the nation's leading constitutional law scholars, debated these issues. Panelists: Charles Fried, Laurence H. Tribe, Randy Barnett, I. Glenn Cohen
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Racial Disparities in Health Care Delivery
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Forty years after the end of the Jim Crow era and the passage of Title VI of the Civil Rights Act, there remain large racial disparities in the American healthcare system. This panel explored the strengths and weaknesses of various policies that may be employed to alleviate ongoing racial health disparities. Such policies include those that enhance the enforcement or reach of existing civil rights laws and those that call for more direct and targeted quality-improvement initiatives. In addition, the panel discussed those aspects of the Affordable Care Act that may lead to reduced disparities in care. Panelists:
David Barton Smith, Anup Malani, Gregg Bloche , Amitabh Chandra, Michael Frakes
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Female Circumcision: Ethics and Human Rights
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The practice of FGM has been at the center of health and human rights debates for decades. Public health, women's rights and child rights advocates, governments and health professional associations--in Africa, Asia, Europe and the US-- have taken positions running the gamut from abolition to harm reduction. In April 2010, the American Association of Pediatrics issued a Policy Statement on female genital cutting that was quickly retracted in the face of significant opposition. The controversy surrounding the report presents an excellent point of departure for examining the issues that still complicate our thinking about the issue. This panel explored the ethical, legal, and human rights dimensions of female genital circumcision including dimensions of toleration, prohibition, harm-reduction, and cultural competency. Panelists: Dena Davis, Hope Lewis, Nawal Nour, Sarah Waldeck, I. Glenn Cohen, Mindy Roseman |
What (If Anything) Can the Mind Sciences and Evolutionary Biology Tell us about the Law and Morality?
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This
panel discussion examined how developments in evolutionary biology and
the mind sciences should inform law, philosophy, and economics, and
focused on subjects such as punishment, responsibility, racism,
addiction, and cooperation. Participants included I. Glenn Cohen, Joshua Greene, William Fitzpatrick, Adina Roskies, Walter Sinnot-Armstrong, and Thomas Scanlon
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Developments and Debates in New Legislation on Biologics
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Peter Barton Hutt, Senior Counsel, Covington & Burling, LLP and Lecturer on Law at Harvard Law School, and Bruce A. Leicher, Senior Vice President and General Counsel at Momenta Pharmaceuticals
discussed and debated emerging issues related to this topic.
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Health Law, HIV/AIDS Policy and Disability Rights in the New Administration
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Jeff
Crowley, the White House Director of National AIDS Policy and Senior
Advisor on Disability Policy, visited Harvard Law School to speak about
the Obama Administration’s agendas for health reform, developing a
national AIDS strategy, addressing health disparities, and disability
rights. Mr. Crowley addressed the issue of health reform, noting that
it dominates the Obama Administration’s domestic agenda. He said
the Administration’s perspective is that “we can’t get our economy back
on track unless we take on the health reform issue.” Mr. Crowley stated
that support for health care reform is currently gaining ground in the
political and national debate.
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When Medical Care Compromises Financial Health
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Universal
health insurance may be on the horizon, but a growing body of empirical
research has shown that, even for those who enjoy health insurance,
medical crises can push families to the financial brink, causing them
to load up credit cards, miss work, forgo additional care, lose their
homes to foreclosures, and even declare bankruptcy. This panel
explored these problems and debated potential solutions, including
insurance regulation, paid family leave, and reforms to the tax code,
the bankruptcy code and debtor-creditor laws. Panelists included Melissa Jacoby, Cathy Schoen, Matt Selig, Christopher Robertson, and I. Glenn Cohen
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Conflicts of Conscience in Health Care
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On the occasion of publication of a new book on physician conscience clauses written by PFC academic fellowship alumni Holly Fernandez Lynch,
this panel examined the legal and ethical aspects of the current
debates surrounding physicians and health care practitioner’s rights to
refuse to perform legally permissible medical procedures on the grounds
of moral objections. The author of Conflicts of Conscience in Health Care: An Institutional Compromise, Ms. Lynch was joined by Prof. I. Glenn Cohen, of Harvard Law School and the Petrie-Flom Center, and Prof. Dan Brock of Harvard University’s Program on Ethics and Health.
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A Debate on Human Dignity and Bioethics
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With
the advance of medical technologies and the increasing power over life
and death that they afford, discussions of “human dignity” have begun
to take a more central role in bioethics. How should we view this
dignity discourse? Is “human dignity” a useful concept that leads
to determinate answers on issues like stem cell research and care for
the dying? Or, is it instead a concept prone to misuse, an empty vessel
or a camouflage for unconvincing arguments and unarticulated biases?
This debate examined these questions and brought together
speakers from a variety of backgrounds and expertise spanning the
disciplines of philosophy, law, theology and medicine. Among the
participants were Nick Bostrom, Dan Brock, Martha Nussbaum, and Edmund Pellegrino
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