5/2-3: Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy”

Petrie-Flom Center 2014 Annual Conference: Behavioral Economics, Law, and Health Policy

May 2-3, 2014

Wasserstein Hall, Milstein East ABC, Harvard Law School, 1585 Massachusetts Ave.

Richard H. Thaler and Cass R. Sunstein’s book  Nudge: Improving Decisions About Health, Wealth, and Happiness brought behavioral economics to the masses, beginning a discussion of libertarian paternalism and the many ways that “choice architects” can help nudge people to make better choices for themselves without forcing certain outcomes on anyone. Some of their examples fall in the realm of health policy, as is also the case of Daniel Kahneman’s recent book, Thinking, Fast and Slow, which examines various cognitive errors people make in their judgments, choices, and conclusions, as well as how we might correct them.  But the conversation has only just begun.

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New Profile of Petrie-Flom Annual Conf. Keynote Speaker Cass Sunstein

From the article. (Nadav Kander/Trunk Archive)

The Atlantic has just published a new piece profiling Harvard Law School Professor Cass Sunstein, “Our Nudge in Chief,” exploring “How, and why, Cass Sunstein believes laws and public policies should help save us from our irrational impulses.”

Sunstein, the Robert Walmsley University Professor at Harvard Law School, will deliver the keynote lecture at the Petrie-Flom Center’s upcoming annual conference, “Behavioral Economics, Law, and Health Policy,” on Friday, May 2. His talk is entitled “Choosing Not to Choose.” You can find out more about the conference here.

Read the full profile.

FOR HARVARD STUDENTS: TOMORROW: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

Harvard Effective Altruism (HEA): Thursday, April 17th: Critch on Aversion Factoring & Career Choice

A communication from Harvard Effective Altruism:

Aversion Factoring & Career Choice

with Dr. Andrew Critch

Thursday, April 17th 7-8:30 PM

Emerson 305

We often limit ourselves by avoiding things we find bothersome or scary.  But for almost anything you find bothersome, there’s someone out there who doesn’t!  How does that work?  Can you copy their enjoyment-powers?  If so, you have many more options for growth, career choice, and general do-gooding.  This presentation is based around a technique Dr. Critch teaches at the Center for Applied Rationality for using aversions as a source of creativity, and then getting over them.

Dr. Critch’s interest in rationality began as a teenager growing up in Newfoundland, Canada, where he says he “just had a lot of time to think about it”. When he was 14, he made his first attempt to extrapolate his instinctive preferences into a function whose expected integral he wanted to maximize. (In college he found out that some economists had been crazy enough to think humans worked this way automatically). He also won numerous national awards in mathematics and public-speaking competitions.

 

5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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CONFERENCE – CLASHING RIGHTS & REPRODUCTIVE AUTONOMY

Join us at Northeastern University School of Law at 1 p.m. on April 25, 2014 as leading academics and practitioners discuss the tensions between free speech and reproductive rights.

For more information, see http://www.northeastern.edu/law/academics/institutes/health-law/events/clashing-rights/

FOR HARVARD STUDENTS: 4/16: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

TOMORROW: Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

This event is free and open to the public. Lunch will be served.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

4/10 Book Launch: The Witch-Hunt Narrative: Politics, Psychology, and the Sexual Abuse of Children

Thursday, April 10, 2014, 12:00pm

Wasserstein Hall 2019A, Harvard Law School, 1585 Massachusetts Ave.

Please join us for the launch of Professor Ross E. Cheit‘s new book The Witch-Hunt Narrative: Politics, Psychology, and the Sexual Abuse of Children (Oxford University Press, April 2014). It has become widely accepted that a series of high-profile child sexual abuse cases from the 1980s and early 1990s were “witch hunts.” That view first took hold in the media, then spread to the courts and academia. But purveyors of the witch-hunt narrative never did the hard work of examining court records in the many cases that reached the courts throughout the nation. Drawing on fifteen years of original trial research into these child sex abuse cases, Cheit challenges the accuracy of the narrative. The launch event will feature panel discussion including:

  • Ross E. Cheit, Professor of Political Science and Public Policy, Brown University
  • Jeannie Suk, Professor of Law, Harvard Law School
  • Alan A. Stone, MD, Touroff-Glueck Professor of Law and Psychiatry, Harvard Law School

This event is free and open to the public.

For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

TOMORROW: Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

April 2, 2014, 12:00 PM

Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA

Please join us for this esteemed panel of leading patent experts, including members of the European Patent Office. Discussion will address U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.

Panelists:

  • Aliki Nichogiannopoulou, Director, Biotechnology, EPO
  • Anja Schmitt, Examiner, EPO
  • Maaike van der Kooij, Examiner, EPO
  • Tom Kowalski, US Patent Attorney
  • Moderator: Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute

This event is free and open to the public, but space is limited and registration is required. Register here.

Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

Cosponsored by the Broad Institute of MIT and Harvard.

RESCHEDULED: 4/11, Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

This event is free and open to the public. Lunch will be served.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

Saturday, April 5th: Aid Grade! (from Harvard Effective Altruism)

A communication from Harvard Effective Altruism:

 

Hi altruists,

Saturday, April 5th is a big day for EA at Harvard: we have three different awesome events for you! Our guest for the day, flying up from DC for the occasion, will be Dr. Eva Vivalt, the founder of AidGrade. AidGrade helps figure out what works in international development by doing rigorous and engaging analyses of different interventions to find out their effects. They’re also looking for interns and full-time hires for this work, so please visit if you’re interested!

We’ll be having a talk on AidGrade’s research from 1-2pm, followed by a research-a-thon from 2-6 where we help AidGrade do some meta-analysis. The day will be topped off by a Boston-area effective altruism meetup at Clover–with another special guest, Jacob Trefethen of 80,000 Hours Cambridge UK, and many awesome local effective altruists.

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CFP: CLE/CEU symposium on outstanding challenges in healthcare reform implementation

With the help of Medica Health Plans, the Health Law Institute at Hamline University School of Law and the Hamline Law Review seek proposals for presentations and papers for our all-day CLE/CEU Symposium that will examine the outstanding challenges confronting the implementation of healthcare reform.  The Symposium will take place on Friday, October 24, 2014, at Hamline University’s main campus in Saint Paul, Minnesota.

Anyone interested in speaking at the Symposium and/or publishing in the Hamline Law Review’s Symposium issue should submit both a CV and a 500-word abstract to healthlaw@hamline.edu by April 15, 2014.  While the primary focus of the presentation or paper need not be Minnesota-specific, please explain the regional relevance of your topic and thesis.

Additional information can be found here. Please feel free to share this information with anyone you think may be interested.

TOMORROW: panel discussion, Current Legal Issues in HIV/AIDS Work

Current Legal Issues in HIV/AIDS Work

Thursday, March 27, 2014, 12:00pm

Wasserstein Hall 1019, Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

More than 30 years have passed since AIDS first appeared in the United States. Today the CDC estimates that 1.1 million Americans are living with HIV/AIDS, and each year 50,000 Americans are newly diagnosed. Despite great strides in education, awareness, prevention, and treatment, people affected by HIV/AIDS still face significant discrimination, including unequal treatment under the law. This panel will explore some of the legal barriers faced by people living with HIV/AIDS in the United States, including FDA’s ban on men who have sex with men donating blood and laws criminalizing HIV transmission. Panelists include:

  • Felix Lopez, Director of the Legal Department, GMHC
  • Jason Cianciotto, Director of the Public Policy Department, GMHC
  • I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
  • Moderator: Aziza Ahmed, Visiting Scholar, Petrie-Flom Center; Associate Professor of Law, Northeastern University School of Law

This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

This event is cosponsored by Gay Men’s Health Crisis (GMHC). Founded in New York in 1981, GMHC is one of the world’s first and leading providers of HIV/AIDS prevention, care, and advocacy. 

4/2: Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

April 2, 2014, 12:00 PM

Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA

Please join us for this esteemed panel of leading patent experts, including members of the European Patent Office. Discussion will address U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.

Panelists:

  • Aliki Nichogiannopoulou, Director, Biotechnology, EPO
  • Anja Schmitt, Examiner, EPO
  • Maaike van der Kooij, Examiner, EPO
  • Tom Kowalski, US Patent Attorney
  • Moderator: Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute

This event is free and open to the public, but space is limited and registration is required. Register here.

Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

Cosponsored by the Broad Institute of MIT and Harvard.

Video Debate: Richard Epstein and Ryan Abbott on FDA Involvement in Off-Label Drug Use

Video: Here.

On January 13, 2014 the Southwestern Law School Federalist Society student chapter hosted a debate about the FDA’s role in regulating off-label drug use featuring Professor Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution, and Ryan Abbott, Associate Professor of Law at Southwestern Law School and Visiting Assistant Professor of Medicine at the David Geffen School of Medicine at UCLA.

Before a drug can be sold legally in the United States, the Food and Drug Administration (FDA) must approve it as safe and effective for a particular indication or use — the use then appears on the drug’s label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any other indication, even though the FDA never evaluated the safety or efficacy of the drug for that use.

Off-label prescribing is an integral part of modern-day medicine. Patients may benefit when they receive drugs or devices in contexts not approved by the FDA. In fact, in some instances an off-label use may be the standard of care for a particular health problem. However, off-label prescribing can also harm patients, especially when an off-label use lacks a solid evidentiary basis.

For this reason, the FDA forbids drug companies from promoting their own products for off-label use, except for certain activities such as disseminating research literature and sponsoring educational programs. In recent years, civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated, leading to many large settlements. For example, in July 2012, GlaxoSmithKline pled guilty and paid $3 billion to resolve criminal and civil liability arising from the company’s unlawful prescription drug promotion, failure to report safety data, and false price reporting practices.

As a result of this recent litigation, many have questioned the FDA’s current role in regulation of off-label use and whether more or less intervention is needed. This debate sought to address these very issues.

Both Professors have written about FDA regulations. For example, Professor Epstein in his book, Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation, and in an article in the Minnesota Law Review, “Against Permititis: Why Voluntary Organizations Should Regulate the Use of Cancer Drugs.” Professor Abbott has written about FDA regulations in the Iowa Law Review, Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety, and he has an article forthcoming with Ian Ayres at Yale Law School on Mechanisms for Regulating Off-Label Drug Use.

3/27: panel discussion on Current Legal Issues in HIV/AIDS Work

Current Legal Issues in HIV/AIDS Work

Thursday, March 27, 2014, 12:00pm

Wasserstein Hall 1019, Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

More than 30 years have passed since AIDS first appeared in the United States. Today the CDC estimates that 1.1 million Americans are living with HIV/AIDS, and each year 50,000 Americans are newly diagnosed. Despite great strides in education, awareness, prevention, and treatment, people affected by HIV/AIDS still face significant discrimination, including unequal treatment under the law. This panel will explore some of the legal barriers faced by people living with HIV/AIDS in the United States, including FDA’s ban on men who have sex with men donating blood and laws criminalizing HIV transmission. Panelists include:

  • Felix Lopez, Director of the Legal Department, GMHC
  • Jason Cianciotto, Director of the Public Policy Department, GMHC
  • I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
  • Moderator: Aziza Ahmed, Visiting Scholar, Petrie-Flom Center; Associate Professor of Law, Northeastern University School of Law

This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

This event is cosponsored by Gay Men’s Health Crisis (GMHC). Founded in New York in 1981, GMHC is one of the world’s first and leading providers of HIV/AIDS prevention, care, and advocacy.