What are GM Foods?

By Joanna Sax
[Ed Note: Cross posted at HealthLawProfBlog.]

I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.

The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.

But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.

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Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

Human Subjects Research Regulations Book CoverThe Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch.  This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

The book is currently available from MIT Press and Amazon, in hardcover and paperback.  We will be hosting a book discussion at Harvard Law School on October 22, and in Baltimore on December 5 at Public Responsibility in Medicine and Research (PRIMR)’s annual Advancing Ethical Research Conference.  Details will be announced shortly.

 From the book jacket:

 The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.

After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.

Contributors
 Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf

For a more information, including the full table of contents, check out the book on the MIT Press website

Public health in the shadow of the First Amendment

The First Amendment has been repurposed as a powerful deregulatory tool, especially in health care (NEJM on data privacy) and public health (NEJM on smoking). Amy Kapczynski at YLS has put together a timely and powerful conference, Public Health In The Shadow of the First Amendment. October 17-18 in New Haven. Register here.

@koutterson

 

REGISTRATION OPEN: 9/18 conference on post-trial access

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014

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

This event is free and open to the public, but due to limited seating registration is required. Please register online.

Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions.  Areas that currently lack clarity include:

  • What types of interventions or resources should be included within post-trial responsibilities?
  • What is a reasonable duration for post-trial responsibilities to extend?
  • What is the mission and purpose of various stakeholders in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities?

This conference will bring together diverse stakeholders to address and develop consensus around some of these questions.

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Sunstein Keynote at Petrie-Flom Annual Conference featured in Harvard Law Today

sunstein-atlanticHarvard Law Today has posted a feature on Cass Sunstein’s keynote address at the 2014 Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy.” Sunstein, who is the Robert Walmsley University Professor at Harvard Law School and the co-author of Nudge: Improving Decisions About Health, Wealth, and Happiness, addressed the opening day of the conference on May 2, 2014, on the subject of “Choosing Not to Choose.”

Full video of the conference will be available soon via the Petrie-Flom Center’s website. In the meantime, you can read about and view Sunstein’s keynote address here.

National Conference on HIV Criminalization

By Sterling Johnson, JD

Grinnell College in Iowa will host the first National Conference on HIV Criminalization next week, June 2-5 on its campus.

One of the stated goals of the conference will be to discuss the recent legislative changes in Iowa and how to apply the lessons to other states with laws that apply specifically to people with HIV.

Currently, 43 states criminalize actions by HIV-positive individuals. Check out our map at LawAtlas.org for more details.

US states with HIV criminalization laws

In 2009, Iowa became the center of this battle when Nick Rhoades, who is HIV-positive, had a one-time sexual encounter with another man, Adam Plendl. Three months after, Mr. Rhoades was arrested on suspicion of engaging in intimate contact without disclosing his HIV-positive status. At the time of the sexual encounter, he used a condom, had an undetectable viral load and his sexual partner did not contract HIV; however, Nick Rhoades was sentenced to 25 years in prison and classified as a sex offender. The case is now is now on appeal and being argued by Lambda Legal. The Iowa court of Appeals affirmed the conviction and the case is now under review by the Iowa Supreme Court. Mr. Rhoades’s case led to community organizers lobbying to reform the HIV criminalization law in Iowa. Continue reading

DUE 6/3: Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

            PFC_Logo_300x300                    FDLI_Logo_380

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:  Continue reading

SAVE THE DATE: 9/18/14, Post-Trial Access to Medicines: Responsibilities and Implementation

pills_genericvariety_slide

Please join us for a day-long conference at Harvard Law School on September 18, 2014, which will include presentations by leading experts and varied stakeholders as well as small group discussion and break out sessions that will work toward developing consensus in this difficult area.

Key questions include:

  • How should post-trial access be defined?
  • What type of interventions should be included in post-trial access obligations?
  • What are the responsibilities of various stakeholders?

More information, including the developing agenda, will be posted on the Petrie-Flom Center’s website as it becomes available.

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.

PFC_Logo_300x300MRCT

TUESDAY, 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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Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

PFC_Logo_300x300FDLI_logo_pink

 

 

 

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:

  • Stem cell therapies
  • Nanotechnologies
  • Genetic (and biomarker) tests
  • Gene therapies
  • Personalized medicine
  • Comparative efficacy research
  • Drug resistant pathogens
  • Globalized markets
  • Tobacco
  • GMO
  • Bioterrorism countermeasures
  • Mobile health technologies
  • Health IT
  • Drug shortages
  • Other related topics

Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at dsr@fdli.org by Tuesday, June 3, 2014. Questions should also be directed to Davina Rosen Marano.

We will notify selected participants by the end of June.  Selected participants will present at the symposium, and will be expected to submit a completed article by December 15, 2014 (after the event) to be considered for publication in a 2015 issue of FDLI’s Food and Drug Law Journal (FDLJ).  Publication decisions will be made based on usual FDLJ standards.

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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#BELHP2014 7: Defaults in Health Care

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Our esteemed moderator Gregory Kurfman of the New England Journal of Medicine oversaw a session that dug deep into how defaults work and why. The result was a better understanding of the regulatory tool most associated with soft paternalism, but doubt about whether its operation in healthcare is as libertarian or asymmetrically paternalistic as advertised.

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#BELHP2014 Plenary 3, Michael Hallsworth, UK Behavioral Insights Team

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Today’s lunchtime plenary, Applying Behavioural Insights in Theory and in Practice, was presented by Michael Hallsworth, Principal Advisor, The Behavioural Insights Team (BIT)

Michael described the BIT as a “social purpose” company, originally founded within the UK government, but separated from it (in part) in February 2014.  The company is now partly owned by government, partly owned by its employees, and partly owned by the innovation charity, Nesta.  Michael indicated that when the Team was started, there was genuine doubt about whether behavioral interventions could make a difference or whether this was just a trendy new fad.  The Team responded by implementing rigorous methods of testing, measuring, and evaluating its proposals.

What does the BIT do?  Michael explained that its goal is to incorporate empirical findings about behavior into policy making. Although it has been colloquially referred to as the “Nudge Unit” and Richard Thaler does indeed advise them, the BIT is not actually a nudge unit.  Its first question is not how to nudge but rather how to solve policy problems.  It is a fact that policy tends (and is intended to) influence behavior.  Behavioral insights can allow governments and other policymakers to enhance and assess policy options, and offer new ones.  Put another way, Michael explained that there is not a distinction between policy-making and influencing behavior, they are one and the same.

Michael also argued that we should use behavioral insights as a lens through which to see all government action.  Moreover, whenever the government has decided to act, it should do so in way that it is actually most effective; there is a moral duty to maximize effectiveness and to spend limited government resources wisely.

Michael then went on to describe seven different ways of applying behavioral analysis to show that the best option is to:

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#BELHP2014 Panel 6, Deciding for Patients and Letting Patients Decide for Themselves

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Christopher Robertson is moderating this session.

This session was kicked off by Matthew Lawrence, a Fellow at the Petrie-Flom Center, on “Rationing Justice by Default”. His paper departs from the fact of a huge backlog in Medicare appeals. The question is, if procedural justice is scarce, how do you ration it? Trim procedural protections for everyone? Limit access by a filing fee? Quadruple funding? Lawrence proposes a better alternative: Give full procedural protection to some and none to the rest based on the value that claimants get by from procedure claim, which is heterogeneous. You can then sort the cases via choice architecture. Many Medicare appeals are by large repeat players like the Scooter Store. Beneficiaries appealing is very small. The reasons why we give process lines up quite well to identity of appellant. Fairness, dignity/autonomy, normative legitimacy. The first two of the three probably apply less to the Scooter Store, whose interest is primarily financial. How do you sort? The classical solutions would include: (1) Treating providers differently – but that would discourage assignment, results in inequality, and would be over and under inclusive. (2) Fee for hearing – but leads to externalities since there are public values of process, there are behavioral biases that lead to undervalue process, and perhaps it normatively should be free. His preferred approach: sort with default rule. Maximize the stickiness. Give incentives for sophisticated party to opt into efficiency track. He explained this approach and then considered a set of objections.

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#BELHP2014 Plenary 2, Russell Korobkin

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Today opened with a plenary talk by Russell Korobkin, who is the Richard C. Maxwell Professor of Law at UCLA School of Law.   His talk was titled “The Choice Architecture Problem and Health Care Decisions.”

He began by suggesting that the fundamental problem that unites the conference is that efficient health care decisions are often too difficult for boundedly rational individual to make optimally.   Classical economics suggests that revealed preferences match predicted hedonic experience.  Behavioral economics shows us that this is not true, and provides insights into why.  The million dollar question is what should policy makers do with these insights.

Yesterday, most of discussion oriented around the solution of libertarian paternalism.   But as Korobkin notes, that is just one approach and it has several drawbacks that keep it from providing a complete solution.  First, policy makers don’t always know what is best, so we don’t know which way to nudge.   Second, the best choice is often heterogeneous.   Third, the best choice for individuals is not necessarily socially optimal.  With these limits in mind, Korokin’s central claim is that the menu of non-coercive responses to bounded rationality should be expanded.  He proposes two additional choice architecture options: (1) simplification, and (2) libertarian welfarism.

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#BELHP2014 Panel 4, Crowding Out

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

This panel, moderated by Dr. Neel Shah concerned motivational crowding out.

The first paper, presented by Aditi Sen, was a paper co-authored with Huffman, Lowenstein, Asch, Kullgren, and Volp. The paper examined motivational crowding out from incentive payments in the weight loss context. They measured motivation via a survey administered before and after the introduction of financial incentives in two weight loss field experiments and found no evidence that intrinsic motivation fell when participants were given financial incentives as compared to controls.

The second paper, by Kristen Underhill, went deep into the theory of motivational crowding out.  The article reviews the existing literature and shows how sloppily the notion of crowding out is used. She offers 9 different dynamics of crowding out and discusses which have been validated when. She then offers a framework for thinking about when regulatory interventions are justified focused on autonomoy, behavioral outcomes, and the principal and beneficiary of the incentive scheme. The goal of the project was to offer “incentive architecture” techniques for regulators and guidance as to when they are appropriate.

The audience questions include: in what contexts do crowding out occur or not and how woudl we predict? Tax incentives as an example of the relevant incentives? Does motivational crowding out varies with SES? Do the empirical results apply more to moralized behavior like smoking and weight loss than others, and other topics?

#BELHP2014 Panel 3, Behavioral Economics and Health Care Costs

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Our third panel, moderated by PFC Academic Fellow Matthew Lawrence, addresses the use of behavioral economics techniques to control health care costs.  Speakers are Christopher T. Robertson, Brigitte Madrian, Ameet SarpatwariAnupam Jena, and Jim Hawkins.  (Many projects are co-authored, but I’m only listing the presenters here)

The first speaker is Professor Christopher T. Robertson, coming from Arizona Law but visiting Harvard and the PFC this year, speaking on Cost-Sharing as Choice Architecture.  He starts by talking about the cost side of cost sharing, which we know works in reducing consumption from empirical evidence; from the RAND study, it reduced use without reducing health.  More recent studies also confirm this.  But cost sharing presents four problems:

  1. Underinsurance relative to ability to pay
  2. Indiscriminate reductions in health care (more of an ax than a scalpel)
  3. An unfair tax on sickness (more tentative if we can solve the first two)
  4. The burden of deciding.

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#BELHP2014 Panel 2, Potential Problems and Limits of Nudges in Health Care

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

By Matthew L Baum

In this next installment of today’s live-blogging of the conference (and with all of the caveats of live-blogging mentioned by my colleagues and my apologies for any errors or misrepresentations) we have Professors David Hyman (DH), Mark White (MW) and Andrea Freeman (AF) in a panel moderated by Glenn Cohen (GC) on the “Potential Problems and Limits of Nudges in Health Care”.

The panel began with DH, H. Ross & Helen Workman Chair in Law and Director of the Epstein Program in Health Law and Policy, University of Illinois College of Law, and a talk entitled, “what can PPACA teach us about behavioral law and economics” (Patient Protection and Affordable Care Act). DH began with the observation that nudges often work quite well… “unless they don’t”. While many nudges are “sticky”, i.e. they influence behavior in the way they were intended, others are “slippery”, i.e. they fail to influence behavior in the way they were intended. His talk set out to illustrate the phenomenon, and to pose two questions. The first was an empirical question: what makes a nudge sticky vs slippery? The second was philosophical: is it meaningful to talk about a “failed nudge” or when we do, do we really just mean failed marketing? He focused on an analysis of PPACA as a case study.

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