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

Petrie-Flom Center Annual Conference, Call for Abstracts: Law, Religion, and American Health Care

The Petrie-Flom Center invites abstracts for its 2015 Annual Conference: “Law, Religion, and American Health Care.” The conference will be held at Harvard Law School on May 8 and 9, 2014.  

The conference seeks to address the following topics:

  • Analysis of the First Amendment, the Religious Freedom Restoration Act, and other federal, state, and local legal provisions that come into play at the intersection between religion and health care
  • The Affordable Care Act and employer-based health care coverage, including the contraceptives mandate and related court decisions
  • Legal obligations and accommodations of religious health care organizations
  • Protection (or not) of health professional conscience
  • Health care decision-making for minors with religious parents
  • Religious objection v. discriminatory behavior
  • Informed consent and information flow, e.g., religious objection to providing certain information, inclusion of religious information in consent disclosures, etc.
  • “Medicalization” of religious beliefs, e.g., regulation of homosexual conversion therapy
  • Abortion policy, including clinic protests and protections, and its relationship to religion
  • Embryonic stem cell policy and its relationship to religion
  • End-of-life care, including assisted suicide, and its relationship to religion
  • Complicity as both a legal and religious concept
  • Comparative analysis, e.g., between professions, health care practices, countries, etc.

Please note that this list is not meant to be exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here. Abstracts are due by December 1, 2014.

For a full conference description, including the call for abstracts and registration information, please visit our website.

9/18/14: Post-Trial Responsibilities Conference

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014 7:30 AM – 5:30 PM

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

The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here.

The term “post-trial access” is used broadly to connote a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended.  For the purposes of this conference, we will focus discussions on the following:

  1. Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefiting (whether between the end of the trial and product approval or indefinitely)
  2. Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
  3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

The full background, conference objectives, and agenda are now available on our website

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.

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.

Continue reading

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.

Continue reading

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

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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

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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.

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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.

Continue reading

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.

Continue reading

#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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