FDA Commissioner Scott Gottlieb issued a statement on Tuesday about the controversial plant Mitragyna speciosa, which is also known as kratom. According to Gottlieb, kratom poses deadly health risks. His conclusion is partly based on a computer model that was announced in his recent statement. The use of simulations to inform drug policy is a new development with implications that extend beyond the regulation of kratom. We currently live in the Digital Age, a period in which most information is in digital form. However, the Digital Age is rapidly evolving into an Age of Algorithms in which computer software increasingly assumes the roles of human decision makers. The FDA’s use of computer simulations to evaluate drugs is a bold first step into this new era. This essay discusses the potential risks of basing federal drug policies on computer models that have not been thoroughly explained or validated (using the kratom debate as a case study).
Kratom grows naturally in Southeast Asian countries such as Thailand and Malaysia where it has been used for centuries as a stimulant and pain reliever. In recent years, the plant has gained popularity in the United States as an alternative to illicit and prescription narcotics. Kratom advocates claim it is harmless and useful for treating pain and easing symptoms of opioid withdrawal. However, the FDA contends it has no medical use and causes serious or fatal complications. As a result, the US Drug Enforcement Agency (DEA) may categorize kratom in Schedule I, its most heavily restricted category.
In the past several years, the United States has struggled to respond to viral outbreaks, such as Ebola and Zika. There is now an awareness of the need to rapidly develop vaccines and treatments for epidemics that can quickly spread from country to country. But questions remain as how to best conduct clinical trials and development of vaccines in the context of an epidemic or outbreak.
Join two health policy experts in examining the appropriate conduct of clinical trials during public health emergencies.
Susan Ellenberg, Professor Of Biostatistics, Biostatistics And Epidemiology, the Hospital of the University Of Pennsylvania and Director, Biostatistics And Data Management Core, Penn Center For AIDS Research
Jason Schwartz, Assistant Professor of Public Health (Health Policy), Yale School of Public Health and Assistant Professor, Program in the History of Science and Medicine, Yale University
Moderator: Carmel Shachar, Executive Director, the Petrie-Flom Center, and Lecturer on Law, Harvard Law School
Lunch will be provided. This event is free and open to the public.
Until February 2016, medical assistance in dying (MAID) in Canada, which encompasses both euthanasia and physician assisted suicide, was prohibited under the criminal code as a form of homicide. This ruling was challenged in Carter v Canada in the Supreme Court and overturned on the grounds that the ruling opposed the Canadian Charter of Rights and Freedoms. In June 2016, MAID became legal in Canada under Bill C-14.
Under this law, a person may receive medical assistance in dying if they meet all of the following criteria:
They are eligible for health services funded by a government in Canada
They have a grievous and irremediable medical condition. This includes an irreversible state of decline that causes intolerable suffering that cannot be relieved, with a reasonably foreseeable natural death
They have made a voluntary request for medical assistance in dying that was not made as a result of external pressure
They give informed consent to receive medical assistance in dying after having been informed of other means that are available to relieve their suffering, including palliative care
They are at least 18 years of age and capable of making decisions with respect to their health
“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).
Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.
Reporting to the Administrative Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and working closely with the Center’s Executive Director, Faculty Director, and other staff, the Research and Communications Associate will support the Center’s work on its sponsored research programs, as well as the Center’s core administrative needs, with a focus on communications and finance. The position has three major areas of responsibility: (1) communications; (2) conducting research and publishing under the direction of the Faculty and Executive Directors; (3) other administrative support, including meeting and event support.
The Research and Communications Associate will devote a significant portion of his/her time to scholarly activities in furtherance of the Center’s research agenda, including assisting on sponsored research projects on topics such as, but not limited to, the ethics of translational research, advanced care planning, and personalized medicine. Depending on the Associate’s experience and expertise, he or she may be involved in leading writing projects or in assisting other Center staff through research and collaboration. The Associate is expected to attend and participate in research workshops on health law, bioethics, and biotechnology, and other events designated by the Center. The Associate is also expected to help plan and execute a small number of events in his/her field of expertise during his/her tenure, and to present his/her research in at least one of a variety of forums, including academic seminars, speaker panels, or conferences. The Associate will work closely on a day-to-day basis with the Executive and Faculty Directors on his/her research. Continue reading →
This week features a first time visit from Carl Ameringer, professor of health policy and politics at Virginia Commonwealth University in Richmond, Virginia. A lawyer with a PhD in political science, he is an expert on issues surrounding our national debate on health care reform. We discuss his latest book “US Health Policy and Health Care Delivery: Doctors, Reformers, and Entrepreneurs,” published by Cambridge University Press. Our conversation connects the past and future of American health care, from 19th century development to the ACOs of the ACA. We close with some reflections on path-dependence: is American exceptionalism a permanent impediment to health sector rationalization, or does it provide some models for improvement? Muddling through history, policy, and law has rarely been more edifying, and we hope you enjoy the conversation as much as we did.
The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher RadioTunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.
Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from the savings possible from greater generic substitution in Medicare; to proposed federal right to try legislation; to the characteristics of interim publications and final publications from RCTs. A full posting of abstracts/summaries of these articles may be found on our website.
UK national and social media have been buzzing all last week about a letter sent on Monday 29th January 2018 by the NHS Confederation to the Justice Secretary and copying in the Secretary of State for Health.BBC news set the scene under the banner headline, ‘Curb rising NHS negligence pay-outs, health leaders urge’.
The NHS Confederation is a charity and membership body that brings together and speaks on behalf of all organisations that plan, commission and provide NHS services. Members are drawn from every part of the health and care system. The letter coordinated by them had several co-signatories in the medical establishment including the Chief Executives of the doctor’s defence organisations, the British Medical Association (BMA), The Academy of Medical Royal Colleges. The letter said that the current level of NHS compensation pay-outs is unsustainable and is diverting significant amounts of funding away from front line care services. Last year the NHS spent £1.7 billion on clinical negligence claims, representing 1.5 % of front line health services spending. This annual cost has almost doubled since 2010/11 with an average 11.5 % increase every year:
Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.
To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.
This event is free and open to the public, but seating is limited and registration is required. Register now!
Check out the new op-ed from Francis X. Shen, Senior Fellow in Law and Neuroscience at the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behaviorat Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
From the op-ed:
As final preparations are made for the Super Bowl Sunday, traditional excitement for the game is being countered by criticism about player safety.
In both Illinois and New York, for instance, legislators have proposed banning youth tackle football. Football legend Brett Favre has made headlines telling reporters he prefers his grandchildren play golf instead of football.
Typical criticism of youth football points out that given advances in our knowledge about the brain, it is dangerous to let your kids play football, and unethical to enjoy watching such a barbaric sport.
As a professor whose research is devoted to the intersection of neuroscience and law, I have often found myself at the heart of these football debates. I have testified multiple times in front of the state Legislature, and teach a seminar devoted entirely to “sports concussions and the law.”
Given this background, I often get surprised looks when I defend the value of collision sports. Some find it hard to reconcile my love of the brain with a policy stance that they think promotes brain damage. But I think you can embrace neuroscience and the NFL.