Yesterday was a big day in the fight against antibiotic resistance. The White House released an Executive Order and a National Strategy document on Combating Antibiotic-Resistant Bacteria, the President’s Council of Advisors on Science and Technology (PCAST) released a report on antibiotic resistance, and the National Institutes of Health and the Biomedical Advanced Research and Development Authority announced a $20 million prize for developing tests to identify highly resistant infections. Kevin Outterson at The Incidental Economist, Food Safety News, and the New York Times provide a good summary of these developments.
It is clear that the administration recognizes the grave threat posed by antibiotic resistance and that it intends to make combating this danger a national priority. Its approach is broad—the National Strategy includes a “Guiding Principle” that “[d]etecting and controlling antibiotic resistance requires the adoption of a ‘One-Health’ approach to disease surveillance that recognizes that resistance can arise in humans, animals, and the environment,” and the strategy pays much attention to the role of antibiotics in food production. One main objective of the strategy is to eliminate the use of medically important antibiotics at subtherapeutic levels for growth promotion (the practice of feeding animals antibiotics to make them fatter, not to make them well).
But in regards to the use of antibiotics for growth promotion in animals, the strategy does not provide the tools, or even the rhetoric, to support meaningful movement towards decreasing their use. The strategy calls for FDA to implement Guidance #213,to enhance its data collection capabilities, and to increase educational outreach on the appropriate use of antibiotics. Guidance #213, issued in December 2013, is intended to provide drug sponsors with information as to how they can “modify the use conditions” of medically important antimicrobial drug products to limit use to that “necessary for assuring animal health,” and only under veterinary supervision. Not only do guidance documents not establish legally enforceable duties, the recommendations in Guidance #213 are characterized as voluntary. FDA, moreover, has known the dangers of using antibiotics in animal feed at subtherapeutic levels for four decades, and has been sitting on the information. Swift and strong action is needed now.
The research assistant will work with the principal investigator Nir Eyal and collaborators from the Harvard TH Chan School of Public Health, Duke University, Massachusetts General Hospital, and the Brigham and Women’s Hospital as well as the ACTG HIV trial site network. The multidisciplinary team uses methods of clinical epidemiology, economics, simulation modeling, and normative theory to predict risks in early-phase HIV cure studies, assess how much likely candidates for participation understand those risks, and make ethical recommendations on the conduct of HIV cure studies.
The research assistant will help prepare, conduct and analyze a pilot survey expected to take place in a US site of the AIDS Clinical Trials Group (ACTG). The survey will assess perceptions of HIV cure and of cure study risks. The research assistant will also promote other research and grant-related activities, through literature reviews and assistance in the preparation of abstract, poster, and manuscripts for publication, grant applications, a simple project website (using Harvard’s user-friendly OpenScholar platform), and slides for lectures and seminars. The research assistant will be in touch with top researchers in HIV cure, medical decision making, and ethics from around the country, to facilitate our meetings, a workshop, and regular conversations to plan the research and debate ethical issues around early-phase HIV cure studies.
When the Human Genome Project began in 1990, the National Center for Human Genome Research – now the National Human Genome Research Institute (NHGRI) – created a research funding program for evaluation of the ethical, legal, and social implications (ELSI) of genomics. ELSI scholars study a wide range of issues, from the responsible conduct of genomic research, to implementation and outcomes of genetic testing programs, to intellectual property challenges. But how should this research be evaluated? In particular, what impact should we expect for this kind of research? These questions are particularly challenging for those of us who work in the multidisciplinary Centers of Excellence in ELSI Research (CEERs) funded by the NHGRI, because these centers have been given a programmatic charge to consider policy-relevant questions and help to inform the policy-making process. A group of ELSI researchers, representing seven CEERs, have been deliberating these questions and recently published a paper with recommendations.
We noted, first of all, that policy-making occurs in many venues. Although discussions often focus on governmental policies, policy-making in other venues often influences genomic translation, including actions as diverse as Institutional Review Board (IRB) decisions about consent and return of results; guidelines promulgated by professional organizations; funding decisions of health insurers; and investment decisions of venture capital. In addition, policy-making in one arena may influence the need for policies in another. For example, practice guidelines influence the use of genetic testing and may in turn influence how clinical data are accessed to evaluate test outcomes, or how IRBs decide what genetic results should be returned to research participants. Continue reading →
Yesterday, Medicare’s Departmental Appeals Board set aside a thirty-year-old National Coverage Determination excluding Medicare coverage for sex change surgery. As a result, Medicare beneficiaries may now seek coverage for sex change surgery, though the ruling does not make such coverage automatic; it only lifts the blanket national exclusion. Regional and case-by-case determinations that such surgery is not “medically necessary” could still apply. For news coverage, see here, here, and here.
The decision is not entirely surprising, Medicare had already in December reopened consideration of the National Coverage Determination precluding coverage. One question to watch is whether this decision, and the changed Medicare policy that ultimately results from it, winds up furthering the case for coverage in private insurance. There is an unmistakable trend in this area toward more coverage. Connecticut recently mandated coverage for many plans, and California and Oregon expanded coverage last year. And let’s not forget prison, in the First Circuit, at least, the refusal to provide sex change surgery to Michael Kosilek that doctors deemed to be medically necessary was ruled “cruel and unusual punishment.” (Coverage in the Globe here.)
Privacy is never easy to think about. This week it became harder. Two pieces framed my week. First, Eben Moglen’s essay in The Guardian (based on his Columbia talks from late last year) took my breath away; glorious writing and stunning breadth combined to deliver a desperately sad (but not entirely hopeless) message about government and corporate overreaching in data collection and processing.
A wry speech posted by software developer Maciej Ceglowski also helped frame my thoughts. He wrote, “The Internet somehow contrives to remember too much and too little at the same time, and it maps poorly on our concepts of how memory should work.” There’s the problem in a nut. Ceglowski alludes to the divide between how human (offline) memory operates (it’s “fuzzy” and “memories tend to fade with time, and we remember only the more salient events”) and the online default of remembering everything. Government and Google and, for that matter, Big Data Brokers tell us that online rules now apply across the board and ‘that’s just peachy’ because we’ll have better national security, better searches, or more relevant advertising. But, that’s backwards. Continue reading →
You know the King of Pop died in 2009 while rehearsing for a comeback tour in London. Here’s a twist you may not have heard about: Michael Jackson fan club members sued Conrad Murray, the doctor who administered the lethal overdose of anesthesia. And the celebrity enthusiasts won. A French court recently awarded five of the grieving fans economic damages (albeit just a euro each) to compensate for their emotional suffering.
The case highlights a neglected problem in our own law, not just medical malpractice, but constitutional and common law too. It’s this: Supreme Court rules and policies about harm, compulsion, and intentionality rely on the flawed assumption that operations of the mind are meaningfully distinct from those of the body. In our new essay on Dualism and Doctrine, Alex Stein and I (1) demonstrate just how this fiction distorts the law, (2) argue that the reasons for its persistence cannot save it, and (3) identify the ways in which courts should uproot dualism’s pernicious influence on our legal system. Continue reading →
Every year, in order to prevent a statutorily-triggered decrease in physician reimbursements under Medicare, Congress must adjust the statutorily-prescribed fee schedule. This is known as the “doc fix.” The American Medical Association, for what it is worth, has lobbied for a permanent doc fix, but that has not happened yet.
This year’s automatic pay cut was going to be 24%, and for a moment a temporary fix was in doubt because of bipartisan support for a permanent fix. But thanks to some procedural maneuvering yesterday, it looks like a temporary doc fix is through the house, at least. (See coverage in Politico here and Washington Post here. And just for fun, see a show about getting things through the house with procedural maneuvering here.)
In addition to the doc fix, a provision included in the House bill would forbid the Department of Health and Human Services from conducting post-payment review through Recovery Audit Contractors of inpatient hospital admission until March 31, 2015. This will stop for at least a year a review program that, in its last full year of operation, returned to the Medicare trust fund (and took away from hospitals) billions of dollars. (See commentary condemning the delay here and commentary criticizing the Recovery Audit Contractor program here.) It’s a notable development and if passed will kick the can down the road a short ways for Medicare to decide how it wants to handle utilization review in this area.
China’s highest executive organ, the State Council, put out the Food and Nutrition Development Outline 2014-2020 (the Outline) in February of 2014. The Outline was jointly drafted by China’s Ministry of Agriculture (MOA) and National Health and Family Planning Commission. The Ministry of Finance, Ministry of Education, Ministry of Commerce, Ministry of Science and Technology, and National Development and Reform Commission also participated in its development. Based on a review of China’s growth and problems in food and nutrition, the Outline sets a seven-year plan that highlights basic policy objectives. The areas of focus are food supply systems, nutrition intake and balance (especially amongst population sub-groups), regulatory and surveillance mechanisms, industry development, research, and education.
The Outline lays out its “guiding strategy” that the government should regard the effective supply of food, balanced nutritional profile, and production-consumption coordination as its chief missions. To execute these missions, the government identifies certain key products (quality agricultural products, convenient processed foods, and dairy and soy foods), key areas (poor, rural, and newly urbanized areas), and key population groups (the pregnant women and nursing mothers, infants and children, and the elderly) as starting points to promote better food and nutrition development patterns. Such points are further elaborated in the document. The guiding strategy ultimately aims to improve public health and a well-off society.
March 28, IU Robert H. McKinney School of Law, Indianapolis. The Hall Center for Law and Health and the Indiana Health Law Review present a major conference on neuroscience and the law. Speakers include:
Oliver R. Goodenough, Professor of Law, Vermont Law School
Geoffrey K. Aguirre, Associate Professor of Neurology, Perelman School of Medicine, University of Pennsylvania
Brenna C. McDonald, Assistant Professor of Radiology and Neurology, Stark Neurosciences Research Institute, Indiana University School of Medicine
Matthew Mitten, Professor of Law and Director, National Sports Law Institute, Marquette University Law School
Jean M. Eggen, Distinguished Professor of Law, Widener University School of Law
Tracy D. Gunter, Associate Professor of Clinical Psychiatry, Indiana University School of Medicine
Robert M. Pascuzzi, Professor and Chairman, Department of Neurology, Indiana University School of Medicine
Leslie A. Hulvershorn, Assistant Professor of Psychiatry, Indiana University School of Medicine
Amanda C. Pustilnik, Associate Professor of Law, University of Maryland Francis King Carey School of Law
Jennifer A. Drobac, Professor of Law, Indiana University McKinney School of Law
Andrew J. Saykin, Raymond C. Beeler Professor of Radiology and Director, Indiana University Center for Neuroimaging, Department of Radiology, Indiana University School of Medicine
Rebecca S. Dresser, Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine, Washington University School of Law
Eric Racine, Director, Neuroethics Research Unit, University of Montreal and McGill University
Why do people have radically different opinions as to who to help and how? How can we get along with people who seem to fundamentally disagree with us about what to want? Professor Josh Greene addresses this and more in Emotion, Reason, and Altruism.
Joshua Greene direct Harvard’s Moral Cognition Lab, which uses cutting edge cognitive neuroscience techniques to study how people actually make moral decisions, integrating thinking from philosophy, social science, and social psychology to address questions of why people disagree as much as they do, and what we can do about it.
High hopes for overcoming the HIV epidemic rest to a large extent on HIV Treatment-as-Prevention (TasP). Large cluster-randomized controlled trials are currently under way to test the effectiveness of different TasP strategies in general populations in sub-Saharan Africa. At the same time, however, international antiretroviral treatment (ART) guidelines have already moved to definitions of ART eligibility including all – in the US guidelines – or nearly all – in the WHO guidelines – HIV-infected people. In this panel, we are bringing together the leaders of three TasP trials in sub-Saharan Africa, bioethicists, and public health researchers to debate the tension between the policy intentions expressed in these guidelines and the historic opportunity to learn whether TasP works or not. Please join us in considering different options to resolving this tension.
Till Bärnighausen, Harvard School of Public Health, and Wellcome Trust Africa Centre for Health and Population Science
Max Essex, Harvard School of Public Health
Deenan Pillay, Wellcome Trust Africa Centre for Health and Population Science, and University College London
Velephi Okello, Swaziland National AIDS Programme, Ministry of Health
Dan Wikler, Harvard School of Public Health
Nir Eyal, Harvard Medical School
Moderator: Megan Murray, Harvard School of Public Health and Harvard Medical School
HEA’s first talk of the semester promises to be a good one, in an area we haven’t covered much before: shaping the far future. In the footsteps of the Future of Humanity Institute, and Nick Beckstead‘s research on the altruistic importance of the far future, we present:
Exploring how we humans have repeatedly underestimated not only the size of our cosmos (and hence our future opportunities), but also the power of our humans minds to understand it and develop technologies with the power to enrich or extinguish humanity.
Known as “Mad Max” for his unorthodox ideas and passion for adventure, his scientific interests range from precision cosmology to the ultimate nature of reality, all explored in his new popular book “Our Mathematical Universe”. He is an MIT physics professor with more than two hundred technical papers and has featured in dozens of science documentaries. His work with the SDSS collaboration on galaxy clustering shared the first prize in Science magazine’s “Breakthrough of the Year: 2003.”
For privacy advocates the last week contained something of a gut-check when the UK’s splendidly descriptive Health and Social Care Information Centre announced something of a bonanza for big data companies; the NHS’s care.data program, here, will make anonymized clinical data broadly available to researchers and commercial interests with few limitations, here.
For once, however, the US attitude to the growing big data phenomenon has appeared more robust. Writing on the White House Blog, here, Presidential counselor John Podesta announced he will be leading “a comprehensive review of the way that ‘big data’ will affect the way we live and work; the relationship between government and citizens; and how public and private sectors can spur innovation and maximize the opportunities and free flow of this information while minimizing the risks to privacy.” Results are promised in 90 days.
For health lawyers, however, the most interesting recent development has been the FTC’s denial of LabMD’s motion to dismiss, here. The LabMD complaint involves the data security practices of a clinical testing laboratory. The FTC alleged “unfair . . . acts or practices” under Section 5(a)(1) of the FTC Act. One of LabMD’s arguments for dismissal was that the specific HIPAA and HITECH statutes dealing with the health privacy and security obligations of covered entities blocked the FTC from enforcing its more general authority. According to the FTC:
Nothing in HIPAA, HITECH… reflects a “clear and manifest” intent of Congress to restrict the Commission’s authority over allegedly “unfair” data security practices such as those at issue in this case. LabMD identifies no provision that creates a “clear repugnancy” with the FTC Act, nor any requirement in HIPAA or HITECH that is “clearly incompatible” with LabMD’s obligations under Section 5.
LabMD is an important development. I have argued at length, here, that big data activities outside of HIPAA-protected space have illustrated the gaps in data protection because of the manner in which the US has regulated discrete vertical industries. LabMD suggests that the FTC is prepared to fill in the gaps.
I recently posted this draft on SSRN. Feedback much appreciated. Here is the abstract:
Fragmentation and lack of coordination remain as some of the most intractable problems facing health care. Attention has often alighted on the promise of Health care Information Technology not least because IT has had such positive impact on many other personal, professional and industrial domains. For at least two decades the HIT-panacea narrative has been persistent even though the context has shifted. At various times we have been promised that patient safety technologies would solve our medical error problems, electronic transactions would simplify healthcare administration and insurance and clinical data would become interoperable courtesy of electronic medical records. Today the IoM is positioning HIT at the center of its new “continuously learning” health care model that is in large part aimed at solving our fragmentation and lack of coordination problems. While the consensus judgment that HIT can reduce fragmentation and increase coordination has intuitive force the specifics are more complicated. First, the relationship between health care and IT has been both culturally and financially complex. Second, HIT has been overhyped as a solution for all of health care’s woes; it has its own problems. Third, the HIT-fragmentation solution presents a chicken-and-egg problem — can HIT solve health care fragmentation and lack of coordination problems or must health care problems such as episodic care be solved prior to successful deployment of HIT? The article takes a critical look at both health care and HIT with those questions in mind before concluding with some admittedly difficult recommendations designed to break the chicken-and-egg deadlock.
Historically, death has been a very simple and intuitive thing to understand – it occurs when someone stops breathing and their heart stops. Visually, it is a dramatic change that anyone can comprehend.
However, we now live in an age where machines can keep people breathing, and their hearts beating, when they would otherwise die. These medical advances have been revolutionary, and they are vital to allowing living patients to recover after severe illness or injury. On the other hand, they can make it more difficult for people to accept and understand death, because it can make dead patients “appear” alive.
Brain death refers to the irrevocable loss of all functions of the brain, including the brainsteam. Someone with brain death is just as dead as someone who has stopped breathing and whose heart has stopped. Doctors confirm brain death through a neurological examination, and once diagnosed the patient is dead. That person will never have any brain functioning and will never return to life or “wake up.”