In Regulating E-Cigarettes, No Easy Fix For The FDA

A new post by Wendy Parmet on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

Read the full post here.

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the February 20th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

child_pediatrician_slide_270_200_85_c1FREE REGISTRATION!
Families Matter: Ethically, Legally, and Clinically

March 18 – 20, 2015
Harvard Medical School
Boston, MA

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter. Continue reading

Problems with fMRI as a tool of lie detection

by Zachary Shapiro

Functional magnetic resonance imaging (fMRI) evidence of lie detection has, appropriately, faced difficulty gaining evidentiary acceptance in criminal courts. While a comprehensive discussion of the case law is beyond the scope of this post, it is important to note that courts have repeatedly refused to admit such evidence, both under a Daubert test, using Federal Rule of Evidence (FRE) 702, as well as under FRE 403.

Under Daubert, which governs the admissibility of expert testimony, courts have found that fMRI lie detection falls short in meeting the necessary standards, including the identification of error rates and maintenance of uniform testing standards. Courts have also pointed out that the motivation to lie may be different in research v. real-world settings.[1] In a laboratory experiment, one can assume that the participant is complying with investigator directions. However, if the scan is to be used in the courtroom, the subject will have a personal interest in the outcome, and may try to employ counter measures, or disregard instructions, in order to “fool” the scanner. Recent research shows that this task may not be hard, at least not for those who know how to effectively “trick” the scanner.

Judges have highlighted that while there are peer-reviewed studies of fMRI lie detection, said studies have very small patient bases (all N<60), and included a range of participants who were not representative of the general population. Courts recognize that neuroimaging, for the purposes of lie detection, is still not generally accepted by the scientific community.[2] Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.

Continue reading

Dying: Closing the Gap between What We Know & What We Do

By Susan M. Wolf, JD (University of Minnesota), Nancy Berlinger, PhD (The Hastings Center), and Bruce Jennings, MA (Center for Humans and Nature)

Time is running out on fixing the way we die. As readers of this blog know, the courts first declared a right to refuse unwanted life-sustaining treatment in the 1976 Quinlan case. Nearly 4 decades later, too many people are still burdened with treatments they don’t want, can’t get support for care at home, and are dying without good relief of pain and suffering. So it was no surprise that the highest court in Canada finally threw in the towel. In its Feb. 6 opinion in Carter v. Canada, the court found people still “suffering intolerably as a result of a grievous and irremediable medical condition.” The court thus recognized a right to physician aid in dying. Canada now has a year to set up a system that will permit the practice while protecting the vulnerable from abuse.

Regardless of your views on physician aid in dying, too large a gap remains between what we know is high-quality care at the end of life and what we actually do to care for dying people. The Feb. 12 issue of the New England Journal of Medicine included four articles on the problem, including our analysis of “Forty Years of Work on End-of-Life Care: From Patients’ Rights to Systemic Reform.”  Continue reading

Unexpected Channels of Patient Misinformation

by Vadim Shteyler

As a medical student on the wards, physicians often recounted stories of horrifying acts of paternalism from the days of their training. Though paternalism is far from abolished, the progress we have made as a profession has become a source of some pride. On the wards, autonomy has become exalted as a sacred right and invoking paternalism can end most debates. Though autonomy is a complicated and frequently debated concept, most agree that the cultural shift is a step in the right direction. And though perhaps we should be proud of our steps towards protecting the way patients receive information in clinic, we should be more aware of other sources of patient information as well.

Of course, it may not come as a surprise that a lot of the medical information available to patients is less than accurate. With the Internet, ubiquitous misinformation about anything should be expected. However, when we think about the sources of that misinformation we often think about random websites found during quick Google searches, Wikipedia, sensationalized media coverage, and pharmaceutical advertisements (the later will be discussed further below). A few recent studies are bringing attention to more surprising culprits: Hospitals and Academic Institutions. Continue reading

Going for gold: behavioral science reveals new biases in ACA exchange shopping

A new New England Journal of Medicine commentary by Peter A. Ubel, M.D., David A. Comerford, Ph.D., and Eric Johnson, Ph.D. highlights significant flaws in the way information is presented to insurance shoppers on state and federal exchange websites. The authors present original survey data to support the argument that subtle aspects of current website designs inappropriately bias decision making. The authors make their case most strongly in an analysis of the well-known gold, silver and bronze labels:

Consider the decision to lump health plans into categories with names such as bronze (for low monthly premiums and high out-of-pocket costs) and gold (for higher monthly premiums and lower out-of-pocket costs). These labels could have unintended effects on people’s attitudes toward which plans are best. After all, gold, silver, and bronze convey best, second best, and third best through association with sporting events, but the best plan for one enrollee will be different from the best plan for another.

To test whether such associations might influence people’s perceptions of insurance plans, two of us recruited a convenience sample of participants from public buses in Durham, North Carolina, and asked them which category of plans they would look at first if they were shopping for health insurance. To half the people, we described the gold plans as having higher monthly premiums and lower out-of-pocket costs — the language used by many exchanges. For the other half, we switched the gold and bronze plans, describing the gold plans as having lower monthly premiums and higher out-of-pocket costs.

Continue reading

AGENDA NOW AVAILABLE! 2015 Annual Conference: Law, Religion, and Health in America

2015 Annual Conference – Law, Religion, and Health in America

stethoscope_bible_slideMay 8 – 9, 2015

Milstein East BC
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA 02138 [Map]

Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated.  Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience.

This conference, and anticipated edited volume, will aim to: (1) identify the various ways in which law intersects with religion and health care in the United States; (2) understand the role of law in creating or mediating conflict between religion and health care; and (3) explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

Special sessions include:

  • Thursday, May 7, pre-conference session on the Supreme Court’s Hobby Lobby decision
  • Friday, May 8, Keynote: Douglas Laycock, University of Virginia School of Law - Religious Liberty, Health Care, and the Culture Wars
  • Saturday, May 9, Plenary Session: Adèle Keim, The Becket Fund for Religious Liberty, and Gregory Lipper, Americans United for Separation of Church and State – The Contraceptives Coverage Mandate Litigation

 A full agenda is now available on our website

The conference is free and open to the public, but space is limited and registration is required. REGISTER ONLINE.

Pre-conference session co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb Initiative on Religious Freedom and Its Implications at the Harvard Kennedy School Center for American Political Studies.

The full conference is supported by the Oswald DeN. Cammann Fund.

The Timeline Approach to Medical Malpractice Defenses

By Alex Stein

California’s Court of Appeal has recently delivered a first-impression decision on the conditions under which a patient’s own negligence can be asserted as a defense against medical malpractice allegations. Harb v. City of Bakersfield, — Cal.Rptr.3d —- (Cal.App. 5th Dist. 2015) 2015 WL 302291.  Among the materials cited by this decision was my article, Toward a Theory of Medical Malpractice, 97 Iowa Law Review 1201 (2012). The court used my “timeline approach” to separate the patient’s pre-treatment negligence, upon which providers of substandard medical care cannot rely, from self-injurious behaviors that occur during and after treatment and that can properly mitigate – and in extreme cases, even eliminate – the legal consequences of medical malpractice. Continue reading

EVENT NEXT WEEK (2/25): Measles, Vaccines, and Protecting Public Health

15.02.25, measles posterMeasles, Vaccines, and Protecting Public Health

Wednesday, February 25, 2015, 4:00 PM 

Wasserstein Hall, Room 1010 Harvard Law School 1585 Massachusetts Ave., Cambridge, MA

The recent measles outbreak centered around Disneyland in California has reignited the contentious debate over childhood vaccination in the United States. Join us for a discussion of the ethical, legal, and public health issues surrounding vaccines, including mandates, exemptions, parental rights, and the role of misinformation in modern medicine.

Panelists:

  • George Annas, Boston University School of Public Health, School of Medicine, and School of Law
  • Nir Eyal, Harvard Medical School
  • Dyann Wirth, Harvard School of Public Health
  • Moderator: Ahmed Ragab, Harvard Divinity School

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

Highlights from the 21st Century Cures Act

At the end of January, the House Energy & Commerce Committee released a discussion draft of the 21st Century Cures Act.  This document marks the beginning of the legislative phase of the 21st Century Cures Initiative, during which the Committee has held numerous roundtables and hearings and issued several white papers.  The first discussion draft of the Act, clocking in at nearly 400 pages (even with several sections “to be supplied”), is incredibly wide-ranging, including proposals that could affect every stage of the innovation process.

The discussion draft should be of interest to everyone in the health policy field.  One series of proposals is targeted at the NIH, including more support for the National Center for Advancing Translational Sciences and for the NIH’s BRAIN initiative.  Another set would act on the FDA, including one provision giving new drugs for unmet medical needs the option of 15 years of exclusivity.  This provision, based on the MODDERN Cures Act, is particularly likely to inspire a great deal of controversy and opposition.  The draft also contains a series of proposals designed to promote the development of new antibiotics, in keeping with President Obama’s recent focus on this issue.  Its attention to the use of social media by drug companies and to the FDA’s regulation of health-related software will be of interest to many, as well.

The proposed draft is much too long to catalog fully in this brief blog post, although those who are interested in a broader summary might enjoy the 13-page summary of the Act put out by the Committee, the Science summary by Kelly Servick and Jocelyn Kaiser, or Alexander Gaffney’s comprehensive Regulatory Explainer.  But I do want to highlight one section of the draft which deserves more attention than it has gotten: section 2021, which would create a national Medical Product Innovation Advisory Commission.

Continue reading

Organ Transplant Malpractice and the “Proximate Cause”

By Alex Stein

Everyone interested in that area must read Shierts v. University of Minnesota Physicians, — N.W.2d — (Minn.App.2014), 2014 WL 7344014.

This important – yet, unreported – decision deals with a medical-malpractice action arising out of the patient’s death from cancer contracted from a donated pancreas. The trial court dismissed the action summarily based on the “proximate cause” doctrine, and the plaintiff appealed against that dismissal. Continue reading

Discrimination, by what yardstick?

By Kelsey Berry

It’s time to talk about discrimination again — this time, in insurance benefit design.

A recent study in NEJM by Jacobs and Sommers has coined the term “adverse tiering” to describe the use of drug formularies by insurers “not to influence enrollees’ drug utilization but rather to deter certain people from enrolling [in the plan] in the first place.” [emphasis mine] Evidence of adverse tiering includes the placement of all drugs for certain condition in the highest cost-sharing tiers of drug formularies. This practice, it turns out, occurs fairly frequently – at least when it comes to a common HIV medication, nucleoside reverse-transcriptase inhibitors (NRTIs). Jacobs and Sommers analyzed the placement of NRTIs on formularies for 48 plans in 12 states using the federally facilitated insurance marketplaces, and found evidence of adverse tiering in 25% of plans. Their conclusion? Many insurers may be using benefit design to dissuade sicker people from enrolling in their plans. This raises concerns about adverse selection, as well as discrimination on the basis of health status – a practice the ACA was meant to address via community rating and guaranteed issue requirements, among others.

The study provides an important data point as we continue to assess whether the ACA is living up to our goals for health care reform. I believe we’ll see several more studies of this nature coming down the line, drawing attention to insurer practices that fail to comply with regulations, that are creative interpretations of vague requirements, or that aren’t addressed in existing regulations and may require new scrutiny. As we digest these, I’ll raise two important points for consideration:

Continue reading

Art Caplan: Revoke the license of any doctor who opposes vaccination

A new opinion piece by Art Caplan, via the Washington Post:

Amateurs and hucksters are not the only people telling parents not to vaccinate their children. Unfortunately some doctors — men and women sworn to the Hippocratic Oath — are purveying junk science. They say that vaccines cause autism, as in the famous case of Andrew Wakefield, whose study drawing the link has been retracted. Or that measles isn’t that bad, so your child can skip the shots, as Jack Wolfson, a cardiologist in Arizona, says, adding that “the facts” show vaccines to be full of “harmful things” like “chemicals.” Or that, according to some parents, vaccines cause “profound mental disorders,” as Sen. Rand Paul, an ophthalmologist, warned before he walked the statement back. Or that vaccines cause “permanent disability or death,” in the words of Bob Sears, a pediatrician in California.

Thankfully, only a few physicians in America have embraced fear-mongering in the middle of this dangerous and costly measles epidemic. They deserve a place of honor next to climate-change skeptics, anti-fluoridation kooks and Holocaust deniers. They doubt the facts, ignore established evidence and concoct their own pet theories. They shouldn’t be allowed near patients, let alone TV cameras. But because their suggestions are so surprising and controversial, they often find themselves on cable news shows and in news reports about the “anti-vaxx” crowd. Their power, therefore, is radically disproportionate to their numbers. [...]

Read more here.

Synthetic biology and intellectual property rights: Six recommendations

On 26th November 2013, the Danish Agency for Science, Technology and Innovation organized an expert meeting on “Synthetic Biology & Intellectual Property Rights” in Copenhagen sponsored by the European Research Area Network in Synthetic Biology (ERASynBio). The meeting brought together ten experts from different countries with a variety of professional backgrounds to discuss emerging challenges and opportunities at the interface of synthetic biology and intellectual property rights. The aim of this article is to provide a summary of the major issues and recommendations discussed during the meeting.

The ERASynBio consortium consists of 16 governmental funding bodies from 12 EU Member States (Austria, Denmark, Finland, France, Germany, Greece, Latvia, Netherlands, Portugal, Spain, Slovenia, and UK) and two Associated Countries (Norway and Switzerland)

Timo Minssen, Berthold Rutz and Esther van Zimmeren: Synthetic biology and intellectual property rights: Six recommendations. (2015) Biotechnology Journal Special Issue: Synthetic Biology Volume 10, Issue 2, pages 236–241

Summary of the recommendations addressed in the publication: Continue reading

Do Medical-Malpractice Time Bars Apply to Hospitals’ Indemnification Suits Against Doctors?

By Alex Stein

The South Carolina Supreme Court has recently decided that a hospital’s indemnification suit against doctors whose malpractice made it pay compensation to the aggrieved patient is subject to the same time bars as patients’ actions against defaulting physicians. Columbia/CSA-HS Greater Columbia Healthcare System, LP v…., — S.E.2d —- (2015), 2015 WL 249536 (S.C. 2015).

Chief Justice Jean Hoefer Toal wrote a vehement dissent in which she was joined by Justice Kaye Hearn. In that dissent, she wrote that “The majority’s holding represents a fundamental misunderstanding of the nature of indemnification actions which I fear will have far-reaching effects on the ability to seek indemnification.”

The Chief Justice was absolutely right. Continue reading

Worth Reading This Week

By Nicolas Terry

What Ebola Teaches Us About Public Health In America

A new post by George Annas on the Health Affairs Blog, as part of part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

2014 saw an epidemic of Ebola in Sierra Leone, Guinea, and Liberia, and an epidemic of fear in the US. Neither epidemic covered public health in glory. For Science, Ebola was the “breakdown of the year;” the Association of Schools and Programs of Public Health called it “the most important public health story” of the year; Politfact labeled it the political “lie of the year,” and Time magazine named “the Ebola fighters” its “Person of the Year.” All of these characterizations contain some truth.

Response to the epidemic in Africa relied heavily on volunteer organizations, especially Christian charity groups like Samaritan’s Purse and SIM (Serving In Mission), and medical NGOs, most notably Doctors Without Borders (MSF). It was MSF that called out the World Health Organization (WHO) for its failure to recognize the epidemic, and then its inability to respond to it. Their International Health Regulations, it turned out, were much more like guidelines than any form of law, and the WHO had no capacity to effectively respond to a new epidemic. [...]

Read the full post here.

Tomorrow (2/12): A Dialogue on Agency, Responsibility, and the Brain with Stephen Morse

MorseA Dialogue on Agency, Responsibility, and the Brain with Stephen Morse

Thursday, February 12, 2015, 12:00 PM

Wasserstein Hall, 3019                       Harvard Law School                                       1585 Massachusetts Avenue                     Cambridge, MA 02138 [Map]

Join guest speaker Professor Stephen J. Morse, JD, PhD, former MacArthur Foundation Law & Neuroscience Project co-Chair and co-Director of the Center for Neuroscience and Society and CLBB Faculty members Judge Nancy A. Gertner and Professor Amanda C. Pustilnik for a conversation about how – or whether – new knowledge about the brain is changing legal concepts of agency and responsibility.

Stephen J. Morse is the Ferdinand Wakeman Hubbell Professor of Law; Professor of Psychology and Law in Psychiatry; and Associate Director, Center for Neuroscience & Society at the University of Pennsylvania. Morse works on problems of individual responsibility and agency. Morse was Co-Director of the MacArthur Foundation Law and Neuroscience Project. Morse is a Diplomate in Forensic Psychology of the American Board of Professional Psychology; a past president of Division 41 of the American Psychological Association; a recipient of the American Academy of Forensic Psychology’s Distinguished Contribution Award; a member of the MacArthur Foundation Research Network on Mental Health and Law; and a trustee of the Bazelon Center for Mental Health Law.

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

Part of the Project on Law and Applied Neuroscience.

Studies provide new insights into youth and adolescent concussion

By: Christine Baugh

In the past several weeks there have been two studies with important implications for youth and adolescent concussions. They are summarized briefly in this post.

Post-Concussion Rest. Thomas and colleagues recently published a study in the journal Pediatrics examining whether standard of care (1-2 days rest) or 5 days of strict rest (both physical and cognitive) following concussion led to better short-term health outcomes in a population of 11-22 year old patients. The full text of this manuscript is available here. Expert consensus recommends strict rest –of relatively undefined duration — followed by a gradual return to cognitive and then physical activity. The study’s authors hypothesized that increased rest would improve outcomes, but found that the strict rest group did not have measurable health improvements compared to standard of care. In fact, symptom reporting was modestly higher in the strict rest group. Main study limitations include: small sample size and short follow-up period (which does not allow for insight as to longer term implications). This was the first randomized control trial of rest duration following concussion diagnosis in a youth and adolescent cohort, and the study added critical information to an important area of inquiry. Continue reading