In light of the measles outbreaks in California and now in Nevada, many, including myself, have wondered how we’ve come to this point where a completely preventable disease seems to threaten the lives of so many. While there are recognized legitimate reasons to opt-out of receiving vaccinations, such as for medical and religious reasons, several states allow for opting-out based only on personal beliefs against a scientifically proven fact. As California suffers from the greatest measles outbreak in this country in over a decade, lawmakers have begun to consider repealing the personal belief exemption. If repealing the provision proves to be impossible, seeing as how the parents of over 10,000 kindergarteners in California have already chosen to take advantage of the exemption for non-religious reasons, it may be necessary to consider other strategies to encourage a rate of vaccination high enough to maintain herd immunity within our communities.
Jacobson v. Massachusetts was a seminal case in public health law from the early 20th century because it held that the State could mandate vaccinations, or other public health measures, when necessary to protect public health and safety. The Court recognized some limits to this intrusion of liberty, such as when an individual would suffer harm from the measure or when the individual would be unduly burdened — as in the case of someone with strong religious beliefs against the measure. Furthermore, the Court articulated some general standards: the measure must have a real and substantial relation to the public health goal and the burden caused must not be disproportionate to the benefit. The public health measure in Jacobson met these standards — it compelled smallpox vaccination during an outbreak or required payment of a nominal monetary fine for those who refused to comply without a legitimate reason. As Jacobson had no medical reason to opt-out of receiving the vaccination and had not asked for a religious exemption, the Court found that he was required to either be vaccinated or to pay the fine. His skepticism toward the medicine and doubt in the government were not enough. Jacobson’s reasoning sounds strikingly familiar to the reasoning of many who choose to opt-out today, yet today the science is even more advanced and the benefits of vaccination are even clearer.
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.
This multidisciplinary program has been developed to inform and deliberate with ethicists, health care providers, attorneys and the public about changes in conceptions of the family and medical technologies and practices that challenge moral conventions and contemporary law. Faculty experts and participants will engage in thoughtful discussion regarding a broad range of ethical and legal issues that arise from new ways of creating and new ways of understanding families and providing health care for expectant parents, growing fetuses, infants, children, adolescents….and their families.
The fragmented nature of regulatory authority over food in the United States is well known. More than a dozen federal agencies are responsible for the safety of the nation’s food supply. The Food and Drug Administration (FDA) and the Department of Agriculture (USDA) have the lion’s share of responsibility, together overseeing over 80 percent of the nation’s food safety.
Generally, the USDA regulates meat, and the FDA regulates everything else, but overlaps, exceptions, gaps, and therefore examples of resulting absurdities abound: the FDA regulates frozen pizza, unless it has pepperoni. The FDA regulates seafood, unless it’s catfish. The USDA has jurisdiction over packaged open-face meat sandwiches, but if the sandwiches are closed, authority shifts to the FDA.
This division in regulatory authority is neither planned nor rational. It is instead a historical accident, originating in the early twentieth century. When the Pure Food and Drug Act and Meat Inspection Act were passed on the same day in 1906, both targeting the adulteration of the food supply, their oversight was assigned to different departments within the USDA. The fissure widened when the FDA was moved out of the USDA in 1940. This divided regulatory framework is not the only reason for the fragmentation of regulatory authority over food in the US, but it is a main driver.
The President’s Proposal for a Single Food-Safety Agency
The President’s 2016 Budget, released last week, attempts to put the pieces back together and consolidate control over food safety. It proposes a new agency within the Department of Health and Human Services (HHS) that will incorporate the food safety functions of the FDA and the Food Safety and Inspection Service (FSIS) of the USDA.
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology &Global Health Policy, University of California, Irvine School of Law
As the majority of state legislatures get back in session, it is clear there will be no dearth of “anti-choice” legislation proposed and considered throughout the country.
In Texas, Representative Matt Krause (R-Fort Worth) is pushing a new law that would provide representation to fetuses in court hearings. This law responds to Marlise Munoz’s case, a brain-dead pregnant woman left on life support for two months because doctors refused to honor her family’s request to remove her from life support. Doctors claimed they were prohibited from doing so because Texas law prohibits withdrawing or withholding life-sustaining treatment from pregnant patients, regardless of their previously-expressed wishes.
South Dakota Representative Isaac Latterell (R-Tea) is sponsoring House Bill 1230, which seeks to ban dilation and evacuation (D and E) procedures sometimes used in second-trimester abortions. The bill uses inflammatory and graphic language (for example, making it illegal to “knowingly behead a living unborn child”), arguably intended to provoke disgust over the procedure to increase support for the bill. HB 1230 includes criminal penalties and physicians violating the law may be charged with a Class 1 felony and face fifty years imprisonment.
Fifty Ohio legislators have introduced House Bill 69, a “fetal heartbeat” law that would outlaw abortion after a heartbeat can be detected. This can occur as early as six weeks gestation, before some women even know they are pregnant. Continue reading →
The sale of cigarettes and tobacco products at retailers with pharmacies has received considerable attention over the past year. The national debate reignited in February 2014, when CVS/pharmacy announced that we would quit the sale of cigarettes and tobacco products in our 7,800 pharmacies nationwide. In September 2014, we announced we were officially tobacco free — one month earlier than planned. This was met with kudos from the media, public health officials, and even the President of the United States.
But one question that did not receive anywhere near that level of attention was whether or not our actions would make a difference in the prevalence of smoking and, ultimately, in the public health.
One factor influencing the decrease in participation may be parental concerns. A recent survey of parents conducted jointly by ESPNw and the Aspen Institute characterized these concerns finding a large percentage of parents were worried about the risk of injury, behavior of coaches, cost, time commitment, and the emphasis on winning over having fun. Concussions and head injuries were the most worrisome injury for parents in this study. Despite this concern, very few parents reported keeping their child from participating in sports due to this risk. The AMSSM position statement characterizes the preoccupation with specialization and competition within sports at such a young age as a risk factor for injury and burnout. Continue reading →
Frank Pasquale and Nicolas Terry are pleased to announce The Week in Health Law Podcast. We (and our guests) enjoy a commuting-length discussion about some of the more thorny issues in Health Law & Policy.
Wasserstein Hall, Room 3019
Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA 02138
Do criminal penalties have any deterrent effect on drug addicts – people who already are willing to throw away their jobs, relationships, or even lives for their “fix”? What does brain science tell us about addicts’ capacities to exert self control and to be held criminally responsible? This panel discussion brings together a leading neuroscientist of addiction, a criminal law scholar, and a former judge to ask whether the law should reconsider aspects of responsibility and punishment in light of new science about self-control.
Joshua Buckholtz, Assistant Professor, Harvard University Department of Psychology
Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience, Petrie-Flom Center/Center for Law Brain and Behavior, and Associate Professor of Law at the University of Maryland School of Law
The Supreme Court of New Mexico has recently delivered an important decision protecting peer reviewers’ statutory entitlement to confidentiality. Yedidag v. Roswell Clinic Corp., — P.3d —- (N.M. 2015), 2015 WL 691333. The Court ruled that peer reviewers can sue violators of their confidentiality right and recover compensatory and even punitive damages. This ruling applied the common law criteria for identifying statutory violations as a breach of contract. Based on those criteria, the Court categorized peer reviewers as members of the class protected by the peer review statute, who deserve remedies for violations of their confidentiality right. The Court also estimated that the criminal penalty imposed by the statute on the right’s violators was too lenient to discourage violations. The Court projected that allowing peer reviewers to sue violators will compensate for the resulting shortfall in deterrence. As a conceptual matter, the Court decided that peer reviewers’ confidentiality entitlement is a “mandatory rule of law incorporated into physician-reviewer employment contracts.” Continue reading →
February 23, 2015 5:00 PM Griswold Hall, Room 110 (Harvard Law School) 1525 Massachusetts Ave., Cambridge, MA [Map here.]
Professor Kapczynski’s presentation, “Order Without Intellectual Property Law: The Flu Network as a Case Study in Open Science,” is available upon request. Please contact Jennifer Minnich (email@example.com) if you would like a copy.
Amy Kapczynski is an Associate Professor of Law at Yale Law School and director of the Global Health Justice Partnership. She joined the Yale Law faculty in January 2012. Her areas of research including information policy, intellectual property law, international law, and global health. Prior to coming to Yale, she taught at the University of California, Berkeley, School of Law. She also served as a law clerk to Justices Sandra Day O’Connor and Stephen G. Breyer at the U.S. Supreme Court, and to Judge Guido Calabresi on the U.S. Court of Appeals for the Second Circuit. She received her A.B. from Princeton University, M. Phil. from Cambridge University, M.A. from Queen Mary and Westfield College at University of London, and J.D. from Yale Law School.
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.
March 18 – 20, 2015
Harvard Medical School
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 →
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. 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. Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.
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.
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 →
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
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 Sciencesummary 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.
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:
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. [...]