Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus of this symposium is to explore this area from various perspectives – privacy and security, policy, open clinical trial data, systems and disease-oriented synthetic efforts and individually-provided, aggregated crowd-sourced data. The goal is to engage our biomedical and public health research community in a more nuanced appreciation of these and similar issues.
Topics include: data aggregation, access, annotation, refocusing on novel or unanticipated questions, and recombination with diverse demographic/epidemiologic data. Continue reading →
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
In a previous post, I discussed three possible methods of increasing vaccination and decreasing vaccine refusals in the United States. One of these options was using tort law and allowing lawsuits against parents for refusing/failing to vaccinate their children. The Pakistani government has recently taken it one step further, arresting and issuing arrest warrants for parents refusing to vaccinate their children against polio. Last week, approximately 512 people, 471 in Peshawar and 41 in Nowshera, were arrested and jailed and arrest warrants were issued for 1,200 more parents for refusing to vaccinate their children.
Currently, the government allows parents to be released from jail and return home if they sign an affidavit promising to vaccinate their children. Despite the fact there is no law requiring polio vaccination, some view the recent crackdown as “a blessing in disguise” for unvaccinated children. This drastic approach responds to high rates of refusal, a contributing factor to Pakistan’s significant number of polio cases. According to the World Health Organization, in the period since March 2014 Pakistan registered 296 polio cases, the most in the world and drastically higher than even the second-highest rate of 26 cases registered by Afghanistan. Why is Pakistan’s vaccination rate so low? For many reasons, including religious beliefs, attacks on medical workers, displacement of individuals due to ongoing military operations, and a lack of trust in health care workers and the vaccine. Continue reading →
A new piece by contributor Art Caplan on NBC News:
Guns are a medical issue — no matter how often the NRA denies it. Eight national health groups, including the American Academy of Pediatrics, just released a joint statement echoing that sentiment.
But among the barrage of media questions leveled at politicians on the presidential campaign trail, no one is asking the contenders about firearms. The topic appears to be strangely and entirely off limits.
Everything else seems to be fair game: Do you think President Obama loves this country? What do you think about vaccines? Do you believe in evolution? Did you embellish anything on your resume? Do embryos have rights? Are you too old, fat, short, ill-tempered, religious, atheistic, feminist, or in the pocket of your donors to make a good President? […]
There are lots of reasons why measles, having gone to Disneyland, is enjoying a comeback around the United States and Canada. Unfounded fears of autism scare some parents. Others buy the daffy conspiracy theory that pharmaceutical companies are just pushing vaccination to make a buck. Some parents invoke religious concerns despite that fact that hardly any religions think vaccination is bad and most teach that it is an obligation in order to protect children and the vulnerable in the community.
One key reason behind falling vaccination rates is that if you believe any of the above untruths it is very easy to get an exemption. Most states let you out on religious or philosophical grounds. Every state excuses you or your kids for health reasons. So you might presume those ducking vaccines get approval to dodge vaccination from physicians. Uh uh. In 17 states, D.C. and Puerto Rico naturopaths, healers who believe in a mishmash of nutritional medicine, botanical medicine, naturopathic physical medicine including chiropractic manipulative therapy, rolfing, iridology, and homeopathy among other New Agey philosophies can get licenses in their state. There are thousands practicing in the United States. Put aside the issue of why states are recognizing these ‘healers’ who rely on an evidence base only a few steps above astrology and palm-reading. The fact is in many states a naturopath can excuse a child from vaccination. And since many naturopaths take a pretty dim view of vaccination they give a lot of exemptions. […]
The numbers paint a telling picture. In the United States of the 1950s there were between 3 million and 4 million annual cases of measles, a highly infectious virus that causes severe flu-like symptoms and a spreading red rash. Roughly 48,000 of those infected each year were hospitalized, and 400 to 500 died.
By 2000, through an effective and widely used vaccine, measles was essentially eliminated in the United States.
But for the last several years, the Centers for Disease Control and Prevention has reported a significant uptick. Last year, the CDC recorded more than 644 cases from 27 states, the worst since 2000. Only two months into 2015 the United States is facing more than 150 cases reported across the country, many of them tied to a December outbreak at Disneyland in California.
The resurgence involves measles-stricken travelers and American parents who don’t vaccinate their children. […]
On January 20, 2015, Michael J. Davidson, MD, a cardiothoracic surgeon, was fatally shot on the premises of the Brigham and Women’s Hospital in Boston, Massachusetts. In the year leading up to this tragic day, a total of 14 active shooter incidents occurred in hospitals throughout the United States, leaving 15 fatalities in their wake. This reality and its potential amplification by copycats has reignited the debate over the adequacy of current and future hospital security arrangements. In this Viewpoint, we discuss the evolving frequency of hospital-based active shooter incidents, the relevant legal framework, and the role of hospitals and physicians in countering this threat.
As defined by the US Department of Homeland Security, an active shooter incident is one wherein “an individual is actively engaged in killing or attempting to kill people in a confined and populated area.” By several accounts, the overall prevalence of this otherwise rare occurrence is increasing. A study by the Federal Bureau of Investigation (FBI) reveals the overall number of active shooter incidents to have increased from 6.4 per year (2000-2006) to 16.4 per year (2007-2013). Similar rates have been reported for the hospital setting wherein the average number of active shooter incidents has increased from 9 per year (2000-2005) to 16.7 per year (2006-2011), claiming 161 lives in the process. It would thus appear that the frequency of hospital-based active shooter incidents has evolved to constitute at least a monthly occurrence. […]
The political paralysis plaguing gun laws notwithstanding, hospitals are not without recourse in seeking to mitigate the threat of active shooter incidents. On the local advocacy front, advancing and enacting bills for gun-free zones in health care settings constitutes a worthy effort in that a comparable federal statute remains unlikely. Concurrently, selective locale-specific enhancement of hospital security arrangements may increase deterrence, thereby mitigating risk and civil liability. […]
There is a delicate balance between preserving individual rights and protecting public health when it comes to vaccines, experts argued at a panel discussion at Harvard Law School on Wednesday.
In the wake of the recent outbreak of measles in California, the panel emphasized the need for Americans to be more informed in their decisions for or against vaccination. While allowing an opt-out option to remain in place, the panel proposed making the opt-out process for vaccines more difficult. […]
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 →
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 →
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.
George Annas, Boston University School of Public Health, School of Medicine, and School of Law
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. […]
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. […]
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.
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 →
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology &Global Health Policy, University of California, Irvine School of Law
A legislative advisory committee is set to present an amended bill to the Minnesota State Legislature this session that raises the standard of care provided to incarcerated pregnant women in Minnesota prisons.
The amendment seeks to clarify language of a law passed on May 8, 2014 seeking to ensure incarcerated pregnant women receive the same standard of care they would receive outside a correctional facility. The Minnesota Senate and House unanimously passed the bill, which was described as “a first step toward providing a healthy start in life for the babies born to the estimate 4,200 women per year in [Minnesota] who are pregnant at the time of their arrest.” It was the first law to consider the unique needs of pregnant inmates. Continue reading →