In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.
The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:
“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”
I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Continue reading →
Neuroscientist John Cacioppo, who has spent much of his career working on loneliness, defines “loneliness” as “perceived social isolation.” Similarly, Masi, et al. (following Russell, et al. 1980) define “loneliness” as “the discrepancy between a person’s desired and actual social relationships.” As Masi, et al., point out, there is a distinction to be made between loneliness, on the one hand, and social isolation, on the other, although the two phenomena may indeed often go together. Whereas social isolation “reflects an objective measure of social interactions and relationships,” loneliness “reflects perceived social isolation or outcast.” Following Peplau & Perlman 1982 and Wheeler, et al. 1983, they go on to point out that “loneliness is more closely associated with the quality than the number of relationships.” (It’s important and timely to note that the 2016 Nobel Laureate in Literature, Bob Dylan, brought out one application of this conceptual distinction in his song, “Marchin’ to the City,” when he sang: “Loneliness got a mind of its own / The more people around the more you feel alone.”)
The health risks posed by loneliness are several and can be severe. Loneliness can contribute to increased risk of coronary heart disease, cardiovascular disease, and stroke. In a 2016 systematic review and meta-analysis in Heart, Valtorta, et al., reported that “poor social relationships were associated with a 29% increase in risk of incident CHD [coronary heart disease] and a 32% increase in risk of stroke.” And in a March 2015 meta-analysis in Perspectives on Psychological Science, Holt-Lunstad, et al., reported that a substantial body of evidence supports the following two claims:
Loneliness puts one at greater risk for premature mortality. In particular, “the increased likelihood of death was 26% for reported loneliness, 29% for social isolation, and 32% for living alone.”
The heightened risk for mortality due to “a lack of social relationships” (whether reported loneliness, social isolation, or living alone) is greater than the risk due to obesity.
I just watched the movie Concussion (2015) as an assignment for one of my bioethics courses. The movie is about a physician, Dr. Bennet Omalu, as he unravels the association between playing in NFL and an acquired neurodegenerative disease, a condition he calls, “chronic traumatic encephalopathy” (CTE). At one point Dr. Omalu tries to convince a prominent researcher that, despite suffering head traumas similar to those of football players, animals like the woodpecker have the means of avoiding CTE;
“The woodpecker’s tongue comes out the back of the mouth through the nostril and goes around the top of its head. Basically, it’s one big safety belt for the brain.” (source)
The tongue shoots out through the nostril? As a medical student, I found this trivial aside absolutely fascinating. But when I tried to learn more I quickly realized–to my dismay–that most experts would balk at this characterization. Woodpeckers don’t develop CTE for a variety of reasons, including; (1) smaller mass means less force from deceleration; (2) no head rotation during each peck as to decrease angular forces, and; (3) their skulls have a physiologic protective cushion. I won’t delve further into the weeds about where exactly the movie’s assertions depart from reality, but to put it generously, this crucial argument totally misrepresents the science.
The problem with all of this is that it’s tempting to watch Concussion and feel better informed about the controversies surrounding professional football and CTE. To be honest, I was mesmerized watching familiar events brought to life on screen, and it all seemed credible as it used the actual names of people involved. Movie reviews by Rolling Stone even suggest that it should be mandatory for football fans, and The New York Times remarks on how it, “sells a complex issue.” Sure, everyone knows Concussion is “for entertainment purposes only,” but can’t stories that are true also be entertaining? However, the seemingly-trivial inaccuracy about woodpeckers was a potent reminder that this film is not a documentary. Concussion should be viewed as it is–a major Hollywood blockbuster starring Will Smith and Alec Baldwin.
In 2012, a Jane Doe suspected of transporting drugs was detained by U.S. Customs and Border Protection (CBP) agents without a warrant, and brought to University Medical Center in El Paso, Texas. Medical Center personnel — under the direction of the law enforcement agents — performed an X-ray, CT scan, and cavity search before determining that the woman was not in fact carrying any controlled substances. A few months after suffering this traumatic — and possibly illegal — event, the woman received a $5400 bill from the Medical Center for the services rendered as part of the search.
While the woman was compensated to some extent — she settled lawsuits with University Medical Center and the CBP to the tune of $1.1 million and $475,000, respectively — her story, and stories like hers, raise important questions about the ways in which hospitals should (or shouldn’t) work with law enforcement to perform invasive searches.
It’s understandable why hospitals and medical professionals are inclined to cooperate with law enforcement requests for invasive procedures and cavity searches — law-abiding citizens often don’t want to obstruct law enforcement agents from doing their jobs. But in the course of bringing suit against University Medical Center, Edgar Saldivar of the ACLU of Texas noted that the hospital and many of its personnel didn’t know where the obligation to assist the CBP stopped. Many medical professional don’t know that — according to the CBP’s own Personal Search Handbook — they are under absolutely no obligation to comply with requests by law enforcement to perform cavity searches with or without a warrant.
A special TWIHL episode with analysis of the new EEOC regulations under the ADA and GINA on Employer Wellness Plans. Nic is joined by Professor Wendy Mariner. Professor Mariner is the Edward R. Utley Professor of Health Law at Boston University School of Public Health, Professor of Law at Boston University School of Law, Professor at Boston University School of Medicine, and Co-Director of the J.D.-M.P.H. joint degree program, and a member of the faculty of the Center for Health Law, Ethics and Human Rights at BUSPH. Professor Mariner’s research focuses on laws governing health risks, including social and personal responsibility for risk creation, health insurance systems, implementation of the Affordable Care Act, ERISA, health information privacy, and population health policy.
Our discussion concentrated on the ADA regulation and examined how the agency responded to comments (including ours), the concept of voluntariness, the status of EEOC v. Flambeau, Inc., data protection (including issues raised when employers research the health of their employees), and the policy flaws in the wellness space.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 iTunes, listen at Stitcher Radio, Tunein and 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
Witnesses have a general immunity against private suits in connection with their testimony (Briscoe v. LaHue, 460 U.S. 325, 345-46 (1983)). Perjury prosecution is their only fear. For expert witnesses testifying about their opinions rather than empirical facts, perjury prosecution is not even a viable prospect. Doctors testifying as experts in malpractice suits filed against their professional peers, however, may face disciplinary proceedings in medical associations to which they affiliate. The consequences of those proceedings for doctors can be quite devastating. They include expulsion and loss of job opportunities. Moreover, a negative finding against a doctor can impeach her as an expert witness in a subsequent court proceeding, which will make lawyers reluctant to retain her as an expert in the first place.
Yet, the only protection that those doctors get from the law is basic due process. All they are entitled to as defendants before their professional disciplinary board is a notice about the complaints or charges and the right to be heard and present evidence. Worse yet, violation of this basic due process right does not entitle the doctor to void the negative disciplinary finding automatically.
The recent Fifth Circuit decision, Barrash v. American Ass’n of Neurological Surgeons, Inc., — F.3d —- (5th Cir. 2016), 2016 WL 374134, is a case in point. Continue reading →
Following the Supreme Court’s decision in NFIB v. Sebelius, states have had the option whether to expand Medicaid or not. As of this writing, 30 states and the District of Columbia have expanded Medicaid. Kentucky was the only Southern state that decided to expand Medicaid and run their own exchange. The decision brought great success. Under Democratic Governor Steve Beshear, Kentucky saw their uninsured population drop by 10.6% from 2013 to 2014. As Governor Beshear put it, Kentucky was the “poster-child for the implementation of the ACA.”
Last month, Kentucky elected Matt Bevin governor. Mr. Bevin, a Republican, had promised to dismantle Medicaid and the insurance exchange. When asked about Medicaid early in his campaign, Mr. Bevin responded, “No question about it. I would reverse that immediately.” Many feared that Mr. Bevin’s election put Medicaid in critical condition. But since his election, Mr. Bevin has shifted his position.
Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.
First, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Continue reading →
My last post presented the debate over force feeding hunger striking prisoners in Israel. This post will discuss another group subjected to the dramatic means of force feeding in extreme circumstances, Anorexia Nervosa patients (AN).
Although ethical justifications for force-feeding are similar for both Anorexics and Hunger strikers (save life), the legal framework is completely different in each context. Whereas hunger striking prisoners were dealt with via ad-hoc legislation meant to answer national security threats, AN patients are handled within the framework of mental health law. In the U.S., compulsory hospitalization of mental patients occurs through the state’s Civil Commitment Laws, which require dangerousness resulting from a mental illness to be evaluated by a psychiatrist.
Is the different legal attitude justified? How is it that the same act performed by prisoners is viewed as a political assertion but when done predominantly by adolescent middle-upper class girls, it is considered mental illness?
I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.
Tuesday, June 30, 2015 8:00 AM – 5:00 PM Wasserstein Hall, Milstein West A
Harvard Law School [Map]
Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain? Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.
In the course of my year-long project with Petrie-Flom, I am studying the potential impact of neuroimaging techniques on criminal law. During the course of my research, I found a story of an individual whose case presents difficult questions for our conceptions of criminal guilt and responsibility.  While this may be a bit longer than a normal entry, I want to share this story with you.
In 2000, a 40 year-old man, “Mr. Oft”, found himself developing an increasing, and nearly uncontrollable, interest in child pornography. Mr. Oft began collecting pornographic material, while making efforts to conceal his behavior from his family, and from those who knew him. Collecting pornography gave way to soliciting prostitution at “massage parlors,” and while Mr. Oft at first made careful attempts to conceal his actions, his aberrant behavior continued, and soon Mr. Oft was obsessively collecting and downloading child pornography, both at work and at home. Before long, Mr. Oft began making subtle sexual advances toward his prepubescent stepdaughter. After several weeks, his stepdaughter informed his wife of this behavior, leading to the discovery of his newly collected child pornography.
After his wife reported him, Oft was found guilty of child molestation and was ordered to either undergo inpatient rehabilitation in a 12-step program for sexual addiction or go to jail. Despite Oft’s strong and clear desire to avoid prison, he found himself unable to resist soliciting sexual favors from staff and other clients at the rehabilitation center. The center expelled him, and Mr. Oft prepared to go to jail. However, the night before his sentence was to begin, Oft was admitted to the University of Virginia Hospital emergency department complaining of severe headaches. In the course of his neurological examination, Oft made numerous sexual advances towards the hospital staff, and appeared totally unconcerned after urinating on himself. This behavior, combined with his seemingly unsteady gait, caused doctors to undertake a full neurological evaluation, eventually ordering an MRI scan of his brain.
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 →
By: Allison M. Whelan, Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law, Guest Blogger
For many years now, there has been ongoing debate about childhood vaccinations and the recent measles outbreak in Disneyland and its subsequent spread to other states has brought vaccinations and questions about communicable diseases back to the headlines. Politicians, including potential presidential candidates such as Hilary Clinton, Rand Paul, and Chris Christie, are also wading back into the debate.
Most recently, five babies who attend a suburban Chicago daycare center were diagnosed with the measles. As a result, anyone in contact with these infants who has not received the MMR (measles, mumps, rubella) vaccine must remain home, essentially quarantined, for the next twenty-one days—the incubation period for measles. All five of these infants were under the age of one and therefore did not yet have the chance to receive the vaccination, which is not administered until one year of age.
The Chicago outbreak is a prime example of why public health officials emphasize the reliance on herd immunity to protect those who are not yet, or cannot be, vaccinated for legitimate reasons. Unfortunately, the United States has reached a period where it can no longer place much reliance on herd immunity, particularly as more parents decide not to vaccinate their children against very contagious, yet highly preventable diseases. Illness and death are two of life’s certainties, but why should they be given that they are preventable in this situation? What are the strongest, most rational arguments in this debate? What policy solutions should states consider? Several options have been proposed over the years, some more feasible and likely than others. Continue reading →
Should pediatricians be able to refuse to treat children who are not vaccinated for measles? This issue was raised by Carey Goldberg [here], in which she describes the basic considerations needed to answer this question. Briefly, she reports that several national studies indicate that some pediatricians do discontinue caring for non-vaccinated children, but there is wide variation in this practice. Considering whether pediatricians should be permitted to refuse patients based on vaccination decisions raises a host of questions: Would refusal constitute patient abandonment? Do a clinician’s obligations to this patient outweigh his or her obligations to protect other patients? Does refusing to treat a patient constitute discrimination? Does the refusal infringe on parental authority?
A physician’s decision to refuse patients based on vaccination decisions depends largely on the vaccination under consideration. For example, the MMR carries different risks and benefits (including public health benefits) than the HPV vaccine. The MMR vaccine raises unique public health and individual health concerns, given that measles is highly infectious, the low risk and high efficacy of the vaccine, and the potentially tragic outcomes of the disease (which are wide-ranging, and include pneumonia, encephalitis, death and others complications [here]). Continue reading →
A new piece in Forbes on suing parents who don’t vaccinate, by Dan Diamond:
I heard it over dinner at a friend’s house. I talked about it on a call with a scientist. I discussed it while waiting for public health officials to issue an update on the measles outbreak.
The same murmured question, the same growing fear.
What happens if a child dies because some parents decided not to vaccinate their own kid?
What happens if it’s my child?
Thankfully, it’s still a hypothetical. But there’s reason to worry: More than 100 people in six states are now sick with the measles, in an outbreak that can be traced directly back to Disneyland. Dozens of newborns have been put into isolation.
In announcing the federal government’s approval of Indiana’s Medicaid expansion, Governor Mike Pence invoked common sense in defending his insistence that beneficiaries shoulder a share of their health care premiums. According to Pence, “It’s just common sense that when people take greater ownership of their health care, they make better choices.”
But relying on common sense is not a good way to make health policy. Common sense leads people to incorrectly believe that they are more likely to catch a cold by going out in cold weather or to take megadoses of vitamins that provide no additional health benefit and can be toxic. Common sense also leads physicians down the wrong path. Because lowering blood sugar has been good for the health of diabetics, medical experts recommended tight control of blood sugar levels. But that resulted in an increased risk of death for many patients. Continue reading →