Earlier this evening, the House of Representatives released the most recent draft of the 21st Century Cures Act. This is the fifth time I’ve blogged about the Act (prior posts here, here, here, and here), which has ballooned from a 200-page discussion draft in April 2015 to a 996-page draft version today. (The House has a 44-page summary here for those with more limited time.) To be fair, the Act now contains a whole set of provisions around mental health, substance abuse, and child and family services which were not originally part of the Act. The 21st Century Cures Act is the biggest Christmas tree bill I’ve ever had occasion to read.
There will be an enormous amount of commentary on different parts of the bill, so here are some quick thoughts on the new draft, focusing not only on the provisions which are likely to attract the most attention, but also on a few quieter provisions that are nonetheless worthy of scrutiny.
Some controversial provisions have been eliminated entirely or softened greatly. One of the most controversial provisions in the last draft of the bill would’ve “farm[ed] out the certification of safety of modified devices to third parties, circumventing the FDA altogether.” That provision seems to be absent from the new draft. The last draft, in creating a program for breakthrough review of medical devices, controversially called for the use of “shorter or smaller clinical trials” for those devices. The new draft asks the Secretary only to ensure that the design of such clinical trials is “as efficient and flexible as practicable, when scientifically appropriate” (section 3051).
Other controversial provisions remain, sometimes under new names. One of the most troubling provisions in the previous draft of the bill would’ve created a program for the use of “clinical experience” evidence in drug approvals. Rather than relying on the gold standard of randomized clinical trials, this provision “would[‘ve] require the Secretary to establish a draft framework for implementing” such evidence. The new draft keeps this provision but changes the term “clinical experience” to “real world evidence” (section 3022). To be sure, this provision gives enormous discretion to the Secretary to limit (and maybe even reject) the use of such evidence. But in light of recent high-profile clinical trial failures, most notably just two days ago, we ought to be concerned about claims that the FDA is too slow and imposes too stringent requirements on drug approvals.
This past week week I attended the International Neuroethics Society’s (INS) annual conference in San Diego, California. Neuroethics is multidisciplinary field that grapples with the implications of neuroscience for—and from—medicine, law, philosophy, and the social sciences. One of the many excellent panels brought together scholars from each of these four disciplines to discuss the diverse approaches to the field. The panel featured; Paul Appelbaum, a Professor of Psychiatry at Columbia University; Tom Buller, Chair of philosophy at Illinois State University; Jennifer Chandler, Professor of law at the University of Ottawa, and; Ilina Singh, Professor of Neuroscience & Society at the University of Oxford.
The panel started by considering the importance of the “competing identities” present in the field of neuroethics. As moderator Eric Racine explained, right from the start, even the term ‘neuroethics’ suggests a tension. Consider the variety of research methodologies employed in the field. For instance, a scholar trained in philosophy might approach neuroscience from a conceptual and purely analytical basis, and yet a social scientist might research the same question by collecting empirical interview data. The interplay between empirical and theoretical work was a theme that defined the discussion.
A psychiatrist by training, Dr. Applebaum spoke on the medical approach to the field. He argued that a focus on ethical issues in clinical psychiatry and neurology should be viewed as a part (but only a part) of neuroethics. Furthermore, medicine’s empirical approach to neuroethics is one (but not the only) way to advance thinking on neuroethical issues. Continue reading →
As we approach the 2016 presidential election and change of administration, there are many questions about the future of health policy that the 45th President and Congress will have to address starting in 2017. This event brings together health care experts from both sides of the aisle to discuss what health care will – and should – look like under the next administration.
Suicide is one of today’s most pressing public health issues. It’s the second most common cause of death for those ages 15-34, and claims over 40,000 lives every year. Of those, a staggering 20,000 are the result of firearms. To put that in perspective, there are about 30,000 gun deaths overall in the United States each year, which means that self-inflicted fatalities make up over 60% of total domestic gun deaths. Of the most prevalent means of attempting suicide, firearms are by far the most lethal. Firearm suicide attempts end in death more than85% of the time, whereas attempts by drug overdose — the most common method — are only fatal 3% of the time.
While suicides by firearm have been on the rise in recent years, there may be an easy way to substantially reduce their incidence. A new study out of the University of Alabama Birmingham by Vars, et al., suggests that allowing individuals at risk of suicide to put themselves on a voluntary “Do-Not-Sell’ list, which would result in a waiting period before they could acquire a firearm, could be effective in preventing suicide attempts. The researchers surveyed 200 patients at both in- and out-patient psychiatric facilities who had disorders associated with anxiety and depression, and found that nearly half of them would put themselves on a list which would preclude them from quickly accessing firearms in the event that they were contemplating suicide. This is particularly notable given that these were all Alabama residents — a state that ranks in the top 10 of Guns and Ammo’s list of the best states for gun owners. In other states with more robust gun control and fewer gun enthusiasts, the Do-Not-Sell rate could very well be higher.
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.
In 2012, there were estimated to be 356,268 inmates with severe mental illness in prisons and jails. There were also approximately 35,000 patients with severe mental illness in state psychiatric hospitals. Thus, the number of mentally ill persons in prisons and jails was 10 times the number remaining in state hospitals.
In 44 of the 50 states and the District of Columbia, a prison or jail in that state holds more individuals with serious mental illness than the largest remaining state psychiatric hospital. For example, in Ohio, 10 state prisons and two county jails each hold more mentally ill inmates than does the largest remaining state hospital.
Similarly widely reported and acknowledged is that prisons often either cannot or simply do not serve the mental health treatment needs of those housed within their walls. As Ana Swanson of The Washington Postobserved:
Unsurprisingly, many prisons are poorly equipped to properly deal with mental illness. Inmates with mental illnesses are more likely than other to be held in solitary confinement, and many are raped, commit suicide, or hurt themselves.
Madisyn Moore, handcuffed at school and left for an hour unattended. Her mother is now suing.
Co-authored with Eliana Grossman.
By all accounts the U.S. drug war has failed: more drugs are sold on black markets, streets, and in alleys than before, trillions of dollars have been spent, and millions of non-violent offenders are now locked away. Some men and women will be incarcerated for the rest of their lives for non-violent drug crimes.
However, in wake of the drug war and robust mass incarceration, the pattern of policing has trickled down to children. The “school to prison pipeline” is more than a euphemism. It describes zero tolerance policies, subjective discipline, suspensions, and expulsions. Most disturbingly, it describes a process that starts for some kids as young as five and six years old.
In our recent Huffington Post article, we describe how Madisyn Moore, a six year old, African American, was handcuffed behind a dark stairwell for more than an hour by a school guard who mistakenly believed the little girl stole a piece of candy. In defending his actions, the guard claimed, “‘I’m teaching her a f — -g lesson. She took a piece of candy and I handcuffed her under the stairs.’” It turns out the Madisyn’s mother packed the treat for her daughter. The guard was later fired, but the trauma Madisyn experienced will likely last for a long time. Continue reading →
There is no denying that the United States is experiencing an opioid overdose epidemic. Drug overdose deaths generally in the United States have been associated, at least in part, with increasing mortality rates among white non-Hispanics, which is counter to trends in other wealthy nations. The Urban Institute’s Laudan Aron recently posted about the underlying causes of our current epidemic, paying special attention to aggressive marketing of painkillers, the related spike in opioid prescriptions, and the closely correlated increase in opioid abuse. The issue has even made it into the current Presidential campaign, however briefly. President Obama has sought increased funding to address the issue, as well as a focused private, state, and local effort to tackle prescription drug abuse. While opioid abuse has been on the rise, it is not typically part of employee drug testing, when employers choose or are required to test. This may be changing.
The Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency responsible for drug testing standards for federal agencies, is poised to release drug screening guidelines (see page 4 (28104 in the Federal Register) that would expand drug screening for opioid abuse to federal employees, and could influence employee drug testing policies across the nation. The US Department of Defense has been testing for hydrocodone and benzodiazepines (used to treat anxiety and seizures among other things) since May 1, 2012. SAMHSA cites sobering statistics about opioid-related deaths now outnumbering deaths from illicit drugs, as it prepares to test for oxycodone, oxymorphone, hydrocodone, and hydromorphone, all classified as Schedule II drugs, or drugs with high risk of abuse, by the United States Food and Drug Administration (FDA). The proposed guidelines were released May 15, 2015, so the final rules should be coming soon. Continue reading →
The Policy Surveillance Program recently updated its dataset analyzing state laws governing the short-term emergency commitment process. This dataset includes state laws that limit an individual’s right to possess a firearm following short-term emergency commitment. This aspect of the law captured by the dataset is particularly relevant given the unfortunate rise in mass shootings throughout the United States in recent years, with the latest shooting occurring in Kalamazoo, Michigan on February 21 (see also Deadliest U.S. mass shootings – 1984-2015 from the Los Angeles Times). These mass shooting tragedies have spurred debate and legislative action on gun control, to which issues of mental health have become inextricably intertwined despite research that indicates that mental illness is only a small factor in violence (see for example Mental health legislation complicated by gun control debate from The Washington Post; and Debate over gun control, mental health starts anew from CBS News). Additionally, on January 5, 2016, President Obama announced an executive action to battle gun violence, which includes a $500 million investment toward increasing access to mental health care.
With respect to the legal landscape, federal law restricts the sale of firearms to individuals who have been adjudicated as a “mental defective” or “committed to any mental institution.” Committed to a mental institution in this instance encompasses long-term involuntary commitments, but does not include those admitted for observation, i.e., short-term emergency commitment. Some states, however, have gone further and have enacted more extensive legislation that limits the right to possess a firearm for individuals who have been subject to short-term emergency commitment. With short-term emergency commitment, law enforcement officers and certain other individuals have the right to involuntarily admit individuals to a mental health care facility for a short period of time if they are displaying symptoms of a mental illness and pose a danger to themselves or others. Continue reading →
A less covered provision of Medicaid law that has been in existence since the establishment of the program in 1965 and has been making some news over the past several months, the IMD exclusion is a provision that restricts Medicaid payments for certain institutions, potentially reducing the access to available services for low-income individuals with mental illnesses.If you haven’t been hearing everyone talking about it… well, I guess you talk with fewer health policy nerds than I do.
What is the IMD exclusion?
According to the good people at the National Alliance on Mental Illness (NAMI), the IMD exclusion can be defined as: Institutions for Mental Disease (IMDs) are inpatient facilities of more than 16 beds whose patient roster is more than 51% people with severe mental illness. Federal Medicaid matching payments are prohibited for IMDs with a population between the ages of 22 and 64. IMDs for persons under age 22 or over age 64 are permitted, at state option, to draw federal Medicaid matching funds.
Why does Medicaid have this provision?
This is because when Medicaid first started, states were responsible for the care of people with severe mental illness. States cared for many people with mental illnesses in a custodial setting; essentially states often were providing people a place to sleep but no mental health services. When drafting the Medicaid bill, the federal government did not want to supplant this existing state program with federal Medicaid funding. Additionally, while President Johnson was notorious for not spending a large amount of time on the cost of Medicare, the addition of these services would add $1.8 billion to the Medicaid budget, nearly doubling the first year price tag.
Mass incarceration’s invisible casualties are women and children. Too often, they are the forgotten in a tragic American tale that distinguishes the United States from all peer nations. Simply put, the U.S. incarcerates more of its population than anywhere else in the world–and by staggering contrast. While the U.S. locks away over 700 men and women for every 100,000, here are comparable figures from our peer nations: England (153 in 100,000), France (96 in 100,000), Germany (85 in 100,000), Italy (111 in 100,000), and Spain (159, in 100,000). The U.S. accounts for less than 5% of the globes population, yet locks away nearly 25%. Sadly, this has grave social, medical, psychological, and economic consequences.
In a recent essay, published in the Texas Law Review, I explained that, the population of women in prison grew by 832% in the period between 1977-2007—nearly twice the rate as men during that same period. More conservative estimates suggest that the rate of incarceration of women grew by over 750% during the past three decades. This staggering increase now results in more than one million incarcerated in prison, jail, or tethered to the criminal justice system as a parolee or probationer in the U.S. The Bureau of Justice Statistics underscores the problem, explaining in a “Special Report” that “[s]ince 1991, the number of children with a mother in prison has more than doubled, up 131%,” while “[t]he number of children with a father in prison has grown [only] by 77%.” Continue reading →
Doctor Strafford delivered a masterful overview of the trajectory of scientific perspective and research about children and pain. Over the course of her career, the medical perspective has transformed from “children do not feel pain” to “children do not remember pain” to inquiry into “when and how children feel pain.” Strafford described the medical complexities of understanding the physical and subjective aspects of pain as well as the impossibility of confidently “pinpointing” the exact point in fetal development when a neonate experiences pain.
Professor Pustilnik gave an equally compelling review of law and legal language regarding abortion, particularly law that specifically references fetal pain as a reason for limiting abortion. This served to frame a conversation about pain and suffering in the law and the ways in which law reflects normative considerations and provides rhetoric (viewed respectively by partisans as “compelling” or “inflammatory”) to political discourse. In this case, discourse about fetal pain both attracts attention and is intended to facilitate empathy for the neonate. Continue reading →
This morning I saw an announcement about a new initiative called “Law Enforcement Leaders to Reduce Crime and Incarceration” and thought it was an important thing to share on this blog. This alliance consists of 120 top current/former police commissioners and prosecutors, including both district attorneys and state attorneys general. These law enforcement leaders have come together to influence legislation and public opinion around mass incarceration. Their first project: supporting the Sentencing Reform and Corrections Act of 2015, a bipartisan bill currently moving through the Senate. This issue matters because there are currently over 2.2 million people in American prisons and jails.
Why is criminal justice a health policy issue? Well, there are many reasons, but let’s start with the fact that the largest mental health provider in the United States is the Cook County Jail. This does not reflect well on our criminal justice policy or our health policy.
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?
In recent years, there have been a multitude of state- and federal-level discussions about how to use law to minimize gun violence as active shooter events increase. During these deliberations, one point that has repeatedly been debated is whether people with mental illness should have their gun possession rights limited.
A potential difficulty, but also an opportunity, relating to using neuroimaging evidence in legal cases arises from the difficulty brain researchers have in separating emotional and physical pain. We know that pain and emotion are tightly linked. In fact, “emotion” is in the very definition of pain. The IASP definition of pain is: “An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.” Yet, the legal system deals with “physical” versus “psychiatric” versus “emotional” pain in different ways.
Chronic pain is associated with anxiety, depression, and stress. These factors can exacerbate the pain, and pain can exacerbate them. Pain’s sensory and emotional components connect in a “feed-forward” cycle. It may not be possible to entirely separate the sensory and emotional components of pain, biologically or experientially. But it might be necessary for the purposes of legal cases, as important areas of law create sharp distinctions between physical and emotional, or body and mind.
This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).
Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Continue reading →
The entirely predictable media obsession with the tragedy of the Germanwings jetliner that crashed into the French Alps on March 25 is moving forward full force. The media, especially cable television, love airline disasters. Once German prosecutors revealed that Andreas Lubitz, the pilot at the controls of the Germanwings jetliner when it crashed, had a mental illness but had kept the diagnosis hidden from his employer, all media hell broke loose.
One of the key questions raised by the spectre of mental illness was whether the pilot’s doctors tried to establish Lubitz’s mental fitness to fly and if they were concerned should they have revealed their worries to his employer. Despite a whole lot of talking heads jawing on these points few had anything useful to say since almost none of the experts consulted seemed familiar with the accuracy of mental health screening, or with the nature of German requirements for health screenings for crews or mechanics, or with German privacy law. When the discussion shifted to what about America, things still stayed fuzzy. […]
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.
One of my previous blogs discussed how potentially discriminatory practices in insurance design may continue to dissuade people with high-cost conditions from enrolling in insurance plans, even in a post-ACA world. Last week, colleagues Haiden A. Huskamp, Howard H. Goldman, Colleen L. Barry and I published new findings in Psychiatric Services on the same issue, except with a focus on an area that has historically been subject to considerable regulation: mental health benefits.
The Affordable Care Act shows considerable promise for extending mental health benefits with federal parity protections to several million Americans, which has been a main aim of mental health policy advocates for decades. However, insurers may still have an incentive on health insurance exchanges to avoid enrolling individuals who use mental health services because their care is more costly than average. In the study, we examined benefits information available to consumers shopping on state health insurance exchanges to assess whether the new insurance offerings were living up to the promise of mental health parity laws. We found that some plans may still be offering people with mental illness insurance benefits that are less generous than benefits for other medical conditions.Specifically, one-quarter of the health plans being sold on health insurance exchanges set up in two states through the ACA offer benefits that appear to violate the federal parity law requiring equal benefits for general medical and mental health care. Such benefit designs may dissuade people with mental health and substance abuse treatment needs from enrolling in the plans, furthering concerns about adverse selection and suggesting that some discriminatory practices persist despite efforts to equalize insurance offerings for individuals with behavioral health conditions. Continue reading →