State Concussion Legislation: Variable Implementation

By Christine Baugh

The most recent issue of the Journal of Law Medicine and Ethics (generously made available for free by the American Society of Law Medicine and Ethics) included several articles examining state concussion laws. One theme that arose across the articles is that although concussion-related legislation is on the books in all 50 states and the District of Columbia, the extent to which it is creating an improvement in youth and adolescent athlete health outcomes is unclear.

In their article titled “State experiences implementing youth sports concussion laws: challenges, successes, and lessons for evaluating impact” Kerri McGowan Lowrey and Stephanie Morain interviewed stakeholders (e.g., officials at state departments of public health, state athletic associations) at a majority of states with concussion laws in order to understand how the laws had been implemented. Although previous research in the area (see, for example: Hosea Harvey’s piece in the American Journal of Public Health) presented concussion legislation as relatively homogenous, McGowan Lowrey and Morain’s approach provided critical insight. They found that while the state laws are relatively uniform in their construction, there is substantial variation in their implementation. In particular, McGowan Lowrey and Morain reported variation in compliance with the statutes, variation in how much stakeholders were included during formative stages in the legislation’s composition, and variation in what constituted concussion education.

In another article in the issue, my colleagues Emily Kroshus, Alexandra Bourlas, Kaitlyn Perry, and I specifically examined the concussion education and acknowledgement provisions of state concussion laws. This investigation was conducted in two parts: first we examined what the statute mandated and then we examined what the high school athletic association and/or department of education in that state actually provided for education. Similar to McGowan Lowrey and Morain, we found that implementation did not always match statute. In some promising cases the education provided exceeded the information minimally required by statute. In other situations, the concussion information was provided in such a way that it was required to be returned with a parent signature. In cases like this, compliance with one part of the statute (mandating acknowledgement of receipt of information) may have been compromising another (providing concussion education). Although the education and acknowledgement tenets were relatively similar across states, more heterogeneity was found in the implementation of these aspects of the statutes.

In general, these two studies suggest that the approach for examining statute, and particularly its efficacy, needs to be designed to address implementation stage information. Strict examination of the statutory language obscures critical implementation-level differences. These concussion-related statutes, enacted now in every state, are ostensibly supposed to reduce risk and improve athlete health outcomes. The extent to which they are reliably accomplishing this goal is unclear. What is clear is that implementation of the laws, and enforcement in cases where schools do not abide by statute, are necessary precursors to consistent efficacy. Although it is important that all states have taken steps toward protecting the health and safety of youth and adolescent athletes, approving a statute is not the final step toward this aim. Further research is needed to understand what health effects the current laws are having and critically where improvements can be made in this important area of public health law.

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

De-Prioritizing Treatment for Mental Illness May be Due to Flaws in Reasoning

By Kelsey Berry

In a recent article in Science Translational Medicine, former NIMH Director Steve Hyman explores possible reasons for the policy failure to prioritize treatment of mental disorders worldwide, even when evidence and cost-effective interventions are available and validated.

Hyman notes a number of potential factors, loosely falling into four categories.

  1. Stigmatization challenges;
    • Fear of the severely mentally ill
    • Superstitions about the causes of mental illness
    • Attribution of imagined moral flaws or weaknesses to sufferers or their families
    • Belief that mental health professionals are in the profession because they are similarly troubled
  2. Scientific challenges;
    • Relatively slow scientific progress and translation of discoveries into clinically useful diagnostics and therapeutics
  3. Advocacy challenges;
    • Diminished ability of the mentally ill to advocate effectively for themselves
    • Low commercial advocacy due to difficultly in discovering marketable treatments
  4. Flaws in reasoning;
    • A tendency to focus on saving lives versus improving them – a problem that puts most non-lethal disabilities at a disadvantage in priority setting
    • A tendency to distinguish mental disorders from other “biologically based” disorders that we do not control, due to the subjective experience of one’s own (healthy) mind

Though none of the categories above are without normative dimensions, the last category raises two clear points worth mentioning just now.  Read More

Averting Mental Health and Fiscal Crises: Crisis Intervention Teams and Access to Meaningful Treatment for Mental Illness

[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Tara Adams Ragone. This post was cross-posted at Health Reform Watch.]

By Tara Adams Ragone

Social media recently focused my attention on two very different law enforcement interactions with people with mental illness that reinforce the need for increased training of law enforcement in crisis intervention as well as the need for improved access to treatment for people with mental illness.

The first is a video of the fatal police shooting of Kajieme Powell in St. Louis, Missouri earlier this month.  Mr. Powell was twenty-five years old and suspected of shoplifting junk food from a convenience store.  The first eighty seconds of the video show Mr. Powell pacing and muttering on the sidewalk — with four pedestrians passing by without incident — before the police arrive.  The police then exited their vehicles with their guns drawn, shouted at Mr. Powell to drop his weapon, and fired about twelve shots fewer than twenty seconds after they arrived on the scene.

The second is an NPR story that included an audio recording of law enforcement officials in San Antonio, Texas responding to a 911 call about a twenty-four year old group home resident named Mason, who was off of his medications, had set his blanket on fire, and was a danger to himself and others.  When they arrived at the scene, the officers acknowledged that they did not use the “tough guy command voice” that they typically would in responding to a 911 call reporting suspected criminal activity.  Instead, in plain clothes and without their weapons drawn, they spoke calmly with Mason, reassuring him that they wanted to get him help.  They astutely noticed signs suggesting that Mason was experiencing tactile, auditory, and visual hallucinations, and with patience and skilled questioning, got him to acknowledge the hallucinations and seek psychiatric treatment.

The San Antonio officers were members of a six-person mental health squad that the city created to confront severe prison overcrowding. Read More

Serious Risks from New Prescription Drugs

by Donald W. Light

Based on https://www.ethics.harvard.edu/lab/blog/436-new-prescription-drugs-a-major-health-risk

Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.

Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.

Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?

However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.

In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.

Read More

How an IRB Could Have Legitimately Approved the Facebook Experiment—and Why that May Be a Good Thing

Image courtest Flickr
Image courtesy Flickr

By Michelle Meyer

By now, most of you have probably heard—perhaps via your Facebook feed itself—that for one week in January of 2012, Facebook altered the algorithms it uses to determine which status updates appeared in the News Feed of 689,003 randomly-selected users (about 1 of every 2500 Facebook users). The results of this study—conducted by Adam Kramer of Facebook, Jamie Guillory of the University of California, San Francisco, and Jeffrey Hancock of Cornell—were just published in the Proceedings of the National Academy of Sciences (PNAS).

Although some have defended the study, most have criticized it as unethical, primarily because the closest that these 689,003 users came to giving voluntary, informed consent to participate was when they—and the rest of us—created a Facebook account and thereby agreed to Facebook’s Data Use Policy, which in its current iteration warns users that Facebook “may use the information we receive about you . . . for internal operations, including troubleshooting, data analysis, testing, research and service improvement.”

Some of the discussion has reflected quite a bit of misunderstanding about the applicability of federal research regulations and IRB review to various kinds of actors, about when informed consent is and isn’t required under those regulations, and about what the study itself entailed. In this post, after going over the details of the study, I explain (more or less in order):

  • How the federal regulations define “human subjects research” (HSR)
  • Why HSR conducted and funded solely by an entity like Facebook is not subject to the federal regulations
  • Why HSR conducted by academics at some institutions (like Cornell and UCSF) may be subject to IRB review, even when that research is not federally funded
  • Why involvement in the Facebook study by two academics nevertheless probably did not trigger Cornell’s and UCSF’s requirements of IRB review
  • Why an IRB—had one reviewed the study—might plausibly have approved the study with reduced (though not waived) informed consent requirements
  • And why we should think twice before holding academics to a higher standard than corporations

Read More

An Autism Diagnosis: Still the Key to Unlocking Needed Services?

By Kate Greenwood

Cross-Posted at Health Reform Watch

In a recent, very moving, post about her son’s diagnosis with autism at age eight, blogger Amy Storch writes: “I guess I should mention the obvious — district services for Autism are much more comprehensive than ADHD.” An autism diagnosis should not, as a matter of law, be the key that unlocks needed special education services. Both autism and ADHD “count” as disabilities under the Individuals with Disabilities Education Act (the relevant regulation is here), and the Act provides that a child with either diagnosis who needs special education services is entitled to an educational program “designed to meet their unique needs.” As a matter of fact, though, an autism diagnosis may mean—as it apparently does in Storch’s school district—a more comprehensive program. An autism diagnosis can also be the key to getting necessary services outside of the school setting, through private health insurance.

According to the advocacy group Autism Speaks, 37 states plus the District of Columbia and the United States Virgin Islands have enacted laws requiring state-regulated private health insurance plans to pay for applied behavior analysis and other therapies children with autism often need. As I blogged about previously here, some of these state insurance mandates are relatively broad—New Jersey’s law requires private insurers to cover applied behavior analysis for children with autism, but also to cover occupational, physical, and speech therapy for individuals with “autism or another developmental disability.” Other states’ mandates, however, are strictly limited to children on the autism spectrum. Daniela Caruso of Boston University School of Law writes about Florida’s decision to limit its insurance mandate to children with autism here, attributing it at least in part to advocates’ success persuading legislators to view autism through a “dual frame of beauty and invasion.”

The Patient Protection and Affordable Care Act’s requirement that individual and small group health insurance plans cover ten essential health benefits, and in particular its requirement that plans cover “rehabilitative and habilitative services and devices,” promised to ease access to applied behavior analysis and other therapies often needed by children by autism. Habilitative care is left undefined in the statute, but it is defined at HealthCare.gov as “[h]ealth care services that help you keep, learn, or improve skills and functioning for daily living,” for example “therapy for a child who isn’t walking or talking at the expected age.”

There is a wrinkle, however. Read More

“Isn’t Incarceration Better than Death?”

Katherine L. Record, JD, MPH, MA

Shortly after criticizing Massachusetts for incarcerating innocent individuals with substance use disorder (SUD) when drug rehab facilities are full, I received an email from a woman who lost her son to a heroin overdose just four months ago.

“Is preventing an overdose by detaining the SUD sufferer not a better alternative than leaving them to languish?” she asked.

She had found her 24 year-old son cold and blue, just hours after kissing him goodnight. He had been evicted from his sober living home for testing positive for drugs, but his mother did not know he had relapsed when he arrived at her front door. He was, in hindsight, a clear danger to himself – so why did his step-down house let him wander away? Why didn’t anyone call the authorities? Is jail not better than death?

Read More

A Drug Epidemic’s Silver Lining

By Katherine L. Record

Can there be a silver lining to a drug epidemic that is so extreme it is deemed a public health emergency? As prescription opioid (painkiller) addictions drive individuals to heroin, there just might be.

Heroin use has surged recently – seizures of supply increased by nearly 70% over the last few years in New York (the epicenter for imports into the United States). In Boston, overdoses increased by nearly 80% between 2010 and 2012. This has followed a rising trend in prescription opioid addictions – 4 out of 5 users are addicted to prescription painkillers when they first try heroin. Turning to the street opioid is often a move of desperation; prescription opioids are now harder to abuse, more expensive, and harder to obtain than heroin. In other words, heroin provides a cheaper, easier to score, and stronger high.

This surge in use is changing the face of heroin; the Office of National Drug Control Policy’s director recently described the drug as a former “inner city problem” that has become classless, affecting “all populations and all ages.” To be blunt, white people – many with high paying jobs and fancy apartments – are now doing 8 to 10 bags a day.

Read More

The U.S. Supreme Court vs. The American Psychological Association

By Dov Fox

The U.S. Supreme Court has not in recent years held the views of the American Psychological Association (APA) in so high regard as it did this week.

In 2012, the Court set aside the APA’s arguments for why due process requires the exclusion of eyewitness testimony obtained under suggestive circumstances that rendered it especially likely to be unreliable.

And in 2011, when the Court struck down on free speech grounds a state regulation on violent video games, it gave short shrift to the APA’s warnings about those games’ connection to violent behavior in young boys.

But in its recent death penalty decision, Florida v. Hall, the Court relied heavily on important APA insights in declaring it unconstitutional for states to set an IQ cutoff to determine whether a prisoner is eligible to receive capital punishment. Read More

Technology and The Horrors of Child Pornography

By Michele Goodwin

A recent spate of arrests in New York emphasizes the potentially dangerous connection between technology and sex crimes.  In a landmark police bust, authorities tracked down and arrested more than seventy people in the New York City area who were trading child pornography.  Among those arrested were a rabbi, police chief, nurse, architect, and nanny.  Police infiltrated chat rooms where traffickers made available images of children engaged in sex acts with each other and adults.

What is the role of technology in the arrests and distribution of these images?  While technology helped officers track down child pornography traffickers, the internet also facilitated the trading of those harmful, illegal images of children.  On line chat rooms and other social network spaces provide for the broad-spread, easy distribution of child pornography.

Importantly, the children whose images are trafficked are re-victimized each time their images are shared, bought, and sold.  The frequency at which this can occur is intensified over electronic media, opening a horrific floodgate as demonstrated in the New York arrests where thousands of obscene, pornographic images of children were collected from dozens of confiscated laptops. Clearly, solutions to this problem must necessarily emphasize examining technology’s  unwelcome dark side.