baby held in mother's hands in lap

US Legislators Take a Scattered Approach to Neonatal Abstinence Syndrome

 By J. Alexander Short

Pennsylvania is the latest state to enact legislation in reaction to the growing impact the opioid epidemic has on infants. Governor Tom Wolf signed H.B. 1232 in June, effectively requiring hospital officials to notify child protective services when children are born affected by the mother’s substance abuse or affected by withdrawal symptoms as a result of prenatal drug exposure.

Such outcomes generally fall within the parameters of neonatal abstinence syndrome (“NAS”), a group of health problems that occur in newborns who were exposed to drugs while in the mother’s womb.  This legislation brings Pennsylvania into full compliance with the 2003 Federal Child Abuse Prevention and Treatment Act.

This legislative response makes sense.

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The Health Imperative: Reunite Migrant Children with their Parents

By Gali Katznelson

Japanese family awaits evacuation 1942
A Japanese family awaits an evacuation bus to an internment camp in 1942. Children who spent time in the camps have high incidence of trauma and health problems, studies have shown. Photo via US National Archives.

Former first lady Laura Bush published an op-ed in the Washington Post where she reminded us that today’s mass detention centers for children whose parents are accused of illegally crossing the border is a public health crisis — one we have seen before.

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a pile of vaccine vials and a needle

Long Overdue: Check Out the Vaccine Resources Library for Expert Witnesses

By Dorit Reiss, Stanley A. Plotkin, Paul A. Offit

A new tactic has emerged in a few recent family law vaccination cases: using arguments created by the anti-vaccine movement.

Lack of familiarity with anti-vaccine claims can trip up even the most qualified expert. But a new resource library at the Vaccine Education Center at the Children’s Hospital of Philadelphia aims to combat anti-vaccine rhetoric and by giving experts the information they need to respond.

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The Notable Absence of Regulating Cannabis in FDA Commissioner Scott Gottlieb’s Keynote Address to FDLI 2018

by Tara Sklar

At the Food and Drug Law Institute (FDLI) 2018 Annual Conference, the Commissioner of Food and Drugs, Scott Gottlieb, gave the Keynote Address to kick-off the largest turnout yet for this event of over 900 attendees. Commissioner Gottlieb’s remarks started off with how previous FDA Commissioners used this opportunity to recap the past year, but he would be different, he would lay out the strategic priorities for next year.

The room went nearly silent, as Commissioner Gottlieb steadily went through the many sectors the agency oversees, and where he believes the FDA will play a larger leadership role, including in the epidemics of addition (opioid crisis), drug costs, and greater access to generic competition. He laid out a vision that most people in the room would probably subscribe to, including “You’re public health minded, and work hard to deliver innovations that’ll advance human health. The problem is that a few bad apples, that game the system, can tarnish the entire brand of an otherwise principled industry.”[1] Close to the end of his thirty-minute speech, Commissioner Gottlieb firmly addressed the companies that produce e-cigarettes, and said, “If you target kids, then we’re going to target you.”[2]

Indeed, Commissioner Gottlieb mentioned so many FDA strategic priorities, and in such unequivocal detail for how they plan to regulate, that when the President & CEO of the FDLI, Amy Comstock Rick, thanked him and introduced the follow-up panel to discuss the issues Commissioner Gottlieb raised, she said, “We reserved one-hour in the conference to discuss Commissioner Gottlieb’s Keynote Address, but we may need five.” However, there was an area that was not brought up in Commissioner Gottlieb’s wide-ranging speech, despite its very active place in the media and scientific journals calling for the FDA to have a greater role, and more consistent guidance, and this prominent area is the future regulation of cannabis. Read More

States Tackle Youth Sports Concussions – New Data!

By Benjamin Hartung, JD, Joshua Waimberg, JD, and Nicolas Wilhelm, JD

While brain injuries and studies associated with professional football get the majority of media attention, student athletes, especially young football and soccer players, are also at risk for similar brain injuries. Each year, as many as 300,000 young people suffer from traumatic brain injuries (TBIs), more commonly known as concussions, from playing sports.

State governments have responded to the problem of brain injuries in youth sports by adopting laws aimed at reducing the harm that comes from injuries that occur during team practices or events. Delaware was the first state to pass a regulation relating to youth TBIs in 2008, with Washington State following shortly after in 2009. In the years since, all states have passed youth TBI laws, many modeled after the Washington law, that mandate when student athletes are to be removed from the field, how parents should be notified in the event of a concussion, what training is required of athletic coaches, when a student athlete may “return-to-play,” and who may allow this return to the field. Read More

New data: Baby-Friendly Hospital Laws

The Baby-Friendly Hospital Initiative (BFHI) is a global initiative of UNICEF and the World Health Organization aimed at promoting hospital policies that encourage and support breastfeeding. Baby-Friendly USA, the organization primarily responsibile for implementing BFHI in the United States, has outlined 10 evidence-based practices that hospitals can implement to support breastfeeding — called the 10 Steps to Successful Breastfeeding. These include written breastfeeding policies, staff training, rooming-in, and educating mothers about the benefits and management of breastfeeding.

Several states have enacted statutes or regulations encouraging or requiring hospitals to adopt one or more of these “baby-friendly practices.”

The newest map on LawAtlas.org, which was created and is maintained by ChangeLab Solutions, identifies key features of state laws and regulations regarding recommendations or requirements for hospitals related to any of the 10 Steps to Successful Breastfeeding. It also includes state laws recommending or requiring certain hospital discharge practices related to breastfeeding.

In 15 of the 18 states with laws laws or regulations that encourage and support breastfeeding initiation and continuation, hospitals must follow one or more baby-friendly practices
In 15 of the 18 states with laws laws or regulations that encourage and support breastfeeding initiation and continuation, hospitals must follow one or more baby-friendly practices.

As of October 1, 2016, 18 states had enacted laws or regulations that encourage and support breastfeeding initiation and continuation. In 15 of these states, hospitals must follow one or more baby-friendly practices.

Explore the maps and download the data at LawAtlas.org.

‘Concussion’ distorts the scope of traumatic brain injury

By Brad Segal 

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.

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Patient Safety and Clinical Risk in Neonatal Care

By John Tingle                                     

The CQC (The Care Quality Commission)  is the independent regulator of health and adult social care in England. They make sure that health and social care services provided to people are safe, effective, compassionate, high-quality care and they encourage care services to improve. The  CQC inspects health facilities and they have important statutory regulatory powers and sanctions.They have recently produced a report on neonatal care and  on  providing care for infants in the community who need respiratory support. As well as some positive findings, the report does reveal a number of major patient safety risks and failings.

In England, one in every nine babies is born needing care from neonatal services and  this is on the increase. The care process here can be challenging with sick babies with complex health needs receiving hospital care and then care at home and in the community. The care of the baby traverses’ distinct pathways or care areas and sometimes problems can occur:

A lack of consistency in care and communication across a pathway can result in poor outcomes for both babies and parents.” (p.3)

The report looks at current practice in three different aspects of care: Read More

Prior Authorization Policies for Pediatric ADHD Medication Prescriptions

According to the Centers for Disease Control and Prevention, more than 6.4 million US children 4-17 years old have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). The percentage of US children diagnosed with ADHD has increased by 3-5 percent per year since the 1990s. Relatedly, the percentage of children in this age group taking ADHD medication also has increased by about 7 percent per year from 2007-2008 to 2011-2012.

In response, some state Medicaid programs have implemented policies to manage the use of ADHD medications and guide physicians toward best practices for ADHD treatment in children. These policies include prescription medication prior authorization requirements that restrict approvals to patients above a certain age, or require additional provider involvement before approval for payment is granted.

In a new article published this afternoon in MMWR, CDC researchers compared Medicaid and employer-sponsored insurance (ESI) claims for “psychological services” (the procedure code category that includes behavior therapy) and ADHD medication among children aged 2–5 years receiving clinical care for ADHD.

The article references a newly released LawAtlas map that examines features of state Medicaid prior authorization policies that pertain to pediatric ADHD medication treatment, including applicable ages, medication types, and criteria for approval.

States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.
States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.

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Humanizing Pain: Advocacy, Policy and Law on Abortion, Execution and Juvenile Life Without Parole

By Robert Kinscherff

I recently attended a presentation on Fetal Pain: An Update on the Science and Legal Implications, jointly sponsored by the Center for Law, Brain and Behavior (Massachusetts General Hospital) and the Petrie-Flom Center (Harvard Law School).  Presenters were Amanda Pustilnik, JD (University of Maryland School of Law) and Maureen Strafford, MD (Tufts University School of Medicine). Video of the event is available on the website, and I encourage everyone to watch the full discussion for themselves.

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. Read More