Recently, a nursing mother in Pennsylvania made national headlines when her infant died from ingesting a combination of fatal drugs through breastmilk. According to the coroner’s report, the infant died from a combination of methadone, methamphetamine, and amphetamine toxicity. The Bucks County District Attorney charged the mother, Samantha Jones, who also has a two-year old child, with criminal homicide. According to published reports, Jones was undergoing Medication Assisted Treatment (MAT) and receiving doses of methadone to treat her addiction to opioid painkillers.
Multiple commentators swiftly voiced opposition to the District Attorney, decrying the criminal charges against Jones, arguing it is “highly problematic” to levy criminal charges against a person undergoing treatment for Substance Use Disorder.
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.
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.
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.” 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.”
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
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
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.
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.
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.
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
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.