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.
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.
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.” 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. Continue reading
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. Continue reading
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.
Explore the maps and download the data at LawAtlas.org.
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.
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: Continue reading
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.
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. Continue reading
Last week, Senator Edward Markey (D-MA) placed a hold on the Senate’s nomination of Robert Califf’s as head of the Food and Drug Administration (FDA). The move was less against Califf and more as political leverage against FDA’s approval of OxyContin. In August 2015, FDA approved OxyContin, a prescription painkiller, for pediatric patients ages 11 to 17. OxyContin is the painkiller most associated with United State’s prescription drug abuse epidemic, accounting for an increase in drug overdose and death over the last decade. FDA’s approval of OxyContin for children drew concern from Markey and others that the approval would lead to an increase in drug misuse for children and their family members. Markey, who has prioritized the fight against opioid addiction in his legislative agenda, hopes he can use the hold to convince FDA to reverse its August decision.
Senator Markey’s message is well intentioned, but may ultimately do more harm than good for children.
Before FDA approved OxyContin in August, children who suffered from severe, chronic pain due to cancer, extensive trauma, or serious surgeries had few drugs approved to treat their pain. Many physicians treating severe pain in children prescribed OxyContin off-label, without proof that OxyContin could safely and effectively treat children. These physicians often relied on their experience or intuition to not under or overprescribe the drug. FDA’s approval in August meant the pharmaceutical manufacturer finally provided physicians with instructions, backed by controlled studies, explaining how physicians could safely use OxyContin to treat children with severe pain. Continue reading
By: Claire E. Wakefield, Lucy V. Hanlon, Katherine M. Tucker, Andrea F. Patenaude, Christina Signorelli, Jordana K. McLoone and Richard J. Cohn
Genetics research often pushes the boundaries of science, and by the far-reaching nature of genetic information, pushes us out of our comfort zones to consider new psychosocial, ethical, and legal scenarios. Conducting genetic testing on children arguably pushes our boundaries most. Yet, there can be medical benefits for some children, who may then be offered tailored medical care to match their risks. Children can also be indirectly affected by genetic testing, when they learn genetic information about themselves because a family member has had a genetic test. Continue reading
Ashley is young woman who was born in 1997 with a severe mental and physical disability that prevented her from ever eating, walking or talking by herself. Her mental capacity was also not expected to develop further than that of an infant. In 2004, When she was six and a half years old, Ashley‘s parents and the Seattle Children’s hospital physicians who had been treating her sought to perform on Ashley a novel medical intervention that would include hormonal treatment for growth attenuation, surgical removal of her breast buds, and a hysterectomy. This surgical intervention was presented as beneficial to Ashley by allowing her parents to take care of her longer and postpone institutionalization. The removal of breast buds and hysterectomy were meant to spare Ashley the pain and discomfort of menstruation and the development of fully-developed breasts, and also to “avoid sexualization” in order to make her less vulnerable to sexual abuse when she was ultimately institutionalized. Continue reading
A few weeks ago I ran across this BuzzFeed post, telling the story of Corey Mason, a 14 year old male to female Trans teenager who was filmed getting her first pack of estrogen hormones. Her mom Erica, who uploaded the video to Facebook and YouTube, spurred a social-media discussion on the topic of hormonal treatment for Trans children and youth.
Erica said the vast majority of reactions were very supportive. On the other hand, different views and opinions were put on the table as well, even from people who ally completely with Trans identity politics. One of them, a Trans woman, said she fears from rushing (perhaps gay) teenagers into irreversible treatments, as most Trans kids “GROW OUT OF IT”. This position was also taken by Alice Dreger, a Bioethicist and a historian writing on Intersex issues, in describing the uneasy choice between the two models available at the moment: On the one hand you have the ‘therapeutic model’ offering mental health support to the Trans person and/or family, to help ease up the tensions caused by gender identity dysphoria (GID). This model aims to relax the dysphoria and so avoids any medical irreversible interventions. On the other hand, you have the ‘accommodation model’ asserting there’s nothing wrong with the trans person and/or his/her family, and so offers medical interventions to accommodate it.
UPDATE: Plaintiffs have filed an appeal in the U.S. Court of Appeals for the Eleventh Circuit. Their brief is due on October 19.
The district court has granted summary judgment (opinion pdf) for all remaining defendants as to all of plaintiffs’ remaining claims in Looney v. Moore, the lawsuit arising out of the controversial SUPPORT trial, which I last discussed here. This therefore ends the lawsuit, pending possible appeal by the plaintiffs.
Plaintiff infants include two who were randomized to the low oxygen group and survived, but suffer from “neurological issues,” and one who was randomized to the high oxygen group who developed ROP, but not permanent vision loss. In their Fifth Amended Complaint (pdf), plaintiffs alleged negligence, lack of informed consent, breach of fiduciary duty, and product liability claims against, variously, individual IRB members, the P.I., and the pulse oximeter manufacturer. What unites all of these claims is the burden on plaintiffs to show (among other things) that their injuries were caused by their participation in the trial. Continue reading
By Emily Largent
In 2013, M.C. (a minor child), by and through his adoptive parents, filed a complaint in federal district court against the physicians who recommended and performed M.C.’s sex assignment surgery and the South Carolina Department of Social Services (SCDSS) officials who authorized it. This was the first lawsuit of its kind filed on behalf an intersex child who was given sex assignment surgery while too young to give informed consent.
By way of background, M.C. was born with ovotesticular difference/disorder of sexual development (DSD). Ovotesticular DSD is a condition in which an infant is born with the internal reproductive organs of both sexes; the external genitalia are usually ambiguous but can range from normal female to normal male. Shortly after birth, M.C.’s biological parents expressed their desire to relinquish their parental rights, and M.C. was placed in the custody of SCDSS. A team of physicians subsequently evaluated M.C’s condition and recommended to SCDSS officials that M.C. undergo sex assignment surgery in order to make his body appear female. SCDSS consented to the surgery, which was performed in April 2006.
M.C. was adopted in December 2006. Initially, his adoptive parents raised M.C. as a female in accordance with his assigned gender. M.C., however, refused to be identified as a girl. His adoptive mother has described being “really sad that that decision [regarding surgery] had been made for him. . . . And it’s becoming more and more difficult just as his identity has become more clearly male.” M.C. is now living as a boy with the support of his family, friends, school, and others.
By: Christine Baugh
Youth sports participation comes with a variety of health and social benefits. The position statement put out by the American Medical Society for Sports Medicine (AMSSM) indicates that over 27 million individuals age 8-17 participate in team sports in the United States, and over 60 million participate in some form of organized athletic activity. These youth and adolescent athletes benefit from better overall health as well as increased socialization and self-esteem. However, a recent report by the Aspen Institute’s Project Play Initiative indicates that there has been a significant decline in sports participation in recent years.
One factor influencing the decrease in participation may be parental concerns. A recent survey of parents conducted jointly by ESPNw and the Aspen Institute characterized these concerns finding a large percentage of parents were worried about the risk of injury, behavior of coaches, cost, time commitment, and the emphasis on winning over having fun. Concussions and head injuries were the most worrisome injury for parents in this study. Despite this concern, very few parents reported keeping their child from participating in sports due to this risk. The AMSSM position statement characterizes the preoccupation with specialization and competition within sports at such a young age as a risk factor for injury and burnout. Continue reading
By: Christine Baugh
In the past several weeks there have been two studies with important implications for youth and adolescent concussions. They are summarized briefly in this post.
Post-Concussion Rest. Thomas and colleagues recently published a study in the journal Pediatrics examining whether standard of care (1-2 days rest) or 5 days of strict rest (both physical and cognitive) following concussion led to better short-term health outcomes in a population of 11-22 year old patients. The full text of this manuscript is available here. Expert consensus recommends strict rest –of relatively undefined duration — followed by a gradual return to cognitive and then physical activity. The study’s authors hypothesized that increased rest would improve outcomes, but found that the strict rest group did not have measurable health improvements compared to standard of care. In fact, symptom reporting was modestly higher in the strict rest group. Main study limitations include: small sample size and short follow-up period (which does not allow for insight as to longer term implications). This was the first randomized control trial of rest duration following concussion diagnosis in a youth and adolescent cohort, and the study added critical information to an important area of inquiry. Continue reading
By Allison M. Whelan (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
(co-written by Susannah Rose and Jalayne Arias)
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
Mississippi, dead last in the nation’s overall health rankings in 2012, 2013, and 2014, leads the nation in childhood vaccination rates, and hasn’t had a measles outbreak in more than two decades.
How did this happen?
Mississippi’s state childhood immunization law does not offer exemptions for religious or personal beliefs, and its medical exemptions may only be issued by pediatricians, family physicians, or internists.
Why doesn’t Mississippi have a religious or a personal belief exemption?
First, states are not obligated to offer one, Continue reading