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 →
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.
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 →
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, Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law, 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 →
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?
Allison M. Whelan, J.D. Senior Fellow, Center for Bioethics and Global Health Policy, University of California, Irvine Guest Blogger
On December 18, 2014, President Obama signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act includes new timeliness and tracking measures to ensure newborn babies with deadly yet treatable disorders are diagnosed quickly. These changes responded to a Milwaukee Journal Sentinel investigation that found thousands of hospitals delayed sending babies’ blood samples to state labs. A primary purpose of newborn screening is to detect disorders quickly, so any delays increase the risk of illness, disability, and even death.
Although a major reason for the Act’s amendments is to address these problematic delays, another important addition to the Act establishes a parental consent requirement before residual newborn blood spots (NBS) are used in federally-funded research. The Act directs the Department of Health and Human Services (HHS) to update the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to recognize federally-funded research on NBS as “human subjects” research. It also eliminates the ability of an institutional review board to waive informed consent requirements for NBS research.
Between 2009 and 2014 all U.S. States and the District of Columbia implemented concussion legislation. Generally modeled after Washington State’s Zachery Lystedt Law, most of these statutes require that youth and adolescent athletes are provided with information about concussions prior to sports participation, that they are removed from play if they are suspected of having sustained a concussion, and that they receive clearance from a medical professional prior to returning to sports participation. One of the main purposes of the Zachery Lystedt Law, and presumably those laws modeled after it, is to prevent the catastrophic neurological injury that can occur when a youth athlete returns to play too quickly following a concussion.
Gibson and colleagues recently published their study “Analyzing the effect of state legislation on health care utilization for children with concussion,” in JAMA Pediatrics. This study compared concussion care utilization for adolescents age 12 to 18 in states with and without concussion legislation using an insurance claims database. After controlling for potentially confounding factors such as median income and number of insured individuals per state, Gibson et al. found that states that had implemented concussion legislation had increased concussion care utilization (92% increase) compared to those without legislation (75% increase). The increases in care utilization were driven primarily by increases in visits to the doctor’s office and to a neurologist, not through increases in emergency department care, which the authors described as encouraging.
With the emergence of new techniques in the field of reproductive technology, applications arise that seem more the realm of science fiction than reality. While many have considered stem cells to be the next frontier of modern medicine, reproductive technology may offer hope to many individuals suffering with rare and unique genetic diseases.
The term “savior siblings” refers to the use of pre-implantation genetic diagnosis (PGD) and other forms of in-vitro fertilization (IVF) in order to create a sibling for the purpose of providing biological material (bone marrow, blood, etc.) that can help treat or cure an existing terminally ill child. It is estimated that up to one percent of PGD in the United States is used to create children that are tissue matches for their siblings. See here.
There has been little meaningful discussion about savior siblings in bioethical or legal circles, and there is no formal regulation governing their use or creation in the United States. This stands in stark contrast to other countries, particularly England, France, and Australia, where a regulatory framework for the use of savior siblings has arisen along with debate over their acceptability. These countries are already discussing how to ethically deal with this extremely complicated issue. Continue reading →
As we enter into the fall sports season, it’s unlikely that a week will go by where we don’t hear the current buzzword in sports community: concussion. Whether in reference to an acute player injury, an untimely death, new or ongoing litigation, or rule changes in sport, the athletic community and the public are increasingly aware of the impacts of these brain injuries. Although much of the media attention is directed toward college and professional athletes, youth and high school athletes significantly outnumber their older counterparts and it is thought that they take longer to recover from these injuries.
A recent publication by Mannings and colleagues surveyed 369 parents of 5-15 year old full-contact football players in order to assess the parents’ understanding of concussion (1). Although the study does have limitations, its finding could have important implications. The parents surveyed were often missing critical information about concussions. For example, less than half of parents correctly identified that concussion is a mild traumatic brain injury. Additionally, none of the parents surveyed correctly identified all of the symptoms of concussion queried in the study. Although it is mandated by statute in the majority of states (2) that parents and/or athletes are provided with information about concussions prior to sports participation, the extent to which the information provided (normally in the form of an information sheet) is read, understood, or retained is not well understood.
Sports participation is associated with a myriad of positive physical, psychological, and social outcomes. However, it also comes with the risk of injury, including concussion. For youth and adolescents, parents play a critical role. Most often, children and adolescents rely on parental consent to participate in sports. Given parents’ role as decision-makers, and the finding of Mannings and colleagues, an important ethical issue that needs to be addressed is what level of knowledge should be required for parents to provide informed consent for their child to participate in inherently risky activities such as contact sports?
[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.]
Clinical Ethicist Boston Children’s Hospital Boston, MA
The Office of Ethics at Boston Children’s Hospital has an immediate opening for a clinical ethicist. Applications are being accepted online, at www.childrenshospital.jobs. To locate the position on the website, enter “32902BR” in the box labeled “AutoReqID.”
Boston Children’s Hospital is a 395-licensed-bed children’s hospital in the Longwood Medical and Academic Area of Boston, Massachusetts. At 300 Longwood Avenue, Children’s is adjacent to its teaching affiliate, Harvard Medical School.
Job description: Clinical Ethicist 32902BR
The Clinical Ethicist provides formal and informal ethics consultations. Organizes and participates in clinical ethics rounds, and collaborates with clinical teams, patients and families, to address ethical issues in pediatric health care and research. Develops ethics resources and education and serves as a facilitator for change directed toward strengthening the Hospital staff’s sense of moral responsibility and moral community.
Art Caplan has coauthored a new opinion piece in the journal Pediatrics on the controversy over the case of Sarah Murnaghan, in which a federal judge ordered the Secretary of Health to place a pediatric patient on the adult transplant list to increase her chances of receiving a donor organ. From the piece:
Lung transplantation is a potentially life-saving procedure for patients with irreversible lung failure. Five-year survival rates after lung transplantation are >50% for children and young adults. But there are not enough lungs to save everyone who could benefit. In 2005, the United Network for Organ Sharing developed a scoring system to prioritize patients for transplantation. That system considered transplant urgency as well as time on the waiting list and the likelihood that the patient would benefit from the transplant. At the time, there were so few pediatric lung transplants that the data that were used to develop the Lung Allocation Score were inadequate to analyze and prioritize children, so they were left out of the Lung Allocation Score system. In 2013, the family of a 10-year-old challenged this system, claiming that it was unjust to children. In the article, we asked experts in health policy, bioethics, and transplantation to discuss the issues in the Murnaghan case.
Art Caplan has coauthored a new piece in JAMA on problems with Belgium’s new law allowing terminally-ill children and their families to choose euthanasia. From the article:
The Belgian pediatric euthanasia law seeks to respect the moral status of children as agents who possess the nascent capacity for self-determination. Specifically, the law requires the medical team to demonstrate a patient has the “capacity for discernment,” indicating that he or she understands the consequences of a choice for euthanasia.
What the law does not consider, however, is that adults choose euthanasia for reasons that go beyond pain. For adults, the decision to end their life can be based upon the fear of a loss of control, not wanting to burden others, or the desire not to spend their final days of life fully sedated. These desires might be supported by the experience they have had witnessing a loved one express a loss of dignity or because they understand what terminal sedation is and wish to refuse it. Children, however, lack the intellectual capacity to develop a sophisticated preference against palliative interventions of last resort. Instead, in the case of the new Belgian law, children seem to be asked to choose between unbearable suffering on the one hand and death on the other.
This possibility causes the Belgian euthanasia law to fall short of the standard required for valid assent. The criterion related to the “capacity for discernment” runs the risk of ignoring the fact that children and adolescents lack the experiential knowledge and sense of self that adults often invoke—rightly or wrongly—at the end of their lives.
The news about the return of dangerous “childhood” illnesses gets worse and worse. Columbus, Ohio reports an outbreak of 225 cases—with over 50% students at Ohio State University. It is probably no coincidence that Ohio State recommends but does not require students(outside of those in healthcare settings) be vaccinated in order to attend class. It’s not just Mumps. We are seeing cases of preventable diseases like measlesand mumps and whooping coughbecause of parental decisions not to immunize their children but there is increasing evidence that the immunizations most adults received as infants or young children wear off—leaving the population at large vulnerable to infection once an outbreak occurs. Science Daily just reported a confirmed case of a fully vaccinated young woman contracting measles. The CDC has not yet recommended that adults get booster shots for Mumps and Measles—although they have in some circumstances for Whooping Cough and Polio. But the more likely it is for a person to be exposed to these diseases, the more important it is to be fully vaccinated.
Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission. Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative. The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.
This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director. Bring your questions!
This event is free and open to the public. Lunch will be served.