Hot Topics: Pediatrics
Children are not small adults. This is a phrase we say in pediatrics on a regular basis. The reason for such an absurd comment is that we are constantly faced with medical decisions that force us to rely on adult data to inform our practice. Pediatric patients face unique diseases and metabolize medications differently from adults. Their ability to recover from injury is often superior to their adult counterparts and thus the Quality Adjusted Life Years can be substantially different. I argue that we have an ethical imperative to conduct pediatric research because 1. research brings forth generalizable knowledge for the good of the pediatric population and 2. because research guides clinical practice and the physician has a duty to provide the best possible care to the patient.
Research in human subjects is justifiable if it satisfies the following conditions: 1. A goal of valuable knowledge, 2. A reasonable prospect that the research will generate the knowledge that is sought, 3. The necessity of using human subjects, 4. Favorable balance of potential benefits over risk of the subjects, 5. Fair selection of subjects and 6. Measures to protect privacy and confidentiality. This list does not suggest any condition that could not be applied to pediatric research subjects as they all promote fairness, beneficence and non-maleficence. Typically, we do not consider clinical research as something that provides significant benefit to the individual subject. Generally, a clinical trial is initiated with equipoise on the efficacy for if not met with equipoise, there would be no need for the study as the outcome would already be known. Thus, if a clinical trial were to test the efficacy of a given medication, the human subject could benefit from being in the trial if the medication works OR could suffer from side effects and receive no benefit from participation. So, although there is potential for individual benefit after participating in the study, the main purpose is to benefit future patients and add to the general knowledge of the topic. A utilitarian approach would look at the potential consequences of pediatric research and determine it to be right or wrong based upon the balance of good or bad. Pediatric research must go through the same pathways as adult research with all human subjects’ trials needing to have a careful justification that the benefits outweigh the risks. Utilitarian theory is focused on value and thus the best action is the one who promotes the most good for all involved. This is precisely the goal of research. Research is conducted to affect change and improve care across a larger population. Through clinical practice, a physician may help hundreds to thousands of patients over the course of a career. However, through research, that same physician could affect the lives of thousands to millions of patients over the course of her life and far beyond. Therefore, in a carefully planned and executed pediatric clinical trial where the potential benefits outweigh the risks, the outcomes could be exponentially beneficial to the pediatric population, thus supported by a Utilitarian approach.
The physician takes an oath to promote the patient’s best interest and to avoid harm. Currently, the majority of treatments we provide to pediatric patients are not evidenced based because no clinical trials have been conducted to test that hypothesis. Therefore, each day we care for pediatric patients without evidence of treatment safety nor effectiveness, we are potentially causing harm. Pediatric researchers support a Kantian theory where morality is judged by their motives. Thus, if a researcher wants to conduct a clinical trial only for the fame from discovering the essential element and not because of a desire to promote good, this would not be a moral-worthy endeavor. Therefore, if we examine the physician’s obligation to her pediatric patient, a duty-based ethical theory would tell us to treat each of them with the best possible practice available. Research guides our clinical practice and help to ensure that we are minimizing harms and maximizing benefits. If we support a Kantian approach, in order to satisfy our obligations, we must utilize the available data to make the best possible decisions, and thus, the available data must come from clinical trials on pediatric patients to ensure scientific rigor.
One objection to pediatric research is that these patients are considered a vulnerable population, incapable of independent informed consent and at risk of exploitation. Due to this fear, special protections have been placed on pediatric research leaving an even more limited pool of subjects in which to study. This is justified by some stating that we should proceed with caution and only permit research when the potential for benefit is extremely likely. However, if the criteria are too narrowed, we risk excluding potential participants from research and unjustly diffusing the risks to a non-uniform population. Rights Theorists would protect the pediatric patient against oppression, unequal treatment, etc. Therefore, upholding the decision to conduct pediatric research allows for the rights of all patients to be upheld and for providers to contribute to the overall body of science, thus practice safer and more effective medicine to the benefit of all patients. When we practice medicine on children without data, we are unnecessarily exposing them to the same risks we fear and are doing so without the oversight and protection imbedded in clinical trials.
In conclusion, I support that pediatric research is both essential and ethical as it 1. generates a generalizable body of knowledge to the benefit of the pediatric patient of the future and 2. clinical practice is best guided by empirical data conducted through research. Clinical ethics outlines our responsibilities as physicians to our patients including veracity, privacy, confidentiality, and fidelity while upholding our role as a clinician. In contrast, research ethics contributes to the greater good by promoting generalizable knowledge for all future patients.Full Article
by Craig Klugman, Ph.D.
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Examining Physician Interactions with Disease Advocacy Organizations
Reweighing the Ethical Tradeoffs in the Involuntary Hospitalization of Suicidal Patients
Exploring the Role of Shared Decision Making in the Consent Process for Pediatric Genomics Research in Cameroon, Tanzania, and Ghana
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Transgender Children and the Right to Transition: Medical Ethics When Parents Mean Well but Cause Harm
Just Policy? An Ethical Analysis of Early Intervention Policy Guidance
When Parents Refuse: Resolving Entrenched Disagreements Between Parents and Clinicians in Situations of Uncertainty and Complexity
The Harm Principle Cannot Replace the Best Interest Standard: Problems With Using the Harm Principle for Medical Decision Making for Children
Best Interest, Harm, God’s Will, Parental Discretion, or Utility
Would you be willing to zap your child's brain? Public perspectives on parental responsibilities and the ethics of enhancing children with transcranial direct current stimulation
All children will be able to receive whole genome sequencing at birth, under ambitions laid out by the Health Secretary.
Matt Hancock said that in future, the tests would be routinely offered, alongside standard checks on newborns, in order to map out the risk of genetic diseases, and offer “predictive, personalised” care.Full Article
A critical chemotherapy medication is in short supply, and physicians say there is no appropriate substitute.Full Article
State officials stripped Stuart Copperman of his medical license almost 20 years ago. Armed with a new law, his former patients hope to file civil lawsuits.Full Article
A new smart phone app takes advantage of parents’ fondness for snapping pictures of their children to look for signs that a child might be developing a serious eye disease.Full Article
The American Academy of Pediatrics issued new guidelines on Monday that uphold the central role of medication, accompanied by behavioral therapy, in ADHD treatment.
However, some parents, doctors and researchers who study kids with ADHD say they are disappointed that the new guidelines don’t recommend behavioral treatment first for more children, as some recent research has suggested might lead to better outcomes.Full Article
Normally, parents make decisions about their children’s health care. But when it comes to the prevention of sexually transmitted diseases and cancer, kids should have the right to protect themselves. That is why Senate Bill 3899A, which would allow teenagers, in consultation with their physicians, to receive vaccines against HPV (human papilloma virus), ought to become the law in New York.Full Article
Every year, the state of Illinois struggles to find a place for hundreds of children with serious mental-health issues—holding them in psychiatric hospitals for sometimes weeks or months even after they’re cleared for discharge.
Ever since scientists created the powerful gene-editing technique CRISPR, they have braced for the day when it would be used to produce a genetically altered human being. Now, the moment they feared may have come. What’s likely to happen next?Full Article
The children granted wishes were substantially less likely to visit the emergency department or to have an unplanned hospital admission within two years as compared with children who hadn’t received wishes. (Researchers matched the children’s personal and disease characteristics in the study.)
“My hypothesis is that these kids, when they come back, are more engaged with their families and medical providers, and perhaps they’re more adherent to their treatment plan,” says the study’s lead author Dr. Anup D. Patel, section chief of neurology at Nationwide Children’s Hospital and an associate professor of pediatrics at Ohio State University College of Medicine in Columbus.Full Article
Nearly 70,000 children end up in emergency rooms every year after experiencing adverse reactions to antibiotic drugs, according to an analysis by the Centers for Disease Control and Prevention (CDC) published in August in the Journal of the Pediatric Infectious Diseases Society.
About 74 million antibiotic prescriptions are doled out to kids each year, the study notes, and past research has indicated that at least one-third of these pediatric antibiotic prescriptions are unnecessary.