On March 8th, Dr. Stacy Kahn from the University of Chicago spoke regarding the ethics of Fecal Microbiota Transplant (FMT) in pediatric patients during a three-part lecture series hosted by the University of Minnesota Consortium of Law and Values.
Kahn opens up her case study
Assume you are a physician. You have a 13-year-old female patient with ulcerative colitis. There is discomfort and blood streaks in the stool, signs of early ulcerative colitis. The patient's mother put her on a dairy and gluten-free diet along with various vitamins and natural supplements to aid in easing the condition.
Mom wants to do an at home FMT and is convinced, based on videos and books, that she can treat her child. After much deliberation about the risks the mother says, “Thanks doctor, but I’m going to do FMT anyway.”
As a physician, what do you do? Do you call child protection services? Do you give information about FMT and stool banks despite the treatment not being FDA approved and still in clinical trials with not enough data to support or invalidate its efficacy? Do you let the parent go on with the decision? These are all ethical questions around FMT and the field of pediatrics.
What is FMT?
FMT stands for Fecal Microbiota Transfer where bacteria from the gut in the form of feces is transplanted into a patient to recolonize the damaged tissue. FMT is often performed via colonoscopy, nasal tube, or orally in a pill. The process is currently a treatment for GI conditions like irritable bowel disease, ulcerative colitis, and Crohn's Disease. FMT also has the potential to treat other diseases associated with non-GI microflora including: psoriasis, acne, asthma, diabetes, and obesity. Despite the recent media attention, FMT is not new. The first FMT in the states was conducted in the 1950s for a disease similar to recurrent ulcerative colitis, although there are historical accounts dating back to 4th Century Chinese “dragon soup”. FMT is FDA allowed but not approved and lacks many of the typical clinical and animal studies. There are also concerns about intellectual property, regulations, and safe practices among other things.
FMT and pediatrics
Now it’s important to consider the ethical pillars of medicine:
Beneficence: duty to do good.
Non-Maleficence: duty to not do bad/cause harm.
Autonomy: respect for patient's individual rights and self determination.
Justice: to treat all equally and equitably.
But when it comes children the pillars don’t quite fit. Children don’t have autonomy; they have a legal guardian or parent to advocate and speak on their behalf. Doctors need consent from a guardian and assent, approval, and understanding of the procedure from the patient.
Also children’s metabolism of drugs and foods are different due to differences in blood volume, hormone secretion, and activity levels. So dosing matters. The problem is that most drugs being studied and two-thirds of drugs sold on the market don’t use clinical studies involving children or have never been tested for children. We don’t know the efficacy of the drugs prescribed nor the safe and effective dosage, which is very concerning for both parents and physicians.
Perceptions and concerns of the treatment
But the concerns are not felt in the same way across the parties involved. Patients are frustrated with the slow rate of drug development, physicians, and pain. The constant effort for effective treatments is exhausting. Patients are desperate for any type of relief. FMT, in the patient’s perspective, is believed to be natural and therefore safer than western medicine practices and pharmaceuticals. The books and articles out on the market give patients a false sense of security by restoring autonomy over their own health. There is a general lack of data regarding the efficacy of the treatment and a risk that at home treatments will worsen the condition.
Doctors, on the other hand, are concerned about the ethics and efficacy of the treatment. There’s no data to support the benefits or assess the risks, making it difficult to prescribe despite patient requests. Being able to reconcile all these concerns starts with open conversation about FMT and the concerns.
More research needs to be conducted about FMT and its effects. International Review Boards and local research institutions need to coordinate with larger research institutions to effectively disseminate information and document findings. This keeps physicians up-to-date with treatment research to better serve their patients.
But most importantly, patients need to be involved in the conversation. The risk of adversarial conversations is likely to inspire patients to go rogue with high risk and poorly informed self treatment.