Season Nine, Episode 12 of Shark Tank features a Harvard Business School graduate and entrepreneur pitching her product, EverlyWell. Based on her own experience spending thousands of dollars on countless lab tests that failed to diagnose her fatigue, aches and brain fog, she proposed a direct-to-consumer (DTC) lab testing company. DTC testing allows patients to directly purchase medical testing materials and send them for analysis and interpretation via mail. Her pitch was well-received, and she was rewarded with a one-million-dollar investment from the show’s sharks. Most popular among EverlyWell’s products is its food sensitivity test, which is an assay for IgG antibodies against ninety-six foods for the price of $199.
EverlyWell’s direct-to-consumer lab testing idea is not a novel one, but one that is certainly rising in popularity, as evidenced by the preponderance of similar at-home testing kits. This sort of do-it-yourself (DIY) medicine is particularly appealing to those who wish to take their health into their own hands and remove costly, time-consuming physicians from the equation. Crucial, however, is the fact that these companies are independently run and thus are not regulated by any governing scientific body. As such, they are free to make claims about health and disease without the requirement of an evidence-based foundation, a situation that is fodder for pseudoscience.
Food sensitivity tests are an exemplar in this regard. The theory behind such testing is that food sensitivity (defined as a non-anaphylactic adverse reaction to food) is immune-mediated, effected via the development of IgG antibodies against food antigens. Superficially, this hypothesis sounds scientifically plausible. In reality, however, the literature does not support this reasoning. As elegantly stated in the Journal of Allergy and Clinical Immunology, “…the production of IgG antibodies to foods is a normal immunologic phenomenon. IgG antibodies to foods are found in virtually all healthy individuals. In fact, contrary to the notion that the development of IgG or IgG4 antibodies could lead to food intolerance, the development of such antibodies has specifically been linked to the development of food desensitization or tolerance.” This is pseudomedicine: the practice of drawing from hypothetically plausible yet disproven scientific principles to make unsubstantiated claims about health.
A recent article in Vice argues that food sensitivity testing, in light of its unscientific basis, creates “traps for disordered eating.” Most alarmingly, the author confronted EverlyWell about the lack of science supporting IgG testing, to which EverlyWell replied, “We believe there is a divergence of views regarding IgG tests. We recognize that the [American Academy of Allergy, Asthma, and Immunology] does not support any form of food sensitivity testing (which is not just limited to IgG testing), but they are not the entire ‘medical community,’ and AAAAI does not speak for all health care providers.” This retort exemplifies another tactic employed by pseudoscience purveyors: invoking controversy in the literature, even when none exists, and accusing mainstream medicine of not understanding the research.
Imagine the absurdity of this statement in the context of another topic that is well-studied and accepted within the scientific community. Consider blood pressure control: We believe there is a divergence of views regarding blood pressure. We recognize that the American College of Cardiology advocates for patients to keep their blood pressure under 120/80, but they are not the entire ‘medical community,’ and do not speak for all health care providers. To the medically literate, such proclamations discarding and undermining evidence-based expert opinion are comically unscientific.
I had my own recent experience with DIY medicine that left a similar impression. Due in part to my professional interest in the gut microbiome and in part to my personal interest in teasing out science from pseudoscience, I purchased a kit from BIOHM, a company that offers direct-to-consumer stool microbiome culturing for $220. As part of BIOHM’s product, I received a phone consultation with a nutritionist to receive personalized dietary advice based on the results of my cultures. Despite the limitation that different companies utilize different methods leading to different results, I thoroughly enjoyed reading through my “gut report” and seeing the varying concentrations of bacteria and fungi cohabiting my body. It provided a window into a world that I couldn’t see but had always been curious about; I imagine this is how non-medical folks feel about directly accessing medical information. And I equally enjoyed the phone consultation with the nutritionist, whom I found knowledgeable and educated in evidence-based practice.
I was profoundly surprised and disappointed, however, when two days later I received a written report with further recommendations from the nutritionist. I was recommended breathing exercises to “reset and calm the vagus nerve,” a flagrant misrepresentation and oversimplification of neurologic physiology. The nutritionist also suggested that I add “adaptogens to support stress response” despite there being no convincing high-quality human research that such substances (e.g., ashwagandha) regulate hormonal physiology. Finally, the last line of the report stated, “You may want to work with your holistic practitioner to determine if small intestinal bacterial overgrowth (SIBO) is an issue.” In addition to the gratuity of this suggestion — I had not endorsed any abdominal complaints — I was struck by the advice to consult my “holistic practitioner.”
Clearly, the wording here was intentional, targeting a population doubtful of science and doctors. And indeed, SIBO, while certainly a real condition, is a favorite scapegoat of pseudoscience practitioners for abdominal complaints despite an inconsistent relationship between SIBO and gastrointestinal symptoms. Thus, instead of advising me to speak with my physician about abdominal complaints that could represent irritable bowel syndrome, inflammatory bowel disease, celiac disease, or anything else on the differential diagnosis, I was counseled to seek my “holistic practitioner.” It became clear to me that, while DIY medicine has enormous potential to reduce health care costs and provide easier and more affordable care to patients, it is unregulated and often marketed toward the consumer who is skeptical of conventional medicine and who seeks an illusion of control over their own health care.
Thanks to the rapid development of scientific technology, Big Data has infiltrated health care; epiphenomenal to this development is the creation of DIY medicine. Consequently, it has provided patients and physicians with an overabundance of information that outpaces our understanding of that very information. What are we to do with a patient who brings in their gut report, their entire DNA sequence, their IgG levels to almost one hundred different foods, their vitamin metabolite levels, and a year’s worth of heart rhythm tracing from an Apple Watch? In this unprecedented age of ever-expanding health-related data accessibility, it is more important than ever for physicians and health systems to engage in and encourage high-quality research to understand the deluge of information that is constantly being uncovered (such as the NIH Human Microbiome Project).
It is equally important for physicians and health care providers to continue the indefatigable fight against pseudoscience. DIY medicine is in its prime and will only continue to expand. Patients, however, will not concurrently grow more familiar with the literature on IgG antibodies to foods or the relevance or non-relevance of a certain DNA mutation. Physicians have the chance to shape the future of DIY medicine in its nascent state, grounding it on a firm foundation of evidence and crafting it for maximal patient benefit. It is in the interest of both science and our patients not only to speak out loudly and firmly against pseudoscience and its hydra-headed manifestations, but also to educate our patients, equipping them with tools to help separate fact from the vast sea of fiction.
And, for patients, the age-old TV drug ad advice continues to provide the most important counsel of all: “Talk to your doctor…”