When pandemic lockdowns prevented access to traditional health care facilities, the demand for alternative and complementary health products skyrocketed. Do-it-yourself remedies went viral and biohacking, which is quantifying your biology in order to monitor and optimize your health, became more mainstream. Challenged public health communication fueled skepticism in science and medicine, compelling consumers to seek influencer-led health solutions to boost immunity, defy disease, and perhaps contest aging altogether.
This interest in “cutting-edge” wellness solutions that promise healing and health-enhancing benefits continues to burgeon. From people misunderstood by the medical system to those underwhelmed by the often perfunctory annual wellness check, increasingly savvy health consumers are self-assembling a personalized patchwork of products and services from the wellness industry. As such, the distinction between diagnostics, devices, and drugs used for optimizing wellness versus managing disease is blurring.
And regulators are rightly on high alert. In a show of force, in April the Federal Trade Commission issued a strong statement to 670 wellness companies demanding that health claims must be backed by “reliable scientific evidence.” In a further statement of support, three FTC commissioners wrote, “If a company claims that its product can cure, mitigate, or treat a serious disease such as cancer or heart disease, it must back up that claim through the accepted standards of scientific testing, including randomized control trials,” the gold standard of evidence.
As trained health experts — one of us is an internist with a clinical focus on cardiometabolic health, the other a Ph.D. in nutrition and exercise science — we do not condone unsubstantiated nostrums and strongly condemn misleading advertising.
But as longtime fitness instructors and health optimizers, we support the democratization, dissemination, and delivery of health solutions outside of traditional health care settings and applaud the growing consumer instinct to seek greater agency and ownership over one’s well-being. Time and again, we have seen how certain novel, off-label, and even “fringe” therapies enhance energy, mood, and clarity, for reasons that we do not yet scientifically understand. (Could it be the placebo effect in some cases? Perhaps — but an effect is an effect.)
The problem is that for many of these increasingly popular wellness solutions — peptide injections, cannabidiol and plant medicine, IV micronutrients, and psychedelics, to name a few — we face a so-called absence of evidence. The National Institutes of Health appropriates a paltry 1% of its annual budget to investigating complementary modalities, therapies, and tools. And many trendy therapies with some small-scale data cannot be patented and, hence, carry no financial incentive for large-scale, biopharma-sponsored clinical trials. An unfortunate risk of this persistent absence of evidence is the condemnation, overregulation, or altogether termination of various therapies that may not meet the onerous standards of evidence-based medicine but play a helpful role in a holistic care plan. Marijuana and related isolated cannabinoid use have therapeutic effects across several pathologies, for example, despite the arduous and federally regulated research process that limits robust clinical trials.
That said, self-experimentation and self-guided wellness plans are problematic, too. Most consumer-directed “n of 1” data lack objectivity and controlled conditions. Hence, purported outcomes are ripe for confirmation bias, which fuels over-eagerness that can propagate across social media and even garner enthusiastic investment based on anecdotal hype. The use of unsubstantiated medical claims incurs the understandable ire and, when necessary, legal action from regulators. Like when a high-profile influencer promises devoted wellness seekers that a vaginal jade egg would “balance hormones, regulate menstrual cycles, prevent uterine prolapse, and increase bladder control” or claims that her proprietary blend of essential oils could prevent depression.
These untested and unregulated wellness solutions invite not only safety risks and misappropriated protocols, but consumer exploitation for commercial gain masquerading as clinical benefit. As veterans in the wellness and fitness industries, we understand how dogmatic ideologies and extreme approaches present a potential harm to the individual. If we want to continue to benefit from effective wellness solutions and distinguish them from the litany of seductive gimmicks, snake oil, and fads, all stakeholders — consumers, regulators, academia, and industry — have a pivotal role to play.
The patrons who desire a more personalized and proactive health plan designed to fit their unique physiology, psychology, and preferences must shift their mindsets from consumers to citizen scientists. As a citizen scientist, you actively participate in the scientific research process by helping to prioritize the agendas of research institutions, recruit fellow participants into clinical trials, share de-identified data from a multitude of health monitoring devices and diagnostics, and most importantly, trust in the essential messiness of the scientific method. Biohacking thereby evolves into a collaborative process of collective knowledge creation in which evidence is shared by many but analyzed separately in a streamlined, rigorous, and objective manner. That way, we remain stakeholders in the outcomes while countering our innate urges to cherry-pick individual studies, expert opinions, or sensationalist headlines that reinforce our biased beliefs and experiences.
Academics, who focus on rigorous research and scientific publication, have pioneered longitudinal, prospective datasets across large populations to identify key signals in human health. The Framingham Heart Study and more recently the U.K. Biobank and the NIH All of Us program have determined critical chronic disease risks that have informed treatment guidelines and public health policies. But to date, these datasets have not included the growing segment of health and wellness consumers. Researchers could diversify their funding and accelerate their scientific productivity by partnering with forward-thinking and data-driven wellness startups and health tech companies to help establish, bolster, and analyze their datasets. And clinical trialists could experiment with ways to make research more accessible and engage more participants by leveraging virtual technology and decentralizing interventions away from academic centers, elite institutions, and urban centers.
Regulatory bodies that are primarily concerned with patient safety and risk mitigation must strike a careful balance between restrictive oversight to ensure quality standards while opening new avenues for innovation. The FDA could expand its Pre-Cert program, which explored an adaptive approach to regulatory oversight, from digital health software to other popular therapeutics and wellness products by partnering with reputable and high-quality companies — manufacturers, compounding pharmacies, and clinics — that are committed to building the clinical evidence base and monitoring real-world performance of their offerings in the market. Supplement companies that voluntarily provide product listings, safety data, and recall authority to the FDA, could be granted increased marketing leeway. And current FDA-supported research into wellness solutions could be further democratized by the establishment of a special pathway at the FDA to evaluate research prioritized by patients and consumers.
Ultimately, it is incumbent upon the companies that are providing these wellness solutions to sponsor and directly participate in the research process. The wellness industry, which is focused on profit and growth, must lend its infrastructure to support clinical trials, engage their customers to participate and ethically share their clinical data, and invest in the necessary talent, oversight, and academic partnerships needed to conduct unbiased research. This requires relaxing NDAs and allowing for academic freedom, even if the findings directly challenge their current claims and desired conclusions.
There are, thankfully, some models for this. Wearable companies like Whoop and Levels Health, supplement companies like Elysium, and innovative wellness clinics like Numinus have followed the example of pioneers like Gatorade by investing in in-house “labs” and engaging scientific experts to conduct clinical research. These companies are able to instantaneously disseminate data on the safety and effectiveness of their products via various digital channels while simultaneously building their credibility and brand via academic publishing. While this may reduce short-term profit and growth, this long-term investment in scientific truth builds a more enduring currency with increasingly savvy health consumers: trust.
Consumer demand for wellness products and therapies continues to surge with an estimated market of more than $7 trillion per year by 2025. These big dollars indicate a deep well of motivation, a powerful resource that must be harnessed to advance human health. In order to march toward a future in which easily accessible clinical proof of safety and effectiveness of wellness solutions empowers consumers, health care professionals, and the various suppliers and stakeholders in between, all of us must build the evidence base.
Rich Joseph, M.D., is the chief medical officer of Restore Hyperwellness and a faculty member at Brigham and Women’s Hospital and Harvard Medical School in in Boston. Rachele Pojednic, Ph.D., is the director of scientific research at Restore Hyperwellness and a research associate at the Institute of Lifestyle Medicine, Harvard Medical School.