As a physician who continues to practice at an academic medical center while also serving as Chief Medical Officer at Labfront, I have had the privilege to witness firsthand the shifts and tensions between the two worlds of biomedicine and the burgeoning digital health sector.

Biomedicine: Targeted, Expensive Biologics

Growth of Biologics

From what I can see, modern medicine appears to be going all in on biologics – targeted drugs/molecules made from living cells using recombinant DNA technology. Humira (adalimumab) - the first $20 billion/year drug – is an example of one.

In 2009, the global biologics market was valued at $99 billion, reached $461 billion in 2023, and is projected to reach $1 trillion in 2030 [1]. Biologics went from representing 15% of drugs in pharmaceutical company pipelines in 2010 to more than a quarter of pipeline drugs in 2018. Now biologics make up about half of recent drug approvals. [2]

Economic and Healthcare Implications

I can appreciate the enthusiasm. With dramatic advancement in our understanding of signaling pathways, molecular markers, and biologics production, it’s only natural to work towards targeting key molecules considered central to a disease process. But this has become biomedicine’s version of targeted, personalized medicine – basically reductionism taken to the extreme.

And, if you ask me, it’s a mistake.

High Costs and Inequity

For one, biologics come at a steep cost. Biologics only account for 2% of all prescriptions in the United States yet represent 43% of invoice-level medicine spending. [3] And these biologics often require cold storage (along with costly shipping/transport chain), are administered intravenously (with its associated personnel, supply costs), and frequently are prescribed over a long duration (months to years). It further accentuates the rich-poor gap in access to care.

Not a Cure-All: Biologics' Limits

Second, biologics are not really the panacea that many would like you to believe. Chronic disorders like diabetes, morbid obesity, and congestive heart disease cannot be ascribed to a single mutation/haplotype, and so targeting a singular molecule just doesn’t work.  

Plus, nature – in all its complexity - just finds a way to bypass these interventions by either resorting to an alternative pathway or creating an immune response to these biologics. Remember the series of monoclonal antibodies during the COVID-19 pandemic that ended up losing effectiveness as SARS-CoV-2 morphed into different strains? Yeah, it’s kind of like that but within the human body.

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Rise of the Digital Wellness Economy

Lifestyle as Medicine

Meanwhile, the digital health sphere largely targets lifestyle optimization for wellness and performance - areas like nutrition, mental health, sleep, exercise, and social connections.  

The Million Veteran Program – a large epidemiological cohort (>900k strong!) run by the US Veterans Administration (VA) identified eight lifestyle habits that can extend life by up to 24 years: exercise, managing stress, plant-based diet, good sleep, positive social relationships, avoiding opiates, no tobacco, and no binge drinking. [4]  

Because no specific medical claims or diagnoses are made, these ventures can remain outside the FDA’s wheelhouse and so things can move fast.

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Sorting Facts from Fads

This digital health economy is fueled not only by the wide array of apps and shiny new wearables, but also by enthusiastic citizen scientists and YouTubers/Tik-Tokers who provide their unique perspectives into their personal health and how they interpret their digital data.  

This is the digital health version of personalized medicine: it is filled with myriad narratives, rich anecdotal descriptions, and individualized interpretations. This is how intermittent fasting, cold baths/showers, and breathing exercises (think Wim Hof method) entered mainstream consciousness.

With access to personal, “in-the-wild” data and to the wealth of community-sourced learnings, citizens are empowered to take charge of his/her own well-being and to customize interventions tailored to their specific needs…

Or at least, that’s what avid digital health proponents are saying...

In truth, the unregulated, hodge-podge nature of digital health permits questionable or unsubstantiated health claims to circulate widely; lack of integration among apps lead the need for separate app/wearable for each health concern; users find themselves sifting through conflicting advice across different platforms; and some apps emphasize persistent health monitoring or detailed tracking, potentially fueling unwarranted health anxieties or obsessive behaviors.

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Over-Reliance on AI and Machine-Learning

Furthermore, in my opinion, there is an unhealthy over-reliance on AI/machine-learning techniques to guide the “science” of many digital-health applications.

I have found that the scientific lead for startups and tech companies is frequently a data-scientist or an engineer – which is perfectly fine if the technology has some foundation in human physiology.

More often than not, however, it is the AI algorithm being touted as the main innovation, rather than techniques/methods to better capture or understand disease/healthy physiology.

And, to me, this is where our greatest knowledge gap lies: in knowing which physiological-based measure to acquire, what biological processes exist within the signal, and how it relates back to a dynamic, unique human being living in a complex world.

When Two Worlds Collide

These two healthcare paradigms sometimes find themselves at odds. Consider the potential risks of intermittent fasting for insulin-dependent diabetic patients or the dangers a cold shower might pose to someone with cardiac issues. Or the sleep doctor cautioning an insomnia patient from focusing on an Oura sleep score since it generates more anxiety (and thus less sleep).  

Patients – and healthcare providers – are finding it difficult to navigate these conflicting messaging, and knowing how to best manage the intersections between the two sectors is an ongoing challenge.  

Philosophical Divide: Speed vs Scientific Rigor

But even at a broader level, there are larger philosophical differences in the two sectors that exemplify where greater tensions may arise.  

Biomedicine is heavily invested in molecular sciences and, by extension, in disease (since wellness cannot be readily traced to a single molecule). Progress is typically slow and deliberate, relying on time-tested methodologies (like randomized controlled trials) which are resource-intensive and – can I say again? – really slow.

Digital health is driven by profit - thus economic demand and the consumer experience are strong motivating factors. Since many of the use-cases are grounded in lifestyle, the stakes do not have immediate life-or-death implications. So moving fast and mottos like “failing fast and early” are embraced with zeal. This rapid, iterative approach is advantageous for quick innovation and adaptability but can sometimes bypass the rigorous checks and balances emphasized in traditional biomedical research. The juxtaposition of these two philosophies – one meticulous and patient, the other agile and opportunistic – can clash.  

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Lost in the Divide: The Plight of Long-COVID Patients

Patients with conditions like Long-COVID exemplify the tragic consequences of this divide. These individuals often find themselves lost in a system where neither traditional medicine nor digital health solutions can fully address their needs.

They need a system that has the scientific rigor and knowledge of biomedicine and the agility and lifestyle focus of digital health. Yet, what they find is a medical system that is highly silolized, incapable of integrating the multi-organ involvement (i.e., fatigue, brain fog, POTS, blood clotting, diarrhea, diabetes, etc..), reliant on the drug validation process (cell studies -> animal models -> RCTs) which is exceedingly slow, and lacking the bandwidth to incorporate real-life data such as sleep, physical activity or stress. And what they find in digital health is a system that is similarly silolized, ungrounded in physiology or biomedicine, and unable to integrate with validated biomarkers such as cortisol, immune or cytokine markers (T-cell function), levels of reactivated virus, clotting tests, cardiopulmonary exercise tests, and tilt-table autonomic nerve testing.

Labfront: Breaking Down Siloes, Bridging the Gap

The struggles that patients must go through in navigating between biomedicine and the digital health sphere are not lost to us. We recognize that, to better serve patient needs, a more coordinated way in which these two sectors can work together in an aligned manner is required. In essence, facilitating a system that fosters innovation rapidly when possible, while still upholding scientific rigor and verification of claims.

Facilitating a Two-Way Street for Health Innovation

So how do we go about doing this? At Labfront, we’re focusing - at the moment - on creating threads of communication – essentially pathways for integration – between the biomedicine and digital health worlds.

This involves validating home-based physiological markers and biomarkers against “gold-standard” biomedical tests, designing algorithms that accurately and passively capture home physiology data, and designing tools that encourage academic researchers to bring their attention and skills into the home setting for real-world testing.

It starts with providing a user-friendly app to enable home-based surveys, solidifying heart-rate variability and actigraphy, incorporating continuous glucose monitors, and then developing ecological momentary assessments (EMA) and just-in-time adaptive interventions (JITAI).

In this way, the two worlds can begin to meaningfully interact.

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Embracing Complexity and Dynamism

But we view our task as being greater than this too. Bridging the gap between these two sectors also requires a reboot in our sciences. The human body is dynamic, non-linear, and complex.  

The reductionistic paradigm which underpins modern medicine works well for acute conditions and operates fine in a system that asks patients to visit episodically – usually once a year. But the moment we are given access to continuous (at times, second by second) and varied data – like the rich data obtained from wearables and internet-of-things devices, the complex tapestry before us poses a scientific and analytical challenge.

How do stress, lack of sleep, and physical activity interact in a dynamic way within a pregnant woman with limited access to adequate home heating? And how does vascular function get impacted by over-exertion, insufficient sleep, and humid weather in a person suffering from POTS and Long-COVID?

These are the type of massively difficult questions that have mulled my mind for years [5,6]. And I believe, the answers are rooted in comprehensive understanding of dynamic physiology, appropriate signal processing and analytical methods, and focus on systems-based approaches.  

For this, we will rely heavily on our experiences in non-linear dynamics and on our deep understanding of human physiology – with the ultimate goal of bringing high-grade, rigorous sciences to each individual in a quick, responsive, and personalized way.

Democratizing Health Sciences: Our North Star

A Journey into Nonlinear Science

Systems-based, nonlinear science introduces a lexicon enriched with concepts and terms such as fractal dynamics, coherence/synchrony, and multi-scale entropy. Additionally, the blending of mixed-methodologies, combining subjective with objective data, demands further exploration. Recognizing the imperative to elucidate these methodologies for a broader audience, we plan to release a series of tutorials and ongoing discussions over time. Our goal is to demystify these methods, channeling the dynamic enthusiasm of the consumer digital health community towards informed avenues, and fostering partnerships with both patients and advocates.

Partnerships, Progress, and the Patient: Crafting a Collaborative Ecosystem

At Labfront, our guiding principle is to “Democratize Health Sciences.” We understand that achieving this goal requires a broader perspective, encompassing the intricate dynamics within the healthcare ecosystem with the push-pull forces of speed vs. scientific rigor.

Our device-agnostic stance, combined with our strategic collaborations with companies that champion public accessibility, signifies our commitment. We prioritize a spectrum of physiological tools, from smartwatches to glucose monitors, ensuring both diversity and affordability. Further, our support for research through grants and our dedication to creating educational resources reaffirm our belief: truly democratizing health science requires bridging divides between academia, industry, policymaking, and the patient narrative.

Progress will necessitate partnerships across sectors to validate digital tools, implement them responsibly, apply research in people’s daily lives, and regulate this new frontier of health technology. It is a complex challenge, but with collaborative action and a shared commitment to the citizen/patient experience, we can cultivate an ecosystem that allows biomedicine and digital health to complement rather than be at odds with each other.

References

1. "Biologics Market Size, Share & Trends Analysis Report", Grand View Research
2. "Novartis funnels $300M into early biologic drug manufacturing", BioPharmaDive
3. "Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary", ASCPT
4. "Eight Modifiable Lifestyle Factors Associated With Increased Life Expectancy Among 719,147 U.S. Veterans", Science Direct
5. "The limits of reductionism in medicine: could systems biology offer an alternative?", PubMed
6. "The clinical applications of a systems approach", PubMed

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