His situation is increasingly common in cardiology and primary care. Mid-sixties man with non-obstructive coronary artery disease, with a 50/50 split between calcified and non-calcified plaques on CT angiography. Elevated lipid and inflammation markers, including vascular specific and endothelial dysfunction parameters. He is asymptomatic. He opted out of working with us in 2024. A year later, he still had the same questions, and the same laboratory values. A handwritten scribble on his lab results print out read “LDL less than 100 is good”.

In 2024, he came to us seeking alternatives to statin therapies. His goal was to “reverse high cholesterol naturally.” This ask is so common at the Holistic Heart Centers that we offer a program called Statin Overprescribing Solution to many patients. In fact, my podcast episode on statin overprescribing was the most popular of 2025.

I have received numerous inquiries from physicians as well, with requests to land an integrative cardiology viewpoint to their patient cases. This morphed into our educational platform, Holistic Heart University, with several courses focusing on lipids and metabolism, and a dedicated case review space.

As you could have guessed, his cardiologist already prescribed a high-intensity statin which this patient had no intentions of taking. He, and many patients like him, are quiet quitting their physician recommendations and ditching statin prescriptions, despite seemingly understanding the gravity of their vascular risk. I say “seemingly” because a traditional concept of vascular risk is vague and impersonal, reduced to population-based statistical probabilities, and bearing little to no relationship to patients’ top of mind concerns. Patients are increasingly demanding a personalized solution, seeking alternatives to one-size-fits all treatments.

So I want to let you in on a little secret, completely counterintuitive to what you may be thinking, to help your patients turn their statin rebellion into an opportunity for health optimization.

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In a research abstract at the meeting, investigators reported that an OBSERVATION derived from hundreds of medical records that habitual use of melatonin for insomnia (defined as use for at least a year) significantly increases the risk of heart failure including hospitalization and death.

Since there is no publication, just a poster presentation, it is impossible to know all the biases, strengths and weaknesses of the study but some are glaring.

Key Findings

1. In a large study looking at medical records, those who used melatonin for at least a year were almost twice (2x) as likely to have new onset heart failure diagnosis over the 5 years, and 3.5 times more likely to have heart failure hospitalization.

2. Study is observational, not cause and effect. Patients did not have history of heart failure.

3. Significant study limitations include underreporting by patients, inaccuracies int he EHR data, and the use of melatonin as over the counter supplement except for the UK.

4. Limiting data to the UK and looking at prescriptions data, the risk was still significant at 82%.

5. Is it really melatonin or the insomnia itself? Cases and controls were matched but it is unclear if they were matched for the degree of insomnia or inflammation.

6. Insomnia, and associated circadian sleep disruption impact multiple health domains.

7. Insomnia is an inflammation multiplier, and inflammation is at the core of heart failure, atrial fibrillation and CAD.

8. Taking Melatonin? Lets figure out why you need it, and what actually is happening with your circadian rhythm, sleep and stress.

Here is the study design and the findings with my comments in italics.

Is This A Signal or A Red Herring? See Problems.

The study data was from TriNetX, established in 2013, a growing global network of real-world, de-identified patient data available for research. The study included 130,828 adults (average age of 55.7 years; 61.4% women) diagnosed with insomnia.

• 65,414 participants had been prescribed melatonin at least once and reported taking it for at least a year. Problem: attribution bias. Patients often underreport supplement use, and we all know that medical records are often erroneous, mentioning same medications or supplements even if a patient stopped those.

• A second group of people were examined for comparison (control group) — those who had never been prescribed melatonin and were matched to the group taking melatonin on 40 factors including demographic information, health conditions and medications. Same problem as above: reliance on patient reporting and EHR data is open to inaccuracies as patients often do not consider over the counter supplements important enough to report. Also, in many countries melatonin is over the counter and would not be dispensed by prescription.

The main analysis found:

• Among adults with insomnia, those whose electronic health records indicated long-term melatonin use (12 months or more) had about a 90% higher chance of incident heart failure over 5 years compared with matched non-users (4.6% vs. 2.7%, respectively). Problem: is this melatonin or the insomnia itself? It is entirely possible, even likely that chronic use of melatonin was for severe insomnia which leads to multiple metabolic disturbances and is an inflammation amplifier. It is unknown if these patients were evaluated for sleep apnea, a condition commonly associated with incident heart failure. So the study is akin to seeing ambulances at the scene of an accident and concluding that ambulances cause accidents.

• There was a similar result (82% higher) when researchers analyzed people who had at least 2 melatonin prescriptions filled at least 90 days apart. (Melatonin is only available by prescription in the United Kingdom.) This is better, but having one region substantially lowers the strengths of these findings. While it is by RX in the UK, patients can still get it over the counter including the internet.

A secondary analysis found:

• Participants taking melatonin were nearly 3.5 times as likely to be hospitalized for heart failure when compared to those not taking melatonin (19.0% vs. 6.6%, respectively). Problem: again, is it melatonin or the inflammation due to severe insomnia resulting in chronic use?

• Participants in the melatonin group were nearly twice as likely to die from any cause than those in the non-melatonin group (7.8% vs. 4.3%, respectively) over the 5-year period. Now we really have a problem but again, it is not clear if this was melatonin or the insomnia itself. Likely the latter.

What Should You Do if You Are Taking Melatonin

1. Speak to a trained integrative or functional medicine physician and engage in collaborative conversation.

2. Find the root causes of your sleep disturbance such as sleep apnea: get home-based sleep study! I am testing a home-based device from Empower Sleep, and will report on it later.

3. Address inflammation, oxidative stress, hormonal imbalances, environmental exposures, sleep apnea, excess weight.

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While I cannot make up for the past time, the summer pause brought an opportunity to reflect on a new phenomenon: the emergence of citizen doctors.

Vital Signs

Over the past three months or so, I've noticed an interesting pattern. Patients are using generative AI all-purpose chatbots to interpret their test results and then attempt to cobble up an intervention based on the AI inputs.

I called these patients “citizen doctors” because, just like citizen scientists or citizen policemen, they attempt to engage in the work that requires specialized training, experience, and expertise.

Wikipedia provides a nice review of citizen science, including the origin of the term, its current definition, and the evolution of the citizen science role. There is a typology to citizen scientists, with the most recent definition in activities described in 2022 as “co-creation and participatory approaches” and “contributory citizen science.”

Here are a few notable “citizen doctors” examples:

A 73-year-old man with CAD and ischemic cardiomyopathy (received stents and a defibrillator):

“Hi Dr. Druz,
ChatGPT identified several imbalances in my stool, so I would like to follow up when you are ready: absence of Lactobacillus, low Bifidobacterium, Candida overgrowth, low short-chain fatty acids (SCFAs), and reduced pancreatic elastaseâ?? Related to the 28-day course of amoxicillin I completed in May? Lowering beneficial bacteria and opening the door to yeast overgrowth and reduced gut fermentation? I welcome your help and wonder about enzyme/antifungal support. Thanks and warm regards.”

A 49-year-old woman with cryptogenic CVA due to PFO, idiosyncratic reaction to an antibiotic, and/or Eliquis with transient elevations in liver enzymes after the PFO closure procedure:

“After stopping ALL medicines (except metoprolol) and supplements, AST-ALT returned to normal, but in analyzing historic and very recent bloodwork, I see consistently high MCV and MCH, low RBC and RDW, and high ferritin. This, coupled with my history of PCOS and high cholesterol, makes me wonder about NAFLD and the benefit of a high-impact intervention like metformin (also high glycaemic protein)? Did we also test for hemochromatosis? I am trying to connect the dots! Thank you!!”

Bottom Lines

Generative AI is a radical innovation. Radical innovation is often used in a business or technology context to describe technology or a process that is fundamentally different from the current state and offers transformation through disruption.

I found this definition from “Digital Leadership” to be helpful:

“Radical innovation is a term that encapsulates a groundbreaking and transformative form of innovation. At its core, the definition of radical innovation lies in its departure from incremental improvements or minor modifications. Instead, it represents a profound shift in thinking, technology, or business models. This type of innovation introduces entirely new concepts, products, or services that challenge existing norms and redefine industries. The radical innovation meaning is characterized by its disruptive impact, creating a significant departure from the established status quo. In essence, radical innovation is not an incremental enhancement but a revolutionary leap, paving the way for novel solutions, approaches, and opportunities.”

In using generative AI, patients are radically innovating on the traditional process of medical testing and healthcare delivery by taking a shortcut to fulfill their jobs. To fully understand jobs, pains, and gains, and how those shape the emergence of innovative technology or process via products or services that are gain creators or pain relievers, check out the value proposition canvas on Strategyzer.

What often does not get discussed is that radical innovation produces both positive and negative externalities. Externalities are essentially unintended consequences. These terms are most often encountered in economics to explain how activity in one part of a business may produce an unexpected cost or benefit somewhere else outside of a company. Investopedia defines an externality as “a cost or benefit caused by an economic actor that is not suffered or enjoyed by that same actor.”

Generative AI's positive externality is enabling patient agency and access to test results interpretation. But a much more significant negative externality is a breakdown in the medical thinking process and violation of the checks and balances that underlie diagnostic and treatment decisions. This negative externality enables cognitive bias (Dunning-Kruger effect), where “citizen doctors” lean out of co-creation and collaboration, and lean in to shortcuts that will end up taking many down irrelevant rabbit holes.

Fortunately, my patients did lean into collaboration. I believe the significant positive externality of these generative AI experiences is patient engagement with a trusted physician…of course, provided that they have one who is willing to engage comprehensively and collaboratively.

What do you think? What have been your experiences? Please drop a comment and let’s discuss!

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One thing is clear: the beginning is hard!

There is so much I want to say… but where do I start? I am pretty good at conversation, but writing is an entirely different medium. And there is no use of ChatGPT for this!

1. Why this, and why now

Plants and humans grow in spurts. There is seasonality to our growth. For many mid-career physicians, including myself, the “mid” season is not about a growth spurt, but rather stagnation. One begins to question their purpose. Clinical work becomes repetitive and uninspiring. There is a longing for something else, something bigger than the daily grind…

This is not burnout. This is a call to action. And if you are willing to head it, you may end up doing things that you have never thought of, like completing an executive MBA at 53. Founding a company. Radically shifting your mindset.

This is the real reason beyond “Vital Signs and Bottom Lines”. I want to take you on an experiential journey of discovery. Come along to explore the intersection of healthcare with disruptive technologies and evolve in your entrepreneurial thinking. Open your “third eye” to see the future.

2. What kind of community would I like to build here

The speed of innovation is astounding. The amount of healthcare data is doubling every 73 days globally. Patients have become consumers, and now, with generative AI tools, they have become “citizen doctors”. If you are excited about the possibilities that this data explosion and health digitization can bring to improve and optimize our healthspan and lifespan, and perhaps a bit anxious about it, then this is the space for you.

3. What you may expect from this Substack

I will be posting every few weeks. The posts will always have two key sections:

• Vital Signs: reflections on the value and benefits of companies, services, and technologies that are reshaping healthcare.

• Bottom Lines: a business case-like analysis and entrepreneurial takeaways.

• Many posts will be free.

• Posts for paid subscribers will be in-depth case studies, complete with strategic, operational, and financial discussions. You can think of them as a mini-MBA series. These posts will have interactive features, including discussions.

Let’s get started!