Personalized Medicine and Public Health

Big data, 'omics, and the proper role of government in health care

“The Good, the Bad, and the Ugly” pretty much sums up the situation.

We have all heard the pitch about big data in medicine, from POTUS to Larry Ellison (“Stargate”), to the Silicon Titans of Technology, the WEF with its acolytes like Yuval Harari, down to the level of Elizabeth Holmes of Theranos. Even MAHA leadership has largely succumbed to this particular Pied Piper, alternatively named “Personalized Medicine” or “Personalized Public Health”. The latter, on its surface, appears to be a self-evident oxymoron. “Public Health” operates at the level of populations, and is the exact opposite of anything personalized. But this is serious stuff, and trillions of healthcare dollars will be directed towards enabling this vision. Meaning those dollars are NOT being spent on obvious and more practical things.

But maybe if we were to comprehensively apply molecular biology to all of medicine, together with applied big data analytics and a generous dose of high-performance computing and large language modeling thrown in to the brew, we actually could Make America (and the world) Healthy Again?

The argument goes that if we only had enough data on every person in the world, then we could solve the puzzle of (fill in the blank) disease and engineer a cure. Designer drugs, biologicals, gene therapy based on genetic risk analysis. In the industry, this is called target discovery and validation, and there is big money in just identifying a “druggable target”. Why, you might ask? Because it is wicked hard to identify valid druggable targets.

The Stargate pitch is one variant on this theme - that being (paraphrased) “if we only had enough data on each person’s particular cancer, and a sufficiently powerful AI, we could produce personalized mRNA vaccines for treating everyone’s cancer. And that would then lead to a universal cancer vaccine.” Or some variant of that narrative. Remember? All who were paying attention after the inauguration cannot forget. So easy to sell the rubes on the vision, so hard to deliver, but once the money is allocated there is always a convenient excuse for why the promise never materialized. Meanwhile, fortunes are made by exploiting hope and the fear of death. Keeping in mind that all will eventually die.

The unspoken inconvenient truth part to the “Stargate” pitch being “why are we seeing the explosion in cancers in the first place?”

If we could only develop a warp drive, we could all live in a woke Star Trek/Paramount universe of brave new worlds. And if pigs only had wings, they could fly.

You get my point.

Or maybe I have just become a stranger in a strange land. An isolated anachronism in the strange new land of 21st century corporate medicine. A true believer in a time tested model for medical practice that extends back to the earliest recorded history. Can you grok that?

I have been burning processor cycle time trying to imagine an alternative future medicine beyond the shopworn socialist/utilitarian/corporatist “public health” logic that drives CDC and WHO, and the old school hippocratic patient-centered approach that I thought I was sacrificing my youth for while training to join my chosen profession back in the 1980s.

Why bother, you ask? Just go ride the horse and take care of the wife.

Because, at age 65, when I had hoped to retire, consequent to a strange set of circumstances that can best be explained as some perverse divine intervention, I find myself as a medical advisor to the MAHA alliance (leading the most significant bi-partisan grassroots political movement in decades), and appointed as co-chair to the CDC’s ACIP. I am in the strange position of having to think about the future of medicine and public health to do my job(s). Writing and discussing ideas with others (particularly with my wife and editor Dr. Jill Glasspool Malone, PhD Biotechnology and Public Policy) helps me to think more clearly.

And hence, dear reader, this brief essay. I hope you will share your thoughts in the comments so that I can plagiarize (just kidding, Sasha) and integrate those, thereby improving overall clarity.

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Ahh, yes. Hillary care. I remember it well. The transformation of medicine really got rolling with that. The core thesis here is that the State has an obligation to manage and promote the health of its citizens. Seeking to frame this issue in a way that those of the Woke persuasion can appreciate it, this logic is profoundly paternalistic and Statist. This concept of state-sponsored management of medical care is nowhere to be found in the Federalist Papers, the US Constitution, the Declaration of Independence, or the Bill of Rights.

Where does this notion come from, this idea that is now so widely integrated into US politics that it cannot be questioned? The logic and writings of Karl Marx and colleagues is the answer. The idea that the State has this responsibility to promote health as part of promoting general welfare is the gateway drug to modern State-based Socialism/corporatism. And you know what term Benito Moussilini applied to the fusion of socialism and corporatism…

Take a trip with me (no Ketamine or Lysergic acid diethylamide, please) on the Way Back Machine to before Hillary Clinton began pushing her particular version of socialist medicine, in which the State assumes responsibility for meeting what has been billed as a fundamental human right. Before then we had local non-profit hospitals, often aligned with a church or charitable organization. Most physicians operated as small businesspersons. They had a close cooperative relationship with their communities, which typically understood that the physicians who lived among them charged those who could afford to pay but also provided charitable services to the poor and indigent. It was a social contract between the physician and the community being served. All of that has now been swept away. Corporatized, the modest profit drained away to support hedge funds, real estate investment trusts, middle managers, and insurance companies. When was the last time you saw a non-profit community hospital? Big government took control, regulations and paperwork multiplied like fleas on a stray dog, mega corporations that had the resources to comply with the paperwork and regulations swooped in, and the community-based primary care physician was reduced to being just another indentured employee-technician servicing a corporate master.

And then Obamacare. The “Affordable Care Act”. Which turns out to be just another turn of the wrench, and is apparently about to blow up medical costs for the average Joe, so much so that the Democrat party that gave birth to this slouching rough beast is willing to shut down the government to get more taxpayer dollars to prop up their Potemkin village.

“The nine most terrifying words in the English language are: I’m from the government, and I’m here to help.”

Ronald Reagan, press conference on August 12, 1986, while discussing agricultural policy and government intervention.

Personalized Medicine (also known as precision medicine) is an approach to healthcare that tailors medical treatment to the individual characteristics of each patient. Personalized Public Health takes this a step further, and basically proposes that if we only had enough data on every aspect of every life, we could design and deploy “public health” policies that would essentially “Make America Healthy Again”. You see where I am going here?

The vision typically involves using information about a person’s genetics, environment, and lifestyle to prevent, diagnose, or treat diseases more effectively. Instead of a one-size-fits-all approach, personalized medicine aims to customize therapies, medications, or interventions to match a patient’s unique biological makeup, such as their genetic profile, to improve outcomes and minimize side effects. For example, in cancer treatment, personalized medicine might involve analyzing a tumor’s genetic mutations to select a targeted therapy that works best for that specific patient. The term gained prominence with initiatives like the one announced by President Obama in 2015, which focused on advancing research and technologies to support this approach.

The rub is that it is increasingly clear from the metadata that your genome has much less of an effect on your long term health that do factors such as social status, wealth, where you live, what you eat, what chemicals you have been exposed to, and other influences. If genetics is “nature”, and social context and behavior writ large is “nurture”, then the paradox has now been resolved once and for all. Nurture has a greater impact on health than does nature.

Disclaimer: Opinions expressed in this essay are those of the author, and do not necessarily represent the opinion of the US Government, the Centers for Disease Control and Prevention, or the Advisory Committee on Immunization Practices.

Let’s take a step back in time. To the days when Obama was POTUS. Days of hope, wine, and roses. For much of this enthusiasm for big data-based precision medicine traces back to a statement by the then POTUS.

On January 20, 2015, during his State of the Union address that evening, President Barack Obama endorsed personalized medicine, also known as precision medicine. He announced the launch of the Precision Medicine Initiative (PMI), a major federal effort to advance tailored treatments based on individual genetics, environments, and lifestyles. He stated: “Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier.” This marked the first high-profile endorsement from Obama, with follow-up details released on January 30, 2015. The initiative aimed to create a national research cohort of over 1 million participants and accelerate genetic sequencing for better-targeted therapies, building on advances like those in cystic fibrosis treatment.

By the way, that phrase “building on advances like those in cystic fibrosis treatment” was code for endorsing the vision of the future head of the NIH, Francis Collins, whose claim to fame (before the human genome project) was identifying the Cystic Fibrosis Transmembrane Regulatory Protein using genomic methods.

An Aside-

Well, actually, Francis Collins did not discover the CFTR gene in isolation, but he was a key leader in the international collaboration that identified it. In 1989, Collins, working with Lap-Chee Tsui and their teams at the University of Michigan and the Hospital for Sick Children in Toronto, successfully identified the gene responsible for cystic fibrosis, which was later named the CFTR gene. This discovery was a landmark achievement in human genetics and provided the foundation for understanding the molecular basis of the disease. AI programs assert that Collins played a central role in the research that led to the identification of the CFTR gene, its molecular structure, and its function as a chloride channel.

In other words, Collins was a government funded administrator overseeing a large project focused on a rare disease, but somehow came out identified as the important innovative scientist responsible.

Sound familiar?

Backing out of that rabbit hole now…

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The cumulative amount appropriated and spent to date on the Precision Medicine Initiative is approximately $3.5 billion from FY2016 through FY2025 year-to-date. And by the way, in the world of DC, a $3.5 billion spend over 10 years is a rather modest allocation (350M$/year). For comparison purposes. the CDC spent $92.8 billion over the same period, and NIH spent $463.8 billion.

I asked SuperGrok to list the therapeutic achievements produced by Obama’s Precision Medicine Initiative (PMI):

Below is a list of key therapeutic achievements directly or indirectly tied to the PMI, based on available evidence and program outcomes through 2025:

• Advancement in Targeted Cancer Therapies

• Progress in Rare Disease Treatments

• Improved Pharmacogenomics for Drug Response

• Development of Polygenic Risk Scores for Personalized Treatment

• Breakthroughs in Cystic Fibrosis Treatment

• Enhanced Therapies for Diverse Populations

These therapeutic achievements stem from the PMI’s emphasis on large-scale genomic data, diverse participant inclusion, and inter-agency collaboration (e.g., NIH, FDA, NCI). While many outcomes are still in the research-to-translation pipeline, the initiative has laid critical groundwork for personalized therapies, with ongoing data releases expected to drive further therapeutic innovations.

To my eyes, this is pretty modest for a POTUS-level major federal program. Lots more bureaucratic scientific initiatives with happy names, but not much in the way of actual, measurable, quantifiable improvements in human health for the likes of you and me.

In fact, we know that during this same period, American citizens’ average lifespan slipped, infant mortality increased, and overall health declined. However, academic careers and programs were most definitely advanced by injecting approximately $350 million per year for a decade. I am confident that we could also demonstrate a statistically significant quantitative positive impact on academics that were associated with the keywords “Precision medicine” achieving tenure during this period.

Which brings me to the central point

There is a massive push to gather all health data available for each and every one of us, and to aggregate that into databases that will be merged with the massive warehoused data on all other aspects of our lives (see “surveillance capitalism”), all justified as somehow enabling a new medical nirvana in which we will all live longer, healthier lives and in this way vanquish disease.

Never mind that much of the data are contaminated by the mindless (and mind-numbing) reductive obsession with cataloging all “procedures” and “diagnoses” based on whatever AMA-endorsed Current Procedural Terminology (CPT) code can be used to justify billing for a particular physician-patient interaction.

The fascination with this siren song is bipartisan. Obama, Biden’s “moonshot”, Trump, and now even MAHA. That is the magic of health initiative funding. Who can say “no” without coming across as Scrooge? Which is probably the origin of the paradox behind the Precision Medicine initiative - if this is so great, why only spend $350M/year? Because it makes it look like you are doing something to advance the application of high tech to medicine, when in reality, you are doing almost nothing.

However, the underlying inconvenient truth is that, to the extent this sort of thing advances “health”, it is likely to benefit those with the financial means to take advantage of what will be expensive, personalized treatments, yielding ever greater disparities in both life expectancy and practical measures of “health” when stratified by socioeconomic status.

And maybe that is good that these benefits will only be available to the rich, all things considered, particularly when you factor in other parallel initiatives like vaccine passports, digital ID, central bank digital currency, and the insidious push for state-sponsored medical assistance in dying (MAID). It all leads right down the toilet to the same politically, algorithmically and fiscally driven septic system. The State and the Corporations always seek more power over the individual.

Perhaps the rest of us could “just say no” and be left alone? Not likely. Because they need our data. In a very real sense, we are the controls.

However, consider the underlying assumptions that underpin this fantastically optimistic, yet to date grossly underperforming vision.

• We should sacrifice our privacy for the (to date) unmet promise of greater health and longevity? I am reminded of the aphorism that those who would sacrifice liberty for security will have neither.

• Does the State have an obligation to ensure equity of health outcomes?

• More data will yield greater health, as if data volume approaches some Calculus-derived asymptotic approximation of ideal health?

• We should spend scarce fiscal resources on massive data gathering and analysis projects at the expense of more pragmatic interventions such as guardrails on predatory monopolistic megafood “producers”, regenerative farming, or regional decentralized food production systems?

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In trying to prepare my mind to explore this thought landscape of “Precision (or personalized) Medicine” and “Personalized Public Health”, I spent time searching these keyword phrases on PubMed and diving into selected peer-reviewed publications that, based on the abstracts, appeared to represent current thinking. If “thinking” is the relevant term. To the extent that logic is involved, it is hard to wade through the wandering “feel good” language and get to the point.

I quickly felt the need to keep James Lindsay’s “Translations from the Wokeish” at hand as I worked through many of these publications.

This one from BMJ Open is fairly representative:

The abstract below is a reasonable summary of the entire paper. Reading it provides a pathway into the mental world of 21st century academics pushing this logic. Its all about fairness, equity, and entitlement. Clarity of thought and reasoning is not a strong point. If you dare to read the whole thing (linked above), you will gain a more complete appreciation for how this academic discipline seeks to redefine the practice of both medicine and “public health”.

Abstract

As currently conceived, precision public health is at risk of becoming precision medicine at a population level. This paper outlines a framework for precision public health that, in contrast to its current operationalisation, is consistent with public health principles because it integrates factors at all levels, while illuminating social position as a fundamental determinant of health and health inequities. We review conceptual foundations of public health, outline a proposed framework for precision public health and describe its operationalisation within research and practice. Social position shapes individuals’ unequal experiences of the social determinants of health…

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To wrap this up, I am still seeking an answer to the question of what an alternative “medical care delivery system” looks like for the second half of this current decade, let alone for the 21st century. The Statist/Socialist version promoted by WEF, UN, WHO, the old CDC, the Democrat party in the USA and their corporate/Pharma allies is failing slowly, and threatens to fail abruptly and catastrophically.

Will the Tech Bros of Silicon valley be able to save this medical/pharmaceutical/industrial complex from itself? Can anyone that takes the time to look under the skirts of Big Data really think that “Precision Medicine” or “Precision Public Health” is the answer? PT Barnum sagely observed that there is a sucker born every minute.

Like so many before it, a subset of the MAHA movement has been seduced by the glitter and promises. A different subgroup within MAHA, and what I hope is the larger proportion, is more focused on getting back to sustainable basics that have stood the test of time. Pure food. Regenerative farming. Freedom to choose based on transparent labeling including disclosure of synthetic additives. Investing in promoting health rather than treating illness. And putting personalized care for the individual patient back into medical practice.

Once upon a time, long long ago, an ambitious medical student, highly trained in biochemistry and molecular biology, took his first training in clinical medicine in the wickedly cold city of Chicago. He was drilled by supervising physicians, day after day, in a commitment to soliciting and clearly stating the patient’s chief complaint, and using that above all else as the guiding light for diagnosing and treating each individual patient.

Maybe it is time to revisit that way of thinking about the physician-patient relationship. Let doctors be doctors. And get the Silicon Valley Tech Bros, the woke “public health officers”, and the State out of the physician’s office. It worked for Hippocrates, and for centuries afterwards. Maybe it still can work in the 21st century.

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