Chapter 16 – Individualized Medicine – Our Last, Best Hope

This is Chapter 16 of my book-in-progress, “Open Wide And Say Moo! – The Good Citizen’s Guide to Right Thoughts And Right Actions Under Obamacare.” Comments are fervently sought; you can leave them here.

You can read my rationale for undertaking this project, and thus opening myself up to the possibility of public failure, humiliation, derision, disapprobation, and unwanted scrutiny, here.

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Update – September 1, 2012

Open Wide and Say Moo! is now revised and published!

 

You can find it on Kindle here.

 

Now available in the audiobook version!

 

 

 

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Chapter 16 – Individualized Medicine – Our Last, Best Hope

Herd medicine – the top-down, centralized control of medical decisions as handed down by carefully selected panels of experts – is the hallmark of Progressive healthcare in general, and of Obamacare in particular. As we have seen, the entire structure of Obamacare is designed specifically to remove important (i.e., costly) medical decisions from the purview of the individual doctor and patient. The role of the doctor is now to relay expert-guided determinations of what is best for the herd down to the level of the individual patient, and to do it in such a way that their patients do not realize that the doctor’s recommendations are population-based, and not tailored to their own needs. (Alternately, the doctors may try to convince their patients that population-based recommendations are in fact always the right recommendation for each individual. All too many doctors seem to have convinced themselves that this is actually the case.)

The role of patients under Obamacare is to trust the wisdom of the experts (as imparted to them by their doctors). They are to behave as Good Citizens, and comply fully and enthusiastically with their doctors’ recommendations, for their own good and for the good of the whole. (Those old Soviet propaganda films accurately depict how Progressives view the ideal citizen: Happy, hearty peasants jauntily marching along to the tune of uplifting anthems, to their patriotic work in the collectivized fields.)

If everyone would simply behave in the prescribed manner, we would be one giant step closer to achieving the perfect society, and all would be well.

In this light, individualized medicine – using science and technology to tailor medical care to the best interest of the individual instead of the best interest of the herd – ought rightly to be seen as an existential threat to Progressive healthcare. Individualized medicine is the antithesis of herd medicine. If medical decisions are to be carefully tailored to the needs of each individual, centralizing the control of those decisions becomes impossible. Individual decision-making (and the individual autonomy that goes along with it) becomes necessarily predominant. It is hard to see how any truly Progressive healthcare system – and therefore, any truly Progressive system of government – can survive under a paradigm of individualized medicine.

For those of us who still value the Great American Experiment, and who see Obamacare as its death knell, individualized medicine may be our last best hope. For Progressives, it is something that must be nipped in the bud.

What Is Individualized Medicine, and Why Is It So Important?

For the purposes of this discussion, individualized medicine means gathering specific physiological information pertaining to individuals, compiling that information into a digestible and actionable form, and presenting that compiled information to the individuals themselves (and to their doctors or other designated agents), in order that they may decide what action to take on behalf of their own well-being.

Today, individualized medicine, as I have just defined it, is feasible for the first time in history. It is feasible because of the fortuitous convergence of several technologies, including the Internet, ubiquitous wireless communication, massive data processing power, new physiologic sensors, the power of genomics, social networking, and smartphones (i.e., personal information and communication systems). These kinds of technologies are being brought to bear to provide individuals with the resources they need to manage almost every aspect of their lives – except their healthcare. I will describe later in this chapter why healthcare is lagging behind. But despite the lag, this remarkable technological convergence has made it possible to devise systems with which people can control their own healthcare in ways that were unimaginable a decade or two ago.

If these technologies are permitted to develop “naturally,” over time they promise to render impossible a healthcare system built around top-down, centralized medical decision-making. By so doing they threaten to wreck Progressive healthcare.

Obviously, then, Progressives will do whatever they must to prevent these technologies from developing freely. So, whether individualized medicine ultimately overwhelms Progressive healthcare, or whether instead the Progressives manage to poison the whole thing before it ever really gets started, may very well turn out to be the main event, the battle that will determine where our healthcare system, and our society, ultimately will go.

What Will Individualized Medicine Look Like?

It is always risky to try to predict the long-term results of emerging technologies. When the Wright brothers first launched themselves to the lofty height of 20 feet over the sands of Kitty Hawk, who would have predicted that a few decades later flying machines would be routinely transporting 300 people at a time from coast-to-coast in four hours – or that before boarding these machines all 300 of those people would have to remove their shoes and belts, raise their arms above their heads, and submit to intimate fondling by bored government agents? When Gutenberg printed his first Bible in the vernacular, who could have known that he had just launched an era of individual empowerment that eventually would result in the Declaration of Independence – but only after Western civilization first spent a couple of hundred years killing off its citizens in religious wars?

Trying to predict what individualized medicine will look like in ten years is a fool’s errand. I will stipulate up front that nobody can know the directions which individualized medicine will take (if it is permitted to develop at all). Indeed, the possibilities seem almost endless. So I am going to limit myself to briefly reviewing the two general areas in which individualized medicine is poised to take off – personal biosensors and genomics.

Personal Biosensors

Numerous sensors exist or are being developed that can measure various interesting aspects of our physiology that can reflect the status of our health, help us detect acute illness, or assist us in managing chronic medical conditions. These biosensors can be worn on clothing or jewelry, held against the skin by a Band-aid-like adhesive patch, or inserted beneath the skin. They can be coupled with wireless technology that will allow them to communicate with a smartphone, a smart wristwatch, or the Internet. The data transmitted by these sensors can then be processed either locally (by a smartphone, for instance) or distantly (by powerful computers in communication with the Internet), and then presented to our doctor – or back to us – in a usable form.

Many uses for biosensors like these immediately come to mind. Indeed, the uses I am about to list are not the product of my fertile imagination, but are things that are being actively explored today, generally by small start-up companies nobody has ever heard of. Many of these technologies currently exist in one form or another, and have already been used, at least experimentally, in actual patients. The deployment of these things into general clinical usage does not depend on any new scientific breakthroughs, but only on our interest in having them.

Diabetes. A key to preventing many of the complications of diabetes is to keep the blood glucose levels within a relatively narrow range at all times – or as close to “at all times” as one can manage. New sensors are being developed that can measure blood glucose levels nearly continuously, which will allow insulin doses to be titrated much more precisely than current systems permit. These glucose sensors can even be coupled with a wearable, automatic insulin pump, to create a “closed-loop” system that automatically controls glucose levels – a virtual artificial pancreas.

Heart failure. Sensors that measure the resting heart rate, the rate of breathing, activity levels, the “angle of repose” (whether one is able to sleep flat, or must sleep with the head elevated), and body fluid levels can be used to monitor patients with chronic heart failure. Keeping track of these parameters can help medical personnel, or the patients themselves, more tightly manage the treatment of heart failure, to prevent symptoms from developing and reduce the need for hospitalization.

Asthma and chronic lung disease. Similarly, sensors can measure the rate of breathing, resting heart rate, the relative degree of obstruction of the airways, body temperature, and blood oxygen saturation, to help patients with asthma and chronic lung disease manage their conditions.

Neurological disorders. Sensors can be used to monitor balance, tremors, activity levels, and even mood changes in patients with neurological disorders such as Parkinson’s disease.

Cardiac arrhythmias. Sensors deployed on a Band-aid-like patch can be worn comfortably for weeks at a time to check for known or suspected cardiac arrhythmias, such as atrial fibrillation. Knowing that certain arrhythmias are occurring can lead to treatment to prevent severe consequences (such as sudden death, or stroke).

Home care for the elderly or disabled. Sensors can be used to make the home environment safer for elderly people or people with disabilities, and thus can make living at home feasible for these people when it otherwise might not be. These sensors can monitor activity levels, changes in balance, sleep quality, medication compliance, the state of hydration, and changes in vital signs.

Sleep disorders. Unobtrusive biosensors can monitor sleep apnea, as well as general sleep quality (by tracking the duration of total sleep, and of REM sleep). Formal sleep studies, which today require an expensive, in-hospital, ungainly, uncomfortable process which can only be done for special indications, could be conducted routinely and cheaply at home, as often as might be desired.

Blood pressure monitors. Sensors that can measure blood pressure either continuously or frequently can revolutionize the therapy of hypertension, which today is all too often done poorly.

Heart attack detectors and stroke detectors. Sensors that can detect acute heart attacks or acute strokes (conditions in which rapid treatment can prevent permanent disability or death) do not yet exist, but are conceptually possible. Such sensors could reduce the delays in treatment that are often seen today with these acute conditions.

Dysautonomia. The dysautonomias are a family of often-disabling disorders which include vasomotor syncope, inappropriate sinus tachycardia, postural orthostatic tachycardia syndrome, and post-traumatic stress disorder, among several others. These conditions are commonly characterized by rapid, unexplained fluctuations in heart rate, blood pressure, breathing rate, and skin temperature. The dysautonomia disorders are very often misdiagnosed by doctors as “anxiety.” Biosensors could help to pin down the diagnosis, and to help in the management of these often very frustrating conditions.

Miniaturization and personalization of sophisticated diagnostics. Current technology would allow the SIM cards inserted into a smartphone to rapidly analyze a drop of blood, urine, or saliva for electrolyte disturbances or chemical imbalances. A transducer plugged into a smartphone could convert the device to a portable echocardiogram machine, so that the heart, blood vessels, and certain other organs could be visualized.

The possibilities abound, and I have only scratched the surface.

All the technologies I have listed (most of which exist today, and all of which are entirely feasible) are very threatening to any healthcare system which is built around the centralization of every important medical decision. Deploying these sensors will inherently individualize medical care – by providing specific, actionable physiological information, on an as-needed basis, to the affected individuals themselves. Judgments must necessarily be made locally (either by the doctor and patient working together, or – heaven forbid! – by the patient him-or-herself) on how to respond to this information, in order to optimize medical care according to the often-fluid needs of the individual. The centralized decision-makers are cut out altogether.

Under Obamacare this will never do.

Human Genomics

If you have not been paying attention, you may have missed some of the remarkable things we have learned about human genetics since the completion of the Human Genome Project in 2000. This would be understandable, since the common wisdom is that we really haven’t gotten much out of it. This general perception was well illustrated on its 10-year anniversary, when numerous publications (such as the New York Times and the Wall Street Journal) offered postmortems on the Human Genome Project with titles like, “The Failed Promise of Genomics.”

It is true that scientists haven’t yet cured cancer or stopped the aging process, as we were all promised. But we have nonetheless learned a lot.

The human genome turns out to be much more complex than anyone had predicted. The basics haven’t changed, of course. DNA still consists of long, paired polymer strands of four different bases, with every three base pairs coding for one amino acid. At appropriate times the code is translated, and the appropriate amino acids are assembled into proteins. Each gene codes for one protein.

Given the six billion bases contained in the 23 paired chromosomes of the human genome, everyone was expecting that the human genome would contain at least 100,000 distinct genes. But that’s not the case. It turns out that the entire human genome codes for only 23,000 genes. Indeed, researchers now tell us, nearly 99% of the DNA in the human genome does not code for any genes at all.

So what is all that “extra” DNA doing? It seems that most of our DNA actually codes for various species of RNA, and that the RNA serves a regulatory function. Our genome, it appears, is an extraordinarily highly-regulated system. All of that regulatory RNA helps to determine when a gene will code for a protein and when it will not, under various times and circumstances, and in various organs and cells – and even helps to determine the function of that protein once it is coded. The amazingly complex regulatory influences, tugging this way and that on every gene, makes it relatively unlikely that a single mutation in a single gene will result in that gene having a runaway influence over some important physiological function. Indeed, it appears that the remarkable regulatory complex that is our genome has evolved, over many millenia, specifically to keep things from changing radically should a gene go awry.

The human genome thus resembles what a Progressive society would look like if human nature could be perfectly controlled, and society could thus develop as Progressives have envisioned. That is, for every worker who is actually producing a product, there are 99 experts and regulators telling him or her what to do. They are busily making sure the worker is doing precisely the assigned task, at the right time and place, without a nanosecond or a millimeter of variation. In other words, the huge majority of what the human genome appears to be doing is the biologic equivalent of paperwork.

Another thing we have learned is that only a very few diseases can be tied to the simple, single-gene mutations of classic Mendelian genetics. Rather, it appears, most genetically-influenced diseases are related to the summation of the behaviors of many different genes. Furthermore, thanks to the extremely tight regulation inherent in our genome, most of the genetic variants that have been identified seem to merely influence, rather than to determine, whether a person develops a disease. So the odds that an individual will develop most kinds of genetic-related diseases is not definitively determined just by knowing what is in the genome. In most cases, the odds of developing most genetic-based diseases is a probabilistic function rather than a deterministic one.

Therefore, every person’s genome is a cauldron of probabilities. And researchers are rapidly assembling a database of specific combinations of genetic variants, along with the probabilities these genetic variants yield for the specific diseases with which they are associated. This database is growing monthly.

It is now possible for you to send a DNA sample to one of a few companies for a GWAS analysis – a Genome Wide Association Study. The GWAS will yield your lifetime probabilities of developing a whole series of various diseases. A GWAS does not sequence every one of your base pairs (that kind of study is called whole genome sequencing). Rather, it uses a catalog of known single-nucleotide polymorphisms (SNPs) to map various known regions of your genome for variants known to be associated with particular diseases.

If you were to have a GWAS done, for instance, you might find out that you have a 75% lifetime probability of developing prostate cancer. This knowledge might cause you to decide to have that PSA screening test (or to wish you could have one, since the United States Preventive Services Task Force now says you may not). A 10% probability might make you OK with the recent USPSTF directive prohibiting the PSA testing.

An area where GWAS appears to offer a particularly tangible benefit is in pharmacogenetics – associating genetic variants with the response to drug therapy. It looks like genetic variations are quite deterministic (as opposed to probabilistic) when it comes to a person’s response to drugs. This is likely because we humans have not had time to evolve the regulatory RNA necessary to mitigate drug-related issues, so single-gene variations affecting the response to drugs are much more likely to be expressed.

For instance, GWAS has allowed researchers to predict, with a high degree of accuracy, which patients with hepatitis C will respond to interferon therapy. GWAS can also tell doctors which patients will fail to respond to Plavix – a blood thinner which is important in patients who receive stents for coronary artery disease. Perhaps more importantly, it looks like GWAS may be able to predict which people are likely to have specific side effects from specific drugs, for instance, to have muscle or liver toxicity from statins.

GWAS, then, may turn out to be important for drug therapy, both to predict the likelihood of a response in an individual, and to predict the likelihood of specific side effects. GWAS may even help to “resurrect” drugs that have been removed from the market because of side effects – drugs like Vioxx, which relieved painful symptoms in many patients who were not helped by other anti-inflammatory agents. If we are able to say ahead of time which individuals will have side effects and which will not, we can target drug therapy only to the people who can take them safely.

Some day, all of us may routinely choose to have GWAS performed. Then, as the database of genetic associations grows, each person would have an ever-expanding list of specific lifetime probabilities of developing various diseases, and, more importantly, an expanding list of likely responses (favorable and unfavorable) to specific drugs. This latter benefit is likely to turn out to be the most practical use for GWAS.

Whole Genome Sequencing (WGS) – mapping out every single one of the 6 billion bases in a person’s chromosomes – so far is prohibitively expensive to do routinely, but the cost is coming down exponentially. WGS has proven useful, in several cases, in identifying a specific genetic abnormality that is causing a disease that has been difficult to diagnose or treat. Knowing the precise genetic abnormality can help to target therapy to the specific protein with which it is associated.

The most obvious use of WGS is in the treatment of cancer. Cancer, by definition, is caused by a mutation in the human genome. By comparing the genome of a patient’s cancer cells with the genome of the patient’s non-cancer cells (a process that requires doing two full WGS analyses, and then painstakingly comparing the two results), it has been possible to target therapy at the root cause of a patient’s specific cancer. So, instead of using chemotherapy aimed at “breast cancer,” therapy can be aimed instead at the specific genetic abnormality being displayed by the patient’s actual breast cancer cells. This optimal therapy may turn out to be treatment that is typically used for leukemia or prostate cancer, for instance, instead of for breast cancer. By specifically targeting therapy at the individual’s own cancer cells, the probability of a favorable response can be greatly increased.

Today, the great expense and severe impracticality of doing WGS for cancer, or for other diseases, precludes using this method except in a very few exceptional cases. But in those cases, early results have been quite encouraging. I will give just one example.

On July 12, 2012, the New York Times reported on the case of Dr. Lucas Wartman, a young physician who developed adult acute lymphoblastic leukemia, a disease that is usually rapidly fatal, and for which there is no effective treatment. Dr. Wartman’s colleagues at Washington University performed WGS on his cancer cells, and on his normal cell line. The job required round-the clock work for many days by the University’s 26 sequencing machines, a supercomputer, and several senior scientists. But after making this monumental effort they discovered a single gene mutation in his cancer cells that was producing a protein that appeared to be stimulating the cancer’s growth. It turned out that a new drug existed that was targeted specifically at shutting down the offending protein, a drug that to that point had been used only for kidney cancer. When they administered the drug to Dr. Wartman, his cancer went into complete remission.

Discovering the “right” treatment for Dr. Wartman’s specific cancer would not have been possible without WGS. The cost of doing routine WGS is currently prohibitive, but the cost has come down remarkably in just a few years, and in a few more years is likely to be within the range of costs we typically see in the healthcare system.

So, while the aging process has not been halted, and while cancer has not been cured, the mapping of the human genome has opened up a whole new field of endeavor for understanding, preventing and treating a host of diseases.

By definition, using a person’s genetic makeup to guide their medical care is individualized medicine. It is not herd medicine. As in the case of Dr. Wartman, genome-based therapy will require gathering specific genetic information about an individual, and puzzling out a unique solution for the individual’s medical problem. Genome-guided medicine cannot be dictated or controlled by a centralized panel of experts dictating generalized directives. It utterly undermines the underlying operating principle of a Progressive healthcare system.

Therefore, we should expect our Progressive healthcare system to make every effort to stifle it.

How Will Individualized Medicine Be Stifled?

If it turns out I am wrong about all this, that I am being unreasonably paranoid about what the Progressives will do in response to individualized medicine, all the better. For, if Progressives fail to take steps to stop individualized medicine and instead allow it to evolve naturally, then the Progressive healthcare system which I described in Part II of this book is doomed to fail, and all will be well. So I hope that, as many readers undoubtedly believe, I am simply being paranoid.

Unfortunately I do not see how this is possible. I assert that Progressives, eventually and one way or another, will have to pull out all the stops to cut off individualized medicine. They will have no choice in the matter, because individualized medicine fundamentally undermines their entire program. It is a simple issue of survival for the Progressives.

Inhibiting The Development of Biosensors

When it comes to inhibiting the development of personal biosensors, it is unfortunately true that Progressives will have to do very little additional work. The healthcare system as it currently exists, even before Obamacare takes effect in any major way, makes it extremely difficult to make much progress on this front.

I have had a fair amount of personal experience in this area. When I left medicine in 2000 (after 25 years of hands-on medical practice), I was recruited by the CEO of a major medical device company to serve on a 5-person “skunk-works” team he was assembling, that was charged with advising the company on (and I quote) “what to do about the Internet.”

Uninitiated readers might blanch at the idea that a major biotech company took so long to figure out that the Internet was more than just a flash in the pan, and was, in fact, something that ought to be considered in long-term business plans. Consider this startling fact to be an introduction to the idea that the healthcare system – from top to bottom – tends to be fundamentally conservative and sclerotic in outlook. This is what happens when you function in a system where every step you take is massively regulated – once you learn to survive in such a dystopian environment, then anything really new that comes along tends to be viewed as a major threat to your modestly satisfactory existence. Fundamental innovation is to be avoided, and if it cannot be avoided, then it is adopted as slowly (and painfully) as possible. This is a hallmark of heavily regulated systems – you get stability of a sort, but not innovation. (Again, the similarity to the human genome is striking.) If you doubt my words, ask yourself why the healthcare system has had to be dragged, kicking and screaming, to adopt electronic medical records, or why doctors still have not discovered e-mail.

Our skunk-works team consisted of myself (serving in the role of grizzled clinician) and four brilliant bioengineers, who were young enough and low enough in the company hierarchy to still maintain their air of excitement at the idea of innovation as a way of improving peoples’ lives. Remarkably, as it turned out all five of us had been independently thinking about the application of the Internet to modern medicine, and when we began brainstorming together our thoughts dovetailed. Within a few hours we had agreed on the broad outline of our plan.

Our thinking went like this: The company (a manufacturer of pacemakers and implantable defibrillators) already had their products positioned inside patients’ bodies. Those products contained sophisticated, battery-driven microprocessors that took electrical signals from the heart, processed those signals with complex algorithms, and accurately decided to deliver or withhold therapy (a pacing impulse, or a defibrillating shock) on a moment to moment basis. Why not take advantage of: a) the inside-the-body location, b) the microprocessor, and c) the existing expertise with algorithm development, to deploy biosensors in these devices, biosensors that could detect useful information about a patient’s physiology? Such information could easily be transmitted outside the body by inserting, say, a Bluetooth radio in these devices to send data to some sort of external relay, which could then send it on to the Internet. (Smartphones did not exist in those days.) In this way the data gathered by the biosensors could be passed on to more powerful computers at the server level, and applied to more sophisticated algorithms, and even combined with data from other sources (the patient’s medical history or medication list, for instance), in order to turn it into actionable information. This information could then be distributed to whoever ought to see it – the patient, the doctor, the patient’s family, &c.

We then spent time compiling a list of biosensors that either existed or could be rapidly developed, and with that list devised another list consisting of the medical conditions that could benefit from monitoring these biosensors. (The list we devised looked remarkably like the list I produced earlier in this chapter. Many would-be innovators have come up with similar lists.)

Our value proposition was this: By using targeted biosensors to monitor a patient’s physiology, we could enable the precise titration of therapy for chronic medical conditions, thus preventing acute exacerbations of those conditions. Expensive hospitalizations could be avoided; patients would remain healthier and happier; and lots of money could be saved. Since the healthcare system would save so much money, we figured naively, a mechanism could easily be devised to return a portion of those cost savings to the company that was producing them.

Because a relatively high proportion of patients who received the company’s products had chronic heart failure, we recommended that heart failure should be the initial focus for the company. Accordingly, we devised a first-pass algorithm which incorporated several readily-available biosensors to assist in the management of heart failure. After working diligently for three months, we had a business proposal ready, and a formal presentation before the company’s top management was scheduled.

After listening to our presentation with increasing dismay,  management tossed us out of the board room on our respective ears. To say that our proposal was ill-received would be to understate the matter significantly. They more than hated it; they were horrified by it.

There were several reasons the top executives were horrified. A few of those reasons were bogus, and can be attributed to a general fear of embarking on a major change in the company’s direction. But two of those reasons were quite legitimate, and made their decision to banish our skunkworks team into the wilderness the correct call.

First, despite our naive assumption that surely the healthcare system would be willing to spend a little money in order to save a lot of money, this is not the case. The healthcare system does not reason like this. It reasons like a bureaucracy. For practical purposes, the only things a company (or a doctor) can get paid for in our modern healthcare system are healthcare services for which a Medicare billing code already exists. If you devise a new kind of medical service for which there is no code, you have only two pathways to payment. You can petition Medicare to create a new billing code, and then ask them to assign to the new code a reasonable reimbursement value. This two-step process typically takes several years, and there is no guarantee of success – in fact, odds are that you will fail. Or, you can rationalize a way to shoehorn your new medical service into an existing code, and convince Medicare that your rationalization is justifiable. This pathway has a higher probability of succeeding in a reasonable period of time (say, a year or so) – but then you must accept the reimbursement that is already in place for that pre-existing code, and you must accept it, essentially, forever.

No billing code existed for our biosensor proposal, and the company’s management understandably expressed no interest embarking on the lengthy and difficult process of pursuing a new billing code. And any existing billing codes into which we might conceivably have shoehorned our new service reimbursed only a pittance – not nearly enough to cover our costs, let alone to make the endeavor profitable.

The bottom line was that the only conceivable way for the company to profit from our proposal was to add our proposed heart failure management system as a new “feature” to their pacemakers and implantable defibrillators, essentially at no extra charge. The company would have to rely on this new feature enticing doctors to select its implantable devices over some other company’s devices. In other words, it would have to be a pure market-share play.

And this brings us to the second very legitimate reason top management was right to send our team to the woodshed. Far from enticing doctors to choose this company’s devices over the devices of other companies, our heart failure management system would have doctors avoiding this product in droves. The V.P. of Marketing said it best: “The last thing our doctors want is a data dump, especially data they never asked for in the first place, but which is dumped on them at the whim of some defibrillator they implanted in some patient two years ago. You say it won’t be a data dump, but a reporting of pre-digested, actionable information. Did the doctor ask for that actionable information? Did he ask for it at 3 AM? What is his liability if he fails to act on it within 24 hours, within an hour, within a minute? And does he even remember who the hell this patient is? And how is he supposed to get paid to do this job he never asked for in the first place? Just as there are no billing codes for our company to be reimbursed, there are equally no billing codes for the doctor to be reimbursed for interpreting and acting upon the unsolicited data we are foisting off on him. We will have just placed this doctor on-call, 24/7, for every patient he’s ever implanted a device in, forever, and without pay. And you think the threat of doing this to doctors is going to entice them to select our devices over the devices of our competitors? And finally, if we do this thing, even if the doctor never ever uses one of our defibrillators ever again – as you must admit seems likely – we will have created an expectation out in the world. This product will exist, and doctors who choose to avoid it will be seen as bad doctors, and potentially will be liable for failing to use available technology in patients who might benefit. Not only will doctors avoid our devices, but we will be creating an actual, visceral, permanent hatred for our company among our customers for unleashing such a travesty upon the world. And then our company will cease to exist – and with just cause.”

These, one must admit, are pretty good arguments.

Like the residue from an actual skunk, however, our team proved pretty persistent, and a couple of years later we managed to convince the company to make implantable devices that talked to the Internet – but only to transmit data about the device’s own functionality, and not the patient’s. This feature proved to be very useful and very popular, in that it enabled any device malfunction to be quickly detected and dealt with. Because there was still no viable alternative, it was indeed added to devices as a pure “feature” without additional charge, as a market-share strategy. And, is almost always the case with market-share strategies, the advantage to the company was temporary. The competition soon added their own similar features. So at the end of the day, the cost of doing business went up for all the companies in this space, and their profit margins went down – without much net change in market share for anyone.  This kind of experience does not encourage similar innovations in the future.

Never one to give up easily on what I consider to be a good idea, five years ago I signed on as the chief medical consultant to a start-up company which aimed to devise wearable biosensors to help manage medical conditions. We designed an adhesive patch that contained several biosensors and which communicated with the Internet, that could be worn comfortably (including during sleep, showers, and vigorous exercise) for up to two weeks at a time. We decided to focus initially (again) on heart failure, since the healthcare system by this time had explicitly identified heart failure hospitalizations as a major financial drain, and healthcare bureaucrats were making a lot of noise about employing (and paying for) systems that would reduce these hospitalizations. Also, it looked to us as if doctors – having by now been made wards of the state – would soon have to use such systems whether they liked it or not, once they were ordered to do so.

We actually accomplished quite a bit. We built the devices, derived an algorithm based on several biosensors to monitor the status of heart failure, did a large clinical trial in patients with heart failure to prove that the algorithm worked, and saw a peer-reviewed paper published that documented the effectiveness of the biosensor-based algorithm. Things were looking up.

That’s when the regulators noticed that several entrepreneurs were doing similar things – developing systems for chronically monitoring the physiology of patients with sundry medical conditions – and they became very concerned about it. I am willing to concede to skeptics that their concern may only have been subliminally about individualized healthcare. Their more proximate concern, likely, was the fact that an entirely new area of medical service was being invented right under their feet, and they were worried that (despite the claims of the inventors) it was going to increase the cost of healthcare. In any case, regulatory action was required to suppress it.

And so regulators, without issuing any formal change in policy, began quietly relating to these companies that from now on, before any such “diagnostic” could be approved, it was very likely that the company would no longer merely have to demonstrate that their product accurately measured exactly what it said it was measuring (such as, in our case, that when we said a person’s heart failure was slipping out of control, the heart failure was actually slipping out of control). Rather, companies would have to prove, in a long-term, randomized clinical trial, that using their product would significantly improve the actual clinical outcome of the patients enrolled.

This new sub rosa regulatory requirement essentially blew us out of the water. Randomized clinical trials proving that a therapy changes clinical outcomes are difficult and expensive enough to operate. But when you are testing a diagnostic instead of a therapy, the proposition becomes an order of magnitude more difficult. This is because when testing a diagnostic, the clinical outcome does not merely depend on your product (as it generally does in a therapy trial), but also on the decisions the doctor and patient make in response to the information your product is giving them. How a doctor may act in response to actionable clinical information is extremely variable. And how a patient accepts the doctor’s recommendations, and follows them, is also variable. Such clinical actions are entirely out of the control of the company, and are entirely unrelated to the accuracy of the information the product is providing the doctor and patient.

A quick back-of-the-envelope calculation revealed to us that conducting such a clinical trial would probably cost more than the estimated valuation of the entire company. Not only could we not afford it, but also it was impossible to consider going to outside investors for that magnitude of additional funding. (Only the government is routinely bone-headed enough to “invest” far more money in a favored company than that company could ever be worth.) At that point the company’s leadership made an executive decision  to put heart failure on the shelf. Fortunately, they have been able to redirect their technology to a much more mundane, less exciting, less useful-to-mankind – but reimbursable – application, so at the moment the company is actually doing pretty well. And maybe – when it becomes as flush as Apple and can afford to take the risk – heart failure will be taken up again.

But for at least the foreseeable future this company has had to stop attempting to advance the management of heart failure, or any of the other chronic or acute medical conditions which biosensors can address – and consequently it is no longer advancing the cause of individualized healthcare in any substantial way. That effort has been successfully suppressed.

So my personal experience has taught me that the roadblocks to applying personal biosensors to advance individualized medicine are substantial. There are roadblocks regarding reimbursement. (How can you get paid in a timely manner for a new medical service for which billing codes do not exist?) There are roadblocks regarding the willingness of physicians to change the way they practice. (Individualized medicine, in which doctors might have to react at any time to information that might pop up about one of their patients, without any pathway for receiving payment for such services, is far from an attractive proposition for doctors.) And the regulatory pathway for gaining approval for biosensor-based products has rapidly become virtually prohibitive for any but the largest enterprises.

So, while personal biosensors, in theory, pose a major threat to a Progressive healthcare system, in practice it is going to be a huge challenge to advance these biosensors to the point where they can truly enable individualized healthcare. In fact, to have any chance of getting there some creative strategies will need to be developed, because the traditional pathways have been all but blocked.

The Coming Battle Over Human Genomics

Nothing in the material world defines us as individuals as much as our own personal genome. And while the last decade has taught us that the manner in which our genetic makeup is expressed is far more complex than we had ever dreamed, we have also learned – through occasional blinding new insights – that genomics is the key toward targeting therapy, in previously unimagined ways, to the specific cause of a specific disease in a specific individual. If we allow this line of investigation to continue to its logical outcome, very much of medical care, if not all, will eventually be tailored to the individual.

And nothing I can think of poses a more dire threat to herd medicine.

Since the top-down, centralized control of all important medical decisions is the fundamental organizational structure of Progressive healthcare, genomics-based healthcare ought to be seen as an existential threat by Progressives. They should, one might think, be taking steps to stifle it.

While admittedly I do not have the sort of “inside scoop” regarding genomics that I might have with biosensors, I find it striking that few such stifling efforts by Progressives seem visible. Indeed, far from stifling it Progressives seem happy to let genomic science develop – for now, at least. The Human Genome Project was funded by the government, after all. And the efforts of the government-funded NIH are instrumental in continuing the development of knowledge based on the human genome. I see no signs that government funding for these efforts is going to be slackened any time soon.

How can it be that a Progressive healthcare system, if anything, seems to be encouraging genomic research, when individualized healthcare is such a threat to the Progressives’ entire program? There are several possible answers to this question, and we should consider all of them.

Perhaps I have the entire thesis of this book wrong. Perhaps centralizing the control of all healthcare decisions is not the fundamental tenet of Progressive healthcare. But I submit that the contents of this book, explaining the behaviors we see in our Progressive healthcare system in light of this fundamental tenet, strongly mitigate against this possibility. Readers, of course, must consider the strength of this argument for themselves.

Perhaps Progressives are so excited by the possibilities for curing terrible diseases, cures made conceivable by genomics research, that it has overwhelmed the natural enmity they would otherwise feel for such an individualized approach to healthcare. Indeed, it is very likely that your typical, run-of-the-mill Progressive, the ones who join you around the dinner table at Thanksgiving, are overtaken with this kind of enthusiasm (if they have actually looked into the implications – either positive or negative – of genomic research at all). I am skeptical, on the other hand, that Progressive leaders – the ones who are making the decisions, and who, for instance, undermine the Constitution every chance they get – have let their enthusiasm for medical cures overwhelm their animosity for anything that returns the control of medical decisions to individuals.

The final possibility, the one that is most disturbing, but unfortunately the one that appears most probable, is that Progressives have no intention of stifling genomics research, because instead they intend to control it.

People tend to get very angry when you accuse them of espousing eugenics. So I hasten to assert that I am not accusing Progressives of espousing eugenics – yet. I am merely advising prudence.

When you have a known, convicted sex offender living down the street, even if you have met him and he seems at the moment to be an entirely reasonable and steady person, if your eight-year-old daughter must walk past his house on her way to the school bus it is likely you will take every precaution to make sure nothing untoward happens to her. This is because, as a general rule, something in the makeup of sex offenders makes them likely recidivists. You should never quite trust them around your kids, no matter how normal they may appear at the moment.

In a similar way, eugenics is not merely a prominent facet of the history of Progressivism, it is in the DNA of Progressivism. And while their regulatory RNA seems to have kept it in check for the past several decades, their past history alone ought to give us great pause. We should no more give Progressives control over genomics than we should give our ex-alcoholic brother-in-law control over our liquor cabinet. If they, or our brother-in-law, should become indignant about our refusal to trust them completely, we should not bend. Their past actions have placed us in this position. We should only explain that we love them very much, and for that reason will not willingly allow temptation to get in their way.

The history of the eugenics movement among American Progressives is remarkable, and equally remarkable is the relative success with which that history has been expunged from popular memory. I submit that this is a form of amnesia in which, at this moment in our history, we cannot afford to indulge.

I will not go into a detailed description of the late eugenics movement. I will merely point out that for a half-century it was openly and enthusiastically espoused by the cream of the Progressive crop, and it was more than merely a point of discussion. Involuntary sterilizations were conducted on “undesirables” across the country, and doctors were encouraged to let “defective” babies die. The New York Times encouraged at least the passive euthanasia of defective individuals, urging its readers to look upon such “medical care” “without the horrified exclamations of unenlightened sentimentality.”

I could go on, but I will just make one more point to illustrate the prominence of eugenics in the early 20th century. In 1927, the United States Supreme Court heard the case of Buck v. Bell, which challenged the constitutionality of the involuntary sterilization program then in operation in Virginia. The Court ruled eight to one that the sterilization program was entirely constitutional, and furthermore, Chief Justice Oliver Wendell Holmes in his opinion made the case that involuntary sterilization of undesirables was a natural and useful thing to do, and is well supported by objective science. Holmes wrote: “It is better for all the world, if instead of waiting to execute degenerate offspring for crime, or let them starve for their imbecility, society can prevent those who are manifestly unfit from breeding their kind. The principle that sustains compulsory vaccination is broad enough to cover cutting Fallopian tubes.” Then, addressing the case of the unfortunate young woman whose proposed sterilization brought the issue before the Court, “Three generations of imbeciles are enough.”

And there we see, starkly revealed, what really underlies Progressive compassion. (As one who has been called an imbecile, and far worse, by Progressives who have stumbled upon my blog, such sentimentalities must give me pause.)

The point I am making here is that for many decades eugenics was mainstream. Proudly, enthusiastically, loudly, and assertively mainstream.

The second point I want to make about the American eugenics movement is that it was no fluke. The conditions that led Progressives to embrace it still exist. They will always exist.

Progressives started out, as they invariably do, with the best of intentions, that is, they deeply desired to help the downtrodden. So in the late 19th century they instituted all manner of reforms aimed to lift up the poor, the disabled, and the criminals (who, they believed, were criminals only because they acted in ways that displeased the rich). Unfortunately, as will always be the case, the objects of their sympathetic efforts did not respond in the manner predicted by Progressive dogma – many of them did not become ideal citizens. Far from it.

Because it could not possibly be the Progressive Program that was mistaken, the fault could only lie with the inherently defective natures of the people they were trying to help. It followed, then, that the real fault must be in the genes of these unfortunates. And so, it became clear that in order for the Progressive Program to advance as it would benefit all mankind for it to advance, something had to be done about the gene pool. And hence, eugenics.

Here’s the thing. It seems unlikely to me that human nature has changed very much during the past century. And it seems just as unlikely today as it was a hundred years ago that the citizenry will simply comply, fully and uncomplainingly, with the Progressive program.

Progressives always begin the same way. They assume that, because their system is so inherently logical and scientific, any reasonable person will immediately see the benefits of submitting to the expert-driven system (whichever one they are pushing at any given time) they have prescribed for us. And when human nature compels many of us to fail to subsume our own individual interests to the interests of the whole, Progressives begin to get frustrated.

At first, they attribute the failure of their program to insufficiently educate the public about the great and wonderful benefits of it. As I write this, President Obama has just allowed that the greatest failure of his Presidency, so far, is the failure to “tell the right story.” That is, it’s his failure to sufficiently educate us, the great unwashed, on the righteousness of  his historical journey to a fundamentally different society. This is the classical first-pass Progressive reaction to the people’s mule-like refusal to submit.

When we still refuse to behave as prescribed, even after efforts at educating us have been redoubled, the Progressives invariably come to the conclusion that the actual problem is something other than their suboptimal explanations of benefits. The only other possibility, of course, is that they are dealing with substandard material. We in the unwashed – many of us, at least – just don’t stack up.

Anyone who does not accept the pure logic and scientific correctness of the Progressives, even after all efforts have been made to teach us the right path, can only be evil, stupid or crazy. One is justified, of course, in simply doing away with the evil ones. The ones who are stupid or crazy may deserve a bit more compassion – but still, they need to be dealt with.

And sooner or later it occurs to Progressives that, at the very least, these people need to be kept from propagating, lest their recalcitrance be passed on down through the generations. The Progressive Program requires – absolutely requires – a citizenry that understands the overall goodness of what Progressives are attempting to do. And how can such a thing be achieved if the people who don’t get it – who can never get it, through their own inherent shortcomings – keep perpetuating their genetic material?

Look. I am not saying that today’s progressives are engaging in eugenics, or openly espousing it, or even secretly espousing it. I am merely pointing out that the same circumstances that led them to adopt eugenics in the past – to a remarkable and stomach-churning extent, to such an extent that only the atrocities of the Nazis at last made them back off – still exist today.

The general population, forever slaves to human nature, will still be as recalcitrant to the prescribed program as they have been in the past, and Progressives will become no less frustrated by it. Medical ethicists are already beginning to broach the idea of a kinder, gentler form of eugenics – a type they refer to as “positive eugenics,” in which people with undesirable traits are “discouraged” from propagating. Most Progressives, I’ll stipulate, are not thinking about eugenics today. But the groundwork is being laid for them and will be ready when they get around to it.

And today, thanks to genomics research, the ever objective and scientific Progressives will convince themselves that they’ve got the the tools they need for determining which genetic traits can be considered positive and which are negative.

While the notion of eugenics may remain subliminal at the moment for most Progressives, I am arguing that the very nature of the Progressive program will almost inevitably – if it hasn’t already – bring the consideration of eugenics (doubtless renamed to something with less negative historical implications) to the fore.  We have placed that ex-alcoholic brother-in-law in charge of our liquor cabinet.

If I am correct, the Progressives will be doing something of a balancing act. They will need to allow genomics research to proceed, but while somehow discouraging the development of individualized medicine that would naturally result from it.

In this effort they will have the support of their ever-vigilant allies, the medical ethicists. In reporting on the Wartman case, the New York Times also dug up several medical ethicists for suitable comment.  And of course their remarks indicate that it is indeed unethical to offer such avant-garde therapy to the well-connected. The ethicists question “whether those with money and connections should have options far out of reach for most patients before such treatments become a normal part of medicine.” The chair of the department of bioethics at the University of Washington asks, “If we say we need research because this is a new idea, then why is it that rich people can even access it?”

This is the usual Progressive “fairness” argument, in which we are to achieve equity not by raising up the have-nots, but by tearing down the haves. By the same ethical argument, no major advance in medicine would be able to proceed. Most radical, ground-breaking advances initially require expensive equipment, hundreds of expert man-hours, or procedures that by their very natures can be used, at first, in only a few patients. By this ethical standard we would never have had things like organ transplants, robotic surgery, implantable medical devices, or even coronary artery bypass surgery or MRI scans.

This is a fine argument for stifling medical progress in general, but it is particularly suited for stifling individualized medicine. It is an argument that, if accepted, will permit genomic research to continue, but will simultaneously preclude the application of genomics to solve the unique disorders of specific individuals, as in the case of Dr. Wartman.

So What Now?

Individualized medicine, fully developed, would completely undermine the fundamental paradigm of Progressive healthcare, and would require us to reform the healthcare system in different way – in a way that is compatible with the Great American Experiment, that is, with the primacy of the individual as its organizing principle.

It is therefore inevitable that Progressives will try to smother individualized medicine in its crib. They have made an excellent start at it, with a rigid government-controlled payment system that does not easily recognize new kinds of medical services, onerous regulatory policies that make it extraordinarily difficult to bring this type of product to market, and the enervated sclerosis of a medical profession struggling just to keep its head above water. This “excellent start” merely reflects the long-term results of a gradual shift to a Progressive healthcare system. Obamacare merely accelerates that trend, and makes the real intent of Progressive healthcare quite stark for anyone who cares to see. The question of repealing Obamacare, given the current state of things, is likely to determine not whether we will have a Progressive healthcare system, but merely what trajectory we will take in getting there.

Yet, the tools for individualized medicine are right there before us, tantalizingly close. And whether Obamacare is repealed or not, individualized medicine, threatened as it is, remains our last, best hope for reasserting individual autonomy in our healthcare system.

A critical mass of people who insist on asserting their unalienable rights despite the Progressives, a few entrepreneurs who find creative ways to supply them with the tools they need, and a few brave doctors who rededicate themselves to the traditional doctor-patient relationship, can allow individualized healthcare to progress to the point where everyone will demand it. Indeed, as long as enough Americans refuse to surrender their individual autonomy, it is difficult to see how a Progressive healthcare system can persist in the long run.

In the next chapter, the last chapter of this book, I will address what we each should do if we want to preserve individual autonomy in American healthcare, and in our culture.
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