Chapter 14 – Stifling Medical Progress

This is Chapter 14 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.

And here is the up-to-date archive for all the chapters that have been posted so far.
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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 14 – Stifling Medical Progress

In 2011, David Brooks – the Progressive who passes as the house “Conservative” at the New York Times – wrote a remarkable piece suggesting that the root problem underlying our unsupportable national debt is, essentially, the unreasonable desire of Americans to be cured of their illnesses. This is indeed an interesting and enlightening formulation.

Since the root problem is the unreasonable attitude Americans have toward disease and death, the only possible solution, Mr. Brooks indicates, is for Americans to drastically change their attitude.

Brooks begins with a paen to Dudley Clendinen, a former colleague at the Times suffering from ALS (Lou Gehrig’s disease), who had recently written about his plan to commit suicide before allowing himself to become completely incapacitated by his illness.

Many of us will understand, respect, and even support Mr. Clendinen’s plan to commit suicide under these conditions. However, understanding and respecting his plan is not the same as insisting that everyone in his position should feel obligated to do likewise, or that failing to do likewise makes you unreasonable (or worse). But this is exactly Mr. Brooks’ position: “[I]t is hard to see us reducing health care inflation seriously unless people and their families are willing to do what Clendinen is doing – confront death and their obligations to the living.” In other words, Clendinen is doing no more than his rightful duty. He does not deserve praise as much as people who choose otherwise deserve criticism.

The problem, Brooks indicates, is our unreasonable desire to be cured of illness, and our failure to just accept our ultimate fate, which is death. Those unreasonable expectations are precisely what is driving up our healthcare costs, and therefore are fundamentally threatening to our society.

The exhortation to suicide was merely Mr. Brooks’ opening salvo. (After all, the failure of most of us to commit suicide in a timely fashion can be only a relatively minor cause of our unsustainable healthcare spending.) He quickly moves on to his main point, which is that our unrealistic expectations regarding healthcare cause us to concentrate too heavily on medical research in a never-ending attempt to find new cures and new treatments. It is our insistence on continued medical progress, in the face of inevitable death, that is the real problem.

He insists that our sustained drive for medical progress is wasteful and ineffective. Indeed, he asserts, real medical progress is mostly an illusion. The War on Cancer was declared over 40 years ago, he points out, and has still not been won. And despite all the research we have done, heart disease is still the number one killer. Indeed, the main thing we have achieved with all our monumental efforts in medical research boils down to “devising ways to marginally extend the lives of the very sick.” It is time for us Americans to readjust our expectations regarding illness and death, and accept gracefully that both are inevitable, and then cut back drastically on all those wasteful and ultimately counterproductive attempts to achieve medical progress.

As his authority in drawing such a conclusion, Brooks relies heavily on an earlier article which appeared in The New Republic, co-authored by the noted medical ethicist, Daniel Callahan. In that article, Callahan set out in detail the problems caused by that which passes today as medical progress (which Callahan describes largely as an extraordinarily expensive chimera), and outlined an approach to fixing those problems. First, he says, Americans need an attitude adjustment: “[T]he public must be persuaded to lower its expectations. We must have a society-wide dialogue on what a new model of medicine will look like: a model that will be moderate in its research aspirations. . .” And then, having had our expectations appropriately reduced, we all will finally recognize that “[t]he only reliable way of controlling costs has been the method used by most other developed countries: a centrally directed and budgeted system, oversight in the use of new and old technologies, and price controls.”

And so, relying on this widely recognized, widely revered authority, Brooks – in America’s Newspaper of Record – spells out in clear terms a critical aspect of any Progressive healthcare system, an aspect that Progressives only rarely dare to mention publicly. Namely, in any truly Progressive healthcare system, the Central Authority will have to stifle medical progress.

While The Progressives May Have A Point. . .

I must interject right away that I am not attempting to defend the status quo when it comes to the current condition of medical research and development. Much of what passes for research and development in the United States today is indeed fundamentally wasteful, and I am in favor of a drastic change in how we move medical technology forward. So when Progressives such as Brooks criticize the rationale under which we strive to find new ways to prevent, cure or ameliorate disease, and when they criticize the effectiveness of such efforts, they generally make some very telling points.

I for one, however, wish the Progressives had discovered this conveniently nihilistic attitude (i.e., that medical progress is an illusion, and we would do well to just accept the fact that we’re all going to get sick and die, and stop expecting modern medicine to do something about it) before they went to all the trouble of taking over our healthcare system. Since healthcare itself is futile, Progressives ought now to realize, then so must be is all the time and effort they are wasting on it.

My objections to the Progressive formulation regarding medical progress is threefold. First, while I will not argue that all of our investment in medical progress has been stunningly successful, I will point out that neither has it all been futile. Hundreds of thousands of cancer survivors are leading happy lives today who would have been dead from their disease in 1970. And while the mortality rate from heart attacks approached 20% in 1970, today (in the U.S at least) it is around 2%. So while we haven’t cured all cancer or all heart disease, our efforts have still improved and extended the lives of a lot of people. Second, the solution our Progressive commentators recommend is precisely the wrong one. (More on this shortly.) And finally, the very reason medical progress is so often counterproductive has a lot to do with our increasingly Progressive healthcare system itself.

I can summarize what I mean by this last point with a simple, three-statement progression:

A) Under any Progressive healthcare system, healthcare is a right.
B) Since healthcare is a right – and since rights cannot be rationed – anything that is deemed to be “healthcare” must be provided by society to each individual.
C) Anything that can be proven to prevent, cure, or ameliorate any illness, no matter how marginally, must be deemed to be “healthcare,” and thus must be provided to each individual.

Under a Progressive healthcare system, therefore, any company that comes up with any new treatment that can be shown, in a clinical trial, to offer some marginal benefit over the currently available treatment, can (theoretically) rely on the healthcare system “covering” that new treatment. The healthcare system has no choice in this regard. Because healthcare is a right, then if Treatment B is demonstrably better than Treatment A, everyone is absolutely entitled to Treatment B. (Progressives, of course, actually withhold medical care on a par with the most heartless of insurance companies, but they do so only in secret, or if they must do it in the open,  carefully explain why the withheld care is doing more harm than good.)  In any case, this formulation creates a strong incentive for companies to produce low-risk, high-reward medical products, products that advance healthcare only marginally and break little new ground – a new statin, say, or a slightly more rapidly-acting erection enhancer – but (since they are “better” in some way than current products), will have to be paid for. At the same time this kind of system discourages companies from working on high-risk products that are more likely to represent true medical breakthroughs. A Progressive healthcare system intrinsically distorts the direction of medical progress.

Progressive healthcare systems inevitably produce all sorts of other counterproductive distortions as well. As we have seen in earlier chapters, a Progressive system attempts to prevent individuals from spending their own money on their own healthcare. It treats each individual as interchangeable members of a herd. It undermines preventive medicine, demonizes the obese (for starters – other groups ripe for demonization will not be far behind), and attempts to covertly ration healthcare services according to one’s value to the Central Authority (manifested by the attempts of Progressives – as is nicely illustrated in Brooks’ article – to expedite the demise of our older citizens).

But, as Brooks and Callahan so passionately argue, a top priority of a Progressive healthcare system will have to be stifling medical progress. Not to reformulate medical progress to make it more efficient and effective, but to stifle it.

The Real Reasons Progressive Must Stifle Medical Progress

Stifling medical progress is a critical need for Progressives. There are at least six reasons this is the case.

1) Brooks and Callahan correctly note that the medical progress we have enjoyed over the past 6o years is the very thing that has so drastically driven up the cost of our healthcare. If doctors were still treating heart attacks with 10 days of bed rest, or depression by telling people to buck up, or cancer with sad looks, we would not have had a fiscal crisis in the first place. The new treatments that medical science develops are virtually always far more expensive than the “treatments” they replace.

2) It is only rarely that medical progress helps the people who are in the Central Authority’s “sweet spot,” that is, the people between 20 and 50 years of age who (as agents of the Central Authority have written – see Chapter 13), are really worth an investment of healthcare dollars. Rather, most medical progress has been made in fighting the heart disease and cancers that affect the far-less-worthy older population, or in treating certain congenital disorders, genetic defects or infectious diseases that affect very young (and thus also relatively worthless) people.

3) As Brooks and Callahan emphasize, it has been the general nature of medical progress that advances in healthcare have tended not to cure or eliminate diseases, but rather, have tended to convert relatively brief (and thus relatively inexpensive) fatal illnesses to the much more chronic (and therefore much more expensive) medical conditions especially enjoyed by our rapidly burgeoning population of older citizens.

4) A large proportion of medical progress has come under the category of “preventive medical services” – items such as the expensive imaging tests we use to screen for cancer and heart disease, or the use of statin drugs to reduce the risk of heart attack and stroke, or the development of implantable defibrillators to prevent sudden death. We have seen (Chapter 11) how preventive medical services always cost the healthcare system far more money than they can ever save.

5) Medical progress is largely unpredictable, that is, despite the best efforts of medical scientists to pursue progress in an organized and predictable manner, the real medical breakthroughs are all too often fairly serendipitous. They often come out of left field, from where you least expect them.

Because medical progress is largely unpredictable, it is largely uncontrollable – you cannot titrate medical progress, or determine ahead of time either its speed or the direction it will take. And when the operational model of Progressive healthcare utterly depends on centralizing the control of the entire system, then allowing medical progress to simply proceed in its own direction and at its own pace presents a huge threat to the system. Just think of the havoc that would result if, for instance, suddenly and without official permission, some independent group of researchers finally developed a practical, fully implantable artificial heart. The healthcare budget would explode overnight.

6) This is the most important reason. The general direction of medical progress during the past decade has passed a critical inflection point, one that presents an existential threat to the Progressive healthcare model. In a word, fundamental advances in medical research, combined with a convergence of wireless technologies, have turned us down the path toward individualized medicine. New therapies are on the horizon that will be targeted toward individual patients with specific needs, and not toward the entire herd. New diagnostics are now feasible that can be accessed and interpreted by almost anyone, that will tend to “democratize” and decentralize the management of medical conditions. I will have much more to say about individualized medicine in Part 3 of this book, as I believe it may offer us our last, best hope to vanquish the herd medicine model that is so critical to the Progressives. But for our present purposes it is enough to note that if medical progress is left unfettered, it promises to undermine and perhaps even destroy the one-size-fits-all Progressive healthcare system – and ultimately, the entire Progressive Program itself.

Allowing medical progress to continue in the direction it has begun to take in recent years will be suicidal for Progressives. If they are to permit medical progress to continue at all in any meaningful way, they will need to control it utterly. They will have to subject it to the same top-down, expert-directed, command and control structure they mean to apply to the rest of the healthcare system. There can be no free-wheeling or even modestly independent research. Medical research, such as it is, will have to be taken in hand and controlled centrally.

Brooks has made the emotional argument, and Callahan the ethical argument, for our Progressive leaders to do just that. However, Progressives being Progressives, and the ends justifying the means, our leaders haven’t been sitting around waiting for the public arguments to be made in order to act.

Indeed, their efforts have already gone a long way toward stifling medical progress.

Insisting On Randomized Trials In All Cases

By insisting that all new drugs and medical devices be “proven” in large, randomized clinical trials (RCTs) before they can be approved, the Central Authority has erected a major hurdle for companies that want to introduce new healthcare products. RCTs, to be sure, have added tremendously to our knowledge over the past few decades, and in many cases they are indeed the only useful way to study the effect of a medical intervention. But as we saw in Chapter 9, RCTs in fact do not separate truth from falsity, as many academics and virtually all regulators seem to insist. RCTs do not even accomplish the one thing they are supposed to accomplish, namely, to eliminate bias from medical research. Rather, RCTs give the designers and interpreters of clinical trials the opportunity to control that bias, and turn it in the direction they wish. And the RCTs which are used to determine whether a medical product can be approved for use are usually designed with the participation of the regulators, and the final interpretation of those studies always is performed by the regulators.

RCTs are often extraordinarily difficult and time consuming to administer, and generally are extremely expensive to run. That expense has increased tremendously in recent years, as the regulators have begun insisting upon enrolling many thousands of patients into these studies. Accordingly, the cost of developing new drugs and clearing them through the regulatory hurdles has become astoundingly expensive in recent years. According to Eric Topol in his recent book “The Creative Destruction of Medicine,” the average cost of bringing a new drug to market in the United States increased from $250 million in 1995 to $4 billion in 2010. Even the big drug companies now have to think long and hard about the risks before attempting to bring new products to market, as one or two failures of that magnitude in a short period of time could bring them down. And for small start-up companies, the expense is simply out of the question.

There are several reasons the pipeline for new drugs has shrunken so markedly over the past several years, but the tremendous cost of gaining regulatory approval – a cost which requires companies to place their bets very, very carefully – is clearly a major one.

Aside from the cost they engender, RCTs are sometimes inappropriate and counterproductive. I will give two brief examples.

In the early 1990s, implantable defibrillators had progressed sufficiently to have become widely applicable in people who had a high risk of sudden death from cardiac arrest. Most cardiac arrests are caused by the sudden onset of a lethal heart rhythm disturbance called ventricular fibrillation, or VF. If a person develops sudden VF, unless the arrhythmia is terminated within a few minutes (usually by shocking the patient’s chest with a defibrillator), the odds of death are virtually 100%. Accordingly, the mortality rate of out-of-hospital cardiac arrest is exceedingly high. The reason implantable defibrillators are so attractive is that, once implanted, they successfully terminate VF – by automatically delivering a shock directly to the heart – over 95% of the time. And in non-randomized clinical trials, in which defibrillators were implanted in high-risk patients, it was clearly documented that people who had these devices had an excellent chance (in excess of 90%) of surviving subsequent cardiac arrests.

So clearly, implantable defibrillators were effective, and they saved lives.

But before regulators would agree to cover implantable defibrillators in Medicare patients, they insisted that an RCT be performed, in which high-risk patients would be randomized to receive either the implantable defibrillator, or “best medical therapy,” with overall mortality as the end-point. The trial was performed, and indeed showed that people who were randomized to the implantable defibrillator lived significantly longer. Medicare subsequently agreed to cover the therapy. But the RCT was very expensive, took several years to complete, greatly stretched the ethics of medical research (since patients who were known – by any minimally objective observer – to need the implantable defibrillator were allowed to be randomized to have it withheld), and sent a major warning shot across the bow of developers of any new medical technology. That message was: No matter how obviously effective your new product may be, and even if it clearly saves lives, you will not be able to sell it before you demonstrate its effectiveness with an expensive RCT.

A more recent example misusing RCTs involves the treatment of malignant melanoma. Malignant melanoma, even with the best available therapy, is extremely lethal, leading to death within a year in the large majority of people who receive this diagnosis. Recently, however, a revolutionary approach to treating malignant melanoma was developed. The biotech company Plexxicon developed a drug (currently known as PLX4032) which is aimed at a gene mutation (the BRAF mutation) that is present in the tumors of about 50% of patients who have malignant melanoma. In patients with the BRAF mutation, an astounding 81% had a profound and rapid shrinkage of their tumor in Phase 1 clinical trials with this new drug. Furthermore, no toxicity was seen. Nothing remotely like this had ever been observed before with malignant melanoma. The “best” drug available, dacarbazine, produces a tepid response in 15% of patients, and causes lots of nasty toxicity.

Given a remarkable response like this, one would think that a creative approach could be devised to confirm the effectiveness and safety of PLX4032 – using as a control, for instance, the universally poor experience seen with all other therapies, an experience that has been very well-documented in the 68,000 people a year who die from this disease – instead of demanding the typical, large RCT in which half the patients are doomed to “standard” ineffective and toxic therapy with dacarbazine.

But our regulators – and the medical academics whose careers rely on a steady stream of RCTs – would not hear of it. The effectiveness of this new drug will not become official until we have an RCT which has generated two different piles of dead bodies, which the regulators can count.

If parachutes were considered a medical device (and why should they not be, since they are meant to prevent injury and death), before the parachute makers could market them within our current healthcare system, they would have to conduct a few randomized trials, in which a couple thousand people are tossed out of helicopters at 10,000 feet, half with and half without the test article. After all, one is almost as likely to survive an unprotected free-fall (by landing on a sloping snow bank, for instance) as an unprotected out-of-hospital cardiac arrest.

While large RCTs are usually a good idea when testing a new medical product, the mindless requirement to apply them in all clinical situations – even in situations where more creative and less onerous approaches would clearly be better – is a bad idea. Especially in the approaching era of individualized medicine (if such an era is really permitted to develop) more and more therapies like PLX4032 for malignant melanoma are anticipated – treatments that will be tailored (usually based on the individual’s genome or their tumor’s genome) to a very specific subset of patients with a particular disease. In these cases there will be a reasonable likelihood of achieving relatively dramatic effects. Insisting on large RCTs for this kind therapy will often be inappropriate and counterproductive – especially in “parachute-like therapy,” where the outcome without the new treatment is well known and very dismal. An absolute requirement for RCTs presents a broad and sometimes unnecessary hurdle to research efforts. It is, however, a useful approach to inhibiting medical progress – and in particular, to inhibiting individualized healthcare.

Insisting On Using Herd Medicine Statistics

It’s not just the requirement to conduct RCTs that present a formidable hurdle to medical progress – it’s the way the RCTs are analyzed and interpreted. Fundamentally, the expert panels that will use the results of RCTs to determine whether or not a medical service will be available to doctors and patients will rely on population statistics – the overall effect of the new therapy on the entire herd.

We considered some implications of herd medicine statistics in Chapter 9. There, we postulated the existence of a new cancer drug that, in a large RCT, increased the mean survival of women with widespread metastatic breast cancer by three months. We noted that any self-respecting panel of experts, weighing the rather short improvement in survival against the high cost of the drug, would conclude that the drug simply does not work well enough to justify its expense. Then we noted that, while this decision makes sense from the collective’s perspective, it does not make as much sense from the viewpoint of the individual woman with breast cancer. That woman is not looking at the population statistic – the mean extension of life by 3 months – but rather, is looking at the chance this new drug offers her for a much more dramatic response (since 10% or so of the women who received the drug were alive and apparently cancer-free a year or two later). Despite the risk of serious toxicity with the drug, it would be entirely reasonable for a woman with breast cancer to wish to give it a try. Using herd medicine statistics robs these individual women of the opportunity to take a chance with such a drug.

Now look at herd medicine statistics from the aspect of the pharmaceutical executive whose company has developed the cancer drug. You just spent $2 billion developing and testing the drug. The results of the clinical trials looked pretty good to you. The mean survival was increased by three months for the whole group, and a substantial minority of women had truly dramatic responses. This is how the treatment of cancer has traditionally progressed – by coming up with successive treatment regimens that advance the mean survival by a few months at a time. You always hope for the home run, of course – a cure, or prolonging life by a year or more – but those are few and far between. In the meantime, developing and selling “leapfrog drugs” like this one – which incrementally improve the treatment of cancer – has, over time, substantially improved the overall survival in patients with many kinds of cancer. And it provides the funds your company needs for continued research and development.

But this new herd medicine paradigm changes everything. If a $2 billion drug that actually works is rejected because it does not improve the mean survival across the whole group to the (unspecified, arbitrary, and changeable) standards of an expert panel, the risk to your company of continuing to work on cancer drugs has just become prohibitive.

In this way, herd medicine will stifle medical progress.

Price Controls, Real Or Threatened

Recently, emails have come to light showing that in 2009, the pharmaceutical industry was busily negotiating behind the scenes with the Obama administration regarding its support for the pending Obamacare legislation. In exchange for a substantial reduction in the $100 billion in “rebates” which Obamacare initially required from the drug industry, Big Pharma agreed to support the law. They did this by spending $150 million on a pro-Obamacare advertising campaign, and giving another $70 million to two 501(c)(4) front groups. There is some sort of convention, I believe, that makes this something other than extortion when the Central Authority is doing it.

The threat of a $100 billion “rebate” was scary enough for the drug companies. (Apparently, thanks to their deal, this was reduced to “only” $80 billion). But what really frightened them into cooperating, judging from the email exchanges, was the threat of placing price controls, in one form or another, on the drugs they sell.

It is widely known, among non-Progressive economists, that “price controls never work.” And this sentiment is universally true, if by “work” you mean that the product whose price you are controlling actually remains available at the controlled price, for a substantial period of time. In this sense, price controls may “work” for a few days or a few weeks (depending on the product being controlled). But after some relatively short period of time, the people who produce this product are no longer able to produce it, because the price they are permitted to charge for it no longer covers the cost of production. And so two things inevitably result. First, shortages of the product develop. And second, black markets develop. So you can still acquire the product on the black market if you really need it, but the price will be very high – in fact, it will inevitably be much higher than the original price that induced the price controls in the first place. (When you buy a product on the black market, you are paying not only the cost of the product according to a now-very-unfavorable supply/demand ratio, but also you are covering the cost of doing business for the black marketeer – things like “acquiring” the product illegally, paying off sundry officials, and purchasing the various layers of offensive and defensive weaponry that the black market industry traditionally requires.)

This is what always happens with price controls. It happens even within the healthcare system, and even with drugs. We are seeing this right now.

Since 2005, in the United States we have experienced severe shortages of numerous critical drugs. Generally speaking the drug shortages have involved sterile, injectable generic drugs. Sterile injectables are relatively expensive to make, and because the requirement for sterility dictates they must have a finite (and relatively short) shelf life, they are relatively expensive to manage logistically after they are made. We are seeing shortages in some of the more important and critical drugs used in medicine, including “crash cart” cardiovascular drugs, antibiotics, and important chemotherapy agents used for cancer. In recent years increasing numbers of patients with life-threatening illnesses have not been able to receive the drugs they need to optimize their odds of survival, and they have had to receive some substitute therapy, that is, instead of getting the drug they ought to have, they get a drug that is available. When your life is in the balance this is not a pleasant thing.

Hospitals have had to resort to semi-legal “grey markets” to get even a minimal supply of these drugs.

We have all heard the arguments over what is causing these critical shortages. Our friends the Experts have studied the problem, and have concluded that the cause is “multifactorial,” and includes things like insufficient production space, disruptions in the supply of raw materials, several drug makers opting out of the generic drug business, and a spate of manufacturing quality issues that have resulted in prolonged production interruptions. In other words, we are asked to believe that a series of disparate, unfortunate events suddenly began happening to the drug industry in 2005 (since prior to that there was no particular problem with these drugs), with no underlying explanation, and that all these unwanted happenstances, quite miraculously, mainly affected only one kind of product – sterile, injectable generic medications.

The problem has all the earmarks of having resulted from price controls. But none of the Experts who are studying the shortages have mentioned an attempt to control the price of these drugs. So what gives?

What gives is a little-noticed provision – Section 303(c) – of the Medicare Modernization Act of 2003, which strictly limits the price Medicare will pay for “injectable” generic drugs. Prices for these drugs can still rise, but only by 6% or less, and only once every six months. Congress (in its great wisdom and expertise in matters economic) made the judgment that this kind of price rise would be sufficient to balance market forces. But Congress was wrong. This law took effect January 1, 2005, and soon thereafter we began to see shortages of those products whose prices were being controlled.

Progressives often talk about placing price controls on the newer, non-generic drugs that are so often very expensive. (It was largely to stifle such talk, I believe, that induced Big Pharma to support Obamacare back in 2009.) One might think that Progressives simply and stubbornly fail to understand that price controls never “work,” and that they inevitably lead to shortages and black markets.

It seems likely to me, however, that at least some Progressives understand perfectly well the mechanics of price controls, and are threatening to institute them on new (on-patent) drugs with a perfect understanding of what the results will be.

For these Progressives, medical progress is the problem. And new drugs – drugs that are not only expensive themselves but that often increase the survival (to at least some degree) of people with expensive diseases – are an important component of medical progress. Enlightened Progressives understand that placing price controls on “new drugs” will lead to a shortage of “new drugs” – that is, it will discourage drug companies from making the incredibly expensive investments necessary to develop new products.

Better yet, since the lead time on new drugs is measured in years, you don’t actually have to institute these price controls. You just have to seriously threaten to institute price controls, and the uncertainty you will create (as to whether it will be possible for the companies to recoup their investments in future years) will slow research and development immediately.

Price controls on drugs have been in the air for more than a decade. As we have seen, price controls were actually instituted, on a portion of the drug industry, in 2005. And threats of severe price controls on new drugs have been clearly articulated to the drug industry during the Obama administration, and (judging from the recently released emails) have been heard by the industry, loud and clear.

It may not be a coincidence that the number of approvals of new drugs has fallen substantially in recent years, or that the pipeline for new drugs has largely dried up, or that resources that drug companies might formerly have spent in research and development have apparently been diverted to mergers and consolidation within the industry.

Indeed, it may be that price controls, or the mere threat of price controls, have “worked” exactly as designed.

Outlawing Doctor-Industry Relationships

A worldwide controversy is now roiling over the appropriate relationship between physicians and industry. Superficially at least, this controversy has to do with the undisputed fact that a physician’s relationship with industry can unduly influence his or her behavior. That is, this controversy is said to be related to the conflicts of interest that are always inherent, to some degree, in such relationships.

I believe there is a deeper, and far more disturbing, reason behind this controversy. I believe that, at some level, it is an effort to stifle medical progress.

Before defending this outlandish claim, we should first talk about conflicts of interest, because it is ostensibly the chief concern that is being expressed regarding physician-industry relationships, and it is in fact a very important issue.

A “conflict of interest” is present when an individual has a primary, fiduciary duty (i.e., a duty of trust) to Entity A, but then develops a secondary relationship with Entity B, which (by creating self-interest, competing loyalties, or even just an inability to be objective), threatens to interfere with the primary duty to Entity A.

Physicians may have (at various times) at least three primary fiduciary duties that must take priority. These are: a duty to patients when practicing medicine; a duty to students (i.e., actual students, colleagues, or the public) when teaching; and a duty to society (and truth itself) when conducting medical research. It is clear that ties with specific companies and their products can easily create important conflicts of interest that may interfere with each of these primary fiduciary duties, and it is equally clear that physicians have commonly allowed this interference to happen.

Far more often than we like to imagine, doctors have allowed bias to creep in when recommending a course of action for their patients, in imparting knowledge to trainees, colleagues or the public, or when designing, analyzing or reporting results of clinical trials. And typically, most doctors who exercise inappropriate bias have convinced themselves that they are really acting in the best interests of their patients, students or society at large. For it is quite difficult to be objective about one’s own conflicts of interest.

And there is no question that industry has become adept at the gentle art of creating conflicts among physicians (subliminally whenever possible), and have carefully incorporated the creation of such conflicts into their business models.

Obvious abuses we have all seen include doctors “shilling” for companies or their products at national meetings; clinical guidelines committees seeded with biased members; unbelievable amounts of money (well above “fair market value”) being paid to key doctors for consulting services; long advertisements disguised as continuing medical education events; and ghost-writing scientific papers, then recruiting prominent physicians to sign on as “authors” after the fact. There are many others.

Such ongoing abuses of their fiduciary duties ought to be deeply embarrassing to anyone in the medical profession.

And if it’s not embarrassing, it is at least becoming painful. In the United States, physicians who are discovered doing some of these things are being called out publicly, are being investigated by Congress if not the Justice Department, are losing their prestigious academic positions, and are having their reputations destroyed. It is hard to be sympathetic toward them.

Despite all the negative attention – both public and legal – that such conflicts of interest have brought to the medical profession in recent years, many doctors continue to have tin ears. Self-policing apparently does not work with doctors any more than it does with other varieties of the human species.

Accordingly, a number of groups – most prominently the Institute Of Medicine – have recently made formal, and tough, recommendations regarding physician-industry relationships. The final “rules” under which doctors will all have to live are still being negotiated. But it is highly likely that they will include many if not all of the following:

- Doctors should not accept any gifts, no matter how small, from industry. These include trivialities such as pens and notepads, and more substantial gifts such as meals and travel.
- Doctors should not give presentations in which content is controlled or influenced by industry.
- Doctors should not consult for industry without a written contract, nor should they receive more than “fair market value” for consulting activities.
- Doctors should not accept drug samples from industry.
- Doctors who have a financial interest in a product or company should not participate in clinical trials in any capacity that involve that product or company, including patient enrollment, data collection, analysis or reporting.
- Doctors who have industry ties should not participate in the development of clinical guidelines.
- Medical schools and professional organizations should not accept direct funding, or attributable funding, for continuing medical education.
- Any interaction with industry will be fully disclosed, and made publicly available.

What this “full disclosure” will look like can be seen in the Physician Payment Sunshine Act, a Federal law which is pending. Under this act, all “transfers of value” totaling $100 or more in a year to any physician will be reported by each company to the government annually, along with each physician’s identifying information. Such “TOV” includes food, trinkets, entertainment or gifts; travel; consulting fees or honoraria; funding for research or education; stocks or stock options; ownership or investment interest, and any other economic benefit. This information will be posted on a public, searchable government website. Companies will be fined $10,000 for each incident of an unreported TOV.

Activities that have been acceptable, and even encouraged, will now be strongly discouraged – and companies and physicians that allow these activities to happen will be punished. Doctors need to choose their interactions with industry very carefully, and very circumspectly.

Everything I have just discussed assumes that the real issue regarding doctor-industry relationships is the issue that people are talking about, i.e., conflicts of interest. Indeed, everything I have discussed assumes a particular way of looking at industry relationships, which I will call Theory A. Theory A goes as follows:

Theory A:
- Medical progress is Good, and benefits mankind.
- Industry is responsible for a high proportion of medical progress.
- Industry-driven progress requires the active participation of physicians.
- Therefore, a well-managed cooperation between industry and physicians is beneficial to mankind, and ought to be encouraged.

If you subscribe to Theory A you believe that, because well-managed physician-industry relationships benefit mankind, these relationships are good. So, fundamentally, it’s the management of these relationships which is at issue. These beneficial relationships produce unavoidable conflicts of interest, which we must manage by strictly limiting their extent, and fully disclosing the ones that are left.

And on the surface, at least, that’s what the debate is about – where to draw the necessary limits. But just below the surface, the debate is about something else entirely. Beneath the surface, Theory A is rejected outright.

Today we hear prominent voices telling us that merely managing conflicts of interest does not go far enough. No amount of conflict of interest is acceptable, and all physician-industry ties should be prohibited. Among these is Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of conflicts of interest is not to have them at all.” For these voices, Theory A simply does not apply. Rather, (I submit) they subscribe to Theory B, which is a natural extension of the anti-progress aims of the Progressives, as articulated in the commentaries of Brooks and Callahan:

Theory B:
- Medical progress creates excessive costs, and produces far more harm to society than good.
- Physician-industry alliances strengthen the biotech industry’s research and development efforts, and thus increase the harm.
- Therefore, crippling these unholy alliances is critical to the interests of society.

Most proponents of Theory B do not present their case publicly as an anti-progress argument. Rather, they generally claim to be working under Theory A: It’s not progress itself they are against, it’s the greed of the biomedical industry.  De-legitimizing any practical relationships whatsoever between industry and physicians will help to stem this greed; and as a bonus it is a useful way to suppress, if not cripple, the research and development efforts of the biomedical industry.

Physicians who cooperate with industry to advance medical progress are now to be stigmatized. This is something new. Until now, for doctors to work with industry has been encouraged, since it helps to advance medical progress in a practical and more clinically useful direction. Physicians who have done so have been regarded as doing good, since their work with industry allows them to bring their clinical perspective to the biomedical engineers developing new products.  Industry itself thrives on the participation of knowledgeable physicians, since developing products that actually help patients are what ultimately produces success.

But now doctors who cooperate with greedy industry will be viewed as tainted, and their names will be posted on public websites as being in the pockets of these forces of evil. As a result, clearly, nothing they say and nothing they write henceforth ought to carry any credibility whatsoever. Academic promotions will become harder to come by. And worst of all, they will become ineligible for participation in the government’s expert panels – panels which will have more authority over life and death than that enjoyed by most kings, and participation on which is destined to become the ultimate determinant of power and prestige in the medical community.

In addition to stifling medical progress, Theory B also advances the Progressives’ goal of controlling the flow of information, that is, of preventing profit-drunk industry – and its greedy physician spokespersons – from expressing their opinions, to either doctors or to the public, regarding the appropriate use of medical technology.

That kind of information can only be managed by unbiased sources. Theory B relies on those government-appointed expert panels not only to determine which products of industry are good and which are bad, but also to manage the flow of information about them. Information coming from anywhere else is to be regarded as being charged with bias and greed, and should be ignored, or even suppressed.

Inherent in this viewpoint is the notion that the Central Authority is an honest broker, with no bias of its own, except to do what is best for the population. The State, in its disinterested beneficence, is the only civil entity which can pass judgment on which medical information is suitable for general consumption.

Even as a general proposition no government is an unbiased and honest broker. Government officials do not cancel their own human nature when they put on a government name tag. As they go about the business of determining who gets what, when and how, they inevitably – and most often intentionally – create various favored constituencies, fiefdoms, and clienteles to suit their own goal. That goal is to consolidate and expand their own authority. In this way, in the exercise of its political mandate the government always creates co-dependencies, and determines winners and losers. So even in the general case, the government cannot be an honest broker.

But with regard to healthcare, as we have seen, the bias of the Central Authority goes far beyond the general case. To agents of the Central Authority, controlling healthcare spending is an existential problem, an issue that justifies any solution that has even a slight chance of working. This is why they cannot restrain themselves from demonizing the obese, or of trying to “lower the expectations” of the elderly, to the point of encouraging suicide. And this is why they cannot restrain themselves from trying to stifle medical progress.

Yes, industry is biased, and industry will act on that bias whenever they can get away with it. Industry just can’t help itself. That’s just the way it is.

But the Central Authority is also biased. And the Central Authority will also act on that bias whenever they can get away with it. The government can’t help itself. That’s just the way it is.

Industry will try to exercise its influence over doctors by data-driven persuasion, and when that fails they will try to sweeten the persuasion, perhaps even with subtle or not-so-subtle bribes.

But the exercise of persuasion is even more dangerous when done by the government. While the government may also try to influence doctors with data-driven persuasion, it is very quick to resort instead to propaganda (i.e., the art of information-control by which people are told only what the expert classes have determined is best for them), and when that fails, the Central Authority will resort to its ultimate form of persuasion – the enforcement of new and suppressive regulations at the point of a gun.

Medical progress driven by industry-physician collaboration is good for mankind. But that collaboration inevitably creates conflicts. Physicians need to control those conflicts, or the collaboration will be forcibly terminated altogether. Physicians’ professional history to date is bleak in this regard, and they only have one chance left to get it right, if that.

But in controlling their conflicts of interest, physicians should not allow themselves to be pushed too far. They should agree to reasonable limits on conflicts, and on full disclosure of any conflicts that remain. But they should draw the line when they are urged to forgo all relationships with industry altogether. They must recognize that industry and its selfish goals provide a necessary counterbalance to even more powerful forces whose own selfish goal is to stifle medical progress altogether.

Is The Biomedical Industry Really Evil?

Of course, nobody needs to remind us that the biomedical industry is evil. We have all observed as the pharmaceutical industry has fired off a never-ending parade of wasteful “me too” drugs, mainly aimed at keeping the joints, bowels, bladders and genitalia of Old Farts nicely lubed up, then running a steady stream (so to speak) of television commercials regarding same, which renders prime time TV far too embarrassing to watch with preadolescents.

Other evil behaviors abound. We can all see the biotech industry systematically fail to publish research that makes their products look less than spectacular; routinely over-hype research that suggests a modicum of effectiveness; callously corrupt doctors with plastic, logo’d ink pens; and likewise corrupt legislators with huge campaign contributions, rides on private jets equipped with plenty of booze and bimbos, and $150 million advertising campaigns to support their favorite legislation (after which the indignant legislators propose laws against plastic logo’d ink pens); and most annoying of all, gouge American citizens with astronomical prices for their new drugs, while selling those same drugs to Canadians and other undeserving foreigners at greatly discounted prices.

But still, most objective observers must reluctantly admit that, every now and then, and probably by mistake, a medical company will do something worthwhile. Here and there they manage to come up with a real breakthrough product that cures a disease, prolongs survival, restores functionality, or relieves suffering. That is, the biotech industry (in spite of all its evil behavior), has done a lot of good over the years. Ask a parent whose child has survived acute leukemia, or the person who has survived a life-threatening infection, or the woman whose heart attack or stroke was aborted with clot-busting drugs, or – yes, this too – the aging Lothario who once again can enjoy fine and durable erections upon demand. Such individuals, even if today they would join the Progressives in promoting the demise of the biotech industry, have undeniably had their lives improved by that industry.

So the question we must address before we allow the Central Authority to cause the biotech industry to roll itself into a ball and hide in the shadows for the duration, is not, “What have you done for me lately?” (since their inventions will live on even if they do not), but rather, “What can you do for me tomorrow?” Some of us in the boomer generation, for instance, would like to think that current research in the areas of Alzheimer’s, Parkinson disease, kidney disease, heart attack, stroke, arthritis, osteoporosis and cancer will allow us to remain healthy and functional for a few extra years. And judging from the massive amounts of money American citizens of all ages donate to medical research of all types, it is apparently not held among the whole of the populace that medical progress has already gone as far as it should. Many of us would not be entirely pleased to stand pat right here. Many of us would like to see more improvements.

And while it may not seem obvious to many of us, we stand at a threshold of truly amazing medical innovations. These innovations are made possible by a convergence of several divergent technologies including wireless communication, social networks, physiologic sensing technology, new knowledge regarding the human genome, and ubiquitous personal computing/analysis/communication devices (known as smartphones). These convergent technologies make possible – today – healthcare products and services that were unimaginable just a few years ago. A key feature of these new products and services will be their decentralization of critical and actionable knowledge – that is, they will empower individuals to manage their own healthcare.

Such advances will collapse the centralized, top-down, command-and-control structure of any Progressive healthcare system. Therefore, such innovation poses an existential threat to Progressives. And the drive to stifle medical progress is largely the drive to prevent any of this from actually happening.

I will discuss these emerging medical advances in more detail in Part 3 of this book, and consider what we must do to allow such advances to proceed. The Progressives – who for the most part control the Central Authority with all its power and all its enforcement muscle – mean to stop it in its tracks.

This is why Progressives are beginning to say out loud what they have long been thinking – that medical progress is a bad thing, and must be suppressed. It is a difficult message to sell – but they have a lot of resources. And in the meantime, whether they can sell the message or not, they are pulling out the stops to actually accomplish it.

As a result, we in the huddled masses have only a limited window of opportunity to set medical progress solidly along the path to individualized healthcare. Unfortunately, in contrast to the Progressives, most of us don’t realize that there’s a fight going on, or even that there’s anything to fight for, or that time is wasting.