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 Why They're Trashing the JUPITER Trial [17:44m]: Play Now | Play in Popup | Download (57)

This week, the Archives of Internal Medicine published four (four!) articles assaulting the legitimacy and the importance of the JUPITER trial, a landmark clinical study published in 2008, which showed that certain apparently healthy patients with normal cholesterol levels had markedly improved cardiovascular outcomes when taking a statin drug.

Superficially, at least, the JUPITER study appears to have been pretty straightforward. Nearly 18,000 men and women from 26 countries who had “normal” cholesterol levels but elevated C-reactive protein (CRP) levels were randomized to receive either the statin drug Crestor, or a placebo. CRP is a non-specific marker of inflammation, and an increased CRP blood level is thought to represent inflammation within the blood vessels, and is a known risk factor for heart attack and stroke. The study was stopped after a little less than two years, when the study’s independent Data Safety Monitoring Board (DSMB) determined that it would be unethical to continue. For, at that point, individuals taking the statin had a 20% reduction in overall mortality, a dramatic reduction in heart attacks, a 50% reduction in stroke, and a 40% reduction in venous thrombosis and pulmonary embolism. All these findings were highly statistically significant.

This study is noteworthy because it is the first large randomized trial to show that taking a statin can markedly reduce the incidence of some very nasty cardiovascular outcomes in people who are considered to have “normal” cholesterol levels. (Notably, typical LDL cholesterol levels among primitive hunting/gathering cultures is around 50 mg/dL, instead of the 100 – 120 mg/dL we consider to be normal. These primitive folks have an extremely low incidence of cardiovascular disease, so maybe humans’ optimal cholesterol level is much lower than we now think. On the other hand, the low risk of cardiovascular disease among hunters/gatherers may instead be related to the fact that many of them are consumed by various species of carnivores before they’re 30.)

To be sure, the JUPITER trial was far from perfect. Because of its design, it could not (and did not) tell us whether the beneficial outcome is specific to Crestor, or is a class effect of all statins (which seems very likely). It did not tell us whether reducing CRP levels is itself beneficial, or even whether using CRP as a screening tool is actually helpful. (The people enrolled in this trial tended to have several other risk factors, such as being overweight, having metabolic syndrome, and smoking, and it is not clear how much additional risk elevated CRP levels really added in this population.) And this trial did not tell us the risks of lifelong, or even very long-term, Crestor therapy.

But JUPITER did tell us something that is very useful to know, and with a very high degree of statistical surety: Giving Crestor to patients similar to the ones enrolled in this study can be expected to result in significantly and substantially improved cardiovascular outcomes, and in a relatively short period of time.

If medicine were practiced the way it ought to be – where the doctor takes the available evidence, as imperfect as it always is, and applies it to each of her individual patients – then the incompleteness of answers from the JUPITER trial would present no special problems. After all, doctors never have all the answers when they help patients make decisions. So, in this case the doctor would discuss the pros and cons of statin therapy – the risks, the potential benefits, and all the quite important unknowns – and place the decision in the perspective of what might be gained if the patient instead took pains to control their weight, exercise, diet, smoking, etc. At the end of the day, some patients would insist on avoiding drug therapy at all costs; others would insist on Crestor and nothing else; yet others would choose to try a much cheaper generic statin; and some would even opt (believe it or not) for a trial of lifestyle changes before deciding on statin therapy. In other words, there is a range of reasonable options given the limitations of our knowledge, as there often is in clinical medicine. As time goes by, more scientific evidence is often brought to bear and clinical decisions can become more informed. But whatever the state of the evidence, doctors and patients can generally get by without violating too severely any ethical or medical precepts that would cause objective and neutral observers to complain very much.

But in recent years, and especially now, as we bravely embark on our new healthcare system, this is not how doctors will practice medicine. Instead, they will practice medicine by guidelines. These guidelines (which, in modern medical parlance, is a euphemism for “directives”) are to be handed down from panels of experts, identified and assembled by members of the executive branch of the federal government.

And this makes the stakes very high when it comes to a clinical trial like JUPITER. For guidelines do not permit a range of actions tailored to fit individual patients (consistent with the uncertainties inherent in the results of any clinical trial). Instead, guidelines will seek to take one of two possible positions. That is, under a paradigm of medicine-by-guidelines, the results of clinical trials generally cannot be permitted to remain imperfect or nuanced or subject to individual application, but must be resolved by a central panel of government-issue experts into a binary system – yes (do it) or no (don’t do it). In the case of JUPITER, the guidelines must decide whether or not to recommend Crestor to patients like the ones enrolled in the study, at a potential cost of several billion dollars a year. It should be obvious that the answer which would be more pleasant to the ends of the central authority, and  by a large margin, would be: No, don’t adopt the JUPITER results into clinical practice.

However, the expert panels which are called for by our new healthcare legislation have not been formulated yet, and we are still operating under the “old” rules. So, still subject to all the duress which is created by unfortunately-resolved clinical trials like this one, the FDA, somewhat reluctantly, approved the use of Crestor for JUPITER-like patients in late 2009. That approval, of course, is subject to review by the new expert panels, whenever they are assembled.

This, DrRich submits for your consideration, is likely what instigated the almost violently anti-JUPITER issue of the Archives this week. DrRich theorizes that what we’ve got here is a bunch of wannabe federally-sanctioned experts, auditioning for positions on the expert panels. What better way to get the Fed’s attention than to let them know that you are of the appropriate frame of mind to assiduously seek out scientific-sounding arguments to discount the straightforward and compelling, but fiscally unfortunate, results of a well-known clinical trial?

Of the four papers appearing in this week’s Archives, three are more-or-less legitimate academic articles that make reasonable points, but do no harm to the main result of JUPITER. The fourth is a straightforward polemic, which has no place in a peer-reviewed medical journal, and whose very presence, DrRich believes, very strongly suggests that the editors of the Archives themselves must be auditioning for the Fed’s expert panel.

So as not to bore his readers any more than necessary, DrRich will make short work of the three reasonably legitimate articles in this issue. One pointed out that JUPITER did not tease out the real importance of CRP levels, or whether lowering those levels is useful. This is true, but that fact does not touch the main conclusion of JUPITER. Another article was a meta-analysis which incorporated several other primary prevention trials using statins, and concluded that there is no overall benefit to statins in primary prevention patients. Aside from the usual problems inherent in meta-analyses, a) the JUPITER study looked at a specific population of primary prevention patients not addressed by these other studies, and b) since JUPITER is the first study to show a benefit in using statins for primary prevention, it is a foregone conclusion that if you assemble enough of the previous, negative studies and lump them together with JUPITER in a meta-analysis, you will be able to dilute the results of JUPITER sufficiently to achieve an overall negative result. Actually doing such a meta-analysis, then, is merely an exercise in math, not in revelation.

The third article criticized the JUPITER DSMB for stopping the trial earlier than originally planned. The DSMB, however, had no real choice in the matter – ethically or legally – given the striking statistical significance of the benefit seen with Crestor. When a patient signs an informed consent agreement to participate in a clinical trial, part of that “contract,” a part required by law, is the statement to the effect that if information comes to light during the course of the study that might impact a patient’s willingness to continue participating, that information must be made available. The fact that the Crestor branch of the study was found to have markedly improved survival, fewer strokes and heart attacks, etc., than the placebo branch, clearly constitutes such information. Stopping the study when they did was not “premature;” continuing the study would have been illegitimate. This is why independent DSMBs exist in the first place – to protect the rights and welfare of the research subjects under the fiduciary agreement that comprises informed consent.

The fourth article is more striking (and more fun) than the other three. Interestingly, it is categorized by the Archives as an “Original Investigation,” despite the fact that it describes no investigation of any kind whatsoever – original or derivative. It merely revisits the data from JUPITER (in a spectacularly biased manner), and offers a spate of ad hominem attacks, alleging bias to the point of corruption, without any supporting evidence, against JUPITER’s sponsor, its investigators, and most astoundingly, the chair of the DSMB (who is a well known and highly respected figure, especially known and revered for his complete objectivity and lack of bias). If such an article has any place at all in a peer-reviewed medical journal – which DrRich doubts – it ought to be clearly labeled as an opinion piece, and not as a piece of original research. Whatever it may be, it’s not that.

But the most delicious aspect of this fourth article is that two of its authors, including its lead author, are members of a fringe medical group known as The International Network of Cholesterol Skeptics (THINCS), whose stated mission is to “oppose” the notion that high cholesterol and animal fat play a role in cardiovascular disease. Members of THINCS also take an extraordinarily strong position opposing statins for any clinical use whatsoever. (One might actually assume that, since JUPITER shows that cardiovascular outcomes can be improved by statins in people with normal cholesterol levels, the THINCS would embrace the study as evidence that perhaps cholesterol is not as important as it’s cracked up to be. But apparently, this argument is completely negated by the fact that statins were the vehicle for making it. Many in the anti-statin crowd would object to statins even if they were proven to cure heart disease, cancer, baldness, and obesity AND produced fine and durable erections upon demand.)

The best part of all this is that the astounding anti-cholesterol, anti-statin bias of the authors was not disclosed in their article – whose main thrust, again, was to criticize the disclosed biases of the JUPITER investigators.

The excellent Pharmalot blog noted this irony, and contacted Rita Redberg (editor of the Archives) and Michel de Lorgeril (THINCS-master and prime author of the fourth article) to ask them why the association with THINCS was not disclosed.

Redberg:

“I’m not clear this is an undisclosed conflict. The policy mentions a personal relationship that could influence one’s work. I think that could be a big stretch. My initial impression is the group has an intellectual message, but doesn’t fit as a personal relationship that could effect the authors’ work.”

de Lorgeril:

“[While it is] very important to disclose financial [emphasis DrRich's] conflicts of interest that can influence our way of working and thinking about cholesterol and statins, there is so far no obligation to provide a CV each time we publish any thing…May I underline the fact that being a member of THINCS – not a group of terrorists, mainly a club of very kind retired scientists with whom I have interesting and open discussion – is not a conflict of interest?”

DrRich may be old fashioned, but he thinks that being a member of an “out there” group like THINCS, which appears to advance selected and distorted data on its website aimed at furthering its stated mission of “opposing” (not investigating or questioning) the cholesterol hypothesis and the use of statins, might make one prone to a bit of bias when writing a broadside critiquing a study like JUPITER, and loudly criticizing anyone associated with that study for their bias. This sort of bias (demonstrably rooted in a willingness to select/ignore/distort data in order to make a preconceived point) is likely to be as strong as any that might accompany, for instance, receiving a stipend from a statin company for participating in clinical research. Membership in THINCS may not preclude one from writing such an article, but DrRich thinks the association at least ought to be disclosed, just as financial relationships must be disclosed.

DrRich has a hard time explaining how this can happen with a prestigious medical journal like the Archives. But like Sherlock Holmes says, when you have eliminated the impossible (such as, the idea that this article deserved to be published in its current form), whatever remains, however improbable, must be the truth.

And this is why DrRich can only conclude that several of the authors appearing in this week’s issue of the Archives of Internal Medicine, along with its editor, are in the mode of ingratiating themselves to the sundry officials and czars within the Obama administration who will be assembling the expert medical panels, those panels which will be making the momentous decisions that will determine the flow of hundreds of billions of dollars, and (forgive me) of life and death.

We wish them the best of luck in their audition, and will be monitoring the memberships of the new panels with interest, to see if any of our new friends are ultimately successful.

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DrRich critiques more arguments for withholding Crestor here.

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_Sources:

_{de Lorgeril M, Salen P, Abramson J, et al. Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy. A critical reappraisal. Arch Intern Med. 2010; 170:1032-1036.}

_{Kaul S, Morrissey RP, Diamond GA. By Jove! What is a clinician to make of JUPITER? Arch Intern Med. 2010; 170:1073-1077.}

_{Ray KK, Seshasai SRK, Erqou S, et al. Statins and all-cause mortality in high-risk primary prevention. A meta-analysis of 11 randomized controlled trials involving 65 229 participants. Arch Intern Med. 2010; 170:1024-1031.}

_{Green L A. Cholesterol-lowering therapy for primary prevention. Still much we don’t know. Arch Intern Med. 2010; 170:1007-1008.}

________________________________

Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

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 Breaking the Doctor-Patient Relationship (Limiting Individual Prerogatives, Part 3) [20:54m]: Play Now | Play in Popup | Download (14)

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Part 1 of Limiting Individual Prerogatives

Part 2 of Limiting Individual Prerogatives

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The thing about Progressives is that the characteristic which makes them most endearing (and, which makes them most attractive to the unaware), is the very characteristic which makes them the most dangerous.

Fundamentally, Progressives believe in the perfectibility of mankind, or at least, of society. Indeed, they have discovered the very Program which will lead to the perfect society, a society which will maximize the good of the whole. Their vision is so compelling, and their ends so utterly and undeniably right, that it becomes legitimate for them to engage in whatever means are necessary to achieve it. (Indeed, for those who have been paying attention, “By Whatever Means Necessary” appears to have supplanted “Hope and Change” as the catchphrase of our current political leaders.)

The thing that always trips up Progressives (and their more revolutionary cousins, the Communists), is, of course, human nature. In order for their Program to work, it is necessary for each individual to behave in the prescribed fashion. And, at the end of the day, a substantial proportion of the population (any population) will insist on striving for their own individual benefit, rather than (as the Program requires) for the benefit of the collective.

The major competing system of societal organization – capitalism – recognizes this facet of human nature (i.e., the essential imperfectability of mankind, as manifested by the non-suppressibility of self-interest), and attempts to channel it into relatively productive and non-destructive (but still competitive and individually-directed) behaviors that limit the damage, and maximize the public good to a reasonable degree.

In contrast, Progressives attempt to change human nature to fit their inherently superior Program.

The fact that you cannot change human nature to fit the Program is what makes them dangerous. Their initial wide-eyed optimism that us folks will just “get it,” once they explain it to us, invariably evolves to an essential contempt for our limited intellectual capacity. This contempt justifies all manner of prevarications, to fool us into going along. Even in societies where the tyranny of correct-thinking has gone so far as to elicit the cooperation of the people at the point of a gun (rather than through the preferred methods of “education” or misdirection), the achievement of the predicted perfect society is invariably prevented by the recalcitrance of human nature. (The final realization that not even an all-powerful central authority can make people behave in the prescribed way always produces a nearly psychotic frustration that – in virtually every Communist country – has led to atrocities against various subsets of the recalcitrant people.)

DrRich does not believe there will ever be pogroms in the United States.

But this does not mean that the Progressives will always be kind and gentle as they attempt to achieve their goals. As DrRich sees it, in the U.S. the Progressives have clearly evolved to the “contempt for the masses” phase of their Program, a phase which justifies all manner of techniques – just this side of violence – to get us all to cooperate. Currently they are intent on demonizing their opponents as being racist, stupid, uneducated, selfish, overly dependent on outmoded supernatural beings, violent, and (of course) obese. This demonization is quite useful, since there is obviously no need to address any actual ideas put forth by such as these, even if they were capable of the feat of “ideas.”

Healthcare is, at present, the chief battleground in the war between Progressives vs. non-Progressives in the U.S., and the outcome of this battle will likely determine the success or failure of the entire Progressive Program. And the most fundamental (and emblematic) aspect of this battle is over what to do about the “doctor-patient relationship.”

The classic doctor-patient relationship was a celebration of the primacy of individual rights. And, for over 2000 years (at least since the advent of the Hippocratic Oath) guaranteeing the sanctity of that relationship was the basis of all medical ethics.

Until very recently doctors, patients, philosophers and ethicists recognized that, when you are sick, you are no more capable of navigating a complex and hostile healthcare system than are accused felons a complex and hostile legal system, and you are no less in peril if you run afoul of that system. And, just as the felon has a right to a personal advocate, a professional whose job is to protect his individual interests against the conflicting aims of the “system,” so does the patient. That is (quaint conventional wisdom held), when you are sick, you should be entitled to at least the same protections as when you rob a convenience store. And the doctor-patient relationship was supposed to guarantee you that right.

This is why, throughout the ages, the basic precepts of medical ethics were aimed at guaranteeing the sanctity of the doctor-patient relationship. Fundamentally, these ethical precepts required the physician to place the needs of his or her individual patient above all other considerations.

It should be clear to everyone that, under either our “old” healthcare system or the one that Obamacare promises us, this formulation of the doctor-patient relationship cannot be allowed to stand. Neither the insurance executives nor government officials can allow spending decisions – that is, decisions on how to spend their money – to be made by individual patients (and their personal advocates). For this reason, the classic doctor-patient relationship had to go.

And so, in 2002, official medical ethics was formally amended to require physicians (while still giving lip service to their obligation to individual patients) to strive for a “just distribution of healthcare resources.” That is, official medical ethics now makes it ethical for physicians to ration healthcare, covertly, at the bedside – and indeed, makes it unethical for them to fail to do so.

The New Ethics has been enthusiastically supported by medical ethicists worldwide (a field which now seems to be dominated by utilitarians), and worse, has been embraced by all the world’s major medical professional organizations. DrRich has not embraced the New Ethics (on the grounds that it places individual patients at great peril, and destroys the profession of medicine), and neither have many (possibly a majority) of older physicians. But it has been taught in medical schools around the world for over a decade, and in another decade it is likely that the vast majority of practicing physicians will accept as a matter of course that their primary obligation is to control healthcare costs, and only secondarily to try to meet the needs of their individual patients.

The plan, therefore, is for Obamacare to provide physicians with directives from expert panels on which medical services to supply to which patients and when, and for the New Ethics to allow physicians who go along with such directives to live with themselves. The feasibility of this plan depends entirely on physicians acceding to the program.

So, incentives are being put in place to “help” doctors cooperate. Quality measures will be implemented, with “quality” being defined as doctors doing what they’re told, and reimbursement will be tied to one’s quality rating. Possibly more persuasive will be the fact that the Feds can construe the failure to follow handed-down rules, regulations and guidelines, at any time, as a federal crime. (Even doctors who don’t mind being labeled as “substandard quality” – perhaps even considering the label as a badge of honor – will mind going to jail.)

But by whatever means necessary, the happiness of the government is to be the doctor’s first consideration, and not the happiness of their individual patients. The classic doctor-patient relationship is being terminated with extreme prejudice.

To see just how important it is to destroy the doctor-patient relationship, one merely has to observe what is happening to primary care doctors who have the audacity to leave the system, and set up a direct-pay medical practice.

Part of the problem, to be sure, was caused by these doctors themselves. The first few to do so unabashedly catered to rich patients, and to attract the rich, referred to themselves as “concierge” practitioners. This name (and its elitist connotations) have been forcibly affixed to all direct-pay practitioners, even as this style of practice has evolved into a much more democratic form. Today, more and more doctors are starting direct-pay practices (in which patients pay the doctors out of their own pockets) which are easily affordable to anyone who can afford a cell phone or cable TV contract.

While many direct-pay practices offer patients certain benefits they can usually not get from primary care doctors who remain in the approved system (such as phone and e-mail access, same-day appointments, appointments lasting as long as necessary instead of the allotted 7.5 minutes, etc.), the fundamental benefit, to both the patient and the doctor, is that it restores the classic doctor-patient relationship. The physician’s primary obligation is no longer to the 3rd-party overlord, or to the Progressive ideal of social justice, but to the patient.

And while critics (who abound) attack direct-pay practitioners for their elitism, laziness, and greed, their real issue is that direct-pay practitioners are acting as if their primary duty is to their individual patients, and not to the needs of society. This latter fault simply cannot be tolerated.

Having gained nearly complete control over the behavior of primary care practitioners, it is critical for Progressives – in making sure that practice by handed-down “guidelines” is not simply the only legal way to practice, but also the only ethical way to practice – to shut the door to any alternative forms of primary care. Direct-pay practitioners are a menace because they threaten to raise the expectations of both doctors and patients. Perhaps, doctors and patients might tell themselves, there really is a way to maintain individual autonomy within the healthcare system.

The attacks on direct-pay practitioners have followed the usual scheme Progressives follow when they discover a faction they need to suppress. First, they were ridiculed. “For a Retainer, Lavish Care by ‘Boutique Doctors,’” said a headline in the New York Times in 2005. Then, they were demonized, widely attacked for their elitism, laziness, greed, and lack of fundamental medical ethics. In this latter effort, it was not difficult to find fellow physicians – generally, from the medical organizations which promulgated the New Ethics – to lead the attacks. There are countless examples. DrRich will give just two.

Anthony DeMaria, then President of the American College of Cardiology, criticized the practice of direct-pay medicine in an article in the JACC in 2005, saying, “Personally, I do not mind if people acquire yachts or personal trainers if they have enough money, nor would I object if they secured a physician at their beck and call. However, unlike yachts, health care is not discretionary, and everyone should be entitled to the same quality.” As a matter of social justice, direct-pay physicians improve healthcare quality for only some patients, and so have no place in the healthcare system.

In an article in the New England Journal of Medicine, Troyen A. Brennan (M.D., J.D., and M.P.H., so we know we’re in trouble) really gets to the point. Referring to direct-pay practices as “luxury primary care,” he notes that “traditional medical ethics is rather poorly equipped to address issues related to luxury primary care.” That is, while “traditional” medical ethics always places the individual patient first, that kind of thinking is now outmoded. “(M)ost ethicists now agree that the financial structure of health care is an important subject for ethical consideration. Access to health care, in particular, is a salient ethical issue.” Direct-pay practitioners threaten (by their elitism and the limited size of their practices), to limit access to primary care, and thus are in fundamental violation of medical ethics.

The argument here, for those who missed it (advanced by fellow physicians no less), is that, of the two competing ethical precepts now established by New Medical Ethics (i.e., the physician’s obligation to the individual patient vs. the physician’s obligation to society), clear primacy is to be given to the physician’s obligation to society. Physicians must (like it or not) participate in covert bedside healthcare rationing. Physicians who take the only path remaining to them that allows them to make the individual patient their primary obligation are to be castigated as ethically deficient.

When ridicule and demonization fail to suppress their opposition, Progressive dogma indicates it’s time to resort to force. The first pass in this regard, of course, is always to render the opposition illegal. (Actual violence is reserved for criminals who persist in their misbehavior, despite more polite efforts to get them to behave lawfully.)

Making direct-pay medical practice illegal has not been accomplished yet, but clear efforts have been made in this regard. Noting with alarm the rise of direct-pay primary care, numerous Congresspersons have issued statements of concern, suggesting that perhaps Congress should look into the propriety of such activities.

Indeed, the first step by Congress has already been taken. In 2003, as part of the Medicare Prescription Drug, Improvement, and Modernization Act, Congress directed the GAO to study and report on the effect of direct-pay practices on Medicare patients. The GAO did so in 2005, and a fair paraphrase of its report is as follows: “The practice of direct-pay medicine is not currently a threat to Medicare patients, because the direct-pay movement is not large enough yet to have an impact. If it does begin to have an impact on Medicare patients, action will have to be taken.” That is, direct-pay medicine was considered OK in 2005 not because it was inherently an ethical and legal form of medical practice, but simply because there were not enough practitioners at that time to significantly affect Medicare patients. The clear implication is that Congress stands ready to pass laws outlawing – or, at least, severely limiting – direct-pay practices, as soon as those practices begin to “impact” the system.

Certain state governments are not waiting for Congress to ban direct-pay practices. The state of Maryland (and a few others) have taken the creative position that, because many direct-pay practices work on a retainer basis, they meet the definition of a health insurance company. And as a health insurance company, to be considered legal entities, they have to have millions of dollars set aside to pay for unforeseen “claims.” (Interestingly, this same argument was not applied to Maryland lawyers, who also often work on a retainer model.) According to the Baltimore Sun, the state’s stance in this regard has already successfully caused several primary care physicians to abandon their plans to become retainer practitioners.

Less devious (but more draconian) than the state of Maryland is the state of Massachusetts (whose universal healthcare system, we’ve all heard, is a preview of Obamacare circa 2015). A bill is under consideration in the Massachusetts Senate (Bill 2170) which requires doctors, as a condition of their licensure, to accept payment rates as determined by the government. If it passes, it will be the first actual legislation in the U.S. to ban direct-pay medicine, if only by making it completely impracticable. (Thanks to Dr. Wes for pointing out this important development.)

Since medical licensing is controlled by the various states, of course, it would take 50 bills like the one in Massachusetts to really get rid of direct-pay healthcare. But there are other ways for the Feds to accomplish the same thing. Now that the federal government directly controls all student loans, for instance, it would be a simple matter to make those loans contingent on agreeing to become primary care doctors working strictly within the government controlled system, or to offer loan forgiveness for doctors who agree to do so, or to rescind favorable re-payment conditions (retroactively, and decades after the fact, if necessary) for doctors who go to a direct-pay model later in life.

DrRich does not really know how the Progressives will actually place the final nail in the coffin of the doctor-patient relationship. All he knows is that they have – well, more than the desire – the deep and abiding need to kill that relationship, once and for all. Unless we the people decide we ought to stop them, this is going to happen.

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Part 4 of Limiting Individual Prerogatives

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 PCPs: Here's All You Need To Know About Our New Healthcare System [14:47m]: Play Now | Play in Popup | Download (3)

DrRich has decided it is time to begin studying the 2700-page healthcare reform bill that the Senate passed on December 24, as that is the bill which will actually become the law of the land. In the fall, DrRich had spent quite a bit of time with the House bill. This was such a painful and useless exercise that DrRich decided he would not waste any more of his time with proposed legislation, but instead (as Nancy Pelosi has wisely suggested) would wait until Congress passed a bill so he could find out what’s in it.

Now, DrRich does not have the stamina to study the new law all at once, as a whole. He must bite off little pieces. And the first thing he sought in embarking on his study of our new healthcare system was evidence of how the new law would rescue the Primary Care Physician.

This is important, since everyone acknowledges that we have a severe shortage of PCPs already, and when we add 32 million Americans to the rolls of the insured, that shortage will become extremely acute. Further, we know that very few medical school graduates are deciding to become PCPs, and further, that the PCPs who are in practice today are becoming older rapidly, and many may not be around in 10 years (or even in 10 months, once this reform bill passes).

As we all have heard, our President and his Congress have explicitly recognized the problem, and have frequently explicated on the need to build up and support our beleaguered primary care workforce. They have promised that their healthcare reforms will aggressively address this issue. And it is largely due to this promise that prominent physician organizations, like the AMA (which really represents a relatively small minority of the medical profession) and the American College of Physicians (which represents a large proportion of internists, of whom many are PCPs), have come out in support of the President’s reform efforts.

DrRich believes, of course, that for the Feds to suddenly make themselves the champions of PCPs, after spending nearly two decades systematically rendering primary care medicine a completely untenable proposition for American physicians, would be an unlikely outcome for any reform bill. Just to remind his readers, here’s what DrRich has previously observed about the carefully engineered plight of the American PCP:

“Their pay is determined arbitrarily by Acts of Congress, not by what they’re worth to their patients or to the market, and indeed in this way PCPs have a lot in common with workers in the old Soviet collectives.

They are directed to “practice medicine” by guidelines and directives which are handed down from on high; guidelines which, being forcibly based on what is called “evidence-based medicine,” necessarily address the average response of some large group of patients to the treatment being considered and do not allow much if any latitude for an individual patient’s needs; and which are often promulgated less to assure the excellent care of patients and more to further the agenda of various and competing interest groups, professional, governmental and otherwise.

They are limited to between 7.5 and 12.5 minutes per patient encounter (depending on the third party that controls a given patient’s medical care), and the content of what must occur during those 7.5 minutes is strictly determined by sundry Pay for Performance checklists, so as to strictly limit any interchanges between doctor and patient that do not meet the approved agenda for such encounters.

Their every move must be carefully documented according to incomprehensible rules, on innumerable forms and documents, that confound patient care but that greatly further the convenience of healthcare accountants and other stone-witted bureaucrats who are employed specifically to second-guess every clinical decision and every action the PCP takes.

They are expected to operate flawlessly under a system of federal rules, regulations and guidelines that cover hundreds of thousands of pages in immeasurable volumes that are never available in any readily accessible form. If they do not operate flawlessly according to those rules, regulations and guidelines, they are guilty of the federal crime of healthcare fraud. Furthermore, the specific meanings of these rules, regulations and guidelines are not merely opaque and difficult to ascertain, but indeed they are fundamentally indeterminate – that is, no individual or group of individuals in existence can say what they mean. So, PCPs operate under a massive quantum cloud of rules as best they can, but their actual status (regarding healthcare fraud) is, like Schrodinger’s cat, fundamentally unknowable – until the “box is opened” (typically through criminal prosecution), whereupon the meaning of the rules is finally crystallized in a court of law, and doctors who had been practicing in good faith find that they have at least a 50- 50 chance (like the cat) of learning that they are actually professionally dead.

Worst of all, PCPs have been charged with the duty of covertly rationing their patients’ healthcare at the bedside, and they have been pressed to nullify the classic doctor-patient relationship, by the healthcare bureaucracy that determines their professional viability, by the United States Supreme Court, and by the bankrupt, new-age ethical precepts of their own profession.”

How does our new healthcare law propose to “fix” these problems? DrRich can find two proposed solutions in the Senate bill.

First, the new law promises to address some of the pay discrepancy which punishes doctors for going into primary care specialties. It is unclear to DrRich how much this new pay fix will bring to PCPs. He will merely observe that, until now, the Feds have intentionally rendered primary care medicine such a soul-wrenching, personally and professionally demeaning endeavor that it has pushed most PCPs beyond mere anger, frustration, or resignation. Many of them are desperately looking for any practicable exit strategy. And to DrRich’s thinking, since it is not primarily their relatively low income that has caused all this anguish, a mere boost in income cannot overcome it.

But, of course, that’s for the PCPs themselves to decide.

Second, the new law proposes to fund new training opportunities for PCPs. This also sounds nice. But DrRich wonders what effect these new training programs will have, when the training programs that already exist cannot come close to filling their slots.

DrRich contends that these two stated “fixes” for manufacturing more PCPs cannot possibly provide an actual solution to the PCP shortage, and further, that the authors of the Senate bill cannot possibly believe they will. And so, DrRich decided to look a little deeper.

The answer to the PCP shortage – at least, the answer our political leaders are actually relying upon – is revealed deep in the Senate bill, in Section 5501, where the definition of “Primary Care Practitioner” is actually provided. Note, first of all, that once this bill becomes the law of the land, “PCP” will no longer mean “primary care physician,” but rather, will mean “primary care practitioner.”

And here’s how the new law defines Primary Care Practioners:

The term ‘primary care practitioner’ means an individual who —

(I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or

(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in 9 section 1861(aa)(5))

And so, to his readers who are primary care physicians, DrRich must report that the real “fix” your political leaders have envisioned for the PCP shortage has been to declare you and nurse practitioners to be functionally (and legally) equivalent. This, DrRich submits, is all you need to know.

Having painstakingly reduced you unfortunate practitioners of primary care medicine to tools of the state – whose job is to follow the guidelines and place chits on the checklists which are handed down from on high, and to fill out the electronic forms which are designed not to advance patient care but to convenience the healthcare accountants who will thereby judge your “quality” – it is only natural for the central authority to eventually notice that you really don’t need all that training to do the kind of job they have invented for you. Nurses – who can be “trained up” much more rapidly than you, who will work for much less money than you, and who (they think) will be much less recalcitrant about following handed-down directives than you – will fill the gap. And you, doctor, can go pound salt.

DrRich must hasten to add, by the way, that, regarding the nurse practitioners, he believes the Feds have miscalculated. DrRich knows a lot of nurse practitioners and greatly admires their professionalism. He believes that “PCP” has been so successfully demeaned that many fewer nurse practitioners than our political leaders think will actually jump at the opportunity to become one (especially when you take into account the liability you assume when you become a PCP in a non-tort-reform paradigm like the one our leaders have made for us). Trusting in their common sense, DrRich will leave the nurse practitioners to their own wise counsel.

To his primary care physician friends, who have bravely held on, clinging to the promises made by our political leaders that their noble efforts will not go unrewarded, and to the assurances made by their own professional organizations that all will be well once the system is reformed, DrRich is forced to say: Told you so.

He also reminds you that it is still not illegal to opt out, and urges you to consider that it soon might be.