When Is It OK Not To Follow The Guidelines?

DrRich | June 20th, 2011 - 7:21 am

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In an article appearing last week in the American Heart Journal, investigators concluded that if American doctors would prescribe for their patients with heart failure each of the six therapies which are most strongly recommended in current heart failure guidelines, 68,000 lives per year could be saved.

The following (for the interest of the reader, and for the convenience of any attorneys who may follow DrRich’s offerings), is an ordered list of these six proven, life-saving heart failure therapies, along with the number of American lives that could be saved each year if only American doctors would stop grossly under-utilizing them in violation of published guidelines:

  • aldosterone antagonist therapy – 21,407 lives
  • beta blockers – 12,922 lives
  • implantable defibrillators (ICDs) – 12,179 lives
  • cardiac resynchronization therapy (CRT) – 8317 lives
  • hydralazine plus isosorbide – 6655 lives
  • ACE inhibitors or angiotensin receptor blockers (ARBs) – 6516 lives

The authors, of course, are careful to point out that their analysis is based on statistical methods, and thus must be counted as merely estimates of the magnitude of the benefit that would actually occur should American doctors suddenly begin managing their heart failure patients appropriately. (Their presentation of these estimates to five significant figures implies a level of precision far in excess of what can be justified, and therefore must be an oversight not only by the authors, but also by the reviewers and the editors. But still, one gets the idea. A lot of preventable deaths are being left on the table.)

Several studies have reported, over and over again, that fewer than half of American patients with heart failure are receiving all the treatments available to them that have been shown to reduce symptoms and/or prolong life. Indeed, DrRich, on his patient-oriented heart disease website at About.com, has long urged patients with heart failure to familiarize themselves with all the recommended therapies for their condition, so that when they are with their doctors at least somebody in the room will bring it up.

(Such advice, DrRich reminds his readers – all of whom are likely to be patients one day – ought to be considered generalizable for all American patients with all medical conditions, in an era when doctors are being coerced to ration healthcare at the bedside by omitting mention of sundry available medical services.)

But DrRich’s purpose here is not to address those unfortunate heart failure patients whose lives are being jeopardized by their physicians’ acts of omission. but rather, is to strategize with his colleagues who treat heart failure patients as to how they should respond to this embarrassing revelation that by failing to follow published guidelines, they are killing so very many patients.

After all, only a few months ago, when another research study showed that 23% of ICDs were being implanted outside of published guidelines (even though the large majority of those “inappropriate” implants turned out to be actually indicated, but were performed within a 40-day waiting period that the guidelines specified), not only was this violation played up on the evening news and splashed across newspaper headlines, but also the Department of Justice immediately launched an investigation to determine whether it could bring criminal charges against implanting physicians. That is, failing to follow recommended guidelines to the letter is now not merely suboptimal medical practice, but also criminal behavior.

And how much worse than implanting indicated ICDs a few days earlier than the government would prefer, is behavior that causes the unnecessary deaths of 68,000 people a year? It seems to DrRich to be quite a bit worse.

So should American doctors who treat patients with heart failure be feeding their Swiss bank accounts, changing their identities, and stocking their lean-tos in the Montana backcountry?

DrRich brings good tidings – there is no need for you to overreact. The Feds cannot possibly prosecute all deviations from all clinical guidelines. Not only would that be unfeasible, it would also be counterproductive. And deviations from the heart failure guidelines are just the kind of deviations from which the Feds are inclined to look the other way.

We must remember that the primary directive of the American healthcare system, whether it is run by insurance companies or the government, is to ration healthcare covertly. Covert rationing means withholding whatever medical services you can, from whatever patients you can, whenever you think you can get away with it. If one remembers this simple rule, one can accurately predict the response of the health insurance companies or the government to any particular guideline violation.

So: When doctors implant expensive ICDs outside of the guidelines, even when the deviation is to place an indicated ICD a few days earlier than specified, it is a potentially criminal offense. Those ICDs cost a lot of money, and worse, prevent inexpensive sudden deaths, so it is clear that steps need to be taken to prevent their usage. Enforcing the guidelines to the letter therefore is imperative.

On the other hand, when deviations of guidelines result in NOT spending money (say, on drugs, ICDs, and CRT devices), those deviations will  be viewed quite differently. And when those same guideline deviations result in the premature deaths of tens of thousands of patients with chronic and expensive medical conditions (and who, had they survived for another five or 10 years, would have consumed lots and lots of extra healthcare dollars and, in most cases, Social Security payments), the last thing you would want to do is to engage in guideline-enforcement activities.

If you doubt DrRich on this point, ask yourself whether you’ve been treated to news stories over the past 10 days on how American doctors are killing 68,000 people each year by failing to follow guidelines. That story, it seems to DrRich, would be much sexier than the one that made a splash in January about ICDs being implanted too early. Yet we’ve heard next to nothing about it. These are not the kinds of guidelines violations we need to put a stop to. These guidelines violations do not fit the narrative.

Also, consider the editorial that accompanied the article in the American Heart Journal last week. It constitutes a strong apologist argument for violating the heart failure guidelines. It points out, rightly, that perhaps there were good reasons that some patients with heart failure do not receive all six of the recommended therapies, and that not all guidelines are applicable to all patients. It also points out that the number 68,000 was estimated by compounding several assumptions together, which would place large error bars around that estimate. So perhaps the guidelines deviations were not as lethal as the authors estimated. But most striking of all, the editorialist argues that it would just be too expensive to follow the guidelines for all patients with heart failure.  If ICDs were used in all patients for whom the guidelines say they should be used, for instance, this alone “would divert most of the money anticipated for all heart-failure care next year to these devices.”

The editorial is correct, and it is honest. It, at least, openly acknowledges that doctors are obligated to ration healthcare, based on costs, at the bedside, and that following these guidelines would violate the imperative to ration. Current guidelines on heart failure would cost a lot of money up front, and would result in the prolonged survival of a lot of very expensive Americans. And therefore, doctors will not be held accountable for failing to follow them.

American doctors can continue deviating from the heart failure guidelines, secure in the knowledge that their activity (or inactivity) will not capture unwanted attention from the Feds. These are not the guidelines our leaders are talking about when they assure the population that they are going to make sure that doctors are doing all the things the experts specify they should be doing.

These are those other kinds of guidelines.

If you are an American patient with any kind of medical problem whatsoever, DrRich begs you to become an expert in your medical condition. The patients with heart failure who are doing so, and who are prepared to challenge their doctors on their treatment, are among the minority who are receiving all the therapies proven to prolong their survival.

Who Writes Those Clinical Guidelines, Anyway?

DrRich | January 19th, 2011 - 8:50 am

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While DrRich is a conservative American, and has made plain the difficulties he has with the Progressive program in general and with Progressive healthcare reform in particular, at times he is forced to admit that, on occasion, the Progressive way of looking at the world has certain merits. And as DrRich contemplates a question that has been bothering him lately, a question that no doubt plagues many American physicians who (unlike DrRich) are still toiling away in the trenches, he finds that this is one such occasion.

That question is: Just who are the people writing all those clinical guidelines – the  “guidelines” physicians are now expected to follow in every particular in every case, on pain of massive fines, loss of career, and/or incarceration?

DrRich is quick to say that the act of creating clinical guidelines is not inherently evil, and indeed, back in the day when guidelines were merely guidelines (instead of edicts or directives that must be obeyed to the last letter), creating clinical guidelines was a rather noble thing to do.

But today, we have physicians clamoring to become GOD panelists (Government Operatives Deliberating). These aristocrats of medicine will render the rules by which their more inferior fellow physicians, the ones who have actual contact with patients, will live or die. Clearly positions of such authority will be very desirable, and so, as one might predict, they are being vigorously pursued. And we are seeing candidates audition for these panels with efforts ranging from amateurish to ruthless. It puts one in mind of the early-season contestants on “American Idol.”

We see them vociferously extolling, in every public venue they can find, the idea of “fly by wire” medicine, whereby every decision physicians make will be determined not at the bedside but by the best and the brightest experts, acting at a distance. The experts will distribute rules of action based on only the best scientific evidence (“best” being determined by those selfsame experts). The directives they hand down will be models of actionable simplicity,spelled out so unambiguously that even doctors born, raised, and trained in the Midwest or the South will be able to follow them.  (And if the doctors refuse to cooperate sufficiently, non-physician medical professionals will be able to do the job.) We see them writing scientific papers that spin the evidence in such a way as to generate conclusions which will be soothing to the Central Authority. We see them editing medical journals in order to make certain that the correct conclusions are published, and the incorrect ones are not. We see them taking control of professional organizations, and using their positions to promulgate changes in medical ethics that advance the Borg-ification of medicine, and to formally endorse Obamacare on behalf of American physicians who, for the most part, were against doing so.

These people have gained great prominence within our healthcare system, and practicing physicians will be dealing with them and the consequences of their actions for many years to come. While the natural impulse of us typical American doctors may be to simply marvel at the wonder of it all, shake our heads resignedly, and go about our increasingly distressing business, it may behoove us to take a closer look at these individuals, to attempt to understand them a little better. After all, their activities in the near future promise to greatly impact our lives, our fortunes, and our sacred honor.

So – who are they, anyway?

This, dear reader, is where the Progressive mode of thought comes in handy. DrRich refers, of course, to the Progressive doctrine of Diversity.

Diversity, for those who pretend not to know, is perhaps the chief mechanism by which Progressives attempt to control the behavior of the population.

Recall that the Progressive program is to create the perfect society. The Progressive elite know just how to do this, of course, but individuals within every population throughout human history have insisted upon acting in their own self-interest, which is counterproductive to the collective goal. In past efforts to perfect human societies, such individual recalcitrance has been dealt with by means of concentration camps and pogroms and the like. “Diversity,” we all should admit, is a much kinder and gentler approach to curing the problem of individualism.

Specifically, the doctrine of Diversity defines the range of permissible behaviors and thoughts for a given group of people within a society. The numerous celebrations of Diversity we see all around us invariably turn out to be strategies to reinforce those allowable ranges of thought and behavior. In this way, members of a particular group who begin behaving and thinking outside the allowable range can be quickly identified and dealt with, either through correction (which brings them back into the group), or through vilification (which marginalizes them). It is easy to become confused about this, since classically “diversity” means something other than “conformity.”  (As a general rule, if you want to know what Progressives are really up to, listen to what they say and then look to see if their deeds are actually working toward the opposite thing.  DrRich thinks that much of the time you will find that they are.)

In any case, while in general DrRich does not approve of Diversity as it is being practiced today, he finds that the concept might be useful in attempting to answer the question at hand.

Specifically, DrRich refers to his theory that physicians (like any humans) tend to end up in careers that best suit their underlying personalities and proclivities, and so physicians in a given specialty will tend to think and behave like other physicians within that specialty, and unlike physicians in other specialties. If this theory has any merit (and let us call it the Diversity Theory of Physicians), it will allow us to make some generalizations about the characteristics of individuals who have chosen specific kinds of medical careers. DrRich stresses that he is aiming to make generalizations only, and while those generalizations might help enlighten us to a modest degree regarding, say, what sort of physician will end up on the GOD panels, they can tell us nothing about particular individuals.

With that annoying disclaimer out of the way, let us examine some ways in which the DTP reveals Truth. An obvious example is the specialty of psychiatry, which tends to attract doctors who are, perhaps subliminally, concerned that they are just a little crazy themselves. As it happens, it often turns out they are correct. In DrRich’s experience, and in the experience of just about anyone who has encountered more than a handful of shrinks, these fine physicians, on average, display an astonishing degree of off-the-wall psychopathology. (Not that there’s anything wrong with that.)

Emergency room doctors have short attention spans and are afraid of commitment.

Endocrinologists get their jollies by sitting alone in cramped offices, parsing tremendous volumes of laboratory data from blood tests, which they claim reflect moment-to-moment variations in hormone levels, and from this arcane evidence are able to parse out (so they say) subtle glandular difficulties. If endocrinologists were not physicians they would be accountants; the more aggressive endocrinologists (who are identifiable by the dirty glance they give you if you happen to interrupt their lonely cogitations) might be forensic accountants. (How anybody could specialize in any organ that just sits there, perhaps secreting various invisible substances, but otherwise not doing anything whatsoever,  DrRich will never understand.)

Orthopedic surgeons are former jocks, or wish they were, and the ones who end up replacing hips in old ladies instead of patrolling the sidelines at college football games are often very frustrated individuals.

Party animals who manage to gain entrance to medical school often end up as anesthesiologists.

Cardiologists like to envision themselves (and would like others to envision them) as living on the edge. After all, they put catheters into damaged coronary arteries in patients on the brink of heart attacks, and, through their skillful manipulations, open those arteries and save lives. They are the extreme sportsmen of medicine, so they believe. But really, their jobs are ones of relative security, predictability and instant gratification. What they do in the cath lab actually is pretty rote, and it provides them with immediate, concrete results. They can even show the “before” and “after” pictures to the person they just saved, who will then heap praise and shed tears of gratitude upon them. But any time fixing a particular artery looks a little too risky, they call a cardiac surgeon right away. This pattern of behavior suggests to DrRich that their aggressive personnas and glory-seeking activities are actually masking an underlying insecurity.

It would not be fair of DrRich to psychoanalyze all these other specialists – who have done nothing to provoke him – without also doing the same for electrophysiologists. All electrophysiologists started out as cardiologists, of course, so they have that going for them. But to really understand electrophysiologists, one must invoke the principle of sublimation. To sublimate is to channel an underlying negative tendency to some activity that partially gratifies that tendency, but that is considered worthwhile by society. So, for instance, people with a tendency toward pyromania may become volunteer firefighters. People with sadistic tendencies may become prison guards. Foot fetishists can become shoe salesmen. Compulsive liars can become novelists.

Who, then, become electrophysiologists?

Back in the 1980s and 1990s, when DrRich was practicing, what electrophysiologists mainly did was to try to prevent sudden death in patients who had a high risk of dying suddenly from cardiac arrhythmias. And in order to find the optimal therapy for these patients, it was necessary to induce, intentionally and repeatedly, cardiac arrests under controlled conditions. This was done in an effort to find an antiarrhythmic drug that would prevent the induction of cardiac arrest. This behavior we euphemistically called “serial drug testing.”  Fortunately, this procedure is no longer necessary, since the implantable defibrillator has been perfected and is now widely available for high-risk patients (if you can get it paid for).

While it has been widely remarked that those early-day electrophysiologists were a very strange group indeed, most of us who did this serial drug testing ended up successfully absorbed into normal society, and today (as far as DrRich can tell) we are for the most part generally pretty harmless. But DrRich sometimes finds himself wondering what might have become of some of us (some in particular more than others) if we had not had this remarkable opportunity to sublimate what one might speculate to be some rather unpleasant tendencies. And what is to become of that young person today who has whatever those unfortunate tendencies might be, and who, 30 years ago, might have found release as an electrophysiologist? One must not think too deeply about this.

Let us now turn our attention to those would-be GOD panelists, and see if we can decipher what kind of people these might be. Admitting that what follows – and, for that matter, what has just been said – amounts only to an educated guess, DrRich submits that the GOD panelists are people you already know well, if you have worked within the American healthcare system.

These are the kids you knew in college who studied all the time and got straight A’s in all the hardest courses, buttered up their teachers, then aced their MCATs. For them the hardest part about applying to medical school was in deciding which of the many schools that accepted them they should attend. Likely, they chose one of the Ivy League ones. Their first two years of medical school – the didactic years – were much like their college experiences. They studied hard, aced all the exams, and were generally acknowledged by both faculty and peers to be at the very top of their class.

Then they reached their clinical years, and things changed. They still knew more information than anyone else, and in fact their information base continued to expand. They read all the journals, and could always quote new research findings chapter and verse. They could conjugate the Krebs cycle on demand (or whatever it is you do with the Krebs cycle), and could recite precisely which enzyme that new drug inhibited, and could say why doing so made it OK to eat pizza again.

But what they could not do was be a good doctor. They had no instinct for it; no ability to get the patients to tell them the important information; no ability to read a patient’s facial expression, or phraseology, or body language, those signs that reveal the real truth. They had no ability to discern useful information from the flood of partial and contradictory clinical evidence that is always pouring in from several sources. When time was of the essence, they had no capacity to figure out what was going on or what they should do about it. They could not adjust to changing clinical situations on the fly. In an emergency they were paralyzed, trying to match the quickly evolving situation in front of them with the static words on the printed page. And often they were klutzes.

They were perfectly cut out to learn medicine, but lousy at actually doing it. What was worse, some of their colleagues who were mediocre in the book-learning department suddenly blossomed into highly competent clinicians on the wards, and quickly became recognized as rising stars by attending physicians, while they themselves were repeatedly chastised, or ignored.

And it just wasn’t right. It just wasn’t fair. They had worked harder than everyone else, had twice the brains as those others, and had learned the material three times as well. But the way God set it up, they just weren’t good doctors.

Many of these unfortunate souls quickly left clinical medicine, and branched off into research, academics, or administration. Most of them did quite well for themselves, because they really are very smart. But they never really got over their frustration and anger over their unjust  failures on the clinical wards, a place where their obvious inferiors lorded it over them. They have now spent years engaging in cognitive dissonance, convincing themselves that their apparent failure was an illusion, merely a sign of having been subjected to the anti-intellectual, shoot-from-the-hip, do-it-quickly-and-make-more-money environment that is American healthcare. After all, how could they be sub-optimal physicians when they are clearly far more intelligent and knowledgeable than the supposed “stars?” If the healthcare system had been arranged differently, in such a way as to make the cowboys behave the right way, they would have proven themselves to be the best clinicians in the land.  It is a bitter, bitter pill.

These are the guys, DrRich thinks, who are chomping at the bit for the opportunity to sit on the GOD panels. They would dearly love the chance to utilize their superior intellectual firepower, to distill the clinical research data, to digest it painstakingly and thoroughly (not haphazardly and on the fly like those others), to put down on paper the RIGHT way of practicing clinical medicine -  and to have the authority to do it in such a way (backed up by the full force of the Central Authority) that those lesser doctors will HAVE to do it their way, at long last.

The point of all this psychoanalytic guesswork is to suggest that the GOD panelists, even the GOD panelists who are physicians, will have no sympathy for the idea that the practice of medicine should be individualized to any degree whatsoever. The idea of individualizing medical care, rather than practicing by formula from a book, is what caused these people the most uncomfortable moments in their professional lives. Far from being sympathetic to the idea, they will probably be more hostile to it than the non-physicians on the GOD panels. When somebody on the panel suggests that, perhaps, we should give the doctor a little more leeway on this particular issue, these physicians will speak up and say, “Listen. I’ve been there and you haven’t. These doctors don’t need any more rope, unless it’s to bind them even tighter.” They were themselves shown no quarter, in the tough arena of clinical medicine where outcomes (and not process or book knowledge) is the only mark of success, and they will offer none in their turn.

DrRich cannot prove any of this, of course. He is just theorizing, based on his own personal observations and prejudices, having observed many of these whiz-kids in his 25 years of teaching medical trainees, and watching where they wound up. He could, of course, be wrong.

In any case, for allowing him to carry on in this manner DrRich owes one more expression of gratitude to his Progressive friends, whose doctrine of Diversity supplies the necessary substrate, and the ethical “cover,” for mercilessly stereotyping selected groups of what otherwise might turn out to be individuals.

Another Reason It Sucks Being A PCP

DrRich | August 18th, 2010 - 6:09 am

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DrRich entered medical school 40 years ago with every intention of becoming a general medical practitioner, and indeed he became one. But after only a year in practice as a generalist, he found himself so frustrated with the frivolous limitations and the superfluous obligations that even then were being externally imposed on these supposedly revered professionals, that DrRich altered course and spent several years re-training to become a cardiac electrophysiologist.

(Electrophysiology is a field of endeavor so arcane as to be mystifying even to other cardiologists. DrRich hoped that the officious regulators and stone-witted insurance clerks would be so confused – and possibly intimidated – by the mysterious doings of electrophysiologists that they would leave him alone. Happily, this ploy worked for almost 15 years.)

Still, DrRich has always held general practitioners (now called PCPs) in the highest regard, if for no other reason than these brave souls – unlike DrRich himself, who cut and ran at his earliest opportunity – have stuck it out.

But, as we all know, the practice of primary care medicine is today in crisis. Today’s PCPs are mostly looking to get out as soon as they can afford to do so, and today’s medical students are avoiding primary care in droves.

But not for the reasons most often claimed.  DrRich’s contention is that doctors are abandoning primary care medicine for reasons that actually have relatively little to do with low pay and high educational debt. The real reasons have much more to do with the fact that primary care medicine has been systematically and purposefully demeaned and diminished, to the point that it has become nearly an untenable choice for most doctors.

Accordingly, every now and then DrRich likes to point out – for the edification of his readers – some of the ways in which this fundamental devaluing of primary care medicine is being accomplished.

And so, here’s another reason it sucks being a PCP:

PCPs whose patients fail to quit smoking are now at risk not only of being publicly labeled as low-quality physicians, but also of being sued.

To see how this works, dear reader, DrRich asks you to place yourself, for a few minutes and for the sake of empathy, in the position of a modern American PCP.

As a PCP, one of the major banes of your existence is the struggle you must make during each and every “patient encounter” to get through a long Pay-for-Performance Checklist (different checklists for different patients, depending on their insurer). Completing these checklists, within the 7.5 minutes that have been graciously allotted to you for such encounters, is of course critical in order to demonstrate to the appropriate healthcare accountants the adequacy of your performance as a modern, high-quality American physician.

One item that invariably appears on each of your mandatory checklists, doctor, has to do with counseling your patient on smoking cessation. It’s likely you may have thought this to be one of the less objectionable mandates you must accomplish during each patient visit. After all, you can get through your well-rehearsed pitch on smoking cessation in 20 seconds or less (unless you are dealing with one of those rare patients who is actually serious about trying to quit), and thereby make up some of the precious time, from your 7.5 minutes, that you have already spent achieving some more challenging check mark (trying, perhaps, to talk a diabetic patient into taking the extraordinary steps necessary to get his hemoglobin A1c down that last 0.5% to target).

So: 20 seconds spent on smoking cessation. Check.

But whoa. Not so fast there, Dr. Welby.

Did you know there are guidelines for physicians on smoking cessation? Did you know that these guidelines were devised under the auspices of the federal government, by a committee of individuals who are anti-smoking zealots (not that there’s anything wrong with that)?

From this latter fact, of course, there are certain things you will already know about these guidelines before you ever see them. You will know that the guidelines must be very long and detailed and tedious, because a) they are federal guidelines, and b) they are devised by people whose one and only mission in life – a mission they clearly believe is far more important than, say, oil spills, terrorism, global warming, jobs, or achieving fine and durable erections upon demand – is to save the world from the scourge of smoking. And now, these zealots have been granted the authority (i.e., the federally-approved authority to generate medical guidelines) to make it your primary mission in life, too.

Now, doctor, have a peek at the actual guidelines, which you can find here. Notice, first, that the federal guidelines for physicians on smoking cessation are 196 pages long. Notice how they step you through the process of counseling, and then step you through each of the measures you must take in order to guarantee that your patient achieves total success. And notice that an early branch point in the process of counseling is the one where the patient informs you whether he/she is willing to go any further with efforts at smoking cessation; and notice further that when the patient concludes that he/she is indeed NOT willing to go any further, thank you very much for your concern, the guidelines do not relieve you of further immediate obligations – no – but instead specify additional interventions you must now, at this moment, embark upon with this unwilling patient, which are “designed to increase their motivation to quit.”

The brash sales techniques required of you by the federally-sanctioned smoking-cessation guidelines would embarrass even a telemarketer, or an annuity salesperson.

This, of course, is all to say: Your 20-second spiel on the evils of smoking just doesn’t cut the mustard, doctor. To really earn that smoking-cessation chit on your P4P checklist, you need to do a lot more than that. The 196 pages of deadly serious federal guidelines detail what that is.

Lest you are tempted to dismiss as an absurdity the expectation that you are actually supposed to cram 2 hours of anti-smoking counseling into a 7.5 minute patient visit, there’s one more thing you ought to know.

One John Banzhaf, Executive Director and Chief Counsel for Action on Smoking and Health (ASH), who bills himself as the “law professor who masterminded litigation against the tobacco industry,” is not taking lightly, doctor, your obvious laxity in following federal guidelines on smoking cessation. Accordingly, some time ago he sent letters to each of the 50 state health commissioners warning them that he will soon begin instigating medical malpractice suits, on behalf of smokers who continue to smoke as the result of their doctor’s refusal to follow federal guidelines to the letter.

Mr. Banzhaf informs the commissioners that “physicians are killing more than 40,000 American smokers each year by failing to follow federal guidelines.” That’s right, doctor, you’re killing them. (Cigarettes don’t kill people; people kill people.) Specifically he invokes your sacred obligation to “warn the smoking patient about the many dangers of smoking and provide effective medical treatment for the majority who wish to quit.” (Emphasis DrRich’s.) That is, it’s your job not just to counsel them and treat them, but also to see that they actually succeed in quitting. If you don’t follow this mandate, you’re killing them. And you must pay.

When the federal government takes the pains necessary to draft detailed management guidelines for physicians, guidelines that, if followed as written, will save tens of thousands of lives each year, then surely society has every right to expect you to follow those guidelines to the letter – and to save those lives.

This is such a brilliant scheme for ending smoking-related death and disability, one must wonder why it hasn’t yet been applied to other intractable medical problems. Just think of all the good that could be accomplished, for instance, by federal guidelines requiring PCPs to assure that each of their patients maintain an optimal body weight, follow an exemplary diet, exercise vigorously for at least an hour a day, maintain unfailingly positive attitudes, and work diligently at their allotted tasks each and every day (secure in the knowledge that adopting right thinking and right behaviors will be invaluable to our dear leaders, as they bravely go forth to assure the good of the whole).

In any case, doctor, consider these anti-smoking guidelines carefully next time you’re putting that little check mark next to “Smoking cessation counseling” on your P4P checklist, and ask yourself: “Have I really done all that I am obligated to do, under the law, to guarantee that this patient has lit up his last smoke?”

Making PCPs responsible for their patient’s personal choices and behaviors, of course, is a time-honored method of covert healthcare rationing. It gives doctors powerful incentives to invent mechanisms for avoiding patients who display obviously unhealthful lifestyles, thus making it relatively inconvenient for these patients to gain access to expensive healthcare services.

But more to the point of this post, it is yet another example of how micromanagement by politicians, activists and bureaucrats has come to infest the practice of primary care medicine, and to relegate PCPs to the diminished role of simply following the checklists continually produced by such as these. If this is what primary care medicine has come to at last, why would you expect anyone who has a choice to take such a career path?

DrRich, for one, does not believe the 10-15% increase in pay hinted at by Obamacare will change the calculus for PCPs very much, and in fact, if it does – given all that is being done to primary care medicine – we should all be very much distressed by the implications.

More Arguments for Withholding Crestor

DrRich | July 7th, 2010 - 7:34 am

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DrRich’s last post addressed a recent issue of the Archives of Internal Medicine which, strikingly, was largely dedicated to trashing the JUPITER study.

The JUPITER study was a landmark clinical trial in which giving the statin drug Crestor to apparently healthy individuals who were at increased risk of cardiovascular disease (and most particularly, had high CRP levels) resulted in a significant improvement in outcomes. In particular, within two years, individuals taking the statin had a 20% reduction in overall mortality, a 54% reduction in heart attacks, a 48% reduction in stroke, and a 40% reduction in venous thrombosis and pulmonary embolism. All these findings were highly statistically significant.

DrRich attempted to show that the criticisms of JUPITER recently offered by the Archives were sufficiently spurious to raise the question of what the authors and the editors were really trying to accomplish, and for him to suggest that perhaps they were auditioning for appointments to the government’s expert medical panels, which will soon begin determining who gets what, when and how. Indeed, DrRich will actually be quite surprised if none of these individuals end up with such an appointment. They have clearly demonstrated they have the right stuff.

Still, as DrRich also pointed out, the JUPITER study, while a reasonably straightforward clinical trial whose results seem impressive, was anything but air-tight. No clinical trial is air-tight, however, and if medicine were still practiced the way it should be, the JUPITER trial could be smoothly incorporated – with all its limitations – into clinical practice without a hitch.

But, since medicine is now practiced by guidelines, JUPITER poses a major problem. In fact, it has led to major and contentious debates between those who insist its results must be incorporated into formal clinical guidelines, and who insist they should not. On one hand, many point out that JUPITER is an important clinical trial which has demonstrated a vital clinical benefit (prevention of heart attack, stroke and death) with a high degree of statistical significance, which meets the high standards demanded by evidence-based medicine, and which therefore obviously demands a change in the clinical guidelines. But on the other hand, many others insist that the JUPITER trial simply does not demonstrate enough of a benefit with Crestor to justify changing the guidelines.

DrRich’s position – that the results of the JUPITER trial are striking and important but incomplete, and ought to change the conversation between, but not dictate the actions of, doctors and patients – simply does not obtain in the modern era.

So, unable to side with either party, DrRich observes with great interest the debate between those who want to change the guidelines, and those who believe that changing the guidelines would be the greatest of travesties.

Those who want to change the guidelines have, in their favor, the virtue of consistency. For, if one insists that every action by physicians must be supported by evidence-based medicine, then one is pretty much obligated to fully embrace legitimate clinical trials like this one that give clear-cut and statistically significant results. Unfortunately, the evidence-based strict-constructionists have painted themselves into a corner when it comes to JUPITER. They will not be able to say, for instance, “Statins are pretty much alike, so we’ll make the guidelines say ‘statins’ instead of ‘Crestor.’” For JUPITER did not study “statins,” it studied only Crestor, the most expensive statin on the planet. Expanding the results to all statins (despite a large body of experience that suggests this would be just fine) does violence to the whole concept of evidence-based medicine. It’s just not possible. The strict constructionists have therefore boxed themselves in to advocating a new, multi-billion dollar annual expenditure.

It is even more amusing to observe those who do not want to change the guidelines.

These people fall into two general camps. First, and easier to dismiss, are those who believe that drug companies are the embodiment of evil, and that any clinical trial sponsored by a drug company must be dismissed out of hand, particularly if the drugs which are being promoted are statins. (This, in fact, is the level of argument on which the main article in the recent issue of Archives relies.)

DrRich simply notes, once again, that the advancement of clinically useful medical science – in America and in the world – is almost entirely dependent on drug companies and other corporate dens of iniquity. That companies must pay for our medical research is the system we’ve invented. Furthermore, our total capitulation to the dictates of evidence-based medicine means that companies must fund large, expensive clinical trials like JUPITER before they are allowed to sell a new product, or to create a new indication for an old product. This evidence-based paradigm is inherently a double-edged sword. Sure, it creates a huge barrier to the development and adoption of expensive new therapies (which is the covert rationing dividend of evidence-based medicine), but it also creates opportunities, for companies who manage to successfully complete such trials, to create iron-clad indications for their products. For, once a product has been “proven” in a randomized clinical trial, there is no easy way to legitimately keep that product out of the guidelines and off the shelves. The makers of Crestor have simply figured out the rules. One can whip up anti-corporate emotions by criticizing the sponsor for playing the game well, but the fact that the sponsor stands to gain does not negate in any way the results of a well-designed study.

That the anti-pharmaceutical and anti-statin crowds vociferously object to the results of the JUPITER trial is, of course, entirely expected and cheerfully acknowledged. DrRich will merely observe that their position is one of default. It is not dependent on the scientific merit of JUPITER (or any company-sponsored study), and thus it adds no useful information to the debate. We can only note their objections and move on.

The second group of people who object to changing the guidelines are less dogmatic and more open to reason, and indeed (and very interestingly so) claim to be proponents of evidence-based medicine, and thus claim to be willing to follow the data to where it will lead. It seems pretty clear (to DrRich, anyway), that the chief concern of these individuals, as it relates to JUPITER, is cost. That is, this group feels strongly that the implications of the JUPITER trial are simply too costly to follow to their logical conclusion. This, indeed, is a very reasonable position to take.

Unfortunately, the only legitimate way to turn aside the results of a costly but statistically definitive, evidence-based study is by rationing healthcare. (To ration, remember, is to withhold at least some useful medical services from at least some people who would be likely to benefit from those services.) But we can’t do that, because, well, it would be rationing. Because members of this second group are unable to invoke the “r” word, they are therefore forced to find other “reasons” for keeping the guidelines unchanged. This unfortunate situation leaves them little choice but to discover ways in which to impugn the legitimacy of the JUPITER trial.

In short, they find themselves forced to engage in statistical legerdemain in order to diminish the significance of the JUPITER trial. There are several useful statistical arguments they can employ.

From what DrRich has seen, many of the arguments that have been ginned up to this end have not come directly from the JUPITER trial itself, but instead from an editorial accompanying this study, written by Dr. Mark A. Hlatky.

Most of Dr. Hlatky’s editorial is measured and reasonable. But he threw in a key summary sentence that has been greedily grasped by the anti-alter-guidelinetarians, to wit: “The proportion of participants with hard cardiac events in JUPITER was reduced from 1.8% (157 of 8901 subjects) in the placebo group to 0.9% (83 of the 8901 subjects) in the rosuvastatin [Crestor] group; thus, 120 participants were treated for 1.9 years to prevent one event.”

This statement, at least taken at its face value as a stand-alone analysis, is statistically naive and wrong. DrRich realizes that one or two of his readers might not enjoy statistical arguments, so if you do not wish to wade through the reasons why, simply skip the next two indented paragraphs.

In a long-term clinical study in which the endpoints are events that can occur at any time (such as heart attack, stroke or death), then the probability that an enrolled patient will reach an endpoint in the trial increases the longer he/she has been enrolled in the trial. But in virtually all clinical trials, the length of time different people are enrolled varies greatly. This is because it often takes years to enroll people in clinical trials, so that when the trial ends, some will have been in the trial for many years, others for only a little while. This means that the risk exposure of each research subject is different, and is proportional to the total time they were enrolled. Not uncommonly, the enrollment process is not smooth – there are periods of more rapid enrollment, and periods of slower enrollment – so if all you do is average the enrollment time (as was done by Hlatky – 1.9 years) you are likely to get skewed results. So it is simply not statistically legitimate to do so.

There is a legitimate way of analyzing such longitudinal outcome statistics, and it’s called the Kaplan-Meier method. And indeed, the authors of the JUPITER trial presented in their paper a complete Kaplan-Meier analysis of their data (see Figure 1 of their paper), and the results look quite a bit different from Hlatky’s summary statement. The Kaplan-Meier analysis reveals that the risk of heart attack, stroke, and death all increase steadily through at least 4 years (5 years was the longest time anyone was enrolled in this study), so that at 4 years, the risk of reaching one of the “cardiovascular event” endpoints was about 8% (not 1.8%). Further, the Kaplan-Meier analysis shows that the protection imparted by Crestor persists through at least 4 years, and that indeed the magnitude of protection (i.e., the difference in outcomes between the treated group and the placebo group) increases throughout that entire duration. So, at 4 years, the placebo group had roughly an 8% event rate, compared to roughly a 3% event rate for the Crestor group – an absolute difference of about 5% (not 0.9%). This is a far greater benefit than is suggested by Hlatky’s shorthand summary.

Suffice to say, then, that Hlatky’s summary statement apparently ignores the appropriately analyzed data which is clearly presented in the JUPITER paper itself, and which documents that the clinical benefit of Crestor was substantially more impressive than his widely-quoted summary statement suggests.

But as illegitimate as this summary statement may be, let us accept it at face value for a moment just for the sake of discussion, since that’s the data the anti-alter-guidelinetarians have latched on to.

Taking these numbers, the “antis” make the following argument: While the relative reduction in “hard cardiac events” is 50% (1.8 to 0.9), the absolute reduction is only 0.9%, which, anyone would agree, is a pretty small number. So, they conclude, the actual benefit imparted by Crestor is actually quite small.

That’s a very interesting argument. Let’s look at it in a couple of ways.

So we’ve got a population of patients whose risk of heart attack, stroke, bypass surgery/stenting, or death is about 2% at about 2 years, and by giving them a pill we can reduce that risk to about 1%, and we’re arguing that the absolute drop of 1% is not very much to crow about. Well, OK. But what if we found a pill that reduced their risk to zero at 2 years? That is, it completely wiped out the risk of cardiovascular catastrophes altogether. Would that be a good thing? Or would we say, “It’s just a 2% drop, really not much greater than the 1% drop we had with Crestor, so it’s no big deal?” DrRich thinks not. DrRich supposes we would think that totally eliminating all cardiovascular risk would be a very big deal.

When you’re starting at a 2% risk, then any drop in risk is going to be an “absolutely” small number. And if we’re not going to pursue improvements in outcome of such a small magnitude, then why the heck are we worrying about preventative medicine in the first place? Once you get past the big things (drain the swamps, don’t drink the water downhill from the outhouse, etc.) then all preventative medicine tends to consist of small, incremental improvements in outcome. Popular pronouncements to the contrary notwithstanding, preventative medicine is largely the art of spending a lot of money for this kind of incremental improvement. If we decide we shouldn’t do this anymore, then DrRich would find it unfortunate but understandable. But it hardly seems reasonable to arbitrarily focus on this one, particular improvement in preventative cardiology, and (within a healthcare system that insists it is not rationing care) pronounce that this is the one we’re not paying for.

Another way of looking at this “the benefit is too small” argument is by considering that 7.4 million Americans fit the entrance criteria for JUPITER. By giving all these people a statin, we would be preventing about 66,600 major cardiovascular events over a 2 year period. If you’re going to say that 1% is a small number, DrRich will counter that 66,600 is a big number. So do statins offer a substantial benefit or not? It depends on whether you choose to focus arbitrarily on the 1% or the 66,600.

(DrRich understands that many of his readers are not focusing at this moment on the 66,600 cardiovascular catastrophes that could be prevented, but on the 7.4 million people who will be taking a drug that costs $120 per month. But we’re not talking about cost yet, we’re only talking about whether the drug does some good. If we decide it does, then we’ll need to link that “good” to a procedure that measures whether the “good” is worth the money we would need to spend to achieve it. The “antis” try to avoid talking about cost – since that would admit they’re rationing – by insisting that there’s just not enough “good” to bother with. DrRich is simply pointing out that such an argument – that preventing 66,600 very bad outcomes is not enough to bother with – is on its face absurd.)

Another argument invoked by the anti-alter-guidelinetarians is based on the “number needed to treat” (NNT) analysis. Again they rely on Hlatky’s unfortunate summary of the data: “120 participants were treated for 1.9 years to prevent one event.” This number – which the “antis” insist is just too high – is misleading for the reasons already discussed. The real NNT, based on more legitimate statistical analysis, is plainly laid out in the JUPITER paper itself. It turns out that the longer patients in this trial were treated with Crestor, the lower the NNT became. So: At 2 years, the NNT was 95; at 4 years, it was 31; and at 5 years, it was projected to be only 25. Whether you think it is reasonable to treat 25 people with a pill for 5 years to prevent one of them from having a heart attack, stroke, or death is, DrRich supposes, a matter of opinion. But based on NNT analyses for many widely-accepted therapies in medicine today, it looks pretty good.

All these arguments, of course, are merely distractions. The fact is that JUPITER showed a pretty striking reduction in nasty cardiovascular events over s pretty brief period of time, and the only real reason there’s any controversy at all is because of the cost of Crestor.

That cost is what makes us want to withhold Crestor, even though it is imparting at least some (and, DrRich, argues, quite a bit of) clinical benefit. In other words, the high cost makes us want to ration Crestor. The fact that we can only ration covertly, instead of openly, is what makes us want to bastardize the science and do a Kabuki dance with the statistics.

If we were rationing healthcare openly, then we could do an objective, full-bore cost-benefit analysis on the use of Crestor in JUPITER patients, using legitimate and not ginned-up statistical analysis, and taking into account not only the cost of the drug, but also the cost that would be incurred by failing to stop preventable heart attacks, strokes, etc., and then determining where the overall cost-benefit result fell within our coverage criteria. If it met the criteria we would cover it, if not, not. This decision would not be arbitrary. It would be a fully transparent process, so that if the sponsor did not like the results, they would try diligently to find a way to reduce the cost of Crestor (DrRich thinks they would succeed) to a value that would be compatible with their staying in business. (And for the first time, the price of medical products would be determined by a Laffer-like curve, where a price that was too high – like taxes that are too high – would reduce revenue, instead of increase revenue. Companies, being fairly rational, would ratchet their prices down to the optimal price point.)

But since we insist on doing our rationing covertly, DrRich is sorry to say that we’re destined to keep making spurious arguments, and using dumbed-down statistical analysis to back them up. The JUPITER trial, while it is imperfect and while it does not answer every question, really is pretty straightforward. That we get so wrapped around the axle trying to fold such clinical trials into our covert rationing paradigm is simply another demonstration of the fact that covert rationing corrupts everything it touches.

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Why They’re Trashing the JUPITER Trial

DrRich | July 2nd, 2010 - 9:29 am

Podcast:

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!