More on rivaroxaban trials

Recently, I referenced two clinical trials published in the NEJM which compared a new oral anticoagulant,rivaroxaban, with the low molecular weight heparin enoxaparin for thromboprophylaxis in patients undergoing hip arthroplasty and knee replacement surgery.Both studies showed an advantage for rivaroxaban over the comparison drug in terms of fewer thrombotic events and showed no real difference in bleeding.

Dr. RW pointed out that the dose of enoxaparin was lower than the standard recommended dose,that is the dose recommended in the United States. In both studies, the dose of enoxaparin was 40 mg. daily.This is in contrast to the 30 mg. every 12 hours which is the standard dose used. Could the use of the lower dose of the drug to which rivaroxaban was compared be an instance of "stacking the deck"? In the hip surgery study, there were 33 patients out of 1678 with major venous thromboembolism events versus 4 in 1686 patients in the rivaroxaban arm seemingly indicating the superiority of "riva".

Would the higher enoxaparin dose that is typically given resulted in fewer cases making the comparison less favorable to rivaroxaban? Maybe, but in a 1994 dose finding study the outcomes with 40 mg once daily and 30 mg twice daily were not statistically different.There were 27/199 (14%) patients with clots in the 40 mg dose and 22/208 (11%) in the 30 mg twice a day dose, a difference not statistically significant. Admitedly this was not a mega trial so a false negative could have occurred but the 40 mg dose has been used in other trials.The PDR gives the 30 mg. twice daily dose as the recommended dose but also suggests that in hip surgery patients the 40 mg regimen is reasonable alternative.After all of that, it seems to me that the 40 mg. used is not a unreasonable dose and has been used in other trials with enoxaparin .

In regard to the knee surgery study, the authors stated that the enoxaparin dose used was the dose approved in Europe and not the 30 mg twice daily dose approved in the U.S. for that application. Further, they started that a trail is currently in progress with the 30 mg. twice daily dose.

With those considerations in mind my speculation or veiled accusation that the deck was stacked has little evidential support.It may be best to shoot after aiming.

In a thoughtful followup to his first posting Dr RW makes the important fact that you need to look at the facts of how the trial was designed and executed rather than basing any decision regarding the validity of the trial by simply looking at who paid for it. With some of the drug trials scandals (the Ketex studies come to mind)and the possibility that some data has been withheld in some trials I have become so jaded and distrustful that my objectivity titer has diminished and his suggestion to look at trial critically and then look at the funding makes sense.

This time,new oral anticoagulants may well make it to the market

I had my hopes that ximelagatran would be the replacement for warfarin. That did not happen because of liver toxicity problems with the drug. Now several new drugs are traveling through the clinical trial pathways.Most of these are in a new class of anticoagulants known as Factor Xa inhibitors.

The medication leading the pack, in terms of being closest to approval, is rivaroxaban. Clinical trial results are found in the June 26,2008 issue of NEJM for the hip arthroplasty and total knee replacement studies. Both found fewer episodes of thrombosis in the rivaroxaban group and no statistical difference in bleeding when compared with enoxaparin. The liver toxicity that killed ximilagatran so far has not been a problem. Another Factor Xa inhibitor,apixaban, is in trials as is a direct thrombin inhibitor,dabigatran.

If and when the clinical trial(s) comparying "riva" with warfarin in chronic atrial fibrillation demonstrates similar good results we may finally have a new oral anticoagulant than does not require frequent blood test monitoring and may be free of much of the vexing vagaries of trying to get the dose of warfarin right and keeping it there.

More on end of Era of the Oslerian Internist

DB Rants takes on the issue of "what will happen to the Internist" in this entry and more and more internists are offering a pessimistic prediction of their future. It seems the internist has to choose between being a "office internist" and in the view of some being relegated to a position that seems little different from a Family Practice doc except that the FP doc can do more or being a internist who only sees patients in the hospital.

A third option may be the retainer practice in which maybe the internist doc can still do both but even that seems weighted to the out patient practice.

The Happy Hospitalist gives us this mini view of the economic environment that is a main driver for the changed world of the internist.

Help for the environment is on the way but maybe not for asthma patients

Fears of ozone depletion and the purported health effects of that should be soothed somewhat with knowledge that the CFC containing bronchodilator inhalers will be outlawed in December 2008. See here for The FDA message concerning the impending prohibition.

The new non-CFC inhalers (some contain HFA) will taste different, need regular priming and cleaning to prevent them from plugging and blocking delivery of medication to the lungs but that is the least asthmatics can do to help the environment. Additionally there are no generics for the non-CFC units so cost will increase. I wonder if we will see black market old fashion type albuterol inhalers.Again it is the least asthma patients can do to prevent sunburn and skin cancer in Australia.

Judging from how hard it may be to instruct someone to properly use an inhaler, I'll bet there will be more than a little trouble in switching over to the new units. There are 4 brand names and apparently the priming and cleaning directions vary by brand.Further, different pharmacy management companies may well favor one unit or another based on deals they make with the manufacturers .

Dr. Mintz in his medical blog does an excellent job of explaining the new inhalers here
Several of his readers replies are also instructive and I think a harbinger of the problems to come.I believe the confusion about them will lead to problems for asthma patients, in some- just inconvenience but for others- poorer control and more visits to the ER before everything is sorted out.

A huge number of skin cancers are alleged to be prevented by the CFC ban ( see here for a old CDC request for comments regarding CFC in asthma inhalers).Here is a link to an entirely different view on the issue which raises issues of the lack of proven safety of the new inhalers and other potential problems they may present and several presumed experts who maintain that any contribution of the CFC from the asthma inhalers is basically too small to have any effect on ozone depletion. The new HFA units have only been used for a relatively short time and recent events involving side effects that became evident long after all the clinical trials leading to approval were completed might give the FDA pause.

At least two questions are raised by the banning action of the FDA.Will the ozone zone recover faster when the CFC ban is completed or will it have any effect and it there any way anyone will even know. I claim no expertise in that area but my basic cynicism leads to think that the stratosphere will not really change much one way or the other long after asthma patients and others with obstructive lung diseases pay more for their medication.

The other interesting aspect is that I think this is the first time that the FDA bans a medication or group of medications not because they are thought or proven to be harmful to those who use but because they are thought to possibly harm folks who do not use it. (OK, the purported skin carcinogenic effect of increased sun rays from the purported decrease in ozone layer thickness would affect everyone- even asthmatics.) Since the task of determining harm to medication users has proven much harder that the FDA or anyone ever thought, it is admirable that the FDA will take on an even more difficult task.

Let us shift the risk factor paradigm-it is about time

The June 6,2008 NEJM published a very important editorial. This is one should be handed out to medical students and house officers. This insightful filled essay was authored by Drs. Harlan Krumholtz and Thomas Lee.Dr. Krumholz is prominent in the area of outcome research and hopefully his views will have a positive impact in reassessing and reining in the current risk factor modification craze which has neglected the fact that how one modifies the factor may change the disease outcome of interest. It might be added that in some instances we have little or no evidence that modifying a risk factor will matter at all as appealing as the pathophysiologic rational may appear.

From the essay we read:

It is increasingly apparent that the specific strategies used to modify them [the risk factors] make a critical difference in patient outcomes.

The now canceled ILLUMINATE trial illustrates dramatically the main point. Raising the HDL with a particular medication (torcetrapib) was associated with a higher mortality rate. How you raise the HDL may well matter.

What do the authors propose?

..we should no longer support the use of target without reference to the strategies used to achieve them....Second, guidelines and performance measures should incorporate more sophisticated and explicit considerations of the risk of the disease and the adverse consequences posed by the intervention.

A clinical trial is ultimately a test of strategy,and we should not be surprised that different strategies may have different effects on patients beyond their effect of risk-factor levels.

You would hope that publishing those thoughts in a high impact journal such as NEJM would have actually have an impact.

Guidelines-good suggestions or edicts or (sometimes) shameless self promotion

Two medical bloggers have recently made very cogent comments regarding medical guidelines,
Dr. Robert Centor and DrRich. Medical students and house officers would do well to read both because they have never lived in a medical world without the guidelines and physicians reading the blogs may get a different perspective on what is being done to them in the name of doing something for them and patients and to further the abstract goal of quality. (the 2 postings are highlighted below)

Both make the very important observation that guidelines that purport to be evidence based may be just as likely as the advice from your uncle Cyrus or your charming used car salesman to reflect their own personal and professional interests and are in word-biased. No, they all are not- at least not to the same degree- if there were things were that simple, you could just ignore all of them.

And of course, we should not forget Goodhart's Law, namely when a measure becomes a target it no longer functions as a measure.

Dr. Centor has informed us previously us about the nature of pharyngitis in adults, a subject he has studied and written about for a long time and in this recent entry delves into PSA screening. The bottom line is that there are numerous guidelines and they all don't agree with each other. Various guidelines writing groups begin their task with different world views.

The public health oriented wonks have a different perspective about PSA (or whatever screening procedure is at issue) screening that a practicing urologist might.The former group has to consider the total cost to society( which I believe is basically a bogus concept in that context) while the later wants to detect cancer earlier and yes, he has the economically advantageous opportunity to do more procedures ( from biopsy to surgery) if lots of men have their PSA values measured. If you believe that entities allegedly writing in the context of the greater good, really only have their nebulous goal in mind (this includes the prestigious USPSTF panels), you should read this entry.

DrRich takes us through the fascinating history of the rise and fall and rise of the concept of "metabolic syndrome" and what, if any, specialty medical group should promote and exploit it and coins (I think he coined it) the intriguing and thought provoking term of predatory guidelines.

Physician and lawyer ownership-interesting contrast

Hat tip to the Blog A Stitch in Haste for pointing out this interesting distinction.Physicians, in Mr. Pete Stark's view cannot or should not be trusted to own ,for example,a hospital because of the fear their avarice will overwhelm their fiduciary duty to their patients. ( I have written before about what I believe to be an erosion of that duty by the New Professionalism). Pete Stark has a penchant to introduce legislation to limit what a physician can do in terms of referring patients to various health care facilities. To get flavor of the "Stark Law" go to this analysis of the complexities involved in this statute.More on recent congressional efforts to restrict who can own hospitals can be found here.

By startling contrast-any one but a lawyer is legally not allowed to own a law firm.No one but a lawyer can own a law firm-others cannot be trusted.Of course, owning a law firm is one thing, owning a hospital or imaging center is something else but the disconnect between the general level of public trust for the two professions and the perceived need to control one group to a much greater extent than the other is something to think about.

New Asthma guidelines (again) and another meta-analysis re:LABAs and asthma

The National Heart,Lung and Blood folks have authored still another set of asthma guidelines-all you would ever want to know in 440 pages. (5.22 MB).Several links from the NHLBI site did not work and one version was only 3.88 MB. This one seemed to work, however.Physicians who treat asthma are obligated to plow through it but if you prefer to read the written page as opposed to the computer screen be prepared to replace your print cartridge.

In other asthma news,the issue of the safety of LABA use in asthma has been revisited in a recent issue of the Annals of Internal Medicine.I have written before about the candidate for the worse randomized clinical trial of the century,the memorably flawed SMART trial, and the subsequent impressively flawed meta-analysis (relying heavily on the results of SMART) unfortunately published in the Annals of Internal Medicine by the Salpeter team and the kurfuffle it generated. In an act of apparent contrition, the Annals has published another meta-analysis regarding the use of long acting beta agonists (LABAs) in the treatment of asthma and found LABAs innocent. (Since I have been so critical of certain aspects of meta-analyses,one could ask why I would believe this paticular one. The answer is I believe-or at least I quote- those that conform with my preconceived notions and biases about the subject.) Here is another meta-analysis that provides support for the widely held position and my notion that LABAs are beneficial in COPD.

Used properly LABAs add value to asthma treatment. They are to be added to the treatment program after inhaled corticosteroid (ICS) have been started but along with resuce beta agonist use appear to be inadequate for control. This is the role for LABAs according to the new guidelines. LABAs are not to be used for rescue therapy. Frequent use of a short or long acting beta-agonist in a poorly controlled asthmatic (one who should be on steroids) is a harbinger of ER visits, a required intubation and worse.

It is not your father's medical ethics any more

Can the traditional medical ethical prime directive of placing the individual patient's interest first survive in a financial environment in which physician autonomy is greatly diminished and income for most physicians is controlled by third party payers. More broadly put, Dr. Edmund D. Pellegrino asked in 1995 (JAMA,May 24/31,1995,Vol 273,no 20,) " Is medical ethics a social, historical, or economic artifact?Or are there some universal , enduring principles?

In 1988 Hall and Berenson writing in the Annals of Internal Medicine said that "the traditional ideal" was "not compatible with the role that existing insurance contracts and manged care arrangements define for physicians." Their comments were not subtle when they said :

We propose that devotion to the best interests of each individual be replaced with an ethic of devotion to the best interests of the group for which the physician is personally responsible.

Incredibly, the authors claimed that this shift in ethical focus would actually increase patient trust, an attribute that even in the late 80's was in a decline as patients tried to live (sometimes literally) with the HMO's restrictions to medical care. Incredibly, they claimed that by not having the patient's interest as the prime directive there would be increased trust in their physician.

The expected wave of letters to the Annals editors expressed the belief that advocacy for the individual patient was the prime directive and what it was all about and to replace it was to effectively do away with medical ethics as it had been known and practiced for a very long time. This is what would be expected from an audience of internists who had grown up medically inculcated with an ethic which was the polar opposite of what the authors proposed. Practicing internists at that time were reared to believe that the physician was completely and ultimately responsible for their patients.

The average practicing internist if they read the article at all may have thought this was the contrived advocacy of someone who was attempting to make manged care appear ethical. All that was required was to turn medical ethics on its head.When I read that article I thought "you've gotta to be kidding me".

A few years later ,I saw no one was kidding as the ACP, ABIM and the European Federation of Internal Medicine joined forces to formulate what was called the New Professionalism in which physicians were admonished to do more than maximize the health of all the patients in their HMO, which was as far as the Annals author went. Now, they had an ethical obligation to strive for Social Justice.This joint effort was said to be necessary as the "old ethic" needed to be revised to align itself with the new economic environment in which physicians now lived and "medicine's commitment to the patient was being challenged by external forces of change within our society".

While the 1988 article's authors stopped short of suggesting physicians should conserve resources for others in society at large and just concern themselves with their own HMO's population, the new ethics or professionalism as it was now called, headlined social justice raising it to the level of the big three ethical precepts-patient welfare, patient autonomy and social justice.More than one observer has asked does precept three conflict with precept one?

The era from 1963 to about 1990 has been termed the time of "retail medical care". Physicians and patients enjoyed the situation in which a patient's insurance followed the patient so that he could choose any physician and the physicians' fees were not set by the insurer but largely were set by what the physician considered and the payer agreed to be "reasonable,customary,and prevailing".

Things were good for physicians in those days as not only was physician autonomy largely unchallenged,but also Medicare has brought about a large influx of money to be spent largely at the discretion of the doctor and their patients and exciting new diagnostic and therapeutic tools were available. More could be done for your patients and more patients could afford medical care. Referrals could be based on the physician's knowledge of the area consultants and prescriptions were written without concern for some third party's list of permissible choices. But things were to soon change as the era of "wholesale medicine" replaced the old ways with the HMO being the middleman.

A series of articles was published in 1995 in JAMA authored by Dr. David Eddy that discussed the metrics and merits of decision analysis which he hailed to be the mechanism to perform magic. The magic was to increase quality of medical care while reducing cost. But it was all merely playing with words and defining words to suit the argument. Eddy defined quality as the greatest medical good for the greatest number within the eco-medical collective (aka HMO). It did not go unnoticed to the skeptical reader that Dr. Eddy listed his affiliation as "Kaiser Permanente of Southern California")

Pellegrino in 1995 also asked ...can physicians change the ethics of the profession at will ( as proposed by Berenson and Hall) or is there a more fundamental and universal foundation for the ethics of medicine in the special nature of the physician-patient relationship?

Pellegrino's quotes are found in an article entitled "Guarding the Integrity of Medical Ethics-Some Lessons from Soviet Russia" . The subversion of medical ethics in Russia suggested to Pellegrino two lessons. 1) corruption will afflict any health system not designed with care of the patient as the its primary driving force. 2) medical ethics must be independent of political exigency. "... a morally responsive profession is an indispensable safeguard for the sick against the statistical morality of utilitarian politics, even in democracies."

The statistical morality of utilitarian analysis seems to be increasingly unopposed as the group outcome analysis derived data plays an increasingly large role in the decisions regarding the individual patient exhibited in part as guidelines executed by mid level practitioners. In this new day, the physician has more to worry about that just her patient, she must be concerned for everyone but at least she has been removed from the impossible role of being responsible for every aspect of his patient's well being as she is now (merely) a member of a team and part of a system of health care.

The philosophy supporting the "diabetes police" is more than frightening

I have written before about the movement of at least some of the public health community into areas not traditionally thought to be within their purview such as local public health departments monitoring the hemoglobin A 1 C levels. I was not aware of the degree to which the philosophy animating this movement was developed and being expounded in very explicit terms.

Thanks to Sandy Szwarc of Junkfood Science . Her entire piece should be read but below are some of the comments made by exponents of what you might call "the new public health ethics".

In a nutshell,the basic notion is that an individual's health and health related behaviors are too important to be left to the individual as they poise a threat to society and government must act for the good of society.

Ms. Szwarc quotes from a "thought leader" in this field of public health ethics, Dr. Angus Dawson who is at the Centre for Professional Ethics at the University of Toronto as he discusses his approach to the problem of obesity.

[the educational approach to battle obesity] "will fail as it wrongly assumes..that we ought to respect an individual's existing preferences " and "an ethical obesity policy ought to focus on collective interventions [ in which] the individual will not be able to opt out.

If people will not do what we know to be best for them and society we will make them do it.This seems to be the core of the public health ethics.

Lest you think that we are dealing with the relatively, unheard voice of a fringe philosopher in the wilderness (or at least in Canada),essentially the same theme is expressed by Dr. VJ Guillory who served on the AMA Expert Committee on Obesity when he wrote in the Journal of Public Health , "The mandate to ensure and protect the health of the public is an inherently moral one...and it implies the possession of an element of power to carry out that mandate."

In this age of supposedly evidence based medicine it is interesting to read one of the comments from a report about a meeting of the AMA Expert Committee on Obesity : "The magnitude of the obesity is too great to wait for evidence-based guidelines before increasing efforts focused on prevention and intervention." So it is ready, shoot, aim- all with very generous funding from the Robert Wood Johnson Foundation and it is individual freedom and autonomy the targets.

Will the options for internists be even fewer as time goes by?

Had retirement not worked out to be better than I had hoped for, I had thought that a concierge practice or being a hospitalist would be the way for me to go. The retainer practice might allow me to escape from the clutches of the third party payers whose ever tightening of the control and payments screws sucked much of the joy of patient care and the threat of things getting even worse casting a pale over the future. The hospitalist gig offered the relief of no call and a opportunity to attend the type of complex,often very ill patients which seemed to be what an internist was trained to do.

But now we hear that perhaps the hospitalist role may not be a safe haven for the internist for very long. Dr. RW tells us about that scenario here.

Even as the future for hospitalist might appear less rosy, we should not forget that the safety and quality movement leader guru, Dr. Donald Berwick still has much for them to do as they become the change agents and integrators of a new medical system that will provide quality care, reduce costs and improve public health. I guess it is better that I did not become a hospitalist as all I could do on a good day was to take as good of care of my patients as I could leaving the problems of maximizing public health and obtaining universal medical coverage to someone else.

The diabetes police concept moves to Texas

Thanks to Sandy Szwarc of the blog Junk Food Science for this alert.

The Metro Health District in San Antonio is creating a "surveillance program" to identify diabetics. Earlier I had written about a similar program in New York. Hemoglobin A1C levels will have to be reported by the clinical labs to the public health folks.

The project is described as a pilot program which came into being by actions of the Texas Legislature.If successful(those sorts of program are very likely to be judged successful by the folks who administer it)it will be transplanted into other metro areas in Texas.

The notion that medical care ( health care) is too important to be left to individual physician and the individual patient gains more traction as the nanny state move on, privacy being a quaint concern of an earlier era.

Safe drinking water and mosquito control are considered to be legitimate concerns of public health authorities, my blood sugar level, hemoglobin A 1C and blood pressure level are not.

Peri-operative beta blockers-quality measure or risk factor for stroke and death

The now published results of the POISE trial raises the question that the rush to make peri-operative beta blockers a quasi-mandatory quality measure may have lead to a number of deaths from stroke . Could that possibly be right?

In the words of at least one of the trial investigators the answer is yes.Dr. P.J. Devereaux's comments can be found here in Medscape news report describing the trial and various commentators' reactions to the results.

POISE was a large ( 8000 plus subjects) randomized trial designed to determine the effect of the peri-operative use of Metoprolol-XL. 100 mg was given 2-4 hours preop and again 0-6 hours post op and then 200mg daily for thirty days.

Total mortality was increased in the treatment arm (3.1% versus 2.3%,Hazard ratio 1.33,p=03) while myocardial infarctions were decreased but strokes were increased.Strokes occurred in 1% of the treatment arm patients versus 0.5 5,Hazard ratio 2.17. Hypotension was also significantly increased in the treatment arm while the incidence of atrial fibrillation was decreased.

Critics of the trial might argue that the dose of Metoprolol was simply too high and too much of this putative good thing might well cause more hypotension. They might argue that POISE only demonstrated that if you give an inappropriate dose of a beta blocker you cause harm. But I do not believe that the results of the trial will be dismissed based on different experts differing on dosing details of the trial.More likely major changes in guidelines will be made.(I will have to admit that if I took 200 mg of metoprolol a day, I would move like a turtle and have a heart of 12.)

If there is a lesson here it is not just that a large randomized clinical trial gives results opposite to earlier smaller trials-that is a story we have heard more than once before. The lesson is not that expert committees sometimes have to revise their recommendations as new information becomes available.The lesson I think that should be emphasized is that overzealous quality rule writers and enforcers can be a hazard to your health ( and I have said that before). Read Dr. Devereaux's comments regarding how many patients may have been harmed by taking peri operative beta blockers and then wonder how many patients received them simply because premature quality guidelines were in place and physicians were caught up in the rush to treat even though it seems clear now that the evidence for such zealous efforts was inadequate.

Dr. DB (AKA Dr. Robert Centor) nailed it when he recently spoke about in this regard " the performance and quality movement which has a 'ready,fire, aim' philosophy".

Still more on Medical Home AKA medical utopia

Yesterday, I signed up for a new, free newsletter, The Medical Home Monitor. This is apparently aimed at those who are interested in this latest version of managed care and its new packaging and how this bogus concept can be sold to the public.

Its advocates promote the Medical Home as a revolutionary sea change in medical care for which the term Utopian fails to properly denote both its purported magnificence and its absurdity.

The Medical Home Monitor uses 7 (count them,seven) back to back adjectives to describe the Home. They are: accessible,continuous,comprehensive,family centered (alternatively the term patient centered is used),coordinated,compassionate, and culturally effective. Not only that but there will be improved clinical outcomes and patient satisfaction and it will not increase health care costs. Think of it, provide many more services that the typical patient now receives and it will not cost more.

Sandy Szwarc in her consistently insightful blog, Junkfoodscience, explains clearly the difference between the hype of the Medical Home and the reality of what it is as envisioned the single payer called CMS. This CMS version of Medical Home as contrasted the warm fuzzy words imployed to hype it gives a new dimension of hubris to the concept of bait and switch.

The Happy Hospitalist explains in agonizing, mind boggling detail the particulars of how the Medical Home will be constructed in the regulation driven world of Medicare.Any doc or any patient who might be conned into taking part in this scheme should read these two blogs.Anyone who believes that Medicare should serve as the paradigm for a universal single payer just might be disabused of that belief by digesting these two essays.

Nurses and doctors, of course, will play a key role in this Medical Care Utopia but patients will be interested to learn that in the Medicare version as structured by the AMA's RUC committee the nurse will be allocated 3.5 minutes for a patient with one condition and 9.4 minutes if 4 or more conditions are present to provide the comprehensive,compassionate, culturally effective care it purports to deliver. Similar micro managed time allocations are given for physician's time. I am not kidding, the RUC wonks describe activities in term of tenths of minutes. Doctors will be allowed 12.5 minutes for those patient classified as "very sick". If anyone on the RUC task force actually took care of complicated, complex medical cases , he/she must have slept through most of the sessions.12.5 minutes should be more than enough to evaluate a elderly person with heart failure,COPD, diabetes and new onset severe back pain who is living alone and taking nine different medications, leaving time to ask about dental flossing and seat belt use and immunization status and to make a few well chosen culturally sensitive comments and hand out three health care educational booklets and allow time for the patient to proudly show the latest photos of her grandchildren.

Dr. Roy Poses takes on this issue in his latest posting on Health Care Renewal as has Kevin in his May 8, 2008 entry blog (see here) and Dr. Vijay Goel in his blog,Consumer-focused Health Care, as he heartedly seconds the analysis of the Happy Hospitalist. If you think-well this is just the government bureaucratic mind set at work and private entities will show everyone how the "Home" should be built- read this earlier entry by DrRich in his blog, Covert Rationing Blog, as he explains how United Health Group plans to do it. I made some comments about that also.

I have been critical of the American College of Physicians' position and role in the Home concept and I await their justification of the RUC 's plans and how they can possibly support what would be a disaster for primary care.Rather than their typical sound bites (quality evidence based, patient centered care,electronic medical records, medical home, blah, blah, blah), they should be saying to the RUC and CMS "Gentlemen , we have read your proposal and as internists we know more than a little about caring for complex medical patients and we know that you cannot attend a complicated patient in 12.4 minutes and if you think it can be done you have no business writing guidelines or rules."

Look who is going to write the compensation rules for the "Medical Home"

The American College of Physicians and others have been touting their solution to most (if not all) of the problems destroying primary care medicine under the banner of "Medical Home". One major obstacle to providing the accessible,continuous and coordinated care has been and is that physicians are not compensated to provide that type service.For example, how would Mediare compensate docs for those activities?

Now we learn that AMA's friend of the primary care doc,the RUC (relative value scale update committee) will play a major role in setting up the rules and ultimately the fee structure for the Medicare version of the Medical Home. The Tax relief and Health Care Act of 2006 mandated a demonstration project .

Here is a link to the AMA site with a description and from there a further link to the full set of recommendations from RUC. Anyone who thinks the Medicare funded Medical Home will be anything different from the morass of rules and tricks and traps of the fee structure and coding mysteries that typifies dealing with CMS should take a few minutes and read what RUC has authored. If you think the current coding games doctors have to play are onerous and irrational
(go to the latest from the Happy Hospitalist to get a flavor of that) wait until you see what the RUC thinks need be done to deliver the "coordinated continuous care" envisioned by the pie-in-sky Medical Home concept.

"Free" pizzza may be gone for students and house staff but speaker's bureaus may be another matter

Go here to read the NYT article on the recent statement made by the Association of Medical Colleges.

The Association seems adamant when it states ""drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff and students."

However, in regard to the sometimes lucrative and sometimes very lucrative speaker's bureaus a somewhat weaker statement emerges;

...medical schools should 'strongly discourage participation by their faculty in industry-sponsored speakers’ bureaus,' in which doctors are paid to promote the benefits of drugs and devices."

On the one hand, banning on the other discouragement.

Dr. Robert Alpern, Yale's Medical School dean, is quoted by the NYT as saying :

“I don’t have a problem with doctors making $3,000 or $5,000 a year on the side, but it’s a totally different thing when it’s $80,000,” he said. Even more distasteful, Dr. Alpern said, is that the slides used in many of these presentations are created by drug makers, not the speakers."

Is he really saying it is ok to be a "ghost speaker" (Alpern's term) if you don't get paid too much?
(We have already determined what you are, Madam, we are just negotiating the price now.)

Dr.Carlat believes we are entering a new era which he labels "post deceptive" Dr. Wes is less impressed.

Dr. Howard Brody who has had much to say about this general issue makes these comments.

My non-insider take is that there will be a flurry of high profile (within the institutions at least) announcements of "no more free lunches" and much self congratulation and talk of professionalism but somehow I doubt the faculty will give up the lucrative lecture gigs although a veneer of word smithed propriety and oversight will be grafted onto it.

The FDA and "Regulatory Capture"

Dr. Howard Brody in his bog, Hooked: Ethics,Medicine and Pharma, hits another home run.

As explained in HOOKED, this shows the ambivalent relationship that is set up by the phenomenon of "regulatory capture" of a Federal agency by the industry it is supposed to regulate. The drug companies are walking a very fine line. They want the FDA to be rendered sufficiently toothless as to be unable to take any actions that cause any inconvenience or lowered profits for them. But at the same time they want the FDA to appear powerful and threatening enough so that they can turn around and blame the FDA oversight process whenever a scandal arises like tainted Chinese-made heparin. Ditto for the present efforts of the industry to support FDA rules changes that would allow companies to market drugs off-label by circulating reprints from medical journals (based on the assumption that the FDA stringently regulates this process so that no false information could ever get through), and to convince the U.S. Supreme Court that they should be shielded from any legal liability in relation to any drug that has been FDA approved (again assuming that the FDA approval process is so stringent that the public needs no additional safeguards).

The term "regulatory capture" refers to the phenomenon in which a governmental agency ostensibly tasked with acting in the public interest to regulate an industry becomes controlled or dominated by the interests of that industry.This is not so much like authorizing the fox to oversee hen house safety but more like the game warden helping the poachers poach while posturing that they are doing just the opposite. Note- finding a different fox believed to be more concerned with the hen's interests is not likely to change the situation in any meaningful way nor will a more dedicated game warden.

Nobel laureate and Chicago School economist George Stigler is credited with this concept in his Economic Theory of Regulation.

Regulatory capture is one of the mechanisms by which interest groups will use government power and coercion to benefit themselves.


I might quibble with Dr. Brody's characterization stating there is an ambivalent relationship between the drug companies and the FDA. Pharma will act in its interest and will control- to the extent it can manage to do so- the FDA's actions, nothing very ambivalent about that as that is the tendency for all such "regulated" industries.

There have been suggestions as to ways to "strengthen" the FDA and at least move to escape from this capture but I am pessimistic.

Thomas Sowell has suggested when you try and understand why a government agency acts the way it does, do not bother with their mission statement but rather consider the incentives and constraints within which it operatives and the feedback it receives. Combine that with the "follow the money rule" and you will likely come up with some useful insights.

Who will sing for me?

The WSJ 's medical health blog talks about general surgeon being the primary care docs for surgery and echoes the thoughts of several bloggers ( see here ) for one who inform us that the ranks of the general surgeon is decreasing much as the primary care docs are seeing refuge elsewhere and for much the same reasons.

Back in day when I was an internist in training we thought about the general surgeon as the other group of "real docs",we internists were the really real docs, all jokes about surgeons notwithstanding.OK, we should have included peds but I think we meant that when someone was "really sick" you would need an internist or a surgeon or both. They would take care of the horrible surgical abdomen patients regardless of what the cause.Perforated bowel, leaking aneurysm,gall bladder, ruptured appendix-all were within their area of expertise. In the strange now forgotten "system" under which we trained the first year medical resident was called to evaluate patients in the area of the hospital that was sort of an ER and sort of a triage out patient area. From time to time there would be a dispute as to whether the patients was "surgical" or "medical". In some of that encounters I would find myself completely out manned facing off with a senior surgery resident who had by that time endured some 4 or 5 years of post MD degree rigorous surgical training. I still admire the skill , confidence and medical expertise of those folks and what they went through to obtain that experience and expertise as I did in practice when I called a general surgeon at 2:00 am .

Fewer freshly minted internists go on to do primary care as more and more become sub-specialists or hospitalists and fewer rookie surgeons go on to do general surgery as more and more do sub-specialty fellowships. Money,control of one's practice and "life style" concerns appear to be the major culprit drivers in this shift as third party payers continue to squeeze the purses and tighten the controls and drain the joy out of being a physician.

I think back attending sick patients and calling in a general surgeon to help sort it out (and sometimes fix it and often follow the patient with me though an often complicated and challenging course in the hospital) and wonder who will be available to play those roles should I be on the other end of the stethoscope and knife. Emmylou Harris's song comes to mind.

Latest we-won't-pay proposal from CMS-Silly is too weak a word

The latest proposal from CMS to not pay for treatment of certain conditions appears to demonstrate evidence of such an outstanding ignorance of medicine that it is difficult to find words strong enough to characterize them. These conditions are referred to as " hospital acquired conditions" that are "reasonably preventable through the applications of evidence based guidelines" This are beyond absurd. The actions taken by hospitals to live with this rule (if it is finally approved and becomes a rule) will elevate the concept of unintended consequences to new heights.

Here is press release and here you can find comments by Dr. Roy Poses.

DVT/PE ( deep vein thrombosis/pulmonary embolism) is one such condition. There is no prophylaxis that lowers the attack rate to zero or close to zero. The heparins and warfarin and other non pharmacological preventive measures have not been shown to regularly achieve reductions to less than 10-20%% incidence and in a number of studies studies the treatment arm of a number of randomized trials with various anticoagulants may be as high as 25% to 40%. (for example the 1996 study from several institutions in Canada by J.R. Leclerc reported an incidence of DVT in 36.9% of knee replacement patients receiving fixed dose enoxaparin.See here for details.) If you do hip surgery, knee replacements, spine surgery, or neurosurgery you will have patients with DVTs in spite of the best preventive measure known to man.

Delirium is another event CMS seems to believe that can be totally prevented in hospitalized patients. Dr. Poses discusses the lack of evidence for any really effective preventive measure for this common complication of the elderly who become ill whether or not they are in a hospital.

Ventilator acquired pneumonia is another candidate condition. Again zero incidence is beyond what current knowledge and techniques can achieve.

What is going on when a government agency demands the impossible? What is going on when well meaning professionals attempt to do it? And you know they will. How long was the list of hospitals that refused to play along with the four-hour pneumonia rule?

Is it possible that a government agency charged with payment for medical services for millions of people could be so ignorant of fairly simple medical facts? Are there no folks there who know enough to say "wait, these things cannot be entirely prevented"? At least two medical bloggers suggest what is really going on with this absurd recommendation. Their comments can be found here and here. If it is about quality, we are in trouble with outrageous non-reality based proposals. If it really about saving money and rationing care while pretending to do something else it is another frightening chapter in the play book of covert rationing as explicated by DrRich.

When a measurement becomes a target, it is no longer a valid measurment

The title of this essay is one version of an insightful observation made by various people in a variety of settings .

The first time I became aware of that general thought was when I read about the Westinghouse Effect which is that the observation of an event is influenced by the act of observation.

Two eponymous designations refer to formulations that expand that concept and give it more useful meaning; Goodhart's Law and the Lucas critique. These have important implications in this era of hyperplastic medical guidelines, pay for performance, quality measures which pretend to measure the unmeasurable and the cookbookization of primary care medicine.

Charles Goodhart was an economist in Great Britain who expressed the following thought:

Once a measure is made a target for the purpose of conducting policy, it will loose the information content that would qualify it to play such a role.

A medical example is the four-hour pneumonia rule. There are data indicating that those pneumonia patients who received antibiotics within some several hour time frame did better that those whose antibiotics were delayed. This even conforms with common medical sense-a patient with a serious infection requiring antibiotics should do better getting the medication sooner rather than later. So promptness of delivery antibiotics was considered to be a measure of quality and then became a target. Once a target, ER personnel seemed to have treated towards this target and later we learned that one unintended consequence was some not insignificant number of patients were given antibiotics within the magic time frame but did not have pneumonia at all.

This line of thought was developed further by another economist and Nobel prize laureate, Robert Lucas.

Lucas said it was naive to think one could predict the effect of a policy purely based on aggregated historical data. An example might be the data suggesting promptness of treatment influenced pneumonia outcomes.To predict the outcome of a policy change one has to consider how individuals are likely to behave given the change.

To predict the effect of a policy change (rewarding 4 hr treatment for example) you need to consider the constraints the players operate under and basic human nature.Outcomes may change ( even if those outcomes are not measured) when policy ( or rules of the game) is changed.The effort to meet some deadline that folks are graded on may well take away efforts to provide necessary timely care for other patients not currently covered by some quality rule and target.In the era before the imposition of the four hour rule, promptness of antibiotic administration may have been one of a number of indicators of a good general care. Once it became a target it lost its value as an indicator of quality even though now it was considered to be an official indicator of quality.

This general theme was discussed recently by the Management editor of The Guardian.See here.

He offers this example also from the medical world having introduced a concept analogous to Gresham's Law, bad measurements drive out good ones.

What happens when bad measures drive out good is strikingly described in an article in the current Economic Journal. Investigating the effects of competition in the NHS, Carol Propper and her colleagues made an extraordinary discovery. Under competition, hospitals improved their patient waiting times. At the same time, the death-rate following emergency heart-attack admissions substantially increased. Why? As targets, waiting times were and are measured (and what gets measured gets managed, right?). Emergency heart-attack deaths were not tracked and therefore not managed. Even though no one would argue that the trade-off - shorter waiting times but more deaths - was anything but a travesty of NHS purpose, that's what the choice of measure produced.

At the risk of underlining something too much-the point is that measurements loose their value as measurements once they become targets and that does not depend on the original validity of the measure. It can be a great measure, but it is ruined when it become a target. So the answer is not to get better measures much as the answer to bad government is not to replace the officials with better ones.

Goodhart and others made this observation some time ago but fortunately we in medicine were- for quite a while- spared the pain of seeing it first hand in our practices.