Kick backs for switching to generics

Three years ago,my brother-in-law was started on a brand name lipid lowering medications. He complained that he had about 80$ per month out of pocket expense. He believed that the physician received some type of kickback for prescribing the medication. I assured him that could not be case.

Now we see this news item in which we learn that physicians were paid to switch from a brand name drug to the cheaper generic. According to the news report some doctors in Michigan were paid $100 by Blue Cross for each patient they switched from Lipitor to a generic drug. A news release from the AMA warns physicians that this or similar activities is illegal.

More and more we witness the downward spiral of physician's ethics and pride.

The pathophysiology of primary care dwindels

There are two recently published sources of important information regarding a major cause of the primary care exodus. One is in JAMA ( JAMA,November 21, 2007) Vol.298,no.19, pg 2308, " The Unintended consequences of Resourced-Based Relative Value Scale reimbursement", Goodson, J.D.) and unfortunately as important as this is, you need a subscription to read it. The other source is free and we can thank The Happy Hospitalist for his insight.

The major cause is decreasing take home pay. This plus increasing third party requirements and mandates and the threat of malpractice and the perceived greener pastures of the non primary care branches of medicine add up to the perfect storm.

And the cause of the decreasing take home pay is the system of CMS payment fee schedule. What follows is a description of how the price controls on physician's fees are implemented. In 1992 the RBRVS was put into place allegedly to mitigate the payment gap between procedure type docs and those who just see patients. Over the past 15 years it seems to have had just the opposite effect.

These price controls seems to have disproportionately impacted the income of the primary care sector. Until recently I was not ware of the role the AMA and a group known as the RUC played in this story. The AMA web site give a rather sterile and uninteresting rendition of who and what the RUC is. It is a group that gives advice to CMS about the details of the price controls.According to the JAMA commentary, their "advice" is put into motion about 80 % of the time by CMS. The committee is disproportionately represented by surgical and other non-primary care physicians. Of the 30 members, 27 have no term limits and the meeting are not made public.The proceedings are said to be proprietary (the AMA owns the CPT (current Procedures and Terminology to which the RVU ( Relative Value Unit) systems is linked.)

"All animals are equal but some animals are more equal that others."

So the story seems to be that the "remedy" set up in 1992 to make more equitable the payments from CMS to procedure and non procedure physicians has been largely controlled by a group of physicians who do procedures and the gap between the two broad groups has now so widened that there is now much scurrying to leave a sinking ship.

To summarize and embellish. There are wage controls on physicians fees. These are implemented by CMS with advice and consent from a procedurist dominated, AMA sanctioned group, the RUC. The third party payers follow suit. Wage controls lead to shortages (of primary care docs who are disproportionately impacted ),poorer quality and increased waiting times. Every year the AMA goes to Congress to plead, beg and weakly threaten them to not cut the overall CMS funding by as much as proposed. This dysfunction "system" is not going to correct itself.

I make no claim to the "answer". One approach that resonates in my libertarian consciousness is that made by the American Association of Physicians and Surgeons. The following is copied from their website. It is basically an escape route away from the wage controls and favors individual choice over the current command and control arrangement.

“FREEDOM FOR PATIENT AND DOCTORS WILL MAKE A DIFFERENCE.

H.R. 580 Seniors”Health Care Freedom Act of 2005, and

Say “NO” to Government Cookbook Medicine

“We oppose the various bills playing with the Sustainable Growth Rates (SGR), such as HR 3617, HR 2356, HR 1162 and S. 1574. Instead of changing the SGR, we support H.R. 580, the Seniors’ Health Care Freedom Act of 2005” that would allow the use of private contracts under the Medicare program. This is a win for patients, doctors and taxpayers as well.

“Our survey shows that 63% of doctors would be more willing to treat Medicare patients if unrestricted private contracts were allowed. Patients could pay doctors more than Medicare allows if they think the service is worth it. It would be up to the patient.”

I know ,the chances of something like that passing have to be slim to none and as Dan Rather was fond of saying, "slim just left town."Still it is good to dream of the day when physicians could join the other professions (lawyers,accountants, dentists, veterinarians,etc) who do not go to Congress every year to beg for crumbs.

The Massachusetts Plan for health Insurance, Success is what you say it is

I have mentioned the Massachusetts plan to solve the health care "crisis" by making everyone who can afford insurance buy it. This news report indicates that more people have have signed up for subsidized insurance than the state planed to have funds for. No problem , since they are using taxpayers' money , they will just get some more. This is a news item of the dog bites man type and would attract little interest.

What interested me and the author of the blog Health Care BS was that this is labeled a success. Labels are important and they have been used expertly in the medical care universe of discourse. The label "managed care" was a PR and propaganda home run. Who could be against care that is managed? The accurate label "rationed care" would not have flown.

The term "Medical home" cannot but evoke mom and apple pie. However, the version of managed care/P4P/control-what-the-doc-does that United Health Care has kicked off is anything but that. I have fumed about that before.

It seems that in Massachusetts, not everyone who is mandated to buy insurance has and many people who cannot afford insurance have signed up for a free health care program. I am not sure what part of this is a success.

Health Care BS quotes George Orwell. Here is another quote from Orwell.

Political language... is designed to make lies sound truthful and murder respectable, and to give an appearance of solidity to pure wind.

There is hope for medical research yet

I have been accused of going over board in my rants about meta-analysis that are often contradicted by randomized clinical and meta-analysis (MAs) that are critically dependent of the choice of the summary statistics and the choice of studies to include trials and are contradicted by other MAs, and observational studies that link everything to everything else only to be contradicted by other observational trials that fail to do so.

But from time to time my cynicism of the medicine business ( I remember when it was a profession) fades away at the sight of a thing of beauty - a mind boggling piece of clinical research that I can appreciate all the more after years of grueling study and practice . Here is reference to a project that demonstrated that nursing home patients who have trouble seeing do better when they get glasses that help them see. Who would have thought?

And- in the same week, we are treated to a research paper that demonstrated that when clinical trials are done and/or sponsored by a drug company, sometimes the materials is presented in such a way as to put the drug in question in a favorable light. Here is a review of that publication.

The shocking revelations continue.We are also informed that (see here for a review of the research involved) that college students engage in binge drinking, participate in sex that is often unprotected, spend much time on the computer not doing homework and often stay up late. A likely future project is rumored to be investigating if college students call home for money.

I was not the only one taken back by comments on the beta-blocker peri-operative mortality morbidity issue

Here the Happy Hospitalist had the same reaction I did to recent comments made in Dr. Robert Wachter's blog regarding the disappointing results of a clinical trial with beta-blockers ( the Poise trial). The Happy Hospitalist sums up Wachter's entry by saying "Oh Well".

Wachter enlisted the comments of his colleague, Dr. Andrew Auerbach who, in regard to the study that demonstrated increased risk of stroke from peri-operative use of beta-blockers said in part"

"So I agree with Bob – it wasn’t unreasonable to include them as a quality measure at the time. We were wrong, but at least we are in good company (can anybody say estrogen replacement therapy?). "

That comment may appear to be more flip and radiates more hubris than was intended . There is nothing flip about a stroke. Being in good company will do little to improve a hemiplegia or aphasia and I am sure Drs. Wachter and Auerback would not belittle the seriousness of the unfortunate events that seemed to be more common in the beta-blocker treated group.

Quality measures to a greater or lesser extent often drive care and influence the way physicians care for their patients. If a physician should exert great care in deciding what to do for an individual patient it would seem a greater level of concern and contemplation should be expended in writing "rules" that will influence the care of many patients.

I do not mean to imply that physicians who author quality rules take their responsibility lightly but events such as the beta-blocker saga should perhaps make us insist on a very high standard of proof of efficacy and safety be shown before we presume to tell others physician what they should do particularly when those rules are "enforced" by economic carrots or sticks. Further when an intervention is to prevent something, i.e to decrease the risk of a bad outcome, the level of certainty should be higher than in the circumstance when the physician is treating a certain medical condition. In a seriously ill, patient you often have to act, even to use treatments that lack super solid proof or efficacy; when you are in the prevention mode, you had better be more sure.

The individual docs not only have a fiduciary duty to do what it right for the patient but they are held to a legal duty.

The individual physician deals with the stroke patient and has to answer to him and the family, and perhaps to the family's attorney while the quality rule writers have to answer to whom. The individual physician strives to do what it the right thing for his patient and hopes that what he does is right, the quality rule makers seem presume to know what is good for everyone. Obviously, they frequently do not.

Will making people buy health insurance really work?

There were voices singing out early on that Massachusetts plan to mandate health insurance might not be the simple panacea that some heralded it to be.

The push-come-to-shove-day is almost on us and this report indicates there are about 100,000 souls still uninsured. About one half may have incomes too high to qualify for state subsidies, but at this point no one is really sure of the numbers. More details can be found here. It seems that there is a contingent of healthy young men who don't want to spend there money on health insurance. It is time for the health insurance police to mobilize and make these people get insurance. We know how effective the state is in making people have insurance.

I have lived in two states with mandatory auto insurance. I was involved in two minor accidents , one in each state. As luck would have it, in both instances the other party did not have the mandatory insurance. Fortunately, I had on my policy a provision known as "coverage for uninsured motorists". Now why would such coverage be offered?

The insurance mandate idea reminded this Business Week contributor of the story of King Canute who tried to stop the rising waters by commanding the water to roll back.

More on "quality movement can be hazardous to your health"

I have mentioned before the danger of the "four-hour"pneumonia rule and the ill advised rush to quality rules about peri-operative beta blocker use and those likely only touch on the tippy top of the iceberg.

I have seen so many Journal supplements that are poorly disguised promotions for certain medications or classes of medications that when I see a supplement I cringe, but the April 2007, volume 120 Supplement of the American Journal of Medicine seems to be different( although I don't rule out the possibility that the issue is promoting something or other since a major drug company sponsored it.) I have become very cynical over the last two years.

This is on a topic near to my heart, the heterogeneity of treatment effects (HTE) which I have written about before,highly recommending a landmark article in the Millbank Quarterly,which I think is no longer available on line.

The editor of the issue is Dr. Sheldon Greenfield from UC-Irvine School of Medicine. He presents an important editorial and co-authors an article with Dr. Richard Kravitz, also from UC-Irvine, who was the lead author on the above referenced Milbank article. I believe if you go to www.amjmed.com and register you can obtain the AJM supplements for free.

The major points made by Greenfield in his editorial are:

He asserts that there are 2 evolving phenomena that "impair the ability to develop guidelines, payment rules and quality of care measures based on randomized clinical trials (RCTs)." They are:

First,there is now a broader spectrum of illness severity included in trials . That is, more patients with less severe illness who will be less likely to favorably respond to an agent than the more seriously ill patients.This results in less ability of the trial to detect a true difference.

Secondly, RCTS typically exclude patients with multiple chronic diseases,

" Only to have findings subsequently generalized from young trial-eligible patients to these older,complex patients whose mortality from comorbid conditions reduces treatment effectiveness."

So, on the one hand more false negative trials and on the other hand, trials with less external validity which may be used anyway to make quality rules for groups of patients who may differ markedly and in important ways from those patients who took part in the trial.

More and more decisions are taken out of the hands and minds of the individual physician and the individual patient and determined by third party rules which in turn are increasingly "enforced" by the devilish P4P system. The work of Kravitz, Greenfield and others make it clear how flawed RCTs can be and it follows that rules and rule-derived payments to physicians based on these RCTs can result in clinical mismanagement and harm to patients.

So we can look forward to more quality rules that , in one sense, backfire and which will be enforced by the powers inherent in the economic hegemony that third party payers enjoy over physicians.

I have written about physician's spiraling downward pride and ethics (now known as professionalism) before as have others. Many hospitalists and emergency physicians are either employees of a hospital or are contracted with a hospital. When such things as the four hour rule and give almost everyone peri-operative beta-blockers become institutionalized as quality indicators it is not difficult to imagine the position a physician find herself if she dare object or worse refuse to play by those rules.Accusations of being a disruptive physician may be hurled and what happens to employees who do not play by the boss's rule.Of course, it is not just ED docs and hospitalist impacted by these rules and their enforcement mechanisms and not just those whose pay checks comes directly from a hospital. I still believe that physicians still want to act primarily in the best interest of their patients and many times still do but it gets hard and harder to continue to do so.

I am reminded of the old saw version of the Golden Rule (He who holds the gold makes the rules) . The economic reality of today's medical practice makes it harder and harder for the physician to act in the fiduciary interest of the patient and this is all the more bitter as we become more aware and educated in the foibles and weaknesses of the "knowledge" base on many of the quality rules allegedly derive from.

The blogger, The Happy Hospitalist, in his recent entry "Dr. Government Vs Littol Sally" and those who posted comments all sound the note that the good physician is the one who can determine when it is appropriate and in the patient's interest and when it is not to go with the guidelines. The constraints, incentives and feedback that physicians face constitute a practice environment that could not be less conducive to "dong the right thing".

cause of elite marathoner death not revealed by autopsy

It was a perfect weather day in New York for an Olympic marathon trial. At 5 1/2 miles into the race, world class runner Ryan Shay collapsed and died.

The preliminary autopsy findings did not reveal a cause.

According to a very good web site on sudden death in athletes which is actually entitled "Sudden Death In Athletes",The top three causes are Hypertrophic Cardiomyopathy (HCM)-26%, Commotio Cordis 20% and Congenital coronary artery abnormalities 14%. He was not struck in the chest and Anomalous coronary artery would have been noted on a gross autopsy but according to Dr. Douglas Zipes, a spokesman for the American College of Cardiology, differentiation between HCM and a very hypertrophied "runner's heart" can be difficult. At 5 miles into the race on a cool day there would be no reason to consider hyponatremia in an elite seasoned distance runner. I assume a cranial exam was done and no cerebral aneurysm was detected. So what is the answer? In some well publicized cases of athlete's death the answer was never made clear.

Two well known cases of sudden death during an athletic event,both leading to legal complications and controversy, were the deaths of Celtic basketball player,Reggie Lewis, and college basketball player Hank Gathers in Los Angeles. Apparently neither HCM nor anomalous coronary artery were the cause in either death which were surrounded with charges and counter-charges regarding how early symptoms were handled in these very "valuable"athletes.

In Italy, where the cardiology community is quite involved in screening athletes for potentially lethal cardiac conditions,an entity uncommon in the U.S. is said to be much more common namely, arrhythmogenic right ventricular cardiomyopathy (ARVC), a good discussion of which can be found here. The most common EKG finding is inverted right sided t waves, but this is also commonly seen with the benign incomplete RBBB pattern.A notch on the downstroke of the right precordial QRS complex is sometimes the tip off. In Italy, routine EKGs are recommended but that is not the consensus in the U.S. The Italian cardiologists have offered evidence that their evaluation which include EKGs have saved lives.

Shay's father has talked to the press and indicated his son had a history of "enlarged heart" as early as age 14 but he had been evaluated in the past and more recently and was given the OK to compete .

Peri-operative beta-blockers- A quality indicator or a bad idea?

The November 9,2007 edition of Med Page Today features a report of a paper given at the AHA meeting that casts serious doubt on a major recommendation of the AHA and a widely used "quality" measure.

There have been rumblings for some time that the rush to use beta-blockers to reduce cardio-vascular mortality and morbidity during and after surgery was ill advised.The rumblers now have a more convincing argument.

Dr. P.J.Devereaux reported the results of the POISE trial, which was an drug company randomized trial of over 8,000 patients, aged 45 or over undergoing noncardiac surgery and who had or were at risk for arteriosclerotic disease. The treatment arm received metoprolol 2 to 4 hours pre-op and had the medication continued for one month after surgery.

There was a decrease in nonfatal MI ( 3.6% versus 5.1%) but there were more strokes in the beta-blocker group ( 1.0% versus 0.5%) and a greater total mortality in the treatment arm (3.1 % versus 2.3 %),

I have suggested before that quality measures may be hazardous to your health in regard to the four hour pneumonia rule. This may be an even more glaring example. I submit that in the rush to infuse "quality" into medical practice we may have codified a practice, that may generate more harm than good, (I am sure folks will argue over that) based on far less than convincing evidence.

Current issue of Mayo Clnic Proceedings critical of ED docs handling of vertigo and current diagnostic paradigm

Ever since I heard Dr. Martin Samuel's classic lecture on vertigo, I took his advice and tried to become fairly knowable about vertigo so I could really look forward to seeing my "next dizzy patient".

Part of his approach is incorporation of the widely used classification proposed in 1972 by Drachman and Hart in which four categories are outlined.

vertigo
presyncope
disquilibrium
non-specific, or lightheadedness ( what Samuels calls "true vertigo")

In the Nov. 2007 issue of the Mayo Clinic Proceedings, several authors are rather critical of the manner in which ED docs approach and manage vertigo patients. (Full text is available after registration on their site).

The editorialist comments that ED doc training seems lacking in neurological matters and in his analysis of a number of missed diagnosis of cerebellar infarction that histories were incomplete, neurological exams were inadequate and there was undue reliance on CT scans. I would like to hear what ED docs think of that ( if any read this).

One article suggested that the emphasize on "quality of symptoms" ( which is basically over emphasizing the above mentioned classification) may lead to missing diagnoses, the most important of which is cerebellar hemorrhage which in some instance is treatable by surgery. So not only are ED docs (just ED docs?) accused of screwing up, the paradigm taught for years and used by many is also under attack by this multi-institutional cadre of authors.

In a rather complicated article based on a survey of 505 ED attendings and residents the authors ( it seeemed to require 12 authors to interprete the results) concluded that "the dominant paradigm...is the quality of symptoms approach ....the standard approach ..suggests a potential link to misdiagnosis".

I think they are saying that over reliance on a simplified approach to vertigo/dizziness may lead to missed diagnosis of brain stem strokes and cerebellar infarcts or hemorrhages. The simplified approach they think is being used involves the following thought chain: vertigo--->vestibular--->otolaryngology type cause. The reasoning I thought was applicable was vertigo--->vestibular or central (brain stem or cerebellar cause.) In other words, one has to differentiate between peripheral and central causes of vertigo.

What always bothered me was "Don't miss cerebellar hemorrhage" and to that end I think the following points are valid and helpful,some of which the Proceeding's authors make.

Vertical nystagmus within a single bout of prolonged vertigo almost always means a central cause.

Head motion or positional trigger of vertigo usually means peripheral BUT cerebellar stroke related vertigo can also be made worse by head movement.

The typical head CT done in ED does not rule out a cerebellar hemorrhage and MR may be needed.

If the patient is so vertiginous or disqulibrated ( probably not really a word) that he cannot walk you had better really worry about a cerebellar stroke.

Absence of headache does not exclude a cerebellar hemorrhage.

You really need to do a history and a neurological exam. Brain stem strokes almost always have other neurological findings-diplopia,cranial nerve palsies ,dysarthria, etc-but midline cerebellar disease may only have vertigo, nausea and inability to walk so intense is the disequilibrium.So absence of cerebellar signs-upper extremity- dysmetria,past-pointing etc-does not exclude a cerebellar stroke.

I blogged about cerebellar hemorrhage before here.

In that posting I referenced an article written by an ED physician who missed a cerebellar hemorrhage and with more than a little courage discussed in detail how it happened.

The Proceeding authors' thesis is, in part, that more emphasis should be place on the timing or duration of the symptom(s) and on the triggers. Perhaps so but whether or not their survey indicates a major and widespread defect in diagnostic reasoning is unclear. David Drachman in a 2000 Annals of Internal Medicine editorial said that the physician needs to evaluate vision,vestibular function,motor function and search specifically for certain conditions. In other words, evaluate the patient,try and make sense of clinical findings and search particularly for potentially serious and treatable conditions. Rigid adherence to his categories was never intended.

Drachman's decades old outline is just that, an outline, a reasonable broad category checklist to consider in the evaluation of the dizzy patient not a rigid algorithm that would use a patient's description of symptoms as a mechanism for premature closure.

Consultant fees ,bribes or kick-backs to academic othro surgeons?

Medical ethics news seems to get worse and worse. Health Care Renewal refers to articles on orthopedic device manufacturers paying-in some instances-unbelievably large fees to orthopedic surgeons. The nature of what they did to earn such fees is let to the imagination but four orthopedic device manufacturers were charged with violating federal anti-kickback laws by paying orthopedic surgeons to use their products.

Sites that list in detail the physician recipients can be found on the Health Care Renewal blog. Perhaps the most striking payment was for over six million dollars to the head of orthopedics at Brighams and Women's Hospital. There were 21 instances of physicians receiving one million dollars or more from one manufacturer.

Certainly, physicians can perform various legitimate consultative activities for drug and device manufacturing companies and we do not know what the fees were for but the accusations of receiving kick-backs delivers still another blow to the prestige and reputation of physicians in general.

Earlier I wrote about the accusation of renal doctors receiving rebates for the use (and some would say the overuse) of erythropoesis stimulating agents in patients with renal failure. I have also commented on the accusation that oncologists were profiting from the in-office administration of chemo drugs and that such profit may have lead to the inappropriate use of such drugs. From my positive personal associations with renal docs and oncologists I had no reason to believe those accusations and did not want to believe them but some who commented to my blog believed otherwise. No doubt many in the lay community will apply the adage "where there's smoke, there's fire" to this most current revelation about money exchanging hands.

Several years ago my brother-in-law after paying $90 for his first month supply of Zocor commented that his physician was probably getting a kick-back from the drug company. I self-righteously told him that sort of thing doesn't happen. I am not sure what I would say now.

The old time "peripheral brain" of house officers is now the external universal mind

Returning home from a vacation in Europe I read a delightful and insightful piece by David Brooks in the International Herald tribune entitled "The External Brain". It can be found here.

I actually still have my little black book which was a lab coat pocket sized binder notebook in which house officers in the day wrote things that they thought they needed to know and no, I don't use it anymore. That and the Washington Therapeutic Manual were our "peripheral brains." I find an 40 year old entry under CHF which talks about how to slowly "digitalize" a patient with congestive heart failure and another on how to do the "Ivy bleeding time, both of which are medical museum pieces.

Brooks, in what I believe to be at least in part a tongue in cheek essay talks about how by becoming progressively reliant and dependent on his GPS system he was discovering the "Sacred order of the External Mind." He could now out-source mental tasks to a satellite brain, an external Mind. He says he may now no longer need a memory because with a few key-board strokes he can get what he needs on Google or Yahoo and the drudgery of having to remember so much stuff is eliminated or for more personal material open up his Blackberry.

He writes that he discovered that the magic of the information age was not we could now know more but that it "allowed us to know less."

The clunky,relative information-poor little black book of yesterday's intern has morphed into the powerful PDA through the mystery and magic of the silicon chip animated by the unforgiving logic of the algorithm.This can not only hold a PDR, one of the available antibiotic guides and five Minute Clinical Consultations,etc,etc but when Internet-enabled the entire universe of the external brain can be accessed.

Brooks continues " I have relinquished control of my decisions to the universal mind...Life is a math problem and I had a calculator"

One possibly disturbing counterpoint is noted in Brooks' reference to a piece by Clive Thompson in Wired which claims that one third of folks under age 30 can't remember their own telephone number.

Of course, physicians cannot really relinquish control to the universal medical mind. However, when you have the background and the context of experience, access to the "outboard brain" is unbelievably empowering and having tasted of it you never want to do without it. But as Clive Thompson said in his closing, I would like to still remember my own phone number.

There are no average patients

Dr. Robert Centor has an important entry in his blog, DB's Medical Rants, dealing with a issue dear to my heart. He refers to an article in American Scientist by Drs. Rodney Haywood and David Kent. These are the same docs who published a recent article in JAMA that I talked about here.

The basic notion here is that averages hide individual differences and Haywood and Kent emphasize the need for risk stratification to be included in randomized clinical trials.


Earlier on I had been able to access a full text version of a classic article on this same general topic but now my attempts to link to that have been met with the realization that now a subscription is required. This is a real shame as it is an article every med student and physician should read and digest.
The Journal is

Milbank Quarterly ( 82(4),661-687, Dec. 2004 and the article is " Evidence-based Medicine;Heterogeneity of treatment effects and the trouble with averages" by Kravitz,RL,Duan N, and Braslow J.

Here is the abstract ( apparently all you can get without a paid subscription now) with my addition of the highlighting of certain phrases.

"Evidence-based medicine is the application of scientific evidence to clinical practice. This article discusses the difficulties of applying global evidence ("average effects" measured as population means) to local problems (individual patients or groups who might depart from the population average). It argues that the benefit or harm of most treatments in clinical trials can be misleading and fail to reveal the potentially complex mixture of substantial benefits for some, little benefit for many, and harm for a few. Heterogeneity of treatment effects reflects patient diversity in risk of disease, responsiveness to treatment, vulnerability to adverse effects, and utility for different outcomes. Recognizing these factors, researchers can design studies that better characterize who will benefit from medical treatments, and clinicians and policymakers can make better use of the results."

Guidelines are based-ideally-on evidence.The highest rung on the evidence ladder is generally said to be the randomized clinical trial(RCT).The conclusions of RCTs are expressed in terms of averages and the problem is averages are abstractions of data and there are no average patients.

I am glad that DB is pushing on with this topic. He is widely read and a prominent educator and at least his students will benefit from discussion of averages and the madness of guidelines. Also be sure and read the insightful comments to DB's entry by Dr. Richard Fogoros

More on "Is there no end to the wonders that statins will bring about?"

Here is a link to one more in the ever growing list of the wonderful things that statins can do for us all. We now learn that the rate of loss of lung function is lessened in statin users with COPD.

Earlier I had listed some of the other benefits attributed to statins . These included

decreased risk of death from COPD and heart failure
decreased risk of advanced cancer of the prostate
decreased risk of pneumonia in diabetic patients

I also previously commented a study that seemed to show a decreased risk of sepsis in dialysis patients who took a statin. I cynically wondered aloud if some or all of these observational studies on the benefits of statins were not a big push by the statin manufacturers to generate more evidence that the value of the statins extend far beyond the LDL lowering effects and include the nebulous effects "pleotrophic" effects. Such a effort could well be triggered by the market success of Zetia.

There was also the issue of the dueling case-control studies that dealt with the question "do statins decrease the risk of colon cancer" with various studies reaching opposite conclusions. That saga seemed to prove once again you should not bet the farm based on the results of a case-control study.

I certainly do not rule out that some or all of the statins may bring about some type of benefit apart from the cholesterol lowering but the fact is the studies mentioned above are observational studies and are a hotbed of all the potential biases that we learned about in doctor school and basically cannot prove causation. and we need to particularly be wary of the healthy user effect.

changing mind set in medicine

Kevin MD references a posting on what life is like for a hospitalist at Kaiser that tells the readers more than what life is like for a hospitalist at that particular HMO.The blog that Kevin refers to is EM Physician-Back Stage Pass and here is the essay.

I believe it tells a great deal about what may be a major paradigm shift in the self image or mind set of physicians in this new culture of managed care.

Here is a quote:

Medical students and residents are seeking a better lifestyle for themselves. I guess we're finally coming to realization as a group that medicine isn't worth your happiness and sanity. That it's hardly admirable to subject yourself to abuse (by CMS, by DHA, by joint commissions,by society by medicine) and be absent in the lives of your loved one. Maybe when doctors were respected,autonomous and paid well...but now,not as much. when this happens, when docs start seeing themselves as employees with jobs,continuity of care sounds like crazy talk. Think how crazy it would sound if we suggested that nurse (or anyone else on the 'healthcare team' were made to "feel guilty" about going home at night....Everyone has a job these days..which is what government created and physicians (at least the professional societies) have allowed to happen.

The loss of pride that DrRich and I have blogged about seems evident in this doctor's view. It seems the doctor author sees himself as 'only" an employee. I re-read his piece and I go back and re-read the an early entry I submitted for this blog which dealt with the transformation of a lay person to a physician and at first conclude that our views are miles and ages apart.Or maybe my views are what I was taught a physician should be and his/hers are what the reality of the current economic medical landscape are turning physicians into.

Different meta-analytic technique fails to confirm increased risk from rosiglitazone

It was only a matter of time before someone published an article using a different meta-analytic technique from that used in the now famous rosiglitazone study by Nissen that failed to confirm Nissen's findings. George Diamond is the senior author of such an article in the Oct. 16, 2007 issue the Annals of Internal Medicine in which by using different techniques from Nissen neither an increased nor a decreased risk from the use of rosiglitazone in diabetic patients was demonstrated.( a subscription is required for full text )

No one should be surprised. The tools of the meta-analysis trade are arcane and the average or even way above average physician reading a meta-analysis either has to accept the findings at face value or ignore the thing entirely because he basically does not understand what was done and is in no position to meaningfully critique the techniques.If the issue is important and/or major economic forces have an interest there will soon be what we have here namely dueling statisticians.(I am not implying that the authors of the Annals article were motivated by those forces and would be surprised if they were)

Is the technique used by Nissen correct or is the method used by Diamond or is that even a meaningful question? It may be the case that combining disparate, incomplete sets of data, often without patient level data cannot ever answer certain questions such as the one posed by the rosiglitazone data analyses. It may well be a randomized clinical trial is the only way to possibly generate a meaningful answer which is what , at least in regard to the "rosi" question, is what Diamond et al suggested.

I have ranted on and on about meta-analyses (MAs) before and have borrowed heavily from the powerfully instructive writings of Dr. Steve Goodman. Medical students should have the following sentence grafted into their frontal lobes. The outcome of a meta-analysis is a function of the studies that one decides to include and the summary statistic used and various experts differ in regard to what statistic to use and the method of inclusion of studies.

They are basically observational studies in which the "subjects" are studies or trials and the "truth obtaining" value of observational studies is well recognized to be several notches lower that the randomized trial. Statistically combining two or three randomized trials does not always magically generate a higher degree of truth ( ie. correspondence to reality) than does the individual trials although sometimes it might. The trick is how to figure how when it does and it is a trick I have not learned.When are we dealing with apples and oranges and when are we merely seeing apples with minor and insignificant variations in color and consistency?

There is an editorial in the same issue of the Annals by Mulrow et al that says in part:

The analyses by GlaxoSmithKline,Nissen and Wolski and Diamond and colleagues and the FDA teach us that summarizing data about scarce adverse events is difficult. Summary estimates, confidence bounds and statistical significance can vary depending on analysis techniques.

This means that well meaning, honest investigators can reach completely opposite conclusions based on how they decide to analyze the data and there can be honest disagreements about how to decide on which technique to use.

But in regard to rosi I believe we cannot get the cats back in the bag. With what has been published and magnified in the news and on the web to prescribe rosi to a new type 2 diabetic would be to pin a large target on your back with a sign that says sue me please even if we really are not sure if rosi increases risk of cardiovascular events or not and we may never "really know". Sometimes issues are just dropped and we move on to something else.

Even PAs are moving away from primary care?

An article that can be found here suggests that my prediction that not too far down the road primary care will be delivered mainly by "mid level" practitioners may not be on target. It seems that fewer PAs are opting for primary care mirroring a trend in med students to shun primary care. Low pay, shrinking prestige ,cost of education and low level of job satisfaction are factors said to push docs away from primary care and the same factors may have a similar effect on PAs .

Thanks to KevinMD for calling attention to the article referenced above.

Maybe "mid levels" will be replaced by something like PA assistants (PAAs) or NPAs ( nurse practitioner assistants). The third party payer spin doctors will need a better name than "lower levels" to refer to them, however.

The 2007 Chicago marathon-a hot weather wipeout

The weather is not supposed to be hot for the Chicago marathon which is held in October. This year it was hot and so hot that things seemed to get out of hand. One news report described what took place as "havoc".

The race directors at some point canceled the race in mid course due to the excessive heat which should not have been a surprise as the preceding week had been unusually hot. Many runners continued ,however, ignoring barriers and the shut down of the watering stations. One runner died but the official report is that he did not die from heat related cause but from a pre-existing cardiac condition. Some runners blamed the race directors for poor planning and at least one person connected with the race blamed the runners for pouring water over their head instead of drinking the water. He was quoted as saying he had never seen runners pour water over their heads. He should watch runners in the summer and fall in Houston.Apparently some runners left the course to get drinks at local stores. Things did not go smoothly.

Many runners were treated by the medical teams set up for the race. This brings to mind the issue of medical management of the collapsed runner, an issue of personal and professional interest to me. Professional because internists are supposed to know all about electrolytes and the like and personal because I continue to participate in marathons and if I ever collapse I hope someone knows what to do.

I have posted before on this subject quoting the work of Dr. Noakes from South Africa who is a well known authority in this area who has emphasized the importance of hyponatremia and the critical necessity to know the serum sodium level in a collapsed runner and has urged race directors to arrange for access to point-of-care serum sodium determinations. The point has been made that determining the sodium level should precede the reflex starting of normal saline as that is not the appropriate treatment for severe hyponatremia.

This sodium issue has to be raised in regard to the death of the young runner concerning whom news reports indicate he died from mitral value prolapse (MVP).

I was puzzled as to how MVP would be the mechanism of death and my doubt was reinforced by a very recent posting by a cardiologist, Dr. Wes. He knows much more cardiology than I and he expressed his doubt about the putative cause of death.You have to wonder about electrolyte problems and arrhythmias.There are well documented deaths in marathoners due to severe hyponatremia . After the 2000 Houston marathon ,during which temperature was as high as 86 degrees, which was only slightly cooler than Chicago, there was a report of four young female runners were hospitalized with severe, life threatening hyponatremia , all of whom were successfully treated.

I bet there will be many calls from patients with the diagnosis of MVP- many of whom have in fact very little wrong with their hearts- to their primary care doctors or to cardiologists.

Yet another reason why students do not choose primary care-from DrRich

Primary care providers-at least those with a M.D. degree- are seemingly moving along a path leading to extinction. In The Covert Rationing Blog, DrRich gives us an important essay describing another reason why docs will not be going into primary care and those who in doing it now will be more likely to opt out.

The latest reason is the rise ( I am not sure how widespread the practice really is) of something called care management consultants.

Go to his blog and read his comments and the reference to a Wall street Journal article on that topic.

This is still another chapter in the book entitled "Medicine is too important (read costly)to be left in the hands of the physicians and their patients".

Cynics would say that these management consultants are just another mechanism to decrease the expenditures of insurance companies while the "vision " statements of the companies proudly state they are trying to improving the quality of health care. To read details about how the big three insurers are improving quality for folks who signed up for the Medicare funded health plans go to this essay by Dr. Roy Poses.

Are physicians no longer "proud" and "Ethical"

The Covert Rationing Blog's author DrRick uses the phrase "Once-proud,once ethical" to refer to the medical profession. I certainly do not want to believe that the modifier "once" is correct.
However, there seems to be much awash in the land to push the vectors in the direction of less pride and less ethical behavior.

When a doc has to depend on a clerk in some distant place to tell her if she can order a certain test or prescribe a certain drug or perform a certain operation, obviously pride will suffer. What does it do to the ethical framework when a doc in tempted to game the system to make it possible that that test or that drug can be ordered or that operation be perform? How much pride can you feel when you rush through a 7 1/2 minute patient encounter when you realize there are issues that the patients brought up that you can only brush off and move on to the next overly-hurried,doomed to be incomplete patient encounter?

What happens to pride when your medical group agrees to mandate 32 patient encounters per day rather than the leisurely 30 you now plow through? Does your spider-sense ethics tingle
annoyingly when you realize you are setting the stage for even more inadequate medical practice solely because of the perceived need to increase volume? Does your pride titer decrease when you agree to no longer attend patients in the hospital, even though a major part of your internal medical training and to date professional experience has been caring for seriously ill,complicated patients in the hospital and you know that you can do a better job than the recently hired internist-self proclaimed hospitalist who is one year out of training solely because it appears to be economically advantageous to do so?

Does your pride suffer when you see the latest survey of professional compensation that illustrate that your years of training as a internist or psychiatrist or pediatrician or family physician earns you about the same as a CRNA?

What is the effect on your pride when you are labeled a "disruptive" physician because you repeatedly pointed out that the four-hour rule for treatment of pneumonia is wrong headed and likely to cause more harm than good?

I personally am not proud of the-what I consider to be a sea change-in the stated principles of medical training for internists? I refer to the deletion of what was the touchstone of an internist's training- "... in no case should the resident go off duty until the proper care and welfare of the patient is ensured."

I personally am not the proud of the concepts slithered into the new medical professionalism.I have written about this before .I refer to an attempt to substitute for the time honored and pride generating fiduciary duty to the patient a collectivist view of conserving society's resources.

Having said all of that, the really big elephant in the room derives from the fact that much of medical care is paid for with other people's money and as expected those other people want to spend less money and much of their concern seems manifest -as DrRich has eloquently explicated-by covert rationing. With those economic forces at work pride and traditional medical ethics are not likely to enjoy any resurgence any time soon.