Megestrol use in nursing homes.Are we treated the chart?

Megestrol acetate ( Megace ) at a dose of 800 mg/day was shown in a RCT in patients with AIDS related cachexia to stimulate appetite, increase food intake and bring about weight gain that appeared to be nonfluid weight gain. Since one of the quality indicators monitored by state agencies in nursing homes is weight loss, it is not surprising that there would be interest in megestrol use in that setting. A clinical trial of megestrol in nursing home patients was reported in 2001 by Yeh et al. The results are interesting but hard to explain mechanistically.After 12 weeks of 800mg/day there was no change in weight but reportedly better appetite and sense of well being but 3 months after treatment was stopped, the treatment group had more weight gain.Could there have been some lingering appetite stimulating effect that lead to weight gain? Yeh et al have suggested that megestrol might decrease cytokines which have been implicated as one factor in the weight loss syndrome of the frail and elderly. More recently Simmons et al report a small study (n=17) where there was no increase in food intake under "usual" nursing home care but there was a significant increase in food intake when combined with " optimal mealtime feeding assistance" The abstract made no mention weight measurements. Also from the abstract one cannot tell the real operational difference between the two feeding approaches. So it seems fair to say neither of these trials were associated with significant weight gain, yet from my experience there is a definite tendency for nursing home staff to encourage its use. The data supporting its use are scarce and in journals not widely read, how do nursing home nursing staff know about it? Could drug detailing play a role. You think? Or is is it that docs who see patients in nursing homes have learned that megestrol really works and they have transmitted their experience through staff meetings and informal consultations with primary care doctors?
My 94 year aunt has been a nursing home patient for 3 years. With progressive vascular dementia and probably Alzheimer's disease, her apraxia had progressed to the point at which she could not regularly feed herself. Her weight began to fall and the nursing home nursing supervisor contacted the attending physician and Megace was ordered on the nurses suggestion. Apparently this is standard operating procedure there.Over the next several months her weight increased and bilateral edema to midthigh was finally acted upon when he developed acute pulmonary edema. I believe the fluid retaining properties of megestrol played a role in tipping her over into CHF. So important is the imperative to not have nursing home patients loose weight, several weeks later the nurses wanted to restart megestrol. I was able to intervene and her chf has been well compensated for the last 5 months. Venous thromboembolism may well be a more concerning side effect in general but in this case, I think, megestrol lead to her decompensation.
In conversations I have had with geriatric docs and NPs who attend at nursing homes, megestrol is fairly widely used ( I realize this is not much of a scientific survey) and the 2 academic geriatric physicians I contacted both discourage its use because of lack of proof of efficacy and the concern for thromboembolism and fluid retention. Monitoring nursing home patients for weight loss by state regulatory agencies concerns nursing home personnel and use of Megace is appealing. How effective this off-label use may be is another matter. Data are scarce and the prevalence of its use seems disproportionate to evidence supporting its safety and efficacy.They may be trying to treat the chart but if it doesn't work they are not even doing a good job of that.

More on the Fate of general Internists

The comments that I made in a recent post regarding the current and future role of the general internist have attracted some attention.Kevin MD mentioned it and several others have made comments. My comments were made based on my observations on private practice and some second hand information about academic IM from my spouse who spent many years as an academic oncologist and informal conversations with many of my colleagues over the past few years. Until today I had not made any effort to read what the academic general internists have written about this issue.Today I did and I came across an excellent article
by Drs. Thomas Huddle, Robert Centor and Gustavo Heudebert which discusses in candid and well expressed detail much of what I had personally observed and about which I had opined.The authors expressed basically the same concerns that I had expressed in my much more informal and less well organized way. In fact, having read that article I believe my views were largely validated. This article should be on my medical student's mythical reading list as it provides an insiders' look at some very important aspects of medicine in the real world.

MEDRANTS also commented on my thoughts in his blog.He suggested that I have overlooked an area in which the expertise of the generalist internist was sorely needed, this being in the management of complex,complicated cases involving patients with multiple medical problems. He is correct; I did not discuss that aspect. Often these patients not only have several illnesses but are taking numerous medications and are interacting with several doctors who may or may not have a sense of the overall picture.I agree that this type practice is really what internists were and are all about. This role is the role of the consultant for the difficult problems and someone who can manage the overall picture of these often perplexing cases. These are problems where the internists can do what he was trained to do and this role of the Oslerian physican with a deep and broad knowledge was what I believe was modeled by the physician educators that I was fortunate enough to have had as role models during my medical training.No one other than the internist is trained for this role in adult medicine.MEDRANTS says general internists are important.They are.My concern is that in the current medical practice environment their future survival in this classical, general internist role is in doubt.

Care of the complicated, multifaceted medical conditions requires time and in the out patient setting time is money.The money as doled out by Medicare and managed care does not properly compensate for the time consuming cognitive activities involved in the management of this type patient.
I believe for the generalist internist to survive there must be a major change in the reimbursement schemes used to compensate outpatients. In the absence of this the internist as office physician will morph into what will not be distinguishable from the family practice doctor or the independent nurse practioners.

 I believe MEDRANTS' views and mine differ little if at all.
I hope that Dr. Centor, in his role as president of the Society of General Internal Medicine, is able to gather support from the medical establishment (ACP,AMA and maybe even subspeciality societies such as ACCP) to educate the relevant players-including the public- about the importance of the general internist and to lobby for meaningful changes in the reimbursement system so these complex, complicated cases can be managed by those physicians who have been trained to do so and not let the tradition die out.

still more troublesome news about Big Pharma and cahoots

PLoS again has published an article ,which if its allegations are true, is more cause for concern about who the heck we can trust and what data about medications we can believe.The PloS article is a story of 5 whistleblowers including the outspoken Dr. David Graham who has 20 years of experience as as FDA safety officer . It includes the comments also a former drug rep who has written and directed a movie about drug detailing. The article is written by a freelance journalist from New York. Health Care Renewal has a recent posting also on the revelations of drug detailing and refers to a different sales rep than the one in the PLoS piece. Some of the accusations are the kind of thing I don't want to believe because it seriously calls into question the underlying data base from which I have drawn over the years to prescribe medications. Having some experience in the legal area as a expert witness and once as a plaintiff, I know that hearsay evidence is not at the top of the evidentiary food chain and often is not even considered by the court and at least some if not most of the material in the PLoS article is hearsay.
I believe if one wants more facts and figures a better and bigger source is the recently published book by former NEJM editor, Dr. Marcia Angel which received a very good review in the June 22, 2005 JAMA. The New York Review of Books offers a brief summary of some of Angel's main points.
The "cahoots" part of the title refers to comments of one of the whistleblowers in the PLoS article, Allen Jones, who was an investigator for the Pennslyvania Office of the Inspector General and his allegations that drug companies made payments to state officials to develop a medication treatment algorithm. BMJ has a recent article which alludes to the TMAP (Texas Medication Algorithm Project) and quotes Allen Jones , who asserts among other things-that this project was strongly influenced by Big Pharma, was exported to Pennsylvania where drug company money was also used to influence that program. The headline is attention getting: " Bush plans to screen whole US population for mental illness." The BMJ article discusses the Bush adminstration proposal to fund projects to screen for mental health problems using the TMAP as a model. Reference is to Bush's New Freedom Commission on Mental Health and the commission report can be found here.
The BMJ article refers to the controversy over alleged improper influence by drug companies on the choice of drugs used in the treatment algorithm and points out purported relationships between Lilly and the Bush family and administration. Supporting both the TMAP and national program is Dr. Darrel Regier, director of research at the American Psychiatric Association (APA). Not mentioned in the BMJ article is the larger issue which libertarians would quickly raise , namely should the government be involved in funding mental health screening at all. At the end of this we seem to be left with allegations and claims and a "he said-he said" situation which most of us would feel unable to sort out. Allegations regarding the influence of drug companies are more credible, however, since we have been enundated with account after account describing Big Pharma's role in manipulating medical research and the techniques used to promote their products.

Will there be general internists in the future? Should there be and what will they do?

These comments are now over ten years old. I republish it now as most everything I said then seem more on point now.


The current data are clear.There are fewer docs going into general internal medicine.Lower pay, less prestige are two of the reasons offered.

A  "op-ed" like piece in the ACP Observer by the President D. Anderson Hedberg is entitled "Finding the Art within the science of internal medicine". My gut reaction to it is " wouldn't it be nice if it were [still] true.?"The internist he portrays does resemble the internist I thought I was training to be. But I doubt if it is possible to be that type physician today.

Dr. Hedberg quotes a 1998 article by Dr. Robert L. Wortmann, chair of IM at the U. Of Oklahoma in Tulsa. Dr. Wortman said the four distinguishing characteristics of internists are: 1) the ability to be a diagnostician ( internists were once called that) who can practice the deductive scientific process that leads to therapy. 2) the ability to provide care of complex acute and chronic problems. 3) the ability to be a consultant for generalists, specialists and subspecialists and 4) curiosity. One comment he made re "curiosity" does resonate with my IM training. He said that to the internist it is important to consider the "links between disease and pathophysiology as well as between the therapy and its mechanism of action"

These comments definitely had more currency at a time when: 1) there was no competition in primary care save for GPs. and there was a clear distinction between GPs and internists. There were no family doctors-from whom the distinction between them and internists is harder now to draw- and no competitor from nurse practioners. 2) there was the reasonable likelihood of being able to spend enough time with a patient to play out those characteristics and patients did not have to be seen every 10-15 minutes to either meet the clinic or HMO quota or generate enough income to keep the practice going. 3) there was no need to worry and try and determine if the recommended therapy was approvable by the HMO, Insurance company or pharmacy management company.4) there was no hospitalists to compete with you. You were the hospitalist. 5) there was time and opportunity to pursue efforts to satiate your curiosity.

Only about 25 % of internists consider themselves general internists and more and more subspecialists refer back to the general IM doc or the FP problems not clearly linked to their subspeciality.Hospitalists are growing in numbers and the arrow points in the direction of at least some general IM docs pulling back from their roles in the hospitals making them more like FPs than internists.

In short, in today's environment how realistic are the comments of the two physicians quoted above? I think not very. I am afraid their comments were more relevant in an earlier era.It is hard to say what are the distinguishing characteristics of internists in the current practice of medicine.
I believe it is a confluence of factors and forces that are leading to the demise of the general internist. Another major determinative factor is the following:A few decades ago the internist (there was no "general" preceding the designation) was the recognized expert in diseases of the heart, lungs, and kidneys as well as the expert in endocrinology and hematology. Tremendous growth and development of the subspecialist domains of expertise has changed the landscape. Cardiologists are now called in to treat coronary syndromes, pulmonary docs for respiratory failure, etc etc. Oncologists take care of the cancers, kidney doctors the ESRD cases and it is the rheumatologists now giving the disease modifying treatments for rheumatoid arthritis .When emergent or semi-emergent medical issue arise after hours the patient is likely seen in the ER by an ER doc and if hospitalized, then seen by a hospitalist who more likely than not calls in specialists.In short, the areas in which the internist was the expert have largely disappeared and the experts are the IM subspecialists. To a large degree many internists are left with office treatment of the same conditions managed by FPs and nurse practitioners ( hypertension, type 2 diabetes,annual check ups, elevated cholesterol,URIs etc ) How many internists would want their myocardial infarction treated by an internist? I want a cath cardiologist.

JAMA article & editorial:green sputum does not equal give antibiotics

A recent JAMA article from Great Britain concluded there is little to be gained from prescribing antibiotics for acute bronchitis. Their conclusion differs a bit from a meta-analysis by the Cochran group which concluded there may be modest benefit from antibiotics in this "entity". This study involved both children and adults and excluded patients with COPD or asthma and several other conditions including heart disease and was an open study, i.e. not double blinded, the patients knowing if they were taking antibiotics or not. The JAMA editorial takes a strong don't -use-antibiotics-for-acute bronchitis- stance but not only opponents of their use but also proponents can extract some data from the study supporting their position. Antibiotic use did seem to shorten the duration of "moderately bad symptoms" albeit by only one day on average-but that is an average- and fewer patients returned later presumably with the complaint of lingering cough. The 2004 Cochrane review suggested that for most patients antibiotics probably provide modest symptomatic relief. The authors of the current study in what sounds like typical British understatement say [their study]" suggest that the ...likely effects... are likely to be rather more modest than documented in the Cochrane review." The editorialist in his title says ".. do the right thing" by which he means forgo antibiotics in acute bronchitis in an otherwise healthy patient,the presumed decrease in the induction of community resistance organisms apparently playing a role in his analysis of what to do in management of acute bronchitis. However, the editorial does admit that there may be a small subset of patients who do benefit from antibiotics but we don't know how to determine who they are when we see them in the office. Maybe the best information we get from the article is that usually acute bronchits, counting cough duration, is about three weeks but not uncommonly 4 weeks in duration and even in Great Britain patients come back to the office when their cough does not "go away".

Former ACP official's straight talk re P4P "... a disaster"

At the annual meeting of the American College of Physicians in San Francisco this year, Dr. Eric B Larson, the immediate past chairman of the ACP board of regents had this to say regarding the pay for performance movement. "...Word on the street is it's a disaster". Details of this disaster were discussed in part in an earlier blog It is refreshing to hear some straight talk from someone high up the ACP organization as opposed to some of the politically correct platitudes we sometimes hear from the ACP, a peeve I ranted about here.
We can only hope that the joint efforts of ACP and AAFP with the Agency for Healthcare Research and Quality will be able to turn around the harmful programs that some insurance companies imposed unilaterally and put something reasonable in place.

retired Doc's suggestion for medical curriculum,part 11, pathophysiology

Pathophysiology was a major emphasis in the specialty of internal medicine which had its origins in Germany (Inner Medizin) and was transported to the U.S. in the early 1900s.By 1915 the American College of Physicians was founded and by 1936 the American Board of Internal Medicine.In the early years all internists were practioners of general internal medicine although they were not so named.Even when I trained, in the 1960s, all of the IM faculty were thought of as internists though most all had a speciality as well. There was no section of general internal medicine. Pathophysiology was emphasized and in my school days most frighteningly on Saturday mornings when various clinical profs would teach in their area of special expertise and ask questions. Most dreaded was the appearance of the chief of medicine. When he finally arrived for his lecture ( there was no published schedule) some of our fears were validated. He asked which atrium usually fibrillates.One of the students who was at the top of the class, volunteered an answer.He opined it was the left atrium because he figured rheumatic heart disease and mitral valve damage were a fairly common cause of atrial fibrillation. The prof said " No concept of pathophysiology, when one atrium fibrillates , both atria fibrillate , no concept at all" The emphasis on pathophysiology was also evident in the surgery courses and pediatrics. We grew up medically thinking that way. So it is with more than a little concern when I read some ( certainly not all) meta-analysis (MAs) and RCTs which make no mention of disease mechanisms. MAs seem to be more guilty of that omission.
Medicine has a long history of determinism which is basically elucidating and studying disease mechanisms or pathophysiology.This is one reason, perhaps, why physicians over the years have distrusted statistics with its randomness implication. The best thought experiment I have heard to highlight the distinction between the random and the deterministic ways of thinking was brought to my attention by Dr. Steve Goodman from Johns Hopkins in an wonderful Annals of Internal Medicine article. ( Here is another one of those articles that should be on the medical students reading list). Here is my paraphrased version. Mr. Jones is faced with the need for surgery.The particular procedure is generally accepted to pose a 15% risk of death. Let us magically produce 100 clones of Mr. Jones. When they all undergo surgery, what will happen? In the random process model ( stochastic interpretation) , 15 will die but we cannot tell beforehand who they will be. In the deterministic model, either all 100 will live or all 100 will die depending on whether Mr. J. and all his clones have or do not have some biochemical or physiological condition(s) that are in fact what causes the mortality risk of the procedure.
The recent meta-analysis I mentioned in my blog that concluded that beta lactams were the drug of choice in community acquired pneumonia was devoid of any disease mechanism discussion.The authors point out that even in cases of atypical pneumonia (excepting Legionella) that beta lactams, which are not senstive to atypicals, produced results equivalent to those produced by antimicrobials which are known to eliminate those organisms. Now, either we have to rethink our concepts of community acquired pneumonia or something is misleading about the data.
Outcome analysis is, of course, important. However, let's not forget Claude Bernard's admonition [quoted from Goodman's article]"What really should be done, instead of gathering facts empirically (I think if Bernard were writing today he would realize the importance of statistics but not to the exclusion of the following) is to study them more accurately, each in its special determinism". The data alone are not enough, we need to figure out what's going on. As Goodman has emphazied we need to consider prior data and biological plausibility ( or pathophysiology) as well as the latest outcomes research factoids. The tools of outcomes research and aggregate data analysis are seductive and computers have transformed the heavy statistical lifting to low energy key strokes but let's not forget the deterministic partner who brought us to the dance.

Latest Mild cognitive Impairment treatment trial:disappointing results

The June 9, 2005 issue of NEJM published results of a treatment trial of mild cognitive impairment(MCI)with Vitamin E and donepezil which was disappointing in several regards.Vitamin E, which had previously been shown to be of slight benefit(by the same research group which published the NEJM paper) in moderate to severe ALzheimer's Disease seemed without benefit in this group of patients with the amnestic type of MIC many of whom probably have "very mild" Alzheimer's Disease.Although donepezil did not change the rate of progression to Alzheimer's in three years (this was the primary end point of the study)it did seem to decrease the rate of progression in the first twelve months of treatment. The treatment effect was slight and transient in the group as a whole. A subgroup(those who were carriers for APOEe4) did show a slowed progression for the entire 36 months.The bad news continued in the related editorial which informs us that preliminary results from 2 other trials with galantamine also have negative results over a two year period.So even though we seem to be able to detect very early dementia with functional brain imaging,there is no treatment available of proven efficacy.Now a question for the two medical students who sometimes read this blog.When two RCTS are done by the same group and one shows that Vit E helps moderate to severe Alheimer's disease and one shows no effect in MCI which appears at least most of the time to be really very mild Alzheimer's, which do you believe ? Or for that matter,let us address the question to the masters of EBM.

even the venerable cxr distinction between primary and reactivation tb may be wrong

The old truths seem to crumble away. Reactivation tb has always been thought to be associated with a cxr of upper lobe infiltrates, with or without cavitation and typically upper lobe volume loss with hilar retraction while primary tb is typically associated with hilar nodes , middle and lower lobe parenchymal disease and pleural effusion. Molecular diagnostic techniques have caused an amendment to this venerable distinction.
An article in a recent issue of JAMA points to HIV infection playing an important role in the radiographic appearance of tuberculosis. The authors state "The altered radiographic appearance of pulmonary tuberculosis in HIV is due to altered immunity rather than recent acquisition of infection and progression to active disease."and "... radiographic findings have implications regarding host immune status...but whether a patient's disease is due to remotely acquired infection cannot be determined from them."
An earlier article also found no difference in cxr patterns in primary and reactivation tb. Both articles used restriction fragment length polymorphism (RFLP) analysis to define clusters of cases and made observations of cxr patterns in clustered and non-clustered (presumed to be reactivation) cases. There were clustered cases-presumably due to recent infection- which had upper lobe infiltrates.Reference is made by the authors in the earlier article to cases of documented recent infection with radiographic finding suggestive of reactivation. Well, I guess I shouldn't be surprised. We used to treat CHF (now HF) with bed rest, now we recommend exercise.We used to risk malpractice if we gave a CHF patient a beta blocker,now we risk it when we don't. Heraclitus had it right. All is flux.

"The best doctors take responsibility for everything they touch"

The quote in the title comes from the following article in Medical Economics. The case history and the physician's narrative and thoughts say a great deal about what it is to be a physician.The events also provide a platform for a valuable lesson on brain hemorrhages from a neurologist who obviously knows a great deal about that.

The general topic is the differential diagnosis of vertigo and some of pearls are you don't necessarily have a headache with cerebellar hemorrhage and the inability to walk is an important finding in the acutely vertiginous patient that might point to the diagnosis of cerebellar vascular insult and a emergency brain imaging study is needed because cerebellar hemorrhage is one of the relatively few times when a neurosurgeon may be needed in a patient with vertigo.

The short version of the story related by an ER doc is that an elderly patient with vertigo was incorrectly diagnosed as having acute labrynthitis.The ER doc relying on the resident's exam and the absence of headache in the history handed off the patient to the next shift and ultimately the patient died with acute cerebellar hemorrhage. A very erudite and useful exposition of the signs and symptoms of cerebral hemorrhage ( and how there need not be headache) can be found here.

Emphasis is placed on the inability to walk as a possible tip off to cerebellar problems and in the setting of an elderly patient with cardiovascular risk factors, cerebellar hemorrhage.The discussion about brain hemorrhage is from the blog NEURO which is a continuing source of great material.
I quote the final paragraph from the article that a ER doctor was brave enough to publish.

"But the best doctors take responsibility for everything they touch. They don't blame textbooks,teachers, or anyone else for their own failings, for relying too much on the absence of one symptom, for not telling Frank [the hand off doc] If she's not walking in an hour, get a CT. The best doctors make everyone around them good enough to save that patient's life."

That kind of attitude is part of what a lay person is transformed into by the best of the medical school and residency training processes. We cannot be transformed into masters of the universe ( a term mentioned in a comment to one of my recent blogs) but I think we can be transformed into caring deeply about what we do and taking responsibility. Or is it the case that those caring about what they do were already that way and all the training gave them a set of skills to be caring in a very special way?

JAMA article: Quality Improvement Organizations do not increase quality indicators.

The June 15, 2005 issue of JAMA published an article that evaluated the impact of Quality Improvement Organizations (QIO) on "quality" of care for Medicare beneficiaries". Until 1992 the Medicare program's focus on quality problems with Medicare was on the PSROs and the PROs. These efforts were criticized for lack of efficacy and emphasis on cost containment. In 1992 emphasis was shifted to the QIOs to work with hospitals regarding quality improvement programs. The authors of this article report that there was no improvement noted in 14 out of 15 quality indicators between hospitals who took part in the program and those who did not. So it appears that this quality program did not increase quality of care. Currently $ 200 million is allocated annually for quality improvement. Medicare has recently signed a new 3 year contract with QIOs to continue their efforts in quality promotion. Let's hope the new efforts work out better than the old ones but perhaps calling a project "quality improvement" and spending large amounts of money are not enough.

BMJ meta-analysis challenges ATS pneumonia guidelines

In the June issue of Cleveland Clinic Journal of Medicine, (vol 72 number 6 june 2005, pg464 ) in their Patient Oriented Evidence that Matters section we find their summary of a recent BMJ meta-analysis of 18 studies that included 6,7049 patients. The conclusion is in the headline of the POEM section "Antibiotic choice makes little difference in community-acquired pneumonia".
The referenced article is by Mill GD, et al BMJ 2005:330 456-460. Since POEMs are said to be evidence that matters, there must be a take home lesson in each of them. Here it would appear to be "go with the [cheaper] beta lactams for community acquired pneumonia (CAP)". Yet this advice would be counter to the recommendations of both the ATS and IDS in regard to CAP. Both have said a beta lactam alone is not adequate. So when the cards of the EBM are dealt and one hand is a Meta-analysis and one is a treatment guideline from a national speciality organization, which is the trump? From a defensive medicine point of view, you probably have to go with the guidelines. The response of the ATS CAP committee members will be eagerly awaited as clearly the gaunlet is thrown down by these investigators from New Zealand. They state clearly these data support the BTS recommendation to use beta lactams and point out this is contrary to the ATS guidelines. To date none of the rapid responses seem to be from ATS committee members.
One caveat is that these patients were mild or moderately severe cases not severe cases requiring IV drugs.
Subgroup analysis showed no difference between drugs active against atypical pathogens (Mycoplasma and Chamydia) and beta lactams in cases in which those pathogens were the causative agent.A difference was shown in regard to Legionella. I would be interested to hear what the pulmonary docs at Pulmonary Roundtable think of this article. Should we abandon the "U.S. approach" i.e include coverage for the atypical pathogens based on this Meta-analysis?
I think not. Meta-analysis certaintly have their limitations which have been discussed here before. We have seen MAs reach opposite conclusions on the same issue and we have seen instances on a large RCT trumping an earlier MA.

Medicine IS awesome and I miss it but many docs can't wait to retire

Medical Madhouse recently commented that at least some of what is done by doctors is "F**king awesome" and added that in the heat of the moment we do not appreciate the awesomeness of the activity. (having made that attribution I can't find that comment on his blog site).He is right.

Further to that, when you retire from medicine the fact is that very little you routinely do is even in the same neighborhood as awesome. The intensity of the awe generating activities for most physicians may peak out in the house officer years, at least I believe that is true for internsts. For example, as a first year resident ( now called a second year resident) I treated 14 cases of DKA in coma.They all seemed to occur at night and in those days the first year resident ran the show. All recovered-one was apneic in the ER.In many years of practice I saw no DKA with coma, and in general the awesome incidence was much lower. Lower, but not absent.There was also more low key awe. Longer term relationships with patients, small victories and the occasional burst of awe.There is the satisfaction of doing things in keeping with current thinking in a given application and explaining to a patient why this or that approach might be best and having the patient actually do what you suggest and subsequently seeing that particular approach actually work. There is a bit of awe there. It is clearly awesome to treat an acute asthmatic patient and see their dyspnea lessened fairly quickly and to see the shortness of breath markedly improve in minutes with treatment of acute pulmonary edema. I thought it awesome to have several members of a law firm call for check up appointments because you had diagnosed atrial septal defect in their 46 year old female partner who claimed she couldn't have that because she had had 30 exams in her life and none had said anything, but she had it and she was operated. But....

I have recently been at my 1965 medical school class reunion. Many had retired and none of the retirees would admit they missed anything. No one talked about the awe of medicine.
(admittedly this sample is likely biased i.e. limited to those who retired and who go to reunions, while some or maybe all of the reunion non-goers may be euphoric or at least content at their continuing practice) But at least for a sizeable number of my class they could not wait to retire and miss nothing of it according to their accounts. Those who retired could only speak of the multiple negative effects of managed care and concern about malpractice. Many had been retired for 4 or 5 years having retired before age 60. The alumni organization had arranged lectures on various aspects of current medical education and those who spoke radiated enthusiasm and described exciting medical advances and I left that meeting supported by their energy.

 The 1965 class dinner, though filled with handshakes and hugs and a few shared memories and seemingly sincere laughter, projected the picture of a group of people who were glad to quit and sad that the profession that seemed to offer so much a few decades ago offered them now no pleasure and little satisfaction and more than a little bitterness. I hope that the docs who don't go to med school reunions represent a different mindset.

Hospital requirement to use hospital employed hospitalist

At a recent reunion-med school class 1965- a retired internist from Florida told me that at the hospital he used it was mandatory for a hospitalist to consult on any patient admitted to the ICU. (Pulmonary-critical care docs were exempted from this rule). The several hospitalists employed by this hospital were all general internists, no one had critical care certification or training but the hospital basically coerced the internist who was not self designated as a hospitalist to allow other internists who were self designated as hospitalists to take over his patient's care. I have no sense of how widespread this practice is or of the exact details of this arrangement. HCRENEWAL has a post referencing the AMA's recent move to lobby for federal legislation to prohibit hospitals from hiring physicians. It seems like the old corporate practice of medicine issue is being revisited. This should energize lobbying efforts on both sides of this issue.

more and more issues surface in the hospitalist saga

A comment to Kevin, MD speaks of his hospitalist group contracting with a hospital to shorten hospital stays. I realize this is heresay but it is troublesome if true. Obviously this would place the hospitalist in a conflict of interest position, if shorted stays become a contractually obligated,determinative clinical management imperative.
Several other issues in the hospitalist saga are brought out in the June 1, 2005 issue of Internal Medicine News. These include:
1.With the rise of hospitalists, what about the credentialing of those internists who now no longer go to the hospital, can they get it , do they want it ?.
2.If docs loose credentialing what about their loyalty to the hospital?.
3.Will it be defined as a specialty, or remain as a major part of what an internist does ( or did)?
4.Will the hospitalists be in an economic bind if the hospitalists are pressured or contracted with as alleged above to achieve cost savings and their income depends on the hospital. Does this raise issues that have been part of the corporate practice of medicine which in some states continues to be legally not allowed?
5.The Society of Hospital Medicine is working on a core curriculum which raises numerous questions. Dr. Michael Pistoria, Chair of the curriculum task force commented "The concept of the core curriculum was really one of trying to find out who we are and what we are..." wow! I'll bet orthopedic surgeons don't have have that problem.
6.At the recent meeting of the Society of Hospital Medicine, Dr. David Melzer reported on the largest study on the outcomes and costs of hospitalist programs. Taking all six academic centers in the study the investigators apparently concluded that hospitalists did not affect the average length of stay or costs or outcomes. In 2 of the 6 there was savings.If this an accurate assessment of such programs, you have to ask what is it all about anyway? In an apparent rebuttal to his own paper, Dr. Melzer is also quoted by Internal Medicine News as saying the evidence for improvement resulting from hospitalists remains robust with more than 20 studies show average cost and length of stay reductions of about 15%. I would like to see a study comparing internists who call themselves hospitalists with internists who take care of patients in the hospital but don't self designate as hospitalists. Am I wrong here or is it true that- with the exception of pediatric care- hospitalists are internists who don't see outpatients.
7.There are now 3 defined IM residency tracks said to be generally accepted; general internist, sub specialist and hospitalist. An article by Arora V et al "Closing the gap between internal medicine training and practice." AM J Med. vol 118, no 6, pg 680, june 2004 discussed-among other issues-the possibility that hospitalist led teaching of IM residents may influence career choice of house officers as they have less contact with general internists and subspecialists, the implication that fewer residents might choose those 2 paths. ( With the current delta between general internists and specialists, I doubt fewer wil choose the speciality route)
A flippant summary would be:hospitalists are not sure who they are, their compensation may be an issue, there is a real question regarding if they save money or decrease hospital stays, too many hospitalists teaching residents might not be a good idea, and will their interaction with hospital administration pose a conflict of interest.

Is Co Q 10 getting more medically main stream?

A paper presented at the recent American College of Cardiology, as reported in Internal Medicine News, claimed that supplementation with Co Q 10 (100 mg a day) reduced statin related myopathic pain. This was a small RCT ( n=41). The subjects complained on muscle pain while taking a statin and had either normal or minimally elevated CK levels and 18/21 patients reported improvement in symptoms while taking the Co Q 10.
There is a large body of published material on Co q 10 and many of the Google hits take you to sites that are health product sites selling numerous supplements.
There are data that indicate that statins may lower the blood levels of Co Q 10 in animals and humans and muscle levels in animals and that these levels can be raised by oral administration of Co Q 10 which seems relatively free of side effects and drug interactions. (coumadin may be an exception) In Europe it has been used to some extent in the treatment of heart failure but in the U.S. it is not found in the medication list recommended by the ACC for HF treatment.
Dr. Peter H. Langsjoen, a cardiologist in Tyler Texas, has written extensively expounding the thesis that myocardial depletion of Co Q 10 is caused by statins and this plays a role in what he describes as a epidemic of heart failure. A 2003 Fortune article featured some of Dr. Langsjoen's views in an article on Lipitor and its promotion by Pfizer. (a subscription is needed to view the article so I have no link but the purported heart failure link to statins received some attention at that time).
The Wellness movement has written extensively about the value of Co Q 10 as a supplement to prevent statin related side effects. Dr. Julian Whitaker petitioned the FDA on May 24, 2002 to require a black box warning of all statins recommending that 100-200 mg of Co Q 10 be taken with the statin. Dr. Whitaker is described in the petition as the Clinical Director of the Whitaker Wellness Institute.
There is at least one indication that Co Q 10 is getting more into the main stream. A web site from UCSD mentions Co q 10 as possibly useful in the muscle problems that might occur with statins. They stop short of actually recommending it, however. It was a group from San Diego who reported the " syndrome" of myopathy with normal CK which attracted considerable attention and an editorial from the NCEP group's chairman,Dr. Scott Grundy, who opined the syndrome might be real and should be investigated further but made no mention of Co Q 10.
I have noticed that more and more physicians are trying Co Q 10 to mitigate complaints of muscle aching in patients on statins who have a normal CK for whom they feel the cholesterol lowering is a clinical priority. Most docs, in my experience, would discontinue the statin if the CK is elevated.

More coercive guidelines,a surgeon fights back and The Borg

A Florida physician is fighting back against what he perceives to be more interference with medical practice. I could not tell from the news article the exact nature of the requirement or who was imposing it but it appears to be a Florida state requirement to report some aspect of antibiotic use in surgical patient. I applaud the neurosurgeon for fighting back.
This news item was pointed out by Kevin,M.D. and I am reminded of comments made in Medical Metamusings in March this year. The following comments borrow heavily from that blog's comments as well as thoughts expressed in the two articles that are referenced by it.
Guidelines and lack of adherence to them should not be used as a basis for determining the quality of medical practice.One of the articles mentioned above is by Dr. Mary Tinetti in which she addresses the issue of how RCTS often exclude patients with coexisting diseases and guidelines based on those trials may not apply to real life situations.
Tinetti makes the following points:1) guidelines are typically based on RCTs that often have relatively small improvements in relative risks and have eliminated subjects with other illnesses and who take certain other medications and who are too old and have relatively short periods of observation. On, the other hand, real patients tend to get old, have multiple illnesses and take the medications for longer periods of time. 2)Multiple drugs have multiple interactions 3) patients that are older and have multiple illnesses may not have the same priorities as the trial authors or the guidelines authors and may opt to not take all of the drugs or undergo all the procedures that the multiple guidelines recommend or take the drugs for a while and decide to stop.
All of which leads up to : Disease specific guidelines may not apply to patients with multiple diseases and to patients whose characteristics are not similar to those in the trials.
With all the increasing talk of conformity," quality" based on adherence to guidelines and now the specter of state mandated reporting , I am also somehow reminded of the borg who may represent the penultimate in quality improvement programs. I quote from the above Wikipedia reference regarding them. "According to themselves, the Borg only seek to "improve the quality of life in the universe" and add to their own perfection. To this end, they travel the galaxy, improving their numbers and advancing by "assimilating" other species and technologies, and forcing captured individuals under the control of the Hive mind..."

Which would a patient prefer- a hospitalist plus an officist or an officist-hospitalist

If a hospitalist only sees patients in a hospital then a officist (see below for attribution for the term) only sees patients in the office and an officist-hospitalist does both. Officists do not yet have their own unique specialty certification; neither do hospitalists but they are further along to that end. When I was in practice I was an officist-hospitalist (OH). Many internists still are but the trend seems to be away from that. An OH sees the patient pre hospitalization, during the hospitalization and afterwards. This would seem to maximize continuity of care. After hospitalization, the OH gets to see if his plan to have the patient get PT and home help has helped and if his new medication treatment plan is working or not. He gets to find out if the new medication is not on the patient's drug plan formulary for the 3 months refills. He gets to hear how the hospital screwed up his bill.
He gets to see how the patient had to go to the hospital because his treatment program wasn't getting the job done and for some reason the lasix Rx never was filled.Here's the thing;the internist who is a OH takes care of his patient when he is sick and sees him when he is well.That was what a internist was all about.
On the other hand the officist (the O) gets to explain why the H changed all of the medications. "Doctor, why did Dr. H take me off of all the old pills, did he think I didn't need them?"An occasional awkward moment, however, may well be well worth the piece of mind one gets from not getting late night calls from the hospital and not having to make rounds.
Of course, this all may be fanciful satire. I had briefly hoped that I would be immortalized in medical lore as the person who coined the term "officist" but in the google era it took me only a millisecond to be referred to a wonderful piece of medical writing by Dr. Farrin A. Manian in the NEJM in 1999. He talks not only of officists but of other characters in the newest medical care paradigm such as the screenist and the SNFist (doc who takes care of patients in a skilled nursing facility) and his comments are worth saving and should be read by anyone taking either side in the hospitalist issue.
Since we live in the era of evidence based medicine, let's look at some of the evidence.
Articles about H's have documented the efficient and efficacious care they provide. I do not claim to offer a systematic review but there have been at least two studies in the Annals of Internal Medicine in the last few years. Particularly robust is the the offering by Meltser, D et al
( " Effects of Physician Experience on Costs and Outcomes on an Academic General Medicine service"Annal Int Med. 3 Dec. 2002, vol 137 issue 11, pages 866-874) who reported a two year experience of 6511 patients managed by two hospitalists (yes,2, that is not a typo). Costs were decreased by $782 and in the first year the average length of stay was reduced by 0.29 days the first year of the study and by a 0.49 the second year. In the second year,but not the first, nor in both years when added together, the 30 day mortality was lower.
Another study (Auerbach, AD et al "Implementation of a Voluntary Hospitalist service at a Community teaching hospital:Ann Int Med. 3 dec 2002,vol 137 issue 11/p 859 865) showed similar findings with the improvement in terms of shorter stays, lower costs and decreased deaths.
These and other data seem have been sufficient to give the concept of H's momentum and managed care seems enamored with the notion as indicated in the following link
from the managed care literature.Although these two articles mentioned above may not offer the most convincing of data,Dr. Robert Wachter,associate chairman Department of Medicine,UCSF in a succient discussion of many aspects of the hospitalist issue quotes five studies that basically show decreased costs and time in hospital and no change in outcome and patient satisfaction.(Dr.Wachter is credited as co-coiner of the term,hospitalist,in 1996."
A recent report in Internal Medicine News casts some doubt on whether much is really saved by such programs.
However, If it is as good as portrayed by Dr. Wachter, who could complain ?(Although neither of the two articles I quoted above asked the patients what they thought of the arrangement)
Follow the money. It has been claimed the O does better by seeing more patients in the office at a higher hourly rate than seeing patients in the hospital (although in our practice we made rounds before or after office hours) and HMO are claiming savings.Or as Dr. Manian puts it [paraphrasesd]the officist provides cost effective care in his office seeing patients as long as they are well. If money is saved for the HMOs and insurance third party payers and hospitalist groups can earn a reasonable income, there will be more and more of this practice. We are talking about cost effective care and the economic entities that are the movers and shakers in 21st century American medicine are driven by cost effectiveness concerns and protestations of the minor supporting players-i.e. doctors and patients-typically are of little concern.
According to Dr. Wachter, patients are as happy with the hospitalist arrangment as with the older style of care. Dr. Wachter and Dr. Manian offer different portraits of the hospitalist scenario,the later, I would argue, tells it like it is and the former supplies us with an academic presentation of a current movement replete with aggregate data and cost effectiveness concerns. If you read both you get a fairly good idea of what it is all about. My thinking is the OH offers something tha is not equaled by the combo of an O and an H, namely continuity of patient care by a physician of the patient's choosing.There should still be room for both ways of taking care of patients.

Correlation does not equal causation-back to the basics

A recent post by California Medicine Man is worth reading in part because it discusses a text book example of over hyping a statistical association and engaging in hypertrophied, sweeping and unjustified policy recommendations.

There are at least two issues here: 1.the basic statistical concepts 2. recommendations for policy changes based on inadequate data and the fallacy that there is a government answer to every purported problem.Everyone should know and could not attend statistics 101 and be even occasionally conscious and not come away knowing that correlation does not equal causation. How many times does a student hear that causation is not proven by observational studies and case control studies?. How many times is the term "hypothesis generating" applied to those types of data?
We are inundated with medical headline news often from observational or case control studies about X risk factor increasing or decreasing the risk of disease Y. Here are a few recent ones'
1."tree pollen peaks are associated with increased nonviolent suicide in women"
2.Thiazide use linked to cholecytitis risk.(here the reported relative risk was 1.16). Should the ALLHAt advocates rush to retract their recommendations for use of diuretics as first line hypertension treatment?
3. High Folate intake is associated with more rapid cognitive decline ( high is is 400 micrograms which is what is in Foltx and similar popular pills used to hopefully decrease CAD risk). Even the authors expressed surprise with the findings.
4. Milk consumption in midlife increases Parkinson's Risk. This is from the Honolulu Heart study.The risk was 2.3 fold higher in men who drank more than 16 ounces of milk per day.
5.Recent studies have also shown that early oophorectomy and history of exposure to pesticides increased Parkinson risk. On the other hand, diet high in Vitamin E is said to decrease risk. A decreased risk has also been reported with ibuprofin use. (In my brief effort to round up some of these factoid articles, I considered adding a feature entitled "the Journal of Silly Articles" along the lines of the Ministry of Silly Walks. Please note that I do not mean to imply the above mentioned articles would be considered for that mythical journal,though some of them may have been funded by "government grants".)
There are so many studies showing weak correlations, multiple studies showing contradictory findings and so many of these studies getting headlines on TV and in the newspapers and the medical news publications that the credibility level of medical news in general has to suffer. For most of the studies an appropriate comment to a patient who asks about it might be " This is very preliminary, it is the type of research that may suggest relationships but cannot prove cause and effect and we will just have to wait and see if the questions raised by this study will be verified or validated as more is learned about the issue."

A chicken pox vaccine for adults offers decreased risk of zoster and postherpetic pain

I was not yet fifty when I tripped and fell on a jog in the park and banged my right rib cage.So that for the next 4-5 days I attributed the strangest pain I ever had to the fall. Oddly, the pain was less when I jogged which should have told me something as rib or muscle pain should have increased with the bouncing up and down.By day 7 the rash appeared.The "vir" drugs were not yet used for zoster so I self treated with prednisone and had a college rx some codiene. Fortunately the pain subsided in weeks with no significant postherpetic neuralgia but in some patients the pain can be persistent and severe .
In this week's NEJM the results of a RCT of a live attenuated VZV vaccine for adults are published.
It took 38,546 adults 60 years of age and older, and over 3 years of followup and fifty authors to let us know that the incidence of zoster decreased by 51.3 % and the incidence of post zoster neuralgia by 66.5 %. It seems safe and efficacious and hopefully will get approval from the FDA in a reasonable time frame. (this is not the children's vaccine, more virus is needed in adults to ramp up the cell-mediated immunity.) Merck could use the good press, reprising the old notion of a business doing well by doing good.

Recent physician compensation data will discourage general internal medicine as career

The latest data from Delta Medical Consulting (www.deltamed.com) places general IM, Peds,and FP at the lower strata of the medical compensation pecking order. This should not be a surprise to anyone but the magnitude of the difference between a general internist and medical subspecialties has to be of concern to medical graduates considering a career in internal medicine.
Using rounded figures the following are the starting annual compensations as published by Delta.
internal medicine 166,000
cardiology 323,000
oncology 337,000
gi 358,000
pulmonary 248,000
endo 172,000
hospitalist 179,000
Cardiologists, oncologists and GI docs make about twice as much for two years more training and pulmonary docs do ok. EM docs makes about 237,000.(You can view the entire survey by going to the Delta Consulting site and hitting the "show me" button.)
Delta also provides current average locum tenens bill rate per 8 hour day and, of course, they show a similar ordinal ranking. But it gets worse. While the internist,FP and ped all make $760 per day, the CRNA brings in $ 1,140 and a hospitalist makes $975. An internist has to sub specialize to make more than an anesthesia nurse. If lack of prestige is one factor in not choosing general IM, that fact should resonate in the limbic cortex's self esteem circuits.
A recent study quoted in Amednews.com indicates only 19% of first year residents choose primary care. Dr. Roy Poses in hcrenewal has written about this ( May 24 th posting) and quotes more data and although a number of educators and internal medicine leaders have expressed concerns, I have heard no convincing or realistic plans to change things. It is not just the money but income obviously is very important and so are med school loan obligations.
The subspecialist will only have to keep current in his field not with everything and everything gets more and more impossible. Many of us feel less stressed when we have limited the universe of information about which we are obligated to be expert. Further, the general internist has competition not only from FP docs but from NPs, a situation not an issue for the subspecialist. The subspecialist can dabble (I know that is probably too strong a pejorative) in as much or as little general IM as her interests and comfort level allows and send the rest back to the primary care doctor or other subspecialist.

VA's computerized medication system does not fix the problem of adverse drug reactions

In this month's Archives of Internal Medicine an article describes what so far has not been accomplished by the VA's highly touted computerized interventions in medication delivery.
The authors ( Nebeker JR et al " High Rates of Adverse Drug Events in a Highly computerized Hospital; Arch Intern Med/Vol 165, May 23, 2005 p 1111-1116) quote the literature that indicate that specific computerized interventions can reduce medication errors and hopefully reduce adverse drug events (ADEs). The VA system has earned praise for their efforts to reduce medication errors by computerized physician order entry (CPOE) and bar coding medication delivery and EMR, automated drug interaction checking and allergy tracking and alerting. These authors deserve praise for looking at how well the emperor is clothed. They studied the ADEs in a 20 week period at the VA Hospital in Salt Lake City.
The authors address the question "Do CPOE and related systems reduce ADEs?" Since they did not compare a control period-i.e. ADE rate prior to the introduction of these various systems-they cannot determine conclusively from their data if these systems bring about a reduction in ADE rate.
Interesting they report higher rates than do other studies (the author quote their incidence density of 70 ADEs per 1000 patient days as being 5 to 19 time higher than generally previously reported). The authors doubt their rate is really higher but that they merely found more cases because of their diligence in case finding and use of clinical pharmacists to find cases and legible and accessible medical records. Understandably, they reject the notion that their systems lead to an increase in ADEs.
On a positive note, they found that their system had apparently virtually eliminated ADEs due to transcription error and bar code administration. The three most common events were constipation, low potassium and hypotension.
The authors describes the ADE rate as high the ADEs as serious and recommend improvements in computerized interventions. For example, they suggest that CPOE could suggest a order for supplemental potassium and for monitoring potassium and creatinine when loop diuretics are ordered.( I cannot help but wonder why house officers or their attendings don't already do this, Isn't that what you do on rounds? I am more concerned that house officers don't already know some pretty basic material than I am that we have not yet perfected a computer system to relieve doctors of the burden to know what they are doing) Generally they recommend more computerized decision support with such computerized systems and warn that purchasers of generic or off the shelf CPOE and bar code systems against expecting dramatic reduction in ADE rates. The entire article is worth reading for its detail both in regard to the data found and the methods used to look at errors and adverse reactions and to serve as a precautionary tale to those who think adverse drug events will be banished by buying a CPOE and having a few training sessions.

Big Pharma's bad news shared by at least one generic manufacturer

Able Laboratories-a manufacturer of over 40 generic medications- has stopped production and recalled its products.Its history of problems with the FDA are outlined here.
Its CEO has quit and the company's president has taken over. Apparently the company has had problems since 1992 and have been under surveillance by the FDA, had been previously fined and some its officials had been forced to resign earlier. Manufacturing problems and quality control issues have been on the table for quit a while. This is the kind of thing that must make patients feel angry and betrayed to the extent they were coerced by their insurance plan's pharmacy management company to accept generic drugs.
Interesting reading is a 1989 FDA report
on several generic drug manufacturers problems which documents some egregious behavior by several companies (including bribing an FDA chemist) but finds no violations for Abel Labs, their problems apparently surfacing a while later.

statins and colon cancer-still another case-control study will not answer the question

Here is a case control study that I really would like to believe but I am skeptical. In the May 26, 2005 issue of the NEJM a 47% reduction in colon cancer is reported by JN Poynter et al from Israel.I have been taken Pravachol for 5+ years and I have a strong family history of colon cancer so I would really like it if my pill were multi-tasking prevention wise. The related editorial give us some context. There have been other case control studies- which no one should be surprised- have given somewhat conflicting results. (The case control studies regarding the effect on coronary artery events and hormone replacement therapy were also some what conflicted and we know how that worked out)
We are also told that secondary analysis from of three large meta-analyses of prospective statin trials designed to detect reduction in coronary events failed to show any colon cancer risk reduction. And then a comment is about how those studies might have not been adequately powered to detect a cancer risk difference. A Canadian case control showed a 28% reduction in colon cancer risk (surprisingly in only 2.7 years of follow-up causing one to wonder if some patients already had early colon cancer when the drugs were started) while another study showed an increase in colon as well as prostate and bladder cancer.
This exemplifies the sort of thing you see all the time when you look a set of articles that use coarse grain instruments (such as case controls and meta-analysis) to determine associations and causal links. This is what you have here. Some studies show decreased risks, some increased risk and some no difference. The authors of the article in their introduction say " to clarify the association " we evaluated data in... a case-control study. In light of the context of multiple conflicting case-control studies, how reasonable is it to expect that another case-control will ever clarify anything? Case control studies and multiple logistic regression analysis, according to Harvard epidemiologist, Kenneth J. Rothman, are two of the most important developments in epidemiology in the last fifty years. Case control studies are said to be efficacious and efficient and he characterizes it as the central tool of modern epidemiology. How many times have we heard the phrase " hypothesis generating" in regard to case control studies? Perhaps someone more skilled in epidemiology than I can explain what is the utility of doing another case control in a situation in which several earlier case control studies have resulted in contradictory findings in regard to a particular association. It reminds me of what one of our endocrinology attendings was fond of saying" if one endocrine test is equivocal, all the other tests you do to clarify it will also be equivocal." The editorialist opines that we won't really know more until a RCT is done, but that comment was just as cogent before this publication appeared.

NEJM headline news-CABG better than stents (at least they were in the past)

The May 26 issue of the NEJM article "Long-term outcomes of coronary artery Bypass grafting versus Stent implantation" concludes in part ". For patients with two or more diseased coronary arteries, CABG is associated with higher adjusted rates of long-term survival than stenting".
So is the issue settled?.Of course not. This is a very large data base (37,212 patients), so robust conclusions should be drawn and clinical practice illuminated. Well maybe not.
The procedures took place between Jan 1, 1997 and Dec 31, 2000 and since then both stent procedures, surgical techniques and supportive medical therapy have changed. One highly publicized change is the introduction of the drug eluting stents which have markedly decreased stent related re-stenosis. Post stent patients now are ( or should be treated) routinely with multiple drugs which are likely in the aggregate to decrease disease progression. Statins, ACE inhibitors, ASA , Plavix, beta blockers are widely used under the rubic of risk factor reduction for post surgical patients as well as post stent patients.
If drug eluting stents had not been developed and if medication regimens had not been developed and if things were frozen in time as of Dec 21,2000 we would have the answer, namely, do CABG for patients with two or more vessel disease. But medicine is not static and- to the degree that is true-outcome research is always history. Sometimes, by the time we figure out if what we are doing is any good, we are doing something else.

More Bad News for Crestor possible good news for Vytorin

A recent article in Circulation indicates that rosuvastatin leads the other statins in the adverse effect category. Although the absolute rate of AERs ( adverse effect reports) are low for all of the categories of side effects (muscle, liver, kidney) Crestor has the highest in each. Since Crestor lowers the LDL to a greater degree than the others, we would like to know the side effect rates for various doses of the drugs but that data are not provided.
This should be good news for Vytorin which seems to lower the LDL better than large doses of the statins and seems safe but we do not have a long track record to prove its safety. In addition, we don't know that lowering LDL with Vytorin works as well ( in the sense of decreasing coronary artery events) as large doses of the statins. It could be that one or more non-LDL lowering effects of larger doses of statins does good things to the vessel wall or something to decrease coronary events above and beyond the LDL effect.
With the current data available, even though the absolute risk from Crestor seems very small, personally, I would see almost no reason to use Crestor at this time ( perhaps in someone in whom nothing else works to adequately lower LDL).
If you can't hit the magic LDL target with Zocor or Lipitor or Pravachol you can always add Zetia or change to Vytorin if the patient was taking Zocor.
On June 9, 2004 The FDA issued an advisory and on 3/3/05 issued an alert calling attention to possible muscle damage and the need for lower doses in Asian patients but indicated they had no data indicating a higher risk than with the other statins. Stay tuned for what FDA will do now with the new data.

If IM residents are not learning to be hospitalists already, what are the 3 years about anyway?

A recent article in the AMA News-soon to be a publication to which only AMA members are privy-describes what some perceive to be a need for a " hospitalist track" in the IM residency training program. It was not that long ago when the most pressing weakness of IM programs was thought to be too much emphasis on hospitalized patients and not enough on out patient care. Enter the requirement for continuity clinics. Basically as medicine residents we learned how to take care of sick people in hospitals.This including working with surgeons, neurologists , psychiatrists, ob-gyn,orthopedists and urologists.CCU,ICU and surg.ICU were places in which we became comfortable.
The Society of Hospital Medicine suggested several areas that need to be " beefed up":
working with nurses,pharmacists and administrators, (how one could work in the hospital as a internist and not work those folks is unclear), learn about hospital systems and infrastructure, (OK I didn't have that training and I'll admit I don't know what that means), end of life care and care outside the hospital, palliative care and of course "quality" improvement..
I think sometimes you just have to comment on the emperor's clothes.Here's the thing" Internists are already trained as hospitalists"

SPN's, malpractice and Stephen Gould's essay " the Median is not the message"

Stephen Jay Gould's family is suing the Dana-Farber Cancer Insititute and Brighams and Womens Hospital for allegedly missing a solitary pulmonary nodule on a CXR which was apparently an ultimately fatal cancer.
Missing a SNP haunts radiologists and pulmonary docs.I have been abnormally sensitive to that issue ever since my oral exam in pulmonary disease (yes, at one time the pulmonary exam was oral and the internal medicine exam had both an oral and written component) The examiner had a stack of cxrs which he put on the view box one at a time and asked what I saw. The first 15 or so films or so were normal and the 16 th had a faint, poorly outlined SPN behind a rib on a underpenetrated film,which I missed.
Apparently, because my performance otherwise was so incredible, I passed anyway but I was scarred for life. Years later, ,a seasoned chest doc told me the best way to not miss the SNP was after you viewed the film in the usual way,to view it upsidedown.(This is easier if you invert the film, as opposed to standing on your head, although that might work as well).When you view a film this way small shadows that don't belong really do seem to jump out of the film to your visual consciousness. Anyway, it works for me.
Gould died in 2002 ,20 years after the diagnosis of an abdominal mesothelioma and according to news articles not from mesothelioma.When he learned of the diagnosis, he researched the prognosis, learned the median survival was said to be 8 months and wrote the well known essay "The Median Isn't the Message".It is worth reading. He talks about means and medians etc being the abstractions and that variation is the hard reality. He relates that his oncologist hesitated to give him a time frame from survival. I remember my very avuncular chief of pathology in medical school telling the class to be careful about telling someone how long they have to live , they may end up pissing on your grave. A recent article from the NCI gives imformation on current treatment and outcome of abdominal mesothelioma.

Thoughts on what does clinical experience bring to the table.

An interesting editorial appeared in ACP Journal CLub ( May/June 2005/volume 142 no. 3 p A-8) entitled " Does clinical experience make up for failure to keep up to date?" by GR Norman and KW Eva , both PhDs from McMaster University.(this publication requires a subscription).
They suggest the following thesis:Physicians in practice tend to not keep up but this seems to have little impact in patient outcomes.(Interestingly, they quote articles claiming that board certification and subspecialization both are associated with an absolute mortality difference (Norcini JJ, et al Med Educ 2002: 36;853-859)) As I have blogged about before,I am not convinced how prevalent the tendency is to not "keep up" or how valid the data is demonstrating that but the authors present some interesting ideas, at least some which is back up with some data and make several comments worthy of repeating.
They say experience makes docs make decisions rapidly. It is as if a vast medical storehouse of clinical cases is stored and a pattern-recognition process is triggered and a diagnosis is reached without conscious reflection. The authors also make the point that adherence to practice guidelines may be optimal-in some sense-at the population level but when an experienced physician considers a given cases, he may deliberately deviate from the guideline to more appropriately take care of the individual patient's needs.Less experienced docs tend more to adhere to the prescibed practice approach. So if we equate "quality" with adherence to guidelines are we really getting it right or is that just the easy way to claim we are evaluating physician's care?
It is probably too simple to say that young docs go by guidelines more and older docs have more experience based context into which to put things but there may be a trend in that direction.
Older docs can improve the degree to which they are current on guidelines-even if they decide if they are applicable or not on a case by case basis-but the only way young docs get the experience is to get to be old docs.

Retired Doc's suggestion for medical curriculum,part 10, Beware of misleading bias in drug trials

Dr. Richard Smith, a editor of BMJ for 25 years,discusses some of the ways that drug companies get the results they want published in main line journals. Kevin,MD also has a recent post referencing Dr. Smith's insights.
Writing in PLoS Medicine (Smith, R (2005) PLoS Med 2 (5) : e 138)"Medical Journals are an extension of the marketing arm of pharmaceutical companies.", he gives handy hints for methods that drug companies can use to get the results desired from clinical trials.For example, trial your drugs against too low a dose of the competitor drug or conduct a trial against a treatment known to be inferior, or use multiple end points in the trial and select for publication those that give favorable result. Note he is not talking about making up data or that the trials are not conducted in a technically well done manner, but rather that bias is introduced in subtle ways. He also describes the practice of publishing the positive results more than once and to combine the results from various centers in multiple combinations. There are a number of ways that physicians can be- and apparently have been-mislead about the virtues of various medications.
As medical students learn the catechism of evidence based medicine they need to learn to be critical of trials even in the best of journals.There is good reason to believe that not only have readers of journals been taken in at times but so have the editors.Smith says editors are beginning to catch on to at least some of the manipulative techniques that have been used and may take appropriate defensive action. He admits it took him over 20 years to realize what was happening.
Medical students are appropriately taught that RCTs are the highest standard of proof in the on going search for medical truth. However,at least some the RCTs on which some standards of care are built may have been spun by the drug companies to give favorable press to this or that particular medication and present some thing far less that the whole truth. He quotes data indicating that at least 2/3 of trials published in JAMA, the Annals of Internal Medicine,NEJM and Lancet were funded by the drug industry. So it could be that these practices could be rather wide spread. Smith's article should be mandatory reading in the EBM course. It might serve as a partial antidote to the over exuberant enthusiasm for EBM precepts that some impressionable students might develop. Look at the nature of the evidence.
So what can the overwhelmed medical student do? Right now, the best I can suggest is to use the table of techniques in Smith's article but realize this is not likely to be exhaustive. The EMB gurus from McMaster might add a section in the " How to find current best evidence" chapter in their book, " Evidence Based Medicine " by Sackett et al on" How to detect bias in a drug trial publications".
Smith suggests that journals not publish trials and the protocols and results be available on the web . This, he says, is radical and not likely to happen.But with the issue more on the table now, editors will be more savvy and skeptical as, hopefully, will be the readers.
Between Ghost writing, the manipulative arsenal of big pharma described by Smith, the alleged marketing and other corporate techniques related to the cox-2 drugs and the recent " it's safe, wait, no it's not" antics of the FDA ( which in part is allegedly related to the aforementioned manipulations) it should be no wonder that patients may have less faith in what the doctors are prescribing and so should the docs.

Shout Out to AAFP for stating the obvious about one pay for performance plan

Unlike the ACCP, the AAFP seems to be calling it like it is in regard to one recently imposed pay for performance program, namely the United Health Care initiative. St. John's Mercy Health Care in St.Louis calls the UHC plan " ill conceived and poorly planned". The local and state medical society also have criticized the plan. The most recent issue of the ACP's Internist Observer, on the other article has a rather lengthy, platitude-filled article describing how the ACP will lead the way in helping to craft programs that will reward physicians for quality care. If the ACP needed an object lesson in an insurance company talking about quality and acting about saving money, this major problem in Missouri might be it. The Observer went to press some time after the dispute in St. Louis was well under way so it seems it ignored it rather than overlooked it.Dr.Tony commented on the PFP issue recently pointing out saving money not generating quality is what it is all about.Also, hcrenewal called attention to the incredible annual compensation of the CEO of UHC's parent company (124.8 million counting options exercised).It looks like one can improve quality and make money or at least talk about improving quality.

New Criteria for Metabolic Syndrome

The IDF has published new criteria for the Metabolic Syndrome. Obesity as defined by waist circumference is required plus two more criteria out of a possible 4. The waist sizes are smaller than the NCEP criteria.For Europids ( a term I had not heard before) it is 94 cm for men and 80cm for women.Different criteria are used for South Asians and Chinese and different for Japanese as well. The BP and blood tests criteria are the same for all for all races, BP 130/85, HDl-40 for men, 50 for women, FBS 100, and TGs 150.

Retired Doc's opinion on "Big Pharma" at all time low and falling

The first medical memory I have of what- at the time- were known as "ethical drug companies" was actually part of the rites of passage from medical student to doctor. It was the doctor black bag that Lilly gave to graduating medical students .
For years,I considered the detail men who brought samples and doughnuts to the office as basically benign and took their brief promotional comments re their drugs superiority over competitors with healthy skepticism.
But now, once I read alleged details of Merck's action re the VIGOR study and its marketing of Vioxx, I cannot think of Merck and- by extrapolation and belief there may be no difference among large pharma entities-other large drug companies with any thing but suspicion and distrust.
The gist of the "Kaiser Health Report" linked above describes marketing techniques that seem, at best, misleading in turn leading physicians to prescribe Vioxx, which a number of doctors now wish they had never done. If this was merely one company misleading physicians and the public about side effects of a drug, that would be bad enough.But there appears to be more.
There is reason to believe that in some instances drug companies have manipulated study results so that when they are published ( in main line journals) the results do not represent all of the data in such a way that opposite conclusions may have been reached if more of the data set were presented to the journal. Case in point: The 2000 JAMA article regarding celecoxib (Pfizer's Celebrex) which published 6 month data showing a better side effect profile re: GI concerns than older NSAIDs while they withheld the 12 month data which painted a different picture.
You have to worry that this is a ice berg tip and how many of the drug industry- financed and designed RCTs if carefully analyzed ( with data even journal editors do not have access to) may not really demonstrate what the articles concluded. And it is the RCTs which are the gold standard of information feed into various consensus and guidelines writing committees.
A number of professional organizations have warned physicians about undue influence regarding free meals and trips etc. If the manipulative antics of two of the drug industry giants are any thing but two isolated aberrations, the influence we need to be concerned about is much more serious than a free dinner at a toney establishment. We need to worry about how much of the "evidence" in "evidence based medicine" is suspect and how many well intentioned, honest hardworking academic physicians may have been conned as well. A recent Health Care Renewal posting links to a detail filled Wall Street Journal article dealing in part with discrepancies between the data obtained and the data reported in a number of articles at least some of which were drug company designed and managed. There is also the issue of "ghost writing, which has been well blogged about, in which drug companies hire "medical information" companies to write articles promoting a given product or group of products and then enlisting academic docs to add a bit of prestige veneer to the publication.
I don't know when Lilly stopped giving out the black bags, but I don't think many med schools would favor resumption of the practice. About forty years ago when I began to carry around my black bag as an intern, the descriptor "ethical" attached to " drug company" would have seemed quite reasonable if anyone would have given it any thought, which we didn't. But now...By the way news articles still use that term.

Retired Doc's suggestion for Medical Curriculum,Part 9, The Nazi transformation for Healing to Killing,

Media coverage of the 60th anniversary of the end of world war II has focused on various events including the anniversary of the liberation of Auschwitz (Jan 27,1945). A few blogs ago I wrote about the transformation of a lay person into a physician. The anniversaries highlighted this year made me think of another transformation; the transforming of more than a few German physicians into mass murderers. Some teaching time needs to be spent to make medical students aware of the major role that doctors played in state sponsored killing of unbelievable magnitude and genocide. Robert Jay Lifton's " The Nazi Doctors-Medical Killing and the Psychology of Genocide" would be a good reference source.It available on Amazon.com
(also the AMA has teamed with the US Holocaust Memorial Museum to sponsor a series of lectures.)

Students will learn of the major role doctors played at Auschwitz and of the progression from the compulsory sterilization movement (to rid the German nation of inferior(Jewish) blood to the children's "euthanasia" program to the T4 program which focused on killing adult patients judged"not fit to live" providing the preliminary "learning curve" of perfecting the mass killing techniques later used in the camps. Lifton explains how the T4 program involved "virtually the entire German psychiatric community and the related portions of the general medical community" It was not just a few psychopaths.The processes became bureaucratized and participants could think of themselves as just "cogs" and maybe thereby lessen guilt.

It still seems inconceivable that there could have been this transformation of many physicians from healers to killers. Dr. Lifton discusses factors involved in the specificity of the Jewish genocide and provides material that might help illuminate broader questions of life and death and state control that are of enduring interest to physicians including the sacrifice of the individual to the state.The malignant racism and Anti-Semitism cannot be over emphasized but medical students need to know there were also large killing programs managed by physicians that murdered non-Jewish German children and adults who were labelled a burden to society.

The philosophical underpinnings of the "nazification of the medical profession" is discussed by Lifton. The influential manual of Rudolf Ramm proposed that physicians be the "Physicians to the Volk". The physician was to be concerned with the health of the Volk and was to overcome the old individualistic principle of the right to one's own body and the embrace the duty to be healthy and the physician duty was to the collectivity.The physician was the cultivator of the genes.National socialism was thought of as an "applied biology".Physicians were to be the technicians and engineers of the pseudoscience of race hygiene.

Some of the factors leading to the transformation from healing to killing emphazied by Lifton are:the acceptance of the notion that the state was the patient and not the individual human being,the belief or rationalization that the physician was just a cog in a machine and not to blame and that they were powerless to stop the evil because the orders came from someone else and ultimately the Fuhrer.
How all the medical ideals were betrayed and physicians became key players in unprecedented horror, murder and torture should be worth a few hours of instruction and discussion among medical students.

More thoughts on Older doctor bashing,

Dr. Philip R. Alper has a regular column in Internal Medicine World Report. In the April 2005 issue, he discussed the Annals of Internal Medicine article Entitled " The Relationship between Clinical Experience and Quality of Health Care" (Ann Intern Med 2005:142;260-273.) He was critical of the article and the trailing editorial as was Medical Metamusings in an earlier blog and was Dr.Roy Poses (hcrenewal.blogspot.com) in his excellent analysis of the Annals article in his blog. Basically, the article, a systematic review, concluded that older doctors provided lower quality of care.
The editorial in the Annals accepted the article at face value-even though as Poses, Medical Metamusings and Alper point out the study had serious methodological problems-and used the article to claim that "quality improvement interventions" were needed.The editorialists, at least some of whom are members of the American Board of Internal Medicine, used the article to bolster their campaign for recertification giving the perception that their friendly acceptance of the flawed article might be self-serving.,
I bring this issue up again though it has been well blogged already to be able to quote a great insight Dr. Alper wrote in his column.
"...most of guideline surveillance should be automated.It is the subtleties of diagnosis and treatment and the establishment of a therapeutic relationship with the patient that cannot so readily automated.Everything is important but the notion of placing global responsibility on the primary physician's shoulders make sense only to those who seek to be their superiors.

Dr. Alpers also says in regard to recertification and other control measures "The absence of proof that uniform central planning in medicine will achieve the goals desired by its proponents (and may even be counterproductive) adds to my discomfort"
Not only is there absence of proof there is much proof demonstrating how badly central planning in general works.But,at least for some of the people who advocate it it is not about proof it is about power and control.

Cost effectiveness of X, , how can a doctor possibly interpret what that means?

A typical cost-effectiveness article appears in the May 2, 2005 Annals of Internal Medicine. The summary states in part "alendronate ... is not cost effective."
When I was doing research on pulmonary function testing in diffuse lung disease, I could read an article , plow into the methods section and learn what technique of certain tests were done, what prediction equation was used, etc etc and could understand to a reasonable level of knowledge what it was all about.
Try that with the Annals article.
You will read that " We used a QALY value estimated with the EuroQul questionnaire and ...we derived the QALY value ...from direct prospective estimate of Kanis and colleagues" And " we constructed a Markow cost-utility model that contained 8 health states and compared 5 years of treatment with alendronate with no drug therapy..." and "We assumed relative risk for incident vertebral fractures of 0.54 and 0.82 for those with femoral neck T-scores of -2.0 t0 2.4 and -1.5 respectively..." And on and on the methods section goes through an elaborate mathematical exercise.
How could a hypothetical well informed general internist-the hypothetical ideal target of Annals articles- possible analyze what was done procedurally.How could she know if the assumptions are reasonable or biased towards some particular outcome?.How would he know if the Markow model was done correctly or more basically how valid is that approach or any of the particular details are in the first place?
You wonder who is the targeted audience of this type article. Is it an internist who would, armed with this latest research,inform his patient that they should not take X because it has been "shown to be" not cost effective. Is it aimed that a benefits manager who who would love some more quasi-justification to save money?
And even if you could understand- or give up and just accept- what they actually did, then you have to deal with the following statement."Assuming a social willingness to pay $ 50,000 per QALY gained...our results indicate that alendronate is not cost effective..."
I don't claim to be expert in Markow chain nuances but I do know that the authors or any one else cannot "determine" societal willingness " because that is not a thing you can determine.It is a meaningless abstraction.
Cost effectiveness articles should not be considered Evidence based medicine. They are calculations based on stacks of assumptions and typically end by concluding that something is or is not cost effective based on whether the indicator of interest is above or below an arbitrary dollar value that other authors have decided will be the threshold value.(The magic number,typically,is $50,000 per QALY,which is treated as a constant of nature rather than a contingent construct based on a stream of guesses) I ranted about this general topic few blogs ago but keep returning to it as articles appear and I see so little criticism of these pseudo-scientific papers.

Retired Doc's Suggestion for Medical Curriculum,Part 8,Meta-Analysis -know its limitations

The twin pillars of the epidemiologic-statistical foundations of the "best evidence " part of Evidence based Medicine (EBM) are the randomized controlled trial (RCT) and the quantitative systematic review AKA meta-analysis (MA).

In a earlier blog, I suggested that a major insight of the RCT is that everyone does not react the Same to a given treatment.
That is one of the basic facts of life in MAs as well since a systematic review typically reviews RCTs.

Two others are:

The conclusion of a MA is dependent on the published (or unpublished) studies included in the pooled analysis and the outcome statistic chosen.
Just as clinical advice needs to be linked to cases to give them limbic valence,these abstractions can be made meaningful with a real life case of different MAs reaching conclusions that would have very different implications for clinical medicine.
Two Danish researchers (Olsen and Gotsche-Cochrane data base Sys Rev. 2001;CD0018777) concluded that screening mammography was not effective.In the same time frame the USPSTF concluded the opposite:both groups based their conclusion on MAs.

Dr. Steven Goodman's explanation of that discrepancy should be part of handouts to medical students in their course on EBM. In an editorial in the Annals of Internal Medicine, sept 2002,volume 137 issue 5, pages 363-365 (He explains that a MA is basically an observational design wherein the subjects are published studies.Those studies that are considered but eliminated from the analysis can make a big difference.Why studies are kept or not rests on "competing claims" of methodologic validity.In this regard the average or for that matter super doctor is challenged to know which expert is correct.The Danish epidemiologists excluded more trials from their analysis than did USPSTF and reached a different conclusion.Another reason for the difference was that the US group used breast cancer mortality while the Danes chose all cause mortality as a summary statistic.

So ,the choice of studies to include and the summary statistic chosen determine the outcome. This example alone should convince medical students that meta-analysis are not infallible. There are context dependent.
I became aware of Goodman's Annals of Internal Medicine editorial in the blog "Medical Metamusings"and I later learned of two other publications that would be good additions to the study list given medical students to illustrate the limitations of MAs.

LeLorier et al from Montreal published an article in NEJM in 1997 in which they described discrepancies between MAs and subsequent large RCTS. An editorial by John Bailar followed, entitled "The Promise and Problems of Meta-Analysis"(NEJM-volume 337:559-561,aug 21,1997).

A major point made by Bailar and LeLorier is that while a well done MA can be helpful in presenting disparate studies on a common scale - using odds ratios- the problem may arise when all of the data is summarized into one odds ratio which is supposed to capture the entire issue but actually may oversimplify a complex issue and lead to erroneous conclusions. Simple answers to complex problems are welcomed but life is so messy they are often just wrong. Meta-analysis is not rocket science-its techniques and particulars are still being working out to some degree and reputable researchers may disagree over operational issues.There is still a lot to learn about the best way to do them.