Thursday, February 22, 2007

Family Practice may be joining Internal Medicine in identity crisis

This recent commentary in a family practice journal speaks of a major attitudinal change in family practice . Recently trained Family doctors seem to abandoning their "roots".According to the author the rigors, and risks of doing ob is something that only a shrinking number of FP docs choose to do. Other recently minted FP docs seem to be opting to doing fellowships in such areas as geriatrics, sports medicine, OB, and hospital and critical care seemingly abandoning their traditions of generalism just as some one us believe that internists may be abandoning their tradition of the care of complex and critically ill patients for the regular hours of an office practice,doing mainly primary care and punting to the hospitalists (who ironically now may as likely as not be a family practice doc) when someone gets sick.

The forces of increased medical school debt and decreasing payments for physicians-particularly those in primary care- seem to be at work in fostering the turmoil in both FP physicians and IM physicians. As IM and FP docs seem to be spending much of their time doing the same things the other does-at least in an office setting-there seem to be the same trend for both FP and IM docs as they end their residency to further specialize gaining higher pay,shorter hours and probably more prestige.

The author, Dr. James Glazer, argues for the value of maintaining the core values of the FP generalism which he believes is the heritage of the Family Practitioner. We are seeing internists morphing into primary care docs and the classical primary care doc-the family practice physician-morphing into a "generalist specialist".

As best I can tell, neurosurgeons at least, still know who they are .

Tuesday, February 20, 2007

Tight blood sugar control for ICU patients-stay tuned again

Randomized clinical trials work best for discrete outcomes in well defined groups of patients. In studies involving more complicated, heterogeneous groups of patients with multiple variables, results tend to be less clear cut as biases, confounding factors, the play of chance and the problems of squeezing subset analysis to make some sense of it all conspire to often make the conclusions less than satisfying or useful for real life clinical medicine.

A case in point is the recent prematurely stopped trial of tight glycemic control in ICU patients reported here. No advantage in terms of 28 day mortality rate or duration of stay in the ICU was seen in the tighter control group although other trials have suggested that mortality is lowered with stricter glucose control.Two studies from Belgium had been hailed by some as landmark studies ( at least the 2001 surgical ICU study was) and largely on the basis of the 2001 study both the ADA and the AACE issued recommendations regarding tighter control of blood sugar, the former organization targeting glucose values less than 180 and as close as possible to 110. A new standard of care emerged. Here is a thoughtful analysis of the 2001 NEJM paper and a partial review of other data tending to dampen enthusiasm for tight sugar control.

The 2006 medical ICU Belgium study, which I have commented on before, gave intensivists ( a group of physicians who treat very sick patients and used to be called internists) pause for concern in their enthusiasm to "treat to goal" (a recent mantra that makes me wonder what about the old saw about treat the patient not the numbers) as the data had to be tweaked to show a mortality advantage to the tight control group.(One analysis seemed to indicate increased mortality for the first 3 days and then a mortality advantage for the tighter group). There did seem to be less need for dialysis and there was earl er weaning from ventilators in the tight control arm of the study.

The recently reported study (European Glucontrol trial) found no mortality difference for the 536 patients treated to a blood glucose of 80-110 as compared to a group of 546 who glucose was maintained in the 140-180 range.One of the investigators, Dr. Presier from Belgium, is quoted as saying that there is no reason to recommend the use of 110 mg as a target and that 140 or 150 would be wise.

I think we have learned that elevated blood sugars should not be ignored in the critically ill patient but that we can go the way of "too much of a good thing" in attempting to impose a blood glucose of 80-110 particularly in light of recent evidence of lack of clear cut benefit and the very real increased risk of hypoglycemia about which I am just old-fashioned enough to believe it is not a good thing. In the Glucontrol trial of those with a serious hypoglycemic the mortality was 18% versus 11.6 % in those without such a reaction. For those of us still optimistic enough to believe a bigger better randomized trial will show the way, we can wait for the results of the Nice-Sugar trial.

Monday, February 19, 2007

Medical Knowledge Self Assesment Program (MKSAP) -one more time at least

MKSAP 14 has been available for over a year and I finally could resist it no longer and ordered a hard copy of it.I have enjoyed/suffered through all of the previous editions.Even though I am no longer in practice I felt compelled to spend the hours reading the texts and taking the tests-perhaps it gives me a bit of a illusion of still doing what I used to do.

One of the major additions in recent versions of MKSAP is a very large booklet entitled "General Internal Medicine". This section seems to me in part to be the manifestation of the doctrine "Why can't an internist be more like a family doctor?"

There are sections on contraception and abnormal uterine bleeding. When I trained and when I was in practice women who wanted advice about contraception and who had abnormal uterine bleeding were referred to their gynecologist.Very few of the women I saw as patients did not have a gynecologist.

Does the American College of Physicians (ACP) believe and encourage that internists should be adequately expert and trained to go through the vagaries of abnormal uterine bleeding complete with ordering ultrasound and doing a endometrial biopsy? Some of the questions seem to imply just that. Are IM residents trained in this now? At best we internists might be sort-of well read novices in this area and should we not as a matter of professional ethics refer our patients to the specialists who are best able and most expert? Some of the questions in this section seem to assume internists should be able to manage these maters.

I have recently encountered some younger internists who have carved a pseudo-niche in "women's health".These, in my limited experience are mainly female internists, who among other things do the annual paps and help their patients "manage menopause" and offer contraceptive advice. As I have commented on before this is not why I became an internist.Expanding the services I offer perhaps to compete with family doctors and NPs was not something I choose to do.

Internists seemingly are also expected to be able to diagnose and treat various skin disorders including the papulosquamous problems as well as lice and scabies. A section on corneal abrasions implies internists need fluorescein strips and Wood's lights in their office as the expectation is that not only will such patients be evaluated by the internist but treated and the internists will have the patients come back for follow up observation to see if a referral to an opthalmologist is needed.This sounds like the days of gate keeping when every referral needed approval by the insurance clerk.

In spite of the apparent theme that internists need/should/might do many of the things dermatologists and gynecologists do the, MKSAP is a great exercise in reviewing the ever increasing panorama that internal medicine has become. Plus it is probably the only time you will "see" or at least answer a question about a case that turns out to be Whipple's Disease.

Wednesday, February 14, 2007

The efficacy-effectiveness phenomenon stirkes again-this time with drug eluting stents

Our old friend,the efficacy-effectiveness phenomenon (EEP) can be found in the drug eluting stent (DES) controversy.The NEJM electronic issue hit the ether on 2/14/07 presenting 4 meta-analyses, two editorials and the well publicized Swedish registry study which alarmed cardiologists and patients. Subscribers also could listen to an audio segment in which Dr. Steve Nissen of Cleveland Clinic debated Dr. Donald Baim of Boston Scientific. Nissen recommended that a RCT be done to compare DES with bare metal stents while Dr. Baim announced that a trial was already underway to compare DES with coronary artery bypass surgery (CABG).The DES which seemed to have solved the problem of early stent restenosis stand accused of leading to late stent thrombosis and increased coronary events-trading short term gain for long term harm. Data and conflicting interpretations and opinions fly back and forth.

The term EEP refers to the often striking differences in outcomes that occur when an intervention shown to be very efficacious and safe in a RCT is applied to a broader group of patients as the intervention moves from the very controlled world of a trial to the more chaotic settings of real clinical practice.

Some of the difference is due to the fact that the intervention is now being used to treat patients who may vary in many important-and outcome determining-ways from the treatment group in the trial. A recent article in the Archive of Internal Medicine suggest that a more subtle mechanism may be at work as well.Results may also be less impressive when the intervention is applied to patients with the identical characteristics as the treatment group in the trial an effect speculated by the Archives article authors to be due at least in part to general greater care in their treatment and more uniform and consistent application of other generally accepted and recommended aspects of care. Further. there may well be differences in trial subjects related to the fact that they agree to be in a trial.

Safety issues are more likely to become evident in the observational data that accumulate as the intervention becomes widely used. RCTs are relatively small and generally recognized not to be the method of choice to determine if less common side effects occur. Observational data as they accumulate develop much more statistical power for short term effects and because observation can continue much longer the longer term outcomes become evident.So we clearly need to rely on observational data but the rub occurs in interpretation of the data. The groups that are compared in observational data are not randomized and while various statistical techniques are applied to try and compensate for the biases that plaque non-randomized comparisons there is a thick messy residue of doubt and controversy. The techniques seem an attempt to make observational data more like controlled trials which of course they aren't.

When DES were approved by the FDA the striking fact impacting the minds of interventional cardiologist was that the restenosis rate ( the main problem with bare stents) was about 20% and that seen in the DES trials for the coated stents was about 10%. Of course, cardiologists were anxious to apply that technology to their coronary artery patients and very quickly DES took over and by a year after approval about 80% of the percutaneous interventions involved use of DES. Not only were they applied to patients who were exactly like those in the trials ( basically short lesions and large arteries in a non acute setting) but also to patients with more complicated lesions and those in the middle of an acute coronary syndrome.

From a mechanistic point of view, it seems that the addition of drugs to the stents worked to prevent the over-exuberant growth of intimal cells onto the stents causing early restenosis ( in the six month time frame) but also may have overdone it in some patients leading to inadequate neointimal coverage of the DES and late thrombosis of the stent. Some cardiologists have suggested that the late thrombosis event coincided with stopping Plavix and have suggested continued use of Plavix for three or more years rather than the one year now commonly recommended.

The FDA's position seems to be that for the on label indications for DES, there appears to be no real issue with late thrombosis and that there is an increased risk of late thrombosis in patients with more complicated lesions and those with renal disease and diabetes. . How long to take anti-platelet drugs is an unsettled question as is the use of DES in patients whose coronary artery disease features do not confrom with the current on-label indications.

When a RCT is published and publicized and the results appear to be really great the best advice may be -as Bob Dylan said- "don't speak too soon, the wheel's still in spin"

addendum: 3/23/07.I have revised the next to last paragraph as somehow the original published version was garbled .

Tuesday, February 06, 2007

A patient as "a fellow creature in pain"

A reprint of a recent " A Piece of My Mind" section of JAMA should be handed out to all medical students. The title- "The importance of the Right Heart" by Dr. Lawrence J. Hergott. (reference-JAMA Feb.,7,2007 vol. 297, no 5 p 447)

He speaks about making judgments "beyond the medical judgment". Much is being written about the diseases that are "self inflicted " and the blame that physicians may place on those patients which may well be manifest as "an attitude that would be difficult to conceal from such people they treat."Obesity, diseases closely associated with cigarette use and excess alcohol and "unsafe" sex come to mind. We have all seen that attitude manifest as comments about patients who are obese or who abuse themselves with drugs and alcohol and I remember hearing and making those comments from the time I was a medical student and intern. Who has not tended to treat with " greater feeling" the blameless patients, perhaps a young mother ravaged by cancer than the street bum reeking of alcohol and dirt dumped in your hospital while you are on call.

Dr. Hergott's current essay is only available by subscription but an earlier JAMA submission is full text available here and is more than worth the reading time.Here he speaks of the difference between reputation and character.Another essay entitled "Playing the Moonlight Sonata from Memory" is found in a 2002 issue of JAMA and in it he writes eloquently about the anguish a physician experiences when a patient dies because of what the physician did and the extremely long half live that anguish possess. All of his essays would be valuable to medical students and all resonate with physicians who have been there and done that for a while.

Near the end of his current manuscript he quotes part of the Oath of Maimonides:

May I never see in the patients anything but a fellow creature in pain.

Not as someone who deserves his dyspnea because of cigarette use defying years of advice to quit, not as someone whose ascites is his just due from profligate use of alcohol, not as someone who should not be in this country at all, not as someone who would not be having the myocardial infarction at all if he had done what his doctors told him to do and not as someone who is taking "scarce medical resources" from someone who deserves them more or for whom the treatment could be more cost effective but as a fellow human whose is in need of what physicians spent so many years of their lives preparing themselves to be able to offer.

The oath should remind us that being face to face with a fellow human in need

..makes judgment beyond the biomedical not only unnecessary but inappropriate.