Friday, April 29, 2005

Paradigms can turn on a dime,or maybe a data-dredge,Case in point digitalis

With in memory (ok, a long memory) we did not worry about should we give digitalis to heart failure patients, the only issue was how much of which preparation.Some of us even remember digitalis leaf being talked about.
The earlier-day paradigm envisioned the heart as a failing pump and drugs to increase contractility seemed to make sense and digitalis was considered an inotrope and it still is but is now thought to do more good as a renin inhibitor and to tone down over- exuberant sympathetic activity.
Decades of observed improvement from digoxin were in part validated by two clinical trials that gave enough data for the FDA to approve it as a treatment for CHF. But there were problems and the results were not nearly as conclusive as those demonstrating the value of ACE inhibitors. The ACE inhibitors did it all, decreased symptoms, increased exercise tolerance and improved survival. Digitalis did not increase survival in the large DIG trial but did decrease the need for hospitalizations.The RADIANCE trial interestingly showed that patients on digoxin worsened when it was discontinued.
The data seemed sound enough for the AHA/ACC 2001 guidelines to recommend its use,either early on while the ACE inhibitors were taking their time to work or later in the progression of disease when the patients had already been treated with diuretics, ACE inhibitors and beta blockers.And-after 200 years of use-the FDA had approved its use as a treatment for CHF.
Then in October 2002, a retrospective analysis of the DIG trial was published in NEJM. There was a 4.2 % increase in mortality in women in the DIG trial. The AHA/ACC guidelines had made no distinction based on gender, but the authors of the analysis suggested perhaps they should rethink that.
In the same issue a "Perspective" was offered pointing out that perhaps higher digitalis levels may have played a role in the findings as after one month of treatment they were higher in women.However, an adjustment was not made in their analysis for digitalis levels. The authors cautioned against abandoning a therapy that may help women in heart failure but that greater attention was needed in doses and monitoring.
I do not really know how much the digitalis paradigm was turned around by this one article; there are other arguments for using it sparingly if at all. But when a paper really turns around a practice or a mindset, I hope it will usually be something more substantive that a retrospective sub set analysis of data. Perhaps something like the Woman's Health Initiative which took HRT from a means of decreasing heart attack risk, maintaining bone density,healthy skin and urogenital structures to posing a risk of heart attack, stroke blood clots and breast cancer. On the other hand,just because sub set analysis is more vulnerable to biases it does mean that the conclusions based on it could not be correct. This seems to be still another instance in which we have large clinical trial-the DIG study (randomized,etc,etc)-and various analysis of the data, and we still are not sure what to do. Do you give digitalis to women with CHF or not?

Thursday, April 28, 2005

Retired Doc's suggestion for Medical Curriculum, Part 7-how to apply population data to individual patients

The basic message is "everyone does not react the same to a given treatment".
This should be obvious but in the frenzy of jumping on the Evidence Based Band wagon, it may have been forgotten or overlooked.
An excellent article that should be part of medical school teaching was published in a journal that no one would have ever read in the pre-internet era and even now probably languishes on the shelves of unread papers. ( I would not have found it had it not been mentioned in a December 2004 blog on Health Care Renewal).
The Journal is Milbank Quarterly and the article is " Evidence-based Medicine;Heterogeneity of treatment effects and the trouble with averages" by Kravitz,RL,Duan N, and Braslow J.
Here is a brief outline of the main points but the entire article is worth reading and should be handed out to medical students as part of their course in Statistics or EBM or something.
Heterogeneity of treatment effects (they abbreviate it as HTE) simply means
that the basic fact of life in a clinical trial is that everyone does not respond the same to the treatment.If , for example the average blood pressure decrease is x, there will be patients whose bp change is greater than that, less than that and in some patients some type of harm actually occurs.
The clinical problem is how to apply this population data to the individual patients.
The corresponding statistical problem is heterogeneity of treatments effects.
This variation in turn is due to the following three factors, acting alone or interacting with each other: 1) the degree to which an individual disease is likely to progress (i.e.the risk without treatment) 2) the responsiveness of the patients to treatment (this sounds a bit circular,but refers to how well does the drug favorably work in a given patient), 3) vulnerability to side effects.In the future to a greater degree than now we may be aware of various genetic polymorphisms that might explain some that variation and allow us to predict better who will respond to what.Additonally-in deciding should a particular treatment be recommended- there is the issue of utilities for different outcomes, meaning various patients value the same outcome differently.
All of this means you cannot expect the "average effect" to occur in the given patient you are treating. This is the basic clinical conundrum.
On the one hand the RCT may be the best information the doctor has since he lacks specific information on the patients' risk without treatment and susceptibility to positive or negative effects on treatment.
So what do you do? 1.Realize that the RCT is better guidance that just "winging it" completely, 2. As best you can try and determine to what degree your patient is like the average of the group treated and/or like or dissimilar from any subgroup that was analyzed in the study ( yes, we know subgroup analysis can be fallacious but..) and remember that your patient who is at greatest risk from the disease is likely to get the greatest net benefit from treatment. Also ask would your patient even been eligible for the trial and if not was the reason likely to be clinically important.It is a clinical judgment issue and for that there is no meta-algorithm.The physician's ability to predict how a given patient will respond to treatment X depends on our knowledge of those 3 factors.
So the student should remember that the often modest benefit that occurs on average in a RCT typically reflects a mixture of significant benefit for some, slight change for many and harm for some. There is a lot of clinical context and patient preference to factor in and blind adherence to guidelines - be it for pay-for performance or some sort of quality ranking-is not the way to go.
There are obvious implications for guideline makers and the pay- for- performance issues and even FDA approval for drugs,to all of which the authors address comments.

Wednesday, April 27, 2005

Medical Ghost Writing-you just don't know who to trust

The blog,( has featured several excellent pieces on the topic of the practice of drug companies planting articles in medical journals and recruiting academic medical authors to adorn the articles with a venere of scholarly credibility. What seems to be happening in this propaganda exercise is courageously outlined by Dr. Adriane Fugh-Berman in a comment in the Journal of General Internal Medicine. I had noticed that in some of the "throwaway" publications, an occasional article seemed to be a subtle or not so subtle ad for a particular medication or class of medication. It seems that even respected, main stream journals may not be immune to that type of manipulation.
The Health Care Renewal blog is one I recently discovered and recognize it as a great source of well researched information of health care issues. I have added it to my Bloglines feeds for daily reading. I hope that the author(s) of that blog add its feed to Medlogs listings so more medical bloggers can lock on to it.

Tuesday, April 26, 2005

"Cultural Competency" courses required for N.J. medical licensure

The April 24, 2005 issue of American Medical News reports that New Jersey has passed a law requiring "cultural competency training" to be licensed to practice medicine.Details of the training are yet to be determined by the State Board of Medical Examiners.Often the devil is in the details, but here we have enough devil by the proposal and passage of the law itself. The N.J. legislator who proposed the bill said it "was the first step in eliminating disparities in medical care among minority groups." It was not explained how doctors receiving lectures or handouts will accomplish that goal.From the reactions of medical school representative and the Medical society's president,we get a glimpse of a town-gown gap.The VP of NJ's med school said "the new law has the potential of actually working".I have no idea of what actually working might mean in this context. The president of the med society said, " You really don't teach people cultural competency in a classroom learn it in the lap of your grandmother".I found the content of a cultural competency program on the AMSA website to be very much like what is found in "diversity" training programs that virtually all large corporations have bought into.

Thursday, April 21, 2005

The "Transformation " of a lay person into a physician

Dr. Lawrence G.Smith, writing in the April 3, 2005 issue of the American Journal of Medicine speaks of this transformation. Professionalism has been written about extensively as it relates to doctors. Smith maintains the core of professionalism is the "personal transformation of self that takes place in stages during the early years of medical training and practice" When transformed the person now interacts with society in a new and different manner.
I have no doubt that happened to me. I can still remember comments made by teachers now over thirty years ago which were part of that process. I remember the attitude of respect and seriousness that was passed to me from the professors of gross anatomy as it related to behavior to the cadavers and behavior in the lab. I remember the pathology professor who told us that when we saw patients at night in the hospital how important it was for us to look and behave like physicians.I remember the chief of surgery who insisted that his residents wear shirts and ties in the hospital and clean coats and that his definition of a surgeon was a physician who knew how to operate.I remember how the clinical faculty typically treated the patients in the county hospital always with courtesy and respect, even though at time residents might have not.
In the first few months after I completed training I was doing a locum tenens and had the occasional to call the chief of medicine, with whom I had trained, to see a private patient at 3 am. She had end stage lupus and he had seen her several years before. He arrived soon after I called him at home. He was well shaven and well dressed in a suit. He spent over a hour with the patient and family, completed a page and half note and spent another 10 minutes with me.The family was greatly relieved that all that could be done was done. I was greatly relieved and felt that the chief had taught me another lesson;how a physician can do things the way that should be done in the real world.
These are just a few snap shots of the events and attitudes that lead to my transition from a college kid who really had no idea what to expect in med school or beyond to a person who felt he was trained to do serious, important work and that it all was a privilege and a great obligation and that doing the right thing for the patient was what it was all about. Much of what my high school friends had done while I was in training, I had missed and in the years of training much of transpired in the world I had also missed. And much of the everyday concerns of relatives seemed to be so much less important.I believe part of that transformation process is the isolation from the daily events of the world that seems required by the intense study and training lasting for years past the usual time an adult joins the work force. Part of that transformation occurs because most of your waking hours are spent with other physicians and professionals doing what doctors do and talking about things doctors talk about.Role models are everywhere.
As Dr. Smith said, once the transformation occurs you cannot think of being a physician as just a job.And it is difficult to think of yourself as any thing but a physician.
And because of that transformation it becomes very hard for a physician to retire or to be forced to leave practice because of illness. Are you transformed back into a lay person or are you still a physician who ...?

Retired Doc's suggestion for Medical Curriculum,Part 6

Cost-Benefit Analysis and cost effectiveness are frequent topics in medical articles.Students should have a basic understanding of what they are. They should also have exposure to a body of thought that argues that such procedures-as they apply to public policy decisions- are basically invalid and offer simplistic, pseudo-scientific solution to complex basically moral issues.
For a medical procedure the CBA would purport to aggregate the "costs", aggregate the benefits and if the benefits are greater than the cost, then a case for utilization of the procedure would be made.To choose between procedures one could then to a cost effectiveness analysis wherein the costed quality adjusted life years (QALY) would be "computed"for each and then either compared or -as is sometimes done-a procedure would be dismissed because the cost per QALY is greater than some arbitrary value is exceeded. To ascribe a numerical value to someone's "quality" of life, may be thought of as more of an act of hypertrophied hubris than scientific precision.
An excellent critique of the assumptions involved in CBA ( which also apply to QALY) can be found in a book by Robert Formaini entitled "The Myth of Scientific Public Policy" and is available at Amazon.Com.
CBA is based on Neoclassical economic theory and much of Formaini's effort is aimed at pointing out the fallacies of that approach.
CBAs etc are usually presented in medical journals as "scientific papers", physicians writing editorials often assume the role of policy consultants based on these analysis.
R. Gillion writing in the British Medical Journal ( BMJ 1994:309:184 (16 July) describes QALY and being tempting in its "Definitiveness and simplicity" and warns against being seduced by "systems that seek to convert these essentially moral choices into apparently scientific, numerical methods and formulas"
Medical authors often speak of a given treatment or medical program as " being ( or not being) cost effective as if that were an invariant property of a system whose value had been determined by scientific methods (" invariant"is meant here in the sense of a property that independent of the point of view-or choice of coordinates-) when actually its foundational validity is assumed to exist without evidence. A basic unit of "measurement" in these studies is "cost", but cost is really an income transfer and is a "cost" only when considered from a certain view point.
In the late 1970s and early 1980s, medical CBAs began to be published. Authors such as Alvin Feinstein and Wm Schwartz spoke out against what thought to be a simplistic, artificial and pseudo-scientific approach. (see an excellent article by Asch and Hershey in Annals of Internal
Medicine ( 1995: 122;846;) entitled " Why Some Health Policies Don't Make sense at the Bedside" Medical students should be aware that there is a point of view that maintains that these policies may not make sense at all.
The arguments of Feinstein and others seem to have been forgotten and the proponents
of CBA seemingly have won due largely to their persistence and perhaps from a conscious or unconscious preference for utilitarian statistical ethics by journal editors. Medical students need to think about these procedures critically before accepting the whole package deal as strong scientifically based "evidence based medicine"and pehaps when someone say that procedure x or treatment Y is not "cost effective" a question might be " what is the nature of the evidence?"

Sunday, April 17, 2005

AMA's American Medical News for a change has good news -HMOs are in trouble

The March 18, 2005 issue reports news from the annual National Managed Health Care Congress where speakers gave bad news to those who might think HMO's are the way to save money and improve quality of care. In that regard, one speaker talked about "broken promises". HMO members are down from 80.9 mllion in 2000 to 68.8 million in 2004 and the remaining HMOs are talking less about gatekeeping and more about open access. Richard Nixon in 1971 talked about HMOs as an alternative to the "illogical incentives" of the then status quo wherein he alleged that doctors and hospitals profited from illness not health and HMOs would reverse that incentive. The rhetoric was HMOs would profit from health, the reality has been they profit from not spending money on illness. The bad news from the meeting was the fact that Disease Management programs are still being sold as means of -guess what-saving money and improving quality and Pay for Performance is still on the front burner.

Wednesday, April 13, 2005

With the AMA's Pay for Performance principles and $ 4 you can get a grande Frappuccino at Starbucks

In my most recent post I mentioned the AMA's pay for performance (PFP) principles. They are reasonable, well thought out and have no relationship to what managed care companies will do.
If you are looking for principles to construct a program that would reward physicians for quality care (I know that begs the question of can you even measure quality), the AMA list would be a good place to begin. Such a program would actually cost more money. If you look at the incentives and constraints under which managed care operates, spending more money is not in their interest.
Can anyone recall a program initiated and supported by managed care that was designed to increase quality care by spending more money? Is there really anyone who is fooled by managed care's talk about pay for performance? Both the AMA and ACP talk about PFP but seem to mean something entirely different from what recently was imposed by United Healthcare. Do the folks at either doctor's organization really believe that their talking about PFP will have any impact on what the insurers do ?
I am reminded of Charlie Brown running still again to place kick the football with Lucy holding,this time-he thinks-she won't let go.

Tuesday, April 12, 2005

"Pay for Performance", now we know what they mean

This is the third blog I've written on this topic.The current issue (April 11, 2005) of the AMA Medical News reports on United Healthcare 's "Performance Program". They have implemented some type of measurement system which designated physicians as "performers".
If you are not so designated, according to the AMA News report, you are virtually delisted.Critics of the program,which is almost everyone,(included the AMA and several local medical societies) claim that the classification is based on cost- not quality. Many (actually most)of the physicians on the UHC plan don't meet the volume criteria to be ranked and if they not ranked they cannot be "performers".If you are not a performer,so defined,patients have to pay more to see you.
Doctors affiliated with the Barnes-Jewish Hospitals in St. Louis have threatened to drop UHC as only 18% of its 4,000 doctors were designated as performers.
This is exactly the type of semantic smoke and mirrows maneuver that one has come to expect from insurance plans.Pay for Performance was touted as rewarding physicians for quality work and what we get is some non transparent system which punish doctors based on cost issues and sugar coats the program with performance rhetoric.
An editorial in the same issue says in part "the physician community has the opportunity to help shape its (pay for performance) direction." Wouldn't it be nice to think so? The physicians who are part of the UHC plan had about as much opportunity to shape that plan as the UHC patients did, namely none and both groups will be the losers.
The AMA has proposed 5 principles for pay-for-performance programs.They are: ensure quality of care,foster the Dr-Patient relationship,offer voluntary participation,use accurate data and fair reporting (wherein docs are allowed to appeal results prior to the use of the results for programmatic reasons), and provide fair and equitable program incentives.Details of each element are found on the AMA website and they seem to bear no resemblance to what UHC has rolled out, surprising to only the very naive.(Remember the quality enhancement that resulted from the gate keeper initiative of the managed care companies)
After the fact the AMA and others complain about it.As the saying goes "The dogs bark but the caravan moves on".

Sunday, April 10, 2005

Does managing a given disease constitute a "Burden" on health-care systems?

It is almost mandatory in the introduction to medical articles that the author(s) point out that the disease at hand is common and important, often considered a "public health problem" and in the March 2005 Pulmonary perspectives (which is attached to the March issue of Chest) places a huge "burden" on ... health care systems." (this said in regard to caring for patients with lower respiratory infections)

The diseases at hand were the constellation of lower respiratory infections. Patients with pneumonia and acute exacerbation of COPD (AECB) are seen in ERs, some admitted to hospitals, treated by physicians, given antibiotics have lab tests and x-rays done, in short all of the usual things that happen when patients with various medical problems seek care. These are the things that happen in what is called " the health care system" which is not really even a system . Why is that a burden?

The dictionary give several definitions to "burden": something difficult to bear, a worry or a duty or responsiblity. Which does the author mean? Is managing AECB a worry for a pulmonolgist or is that just her job?.Certainly it is a responsibility. Filling out insurance forms may be characterized as a burden but treating patients with real diseases is what physicians do.Why do we not speak of changing oil as a burden on the car care industry?

Thursday, April 07, 2005

What has Justice got to do with it? Recent paper suggests little if any in clinical decisions

A recent Archive of Internal Medicine article ( " Physician's Responses to Resource Constraints , Hurst, SA et al. Arch Intern Med 2005;165:639-644) reports results of a survey inquiring about "resource constraints" in practice. In regard to what they describe as "resource allocation", reasoning about "justice" appears to play only a small role.( Only about 10% of responding physicians indicating it played a role in an allocation situation) This finding appeared to be a cause for concern to the authors as they describe this situation as a "gap" that could be bridged in fostering allocation of resources in difficult cases. I found the survey replies encouraging as typically in a resource allocation issue the answers revealed a strong concern for the patient's' welfare. Physicians in the real world,thank goodness, still seem to be more concerned with what it right for the individual patient,to whom they owe a fiduciary duty, than to some nebulous, poorly defined distributive justice, which seems to be mainly the concern of some academic bioethics departments. The constraints on resources typically is from HMO and other managed care entities' efforts to control costs. In that setting, pontificating about distributive justice, seems to be just a smokescreen.In this setting the unmodified term "justice" as typically discussed by certain bioethicists means "distributive justice" which by no means is the dominant secular view of what justice is-at least in this country.Medical Metamusings has a blog entry that I believe is worth reading and broaches the issue of "justice" as a medical ethical imperative.I would be very interested in a historical account of the origins of that concept's position in medical ethics becasue I can remember a time when it was not talked about.

ALLHAT Redux: Diuretics "best" for black and Nonblack patients but stay tuned

The data regarding blacks are analyzed in the April 6, 2005 issue of JAMA.The conclusion is that diuretics and CCBs are preferred to ACE inhibitors as initial single drug therapy.The authors in the editorial in the same issue state that -in regard to comparisons of diuretics with other classes of BP lowering drugs-"the issue has been settled". But, it is not settled. ALLHAt compared chlorthalidone, lisinopril and amlodipine but JNC VI and the current editorialists construe the finding broadly to the classes of drugs to which each of the comparison drugs belong.There are problems with that. Cholorthalidone is not widely used (HZCT is), there are several classes of CCBS, and are we really sure that all ACEs are created equal.
The ASCOT trial was recently halted and early reports indicate that the combination of an ACE inhibitor and a CCB was superior to a beta-blocker and a diuretic. When the data are published from this trial, the debate over which BP pills to use will start again, if it ever ended.
The debate should not end because there are scientific questions left to answer and ALLHAT is not the answer to everything for all time.The debate will not end because drug companies have much to gain from sales of ACE inhibitors and ARBs and likely other drugs as well in the future.
There are at least two interesting omissions from the JAMA editorial; 1) the issue of can-or should- the data be extrapolated to other members of the classes of drugs, 2) the issue of low versus high renin hypertension .
The consensus statement of a working group of the International Society on Hypertension in Blacks is -in my opinion-a more reasoned approach than is found in ALLHAT and the above editorial and is more in keeping with the overarching principle that our approaches are provisional, subject to change and are rarely annnoited with apodictic clarity.

Monday, April 04, 2005

Mandatory reading for authors of medical articles,med students and anyone who thinks Government will solve their problems

The following quote is so good ( it consititutes one of the all time major insights) that it definitely should be included somewhere in the medical student's reading list. It is the opening sentence of Chapter five, in Thomas Sowell's classic "Knowledge and Decisions" (Basic Books ,Inc.1980)
" The government as a decision maker is often regarded as simply the institutional personification of "society". But the diversities,conflicts and disparate incentives and constraints which make "society "a meaningless abstraction as a decision making unit also make government a fragmentary aggregation of decision makers." This is why "throwing the rascals out" won't work.(the replacments will likely become rascals as well as they face the same incentives and constraints). This is one of those insights with great explanatory power.
This statement came to mind, when I posted the comments about Medicare paying for glaucoma screening and the USPSTF concluding there was not evidence enough to recommend for or against screening.

Friday, April 01, 2005

Government and Medicine, re glaucoma screening and mixed messages

In November, 2004 The DHHS announced its preventive medicine initiative for Medicare patients.This included glaucoma screening. The USPSTF recently published its recommendations regarding glaucoma screening and - as seems usually the case for this organization-found there was insufficient evidence to recommend for or against such screening.
It seems Medicare offers screening and USPSTF says they don't know if you should or not.
Thomas Sowell has correctly described the government as a " fragmentary aggregation of decision makers" so we should not be surprised with this current example of the left-hand- right- hand consistency gap. And we should not be surprised with the USPSTF 's recommendations as it seems they rarely find the evidence adequate to conclude anything .Unfortunately, physicians in the real world of giving advice to patients often do not have that luxury.