Tuesday, January 29, 2008

Word of the month(well the year so far) is Quackademics

Hats off to Dr. RW for his coining of the term quackademics. His relentless battles against the forces of altie medicine and quackery sliding into the halls and curriculum of medical school and in the mind sets of at least some members of the SAMA is appreciated. ORAC has been doggedly pursuing this issue for some time and keeps us up to date with his Academic Woo Aggregator which list the academic centers who have their fingers in the altie pie and there are more than one web sites devoted to the exposing of medical quackeries and woo. Alumni of a number of very well known and respected medical schools cannot be happy when they see their schools teaching reiki which may not be the most absurd thing ever but it is close.Orac gives some alarming information about where reiki can be found.

The phenomenon of the establishment of so-called alternative medicine into a number of medical schools itself is perplexing. How, why ? Dr RW offers some reasonable explanations for this with money leading the list. I've wondered about the role of political correctness and the influence of post-modernistic thought as has RW and a recent commenter to his blog about the state of affairs in some medical school down under. I hope things aren't as absurd there as the commenter relates.

The medical blog world has been percolating various thoughts about this issue for some time which is a good thing but as Dr RW points out a larger movement is needed if this absurd trend is to be reversed. The choir is convinced . A recent discussion on Medscape might have helped a bit and alerted more physicians to the issue and I think the ire of well healed alumni putting pressure on their alma matters might not hurt although I am not aware of much of that actually happening. However, the combination of money ( from patient services paid for in cash and the infusion of grant money) plus the effect of the rhetoric of political correctness and post modernism BS are formidable forces pushing things very much in the wrong direction. I fear that we are not that close to a tripping point to turn the tide. If any one has any ideas, let me know; we retired folks have time on our hands.

The ABIM's certification in Comprehensive Internal Medicine -too silly even for the ACP?

The American College of Physicians (ACP) apparently has problems with the latest proposal from the American Board of Internal Medicine (ABIM) which involves the concept of the Comprehensive Care Internist (CCIM). I have written about this before when details were few but now the plan has been revealed-although some particulars remain to be worked out.

Here is the executive summary of the proposal and from that the interested reader can access all the details. When I read the details I concluded that ABIM is proposing certification for a type practice that really doesn't exist which will involve assessment of various skills and roles for which they have no assessment tools. ACP addresses that fact in more polite understatement;

"The lack of valid and reliable assessment tools for CCIM competencies is a substantial limitation."

Yes, not having the tools to assess the competencies on which the certification is based would be a limitation -actually it would be impossible.

Internists who earn this new certificate would be referred to a "Comprehensive Care Internists". The standard dictionary definition of the word comprehensive is including all or everything.
Since the comprehensive care internist would be basically an physician doing office work and not taking care of sick patients in the hospital ( an activity once associated with internists) the designation "comprehensive" seems off base. I suggest the term Non-comprehensive Care Internist would be more appropriate. Although the "comprehensive" internist would not take care of sick patients in the hospital she would be certified as a "change agent" and a "team leader" -that is once they figure out how to assess those skills. I feel confident that if my very elderly but still very savvy and sharp aunt were asked what she wants in her physician what she would not say is that she wanted someone who was a change agent and a team leader.

In summary, then we have a proposal for a board certification for a comprehensive internist whose practice is really not comprehensive that envisions a type of practice that really does quite exist yet and for which the set of tools to carry out the assessment do not exist. Sounds like a plan.

Just when you thought we were through with Ketex

I have ranted about various aspects of the Ketex saga before-fatal liver side effects and bogus clinical trial data and a major thought leader enabled , pseudo-CME, hyped up, thinly disguised advertisement campaign for a medication which, in my humble opinion, served no rational purpose in a doc's antibiotic quiver.

Now a House Panel is busy looking into some of the "data integrity " problems that would appear to be mainly yesterday's news but now apparently the FDA is being accused of not supplying material for an House subcommittee investigation investigation. See here for some thoughts on how bad the integrity problem was and here for a WSJ blog article on the House activities in that regard.

Wednesday, January 23, 2008

How the world works-should be part of med school curriculum

I am quoting this paragraph from Health Care Renewal because it is such an excellent sketch of the outrageous situation that now exists with a certain type of medication marketing that holds itself out as CME. Read about how the players in this scenario are interrelated and how everyone benefits, well almost everyone, the docs who at best gets a little wink-wink-nudge-nudge- "CME credit" are mislead and we can guess what the results might be for the patients of the docs who are mislead.

... The standard formula calls for corporate sponsorship channeled through an “unrestricted educational grant” to a medical education communications company (MECC). The MECC employs writers to prepare the “educational content,” and academic KOLs are recruited to deliver this content. The KOLs are chosen for their willingness to be “on message” for the corporate sponsor. If they go “off message” they know they will not be invited back. The talk of “unrestricted grants” is window dressing. The MECC also secures the imprimatur of a nationally accredited CME sponsor, typically an academic institution. The sponsor is paid to certify that the CME program meets the standards of the Accreditation Council on Continuing Medical Education (ACCME). Everybody turns a buck: the MECC and its staff are handsomely paid (CME is now a multi-billion dollar business); the KOLs are generously rewarded with honoraria and perquisites; the academic sponsor is well paid by the MECC; the ACCME receives dues from the academic sponsor; the audience obtains free CME credits rather than having to pay for these required educational experiences; and the corporate sponsor gets what it considers value for its marketing dollar.

I have been invited to a number of these events and with the lure of a good meal and nothing else to do I have attended more than one. There was a time when I was not aware of what the above description depicts but now I know how to follow the money.

I have written before about how the tools and verbiage of evidence based medicine can be misused (Note I am not degrading the value of honest proper application of EBM principles or the principles themselves) and the above scenario has to be about as bad as that gets .

Bernard Carroll's paragraph quoted from HCR should be part of the basic curriculum of every medical school, every nursing school, every PA school , and every residency program.

With this concise but detailed description of the anatomy of what passes for CME in mind, one would expect growing support for the Macy Foundation report which calls for the abolition of commercial interest sponsored CME but also we can expect resistance from the well funded interested parties and some of the recipients of those funds.

We find a interesting turn described in this blog posting by Dr. Carlat who knows a little about some of the aspects of commercial interested sponsored CME. He describes a meeting he attended at Harvard and the comments made there by Dr. Martin Samuels. Anyone who has heard a lecture by Dr. Samuels will be very favorably impressed and since I have heard several( and remember much of what he said) I have to take what he says seriously.

Martin Samuels describes the Macy Report as a "house of cards" made less credible by the self interest of some of the participants. He asserts that Denise Basow who was one of the organizing committee members of the Macy Report is a principal in the online medical education endeavor known at UpToDate and that the report's recommendations fit nicely with the commercial interests of UpToDate. Let me make it clear- I am not critical of the educational value or usefulness of the UpToDate product.Everything I have heard about it indicates it is a good product.

Samuels also defends one particular MECC with which he is involved, Pri-Med. I have heard his talks on dizziness and the heart and brain interrelationships at Pri-Med meetings and in those there was no promoting of any particular product and as with all of his talks they were brilliant. Maybe Pri-Med is different from the usual MECC but I have attended 3 Primed conferences ( I plan no others) and in my opinion, some of the other talks were very little disguised drug advertisements while others appeared as valid education sessions with drug promotion either absent or so subtle I missed it. I like to think I can tell one type from the other but... It should be noted Samuels did not defend MECCs in general and also called for the abolition of the quite popular satellite educational sessions that latch onto national medical meetings.

As usual things get hard to sort out but to my thinking it is clear that much of the industry sponsored medical education is nothing more than product promotion given a veneer of respectability by their affiliation with medical school KOLs and the schools themselves and the CME certification organization known as ACCME,whose credibility also is at risk.

Tuesday, January 22, 2008

Now allegations of conflict of interest in advocates of CT scanning for lung cancer

Probably every lung doc in his career has seen a patient who has been apparently cured ( at least has gone over five years without evidence of disease) after a lung cancer was incidentally detected and then resected . The typical scenario was that an incidental chest xray demonstrated a solitary pulmonary nodule (SNP). ( A single nodule less than 3 cm in diameter) With the prognosis of lung cancer detected at a symptomatic stage so dismal it is understandable that we would yearn for some method of early detection.There is no general agreement that such a method has been found and some wonder if it is even possible.

The clinical trials that examined results of screening with annual chest x-rays have not clearly shown benefit and arguably suggested harm. This has resulted in most groups not recommending periodic chest film screening even in smokers.

Lung CTs are the latest candidate for a early detector of lung cancer and that technique has not been warmly received even though pulmonary physicians certainly would welcome something to make the prognosis of detected lung cancer much better as progress in that area is not one of the cancer cure success stories of modern medicine.

A number of articles have been published in which the authors concluded that CTs are very helpful and have recommended their application. Now in the WSJ health blog we are given some details of what seems like fairly big red flag involving conflicts of interests and failure to disclose those potential conflicts in some of these researchers who have written and spoken widely advocating CT screening.

One of the major "pro-screening" articles was published in the NEJM and I have commented about that before as well as delving into the issue of "how do we decide if screening really works ?" I think much of that answer depends on if you think survival rates ( e.g five year survival rates) or cause specific mortality for a specific cancer (I am note sure if we can ask that about cancers in general as I believe it depends on the natural history of the cancer) should be the statistical arbiter. Most people who write about this favor cause specific mortality and that is the conventional wisdom but there is at least one articulate advocate of the other view mentioned in my above self reference. Which view I take seems to depend on whose article I have read most recently.

The contrarian in this regard is Dr. Gay M. Strauss from Dana-Farber Cancer Institute.He presents his case in Chest 1997:112 216 s-228s ) "Measuring Effectiveness in Lung cancer Screening." I think a subscription is required. Anyone interested in this issue will find his argument either interesting but flawed or convincing and spot on or will be unable to decide which assessment is correct.

His argument suggesting that RCTs may not be the final answer regarding the efficacy of screening for various cancers does not convince me because I really don't understand it. Whose fault is that? He asserts that small absolute differences in disease risk between screened and control group often persist after randomization and translate in large proportional difference in the size of sub groups at risk for disease specific mortality and may give misleading results when a randomized clinical trial (RCT) is applied in the preventive medicine arena. He is not arguing against the value of RCTs in other contexts.

One of his other arguments resonates with me to a much greater degree. One anti-screening argument is that survival rates look favorable for screening while mortality rates do not is explained by the detection of large numbers of indolent lung cancers which really did not need to be treated. This argument is commonly made in regard to prostate cancer. Strauss argues that this is not valid as regards lung cancer. Now if this "lead time bias" is at work here, he continues,therapy would irrelevant to outcome. So let us look at the outcome of those stage 1,non-small cell cancer patients who were screened but did not undergo surgical resection .What is their outlook. Five year survival was 5%- rather low survival for supposed indolent cancers. This is far less than the what we see with resected lung cancers that present clinically as SNPs.

Prostate cancer is not rare in autopsy series-some have shown over 50% prevalence of latent prostate cancer so the concept of indolent or very slow growing prostate cancer is very reasonable while "surprise" lung cancer at autopsy , according to Strauss, has a prevalence of 0.8%. Again if we are detecting this not clinically important entity by CTs , why do we not see large numbers of lung cancers at autopsy? ( It should be noted that at least one autopsy series showed a much higher number of previously undetected lung cancers.)

So who is right? I don't have the answer but I believe that there is more to it than simply closing the debate by shouting firmly " Lead time bias ".

Now entering the discourse is the accusation of possible conflict of interest in some of those who are recommending lung CT screening.In a world where decisions were made with the pure logic of a Mr. Spock the possibility that someone taking a particular position possibly gaining from acceptance of that position should not be determinative in the debate about the truth of that argument, but in the non Spock world thorough we pass people who have no Vulcan genes definitely take into account the "credibility of the witnesses". ( In some settings Spock would consider that also).

As pointed out by Dr. Howard Brody, conflict of interest is not localized to Big Pharma and

"Nothing like knocking public trust in academic medicine and medical research down a few more notches."

Friday, January 18, 2008

Is it too soon to say we were off base on the heart attack cholesterol deal?

Several thoughtful bloggers, on the heels of the Enhance trial, have raised the question and given their views of the issue of "should the cholesterol -coronary artery disease hypothesis be re-visited and perhaps revised." Dr. DB correctly, in my view, suggests that we may have been too literal and dogmatic about the LDL "targets" and Dr. Howard Brody is a bit more sweeping in his foray into revisionism but both make good points.

It is certainty possible that the well proven reduction in CAD incidence may be due at least in part to an effect or effects of the statins apart from their ability to lower the LDL cholesterol. The Enhance trial failed to show that a more marked LDL cholesterol lowering brought about a greater reduction in blood vessel wall thickness and in a study not powered to show it did not show any changes in the attack rate of CAD in its various clinical presentations. So, I would characterize this as a failure to demonstrate that greater lowering of LDL was associated with a beneficial change in a CAD surrogate and really nothing more.

If memory serves lowering the LDL with niacin and by certain types of bariatric surgery have also been associated with lowering of the incidence of coronary artery diseases indicating that the correlation of lowering LDL and decreased heart attacks is not unique to the statins.

Could the maxim that the decrease in CD is proportional to decrement in LDL be a oversimplification? Of course, the magical linearity of CAD and LDL level with the claim that a x change in LDL brings about y change in CAD always did seem a little to pat to really tell the whole story.

But again I have to bring up that Enhance dealt with a surrogate marker whose ultimately relationship to what we probably really care about ( number of heart attacks etc) is not known and we continue to learn how reliance on surrogates can get us in trouble.

Now, both the American College of Cardiology and The American Heart Association have advised us all to just sit there and not do anything which probably makes sense. Even so, the speed with which they presumed to advise us all not only struck me as at least interesting and stimulated Dr. Roy Poses to point out some interesting things about those advisories and the folks responsible for them. In this regard and in numerous others he has done a yeoman's job of educating his readers about the "pervasive web of conflicts" that involve so many physicians many of whom are labeled as thought leaders and various types of medical organizations that many of us have generally relied upon to give good sound, unbiased advice and recommendations.

Steve Lucas, in a comment to DR DB's posting on the Enhance trial, makes a very quotable comment - namely that this is another instance of marketing overtaking science.

And it is not only the medical bloggers that are contemplating what we may really maybe doing with statins for almost everyone, Business Week has a lengthy article on statins as well, raising the question of oversell- replete with NNT numbers.

Thursday, January 17, 2008

"The silent evidence"-unpublished "negative trials"

Here is a recent WSJ article in which we read about drug trials ( in this instance antidepressants) that do not see the published light of day. WSJ is quoting from a NEJM article a summary of which can be found here.

This is another example of how the solid and valid methods of EBM ( evidence based medicine) can be corrupted and misused to serve a particular end-in this case one that can be discerned by application of the old Mafia rule-follow the money. A number of RCTs are done,which can be done absolutely correctly, but only those trials that support superiority over placebo of the a given drug are submitted for publication. Then, in support of the given drug only the published trials are mentioned.

Note: This is not an indictment of proper application of EBM methods and principles and not an indictment against EBM in general but an indictment against lying and cheating. I only mention the obvious because of what I hope to be a misunderstanding of what I have said from time to time. I have been accused of a paranoid,off the deep end attack against the principles of EBM itself. This was never my intent. Back to the main point-

The lead sentence in the NEJM article nails it- if in a bit understated fashion:

Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased.

Publication bias is nothing new but perhaps with the impact factor of the NEJM more folks will become aware of the issue and carry a bit more skepticism with them as they attempt to evaluate the efficacy of various medications. Obviously, it is difficult ( more understatement) to evaluate evidence that is unpublished.

The term silent evidence comes from a book I am currently enjoying, entitled "Fooled by Randomness" by a former securities trader named Nassim Taleb. which I have mentioned before. More details and commentary regarding the silent evidence regarding antidepressant trials can be found here at the ever alert blog,Clinical Psychology and Psychiatry:A closer look.

Wednesday, January 16, 2008

The Enhance trial,ACC quick action to allay "panic" and Wittgenstein's Ruler

In the wonderful age of the recursive, self amplifying, instant news Internet few people have yet to comment on the Enhance trial which failed to show enhanced reduction in vessel wall thickness by the addition of Zetia to simvastatin in patients with heterozygous hypercholestrolemia.

The media shy Steven Nissen tells us what the study "showed". "The study showed it matters how you lower cholesterol -not just how much you lower cholesterol." As indicated below I am not sure what it showed.

In record time, the American College of Cardiology (ACC) has issued reassurance that we should not panic. Since apparently no one was harmed in the trial,it is not clear to me who would panic anyway except the drug company that makes Vytorin. See here for the ACC summary of the trial and here for the ACC 's comments on the trial and the non-panic advisory.

This was a trial that looked at a surrogate maker-what the bottom line is regarding the drugs that lower cholesterol is the reduction of heart attacks or cardiac events. Enhance looked at vessel wall thickness and there was no shrinkage in the Vytorin group over that seen in the simavastatin alone group. Since we have been warned to not take trials that look at surrogate markers too seriously we should not maybe take any of this too seriously. Had a marked advantage accrued to the Vytorin group we would have been appropriately warned by whomever to not go wild and prescribe Vyotrin to everyone we see on the basis of a surrogate marker trial. Similarly with a negative trial we perhaps should restrain ourselves from calling all the patients on Vytorin and urging them to stop the pills.

All of which gets us to Wittgensteine's ruler.

Unless you have confidence in the ruler's reliability, if you use a ruler to measure a table you may also be using the table to measure the ruler."

Note: I cannot find that Wittgenstein actually said that.I am quoting from a delightful book by Nassim N. Taleb, entitled "Fooled by Randomness" onto whose trail I was put by the blog Healthcare Epistemocrat.

Monday, January 14, 2008

AMA President delcares war on "disease of social injustice"

The comments published by Dr. Ronald M. Davis, President of AMA, published in the AMA News were not the reason I opted not to continue my membership in AMA but they did reinforce my decision.

In a commentary (Jan 21,2007) he outlined the actions the AMA has taken regarding the "disease of social injustice". Dr. Davis is a specialist in preventive medicine. A review of the bio published by the AMA indicates he has spent his entire medical career in preventive medicine and I could find no reference to any clinical practice. ( I do not rule out there was some,but if, so it was not mentioned in the biography).

The preventive medicine vision is one in which it seems reasonable to support and believe in the concept of social justice where in one is concerned about equality of outcome as opposed to the quality of opportunity.There are endless opportunities to monitor for various inequalities and offer mitigating proposals. Job security written in capital letters. One expects to hear comments such as those by Dr. Davis in the publications of various public health organizations, in some of which Dr. Davis has been active. From the preventive medicine world we are used to hearing various issues characterized as disease. These strained metaphors of "disease-ifying" have including the diseases of spousal abuse, child abuse and illiteracy to name a few.

I believe the membership of the AMA to mainly consist of practicing clinical doctors rather than preventive medicine specialists.I am unsure what the role of a preventive medicine specialist is in leading such an organization or how appropriate is such a background to lead a group largely composed of physicians who actually practice medicine.

Dr. Davis outlines some of the AMA's accomplishments in this battle against social injustice including arranging seminars on the topic and urging the restriction of sodium in food products.

One of the most striking inequalities that practicing internists and family physicians might notice is that authored, encouraged and abetted by the AMA's RBRVS Committee (RVC) namely the delta between the CMS's compensation for the procedurists and the non-procedurists. An excellent review of that issue can be found here. I believe this to be a major factor in the worsening crisis in primary care.

Dr. Davis might do well to realize that as more and more docs opt out of primary care it will not be the more affluent population who suffers the most-although they ultimately will suffer too- and that the AMA has played a major role in that demise of primary care, seminars about inequality and campaigns to decrease dietary salt intake notwithstanding. I have made my views of the social justice issue clear before.Now I am suggesting that if Dr. Davis is concerned with improving health care for all -not just certain pre-defined demographic categories-he should focus some effort on correcting a major part of the problem caused by the AMA. If the ship sinks there should be little satisfaction in noticing the ultimate equality evident in that everyone is deprived a a life preserver.

Tight blood sugar control in the critically ill-maybe not too tight

What the New England Journal can give it can take back.

In 2001 the Journal published what can be called the first Van den Berghe study in which it was demonstrated that in critically ill surgical patients intensive insulin therapy had a beneficial effect. It was a large trial and the results seemed impressive and from the data the authors presented they recommended that blood glucose be targeted to be less than 110 in critically ill patient in the surgical intensive care unit. We love to extrapolate- maybe it would be just as good for medical ICU patients. So another trial was launched.

The second Van den Berghe paper appeared in 2006 and investigated blood glucose control in medical ICU patients with different and somewhat puzzling results. Different in that the over all morality benefit to the tight control group did not occur and puzzling in that a subset ( those with ICU stays greater than 3 days) showed benefit while the complementary subgroup ( those
with stays less than 3 days) showed detriment. This lead some observers to recommend a middle ground namely treat to a a blood glucose of less than 150 for first few days and then go for more intense control ( 110) after that.

Maybe this is reasonable but I am always suspicious of subgroup analysis as some strange findings can appear and the more subgroups you look at the greater the likelihood of a false positive result misleading you. ( My favorite subgroup analysis story can be found here in the discussion of how the benefits found in the landmark thrombolysis trial (ISIS-2) trial did not apply to those patients unlucky enough to have been born under the sign of Gemini or Libra). We are not told about the astrological signs of the participants in the Van den Berghe study.

It has been pointed out that the benefits effects of intensive insulin therapy on postoperative survival was mainly seen in post-op surgical patients who were given rather large glucose loads on admission to the surgical ICU and it makes sense they needed more insulin to mitigate the potential harm of overzealous sugar loading.

In still another NEJM article on intensive insulin therapy in the critically ill published in the Jan 10,2007 issue we are told that the use of "intensive insulin therapy place critically ill patients with sepsis at increased risk for serious adverse effects related to hypoglycemia " and that there was no difference in mortality at 28 days. The authors of this article conclude that when one takes into account both of the Van den Berghe articles and their publication that

" intensive insulin therapy has no measurable,consistent benefit in critically ill patients in a medical ICU, regardless of whether the patients have severe sepsis..."

In what could be characterized as a effectiveness study using historical controls ( i.e. not a randomized trial) treating to a blood glucose of less than 140 it was demonstrated that that regimen seemed doable and was associated to a number of measurable benefits. Comparing results then and now is tricky business as many variables change over time and how well they can be controlled for is really never known.

DR RW gives a nice review of the glucose issue here.

The 2004 Surviving sepsis Guidelines suggest a blood glucose target of less than 150
using an infusion of glucose and insulin. The 140 to 150 range seems a reasonable and reasonably safe approach-pushing to the arbitrary 110 may well cause hypoglycemia episodes and do more harm than good.

Friday, January 11, 2008

Corticosteroids in septic shock-the wheel keeps turning

I remember forty years ago as a house office that we used steroids in patients with septic shock. We also used antibiotics,fluids and vasopressors. There were no large randomized clinical trials (RCT) whose results formed the basis of our treatment plans. The age of evidence based medicine (EBM) had not yet arrived.

Since then we have had RCTs that demonstrated the benefit of high dose steroids followed by larger trials that showed no benefit. Was that the end of steroid use ?No it was not. The stage shifted to the use of low dose or so-called physiological dose steroids.It seemed we were giving too much and perhaps we were not selective enough . Enter the phase of testing for adrenal function in spesis patients.

A trial by Annane et al published in JAMA in 2002 used a corticotrophin stimulation test to divide sepsis patient into those who responded with a cortisol increase to some decided upon cut off and those who did not. The latter group appeared to benefit from corticosteroid treatment.This was not the only trial suggesting the value of low dose steroid and testing for adrenal function,there were several others but the Annane number may have determined the meta-analysis outcome.

RCTS work best in studying treatment effects in a relatively homogeneous,relatively clinically stable conditions where there are not be-deviling co morbidities and a rapidly changing clinical picture in which the timing of various intervention may be determinative. In sepsis small clinical trials and reliance on adding up those trials which may vary in critical ways and calling it a meta-analysis may well lead to recommendations that are faulty because of all the reasons we learn in epidemiology 101 that cause clinical studies to be misleading.

RCTs are often small and fail to capture the perplexing diversity of relevant variables (known and unknown) that lurk in complex, hospitalized patients. It is the sickest patients that simplistic rules formulated by committees harm the most and in whom the pathophysiological diversity is likely to overwhelm premature generalizations and an overly eager rush to mandate treatment rules.

Now the evidence wheel is turning back over to the " no significant difference" marking regarding the use of low dose steroids. This "negative study" appears in the Jan 10,2008 issue of the New England Journal of Medicine. This study, the Corticus study, gives results markedly different from the Annane trial. See here for a discussion of the trial. A brief review of the discussion section informs us that there were major differences in the two trials.These included difference in entry requirements, duration of therapy and a major difference in the survival rate in the placebo group to name a few of those factors discussed in the article. As if that were not enough to muddy the waters the authors tell us about the "lack of adequate power" and say further:

On the basis of the current data,however, the likelihood of seeing any differences in outcomes between the two study group was unlikely.

(Apparently the trial was stopped because they ran out of money and they are telling us they did not round up enough patients to show a difference if one really existed. Is there something wrong here?

So we are told the Corticus trial was quite different from the Annane trial in a number of possibly important procedural matters and it was too underpowered to show a difference.
The authors are not deterred from making a recommendation anyway-at least in sort of a negative way. They say that "hydrocortisone cannot be recommended as a general adjuvant therapy for septic shock nor can corticotrophin testing be recommended." However, they admit hydrocortisone may have role if given early to patients in whom the administration of high dose pressors does not raise the blood pressure. Isn't evidence based medicine great? I think that is what we did forty years.

Another important point was mentioned in the companion editorial by Dr. Simon Finfer. Apparently one of the problems in recruiting patients for the trial was the fact that earlier guidelines had already enshrined the used of steroids in septic shock. Finfer said:

...apparently authoritative guidelines may make the conduct of important confirmatory trials more difficult.

So it looks like small clinical trials may give apparent positive results that then may get incorporated into guidelines whose controlling effect on clinical practice may inhibit or even foreclose on larger trials that might correct the earlier faulty false positive trials.

Monday, January 07, 2008

Retainer Medicine,Social Justice and the importance of framing the debate

In the not too distant past, but well before the current generation of medical students and house officers were born, a person might go to a physician with some medical problem and be charged for the medical services and then pay for the service either out of pocket or out of pocket and then file with an insurer to get or all some of that reimbursed. It was a private transaction between two persons in a country in which private transaction between individuals was so normal as to not attract any attention. The ethics or justice of such a transaction was simply not a topic for discourse.

In the not too distant past, the ethics of the medical profession was generally well defined and could be expressed in a few simple sentences and seemed to be firmly imprinted in the physician's mind as part of the transition process from a lay person to a physician.
Respect for autonomy, beneficence, and non-maleficence. It was all about the physician and the patient-do no harm, act in the patient's best interest and respect the patient's views and wishes . It was a two party deal.

The AMA 2001 published version of the ethical principles is a bit more detailed but contained little to be contentious about and does not contain the word "justice". More on that latter.

Later, a fourth major principle was grafted on the the ethical framework-justice. In the beginning there could have been a bit of ambiguity as there are many definitions of justice. But it became quite clear what was mean by justice with the publication of the Medical Professionalism in the New Millennium.A Physician Charter.( Annals of Internal Medicine 5 Feb. 2002, vol 136 pg 243-246.

The justice of which they spoke was social justice. Thomas Sowell makes the distinction between the traditional American society's version of justice and social justice in this way. On the one hand, we have justice as basically applying the same rules and standards to everyone -equality of opportunity or equality under the law. On the other hand, we have the redressing of those inequalities that proponents characterize as the fault of society-equality of outcome. In the latter, whatever characteristics at issue are thought to be unequally "distributed" between various groups (income,medical care,access to swimming pools) should be "redistributed". Whatever may have been distributed by acts of God, accidents of history, an uncaring society , or whatever, to achieve social justice someone or something needs to correct the mal-distribution. When redistribution is needed, force or the threat of it is required.

Making everything right would appear to be quite a task to assign to busy, working in the trenches docs, so one should not be surprised by the results of a survey,that I talk about here, that indicated that concern for social justice does not take up a large amount of a physician's times or enter heavily into his daily clinical decisions and activities.

Not only it is quite a task, proponents of new professionalism tell us in August 2007 JAMA article that after "further reading" of the tenets of the new professionalism that physicians alone cannot do it. So who should do it? We are told it should be a medical societal alliance. My translation is that again we told medicine is far too important to be left to the individual patient and the individual physician and we need more powerful players, probably the government,likely big insurance and well connected medical academic intellectuals, such as those who write such articles to mobilize things and makes the inequities right.

Thomas Sowell writes about a "moralistic approach to public policy" in the concluding section of his book, "Knowledge and Decisions". I characterize the authors of the New Medical Professionalism with their insistence of physician's allegiance to social justice - in a society where there is no dominant secular view of justice at all-as medical moralists.

In Sowell's section entitled "Embattled Freedom" we read ...The desire for freedom and its opposite,power, are as universal as any human attributes....The moralistic approach to public policy is not merely a political advantage for those seeking concentration of power. Moralism in itself implies a concentration of power...The reach of national political power into every nook and cranny has proceed in step with campaigns for greater "social justice".

The recent, at-times heated,discussions (see here for some links) about the ethics of retainer practices illustrate how the concept of social justice as an alleged medical ethical imperative as promulgated by the medical moralists has framed the discussion and attempts to control the dialog.

Tuesday, January 01, 2008

closing thoughts for the year 2007

P4P,quality,the plight of the general internist, the control of third party payers over physicians lead by CMS's price controls, the limits of evidence based medicine and its misuse, the egregious behavior of various entities that continues to sap the essence out of what being a physician was and should be are some of the topics I have thought and fumed about this year.

Several prolific and thoughtful medical bloggers have served to enlighten me on these and other topics .Those that come to mind are DrRich of The Covert Rationing Blog", Dr.Robert Centor of "DBs Medical Rants", Dr. R.W. Donnell of "Notes from Dr. RW" The hospitalist who writes the "Happy Hospitalist" blog, the tireless Dr. Roy Poses in the blog "Health Care Renewal" which explains and exposes so much of what is wrong with the vast medical business complex that you should not read it right at bedtime or after a heavy meal.

In regard to the internist's continuing hard times, Dr. Philip Alper in his "IM Insight" commentary found in Internal Medicine World Report ( www.imwr.com) informs us that two large California medical groups have stopped hiring internists apparently because they can't do as much as FPs can and are more costly than NPs. I have commented before about the loss of ethics and pride in the medical profession (hat tip to DrRich) and to my eyes that phenomenon seems more so in the internist world.The view of those two organizations should not do much good for the pride of internists.

It seems that they figure that internists are not good for much. The medical blog " In My Humble Opinion" give us some examples of cases where an internist did some good. In the cases he describes,we can see how much can go by and be missed by specialists and how the particulars and nuances of the cases are basically beyond the expertise and skill sets that mid level practitioners are likely to possess and fit exactly into what the internist is trained to.The internist whose cases are described to you clearly was taking total responsibility for his patients and worrying about his patients traits that the emphasis on the importance of which, old, over the hill docs fear may be lacking in the current resident training environment and that are being crushed by the current economic situation that squeezes the time available for physician-patient encounters and tries to replace their judgment with simplistic algorithms compliance with which may determine their economic survival.

The Happy Hospitalist puts pencil to paper and makes a convincing ( and depressing) case that the planned cuts in Medicare over the next few years may well make internal medicine practices financially insolvent.Go here and read how devastating these cuts will be to private IM medical care.

If it were a matter of rational argument and common sense ( as argued so well by Dr. Robert Centor) P4P would be dead in the water but as DrRich has made it so clear ,P4P is not about quality but merely another semantic maneuver to control costs and ration care. Centor's thoughtful commentaries regarding quality in medical care make me think that quality and P4P have as much to do with each other as do hot dogs and warm puppies. Dr. RW provides numerous examples replete with links illustrating how quality measures can go wrong and sometimes be harmful.

To get a sense of the issues covered by Dr. Poses I suggest you go to the November 2007 archives of "Health Care renewal" and I guarantee you won't think about some things the same anymore.

While it may not have been a good year for medical practice ( but at least maybe we are getting some clues as to some of the problems) it has been a good year for medical blogging and we are all fortunate to have so many intelligent,articulate, caring physicians out there trying to make things better and hopefully maybe they can. A ray of hope might be the increasing talk about and actual activity in the retainer practice arena. Maybe we can back to the premise that medical care is best determined by the individual patient with the help of his physician.

Happy New Year.