Sunday, September 30, 2007

Practical aspects of early treatment of sepsis

Some nuts and bolts from Emergency Medicine News concerning antibiotic choices, EGDT and activated protein C. There’s also a hint concerning the results of CORTICUS and how they may change our use of corticosteroids.

Saturday, September 29, 2007

What can turn an $800 medical encounter into a $4000 encounter?

Defensive medicine and the fear of litigation, that’s what. RangelMD gives an example. Compelling reading.

Via Kevin M.D.

Conflicting views about disclosure

Medical journals are becoming increasingly strict in their disclosure requirements concerning authors’ financial conflicts of interest. Dr. Jerome Kassirer addresses the problem in a recent MedGenMed Webcast Video Editorial. He correctly points out that disclosure, while necessary, does not “fix” the problem of potential bias in practice guidelines and journal reviews. But the focus of this editorial is inappropriately narrow, singling out financial ties with drug companies while ignoring multiple other important conflicts.

Concerning disclosure, Kassirer states:

Disclosure may alert readers of possible bias, but it requires them to become mind readers. Did the author pen an unvarnished manuscript? Were his opinions subtly influenced by consulting or speakers' fees? Did he intentionally bias the material to satisfy the company whose fees help to pay for his daughter's college tuition? Interpreting the opinions and recommendations of financially conflicted authors in editorials and review articles is more akin to reading a mystery novel than reading a scientific paper.

Mind readers? Absurd as that seems some of the harshest cynics seem to think they can read authors’ minds. For the rest of us, disclosure alerts to possible bias and suggests the direction of such bias. While this doesn’t require mind reading it prompts discerning readers to look critically at the authors’ recommendations and to check primary sources. Those are skills doctors learned, or should have learned, in training.

Kassirer concludes with a call to go beyond disclosure and eliminate conflicts by finding “unconflicted experts”. But isn’t that an oxymoron? Anyone with expertise in a field is likely to have a personal stake. As Thomas Stossel recently pointed out, excluding all experts with potential personal or commercial interest risks leaving us with “the second best and not so bright”. The New England Journal of Medicine realized this in 2002 when editors found they had to relax their conflict of interest policy in order to find qualified experts.

The focus on drug company ties represents selective outrage in the debate over conflicts of interest. Drug company influence is only one of many conflicts, financial and otherwise, which may bias reviews and practice guidelines. A fair and intellectually honest approach to the issue should question all conflicts of interest that might impact conclusions and recommendations drawn from medical research. Should gastroenterologists, for example, who might gain financially from doing procedures, write guidelines on the indications for endoscopy and who should perform it? Should invasive cardiologists participate in the writing of guidelines for cardiac catheterization and stent implantation? As this list goes on and on one has to wonder how many “unconflicted experts” even exist.

Sunday, September 23, 2007

Activated protein C in severe sepsis: patient selection is getting harder

A meta-analysis recently published in BioMed Central Anesthesiology raised troubling questions on the use of recombinant human activated protein C (rhAPC) in severe sepsis.

First a little background. Sepsis is defined by known or suspected infection in the presence of the systemic inflammatory response syndrome (SIRS). Sepsis is defined as being severe when accompanied by dysfunction of at least one organ system. For decision making purposes clinicians attempt to further subdivide cases of severe sepsis into those with a lower risk of death and those with the highest risk of death.

Since rhAPC was approved in 2001 it has been the subject of controversy because its approval was based on a subset analysis of a single randomized controlled trial, PROWESS. The patients in PROWESS determined to have the highest risk of death based on an APACHE-II score of at least 25 or involvement of 2 or more organs accounted for the reduction in mortality associated with rhAPC.

The FDA required a follow up study of rhAPC in patients with severe sepsis defined as having a lower risk of death. This study, ADDRESS, was halted early due to futility. On the basis of PROWESS and ADDRESS rhAPC was recommended only for patients with severe sepsis who had a high risk of death.

ENHANCE was a single arm open label post marketing study to evaluate the efficacy and safety of rhAPC in conditions resembling real world clinical practice, using patient selection criteria similar to PROWESS. No distinction was made among patients with severe sepsis between those having a high or low risk of death although the vast majority of patients had dysfunction of 2 or more organs. The mortality in ENHANCE was almost identical to that observed in the PROWESS treatment arm although the rate of bleeding complications was higher. A notable finding in ENHANCE was that patients treated within the first 24 hours of the first evidence of organ dysfunction had a lower mortality than those treated later.

The BioMed Central Anesthesia meta-analysis raised concerns about the efficacy of rhAPC and proper patient selection. The authors performed a pooled analysis of PROWESS and ADDRESS to assess the effect on mortality, and included several other studies in a cost effectiveness analysis. There was no statistically significant overall effect on mortality (RR .93, CI .69-1.26). That finding represents the overall patient population and is not particularly surprising considering that the less severely ill ADDRESS patients, for whom rhAPC is off label, were included.

But that’s not all. The subgroup analysis produced worrisome findings. In order to understand the subgroup analysis it is important to emphasize that the ADDRESS cohort of less ill patients contained some with APACHE-II scores over 25 and some with multiple organ dysfunction. That confusing situation arose because labeling criteria for defining patients at high risk of death, which were used to select patients for ADDRESS, tended to be vague and varied among participating countries.

Here’s the graphic representation of the subgroup analysis for the pooled results of ADDRESS and PROWESS. The findings of interest were these:

APACHE-II score of 25 or greater: RR .9, CI .54-1.49.
Two or more dysfunctional organs: RR .84, CI .70-1.00

These results may be skewed by the patients in address with APACHE-II scores of 25 or greater, in which the RR was 1.19 (CI .83-1.71).

How can the different results in the ADDRESS patients with multiple organ dysfunction or high APACHE-II scores be explained? First, these were probably less severely ill patients than those in PROWESS. Secondly, ADDRESS study sites included many smaller community hospitals where the level of investigator expertise may have been low. Complex and potentially dangerous drugs like rhAPC generally perform better in the hands of expert clinical trialists than they do in the community.

In light of this new information, what is the status of rhAPC (Xigris) today? My impressions are as follows:

1) Xigris can ethically be considered for additional clinical trials.
2) Xigris is a niche drug for more gravely ill patients with severe sepsis. A simple formulaic approach to patient selection based on the APACHE-II score is not sufficient. The APACHE-II score must be coupled with clinical judgment. Suitable candidates might include patients with both a high APACHE-II score and multiple organ dysfunction.
3) Clinical expertise is important for optimal use of Xigris. Hospitals and health care systems may wish to restrict its use to critical care specialists.
4) Early use of Xigris is important for optimal results. Benefits diminish beyond 24 hours after the first evidence of organ dysfunction.
5) Although Xigris has a role in patients with severe sepsis and can be a life saving drug when used in the optimal patient population and with appropriate expertise it should not, in my opinion, be considered standard of care.
6) New information about rhAPC presents a difficult challenge to the writers of the next version of the Surviving Sepsis guidelines.

This paper gives me yet another reason to appreciate BioMed Central: it’s apparently off the radar screen for popular media outlets such as the New York Times. Thankfully, nobody there seems to have noticed the paper, which could have been published in NEJM or JAMA. If it had, the media would have pounced on it. I can just see the headline: “Eli Lilly’s expensive sepsis drug ineffective”.

Sepsis review from Hospital Physician

This review on the diagnosis and management of sepsis from the June 2007 issue of Hospital Physician covers multiple aspects of treatment including practical application of the Surviving Sepsis Guidelines.

Of special note, the section on early goal directed therapy (EGDT, the Rivers protocol) emphasizes the underappreciated point that EGDT is time dependent. As such it is an emergency department protocol which commences as soon as severe sepsis or septic shock is recognized, and is carried out during the first 6 hours. The article appropriately cautions that EGDT should not wait until arrival in the ICU.

This caveat is supported by largely forgotten evidence that goal directed therapy which commenced in the ICU (late goal directed therapy, when a pulmonary artery catheter could be inserted) was ineffective.

If you treat patients with sepsis this is a must

Add the MUST Guide to your bookmarks.

Friday, September 21, 2007

Prison time for a medication error?

That’s what may happen to an Ohio pharmacist.

The neutraceutical-industrial complex

Herbal woo is a big money industry. It’s coming on strong, largely unchallenged. Compared to the rigorous scrutiny of Big Pharma the N-I complex is getting a free ride. This article from Clinical Pharmacology and Therapeutics is a fascinating exposé:

In conclusion, the N-I complex is rapidly growing despite limited proven value of the products they produce, no known benefit in most cases, and even harmful effects in some instances. Its distribution models often prey on the poor and naive, and the industry is a master of misinformation, confusing the public with many techniques, some described above. Moreover, for reasons one can only speculate about, our culture has created and continues to propagate this powerful meme, which, sadly, is probably aided by missteps in marketing and drug development as well as other serious issues plaguing the pharmaceutical industry.

Read the rest.

Thursday, September 20, 2007

Hospital efficiency tips

If you’re part of a hospitalist program you can bet your administration will be tracking your length of stay and charges per case. Hospitals tend to lose money on Medicare inpatients, and hospitalists can help stop the bleeding.

That’s why an article in the American College of Physicians publication ACP Hospitalist is timely. It contains tips for efficient care of hospitalized patients and was written by Dr. Robert M. Centor, better known to many of us as DB of DB’s Med Rants. Very helpful stuff.

Wednesday, September 19, 2007

Sphygmomanometer on the verge of extinction

The way things are going there may come a time when you have to visit the Mütter Museum in order to see one. If you don’t believe me, next time you’re on the ward ask the nursing staff for one and note the blank stares.

Dr. Wes muses about the vanishing sphygmomanometer and laments that the phenomenon is symptomatic of declining basic clinical skills. He’s a little conflicted, though, because it’s good for business if you’re an electrophysiologist.

I don’t particularly mind the newer electronic BP machines (all you have to do is push the button) except when I need to check a patient for pulsus paradoxicus.

Tuesday, September 18, 2007

Avandia and Actose: Are there lessons for diabetes care and drug safety?

In light of new developments in the thiazolidinedione (TZD) controversy now might be a good time to take stock of where we are in drug therapy of type 2 diabetes. First there’s the latest spin from the New York Times, an article worth reading principally as an example of popular media distortion.

It mentions two new studies in JAMA and notes a doubling of heart failure risk from Avandia without making a clear distinction between TZD associated heart failure and Avandia associated myocardial infarction (MI). TZD associated heart failure exacerbation was reviewed in the Cleveland Clinic Journal of Medicine. The review makes this statement:

The incidence of congestive heart failure reported in clinical trials is less than 1% and appears to be related to underlying dysfunction, with decompensation caused by sodium retention and fluid accumulation rather than a direct cardiac suppressive effect.

This important distinction from drugs which are truly cardiotoxic is known to physicians but not to most Times readers, who might think Avandia is a cardiac poison like adriamycin. The distortion gets worse. One of the JAMA authors is quoted as saying that Avandia causes blindness and doubles the rate of fractures in women. The Times doesn’t bother to elaborate or even cite primary sources. As the statement stands it’s a half truth.

The blindness comment refers to macular edema. The primary source is here in a report from CMAJ. According to that report macular edema due to Avandia is believed to be rare, may reverse with drug discontinuation, may be anticipated by the development of peripheral edema, and does not invariably lead to blindness. The New York Times article left out another detail---insulin therapy in patients with type 2 diabetes is an established risk factor for macular edema. [1] [2].

And the fractures? Because the article provides no elaboration or background, readers might naturally assume these are hip or spine fractures. But the primary source, a study in NEJM from last December, reveals no increased rate of hip or spine fractures. The problem was confined to arm and foot fractures. That finding, although worrisome and in need of better understanding, is less concerning than what would naturally be inferred from the Times story, which confuses more than it informs. Unfortunately this type of sound bite coverage will again hijack scientific debate on the findings of the new JAMA studies.

In refreshing contrast is a discussion between Steven Nissen, author of the controversial NEJM Avandia meta-analysis, and Robert Califf, a cardiologist and Professor of Medicine at Duke University. The video and transcript are linked at Medscape Diabetes and Endocrinology. The Medscape editor explains the importance of this resource in the introduction:

The May 2007 online publication of the meta-analysis "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death From Cardiovascular Causes," in The New England Journal of Medicine (NEJM) launched a controversy that has been difficult to navigate. In an attempt to clarify the debate, our colleagues at organized a videotaped conversation between Steven E. Nissen, MD, MACC, Medical Director, Cleveland Clinic Cardiovascular Coordinating Center, Cleveland, Ohio -- and co-author of the NEJM article -- and Robert M. Califf, MD, Professor of Medicine, Vice-Chancellor for Clinical Research, and Director, Translational Medicine Institute, Duke University, Durham, North Carolina. Drs. Nissen and Cardiff review the meta-analysis and the US Food and Drug Administration (FDA) advisory panel hearing, as well as discuss the wide-ranging implications of the ongoing clinical and political debate. It is a thoughtful, collegial conversation that helps parse this controversy and what it means for clinical practice and public policy.

It’s must viewing for anyone who wants the fair and balanced version of this debate but so far it’s been drowned out by sensationalistic media coverage.

The New York Times distortion centered around two studies and an accompanying editorial published in the most recent issue of JAMA. One of the papers, another rosiglitazone (Avandia) meta-analysis, reached the same conclusion as Nissen’s NEJM study. The JAMA meta-analysis, which differed from the NEJM study in that it restricted papers for inclusion to those which reported long term follow up and had a pre-specified intention of looking at adverse cardiovascular outcomes, showed a relative risk for myocardial infarction of 1.42 (1.06-1.91) associated with rosiglitazone and no increased risk of mortality.

Although not mentioned as a potential conflict of interest, the paper could be interpreted as more ammunition against the FDA. One of its authors, Curt Furberg, has been critical of the FDA’s approval and safety monitoring procedures and has had conflict with the agency. When removed form an FDA advisory panel meeting on arthritis drugs in 2004 Furberg expressed concern that agency officials were trying to silence him. The same Washington Post article quotes from an FDA official:

Sandra Kweder, deputy director of the FDA Office of New Drugs, said it was not unusual for advisory panel members to be kept from participating in a meeting if they have clear financial interests or intellectual positions that could keep them from being objective.

The importance of the potential conflict is underscored in this analysis by the fact that only 4 studies out of 140 were selected. Despite this caution the analysis must be taken seriously. It agrees with other research findings and when combined with other reports it strengthens the “signal” for macro vascular harm associated with Avandia.

The other paper, though conflicted due to co-author Steven Nissen’s ties with Takeda pharmaceuticals, the makers of the study drug, also confirms previously known findings. Pioglitazone (Actose), Avandia’s competitor and companion TZD, was found in a meta-analysis to be associated with a reduction in the primary composite outcome of death, myocardial infarction and stroke. This is in line with the controversial PROactive study. Thus it would appear, surprisingly enough, that the two approved members of the TZD class have divergent effects on macro vascular health, once again challenging simplistic assumptions about class effect. (Mea culpa!).

The accompanying editorial gives a helpful clinical perspective and makes suggestions for change at the FDA. Unfortunately label revisions and black box warnings are not enough. As the editorial points out and as I wrote in a previous Medscape Roundtable it has been demonstrated again and again that doctors ignore such warnings. This has not only led to untold instances of direct patient harm but has also deprived patients of beneficial therapy due to the withdrawal of effective drugs form he market. It has unfairly tarnished the reputations of drug companies and the FDA.

Unfortunately this debate has been fueled by a fundamental and pervasive misunderstanding of diabetes treatment. The problem is an inappropriate expectation that anti-diabetes drugs should improve macro vascular outcomes. Myocardial infarction and stroke are examples of macro vascular outcomes. While it’s well established that glycemic control improves micro vascular outcomes (e.g. retinopathy, neuropathy and nephropathy) clinical epidemiologists have been telling us for years that not even the strictest glycemic targets produce macro vascular benefits. In fact it has been known long before the advent of TZDs that drug treatment for type 2 diabetes is associated with macro vascular harm. This fact was recognized decades ago when the University Group Diabetes Program (UGDP) reported increased cardiovascular mortality in association with first generation sulfonylureas.

Although the UGDP study was criticized its findings have been supported in subsequent reports such as this recent analysis of a large Canadian health care database. Not only first generation but also second generation sulfonylureas were associated with cardiovascular death, and the association was dose related. These alarming findings, published last year, went largely unnoticed in the arena of public debate. Where was the outrage? Where was the New York Times? There can only be one explanation. The fact is, these are old, off patent drugs from decades ago. That makes it difficult to bash drug companies and the FDA. While the findings are much more important (because patient deaths are involved) than the Avandia results there’s low potential for hype. Clearly the popular media hysteria is more about finger pointing than patient care.

In order to improve macro vascular health in type 2 diabetes you can’t just lower blood glucose. You have to do something else. What is that “something else”? It is, at the risk of oversimplification, treatment of the metabolic syndrome, the principal dyslipidemia of type 2 diabetes. Such treatment is generally multimodal, based on hygienic measures (diet and exercise) often in conjunction with lipid regulating drugs. Glycemic control doesn’t accomplish this goal, and glucose controlling drugs are ineffective unless they exert additional direct effects on one or more adverse components of the metabolic syndrome. For a glucose controlling drug this is not the norm. When it occurs it’s a bonus. Thus far only two drugs in the vast array of diabetes medications appear promising in this regard: pioglitazone and metformin. Realistically the best we can expect for most diabetes drugs is a neutral effect on macro vascular health.

Background: Here’s the FDA warning for a popular sulfonylurea (Amaryl).

Saturday, September 15, 2007

Vancomycin tips

Not too many years ago the adage was “say no to vanco.” That has changed in the CA-MRSA era as vancomycin assumes front line status for many patients. Today’s Hospitalist discusses current trends.

Varicella-zoster virus and the nervous system

CCJM has a full text review outlining clinical features, diagnosis and treatment.

Churg-Strauss syndrome and related disorders

The spectrum of pulmonary vasculitis, notably Churg-Strauss syndrome, Wegener’s gramulomatosis and microscopic polyangiitis, is reviewed in Current Opinion in Pulmonary Medicine.

Catecholaminergic polymorphic ventricular tachycardia

It’s another genetic cause of ventricular arrhythmias and sudden death. It’s not Torsades---the QT interval is not prolonged and the tachycardia morphology is typically a bidirectional alternans type of tachycardia rather than twisting about an isoelectric point. It’s reviewed here in the Journal of Cardiovascular Electrophysiology, via Medscape. The mechanism is believed to relate to excessive myocardial cytosolic calcium.

An analogous situation is seen in digitalis toxic ventricular ectopy, classically presenting as bidirectional tachycardia, also believed related to intracellular calcium excess. Digitalis exerts its inotropic effect by increasing the delivery of calcium to the contractile proteins.

By the way, UpToDate has an excellent discussion of CPVT in a section on the polymorphic VTs with normal QT intervals which, for obvious reasons, I can’t link here.

Wednesday, September 12, 2007

Erythropoietin treatment in critical illness

Transfusion of red cells has been associated with adverse outcomes. The search for a safer alternative to red cell transfusion in critically ill patients has led to great interest in the use of erythropoietin to help patients maintain appropriate hemoglobin concentrations. A study in NEJM demonstrates again that evidence often tempers enthusiasm for appealing ideas. The EPO Critical Care Trials Group reported, in the September 6 issue, on the use of erythropoietin in critically ill patients. In the treatment group there was no reduction in the use of red cell transfusions and no significant improvement in mortality except in a subset of trauma patients. An increase in the rate of thromboembolism was seen in the erythropoietin group.

Deborah Cook and Mark Crowther in an accompanying editorial warned against premature conclusion that erythropoietin is beneficial in critically ill trauma patients. The absolute benefit was small and the relatively high incidence of VTE in trauma patients may result in a smaller number needed to harm than was reported for the overall group. They concluded:

Without a clear indication for initiating erythropoietin in all critically ill patients, new prescriptions for this drug should be restricted to randomized trials with independent research oversight carefully examining fatal and nonfatal clinically important outcomes.

Tuesday, September 11, 2007

Whither practice guidelines?

How helpful are clinical practice guidelines (CPGs)? How are they most effectively used? A couple of my blogging colleagues have been examining this issue. In a recent series of posts DB examines biases in guideline development, guidelines written with complexity inappropriate for a generalist audience, and the difficulty in applying single disease guidelines to elderly patients with multiple complex problems.

Today Orac provided a useful perspective on CPGs and evidence based medicine (EBM), centering his comments around a paper in PLOS Medicine which on the surface could be construed as diminishing the value of EBM. But that interpretation, though likely to be trumpeted by the popular media and the alties, is not a fair rendering of what the paper actually said, as Orac went to considerable length to explain. The paper was not critical of EBM. What it did do is question the ability of CPGs to help clinicians practice EBM. The authors evaluated randomized controlled trials (RCTs) on which guidelines were based and found a disturbingly low number (about a third) that met two criteria: applicability to the patient populations targeted in the guidelines and reporting of “hard” clinical outcomes. The study may not be generalizable because of its narrow focus on a limited number of guideline recommendations. The authors were circumspect:

In conclusion, our finding that less than one-third of treatment recommendations (and less than half of those citing RCTs in support of the advocated treatment) were based on high-quality evidence in national evidence-based guidelines for common conditions should sound a note of caution to consumers of clinical practice guidelines who assume that the sobriquet “evidence based” means that all recommendations contained therein are derived from high-quality evidence.

For me this paper is a reminder that slavish adherence to CPGs is not the same thing as practicing EBM although it is popularly assumed to be so. The true steps of EBM are rigorous and time consuming as I have outlined before. Here I discussed the general steps of EBM and gave some case examples. In a more recent post I expanded on the first step of EBM (formulating a focused clinical question to be translated into search terms) by introducing the PICO acronym. The P in PICO stands for population and refers to the need to define the specific patient population that corresponds to your patient, and specifying the relevant characteristics in the focused clinical question and the search terms. That addresses one of the problems, cited by the authors of the paper, inherent in the use of CPGs by helping ensure that the evidence applied to the clinical problem at hand matches the attributes of the patient.

Once the search is done and the studies are collected there remains the important step of critical appraisal, an additional check point for the quality and external validity (applicability to your patient) of the evidence.

Much of what is said to be EBM is not EBM at all. The true practice of EBM is onerous. In many situations clinicians lack the necessary time to practice pure EBM. Although the use of guidelines is not a valid substitute for EBM guidelines can be helpful to the time strapped physician when viewed with an appropriately critical eye.

Sunday, September 09, 2007

Thiamine before dextrose

Is it a medical myth? Well, the evidence to support the practice is soft according to this article from Emergency Medicine News.

Out with Pharma, in with Woo---AMSA’s agenda for medical education

In researching the activities of the American Medical Student Association I ran across a couple of items highlighting their efforts to influence medical schools with a double standard for evaluating mainstream pharmaceuticals and alternative medicine. An article from DOTmed news and this post from Health Issues Unmasked both appeared within the past couple of weeks.

The DOTmed news piece describes how AMSA is stepping up the efforts of its PharmFree Campaign to try and rid the academic medical environment of the effects of industry promotions:

"It is important that we work to keep our medical schools and teaching hospitals free of the influence of pharmaceutical companies," said AMSA National President Jay Bhatt. "PharmFree medical students become PharmFree doctors and that commitment to evidence-based medicine benefits our patients and our colleagues."

Read that again. Note he said evidence-based medicine. It’s all well and good until you read the Health Issues Unmasked post from just days earlier describing AMSA’s other big initiative for med schools that’s not so evidence based:

The American Medical Student Association (AMSA) Foundation has just ended a pilot study designed to develop a curriculum for including complementary/ alternative medicine (CAM) training in MD and DO programs nationwide. The study, conducted at six medical schools, was financed with a $1.2 million grant from the National Institutes of Health (NIH)-National Center for Complementary and Alternative Medicin (NCCAM).

That’s right, they’re getting support from NCCAM. They trumpet the fact that they eschew all pharmaceutical industry sponsorship, in the name of evidence based medicine, while accepting a $1.2 million dollar grant from arguably the nation’s most organized and powerful promoter of pseudoscience.

The Health Issues blog post links to the AMSA website for its CAM educational initiatives where their guiding principle is explained:

Medicine today is experiencing a paradigm shift that involves the blending of two disparate philosophies of health and disease, the biomedical or scientific reductionist view and the clinical, experiential holistic view.

But you can’t blend scientific methods with “disparate philosophies”. Science is what it is only because certain absolute rules apply to how we interpret observations. The scientific foundations of medical education are undermined when they are blended with pseudoscience and metaphysical presuppositions. Abraham Flexner, almost a century ago, referred to such presuppositions as dogma and warned that medical schools must not compromise science with dogma. Medical education, influenced by the AMSA and its accomplices at NCCAM, is turning its back on Flexner’s warning.

Friday, September 07, 2007

Taken to task for my criticism of AMSA

Wednesday I criticized AMSA’s promotion of complementary and alternative medicine (CAM) and suggested that the organization might be just a wee bit disingenuous in its purported concern for evidence based medicine. This drew questions from two commenters.

Ladybird asked: “How do you know the chakra methods don't work?” That’s the wrong question because it shifts the burden of proof. The burden of proof should rest on those who make the claim. The appropriate questions should be “How do we know the chakra methods do work?” and “Can you show me an anatomic or physiologic basis for chakras?” Put another way, don’t CAM claims warrant the same burden of proof and degree of skepticism that we apply to the products of Big Pharma?

Paige Hatcher, a KU medical student and blogger who is taking an AMSA fellowship, cites a diversity of viewpoints within the membership of AMSA:

With over 10,000 pages on our website, and 70,000 members, there are many individual members and projects that may differ from AMSA's overall goal of teaching evidenced based medicine.

And this is supposed to explain away a double standard? It doesn’t. A standard of rigorous skepticism for the promotions of drug companies alongside one of nearly unconditional acceptance and credulity for numerous unproven, biologically implausible and even dangerous claims of alternative medicine sends a troubling double message.

Paige, as an enthusiastic participant in the leadership of AMSA you have a unique opportunity. I challenge you to make a difference. Encourage the boosters of CAM in your ranks to apply the same standards of evidence to their methods (e.g. chelation therapy, purging, fasting, homeopathy) as they would to the products of drug companies. This will help the cause of EBM and restore credibility to your organization.

Go Cards!

I spent Labor Day weekend visiting family in St. Louis. Last Saturday I indulged in one of my favorite pastimes as I watched the St. Louis Cardinals defeat the Cincinnati Reds 11-3. I took a few pictures which I’ll share here.

In pre-game ceremonies Cardinals manager Tony La Russa was honored for passing Hall of Famer Red Schoendienst’s all time managerial win record.

From left: Cardinal owner and managing partner Bill DeWitt; Schoendienst; La Russa.

Reds slugger Ken Griffey, Jr.

Cards first baseman Albert Pujols.

Cards win!

With Thursday’s win over the Pittsburg Pirates the cards are one game out of first place in the NL Central division. Will they win it all this year and have to apologize again?

Wednesday, September 05, 2007

The American Medical Student Association---a paradox of skepticism and credulity

The American Medical Student Association (AMSA) is in the news again with the roll out of a collaboration with Medical Letter (via Earth Times). The press release, titled “Medical Students Receive Free Evidence-Based Materials to Combat Marketing Paraphernalia” suggests that AMSA is all about EBM and critical thinking. It goes on to talk about professionalism and critical evaluation of therapies. The Medical Letter is a wonderful resource and should help students learn about rational drug therapy.

But cognitive dissonance sets in when the initiative is juxtaposed with AMSA’s numerous promotions of non-evidence based and implausible alternative medicine modalities. Page 4 of their handbook on Integrative, Complementary and Alternative Medicine for Providers of Primary Care claims, for example, that “Homeopathy is very cost effective over the long term”. The entire chapter on homeopathy in another AMSA alternative medicine publication, Between Heaven and Earth, is uncritical (pp. 34-36). The chapter on Therapeutic Touch explains the technique on the basis of chakras (p. 43):

Blockages of these chakras result in depletion of energy in the physical, emotional or mental dimensions associated with each. For example, a blockage of the root chakra can result in dysfunction in the physical energy layer, causing fatigue or ailments of the lower back, hips, legs and perineum.

It goes on.

What’s up with AMSA anyway? They’ll shun drug company support because they “don’t want to be bought”, demonstrate in front of a drug company’s headquarters by dumping thousands of advertising pens there, yet accept support from the American Holistic Medicine Association which promotes stuff like this.

Tuesday, September 04, 2007

Mechanical ventilation for ARDS

….is the subject of a State-of-the-Art Review in Chest. Not much new here. Low tidal volume ventilation, daily spontaneous breathing trials and protocols for liberation from mechanical ventilation were emphasized. Special modalities such as high peep may be useful rescue maneuvers in individual patients but are not considered evidence based for improving survival.

Continue statins as seamlessly as possible before and after vascular surgery

This study from the American Journal of Cardiology should be of interest to hospitalists, who are increasingly called on to help co-manage surgical patients. Interruption of statin use was associated with increased early postoperative cardiac events. A potential weakness of the study was the fact that those patents undergoing higher risk surgeries such as abdominal aortic procedures were the very patients likely to have longer interruptions in statin therapy due to being NPO for longer periods. The authors state they adjusted for that variable.

They suggest that administration of an extended release statin before surgery may help bridge the gap. Extended release statin use seemed to confer benefit in the study. Fluvastatin (Lescol XL) is the only extended release statin available.