Right now I’m feeling a little morose as Bob Wachter over at Wachter’s World posts bittersweet reminders of the fact that I missed this year’s just completed UCSF Hospital Medicine Conference in San Francisco. It’s one of several high quality CME courses I repeat on a rotating basis, chock-full of updates and thoughtful presentations on this ever more complex field.
As I console myself thinking “maybe next year” I‘m a little concerned about an emerging threat to the existence of this type of meeting. There are people out there, people in high places, who would like nothing more than the end of traditional didactic CME conferences as we now know them. A rising chorus of voices calls for the end of pharmaceutical company support for CME activities, without which many conferences of the high caliber exemplified by the UCSF meeting would simply cease to exist. Others call for a virtual end of all traditional didactic CME, including Dr. Jordan Cohen, former president of the AAMC.
Wachter addresses these criticisms in the concluding paragraph of his post:
People wonder about whether CME does any good, either because content taught in big lectures tends not to stick or because many CME courses are golf-laden boondoggles. It is now Saturday morning, and 90% of our registrants are still here (and they’ve already received their CME certificates and it is gorgeous day in San Francisco – lots of excuses to play hookie). I admire their commitment, and, though I can’t prove it, I think we’re saving a few lives here in the Fairmont Hotel.
No, he can’t prove it, but having attended a couple of Bob’s past conferences I suspect he’s right. I come home from courses like this, read and re-read the syllabus, look up related material and primary sources on the Internet, then return to work with batteries charged, newly inspired to try and make a difference.
As far as "proof" of efficacy of CME goes, some critics of traditional programs insist that accreditation somehow be based on verification that each content element be correlated directly with a change in physician “behavior”. For a more lengthy rant of mine on what’s wrong with that thinking click here.
One of the latest additions to the growing medical blogosphere is Wachter’s World, Robert Wachter’s new blog devoted to hospital medicine. The subtitle reads Lively and iconoclastic ruminations on hospitals, hospitalists, quality, safety and more… Having heard Wachter speak many times I have no doubt that he’ll deliver on that promise. Stop by for a dose of healthy skepticism on the hospitalist movement along with the latest buzz on hospital medicine. I’ll be linking from there often. It’ll be on my blog roll once I get around to the next update.
If woomeisters put the good name of academic medicine behind their claims those claims must be true. If they admit that quackery really does exist they must be appropriately skeptical. Right? Wrong, but don’t tell that to CNN which recently published this credulous piece: 5 Alternative Medicine Treatments That Work.
The article well illustrates two things I’ve been harping on for a while, these being the harm done when academic medicine promotes quackery and the distortion of health issues by popular media. Needless to say it would have been fun to write a debunking piece about this article. I thought about it the other night but was just too tired. Fortunately Mark Hoofnagle and Orac came through. Although both posts are worth reading in their entirety Orac’s conclusion best summarizes what’s really wrong with the recent infusion of pseudoscience into academic medicine:
The bottom line is that the infiltration of woo into academic medicine is a threat to evidence-based medicine because it lends the prestige of scientific medicine to modalities that are not evidence-based, thereby promoting the belief that they are on an equal footing, even though the vast majority of them are not. In so doing, it blurs the line between science and non-science, between scientifically supported treatments and quackery. Moreover, the faculty of the institutes, divisions, and departments dedicated to CAM in medical schools are, by and large, not made up of skeptics, but of true believers, be they M.D.s or not, who apply a veneer of skepticism and science to their studies and curriculae and then give interviews to credulous reporters like Elizabeth Cohen to publish on CNN.com.
Terminology can be confusing. Diagnostic and treatment strategies are evolving. This update in Current Opinion in Hematology is timely.
Noteworthy points:
Among antiphospholipid antibodies, those which prolong the aPTT (so called Lupus anticoagulants) may carry a higher risk of thrombosis than anticardiolipin antibodies (OR 11.0 and 1.6 respectively). This marked difference may be biased by inclusion in the meta-analyses on which these data are based of patients with low titer anticardiolipin antibodies which are of doubtful clinical significance and do not meet current diagnostic criteria for antiphospholipid syndrome.
A common scenario is the need to evaluate a patient for thrombophilia after anticoagulants have been started. Lupus anticoagulant assays can be done on such patients but require special handling and advance notification to the laboratory.
Patients with antiphospholipid antibodies and venous thrombosis, following acute treatment with some form of heparin overlapped with warfarin, should be treated with warfarin adjusted to an INR of 2.0-3.0 long term for a duration of one year to indefinitely.
Data are less clear for patients with stroke and antiphospholipid antibodies. Absent another indication for anticoagulation warfarin adjusted to an INR of 1.4-2.8 or aspirin is suggested. For non-cerebral arterial thrombosis warfarin adjusted to an INR of 2.0-3.0 is recommended.
Naegleria fowleri---it’s the brain eating Amoeba we’ve been hearing about, with 6 infections reported this year in contrast with 23 reported in a 9 year period. Think of it if your patient has been swimming, has an illness resembling meningitis and has a negative CSF gram stain.
Rabies---early recognition is now more important because it may not be hopeless. Think of it in any patient with undiagnosed neurologic disease. An article beginning on page 17 of this issue of The Hospitalist tells you what a hospitalist needs to know about it.
The Resting Electrocardiogram in the Management of Patients with Congestive Heart Failure: Established Applications and New Insights, originally published in PACE, has many useful and fascinating pearls about information that can be teased out of the electrocardiograms of patients with heart failure. Via Medscape.
Following early confusing but dramatic case reports of severe systemic reactions to parenteral vitamin K there has been a persistent and widely promulgated notion that it causes anaphylaxis.
In a recent article in Emergency Medicine News Dr. James Roberts critically examines this claim and attempts to make sense of the evidence. He concludes that there is reason for caution although the mechanism of the reaction, the degree of risk and any relation to prior vitamin K exposure is unclear. Although the problem may be overblown there is likely some risk. Oral vitamin K appears to be safer and should be used when possible.
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.
Defensive medicine and the fear of litigation, that’s what. RangelMD gives an example. Compelling reading.
Via Kevin M.D.
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.
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”.
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.
Add the MUST Guide to your bookmarks.
That’s what may happen to an Ohio pharmacist.
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.
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.
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.
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 theheart.org 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).
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.
CCJM has a full text review outlining clinical features, diagnosis and treatment.
The spectrum of pulmonary vasculitis, notably Churg-Strauss syndrome, Wegener’s gramulomatosis and microscopic polyangiitis, is reviewed in Current Opinion in Pulmonary Medicine.
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.
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.
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.
Is it a medical myth? Well, the evidence to support the practice is soft according to this article from Emergency Medicine News.
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.
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.
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?
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.
….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.
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.
Recently I objected to the new CMS rules on two principles. First, they are unfair because they operate on a presumption of blame for adverse events, many of which are unavoidable. In addition, as a result of the rules, Medicare Part A, which has under-reimbursed hospitals for a quarter century will now reimburse even less when these events occur. Thus the conflicts of interest created by negative cost incentives built in since 1983 will get even worse in 2008.
But these objections are abstract. What will be the real world impact on patient care? Will mistakes decrease as a result of the new policy? It’s not likely, since the most common events addressed by the new rules are not the result of “mistakes”. As David Catron pointed out in a post entitled Medicare’s Latest Assault on Hospitals:
The new rule is very unlikely to reduce hospital errors. It will, however, reduce the number of hospitals. As I have pointed out here, hospitals cannot operate in the red and survive.
Let’s consider some of the adverse events targeted by the new rules. If there’s one area where patients might benefit it’s the prevention of catheter associated urinary tract infections. Hospitals will have an incentive to implement pathways for limiting the insertion of catheters, and for their early removal.
What about decubitus ulcers? There’s no reason to think the new rules will improve outcomes in this area. Hospitals already have strong medico-legal incentives to avoid decubitus ulcers. (Note that three of the top four Google hits for “decubitus ulcers” are resources for attorneys and legal experts). Hospital nursing staffs are already over taxed, so until researchers at the NCCAM figure out a way to levitate patients the only way to improve prevention efforts will be the more widespread use of expensive high tech specialty beds. Medicare’s negative cost incentives will make this prohibitively expensive, and the most likely way around the problem for many hospitals will be earlier discharge of patients with decubitus ulcers to long term acute care (LTAC) hospitals for “wound care”. That may ease the burden for hospitals but will not benefit patients.
What about fall prevention? Restraints are risky and tend to be restricted by Joint Commission and other agencies. Another proposed solution is the widespread use of Vail beds but these devices are expensive and have been associated with major risks. Ideally, all geriatric patients should be attended by an individual sitter day in and day out. Again, Medicare’s financial incentives will discourage hospitals from doing this. Hospitals, already in a no win situation, will suffer more and patients will not be helped. The unintended adverse consequences will outweigh any benefits.
Implicit in the new CMS rules for hospital reimbursement is the idea that every patient fall, every catheter related infection and every decubitus ulcer is the result of a medical error. The idea is ridiculous. No one who understands hospital care believes it, but the media are lapping it up. Another example of this media credulity comes from the Boston Globe (via Medpundit), in which bed sores and patient falls are equated with errors:
Hospitals also need to make public the rate of other medical errors listed by the Medicare regulators, and lay out their strategies to prevent them. These include the number of times patients fall and the number of pressure ulcers, commonly called bedsores, caused by prolonged bed stays.
One of my commenters, a patient activist with her own blog, supports the CMS policy but believes it goes beyond mistakes to criminal neglect:
…but prior to Oct '08, the times those hospitals will have been reimbursed when they should not have been rewarded for errors and neglect, will have already allowed them to get away with these crimes on patients for too many years.
Medical crimes and negligence can be penalized when due process is followed. What’s unfair is the uniform presumption of guilt just because an adverse event occurred. I asked my commenter point blank if she believed in the presumption of guilt and, if not, how crime and neglect in the hospital setting can be fairly adjudicated.
Meanwhile a commenter to a New York Times article on the same subject was quoted by Medpundit:
So, I admit Mrs. Jones, an elderly patient of mine, to the hospital because she has pneumonia. Because of the stress of the infection, she becomes delirious, which puts her at high risk of falling.In the interest of safety, I restrain and sedate her, which necessitates an indwelling urinary catheter.One week later, despite meticulous nursing care, Mrs. Jones develops a urinary tract infection and a minor pressure sore on her back because of her debilitated, immobilized state.My hospital administrator then suggests that I remove the restraints and the catheter and reduce the doses of her sedatives so that the conditions don’t get worse and our hospital doesn’t lose money.Two days later, Mrs. Jones falls out of bed and breaks her hip.How, exactly, has the new Medicare policy improved Mrs. Jones’s safety?
‘Nuf said.
A recent tirade in NEJM on the U.S. health care system, ironically published as a Perspective piece, accused a USA Today editorial writer of blustering because she dared to criticize Michael Moore’s Sicko and defend the U.S. health care system. Citing many distortions and inaccuracies in the movie, she wrote:
Michael Moore's movies are provocative, but this one should be seen for what it is and is not. A no-holds-barred assault on our present health care system? Yes. A balanced documentary? No.
Moore wants a government takeover. To make his case, he relies on one-sided anecdotes — some dating back to the 1980s — that grossly distort the role of health insurance plans in providing access to care to more than 200 million people.
Are anecdotes from 10 to 20 years ago relevant to the state of health care today? The NEJM writer, Jacob S. Hacker, Ph.D., opens with a scene from 1993. Managed care, a player in this story, has been somewhat self correcting over the years and was a more formidable beast in 1993. The story is about an 18 month old seen in an emergency room with a “life-threatening bacterial infection” (I’m guessing sepsis or meningitis). The ER doc was appropriately suspicious and wanted to administer antibiotics. But a phone call to a managed care physician reviewer revealed that treatment was not covered and that the patient had to be transferred another hospital, where she died a few hours later after deteriorating and suffering seizures.
Very likely this tragedy was played out in court somewhere and analyzed extensively, but important details are missing from the NEJM article and, I suspect, (I haven’t seen it) the movie. The limited account we are given raises important questions. Did the first hospital really withhold antibiotics as implied by the article? If so, and if the doctor at the first hospital really recognized a life-threatening bacterial infection as the article states, then this patient suffered as a result of an EMTALA violation and not a deficiency in the U.S. health care system. EMTALA was enacted in 1986 specifically to avert this sort of outcome. Those are some pretty big “ifs”, but since we are to accept this anecdote as a reflection on our health system Dr. Hacker owes it to us to address that glaring question.
Dr. Hacker’s only criticism of Sicko, it seems, is that it doesn’t offer the solution he prefers, “Medicare for all”. While praising Medicare Hacker has this to say about private insurance: “Insurers erect obstacles to care, hassle patients and doctors….” It’s safe to say Dr. Hacker doesn’t take care of Medicare patients. If he did he’d be aware of daily Medicare obstacles to patient care and hassles and threats to doctors’ autonomy.
This piece would be more appropriate for USA Today, perhaps as an editorial counterpoint, than for the NEJM. Dr. Hacker seems more interested in propaganda than nuanced discussion. He writes “We could use more populism and less caution in our health care debate” and wants to see more “populist anger”. I hate to see politically motivated material such as this in the scholarly NEJM, and I hope the journal doesn’t devolve into a political rag.
This has been covered heavily in the blogs recently. I’ve been mulling over whether to weigh in these last few days, and up to now things have been too hectic for me to give this topic sufficient time and depth.
Despite the simplistic media spin this isn’t a simple matter of whether Medicare will “pay for mistakes”. It’s not as if Medicare even pays for the all the appropriate hospital care patients actually get. Medicare hasn’t done that since the advent of DRGs in 1983. That’s not a joke or an abstraction; it’s true in the real world, as evidenced by the fact that hospitals lose money on Medicare inpatients.
For a glimpse of what’s really going on check out the primary sources. Here’s the full text of the regs from the Centers for Medicare and Medicaid Services (CMS). (Warning: large pdf with over 2000 pages containing difficult to decipher alphabet soup and jargon along with innumerable rules inventing an untold number of crimes. Those who want “Medicare for all” take note).
Since Medicare doesn’t even pay for all necessary and appropriate hospital care what is meant by “not paying for mistakes”? As the CMS press release explains, the new rules actually constitute a complete revamp of DRGs including, among many other changes, a list of newly designated hospital complications which can no longer be coded to enhance the DRG payment. Thus hospitals can no longer recoup losses sustained as a result of certain complications which occur during hospitalization.
CMS promotes the new measure as a quality incentive and a means to more “accurate” reimbursement. It’s been widely applauded in the popular media. It is simplistically argued that Medicare should stop rewarding hospitals for preventable complications. That argument doesn’t stand up to close examination. The new policy is unfair on more than one level. First of all, DRG payments under Medicare’s Inpatient Prospective Payment System (IPPS) have never rewarded hospitals for appropriate or even perfect care, let alone for mistakes. The IPPS is an under funded mandate for hospital care of the sickest and most complex patients. Like a hidden provider tax it has penalized rather than rewarded hospitals for years. With its new policy CMS is merely stiffening the penalty.
Implicit in the policy of penalizing hospitals for adverse events is the idea of blame. CMS attempts to justify its position by citing prevention guidelines for each of the conditions listed. The newspaper spin is that potentially preventable adverse events such as falls and decubitus ulcers are medical mistakes which hospitals have been “blasé” about preventing. To anyone with experience in the care of hospitalized patients that’s patently absurd. Orac did a masterful job of exposing the absurdity in a recent post:
I know what some of you are thinking, particularly those less inclined to like doctors. You're probably thinking: Greedy doctors! No wonder they oppose something like this. There's just one problem. Most of the items on the list, although potentially preventable, are not 100% preventable even under ideal conditions. Take pressure ulcers (bedsores), for example. There are certainly nursing care interventions that can greatly decrease the risk of pressure ulcers, but no intervention will reduce that risk to zero. I've seen patients where everything was done right, the patients were turned frequently and placed on the latest beds designed to minimize pressure, who still got ulcers. Remember, Christopher Reeve, who presumably got the best skin care available after he became quadriplegic, died from sepsis due to an infected pressure ulcer.
By CMS and popular media standards, apparently, Reeve’s death was the result of a medical mistake. Pressure ulcers will never be eliminated until someone figures out a way to levitate patients. That would be the ultimate in woo. It’s beyond the pale even for the alties. (Well, most of them, anyway).
The reality is that Medicare’s IPPS forces hospitals to play a game in order to survive. It’s a game with many dimensions in the areas of coding, documentation, case management and cross subsidization. Hospitals that can’t play the game close. When other hospitals get good at the game over time Medicare changes the rules. From where I sit the impending rule change is just the latest of many vagaries of the Medicare game over the years.
A review in Current Opinion in Hematology summarizes the evidence on this topic. Interactions between hormonal therapies and intrinsic risk factors such as hereditary thrombophilias are discussed.
Just the basics. Via Continuing Education in Anaesthesia, Critical Care & Pain.
The science behind the latest buzz on vitamin D is summarized in this review from Current Opinion in Rheumatology. The vitamin D receptor is a transcription factor with varying actions at widespread tissue sites, involving more than calcium and bone metabolism. Implications regarding cancer, diabetes and immunity are discussed.
This review in Cleveland Clinic Journal of Medicine compares the atypicals with older antipsychotics and reviews safety concerns. Recommendations for the monitoring and treatment of adverse metabolic effects (diabetes, weight gain, dyslipidemia) are presented.
This paper from a few months ago in BMC Medical Education looked at attitudes toward and use of complementary and alternative medicine (CAM) at UCI. Students, faculty and house staff were surveyed. The survey is difficult to interpret because the faculty members selected for survey were only those who taught or were planning to teach CAM. There were some interesting tidbits, nevertheless.
Figure 2 summarizes the results and indicates significant rates of use of homeopathy, therapeutic touch and Curanderismo (folk healing) by faculty.
Perhaps more interesting than the paper itself is this survey (also from UCI) which it cited, showing that medical student use of CAM modalities exceeded rates of CAM use in the general population! Students’ use of CAM didn’t decrease over time. The list of modalities used included vitamins, meditation, massage, herbals, chiropractic, traditional Oriental, T'ai Chi, homeopathy, Ayurveda, therapeutic touch and Curanderismo.
Statin use is associated with reduced mortality in these conditions according to a study published in Chest.
This topic was recently reviewed in the American Journal of Medicine. Cirrhosis of any cause is the principal risk factor, particularly related to hepatitis B and C infections, chronic alcohol abuse and non-alcoholic steatohepatitis in the settings of obesity and type 2 diabetes.
Associated paraneoplastic syndromes may occur due to the elaboration of erythropoietin, insulin-like growth factor and parathyroid related protein.
Screening for HCC is controversial although some organizations recommend ultrasound every 6 months in high risk patients.
Diagnostic and treatment strategies are presented.
An update, summarizing key papers for 2006, was published in the American Journal of Respiratory and Critical Care Medicine. The article is open access full text.
Highlights of a recent Cleveland Clinic Grand Rounds covering perioperative cardiovascular medicine, drug eluting stents, statins and cerebrovascular disease. (Via CCJM).
---for the National Center for the Promotion of Pseudoscience (NCPP) or, if you prefer, the National Center for Complementary and Alternative Medicine (NCCAM). It’s been a while, at least a few weeks, since I’ve picked on the NCPP. Maybe I had grown weary and needed to give it a rest. But today Orac stoked the flames with this exposé in the wake of their 2008 budget announcement.
He makes this point that I’ve hammered on many times before:
Indeed, there appears to be no woo so implausible, so without basis in science, that NCCAM won't take it seriously. Homeopathy? Check. Qi gong? Check. Craniosacral manipulations? Check. In children, yet! Shamanic healing? Check! Distant healing? Check!
And this:
Here's the problem. Negative studies don't matter. If a study shows that a particular CAM "remedy" does no better than placebo, CAM practitioners don't believe it. Can anyone point me in the direction of a single "alternative" remedy that, after multiple negative studies, has been abandoned?
The Orac challenge! But worse yet not only do the practicing woomeisters not abandon debunked woo, neither does the NCCAM! Take chelation. (Please!). In spite of high level evidence against the use of chelation in the treatment of cardiovascular disease the NCCAM is funding a large multi-center trial (one which, as I demonstrated before, is riddled with conflicts of interest and methodological flaws). And, of course, there’s echinacea.
The NCCAM just won’t give up on anything. In this editorial they, in effect, rationalize away all their negative studies and explain why they have to do them all over again. They even propose to fund omics analysis on previous negative studies of CAM modalities.
And on and on it goes.
The presence of HIT antibodies (antibodies to heparin-platelet factor four complex) has been found in multiple studies to confer risk of arterial and venous thrombosis even in the absence of overt thrombocytopenia. Results of these studies along with pathophysiologic mechanisms are discussed in this review in American Heart Journal.
I previously cited a study showing a relationship between antibody positivity and a variety of adverse outcomes in patients undergoing cardiac surgery. Data such as these beg the question of whether patients (those with previous heparin exposure) should be screened for antibodies on a wide scale. The review authors suggest patient selection for antibody testing, but do not believe widespread testing is cost effective.
And it improved attendance by 38.4% in a recent study published in BMC Medical Education. Pharmaceutical industry support was used to help defray the costs. The authors felt they addressed any ethical concerns about industry support:
Industry support of MGR raises the ethical concern of industry influence over MGR organizers, content, speakers, and attendees (1-3,17,18). This concern can be addressed by using the following guidelines: 1) industry support should be unrestricted; 2) MGR speakers should disclose to attendees any conflicts of interest; 3) industry representatives should not determine MGR content; and 4) presentations at MGR should be unbiased, especially when the industry sponsor’s products are discussed (3,19,20). These guidelines are rigorously followed at our institution.
They concluded:
Providing free food may be an effective strategy for increasing attendance at medical grand rounds.
You should not say the U.S. has the best health care. You should not even think the U.S. has the best health care. So says Dr. Christopher Murray, head of the Institute for Health Metrics and Evaluation at the University of Washington:
“The starting point is the recognition that the U.S. does not have the best health care system. There are still an awful lot of people who think it does.”
But the information he’s basing that statement on, statistics indicating that the U.S. longevity ranking has slipped to 42nd in recent years, offers no proof of that assertion. It comes from this piece of spin at MSNBC which, in typical sloppy popular media style, didn’t bother to cite the primary source. (I did some poking around, and I think it’s here).
Via Dr. Helen.
Clinical Cases and Images weighs in here.
You may be if you hold to certain political views. I’m not talking about extreme positions and ideas that most decent human beings, regardless of political affiliation, know are morally outrageous. But our professional culture is becoming increasingly Orwellian as an ideologically correct medical thought police, expressing itself through journals, the web and other media, increasingly defines what is acceptable in the realm of speech and ideas.
Though I’ve observed the trend for a long time several recent examples have emboldened me to challenge the prevailing orthodoxy. Recently I linked to this Kevin post about the Lucidicus Project and suggested that medical students check it out as an alternative to the popular dogma concerning single payer health care. This was met with indignant and morally superior comments from two anonymous readers. One, apparently in academic medicine, implied that conservative thinking equals greed:
This philosophy starts at the top with our president who feels tax cuts for his friends the uber rich are clearly more important than health care for children.The best definition I've heard for compassionate conservatism is I feel your pain,I just don't plan to to a damn thing about it. So be greedy, and selfish, but don't complain when some calls you that.
The other commenter was outraged at the mere suggestion that medical students read material supporting capitalism:
So RW the champion of critical thought & skepticism is championing a site that suggests medical students need to read ayn rand and propaganda material about how capitalism is good for medicine? Give me a break.
Of course I wasn’t championing anything. The commenter was clearly rankled. Does he/she believe that medical students should be banned from reading politically conservative literature?
More examples:
Not long ago we were told that if we didn’t feel guilt and shame about global warming we need psychiatric help to increase our anxiety.
And there’s this JAMA commentary that tells us what we may and may not say about health care in the U.S.
More recently Retired Doc dropped a bomb with this post about a JAMA piece which appears to redefine medical ethics in terms of a sociopolitical agenda which favors increased government intrusion into our profession and implies that failure to support such an agenda is a betrayal of ethical principles to which physicians are honor bound.
If you want to promote your political agenda I’m willing to be convinced with evidence or logic. Engage me in a collegial discussion, but don’t try to shame me or impugn my character if I happen to disagree.
Background reading: PC, M.D.: How Political Correctness Is Corrupting Medicine. (Hurry, before it’s banned).
The Scientist has an article (h/t to Medpundit) examining this controversial issue. If the raw facts are too complex or boring for the general public how should scientists present information in a way that informs? One commenter, Greg Van Citters, comes close:
We need to approach communication for the masses at an entry level that assumes perhaps exposure to one high school course in biology. This in no way implies we should "spin" the facts or omit anything important. To the contrary, we need to provide the basic story anyone can understand, and also provide resources for more in-depth investigation. This tiered approach to communication allows the outsider to understand the basics and the more experienced to go beyond, all the way to the original research articles if they so desire.
The best scientists can do is to present the facts in plain language and direct the audience to primary sources. But Professor Matthew Nisbet and author Chris Mooney, writing in Science and the Washington Post apparently don’t think presenting the facts is enough. Their Washington Post piece is titled “Thanks for the Facts. Now Sell Them”. They write:
We're not saying that scientists and their allies should "spin" information; doing that would only harm their credibility. But discussing issues in new ways and with new messengers can be accomplished without distorting the underlying science. Good communication is by its very nature informative rather than misleading. Making complicated issues personally meaningful will activate public support much more effectively than blinding people with science.
Well, it sounds like spin to me. How, for example, can an issue of science be made “personally meaningful”? What can that possibly mean, other than the presentation of an issue in such a way as to play on public fear or special interest? And what does it mean to “activate public support” if not to advance an agenda?
Science should have nothing to sell. Science must remain objective. Scientific discussions at their best are sterile and boring. When such discussions enter the arena of public debate great caution is needed.
With all the recent discussion of UpToDate and how it compares with other resources let’s not forget Pub Med. It’s the ultimate site for evidence based medicine. After all, it’s precise and gets you to the primary sources.
A comment to a recent blog post said UpToDate is not as evidence based as Dynamed. It’s even been claimed that only about 10% of UpToDate’s content is evidence based. I don’t know what that means or how it was derived. UpToDate bases some recommendations on expert opinion but when it does, usually because no higher level of evidence exists, it clearly points that out. Other potential downsides are relatively infrequent revisions of content (every 3 months or so) and imprecise searching (partially made up for by ease of navigation and extensive linking).
Other popular EBM “filtered” resources such as Bandolier, Dare and Trip are useful but suffer from limited depth of content and imprecise searching. That brings me back to Pub Med. But Pub Med has a major hurdle. It requires skill which comes only with training and practice. That’s where PICO comes in. The first step in using Pub Med for evidence based searching is to formulate a focused clinical question which can be converted into Pub Med search terms. PICO is an acronym that lists the essential components of a focused clinical question: Patient population, Intervention in question, Comparison group or treatment and Outcome of interest. And that’s only the first step.
Medical schools are supposed to be teaching the skills of Pub Med searching, but given the widespread dependence of students and house staff on UpToDate trainees may not be getting the necessary practice. In fact, easy resources such as UpToDate and Google may have produced a dumbing down of formal searching skills, as I said here:
The medical Internet has grown and information retrieval is much better now, but there may be a downside. As is true in clinical practice, the ease and convenience that comes with new technology can lead to a decline in basic skills. Though the formal discipline of Boolean searching is as necessary now as it was 20 years ago for precise and comprehensive searching, today’s new and more user friendly resources don’t require the skill and many don’t even support it.
That brings me to this interesting study involving medical house staff at Duke, (via BMC Medical Informatics and Decision Making) which looked at residents’ Pub Med skills and the effectiveness of a software tool to enhance searching. The tool was a user friendly PICO template which served as a Pub Med interface installed on a hand held device. The findings, though inconclusive, (it was a pilot study with small numbers) suggested that residents’ skills were lacking, as evidenced by the number of ineffective searches, and improvement with the use of the template. The article is worth the read as much for its excellent general discussion of Pub Med searching as it is for the study results.
Obesity concerns may be just another example of medicalization according to Dr Hamish Meldrum, head of the British Medical Association. According to This is London:
Obese people are often simply greedy and should not always be treated with pills, the head of the British Medical Association has said. Dr Hamish Meldrum believes an obsession with medical labels may be stopping overweight people addressing their own problems. He said the obesity epidemic is being mistakenly targeted with medical treatments and doctors' appointments.
This topic was reviewed in a recent issue of American Heart Journal. QT prolongation and associated torsade de pointes (TdP) are the most common reasons for drug restriction in the U.S. market. Although the advent of preclinical molecular testing during drug development lessens the likelihood of new arrhythmogenic drugs unexpectedly entering the U.S. market the list of drugs causing QT prolongation and TdP continues to grow, with the most notable recent addition being an old medication, long believed to be safe, which is methadone.
The review discusses electrophysiologic mechanisms, guidelines for QT interval measurement and QTc determination and points the reader to web resources on drugs which prolong the QT interval, all of which I have previously provided here.
Most patients who develop drug induced TdP have at least one additional risk factor, including female sex, interacting drugs, electrolyte disturbances and genetic polymorphisms. This latter risk factor raises the issue of interaction between genetic susceptibility and drug effects with some patients having a forme fruste of congenital LQTS.
I have linked to several tigecycline reviews in recent months. This one from the Annals of Pharmacotherapy (via Medscape) is more comprehensive than most and warrants inclusion here.
The DocSurg is aggravated by the fifth vital sign. So am I. In his July 23 post DocSurg recounts the rise of pain management dogma this decade, focusing on Joint Commission’s mandate and the notion of the fifth vital sign. (By the way, check out his 2005 rant about Joint Commission!). He notes:
And that, my friends, is how we have gotten into the pickle of potentially overmedicating, overnarcotizing, and oversedating patients sometimes to dangerous levels. That doesn't just lead to sleepy patients......it can lead to death.
He then goes on to cite this paper from the Journal of the American College of Surgeons. The investigators set out to test the premise that present day use of unscientific pain scales causes injury and death from overmedication by comparing adverse events in time periods before and after the promulgation of pain rating scales and other pain management dogmas (1994-1998 and 2000-2004, respectively). The study showed an increase in the rate of deaths due to overmedication in the 2000-2004 period and concluded:
The current assessment of pain by computer-stored pain scales is in a state of imbalance, with excessive emphasis on undermedication at the same time ignoring overmedication. This imbalance reflects pain-service attempts to comply with external accrediting agencies. This preventable cause of death and disability in trauma patients is also occurring in noninjured patients. Surgeons must correct this problem by insisting on a balanced assessment of overmedication versus undermedication.
These unintended consequences were not unanticipated. But as the pain management initiatives were rolled out 8 years ago practicing doctors’ safety concerns were largely ignored.
