tag:blogger.com,1999:blog-14747518806454985362012-02-16T13:08:27.941-05:00A discussion forum for physicians, researchers, and other healthcare professionals interested in how clinical trials evidence is generated, disseminated, and incorporated into clinical practice, how the evidence should optimally be incorporated into practice, and what the value of the evidence is to science, individual patients, and society.Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.comBlogger891100tag:blogger.com,1999:blog-1474751880645498536.post-91396442184035803922011-12-18T02:19:00.005-05:002012-01-04T12:00:10.279-05:00

How many studies do you suppose that we need before doctors realize that their tendency to want to transfuse blood in every manner of patient admitted to the hospital is nothing more than an exercise in stupidity futility based on the normalization heuristic?  It's a compelling logic and an irresistible practice, I know.  The hemoglobin level is low, that can't be good for the heart, circulation,

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-38382277518166721502011-11-10T22:46:00.013-05:002011-12-18T02:29:19.706-05:00

You're probably familiar with that Franciscan friar Sir William of Ockham, and his sacred saw. Apparently the principle has been as oversimplified as it has ignored, as a search of Wikipedia will attest. Suffice it to say, nonetheless, that this maxim guides us to select the simplest from among multiple explanations for any phenomenon - and this intuitively makes sense, because there are

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-70228832478982765722011-11-08T19:42:00.008-05:002011-12-18T02:29:50.064-05:00

I came across this PLoS Med article today that I wish I had seen years ago: Why Most Published Research Findings Are False . In this delightful essay, John P. A. Ioannidis describes why you must be suspicious of everything you read, because most of it is spun hard enough to give you a wicked case of vertigo. He highlights one of the points made repeatedly on this blog, namely that all

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-75553859945087773442011-10-06T23:24:00.003-04:002011-10-06T23:34:01.508-04:00

There is perhaps no better way to revive the dormant blog than to highlight an article published in JAMA yesterday about the role and effect of ECMO in the H1N1 epidemic in England: http://jama.ama-assn.org/content/early/2011/09/28/jama.2011.1471.full . Other than to recognize its limitations which are similar if not identical to those of the CESAR trial, there is little to say about this study

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-19717600579298805332011-04-19T00:32:00.012-04:002011-04-19T13:54:55.429-04:00

I have been interested in ECMO for adults with cardiorespiratory failure since the late 1990s during the Hantavirus cardiopulmonary syndrome endemic in New Mexico, when I was a house officer at the University of New Mexico. Nobody knows for sure if our use of AV ECMO there saved any lives, but we all certainly suspected that it did. There were simply too many patients too close to death who

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-37225329824454649072011-04-09T15:58:00.005-04:002011-04-09T16:55:16.640-04:00

In the March 3rd NEJM, Apixaban makes its debut on the scene of stroke prevention in Atrial Fibrillation with the AVERROES trial (see: http://www.nejm.org/doi/full/10.1056/NEJMoa1007432#t=abstract ), and I was favorably impressed. The prophylaxis of stroke in atrial fibrillation is truly an unmet need because of the problematic nature of chronic anticoagulation with coumarin derivatives. So a

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-91377229567399492052011-04-07T00:12:00.006-04:002011-04-07T17:26:46.265-04:00

I awoke this morning to a press release from the AMA, and a front page NYT article declaring that, in a post-trial follow-up of the WHI study, CEE reduces breast cancer in the entire cohort of post-hysterectomy patients, and lowers CHD (coronary heart disease) risk in the youngest age stratum studied.Here's a couple of links: http://well.blogs.nytimes.com/2011/04/05/

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com2tag:blogger.com,1999:blog-1474751880645498536.post-76763160290161052732011-04-03T20:00:00.004-04:002011-04-03T22:56:43.174-04:00

I previously blogged on Torcetrapib because of my interest in causality and in a similar vein, the cholesterol hypothesis. And I was surprised and delighted when the ILLUMINATE trial showed that Torcetrapib, in spite of doubling HDL, failed miserably. Surprised because like so many others I couldn't really believe that if you double HDL that on balance wonderful things wouldn't happen; and

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-22139178079604793702011-03-28T02:10:00.006-04:002011-03-28T02:28:05.302-04:00

There are many differences between cardiology and pulmonary and critical care medicine as medical specialties, and some of these differences are seen in how they conduct clinical trials. One thing is for sure: cardiology has advanced in leaps and bounds in terms of new therapies (antiplatelet agents, coated stents, heparinoids, GP2B3A inhibitors, direct thrombin inhibitors, AICDs, etc.) in the

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-44310246554520441162011-02-23T11:43:00.003-05:002011-02-23T11:49:38.539-05:00

News channels are ablaze with spin on an already spun report of the effects of cell phone radiofrequency (RF) signal on glucose metabolism in the human brain (see: http://jama.ama-assn.org/content/305/8/808.short).I'm not going to say that this study is an example of a waste of taxpayer money and research resources, but WOW, what a waste of taxpayer money and research resources.Firstly, why

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-72572042166142719992011-01-17T14:59:00.003-05:002011-01-17T15:06:55.974-05:00

Even the lay public and popular press (see: http://www.nytimes.com/2011/01/11/science/11esp.html?_r=1&scp=1&sq=ESP&st=cse) caught on to the subversive battle between frequentist and Bayesian statistics when it was announced (ahead of print) that a prominent psychologist was to publish a report purporting to establish the presence of Extra Sensory Perception (ESP) in the Journal of Personal and

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-13962194429726952952010-09-25T15:14:00.003-04:002010-09-25T15:20:48.112-04:00

Several years back, in the American Heart Journal, was published a now-widely referenced study of intercessory prayer to aid recovery of patients who had had open heart surgery (see: Am Heart J. 2006 Apr;151(4):934-42). This study was amusing for several reasons, not least of which because, in spite of being funded by a religious organization, the results were "negative" meaning that there was no

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-8327102384859422272010-08-20T18:19:00.008-04:002010-08-21T02:27:39.998-04:00

The recent article by Stone et al in the NEJM (see: http://www.nejm.org/doi/full/10.1056/NEJMoa0909905 ), which appears to [mostly] conform to the CONSORT recommendations for the conduct and reporting of NIFTs (non-inferiority trials, often abbreviated NIFs, but I think NIFTs ["Nifties"] sounds cooler), allowed me to realize that I fundamentally disagree with the CONSORT statement on NIFTs (see

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This blog was in part borne of an attempt to reduce the number of letters I sent to the editors of NEJM and JAMA.....but sometimes I still find it irresistable. The editors of JAMA, however, were able to resist this letter, and it was rejected, so I post it here.To the Editor: Kilgannon et al (http://jama.ama-assn.org/cgi/content/abstract/303/21/2165?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-92205437124179307872010-05-16T00:20:00.006-04:002010-05-16T00:34:30.178-04:00

I was pleased to see the letters to the editor in the May 6th edition of the NEJM regarding the article on the use of synthetic erythropoetins (see http://content.nejm.org/cgi/content/extract/362/18/1742 ). The letter writers must have been reading our paper on the normalization heuristic (NH)! (Actually, I doubt it. It's in an obscure journal. But maybe they should.)In our article (available

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-56955806076429118512010-05-01T21:00:00.009-04:002010-05-05T02:09:33.123-04:00

At long last, our article describing a bias in the design of RCTs in Critical Care Medicine (CCM) has been published (see: http://ccforum.com/content/14/2/R77 ). Interested readers are directed to the original manuscript. I'm not in the business of criticising my own work on my own blog, but I will provide at least a summary.When investigators design a trial and do power and sample size (SS)

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com3tag:blogger.com,1999:blog-1474751880645498536.post-44929192517567647092010-05-01T14:38:00.005-04:002010-05-05T02:18:16.931-04:00

In the most recent issue of JAMA, Terragni et al report the results of an Italian multicenter trial of early (6-8 days) versus delayed (13-15 days) tracheostomy for patients requiring mechanical ventilation (http://jama.ama-assn.org/cgi/content/short/303/15/1483 ). This research complements and continues a line of investigation of early tracheostomy in RCTs by Rumbak et al in 2004. In that

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com2tag:blogger.com,1999:blog-1474751880645498536.post-13029894727424132222010-03-23T11:42:00.013-04:002010-03-30T09:02:27.439-04:00

A recent article in JAMA ( http://jama.ama-assn.org/cgi/content/abstract/303/9/865) reports a meta-analysis of (three) trials comparing a strategy of higher versus lower PEEP (positive end-expiratory pressure) in Acute Lung Injury (ALI – a less severe form of lung injury) and Acute Respiratory Distress Syndrome (ARDS – a more severe form, at least as measured by oxygenation, one facet of its

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-10487421270492441962010-03-05T19:02:00.003-05:002010-03-06T15:21:31.947-05:00

Another excellent critical care article was published this week in NEJM, the SOAP II study: http://content.nejm.org/cgi/content/short/362/9/779 . In this RCT of norepinephrine (norepi, levophed, or "levo" for short) versus dopamine ("dopa" for short) for the treatment of shock, the authors tried to resolve the longstanding uncertainty and debate surrounding the treatment of patients in various

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com4tag:blogger.com,1999:blog-1474751880645498536.post-5548624769746764702010-02-09T03:20:00.004-05:002010-02-09T03:34:33.734-05:00

From Annane et al, JAMA, January 27th, 2010 (see: http://jama.ama-assn.org/cgi/content/abstract/303/4/341 ):"...patients whose septic shock is treated with hydrocortisone commonly have blood glucose levels higher than 180. These levels have clearly been associated with marked increase in the risk of dying...Thus, we hypothesized that normalization of blood glucose levels with intensive insulin

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-19926219982025156542009-12-29T01:17:00.002-05:002010-02-02T23:47:52.148-05:00

Last month JAMA published another article that underscores the need for circumspection when, as by routine, habit, or tradition, we apply the results of laboratory experiments and pathophysiological reasoning to the treatment of intact persons. Olasveengen et al (http://jama.ama-assn.org/cgi/content/abstract/302/20/2222 ) report the results of a Norwegian trial in which people with Out of

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-4911812927458212672009-12-16T01:12:00.006-05:002009-12-16T01:35:17.613-05:00

Anyone who thought, based on the evidence outlined in the last post on this blog, that dabigatran was going to be a "superior" replacement for warfarin was chagrinned last week with the publication in the NEJM of the RE-COVER study of dabigatran versus warfarin in the treatment of venous thromboembolism (VTE): http://content.nejm.org/cgi/content/abstract/361/24/2342 . Dabigatran for this

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-89508999358638934382009-09-21T00:48:00.010-04:002009-09-22T01:11:37.024-04:00

I'm growing weary of this. I hope it stops. We can adapt the diagram of non-inferiority shenanigans from the Gefitinib trial (see http://medicalevidence.blogspot.com/2009/09/theres-no-such-thing-as-free-lunch.html ) to last week's trial of dabigatran, which came on the scene of the NEJM with another ridiculously designed non-inferiority trial (see http://content.nejm.org/cgi/content/short/361/12/

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com8tag:blogger.com,1999:blog-1474751880645498536.post-27381196931491383492009-09-15T17:37:00.005-04:002009-09-21T02:29:39.712-04:00

Another breakthrough is reported in last week's NEJM: http://content.nejm.org/cgi/content/abstract/361/11/1045 . Wallentin et al report the results of the PLATO trial showing that ticagrelor, a new reversible inhibitor of P2Y12 is superior to Plavix in just about every imaginable way. Moreover, when you compare the results of this trial to the trial of prasugrel (Effient, recently approved, about

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com4tag:blogger.com,1999:blog-1474751880645498536.post-23165210348641901382009-09-06T23:17:00.009-04:002009-09-07T13:53:09.723-04:00

A 20% difference in some outcome is either clinically relevant, or it is not. If A is worse than B by 19% and that's NOT clinically relevant and significant, then A being better than B by 19% must also NOT be clinically relevant and significant. But that is not how the authors of trials such as this one see it: http://content.nejm.org/cgi/content/short/361/10/947 . According to Mok and

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com3tag:blogger.com,1999:blog-1474751880645498536.post-48832050745178735202009-09-05T16:00:00.004-04:002009-09-06T23:46:27.233-04:00

As a critical care physician, I have not infrequently been called to the emergency department to admit a patient on the basis of "abnormal laboratory tests" with no synthesis, no assimilation of the various results into any semblance of a unifying diagnosis. It is bad enough that patients' chests are no longer ausculted, respiratory rates and patterns not noted, neck veins not examined, etc. It

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com2tag:blogger.com,1999:blog-1474751880645498536.post-4978491848520675492009-08-13T19:41:00.005-04:002009-08-13T19:56:30.402-04:00

An epidemiological study of the impact of aspirin (ASA) on outcomes from colorectal carcinoma (CRCA) in JAMA has made quite a splash which has extended to the lay press (see Chan et al: http://jama.ama-assn.org/cgi/content/short/302/6/649?home ; and http://www.nytimes.com/2009/08/12/health/research/12aspirin.html ). I read this study, which normally would not have been of interest to me, because

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com9tag:blogger.com,1999:blog-1474751880645498536.post-8126390159153703462009-08-11T23:54:00.012-04:002009-08-12T11:13:30.728-04:00

"When in doubt, cut it out" is one simplified heuristic (rule of thumb) of surgery. Extension (via inductive thinking) of the observation that removing a necrotic gallbladder or correcting some other anatomic aberration causes improvement in patient outcomes to other situations has misled us before. It is simply not always that simple. While it makes sense that arthroscopic removal of scar tissue

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com5tag:blogger.com,1999:blog-1474751880645498536.post-43940412361499876022009-08-05T19:57:00.004-04:002009-08-05T21:46:35.439-04:00

During a recent review of critical care literature for a paper on trial design, a few trials (and groups) were noted to have pulled a fast one and apparently slipped it by the witting or unwitting reviewers and editors. This has arisen in the case of two therapies which have in common a targeted population in which efficacy is expected which population cannot be identified at the outset. What's

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-87386477579597770832009-07-10T01:52:00.002-04:002009-07-10T02:01:40.618-04:00

The medical evidence blog has turned out to be a fruitful experience for me and hopefully for others. The idea was conceived while I was at OSU auditing a course on capital punishment in the law school taught by the wonderful Douglas Berman, JD, who used a blog as part of the course material and who created the prominent SLAP (Sentencing Law and Punishment) blog. That formative and enriching

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-64931918063852269102009-07-09T00:21:00.003-04:002009-07-09T16:01:26.917-04:00

This a superlative article to jab at to demonstrate some interesting points about randomized controlled trials that have more basis in hope than reason and whose very design threatens to invalidate their findings: http://jama.ama-assn.org/cgi/content/abstract/301/23/2445?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=polymyxin&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT . Because endotoxin has

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-42804024425736672372009-06-20T13:17:00.002-04:002009-06-20T13:22:57.656-04:00

I am incredibly disappointed that the journal that I consider to be the very pinnacle of medical evidence continues to print ideological propaganda without any regard whatever to evidence and logic when it suits the editorial agenda http://content.nejm.org/cgi/content/extract/360/22/2360. Unadulterated propaganda pieces related to capital punishment, abortion, and gun control are shamelessly and

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-64813214521229276122009-05-11T23:53:00.009-04:002009-05-12T11:46:43.963-04:00

In last week's NEJM, there is an article about the purported perils of foregoing vaccinations for your kids. The article is here: http://content.nejm.org/cgi/content/full/360/19/1981 .There are a few points that I think deserve to be made about this issue. First, I digress to outline briefly the idea of "The Tragedy of the Commons."The Tragedy of the Commons refers to the notion that "commons"

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com4tag:blogger.com,1999:blog-1474751880645498536.post-23942128398416090242009-04-30T16:36:00.011-04:002009-04-30T18:04:11.682-04:00

The Cholesterol Hypothesis (CH), namely that the association between elevated cholesterol (LDL) and cardiovascular disease and events is a CAUSAL one, and thus that intervening to lower cholesterol prevents these diseases has seduced mainstream medicine for decades. However, much if not most of the evidence for the causality of cholesterol in atherogenesis and its reversal by lowering cholesterol

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com4tag:blogger.com,1999:blog-1474751880645498536.post-82777829156861688432009-04-21T16:23:00.011-04:002009-04-22T09:18:44.047-04:00

A recent article in the NYT described the adoption by the judicial system of a technology that began as a biomedical research tool (I resist to some extent the notion that DNA technology has directly been a boon to clinical patient care.) (See: http://www.nytimes.com/2009/04/19/us/19DNA.html.) This powerful technology, when used appropriately in appropriate circumstances, provides damning

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The March 26th NEJM was a veritable treasure trove of interesting evidence so I can't stop after praising NICE-SUGAR and railing on intensive insulin therapy. If 6000 patients (40,000 screened) seemed like a commendable and daunting study to conduct, consider that the PLCO Project Team randomized over 76,000 US men to screening versus control (http://content.nejm.org/cgi/reprint/360/13/1310.pdf)

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In the March 26th edition of the NEJM, the NICE-SUGAR study investigators publish the results of yet another study of intensive insulin therapy in critically ill patients: http://content.nejm.org/cgi/content/abstract/360/13/1283 .This article is of great interest to critical care practitioners because intensive insulin therapy (Leuven Protocol) or some diluted or half-hearted version of it has

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com7tag:blogger.com,1999:blog-1474751880645498536.post-31273058315225246292009-03-14T15:00:00.008-04:002009-03-14T15:50:13.130-04:00

Anyone who has played pool knows that you have to call your shots before you make them. This rule is intended to decrease probability of "getting lucky" from just hitting the cue ball as hard as you can, expecting that the more it bounces around the table, the more likely it is that one of your many balls will fall through chance alone. Sinking a ball without first calling it is referred to

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-9075072732502692612009-03-10T21:56:00.016-04:002009-03-12T06:51:02.776-04:00

In the current issue of the NEJM, Serruys et al describe the results of a multicenter RCT comparing PCI with CABG for severe coronary artery disease: http://content.nejm.org/cgi/content/full/360/10/961. The trial, which was designed by the [profiteering] makers of drug-coated stents, was a non-inferiority trial intended to show the non-inferiority (NOT the equivalence) of PCI (new treatment) to

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com5tag:blogger.com,1999:blog-1474751880645498536.post-90477631691975465342009-03-09T23:08:00.009-04:002009-03-11T01:10:08.791-04:00

I usually try to keep the posts current, but I missed a WONDERFUL article a few weeks ago in the NEJM, one that is pivotal in its own right, but especially in the context of good decision making about therapeutic choices and opportunity costs.The article, by Volpp et all entitled: A Randomized, Controlled Trial of Financial Incentives for Smoking Cessation can be found here: http://

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com6tag:blogger.com,1999:blog-1474751880645498536.post-5991200856132734092009-03-04T11:05:00.007-05:002009-03-05T14:43:36.437-05:00

Here is an article that may be of interest written by two perspicacious young fellows:http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WN2-4VP175C-1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=0067dfb6094ecc27303ccd6939257200In this article, we describe how the general clinical hypothesis that "normalizing" abnormal

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-37896494457263419512009-02-10T12:55:00.006-05:002009-02-10T13:10:11.009-05:00

Recently, Grocott et al published results of an intriguing study in which they drew blood gas samples from climbers near the summit of everest and analyzed them at one of the high camps with a modified blood gas analyzer. (See: http://content.nejm.org/cgi/content/abstract/360/2/140 ) This is no small feat, and the perhaps shocking results confirm earlier estimations of low arterial oxygen tension

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-86311522894087148522009-02-09T12:02:00.008-05:002009-02-10T11:26:10.529-05:00

A follow-up study of dexmedetomidine (see previous blog: http://medicalevidence.blogspot.com/2007/12/dexmedetomidine-new-standard-in_16.html )was published in last week's JAMA (http://jama.ama-assn.org/cgi/content/abstract/301/5/489 ) and hopefully serves as a prelude to future studies of this agent and indeed all studies in critical care. The recent study addresses one of my biggest concerns of

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-19732653174142361902009-02-03T22:47:00.010-05:002009-02-03T23:51:54.608-05:00

Amid press releases and conference calls today pertaining to the release of data on two trials of the investigational drug pirfenidone, one analyst's comments struck me as subtly profound. She was saying that in spite of conflicting data on and uncertainty about the efficacy of the drug (in the Capacity 1 and Capacity 2 trials - percent change in FVC [forced vital CAPACITY] at 72 weeks was the

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com3tag:blogger.com,1999:blog-1474751880645498536.post-79834517780988226772008-12-11T09:34:00.001-05:002008-12-11T09:34:51.499-05:00

Type your summary hereType rest of the post here

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-13633516095264759412008-06-02T13:25:00.010-04:002008-06-11T16:55:37.054-04:00

In the print edition of the June 5th NEJM (mine is delivered almost a week early sometimes), readers will see on the front cover the lead article entitled "Aliskiren Combined with Losartan in Type 2 Diabetes and Nephropathy," and on the back cover a sexy advertisement for Tekturna (aliskiren), an approved antihypertensive agent, which features "mercury-man", presumably a former hypertensive

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com10tag:blogger.com,1999:blog-1474751880645498536.post-79044666912146719972008-05-29T11:59:00.008-04:002008-05-29T12:48:34.162-04:00

In this week's NEJM, (http://content.nejm.org/cgi/content/short/358/22/2344) Camilleri (of the Mayo Clinic) and comrades from Movetis (a pharmaceutical company) report the results of a study of Prucalopride, a prokinetic agent, for the treatment of chronic constipation. What is striking about this study is not the agent's relation to Ciaspride (Propulsid, an agent removed from the market a number

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-48932709069639307942008-05-14T19:19:00.006-04:002008-05-15T20:22:05.905-04:00

In today's NEJM, Peacock and others (http://content.nejm.org/cgi/content/short/358/20/2117 ) report that cardiac troponin is STATISTICALLY associated with hospital mortality in patients with acute decompensated heart failure, and that this association is independent of other predictive variables. Let us assume that we take the results for granted, and that this is an internally and externally

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com2tag:blogger.com,1999:blog-1474751880645498536.post-66001229625082375452008-04-29T18:23:00.002-04:002008-04-29T18:51:41.279-04:00

When the ARMY gives up on something, you should be on the lookout for red flags. (Pentagon types beholden to powerful contractors and highly susceptible to sunk cost bias still haven't given up on that whirligig of death called the Osprey, have they?) But the ARMY's abandonment of a blood substitute that it found was killing animals in tests was apparently no deterrent to Northfield Laboratories,

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com6tag:blogger.com,1999:blog-1474751880645498536.post-15761747215849002732008-04-03T17:43:00.003-04:002008-04-03T22:46:28.419-04:00

I'm not sure that this is entirely in keeping with the theme of this blog, but I will justify it by saying that the health of the healthcare system is of vital interest to all stakeholders including researchers with an interest in clinical trials. The following letter was sent via the ACCP to my senators and congressmen in regards to the Medicare reimbursement cuts that are to be instituted in

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com15tag:blogger.com,1999:blog-1474751880645498536.post-16792099879378095482008-03-31T16:30:00.010-04:002008-03-31T19:43:53.100-04:00

Apparently, the editors of the NEJM read my blog (even though they stop short of calling for a BOYCOTT):"...it seems prudent to encourage patients whose LDL cholesterol levels remain elevated despite treatment with an optimal dose of a statin to redouble their efforts at dietary control and regular exercise. Niacin, fibrates, and resins should be considered when diet, exercise, and a statin have

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com7tag:blogger.com,1999:blog-1474751880645498536.post-33971703241832954152008-03-26T18:02:00.008-04:002008-03-26T18:27:55.411-04:00

In today's JAMA, (http://jama.ama-assn.org/cgi/content/extract/299/12/1474 ), Drs. Psaty and Lumley echo many of the points on this blog over the last six months about ezetimibe and torcetrapib (see posts below.) While they stop short of calling for a boycott of ezetimibe, and their perspective on torcetrapib is tempered by Pfizer's early conduct of a trial with hard outcomes as endpoints, their

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com2tag:blogger.com,1999:blog-1474751880645498536.post-80221658021882129482008-03-10T15:35:00.010-04:002008-03-10T19:08:02.576-04:00

The long-awaited results of another trial in critical care were published in a recent NEJM: (http://content.nejm.org/cgi/content/abstract/358/2/111). Similar to the VASST trial, the CORTICUS trial was "negative" and low dose hydrocortisone was not demonstrated to be of benefit in septic shock. However, unlike VASST, in this case the results are in conflict with an earlier trial (Annane et al,

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com4tag:blogger.com,1999:blog-1474751880645498536.post-14111281466416623282008-03-09T18:45:00.010-04:002008-03-09T19:54:15.564-04:00

Nobody likes "negative" trials. They're just not as exciting as positive ones. (Unless they show that something we're doing is harmful or that a product that Wall Street has bet heavily on is headed for the chopping block.) But "negative" studies such as an excellent one by Russell et al in a recent NEJM (http://content.nejm.org/cgi/content/abstract/358/9/877 ) show just how difficult it is to

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-4058611481898590922008-02-18T15:42:00.006-05:002008-02-18T16:01:03.045-05:00

A few weeks ago in The Lancet (http://www.thelancet.com/journals/lancet/article/PIIS0140673608601051/abstract ) appeared a wonderful and pragmatic article demonstrating the effectiveness of combining Spontaneous Awakening Trials (SATs) with Spontaneous Breathing Trials (SBTs) in the ICU. This strategy of "Wake Up and Breathe" was highly effective and critical care practitioners everywhere should

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-598366295328234432008-01-18T14:55:00.000-05:002008-01-18T15:27:46.509-05:00

Yes, according to this article in yesterday's NEJM:http://content.nejm.org/cgi/content/short/358/3/252Talk about publication bias. According to Erick H. Turner, M.D. and coauthors, the selective publication of only "positive" trials, in addition to publishing in a positive light studies that the FDA considered "negative" leads to a 32% increase in the apparent efficacy of antidepressant drugs, on

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com6tag:blogger.com,1999:blog-1474751880645498536.post-35690438034861613092008-01-16T10:57:00.001-05:002008-01-16T12:12:03.382-05:00

I am reminded of the surgical attending at Johns Hopkins who (perhaps apocryphally) would scream at the intern in the morning when a patient had done poorly overnight:"Whose side are you on, the patient or the disease?!"And I ask the ACC, "Whose side are you on? Patients' or Big Pharma's"?!Their main web page now links to this statement:http://www.acc.org/enhance.htmwhich states: "The American

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com13tag:blogger.com,1999:blog-1474751880645498536.post-88244033525788197072008-01-14T09:49:00.000-05:002008-01-14T10:51:24.313-05:00

Merck (MRK) and Shering-Plough (SGP) have finally released the ENHANCE data and they do not look good, neither for MRK and SGP stock prices (both of which were significantly down in pre-market trading!) nor for patients who have been taking ezetimibe as either Vytorin or Zetia - all the trends were in the WRONG DIRECTION (i.e., they favored simvastatin alone) IN SPITE OF robust additional LDL

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com4tag:blogger.com,1999:blog-1474751880645498536.post-66000858705263885372008-01-11T20:22:00.000-05:002008-01-11T23:23:05.653-05:00

In this week's NEJM is an anxiously awaited article about intensive insulin therapy in severely septic patients in the ICU: http://content.nejm.org/cgi/content/short/358/2/125This business of intensive insulin therapy began with publication in the NEJM in 2001 an article by Van den Berghe et al showing a remarkable reduction in mortality in surgical (mostly post-cardiac surgery) patients in a

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-46924358210380493132008-01-11T13:38:00.000-05:002008-01-11T13:49:53.428-05:00

Matthew Herper continues to lead the pack in investigating the shenanigans perpetrated by Shering-Plough (SGP) and Merck (MRK)in the conduct of the ENHANCE trial of Vytorin. I reiterate that it is my strong but measured and carefully considered opinion that this drug or ezetimibe should NOT be used in ANY patients until definitive evidence of efficacy is available, since alternative, more proven

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-9528244163328920242007-12-31T15:26:00.000-05:002008-01-02T14:33:17.434-05:00

Recently, Tobin and Jubran performed an eloquent re-analysis of the value of “weaning predictor tests” (Crit Care Med 2008; 36: 1). In an accompanying editorial, Dr. MacIntyre does an admirable job of disputing some of the authors’ contentions (Crit Care Med 2008; 36: 329). However, I suspect space limited his ability to defend the recommendations of the guidelines for weaning and

James M. O'Brien, Jr., M.D., M.S.noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-43714793648286238892007-12-28T21:53:00.000-05:002007-12-28T22:12:46.453-05:00

The purpose of the poll that has been running alongside the posts on this blog for some months now was to determine if physicians/researchers (a convenience sample of folks visiting this site) intuitively are Bayesian when they think about clinical trials.To summarize the results, 43/68 respondents (63%) reported that they preferred the larger 30-center RCT. This differs significantly from the

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com3tag:blogger.com,1999:blog-1474751880645498536.post-17674028345069310822007-12-21T23:40:00.000-05:002007-12-22T00:07:03.939-05:00

You wouldn't believe it - or would you? The NYT reports today that SGP has data from a number of - go figure - unpublished studies that may contain important data about increased [and previously undisclosed] risks of liver toxicity with Zetia and Vytorin: http://www.nytimes.com/2007/12/21/business/21drug.html Unproven benefits, undisclosed risks? If I were a patient, I would want to be taken off

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com19tag:blogger.com,1999:blog-1474751880645498536.post-20246009841414759182007-12-16T16:48:00.000-05:002007-12-16T18:48:09.055-05:00

In last week's JAMA, Wes Ely's group at Vanderbilt report the results of a trial comparing dexmedetomidine to lorazepam for the sedation of critically ill patients:http://jama.ama-assn.org/cgi/content/short/298/22/2644This group, along with others, has taken the lead as innovators in research related to sedation and delirium in the ICU (in addition to other topics), and this is a very important

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com3tag:blogger.com,1999:blog-1474751880645498536.post-8739886042776559842007-12-12T23:56:00.000-05:002007-12-13T00:12:26.429-05:00

Merck and Shering-Plough had better get their houses in order. Congress is on the case:http://www.nytimes.com/2007/12/12/business/12zetia.html?_r=1&oref=sloginApparently, representatives of the US populus, which pays for a substantial portion of the Zetia sold, are not pleased by the delays in release of the data from the ENHANCE trial. The chicanery is going to be harder to sustain.I certainly

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com5tag:blogger.com,1999:blog-1474751880645498536.post-14434937883090186632007-12-11T22:35:00.000-05:002007-12-11T23:19:22.740-05:00

In this week's New Yorker:http://www.newyorker.com/reporting/2007/12/10/071210fa_fact_gawandeAtul Gawande, a popular physician writer who may be familiar to readers from his columns in the NEJM and the NYT, chronicles the hurculean efforts by Peter Pronovost, MD, PhD at Johns Hopkins Hospital to make sure that the mundane but effective does not always take back seat to the heroic but largely

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-51808193560502167052007-11-30T18:35:00.000-05:002007-11-30T18:37:05.109-05:00

In this week's NEJM, two articles describe the results of two phase 2 studies of Eltrombopag, a non-peptide, oral agonist of the thrombopoetin receptor, one in patients with HCV and thrombocytopenia: http://content.nejm.org/cgi/content/abstract/357/22/2227 and another in patients with ITP: http://content.nejm.org/cgi/content/abstract/357/22/2237. I have grown so weary of investigators who must

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-83493883289082398062007-11-25T19:18:00.000-05:002007-11-28T09:20:56.278-05:00

I'm from Missouri, "The Show-Me State," and like many others, I'd like Merck and Schering-Plough to show me the ENHANCE trial results. I'd like them raw and unenhanced, please. This expose in the NYT last week is priceless:http://www.nytimes.com/2007/11/21/business/21drug.html?ex=1353387600&en=2d41b634a5c553df&ei=5124&partner=permalink&exprod=permalinkI just learned that Matthew Herper at Forbes

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com5tag:blogger.com,1999:blog-1474751880645498536.post-7551845901115595352007-11-25T18:55:00.000-05:002007-11-27T17:17:34.272-05:00

In last week's NEJM, Liou et al in an excellent article analyzed pediatric lung transplant data and found that there is scant evidence for an improvement in survival associated with this procedure:http://content.nejm.org/cgi/content/short/357/21/2143.The authors seem prepared to accept the unavoidable metholodical limitations of their analyses and call for a randomized controlled trial (RCT) for

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-73469416666321401862007-11-21T18:39:00.000-05:002007-11-27T17:21:16.557-05:00

I have watched the torcetrapib saga with interest for some time now. This drug is a powerful non-HMG-CoA-reductase inhibitor raiser of HDL (up to a 100% increase) and effects modest decreases in LDL also (20%) as reported with great fanfare in the NEJM in 2004: http://content.nejm.org/cgi/content/abstract/350/15/1505.Such was the enthusiasm for this drug that one editorialist in the same journal

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-4364768605008789642007-11-07T00:58:00.000-05:002007-11-27T17:18:16.191-05:00

Published early on Sunday, November 5th in the NEJM (http://content.nejm.org/cgi/content/abstract/NEJMoa0706482v1) is a randomized controlled superiority trial comparing clopidogrel to a novel agent - Prasugrel. Prasugrel was superior to Plavix. And it was superior to a degree similar to the degree to which Plavix is superior to aspirin alone. (See http://content.nejm.org/cgi/content/abstract/352

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com8tag:blogger.com,1999:blog-1474751880645498536.post-13011461638684485652007-11-03T18:36:00.000-04:002007-11-27T17:25:57.648-05:00

Victor et al report in the October 25th NEJM (http://content.nejm.org/cgi/content/abstract/357/17/1685) the non-inferiority of Hepatitis A vaccine to Immune Globulin for post-exposure prophylaxis of hepatitis A. The results are convincing for the non-inferiority hypothesis: symptomatic hepatitis A occurred in 4.4% of subjects who received vaccine versos 3.3% of subjects who received immune

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-19266575563045301622007-10-31T21:53:00.000-04:002007-11-27T17:26:44.221-05:00

In this week's NEJM (http://content.nejm.org/cgi/content/short/357/18/1821) authors from the Netherlands report a large series of asymptomatic patients who had brain MRI scans. There was a [surprisingly?] large incidence of abnormalities, particularly [presumed] brain infarcts, the incidence of which [predictably] increased with age. This is a timely report given the proliferation and technical

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-15074164242850314572007-10-07T21:44:00.000-04:002007-11-25T21:42:48.447-05:00

This last week's NEJM contains a long-overdue expose on CROs (contract research organizations): http://content.nejm.org/cgi/content/short/357/14/1365 .These organizations have one purpose: to carry out studies for the pharmaceutical industry in the most expeditious and efficient manner. The problem is that often, it is expeditious and efficient to compromise patient safety.The article states the

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-46795303799628205112007-09-28T08:15:00.000-04:002007-09-28T08:28:18.386-04:00

On the front page of today's NYT (http://www.nytimes.com/2007/09/28/health/policy/28fda.html?ex=1348718400&en=30b7a25ac3835517&ei=5124&partner=permalink&exprod=permalink)is an article describing a report to be released today by teh inspector general of the Department of Health and Human Service that concludes that FDA oversight of clinical trials (mostly for drugs seeking approval by the agency

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-83522854033442994142007-09-27T11:46:00.000-04:002007-09-27T11:57:07.971-04:00

In today's NEJM (http://content.nejm.org/cgi/content/short/357/13/1340), Halpern, Ubel, and Asch describe the use of defaults to improve utilization of evidence-based practices. This strategy, which requires that we give up our status quo and omission biases (http://www.chestjournal.org/cgi/content/abstract/128/3/1497?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&author1=aberegg&searchid=1&FIRSTINDEX=

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-67126175037773771412007-09-26T18:33:00.000-04:002007-11-27T17:27:53.402-05:00

Our letter to the editor of the NEJM regarding the anidulafungin article (described in a blog post in July - see below) was published today and can be seen at: http://content.nejm.org/cgi/content/short/357/13/1347 .To say the least, I am disappointed in the authors' response, particularly in regards to the non-inferiority and superiority issues.The "two-step" process they describe for sequential

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-76794289152704628812007-09-25T20:33:00.001-04:002007-11-27T17:28:44.809-05:00

The problem with non-inferiority trials (in addition to the apparent fact that the pharmaceutical industry uses them to manufacture false realities) is that people don't generally understand them (which is what allows false realities to be manufactured and consumed.) One only need look at the Windish article described below to see that the majority of folks struggle with biomedical statistics.The

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-63262219212863063002007-09-21T14:54:00.000-04:002007-11-27T17:29:16.968-05:00

But they want to: http://jama.ama-assn.org/cgi/content/abstract/298/9/1010This is but one of many unsettling findings of an excellent article by Windish et al in the September 5th issue of JAMA.Medical residents correctly answer only approximately 40% of questions pertaining to basic statistics related to clinical trials. Fellows and general medicine faculty with research training fared better

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-20321497160878110982007-09-15T20:24:00.000-04:002007-11-27T17:30:01.389-05:00

It eludes me why the NEJM continues to publish specious, industry-sponsored, negative, non-inferiority trials. Perhaps they do it for my entertainment. And this past week, entertained I was indeed.Idraparinux is yet another drug looking for an indication. Keep looking, Sanofi. Your pipeline problems will not be solved by this one.First, let me dismiss the second article out of hand: it is not

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-8638285987544537142007-09-05T23:07:00.000-04:002007-09-05T23:11:27.824-04:00

One of our astute residents at OSU (Hallie Prescott, MD) wrote this letter to the editor of the NEJM about the Slotman article discussed 2 weeks ago - unfortunately, we did not meet the deadline for submission, so I'm posting it here:Slotman et al report that prophylactic cranial irradiation (PCI) increases median overall survival (a secondary endpoint) by 1.3 months in patients with small cell

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-55051814472066536112007-08-20T12:09:00.001-04:002007-11-27T17:30:42.625-05:00

Slotman et al (August 16 issue of NEJM: http://content.nejm.org/cgi/content/short/357/7/664) report a multicenter RCT of prophylactic cranial irradiation for extensive small cell carcinoma of the lung and conclude that it not only reduces symptomatic brain metastases, but also prolongs progression-free and overall survival. This is a well designed and conducted non-industry-sponsored RCT, but

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com3tag:blogger.com,1999:blog-1474751880645498536.post-15742464405924530472007-08-06T22:34:00.000-04:002007-08-06T22:46:01.029-04:00

In tracing the history of evidence-based medicine tonight (for a lecture I have to give on Friday), a found the story of thalidomide on wikipedia (http://en.wikipedia.org/wiki/Thalidomide ).(While I recognize that the information provided on this site is uncorroborated, I also recognize that it has been referenced by Federal Distric Courts in various decisions - see http://www.nytimes.com/2007/01

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-67631367079682975452007-08-05T17:07:00.000-04:002007-11-27T17:31:20.078-05:00

Amid all the hype about Avandia recently, a few relatively clear-cut observations are apparent (most of which are described better than I could hope to do in the July 5 issue of NEJM. Drazen et al, Dean, and Psaty each wrote wonderful editorials available at www.nejm.org).1.) Avandia appears to have NO benefits besides the surrogate endpoint of improved glycemic control (and engorging the coffers

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-57226141720179011162007-07-31T22:06:00.001-04:002007-11-27T17:33:36.204-05:00

There are few endpoints that can hold a candle to mortality as the end-all, be-all of clinical trials design, but two appear to be fit for the challenge, (at least according to past FDA decisions) - or are they? Blood Pressure lowering and glycemic control.It is old news that Vioxx kills people, and does so utterly unnecessarily: alternative treatments are available that are generic, low cost,

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com3tag:blogger.com,1999:blog-1474751880645498536.post-52414443085726504912007-07-25T23:10:00.000-04:002007-11-27T17:34:51.125-05:00

The debate on the Swan Ganz catheter continues, this time spurred by a well done report documenting declining use of the catheter over the last decade, the results of an analysis of an administrative database (available at http://jama.ama-assn.org/cgi/content/short/298/4/423 ).The arguments used in this debate continue to befuddle me with their obvious lack of logical consistency with many other

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com1tag:blogger.com,1999:blog-1474751880645498536.post-8499317203851833602007-07-19T09:44:00.000-04:002007-11-27T17:35:25.479-05:00

Today's NEJM contains the report of an exemplary trial (the WAVE trial) comparing aspirin to aspirin and warfarin combined in the prevention of cardiovascular events in patients with peripheral vascular disease (http://content.nejm.org/cgi/reprint/357/3/217.pdf). Though this was a "negative" trial in that there was no statistically significant difference in the outcomes between the two treatment

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-61040024669518321752007-07-10T21:33:00.000-04:002007-11-27T17:35:51.886-05:00

The June 14th edition of the NEJM (http://content.nejm.org/cgi/content/short/356/24/2472) contains an article describing a trial of anidulafungin, a new echinocandin antifungal agent similar to the more familiar caspofungin, in invasive candidiasis. The comparator agent was fluconazole. This is a proprietary agent, and the study was was fully funded by the pharmaceutical sponsor.The trial was a

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com0tag:blogger.com,1999:blog-1474751880645498536.post-6485082648995237572007-07-10T21:16:00.000-04:002007-07-10T21:31:55.902-04:00

The goals of this blog are manifold. I will list a few of them below. Hopefully it will serve as a forum to discuss:Emerging evidence in medicineThe design, conduct, analysis, and reporting of clinical trials evidenceShenanigans perpetrated by investigators and pharmaceutical companies in the design, conduct, analysis, and reporting of clinical trials the impetus behind which appears to be

Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.com2