Sunday, August 31, 2008

CME conference---impressions of day one

Day 1 of the 34th annual Tutorials in the Tetons Update in Cardiovascular Disease took place yesterday.

Aortic aneurysm and dissection
Dr. Timothy Fleming presented an update on aortic aneurysm and dissection focusing on genetics, molecular mechanisms and underappreciated etiologies. A few pearls:

There is a strong association with congenital bicuspid aortic valve (it’s a disease of the aorta, not just the valvular apparatus; listen for that ejection click!).

A very strong and underappreciated association exists between giant cell arteritis (GCA) and thoracic aortic aneurysm/dissection. This is not new information (I first mentioned it here) but it’s underappreciated and seldom mentioned. Screening of patients with GCA for aneurysms, at baseline and periodically thereafter, was discussed.

Aortic dissection is temporally related to cocaine use.

The presentation was relevant and useful for internists, family physicians, hospitalists and cardiologists. It provided ample citations to primary sources and was free of commercial bias (the only two drugs mentioned were generic drugs).

To stent or not to stent---EBM to the rescue
Dr. J. Jeffrey Marshall presented data on the bewildering array of potential uses for cardiac stents, focusing on the new ACC guidelines. Fortunately the new guidelines take away much of the guesswork. Familiarity with the guidelines among hospitalists, general internists and family physicians will lead to a more appropriate and selective approach to referral of patients to cardiologists. The presentation was balanced, free of commercial bias and in conformity with recent evidence and guidelines.

Controversies in lipid management
There were two presentations on controversies surrounding the importance of lowering LDL, the use of medications to block LDL absorption (the Vytorin controversy) and the raising of HDL cholesterol. These incredibly complex topics were given the much needed nuanced treatment NOT provided by recent popular debate. I plan to blog about the issues when time permits.

More soon as time and Internet access permit! (My wife wants to take me shopping in Jackson after tomorrow afternoon’s sessions!).

The patient with antibiotic allergy

What do you do if your patient says she is allergic to “everything that ends in ‘cillin or ‘mycin”? I just found this review which, though a little dated, is useful in sorting it out. Free full text is available via Clinical Infectious Diseases.

CME conference---general reflections

I’ve just completed day one of this conference. Since 1981 this meeting has been part of an annual pilgrimage for self renewal, rejuvenation and learning in a relaxed atmosphere. I leave here each year looking forward to the next For the last few years, though, I’ve had an uneasy feeling about how long the conference can go on. It could not continue without some degree of industry support. In the last few years industry support for CME has been under siege.

The inquisition against industry supported CME is knee-jerk and intellectually lazy because it does not seek to evaluate offerings on their own merits. Yet, the movement is gaining influence and popularity and threatens CME as we now know it.

The burden of proof that industry support invalidates continuing education offerings is on those who call for its elimination. Out of my own heightened awareness of these concerns I plan to critically evaluate individual supported CME offerings in which I participate. One of the chief and most vocal critics of industry supported CME is Daniel Carlat, author of the Carlat Psychiatry Blog. His singular focus in evaluating CME offerings is bias. I think this is too narrow a view. Bias is one of many attributes of CME which include scientific rigor, conformity to evidence, scientific plausibility and relevance to ones specialty. Moreover, all speakers and authors are biased. That may be especially true in this conference because the speakers are experts. They are bound to have their own biases resulting from years of experience. As far as commercial bias goes, I haven’t observed it at this conference. I’ll be commenting on the overall quality of this year’s individual presentations with respect to commercial bias, balance and scientific rigor in the next few days.

Saturday, August 30, 2008

Shoot first, ask questions later

---in the empiric treatment of serious infections in hospitalized patients. Get out the shot gun first. After cultures are back you can deploy the rifle. The new maxim is different from what we’ve been taught in the past. This is another in a series of articles on the subject of emerging gram negative resistance recently appearing in Critical Care.

Recharging my batteries in Wyoming

I arrived at the Grand Teton National Park yesterday. I’ve been doing a little sight seeing today. CME starts tomorrow. I have limited Internet access and plan on doing a little live blogging from the conference as time permits. Since this meeting has some support from pharmaceutical companies I’ll offer my impressions about the scientific rigor and balance of the presentations.

Friday, August 29, 2008

Historical perspective on the AIDS pandemic

Are you old enough to remember the beginnings? Can you remember what you were doing when you heard or read the first report? A recent JAMA editorial reflects on where we’ve come since and where we’re going: Thus, despite remarkable successes, the stage is set for trouble far into the future. Read the rest here.

Joint Commission’s disruptive behavior standard

---has hit the pages of the latest issue of American Medical News. The article expresses concerns that mirror my own. From the article:

The moves are drawing fire from doctors. They say disruptive behavior policies, which can cover everything from criminal assaults to condescension, are often too vague and used against physicians who may step on toes when advocating for patients or who own competing specialty hospitals and ambulatory surgical centers.

Some worry that the commission's actions could make it easier for hospitals to target outspoken medical staff members.

Disruptive behavior policies have "already been used to remove from the medical staff physicians who have a different opinion from administration," said Jay A. Gregory, MD, chair of the American Medical Association's Organized Medical Staff Section Governing Council. "We'll see more of that as time goes on.”

The thought police are everywhere.

Thursday, August 28, 2008

Medical journals promote non-evidence based CAM

I previously mentioned this problem with examples here and here. Quackwatch has placed BMJ and the Annals of Internal Medicine on its list of nonrecommended periodicals (subcategory Excellent Except for Too Many Poorly Reasoned Articles on "Complementary" and/or "Alternative" Medicine). Now Kimball Atwood, blogging at Science-Based Medicine, gives us a masterful expose of The Wooification of Medical Journals, featuring, among other examples, the latest from NEJM.

Vancomycin nephrotoxicity---an emerging concern

Since the publication of dosing recommendations for trough vancomycin levels of 15-20mg/l it appears we’ve been pushing the envelope of nephrotoxicity. Some clinicians are pushing doses as high as 4 g/day. Such doses are associated with nephrotoxicity according to this recent cohort study published in Antimicrobial Agents and Chemotherapy.

Wednesday, August 27, 2008

Off for some CME

I’m flying out tomorrow and will be attending this meeting. I’ve attended almost every one since 1981. This will be my 26th time. The conference could have been titled "Cardiology for the Generalist", as it contains topics of interest to family practitioners, internists and hospitalists. This year’s program again features all star faculty including Dr. Gordon Ewy, chief of Cardiology at the University of Arizona College of Medicine and pioneer in CPR, as well as Dr. H. Robert Superko, a leader in the field of the genetics of lipid disorders and heart disease. The latest in CPR along with controversies in lipid management are among this year’s topics. This will also be a time for relaxation in the Grand Teton National Park. My wife and I plan on a little shopping in Jackson Wyoming and will probably spend a day in nearby Yellowstone National Park.
I’ll be feeling expansive and will blog in real time as I have access. I also have a few items scheduled for autopost.

Here are some Wyoming images from my many past trips.

The Nobel disease


an affliction of certain Nobel Prize recipients which causes them to embrace strange or scientifically unsound ideas, usually later in life.

David Gorski, blogging at Science-Based Medicine, examines Linus Pauling’s descent into pseudoscience as part of a discussion about the lack of evidence for vitamin C as a cancer treatment.

I’m Pharma-friendly!

I just found out I’ve been blogrolled on the Carlat Psychiatry Blog under the category of Pharma-friendly sites. OK, I’ll own that. I appreciate the tools the pharmaceutical industry gives us to help with patient care. Don’t read anything more into it. I appreciate the link from Dr. Carlat as well as his patience in answering my many questions as I press him on some of his views. I’ll add his site to my own list of links once I get around to some long overdue blog maintenance.

Hospitalist lay offs ahead?

It’s only a rumor, and not very well substantiated at that, but one which is getting plenty of attention in the blogosphere. If it’s true it may be an anomaly. Apparently there are 33 hospitalists for 330 beds. That seems like a lot.

Blogging jargon

A glossary from Wikipedia.

Safety concerns in the use of activated protein C

A review in the journal Critical Care summarizes safety data and recommendations including recommendations for patients on therapy who require invasive procedures. It is part of last December’s supplement on activated protein C.

Tuesday, August 26, 2008

Do life expectancy statistics justify single payer health care?


Using international life expectancy statistics as a justification for a government takeover of medicine is misleading and dangerous. Fortunately, some doctors and reporters know better

Via Med Politics

Monday, August 25, 2008

Should the medical profession police its bloggers?

The controversy began with a recent SGIM article which I discussed here. Then CMAJ piled on here and I responded here. Now American Medical News has weighed in with an article in which the crux of the debate is illustrated:

Dr. Lagu said the code is welcome but argued that professional groups should adopt policies explicitly addressing blogging ethics. The American Medical Association has no policy, and none is under development.

Some physicians disagreed with the notion of formal medical blogging standards.

"That's a horrible idea," said Robert M. Centor, MD, a blogger and member of the American College of Physicians' Board of Regents. "The beauty of the Internet and blogging and personal Web sites is that you can do with them what you want to do."

Dr. Centor, aka DB of Med Rants, posted on his own blog this morning concerning this issue:

Long time readers know that I am a social and internet libertarian. I do not want any medical organization telling me what I can or cannot write. I write at my personal risk, regardless of their "rules."

I agree.

H/T to Grunt Doc.

Pharmaceutical companies and continuing medical education: the issue is not new

Popular belief is that the controversy over drug company influence on physician education started in the 1980s. According to this commentary in the August 20 edition of JAMA the issue has been around much longer. Initial concerns surfaced in the 1950s and the debate has not changed substantially. While the deluge of new drugs and promotions is larger now, physicians have better and more readily available sources of information to keep track of new drugs and examine promotions critically.

See if this sounds familiar:

Following studies in the 1950s documenting that physicians consistently rated pharmaceutical sales representatives as the most important source in learning about new drugs, the role of commercial sources in physician education became a subject of research to market researchers, sociologists, psychologists, and the medical profession. These studies challenged the image of physicians as autonomous professionals insulated from the influence of marketing, and cataloged the nonrational bases of many prescribing decisions.

So the substance of the debate has not changed at all even if the conditions have. For all the talk about the profession’s “dependency” on drug companies today, in a very real sense doctors were more dependent in earlier decades. Doctors had a few journals and textbooks (usually out of date) and little else. There was no Internet and there were no EBM tools. Drug companies came to the rescue with multiple “throwaway” journals and monographs full of advertisements.

Absent the dates this paragraph could easily describe today’s climate:

As evidence of the influence of pharmaceutical marketing over prescribing decisions mounted by the late 1950s, a cadre of academically based clinical investigators and educators began to clamor for corrective action. In a widely cited 1957 address, Harry Dowling (an active member of the American Medical Association's [AMA’s] Council on Drugs) argued that the increasing influence of pharmaceutical promotion on bewildered physicians prescribing worthless or redundant drugs constituted a moral crisis and a failure of the profession to uphold its duties of self-regulation of knowledge. Dowling's critique was joined by other prominent figures in the fields of infectious disease (who linked the problem of antibiotic misuse to exuberant pharmaceutical promotion) and clinical pharmacology (who sought to distinguish rational from irrational use of
prescription drugs).

Fast forward to the 1960s when the payer source became a hot topic for debate (italics mine):

In 1963, a JAMA editorial declared of CME: "The principal source of financial support must come from within the medical profession. Financing often determines control, and control must remain in the hands of the profession." However, investing in CME required funds that could not be borne out by tuition fees alone, and the pharmaceutical industry soon proved a willing partner in providing the ever-increasing budget for high-technology communications solutions to information transfer in CME.

In other words over 40 years ago the role of drug companies in the funding of CME was considered important. That concern has gotten plenty of attention in this blog, where I have warned repeatedly against “throwing the baby out with the bathwater.”

Another recurring theme is the idea that the profession should “take control” of CME. While that’s often a call to end industry funding the idea could cut both ways. Loud voices favoring an end to industry funding are in the minority. Surveys suggest that most doctors in the rank-and-file do not want this support to go away. If the profession, with representation of all its members, really takes control of the issue some level of industry support will continue.

Daniel Carlat’s take this morning is here.

Friday, August 22, 2008

Is there a litmus test for CME?

Dr. Daniel Carlat, author of the Carlat Psychiatry Blog, seems to think there is if I read his latest post correctly. His simple litmus test, commercial support (if an activity is commercially supported it can’t be worthy of accreditation) is his alternative to my statement that each offering should be judged on its own merits. Why a litmus test? There isn’t the manpower, it seems, to evaluate each individual offering:

How can ACCME hope to monitor these programs in all the different specialties of medicine with a staff of 12, most of who are not physicians? There are literally thousands of commercially-sponsored programs per year.

So the ACCME doesn’t have the resources to do its job? Maybe the appropriate response would be to advocate for more resources. A litmus test for CME of guilt by commercial association is unfair because it has a prejudicial effect. The bias inherent in such an approach is revealed in Dr. Carlat’s own statement (italics mine):

Yes, it’s true that lack of industry funding does not guarantee unbiased presentations. However, presence of such funding almost guarantees a lack of balance.

Dr. Carlat’s final paragraph concerning the promotion of complementary and alternative (CAM) medicine is interesting. I had linked to three CAM CME offerings as examples of pervasive bias, conflicts of interest and scientifically unsound content in “Pharma-free” programs. I didn’t elaborate because I thought the examples spoke for themselves. Dr. Carlat countered:

Interestingly, the three activities he cites as “concerning” are programs that would never receive industry funding.

Well, yes, of course. That was my point. Maybe I’m missing something. He went on:

They are all courses on integrative or complementary medicine, offered by UCLA, Yale, and NIH. Each covers the clinical evidence for these treatments using evidence-based teaching, but because these techniques have little commercial potential, doctors are poorly informed about them.

Is he giving these programs a free pass? For excellent discussions on what’s wrong with that type of offering I would point Dr. Carlat to these resources.

Thursday, August 21, 2008

Prevention, recognition and treatment of abdominal compartment syndrome

Abdominal compartment syndrome is defined as a critical elevation in intra-abdominal pressure combined with clinical manifestations of renal and respiratory dysfunction in the setting of a variety of conditions (ascites, third space fluid accumulation following massive volume resuscitation, ileus and others). Prevention involves limitation of fluid infusion once the early resuscitation goals have been met. Treatment may involve percutaneous drainage, diuresis, renal replacement and other surgical options or, ultimately, surgical decompression.

Via Critical Care Medicine.

Pre-excited atrial fibrillation

Recognizing and dealing with it.

Wednesday, August 20, 2008

The idea of “never events” will lead to more lawsuits

Worse yet, suggests this WSJ article, it’ll take away the burden of proof! For common complications newly defined as “never events” by Medicare, such as infections, the new reasoning will be: this never happens; this happened; ergo the doctors and the hospital are to blame. That legal doctrine, Res ipsa loquitur, was once reserved for the rare instances of self evident negligence such as leaving an instrument in a patient. Now misguided policy wonks and public opinion leaders have opened it up to common complications which---yes, I’ll say it---are sometimes unavoidable. It may be the next malpractice crisis and it will probably accelerate the mass exodus of doctors from hospitals.

Via Kevin MD

More at Buckeye Surgeon and White Coat Rants.

New controversy surfaces about early goal directed therapy

The Wall Street Journal is not on my list of recommended medical links, but this story piqued my interest, since I have been a staunch advocate of early goal directed therapy (EGDT). The short version is that a multicenter NIH funded trial to assess EGDT is getting underway and at the same time accusations have surfaced about the scientific integrity of the original EGDT study. Apparently the accusations have angered Dr. Emanuel Rivers, originator of EGDT (aka the Rivers Protocol) and chief investigator of the original EGDT study. From the WSG article:

All this has angered the doctor who pioneered the aggressive therapy, Emanuel P. Rivers, vice chairman of emergency medicine at Henry Ford Hospital in Detroit. The controversy has taken on an ugly tone rare in medicine. Dr. Rivers has called his critics in Pittsburgh "the Pittsburgh pirates." In an email to a Toronto doctor, Dr. Rivers said some see criticism of his therapy as a "thinly veiled academic lynching."

We’ve already seen an attempted academic lynching of the sepsis guidelines here, which I debunked here. But Dr. Rivers, I believe, has more reason to be angry at the Wall Street Journal than the academics. The Journal article is full of distortions and confusing statements, and those readers whose attention span doesn’t extend beyond the sound bite may rush to a faulty conclusion about EGDT.

The article claims, but in a very roundabout and confusing way, that Rivers didn’t use an intention to treat analysis. And, all too typical of the popular press, primary sources are not given. The major point of confusion concerns the 25 patients who were excluded from the study. One statement quotes an uncited interview with Dr. Rivers:

Dr. Rivers, in an April interview describing how he proceeded, said "all 288 are randomized" -- that is, placed into either the standard-therapy group or the other group -- "and then some are excluded because they're not considered severe septic shock."

But once patients are randomly placed in a group, they must be included in a final analysis, according to a fundamental principle of medical research. Twenty-five were not, the medical-journal article makes clear.

That would imply that an intention to treat analysis was not used. This informal, uncited interview (which I was unable to find despite serious Googling) cannot be regarded as a reliable source to determine the methods of the Rivers study.

A quote from Rivers later in the article seems to contradict the interview (italics mine).

Dr. Rivers said that "randomization was valid," that "all patients enrolled in the [early goal-directed therapy] study were appropriately selected, randomized and examined statistically," and that "there are no scientific integrity issues in the study."

Well, when in doubt, go to the methods section of the original paper (italics mine):

We evaluated 288 patients; 8.7 percent were excluded or did not consent to participate. The 263 patients enrolled were randomly assigned to undergo either standard therapy or early goal-directed therapy; 236 patients completed the initial six-hour study period. All 263 were included in the intention-to-treat analyses.

Rivers really put one over on the NEJM editors if the WSJ allegation is true. I hope he responds to the WSJ (not that the quality of his research needs explaining).

There are more distortions. From the second paragraph:

Adding to the concerns: That hospital held patents on a medical device critical to the therapy.

We’re not told what the device was, but it must be in reference to a central line and/or an O2 sat monitor attached to it. The use of a central line is nothing new. It’s been common place in the management of critically ill patients for years. And, unless I misunderstand blood gas technology the use of a continuous monitor to measure SVC saturation is not an essential part of EGDT. You can simply draw a sample from the line and run it through a blood gas machine.

The next paragraph implies that EGDT is expensive---

The new therapy typically costs about $1,100 more per patient, by the estimate of Derek Angus, chief of critical care at the University of Pittsburgh. The U.S. has about 750,000 cases of sepsis each year.

---but ignores evidence that EGDT actually saves money.

The article’s description of the protocol is simplistic:

Sepsis kills in part because tissues don't get enough oxygen from the blood. Dr. Rivers's idea: Continuously monitor the level of oxygen in the blood and take steps to raise it if it gets too low.

For monitoring, he used a catheter, inserted in the jugular vein and slid to near the heart. If it showed that blood oxygen was too low, he elevated it with transfusions and often added a drug to make the heart beat harder.

Not quite. The rationale for the Rivers study was to asses whether the achievement of multiple hemodynamic goals makes a difference when done early. Those questions were driven by disappointing results of sepsis treatment reported in the 1990’s: that “any old time” goal directed therapy doesn’t work.

Arguably the most important function of the central line is the initial measurement of CVP to guide fluid resuscitation. The oxygen measurement, SVC saturation, is not a measurement of oxygen delivery as much as an indicator of tissue extraction.

Lead investigators in the NIH funded trial were interviewed in the accompanying video. Aside from what I believe to be a distortion about how widespread adoption of EGDT would impact the blood supply the video was helpful in explaining the NIH study. The three arms will be 1) standard (non protocol driven) care, 2) the full Rivers protocol and 3) the Rivers protocol minus the central line. I think this will be useful because it will help evaluate individual components of EGDT. It adds to the Rivers study, which looked at the whole package. From the NIH press release about the new study:

To implement this approach across the entire country is a daunting task. As a first step, the consortium aims to find out whether the protocol will have similar success at multiple hospitals across the nation.

Following a year-long period of establishing and training sepsis teams, the consortium plans to treat early severe sepsis in nearly 2,000 patients, enrolling patients over a two- to three-year period. It will randomly assign patients to Rivers’ protocol or to the existing “usual care” approach, which does not include such aggressive resuscitation. It will then follow all the patients for a full year after their recovery to detect any long-term differences in health and mortality rates.

Therein lies an unintended consequence. It’ll be years before we know the results. Meanwhile, aided and abetted by the press, clinical inertia will drag on. Hospitals administrators, already obsessed with perfunctory “core measures”, will have yet another excuse (“let’s just wait for the results of the NIH trial”) to delay institutional commitment.

That, of course, violates fundamental tenets of evidence based medicine: science is tentative; go with the best evidence you have at the time. So how good is the evidence for EGDT in 2008? As far as I can tell, the Rivers study is sound. I’ll need better sources than the WSJ to convince me otherwise. But if that’s not enough, his conclusions have been validated independently in other studies (here, here and here).

Tuesday, August 19, 2008

Type 2 diabetes, hospital medicine and primary care

A post and comment thread over at Musings of a Dinosaur provides much food for thought on these subjects. Briefly, one of Dino’s patients with DM-2 and CAD was admitted to the hospital with chest pain. Here’s Dino’s account:

Very nice 60-something patient with coronary disease, hypertension, hyperLDL, gout(the usual) and relatively mild diabetes. A1c's over the last two years ranged from 7.3 to 7.8%; ie, not perfect, but not horrible, MANAGED WITH DIET AND EXERCISE*. Already taking eight different meds for coronary disease, hypertension, hyperLDL, gout (the usual), so I was emphasizing exercise, diet and lifestyle management. Certainly considering adding some metformin at the next office visit.

At the first follow up visit Dino, who doesn’t round at that hospital and received no information from there, learns that the patient was placed on Januvia, metformin and glyburide all at once. Dino is critical of the hospital’s approach. An angry exchange with his commenters follows.

The crux of the matter is whether Dino should have been more aggressive in turning to drugs to push the patient’s A1c to the magic number of 7. Although Dino could have been kinder and gentler with his hospital colleagues I tend to side with him in this debate. The arrogance of some of his commenters is unbelievable.

To discuss benefits of pharmacologic treatment intelligently we have to distinguish between the effects of glycemic control on micro and macro vascular disease. This patient’s greatest risk, in the short term, is from macro vascular disease. What evidence is there that pushing the patient’s A1c to the magic number with drugs will improve macro vascular outcomes? Zilch. Drug therapy may even lead to macro vascular harm. I discussed that issue here and elsewhere.

What about micro vascular disease? The UKPDS suggests benefits of treatment, and that’s where we got the magic number of 7. Before you get too excited, though, read this and decide for yourself how meaningful those modest benefits are and whether they justify the downsides in your patient. (Especially if your patient is already on multiple other drugs to help control the macro vascular disease). So what was Dino to do? It’s not a slam dunk as some of his commenters seem to believe.

Were hospitalists involved in this mess? If so they were probably functioning as admitologists and roundologists in deference to the subspecialists. (That’s known as comanagement these days). This story raises an important question for hospitalists. How much should we fiddle with patients’ long term medications? It’s appropriate in some instances, but I tend to avoid it unless it’s really necessary. When we do fiddle, it’s all the more important to keep the PCP in the information loop.

Monday, August 18, 2008

Commercially supported CME: my response to Daniel Carlat

Daniel Carlat, M.D., author of the Carlat Psychiatry Blog and the Carlat Psychiatry Report, kindly responded to my criticism of his postings on Medscape’s commercially supported CME His reply, a little more nuanced than some of his earlier posts, provoked me to think and examine my own arguments more carefully. I have some further thoughts, but first a disclosure---I have written a few Roundtable Discussion pieces (non CME) for Medscape, and a disclaimer---I make no attempt to defend all of Medscape’s CME offerings.

Dr. Carlat acknowledges that most commercially supported CME is accurate. The problem, he argues, is bias. I think Dr. Carlat would agree that commercial bias isn’t the only form of bias. We’re all a little biased. The problem he’s citing is bias that is pervasive and systematic to a degree that produces distortion. That’s a problem, for example, with television news. It’s accurate for the most part, but, in the general public perception, systematically biased. If the Medscape CME articles he criticizes suffer from similar bias there’s an important difference from television news: disclosure. Disclosure does not fix the problem but it addresses it in significant ways. CME has accuracy, transparency and bias. The news has accuracy and bias but lacks transparency. Imagine how the public perception of television news would change if producers, writers and reporters had to disclose their political leanings.

Using Medscape’s Invega CME article as an example, Dr. Carlat implies that it is little more than an advertisement. He points out that although advertisements are required to be accurate they are very biased. I agree. CME must distinguish itself from advertising. But the bias in the Invega piece and other CME offerings Dr. Carlat cites results from the way the clinical questions are framed. A narrowly focused case scenario is presented which fits a unique niche for the sponsor’s product. Carlot notes:

Medscape's CME article on Invega is accurate, but is nonetheless promotional and commercially biased, because it focuses on the one clinical situation in which Invega offers an advantage over its competitors.

If that disqualifies the piece form accreditation it raises important questions about case based CME. What if a clinical problem under discussion has only one commercially available treatment, or one drug which is clearly superior to the alternatives? Many topics come to mind in my own areas of interest: Thromboembolism prophylaxis and the risk of heparin induced thrombocytopenia in a post cardiac surgery patient. (Arixtra, the only available anticoagulant with a clear advantage, would be featured). Improving outcome in a patient with severe sepsis: modulating the inflammatory and coagulation cascades. (Gotta be Xigris). Or how about Options for basal insulin coverage in a brittle type 1 diabetic. (Lantus and Levemir would be the clear choices). While Carlat might not think these topics worthy of CME they are common clinically important issues. I just made them up but they are typical of offerings we are likely to see more of given the recent clamor among some academics for more focused, case based CME.

Dr. Carlat raises another point. Some of Medscape’s offerings my not be in compliance with ACCME standards. Section 5.1 reads:

The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

On the surface that is so obviously true it’s a cliché, but a literal reading of the words would restrict comments on benefits of drug treatment to coverage of generics and orphan drugs! That’s not what the ACCME intended, so there has to be room for interpretation.

Section 5.2 reads:

Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. If the CME educational material or content includes trade names, where available trade names from several companies should be used, not just trade names from a single company.

Again there’s room for interpretation. Dr. Carlat has opined in no uncertain terms that Medscape CME violates ACCME rules. Although the case is less clear to me we may have an answer from ACCME soon, as Carlat has recently announced his intention to lodge a formal complaint.

While we all agree on the importance of quality educational offerings the debate over CME will go on. My take? Medscape CME may have quality problems. I differ from Dr. Carlat in that I think its offerings should be adjudicated case by case. I do not want to put Medscape out of the CME business. In general the offerings I’ve seen (and am qualified to comment on) are of good quality. Dr. Carlat has challenged me to pay more attention not only to accuracy but also balance. I intend to comment on this aspect of future Medscape CME offerings I link to.

I would be interested in what Dr. Carlat thinks about other forms of commercially supported CME, particularly meetings sponsored by national professional organizations and academic medical centers which are arguably protected by better firewalls.

Finally, I would be remiss if I didn’t point out that identification of the payer source is not a litmus test for the quality of a CME offering. No one has demonstrated a general correlation based on high level data. Dr. Carlat offers a few interesting anecdotes. I can easily counter with some of my own. Recently I attended a prestigious accredited course with no support from device companies in which a speaker promoted numerous non evidence based uses for inferior vena cava filters. I’ve seen similar clean, pharmfree and unbalanced promotions of coronary artery bypass surgery and angioplasty. More concerning examples (all ACCME accredited) can be found here, here and here. I could trot out many others. You get the idea.

Wednesday, August 13, 2008

The role of carbapenems in serious infections

In the treatment of sepsis an adequate antibiotic spectrum for the initiation of therapy (“empiric”) is essential. Patients fare worse if the coverage has to be broadened after the return of culture results. The emerging resistance of gram negative bacteria makes adequate empiric therapy more challenging. In particular, the appearance of extended spectrum beta lactamases makes late generation cephalosporins less attractive in many settings. This suggests an increasing role for carbapenems. A review in Critical Care examines this role. A future concern is the emergence of more resistance to carbapenems. What will we do when they begin to wear out their welcome? There’s not much else to turn to and the dry antibiotic development pipeline limits future prospects. (And you think hospitals are unsafe now!).

To illustrate what a challenge treatment of serious gram negative infections is in some centers, read this from the review:

At New York Hospital Queens, KPC-producing Klebsiella have become endemic. Thus, neutropenic patients with serious hospital-acquired infection receive a five-drug regimen to treat a wide variety of potential multiresistant pathogens. This consists of polymyxin B, vancomycin, rifampin, tigecycline, and a carbapenem.

Practical aspects of using activated protein C

Reviewed in the Critical Care supplement on apC.

Tuesday, August 12, 2008

Back and forth with Dr. Carlat about Medscape CME

Daniel Carlat, M.D. replied to my recent post defending Medscape CME. He made some good points. No time to do it justice now, but I’ll parse it in some detail in the next day or two.

Sunday, August 10, 2008

More fallout concerning Medscape CME

A mainstream media outlet---Business Week---has piled on in an article that draws heavily from Daniel Carlat’s controversial post titled Medscape’s CME Corruption which I previously referenced here. The article discusses Carlat’s criticism of a CME activity which gave favorable mention to Invega, one of the sponsor’s products.

From a recent Carlat post, quoting the article:

A spokeswoman for J&J's Janssen unit says in an e-mail that the company has no influence over its CME providers' selection of course content or faculty. "The accredited provider is solely responsible," she says.Talk about turfing the blame to someone else!

Assuming that their’s any blame to be turfed, all the statement says is that the company is in compliance with ACCME’s standards for commercial support.

From the article:

----Dr. Steven Zatz, Medscape's executive vice-president of professional services. He adds that in polls, 99% of Medscape users say they perceive no bias in the company's online courses.

That refers to a question about bias asked in the post course evaluation of every Medscape activity. Are 99% of Medscape users mind numbed idiots who can’t spot bias?

Concerning the Invega article, cited in his post on Medscape’s “CME corruption”, Carlat wrote "Has Janssen--I mean, Medscape--said anything inaccurate in this puff piece? No." That, we are to believe, is not important. In Carlat’s way of thinking the fact that the CME article is favorable to a product of the sponsor is damning enough without regard to the accuracy of the piece.

Carlat, who is very up front about his conflict (he runs his own for pay CME site), restricts his criticism of Medscape to its psychiatry offerings. In another post he gives two more examples, here and here. I would gladly defer to Dr. Carlat’s expertise in psychiatry concerning the accuracy of the content of these programs, but he doesn’t offer that. His problem with the first offering, about bipolar disorder, which mentions Lilly’s Prozac-Zyprexa combo, seems to be that its discussion of Zyprexa’s well known metabolic risks is too nuanced:

True to form, here is the only discussion of weight issues in this article:“Dr. Thase: Well, the good news on both OFC [Symbyax] and quetiapine is that they do not cause switching, do not induce cycling, and the primary metabolic consequence is weight gain, which is very reliably, accurately measured sequentially and you see it coming. No one will gain 5 kg without first gaining 2 kg, and particularly when they're warned ahead of time. So I would say 1 thing for the interest of primary care prescriber would be to gain some comfort with at least these 2 members of the atypical antipsychotic class, engage the patient in collaborative care and follow-up, watch weight gain closely.The diabetes risk independent of weight gain is rare. It does happen, but you will need to treat well more 100 patients before you actually see someone who develops new-onset diabetes out of the blue, so it is a real consequence, but a rare one and the dyslipidemia is almost entirely weight dependent. So if there is no weight gain, there will be no dyslipidemia.” This is the gentlest discussion of Zyprexa’s side effects that I’ve ever seen.

Gentle compared to media hype, to be sure. I have followed the diabetes story because of my interest in cardiovascular disease and this discussion squares pretty well with what I’ve read in the literature. If the discussants worded the risks much more strongly they would have to recommend a ban of Zyprexa. Would that be the more balanced view Dr. Carlat is looking for? His case would be stronger if he would cite inaccuracies in the discussion. Is their thinking wrong? Are their numbers wrong? Is there anything wrong with the content other than the fact that it’s gentle?

Dr. Carlat then makes an accusation for which he presents no evidence:

The activity is ostensibly a discussion between luminaries in psychiatry, and I’m sure that’s how it began. But the editors can cut and paste interviews to achieve a variety of results--I should know, because I do this every month for my own CME newsletter. When I edit my interviews, I do so for clarity and conciseness—but when Medscape edits, they do so to push the sponsor’s product.

He goes on to profile another CME piece on new approaches to treatment of ADHD, starting with: “There isn’t even an effort to provide the illusion of balance in this CME article.” That’s odd considering his cimplaints about Medscape’s lack of transparency. Again he focuses on the favorable portrayal of the sponsor’s products without commenting on the accuracy.

By the way, concerning the complaint that Medscape is not transparent, Carlat seems to contradict himself again here, in an interview hosted by Psych Central (italics mine):

One of the things that he said was that Medscape is “good, clean, and transparent.” And that bothered me because the real issue, and where the rubber meets the road in this entire debate, is when you look at the actual educational courses, are they biased, are they promotional, or aren’t they? I can give you a lot of rationales for why these things might become promotional, but if you look at them and they are just perfectly good unbiased education, then it really doesn’t matter who’s paying for it.

But when I looked at the psychiatry offerings after Dr. Lundberg published that editorial, I was astounded at how transparently and blatantly commercial and promotional all of the psychiatry CME courses that I reviewed were.

Dr. Carlat is an expert on psychiatric drugs. He is well qualified to offer a nuanced, science based critique of Medscape’s CME offerings in psychiatry but chooses not to. Instead he delivers a dose of his extreme cynicism. Here’s the logic. Drug company sponsors activity. Content is favorable to company’s product. Company stands to benefit. Ergo, “Note to Dr. Lundberg and Medscape: what you are doing is not clean, not good, and most definitely not transparent.” Dr. Carlat might as well type in ALL CAPS. This is not an appeal to scientific evidence and reason. At best it’s an appeal to a certain philosophical bent. At worst it’s an appeal to popular emotion and prejudice. Maybe Dr. Carlat thinks the disclaimer, prominently displayed in his sidebar, that his blog is very biased, gives him license to do this.

I have recently taken on the challenge of evaluating all Medscape CME offerings to which I link for accuracy of content. Eventually I’ll find some inaccuracies or unsupported claims. No CME is perfect, no matter who pays for it. (If you want an example of non industry supported questionable content put on your baloney detector and get a load of this, H/T to PharmedOut).

What does the future of CME hold? Unfortunately, McCarthyism is winning. In that same interview Dr. Carlat was asked about the future of Medscape:

That’s true, Medscape would be out of business, if they felt they needed to continue to produce accredited CME. However, the amount of money companies spend on accredited CME is 1.2 or so billion dollars a year. The amount of money companies spend on non accredited medical education, i.e., various forms of advertising, promotion, dinner talks, dinner programs, web based non CME programs is in the tens of billions of dollars. There’s plenty of money out there for a company like Medscape if they decide that they want to continue to depend on pharmaceutical money. They simply could no longer call their offering “accredited” CME.

I agree with Dr. Carlat on that point. If the inquisition wins, what’ll be left of Medscape if it stays in business at all? Meanwhile CME will get more expensive and harder to obtain. It remains to be seen whether the quality will be better. There’s not a shred of evidence, nor is there any reason to think, that it will.

H/T Kevin MD

Friday, August 08, 2008

What is a troll?

I’ve been Internet naïve. I thought a troll was a horrible monster that lived under a bridge. More recently I learned that troll, according to Wikipedia’s definition, is Internet jargon for “someone who posts controversial and usually irrelevant or off-topic messages in an online community, such as an online discussion forum or chat room, with the intention of baiting other users into an emotional response or to generally disrupt normal on-topic discussion.”

According to the definition a troll is a spammer or a gadfly who acts alone or with a few supporters to disrupt a larger online group. But that definition may be too restrictive. There is a larger sense of the word, as examined in a recent New York Times Magazine article that delves into the vast world of trolling. From the many comment threads and blogs linked there (which are as interesting as the article itself) we can surmise that trolling comes in many forms. There is general agreement that trolling is usually (but not necessarily always) bad and can range from mere naughtiness to sociopathic and even criminal behavior. To complicate the discussion further, distinction between troller and trollee is sometimes fuzzy. In any vigorous on line debate there’s likely to be a little trolling on both sides.

This hits home. In my pre-blogging days I went through a sort of trial by fire at the hands of an online group. Years later I became convinced that even though I was the sole dissenting voice I was, in a very real sense, trolled. Thoroughly, relentlessly, mercilessly trolled. Why? The group had an impassioned agenda and couldn't seem to countenance tough questions and challenges to their views.

I was baited. The administrator, noting a shrill and awkwardly worded contrarian opinion I had expressed elsewhere, “cordially” invited me to join the group by using the piece, verbatim, as my inaugural post. Ignoring a cardinal rule of netiquette, lurk before you leap, I bit. Possessing neither impressive academic credentials nor Internet savvy I provided this august group an easy target for ridicule. Over the next several years many appeals to evidence went unacknowledged and personal attacks trumped collegial debate. Although the group’s raison d’etre was about professionalism much of the on line behavior exhibited there was anything but professional. I had only a visceral awareness of what was going on at the time. Much later, reading about trolling helped me conceptualize it.

It was a valuable and fascinating experience and may have helped stoke a "fire in the belly" that fuelled my blogging. I needed my own sandbox.

When is it inappropriate to enter the long tail?

One of the challenges of the long tail is knowing when and when not to enter it. In Bob Wachter’s recent post on patient centered care he recounted a tragic case of hyperparathyroidism misdiagnosed as leptospirosis. Rather than thoughtful consideration of long tail diagnoses as DB has described, this may be an example (combined with some serious system problems) of an impulsive and inappropriate leap into the long tail ignoring, among other things, the maxim that “common things happen more often.”

Why did the doctors make the leap? We don’t know, but Wachter thinks he’s seen the dynamic before, and relates this story:

When I was a UCSF resident, one of the community-based physicians admitted a patient to me. This physician, may he rest in peace, had a well-deserved reputation for clinical incompetence. “Bob,” he said in his glad-handing way, “I think this guy has amyloidosis.” I was impressed: amyloid is an unusual disorder with a variety of fairly specific organ system derangements. Was it possible that Dr. X had analyzed the signs and symptoms and made this diagnosis? That seemed farfetched. “What makes you say that?” I asked, genuinely interested. “Well, I saw a guy a few months ago who was really, really sick, and he turned out to have amyloidosis.” I’m guessing that some hapless Irish doc saw one serious case of leptospirosis, and he'll keep making that diagnosis until a new case happens along or he retires, whichever comes first.)

I think I’ve seen this on occasion. Someone has a pet diagnosis, an uncommon disease, and leans on it to explain virtually every really sick patient with mysterious signs and symptoms. I don’t know of a label for this sloppy cognitive shortcut, so maybe we should call it the “pet diagnosis heuristic” or the “impulsive leap into the long tail.”

Thursday, August 07, 2008

More food for thought (and healthy skepticism) on patient-centered care

As I was mulling over Don Berwick’s definition of patient-centered care there occurred to me a couple more problems with his model. First, most patients don’t want to be the clinical decision makers, at least according to this large study. Most patients want us to be a little paternalistic.

Second, patients’ participation in clinical decisions is meaningless and may be harmful if their choice is not properly informed. Even for the intelligent patient, the best case scenario, the process is tedious and time consuming as I once described here:

Consider these case examples. You are counselling your patient about upcoming knee replacement. You plan to give enoxeparin for DVT prophylaxis. How do you inform the patient? Sure, you know that it’s the right thing to do and all the experts recommend it, but the patient deserves evidence. So, you do a Pub Med search (or, somewhat more easily, consult a filtered resource such as Up To Date) and cull out the studies you critically appraise as valid and applicable to your patient. In order to advise your patient on the magnitude of benefit of the proposed treatment you look for, or calculate the absolute risk reduction (ARR) for the proposed treatment as well as the absolute risk increase (ARI) for bleeding. In order to translate this into language the patient can understand you then, from the absolute risk reduction for DVT and the absolute risk increase for bleeding, calculate the number needed to treat (NNT) and number needed to harm (NNH) respectively. You then have the discussion with the patient, modifying it as necessary to take into account any unique attributes of your patient which might increase bleeding risk. If the patient is to be discharged early after the surgery you must also provide information concerning the cost of continued enoxaparin at home, taking into account the patient’s financial condition and payer sources. Then you ask the patient and any concerned family members if they have questions, answer them as they arise, and document your discussion in the medical record. Time consuming, eh?

It may sound extreme but it’s the only way to apply Berwick’s model and still practice evidence based medicine.

Wednesday, August 06, 2008

Separating clinicians from automatons: the long tail

DB has written a series of posts on this concept (here, here, here, here, here and here). There’s little I can add but I wanted to get them into my own links, and going through the exercise below has helped my understanding of the concept.

The long tail refers to the horizontal tail of a power law graph. This is a polynomial function which has garnered great interest because of its applicability to a large number of phenomena in commerce and nature. When applied to differential diagnosis the horizontal axis can be visualized as an array of diseases of increasing rarity the farther away from the origin. The vertical axis represents the probability of the given disease explaining the patient’s presentation. A small number of common diseases are clustered toward the origin (to the left). Toward the right (in the long tail) are uncommon diseases, becoming increasingly rare as the graph approaches the horizontal axis as an asymptote.

Individual diseases in the long tail are uncommon. But, because the tail is long (there are many rare diseases), in the aggregate a significant number of patients is represented. That principle, a challenge for the clinician, is explained here.

DB uses the sore throat as an illustration. (If you think sore throats are boring read his posts and listen to his recent Grand Rounds presentation at UAB---scroll to July 30). Pneumonia is another example. Pneumococcal pneumonia would be near the origin. Blastomycosis, ANCA associated pulmonary capillaritis and bronchoalveolar carcinoma, diseases which can present as “pneumonia”, are in the long tail. For recurrent abdominal pain irritable bowel syndrome would belong on the left, with celiac disease and acute intermittent porphyria occupying positions progressively to the right. And so on.

The challenge of the long tail is knowing when to enter it and, once you do, to generate a wide enough differential diagnosis to encompass the disease the patient has, and finally to select appropriate tests to pinpoint the diagnosis. That’s why the long tail separates clinicians from automatons. Algorithms and guidelines won’t help. Up to Date may not even help! What’s needed is judgment along with a vast fund of knowledge about diseases. Key to knowing when and when not to enter the long tail, as DB explains, is knowledge of natural history. How long, for example, should it take your patient with pneumonia to get better? At what point, as a corollary, should you start searching for another diagnosis?

The description of this cognitive process and the contrast between clinician and automaton makes a compelling case for the revival of the original concept of the internist.

Image by Hay Kranen. Source: Wikipedia.

Another medical journal piles on

---in the criticism of medical blogs. A couple of weeks ago it was the Journal of General Internal Medicine. This time it’s CMAJ: Online medical blogging: don’t do it! (Is there a redundancy in that title?). As one rapid response commenter (our own DB) suggested, the authors are inappropriately painting all bloggers with the same brush:

Drs. Baerlocher and Detsky have made an interesting observation, but they have titled it poorly. I suspect that they have not spent much time reading medical blogs.

As blogger for over 6 years, I have never had an entry that resembles their example. Rather my blog focuses on the big ideas in medicine –

what is quality?
what is professionalism?
how does our
payment system impact health care delivery?
what is the impact of residency

I do sometimes include patient stories, but only for the purpose of discussing diagnostic issues.

The world of blogging is quite diverse. I agree with the authors that the type of blog in which one vents about problem patients, with enough information that one could identify the situation, is unprofessional. However, I strongly believe that the best medical blogs represent the 21st century version of Hyde Park, in which we explore ideas and present our opinions on the issues of the day.

I would echo those sentiments. Before I started blogging over 3 years ago there were at least a couple hundred active medical blogs. Many of them were the kind of on line diaries mentioned in the article. I wanted to do something different, and after thinking long and hard decided that clinically focused blogging, which I thought I would enjoy, was an under represented niche. While I’ve maintained that focus for the most part I can’t resist occasionally weighing in on certain hot button issues such as medicine’s New McCarthyism concerning Pharma and doctors and the egregious incorporation of quackery in mainstream medical education.

H/T to Clinical Cases and Images.

Tuesday, August 05, 2008

Too tired to blog

---at my usual pace the last couple of weeks, due to the demands of my hospitalist practice. I’ve slacked on blog reading too, so posting over the next few days may consist of a belated roundup of interesting stuff from other blogs. I even missed my third blogiversary. (It was two weeks ago tomorrow)!

What does “patient-centered” mean?

A few years ago the Institute of Medicine (IOM) told us that health care was suddenly to become “patient-centered.” What did that mean? In my simple way of thinking health care had always been about taking care of patients. Good old fashioned doctoring. How could you be more patient centered than that? Respecting patients’ values and preferences was nothing new. Did the IOM have a loftier concept in mind? No one seemed to offer much of a definition, at least until now.

Yesterday Bob Wachter blogged about an ABIM forum on patient-centered care. Many anecdotes and viewpoints were shared, but I was most interested in Don Berwick’s definition of patient-centered care. Dr. Berwick, leader of the Institute for Healthcare Improvement (IHI), defined it thusly:

The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

Berwick elaborated on the definition by espousing a model of extreme consumerism. Attacking the writings of Eliot Freidson (a sociologist who argued that doctors, because of their professional expertise, had a unique ability to judge their work and decisions) he said:

…Let me drive my stake into the ground firmly at one end of the range between the professionally dominant view of quality of health care and the consumerist view. My stake is far from Freidson’s definition. Indeed, I think it wrong for the profession of medicine, or the profession of nursing, or any other health care profession, for that matter, to ‘reserve to itself the authority to judge the quality of its work.’… For better or worse, I have come to believe that we – patients, families, clinicians, and the health care system as a whole—would all be far better off if we recalibrated our work such that professionals behaved with patients and families not as hosts in the care system, but as guests in their lives.

Well, that kind of thinking turns professionalism upside down and devalues scientific expertise. Berwick was pressed by a member of the audience: would he order a non-evidence based cardiac CT on a middle aged man just because he asked for it and wanted reassurance? He would.

According to Berwick’s notion I may not be very patient-centered. I won’t prescribe antibiotics to every patient with sniffles and a cough who demands them, I won’t order “total body scans” on all patients who ask for them and I won’t tolerate woo in mainstream healthcare just because the public wants it.

Berwick’s ideas are right out of the Postmodern Medicine playbook. Postmodernism in medicine was best articulated by JA Muir Gray’s Lancet paper from 9 years ago. Postmodern medicine, he wrote, distrusts science and legitimizes complementary and alternative medicine. In the postmodern view patient perception and preference trumps professional expertise, which it views as being “paternalistic.” (If this is the view of patient-centeredness the IOM adopts it’s no surprise that they advocate for non-evidence based alternative medicine).

The real problem with Berwicks’ remarks on patient-centeredness is that they don’t square with his speech at SHM 2008 in which he criticized the U.S. health care system for its inefficiency. He trotted out data from the Dartmouth Atlas Project to show how countries with single payer health systems in the developed world achieve comparable outcomes with less cost than the U.S. The reason? The U.S. consumers pay more to get more, but what they get is often ineffective and wasteful!

Has Berwick flip-flopped? More likely, he’s trying to have it both ways. Does he think the radical consumerism in the U.S., where patients want what they want when they want it, is compatible with single payer health? No wonder some call it Kool-Aid.

Monday, August 04, 2008

Will your EMR crash and burn?

From Medical Economics:

Close to 20 percent of healthcare organizations surveyed by the Medical Records Institute in 2007 either had uninstalled an EHR system or were in the process of doing so. The federal government estimates that the EHR failure rate tops 30 percent.

To be sure, some flops can be blamed on a software or hardware "lemon." But most of the time, the culprits are all-too-human problems—poor planning, poor communication, and poor training.

How to avoid this nightmare: build gradually and go slow, according to the experts.

Mechanical ventilation in COPD patients

The May issue of Critical Care Medicine contains a review of mechanical ventilation in COPD including a discussion of noninvasive positive pressure ventilation.

Meta-analysis 101

From funnel plots to forest plots, a CCJM review explains how it works.

Friday, August 01, 2008

Bloggers profiled in the LA Times

Grunt Doc, Kevin, Ob/Gyn Kenobi and yours truly were mentioned. Read it here. Many thanks to author Melissa Healy for mentioning us.

If your blog has Sitemeter

----chances are it won’t open in Internet Explorer. Sitemeter developed an issue today and IE is vulnerable. Firefox works fine. The fix? Go into your template and remove the code for Sitemeter. Be sure to copy and paste your template into a Notepad file so you can restore things if you mess something up.

That’s what I did. I guess I’ll have to live without tracking my stats until I find another blog tracking service or Sitemeter fixes the bug.