Early in my blogging days I reviewed the literature on this topic, concluding that the evidence was soft. That situation had not changed, even as recently as the evidence reviews I presented in our two most recent Medscape Roundtables on physician-industry relations. However, a new development this month warrants a brief revisit.
First a little background. The extensive literature on this subject has been spun by the No Free Lunchers and others as proving that industry promotion is harmful to patients. That conclusion goes far beyond what the evidence warrants. The main points of said evidence are as follows:
Promotions are biased.
Promotions influence attitudes.
Promotions influence prescribing behavior.
Individual doctors, in surveys, believe their colleagues are influenced but tend to underestimate their own susceptibility.
That’s about as far as it goes. Not what you’d call hard clinical endpoints, eh?
Now I don’t consider myself an expert but I’ve followed this literature closely for 10 years. As a participant on the No Free Lunch listserv for several years I heard and examined every argument---over and over again---against industry promotion.
But, hey, don’t take my word for it. It’s easy to check the primary sources. Virtually everything that’s been written on the subject is compiled and nicely organized in a huge repository, the Drug Promotion Database. And, although the web site appears to have an anti-industry bent the conclusion based on its literature review is circumspect. You can read the summary pages here and here and note the conspicuous absence of any evidence about promotional effects on patient outcomes. That’s because there wasn’t any.
Until now.
Yes, there’s finally evidence of the effect of an industry promotion on patient outcomes. And what’s really interesting is it’s one of the most maligned and heavily criticized industry promotions in all of medicine. It’s the Surviving Sepsis Campaign, which has been under extremely heavy fire for its ties with Eli Lilly and Edwards Lifesciences.
This NEJM perspective piece accused the campaign of being a marketing strategy disguised as evidence based medicine. Health Care Renewal (read here and here) and other bloggers heaped on more criticism and, predictably, the popular media jumped into the fray.
So what’s the new evidence?
Recently at the Society of Critical Care Medicine 38th Critical Care Congress the results of a 2 year multicenter study of the effects of the campaign were presented:
"Resuscitation compliance increased from 10.9% at baseline to 30.1% after 2 years," Dr. Levy said. "There was an almost linear increase [in compliance]. It was statistically significant with every quarter."
"Mortality dropped from 37% at baseline to 30% after 2 years," Dr. Levy reported. Although absolute risk reduction was 7%, relative risk reduction was 19% (P less than .01), he added.
To analyze the significance of the drop in mortality, the investigators assessed the baseline mortality on hospital admission.
"Baseline mortality did not change, which suggests a true drop in mortality," Dr. Levy said. "The findings showed us 2 things. One, that we were able to change clinical practice and that we were able to facilitate a knowledge transfer; and 2, that there was a real change in mortality."
Sure enough, industry promotion does influence doctors, and this influence was for the good. It saved lives. What’s interesting is that although guideline adherence almost tripled as a result of the campaign it was still only 30% at study end. It was encouraging that the trend was one of increasing influence over time, suggesting further improvement, and a more robust decline in mortality, had the campaign continued.
Despite these results many critics of physician-industry relations will continue their appeal to ridicule. It’s time to shift to an appeal to evidence.
Free full text review in CCJM.
Topic update in Chest.
Non-cystic fibrosis bronchiectasis is the focus of the review. Etiologies of non-CF bronchiectasis can be divided into post infectious causes, underlying systemic diseases and idiopathic.
Here’s a description of the Straw Man fallacy:
The Straw Man fallacy is committed when a person simply ignores a person's actual position and substitutes a distorted, exaggerated or misrepresented version of that position. This sort of "reasoning" has the following pattern:
Person A has position X.
Person B presents position Y (which is a distorted version of X).
Person B attacks position Y.
Therefore X is false/incorrect/flawed.
This sort of "reasoning" is fallacious because attacking a distorted version of a position simply does not constitute an attack on the position itself.
The Straw Man, a distorted and much weaker argument than the one actually put forth, is a convenient way to ridicule an opponent but fallacious none the less.A common Straw Man in the debate about physician-industry relations is one erected by Dr. Billy Rubin and Dr. Daniel Carlat in their response to our recent Medscape Roundtable discussion on industry supported CME: “I’m a physician and that entitles me to nice things.” As Dr. Rubin put it:I am a physician and that entitles me to nice things. Trinkets, such as free hors d'oeuvres at the cocktail hour following the day's professional meetings, fancy dinners on the tab of the local drug rep, tax-deductible trips to "educational conferences" in the Bahamas--all this is part of the trappings of the lifestyle of a doc. Such is the mentality that resists seeing the obvious conflict-of-interest in industry sponsorship of CME; the defense of the indefensible rests on an emotional response, not a rational one.
This is not new. It is a tired canard. Although this sense of “entitlement to nice things” is supposed to be widespread in our profession I have yet to see evidence that it exists to a significant degree, or that it is “the mentality that resists seeing the obvious conflict-of-interest in industry sponsorship of CME;”. Among the many counter arguments against the proposed ban on industry support I have yet to see the “entitlement” position advanced.
Of course, there is agreement on both sides of the debate on one entitlement, but it has nothing to do with nice things: physicians deserve high quality CME. Beyond that, where is the argument? Digression for personal disclosure: I am appreciative or CME meetings held at nice places but do not feel entitled to them. I will be disappointed if they disappear but I am quite grateful and content that I have received more than a square deal in my professional life. Really. Pharma’s support of such meetings helps reduce registration fees, but it provides no funding towards lodging, meals or any other “nice things.” My registration at meetings such as this is paid by my medical group, as are those lodging and transportation costs directly attributable to the educational program, and will be paid regardless of whether the activity remains accredited so long as I attest to the educational value.
So, is this attitude of entitlement pervasive among my colleagues? Where is the whining? If it really exists to the degree that Dr. Rubin and Dr. Carlat and others claim, it is, to say the least, a very troubling statement about our ethics. I decided to take a closer look at the responses to our Roundtable. They were overwhelmingly in favor of industry support. Some respondents bemoaned the high cost of non-supported CME. (High tuition fees are a significant expense to low salaried primary care docs, many of whom are on a tight budget struggling with practice overhead and educational debt. Some fairly inexpensive offerings do exist but the selection is limited. There are a few non-supported free offerings but they are limited in scope and some are of dubious origin). But among all the responses there was not one mention of nice perks or entitlement.
If Dr. Carlat, Dr. Rubin or other readers are aware of any published defense of Pharma supported CME that’s based on the premise of entitlement to nice things I hope they will cite it in the comments below.
The American College of Physicians has re-posted its guidelines on this topic and now it’s available as free access full text. As Medscape explains, the re-posting has revised disclosure and source information but no content changes. Although I linked to it the first time around it’s worth mentioning again.
I guess now for folks taking methadone all the narcotic contracts will need to be altered to include informed consent regarding the arrhythmia risks and an agreement that the patient will comply with the recommended ECG monitoring.
Reviewed in Seminars in Neurology.
It looks like the Dinosaur has been observing first hand something I blogged about a while back. He writes:
The proliferation of electronic medical records (EMRs) has generated a situation that really roasts my beef, and I am seeing it with increasing frequency. It's the flip side of the lawyers' old canard,
If it isn't documented, it didn't happen.
It seems that more and more doctors are taking that to mean that if something IS documented, then whether or not it actually happened is moot, at least as far as payment is concerned.There are at least two specialist offices who regularly send me letters documenting examinations that I know for a fact did not occur. In one case, the proof is that they document procedures requiring a level of patient cooperation and vocalization incompatible with the patient's age. (ie, How do you get a two-year-old to tell you in which ear the tuning fork sounds louder?) In another, a full body exam is documented at each visit when only the affected limb was examined. Those are the only two where my level of certainty is 100%. There are many others that are highly questionable, but harder to prove because of patient unfamiliarity with examination procedures.
In the paper days there were innocent examples like PERLA (now when was the last time you really checked the patient for accommodation?) as well as some more creative forms of writing. Paper based templates pushed the envelope of fraud, but the EMR became the great enabler.
Examples like those cited above may range from carelessness (to take advantage of the speed of the template generated note you neglect to go back and edit stuff out) to deliberate, thoughtful abuse. In either case you can bet your coding department will bill for what’s in your note!
They’ve devoted a new web site to it. What does it mean to be PharmFree? According to the web site (my italics):
AMSA promotes the conscientious, explicit and judicious use of the current best evidence in clinical care.
It’s straight out of David Sacket’s definition of evidence based medicine. It’s a joke, though, because the medicine AMSA actually promotes is some of the most extreme and non-evidence based woo of any mainstream medical organization I know of.
As reported in Hospitalist News, this will be another option for MRSA. Like many new antibiotics today the approval will probably be restricted to complicated skin and skin-structure infections, and it’ll be up to the rest of us to figure out its other applications. I know little about it but it sounds like vancomycin “on steroids”:
“I voted 'yes,' because I think vancomycin is a dying drug, and I see vancomycin resistance all the time,” said panelist Dr. W. Kemper Alston, who is at the University of Vermont, Burlington. Those voting “no” on the safety and efficacy question cited concerns about the association of the drug with more than one toxicity.
I blogged about vanco as a dying drug here.
The hospitalist model of care is one of discontinuity by design. Much attention has been focused on the patient safety hazards associated with this discontinuity. Researchers reporting recently in the Archives of internal Medicine uncovered another downside. Care by a hospitalist was associated with 57% increased odds of terminal patients spending their final admission in the ICU!
Decision making regarding the duration of oral anticoagulation following an episode of VTE can be difficult. In this study a positive D dimer after cessation of treatment was associated with over double the risk of recurrence.
CMAJ reports that proton pump inhibitors (PPIs), which inhibit the cytochrome P450 2C19 enzyme responsible for biotransformation of clopidogrel (Plavix) from prodrug to active drug, cause a clinically significant interaction leading to reduced effectiveness of clopidogrel. The exception among the PPIs appears to be pantoprazole (Protonix). From the article:
Among 13 636 patients prescribed clopidogrel following acute myocardial infarction, we identified 734 cases readmitted with myocardial infarction and 2057 controls. After extensive multivariable adjustment, current use of proton pump inhibitors was associated with an increased risk of reinfarction (adjusted odds ratio [OR] 1.27, 95% confidence interval [CI] 1.03–1.57). We found no association with more distant exposure to proton pump inhibitors or in multiple sensitivity analyses. In a stratified analysis, pantoprazole, which does not inhibit cytochrome P450 2C19, had no association with readmission for myocardial infarction (adjusted OR 1.02, 95% CI 0.70–1.47).
Via Heartwire.
A similar interaction occurs between clopidogrel and some statins which I have previously mentioned here and here. The significance of that interaction has recently been questioned.
You can read the news release here and the official web page here.
Judging from this news report it must have been an interesting time:
The mood was eerie: relaxed, calm, yet animated. Around 25 participants chatted, bobbing their heads along with their body language, discussing various published studies on acupuncture.It may not have seemed like anything out of the ordinary. Except they all had needles sticking out of the center of their heads.
They call it experiential learning.
The premise seems to be that no matter how implausible the woo if patients want it and believe in it, give it to ‘em with your good name and the credentials of your institution behind it. As one of the speakers explained:
Michelfelder asked the audience to keep an open mind during their day of discovery of different types of integrative medicine. Just because it is not well understood, physicians should not discount it, he said.“You may say to yourself, ‘It makes no sense to me, I’m not even going to recommend it to my patients because I don’t understand it,’” Michelfelder said. But as long as the patient believes it will work and the treatment is inexpensive, he said it’s worth a try.
This little exercise in Quackademic medicine was organized and driven by medical students and, sure enough, the AMSA was in on it.
From the Boston Herald:
A major medical group has canceled a multimillion-dollar convention in Boston, citing the state’s new law cracking down on free gifts, meals and other goodies handed out to doctors by the pharmaceutical industry.
Other life-sciences groups, meanwhile, are sending strong signals that they also won’t
hold conventions in Boston as long as the state’s new law remains unclear and out of sync with industry gift-giving standards.
In a letter to the Massachusetts Convention Center Authority, the executive director of the American Academy of Allergy, Asthma & Immunology said it was pulling out of its 2015 convention contract in Boston because it’s “very difficult” to find sponsorships and to provide education courses under current legal conditions.
The prohibition of gift giving is a moot point in view of Pharma’s voluntary decision to stop the freebies. Massachusetts is not exactly industry-friendly these days and the broader concern is what additional legislation may be in the pipeline, prompting professional societies to play it safe and take their convention business elsewhere.
Via Policy and Medicine.
Read about it here. I’m not sure why they are doing this, given the apparent success of the Journal, or what it means for the overall future of Medscape. The editors indicate that the other resources of Medscape will continue.
---is Vanderbilt’s Gerald Hickson, honored recently by the Doctors Company Foundation. To me his most fascinating work (I highly recommend a PubMed search by author) is in loss prevention, particularly how perception trumps reality in driving malpractice suits and how good communication can help.
More work for hospitalists. Graphic here.
I’ve cited several lines of evidence in this direction before. Here’s the latest:
A study by healthcare market research firm Manhattan Research found that only 9% of U.S. physicians oppose commercial support for continuing medical education (CME) funding. The results of this study are relevant to the ongoing discussion in the medical community about the role of commercial funding of CME.
The proponents of the ban are a tiny minority. Unfortunately they’re the most vocal. Unless rank-and-file doctors speak up they will face restricted choices of educational content.
One of the blog reactions to our recent Medscape Roundtable on pharmaceutical industry support for CME came from the new pseudonymous blogger, researcher, ID doc and part time hospitalist Billy Rubin. (Not to be confused, mind you, with this Billy Rubin). An ad hominem attack and the straw man played tag-team against me to produce some entertaining reading but, unfortunately, a misrepresentation of my section of the Roundtable.
Before I get to the ad hominem I should note that perhaps I started out on the wrong foot with Dr. Rubin in my choice of words. It was my characterization of the relentless hunt for corporate evil in every nook and cranny of medical education and the associated non-evidence based fear mongering as a McCarthyesque purge. OK, it was a little strong. It was intended to grab the attention of folks on both sides of the debate. I smiled when I wrote it. But it must have pushed Dr. Rubin’s choleric button and released some bad humors. It sent him off him on a rant and apparently so rattled him that, suddenly, all self reference shifted to the third person:
Then comes the whammy: The opportunities for continued learning are now better than ever due to the development of the Internet. Unfortunately, there is a movement afoot to limit those options. A growing McCarthyesque purge seeks to restrict our educational choices by banning industry support of continuing medical education (CME).
"McCarthyesque purge"?! Under the category-heading for inappropriate allusions, Doctor Rubin thinks that this statement may likely not be supplanted from its perch for the remainder of 2009. He would point out in detail the foolishness of the historical comparison, but prefers to think it speaks for itself and he has other fish to fry forthwith.
One more thing before I get to the ad hominem. In his opening section Billy asks this very important question:
So who would you want in charge of ensuring this education?
My personal answer to that question, as should be the answer of all practicing doctors, is I want to be in charge of my own education. With the help of self assessment tools such as MKSAP and Harrisons board review I am in a better position than some outsider from the medical thought police to make the best educational choices. Surveys find that the vast majority of doctors also feel that way.
He goes on:
You would think that professional societies, without any affiliations to for-profit companies, would arrange and direct the overwhelming majority of CME activities, but it just ain't so. As of 2001, drug companies paid over sixty percent of the costs of CME, and it does not appear the number is dramatically declining.
The implied premise is that because drug companies help pay for CME they control content. That premise is simplistic. It was partially true 20 years ago, but is much less so today. Gone, for example, are the one company, one drug topic, one speaker restaurant events (they still take place, but they’re no longer accredited). Given that drug company support does influence content to a limited degree even in today’s tightly regulated environment the person in charge is still you, the user. You make the choice. If you want to base that choice on the litmus test of whether the activity in question has industry funding that’s fine. Better that than outsiders making the decision for you. Be assured, though, that if the purge wins you will not be in charge of your CME.
Now on to the ad hominem attack, which was aimed at all four authors. Dr. Rubin wrote (my bold):
None of the four appear to have any expertise in the matter, at least by what Medscape reported about them. Dr. Rubin has no particular problem with non-expert physicians airing their thoughts on medical matters--he is one such non-expert doing so right now--but he does have a problem when the authors are leading a roundtable discussion on a website read by thousands of physicians around the country. Can I huff and puff in my blog? Sure. But I might not be the best person to speak with authority in a more formal setting, unless I had done a good deal of homework beforehand. And it's quite clear from reading the posts that nobody had done a great deal of homework, pro or con.
Authority? Had Dr. Rubin taken a moment to check the background of the Roundtable and find out what it is and purports to be it would have been clear that the series is little more than a soap box (and a very informal one at that) where doctors, medical students, residents and nurses can air out opposing views. No authority or status is implied. If Dr. Rubin wants to make an issue over whether a bunch of bloggers should huff and puff in front of Medscape’s larger audience, I suppose we can debate that some day.
Having thus (what do these non-expert bloggers know anyway) framed the discussion Dr. Rubin goes on to the straw man. Here are some of the positions I did not take, which Dr. Rubin nevertheless attributes to me, then holds up for ridicule:
There's just no evidence that it influences physician behavior in ways beneficial to drug companies! (“It” being commercially supported CME).
To begin with, I made no such statement. Although the proof that CME has any influence on doctors whatsoever is slim let’s hope CME influences doctors just a bit. Otherwise there’d be no point in CME at all. If, of course, I believed CME was pointless I would never have bothered to write the Roundtable piece in question. Taking for granted my position that CME does influence doctors in some way the strong inference is that at least part of the content would be favorable to the use of drugs in some manner.
Physicians just aren't that credulous!
Well, that’s part of what I said. Here’s what I actually said:
Unable to marshal evidence to support their proposal, the proponents of the ban have appealed to a set of beliefs. One such belief is based on the caricature of a credulous physician incapable of critical appraisal of educational content.
A few paragraphs farther down is where Dr. Rubin’s partial representation of this point deteriorates to the level of the straw man:
His last point, one that Doctor Rubin hears time and time again when he chooses to discuss this matter with various colleagues (though truth be told he has learned which colleagues are like-minded on this matter, and tends to avoid the remainder lest he lose his control in public), is perhaps the most precious of all: I'm not biased! Maybe everyone else is, but not...incredibly smart, skeptical me!
Try as I might, reading and re-reading the piece, I just can’t seem to find that particular “last point.”
What gives Dr. Rubin license to make such misattributions? He tells us in his last paragraph (my bold):
Oddly--well, actually, not oddly at all--the real argument running beneath these rationalizations is virtually never spoken of. It's pretty simple, actually, and Doctor Rubin, despite his immense respect and affection for the vast majority of his colleagues, has heard that silent-yet-powerful argument since his early days in med school. The "argument," such as it is, is this: I am a physician and that entitles me to nice things.
Well, I think it is a little odd that Dr. Rubin can hear arguments that aren’t even being expressed. (By the way, although I am biased and at times a little credulous I do confess just a tad of skepticism regarding that particular claim).
But the pièce de résistance comes not from Dr. Rubin but from one his commenters, who wrote:
The Medscape article critiqued here would not have survived editorial review by the Medscape Nursing editors, in my opinion. Physicians, have you written to the editorial director of the Medscape Internal Medicine Web site to request that the article be removed from the site? If not, here is the editor’s contact information…
Wow. When you dislike someone’s opinion piece just petition the editor for a retraction. Wonderful idea.
