CME Funding: Family Fight Redux

(UPDATE below.)

Thanks to all the folks who weighed in on my previous discussion of the pharmaceutical industry funding of CME (and a special thanks to Dan Carlat who sent most of the readers my way). I'm sure it's not the last time I will comment on the subject, but a few points of clarification are probably in order.

Leaving aside the anonymous soul who clearly misunderstood Nancy Frugé's point that the Medscape Roundtable in question wouldn't have passed muster in the Medscape Nursing section, the loudest objections came, not altogether surprisingly, from Dr. RW Donnell, in the comments section of both this blog and the Carlat Blog. Additionally, he devoted two entries in his own blog (here and here--the latter entry delightfully referring to my "unmitigated gall," apparently unaware of the irony that that adjective has for this blogger) to arguing that there is nothing inherently wrong with industry funding of CME. He also got some potshots in at Doctor Rubin, among other things for his use of third-person singular when referring to himself. (For those not completely clear, I referred to Doc Donnell as the "Arkansas doc" when discussing the Medscape Roundtable because I wanted to preserve his anonymity given that Medscape is a semi-private website and at the time was unaware of his blog. Given that I am shy, I will soldier on with my pseudonym, but am happy to use his real-world name henceforth.)

There are two broad issues about which Dr. Donnell complains, first with respect to the structure of the forum (he saw nothing wrong with it), second with respect to the specific points raised about CME. He states in his blog that I had failed to understand the informal nature of the forum by complaining about the qualifications of the four discussants. He then notes that

"...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."

Um, I think we should debate that today. That's my whole point: that it was irresponsible for Medscape to hold a Roundtable discussion with four doctors who do not appear to have any qualifications to air their opinions out on the matter in that kind of forum, which by its very nature is not informal. The Medscape audience doesn't view the site to engage in the cyber equivalent of a water-cooler chat, it does so to seek current medical knowledge from authorities in the various fields of medicine. Nowhere do I find any reference to "informal chit-chats about pertinent medical topics by groups of bloggers" in Medscape's description of itself, and this is appropriate. If I'm reading some article there I want to know that the author is qualified to talk about this, and I suspect that's true of the overwhelming majority of Medscape subscribers. The casual talk, to which I am not opposed, happens in the comments section. I say: give the experts the spotlight in the meantime.

Let's take a real-life example: every year at the Infectious Diseases Society of America there's a point-counterpoint session about current controversies in the field (and I am quite sure that other subspecialties have similar sessions at professional meetings). I particularly remember a showdown in San Diego over whether one should use metronidazole or oral vancomycin for treating Clostridium difficile infection. Now this is a clinical dilemma facing ID docs (and a good number of hospitalists like Doc Donnell!) on a weekly basis across the US. There were, I would guess, about 2,000 physicians at that session. And who represented both sides of the debate (one advocating metronidazole, the other advocating vanco)? It was not the ID equivalent of the Dr. Donnells--or for that matter the Dr. Rubins--of the world, but rather two docs who had published several articles on the subject, so their opinions carried genuine weight with a highly sophisticated audience. Why Medscape (or why anyone) shouldn't assume that their audience has similar expectations for a Roundtable is beyond me.

As to the substance of the argument about CME, though there is much to address I will try to keep it brief. The briefest of explanations would be, "read Marcia Angell's book, then read Jerome Kassirer's book, then get back to me," but that would take away the fun of blogging so I'll press on a bit.

The quick & dirty argument relies on pointing out the obvious potential for bias in educational activities sponsored by groups whose interests are not healing the sick, but making large profits for corporate shareholders. Medical and scientific journals go out of their way, standing on tippy-toes, to avoid publishing articles that have any obvious source of bias. The majority of the comments from reviewers of journal articles concern possible sources of bias, and a huge chunk of letters to those journals discuss potential bias that could affect outcomes. Modern medicine, and modern science as a whole, is built on the premise that actual working knowledge of the world can only be gleaned by stamping out every possible source of bias when conducting an experiment.

So, can you think of any reason why drug companies might want to influence the prescription patterns of physicians? Wait...now let me struggle with this for a few seconds...hmmm...oh, wait, I can think of about two hundred billion reasons! That's the number of dollars currently involved in annual pharmaceutical sales. Now if you're the kind of physician that values unbiased information, how can you not consider drug-industry sponsored CME sessions anything other than friendly forums to turn doctors into mini-ATMs for the drug companies? Most CME activities, if presented in the form of a paper to a standard medical journal, wouldn't get past the front door, so to speak. (Granted, journals are also a target of industry, but let's save that matter for another day. And please, spare me the retort that this is a laughably naive description of CME because "drug companies don't control content." They don't need to control content, directly anyway. There are plenty of doctors willing to have their messages dovetail with Company X for the tidy speaker's fees that they earn at those charming and ubiquitous drug-rep dinners.)

One of my original complaints of Dr. Donnell's prose involved his use of the phrase "McCarthyesque purge," and he explained his use of the term thus:

"...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."

What I find amazing about this passage is the idea that those opposed to industry influence over physicians somehow have to hunt for evidence of corporate malfeasance. You don't even have to go to kwazy, left-wing nutjob blogs with the vitriolic prose of those like Doctor Rubin to read the ongoing horror story of an industry completely lacking in scruples and running amok, holding both physicians and their patients hostage. Think I'm kidding? Okay, let's take a peek at that well-known bastion for Communist propaganda, the Wall Street Journal, for its take on that fantastic antibiotic Ketek. Or here's the NY Times writing on one of Doctor Rubin's all-time favorite drugs, Neurontin, and its maker's attempts to manipulate data to boost its sales (the article title speaks for itself: "Experts Conclude Pfizer Manipulated Studies"). Remembering the halcyon days of Vioxx gives that warm feeling in the tummy, too. (Though watch out! That warm feeling is perhaps a GI bleeder! But not to worry, you can always benefit from a little Nexium, like Billy's Dad did.) It's not like you have to be on a "relentless hunt" for this kind of stuff; it practically whacks you in the head on a daily basis.

One last point I'll take up before calling it quits is that Dr. Donnell implies that advocates for a firewall between industry and docs are "medical thought police" (his words). He circles back on this point a few times, both in his blog and in the comments that he posted here and at Carlat's blog. It's paranoid, true, but also pretty clearly incorrect. I have never written that a doctor should, for instance, be punished in any professional way for consorting with drug reps or receiving educational materials from them. I do believe, however, that those doctors should not be entitled to CME credits for a night out on the town with said rep.

The idea that, by trying to eliminate the potential for industry bias in professional educational activities, a group of intellectual thugs are stamping out the God-given right to freedom seems to me pretty silly, but I'm only exaggerating Donnell's prose a bit. While it does have a nice rhetorical flourish, the "freedom" meme doesn't really hold up to scrutiny from my vantage point. He's free to get his information anywhere he wants it--there are, for instance, a few nutty people with all kinds of theories about chronic Lyme disease, and by all means read it!--but why he feels like he should be entitled to professional education credits is a different matter. And pretending that this is any different from any other aspect of professional conduct, where there are unambiguous regulations on how physicians prescribe medications for their patients (for instance, they aren't allowed to sell narcotics prescriptions), or how they relate to them after office hours (they aren't allowed to have sex with them), or how they study them (IRB approval required), is just nonsense.
--br

UPDATE:
Over the last 24 hours, Dr. Donnell and I engaged in a pas-de-deux in the comments section, which to me seems basically a continuation of the original post, so I have unilaterally decided to bring those five "letters" into the main page. I took the liberty to edit one piece of Dr. Donnell's remarks (excising a long list of corporate sponsors of the IDSA/ICAAC convention), the unedited version of which can be found in the comments section. Since Momma taught me to exhibit decent manners on occasion, I give Dr. D the last word here--although he still has my invitation to continue this in a more formal discussion as part of future blog entries, as I would be happy to reply to the points he raises at the end. I also would encourage readers to follow the link that Dr. Donnell posts below--he's making my points for me! It's a great view into the mechanisms of how this system works. I am in his debt.

Dr. Rubin,
I gather from your post you attend IDSA. How do you resolve their commercial bias? It appears they are calling for industry exhibitors for their 2009 meeting. Here’s a partial list of supporters of past meetings I copied and pasted from their web page. It appears the degree of support is substantial. How can you even go to their meetings with all that potentialfor bias?

"IDSA is grateful to the following companies that supported the Society’s mission through their participation at IDSA 2007 and the 2008 ICAAC/IDSA Joint Meeting*:" [Ed: what follows is an extensive list of sponsors, omitted here.]

You left your reply at 1:44 AM? We gotta get you out more. I finished the post at midnight and it nearly killed me. I guess this explains how you can come up with 30 posts just in February alone (and I mean that with genuine admiration--I certainly don't have the time or the energy to keep up with that pace).

Anyway, thanks for the extensive list! I'm certain that without the complete version your point would have been totally misunderstood. My answer is that I go to such meetings fully aware of the heavy corporate underwriting and the potential influence it has on the physicians who attend meetings like IDSA or ICAAC, and would prefer to have the system minimize that influence. Several of those companies above offer "travel scholarships" so that medical and graduate students, fellows, and international physicians can attend; several others do no market pharmaceuticals. Others still might not have sponsored IDSA alone but were on board for the ICAAC component, which has a similar but slightly different audience and relationship to industry. (Without getting too technical for the non-specialists reading this, the ICAAC convention focuses heavily on drug discovery and development, so many who attend that conference either work for or have close ties to the pharmaceutical or diagnostics industries. This past year they merged the two conventions, which happens every so often so that participants don't have to choose which one they'd prefer given travel & conference costs.)

The point is that meetings of the size and magnitude of either IDSA (annual attendance usually 10,000), ICAAC (attendance usually 15,000) or the third large North American ID conference, CROI (Conference on Retroviruses and Opportunistic Infections, annual attendance ~5,000) can't easily be ignored by any ID specialist, regardless of the corporate sponsorship of the event. I'm not going to cut off my nose to spite my face because the system works the way it does right now. But aside from the genuinely helpful industry contributions like scholarships and fellowships, there are obvious and egregious attempts to get in drug advertisements, and these should clearly be eliminated.

A few examples: when I went to the ICAAC convention in San Francisco in 2006 my electronic hotel room key didn't bear the name of the hotel, but rather had the corporate logo of Sanofi-Aventis and advertised the then hot-new-macrolide Ketek. (Ketek didn't stay hot for long though, as it was withdrawn from the market for being associated with several cases of acute liver toxicity--cases which the FDA alleges were suppressed by the company in order to grease the rails for FDA approval.)

At a different convention, the bookbag I received to carry around convention materials had a big Novartis logo plastered across it. It's one thing to allow drug companies to advertise their products at a convention; it's a totally separate matter to FORCE physicians to advertise their products by just showing up to the convention. And yes, in case you were wondering, I refused to use that bag, thankfully having brought the previous year's edition along which does not sport any corporation's name.

The idea that one can avoid all possible sources of industry bias by refusing to participate in professional meetings is about as naive as supposing that one can find a way to read journal articles that are free of taint. As I noted in the post, even reputable journals have difficulty ferreting out studies where the data have been sufficiently massaged to ensure outcomes favorable to drug companies (file under: Vioxx, Celebrex, Neurontin, and the list goes on). And Medscape too, a website that I find very useful, has a lot of corporate sponsorship. So what am I going to do? Stop reading articles? No, of course not. I'm not a Luddite, though perhaps you believe it to be so. I'm simply proposing that our professional groups should try to minimize their involvement with groups whose job is something other than treating patients, and that if the corporations themselves behaved more responsibly perhaps we wouldn't be at this crossroads. But as a group they don't behave well--I mean, they really, really don't behave well--and you don't exactly have to get out a pair of binoculars to find evidence of it.

Dr. Rubin,
Thanks for your prompt reply. I promise not to make this an endless back-and-forth. We may reach a point where we have to agree to disagree. However, I hope you will be patient and indulge me in some questions, as I struggle to find the consistency in your position.

Let’s start with this. You’ve explained why you feel it important to attend IDSA. But my real question is that given the pervasive influence and huge potential for bias (see page 2 of the pdf below!) how do you deal with it? How do separate the wheat from the chaff to make it a worthwhile learning experience?http://www.icaacidsa2008.org/documents/2008SupportOpportunities_000.pdf

I think a mildly-prolonged back & forth is not a bad idea, actually; I'd be perfectly willing to have a point-counterpoint like we're having in the main post of both your blog and mine. (Shall we invite Dr. Carlat, too?) Seriously, I think there's more to explore about this issue, and I'm genuinely curious about how a physician of your obvious thoughtfulness about medical issues (I didn't read -all- of the February entries, but many--and thanks for the heads-up on fondiparinux!) manages to square the circle with respect to conflict-of-interest issues regarding the relationship between drug companies and docs. So from my point of view there's more to hash out, though I would appreciate laying off the hyperbole about thought-police & witch-hunting & whatnot.

Anyway--how do I deal with the pervasive bias at the premiere meeting for ID docs? The quick answer is: not very well. I suspect that a certain percentage of what I "know" as an internist and an ID physician is bunk. Some of it is bunk because we've just got the wrong scientific model (this was the topic of my post on the JUPITER study, which I think is genuinely interesting because the lower-your-cholesterol angle may be totally wrong, even though that's been the central model for atherosclerosis for over two decades); that's unavoidable and how science works. Some of the time it's because somebody's got some other agenda, and given the huge financial rewards for producing a blockbuster drug, that other agenda is most commonly associated with large pharmaceutical firms. These organizations are highly-organized and determined. Normally in business I think that's a -good- thing, but the evidence that the large, multinational firms try to game the system at every opportunity--via conventions, friendly chats at the office with drug reps, the cushy dinners, and yes, ensuring favorable articles in theoretically objective journals--is to me simply overwhelming. So I have no illusions that at least some of what I take as gospel may be either flawed or the product of manipulation by people who stand to gain lots of money by influencing which medications I prescribe. I have difficulty understanding how other physicians, including those capable of zeroing in on a potential confounder of a study with lighting-fast speed and the vengance of an archangel, can't see the obvious problem this poses. So how do I deal with it? Not well, but with what limited influence I have I can argue that perhaps we should consider doing what we can to create a firewall between Us & Them so that our objectives remain uncontaminated, and their objectives don't place us in any compromising positions (that is, the kind that you read about almost daily in the NYT, WaPost, WSJ, LAT and the rest).

For your second question--how do I separate the wheat from the chaff?--I have two replies. I make no pretense that I have some remarkable ability to divine which drugs are fabulous and which are stinkers, and as I noted above I would guess that some of my prescription patterns are directly influenced by the system or because I don't have the time to chase down all the articles on medications, particularly trivial ones.* That said, I have a few rules that I try to apply:

a. Be suspicious of fantastical claims of new drugs ("new" being vaguely defined as "approved by the FDA over the past 2 to 3 years").

b. Be HIGHLY suspicious of "me-too" drugs, i.e. newly patented drugs in the same class as some other previously-approved drug. I have seen nothing to indicate why Prevacid is better than Protonix is better than Nexium is better than Prilosec--and omeprazole, Prilosec's generic name, should in theory be made by generic companies at a theoretical substantial savings to the entire healthcare system. But you, Dr. Donnell, know as well as I that most hospital formularies carry no such drug--they've been wheeled & dealed by the makers of the patented drugs, often at substantial discounts, so that they can develop brand loyalty when they are discharged and can be customers-for-life as outpatients. So, if it isn't the original in its class, and especially a new one out, I think it has, as Desi Arnaz observed, a lotta 'splainin to do.

c. When possible (not always the case), be suspicious of brand-name claims when there is an equivalent generic available in its class. In ID, you see people (sometimes even ID docs! but usually unaware hospitalists and primary care folks) often inappropriately prescribing really important drugs like Invanz (generic name ertapenem) in place of the considerably-cheaper ceftriaxone or cefazolin because they got lazy and were told a some lunch how great Invanz was. Well--it IS an important drug, one of the most helpful for people with serious and/or resistant infections, but it sure as hell won't be if everyone prescribes it for routine cellulitis or community-acquired pneumonia!

d. I try to attend University clinical case conferences as often as possible. The University where I work, like many in this part of the country, has strict policies on whether drug reps are allowed to bring goodies and discuss their products (in brief, they're mostly not).

None of these are failsafes, and each have exceptions (e.g. I am a big big fan of Atripla for HIV, which came out about 2 years ago, is only a reformulation of previous drugs, and is a cash cow for its makers), but following these precepts certainly help. Or at least I hope they do.--br

*(For instance--is Zofran REALLY that much better than Compazine or Phenergan for non-oncologic cases of nausea? I know it's a lot more expensive, yet the hospital that I do my part-time work for has Zofran as the default anti-emetic in the automatic drop-down order menu in the computer. In other words, you have to go -out of your way- to order the cheaper drugs that for all I know have never been shown to be less effective. But then the nurse calls me later in the night because she's -heard- of Zofran, and why didn't I prescribe that? Sometimes it's not worth fighting the fight, and Zofran is of course a fine medication.)

Dr. Rubin,
You don’t avail yourself of the freebies at those meetings. That’s well and good, but you (or your medical group which pays your registration fees) do benefit from the largesse of the drug companies in terms of reduced fees. In one of the comments above you said “I'm not going to cut off my nose to spite my face…”

But, if you and others who advocate for a ban on industry support are successful, won’t you have done just that? IDSA meetings and others like it would cease to exist altogether, or in anything near their present form without support. That was one of the points I made in the Medscape piece under the category of unintended consequences. I didn’t want to cite personal communications in that piece (maybe I should have) but leaders of CME meetings have said that such meetings would not exist without support. I recently asked Bob Wachter, for example, if he could continue his UCSF hospital medicine course without support. His answer was, essentially, “no way.”

I’m still curious as to why you even bother to go to IDSA in view of your answer:“Anyway--how do I deal with the pervasive bias at the premiere meeting for ID docs? The quick answer is: not very well.” If that’s true wouldn’t you be better off, and save yourself considerable time away from practice and family, to get the same information from sources like Medical Letter, UptoDate, or independent literature searches?

In reference to some comments you made in your post, I want you to understand my position. I am not advocating for CME credit for a dinner meeting with a drug rep and a paid speaker. I thought it would be clear to readers that that type of activity is not on the table for this discussion. Such activities (at least in my state!) are no longer accredited, (haven’t been for some time) nor should they be. And if you can cite an example of accredited “CME” which promotes Nexium or Ketek over better alternatives I’ll be the first to agree that such activities should never have been accredited. That’s a far cry from a total ban of industry support.