Thursday, August 21, 2008

Industry-funded CME: Is Commercial Content Ever Appropriate?

Dr. Robert Donnell (the writer of Notes from RW ) and I have been debating some key topics related to commercial funding of CME.

In his latest post on the issue, he focuses on a core issue. When an industry-funded program highlights the sponsor's product, does this inherently imply bias? What if the sponsor's product actually is the best treatment for the condition under discussion? To quote from his post:
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.

There are definitely a few situations in medicine in which there is one and only one reasonable treatment, and in those cases a sponsored and an unsponsored program would have essentially the same content. But these are exceedingly rare. In psychiatry, I can think of no examples at all. In most of medicine, there are multiple competing treatments, none with any clear advantage for most patients (which is a good thing for medical choice and progress). I suppose that one policy implication of Dr. Donnell's argument is that we might create a list of those few one-best-treatment topics, and allow industry funding for these topics only. It sounds unworkable to me, given the pace of medical progress and the disagreements among academics regarding treatments of choice.
Another point from Dr. Donnell's post:

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.

I disagree. This section does not prevent industry from funding discussions of both branded and generic drugs, as long as the discussion is not slanted toward one particular agent. If there is no slant, then the CME activity does not promote a “specific proprietary business interest.” The problem is that medical education companies have become specialists in the techniques of subtly slanting programs in the direction of the sponsor’s product. Such programs, indeed, are non-compliant with ACCME standards.

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.

By “quality problems,” does he actually mean “bias problems?” The problem with the idea that the solution is to “adjudicate case by case” is that the ACCME will never have the resources to even begin to do this. Working as a volunteer, it takes me hours to unravel the mechanisms of commercial bias in a single psychiatry CME program, and I can do this only because I have a very good familiarity with the literature in the field. 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.

As an example of how ACCME is doing, I lodged a formal complaint about a course on drug interactions in psychiatry well over a year ago, a case involving such blatant manipulation of content that one of the authors called it a “piece of commercial crap.” ACCME is apparently still examining the issue, and will not respond to emails requesting an update. They have no formal process for complaint resolution.

Case by case adjudication is, I fear, a way of ensuring that there will be no reform.

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.

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. Interestingly, the three activities he cites as “concerning” are programs that would never receive industry funding. 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. As an example, few physicians are aware that an NIH consensus statement declared acupuncture to be effective for both post-operative nausea and post-dental procedure pain.


James M. La Rossa Jr. said...

DC brings up a fundamental dilemma in accrediting CME. Should sponsored content be restricted to that rare instance when there is "one and only one reasonable treatment?"

As a journal publisher, I have resisted accrediting "Original Research" for the very reason that the article in question raises first-time data that may or may not be proven over time. Having readers "test" their knowledge of this original research, therefore, seems counter productive, if, in fact, the data does not hold up over time. Logically, that would relegate review articles and evidence-based manuscripts as "proper" CME-accredited enduring materials. If I can be my own devil's advocate for a moment, I'd like to submit the flip-side of this inherent dilemma.

In essence, aren't we always going out on a limb in doing CME programs surrounding new agents and/or indications which may or may not be proven over time? In other words, does medical education content have to be "right" all the time, or are these topics in a state of evolution -- very much like medicine itself? If the material MUST BE RIGHT all the time, aren't physicians limiting their own Socratic debate?

Yes, we almost all agree that CME needs to radically shift ... but is there a worry out there that we might be cutting off our noses to spite our faces? Though I have addressed only a small part of DC's article, am I making sense to anyone? Thanks.

Robert W Donnell said...

James M. La Rossa said---

"... but is there a worry out there that we might be cutting off our noses to spite our faces?"

Yes. That's my worry.

"If the material MUST BE RIGHT all the time, aren't physicians limiting their own Socratic debate?"

Dr. Carlat's argument is that CME should be free of bias. However, his attention to this issue is selective in that he seems to ignore pervasive forms of non commercial bias.

We should strive to safeguard the quality of CME(of which there are many important dimensions, including bias) but some absolute notion of reliable content assumes credulity and lack of critical thinking on the part of physicians, thus an inability to have the type of Socratic discussion you refer to.

That type of discussion is healthy and still takes place at large meetings, but their existence is threatened by the agenda to eliminate their commercial support.

I have been on the planning committee of three over the years and talked to the leaders of others. Most would cease to exist without support.

Anonymous said...

Dr. Carlat, you lost me completely with your last argument. Thirteen members of the NIH planning committee were acupuncture practitioners or working in that field; 24 out of the 24 speakers to the committee were involved in acupuncture. You cannot credibly claim they had no conflicts of interest just because they weren't pharma-funded.

Even so, the NIH's conclusion was far from endorsing acupuncture as effective or that it is evidence-based practice using credible research, such as RCT. In fact, they couldn't help but note that the field was filled with flawed research:
"Acupuncture as a therapeutic intervention is widely practiced in the United States. There have been many studies of its potential usefulness. However, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebo and sham acupuncture groups."