Has the CME Pendulum Swung Too Far? Or Finally Far Enough?

Thanks to a long-time faithful reader for alerting me to this news story:
http://www.medpagetoday.com/PublicHealthPolicy/MedicalEducation/pda/20704

At issue is a new ruling from the continuing education (CME) poohbahs, the ACCME, on eliminating any industry scientists from accredited CME programs. The article quotes a number of my esteemed colleagues among the "Pharmascold" camp who are quite pleased with the ruling. It also quotes some standard medical society types who are going ballistic over it, as well as some level-headed folks like George Lundberg, former JAMA editor, who's fully attuned to the dangers of commercial conflicts.

My own view is quite conflicted and might fall under the heading of "hard cases make bad law." I think the problem is generalizing from specific cases to a general prohibition in all cases. I think if we had a set of case examples of industry scientists giving presentations at CME conferences, we could readily classify them into two piles, "ought to be allowed to speak" and "nothing of educational value lost if this dude is kicked out", for example:

• Case 1: A conference panel is looking at the future of pharmacologic management of diabetes. They begin by accepting the premise, that large-scale trials have failed to show patient-oriented benefits from tight control of blood sugar in Type 2 diabetes, so more drugs to lower blood sugar are a bad idea. An industry scientist familiar with the basic biological mechanisms of diabetes lists several aspects of the basic biochemistry of the disease that seem amenable to control by the right sorts of molecules. He makes no comment about any drug now nearing production, but rather sketches out the general principles clinicians need to know to be able to judge the value of potential future drugs.
• Case 2: A drug company is about to market a new drug for angina. A company scientist gives a glowing endorsement of the drug. He reviews a few published studies of the drug and admits that according to those data, the drug has little efficacy but causes some worrisome adverse reactions. He alludes reassuringly to as yet unpublished studies that show that the drug performs much better and has lower risks than the published studies show (but adds, when questioned afterwards, that presently those studies are not available for review outside the company).

I think we could readily agree that the first guy is adding something of real value to the CME and it would be a shame to preclude him from speaking; the next guy is a paid shill and adds nothing from a CME standpoint. If we could write a rule that the first person would be allowed in and the second not, then we'd be where we want to be. Sadly no such general rule that would include all the good cases and exclude all the bad ones is probably feasible.

It would be very nice if we could say, "Look, just write down the general principles and rely on the good judgment of the CME meeting organizers to make the fine-grained, case-by-case judgments." We tried that and the result is the present-day CME mess where commercialization has completely taken over.

So, if throwing out the bath water with an across-the-board rule assures that some babies will be tossed out as well, what do we do? One reaction is to say that so few babies will get the heave-ho that it does not really matter. Supporting this argument is the fact that we must decide what it is that inside company scientists are likely to know about, that neutral outside experts do not. I have a very hard time imagining that this will have a great deal to do with the clinical side of drug development. I would suspect rather that the inside folks will clearly know a lot more about some technicalities of the molecules and the mass production of same, which frankly is the sort of information that puts CME audiences promptly to sleep.

On the other hand I feel badly about a rule that is obviously an exercise in overkill, for baldly political reasons--it feeds into the Pharmapologist accusations that all that we are doing today is an exercise in some "politically correct" hyper-reaction to a basically non-existent problem.

I have always had what I suspect now is an overly simplistic view of the world--that the real problem in the conflict-of-interest realm is not the industry scientist, the guy who has the drug company's name on his business card and on his paycheck, who is known by all and sundry to have been bought and paid for. This person knows to whom she is responsible and can, with perfect integrity, do her job. The problem, I have always assumed, is the presumably "independent" academic physician who claims to be from Harvard or from Stanford or from U. Miami, but who actually takes such a substantial portion of income from industry that he's largely forgotten where public health concerns leave off and industry sales figures pick up. This latter person, who thinks he can walk on both sides of the street without tripping, is the real threat to professional integrity. It's the latter and not the former who should be banned from CME.

IOM Report on COI: Yes, We Really Mean It

You can tell that I'm not a truly dedicated blogger because I allowed the small matter of being out of town for a few days to delay my posting on the big news of this past week, which of course is the new conflict of interest report just out from the Institute of Medicine. While there are a number of examples of media coverage, the best way into the Report is probably the full text available on line--

http://www.iom.edu/CMS/3740/47464/65721.aspx

--where you have the option of going into the report itself to find the 20-page executive summary, or else sneaking a peek at a couple of 4-page briefs. Also, the New England Journal posted a "Perspective" on the report on its website, that has a 1-page summary of the major recommendations:

http://content.nejm.org/cgi/content/full/NEJMp0810200

Full disclosure: First, I have read the NEJM perspective, the briefings, and the executive summary, but not yet the full report. (Told you I wasn't dedicated.) As a member of IOM I have a high opinion of that organization's heft and prestige. But I was not a member of the committee that wrote the report, and was turned down when I volunteered to be a reviewer of the draft. A couple of folks whom I respect very highly as bioethicists were members of the committee.

So what can I say based on the above? First, the report is quite comprehensive in the different sorts of COI that it addresses--medical practice; research; all levels of medical education; clinical guidelines; and academic institutions. The IOM panel recommends passage of the federal Physician Payment Sunshine Act but with expanded reporting requirements compared to the present bill now before Congress. In general, the report will disappoint some true believers, but comes down pretty strongly on the side of reformers who argue that the more arm's-length the financial relationship between the industry and medicine, the better. In short, from the perspective of this blog, it is a reasonably hard-hitting and positive report. Inevitably, given the multiplicity of previous reports on these matters (Robert Steinbrook in NEJM counted 16 that were cited), it breaks little new ground in its specific recommendations. So mostly the importance of the IOM report is to add further weight to these previous calls for reform.

There is one specific area where an interesting fight might be looming. IOM calls for a major overhaul of continuing medical education--without being able to say what the new system ought to look like, it is quite sure that we need to replace the current system where the industry pays for roughly half of all CME costs, to an industry-money-free system within 2 years. The ACCME, by contrast, that actually runs CME, reportedly (again according to Steinbrook) has said just recently that it is quite pleased with its present rules for managing COI with industry and sees no need for any major overhaul. (Ironically, the position I took in HOOKED would tend to support the ACCME position, at least until more evidence is gathered that the relatively new, stricter ACCME guidelines are not working as intended.)

The IOM is also forthright on an issue that many previous reports (but not HOOKED) have sidestepped. They note that universities are eager to enact policies that beat up their individual faculty over COI, but much less willing to face the prospect of institutional COI. They call upon boards of trustees to develop institutional COI oversight mechanisms and also for NIH to develop nation-wide rules on institutional COI. This at least begins to suggest that institutional COI will be addressed on a level where some sort of meaningful action can take place.