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 He alludes reassuringly to as yet unpublished studies that show that the drug performs much better and has lower risks than the published studies show (but adds, when questioned afterwards, that presently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.

Ban Industry-Funded CME--and the ACCME, While You're at It

I'm indebted both to the Prescription Project and to Danny Carlat's blog for accounts of the hearings of Sen. Herb Kohl's (D-WI) select committee on aging, on the issue of industry funded CME and sunshine legislation.

The decks were somewhat stacked with those opposing industry funding. The redoubtable Dr. Thomas Stossel of Harvard and ACRE (see previous posts too numerous to list) was on hand to offer the non sequitur, that because scientific advances in medicine over the past 40 years had helped people, and for the past 40 years we have permitted industry funding of CME, we need to continue the latter or we risk losing the former. Al Franken, making his Senate debut following his long-disputed election in MN, offered the comment that he did not see any logic in Stossel's reasoning. I suppose Franken, as a former comedy writer, is especially qualified to understand the reasonings of Dr. Stossel and colleagues. (Sorry, couldn't resist that.)

All that is bye the bye, as I think the most important exchange by far at the hearings was the indirect exchange between Dr. Steve Nissen of Cleveland Clinic, and Murray Kopelow, head of the Accreditation Council for Continuing Medical Education (ACCME), the outfit that is supposed to monitor all US CME activity. Kopelow offered what to our commentators appeared to be pretty wimpy testimony. Prescription Project summarized it as: "[A]fter mulling a stop to accredited industry-supported programs in 2008, the [ACCME] 'would not be taking any action to end the commercial support of accredited [CME],' and defended its continued efforts to clarify independence criteria and firewalls." The basic message appeared to be: trust us, we're taking care of everything, just leave it to us.

By contrast, Steve Nissen came out swinging. Again, per Prescription Project, Nissen "called the [ACCME] 'uninterested or incapable' of enforcing its own rules, and called for its end. 'Whatever ACCME is doing is ineffective,' said Dr. Nissen. 'We need ACCME to go away and we need to replace it with something else.' He said that third-party companies called medical education communication companies are very much behind the wheel of CME programs that claim support from 'unrestricted educational grants,' and that based on the selected topics and speakers, he can nearly always guess the sponsoring company." To which Danny Carlat added the anecdote that he knows that at least on some occasions, ACCME slaps the wrist of a CME sponsor that allows undue commercial bias, because they issued such a letter after he once complained. Only ACCME took two years to do it, and Danny cannot tell us any details because ACCME also put a gag order on him.

Now, if you go back and look at some of my earlier posts on this blog as well as in HOOKED, I think in hindsight I was overly deferential to ACCME and took them more at their word, that they were working diligently to create firewalls and police commercial bias, than should have been the case. I have certainly heard comments from CME coordinators to the effect that what the CME rules are supposed to be, and how people behave in real life, are often two different things.

Danny Carlat, who blogged the hearings live, also offered later reflections as follows (http://carlatpsychiatry.blogspot.com/2009/07/senate-cme-hearing-impressions-more.html):

Senator Mel Martinez, a republican from Florida, summed up the mood best with his perplexed question (I'm paraphrasing here): "Wouldn't it just be better if doctors paid for their own continuing medical education?" As a lawyer, he said, he always paid for his own CLE (continuing legal education) and he was never paid to give CLE lectures.To those of us who have lived and breathed this issue for years, his question came across as innocent, but in fact it hit the obvious point, and surely summarized the view of most Americans.