My CME Article Is A ‘Piece Of Commercial Crap’
2 CommentsBy Ed Silverman // September 4th, 2007 // 3:22 pm
That’s how C. Lindsay DeVane described his own ACCME-accredited article, which was published last May in the journal CNS Spectrums. DeVane, a psychiatry professor and vice chair of research in the clinical neuroscience division at the Medical University of South Carolina, offered this blunt assessment in an e-mail he wrote to Dan Carlat, an industry gadfly who blogs about CME issues.
The reason for their exchange was Carlat’s recent fascination with the story behind the article, which was accredited and produced by i3 CME, a medical education company owned by Ingenix, and which was funded by Bristol-Myers Squibb. The article, which was about antidepressant drug-drug interactions, emerged from what was originally a televised roundtable but was adapted by medical writers to form the basis for an industry-supported supplement, Carlat writes.
Apparently, DeVane tipped Carlat off weeks ago, but only now was identified as the outraged author (there were two others listed). DeVane called the article a “ridiculous text…parts of it were inaccurate, simplistic, and had overgeneralizations.” But as Carlat points out, it was published anyway. And it’s accredited by the ACCME for one hour of continuing ed credits.
What’s the big deal? As Carlat notes, Bristol-Myers Squibb, which sells a newly approved antidepressant called EMSAM (a transdermal patch), commissioned the article to convince doctors that EMSAM is safe to prescribe, even though it is an MAO Inhibitor, which can produce fatal interactions with other drugs. The episode is portrayed as an eggregious example of how CME corruption occurs….Keep readiing….
“The controversy,” Carlat writes, “involves a seemingly arcane topic in psychopharmacology, the issue of how drugs interact with other drugs in the bloodstream. In an earlier article in a different journal, published without pharmaceutical funding, Dr. DeVane had argued that these drug-drug interactions were rarely significant when prescribing antidepressants. According to DeVane’s e-mail, that article ‘represents my summary of the field and opinions.’
The CNS Spectrums article, however, claims that these interactions are often significant when certain antidepressants are used. The article also points out that EMSAM, the drug made by the article’s sponsor, has the advantage of not sharing these drug interaction liabilities. If DeVane’s earlier statements had been used as the basis for the article, then EMSAM could not have been claimed to have this competitive advantage.”
For their part, the execs at i3 CME responded to Carlat last month. This is their letter. By the way, we reached out to DeVane, but he hasn’t yet replied by phone or e-mail.
James M. La Rossa Jr.
James La Rossa wrote to Danny Carlat in response to the CME controversy…
Dear Dr. Carlat:
I have read with great fascination your recent criticism of the educational credibility (or lack thereof) of industry-sponsored CME activities, most particularly, CNS Spectrums: “A Piece of Commercial C__p” (Tuesday, August 14, 2007). This was especially interesting in light of author Lindsey DeVane’s blanket 10-count of the BMS-sponsored project, in which he, too, referred to the published article as “a piece of commercial crap.”
As the original publisher of CNS Spectrums, which we started in 1997 and sold to the present publisher in 2003, I might be able to lend some insight into a specific part of the debate; that is—the relationship between publishers, industry, and the ACCME.
I first asked Charles Nemeroff to write a piece on psychotropic drug/drug interactions for CNS Spectrums 10 years ago, when the subject was more noteworthy than, perhaps, it is today. (Remember the CYP 450 debate…?) After the article was published in the journal, we were approached by a sponsoring company who asked if they could license the piece for their use WITHOUT ANY CHANGES TO THE MATERIAL. Nemeroff consented. We were paid for the license and, thus, paid the authors. Commercial interests aside, it was important to me (as a journalist and editor with many science-related bylines) to first have the article independently published. If the article was subsequently sponsored by industry, we were confident that it would pass scientific scrutiny and we would retain the most important qualification of any publisher: Third party credibility. Thus, it was highly critical that we monitored ourselves very carefully. There was never any question of whether the article needed CME accreditation to validate its independence.
Here’s the rub: Publisher’s have First Amendment rights to publish, virtually, anything they want. This luxury has given journals the ability to go directly to a given pharma company to produce sponsored, customized projects BEFORE publication—becoming, in effect, a private content supplier for industry.
Industry does not enjoy the publisher’s First Amendment protection. Consequently, the medical-legal division of these companies have, universally, adopted the rules and regulations of the ACCME in order for sponsored material to pass FDA muster. Ironically, Pharma may not be solely at fault since the FDA has clearly endorsed ACCME-like standards. (See, attached, Final Guidance on Industry-Supported Scientific and Educational Activities. Federal Register; Vol. 62, No. 232. 64073-64092.)
What we are witnessing is that publishers of advertising-generated publications (in all fairness, you could have included me in that category once) bang the same drum over and over again for the simple reason that it is easy. So, it is not a stretch to believe that you are all sick and tired of this, which your blog seems to confirm. In truth, the CME business has become rotten to the core.
The authors of these industry-sponsored “projects” are not solely to blame either. (Though you can blame the editors who should know better…) The galley proofs are thrown at them with such velocity that they have little time for review. The authors are no longer on their own timetable, but that of the sponsor and publisher.
One last thing for the record. DeVane’s denial of responsibility for the CNS Spectrums debacle is not altogether fair. I am willing to bet dollars to doughnuts that Nemeroff never saw proofs of the article either. While it might be fashionable to throw barbs at the big-money speakers, guys like Nemeroff have made a significant contribution to the field.
Yours truly,
James M. La Rossa Jr.
Editorial Director & Publisher
MedWorks Media Global, LLC.
Los Angeles, CA.
James M. La Rossa Jr.
Now that Dr. Danny Carlat has done a wonderful job in bringing potential CME-sponsored conflicts of interest to the forefront (which you reference in a recent posting), perhaps it is time for your readers to undertake a vigorous debate on how they would change CME it was up to them?
For whatever it’s worth, here are my two cents worth: For decades now, people a lot smarter than I am have built this (CME) thing into a behemoth of complexity. Everyone has a different take on it. GSK will sponsor something that Pfizer won’t, and vice versa. There is even profound disagreement in the U.S. Senate. So, I would tear the whole thing up and focus on the group of people that all of these regulations are supposed to help: Physicians.
First, merge Category 1 and Category 2 CME. Period! There’s no need for both. If society cannot trust physicians to abide by the honor system, than we have bigger problems than medical education can cure. When you read a journal or attend a symposia, put the pretest, posttest and answer key in a file in your office. If you’re audited you have the proof that you have been continuing your education. The medical community is a much better over-seer than the ACCME. As an MD, if you don’t keep up with new science, patients—some of whom walk and talk like doctors as it is—will flush that out and make your life miserable. God forbid if you are litigated against. The amount of continuing education, or lack thereof, can come into play in court. So, it is in your personal, professional, and, perhaps, legal interest to get together with colleagues at meetings to hash things over. Enforcement becomes moot.
My second change would be that only teaching institutions can offer CME. The private medical education companies can still set-up the program, but it must pass muster from the university. Remember that all of the test grading, etc., the university would normally do has been waived, since the physician is now keeping her own records. So, the university is saving money which can be passed on to the end-user. The ACCME can monitor the
universities if they so choose, and—most importantly—standardize fees. Yes, BMS should pay a larger fee for putting on a program than should a small association or patient advocacy group. But the fee should be on a standardized, sliding scale that is universal throughout the University CME system. The end result is that the doctor gets the CME for free. That should be axiomatic—no matter who sponsors the program.
James M. La Rossa Jr.
Editorial Director & Publisher
MEDWORKS MEDIA GLOBAL, LLC
Los Angeles, CA.
ps–in the spirit of full disclosure, I have submitted this comment elswhere in order to help spark debate. Thank you.