Conflicts of Interest in Continuing Medical Education Yield Probation at UofL.

On May 2, 2014 Laura Ungar of the Courier-Journal reported that the Accreditation Council for Continuing Medical Education (ACCME) had placed the University of Louisville Program of Continuing Medical Education (CME) on probation. Given that UofL’s School of Medicine itself had just been placed on probation by other accreditors, this second failure of external review is yet another indicator that something is very wrong at our academic medical center.

UofL’s CME program oversees the integrity and scientific merit of postgraduate medical education offerings attended by medical students, interns, residents, faculty, community physicians, and other healthcare professionals. As a nationally accredited program, UofL also sponsors and certifies CME programs in other states, internationally, and on the Internet. Since the majority of CME is now paid for by pharmaceutical and medical device companies, the need for unbiased information is greater than ever. It is in this arena of avoiding commercial intrusion on its academic affairs that UofL stumbled.

What happened?
The specific event reported to have led to this action was the discovery that “a physician employed by a pharmaceutical company taught at one all-day course in Phoenix.” However, representing the University, Dr. W. Daniel Cogan, Assistant Dean for Continuing Medical Education and Professional Development would not name the drug company, the employee, or the partner organization sponsoring the untitled course. “Our program is clean except we had that one error,” he said. “It’s a high-quality CME program.”

The big Lebowski would not let this stand!
A refusal to disclose information that is already in the public domain was disappointing to me, but hardly a surprise given the University’s reflex instinct to avoid disclosure of information incompatible with its public relations spins. When will it learn that the enduring damage from bad news comes from attempts to avoid disclosure, or in covering-up? Refusal to disclose the details surrounding such a core failing of University responsibility drove me to make a Freedom of Information Request to UofL for relevant documents. It took a while and I did not get everything I asked for. Nonetheless, I am not comfortable with what I found, nor in the state of the national enterprise the provides the bulk of medical education to trainees and practicing physicians. In my opinion, the pharmaceutical, medical device, and related industries have captured the mechanism of continuing medical education and have done so with at least the cooperation of institutions of medical learning.

The basic facts.
The program in question was the [2nd Annual] “Hands-On Patch Test Training Workshop for Beginners to Experts.” [Patch testing of the skin is used by dermatologists and allergists to determine what might be causing allergic reactions in a given patient. It requires the application of potential offending antigens to the skin using a variety of medical supplies and test-antigens.] The course was held November 9-10 at The Buttes resort in Tempe, Arizona. The program was “Jointly Sponsored” by the Caribbean Dermatology Symposium and by University of Louisville Continuing Health Sciences Education. Along with the logos of these two organizations, and on the same footer of the promotional flyer, was the logo of “MyPatchLink.” The Beaty Group provided nuts-and-bolts organizational support. The flyer also gave notice of commercial support from an “unrestricted grant from SmartPractice,” whose logo was displayed elsewhere in the flyer which is available here.

Six faculty members were identified, including 2 from the University of Louisville. The one whose participation apparently got UofL in trouble was Dr. Curt Hamann, MD, who was listed as an “International Authority on Latex Hypersensitivity and Polymer Research; CEO and Medical Director of SmartPractice; and CEO and Medical Director of Mekos Laboratories, ApS.” Not disclosed in the flyer, MyPatchLink is associated with the SmartPractice organization. Other faculty members are also associated with MyPatchLink and SmartPractice as consultants, members of a speakers bureau, having sold patents, or as investigators, but I cannot identify if or how any of those relationships were disclosed to the attendees of the course as required. SmartPractice sells patch testing supplies and products.

Disclosure of conflicts of interest.
Potential faculty members are supposed to reveal any commercial conflict of interest to the certifying CME organization ahead of time. Some, but not all, of the disclosure forms submitted to UofL were provided to me. One was of a faculty member whose name did not appear in the flyer and may have been a late substitute. A moderator not identified in the flyer was an employee of SmartPractice. Dr. Hamann was up-front about his ownership of SmartPractice and the Contact Dermatitis Institute. Several faculty members did not check off the required affirmations addressing their “personal financial relationships relevant to the content of this CME activity,” or that the relationships identified “are not associated with the content of my presentation and will not be discussed or presented on any material.” The University of Louisville was apparently satisfied with these disclosures and non-affirmations.  In my opinion, and that of the ACCME, it had no reason to be.

Notification of Non-compliance.
UofL was formally notified of the LCCME’s decision to place its program on probation on March 21, 2014, but since the matter arose during the course of a scheduled re-application for accreditation, the University may have known what was coming some time before. Copies of relevant emails or documents for me were–

“withheld from release as they are preliminary conversations containing recommendations/ opinions and discussing matters not intending to constitute final action. KRS 61.878(1)(i) and (j) authorizes the nondisclosure of “Preliminary drafts, notes, correspondence with private individuals, other than correspondence which is intended to give notice of final action of a public agency” and “Preliminary recommendations, and preliminary memoranda in which opinions are expressed or policies formulated or recommended.”

The University’s first official response to the ACCME on April 3 was to argue that “this is not a recurrence of a previous finding of noncompliance…” and that it is UofL’s understanding that “the ACCME does not move a provider directly into a status of probation unless that provider has not previously rectified that issue…” The University stressed that this distinction was important to it because, “the revenue we generate from joint providerships underwrite much of the funding for all of our other activities.” [Being on probation means that UofL cannot enter any new joint providerships such as that with the Caribbean Dermatology Symposium, or the myriad partnerships it has with CME operations on the Internet! I need to learn more about “joint partnerships” and just what responsibilities are involved.]

Good try but no dice.
This attempt to evade probation did not fly with the ACCME which replied that “noncompliance related to the Standards for Commercial Support is not the only cause for a decision of probation.” For the ACCME, non-compliance of this magnitude concerning the separation of financial conflicts from educational content is a “never” event of the magnitude of leaving a surgical clamp in the abdomen– it must not happen. The University was given the option to request a formal reconsideration that would have required exculpatory information existing at the time of the original review. Since I suspect that such information did not exist, the University accepted it’s probationary status and made preparations for required progress reports.

Is this truly a unique event?
The University would like to characterize this issue as a one-of-a-kind anomaly. What else can they say? In my opinion, the basis for such an assertion is not in evidence. At the very least, the Patch Testing Workshop has been presented three times to date, with a fourth scheduled for later this year. At least three opportunities for review failed! Ms. Ungar’s report noted that the ACCME identified this course among 15 randomly selected courses over the last few years. Without a harder look, a claim of only a single infraction is in my opinion premature.

CME accreditation– UofL is a player.
According to ACCME documents as of May 2014, the University of Louisville was one of 680 nationally accredited CME organizations, but only one of 16 on probation. Over the last year, UofL sponsored 297 “events,” ranking 60th in the most events sponsored. UofL claims having taught 10,132 physician participants over that period and double that number of non-physicians. However its presence on the Internet with live interactive and persisting material means that the number of events and participants are much under-estimated. It is easy to find the UofL CME logo on-line in what is in my opinion the wild west of commercial CME.

Money drives the CME process.
The educational grant from SmartPractice was for $22,500. Each physician faculty member received $2500 and a nurse $1000. Hotel and travel expenses were covered separately. Other expenses not fully understood by me but presumably flowing towards UofL were:

Staff Director $3000
ACCME Joint Sponsorship Fee $4550
CME Reviewer Fee $500
AAD Recognition Fee $200

Additionally, each physician attendee paid $500 or $600 for program sessions, educational materials, and selected meals. There may have been commercial exhibits at this medical conference for which fees are charged to exhibitors. I do not know how such funds were used.

There is a lot more that I would like to write about the commercialization of continuing medical education. With a little encouragement from my readers, I will do so. The take-away message for me is that to the University of Louisville’s list of commercial enterprises (including clinical care, research, sports, and real estate), I now add continuing medical education. The burden on the University of Louisville is to demonstrate to our community that its efforts to expand into the commercial world do not unduly distort or corrupt its traditional academic or clinical values, and that it deserves the ongoing trust of the public it serves. Readers of these pages will be aware that in my opinion, the University of Louisville has not been altogether successful in achieving these standards. This most recent assignment of probation related to one of its core academic responsibilities provides independent outside confirmation that all is not well. I am not the only person in Louisville who should be disappointed. Let’s hear other voices here or in other forums, else we will have only more of the same and ourselves to blame.

As always, if I have made an error of fact, please help me to correct it. I was not provided all the materials I requested, nor have I posted all of the 100 pages. If you would like to see more of the records, please contact me using the link in the sidebar.

Peter Hasselbacher, MD
President, KHPI
Emeritus Professor of Medicine, UofL
July 17, 2014

• The full text of my FOI request, the cover letter to UofL’s response, and my summary of materials received. (PDF 45KB)