Continuing [Surgical] Education Poses Compliance Challenges

Photo by medialab_pado via Flickr

While the drug and device industries are frequently lumped together, there are differences that can pose challenges for compliance professionals and regulators.  I was reminded of this while watching an interesting video interview of Damon Marquis, the Director of Education & Member Services for The Society of Thoracic Surgeons, conducted by Murray Kopelow, the Chief Executive of the Accreditation Council for Continuing Medical Education, in which Mr. Marquis discusses the steps his organization takes to protect the continuing medical education (CME) they provide from undue industry influence.

On the drug side, it is relatively easy for specialty societies and other providers to accept industry support for CME while maintaining at least the appearance of independence and objectivity.  Once the check is cut, there is no need for the funding company to have any further involvement with the funded program, which typically follows a lecture format.

Things are quite different on the device side.  As Mr. Marquis explains, a core part of The Society of Thoracic Surgeons’ mission is to provide “education on procedures using … devices.”  The CME offered at the Society’s annual meeting includes 12 “wet labs.”  (While Mr. Marquis does not define wet lab, a browse of the web suggests that the surgeons are given the opportunity to practice procedures or techniques on animal or human organs.)  Each wet lab is taught by two experienced surgeons with, ideally, expertise in different devices; the Society’s goal is “to incorporate all the products or as many of the products as we possibly can that are available for that procedure.”

Overall, the 12 wet labs use products from over 40 device companies, all provided at no cost to the Society.  And industry involvement extends beyond this in-kind support.  Before the meeting, the companies are asked to weigh in on what devices and materials are needed for each procedure to be demonstrated.  At the meeting, “industry will come in and set up their devices and their materials.  We don’t know how to set that up.  They do.  They have the technical skills.”  One company representative is permitted to remain in the lab area once the set up is complete to observe; Mr. Marquis does not explain why.  More than one representative may remain if they are needed to run a device or devices.  (The representatives are not permitted to do any teaching; they wear a different colored gown from the participating surgeons to aid enforcement of this rule.)

At the conclusion of the interview, Mr. Marquis discussed the Society’s efforts to comply with the ACCME’s commercial support reporting requirements.  The Society relies on its industry sponsors to provide prices for the devices used, but “most of the companies have not added into there the staff time that they literally donate for setting the product up on site.”  Mr. Marquis posits that, from industry’s perspective, the time donated is de minimis, because “they bring people off of the exhibit hall floor … so they think well they’re going to be there already.”  This scenario — sales reps moving from the exhibit hall floor, where their job is to sell their device, to the wet lab, where they are asked to use their technical expertise in support of the surgeons’ educational experience, and then back to selling again — is just one of many examples of compliance challenges unique to the device side.

Renewed Efforts to Reduce Industry Funding of CMEs

Photo by Aleera via Flickr

Last week’s Journal of the American Medical Association (JAMA) reported on the challenges that certain medical schools and medical centers across the country are facing as they decrease or eliminate industry funding of their continuing medical education (CME) programs.  These institutions have shown concern over the potential conflicts of interest when pharmaceutical and medical device companies fund educational programs which could bias future prescribers/customers toward their targeted products.  The adoption of industry-free CMEs could help filter out any potential marketing messages, and leave behind a balanced and evidence-based perspective.  After all, as the New York Times has reported, there are over 700 accredited CME providers in the United States and CME spending hovers around $2.5 billion per year, nearly half of which is paid by pharmaceutical and medical device companies.

Last year, three medical schools declined industry support for their CMEs: the University of Missouri-Kansas City School of Medicine, Nova Southeastern University College of Osteopathic Medicine, and Touro University Nevada College of Osteopathic Medicine.  This past June, the University of Michigan Medical School (UMMS) announced an actual policy change, effective January 1, 2011, whereby the school will no longer accept industry funds, which presently comprise almost 45% of its total CME funding.  UMMS believes contributions from various departments will help offset this sizable loss, as will higher CME registration fees and “less glamorous venues.”  UMMS is the first medical school to introduce such a policy and does so noting “we should take pride in our position as a national leader on this issue.”

This is all well and good, but in light of the enormous industry contributions, the $64,000 question really becomes: “Is Industry-free CME a Sustainable Model?“  And that’s exactly what speakers and attendees asked at the June 25, 2010, PharmedOut Conference entitled “Prescription for Conflict: Should Industry Fund Continuing Medical Education.” The conference was held at Georgetown University (PharmedOut is a Georgetown University Medical Center project funded by the Attorney General Consumer and Prescriber Education grant program.  Its team of physicians and academics lecture on the physician-pharma relationship, and provide access to online and industry-free CMEs).  Dr. Robert Wittes, Physician-in-Chief at Sloan-Kettering’s Memorial Hospital for Cancer and Allied Disease (”Memorial Hospital”), told his colleagues during the Conference that:

[t]here is life in CME after you do something like this.  But you have to be willing to prioritize the activity, such as putting institutional funds toward the balance [previously covered by commercial funds] and/or charge registration fees for CME activities that involve outside physicians.

Memorial Hospital stopped accepting industry money for its CMEs in 2007.  Dr. Wittes acknowledged that “[w]e don’t have these things in hotels in mid-Manhattan anymore; we have them on our own premises.”  Yet he cautioned against any institution from completely severing ties with the industry because there are positive interactions which can result in improved products and commercial science.

For further reading, check out Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy’s whitepaper on “Drug and Device Promotion: Charting a Course for Policy Reform.”  The Center makes several recommendations for overhauling the CME funding mechanism.  It also points out that accountants, lawyers, and other professions pay for their continuing education programs.   Be sure to check out Michael Ricciardelli’s post on industry funding of CMEs for nurse practitioners and Kate Greenwood’s post on ACCME Standards for Commercial Support too.

ACCME: Showing Some Teeth?

This week, the New York Times reported on efforts by the Accreditation Council for Continuing Medical Education (ACCME) to step up its enforcement of its Standards for Commercial Support.  Drug and device companies spent over a billion dollars on accredited continuing medical education (CME) courses in 2008; ACCME’s Standards for Commercial Support are meant to ensure that industry funding does not translate into commercially-biased content.  ACCME’s new focus on enforcement comes in the wake of a Senate Committee on Aging hearing over the summer at which Dr. Steven Nissen of the Cleveland Clinic testified that ACCME should be abolished because it is a toothless watchdog, “uninterested or incapable” of enforcing its Standards.  And that was not the first time ACCME’s oversight of CME has attracted congressional attention.  A 2007 Senate Finance Committee investigation uncovered numerous cases in which drug and device companies violated ACCME’s Standards and expressed concern about ACCME’s years-long delays in imposing penalties for compliance failures.

While noting that medical education is largely self-regulated, Dr. Murray Kopelow, ACCME’s head, told the New York Times that, relative to years past, ACCME was active in 2008 and 2009, investigating twelve complaints and finding five courses to be commercially biased.  In addition, the organization will soon post to its website a list of CME courses and providers found to be biased.  ACCME will also consider a proposal that providers whose courses are found to be commercially biased be required to alert the doctors who attended and provide them with corrective materials.

While these efforts are salutary, an effective enforcement program would require a significant commitment of time and resources (in 2008, there were just under 50,000 accredited CME activities), which ACCME may not have.  Well-known critic of industry-funded CME Daniel Carlat (author of “Dr. Drug Rep,” a fascinating piece about his experience giving paid promotional talks for a drug company) had this  to say about the prospects for effective enforcement:

…if the Atypical Antipsychotic program is bad enough to be pulled for commercial [bias], my conservative estimate is that at least half, probably more, of all industry funded psychiatry CME will also need the retraction treatment. The problem is, who on earth has the time to police these things? Certainly not ACCME. Dr. Carroll and I try to keep on top of the worst of the worst, but we have other things to do in order to make a living. The best and simplest solution would be to end industry funding of medical education altogether.

Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy has recommended just that — that industry funding be ended altogether, on the grounds that drug and device industry funding too often leads to bias and that such bias is incompatible with CME’s educational aims.  Dr. Nissen makes the additional argument that ending bias in CME would reduce inappropriate prescribing of branded prescription drugs, which would in turn yield significant cost savings.  As Dr. Nissen told the Senate Committee on Aging, “That’s one of the ways we can pay for healthcare reform.”