CME at Risk
Dear Editor: Good issue! A couple of comments regarding your July/August editorial [“CME at Risk”]: Yes, at the moment, CME is at risk. Funding for CME is shifting perceptibly to promotional education, because, in pharmaceutical companies that have recently separated medical education from promotion, product managers are reluctant to “lose control” by assigning dollars to programs managed through scientific affairs or a similar department.
You are optimistic when you suggest that the Office of Inspector General will not investigate a good scientific program. The incentive for whistle-blowers is so great that a disgruntled employee or former employee of a pharma company or accredited provider or nonaccredited medical education company may well point the finger at a supposed incidence of undue influence over prescribing. The pharma company, as has happened in recent cases, may prefer to settle rather than fight, whether or not the grounds for action are thoroughly legitimate. [It's not easy to determine,] as U.S. assistant attorney Thomas Kanwit said, that the discussion was not “a result of any activity by the company.” Not much of a safe harbor in that statement, in my view.
Certainly, the Accreditation Council for CME () must do a thorough job of enforcing the revised Standards for Commercial Support when they are finally implemented. But so far, ACCME has not adequately defined what surveyors will look for when they examine data on conflicts of interest and the resolution of these. Unless a whistle-blower notifies ACCME of a suspected violation, enforcement will be retrospective, perhaps as much as four to six years after the fact. The alternative is to require periodic submission of data, program by program, and carry out reviews every three to six months. The cost of enforcement will rise dramatically.
Measurable results from CME will not in themselves be a defense against failure to live up to the ACCME Standards, the OIG regulations, and FDA requirements. Physicians can change behavior just as well — perhaps more so — from attending a promotional education program.
And your comment about evidence-based content needs elaboration. The critical element is fair balance in the evidence presented. I have seen more than one example of a CME program that presents well-documented evidence showing that a supporter's drug outperformed a placebo, with no effort to place that drug in the context of other treatment modalities.
While the immediate future of pharma-supported CME is cloudy, I believe that in 12 to 18 months the sun will shine again. Pharma managers will figure out how to work effectively within the compliance guidelines created by company attorneys, who in turn will modify the guidelines to be more workable. Accredited providers will, with ACCME's more detailed advice, determine how to serve their clients within the spirit of the Standards. Time tends to smooth out the peaks and valleys, I've learned.
Lewis A. Miller, Principal
WentzMiller & Associates LLC
Dear Editor: So far this year, I have been declined nearly 20 percent of my budgeted revenue from industry. I have never been declined a grant request in my years in CME. I am extremely concerned about the financial viability of our CME program. This program has been accredited for nine years and has been in existence through joint sponsorship since the 1970s.
Our program in some ways is fairly innovative. We have piloted an evidence-based CME project similar to that of the American Academy of Fam-ily Physicians. Although we are not accredited to award EB-CME credit, we feel evidence-based content is exceptionally valuable to the learner. Further, our recent Accreditation Council for CME survey gave us exemplary compliance for evaluating the effectiveness of our activities. This information is included in our grant request letters. It has been suggested that companies are looking for evidence-based activities and outcomes measurement; yet despite our ability to offer both, we are still not being approved for a multitude of grants after filling out 20-page applications and including intricate details of our programs.
I am not sure where to go at this point. There is little information or support for providers being offered by ACCME or any other accrediting bodies, e.g., the American Medical Association, or in my case the Medical Society of the State of New York. It has become difficult for me to tell whether I am alone, if this is affecting every CME provider, or if it is affecting just the little guys. I was hoping you might be able to point me to resources which may assist in maintaining the financial viability of our program, as well as perhaps point me to influential decision-makers who might be able to assist providers.
The OIG compliance program is consistent with the PhRMA code and, in my opinion, CME seems to be somewhat of a “safe harbor.” I never imagined that the longtime relationship of the pharmaceutical industry and CME providers would have been this significantly changed or perhaps even become extinct. While I truly appreciate the intent of the compliance program even where it relates to education, I believe, where accredited CME activities are concerned, the ACCME's Standards for Commercial Support place the onus on CME providers to control the content of the activity and ensure that the activity is free of unethical behavior by the supporting reps. If we as CME providers are doing our jobs, then the pharmaceutical industry should have nothing to fear.
Michelle Palumbo, Director of Continuing Medical Education
Medical Education of Vassar Brothers Medical Center
A Speaker's Sales Pitch
Dear Editor: The July/August issue contains a piece about the National Medical Foundation for Asset Protection [“Switching Sides”]. We invited a speaker to give a lecture about a similar topic at our annual session this year.
To be fair, it was one of the more popular lectures in terms of interest but this does not negate the fact that the speaker concluded his remarks with what could only be described as a commercial or sales pitch. Practice-management lectures have long been deemed appropriate CME; more recently risk management has been a popular non-clinical topic. All may not agree, but I think that in our current litigation climate, it is in the best interest of a medical practice to be protected from being wiped out by a lawsuit. This could mean the difference between having access to care or not, so I think this is a good topic — without the commercial!
My suggestion when bringing in speakers on nonclinical topics is to offer them a display tabletop outside the lecture area to meet with attendees. Better yet, sell them an exhibit space. Most importantly, the speaker will probably not be a physician, so explain the guidelines regarding commercial bias and make sure they understand the agreement they sign before they give their talk.
Jim White, Executive Director
Texas Academy of Family Physicians
A Problem by Any Other Name
Dear Editor: I guess I don't understand. Isn't your definition of “outcome mapping” [“Getting Your Meeting Unstuck,” June issue] just forcing a conclusion? It's like going into a meeting about apples, then asking if everyone wouldn't rather enjoy oranges.
While it is true that “problem identification” is possibly a form of negative energy, it is also true that effective identification of problems results in new and as yet unexplored opportunities. It is part of a process. The time to ask about desirable outcomes evolves as the discussion progresses about the “problems.”
I have had desirable outcomes by asking clients (and my own staff) to first focus on what's wrong, then strive to identify solutions. Sometimes I don't even use the same people to cover both aspects. While there are some “learning curve” slowdowns when different people review the work of others, it is offset by the ability to look for and manage creative and potentially rewarding positive outcomes.
By the way, problems don't happen in a vacuum. Negative results are presented through customer feedback, employee comments, even competitor inroads on sales and profits. A sharp organization is always on the lookout for methods of obtaining feedback from all stakeholders: employees, customers, competitors, public interests, and stockholders. Feedback is one of the prime lubricants of the marketing and operations process. What good does it do to identify optimum “outcomes” if the resources are not available to correct problems or seize opportunities? This is particularly true in small businesses and entrepreneurial ventures.
Barry W. Dennis, President
Advertising, Marketing and Public Relations
Site Survey Assistance
Dear Editor: I wanted to compliment you on the two past issues of MM [June and July/August]. The feature articles have been timely, relevant, and informative. They have helped us prepare the staff for our Accreditation Council for CME site survey this fall. Thanks and keep up the good work!
Andrew Crim, Executive Director
Professional and Continuing Education
University of North Texas
Health Science Center at Fort Worth
Fort Worth, Texas