Thomas A. M. Kramer, MD


Medscape General Medicine. 2004;6(3):24 

Medical education in the United States has begun to embrace a new paradigm -- core competencies. The idea behind this paradigm is that it is no longer sufficient to provide education to students and physicians, but that the education system must also somehow ascertain individual competency. As a point of departure for the adoption of the competency model, the Accreditation Council for Graduate Medical Education (the institution responsible for residency training) and the American Board of Medical Specialties (the institution responsible for Board certification) have agreed on 6 general categories of competency. A discussion of all 6 of these is beyond the scope of this column, so I will focus on one of them: "practice-based learning." Practice-based learning is defined as the ability of physicians to remain knowledgeable and current in their field throughout their career.

Traditionally, physicians have maintained currency through some combination of the current literature and continuing medical education (CME) programs in their field. In psychopharmacology, currency is particularly crucial since we have the delightful problem of multiple new agents and new uses for old agents becoming available to us on a routine basis. How do you learn how to use new medications, or discover new uses for old ones? Often, the literature is less than helpful. Clinical trials that can be easily extrapolated into clinical practice are few and far between. Moreover, although drug representatives try to tell us how to use their products, they have problems with credibility and lack of experience -- especially as sales forces for most pharmaceutical companies have evolved from having backgrounds in pharmacy training to ones in marketing training. If you are extremely lucky, you have a colleague easily accessible to you who has experience doing what you would like to learn about. Unfortunately, rarely are we able to find such a colleague. Thus we come to the most positive and constructive reason for drug company-sponsored programs. Colleagues need to share their experience. Pharmaceutical companies have the resources to facilitate such sharing by having a practitioner who has had experience with their product describe it to other practitioners.

It is important to understand that there are 2 distinctly different kinds of pharmaceutical industry-sponsored programs. The key distinction between them is whether they are being given for formal (accredited) CME credit. Pharmaceutical funding for CME programs is unrestricted, meaning the money is paid as a grant, with no influence over the content. Promotional programs, on the other hand, are paid for by the pharmaceutical company with a clear and unambiguous goal of promoting their product.

I started doing drug talks of both varieties in the early 1990s. I enjoyed doing them immensely. I love to teach psychopharmacology, and this was an opportunity to do that and get paid extra money. Having been in academics for my whole career, these talks provided me with an opportunity to get out and talk to full-time practitioners about the realities of their practice, and I learned from them at least as much as I taught them. Moreover, I never felt any degree of compromise of my principles. The clear message I got from the drug reps who hired me was to go out there and be entertaining. If I could say something nice about their product, that was fine, but certainly I never felt it was required. As one rep said to me: "It's my job to be the salesman. Your job is to provide a reason to get all the docs in the room and create goodwill so they will listen to me after they listen to you." I worked for a number of competing pharmaceutical companies and was proud of the fact that they would all compliment me for being fair, balanced, and unbiased.

Four years ago, I took a new job that required me to have no outside income or any professional connection to anything except the institution that was my employer. As a result, I severed all ties with the pharmaceutical industry -- and was thus truly out of the loop for this period of time. About a year and a half ago, I left that job and now have a job in which nonclinical outside income is not a problem. I wanted to get back to doing drug talks.

What awaited me was a welcome to a new and different world. The process of doing CME talks (eg, Grand Rounds presentations, etc.) has not changed very much, and I have had a good time doing a few of those. Promotional talks, however, are a very different story. Recent litigation about pharmaceutical companies actively marketing off-label indications to physicians and increased interest in pharmaceutical marketing practices by the federal government have made pharmaceutical companies considerably more restrictive about what can and cannot be said at a promotional talk.

One company in particular insisted that I attend a 2-day speaker training program before I did talks for them. When I pointed out that I had done over 150 drug talks, they were unmoved. They said that the training program was a requirement for speakers, and I quickly found out why. A substantial portion of the training involved explaining to us what we could not say. Anything that was not explicitly stated in the labeling information (product insert) for the drug could not be said in the talk. They gave us the slides that we were to use. We could not add any slides, even if it was purely disease-related material or just cartoons. And we could not discuss our individual clinical experience. The only exception to the requirements came with questions: if we were asked direct questions about off-label uses or anything else that was not in the product insert (such as our clinical experience), we were allowed to answer them.

This is the new world of promotional drug talks. In contrast to my old drug rep's statement, we were told at speaker training: "When you are giving a talk for us, at that time you are an employee of this company and have to abide by all the restrictions that any employee would in dealing with physicians." In many respects, we have come full circle. Many years ago, as noted above, drug reps for the most part were pharmacists. Later they were marketers, and now, at least in part, physicians are being asked to do some of those same marketing tasks in talks not dissimilar to the drug reps' presentations.

Are there ways around or even out of this conundrum? Certainly doing these presentations in a way that encourages a lot of question-and-answer interaction will bring them closer to what they used to be -- that is, a frank discussion of what physicians in attendance are seeking: your clinical experience with the drug. Attendees may learn that they are better served by asking the speaker pointed and direct questions. Whether physicians will continue to be interested in attending programs in which the speaker gives a similar talk to what they have already heard from the drug rep in their office remains to be seen. Most importantly, we have an obligation as practitioners to educate each other. Clearly, the involvement of the pharmaceutical industry in that process is a moving target.