Does Pharma Use Common CME Activities to Promote of Off-Label Drug Use?

Here is an interesting article published PLoS Medicine describing ways pharma promote off label use of drugs. One author worked in the industry as a physician in medical affairs, supporting marketing and both authors have current contacts within the industry. The authors disclose that unreferenced material in the article “comes from their personal experience, contacts, or information available in public fora such as industry discussions and presentations at trade shows”. Since CME is a forum for discussion of off label uses of drugs this is worth the read for every CME provider. Four of the five techniques purportedly used by pharma to “promote” off label uses of drugs mentioned in the article are activities engaged in by many CME providers. Heads up colleagues.

For a summary of what is said in the article go here. Here are the five techniques pharma are said to use to promote off label uses of drugs:

• Use of “Key Opinion Leaders”
• “Publication Strategies” to Generate Influential Publications Whose Industry Origins are Disguise
• Bleed-Through from Unaccredited “Drug Talks” to Accredited Continuing Medical Education
• Using Obligations Generated by “Unrestricted Educational Grants”
• Use of Compendia and Drug Indices

In some areas of medicine off label use of drugs is common and necessary. For many health conditions most patients are taking something off-label. Some of this evidence based information is published in peer-reviewed journals. Off-label uses of approved drugs should be discussed by physicians utilizing the best evidence available. Independent, evidence based CME is an essential place to do this. This is where the new initiative to educate CME faculty in how to separate promotional presentations from those made in accredited CME activities is very important.  The issue is how to have the information presented in a fair and balanced way without undo influence from industry. The question is whether faculty can speak from both perspectives and not be conflicted. Some say yes. Some say no.

CMPI conference on industry supported CME

We heard a little about the recent CMPI conference on industry supported CME. For those of us who could not attend, the presentations are posted here. It is worth taking time to listen to some of this. Dr. R. W. Donnell a hospitalist in Alaska provides a thoughtful summary of what he thinks are key points made during the meeting.

What is it going to take to get the issue of commercial support for CME resolved? Right now the “debate” over this issue consumes far to much attention. I suppose the next step will come from the ACCME when it makes policy decisions based on responses received from its Call for Comments on related issues. The comments have been posted and are worth a careful review.

National CME Faculty Education Initiatve

Here is something you may want to check out. A national initiative to educate those who serve as faculty in CME to differentiate between independent CME and promotional education. Policy and Medicine gives a nice overview.

Is this needed? In this environment I guess it is. But I must admit, most of the physicians I have worked with over the years who served as faculty for CME activities know the difference and maintain an appropriate separation between promotion and a independent CME. We’ll see how many physicians actually go to the trouble of viewing the information and registering. If we as CME providers don’t require it of our faculty then it won’t get much traction. Unless of course, the funding agencies begin to require it of faculty that are involved in industry supported CME activities. The Golden Rule applies – “He Who Has the Gold Rules”.

I just posted two podcasts on this program. One with Dave Davis the Senior Director of Continuing Education and Performance Improvement at the AAMC and one with Lois Colburn, the Executive Director of the Center for Continuing Education at the University of Nebraska Medical Center. Lois is also the incoming president of the SACME. You might find their insights interesting. Each podcast is about 8 minutes long.

All CME Must Have an Improvement Focus

Twelve reasons why all CME should move towards PI CME. Suggestions made Dr. Norman Kahn, Jr., Executive Vice President and Chief Executive Officer of the Council of Medical Specialty Societies. A new opportunity for accredited CME providers.

Doctors are Closing their Doors to Drug Sales Reps

Contrary to popular belief, physicians are genuinely skeptical of drug sales reps, and are unwilling or unable to meet with them for more than a minute. That’s one of the conclusions from a year-long analysis by Oliver Wyman of sales and marketing operations of pharmaceutical and biotechnology firms.

Only 56% of physicians are willing to meet with drug sales reps and only 24% of docs want to spend more than two minutes with a rep recent survey and research found. Eighty-six percent of physicians believe that the information sales reps share is biased and not completely factual.

The study suggests that to improve the relationship and trust with physicians, pharmaceutical companies must be willing to share better clinical data, Quality-adjusted life years information, and unbiased comparative information.

If physicians are looking for “unbiased data that explains efficacy, outcomes, and patient value”, the CME community needs to find effective ways to assist in providing that information free of commercial bias. Assuming the results of this research are correct and that physicians are skeptical of the reps, can CME providers step up and fill that void? Does this suggest an opportunity for the CME provider? We may need to find effective ways to help meet this need.

ACCME Releases Comments

Well, we should have expected this. It is a common practice of the ACCME to release information related to CME right before a meeting that will be attended by CME providers. At least this time the release is important to the content being discussed at the meeting. The AMA Task Force meeting starts tomorrow and the ACCME has published the responses received from the June and August 2008 calls for comment. It’s worth everybody involved in CME wading through this information. Policy changes can’t be far behind. Check it out here.

Pharma and Device Companies Funding CME? Why bother?

Suppose I own a pharmaceutical or medical device manufacturing company. You know what? I am going to shed providing support for accredited CME and I am doing it right now. My company does not need the extra hassles. Put yourself in their shoes and see if it makes sense to you.