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The EndoFiles Fax

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The EndoFiles Fax
February/March 2005: Volume 6 Issue 2/3

A Periodic Review of Current Clinically Related Endodontic Topics
Tips and hints for the practicing Dentist

With editorial comment provided by:
Robert M. Kaufmann DMD MS (Endo)

Instant Online referrals or Call 783–2971

CE and Conflict of Interest - A Problem for Dentistry?

For most Dentists, keeping our license current means that we must have a minimum number of hours of CE (Continuing Education) credit on file with the licensing body. CE is also a way of trying to stay current in a rapidly expanding and evolving profession. With the explosion in technology has come a myriad of products and techniques - many unfamiliar to us until they are released to the marketplace - for our purchase. Dental product sales are big business and worth hundreds of millions of dollars in sales per year. For example, whereas 50 years ago we had a limited number of choices when restoring teeth, we now have 6th and 7th generation composites that are being touted as the next greatest material. Implants, once thought of as exotic treatment are now being placed routinely. Prosthetic and Aesthetic materials have undergone a revolution. In my specialty, Endodontic treatment now involves the use of Rotary Ni-Ti instruments of differing designs and possible new obturation materials. Endodontic irrigation solutions have now come under heavy study and marketing and are being investigated to maximize their bacteriocidal, tissue digesting and lubricating properties. It seems that every 6 months there is a new material, device or technique that someone is willing to sell you to make your treatments faster, easier and better. And that is the problem.

A fellow Endodontist, Dr. Terry Pannkuk, recently sent me an article that had been written by Dr. Christian B. Sager about this very subject. The title of the piece was "Commercial Conflict of Interest and Continuing Education". Dr. Sager is the CEO of the L.D. Pankey Dental Foundation and the Executive Director of the Pankey Institute, where he leads discussion on ethical and behavioral aspects of patient care. Sager recently became aware of changes that had been adopted by the US Accreditation Council for Continuing Medical Education (ACCME) as a result of a Sept. 29, 2004 article that he had read in the Wall Street Journal. In the article Dr. Sager said that the AACME found that "No longer was it enough for a clinician/lecturer to simply disclose his or her financial relationship with a pharmaceutical company before providing the audience with anecdotal information about a drug. Now, the presenter is required to not only disclose the relationship but also results of clinical trials and a review of the journal must include any negative as well as positive studies". (Editor: This policy was probably partly the result of the fallout from the recent drug fiasco involving Vioxx and other Cox2 inhibitors.) "Drug manufacturers and other commercial providers of health care products and services proactively influence continuing education to sell their products and services." The seven member organizations of the AACME (including that American Medical Association) "endorse keeping continuing medical education separate from product promotion." And "they believe the practice of commercial organizations influencing continuing education is not in the public's best interest".

Dr. Sager then asks the question: "To what extent are commercial inroads biasing your practice of dentistry?" He then went on to paraphrase some of the ACCME's revised standards. While these may not directly apply to dentistry, it interesting to contemplate how they would cause dramatic changes in Dental CE as we know it, should we consider adopting similar changes. They included (my paraphrasing):

1. The goal of the CE program, the educational objective, content selection and presentation, as well as those in a position to control them - must be "free of the control of commercial interest".
2. Wherever a CE provider has a commercial interest, or is aligned with others who have a commercial interest, there is an inherent conflict of interest. Those in control of the CE must be free of conflict in order to act in the best interest of the patient.
3. Non Profit organizations, government organizations and non-health care related companies are permitted to participate in these decisions but commercial organizations producing goods or services not free of commercial interest cannot partner in these decisions.
4. The CE provider (or in our case the body that oversees the issuance of CE credits) should have a mechanism to determine whether those in control of the CE have a conflict of interest. In that case, they should choose someone else who does not have this conflict of interest. (Editor: Should the credit for these CE hours be withheld - if the CE is merely a glorified "infomercial" for a product? Who decides this?")
5. Presenters must disclose any financial conflict of interest before speaking. Disclosure of the relationship (to include company name) is allowed but mention of the trade name is NOT.
6. The CE provider must make all decisions regarding the use of financial support from commercial organizations. This means that the supporter cannot require that the CE provider accept advice, services, teachers and course content OR restrict discussion to THEIR products.
7. The provider is NOT permitted to use commercial funding to pay for travel, lodging, honoraria or personal expenses of the CE learners. Commercial funding may be used for the provider's employees, joint sponsors, and educational partners such as teachers and authors.
8. All educational content must be separate from promotional activities, materials and messages. Product specific advertisements cannot be part of educational slides, abstracts, handouts, or visible as pop ups or ads on web sites. A commercial entity's promotional materials cannot be displayed in the educational space before, during or after the CE activity.
9. CE contents must promote improvements in quality of healthcare and NOT a specific commercial business interest. "Presentations must be balanced and if "trade names" are used - several companies should be used. A balanced view of therapeutic options also means that "No single product or service is over-represented in the educational activity when other equal but competing products or services are available for inclusion".

Dr Sager's article concludes with these questions:

1. What can dentistry learn from the AACME recommendations?
2. Should Dentistry expand its disclosure requirements in a similar manner?
3. Can we abide these recommendations and still hope to maintain financial support from existing partnerships that we have in place already?

These questions are difficult ones to answer. The AACME recommendations seem to apply more to drugs and drug companies than they do to Dental CE. But, as CE moves away from Educational Institutions to the popular "Weekend Sponsored Seminar" or online CE format - How unbiased is it? Is it really CE or is it sales? Dental CE has, of late, come under the influence of the "Dental Guru" and big business. It is easy for Dental manufacturer/suppliers to contract the "Hot Clinician of the Year" to speak on their behalf. Some clinicians receive a % of sales through patents or design fees. Others have been lured by speaking contracts, or "consultant fees". It is even more disquieting when you find a Dentist moving from company to company (i.e./ product to product) in search of more money…all the while claiming that the product they are NOW representing is an improvement on the last one that they were touting only months before. It makes one cynical, indeed.

So, the next time you see a speaker at your local CE program or online (INCLUDING ME !!) , consider these questions in the back of your mind as you listen to or read the information:

1. Does the speaker make a full disclosure before he starts speaking? IE/ Does he explain his bias before the presentation in order to be totally honest with the audience? What's he selling?

2. Does the speaker have a patent on the material or instrument that they are discussing? Is he a paid consultant? i.e. / is he personally benefiting financially from a sale to you today? Caveat Emptor.

3. Although he is a "clinician", how much clinical practice is he currently doing? Or are the consultant fees/royalties so high that shilling the product is equally, or more lucrative than private practice. What does THAT tell you?

4. Does the speaker recognize your demographics and practice situation? (E.g./ How practical is it for YOU to toss $55 or $60 worth of Ni-Ti files after one usage when he gets his files for free!!)

5. Has the speaker "Jumped Ships" recently? And why is that? Did they pay him more?

6. Does he compare his product with competitors and mention the competitor's strengths vs. that of the product he is discussing? Does he mention any problems with the product he is recommending or is it the "perfect" product?

7. How much research has been done with the product that has NOT been funded by the manufacturer or inventor? Is this product so new that HE is the only one with data that supports it conclusively? Is the product "ready for prime time"? You don't want to find out that it isn't - 5 years later!

Your DMD or DDS is not simply a degree that allows you to work in patient's mouths. It also confers upon you certain responsibilities that don't end when you finish school. Don't just rely on the speaker, suppliers and free journals. Keeping current means reading, researching and having a certain level of healthy skepticism when you attend CE. Remember, having a broad knowledge base is your best defense against those who want nothing better tan to sell you their latest "wunderproduct". BTW, when putting together the web site, I made a conscious decision NOT to take advertisement or money from manufacturers. In that way, I can provide you with opinions untainted by commercial influence.

ROOTS SUMMIT V - Monterrey Mexico - May 18th-21st 2005
Join Dr. Kaufmann and the rest of the ROOTS gang in sunny Mexico
3 full days of the best Endo CE available
(see for details)

The Endo Files is provided free of charge. If you know a Dentist who would like to receive a copy,
e-mail, call (204)783 2971 or fax at (204)786 7467 and request that they be put on the mail or fax list.