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Orthodontic Key Opinion Leaders; Who are they and what do they do?

By on October 31, 2016 in Personal opinion, Recent posts with 14 Comments
Orthodontic Key Opinion Leaders; Who are they and what do they do?

Orthodontic Key Opinion Leaders; Who are they and what do they do?

I have just re-read the excellent book “Bad Pharma” by the British Doctor Ben Goldacre. This is about the practices of the pharmaceutical industry in developing and promoting its products. He wrote about Key Opinion Leaders and I wondered if there were any in orthodontics and what they did?

The Key Opinion Leader is a doctor or dentist who is employed to influence their peers clinical practice. Companies hire them to provide input to new developments, conduct studies and give lectures and seminars on the product with which they are associated. This practice is widespread in medicine and pharmaceutical practice. I have recently become aware of this orthodontics. For example, this is an article written by Dr Boschken. He is a a key opinion leader for Propel orthodontics (another orthodontic vibrator device). This is essentially an advertising document illustrating a series of cases that went “quickly” with Propel. He does not mention the contemporary research that shows that vibration does not have an effect. It is simply written to promote the product using the opinion of a clinician. Importantly, Dr Boschken declares that he is a Key Opinion Leader for Propel.

This led me to wonder if there are many Key Opinion Leaders working for orthodontic companies. So, I dug around a bit on the internet and found this information on the Key Opinion Leaders for the following companies (Just click on the links for the list):

Invisalign

AcceleDent

Ormco

American Orthodontics

This is a fairly long list of advocates for orthodontic products and it appears that these roles are becoming popular.

How do they work?

The Key Opinion Leaders provide input to developments, they test the products and then give presentations on their impressions about their clinical performance. Not all of them receive payment.

Nevertheless, there is a conflict and it is very subtle. This is concerned with the way that clinical information is shared or disseminated. If we consider that in an ideal world, the best way we get accurate information about new treatments is the refereed literature. Unfortunately, in the “real world” this is difficult because of the large number of papers that are published, difficulty in accessing the journals behind paywalls and perhaps most importantly a potential lack of understanding of increasingly complex scientific methods. As a result, we tend to get information from conferences, word-of-mouth, advertising and websites.

a-protest-marchThe conference and trade exhibition

When we consider the conference, it appears that two main avenues disseminate information. One is the main scientific programme and the other is the trade exhibition. This is where the Key Opinion Leader has a role. If they are on the main program they present the information as part of a lecture. Similarly, in the trade exhibition they give short lectures and are found on the stands talking to delegates who gather like bees around a honeypot! At the periphery of these exhibition stands I have frequently heard the phrase’ Dr ** is recommends this treatment, so I shall give it a go’. Some companies even hold their own major conferences at which many of their key opinion leaders speak to rows of entranced delegates worshipping at the feet of their gurus…..

Is this a problem?

We now need to consider whether this is a problem. First, we need to remember that companies employ Key Opinion Leaders to influence clinical practice. In short, they promote products. We have all seen this promotion in the absence of scientific evidence. Paradoxically we do not see or hear them mentioning the scientific research that shows that the treatment/philosophy/method of speeding up treatment does not work! This is the subtle and not so subtle influence on practice by key opinion leaders

Solutions?

There is a solution. First, conference organisers should insist that all presenters declare if they are a Key Opinion Leader at the start of their presentations. I know that David Turpin proposed this some time ago, but I am yet to see this happen?

Second, the Key Opinion Leaders should be aware that they have an ethical duty to both clinicians and patients. In this respect, they need to be clear about the level of evidence that they are using when they promote the new treatment. Furthermore, when research is published that does not support the claims that they have been promoting, they should hold up their hands and state that they were “wrong”. Over the past five years there have been several instances of this type of research and I must have missed at least one Key Opinion Leader doing this?

Finally, as clinician scientists do we need to listen to the Key Opinion Leaders?

Declaration: The University of Manchester and the UK National Health Service employs me and pay my salary. I also give presentations on research and research methodology for which I receive payment in addition to travel expenses, accommodation and conference registration. I do not get any income from this blog, I use lecture fees to support the costs.

 

 

 

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  1. ross hobson says:

    Kevin
    assuming you have read ‘Bad Science’ already – now you also need to read the Matthew Synd books ‘Bounce – the myth of talent over the power of practice’ and ‘Black Box Thinking’
    I feel these 4 books (inc Bad Pharma) should be compulsory reading for all

  2. Vicki Vlaskalic says:

    Dear Kevin, I have an identity crisis – please help!
    I get what you are saying, but I believe that there is a lot of grey area in that title, that is more of a marketing method by companies who select these individuals to promote their products. We have “clinical speakers”, “clinical consultants”, “advisory board members”, “clinical directors”, “shareholders” amongst other titles affiliating individuals to varying degrees with companies behind a product. You state that “The Key Opinion Leaders provide input to developments, they test the products and then give presentations on their impressions about their clinical performance. Not all of them receive payment.”…I’m thinking almost every researcher in every orthodontic department may fall into that loose category!
    I’m a black and white kind of girl. We have sponsored presentations and we have not. We have paid consultants and we have not. We have employees and we have not. We have shareholders and we have not. We have sponsored research and we have not. I always thought that any financial interest was to be declared at the commencement of lectures, and that authors publishing in referred journals have to declare and sign off to any financial interest or company affiliation. Isn’t that enough to alert us to potential bias?
    The whole KOL thing is intriguing. I guess Ricketts, Andrews, Melsen were/ are all KOL’s. Probably even Angle. They have been around for ever, but the financial stakes are higher now. To me, a KOL is bestowed the “title”, perhaps initially by a company but perpetuated by us – the audience who may decide to revere them- or not – and invite them back year after year – or not. I say that, as after reading your list of KOL’s, I personally would not bestow that title to many of them. Once numbers go beyond what a reasonable clinician may treat individually in 1 year, I stop listening to their “clinical” technique (or their staff’s), but I do look to their managerial or other skill sets. Most of the individuals you (or companies) have listed represent high patient numbers, a personality, ego and a passion for business. Some are even KOL’s for more than 1 product or company above! Doesn’t mean that we don’t learn from them. Just eyes wide open.
    I respectfully believe that we should not rely solely on these “gurus”, “clinical experts”, or simply the humble “speaker” to declare themselves “KOL’s” as it is quite a non-specific and subjective marketing title. I further believe that we, as a discerning audience should also not always rely on the integrity of the scientific committees providing invitations to speak, on the diligence of the editorial board of journals accepting research papers with low levels of evidence, but mostly upon ourselves. I never once heard Ricketts declare his financial interest prior to speaking, but I knew he had one. And I still learned, selectively.
    Yours faithfully, Miss Identity Crisis!

    • Kurt Dean says:

      I guess I’ve always been a cynic for better or worse and generally considered anyone speaking on a companies product as a hired gun in some shape or another. I think the guru will always have influence, as we tend to also listen to anyone showing success or good outcomes, this is not necessarily a bad thing. However the joke that should always be muttered is ” Everything works in a lecture” . Perhaps, this is also something brought upon ourselves as a profession because there is a tendency to love to bash a new idea with an ” It won’t/doesnt/can’t work”… until of course it does.

  3. Kevin, you raise many good points. i concurrently use a product called Dental Monitoring. I discovered at the WFO meeting in London a little over a year ago. I was delighted to find a sophisticated, scientfic tool to measure tooth movement in a very precise way remotely using the patient’s smart phone as my ” remote monitor”. since it was new to the market i had to do my own informal research. Iliked the information I was getting from the product. The developer of the product liked that I “got” how is product could benefit my patients. He asked if i would present to other orthodontists at trade shows and at study clubs. I was happy to spread the information as I have done in the past for SureSmile. I give my opinions and demonstrate how the product can be used. People ask about how accurate the product is and what research has been done to verify the company’s findings. “that is a great question” I tell them. as a new product it takes a while to develop an interest in the product before any independent researcher will be interested in spending the time and effort to take on such a project, as you know from your years in our great profession. meanwhile i must investigate the product the best I can as clinician. I am lucky to live in Richmond, VA USA where I graduated from VCU school dentistry. The orthodontic department has agreed to do research on Dental Monitoring product. the research is being led by Dr Eser Tufekci. When we discussed the possible research results she stated that “we will publish the findings either positive or negative” in regards to the accuracy of the software. I told her” of course that is what I want. if i am saying how valuable the information I think I am getting is inaccurate I want to be the first to know so I can stop using the product. My reputation is most important to me. I want the truth to be known”. I encourage you to do your own investigation into this new remote monitoring software. when the research is in I will be glad to say there is independent research to show it is accurate or i will sill stop using it and tell others the same. Other universities are also developing the research protocols across the globe. i look forward to seeing those reports . thanks for all your contributions to our profession, Bill Dabney

    • Vicki Vlaskalic says:

      Hi Bill! Having also discovered this visual and digital patient monitoring tool at the recent ASO meeting in Melbourne, and similarly intrigued about it’s potential to accurately provide real time data on velocity and vector of tooth movement (personally I think that is fascinating!) I have started using (evaluating) it on my younger Invisalign patients and those fixed appliance or Invisalign patients who are more remote. Alison Sahhar (U Melbourne, Aus) is now conducting Masters thesis research (its at the ethics stage) using DM to monitor tooth movement in retention. We will disclose that DM are donating their monitoring service to the research subjects. We look forward to sharing findings and experiences with you and the specialty Bill.

  4. Salesse nicolas says:

    I exchanged mainly with KOL for invisalign on the net ( the company which seems to be the most active in this regards ). Behaviour range from :
    – Will speak openly about the fact that I am paid by the company, will be honest about the short coming of the product and other potential option.

    – Will refuse to answer directly to the fact that I am paid by the company, the product has only advantages and no defect.

    But lets be honest you cannot be paid by a company and be completely honest (here I means not lying by omission ) about there product. If a company wants to here the pure and straight clinical truth, it doesn’t need to pay anyone, researcher are already doing this for free :-).

  5. Kevin
    I after with much in this blog, however, like Vicki, I am conflicted by your overall “conclusion”. It is no secret that I have spent a goodly portion of my career in some form of consulting capacity with various manufacturers. I enjoy his role immensely because I have the opportunity to stay informed about the latest innovations and possibly influence the final designs or help prioritize projects based on limited resources. Most of the time I get compensated for my efforts and always have informed every audience of that fact. That being said, John McGill has told me for years that I would be much better off financially if I would simply stay in my office and see patients. You see, for me and for the majority of those I have had the privilege of sharing ideas with on development teams there are vibrant discussions on the scientific validity of products and techniques that are proposed. There are often times when there is little prior research to base development on so the only basis is the experience of alpha and beta testers. The level of disclosure by speakers about contrary research or product shortcomings is more often than not based on the individuals awareness and/or experience, at least for the orthodontists I know well and have attended their presentations or presented alongside. If the existing research is questionable or nonexistent, then certainly most speak based on personal experience and it is up to the listener to judge based upon that premise. There is no question that there are profiteers in the mid as there are in every discipline. Hopefully at the end of the day they lose their audience as orthodontists feel deceived afterwards.

    On the whole, those asked to be KOL’s are reputable, critical thinkers who have the best interests of their patients and our specialty in mind and serve to keep improving our products and procedures.

  6. Dave Turpin says:

    Kevin,
    As you acknowledge, I have been preaching commercial disclosure for authors and speakers for a very long time. Although many of our organizations have added this disclosure to their instructional manuals, many continue to overlook this type of clarity while the audience continues to expect it. One cannot leave it up to the speakers themselves to disclose existing commercial connections because they cannot see their own conflicts. This is a normal human flaw even characterized by members of our Supreme Court. The leadership of our universities and organizations must step up to make these disclosures an automatic part of the educational fabric. To do anything less is to assist the deception of our educational process.

    Dave Turpin
    Moore/Riedel Professor
    University of Washington
    Seattle, WA

    • Barry N. Winnick says:

      Dr. Turpin,

      I overlooked your statement the other day concerning universities and other organizations making disclosures automatic. Actually they are required to do this already if they are incorporated as 501(c)3 not-for-profit corporations, which is most likely. The United States Congress has empowered the Internal Revenue Service to grant and regulate this type of corporation whose status is very valuable since most revenue and donations are usually tax-exempt both on the federal and state level. Also, the donation can usually be taken as a tax deduction on both the federal and state income tax returns by the donor.

      I think that the legal or compliance department of a university will be prepared to give good advice on handling conflicts and proper disclosure since maintaining the not-for-profit status is near and dear to their heart. Everyone has a vested interest in compliance especially if it involves the IRS.

      I imagine that the readers of this blog from other countries may find all these rules and regulations perplexing but there is a fairly simple explanation: conflicts are very common and usually managed with proper disclosure. If an absolute rule of no conflicts was adopted, we would limit education, make populating the boards of organizations with quality individuals that possess the skill sets that the organization requires etc., very difficult.

      Lastly, I am a relative newcomer to this blog initially seeking evidence-based results and best practices but can see that there is much more. I sense from the postings that there high integrity and genuine concern for the profession. Since a conflict of interest many times involves both legal (business law )and ethical (professional) concerns, I suggest that you inquire with your national government and your school or professional association. You may find that there is governance as there is in the United States that is being ignored. You can then inform the affected parties that there are legal and ethical reasons to comply.

  7. I agree with your assesment of KOL. I know in the states most lecturers will disclose if they have any financial interest when delivering a lecture. I very much enjoy your blog Dr. O’Brien. Also, I believe you have mistaken Propel to be a orthodontic vibrating device to speed treatment time. Actually propel is a system of microperforations , with claims of increased rate of movement/ decreased treatment times. I’m not sure there is literature to support microperforations either, so you point is still made.

  8. Tony Collett says:

    Well said Kevin. I have no problems with key opinion leaders, provided there is full disclosure and transparency, which unfortunately can be lacking. These speakers are often good orators with interesting clinical material and most major congresses rely on their contributions. However, the other critical ingredient is a good deal of scientific questioning and scepticism of the attendees; which can also be lacking. When the unofficial title of the lecture is my best six cases collected over the last ten years it is hard to not be impressed, have one’s own inadequacies highlighted and feel this must be the missing link in my practice (one of our best study club nights was our worst treated cases – much to learn). In orthodontics, nobody dies and improper and ineffective treatment methods may not be appreciated for some years. However, as Charpak (winner of the 1992 Nobel Prize in physics) and Broch wrote: “The burden of proof is always on those who assert something new. The more the new claim lies outside previously established natural laws, the stronger the evidence to support it must be. This is especially true if the claim contradicts established laws.”

  9. Barry N Winnick says:

    Dr. O’Brien,
    I think that I could add some perspective to this very interesting dialectic about Key Opinion Leaders and conflicts of interest, which in my opinion, affects all of dentistry and has a legal remedy as indicated in a number of the posts to your blog. Ironically there are laws and guidelines already in place in the United States, however since they are rarely enforced most don’t heed them. I think that it may be helpful to look at this from the perspective of governance for both for-profit and not-for-profit organizations in the United States where there are specific compliance rules that start at the board level to establish the proper culture throughout the company. Incidentally, I gained this expertise having served as the chair of the nominating and governance committee for Independent Health Association, Inc., Buffalo, New York, which is a not-for-profit managed care/medical insurance company. I hope not to bore you but would appreciate if you would indulge me with the following:

    The Internal Revenue Service of the United States (IRS) has certain rules and regulations for the directors of not-for-profit companies. It is imperative that a potential director discloses any conflict(s). If one exists, there needs to be a thorough discussion whether the conflict is manageable. This is a dynamic situation and a disclosure form needs to be filed each year the director serves on the board. Also it is the duty and obligation of any director to immediately notify the board if said director enters into a conflict position. In my 35-year experience as a board member for Independent Health, all conflicts, save one, were managed.

    For-profit public companies that fall under the Sarbanes-Oxley act of 2002 (SOX), conflicts need to be disclosed and there is usually a determination whether the director is truly an independent director i.e. no compensation above a threshold level except for director fees, no immediate family member working for the company etc. The majority of the board needs to be independent directors and certain committees can only have independent directors e.g. compensation committee. The company must name a chief compliance officer. I am fairly confident that if you check the public companies in the orthodontic field such as 3M, Align etc. all have a chief compliance officer and the larger companies probably have compliance departments. In many ways, the SOX regulations are more stringent than the not-for-profit IRS regulations. Many larger (> one billion revenue) not-for-profit companies voluntarily adopted SOX along with the obligatory IRS regulations. The Independent Health board voted in 2003 to comply with the SOX regulations.

    I think my little primer is certainly germane to some of your concerns about conflicts. For example, the Align Corporation compliance department will require any of their lecturers that are not employed by the company to disclose that they will receive financial remuneration for their lecture and travel expenses as well as any stock ownership. Is this a conflict? It certainly is but it is unavoidable since it is not reasonable to expect someone to incur expenses as well as lost income to lecture. I know that the Align Corporation sometimes can be a bad actor, however, I have found in every lecture that I attended that they sponsored there was full disclosure by the presenting doctor. They are following the SOX regulations as required by law.
    If continuing dental education credits (CDE) will be awarded that are required to maintain a state dental license, a second organization will be involved – the state licensing board. Again full disclosure is required. Incidentally privately held companies that are not bound by SOX will be required to disclose if they are sponsoring a course that awards licensing credits.
    I am not naïve and understand that most of us have attended a course where there was not full disclosure and credits have been awarded. I can assure you that there should have been but the fact that someone does not comply is an enforcement issue. In those cases where noncompliance of regulations have been discovered and successfully prosecuted, fines have been levied against the offending companies. At least in the United States, a structure has been established for full disclosure of conflicts. As some of the posts have eloquently stated, the doctor still needs to evaluate the information that is being taught with an understanding that there may be presenter bias.
    Concerning a presentation that is not credit bearing but essentially a sales pitch, will require the doctor to retain the skepticism of a scientist to obtain useful knowledge.
    On evidence-based research as stated by Dr. O’Brien, “If we consider that in an ideal world, the best way we get accurate information about new treatments is the refereed literature.” This is certainly true and everyone wants scientific evidence. I think the reason that we don’t have this is not a lack of researchers but lack of funding certainly compared to medicine where there are more stringent regulations on introducing medical devices and pharmaceuticals probably because there is the potential to do great harm such as death! Hence more funding is required to bring something safely to market. To prove my point, please go to the website of the Moderna Corporation, Cambridge, Massachusetts. I really don’t understand the research that they do but I do understand how much money they spent on research last year – 300 million dollars! This is one company.
    I know that I am drifting away from the main topic but what about our patients and conflicts? Do they exist? The IRS has used threshold dollar amounts for conflict disclosure in business dealings. I think that it would be prudent to disclose to your patients if you own stock in the Align Corporation since there is such a large laboratory and total fee involved. For your information, I have never purchased any of their stock.

    Barry N Winnick
    Chairman of the Board Independent Health, Inc., Buffalo New York
    1993 to 2011

  10. Brian Fryar says:

    Kevin,

    Interesting discussion. I am curious did you attend the Insignia Users Meeting in New York in September? If so, I’m sorry I missed you. If not, how are you able to comment on any alleged “rows of entranced delegates worshipping at the feet of their gurus…..”? I am quite surprised you would insert this statement without attending the meeting yourself. Not very evidence based IMHO.

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