An occasionally irregular blog about orthodontics

Who pays the piper?  An influx of Key Opinion Leaders

By on October 15, 2018 in Recent posts with 32 Comments
Who pays the piper?  An influx of Key Opinion Leaders

 

I am becoming increasingly concerned with the effects of Key Opinion Leaders (KOL) on orthodontic practice. Two recent publications have bothered me and I simply cannot help responding.

KOLs are practitioners who receive payment from companies for their help with product development and promotion.

I have posted about Key Opinion Leaders several times. These posts have generated considerable debate. I have also published a post by Jason Cope, who set out his role as a KOL in a clear and transparent way.  He made the crucial point that a Key Opinion Leader needs to declare any potential conflicts when they speak or write about a product.

Recently, there has been an upsurge in KOL activity on social media. This has resulted in claims being made for the effects of appliances that are not supported by research. Furthermore, two recently published “KOL articles” have concerned me. These are in a editorial in the AJO-DDO and a discussion on self-ligation in the Journal of Clinical Orthodontics.

Let’s start with the editorial by Dave Paquette in the AJO-DDO

In defense of corporate sponsorships and a plea for civility

David Paquette:

Am J Orthod Dentofacial Orthop 2018;154:459-60 https://doi.org/10.1016/j.ajodo.2018.07.007

What did he say?

In this editorial he points out that manufacturers develop new products to help us provide better care. As part of this process Key Opinion Leaders inform us about their clinical experience when using the new products. However, there is an assumption that if a speaker receives payment from a company their opinions must be biased. As a result, there is a vigorous debate on the role of corporate sponsorship and the influence of KOLs. Importantly, some of this debate is unseemly.

He then states that corporate events which promote a product or company are bound to be biased. Furthermore, similar biases are present in the selection of speakers at the annual AAO Congress.

He also writes that most of the time the only evidence to support new technologies is case reports. Importantly, we cannot put new developments on hold, while we wait for the results of a trial.

Finally, he feels that all those on the “public stage” should disclose their associations and biases. By doing this we can all support each other.

What did I think?

I think that his overall message was that when a KOL promotes a treatment they should not always be treated with suspicion. I agree, but only if they declare their association.  In the USA the payments to KOLs are published.  Just go to this website and type in the name of a KOL and you will see their income from a company. (https://openpaymentsdata.cms.gov).

Unfortunately, it was a shame that Dr Paquette’s associations were not declared in this editorial.  In my opinion, this negates his arguments.

Let’s move to the JCO.

We all know that the JCO is not a journal that publishes scientific research.  However, it is a very useful source of great clinical information.  As a result, it has an influence on clinical practice. It, therefore, follows that the editor and members of the editorial board have a responsibility to our patients.

I was, therefore, surprised to come across the editorial and “open discussion” on self- ligating brackets.

The editorial

The pros and cons of self-ligation

R Keim

JCO August 2018

In his editorial Dr Keim states:

“The valid unbiased literature on self-ligation is indecisive”.

and

“The best way for the average JCO reader to get a clear view of self-ligation would be to hear from private practice orthodontists”.

To be honest, I am confused by these comments. In my view, it is clear from the results of several trials and systematic reviews that there are no real advantages of self- ligation. Yet, he appears to disagree with this large body of evidence?

I was equally concerned when he wrote:

“Dr. Graham’s current contribution is a valuable addition to the body of orthodontic practice literature. I learned a great deal from this article, and I trust that you will as well. It will certainly ruffle a few traditionalists’ feathers”.

I interpreted this to mean that those who believe in evidence based care are “traditionalists”.

The open discussion on self-ligation

The hot seat: Self-ligating brackets

JCO August 2018

Let’s move to the discussion led by Dr Graham.  Here are some of the relevant points:

When he asked the sample of private practitioners this question

“Evidence based research on self-ligation does not lean significantly or or against it. Why”?

Derek Bock: “Most studies are twin biased in design, they haven’t asked the right questions”.

Tom Barron: “I totally disagree, there is a growing preponderance of evidence from case reports to in vitro investigations”.

Bill Dischinger: “Is there anything in orthodontics that is evidence based”.

Stuart Frost: “I believe it is about bias in research and who benefits”.

Tom Pitts: “I am experience based”.

Other comments that stood out about other claims for self-ligation were;

Luis Carriere: “There is no pain”. “Treatment time is shorter”.

Tom Barron: “If I had to change to a twin bracket system. I would have to plan a higher percentage of cases with extractions, palatal expanders or surgically assisted RPE”.

What did I think?

All these comments, and some others, oppose the scientific evidence on self-ligation. I wondered why this approach was being taken. I was concerned that we are heading back to the days when the claims about self-ligation were out of control.  Perhaps the selected private practitioners had not read or really understood the literature? Then I had a look at the open payments website……

I found that in 2017, Drs Bock, Dischinger, Frost, Paschal, Barron and Reynolds received total payments of $1,065,000 (not evenly distributed) between them from companies that sell self-ligating brackets. It is easy for you to look up the individual payments on Open Payments. Furthermore, Luis Carriere is a major KOL for Henry Schein Orthodontics and has a self-ligating bracket named after him.

Ironically, if the companies had spent this large amount on clinical trials instead of KOLs then we would have known about the lack of evidence on the effects of self-ligation earlier than we did.

There really is nothing more to say.  However, I am sure that if the JCO had declared these conflicting interests then the article would be interpreted differently.

Summary

Previously, when I have written about KOLs several people have commented that I should not worry and I need to stop raising this as an issue. I am concerned because people have spent many years attempting to raise the evidence base of orthodontic treatment. In my opinion, the last thing we need is specialist orthodontist KOLs providing further misinformation on  products, without declaring their potential conflicts. I cannot help wondering if there is a danger of us becoming salesmen for any technique that we are paid to develop and/or promote. This is not how a respected specialty should behave.

 

 

 

 

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  1. Supriya Nambiar says:

    Dear Dr.O’Brien, I applaud you for the observations that was made by you regarding the role played by Key opinion leaders.Orthodontics should give due credence to the evidence based literature.I just cannot help but agree with the fact that this is not the way a respected speciality should conduct or behave.

  2. RODRIGO ANDRE TAVARES DOS SANTOS says:

    Influenciadore$ de opinião em Ortodontia

  3. Mark Wertheimer says:

    I agree with your sentiments totally and would even go further in saying that it is rather unfortunate that both of the articles were actually published in these journals. I believe it is rather sad that the editors have stooped this low and given valuable space for the publishing of these two articles which are deplorable

  4. Ben Burris says:

    Glad to see you’re an OrthoPundit reader Kevin. Keep up the good work!

  5. Gordon Greene says:

    Last week I read those same editorials with a considerable degree of chagrin, incredulity and dismay. Such self-serving propaganda does not belong in journals. It is quite fascinating that the JCO chose to interview only practitioners who have conducted no research in their purported “area of expertise”. We are all experience-based to some extent – the question is what degree of scrutiny is realistic to expect when such conflicts and biases are in play? This is why data from well done studies is invaluable. To discard the research in exchange for opinion from so-called experts, defies logic. It is incumbent on the proponents to provide valid evidence. Unsupported and unscientific statements simply will not suffice.

  6. andy pearson says:

    There’s no question that if you take money from a company you will be biased in favour of that company. Presumably thousands of us have used self ligating brackets and found them no different to non ligating brackets, and why would they be? It strikes me that part of the problem here is the term Key Opinion Leader which sounds very grand until you realise that it basically means Rep.
    Now I love most of the reps of orthodontic companies and try out all the new stuff but my job is to treat patients in the best way possible and apply a bit of un-biased thought to the process. The first step in doing this is to accept that you may be deluding yourself if you think A is better than B; because what we think is the case and what is actually the case are rarely the same. A study is the only way to confirm or reject the hypothesis. It is true that there is alot of bias in trials but, if a trial shows no difference between 2 therapies then I would be likely to accept it since I would assume that any bias would be trying to find an effect (most researchers want to find an effect when all said and done).

  7. Robert Stoner says:

    As an orthodontist who has practice to Tweed Philosophy for 35 years, the evidence is in. It is highly effective. Unfortunately, we have nothing to sell other than education at the Tweed Course in Tucson. We do not sell “easy”. And none of the instructing staff makes a profit. Unfortunately, the journals do not promote us as there is no “new” product to buy, only evidence. It seems in our society “new and improved” is always better.

  8. salesse says:

    Nothing new about the KOL unfortunately.
    Everything is a number problem. Big companies pay for advertising and for the KOL participation on social media/magazine/event. Evidence-based has nothing to sell.
    It just demonstrates something deep about the human brain, that specialist who did between 6 to 10 years of demanding and selective university training, are subjected to mandatory continuous education, can be so easily moved by what is at the core, pretty simple advertising tricks.

  9. Jan Ledvinka says:

    Great article – thank you.

  10. I totally agree with all your concerns and comments. Specific public disclosure, as is the AAO policy for all speakers at AAO sponsored events, should always be made with any presentation or article published. The distinction between a professional and a salesman can only be truly applied to the treatment of our patients with “evidence based practice”.

    • DeWayne:
      I am a bit confused and I believe Dr. O’Brien is correct on the lack of disclosure in even society sponsored meetings. I spoke at the AAO Orlando meeting a couple of years ago and there was no mention of any conflicts of interest in the on-site program for the meeting. When I raised the issue with Dr. Steve Lindauer, the scientific program chairman, his response was “Everyone has some conflict, so the AAO decided not to include it.”
      If there was conflict disclosure forms completed by the speakers, what good are they if the audience does not have access to them? Dr. O’Brien may even publish the disclosure form used by the AAO for purposes of transparency.

  11. Thank you for the enlightening critics about recents articles and KOL.

  12. Kevin. I just read your post and agree with you which is why I wrote the guest editorial. I do want to clarify something…I DID fully disclose my associations and the AJODO failed to publish it. I had no control over that omission. They are publishing an addendum/correction next month but that is of little help. Another thing to note is that you can only look up payments in the USA if those payments are made directly to an individual, you will not find them if someone has formed a consulting company or sham corporation. Some of the worst offenders operate that way.

    • BARRY N WINNICK says:

      “…you can only look up payments in the USA if those payments are made directly to an individual, you will not find them if someone has formed a consulting company or sham corporation.”

      This is not really true according to the Centers for Medicare and Medicaid Services, which is one of the largest agencies in the United States government. An advanced search should turn up the name of the doctor.
      _______________________________________________________
      According to their a website: “…payments provided to a consulting firm or third party, whom in turn provide the payment (in whole or part), to a physician are reportable. Open Payments requires reporting of both direct and indirect payments and other transfers of value provided by an applicable manufacturer or applicable group purchasing organization to a covered recipient. An indirect payment is a payment or transfer of value made by an applicable manufacturer, or an applicable group purchasing organization, to a covered recipient, or a physician owner or investor, through a third party, where the applicable manufacturer, or applicable group purchasing organization, requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s), or a physician owner or investor.” _______________________________________________________
      Since the purchaser needs to justify a legitimate business expense, one can assume that the said purchaser will not engage in subterfuge by not listing the doctor associated with the “consulting service”.

      • Dave Paquette says:

        Barry, I agree that you should be able to if everyone followed the rules, unfortunately there are loopholes to this system like everything else. Having said that, it is a decent barometer for most speakers and hopefully the exceptions are few and far between.

  13. Thank you for your honesty!

  14. Michael Yar Zuk DDS says:

    It is very important to have the discussion of corrupt information, especially when it is included in approved continuing education. Where I practice in Alberta, Canada orthodontist vs orthodontist and ortho vs gp wars are being raged with the use of the advertising ‘word police’…then lawyers hire expert witnesses who choose a side and beat the professional with whatever study opposes the selected victim. SLB’s were under attack – 18 orthos told to remove the claims, and a year later a gp was told by the same authority they do speed treatment ‘about 30%’ according to their $10K expert BUT the gp was in trouble since quicker treatment somehow implied he was a specialist. Linear thinking used to punish whatever position was made. The UK at least addresses claims at the manufacturer level rather than only on a practitioner basis, but there is still a large anti-gp lobby which now has to deal with non-dentist competitors. Truth is always great…but what if it finds a dental authority, a dental lab and a overly-aggressive cosmetic dentist training program joined at the hip? That’s when it gets very quiet.

  15. Jim Vaden says:

    Kevin– Way back in 2000 Tony Gianelly wrote an editorial for the AJO/DO entitled “Evidence-based treatment strategies:An ambition for the future”. In this editorial he asked if Orthodontics will accept an evidence based approach to treatment decisions. He also asked if orthodontics was ready to alter treatment strategies if the purported claims were not supported by fact. He goes on to say that the responsibility to use the evidence lies with practitioners. You said the same thing in your blog. I commend you for saying that evidence is vitally important and that treatment decisions should be based on our best evidence. Thank you for your forthright expression of your opinion.

  16. Rick Cantor says:

    Thank you for your message.
    Evidenced based information is critical from a clinical aspect. Without openness there is no trust!
    Keep up the great work.

  17. Doug Klein says:

    I would encourage those interested in this topic to read a 2004 book
    written by Dr. Jerome Kassirer. The title is, “On the Take: How
    Medicines Complicity with Big Business Can Endanger Your Health”.
    Dr. Kassirer was the Editor -in -Chief of The New England Journal of Medicine from 1991-1999.
    It is worth taking the time to read this book, as he also offer solutions.

  18. Rohit Sachdeva says:

    I believe that the editors of the journals should shoulder some responsibility in ensuring that the readership is offered a balanced viewpoints in their journals .

  19. Lou Chmura says:

    Kevin, In the words of Ronald Reagan, when confronted with the same spurious arguments, “There you go again”.

    You’re singing the same old tune and I have to ask “is your goal to have anyone with a bias state that bias before rendering an opinion” or is it to call out speakers and KOLs, as if their integrity is more in question than others? The first would be an altruistic aim, the second more like sour grapes.

    We all have biases. By cherry-picking specific parts of two articles to make the case that KOL’s have an obligation to disclose their biases, you’ve exposed yours. Why not new grads who got a screaming deal on their brackets? Why not educators who got a screaming deal for their department? Why not 30 year practitioners who are comfortable doing it “this way” and therefore resist change. Why are you singling out KOLs and why do you refuse to differentiate between those who speak and get an honorarium for speaking and those who are “on the payroll”? Perhaps most importantly, why did you skip the parts of the article that talk about the civility or self-appointed arbiters of truth or that even our forefathers tried reasonable alterations in technique to see if it worked better before they developed a double-blind, prospective study with thousands of participants. It sounds like those comments were passed over because they don’t fit your agenda.

    Based on the website you referenced, the KOL’s listed received over $1M in honoraria in 2017-do you realize some of them (I am fortunate to know most of those and call them friends) are gone nearly every weekend teaching? They speak passionately about techniques and processes that work in their offices-not because they are paid to do so, but because they believe in them. Besides, KOLs should love the stuff they use-they helped develop them.

    I know when I speak, it means time out the office-its not more lucrative-but I’m passionate about dispelling the stodgy position that we cannot help people with sleep apnea. We can and I do all the time. Just don’t have a “cookbook” approach. I’m still having to use my noggin to figure out what’s best for each patient (see three approaches in upcoming Orthodontic Products magazine). By your criteria, I should make note that I am a KOL for HSO and Suresmile as part of the article, even though I didn’t use their stuff for two of the patients.

    Between the honoraria and the travel, my reimbursements last year were listed ast $29K+. Not sure where that number came from. Certainly not from being a KOL at HSO. Furthermore, this site only lists US docs, no-one from Manchester, or South Africa or Cambodia, or anywhere else in the world. Yet, the same group (from Manchester, South Africa, Cambodia) are first in line pointing the finger at KOL’s. Lets see the same transparency for non-US doctors that we have for US doctors.

    Don’t get me wrong. I’m all for transparency, but against your single-minded attempt to demonize KOL’s. Did you realize that I was able to identify at least 5 heads of ortho departments who were on the list-several with higher numbers than I had. Do you seriously expect them to identify the sources every time they write an article or give a lecture?

    The problem is you’re trying to legislate integrity, which has NEVER worked. Those without integrity will find a way around your rules and those with integrity will be offended that you’ve singled them out. Time for you to find another soapbox.

    Lou Chmura

    • Kevin O'Brien says:

      So my point has not changed from the last time that we had this debate. There is nothing wrong with being a KOL providing that this is declared. That was the point of my post. Yes, you are right it is shame that other countries do not have an open payment system but this does not detract from the need for disclosure.

  20. Terry D. McDonald says:

    Kevin, Congratulations on a your very informative blog. Hopefully it will be read by many and especially, orthodontic educators. It is time for all in orthodontic education to face up to the evidence based truth concerning the false promises made in the promotion of the Damon SLB and other evidence lacking gizmos. Not all will listen but as with the Angle -Case debate and Tweed re-enforcement, it is educators that have a major responsibility in promoting evidence based truth and critical thinking to their students. Recent and ongoing CBCT studies (http://www.angle.org/doi/pdf/10.2319/101117-686.1?download=true) continue to point out the damaging effects of expansion orthodontics including the potential for long term negative periodontal impact. As I recall it was once said “Above all due no harm”. It is high time that all in our profession, and most certainly, KOLs, make a serious attempt to adhere to that philosophy in both teaching and practice. As was said by Leonardo da Vinci a few years back “those who fall in love with practice without a science are like a sailor who enters a ship without a compass and who can never be certain wither he is going.

  21. Robert Schatze says:

    I find the feigned outrage and red herring arguments from some of these KOLs to be quite ludicrous. Are we not supposed to know about the conflicts of interest that may be inherently affecting the “expert”? Of course KOLs are viewed (and rightfully so) with some degree of skepticism. The information they present is usually based on their experience/perception, and may lack the rigor of scientific research. This is not news!

    Individuals that accepts remuneration from corporate entities, and don the mantle of a KOL need to comprehend that the burden of proof rests with them to make their case, and not for the rest of us to accept their claims, like we would data published in a reputable journal. Whether they are paid to do so, or they genuinely believe it, the plural of anecdote is not data.

    New grads and educators generally don’t go around lecturing to the masses and concocting far-fetched claims with no evidence, or in contradiction to the evidence, like several KOLs do (and have done in one of the editorials under discussion). As an example, numerous RCTs have debunked the unsupported claims made by several KOLs regarding self-ligation. Yet they persist and insist that the evidence is flawed. Really? All the RCTs? So who are we to believe? Such specious perspectives confer a degree of suspicion regarding the potential for financial or other bias.

    As for time away from the office/practice/income loss etc, that was a decision made by the individual, not a position they were forced into by the rest of the profession.

    In this era of alternative facts, Kevin has been the one bright light across a rapidly dimming profession. If these KOLs expect to be taken seriously, transparency and intellectual honesty are key. The only ones with an agenda here are those whose honoraria are at risk when their claims are scrutinized. Like members of the flat earth society, they resist all facts that don’t suit their “beliefs” – financially conflicted or otherwise.

  22. Richard Portalupi says:

    I do not disagree with your points, but I must say that when I read the article I was well aware of the associations and biases of the members of the panel and able to take it for what it was: opinions by clinicians based on their experiences and preferences along with accompanying biases. I think most of us can prudently read such articles and filter through them pretty well.

  23. Frank Weiland says:

    Thank you, Kevin: you hit the nail on the head! Personally, I prefer NOT to be a part of the esteemed KOLs. I prefer to buy my material myself and then be able to give an independent report if asked. Never accepted to be paid by a company and I certainly will not do this in the future. And I never loose hope that we still have colleagues who are able and willing to critically think about what we are being told. If my teaching has any good: I hope that some of my postgraduates stay skeptic…

  24. Are you the same Kevin O’Brien that got US$27.65 from Straumann according to that open payments site*?

    For a man of your talents, I’d have held out for the price of an Channa Bhuna and pilau rice with extra poppadoms and a few onion bhajis.

    Stephen Murray
    Swords Orthodontics

    *
    https://openpaymentsdata.cms.gov/physician/966565/payment-information

  25. Franco says:

    Que sara sara, is that your new ferarri car? Nice, but I’ll wait for an F50.
    If you think most orthodontists should be “smart enough to know if a speaker is biased”, you are deluding yourself. Don’t feel bad; most people do. That is why we have “double-blinded” studies. That is also why we need extreme transparency on any possible financial incentives.

  26. T. Stamm says:

    I wonder how such intercessors get into a scientific journal. I would not have expected this from AJODO in particular. Do the editors still read the articles at all?

    Can I convince you for an editorial about KOL in HeadFaceMed?

    Kind regards
    T. Stamm
    Editor in Chief Head & Face Medicine

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