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
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.
JCO August 2018
In his editorial Dr Keim states:
“The valid unbiased literature on self-ligation is indecisive”.
“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
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.
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.
Emeritus Professor of Orthodontics, University of Manchester, UK.