June 29, 2020

KOLs take issue with me and my blog.

As you may know, I recently published a post about a trial that showed an absence of evidence for the benefits of orthodontic vibration. This resulted in a strong response from some of the Propel KOLs. I was also disparaged on social media.  This blog is about those comments and my appraisal of the evidence that they put forward.

I have also been listening to a lot of Pink Floyd recently, hence my sub-headings to lighten the mood.

On the turning away

I asked them to let me have some published evidence on the effects of high-frequency vibration.  One of them sent me this list of papers. Another KOL for Propel also posted the same list on Facebook.

So, I had a look at this evidence, and this is what I thought.

Animal and ex-vivo studies

Alikhani M, Alansari S, Hamidaddin MA, Sangsuwon C, Alyami B, Thirumoorthy SN, et al. Vibration paradox in orthodontics: Anabolic and catabolic effects. PLoS One. 2018;13:e0196540.

Alikhani M., Khoo E., Alyami B. Osteogenic effect of high-frequency acceleration on alveolar bone. J Dent Res. 2012;91:413–419. doi: 10.1177/0022034512438590.

These studies were done on rats. While they provided interesting scientific information. Importantly, we need to remember that the medical and dental research is littered with animal studies that do not translate to the clinical situation. We do not treat rats.

Judex, S., & Pongkitwitoon, S. (2018). Differential Efficacy of 2 Vibrating Orthodontic Devices to Alter the Cellular Response in Osteoblasts, Fibroblasts, and Osteoclasts. Dose-Response16(3), 155932581879211. doi: 10.1177/1559325818792112

This study was done on samples of cells in containers. As a result, it is not relevant to the human clinical setting.

Clinical studies

These papers were not published in any of the major orthodontic journals.

Alansari, S., Atique, M. I., Gomez, J. P., Hamidaddin, M., Thirumoorthy, S. N., Sangsuwon, C., … Nervina, J. M. (2018). The effects of brief daily vibration on clear aligner orthodontic treatment. Journal of the World Federation of Orthodontists7(4), 134–140. doi: 10.1016/j.ejwf.2018.10.002

I looked at this paper carefully, and I felt that there were the following significant issues.

  • The error of the software measurement was 0.2mm, and random error was 0.1mm. This equalled 0.3mm. As a result, their measurement error was too high.
  • They only measured the tipping movement of one lower incisor tooth in the entire mouth. This was not relevant to the typical clinical situation.
  • Participants who did not comply with treatment were discontinued.
  • The trial was registered with Clinical Trials.Gov. This stated that the study was sponsored by Propel. The authors did not report this conflict in their paper.  They also registered the protocol for this study after the completion of the study. This puts the paper at high risk of bias.
  • Most of the authors are affiliated to the Consortium for Translational Orthodontic Research. This organisation provides clinical care and promotes MOPs and vibration for increasing the speed of tooth movement.  It also holds the patent for the VPro5 device that was evaluated in the study. The authors did not record this conflict.

Shipley, T. (2018). Effects of High-Frequency Acceleration Device on Aligner Treatment—A Pilot Study. Dentistry Journal6(3), 32. doi: 10.3390/dj6030032

This was a pilot study of 16 patients.

Propel funded part of this study. The lead author is currently a member of the Clinical Advisory Panel of Propel. These conflicts were declared in the paper.

El-Bialy, T., Farouk, K., & Shipley, T. (2018). Effect of the application of high-frequency mechanical vibration on tooth length concurrent with orthodontic treatment using clear aligners: A retrospective study. Journal of Orthodontic Science7(1), 20. doi: 10.4103/jos.jos_53_18

El-Bialy, T., Shipley, T., & Farouk, K. (2019). Effect of high-frequency vibration on orthodontic tooth movement and bone density. Journal of Orthodontic Science8(1), 15. doi: 10.4103/jos.jos_17_19

These two papers were from the same sample of patients whose records were collected retrospectively.  I could not find any information on the pre-treatment characteristics of the patient’s malocclusion. This is important because we do not know if the two groups were the same at the start of treatment.

Propel funded part of this study. Two of the authors stated that they held lectures for Invisalign:” and one author lectured for Propel.

We don’t need no education

The evidence is a collection of animal/ex vivo studies that may not translate to the clinical situation. Other papers reported unclear retrospective studies and a trial that was significantly flawed.  All of the clinical articles were conflicted. I feel that this evidence does not support the selling of an intervention to our patients.

Both of the KOLs attended speciality training programmes that must have included training in appraising the quality of the literature.  I am not sure why they felt that this collection of papers provided useful evidence on the effectiveness of vibration?

I have become comfortably numb

numb

In my blog, I address issues that I feel are important to me. As regular readers know, I post and lecture about KOLs and their behaviour. I appreciate that this is a tricky area, and occasionally I have “crossed the line”.  Unfortunately, this time there were many comments made about me on social media. Here is a selection.

“I don’t think Kevin is an orthodontist any longer. I have never seen any of his cases”.

“Those who can do, those who can’t post crappy stuff about others who can”. (HSO KOL)

“Funny how he has built his entire reputation on hate and attack”. (HSO KOL).

“I am being slandered for being a KOL by middling orthodontist with malignant penis envy”. (HSO KOL).

I have given these comments considerable thought and evaluated my approach to challenging KOLs.  I have decided to continue to highlight unfounded claims made by KOLs on behalf of the companies that pay them.  Nevertheless, I will take more care to make sure that I am respectful.  I hope that they can do the same. If any KOL wants to post about their point of view on my blog, just send me the post, and I will publish it. We can then all have a civil debate?

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Have your say!

  1. Avatar

    You are living legend. The end.

    • Avatar

      Unfortunately , the internet has become much like the wild west not just replete with snake oil but mob mentality, rampant use of straw man arguments and labeling. It appears that you are a victim of the latter along with the ubiquitous sycophants who are happy to pile on. The labeling in particular is a pathetic attempt to have you now be required to come up to their level since you are not a good orthodontist, must have small genitalia, or teach thus have no right to question them or the quality (or lack) of evidence for their claims .These are classic bullying techniques) when logical debate is not an option for the bad actors due to the thin or missing actual evidence for their claims.

      Please keep presenting the evidence for us despite the tough nature of the job.

  2. Avatar

    How ironic and appropriate that the first quote includes a very low evidence base (personal opinion) for it’s assertion.
    Keep up the good work Kevin.

  3. Avatar

    Thank you for sharing!!!!

    Evidence based dentistry is the only truth!!!

  4. Avatar

    Thanks so much for the work you do for all of us. Keep policing our profess. Do not be intimidated by the KOL.

  5. Avatar

    Kevin,
    I am a KOL for Planmeca and I appreciate your blog. I appreciate how you look at papers critically and work to advance our specialty. I think you would agree that there is nothing inherently wrong with being a KOL as long as one works to keep a critical eye on what they say from the podium and post on blogs and social media. One of the main reasons that I am a KOL is that it gives me a voice in our community and allows me to discuss issues I find important to move us forward. Please let me know if you ever hear me say or post anything that is contrary to what the literature would say. I think we should all be willing to have our work and what we say looked at critically. And, if errors are found in what is said or posted, then we should accept these findings and learn from our colleagues. Please keep up the good work and continue to shine a light on how we as a specialty can improve.

  6. Avatar

    “ The truth is still the truth even if no one believes it. A lie is still a lie, even if everyone believes it.”
    Keep It going my friend! Love your posts, and may the science be we us.

  7. Avatar

    There are many words to describe your blog posts, Professor O’Brien, but ‘hate’ and ‘attack’ are not two of them. In my view you invariably aim to be fair, open-minded and, crucially, highlight your personal biases. We should all aspire to these standards in our professional discussions. Congratulations for not being ‘hooked’ by their social media ‘bait’ and letting your standards slip.
    Please keep applying your concise and elegant system for commenting on issues relevant to all dentists involved in orthodontics. I know many colleagues around the world who appreciate your efforts. You are a Leader with Key Opinions! :0)

  8. Avatar

    First of all, does “On The Turning Away” really count as Pink Floyd song? I’m not sure about that one. Let’s ask Roger.
    Secondly, when it comes to many KOL’s, methinks thou dost protest too much. Not all, but many!
    Thirdly, thanks for following the money and attempting to keep them honest.

  9. Avatar

    In my opinion when you opt to be a KOL you have to take the ‘honour’, ‘adulation’ and ‘glory’ of delighting those colleagues who hang to your every word with the those who simply do not agree with your opinion and the scientific basis that your claims hang on.
    Personal insults are degrading and show a complete lack of introspection of the clinician. If you can not take the heat leave the kitchen.

    I was very fortunate to be a Registrar under the guidance of Geoff Webb in Canterbury. After my first year Geoff, (who had 40+ years of experience) showed me his cases that had not worked through his career. He explained why they did not work and how it made him change his clinical practice. He also demonstrated that the new ‘wonders’ in orthodontics, at that time, were just a reinvention of what had been tried several years earlier. It was more refined but that did not mean it would work. Understand mechanics, biology and treat the patient as an individual. Read the evidence critically and everything else will fall into place.

  10. Avatar

    I’m with you, Dr. O’Brien! The well-designed science must lead the knowledge, not the companies with their business interests. Unfortunately, they are using us (Kols) to convince ourselves.

  11. Avatar

    Hi Kevin,
    don’t be afraid to care…
    Best
    Daniele Raviglia

  12. Avatar

    Caring nothing for their personal reputations these particular HSO KOL’s should be but are obviously not embarrassed by their Neanderthal-like and terribly unprofessional public postings. Given they’ve allowed these comments one must question the integrity of HSO. Evidently, even within a “learned calling” good manners have fallen away.

  13. Avatar

    Kevin,
    Do not pay attention to those attacks; you are doing a great service to the profession.
    Keep doing such an amazing job.

  14. Avatar

    As an academic orthodontist, I’m happy to see critical reviews of the scientific literature that has already been published.
    The peer review process is not perfect. I review manuscripts prior to publication, I also see the reviews of the other referee. Sometimes I have missed important issues, sometimes it is the other referee. I would like to think that I have gotten better, and that this has lead to an increase in quality of the papers that are published
    Thank you Kevin

  15. Avatar

    Down, down. Down, down.
    The star is screaming.
    Beneath the lies. Lie, lie.
    Careful, careful, careful with that axe, Kevin.
    [Very loud and prolonged scream]
    The stars are screaming loud.
    Tsch.
    Tsch.
    Tsch.
    (From Pink Floyd, Careful with that axe Eugene)

  16. Avatar

    Wow,Kevin ,you really poked the bear !!LOL
    Points,
    -Time we got rid of the KOL epithet and used “speaker paid by manufacturer“.Individual orthos.can decide if the self -designated title, KOL,is appropraite.
    -Kevin ,you make evidence based analysis of studies ,the individual clinician can ,if they wish ,translate this info.to their clinical practice.If anyone needs to refute your academic opinion then they are free to do so but use literature based responses only.
    -If authors dont indicate manufacturers payments,past and present then ,personally,I dont read the studies .
    -Kevin,when you critique studies ,could you please provide the impact rating of the appropriate journal for simple folk like me.
    Thanks for your valuable work!

    • Avatar

      Thnk you for that clarification. I consider myself a KOL for 2 products I am passionate about, and do not receive a dime from a manufacturer or an entity. If peer reviewed science supports what I do and why I do it, yet do not get compensated should we create a new classification? Many of ‘us’ fall into this category!? I’ve never liked the term KOL, and after reading these attacks on Kevin prefer to be completely disassociated from that term.

  17. Avatar

    These KOLs continue to show their complete and utter lack of class, integrity and professionalism. They have consistently championed chicanery, artifice and salesmanship, over science. They represent the “bottom of the Orthodontic Barrel”. Their delusional pride in espousing questionable science and promoting poor outcomes makes one wonder if they actually went through a residency at all!

  18. Avatar

    I would say this is a perfectly logical next step. For companies selling products, scientific studies with unsatisfactory results aren’t a problem per sé. Most people do not read that much literature, and there are always the KOLs to provide sufficient encouragement to keep orthodontists buying their products like nothing happened. The problem is that your blog has obtained ‘critical mass’, in that it reaches sufficient people to make a real difference as to how people perceive products. This implies your opinions, however objective they may be, have the potential to hurt these companies’ bottom line; companies which often have dedicated social media teams. Strategically, the logical next step would be to advise their KOLs to ’go personal’, attacking the messenger, instead of the message, the aim of course being to decrease the weight your opinions carry. This would preferably be a coordinated effort, with KOLs linking to their colleagues’ social media posts in order to amplify their message. As your posts, as far as I can remember, have never carried the very personal tone these KOLs’ posts carry, I very much suspect this is what is currently going on.

  19. Avatar

    I would not care at all of the KOLs grumble. The cited personal comments on Kevin O’Brien are unprofessional and a sign of bad manners. As the old orthodontics used to say “Let’s put the plaster on the table” today we should always ask all guys recommending new appliances or treatment approaches “Let’s put the data on the table”.
    To ask constantly for the underlying evidence is the great strength of this blog. In my point of view, Kevin O’Brien’s blog is one of orthodontics’ brightest lighthouses. Kevin, thank you for your work!

  20. Avatar

    Your position is perfect!
    We are living in a world where some think that science is not essential to clinical decisions.
    We have to show every day that they are wrong.
    Thank you in the name of our profession and science!
    All my respect.
    Best wishes,
    Klaus

  21. Avatar

    Hi Kevin
    I started to understand evidence based orthodontics with you since 2003.
    17 years gone so fast but I am still learnIng from you.
    I appreciate your time and efforts.

    you told us:
    Be analytical
    Be critical
    Do not believe what you hear!!

    That’s so true

  22. Avatar

    Sorry to hear you have received inappropriate comments to your recent post, that is most unprofessional and I think further undermines their precarious position.

    From a patients perspective, please keep highlighting evidence based orthodontics. It’s difficult enough navigating a way through the conflicting information, and posts of this nature help to steer patients away from treatments that cannot be justified or evidenced.

  23. Avatar

    Revisiting books as Fahrenheit 451 should become compulsory for orthodontic residents.

  24. Avatar

    Kevin,

    Unlike politics, science deals in repeatable and verifiable evidence that may actually help to move the needle on whether something is likely true or not true. Unfortunately, some KOLs appear to be following the methods of politics and screaming their point of view and disparaging those that do not agree to try to gain favor (and profit). Shame on them!

    Keep up the good fight!

  25. Avatar

    The truth hurts.

  26. Avatar

    Dear Kevin.
    I think every reader of this Blog will be impressed by the very patient and gracious way you have responded to these Social Media comments.
    Congratulations on the example you have set.
    With best wishes, Richard Pilley

  27. Avatar

    I had read some of the KOL comments and backslapping on orthodontic group on social media and was taken aback. Your measured and professional response is remarkable given the bile that was written. Ironically I only looked up the group after it had been mentioned in your blog! Please keep up this important work.

  28. Avatar

    Although my professional biases lean towards your favor, in favor of evidence based dentistry, I am so proud of you for recognizing in yourself, a way to improve. “Can’t we debate in respect” and kindess. Well done Doc!

    I am sickened by the gross and rude behavior of our colleagues. How can any of us treat another with such disparaging remarks and think we are in the right? Well done for your humility and yet standing up for your professional beliefs!

    DF

  29. Avatar

    Please do continue to stay ‘Comfortably Numb’ and continue to be The Legend that is Prof O’Brien. Your blogs are much-valued the world over!

  30. Avatar

    Thank you for a well written review of the current evidence. I have recently been approached with these exact articles and asked to take part in a seminar regarding Propel. Just reading the titles and publications raised questions and I am glad that you have decided to deliver the answers in what I feel is a humble and as objective as possible manner. If the orthodontic community disregards from science we’ll soon find ourselves being salesmen instead of health professionals. And really, that’s not what I signed up for.

    Thank you and keep up the great work!

    André Wikholm
    Uppsala, Sweden

  31. Avatar

    Kevin, Thank you so much for the orthodontic contribution and the criticism about the published papers. That criticism just make us more alert about what we read and what is real and reliable evidence.

  32. Avatar

    We really appreciate your work Kevin! Thank you and please keep it up! 🙂

  33. Avatar

    You provided lots of great examples of the ‘ad hominem’ fallacy with those social media posts. When a KOL attacks the person and not their argument they have already lost. Keep up the great work Kevin and thanks for always taking the high road!

  34. Avatar

    Kevin,

    I admire your work and your professionalism. Orthodontics must be based on evidence, not tales from KOL’s.
    To me it seems like some of the KOL’s have run out of arguments when they come up with comments like that. Just one word for that: Sad.
    Keep up the good work!!

  35. Avatar

    Haters gonna hate. Your veracity versus their versimilitude …. mic drop.

  36. Avatar

    How I wish, how I wish you were here.
    We’re just two lost souls swimming in a fish bowl, year after year,
    Running over the same old ground.
    What have we found?
    The same old fears.
    Wish you were here.

  37. Avatar

    Thanks Kevin for being the voice of evidence based orthodontics, your blogs are brilliant “vacuum cleaner” of the nonsense in our profession
    There is a saying in Arabic which I would like to quote:
    ”Progress cannot be stopped by the criticisms of scoundrels”
    الكلاب تنبح والقافلة تسير

  38. Avatar

    Consumers of Orthodontics want a magic solution. They are generally familiar with the literature. Companies are more than willing to pay KOL’s to be the Pied Piper’s for faster, better, non-extraction, non-surgical treatment. Voila, Orthodontics is easy. The ROI must be there. Any blame on those that support the snake oil salesman?

    And if the Pious academic research was so fantastic, how could the shyster practice continue to survive?

    There are 2 sides to every coin…

  39. Avatar

    I want to congratulate Dr O’Brien for his wisdom that enlight us about issues that are nothing but snake oil.
    I was a disciple of Dr Proffit. He was quite good too to identify quackery.
    Keep the faith and continue your battle.

  40. Avatar

    The comments hopefully are not representative of the overall KOLs. The majority I have meant have been respectful and civil, understanding we disagree and will never agree until the evidence backs them in. There is a very good reason why the government introduced a regulatory framework for KOLs in the pharmaceutical industry. We are seen as a smaller and less harmful industry. It is even more important then we have people prepared to stand up with the evidence. Well done. I am of a similar age and also enjoy Pink Floyd; Dark Side of the Moon being my favourite (now that could be worked in somewhere).

    • Avatar

      Hi Tony!
      Would be interested to know how pharmaceutical industry KOL’s are regulated? I am sitting here feeling guilty that I am likely considered a KOL (I don’t feel like one, wish my kids listened more to my opinion!), and how to avoid the sticky conflict of interest.
      Looking at one scenario: an idea, a proposal for feasibility study – usually to a uni as this gives credibility to product , by default the researchers/ faculty involved become the most experienced with the product, they present their findings, companies need this exposure, particularly with pressures of going “public” and IPO looming, and if they haven’t contributed financially to the initial study (the uni department in my experience in USA and AUS usually request this funding), they will pay the researchers expenses to travel and present the findings, even the most preliminary. Our colleagues wanting to keep abreast of new technologies in the field encourage these initial presentations / even publications and before you know it, perhaps unwittingly a KOL is born.
      Then the next step is further research – who better to investigate a product than the “expert” / by now KOL in that product in the department, environment already set up with the infrastructure to test the product? Even when blinded, this protocol attracts by its nature a “inherent bias” label; however it is one capable of speaking to the question. Not to mention often requiring the cooperation of the company in terms of data and other resources. How do we judge the resulting publication? It is difficult to do so objectively and to ignore the inherent bias.The obvious and frequented alternatives are to test in a uni setting, using residents still learning about the basic principles of patient care and orthodontics, or in the private sector with experienced clinicians but lacking in experience with the technology to be tested. This is also a flawed testing ground, influencing the outcome of the technology under investigation with the introduction of a large confounding variable being the clinicians themselves.
      It thus appears to me that the KOL, or 1 pathway to becoming a KOL is a symptom of a larger issue, eluded to by some bloggers above. Fueled by the unpalatable but ubiquitous union of departments requiring funding for research capital with (infant) companies, often with the best intentions requiring in vivo testing and under pressure to launch products in a timeline and protocol that sits at a juxtaposition with that of producing the evidence in a non-biased, independent setting. This is not a revolutionary situation, we have simply failed to change a flawed paradigm and now we live with the symptoms. Is it even possible to conduct unbiased research, allow objective testing of new ideas and products, support university education and additionally cease a common pathway to the birth of the KOL? Would love to hear some ideas, maybe a blog Kevin on modalities of conducting orthodontic research to pick the minds of bloggers all over? I am searching for that ideal protocol…A Momentary Lapse of Reason 1987:)

  41. Avatar

    KOLs in this instance probably have larger organs due to the vibrations ..

  42. Avatar

    Unfortunately, Orthodontics and Orthopedics is full of concepts, disciplines, protocols and appliances that are very questionable.
    Unfortunately, the evidence has also not helped in many cases to reveal or understand the truth of many phenomena and hypotheses.
    This confusion in the mentality of the Orthodontist has made the medium an ideal breeding ground for interests, commercial houses, even ordinary people and patients who feel empowered to dictate the course of the profession.
    This that has just happened with Dr Ken O’brein is a reflection of what I have mentioned here.

  43. Avatar

    Go ahead Kevin. it is impossible to seriously discuss a scientific topic about a product with someone who is paid to sell it

  44. Avatar

    We need you, please continue your work. Your evaluations are precious. Everyone who speak up against the “salesmanship” will be criticised.

  45. Avatar

    Lost for Words
    Sorrow
    Welcome to the Machine
    Money
    We don’t need no Education
    Poles Apart
    Is there Anybody out there?
    Hey You!!
    Breathe
    Shine on You Crazy Diamond

    Appreciate you and the sentiment of comments above. I may be a little KOL, not sure, but I take you and your Blog on the podium each time I speak. You (and vast majority of your contributors) are in my head. Currently it’s the song list above XX

  46. Avatar

    Kevin,

    “Those that can, do. Those that do and can think critically, do more, Those that can do but never can think critically , well I guess they become Key Opinion Leaders”

  47. Avatar

    I would just add that when anyone says either, that they are a great orthodontist, or that someone else is then you should take it with a pinch of salt. How do I really know how good I am or certainly how good anyone else is, have I seen all their cases or just the good ones? The truth is we all (hopefully) try to do the best we can within the biological limitations. The same goes for the reverse, when somebody slags you off for being a bad orthodontist, it’s really a stupid thing to say.
    I would expect better from so called professionals but maybe I’m just naïve. Thankfully I don’t do facebook or twitter or even have a stupidphone.

  48. Avatar

    Kevin thank you so much for your ongoing contribution to orthodontic science and clinical practice. I’m sure your shoulders are broad enough and your skin is thick enough to withstand the abuse you receive from corporate influences. What a ridiculous term KOL is! Another great example of management speak and weasel words. Let’s call a spade a shovel. How about PPM, promoter paid by manufacturer? We, as educated orthodontists, owe it to our educators past and present, not to believe in corporate snake oil and look for the truth. Meanwhile good luck with being respectful Kevin but don’t expect reciprocity :))

  49. Avatar

    Keep up the excellent work Kevin, you are the “rockstar” of orthodontics!

  50. Avatar

    Great work, Kevin, thank you!

  51. Avatar

    There was mention of pharmaceutical regulation for KOLs compared to medical device regulations. At least in the United States, the regulations are essentially the same for both: the KOL declares that there exists a relationship with the company. When judging the content of the material presented, it is assumed that a doctor recognizes this conflict when doing a final evaluation of the presentation.

    Conflicts of interest exist everywhere in law, business, education, research etc. The angst and recriminations expressed by many of the postings are misguided in my opinion. The question is not that a conflict of interest exits but whether the conflict is manageable. To attempt to completely eliminate conflicts of interest would keep society at a standstill.

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