August 12, 2015

Acceledent: The advertising has started!

Acceledent: The advertising has started!

This is a quick additional blog post on Acceledent again. You may remember that I have posted about AcceleDent before. This is because it is a new technology that may have some potential, but there is currently a lack of evidence on its effectiveness.

In two of these posts I have discussed recent clinical trials.  The first of these studies reported an effect of Acceledent on tooth movement. This study, in my academic opinion, was so significantly flawed that it should not have been published. My previous post is here. At present, this is due for hardcopy publication in the Seminars in Orthodontics September edition. I have asked the editor and executive editor of seminars to consider withdrawing this paper from publication but they have stated that the publication will stimulate discussion!  It can be found here, and it is open access.

Screen Shot 2015-08-12 at 17.00.52I was, therefore, very concerned to see that AcceleDent have issued a press release based on data from this low quality study. Importantly, this paper contains a positive result. It was very interesting that they did not mention another trial of higher quality that shows the use of AcceleDent did not need to an increase in speed of tooth movement! This blog post is here.

 

 

 

 

Why does this concern me?

I am concerned because the publication and publicity promotes an expensive piece of equipment that is being recommended to our patients and there is currently a lack of clinical trial evidence to support the advertising claims.

Secondly, it is very disappointing that Seminars has chosen to publish this paper It is worth pointing out the conflict of interest that is declared at the start of the paper.

“Funding, Conflict of Interest: This study was supported by the research grant from the OrthoAccel Technologies, Inc. [(OATI), Bellaire, TX], which was permitted to review this manuscript, but the right to a final decision on the content was exclusively retained by the authors. The corresponding author (D.P.) is a consultant for OATI and had participated in developing the study protocol approved by the FDA. He was blinded to the group assignments and did not participate in either data collection or treatment of any of the enrolled subjects”.

In this respect a journal should carry out the highest levels of review. I still cannot understand how this paper was accepted for publication, when you consider the significant flaws. Furthermore, it is concerning that the editor of this special issue promotes the use of accelerated orthodontic techniques, including micro-vibration, to his patients on his office website (http://www.houseoforthodontia.com/accelerated-ortho).

I hope that the authors of the paper, the editor of the issue and the executive editor can recognise these important issues and consider whether they should have this paper reviewed again?

I know that I feel strongly about these issues and people may disagree with me.  If you feel the same way, could you circulate this post as widely as you can. It is time that we, as clinician scientists, put our patient’s interests first. My plea is that good studies should be done that inform the advertising, particularly on clinicians websites. We owe this to our patients.

I would like to point out that my concerns are not with Acceledent. They have funded a study and interpreted the findings in their advertising literature.  My real problems are with the study authors who should have known that the study was flawed, following feedback from referees of other journals.  I also feel that the editors of Seminars in Orthodontics have “slipped up” by publishing this study and I have to question their editorial and refereeing process.  I still call upon them to get this paper reviewed by experience clinical trial referees.  If not I hope that the editorial board take this issue seriously and advise the editor and executive editor.

If you want to debate these issues please use the comments section of this blog.  There is still no word from Seminars in Orthodontics or the authors of the paper following my last post. It would be great if you could comment?  Also it would be great to hear from other clinicians and academic/clinicians for their views on this. I know that it is the holiday season, but is anybody out there?  Or am I a lone voice?

 

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Have your say!

  1. Avatar

    Dr. O’Brien – thank you for your observations regarding the poor quality of this study. As a paying subscriber to Seminars in Orthodontics, I am disappointed (but not surprised) that a study with this potential bias has been accepted for publication. It causes me to question the value of continuing my subscription. I hope the editorial board and reviewers wake up and consider their role.

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    Thanks for your diligent review of available research on accelodent. It is nice to know that educators like you can take the time to critically evaluate claims made in the industry for products that directly affect us clinicians. I appreciate your service to our profession and I commend you for your honest, independent, critical evaluation of research in our field, and I thank you for your generosity of sharing it with us on your blogs. I am definitely a fan.

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    Hello Kevin

    It’s the usual story – like the drug companies, the promoters of so-called “cures” or wonder devices only quote the results that are favourable to their product, and ignore or suppress the unfavourable ones. Ben Goldacre’s books “Bad Science” and “Bad Pharma” are great books that everyone should read. The snake-oil salesmen are as active and as lively as ever. Plus ca change, c’est la meme chose.

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    Dear Kevin.
    This seems to be the tide of times and there is a feeling of inevitability about all these.
    Acceldent is just a symptom of a much wider problem in our profession.

    In one word “money” at the expense of all else.

    I will list a few:
    1- The crazy trend towards non-extraction. This has become a selling point. Many in our profession have financial motives.
    I believe this trend is driven because:
    a- It is less challenging to treat cases non extraction.
    b-It is shorter.
    c-Added cost of bonded retainers and its maintenance.
    ( d- Added bonus for our surgical cousins to remove the third molars !) (just look at AAOMS white paper which practically says third molars “cause” cysts and tumors (as if prostate cause prostate cancer!)
    2-Miracle techniques such as self-ligating brackets – (as if space/ profile analysis suddenly ceased to exist)
    3-Invisalign- next to no training needed.
    4- Fastbrace systems
    So what is the solution?
    These companies are powerful, there is a lot of money involved.
    The only way is to educate patients.
    Why is royal college of surgeons so quiet?
    Why is our friend GDC so quit?!!
    Why arent there any programmes on national channels where evidence is presented?
    Why is the profession so quiet as a whole?

    Regards

    Houman

  5. Avatar

    Thank you! Orthodontists want a change! and comercial companies want to offer a change no matter what! To read and to analyze research is to care. And for being good professionals we have to care of our patients.
    Thank you for being somebody who cares on research quality and help us to care of our patients.
    Greetings from Perú!

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    It would be interesting to consider the status of critics and critiques of commercial enterprises that market salable nostrums. “The companies” may fund our meetings and supply us with free continuing education, but in the end their responsibilities are to their share-holders, not to us and to our patients. Indeed, it actually may be their legal responsibility to take steps to quash or chill any line of attack that threatens their bottom line. Speaking from personal experience, I have been threatened with lawsuits off and on for a quarter century. It may just have been “the cost of doing business” for the aggrieved, but for someone who has spent a life toiling happily in the groves of academe, it was a series of unpleasant, frightening experiences. The line between commerce and science is becoming increasingly blurred and ill-defined. For a specialty in which nobody dies from bad treatment, the resulting conflict of interests–the 800 pound gorilla in the corner–is something that most seem willing to ignore. After all, when everything works, nothing matters. World without end….

    • Avatar

      Dear Lysle, thanks for the comments. As usual, you make several good points. I agree with you that the role of the companies are to sell their products. They also sponsor our meetings as part of this process. I also have no real issues with the companies supporting and carrying out research, this can be a valuable role. So I have no problems with Acceledent.

      My main issue is with the author of the paper who had been informed by editors and referees of other journals that the study was flawed and yet continued to still seek publication. I know that we all have done this, but there also comes a time when I have taken on board comments and decide that a paper is not fit for publication.

      My other concern is with the journal, which has published this poor paper. In this respect, my opinion is that the journal has failed in its quality assurance role, which is clearly the responsibility of the editor, the executive editor and the editorial board.

      You are also correct to point out that everything ‘works’, but as far as we know, Acceledent does not work and our patients are being sold an expensive product on the basis of poor evidence. Again, this is the responsibility of the profession and the way that we manage conflicts of interests.

    • Avatar

      I would like to share my opinion with you:

      This case (Acceledent) is a good example how our specialty still fails to exercise control over unethical collegues. The case is also an example of the abuse of the status of professional autonomy and self-regulation for private gain.

      1. It is clear that if this technique (Acceledent) is presented to patients without appropriate informations on the low scientific evidence for its efficiancy, than one is acting unethically:

      ADA Code of Ethical Conduct:
      5.A.2. Unsubstantiated Representations. A dentist who represents that dental treatment or diagnostic techniques recommended or performed by the dentist has the capacity to diagnose, cure or alleviate diseases, infections or other conditions, when such representations are not based upon accepted scientific knowledge or research, is acting unethically.

      The Company may also adhere to ethical principles in marketing and to protect its clients (dentists) and thus patients from uneccessary harm/costs:

      According to the Principles of Ethical Marketing, Marketers must comply with regulations and standards established by governmental and professional organizations.

      In my point of view, if we as a profession could establish effective control over unethical collegues, convince the public and companies that we are putting patients interests firsta and our professional standards would do so in reality than cases as Acceledent or others could be avoided.

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    Hi, Kevin.
    Thank you for your constant effort to keep ‘evidence based treatment’. Companies sell products to earn money. Sadly, some of the orthodontists sell pride for the same reason. We should fight to maintain the value of our work. I’m always your fan.

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    Dear Kevin,

    Thank you for your leadership of this important fight back by clinician-scientists. Following your first post, I wrote to the Editor-in-Chief but did not receive a reply. Hence, I would like to share the contents of my letter, making it an open letter to Dr. Moskowitz. Sadly, my letter foreshadowed the next move by Acceledent to use the paper for advertising, now confirmed by your latest post.

    Dear Dr. Moskowitz,

    I am an Orthodontist (and also practising scientist) who is troubled by the encroachment of non-evidence based orthodontics into our profession. The greater the claim, the greater the weight of scientific evidence that is required. As Editor in Chief, you have agreed to uphold this principle, and protect your journal from anyone trying to break it. I do not use AcceleDent because I believe that the evidence is lacking, but will use it once I see good published evidence. Unfortunately, I believe that the paper is flawed by its narrow sample size (22 experimental and 23 controls), biased by the Guest Editor being a proponent of vibration orthodontics, and financed by the vendor of Acceledent. There are other issues with the paper that I do not have space here to include.

    You would not doubt be aware that AcceleDent will now use the name of your Journal to justify its marketing practices as the scientific basis of vibration-assisted tooth movement, and many Orthodontists (who do not read journal articles) will now sell the product because it has been published in a reputable journal. The sufferers will be the patients.

  9. Avatar

    Hi Kevin,
    One of the most interesting posts of your blog-congratulation! And a spot-on comment from Dr. Johnston!

    It seems this is OUR Tamiflu saga (thankfully, without the deaths). I think however that this is just the tip of the iceberg. In this case, the reporting was relatively clear, enabling this whole discussion. We are all aware of many other authors that do no state commercial interests they have, but we surely know they exist. Maybe we should start thinking about including a “declaration of transparency” or something similar like BMJ does (http://www.bmj.com/content/347/bmj.f4796).

    Regarding Seminars in Orthodontics, I don’t have any real comments. It is most of the times a pleasant and informative read, but to my eyes it’s not really a peer-reviewed journal in the classical sense as AJO-DO, EJO, AO, etc

    Best

  10. Avatar

    Hi Kevin

    I totally agree with you about this. I suspect many clinicians will take it with “a pinch of salt” but worry that the less “ethical” will use it as a new selling point.

    Chris

  11. Avatar

    With all due respect, I ask permission to add an ingredient to this interesting discussion.
    The 2015 JDR article (by Dr. Woodhouse et al.) may present good data, but “wrong” data.
    The applied technology presented by AcceleDent® comes from the medical orthopedic field; therefore, we should be talking about bone and not dental issues (positioning or whatever).
    My point is: dental irregularity is an unquestionable tool, but that possibly do not measure what must be measured. When we talk about dental irregularity, this directly implies in lack of bone (dental crowding), isn´t that correct?
    Therefore, I suggest that the mentioned JDR article may have inferred a wrong variable. By measuring apples (irregularity index) we can´t conclude about oranges (bone physiologic acceleration).
    Misaddressed specificity (that can have low beta error) may have carried a false good sensitivity (low alpha error). And the false negative (the appliances do not accelerate orthodontic treatment) brought by the “good sensitivity” may be false, because the premise may be false, if there is no bone to measure in dental crowding scenarios.
    In summary, bone physiologic may have been accelerated. We just do not know it.
    I disclosure that I have none interest in OATI or AcceleDent concepts, business, marketing or results. I am a clinician in the field of Orthodontics.

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