June 26, 2017

Are Ormco/Damon in denial? The response to UK advertising authority ruling on self ligation.

Ormco/Damon response to the UK advertising authority ruling on self ligation.

A short time ago the UK advertising standards agency concluded that Ormco/Damon advertising  on self ligation was misleading. This post is about the Ormco response and my thoughts on the decision.

As may readers of this blog know, I have consistently argued that we, as professionals, should be cautious about advertising claims.    I have been criticised several times for returning to this theme.  As a result, I would like to explain why I feel that this is an important issue.  My feeling is that there is a unique trust between a health care provider and patient.  Unfortunately, we can easily abuse this trust if we recommend a treatment to them, that involves additional cost, and yet we know that there is no evidence that the treatment is effective.  Just imagine this conversation.

“We have a new method of shortening your child’s orthodontic treatment.  This is a new brace/injection/light/vibration device.  It will cost an additional £1,000. Here are the advertisements on my website”.

I think that we must do all we can to avoid taking this approach, when we do not have evidence about the new treatment.

As a result, I think that a good place to start this discussion is to consider some basic concepts.

Ethical behaviour of health care professionals

While ethical governance may vary across the World, a basic tenet is that we should do no harm and put our patients interests before our own.  This includes harms caused by treatment and charging for treatments that may not be effective.

When we consider ethical advertising, I would like to use The UK General Dental Council guidance on ethical advertising as an example.  This clearly states that;

“If you endorse products, you must ensure that you only provide factual information about the product that can be verified by evidence”.

“Avoid making statements that are likely to create an unjustified expectation about the results that you may achieve”.

I have interpreted this as meaning;

If evidence is available, we should support our advertising with this evidence. As a result, if our advertising is not evidence based, then we need to consider if we are practicing unethically.

The role of the salesman

This is straightforward.  Our industrial colleagues develop and sell equipment. Their loyalties are, primarily, to their company and shareholders. In order to promote their products they advertise and this involves making claims. However, it is up to us, as clinician scientists, to evaluate these claims by reading and interpreting the research literature.

The role of evidence

I have also discussed this previously.  Evidence based care is a combination of these three factors.

1 Clinical experience

2 Research

3 Patient opinion

Importantly, when research evidence is available, this should outweigh clinical experience.  This leads us to the evidence on self-ligation.

Evidence on Self ligation

There have now been several well conducted randomised controlled trials, systematic reviews and even a statement by the AAO on self ligation. All this evidence has one clear conclusion

“There is a lack of evidence to support the claims of a reduction in treatment time, less extractions and less discomfort from the use of self ligating brackets”.

This is compelling.  As a result, practitioners who are aware of this research and continue to promote these hypothetical advantages are likely to be acting unethically.  In my opinion, this should not need a decision of an advertising watchdog for practitioners to change their advertising practices.

The Advertising Standards Authority decision

This was important, so I posted the whole decision.  The ASA concluded

“the evidence provided by Ormco was not adequate to demonstrate that Damon braces provided faster and less painful treatment than traditional braces”.

I think that their judgement is interesting because the ASA asked Ormco to provide evidence  supporting their claims. As a result, Ormco produced some evidence, but the ASA felt that this was of a  low level.  Importantly, the ASA stated that they needed to see at least one well designed RCT.  However, Ormco did not appear to provide them with evidence from the several RCTs that did not support their claims.

As we know, the ASA concluded that the advertising was misleading.

I thought that this would be end of the matter. Until today, when Ormco put out a response to their UK based “Damon Drs”.  This can be found here..

The Ormco response

Firstly, they recommended to the “Damon Drs” that they cease using promotional materials which represent a faster or less painful response.

I thought that this was good practice, but then they stated..

“ We stand by all claims we make comparing our Damon braces with traditional braces, such claims being based on over 20 years of experience and development”.

“Notwithstanding the volume of evidence presented and the opinions expressed by our Damon experts, the ASA has concluded that the substantiation is inadequate on the basis that we were unable to present results from a randomized, blinded controlled trial”.

I was confused at these statements, bearing in mind the large amount of trials based research that is available. I emailed them last week asking to see their evidence.  Up until now I have not received a reply.

What do I think about all this?

I cannot help thinking that this is a remarkable series of events.

  1. Firstly, orthodontists bought into the advertising and promoted a product with a limited evidence base. This is important because in the UK Damon treatment is usually not free on the National Health Service, so the patients need to pay for this type of care.  This is why I am concerned.
  2. Subsequently, scientific journals published trials and the orthodontists ignored the results. This raises ethical questions.
  3. The ASA come to a decision and Ormco do not mention these trials in the letter to the “Damon Drs”.

Currently, the UK is a strange place. We have a weakened Government telling us that all is fine in the face of obvious economic and social problems.  I think that our politicians feel that we are all gullible and I do not know who to believe. I am disappointed that this “it is all OK and we are fine” philosophy is coming to orthodontics. We should all ask the “Damon Drs”, Orthodontic Societies, Orthodontic conference organisers (who take the advertisers money), regulators and orthodontists. “do you really think that this is OK”?

I need some Pink Floyd…what about this from Dark Side of the Moon?

“The lunatic is on the grass

Remembering games and daisy chains and laughs

Got to keep the loonies on the path”…..

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Have your say!

  1. Having felt ‘the warm thrill of confusion, that space cadet glow’, and ‘skating on the thin ice of modern life’, finally ‘some bad news for you sunshine’, the Damon Doctor has ‘become comfortably numb’.

    • Today my main concern is aligner companies . patients being said brackets are vintage old fashion and useless, when that’s not true… Hope this will be addressed at some point for the benefit of the profession

  2. I think we need to consider that such unsupported claims (for self-ligation, Acceledent, Invisalign, etc) are promulgated in courses run by Orthodontists, not company salesmen. Until national orthodontic societies find a way of regulating how their members can run courses without financial conflict, this debate about evidence is a waste of time. Indeed learned societies often profit from sponsoring these courses in annual meeetings. Matthew 7:4

    • Prof Tan, I think that is exactly why we need to question and debate the evidence, why critical evaluation of the literature is necessary and why high standards of research are crucial. Because if we don’t do this individually, in collegiate meetings or as a professional society, what we are left with is advertising. We and the public are then left only at the mercy of commercial claims. (BTW – interested to hear / see the unsupported claims that Invisalign are making. I know that there were some scary ones in the past but I am unaware of any recent ). thx VV

  3. Thanks for raising an issue that i and many colleagues are concerned about.

  4. Currently, the UK is a strange place. We have a weakened Government telling us that all is fine in the face of obvious economic and social problems. I think that our politicians feel that we are all gullible and I do not know who to believe. I am disappointed that this “it is all OK and we are fine” philosophy is coming to orthodontics. We should all ask the “Damon Drs”, Orthodontic Societies, Orthodontic conference organisers (who take the advertisers money), regulators and orthodontists. “do you really think that this is OK”?

    Sounds like the Trump presidency. I know we are close allies but we don’t have to be this close.

  5. Here in the US, real life is labelled fake news and lies are called alternate facts and I think I may go ahead and get tickets to see Roger Waters while he is still spreading some truth!

  6. In the US, it boils down to your legal fund. I feel organizations like the American Association of Orthodontists avoid legal battles like this due to cost. Ormco would ensure the legal battle went into the millions and drug on for a decade. Instead the AAO pushes the Consumer Awareness Program (charging its members large surcharges to pay for it) which in my opinion has done very little to restore integrity to the profession.

  7. Seong -Seng Tan has hit the nail on the head. I have no more to say.

  8. To Kevin: Shine on you crazy diamond.
    I noticed that everyone seems to stop short of suggesting that the advertising is unethical. Possibly a clear identification by the profession of unethical practice by companies would be useful and meaningful. You are correct Kevin, it should not take an advertisings standards authority to point out issues that should be heralded by the profession.

  9. Advertising was against the ethics of the American Dental Association and the AAO. No one was allowed to be a member if they advertised. This was back in the days when clinicians served the profession instead of vice versa. Back in 1977 the Carter administration declared that the medical, dental, and legal professions could not restrict advertising as that was restraint of free trade. That opened the door to the unscrupulous. Eventually, those on the edge of ethical behavior jumped on board. Now today everyone has a Facebook page and a website. There is SSO, Reputation promotion, and every kind of advertising you can imagine. Residents today getting out of their program are in severe debt which must be serviced immediately. The system is designed to do exactly what it is doing. Eventually, the detritus will float away and truth will surface. But, until that time orthodontics like the rest of our society has become, “How can the profession server ME.”

    • Dr. Stoner,
      A point of information concerning advertising by the professions: this was actually a Supreme Court decision in 1977 – Bates vs State Bar of Arizona not a federal executive order that ruled it unconstitutional to restrict advertising by attorneys. Following this ruling, federal and state prosecutors only challenged advertising by other professions if it appeared that it was false advertising and harmful to the public. To my knowledge, no one has ever challenged this ruling with a different Supreme Court.

      On the topic of misleading advertising, I find it ironic that some tangential protection is afforded the American healthcare consumer by the Securities and Exchange Commission (SEC) that monitors advertising of publicly traded companies that may harm the American investor. As an example, Align Technologies is VERY careful in their public pronouncements and advertising since over 90% of their sales derive from their aligner business and anything false could affect the price of their stock . If this would occur, the company could have some unpleasant visits by the SEC, Department of Justice, Internal Revenue Service etc. How would you like to start your morning knowing you have visits that day with some of the folks working for any of those departments…. not fun!

      Now a fair question could be how would those federal agencies view the Damon claims? Theoretically they should be concerned but since Ormco is a division in the dental division of a large conglomerate – Danaher with $16 billion in sales last year, additional sales in the Damon line of business would only be a very small fraction of the company sales (total DENTAL sales 2016 1.8 billion). Hence, there would be little impact on the stock price and the public would have to rely on consumer protection agencies, the professions etc. This is where we are today.

      A last point is that there are a number of smaller PRIVATE companies in the dental/orthodontic world that seem to claim great benefits without any solid evidence. Again in the USA, the government oversight, federal, state, local will probably come from less well funded consumer agencies and the professions not the muscular federal agencies.

  10. First let me say that I have a huge admiration for rational studies in the ortho .field.I believe the Cochrane approach pushed us into a much more “science -based ” approach to the benefit of our pts.I enjoy Professor O,Briens blog and am an avid reader.I really appreciate the hard work behind it.
    Why does the word “Damon “,or indeed the expression “psl ” induce such hot air and vitriol in our profession?
    Studies not withstanding ,here are my views based on “anecdata “and pt .feedback and in -house computer analysis as regards “psl “.
    These views are predicated upon adopting a psl “system ” not just a bracket ( ie.early elastics ,light wires ,detailed and case specific bracket placement ,variable torque prescriptions etc.etc.)—Damon ,if you wish but the actual psl bracket used is not a major determinant in my view.
    I find more profit ,less time in the office,less stress re finishing,less orthognathics ,great pt feedback re discomfort and high ,eventual esthetic result. Studies ,I respectfully suggest are just part of the picture.
    I have no comment on the advertising issue as I can see both sides of the argument.
    Finally and with apologies re my lack of brevity ,I note the use of the word “free “in relation to NHS treatment”. To be pedantic the expression is more aptly expressed (in my view ) as “no charge to the pt. at the point of delivery”.To be blunt -someone else’s hard -earned taxes are paying for the tmnt. This may be admirable but (having trained and worked in the NHS.) I have the view that the “free “attitude has a lot to answer for in terms of pt. perceived value and compliance issue (and we all know the value of compliance ).

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