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
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.
- 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.
- Subsequently, scientific journals published trials and the orthodontists ignored the results. This raises ethical questions.
- 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”…..
Emeritus Professor of Orthodontics, University of Manchester, UK.