ASA Adjudication on RSL Steeper
Orthotics Division, Manufacturing Centre
Unit 7, Hunslet Trading Estate
5 September 2012
Internet (on own site)
Health and beauty
Number of complaints:
Bluestorm Design and Marketing Ltd
Summary of Council decision:
Three issues were investigated, all of which were Upheld.
The website www.steeperclinic.com, for RSL Steeper, a company which offered treatment for plagiocephaly (flattening on one side of the skull in babies), stated "Initial treatment usually involves repositioning to relieve the pressure causing the deformation ... In many cases, this will improve the shape of the baby's head without need for further treatment, but in some, further treatment using STARband may be necessary. If required, we recommend starting STARband treatment from the age of 4 months ... as this is the best time to influence the shape" and "Currently, the NHS does not fund the use of cranial remoulding orthoses like STARband, as it feels that deformational plagiocephaly is a purely cosmetic issue and that in the majority of cases it will resolve naturally. We feel that although this is true in some cases, the STARband has been shown to significantly improve the shape of a baby's head with moderate to severe deformational plagiocephaly".
A complainant, a doctor, challenged whether:
1. the suggestion that treatment with a STARband could be necessary from four months was misleading and could be substantiated, because NHS guidance suggested that the condition would resolve itself;
2. the claim that the treatment could "significantly improve the shape of a baby's head with moderate to severe deformational plagiocephaly" was misleading and could be substantiated; and
3. the treatment was conducted under the supervision of a suitably qualified health professional.
CAP Code (Edition 12)
1. RSL Steeper said if infants from four months of age had not already used repositioning techniques (which did not use the STARband) to rectify the flattening, they advised the use of repositioning first, and conducted reviews at six-weekly intervals to monitor progress to avoid unnecessary treatment. They offered cranial remoulding orthotic treatment using the STARband for infants aged four months where repositioning had not been successful. For infants older than six months, they believed it had been shown that repositioning was not effective. They supplied evidence which they believed showed that the use of the STARband was clinically appropriate in that situation and that the claim was not misleading.
2. RSL Steeper supplied the results of a scan and before and after pictures of a patient who had used the STARband from the age of four months after an initial eight weeks of repositioning had failed to improve the shape of his head. They believed there was strong evidence in the form of published literature to support claims that cranial remoulding orthoses significantly improved the shape of a baby's head. They said the treatment was offered privately because it was not usually funded by the NHS, but that they were aware that it was provided by the NHS in Bristol. They said cranial remoulding helmets were prescribed regularly in other countries such as the USA, Scandinavia and the Netherlands.
3. RSL Steeper said orthotists undertook four-year, undergraduate degree courses in Prosthetics and Orthotics and additional training from Orthomerica (the manufacturer of the STARband). They supplied details of that training and what it covered. They said all their patients were treated by paediatric orthotists who were suitably qualified to supply, measure, fit and alter orthoses; who were registered with the Health Professions Council, the British Association of Prosthetists and Orthotists and who also provided paediatric orthotic treatment in NHS clinics on a regular basis. They said all of the children they treated had been seen by their GP about their head shape and that if there were any concerns about complications other than plagiocephaly they were also seen by paediatricians and neurosurgeons for further investigation.
1. & 2. Upheld
The ASA spoke to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Royal College of Paediatrics and Child Health (RCPCH). We noted that NHS guidance on positional plagiocephaly stated that it was a common condition; that it did not cause any health problems and that the shape of the infant's head would usually correct itself by their first birthday. We considered that that suggested there were cases where further action might be needed because positional plagiocephaly had not corrected itself by the child's first birthday. We considered that, to substantiate the claims, RSL Steeper needed to show that treatment with a STARband could significantly improve the shape of a baby's head with moderate to severe deformational plagiocephaly and that treatment from four months of age produced better results than waiting until the child's first birthday and then beginning treatment if deformational plagiocephaly had not already resolved itself. We noted that the evidence cited by RSL Steeper comprised a number of studies and two reviews of available evidence. We noted that both reviews stated that the available evidence did not include controlled, randomised studies that had considered the use of orthoses in the management of deformational plagiocephaly. Of the studies specifically cited by RSL Steeper we noted that, while they tended to accept that cranial orthoses were used as a method of correcting deformational plagiocephaly and were considered effective, they were very cautious in their acceptance of their efficacy because of the absence of high quality trials. Other concerns raised by the reviews or in one or more of the trials, included the commercial interests of some of the authors; the means by which candidates were selected for inclusion in the studies; possible safety implications of the devices; and the subjective reporting method of results. One study in particular reported differences in the ways orthotic bands could be adjusted and were assessed in comparison with orthotic helmets. We noted that some studies referred generally to cranial orthotic devices but that others referred specifically to helmets. Given that, we considered RSL Steeper needed to demonstrate that the results of studies that referred to cranial orthotic devices generally or specifically to helmets also applied to the STARband. Although one study questioned whether it was ethically justifiable to undertake "Class 1" studies (which would be randomised, controlled and blinded), we considered that, for the claims RSL Steeper made, it was nevertheless essential that they held convincing evidence for the efficacy of the STARband and which showed that its use could be necessary from the age of four months. We understood that helmets had a place in that they did not cause harm and they relieved the anxiety of parents but, nevertheless, for the reasons explained above, we considered that the evidence supplied by RSL Steeper was not sufficient and that the uncertainties needed to be resolved by further studies that involved the use of a product identical to the STARband before such definite claims could be made for it. Because of that, we concluded that RSL Steeper had not substantiated the claims and that they were misleading.
On points 1. and 2. the claims breached CAP Code (Edition 12) rules 3.1 and 3.3 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration) and 12.1 (Medicines, medical devices, health-related products and beauty products).
We were concerned that, by combining together the issues raised by and treatment needed for positional plagiocephaly (which the NHS advice stated did not cause any health problems and would usually correct itself naturally, and which the ad intended to communicate that RSL Steeper could help with that condition) and craniosynostosis (which was a potentially serious condition for which medical supervision should be sought), the ad discouraged essential treatment for a condition for which medical supervision should be sought, which was a breach of the CAP Code.
We considered that RSL Steeper's orthotists could (and were likely to) refer concerns about complications other than plagiocephaly for further investigation. We spoke to the Health Professions Council and the British Association of Prosthetists and Orthotists about the role and training of orthotists. We noted that there was no specific training in the normal training of orthotists that would qualify them to diagnose complications beyond deformational plagiocephaly. We noted that the details RSL Steeper had supplied of the additional training from the manufacturer showed that the course was aimed at achieving technical ability to measure and fit orthoses, but did not demonstrate that, after completion of the course, a non-medically qualified person could take the place of someone with medical qualifications and be qualified to diagnose complications beyond deformational plagiocephaly.
Furthermore, we noted that RSL Steeper's website gave contact details and directions for their clinics and stated "We offer, free, no obligation consultations at our clinic and can advise you on the best treatment option available for your baby". The website gave details of open days and awareness days at their clinics where they said clinicians would be available to speak to people who were concerned about deformational plagiocephaly and advise them and to offer preliminary scans to children. We noted that the wording of the ad did not actively discourage parents to forego consulting their GP. We considered, nevertheless, that the wording could encourage people to seek advice from RSL Steeper, where we considered they had not demonstrated that their orthotists were qualified to make a diagnosis, when, in light of that, it would be considered more appropriate for them to seek advice from their GP.
Because RSL Steeper had not provided evidence which showed the treatment they offered was conducted under the supervision of a suitably qualified health professional, we concluded that the ad breached the CAP Code.
On this point the ad breached CAP Code (Edition 12) rules 3.1 and 3.3 (Misleading advertising), 3.7 (Substantiation) and 12.2 (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in its current form.