Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A website for Stratford Dermatherapy Clinic, www.skincareclinic.co.uk, seen on 30 August 2016, promoted bio-identical hormone replacement therapy treatment. Text stated "… the Clinic uses bio-identical hormones to treat hormonal imbalances in men and women. Bio- identical hormones have the same molecular structure as those found in your own body. They are considered a safer option than synthetic hormones as used in conventional hormone replacement therapy". Further text stated "At the Stratford Dermatherapy Clinic we offer a range of services that aim to restore you to your optimal hormonal balance. Before prescribing, we decipher your unique hormonal make-up based on specific blood tests, so that we can tailor the treatment to your specific needs" and "… the results are analysed by your doctor, who will make any necessary changes to your medication and issue you with a new set of prescriptions". The website then listed details of the treatment schedule, which included the claims "Initial consultation - 45 minutes. Your doctor will spend time understanding your history and symptoms, making an initial assessment of your condition and will take blood tests. First Follow-up Appointment - 15/30 minutes. Approximately one week later you will return to the Clinic to review your test results, receive advice on managing your symptoms and order your bespoke prescriptions".
Issue
The ASA challenged whether the claims:
1. that bio-identical hormone replacement therapy was "considered a safer option than synthetic hormones as used in conventional hormone replacement therapy" was misleading and could be substantiated; and
2. "… we decipher your unique hormonal make-up based on specific blood tests, so that we can tailor the treatment to your specific needs" and accompanying claims about blood tests were misleading.
Response
Stratford Dermatherapy Clinic said that they used bio-identical hormones to treat hormonal imbalances in men and women. The hormones were derived from diosgenin, which was sourced from soya beans and Mexican yams. They said bio-identical hormone replacement therapy (HRT) was usually administered in the form of creams, lozenges or capsules. They said that it was regarded as legitimate by clinicians and patients because of its purported ability to become part of the body's "natural" process.
1. Stratford Dermatherapy Clinic said that bio-identical hormones have the same molecular structure as those found in the human body. Therefore, because they were consistent with normal biochemistry, the side effects were minimised. For that reason, they were considered a safer option than synthetic hormones that were used in conventional HRT, which had a different chemical structure to the hormones in the body. They said that many studies showed that conventional HRT adversely affected the body, in particular in relation to an increased risk of breast cancer and heart disease, whereas no widespread adverse effects regarding the use of bio-identical HRT had been reported. They provided 20 studies in support of the claim that bio-identical HRT was a safer option than synthetic hormones as used in conventional HRT.
2. Stratford Dermatherapy Clinic said that their prescriptions were individualised for each patient, and that treatments were compounded under strict guidelines of good manufacturing practice. They said that, before prescribing treatments to patients, they deciphered their unique hormonal make-up based on blood tests, so that they could tailor the treatment to patients' specific needs. They provided an example of a typical hormone request profile based on a patient's blood test. They said that those tests followed international standards of measurement, and were able to prescribe hormonal medicines to patients based on their personalised results. Therefore they could prescribe bespoke treatments for the individuals in doses to achieve optimal functional levels.
Assessment
The ASA took expert advice. We understood that HRT treatments advertised as "bio-identical" typically referred to hormones which were identical in molecular structure to the hormones found in the human body. We also understood there was sizeable cross-over between treatments advertised as "bio-identical" and conventional hormone replacement therapy, whereby many conventional licensed HRT formulations were actually bio-identical, but not advertised as such.
Treatments advertised as bio-identical HRT were often referred to as "natural" hormones, and contrasted with "synthetic" non bio-identical hormones. However, we understood these natural hormones were not found in a bio-identical form in nature, but were instead synthesised from chemicals found in yams and soy. Some clinics offering bio-identical HRT also distinguished the treatment from conventional HRT through their provision of compounded hormones, whereby tailored, individualised hormones were provided based on patients' blood tests.
We understood that there was an established weight of scientific evidence that HRT, including bio-identical HRT, was effective in treating symptoms of the menopause. We investigated whether the clinic could substantiate the claims that bio-identical HRT was a safer option than conventional non bio-identical HRT, and whether bio-identical HRT was able to effectively provide a tailored treatment based on patients' specific needs.
1. Upheld
We considered that consumers were likely to understand from the claim "considered a safer option than synthetic hormones as used in conventional hormone replacement therapy" that all forms of bio-identical HRT were demonstrably safer than non bio-identical HRT when taking into account all relevant adverse conditions associated with HRT such as breast cancer, ovarian cancer, uterine cancer, blood clots, heart diseases and strokes.
We understood that HRT came in the form of either oestrogen-only hormones or a combination of oestrogen and progestogen hormones. Because the claim suggested that all forms of bio-identical HRT were safer than non bio-identical HRT, we considered that the clinic needed to demonstrate that both oestrogen-only bio-identical HRT and oestrogen and progestogen bio-identical HRT were safer than their non bio-identical HRT equivalents.
We noted that the clinic provided compounded hormones to patients in bespoke combinations, doses and preparations that were not routinely available. Unlike individual drugs, compounded drugs were not required to undergo tests in clinical trials to prove their effectiveness. We understood that, because of the absence of any requirement for safety testing, the absorption and bioavailability of bio-identical compounded hormones were unknown. That meant that the relative safety and harm of particular bespoke combinations, doses and preparations were unknown. We therefore considered that the claim that bio-identical HRT was a safer option than non bio-identical HRT could not be substantiated when used in relation to the provision of compounded hormones.
Nevertheless, some forms of bio-identical HRT were not offered in the form of compounded hormones, and we therefore assessed the applicability of the evidence provided by the clinic in relation to uncompounded bio-identical HRT.
We noted that some of the papers did not specifically address bio-identical HRT and instead focused on the general effects of HRT with no comparative data between bio-identical and non bio-identical HRT. Three of the papers provided were reviews of multiple other studies on bio-identical HRT. However, the papers were not systematic reviews. They did not have explicit inclusion and exclusion criterions or an explanation of how studies were identified, meaning that the reviews were not reproducible. The papers also did not critically appraise the studies and evaluate their quality, and so it was not possible to know whether the findings were valid. We therefore considered that those papers did not constitute sufficient evidence.
We identified that seven of the studies provided comparative data on the effects of bio-identical HRT compared to HRT. Two of those studies, however, had been conducted on animals. We considered that the effect of bio-identical and non-bio-identical HRT on animals would not necessarily be the same as when consumed by humans, and therefore studies conducted on animals were not suitable evidence.
Three of the studies examined the comparative effects of bio-identical and non bio-identical HRT in relation to the risk of breast cancer. One of the studies was a randomised controlled trial that compared levels of breast cell proliferation after use of bio-identical and non bio-identical HRT, where the results indicated that there was less cell proliferation in bio-identical HRT compared to non bio-identical HRT. However, we considered that the study was of limited value as only a relatively small number of adequate samples were achieved and the study's authors suggested that the difference in cell proliferation could be due to different routes of administration rather than the nature of the HRT itself.
The second study, concerning the risks of breast cancer, took the form of a retrospective case control study that examined all incident cases of women with invasive or non-invasive breast cancer who lived in two study areas during a two-year period. The results indicated that the bio-identical progestogen – progesterone – did not increase the risk of breast cancer, whereas non bio-identical progestogens did increase the risk. We considered that, although there was the possibility of recall bias, the study used standardised, validated instruments to collect data on women with breast cancer, and therefore the results provided some evidence that the bio-identical progestogen – progesterone – was safer than other non bio-identical progestogens.
The third study on the risks of breast cancer took the form of a nested case-control study on the risks of breast cancer, and assessed all incident cases of invasive breast cancer in postmenopausal women between 1990 and 2002 from a French prospective cohort study on cancer risk factors. The study found that there was a statistically significant increase in the risk of developing breast cancer when non bio-identical progestogens were used compared to the bio-identical progestogen, progesterone. We acknowledged that the study had adjusted for known confounders such as family history, and considered that the fact – that the study was nested reduced the risk of bias as the measurements of the type of HRT used were taken by questionnaire prior to any symptoms arising. We considered that the findings of the three studies, in particular the latter study, provided reasonable evidence that the bio-identical progestogen hormone – progesterone – was safer than non-bioidentical progestogens in relation to the risks of developing breast cancer.
One further study consisted of a case-control study that compared the effects of bio-identical and non bio-identical HRT progestogen hormones in relation to the risk of developing venous thromboembolism (VTE). The results showed that progestogen had a significant influence on the risk of VTE, whereby bio-identical hormones did not increase the risk, but non bio-identical hormones were associated with a fourfold increase in the risk of developing VTE. We acknowledged that this study was single-blinded, controlled and that the cases were consecutive, but considered that there was nevertheless a risk of bias with an observational study compared to a randomised controlled trial. Furthermore, the authors of the study concluded that further randomised trials needed to be conducted to investigate further the effects of different progestogens on VTE. We considered, therefore, that while the paper indicated that there was some evidence that progesterone was safer than non bio-identical progestogens, the study did not in itself constitute sufficient evidence.
One randomised, double-blinded controlled study found that bio-identical HRT increased the exercise time taken to myocardial ischemia (reduced blood flow to the heart) compared to non bio-identical HRT. It reported that bio-identical HRT could therefore be safer for those at risk of cardiovascular disease. However, the sample size was only 18 patients after the drop-out rate and given that the authors reported that further randomised studies were required before any definitive conclusions could be drawn. We therefore considered that the study was not sufficient in itself to prove that bio-identical HRT was safer than non bio-identical HRT in relation to developing cardiovascular disease.
In conclusion, the relative safety and harm of compounded hormones – where untested bespoke combinations, doses and concentrations of hormones were provided to patients – were unknown. Therefore the claim that bio-identical HRT was safer than non bio-identical HRT could not be substantiated. With regards to uncompounded HRT, the evidence provided indicated that the bio-identical progestogen – progesterone – was safer than non bio-identical progestogens in relation to the risks of developing breast cancer. However, there was not sufficient evidence that oestrogen-only bio-identical HRT was safer than oestrogen-only non bio-identical HRT in relation to developing the risk of breast cancer. Nor was there sufficient evidence that any form of bio-identical HRT was safer than non bio-identical HRT in relation to the risks of developing venous thromboembolism, cardiovascular disease or other relevant conditions such as ovarian cancer, uterine cancer, blood clot or stroke. Because consumers were likely to understand the claim to relate to all forms of bio-identical HRT and all relevant conditions, we concluded that the claim that bio-identical HRT was "considered a safer option than synthetic hormones as used in conventional hormone replacement therapy" was misleading.
On that point, the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
2. Upheld
We considered consumers were likely to understand from the claim "we decipher your unique hormonal make-up based on specific blood tests, so that we can tailor the treatment to your specific needs", that the clinic provided bespoke treatments tailored to the needs of each patient based on the consumer's personalised results from the blood tests. We considered that consumers would infer from the claim and the accompanying information about the advertised blood tests that bespoke forms of HRT that were tailored to the needs of each patient based on blood test results were more effective in treating hormonal symptoms such as menopausal symptoms than untailored HRT that was not individualised.
As mentioned above, we understood that the process of individualising the treatment was known as "compounding", and involved hormones being provided to patients in bespoke combinations, doses and preparations that were not routinely available.
The clinic provided a typical hormone request profile which appeared to show the hormonal make-up of a patient based on a blood test result. While we acknowledged that blood tests could reveal an individual's hormonal composition, we considered that this did not in itself demonstrate the efficacy of tailored, individualised treatments. We had not seen any evidence that compounded, individualised HRT had any greater effect than non-compounded HRT. For instance, we had not seen any randomised, controlled trials that compared compounded and non-compounded HRT.
Because the ad suggested that compounded, individualised HRT that was tailored to the needs of each patient based on their blood tests was more effective in treating hormonal conditions than conventional uncompounded HRT, when there was no evidence that it was more effective, we concluded that the ad was misleading.
On that point, the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in its current form. We told Stratford Dermatherapy Clinic not to state or imply that bio-identical HRT was safer than non bio-identical HRT in relation to compounded hormones. We told them not to use the claim in relation to uncompounded hormones with the exception of the bio-identical progestogen hormone – progesterone – which was safer than non bio-identical progestogens in relation to the risks of developing breast cancer.
We also told Stratford Dermatherapy Clinic not to state or imply that compounded HRT that provided tailored treatments to patients had any greater effect than conventional HRT that was not compounded.
