Ad description
Claims on The Homeopathic Clinic's website, on 25 March 2011, stated "Early detection can be vitally important. Tumours grow faster in younger women who have not reached the menopause, so early detection can be the key to saving lives ... A tumour can take years to grow so the earlier an abnormality or an indication of abnormality is discovered the bettwe [sic] to receive treatment as soon as possible ... Digital Thermal Imaging (DITI) is a cutting edge medical screening device. It uses revolutionary high tech appliances and is non invasive. DITI is a medically proven, accurate method of breast screening, detecting breast abnormalities a full 8-10 years before a mammogram, it is that remarkable! The technology detects the subtle, physiological changes that accompany breast pathology whether it is cancer, an infection, fibrocystic disease or a vascular disease. It is the only scan in the current market that can detect inflammatory breast cancer and is exceptional as the only available screening for men's breast abnormalities".
Further claims under the heading "Changes in breast tissue can be detected 8-10 years before a mammography with DITI" stated "All women from the age of 20 should be annually screened to keep a record of any changes in breast tissue from as early as possible. Regular breast screening should not be only thought of as suitable for women over the age of 50. By using DITI and thermographs for breast screening purposes you are immediately removing the risk of radiating healthy breasts unnecessarily. DITI offers a 100% safe procedure of screening and is suitable for women of all ages. If detected at an early stage it can be reversed or stabilised by making small life style modifications such as diet etc. The chances of women having to use a more aggressive treatment are reduced".
Issue
1. The complainant challenged whether the ad misleadingly implied that DITI could detect the early signs of breast cancer.
2. The ASA challenged whether the ad was irresponsible, because it could discourage women from attending routine screenings for a condition for which medical supervision should be sought.
Response
1. The Homeopathic Clinic (THC) explained that mammography was an anatomical test that looked at structure, and could only detect a tumour when it had grown to a size that was large enough and dense enough to block an X-ray beam. In contrast, DITI was a physiological test that used thermal imaging to detect subtle changes in body temperature, in the form of infrared radiation.
THC said temperature increases could be caused by an increased blood supply to cancer cells, as any cancerous tumour would develop new blood vessels to supply blood and nutrients to the tumour. THC said DITI would detect the rise in temperature caused by the new blood engorged vessels at a very early stage of tumour formation, whereas mammography would not be able to detect that early physiological activity. They said numerous medical studies showed that physiological changes detected by thermography (DITI) preceded anatomical detection by mammography by eight to ten years. THC provided copies of five scientific studies and background and review articles on breast thermography, as well as online articles on thermography, online testimonials and articles that assessed whether radiation from mammograms was a cancer risk. They also provided copies of demonstration thermograms and their certifications.
2. THC said they did not believe the ad was irresponsible but actually made it possible for women who were not provided for by the NHS, or who chose not to have a mammogram, to be screened. They argued that there was a difference between diagnostic and routine screening; routine screening was used for detection purposes for women who did not have a ‘condition’, whereas diagnostic screening was used for women who had a condition for which medical supervision should be sought. THC said all DITI scans were interpreted by medically qualified doctors who advised consumers when medical supervision should be sought.
THC said the NHS breast screening programme applied to women aged 50 and over, and there was no provision on the NHS for women under that age despite an increase in breast cancer in women aged 25 to 50 years of age. THC said mammography was not as sensitive in detecting abnormalities with younger women, who had denser breast tissue, and many doctors also thought that it was unethical to subject younger women to the dangerous levels of ionising radiation used in mammography, which could cause cancer.
THC said DITI offered those women a safe and effective method of screening that fitted all the criteria for the early detection of cancer, as well as for those women not suited to mammography, such as women who had had a mastectomy, women with breast implants, women who had been diagnosed with cancer, women who were radiation sensitive or who wanted to avoid the dangers of radiation, and men. THC said DITI was not a replacement for mammography but provided a screening choice for women.
Assessment
1. Upheld
The ASA noted that, whilst the three online articles provided some background on thermography, they did not assess its ability to detect the early signs of breast cancer. We therefore considered that, along with the anecdotal evidence presented in the testimonials, review articles and two articles relating to mammography, they were not suitable to support a claim about the efficacy of DITI.
We noted that the first scientific study on breast thermography and cancer risk prediction, from 1980, assessed women who had been examined for breast abnormalities between 1965 and 1977, and found that in those subjects where thermography had revealed a “questionable anomaly” more than a third went on to develop cancer within five years. We also noted the review article concluded that, in light of developments in computer technology, additional research was needed to confirm and/or continue to develop the potential of thermography to provide an adjunctive tool in the early detection of breast cancer. However, we understood that other, more recent, scientific studies had concluded that thermography was not sufficiently sensitive to be used as a screening tool for breast cancer.
We also noted the four, more recent studies on the effectiveness and accuracy of thermography for detecting breast cancer. We noted that in each of those studies participants were selected who had already been diagnosed with breast cancer or other cancers, or who had been referred for a breast biopsy as a result of a prior mammogram or ultrasound. In addition, we noted that the studies concluded that thermography should be limited to use as an adjunct to mammography, rather than as a substitute for mammography. We therefore considered that those studies were not suitable to support the implication in the ad that thermography could detect the early signs of breast cancer.
We noted that the NHS considered thermography to still be very experimental, and therefore did not use it as a screening tool. We understood that view was based on recommendations made by the Advisory Committee on Breast Cancer Screening and the World Health Organisation’s International Agency for Research on Cancer (IARC). We also understood that other health authorities around the world also considered that there was no current, valid, scientific evidence that supported the use of thermography in the early detection of breast cancer. We therefore considered that, in order to substantiate the claims made in the ad, we would need to see a robust body of scientific evidence that demonstrated that thermography was an effective screening tool in the early detection of breast cancer. Because we had not we concluded that the ad was misleading.
On this point the ad beached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
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.
(Misleading advertising) 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 that the claims in the ad that DITI could detect breast abnormalities eight to ten years before a mammogram, was the only scan able to detect inflammatory breast cancer, and that by using DITI, which was 100% safe, the risk of radiating healthy breasts unnecessarily was removed immediately, could discourage women from attending routine breast cancer screenings.
We noted that the CAP Code required that specific advice on, diagnosis of or treatment for conditions for which medical supervision should be sought should not be offered unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified health professional. We also noted the distinction THC had drawn between routine and diagnostic screening, but considered that consumers were unlikely to appreciate that distinction and that, as breast cancer was a condition for which medical supervision should be sought, both types of screening were caught by the requirements of the Code. We noted that we had not seen evidence that the screening was carried out under the supervision of a suitably qualified health professional, or that medically qualified doctors interpreted the scans and advised consumers accordingly. We therefore concluded that the ad was irresponsible.
On this point the ad beached CAP Code (Edition 12) rules
1.2
1.2
Marketing communications must reflect the spirit, not merely the letter, of the Code.
(Social responsibility) and
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
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.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
(Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in its current form. We told THC not to imply that DITI could detect the early signs of breast cancer. We also told them to ensure they did not discourage women from attending routine screenings for conditions for which medical supervision should be sought.
