Background
Summary of Council decision:
Five issues were investigated, all were Upheld.
Ad description
A website for TAMPAP, www.tampap.com, promoted a home HPV (human papilloma virus) testing kit. Revolving headline text on the home page stated either "Won't have a smear test? Take the TAMPAP TEST. Virtually 100% of Cervical Cancer are caused by HPV" or "Around 3 women each day in the UK die of Cervical Cancer Take the TAMPAP TEST today ... it could save your life".
Text on the web page entitled "WHAT IS THE TAMPAP TEST?" stated:
"Did you know that virtually 100% of Cervical Cancers are caused by high-risk strains of the human papillomavirus (HPV)? Stay a step ahead with The TAMPAP TEST, a modern, accurate test for HPV. Take the test now to find out if you are at risk of developing Cervical Cancer, because early detection could save your life ... Taking the TAMPAP TEST offers peace-of-mind and could save your life:
A negative result means that you are not currently at risk of developing Cervical Cancer.
A positive result can be monitored and allows you to take prompt action if required".
Text at the bottom of the ad stated "Women should also regularly have a smear test to detect any signs of cervical cancer".
Issue
The complainant, a medical doctor, challenged whether:
1. the claim "Won't have a smear test? Take the TAMPAP TEST" was irresponsible and misleading, because it presented a case for avoiding smear tests, but she understood that if a user had a positive HPV test then their GP would recommend that they had a smear test;
2. the claim "Around 3 women each day in the UK die of Cervical Cancer" was irresponsible, because it exaggerated the possibility of dying from cervical cancer as a result of HPV;
3. the claim "Stay a step ahead ...Take the test now to find out if you are at risk of developing Cervical Cancer ..." was irresponsible and misleading, because she understood the test only informed a user about their current infection risk, that most HPV infections cleared naturally, and that the NHS recommended that women have regular smear tests whether they were HPV positive or negative;
4. the claim "A negative result means that you are not currently at risk of developing Cervical Cancer" was irresponsible and misleading, because it failed to explain that the test only informed a user about their current infection risk, whereas she understood that a negative HPV test result still allowed for the possibility of a new infection or re-infection in the future; and
5. the claim "Taking The TAMPAP TEST offers peace-of-mind and could save your life" was misleading, because she understood that there was no evidence that early detection of HPV could extend mortality.
Response
1. Home Test Direct Pty Ltd (HTD) said they had taken great care in their advertising to ensure that they did not advise against, or criticise, smear tests. Instead they said they promoted the test as an "additional weapon in the fight against cervical cancer", not as a replacement for smear tests, and encouraged women to regularly undertake them. They highlighted that on the same web page as the headline claim "Won't have a smear test? ...", below the sub-heading "WHAT IS IT", text stated "Although women should still regularly have a smear test, the TAMPAP TEST will enable you to stay ahead in-between smears". Similarly, they emphasised that text at the bottom of their "CERVICAL CANCER FAQ" page stated "The TAMPAP TEST is not a replacement for the smear test. Women should still attend their regular screening programme". HTD also explained that aftercare advice provided to women who received a negative result stated "Ensure you keep up with your NHS Cervical screening and consider taking THE TAMPAP TEST every 12 months especially if you have changed partners recently".
HTD also explained the advice women would receive if they had a positive result. They said if a woman had not had a smear test within three or five years (depending if they were above 50 years of age), they would be advised to see their GP and undertake a smear test. If they had a received a smear test in the last three or five years, they would be advised to repeat the TAMPAP Test in 12 months' time, by which time the virus would probably have cleared. They then explained that if a woman, repeating the test a year later, still had a positive result, they would advise her to book an appointment with her GP for a smear test or referral for a coloscopy.
HTD also stated that a significant proportion of the female population did not participate in regular screening at all, and therefore they might prefer to perform a self-sampling Human Papillomavirus (HPV) test in the privacy of their own home. They submitted a Daily Mirror article from March 2012 which reported declining smear test participation in the UK. They stated that "we seek to reach women who, for their own reasons, have opted out of participation and eventually encourage them to go back to their GPs". In support of that they provided a research article that stated "a kit for self-collection and return to a testing laboratory, followed by practitioner notification and follow-up if required should result in wider participation".
2. HTD said the claim was based on data from the World Health Organization (WHO). They said the link between HPV and cervical cancer was well established, and that high risk strains of HPV were responsible for 99.7% of cervical cancer cases. They also highlighted that the NHS had started offering HPV testing in some circumstances since April 2011.
3. & 4. HTD said their website and their aftercare programme informed individuals that the test detected their current HPV infection risk; explained what HPV positive and HPV negative results meant; and provided a range of suggested actions for patients in each situation, which included consulting their GP and continuing with their smear programme. They said the test gave a user advance knowledge of whether they had HPV or not and allowed them to seek further investigation, which could result in the diagnosis of abnormal/pre-cancerous cells and consequently could allow individuals to secure early treatment to prevent any cancerous cells developing further.
5. HTD said the complainant's claim was not supported by fact. They asserted that early detection was at the forefront of combating cervical cancer, and highlighted that the NHS supported HPV testing in relation to cervical cancer.
Assessment
1. Upheld
The ASA understood that text advising women to undertake regular smear tests in addition to using the product appeared on several pages of HTD's website. We considered, however, that that text was not given prominence. We also considered that the headline claim "Won't have a smear test? Take the TAMPAP test", which appeared on the home page in very large text, contradicted that text and implied that women who self-screened using TAMPAP could avoid taking smear tests.
We acknowledged the medical journal entry referred to by HTD and noted that the phrase "should result in wider participation" referred to the method of self-screening for HPV, in comparison to the sampling procedure of smear tests and did not imply that an HPV test, such as TAMPAP, would result in wider participation of women attending smear tests.
We also understood that nowhere on their website did HTD explain that a woman who received a positive test result would be advised to contact their GP to discuss the result and request a smear test. We noted that, in a previous investigation regarding HTD's advertising, in the "TAMPAP TEST FAQs" section of the website, the answer to the question "I won't have a smear test. Can the TAMPAP TEST help me?" was "Yes" and did not sufficiently explain that the product was not a replacement for a smear test.
In addition, in the previous investigation we were concerned that the "News" section of their website included an editorial article entitled "Home Smear Test Kit Could Help Shy And Embarrassed Women", which implied the product was a "Smear Test Kit". Similarly, in the previous case we had concerns about an article quoted on the website which stated "Urgh smear tests. We shudder at the thought. But what if you could detect whether you were at risk of developing cervical cancer from the comfort of your own home?". We noted that both of these articles still appeared on HTD's website, and we considered that they could reinforce the belief that a woman could avoid smear tests by using the product.
We understood that the product was not intended to be, and was not, a replacement for regular smear tests, and that regardless of the result, a woman should still regularly have smear tests. We nevertheless considered that in the context of the website, the claim implied that the product would reduce the need for a woman to undertake regular smear tests and therefore concluded that the claim was irresponsible and misleading.
On that point, the ad breached CAP Code (Edition 12) rules
1.3
1.3
Marketing communications must be prepared with a sense of responsibility to consumers and to society.
(Social responsibility),
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
12.2
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).
2. Upheld
The ASA noted that the "United Kingdom Human Papillomavirus and Related Cancers, Fact Sheet 2010" produced by WHO stated "Current estimates indicate that every year 2890 women are diagnosed with cervical cancer and 1111 die from the disease". We considered the context in which the claim appeared and noted that the website stated that 99.7% of cervical cancer cases were caused by HPV but failed to explain that approximately 90% of HPV infections were cleared by the body naturally (Centre for Disease Control). We also noted the complainant's comments that research conducted by Dr A Raffle in Bristol indicated that an increase in uptake of cervical screening could prevent one of the three women referenced in the claim from dying. Whilst we acknowledged the importance of emphasising the seriousness of cervical cancer, in the context of a website promoting a self-screening test for HPV, we considered the claim was irresponsible as it exaggerated the possibility of dying from cervical cancer as a result of HPV.
On that point, the ad breached CAP Code rules 1.3 1.3 Marketing communications must be prepared with a sense of responsibility to consumers and to society. (Social responsibility), 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) 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. (Substantiation).
3. & 4. Upheld
We noted that HTD referred to their aftercare programme, which fully informed individuals about what a positive or negative result meant. We considered, however, that most of that information was not available on their website. We noted that the website only stated that a negative result meant that an individual was not currently at risk of developing cervical cancer, but did not explain they could develop a new HPV infection or be re-infected with a high-risk strain of HPV in the future. We also understood that the "TAMPAP TEST FAQ" section of the website stated "What happens if my result is positive? This doesn't mean you have Cervical Cancer. What it does mean, is that you have a high-risk strain of HPV present that could potentially cause cell changes in the cervix. Changes that could, over time, develop into Cervical Cancer". Nowhere did HTD set out the actions a woman would be advised to take after receiving a positive result and the website did not state that in most cases the individual in question would be advised to have a smear test. We also considered that the website did not explain that in most cases high-risk strains of HPV were cleared by the body naturally.
We acknowledged that the product was not designed to be a replacement for smear tests and was supposed to be used in addition to a woman undertaking her regular smear test programme. Because we understood that a woman who received a positive result would either be advised to wait a year and retake the test, or request a smear test from their GP, we considered that the claim "Stay a step ahead ..." exaggerated the benefits of using the product. We therefore concluded that the claims were misleading and irresponsible.
On points (3) and (4), the ad breached CAP Code (Edition 12) rules
1.3
1.3
Marketing communications must be prepared with a sense of responsibility to consumers and to society.
(Social responsibility),
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)
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.
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).
5. Upheld
We understood that the complainant believed that there was no evidence to suggest that early detection of HPV, outside the context of a screening programme, could increase life expectancy. We acknowledged that since April 2011 the NHS had incorporated HPV screening into their Cervical Screening Programme. We understood, however, that only women who had a smear result that showed borderline changes or cell abnormalities would automatically have an HPV test performed on their samples and that the NHS did not perform HPV tests independently from cervical screening tests. Therefore, we considered that HTD had not provided sufficient evidence to substantiate the claim "Taking the TAMPAP TEST offers peace-of-mind and could save your life" and concluded that it 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 claims must not appear again in their current form. We told HTD to ensure that they made clear that the test was not a replacement for routine smear tests, and not to exaggerate the severity of HPV and the risk of getting cervical cancer from HPV. We also told them to ensure they did not make claims regarding the efficacy of the product without robust substantiation to evidence those claims.
