Background
Summary of Council decision:
Three issues were investigated, all of which were Upheld.
Ad description
A direct mailing advertising a health screening service, received in June 2017, stated “You are probably very well looked after by your NHS GP when you are ill, but you may also appreciate that many serious health conditions don’t show any warning signs. Around 80% of Strokes are caused by a blockage. That's why a cardiac check is included in your health screening (looking for risks of blood clots in your heart that could travel to your brain and cause a blockage) plus an artery screening for peripheral arterial disease because 75% of people with this condition will suffer a heart attack or stroke if left untreated … and because these conditions can be treated, booking your check now can be very good news”. It also stated “Should you wish, you can ask for a detailed … Prostate Cancer Test for men and an Ovarian Cancer Test for women”.
Issue
1. The complainant, a GP, who understood that there was no evidence that screening for peripheral arterial disease could reduce the risk of cardiovascular disease and who believed the ad implied that advice on preventing cardiovascular disease was unavailable on the NHS for those who did not show symptoms, challenged whether the claim “an artery screening for peripheral arterial disease because 75% of people with this condition will suffer a heart attack or stroke if left untreated … and because these conditions can be treated, booking your check now can be very good news” was misleading and could be substantiated.
The complainant, who believed that the following claims implied that the tests advertised were sufficient to diagnose the conditions referenced, challenged whether they were also misleading and could be substantiated:
2. “you can ask for a … Prostate Cancer Test for men”; and
3. “you can ask for a … Ovarian Cancer Test for women”.
Response
1. Bluecrest Health Screening Ltd said that peripheral arterial disease (PAD) was both a risk factor for and a form of cardiovascular disease. They did not offer PAD screening in isolation, and recognised that other tests, as well as family history, were important factors in screening for cardiovascular disease. The test they offered used a Cardiovascular Screening Device to measure the difference in blood pressure between the customer’s upper and lower extremities (the ankle brachial index). They said this was accepted as a marker of PAD and atherosclerosis (the build-up of fatty material in the arteries) as well as a predictor of cardiovascular disease. Bluecrest believed that readers would understand from the ad that the electrocardiogram (ECG) check and PAD screening were not routinely available on the NHS for asymptomatic individuals.
Bluecrest said that undiagnosed PAD was found to be a co-contributor to vascular related deaths. Once PAD was diagnosed, it was important to commence secondary prevention to help slow the progression of the disease, through medical interventions such as taking aspirin (to thin blood), ACE inhibitors (to reduce blood pressure) and statins (to manage high cholesterol). They referenced NICE Clinical guidelines for NHS patients that stated that people with PAD should be offered information, advice, support and treatment regarding the secondary prevention of cardiovascular disease. Bluecrest believed PAD screening was useful in helping reduce the risks associated with worsening cardiovascular disease. They provided an abstract for one study and three full studies that they said supported their claims. They said that if a patient were to visit their NHS GP and provide a report indicating they had PAD, this would be considered and they would be given different advice about helping to prevent any worsening of the condition. GPs would be aware of how PAD increased other cardiovascular disease risk factors and would give specific advice on how to treat and improve the individual's prognosis.
2. Bluecrest said they understood that the prostate-specific antigen (PSA) test that they offered could not diagnose prostate cancer on its own. The letter stated that the test could be included at the time of an individual’s initial examination. However, before an individual elected to have the test, they were guided through the benefits and limitations with a member of staff at their screening clinic and given further guidance on prostate cancer risk management. They were also provided with an Informed Consent statement. This was to ensure that they were fully aware of the risks in order to make a fully informed decision.
Bluecrest said that while the PSA test might not be perfect, without an alternative test available it was the first step towards investigating the disease and one that could benefit individuals greatly by detecting it at an early stage.
3. Bluecrest stated that there was no alternative test for ovarian cancer other than the cancer antigen 125 (CA125) test that they offered. They said the test was widely accepted as a first step before taking an ultrasound scan. They referenced NICE guidance for NHS patients that recommended using the CA125 test for initial detection in women with symptoms that suggested ovarian cancer.
Bluecrest said they did not claim that the test was 100% accurate. As with the PSA test, they provided customers with information about the benefits and limitations of the test along with the Informed Consent statement, to enable them to make their own decision.
Assessment
1. Upheld
The ASA noted that the letter stated “You are probably very well looked after by your NHS GP when you are ill, but you may also appreciate that many serious health conditions don’t show any warning signs”. It then offered “an artery screening (for ‘peripheral arterial disease’), because 75% of people with this condition will suffer a heart attack or stroke if it’s left untreated … because these conditions can be treated, booking your check now can be very good news”. We considered that readers were likely to understand from the claims that having PAD screening would help to lower their risk of heart attack or stroke, in part because the test results would allow them to receive different care and advice from their NHS GP in relation to the prevention of heart attack and stroke than if they did not demonstrate symptoms.
In order to substantiate the claim that PAD screening helped to lower the risk of heart attack and stroke, we expected to see clinical research demonstrating that the act of screening for PAD resulted in fewer instances of heart attack and stroke. We assessed the evidence documents provided in full by Bluecrest. While we acknowledged that a study carried out by the American Heart Association demonstrated that PAD was associated with an increased risk of cardiovascular and cerebrovascular events, including heart attack and stroke, it did not examine the link between PAD screening and actual instances of heart attack and stroke. The second study measured the prevalence of PAD in high-risk hospitalised patients not previously diagnosed with the disease but did not examine the effect of screening on cardiovascular risk. We did not consider that the studies were relevant to substantiating the claim as consumers were likely to understand it.
The third document was a decision model that projected the potential gain in life years for high-risk older adults who underwent PAD screening versus those who did not. While it could act as a basis for further clinical research, it was a modelling exercise rather than a clinical trial and did not measure the effect of the intervention in an actual population. Therefore it was insufficient to substantiate the implied claim that PAD screening would reduce instances of heart attack and stroke.
We noted Bluecrest's assertion that patients with PAD would be given different advice in relation to cardiovascular disease prevention than those who did not have the condition. We understood that the absence or presence of PAD was not a factor that was considered under the cardiovascular risk calculators that were used in the NHS. The NICE best practice guidance on PAD recommended that people diagnosed with the disease should be offered "information, advice, support and treatment regarding the secondary prevention of cardiovascular disease, in line with NICE guidance". It then linked to guidance on addressing various underlying causes of the disease including diet and weight management, lipid modification, and smoking cessation. We understood that this was consistent with the advice that would be offered to NHS patients who raised concerns about their risk of heart attack or stroke, regardless of whether they presented with specific symptoms. Further interventions would be undertaken based on the individual’s level of risk.
The PAD guidance also discussed management of specific symptoms of PAD – these were intermittent claudication (leg pain caused by blockage of arteries in the legs) and critical limb ischaemia (inadequate flow of blood and oxygen to the limbs). Possible treatment for these included surgical options and prescription medicine, as well as specific advice on exercise programmes. While many of these interventions would likely have an impact on an individual’s risk of cardiovascular disease more generally, we noted that they were recommended in relation to specific symptoms of PAD that not everyone diagnosed with the disease would have. Furthermore, encouraging more exercise was one of the key elements in the NICE guidance on general cardiovascular disease prevention. We noted that the NHS Choices web page for PAD stated that the main lifestyle changes that could ease symptoms of PAD were exercising regularly and stopping smoking, along with eating healthily, losing weight and moderating alcohol consumption. Although the NICE guidance in relation to intermittent claudication was slightly more detailed with regard to exercise, we considered that the effect of that advice would not be significantly different in terms of reducing an individual’s general risk of heart attack or stroke than advice on exercise they would receive in the absence of a PAD test. We understood that an individual who had positive PAD test results, and was subsequently diagnosed with PAD by their NHS GP, would be provided with advice and treatment in relation to specific symptoms of PAD (if they had them), and therefore having the test could confer health benefits in that regard. Some of the interventions undertaken to treat those symptoms would also have the effect of reducing the patient’s risk of heart attack or stroke. However, when it came to general prevention of heart attack and stroke, we did not consider that the advice they would receive differed significantly to advice that would be given to asymptomatic patients who were concerned about their risk of heart attack and stroke.
We therefore considered that the claims as consumers were likely to understand them – that is, that having PAD screening would help to lower their risk of heart attack or stroke – had not been substantiated. Furthermore, while we acknowledged that having a PAD test could result in health benefits for consumers inasmuch as they could receive interventions for specific symptoms of PAD, we considered that the claims, as consumers were likely to understand them, exaggerated the extent of the benefit they would receive when it came to general reduction of their risk of heart attack or stroke. We therefore 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).
2. & 3. Upheld
The letter referred to a “Prostate Cancer Test” and an “Ovarian Cancer Test”. We considered that, in the absence of any further information, consumers would understand this to mean that the results of these tests would indicate whether they had prostate or ovarian cancer, respectively.
We understood that the tests referred to were the tests recommended by NICE, for NHS patients, for the initial detection of possible prostate or ovarian cancer. We understood that these tests measured levels of specific antigens in the bloodstream, and that positive results did not necessarily indicate the presence of cancer, while negative results did not necessarily indicate that the patient did not have cancer. We understood that Bluecrest customers with raised antigen levels would be given a report to show to their GP, who could conduct further tests to confirm whether they had cancer.
The information that Bluecrest provided to customers who expressed interest in the “Prostate Cancer Test” or the “Ovarian Cancer Test” gave further details of the risks and limitations of each test, and stated that a positive result did not mean that they had cancer, but rather indicated that further investigation was needed. However, we noted that this information was not provided within the ad. We considered that Bluecrest had not substantiated the claims as consumers were likely to understand them, and concluded that the ad was therefore misleading.
On those points, 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 Bluecrest Health Screening Ltd not to state or imply that having a PAD test would result in a reduced risk of heart attack or stroke in the absence of robust evidence to support this, or to overstate the benefit that having a PAD test would confer on a patient who sought advice from their NHS GP in relation to the prevention of heart attack or stroke. We also told them not to state or imply that the tests they offered were sufficient to diagnose disease if they did not hold evidence to substantiate that this was the case.
