ASA Adjudication on Lifescan Ltd
12 Montacute Road
10 February 2010
Health and beauty
Number of complaints:
In a TV ad for health screening from Lifescan, a man was shown with his family and a 50th birthday cake. He said “I’ve been checked”. A woman who was gardening said “I’ve been checked”. The Lifescan logo appeared on-screen. A voice-over stated “When it comes to our health, more and more of us are enjoying peace of mind with a check-up from Lifescan". An older couple walked into a clinic and the voice-over continued “Lifescan is like an M.O.T. for your body. It’s a quick and easy scan that could detect the early signs of life-threatening diseases, way before the symptoms begin”. The man was shown having a CT scan and then discussing the results with a clinician. The voice-over stated “It's helped us save the lives of people all across the UK and given peace of mind to many more. It only takes a few minutes and could detect the early stages of heart disease, lung and colon cancer, as well as the early stages of osteoporosis and other illnesses, giving you a check-up all in one go”. The couple left the clinic and were shown on a golf course; the woman said "We've been checked". The voice-over said “And what’s more, with seven Lifescan centres nationwide, you’re never far away from finding peace of mind. If you’re over forty and would like to know more, call now on 08XX XXX XXXX or visit ...”.
1. One viewer, a medical doctor, complained that the ad's claims that the scanning was beneficial could not be substantiated, and could mislead vulnerable people into paying for an unnecessary process.
A second viewer, also a medical doctor, complained that the ad was misleading, because it did not refer to:
2. the possible risk of harm from exposure to radiation associated with CT scans; and
3. the possibility of results leading to unpleasant and distressing tests and examinations, which might prove to be needless.
4. The ASA challenged whether the ad misleadingly implied that a CT scan could identify any type of health problem.
BCAP TV Code
1. Lifescan said they had scanned over 60,000 individuals since 2003 and had identified lung cancer, colon cancer or significant heart disease early in aproximately 12%. Where the lungs were concerned, a nodule had been found in 13% of those scanned, but the vast majority of the nodules measured less than 8 mm and required nothing other than a follow-up after six months, which they said they performed at low cost. Regarding the colon, a polyp had been found in 9% of those scanned, but approximately 50% of the polyps measured less than 8 mm. They had identified an above average risk of heart disease in 16% of those scanned, and a high risk of heart disease in 21% of those scanned.
Lifescan submitted part of their patient testimonial database. They said the testimonials were all unsolicited and copies of the patients' letters were available on request. The testimonials referred to scans detecting colon cancer, heart disease, kidney tumours, lung cancer, osteoporosis, a stomach tumour, aneurysms and an enlarged thyroid gland in the patients. Lifescan said they would not allow anyone aged under 45 years to be booked for a virtual colonoscopy, unless accompanied by a GP referral following symptoms, and they did not offer a bone mineral density scan as a one-off product; diagnosis of osteoporosis was only as a result of images gathered from other scans.
They believed clinical evidence and opinion had moved on since the publication of the 12th Report of the Committee on Medical Aspects of Radiation in the Environment (the COMARE report) in December 2007. They submitted several articles, studies and research on screening for colorectal cancer, heart disease and lung cancer, which they said supported the use of optimised low dose CT scans for the detection of those specific illnesses.
Clearcast believed the patient testimonial evidence demonstrated several cases of Lifescan having enabled individuals to take action on detected illnesses before symptoms had begun.
2. Lifescan said the issue of radiation was mentioned in their literature and on their website, and everyone who booked a scan was given an information sheet about CT scans, which argued that the benefits of the scan outweighed any risk of harm from radiation.
Lifescan continued that alleged risks to health from radiation at the low levels used by CT scans were calculated using Linear No Threshold (LNT) theory, which did not stand up to close scrutiny, because it was based on data from Nagasaki and Hiroshima, where individuals were exposed to much higher doses of radiation than those used in CT scans. In LNT theory a linear model extrapolated that all radiation, no matter how small, was dangerous. They argued that that theory had been discredited by the United Nations Chernobyl Forum, set up after the Chernobyl Nuclear Power Plant explosion in 1986, which examined the effects of radiation at doses below 200 mSv and concluded that they were neither hazardous nor carcinogenic. They believed LNT theory was also discredited by the fact that no ill effects on health had been observed in parts of the world which had high levels of natural background radiation, ranging from over 20 mSv to over 100 mSv. They also pointed out that a 100-year study of British radiologists, published in the British Journal of Radiology in 2001, found that radiologists had suffered no greater incidence of cancer than the population as a whole since 1954. Finally, they said a heart scan with Lifescan had the same radiation dose as a flight to Australia, yet airlines were not required to inform passengers of radiation exposure.
Clearcast said most viewers would know CT scans were a kind of X-ray which involved exposure to low levels of radiation. They stated that Lifescan's optimised low dose scans were recommended only once every five years and the radiation exposure level ranged from less than 1 mSv to a maximum of around 12 mSv; they believed that was equivalent to a year's background radiation in parts of the UK, such as Devon or Cornwall, and the theoretical risk of harm was therefore negligible. They added that a prospective client would have access to literature giving information about CT scans, and would be assessed by a health professional before having a scan.
Clearcast thought the ad did not suggest frequent scans were recommended and, if a client was under the impression that frequent scanning would be beneficial, Lifescan would clarify that that was not the case. They believed that, if the ad warned that CT scans exposed patients to radiation and could be harmful if used frequently, that would inform the viewer of something they were likely to be aware of already; could encourage people who were not medical or scientific professionals to make uninformed choices; and could misleadingly suggest that Lifescan would allow individuals to have frequent scans.
3. Lifescan disagreed with the idea that CT scanning often detected benign abnormalities, resulting in a high incidence of unnecessary invasive tests and surgery. They said most of the findings from their scans were of no clinical significance and required no further investigation unless symptoms developed, which would of course warrant intervention in any case. They said there was a tendency in the USA in the late 1990s to investigate everything, including incidental findings, following a CT scan, but rigorous interpretative protocols had been widely adopted since then, dramatically reducing the number of false positives; for example, to operate on a benign non-growing lung nodule was now almost unheard of. Lifescan explained that, in the event of an indeterminate finding such as a small nodule, they would take no further action until a second scan had confirmed growth and therefore malignancy.
They argued that allegations of their scanning generating unnecessary demand for follow-up were anecdotal at best, and their own records indicated otherwise. They had received complaints from only 0.3% of their patients and they had a customer satisfaction score of 90%. They believed that strongly indicated that the rate of false positives was extremely low, even possibly non-existent. They also pointed out that coronary artery calcium had no false positives, because any level of calcification detected in a CT scan was evidence of cardiovascular disease. They said their clinical audit data had established a false positive rate of 1% in colonoscopies. They said their experience indicated that the vast majority of extra colonic findings, such as gallstones, required no further action.
Clearcast endorsed Lifescan's response.
4. Lifescan believed their ad did not suggest that a CT scan for health assessment purposes could identify any type of disease or illness. They pointed out that the ad specifically referred to heart disease, lung and colon cancers and osteoporosis. The ad also referred to "other illnesses" which, Lifescan explained, were the aneurysms and other forms of cancer mentioned in their patient testimonials. They said they did not specifically scan for other illnesses but CT colonoscopy was able to detect other serious extra colonic findings.
Clearcast pointed out that the ad did not refer to a clean bill of health, a unique picture of one's state of health or an assessment of how well the body was functioning. They argued that the ad did not claim to identify any, or all types of, health problem. Instead it was quite specific in mentioning which conditions could be detected: heart disease, lung and colon cancers and osteoporosis. They were of the view that the phrase " ... and other illnesses" would not be understood to mean all other illnesses.
The ASA considered that the ad was aimed at viewers with no symptoms of any illness.
We noted the COMARE report, which constituted advice to the Department of Health and was endorsed by the Health Protection Agency, stated that electron beam CT scanning to determine coronary artery calcification was valuable for predicting cardiovascular risk in asymptomatic individuals, but should be undertaken only on individuals with intermediate risk. However, the report also stated that CT scanning should not be undertaken for identifying osteoporosis in asymptomatic individuals because there were more appropriate methods which had lower radiological risks; that there was no evidence to justify CT scanning of the lungs in asymptomatic individuals; that other screening methods should be undertaken before undergoing a CT scan; and that CT scanning for colon cancer on asymptomatic individuals should only be offered to those aged 50 years or above. It continued that if analysis of data available from a scan intended for other purposes provided clinically useful and reliable information on, for example, osteoporosis, it would be permissible to include those data in the results. We understood that, following a consultation period about the issues raised in the COMARE report, no subsequent recommendations or legislation had been proposed by the Department of Health. In October 2008, COMARE was asked to consider current evidence regarding lung and cardiac scanning to ensure the report's recommendations were still valid; two independent experts confirmed, on behalf of the committee, that no changes should be made to the recommendations regarding those services.
Although we acknowledged that Lifescan's screening could detect illnesses in some people, and noted screening for osteoporosis was not by means of a discrete scan but via images from scans for other conditions, we considered the ad suggested that CT scanning for colon cancer, osteoporosis and lung cancer was suitable for all asymptomatic individuals over the age of 40 years. Because that went against the recommendations of the COMARE report, which was considered the most authoritative and comprehensive advice on the subject, we were concerned that the ad's claims about who would benefit from the scanning had not been adequately substantiated, and the ad could mislead vulnerable viewers into paying for an unnecessary process.
On this point, the ad breached CAP (Broadcast) TV Advertising Standards Code rules 5.1.1 (Misleading advertising) and 5.2.1 (Evidence).
We understood that the COMARE report expected dose reduction and other advances in technology might influence advice on the appropriateness of CT scanning for asymptomatic individuals, subject to new research evidence demonstrating improved benefits, but stated that at present CT scanning should not be used on asymptomatic individuals where there was evidence that it was not the most suitable method to screen for a particular condition because other, more appropriate methods with lower radiological risk consequences were available. We noted the report stated that the detriment associated with a single CT scan, when expressed in terms of the risk of cancer induction alone, was usually below that considered to be unacceptable; however, the COMARE report considered the total potential detriment from the first and subsequent scans, that from other investigations which might be necessary to confirm a diagnosis, and balanced that against the benefit to the individual of the first CT scan. Because established advice was that the level of radiation exposure from CT scanning meant it was often unsuitable for asymptomatic individuals, we considered that in omitting that information the ad was likely to mislead.
On this point, the ad breached CAP (Broadcast) TV Advertising Standards Code rule 5.1.2 (Misleading advertising).
3. Not upheld
Although the possibility of results leading to unpleasant and distressing tests and examinations, which might prove to be needless, could not be ruled out, we considered it unlikely. We noted one of the complainants was concerned that the tests could cause physical or psychological damage, and we recognised that the initial scan might lead to further scans and possibly tests, which might be a distressing process for some individuals, but we considered most viewers would be aware of that possibility, and we had seen nothing to suggest that the likelihood of Lifescan's scanning service leading to unnecessary invasive tests and examinations was strong enough to warrant being stated in the ad.
The COMARE report recommended that the rates of false negative and false positive findings associated with CT scanning of asymptomatic individuals should be independently audited and explained, and the range of further investigations that might be required to confirm initial findings and the risks associated with subsequent scans if recommended, should be discussed with clients attending commercial CT services. We agreed with the COMARE report that an outline of that information should be made available to individuals by some means before they presented for scanning, but considered it was not necessary to include that information in the TV ad specifically.
On this point, we investigated the ad under CAP (Broadcast) TV Advertising Standards Code rule 5.1.2 (Misleading advertising) but did not find it in breach.
We noted the ad stated " ... Lifescan is like an M.O.T. for your body" and "It ... could detect ... other illnesses, giving you a check-up all in one go"; it also referred several times to the service providing "peace of mind". We considered those claims gave the impression that the CT scans offered by Lifescan provided an overall health check-up and would identify any type of health problem, not just those explicitly mentioned in the ad, and if no illnesses were discovered that meant the client was healthy and not at risk. Because it was possible that clients might have certain illnesses which the scans would not detect, we considered that the ad was likely to mislead.
On this point, the ad breached CAP (Broadcast) TV Advertising Standards Code rule 5.1.1 (Misleading advertising).
The ad must not be broadcast again in its current form. We told Lifescan not to suggest that CT scanning for colon cancer in people aged under 50 years, osteoporosis or lung cancer was suitable for all asymptomatic individuals; not to suggest that a CT scan could identify any kind of health problem and provide peace of mind; and to include information about the risk from exposure to radiation.
Adjudication of the ASA Council (Broadcast)