ASA Adjudication on Life Line Screening UK Ltd

Ad

A leaflet, for health screening, was headed "Tests that could help save your life Five tests in about an hour”. Below, it stated “Stroke is the UK's third leading killer. It is also the number one cause of severe disability. But there can be no warning signs, it could happen at any time. We are visiting your local area … We are now offering our fast, accurate and affordable health screens throughout the UK. You can have tests to check for risks of stroke, atrial fibrillation, abdominal aortic aneurysm and heart disease." On the reverse, it stated “We could help you avoid a stroke - in about an hour …. Early detection will allow you to discuss treatment options with your GP that could be lifesaving." Below, it showed diagrams of the areas that the tests were focused on and stated:

"Test 1 Carotid artery screening For risk of stroke Plaque build-up is the abnormal collection of calcium and cholesterol on the artery walls. This build-up can restrict blood flow to the brain causing a stroke. Our painless ultrasound test visualises the inside of your carotid artery to see if there is any plaque build-up.

Test 2 Atrial fibrillation screening For risk of stroke and heart failure Atrial fibrillation (AF) is a condition that affects the heart, causing a rapid and irregular heart beat. This increases the risk of blood clots as the heart cannot pump blood efficiently. Having AF increases the risk of stoke [sic] 5 times.

Test 3 Abdominal aortic aneurysm screening For risk of a ruptured aneurysm An abdominal aortic aneurysm (AAA) is a 'ballooning' of the wall in the abdominal artery (aorta). The majority of people with AAAs have no symptoms, but the mortality rate of a ruptured AAA is over 80%.

Test 4 Peripheral arterial disease screening For risk of heart disease Peripheral arterial disease (PAD) is the build-up of plaque in the arteries of your arms and legs. If you have PAD you are 4-5 times more likely to die of a heart attack. Our painless ultrasound test looks for signs of PAD before there are complications.

Test 5 Osteoporosis screening For risk of brittle bones Our ultrasound scan checks your bone density to assess your risk for osteoporosis, which causes 200,000 fractures a year in the UK. Osteoporosis is painless and silent in its early stages, so screening is invaluable”.

Issue

A doctor believed the leaflet was misleading and potentially harmful because:

1. it implied that the risk of a stroke could be detected by the tests, whereas he understood that there were many other causes of stroke not covered by the tests mentioned;

2.  it claimed screening for osteoporosis was invaluable, whereas he understood that it was only suitable for those subject to certain risk factors; and

3. it did not mention the risks of screening, in particular false positives and false negatives.

CAP Code

Response

1. Life Line Screening UK Ltd (Life Line) said they screened for the three major causes of stroke; carotid artery stenosis; atrial fibrillation; and systolic hypertension (high blood pressure).  They said an ischaemic stroke was the most common type of stroke, accounting for over 80% of cases, and explained that the leading causes of ischaemic stroke were carotid artery stenosis and atrial fibrillation. Life Line said, although not mentioned in the ad, they also checked for high blood pressure, which could contribute to ischaemic stroke, and was the leading cause of the other type of stroke, that of haemorrhagic stroke.

Life Line said the ad did not claim that they could definitely prevent someone from having a stroke.  However, they believed screening could provide clients with information about their health early enough for them to take action, in cooperation with their GP, to help avoid a stroke or related health event.

2. Life Line explained that there were usually no symptoms to indicate that a person was developing osteoporosis, and therefore screening was the only way to identify the disease prior to a bone fracture or serious posture changes.  They believed it could be an invaluable preventative technique.  Life Line said detection for osteoporosis was only good for those with risk factors, the primary risk factor being age, which was why they targeted their screenings to those aged 50 and over.

3.  Life Line explained that there was a chance of false-positives and false-negatives with all screenings, but said they did everything possible to minimise the possibility of either.  They said they had rigorous protocols, overseen by a Clinical Manager and a Chief Medical Officer, as well as trained ultrasound technologists.  They said they had strict quality control procedures. All abnormal screenings were re-checked by another technologist at the time of the screening, and all results forms were double-checked for accuracy of documentation before being reviewed by a fully accredited Consultant after interpretation and documentation by the technologist.  They said their screenings had been evaluated by two independent academic institutions and found to be very accurate.  

Life Line pointed out that the ad referred readers to their website for more information, which included a Frequently Asked Questions section that discussed the issue of false-positives and false-negatives.  They believed the results letter they sent to clients made clear that the results were for informational purposes and not medical advice.  Life Line said the letter also encouraged discussion with a GP where they believed diagnosis, rather than just risk factor detection, would take place.  They believed the claim in the ad, "Early detection will allow you to discuss treatment options with your GP", also made this clear.  They said any and all diagnostic testing and treatment options, which would take the limitations of screenings into account, would be decided by a personal doctor in discussion with that patient, not by Life Line.

Assessment

1. Not upheld

The ASA noted Life Line screened for the three major causes of strokes, including those of ischaemic stroke, which we understood accounted for over 80% of stroke cases.  Although we understood that there were other causes of stroke not covered by those tests, we considered that it was clear from the description of the tests the particular causes for which Life Line did screen.  We noted the leaflet did not claim that Life Line tested for all the causes of stroke and we considered that the claims ... tests to check for risks of stroke ...", "Tests that could help save your life" and "We could help you avoid a stroke ..." made clear that the screenings would not definitely prevent someone from having a stroke.  We therefore concluded that the leaflet did not give a misleading impression of the extent of the screening on offer.

On this point, we investigated the leaflet under CAP Code clauses 2.2 (Social responsibility), 3.1 and 3.2 (Substantiation), 7.1 and 7.2 (Truthfulness) and 50.1, 50.2, 50.3 and 50.6 (Health and beauty products and therapies) but did not find it in breach  

2. Not upheld

We understood that the test for osteoporosis would only be of benefit to those with certain risk factors, including that of age, and noted the leaflet was targeted at the over 50s.  We also noted the leaflet stated that, for a condition not easily detected in its early stages, screening was invaluable.  However, we did not consider that the leaflet suggested that the test had been shown to be important for everyone.  We therefore considered that the claim was unlikely to mislead readers.

On this point, we investigated the leaflet under CAP Code clauses 2.2 (Social responsibility), 3.1 and 3.2 (Substantiation), 7.1 and 7.2 (Truthfulness) and 50.1, 50.2, 50.3 and 50.6 (Health and beauty products and therapies) but did not find it in breach.

3. Not upheld

We noted Life Line had a number of procedures in place to minimize the possibility of false-positives and false-negatives and that information about the limitations of their screening and the possibility of false results was provided in the results letters sent to their clients and also on their website.  We also noted that the ad encouraged clients to discuss their test results with their GP.  We considered that readers were likely to be aware that there was always a small chance of false results in all health screening and testing, and therefore we also considered that the possibility of a false result was unlikely to affect their decision as to whether to be screened or not.  Because of that, and because the limitations of the screening were explained in the results letters and on Life Lines website, we considered that it was not a significant condition that needed to be included in the leaflet and its exclusion was unlikely to mislead.  

On this point, we investigated the leaflet under CAP Code clauses 7.1 and 7.2 (Truthfulness) and 50.2 and 50.3 (Health and beauty products and therapies) but did not find it in breach.

Action

No further action necessary.

Adjudication of the ASA Council (Non-broadcast)