What companies don’t tell you about screeningBMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e2311 (Published 28 March 2012) Cite this as: BMJ 2012;344:e2311
The full page advertisements in the weekend press are hard to ignore. “Your quick and easy way to help prevent a stroke,” goes the headline, with “Did you know that strokes are the third most common cause of death in the UK?” underneath. Two customers support the company offering the tests, Life Line Screening: “No matter how healthy you might think you are, it could save your life,” and “I had very significant narrowing of both coronary arteries . . . I can’t thank you enough for virtually saving my life.”
Life Line Screening doesn’t just advertise in newspapers; it also sends personal looking letters to people; one that I received started, “Did you know that cardiovascular disease is the #1 killer of men and women in the UK—and a leading cause of permanent disability?” Followed by, “Did you know that the majority of strokes can be prevented?”
Life Line’s business model is to send letters to people in an area before setting up ultrasound scanners and electrocardiography machines in church halls or leisure centres. For around £100-£200 (€120-€240; $160-$320) it will perform Doppler ultrasound examinations of the carotid arteries and abdomen, testing for peripheral artery disease, and electrocardiography. It also has extra packages offering ultrasound assessment of risk of osteoporosis and a “10 year heart disease risk assessment [that] includes a cholesterol and preventable diabetes glucose test.”
“Why doesn’t your GP order these screenings?” asks the company’s letter. “The answer is that typically such preventative screenings are not available on the NHS for people without symptoms or family history.”
Life Line Screening is one of many companies offering testing to asymptomatic people; this is a competitive field. Lifescan, which operates from 19 UK venues, ran a television advertisement stating, “There are lots of ways to keep your health in check. Like eating well, taking regular exercise, getting plenty of sleep, and visiting Lifescan. Our highly advanced CT [computed tomography] health checks could help detect signs of serious illness before symptoms appear, including heart disease, strokes, lung or colon cancer, and aneurysms . . . So if you’re 40 or over, keep your health in check with Lifescan.”1 Other companies offer health checks such as a “head to toe clinical exam,” spirometry, faecal occult blood testing, CT calcium score of the heart, mammography, lung CT, and magnetic resonance imaging of the brain.2
Benefits and harms
It is completely legal for the companies to offer these screening services. But their promotion of these services contrasts with the stance of the NHS, which introduces screening programmes only after a robust review of the evidence against internationally recognised criteria by the UK National Screening Committee (UK NSC). NHS screening programmes are subject to rigorous controls and quality assurance to ensure they maximise the ratio of benefit to harm, and there is a clear pledge in the NHS constitution to “provide screening as recommended by the UK NSC.”
The committee’s director of programmes, Dr Anne Mackie, says: “Screening tests should be offered only when there is evidence that their use in asymptomatic populations will produce more benefit than harm.” The UK NSC has a database listing all of its policies and stating whether screening for a particular condition is recommended. When no good quality research evidence is available, or research has found that screening for a particular condition causes more harm than good, the UK NSC will recommend that routine screening should not take place.
Mackie says that “The UK NSC upholds the right of people to buy these services, but offering screening without explaining fully the risks relating to false positives, which can lead to raised anxiety and further unnecessary diagnostic tests, and false negatives, which provide false reassurance, is unethical.” Although Life Line and other providers may give full information to their customers at screening, the letters sent to my home address and the recent full page advertisements do not state the risk of false positive results.
Mackie would like providers of screening tests to be obliged to plainly state the risks of having these tests in their advertisements.
“Screening is not a one way street, and benefit is not inevitable. There must be mention of the risks.” She would like to see “providers of screening tests produce good unbiased information up front that outlines whether the test is recommended or not by the UK NSC, that they are explicit that screening is not a foolproof process, and that there is always a risk that screening will falsely identify people as having or not having a condition.”
This has also been noted by the independent, not-for-profit consumer organisation Which? The organisation has recently investigated screening companies. A spokesman for Which? explains: “We were concerned about the quality of information given to people making important decisions about whether or not to use them.” In particular, Which? wanted to see if the 12th report of the Committee on Medical Aspects of Radiation in the Enviroment (COMARE),3 published in 2007, had changed the way screening tests were offered. This report recommended regulation of private screening clinics, stating that customers should be given “comprehensive information” including rates of false positive and false negative findings, and that CT screening of the whole body or lung should not be offered.
Other organisations also have concerns about the information given to potential customers. The chairman of the BMA, Hamish Meldrum, and Neil Douglas, chair of the Academy of Medical Royal Colleges, wrote to Andrew Lansley in 2010 to ask for improvements in the information on, among other things, false positive and negative results, risks, and limitations of screening tests from private clinics. No legislation has followed.
In the Which? investigation, a researcher posing as a potential customer telephoned five companies requesting information about screening tests and what they could achieve. Analysis of the transcripts—which I helped with— found that three companies (Prescan, the European Scanning Centre, and Lifescan) did not mention false positives or negative results and one company, Vital Imaging, only partially covered the risks.
Which? says “We found that companies were still using CT scans without properly explaining the risks or the further risks about false positives and negatives, even when specifically asked. As well, one company was offering ‘peace of mind,’ which these scans can’t offer and shouldn’t be marketed as such. Our experts were very concerned at the complete lack of information given at the point of booking, even when prompted, and that lung scans were being offered to a healthy person with no risk factors.” Although the clinics may have given better information to people at the point of being tested, Which? says, “We believe that the information given to consumers before they decide to buy should be comprehensive on all risks as well as benefits, allowing them to make an informed choice. It’s unrealistic to expect someone to cancel or change their decision on the day.”
John Giles, is a consultant radiologist and clinical director of Lifescan, which has scanned 65 000 people since 2003. Lifescan’s website says it is “providing awareness, providing peace of mind.” I asked whether he thought that offering peace of mind is fair? “Yes,” he replied, “we only offer to help provide peace of mind—and only for those illnesses for which the use of CT scans for screening is supported by clinical evidence.” Although there has been research into the use of CT of the coronary arteries in cardiovascular risk assessment, as well as CT screening of the lungs and colon, these uses have not been approved by the National Screening Committee. Lifescan’s website says that lung scanning is the “ideal check for those who have either smoked in the past, or been exposed to secondary smoke at home or work, have worked with asbestos and hazardous chemicals, or for those with a family history of lung cancer.”
Giles said that “we do not offer CT chest scans; however, we do offer low dose CT lung scans, which as you know are very different. The COMARE report published in 2007 was superceded by the US trial for lung cancer, which supported the use of low dose CT lung scans in high risk individuals.” This study, however, was of people with a 30 pack-year history of smoking, not passive smokers.4
Most screening clinics are registered with the Care Quality Commission (CQC), which has an interest in “treating people with respect and involving them with their care” as well as staffing and management issues. The commission also enforces the Ionising Radiation (Medical Exposure) Regulations, which are intended to “ensure the benefits outweigh the risk in every case.”5 In a statement, the CQC said that “The essential standards of quality and safety (based on the Health and Social Care Act 2008) state that patients are given appropriate information and supported in relation to their care or treatment choices, that they understand those choices available to them and are able to express their views [about] the care or treatment they are receiving. We would expect to see any service that we regulate have policies and procedures in place to make sure that this happens and would look for evidence of that when we inspect.” However, it does not assess the literature supplied by each clinic.
The medical director of Life Line Screening, Dr John Coltart, passed my inquiries to the marketing director, Peter Blencowe. Does the company think that its media campaigns are fair? “I feel that our communications fairly and accurately describe the services that we offer,” he says. “We focus on an appropriate age group and typically our customers have risk factors such as high blood pressure, high cholesterol, and a family history of vascular disease.” However the advertising letters Life Line sends out can be to people at ordinary risk or who are already being managed by their GP for higher risk.
So who is responsible for regulating the standard of information given to people and ensuring that advertising is balanced? Earlier this year, I and several colleagues complained to the General Medical Council about lack of adequate information in advertising for screening. The GMC dismissed this, saying that “We are unable to investigate a matter of this nature unless the complainant(s) have evidence that the doctors in question did not fully explain the risk/benefits of the procedures.” In other words, potentially misleading advertising from clinics, even if the company is part owned or directed by doctors, is not something that the GMC will investigate.
So who does protect customers? The Advertising Standards Authority has been investigating a complaint about Life Line Screening since August 2011. It also upheld complaints about the biased nature of Lifescan’s advertising in 2008 and 2010.6 7 However, the authority’s impact is limited because adverts can continue running until complaints are upheld: persistent offenders can be referred to the Office of Fair Trading, but this is uncommon.
Dennis Ager, lead officer for health at the Trading Standards Institute, shares concerns about the overlapping responsibilities of agencies in this area. “The regulation of claims relating to health and medical products is complex and involves a number of regulatory bodies, including trading standards, the General Medical Council, and the Medicines and Healthcare products Regulatory Agency.” He says that spurious or inaccurate advertisements can be acted on and tend to be treated more seriously when there is evidence of harm or injury to people. “Anyone making such claims must be able to provide evidence to demonstrate that claims are accurate and that they do not mislead consumers.” Enforcement action is the ultimate sanction.
This hasn’t yet happened to private screening clinics. In June 2011 a revision was made to existing radiation protection legislation to include protection for “any exposure of an asymptomatic individual.”8 The Department of Health has subsequently asked the Royal Colleges of Radiologists and Physicians to produce guidelines on the use of radiation by private clinics offering health checks. There is currently no publication date set. Meanwhile, the adverts promising peace of mind and “quick and easy” non-evidence based and costly screening tests pull people in, with the NHS being left to sort the fallout.
Cite this as: BMJ 2012;344:e2311
Competing interests: The author has completed the ICJME unified disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declares no support from any organisation for the submitted work; no financial relationships with any organisation that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work. MMcC is a GP who often has to deal with the results emerging from such private clinics.
Provenance and peer review: Commissioned; not externally peer reviewed.