{"id":26544,"date":"2013-05-21T16:35:48","date_gmt":"2013-05-21T15:35:48","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=26544"},"modified":"2013-05-21T16:35:48","modified_gmt":"2013-05-21T15:35:48","slug":"margaret-mccartney-clinical-trial-company-tempts-patients-with-free-health-screening","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2013\/05\/21\/margaret-mccartney-clinical-trial-company-tempts-patients-with-free-health-screening\/","title":{"rendered":"Margaret McCartney: Clinical trial company tempts patients with free health screening"},"content":{"rendered":"<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/2013\/05\/21\/margaret-mccartney-clinical-trial-company-tempts-patients-with-free-health-screening\/margaret_mccartney\/\" rel=\"attachment wp-att-26550\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-full wp-image-26550\" alt=\"margaret_mccartney\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2013\/05\/margaret_mccartney.jpg\" width=\"160\" height=\"110\" \/><\/a>When buses in Glasgow started to come with posters asking if people were \u201cConcerned about diabetes?\u201d with an image of an older woman, a freephone number, and webpage for people \u201cto find out about our health screening programme,&#8221; I wondered what was going on. Another bus advert said, \u201cDo you have asthma? Register for a complimentary health check today and you could be part of our research into the future of asthma.\u201d<!--more--><\/p>\n<p>A third advert depicted an x ray image of fingers crossed for luck, with the message: \u201c1 in 2 women over 50 will break a bone due to osteoporosis . . .\u00a0 find out about our free bone density scanning programme.\u201d By now I was irritated, because the adverts didn&#8217;t say that evidence based risk assessment is freely available on the NHS; nor did two of the adverts make it plain that the purpose of the checks was to recruit people into clinical trials.<\/p>\n<p>For all three adverts were placed on the Glasgow buses by UK clinical trial company Synexus, which has seven UK research centres, including one in Glasgow. I complained to the Advertising Standards Authority, and on 15 May, acting on mine and one other complaint, they ruled the adverts were \u201cmisleading\u201d and must not appear again in their current form. (1)<\/p>\n<p>Synexus describes itself as \u201cthe future of clinical trials\u201d who use \u201can innovative model\u201d that has \u201cenabled it to become the only truly global company specialising in the recruitment of patients and running of trials for later stage clinical trials.\u201d The\u00a0 company\u2019s website highlights its ability to recruit large numbers of patients into trials being run by various drug companies. One news article on its website says, \u201cIt took clinical trial experts Synexus just 10 months to carry out 52 000 DEXA scans and randomise over 2700 patients across twelve of their UK, European, and African dedicated research centres.\u201d (2)<\/p>\n<p>However, this advertising had raised concerns with me. I&#8217;m not the only one. Stuart Ralston, lead clinician for the osteoporosis service in NHS Lothian, and recently confirmed as new chair of the Commission on Human Medicines, says, \u201cObviously it\u2019s fair enough that companies do clinical trials\u2014that\u2019s how we get new drugs.\u201d But he is concerned that the adverts are misleading, \u201cThere\u2019s a hidden message, which is that they want to get people into trials.\u201d Many people responding to the adverts have been given bone scans\u2014the results of which have been handed back to the NHS to deal with, whether or not the person goes on to give consent to be in the trial. In the UK, only people at risk of osteoporosis (such as those who have taken steroids or have a strong family history) are offered bone scanning. Ralston thinks this is the right approach. \u201cNot infrequently you see younger women who have been scanned for one reason or another and have been told they have osteopenia. These women have a low risk of fracture and don\u2019t have anything to gain from being on anti-osteoporosis treatments.\u201d<\/p>\n<p>Lester Firkins is a former banker who was awarded an OBE last year for his services to medical research, in particular his work with the James Lind Alliance, which aims to align clinical research with the priorities of patients and clinicians. Firkins, whose son Ellis died of variant Creutzfeldt-Jakob disease, is in no doubt that patients and clinicians can and must work together to decide on what research is most important, yet the adverts on the buses remind him of his previous work in banking. \u201cBasically it\u2019s frightening people into doing something. It\u2019s just like banks saying \u2018come in for a financial health check\u2019 and then it\u2019s all about selling you payment protection insurance.\u201d<\/p>\n<p>Simon Denegri, who is the chair of INVOLVE, a national advisory group that supports greater public involvement in research, and the National Institute of Health Research national director for public participation and engagement in research, also has concerns about the methods used by Synexus. \u201cI\u2019m all for raising awareness about research and opportunities for patients, but I would question the sort of tactics where this is being hidden behind an enticement or where they are gathering patient contact details via marketing surveys. Will patients really know what they are getting themselves into?\u201d He also thinks that the fact that Synexus is a clinical trials company is not made clear enough.\u201cIt\u2019s important that any potential participant asks questions and gets advice to help them see beyond the sales speak. Clinical trials are a vital part of medical research. By definition, a well run trial should be one where patients are very clear why they are there, what will happen, and their role before, during and after.\u201d<\/p>\n<p>Before the Advertising Standards Authority ruling, Synexus told the <em>BMJ<\/em> that all its advertising is compliant with the ASA code and had also been cleared by a National Research Ethics Service committee. In response to my questions, it said that its \u201costeoporosis adverts on radio, direct mail, and leaflets in GP\u2019s surgeries were ethically approved by the NRES Committee in Brent, London.\u201d It said that it had \u201cabsolutely no doubt\u201d that previous trials of PSA screening and prostatic biopsy had detected prostate cancer early, which \u201cprevented many death(s).\u201d The company believes that the public is increasingly interested in clinical trials and has sufficient access to information about its work online or through patient groups.<\/p>\n<p>However, with\u00a0 regard to the Glasgow bus adverts, the company failed in the ASA\u2019s words to: \u201cmake sufficiently clear that the advertisers ran and recruited participants for clinical trials and that the free screening offered was related to potential recruitment for a trial.\u201d\u00a0 In Synexus\u2019s response to the complaints about the Glasgow bus advertisements, it told the ASA that patients had the health checks before clinical trials were discussed in detail. Two per cent of women who went for a bone scan in the Glasgow area went on to join the clinical trial, it said.<\/p>\n<p>Synexus says that overall 90% of people are recruited for trials through their general practitioner, a service for which GPs are paid, and that the company would perform bone scanning only on women aged over 60 and not in the general population. Meantime, as the <em>BMJ<\/em> campaigns for better patient participation and empowerment\u2014I wonder if advertising health tests direct to the public is ever going to be good for us.<\/p>\n<p>Competing interests: I have read and understood the BMJ Group policy on declaration of interests and declare I was one of the people who submitted a complaint to the ASA about the adverts.<\/p>\n<p>Provenance and peer review: Commissioned; not externally peer reviewed.<\/p>\n<p>1) ASA adjudication on Synexus Clinical Research, 15 May 2013<br \/>\nwww.asa.org.uk\/Rulings\/Adjudications\/2013\/5\/Synexus-Clinical-Research-plc\/SHP_ADJ_218666.aspx.<\/p>\n<p>2) Synexus lead the way with 52,000 DEXA scans in 10 months. 2010.www.synexus.com\/do\/ecco\/view_item?listid=52&amp;listcatid=245&amp;listitemid=851<\/p>\n","protected":false},"excerpt":{"rendered":"<p>When buses in Glasgow started to come with posters asking if people were \u201cConcerned about diabetes?\u201d with an image of an older woman, a freephone number, and webpage for people [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2013\/05\/21\/margaret-mccartney-clinical-trial-company-tempts-patients-with-free-health-screening\/\">More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[223,236],"tags":[],"class_list":["post-26544","post","type-post","status-publish","format-standard","hentry","category-guest-bloggers","category-nhs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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