A trial to extend breast cancer screening may be unethicalBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5105 (Published 12 August 2014) Cite this as: BMJ 2014;349:g5105
All rapid responses
Margaret McCartney draws attention to the age extension trial which is less than robust. Detailed concerns about the underlying science and ethics have repeatedly been raised by individuals and by HealthWatch-UK [1,2, 3]. The chief investigator is neither medically nor scientifically qualified, encourages contamination, ignores questions or obfuscates, and both runs the national programme and chairs the (non-independent) Trial Steering Committee.
The study protocol  was only produced after repeated Freedom of Information requests, is eight pages long, and contains no statistical plan, and only two references. The most important outcomes of all-cause mortality and morbidity (e.g. mastectomy) are not mentioned. Neither government policy nor the trial protocol were revised in the light of the Independent ‘Marmot’ Review, which expressed equipoise about benefits and harms - “The impact of breast screening outside the ages 50-69 years is very uncertain” , nor the pilot which found a doubling of recalls for half the diagnoses at younger ages . The governance and oversight are opaque. The original Research Ethics Committee (REC) did not contain a statistician. The new REC has not approved amendments but appears to give continuing blessing to cluster randomisation and inadequate information. Women aged 47-50 and 70-73, who receive the same ‘new improved’ leaflet as women in the programme, are not fully informed about the harms of overdiagnosis. Recruits cannot realise that it is uncertain whether breast screening works at their age or that there may be risks of research participation. There is no assurance they even realise they are in a study.
The age extension trial is the largest ever human experiment. If the trial does not have a proper research question at its core, and/or those who are running it are biased and/or they are not competent then it is not proper science. If it is not proper science and when women are not fully informed, then it is difficult to see how it is ethical. We again call for the age extension trial to be halted while the science, ethics and information given to women are independently reviewed.
Blennerhassett M, Havercroft D. Pryke M, McCartney M, Bewley S, Broderson J. Extending breast cancer screening beyond its limits without waiting for evidence. http://www.bmj.com/content/343/bmj.d6843?tab=responses (accessed 11 August 2014)
 Blennerhassett M, Havercroft D, Pryke M, McCartney M, Bewley S, Brodersen J. Where does the Marmot breast cancer screening review leave the UK ‘age extension trial’? http://www.bmj.com/content/343/bmj.d6843?tab=responses (accessed 11 August 2014)
 HealthWatch-UK. Concerns over age extension trial of mammography screening. http://www.healthwatch-uk.org/concerns-over-age-extension-trial-of-mammo... (accessed 11 August 2014)
 Evaluation of the net effects of extending the age range for breast screening in the NHS breast screening programme in England from 50-70 years to 47-73 years Protocol. http://www.healthwatch-uk.org/wp-content/uploads/2014/07/Protocol-Age-Ex... (accessed 11 August 2014)
 The Independent UK Panel on Breast Cancer Screening. The Benefits and Harms of Breast Cancer Screening. Independent Breast Screening Review. A report jointly commissioned by Cancer Research UK and the Department of Health (England). 2012;(Oct):70 http://www.cancerresearchuk.org/prod_consump/groups/cr_common/@nre/@pol/documents/generalcontent/breast-screening-report.pdf (accessed 11 August 2014)
 Moser K, Sellars S, Wheaton M, Cooke J, Duncan A, Maxwell A, Michell M, Wilson M, Beral V, Peto R, Richards M, Patnick J. Extending the age range for breast screening in England: pilot study to assess the feasibility and acceptability of randomization. J Med Screen. 2011;18(2):96-102. doi: 10.1258/jms.2011.011065
Competing interests: MBa and CR are founding members of HealthWatch-UK (a charity “for science and integrity in medicine”) of which SB, LR, JI and JM are current Trustees. MP was diagnosed through breast screening. SBs interests can be found at http://www.whopaysthisdoctor.org/doctor/58. All other authors declare no conflicts of interest.
This morning the Cancer Research UK website quotes an article in the Daily Mail about breast cancer and the oral contraceptive pill. The Daily Mail is again one of the first if not the first to highlight new research on the contraceptive pill and increases of 50% plus in incidence of breast cancer for women who are using contraceptives. They reference a study just published in USA outlining the risk of contraceptive pills and breast cancer.1
The UK cancer research site responds with a blog telling women to stay cool and keep taking the pills. (like the shopping bags say "stay cool and keep shopping"?) This is not responsible. This is what has happened every time a new reliable study has pointed the finger at the main culprit in breast cancer causation- the oral contraceptive. 2. What will it take for women and doctors to acknowledge the accelerant effect of such contraceptives on breast cancer, and especially on oestrogen positive cancers in young women? It is the emperor's clothes and the problem is that the child (good reliable studies) who shouts "The emperor has no clothes" is being silenced by the very court of the emperor (Official medicine and its organs).
What has this to do with breast screening in 73 year olds you may ask? Instead of screening 73 year olds why not reverse the number and screen 37 year olds? The UK cancer website shows that 45% of breast cancer occurs in those 25 to 49 years old and they have their lives ahead of them and resources are scarce etc. Also why not select those who are taking oral contraceptives since they have an increased risk? A chest X-ray is not done on everyone to screen for lung cancer but mainly on those at increased risk i.e. those who smoke. The same should happen with breast cancer screening it should focus on the most at risk group i.e. those who are or were on hormonal contraceptives. The benefits of breast screening should be offered to those aged 20 to 49 and especially to those in this group who are taking contraceptives or who have taken them. This is simple honesty and reflects all other screening protocols.
1. Beaber EF et al.Recent oral contraceptive use by formulation and breast cancer risk among women 20 to 49 years of age. Cancer Res. Aug 1;2014: 4078-89.
2. Breen EG. The Screech Owls of Breast Cancer. Author House. 2013. Online.
Competing interests: No competing interests
After reading the article I think the "may be" in the title should be replaced by "is". We should beware of a trend for researchers not to conform to international research guidelines, either because they don't know them or because they wish to ignore them, presumably because it takes time and effort. The essense of these guidleines is "informed consent".
Competing interests: No competing interests
Margaret McCartney's concerns seem justified, and one has to wonder how the original ethics committee gave a favourable opinion. The protocol for the trial says nothing about statistical analysis, and very little about data capture and processing. It emerges that no statistician sat on the ethics committee. It surely is bizarre and unscientific to commit to an intervention, in the absence of any robust evidence for it, and to test it at the same time. The government seems to be trying to create policy-based evidence.
It is good practice to set up a trial steering committee, to provide oversight, but not to have this chaired by the chief investigator, as is the case here. The protocol for this, the largest clinical trial ever attempted, runs to a mere eight pages, and leaves many processes undefined.
There is more detail on the issues this trial raises at:
Competing interests: No competing interests
In 2011, I received an invitation to breast screening as part of the NHS BSP age extension for women aged 70-73 years, but the invitation did not explicitly state 'you are being invited to a randomised controlled trial' (RCT) as is usual in research. I had no idea that compliance would have meant randomisation in an RCT until Professor Sir Mike Richards referred to it in an article in the bmj (Breast Cancer Screening. An independent review is under way BMJ 2012;343:d6843) to which I wrote a rapid response. Since then, several of my friends who received similar invitations have been amazed when told about the RCT and they were also unaware of the breast screening ratio of harms to benefit. They, like me, were horrified that there was no consent process for an RCT of an intervention known to cause great harm.
The information which accompanied my invitation signposted a link to further information about the trial, but, at that time, it simply brought up the NHS Breast Screening Programme website home page. I was extremely concerned that this trial was going ahead despite the known harms of breast screening and even continued during and after the Independent Review (Marmot Report).
I wrote about my concerns in Quality in Primary Care (Breast cancer screening: an ethical dilemma, or an opportunity for openness? Q in PC 2013;21:39-42). I also raised questions and made requests under the Freedom of Information Act with the relevant ethics committees, the Director of the NHS Cancer Screening Programmes and my MP. There were significant delays in receiving some replies - all of which which were unsatisfactory – mostly they simply quoted from the NHS BSP website. The reply from the NHS Cancer Screening Programmes was simply: 'The investigators have been through standard procedures and have received ethical approval for this trial. You will have received the approved patient information leaflet when you were invited for screening as part of this exercise.'
I was pleased to see others have now investigated the issues and obtained and published the trial protocol along with the Healthwatch critique at:
Competing interests: Author, 'Breast Cancer Screening: an ethical dilemma, or an opportunity for openness?' Quality in Primary Care 2013;21:39-42