Experts question IARC report saying benefits of mammography in older women outweigh risksBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h3156 (Published 09 June 2015) Cite this as: BMJ 2015;350:h3156
All rapid responses
I wonder if a less 'prestigious' body would get away with this? - There seems to be little public criticism that women can pick up on so it can just slip through the net. The use of weasel words to dupe the general public (men care about women's health too) in such an unethical way, condoned by bodies supposed to protect the public is disgraceful. David Oliver and P Hibbs in BMJ highlight the current buzz words relating to the need to be transparent. There is a Duty of Candour being adopted in clinical practice but if some sections of medicine are deliberately flouting that - their behaviour simply undermines the good work going on in other areas. It seems odd that groups such as Cancer charities or Women in Medicine have made no response. In recent months an invitation to provide a bowel sample, an invitation to get vaccinated against shingles and on Public Health Wales web site a suggestion that it may be 'convenient' to get a flu vaccine at the same time, have arrived out of the blue with no proper information about the first . . . no information at all about the second. They make a nonsense of informed consent. Many people have to make a decision which cynically exploits lack of knowledge.
Competing interests: No competing interests
Prof Bewley and co-author have raised (15 June, rapid responses) a matter of fundamental medical ethics.
Public Health England are stated to have declared that they do not have to aspire to reach the highest standards of informed consent.
If they can blithely dance on the prostrate uninformed women in this (mammography) exercise, they can just as happily trample informed consent in other public health matters.
Presumably, at least SOME of the higher officers in this body are registered medical practitioners, subject to the General Medical Council. Have they quietly acquiesced in this un-ethical "medical" investigation? Has the Chief Medical Officer any views?
Competing interests: A member of the public
More information, but still no assurance of informed consent for largest human experiment ever undertaken
The Health Research Authority and NHS Breast Screening Programme must be commended for finally taking steps to more properly inform women that they are being invited into the largest randomised controlled trial in history (the age extension trial, running since 2009), albeit with no fanfare. The trial has just been registered (01/05/2015) and the trial website will be “available soon” . The leaflet that women aged 47-50 and 70-73 will receive is available on the web  but practical problems remain. The research leaflet is sent alongside an encouraging invitation, a pre-determined appointment and the standard screening information booklet for 50-69 year olds, which will naturally be confusing.
The new leaflet does not explain equipoise clearly. Women who experience a false positive result will suffer anxiety, others may receive a diagnosis of cancer that would never have shown itself in their lifetime and that might lead to unnecessary mastectomy, chemotherapy and radiotherapy. The fact that the inevitable harms (and unknown possible benefits) would only occur for the purposes of research is not spelled out simply. Thus there is no informed consent. Calls to halt the trial have failed, as has an appeal to the HRA against continuing ethical approval [3, 4, 5, 6]. It appears that much of the responsibility falls on the sponsor, the University of Oxford. Public Health England have confirmed they do not have to aspire to the highest standards of communication and research, ie Good Clinical Practice . Following the 2012 independent Marmot report which distinguished good and bad science , and the increasing evidence that information aids improve informed decision making , we fail to understand NHS BSPs reluctance to tell women the truth, the whole truth and nothing but the truth about this flawed screening modality.
We believe women are put in harm’s way as they continue to be deceived about the nature of breast screening, especially whilst staff are not trained nor obliged to discuss and obtain formal, written consent for this unscientific and unethical randomised clinical trial.
1. ICTRCTN registry. Nationwide cluster-randomised trial of extending the NHS breast screening age range in England. http://www.isrctn.com/ISRCTN33292440 last accessed 13th June 2015
2. Public Health England. Age Extension Full Randomised Control Trial (no date of upload given) http://www.cancerscreening.nhs.uk/breastscreen/research-age-extension-fu... last accessed 13th June 2015
3. Blennerhasset 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’? Br Med J 2012 http://www.bmj.com/content/343/bmj.d6843?tab=responses last accessed 13th June 2015
4. Bewley S, Rose L, Gøtzsche P, Blennerhassett M, Colquhoun D, Pryke M, Tindall G, Braillon A, Richmond C, Illman J, May J. Time to halt an out of control trial with ineffective oversight. BMJ. 2014 Sep 16;349:g5601. doi: 10.1136/bmj.g5601.
5. Bewley S. Legal scrutiny of the age extension breast screening trial is required. Medico-Legal Journal. 2014;82(4):167-8
6. Healthwatch-UK. Concerns over age extension trial of mammography screening. Parts 1, 2, 3 and 4 http://www.healthwatch-uk.org/?s=screening last accessed 13th June 2015
7. 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; http://www.cancerresearchuk.org/prod_consump/groups/cr_common/@nre/@pol/documents/generalcontent/breast-screening-report.pdf last accessed 13th June 2015
8. Hersch J, Barratt A, Jesse Jansen J, Les Irwig L, Kevin McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffrey K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. Lancet 2015;385:1642-52 DOI: http://dx.doi.org/10.1016/S0140-6736(15)60123-4
Competing interests: SB, LR and MP are trustees of the charity HealthWatch-UK (“for science and integrity in medicine”). SB has declined mammographic screening and wrote an open letter in the BMJ that precipitated the announcement of the Independent Review.