Abstract
Dear Madam,
Breast screening is not as good as originally hoped, or currently hyped. Presently, women aged 50–69 are invited for regular mammograms, unaware that this has little to no impact on death, and that it increases their risk of mastectomy.
1
The general public holds a more positive impression than is justified by the facts.
2
Although the NHS breast cancer screening programme provides a somewhat pink and “fluffy” 16-page booklet,
3
a simpler “fact box” (Figure 1) might suffice to explain the dilemma
4
and underpins the rationale for why the Swiss Medical Board is discontinuing.
2
‘Fact box’ breast cancer screening.
5
Reproduced with permission from Gerd Gigerenzer, Harding Center for Risk Literacy, https://www.harding-center.mpg.de/en.
Concerns have been raised about the science and ethics of the age extension trial. 5 Screening may do more harm than good, especially when the “rules” about its safe application are not followed. Thus, it is worrying that the UK government extended screening beyond the age range without good evidence. Women aged 47–50 and 70–73 are presently invited for mammography when the facts about risks and benefits are uncertain. 6 Additionally, this “roll-out” has been converted into a randomised controlled trial (i.e. a human experiment), in a design which dispenses with individual consent. Although it might be commendable (in theory at least) to measure the impact of speculative government policy, the actual study is less than robust. Women are enrolled using inappropriate and muddled information, possibly under false pretences. The trial investigators rely heavily on the “implied consent” given by attendance for mammography. The Editor has been supplied with an example of the paperwork a typical 48 year old receives. 7
These invitation letters and leaflets raise the question of whether any woman in receipt could possibly give legally valid consent:
A personal invitation with an appointment time would understandably give the idea that what she is being offered by the NHS is something important and beneficial (particularly if non-attendance is followed by reminders and “disclaimer” forms). A sheet that states “Remember … breast screening saves lives” in very large font may relate to improving uptake in her local centre. It would understandably give the impression that screening is beneficial, maybe even frightening her into attending. However, the unqualified statement is simply untrue: there is no impact of screening on overall mortality, only on mortality from breast cancer. There is even further uncertainty in the extended age ranges – confirmed by the independent Marmot review which supported the age extension trial in principle.
6
The review did not comment on the specifics of the trial design; a cluster randomised trial with “implied” consent rather than individual signed informed consent as would be usual in medical research. The leaflet that applies to 50–69 year olds
2
does not apply to her age range and does not spell out all the absolute risks; specifically, women in the screening arm of the trial cannot be aware of the increased chance of mastectomy. The “age extension” leaflet gives no hint that there is uncertainty about benefit. It contains no data from the pilot study – specifically the doubling of “recalls” and false positives. She is not told, so cannot be aware, that the benefit: risk data are different and unknown outside the 50–69 age range. It is not clear that this is research, as it is described as an evaluation, nor that personal information is being collected by researchers. The controls can have no idea either. The statement about research ethics committee (REC) approval in tiny font at the bottom is out of date as it precedes the Marmot report.
6
The trialists have made much of the fact that they have only received one complaint. But this is hardly surprising: the Ealing and West London REC was dissolved years ago; there is no indication of how to contact the Harrow REC that has ongoing responsibility for ethical conduct; women cannot realise they are being misled without interpreting the “mixed messages” and the small print.
As the Marmot report concluded “clear communication of these harms and benefits to women is of utmost importance and goes to the heart of how a modern health system should function”. 6 Based on the documentation received, women invited into the age extension trial simply cannot understand what is going on. There is no assurance they realise they are in a trial and give their consent to participate. They are given inadequate information about their personal risks of screening, thus they cannot give fully informed consent to the mammography either. Surely, “implied consent” based on false information is not valid?
Women, their doctors and the NHS Breast Screening Programme would benefit from more external legal input and scrutiny – not just about the quality of individual information-giving, but also regarding the structures and governance that led to such an “out of control” trial taking place at all.