Breast screening is beneficial, panel concludes, but women need to know about harmsBMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e7330 (Published 30 October 2012) Cite this as: BMJ 2012;345:e7330
All rapid responses
Doctor Massaro is wrong about the priorities.
The need to better distinguish between progressive and nonprogressive breast cancers diagnosed at screening is a red herring, since screening has been shown not to work. No evidence exists that anyone lives longer as a result of breast screening.
Since nobody has been shown to benefit from screening, distinguishing between progressive and nonprogressive cancers detected at screening won’t produce better results: nonprogressive cancers don’t need treatment, and progressive cancers detected at screening don’t do better than they would have if found later. Improved treatments that have been shown to reduce breast cancer mortality as much or more in non-screened groups.
The most urgent issue to be addressed with regard to breast screening by mammography is to correct the misconceptions of an indoctrinated population of eligible women who believe, wrongly, that they have a hope of benefit and that if there are harms, they are slight, and the risk of sustaining them small. No-one can be assured of any benefit; the harms are grave and affect many. Screen-diagnosed women leave treatment believing what those treating them know to be false. Every day that passes without addressing this produces more preventable grievous harm.
Other technologies for screening must be tested properly to assess whether they could usefully and ethically be used for a screening programme. Mammography screening was never adequately tested before its introduction. One would hope that interested parties would learn from the past before introducing further technologies without robust evidence that they achieve the only aim of screening: prolonged life with quality at a cost in harms that the informed eligible public are willing to incur.
Dr Massaro does not appear to understand that the major problem with breast cancer screening is not with inadequacies of the imaging technology. It is lack of understanding of the natural history of the disease. No imaging technique however excellent is of any use whatsoever if we do not understand the significance of the lesions it detects.
There is no point in screening people to place them in a position of finding abnormal cells whose future course is not predictable on current knowledge. Screeners are doing that without even telling people that while it was hoped some may benefit, they couldn’t know which, so all are gambling for the few prizes but nobody knows who wins – every screen-diagnosed woman thinks she has won and few can be right. I am not sure if anything could be worse, but since we know that treating those abnormalities at this point cannot be shown to benefit any of those people, then we actually know that all screened women are losers.
This is an appalling position which most women are not even told they are in. Discussing better methods is emphatically not a priority. Getting screeners to acknowledge their limitations, first to themselves, is.
Competing interests: Diagnosed through screening
The conclusions of the recent independent review on the harms and benefits of breast cancer screening programmes have reopened a decades-long debate, with concerns focusing on the considerable percentage of over-diagnosis occurring in screened women. (1)
However, this renewal of conflicting reactions may obfuscate one of the most significant remarks of Marmot and colleagues’ report: we need improvements “to better distinguish between breast cancers that will or will not cause harm during a woman’s lifetime.” (2)
Therefore, I call the medical and policy-making community to focus discussions on furthering emerging innovative technologies to detect this neoplastic process, instead of just resuming debate about past screening programme results. Aspiring to direct the debate forward, I provide examples of two incipient technologies, microwaves and coded-aperture X-ray phase contrast imaging.
The majority of breast cancers are detected through imaging tools, with mammography, ultrasound and magnetic resonance imaging (MRI) the most common. Nonetheless, these studies are not definitive, present several limitations and deficits in the specificity, often leading to unnecessary invasive probing. (3) Moreover, in the early stages of the disease, subtle visual clues or overlapping patterns in the diagnostic images make it challenging for radiologists to definitively distinguish benign from malignant masses, affecting clinical management. (4)
Amid these concerns, research to improve accuracy and diminish limitations associated with current imaging techniques demonstrates great promise in the basic science arena. In this regard, in early 2012, I visited Queen Mary University and UCL’s technological incubators, whose scientists are actively engaged in researching innovative breast cancer imaging applications, by using microwave and X-ray phase contract imaging, respectively.
Microwaves, non-ionizing and with relatively long wavelength, are able to deeply penetrate into optically opaque bodies including living tissue. Microwaves may have unique diagnostic properties; by recording the reflected waves scattered from cancers inside a body, an accurate 3D image of these regions can be reconstructed. (5) Microwave-frequency dielectric contrast between malignant and normal tissue may serve to detect abnormal masses and differentiate between benign and malignant breast tissue. (6) However, the breast tissue’s electrical properties, layers of fat, and high water content, acting as the body’s shields against microwave radiations, have traditionally constituted the main barriers to development of this technology. (7)
MediWiSe, an organization affiliated with Queen Mary University BioEnterprises, is intensively investigating obstacles and clinical application of this technology. According to Dr. George Palikaras, MediWiSe’s CEO, “the short microwave’s penetration depth, the possibility to compress the soft tissue—hence to reduce the wave’s propagation path—, the use of non-harmful radiation, and the ability to detect an optimal 3-mm lump size are promising features for a new, preliminary, inexpensive, diagnostic option for breast cancer mass-screening.”
While this technology targets screening of a young, low-risk population, another innovation, coded-aperture X-ray phase contrast imaging (XPCi), may offer reliable diagnostic support for those women at high risk of breast cancer. Dr. Alessandro Olivo, the inventor of the XPCi method at UCL, describes this innovative approach as “a fascinating method, which can potentially transform all applications of X-ray imaging. It utilizes refraction and interference—instead of conventional attenuation—to generate image contrast.” This technique allows enhanced visibility of small details in living tissues (8) and enables detection of breast tissue pathological features hardly visible with conventional devices. As Olivo says, “Due to the demanding requirements XPCi imposes on the radiation source, the main barrier was that this imaging modality was delimited to just synchrotron facilities, where it has been proven to successfully detect breast neoplastic formations.”
Olivo’s method works with a conventional X-ray source like those used in hospitals; it thus overcomes this “environmental” limitation and could make clinical implementation of XPCi achievable for the first time. (9) If successful in emulating encouraging clinical trial results achieved with synchrotron light sources (10), this technology may provide an incredible opportunity to advance diagnostics for breast cancer. XPCi could therefore change the way in which breast cancer is typically diagnosed, rendering conventional mammography obsolete, yet possibly without incurring the high false positive numbers of MRI.
Breast cancer is one of the most common cancers among women worldwide, with approximately 1.3 million new cases diagnosed and 450,000 deaths annually. (11) Imaging studies, already important in detection, diagnosis, and clinical management of breast cancer, will become increasingly relevant as new therapies are developed to treat both localised and widely metastatic disease.
We must then accurately convey and debate the harms and benefits of current imaging screening programmes. We must also promote further future approaches. While health care policy must be based on facts, it must also be supported with innovative technologies. If not, policy setting and implementation is in jeopardy of becoming a process subject only to critical evaluation and evidence gathering, giving insufficient consideration to technological advancements.
The significant limitations of breast cancer traditional imaging methods underscore the importance of pursuing discussion on the utility of promising breakthrough technologies, including microwave and XPCi, from their early developmental stages. Such innovations may create room to rethink the best age for and frequency of screening, establish new screening programs, reduce over-diagnosis, over-treatment (and costs) of breast cancer, and ultimately have a profound effect on both social understanding and medical practice.
It will take significant time, scientific and economic investments to determine the ultimate role for new technologies in the screening and detection of suspicious breast masses. Most importantly, it will require the full support of clinical practitioners, policy-makers and the greater community. Embracing development of novel breast cancer imaging tools going forward must become the core of a new debate: only collaborative progressive research, innovative thinking, and policy implementation well serve to roll back the mortality from this devastating illness.
1. Hawkes N. Breast screening is beneficial, panel concludes, but women need to know about harms. BMJ 2012; 345: e7330.
2. Independent UK Panel on Breast Cancer Screening (Marmot M, Altman DG, Cameron DA, et al.) The benefits and harms of breast cancer screening: an independent review. Lancet 2012; 380:1778-1786.
3. Warner E. Breast-cancer screening. N Engl J Med 2011; 365: 1025–32.
4. Feig SA, Orel SG, Dershaw DD. The breast. In: Grainger RG, Allison D, Adam A, Dixon AK (Eds.), Grainger & Allison's Diagnostic Radiology: A Textbook of Medical Imaging, 4th Ed. Orlando (FL): Churchill Livingstone; 2001, p. 2268–72.
5. Nikolova N. Microwave Imaging for Breast Cancer. IEEE Microw Mag 2011; 12: 78–94.
6. Mashal A, Sitharaman B, Li X, et al. Toward carbon-nanotube-based theranostic agents for microwave detection and treatment of breast cancer: enhanced dielectric and heating response of tissue-mimicking materials. IEEE Trans Biomed Eng 2010; 57 (8): 1831–34.
7. Vorst V, Rosen A, Kotsuka Y. RF/Microwave interaction with biological tissues. Hoboken, NJ: Wiley; 2006.
8. Olivo A, Ignatyev K, Munro PRT, Speller RD. Noninterferometric phase-contrast images obtained with incoherent x-ray sources. Appl Opt 2011; 50: 1765–69.
9. Olivo A. Recent patents in X-Ray phase contrast imaging. Rec Pat Biomed Eng 2010; 3: 95–106.
10. Castelli E, Tonutti M, Arfelli F, et al. Mammography with synchrotron radiation: first clinical experience with phase-detection technique. Radiol 2011; 259: 684–94.
11. Ferlay J, Shin HR, Bray F, et al. GLOBOCAN 2008 v2.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10. Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr, accessed on November 20, 2012.
Competing interests: None declared
Acknowledgments: I gratefully thank Dr George Palikaras and Dr Themos Kallos at MediWise; Dr Alessandro Olivo at UCL; Prof Kilm McPherson at the University of Oxford.
Competing interests: No competing interests
Reply to: Breast screening is beneficial, panel concludes, but women need to know about harms. BMJ2012;345:e7330. Published 30 October 2012
I was interested to read Nigel Hawkes report of the expert panel chaired by Michael Marmot looking at screening for breast carcinoma and the conclusion that “UK women invited to attend screening for breast cancer are three times as likely to be treated for a cancer that would never have harmed them as they are to have their lives saved.” They also conclude that ”clear communication to women of the harms and benefits is essential.”
In the past week I have learned of three new dementia “screening” initiatives all of which report benefits but make no mentions of harm:
1. Reported on the front page of the Daily Mail: ‘Patients at risk will be able to do a series of tests on an iPad in the comfort of their local GP’s office. In only ten minutes the software can determine the difference between people with normal and abnormal memory.’ One such test being widely promoted is the CANTABmobile. It is highly sensitive in the diagnosis of mild cognitive impairment(1).
2. The Dementia Services Development Centre have invited healthcare and non-healthcare professionals to a one-day course, provided across the UK, to provide ‘evidence based’ instruction ‘for diagnosing dementia early.’ This is based on a distributed model of assessment.
3. In our local hospital it is now mandatory that anyone admitted over the age of 65 years undergo cognitive screening.
This may all sound like progress. However let us return to the lessons that we should learn from breast screening. Margaret McCartney asks: “If it looks like breast cancer screening is picking up more cancers, this is likely to include a lot of DCIS. But while DCIS is frequently diagnosed at screening, as we have seen, its progress is less certain. It does not always kill or even maim (2).” To paraphrase, if it looks like cognitive screening is picking up more dementia, this is likely to include a lot of mild cognitive impairment. But while mild cognitive impairment is frequently diagnosed at screening, as we have seen, its progress is less certain. It does not always harm or even progress.
The World Health Organisation, offer ten criteria for screening (3) (here they include selective screening) and it is quite clear to me that at least two of these criteria are not met for screening of early dementia: Firstly we have “The natural history of the condition, including development from latent to declared disease should be adequately understood.” Mild cognitive impairment and early dementia overlap and both the patho-physiology and natural histories are ill-understood and beyond simplification. As Allen Frances has stated, the risk of false-positive diagnoses of dementia becomes extremely high the earlier one tries to detect memory loss (4). Most people had not heard of DCIS before this debate reached the wider press; I am sure that most people have not heard of mild cognitive impairment. The parallels are obvious.
Secondly the WHO ask that,” the test should be acceptable to the population.” Older adults deserve the same clear communication regarding the harms and benefits of cognitive screening as women choosing whether to undergo breast screening: so far there is virtually no discussion of informed consent in this context.
“ that morning we discovered just how preliminary we were. Which was some kind of progress, like they say realising one’s ignorance is the beginning of wisdom (5).”
(1) Blackwell, A. The use of CANTAB PAL in Alzheimer’s Disease, Chief Scientific Officer, Cambridge Cognition, 12 July 2011
(2) McCartney, M. The Patient Paradox 2012. Pinter & martin Ltd. p63
(3) Wilson J. M. G, & Junger, G Principles and Practice of Screening for Disease. World Health Organization 1968
(4) Frances, A. Psychology Today. Published 16 February, 2012
(5) Greig, A. In Another Light. Phoenix. 2004. Page 87
Competing interests: No competing interests
Ms Ramirez states the review findings and says her task is to enable women to understand “the balance of benefits and harms and any uncertainty” and make an informed choice. However, Marmot does not claim to show there is benefit to breast screening; it shows that, according to their methods, old RCTs showed some reduction in breast cancer mortality. They do not claim this shows that anyone today can expect to live longer as a result of finding a cancer through screening. Evidence does not support that. Their shocking estimate of overdiagnosis is probably too low for today, and they are cavalier in downplaying the seriousness of cancer treatment as though having it for nothing is a light matter. There is a marked imbalance between grave harms and no benefit, so there is no real “choice”.
Mike Richards and the NHS are passing Marmot off as definitive and a mandate to continue screening and Ms Ramirez takes her lead from them. The proposed Citizen’s Jury, to which I have been invited to witness, is organized wrongly on many levels, compromising everyone involved, and cannot affect the information women will be given. Its real purpose, as far as I can tell, is to make a pretence of public involvement while screeners continue to distort the facts to protect the programme at no matter what cost in human suffering.
I have been told that the Jury will not decide content but only presentation. Ms Ramirez says they will make “recommendations about how best to communicate the benefits and harms of breast screening.” This is vague, I cannot see how a Citizen’s Jury could be used for this purpose, nor do I see how an account of “my experience” of screening could contribute to it – they presuppose that some women have “a good experience” of screening and others “a bad experience” and that changes in “presentation” can prevent future “bad experiences”. But whatever their “experience”, everyone is in the same position – misled into treatment that has left none of us better off; at best we may have been treated early with no improvement in prospects while about a third of us have been treated unnecessarily; some of us will yet die earlier from our treatments – but these are not breast cancer deaths, so of no interest. Most screen-diagnosed women don’t know this. Ms Ramirez seems at a loss as to how to “present” the truth. The difficulty is not presentation or complexity: it is bringing themselves to tell it like it is. It is easy enough, by saying it in words, such as the words I have just used to say it – they are neither big nor many.
The NHSBSP news webpage proclaims that “screening confers significant benefit and should continue” and omits to mention massive overdiagnosis. Ms Ramirez is either for them or against them and if she is for them she will misrepresent the truth as they do, and if she is against them, they will override her recommendations, as they have ignored evidence they don’t like from the start.
So much for the nonexistent benefit and the massive harm, now for the uncertainty: Ms Ramirez must make clear that DCIS is a red herring as the line between noninvasive and invasive cancer does not coincide with the line between nonprogressive and progressive cancer. Hence a screening diagnosis does not mean a woman ‘has cancer’ but only that she has cancerous changes of uncertain significance. No screen-diagnosed woman can know whether the permanently damaging interventions from surgery to adjuvant drug therapy are to save her from imminent death or prevent cancer developing in the future or are doing gratuitous harm. Placing a person in this position without prior counselling and risk assessment is inexcusable but it has been done to upwards of 200,000 women since the programme began and looks set to continue. Risk assessment is not possible, because that requires knowledge of the course of the disease, and that is not known, as screeners repeat, “We don’t know which cancers will progress so we treat them all.” Yet having this knowledge is a criterion for setting up a programme precisely in order to avoid putting people in this appalling dilemma. 24 years on the criteria for starting breast screening are still not met. Mike Richards has intimated that the review findings not only legitimize screening but now sanction research to investigate the course of the disease – i.e. using screening to enlist candidates for trials, which is not the purpose of screening, to find out what they should already know in order to invite people to screening. But in view of the Nordic Cochrane and other findings, it cannot be claimed that anybody benefits from screening, so such research can only harm its subjects.
This is outrageous, and everybody knows it but unsuspecting women. How much pointless harm would be too much for these people? A doctor in Solihull has been suspended for misinforming women and doing inappropriate breast cancer treatments. What does it take to remove from their positions these unprofessionals who have already placed 200,000 women in a similar position?
Competing interests: Diagnosed through screening
Carte blanche to exclude women with intellectual disabilities?
The coverage of over-diagnosis of breast cancer in women (BMJ2012;345:e7330) is not valid for all women as the reverse is seen for women with intellectual disabilities (ID). Here concern has centred on low up-take of breast cancer screening, which by default reduces the number of neoplasms detected and potentially masks the incidence of breast cancer.1, 2 With the exception of work by Patja et al. (2001), a review on the incidence of breast cancer in women with ID reported lower levels compared to the general population, with more robust evidence reported for women with Down’s syndrome [DS].3 The concern raised here is that, with the suggestion of over diagnosis, low incidence should not be used to dismiss the necessity for women with ID to be screened.
There may be more reasons for not screening women with DS due to their vulnerability to ionising radiation, particularly X-rays, and the protective factors of DS against breast cancer.4,5 Again, a special case may be made against screening women with severe or profound ID due to the problems of obtaining informed consent.6 However, screening should not be dismissed for all women with ID. Breast cancer seems more frequent in women with Cowden’s disease, cerebral palsy and type 1 neurofibro-matosis (NF1).7,8,9 Moreover, the extent of the inherited component of breast cancer remains unknown in women with ID, and they also display a greater propensity for obesity, nulliparity, poor diet and exercise, all of which increase risk of the disease. 10,11,12 These factors surely outweigh the protective factors of early menopause and low oestrogen levels. 13,14,15 As previously suggested by Satgé and Sasco (202) it may be that the debate needs to be reopened about alternatives to screening for women with DS and perhaps include those women with severe and profound ID but a blanket dismissal for all women with ID would be untenable.
With the need for more balanced information in relation to breast screening, discussions about the procedure become additionally complicated for women with ID, since some find abstract concepts and uncertain outcomes difficult to understand. This is aside from the problems they experience in processing and understanding information. It is hoped that women with ID will be given the option to attend breast screening, including women with DS and those women with severe and profound ID where alternatives to the current provision may need to be sought. It is essential that any woman’s decision is based on a fully informed discussion, rather than an emphasis by carers and health professionals simply on ‘getting screened’ as this can lead to women attending screening without really fully understanding the procedure.12
1Patja K, Eero P, Livanainen M. Cancer incidence among people with intellectual disability. J Intellect Disabil Res 2001;45:300-7.
2Sullivan SG, Glasson EJ, Hussain R, Petterson BA, Slack-Smith LM, Montgomery PD, Bittles AH. Breast cancer and the uptake of mammography screening services by women with intellectual disabilities. Prev Med 2003;37:507-12
3Willis, D.S., Satgé, D. AND Sullivan, S FULL REFERENCE????
4Satgé D, Sasco AJ. Breast screening guidelines should be adapted in Down's
syndrome. BMJ 2002;324:1155.
5 Hasle H, Clemmensen IH, Mikkelsen M. Risks of leukaemia and solid tumours in
individuals with Down's syndrome. Lancet 2000;355:165-9.
6 Willis, D.S. Unpublished PhD.
7 Brownstein MH, Wolf M, Bikowski JB. Cowden's disease: a cutaneous marker of breast cancer. Cancer 1978;41:2393-8.
8 Strauss D, Cable W, Shavelle R. Causes of excess mortality in cerebral palsy. Dev Med Child Neurol 1999;41:580-5.
9 Sharif S, Moran A, Huson SM, Iddenden R, Shenton A, Howard E, Evans DG. Women with neurofibromatosis 1 are at a moderately increased risk of developing breast cancer and should be considered for early screening. J Med Genet 2007;44:481-4
10 Robertson, J., Emerson, E., Gregory, N, Hatton, C., Turner, S, Kessissoglou, S, Hallam, A. Lifestyle related risk factors for poor health in residential settings for people with intellectual disabilities. Res Dev Disabil, 21(6) 2000, Pages 469–486
11 Rimmer, JH.; Braddock, D. And Fujiura, G. Prevalence of obesity in adults with mental retardation: Implications for health promotion and disease prevention.
Ment Retard, 31(2), Apr 1993, 105-110.
12Davies N, Duff M. Breast cancer screening for older women with intellectual disability living in community group homes. J Intellect Disabil Res 2001;45:253-7.
13Schupf N, Zigman W, Kapell D, Lee JH, Kline J, Levin B. Early menopause in women with Down's syndrome. J Intellect Disabil Res 1997;41:264-7
14Cosgrove MP, Tyrrell M, McCarron M, Gill M, Lawlor BA. Age at on set ofdementia and age of menopause in women with Down’s syndrome. J Intellect Disabil Res 1999;43:461-5.
15Seltzer GB, Schupf N, Wu HS. A prospective study of menopause in women with Down’s syndrome. J Intellect Disabil Res 2001;45,1-7.
Competing interests: No competing interests
I have had it pointed out to me that the closing paragraph of Professor Amanda Ramirez` and Dr. Lindasy Forbes` rapid response to Nigel Hawkes news item  states: “This approach has had the full support of the NEW [my emphasis] cancer screening information advisory committee, chaired by Professor Sir Mike Richards. The committee will have final oversight of the new invitation for breast screening and accompanying information leaflet which is being developed with the principle of promoting informed choice at its core.”
I am wondering whether this means that this “new cancer screening advisory committee” supersedes and replaces the Advisory Group (of which I am a member) to Informed Choice about Cancer Screening (ICCS) at King`s Health Partners (KHP), www.kingshealthpartners.org/info/informed-choice-about, which was appointed early in 2012 to oversee and govern “A new approach to developing information about NHS Cancer Screening Programmes”? It may be that it is in addition to the one of which I am a member. I have certainly not been told that the Advisory Group to which I belong has been disbanded, but I was unable to find on any website news about this “new advisory committee”.
I`m sure I`m not alone in wanting to know more about this “new” committee, being chaired by Professor Sir Mike Richards.
 Hawkes, N. Breast screening is beneficial, panel concludes, but women need to know about harms. BMJ 2012;345:e7330
Competing interests: No competing interests
I share Hazel Thornton’s deep unease about the Citizen’s Jury. It is not dispelled by Professor Ramirez’s response.
As a citizen, this is how it appears to me:
1. I don’t think the issues of overdiagnosis and ductal carcinoma are complex. It is simply that some lesions identified by mammogram will never harm a woman in her lifetime if untreated. It is currently not possible to say with certainty which ones will progress and which will not. There is controversy among experts about the statistics.
2. The Marmot Report does not mention the extent of differing opinions among histopathologists when women are recalled for biopsies. It does not say whether the National Breast Screening Programme (NHSBSP) ensures that national breast histopathology standards are fully deployed across the country to minimise the risk of histopathology misdiagnoses or “discrepancies” as some experts prefer to call them. The NHSBSP does not publish any statistics on the number of women harmed by histopathology “discrepancies”. We are told that the women taking part in the Citizen’s Jury will receive a full and balanced view of the pros and cons of screening. Will they therefore be told the facts about histopathology uncertainties? Well not if the Marmot Review ignored them.
3. Professor Ramirez says that the balance of benefits and harms and any uncertainty needs to be expressed clearly. Who decides on the “balance”?
4. Twenty women have been recruited to form the Jury and we are told they will be representative of women eligible for breast screening. What are the criteria for being deemed a representative woman?
5. Experts in risk communication will advise how to express benefits and harms. Different citizens have different attitudes to risk. Some are more risk averse than others. Why are risk experts being brought in to apparently achieve a “one size fits all” approach to risk? This is not appropriate for citizens making decisions about their individual healthcare.
6. Women who have been diagnosed with breast cancer through the screening programme will provide evidence of experiences. Who decides what is a “positive” or “negative” experience?
7. The Citizen’s Jury is claimed to be a transparent process, with members of the medical press and charities in attendance. But no ordinary citizens, just the twenty women selected through an undisclosed process to form the Jury and the women selected for their “positive” and “negative” experiences through an undisclosed process.
This Citizen’s Jury? No thanks.
Competing interests: No competing interests
The Independent Breast Screening Review concluded that while breast cancer screening extends some women’s lives, it does so at a cost. The Review estimated that while screening prevents about 1300 breast cancer deaths per year in the UK, it leads to about 4,000 women each year aged 50-70 having treatment for a condition that would never have troubled them . There was a strong recommendation from the Review that women should be given information “that is clear and accessible before they go for a mammogram so they can understand both the potential harms and benefits of the process.”
We are leading the team responsible for developing that information, which will be sent to women invited for breast screening. The information will need to convey the complex issues of overdiagnosis and ductal carcinoma in situ in a way that supports women to make a choice. We will also need to represent quantitative estimates of benefit and harm in an accessible way. The balance of benefits and harms and any uncertainty need to be expressed clearly to support women’s decision-making.
Given these challenges, we want to make sure that the views of those who will be receiving the new leaflet and making a choice about whether to attend for screening are heard and listened to. We have therefore decided to hold a Citizens’ Jury – an engagement approach which we know can be particularly well-suited to deliberating on issues to gain insight into citizens’ perspectives where there are strong and competing views about complex issues.
The twenty women who have been recruited to form the Jury will be representative of the women eligible for breast screening. The event has been designed to ensure that the women taking part receive a full and balanced view of the pros and cons of screening. Witnesses, including a member of the expert panel for the Independent Review of Breast Cancer Screening, alongside experts in risk communication, will give evidence on the benefits and harms of screening as well as how we should express those benefits and harms. We have also invited women diagnosed with breast cancer through the screening programme to provide evidence about their experiences: some will have had positive experiences and others will have had negative experiences. Over the course of three days, the jurors will be able to probe, challenge and discuss ideas with the experts and patient witnesses, as well as among themselves, before making their recommendations about how best to communicate the benefits and harms of breast screening.
We are making the Jury a transparent process, and will invite members of the medical press and charities to attend. However, what will be most important will be that the women taking part feel fully able to ask questions, give their opinions and engage in the debate.
It was therefore disappointing to read Hazel Thornton’s views on the process, particularly as she had been invited to give evidence to the Jury.
This approach has had the full support of the new cancer screening information advisory committee, chaired by Professor Sir Mike Richards. The committee will have final oversight of the new invitation for breast screening and accompanying information leaflet which is being developed with the principle of promoting informed choice at its core.
 Independent UK Panel on Breast Cancer Screening, The benefits and harms of breast cancer screening: an independent review, October 2012
Competing interests: No competing interests
The panel set up to look into breast cancer screening has thrown a few crumbs of comfort to the dissidents. Yes, they finally acknowledge that over-diagnosis is a serious problem. But they had little choice in the matter – the evidence forced their conversion. Yes, they do agree that participants in screening require better information and this, we are told, will soon available in a revised booklet, though its contents are yet to surface. But, as for the crucial question of whether screening saves lives, they confine themselves to chanting the mantra that it reduces deaths from breast cancer. 
The discrepancy between the panel’s estimate of the reduction due to screening in the number of women dying from breast cancer and that of other experts in the field – most notably Peter Gotzsche  – is troubling. The effect of screening on disease-specific mortality remains uncertain.
But, in any case, saving lives from breast cancer is not the same as improving overall survival. This is particularly so when there are serious adverse effects from screening, including over-diagnosis. The undeniable point is that screening is harmful. So how are we to know whether breast cancer screening actually improves survival? The answer, of course, is to look at all-cause mortality.  But when we do so, we find that screening has no effect on overall mortality.  The advocates of screening argue that the reduction in deaths from breast cancer is hidden amongst all of the other causes of death. Yet the same argument may be made about a possible increase in deaths from the adverse effects of screening which would also be undetectable for the same reason.
There is no evidence that breast cancer screening improves a woman’s chances of survival. The same applies to bowel cancer screening.  And yet the general view appears to be that both of these screening programmes are beneficial. This is the consequence of very successful campaigns of propaganda and the belief that large-scale randomised controlled trials and epidemiological studies deliver something of genuine value.
After more than three decades of research involving many hundreds of thousands of women, we are still none the wiser about the overall benefits of breast cancer screening. There can be few better examples of the futility of statistics-based research. 
1. Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet 2012, doi:10.1016/S0140-6736(12/61611-0.
2. Gotzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database of Systematic Reviews 2011, doi:10:1002/14651858.CD001977.
3. Penston J. Head to head: Should we use total mortality rather than cancer specific mortality to judge cancer screening programmes? BMJ 2011;343;d6395.
4. Penston J. Stats.con – How we’ve been fooled by statistics-based research in medicine. The London Press, November 2010.
Competing interests: No competing interests
Letter to BMJ
The Screening debate
In 1989 my group published a paper in the BMJ describing the long term follow up of the CRC1 trial in the management of early breast cancer  In this trial patients were simply randomised to mastectomy with or without radiotherapy. There are three things worthy of note that are relevant to the current debate on screening for breast cancer. This cohort of 2,800 women was recruited contemporaneously with those in the randomised trials of screening by mammography. Next thing to note is that the 10-year survival was about 55%. Finally in the period 8-16 years of follow up the curves for deaths other than breast cancer begin to separate favouring those women who avoided radiotherapy. Most of this excess in mortality was related to deaths from myocardial infarction.
In 2008, nearly 20 years later, I was a co-author of a paper in the Lancet reporting an up date of the ATAC trial  that compared adjuvant tamoxifen with adjuvant anastrozole for postmenopausal women with early breast cancer. The 9-year survival in that cohort was 80%.
In 2010 the TARGIT collaborative group published a paper on intra-operative radiotherapy versus external beam radiotherapy for good prognosis cancers, two thirds of who were screen detected.  Recruitment for this cohort started in 2000 and their recurrence free survival at a median follow up of just under three years was 98.5%.
There are two important messages to take away from all this.
First with adjuvant systemic therapy the window for improvement in outcome has shrunk from 55% to 20%. If the relative risk reduction for screening remains constant at 20% according to the Marmot report  then the absolute benefits will have to be revised down by say 36% (20/55)
Secondly as a result of over-diagnosis, lead time bias and length bias, women with screen detected disease will have a very low risk of dying from breast cancer therefore their risk of dying from the late effects of radiotherapy now become all important. Women treated by radiotherapy after breast conserving surgery frequently receive 45Gy to the whole breast plus a 15Gy boost to the tumour bed. The EBCTCG overview of trials involving radiation estimated a relative risk of 1.27 for deaths from myocardial infarction and 1.78 for deaths from lung cancer in the irradiated group  I have estimated that this might lead to an extra 135 deaths amongst the 4,000 women over-diagnosed with breast cancer of a 20-30 year period of follow up. [See footnote] Yet we are constantly being reassured that modern techniques avoid that danger. (viz: a study of 50 long-term survivors described at ASTRO in October 2012:
https://www.astro.org/News-and-Media/News-Releases/2012/25-years-after-b... ) This is not the case.
The left anterior descending coronary artery is in the field of treatment and remains at risk in spite of recent advances.  This can have devastating consequences amongst breast cancer survivors as summarised in a recent publication in the JCO  and I quote their conclusions.
“Patients with breast cancer have significant and marked impairment in cardiopulmonary function over the entire continuum of disease. As a result, approximately one third of patients with breast cancer have a VO2peak less than the functional independence threshold and reach a predicted age-related
VO2peak, on average, 20 to 30 years earlier than healthy women without a history of breast cancer.”
For these reasons any estimates of benefits and harms based on the trials reported 20 years ago, described in the Marmot report are totally irrelevant to the modern practice of medicine and without knowledge of all cause mortality one can only say caveat emptor.
1.Haybittle JL, Brinkley D, Houghton J, A'Hern RP, Baum M. Postoperative radiotherapy and late mortality: evidence from the Cancer Research Campaign trial for early breast cancer. Br Med J 1989; 298:1611-1614
2. Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialist’s Group. Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial.
Lancet Oncol. 2008 Jan;9(1):45-53.
3. Vaidya JS, Joseph DJ, Tobias JS, et al. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet 2010;376(9735):91-102.
4. Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet 30 Oct 2012, doi:10.1016/S0140-6736(12)61611-0.
5. Effects of radiotherapy and of differences in the extent of
surgery for early breast cancer on local recurrence and
15-year survival: an overview of the randomised trials
Early Breast Cancer Trialists’ Collaborative Group (EBCTCG)
Lancet 2005; 366:2087-2106
6. Lind PA, Paganelli R, Marks LB, Borges-Neto S, et al
Myocardial pefusion changes in patients irradiated for left-sided breast cancer and correlation with coronary artery distribution.
Int. J. Radiation Oncology Biol. Phys 2003, 55; 914-920
7. Jones LW, Hornsby WE, Coan AD, Herndon JE II, Douglas PS, Muss HB, Courneya KS, Mackey JR, Pituskin EN, Haykowsky M, Scott JM.
Cardiopulmonary Function and Age-Related Decline Across the Breast
Cancer Survivorship Continuum.
Published Ahead of Print on May 21, 2012 as http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2011.39.9014
Cumulative (intercurrent adjusted) mortality due to MI in UK women aged 50-79 (the 30-year period under consideration, 100 WOMEN AGED 50 FOLLOWED FOR NEXT 30 YEARS) is 6.15%. If 80% of over-diagnosed women are given RT, which increases this mortality by 27%, i.e. 21.6% increase in all over-diagnosed women.
This translates in 1.33% absolute increase in MI mortality in over diagnosed women, that is 1.71 lives lost in 129 over diagnosed women per 10000 invited to screening or 53 lives lost every year in 4000 over diagnosed.
Cumulative (intercurrent adjusted) mortality due to LUNG CANCER in UK women aged 50-79 (the 30-year period under consideration, 100 WOMEN AGED 50 FOLLOWED FOR NEXT 30 YEARS) is 3.27%.
If 80% of over diagnosed women are given RT which increases this mortality by 78%, i.e. 62.4%increase in all overdiagnosed women, then this translates in 2.04% absolute increase in LUNG CANCER mortality in over diagnosed women, that is 2.63 lives lost in 129 over diagnosed women per 10000 invited to screening or 82 lives lost every year in 4000 over diagnoses.
Excess RT related deaths = 135 (MI and Lung cancer)
Competing interests: Long term advocate of informed choice on screening