Personal View

Harms from breast cancer screening outweigh benefits if death caused by treatment is included

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f385 (Published 23 January 2013)
Cite this as: BMJ 2013;346:f385

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Breast cancer screening has been rolled out in Ireland. The newer digital mammogram machine has replaced older screen film mammogram facilities.

The introduction of digital mammography screening has been accompanied by an increase in the incidence of breast cancer. The following is information from the National Cancer Register of Ireland. The initial Irish publication in the American Journal of Radiology involved a comparison between digital and screen film mammography. This demonstrated a statistically significant increase in the incidence of breast cancer when digital equipment was utilised. The increase in detection rate in first round screening was followed by a statistically significant increase in second and all subsequent screenings. These observations would indicate an increase in incidence in breast cancer with this new equipment.

Interval tumours are a feature of screening programmes. It is always very disconcerting to witness a breast mass following a clear breast screening. The National Cancer Register states; “The proportionate incidence of interval cancer was 27% in the first year after screening, rising to 48% in the second year. Table presents interval cancer detection rates from the Irish screening programme in comparison with those in neighbouring countries for which published estimates exist. In the first year after screening, the incidence of interval cancers in Ireland was highest (7.5/10,000 woman years) of the countries listed” It is noteworthy that Ireland was the first country to my knowledge to convert almost entirely to digital mammography.

There are numerous epidemiological analyses which demonstrate an increase in breast cancer diagnosis following screening. The published data in the National Cancer Register for Ireland also shows that the converse applies. The Eastern European countries which have not as yet introduced screening are those with the lowest incidence of breast cancer.

Digital mammography involves a reduced radiation exposure, but increase in compression. The increase in Stage 4 cancers following such compression might logically be anticipated. It would never make sound scientific sense to compress a soft tumour. Compression might thus reasonably be expected to cause an increase in metastatic disease. This anticipated outcome is realised with an increase of 5)% in incidence of metastatic disease over the ten year interval. Could this compression also account for the demonstrated increase in interval tumours which we have documented in Ireland? It is noteworthy in this regard that these interval tumours tend to be larger, more ill-defined and more aggressive than those detected on screening.

Failure to ameliorate the incidence of Stage 4 cancer with screening, and to watch it remain as a constant 7% of an exponentially increasing incidence, is perhaps the most disconcerting feature of the entire program. The hypothesis that early detection from screening improves life expectancy for women is now shown to be a complete fallacy. Any morbidity and mortality improvement in the Irish cohort must be attributed solely to improved therapies and protocols.

The effects of screening mammography on the health and well-being of Irish women are now evident. The cancer clinics are over-crowded. The workforce has had to cope with debilitating illnesses of women age 50 – 64 years. The National Cancer Register confirms what is clearly visible on the ground. It confirms that the increase in breast cancer incidence is not confined to Stage 1 tumours, but extends to all grades of breast cancer.

The evidence from Ireland would suggest that a Safety Statement is mandatory at this point in time.
A manufacturers Safety Statement should be a prerequisite for use of any equipment. Review of the pathology on which the diagnosis was confirmed might also be indicated. The wisdom of including digital mammography as a diagnostic tool in symptomatic patients with soft lumps would also be questioned.

Yours Sincerely,

Bridget O’Brien

References:
1. Comparison of Digital Mammography and Screen-Film Mammography in Breast Cancer Screening: A Review of the Irish Breast Screening Program. Hambly N et al, AJR 2009 1010 – 1016
2. National Cancer Registry of Ireland Breast Cancer Incidence, Mortality, Treatment and Survival in Ireland:1994 – 2009
3. Effect of Three Decades of Screening on Breast Cancer Incidence Bleyer A t al N EngJ Med 2012;367:1998 2005

Competing interests: none

Bridget O'Brien, General Practitioner

none

Boherbee Medical Center, 59 Boherbee, Tralee, Co. Kerry

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Sidelining overdiagnosis

The UK independent review panel refutes professor Baum’s calculations on deaths from treatments, remaining on one side of the binary opposition between scientific positivists where no real communication or meaning is taking place.1 This is a form of empty speech. However, even within this opposition, the panel isn’t making sense. Its non-sense points to an ideology that fantasises about the power to control cancer, an ideology that demands people to freely believe that too much information is bad for them because it might prevent them adhering to public policy. The policy is being aggressively marketed, not in terms of ‘need’ the distributive factor that might be best thought to apply to the market sphere of health care, but in terms of ‘for healthy people, the potential to prevent a death from cancer – a life to be saved’. A turn to fantasy may well be at work here, fantasy that provides the subject with an imaginary reality that prevents us from accepting our being-unto-death, an ensures the resilience of the product, breast cancer screening, in the market.2 Professor Baum’s response may be a polite call for radical reform but remains locked into a binary opposition, calling for a ‘truly informed choice’ that ignores the ideology at work and that will not ‘unwind’ overdiagnosis?

Marmot et al state3:
‘The Panel agrees that overdiagnosis is important but it is impossible to say, for an individual woman with cancer detected at screening, if her cancer represents overdiagnosis. It is therefore difficult to estimate the magnitude of overdiagnosis.’

Even from a purely positivist perspective this doesn't make sense. I thought the magnitude of overdiagnosis was calculated by comparing the numbers of cancers presenting clinically in a non screened group with a screened group. If there was no overdiagnosis then the numbers of cancers presenting clinically in the screened group would be reduced by the number of screened diagnoses, all other things being equal. With overdiagnosis the number of cancers presenting clinically in the screened group would only be reduced by a proportion of those presenting clinically in the non screened group. So, what would this calculation have to do with knowing whether or not a particular woman's screens diagnosed cancer represents overdiagnosis or not, in a binary sense? Although it could be argued the estimate of the amount of overdiagnosis would provide some information about the likelihood or probability of any one particular screening diagnosed cancer being an overdiagnosis, which might influence decision making, this seems to be contradicted in Hersch's paper: they say that, in relation to screening diagnoses4:
' ......once cancer is detected, evidence based treatment is virtually always indicated because potentially threatening cases cannot be differentiated from those representing overdiagnosis.'

This seems to preclude the possibility of a woman making any decision at that stage - she will just have to have the indicated treatment. But doesn't this contradict the whole notion of providing woman with information about overdiagnosis prior to screening because this will enable them to make a choice. This is one of the points Miriam Pryke makes in her rapid response in this series.

So, why is this important? What might this be signifying?

By conflating the difficulty of estimating the magnitude of overdiagnosis and the impossibility of knowing whether a particular cancer would ever present clinically, the panel, and Hersch et al, may be suggesting that the level of overdiagnosis becomes somehow irrelevant once a woman has been screened. In turn this may suggest that overdiagnosis doesn't really need to be played into the policy decisions about whether women should continue to be invited to screening or should continue to be offered screening. So, why might this be happening?

This would be consistent with other aspects of their letter being part of a Master Discourse delivering an imperative, a ‘judgement’ from on high. Language and context are important. The panel is eminent, and apparently highly respected, it is British, they make a 'judgement' that is portrayed as superior to the Nordic Cochrane review. The concept of ‘clarity’ is invoked as the rationale for the judgment, a concept used several times by pro-screening commentators following the review.5 But ‘clarity’ as a signifier skates over the underlying concepts of reassurance and accuracy which may, in this case, be mutually exclusive, as the Citizen’s Jury implied. If there is much uncertainty then why invoke clarity which implies certainty? Kirwan in the editorial even suggests that the programme should continue in the light of the uncertainty!6 This seems to suggest, incoherently, that screening programmes should be started even when evidence of net benefit is uncertain, as in this case.

The medical profession must be wary of allowing itself to be the arbiter of what information it provides to the public. Withholding information on harms to ensure attendance, as disturbingly suggested in Bekker's editorial in 2010, would seem to give a green light for any politically motivated programme to be marketed at a vulnerable population via a 'consider an offer' approach.7;8 Even whilst ideologically people feel 'cared for' and reassured and free to in effect work for the system, and maintain and reproduce the means of production. This might explain the resilience of the programme

The Marmot panel disagrees with Cochrane. Some experts are strongly in favour of screening. Why would anybody be strongly in favour of screening? Is this evidence of a fantasy of divine power on the part of the policy makers, coupled with fantasies of 'lives being saved and futures guaranteed ' on the part of an anxious Cartesian subject invoked as always uncertain, always needing faith.

Reference List

(1) Baum M. Harms from breast cancer screening outweigh benefits if death caused by treatment is included. BMJ [ 2013 Available from: URL:BMJ2013;345:f385
(2) Glynos J. The place of fantasy in a critical political economy: the case of market boundaries. Cardozo Law Review 2013; 33(6):2373-2411.
(3) Marmot M. re: harms from breast cancer treatment outweigh benefits if deaths caused by treatment is included. BMJ [ 2013 Available from: URL:http://www.bmj.com/content/346/bmj.f385/rr/629307
(4) Hersch J, Hansen J, Barratt A. Womens' views on overdiagnosis in breast cancer screening: a qualitative study. BMJ [ 2013 Available from: URL:BMJ 2013;346:f158
(5) Times. Keep having scans despite the downsides, women told. The Times 2012 Oct 30.
(6) Kirwan C. Breast cancer screening: what does the future hold? BMJ [ 2013 Available from: URL:BMJ2013;346:f87
(7) Bekker H. Decision aids and uptake of screening. BMJ [ 2010 Available from: URL:BMJ2010;341:c5407
(8) Entwistle VA, Salkeld G, McCaffery K, Irwig L, Flitcroft K, Trevena L et al. Communicating about screening. BMJ [ 2008 337:[789-791] Available from: URL:BMJ 2008;337:a1591

Competing interests: GP and PhD student studying overdiagnosis, EBM - positivisms ideology and the subject - a Lacanian discourse analysis

Owen P Dempsey, GP

Manchester Metropolitan University, Manchester

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Professor Marmot says “it is impossible to say, for an individual woman with cancer detected at screening, if her cancer represents overdiagnosis.” This is not new knowledge. It didn’t take a review to find this out. It is the nature of screening. All those thousands of women who now believe “Screening saved my life” could have been told.

If I had been told that no screen-diagnosed woman, whatever her diagnosis, can know if she really has cancer, that most screen-diagnosed women receive no benefit and only harm, that the chance of screening preventing breast cancer death is extremely low even on the review estimates, which are contested amongst experts, that some women die earlier from late effects of the permanently damaging treatments– that screening is a calculated risk with very poor odds, I would not have touched it with Archimedes’ lever.

If the programme were not already running, even on the review panel’s estimates professionals would think it not merely not viable but outrageous to suggest starting a programme that would cause so much serious harm for so little benefit, and unthinkable to suggest that people could in all seriousness be invited to take such a bad gamble with their health. Doctors would say they didn’t enter the profession to carry out unnecessary treatments and worse, knowing in advance they would be doing so on such a grand scale. They could not feel their work was meaningful knowing they were wreaking havoc in so many lives. They would say if we tell women what screening means they won’t come anyway so it’s a non-starter.

But that is the reason women were not and still are not told and, I expect, will not be told in the new leaflets being prepared by a member of the Advisory Committee on Breast Cancer Screening leading Informed Choice about Cancer Screening which is supposedly independent from those with an interest in screening.

Professor Marmot says the motivation for the judgments which yield the panel’s estimates is “to clarify the issues so that women can make an informed choice”. Women cannot make an informed choice if numbers are cherry-picked and the information tailored in order to sound clear rather than to explain what is true, that the numbers are only estimates, derived by contested methods, have a wide margin of error because the trials did not follow up for long enough, were in some cases poorly designed, are old, do not represent the real situation or the current situation, and that experienced experts including the Nordic Cochrane researchers, Professor Baum and others draw different conclusions on these matters of critical importance. Women cannot make an informed decision if they are not told that they are being invited to take a calculated risk with very poor and ultimately uncertain odds and very high stakes and even if they are one of the few if any winners they will never know it.

Competing interests: Diagnosed through screening

Miriam Pryke, PhD student

King's College London, Strand London WC2 2LR

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I truly welcome this response by Sir Michael Marmot and his colleagues.

It was measured and polite in spite of my provocations, but then I would expect nothing less from a group that contains a number of members that I know well and respect, in addition to their leader. I’m particularly pleased, nay “chuffed” that they mention the TARGIT trial that I have lead over the last 12 years. [1] Two thirds of the patients in this trial were screen detected and the results of the second and more mature analysis are at this moment being prepared for publication and have already been presented at the San Antonio Breast Cancer Symposium in December 2012. I am now minded to approach my collaborative group to look at the subset of patients who were screen detected. Yet at the same time that newer radiotherapy techniques are reducing collateral damage, so have newer systemic therapies reduced the gap for screening to manifest its impact.

The timing of this response is also critical as I amongst many others, are advising the committee responsible for the developing the new information leaflet that will allow truly informed consent for symptom free women being invited for screening. We must make sure that this leaflet does justice to the ethos of the full Marmot report and not selected headlines taken out of context.

I think that folk like me (who are zealous about EBM in addition to the individuals right to self-determination) and the Marmot committee, are closer to an accommodation than many observers from the sidelines might think and I for one see clearly a bright future ahead.
• I see the conclusions of the Marmot committee as the first step in the right direction but not the last word on the subject and I feel sure they would agree.
• I look forward to seeing a new information leaflet that truly reflects the conclusions of the Marmot committee and is free of selective citation and any hint of coercion.
• I anticipate that the CRUK will encourage basic research that will improve our methods of the distinguishing the Poodle from the Rottweiler amongst screen detected DCIS
• I look forward to the proposed trial of active treatment versus active monitoring for screen detected low grade DCIS, being funded. [2]
• I anticipate that new techniques that might reduce the collateral damage from radiotherapy will be rapidly adopted.
• I anticipate that the continuing improvements and case selection for adjuvant systemic therapy will continue to narrow the window of opportunity for screening to impact on breast cancer mortality.
• I predict that better techniques of screening will factor in the biological characteristics of the lesions detected so that specificity would include a predictive measure of the natural history of the radiographic opacity.
• I predict that increasingly accurate methods of risk assessment will allow us a triage to help us select those women who will be most likely to benefit from screening.
• I have a dream!
(Sorry about the last one, I got rather carried away)

References
1) 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. Jul 10 2010;376(9735):91-102.
2) Fallowfield L, Francis A, Catt S, Mackenzie M, Jenkins V. Time for a low-risk DCIS trial: harnessing public and patient involvement, Lancet Oncology December 2012. Published on line:
http://dx.doi.org/10.1016/S1470-2045(12)70503-X

Competing interests: None declared

Michael Baum, Prof Emeritus

UCL, 2 Cotman Close

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Dear Sir,

The Panel welcomes the BMJ’s continuing interest in breast screening and in particular the three articles published in the BMJ of 26 January 2013. Dr Kirwan’s editorial (1) has capably summarised many of the issues raised in our Report (2), and the Panel would support her conclusions.

As he did when he presented his views to the review panel, Prof Baum (3) has raised interesting and important issues. The Panel did not “duck” the issue of the effect of breast screening on all cause mortality. It is important, but as we indicate in the full report (p32), a 20% reduction in breast cancer mortality would yield only a 3% reduction in mortality from all cancers and a 1.2% reduction in all cause mortality. The randomised trials that have been done lack the statistical power to examine all cause mortality.

The Panel agrees that overdiagnosis is important but it is impossible to say, for an individual woman with cancer detected at screening, if her cancer represents overdiagnosis. It is therefore difficult to estimate the magnitude of overdiagnosis. The Panel would not accept Prof Baum’s estimates – the Bleyer and Welch paper that he quotes is subject to many of the problems of other observational studies (discussed on p49 of our full report). The paper by Hersch et al (4) confirms what one would expect, namely that the larger the scale of overdiagnosis the more it will affect women’s attitudes to screening. It is thus important that any estimates of overdiagnosis are as accurate as possible.

Similarly, the Panel agrees with Prof Baum that the adverse effects of treatment are important, particularly for patients whose cancer has been “overdiagnosed” since, by definition, there is no compensatory decrease in breast cancer mortality for these women. For this reason we specifically tried to quantify the risks of treatment in the full report (p64) but came to estimates rather lower than Prof Baum’s. The latest Oxford overview (5) estimates that radiotherapy given after conservative surgery for breast cancer increases the risk of non-breast cancer death by 0.2% at 15 years. This is clearly higher than one would wish and changes in radiotherapy (such as the TARGIT trial [6] supported by Prof Baum) should further diminish this.

In addition to reviewing the published evidence, the Panel took evidence from experts with strong views for and against breast screening, including Prof Baum. The Panel’s judgements, as set out in our full report, were reached having heard these views. One important rationale for these judgements is to clarify the issues so that women can make an informed choice about breast screening.

Yours,

The Independent UK Panel on Breast Cancer Screening

References

1. Kirwan C. Breast cancer screening:what does the future hold? BMJ 2013;346:f87

2. Independent Breast Screening Review full report: www.cruk.org/breastscreeningreview

3. Baum M. Harms from breast cancer screening outweigh benefits. BMJ 2013;346:f385

4. Hersch J, Jansen J, Barratt A et al. Women's views on overdiagnosis in breast cancer screening: a qualitative study. BMJ 2013;346:f158

5. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16

6. Vaidya JS, Joseph DJ, Tobias JS, Bulsara M, Wenz F, Saunders C, Alvarado M, Flyger HL, Massarut S, Eiermann W, Keshtgar M, Dewar J, Kraus-Tiefenbacher U, Sütterlin M, Esserman L, Holtveg HM, Roncadin M, Pigorsch S, Metaxas M, Falzon M, Matthews A, Corica T, Williams NR, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet 2010 376:91-102

Competing interests: None declared

Professor Sir Michael Marmot , Director, UCL Institute of Health Equity

Professor D G Altman (Director of the Centre for Statistics in Medicine, University of Oxford), Professor D A Cameron (Professor of Oncology and Clinical Director of the Edinburgh Cancer Research Centre, University of Edinburgh), Professor J A Dewar (Consultant and Honorary Professor of Clinical Oncology, Department of Surgery and Oncology, Ninewells Medical School, University of Dundee), Professor S G Thompson (Director of Research in Biostatistics at the Department of Public Health and Primary Care, University of Cambridge), Maggie Wilcox (patient advocate)

UCL Dept of Epidemiology and Public Health, 1-19 Torrington Place, London WC1E 7HB

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Several contradictions arise in the debates over the UK breast cancer screening programme (UKBCSP) and these challenge and reveal the delimited and repressive nature of the prevailing positivist 'paradigm' for Evidence Based Medicine (EBM).1

The discourse is analysed using an Althusserian perspective on ideology and Lacanian psychoanalytical concepts of the subject and language.2-4 The contradictions reveal key signifiers that demonstrate that EBM must be conceptualized as part of a ‘marketed’ partly public and partly private service, as integrated with political, economic and social drivers.5 They also reveal the subject as essentially ‘split’ and not the autonomous subject capable of totally free choice invoked by positivism.6;7

Always the call for more evidence – Why invoke ‘Trust’ and ‘Independence’? What is ‘sinister’ about the process?

Following the Nordic Cochrane systematic review in 2012, Richards (National Cancer Director acting on behalf of the UK Government) was quoted by Bewley as saying that ‘most UK experts don’t trust’ the Nordic findings.8-11 Such comments remain unsubstantiated and McPherson alleges he was quietly told to cease asking for citations to support such claims by mysterious UK ‘experts’.10 However, as a result, a further so-called UK ‘independent’ review was sponsored by the UK Government and a breast cancer charity, which produced higher figures for benefit and lower figures for harm from the UKBCSP, than the Cochrane review.12 And, it was concluded the UKBCSP should continue.

Why would the Cochrane review not be ‘trusted’, and perhaps be signified as ‘not independent’ by the State and a breast cancer charity? Signifiers such as 'trust' and 'something going on behind the scenes' seem to appear here, perhaps something ’sinister’ to use Greenhalgh’s word.1

A ‘Master Discourse’ – a Binary Opposition

Richards said the so-called UK independent review provided ‘clarity’, proof of the benefits of screening in terms of 1300 breast cancer deaths saved per year, and that women 'should continue to attend screening’.13 Kirwan states: “Given the limitations of the evidence, the authors correctly conclude that breast screening is worthwhile ….. and the decision on whether to participate in screening is a personal one.’14

However, Baum, and others have criticised the review for ignoring the impacts of better treatments on the apparent screening outcomes, for ignoring all cause mortality, for ignoring deaths due to treatments and for excluding more recent data from observational studies.15

This is a Binary Opposition totally enclosed within a logical positivist framework, and one that needs to be refused if the deadlock is to be broken.

The ‘Railroaded’ subject – How autonomous is she?

Two women diagnosed by screening were interviewed on London BBC radio 4, just after the publication of the review, (this is available as a podcast).13 One felt she had been railroaded into cancer surgery, felt placed in an impossible situation with a complete lack of knowledge about the meaning of the diagnosis and yet felt compelled to comply with mastectomy as she felt “under duress”. "It takes a very strong woman at that point to say I'm not going to do anything.” The other woman, had 'ignored' two invitations until her husband found the third. She wanted the surgeon to remove both of her breasts when she had cancer diagnosed, felt her 'life had been saved'. She felt, in retrospect, that she had been “absolutely stupid” to ignore the invitations.13

It is argued that these transitions reveal the subject as, after Lacan, essentially split (constituted by alienation within herself through language), struggling to engage with a symbolic structure but then also resisting it, only to engage with another.4

The Invitation

The invitation (to be screened) demands an urgent decision - which might be the decision to ignore it. It carries an imperative to comply, an assumption or expectation of net benefit? It seems to make redundant any attempt to enable any degree of self-determination by the woman.
The ‘Truth’, ‘free choice’, ‘amnesty’, ‘sincere belief’ and ‘shared decision making’, ’reassurance and accuracy’

Welch argues that the proponents of screening are 'sincere in their belief' and should be offered an 'amnesty' so that we can 'move forward'.16 But it would seem incoherent for people with sincere beliefs to be expected to say: "We now acknowledge we are wrong and sincerely give up our sincere beliefs." As a 'timid explanation' perhaps we can see that 'sincere belief' is not enough to answer the question 'Why?’ - Stefanek suggests that women be told 'The Truth' via ‘Shared Decision Making’ so that they can make their 'own informed decisions' even while the clinician advises the woman.17 Both of these suggestions seem non-sensical and naïve, blinding us to the ideological framework already embracing EBM, the clinician and the subject, and ensure the subject’s ongoing repression.

As Miriam Pryke, in her rapid response in this BMJ edition, points out, the task of the ‘Citizen’s jury’ contains a revealing inconsistency: “The jury expressed preference for the term ‘over-treatment’ to ‘over-diagnosis’ on the basis that it was easier to understand, and felt that benefits should be stated in terms of ‘lives saved’ rather than ‘deaths avoided’ because it was more positive. They were unable though to reach agreement on whether the leaflet should give priority to accuracy or to reassurance; most felt that it should aim for both.” 18

Is this because ‘reassurance and accuracy’ contain a contradiction? To know the accuracy, the uncertainty, might be politically dangerous revealing the fiction behind the publicity. Why would a jury want to be positive?

Winding back ‘Overdiagnosis’?

Today EBM is, perhaps. functioning as an Ideological State Apparatus promoting a fantasy dream promising immortality as an opium for the masses, so that they can ignore life's contingent nature, its mystery and our 'being-unto-death'.19

Certainly, overdiagnosis will not be ‘wound back’ unless EBM is recognized as a means of production for public health services that are marketed within ideological political and economic structures. EBM research, practice and education could explicitly embrace this idea as fundamental to praxis, and make emancipation of the subject foundational.

Reference List

(1) Greenhalgh T. Why do we always end up here? Evidence-based medicine's conceptual cul-de-sacs and some off-road alternative routes. J Prim Health Care 2011; 4(2):92-97.
(2) Althusser L. For Marx. Harmondsworth: Penguin books; 1969.
(3) Parker I. Lacanian Discourse Analysis in Psychology - Seven Theoretical Elements. Theory and psychology 2005; 15(2):163-182.
(4) Pavon Cuellar D. From the Conscious Interior to an Exterior Unconscious. London: Karnac Books Ltd; 2010.
(5) Glynos J. The place of fantasy in a critical political economy: the case of market boundaries. Cardozo Law Review 2013; 33(6):2373-2411.
(6) Belsey C. Critical Practice. Oxford: Routledge; 2002.
(7) Pavon Cuellar D. Marx in Lacan: Proletarian Truth in Opposition to Capitalist Psychology. Annual Review of Critical Psychology , 70-77. 2012.
Ref Type: Journal (Full)
(8) Bewley S. The NHS breast screening programme needs independent review. BMJ [ 2013 Available from: URL:BMJ 2011;343:d6894
(9) McPherson K. Screening for breast cancer-balancing the debate. BMJ [ 2013 Available from: URL:BMJ 2012;340:c3106
(10) McPherson K. review breast cancer screening evidence. BMJ [ 2013 Available from: URL:http://www.bmj.com/rapid-response/2011/11/03/review-breast-cancer-screening-evidence
(11) Gotzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database Syst Rev 2011;(1):CD001877.
(12) Marmot M. The benefits and harms of breast cancer screening: an independent review. Lancet 2012; 380(9855):1778-1786.
(13) The Today Programme. I was railroaded into cancer surgery. London BBC radio 4 [ 2012 Available from: URL:http://news.bbc.co.uk/today/hi/today/newsid_9764000/9764798.stm
(14) Kirwan C. Breast cancer screening: what does the future hold? BMJ [ 2013 Available from: URL:BMJ2013;346:f87
(15) Baum M. Re: Breast screening is beneficial, panel concludes, but women need to know about harms. Letter to BMJ
The Screening debate. BMJ 2013.
(16) Gilbert Welch H. Cancer Survivor or Victim of Overdiagnosis. New York times 2012 Nov 22.
(17) Stefanek M. Uninformed compliance or informed choice? A needed shift in our approach to cancer screening. Journal of the national Cancer institute 2011; 103:1-6.
(18) Thornton H. Re: Women "jurors" are asked how to present risk-benefit ratio of breast cancer screening. B 2013.
(19) Gray J. The immortalization commission: the strange quest to cheat death. London: Penguin Books Ltd; 2011.

Competing interests: currently doing a PhD on : 'Overdiagnosis and Evidence Based Medicine: ideology, positivism and the subject - a Lacanian/Althusserian discourse analysis'

Owen P Dempsey, General Practitioner

Manchester Metropolitan University, Manchester

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Medicine in India usually follows the trends in the west. For years we have been wanting to take breast screening programs to the level of screening in the west, but due to lack of funds,man power, structure and because of the illiteracy levels this has not been possible. Breast screening in India is mostly limited to the upper middle class who present to the hospital for General health checkup. These apparently healthy population is subjected to clinical and radiological screening for breast cancer and if any suspicious lesion is found further treatment is followed. There has been a strong demand of breast screening programs in past few years. Awareness is better among the educated middle and upper class but there are still lapses.

Now with the increasing number of reports talking about the breast cancer overdiagnoisis and the harms it can do, and the suggested changes in the breast screening program, the Indian breast screening program stands confused and so are the general practitioners and surgeons.

There need to be strategic guidelines as to who should really be screened. There is a need to define high risk population which should be subjected to screening rather than doing a mass screening starting at the age of 40. The mass screening programs are sustainable in the west because of the structured health care system, this seems to be far fetched in india. Specially in India screening of high risk population at a younger age should be the plan. this shall reduce the cost of screening programs and also organize and target the case finding.

Competing interests: None declared

Mandeep Kaur, general surgery

Dr Arun Prasad

Indraprastha Apollo Hospital, 679/sector 7b/ faridabad, haryana, India

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Screening rapid response 31 jan 2013
Overdiagnosis, breast cancer screening, and the deadlock – a perspective from outside positivism

Several contradictions, incoherencies and 'silences' are revealed in the debates over the UK breast screening programmes (UKBCSP) and overdiagnosis. These absolute contradictions must make us think again about challenging what Greenhalgh has called the prevailing 'paradigm' for Evidence Bsed Medicine (EBM).1 The contradictions raise the possibilities that a) the, once revolutionary and emancipatory but now perhaps repressive, practice of EBM has been subsumed and distorted by political, economic and social forces and b) the patient is to some extent not as in control of her own destiny as we would like to think, but is always struggling to fit into a social order out there, is essentially 'split', whilst at the same time struggling to resist this 'order' and to be her own person. The subject can be said to be alienated from herself by language that is essential if we are to interact with the world, the ‘I’ who speaks (of the utterance) is alienated from the ‘I’ spoken about (of the uttered). EBM may be acting, largely invisibly, as an Ideological State Apparatus (ISA) under the influence of a repressive State.

In theoretical terms these ideas would be consistent with an Althusserian view of ideology and a Lacanian view of the subject, and language.(2,3,4)

So, what are these compelling contradictions in the discourse of the UKBCSP?
The Master Discourse – Independence

Susan Bewley (Obstetrician) and Klim mcPherson (Epidemiologist) called on Michael Richards (National Cancer Director acting on behalf of the Government) to organise an 'independent' UK review of the UKBCSP. (5,6,7) This followed Richard's comments that most UK 'experts' didn't 'trust' the findings of the Nordic Cochrane review by Gotzsche et al.(8) Such comments have remained unsubstantiated by any published evidence according to McPherson who alleges he was quietly told to cease asking for citations to support these claims by the mysterious UK experts.(9)

But, and here is the first puzzle, why would the Cochrane review not be ‘trusted’, and why would there be calls for a UK government and breast cancer charity sponsored so-called ‘independent’ review when a Cochrane review had just been published?

Concepts such as 'trust' and 'something going on behind the scenes' seem to appear here, perhaps something ’sinister’ to use Greenhalgh’s word.(1)

The Lancet editorial praised the so-called UK independent review as ‘the latest and best available evidence’. Richards said the report provided clarity, proof of the benefits of screening in terms of 1300 breast cancer deaths saved per year, and that women 'should continue to attend screening' (even whilst acknowledging overdiagnosis and suggesting women could now be given 'the facts' and even whilst the review acknowledged the large uncertainties in the data). Even in this edition of the BMJ Cliona Kirwan states: “Given the limitations of the evidence, the authors correctly conclude that breast screening is worthwhile ….. and the decision on whether to participate in screening is a personal one.(14) Such clarity, and superlatives, and the word: ‘should’ may signify an imperative master discourse, possibly signifying the authors as privileged holders of knowledge, knowing what is best for the subject. Kirwan’s statement suggest that the uncertainty is a ‘reason’ for the programme to continue, suggesting that there is no need for any better evidence, the programme should just continue, no matter how uncertain the evidence.

Baum, and others have criticised the review for ignoring the impacts of better treatments on the data, for ignoring 'all cause mortality', for ignoring deaths due to treatments and for excluding more recent data from observational studies. Kirwan’s editorial, the Lancet editorial, ignore Baum, and others. There is no debate occurring here, just opposition(10)

It is possible that there is a Binary Opposition here, between the ‘pro-screeners’ and the ‘pro-informed choicers’, a disagreement not amenable to rational argument or discussion. An opposition totally enclosed within a logical positivist framework, and one that needs to be refused if the deadlock is to be broken, by moving outside of this framework.

The fact that the UK ‘independent review was commissioned, the overblown rhetoric, and the imperative nature of the discourse all point to what is sinister here, the workings of the practice of EBM as an ideology, and ISA. Something all EBM enthusiasts should recognizes and begin to incorporate into their research, and practice. The ISA, is the site where resistance should take place.(2)

Railroaded

Two women diagnosed by screening were interviewed on radio 4, just after the publication of the review, this is available as a podcast.(11) One, felt she had been railroaded into cancer surgery, felt placed in an impossible situation with a complete lack of knowledge about the meaning of the diagnosis and yet felt compelled to comply with mastectomy as she felt urgently imperilled. "It takes a very strong woman at that point to say I'm not going to do anything.” she had entered screening unaware of overdiagnosis, and now campaigns for better information to be made available. The other woman, had 'ignored' two invitations until her husband found the third. She wanted the surgeon to remove both of her breasts when she had cancer diagnosed, felt her 'life had been saved' and now works for a breast cancer charity encouraging women to attend screening. She felt, in retrospect, that she had been 'absolutely stupid' to ignore the invitations.

How did the woman who ignored invitations become the woman relieved to have cancer diagnosed and now the woman encouraging others to respond to invitations? How did another woman accept an invitation, in good faith, only to end up feeling ‘railroaded’ into surgery, and now actively campaigning for more information to be made available? Do these transitions reveal the subject as essentially split, struggling to engage with a symbolic structure but then also resisting it, only to engage with another.

The Invitation

The invitation demands an urgent decision - which might be the decision to ignore it. It carries a weight of masterly command, an imperative to comply, an assumption or expectation of benefit? It seems to contradict, forestall or make redundant any subsequent attempt to enable any degree of self-determination by the woman. After all, the Citizen’s Jury and Richards ‘say women ‘should’ attend screening. (15) The degree of compulsion is hard to ignore.
The ‘Truth’, ‘free choice’, ‘amnesty’, ‘sincere belief’ and ‘shared decision making’, the name: ‘cancer’, ’reassurance and accuracy’

The language of the debates conducted by EBM 'experts' reveal these to be problematic concepts used in ways that expose contradictions, revealing flaws in the almost totally positivist 'expert' approach to the issue of overdiagnosis.

Welch and others argue that the proponents of screening (signified here as 'wrong', signifying himself as 'right' in a binary opposition not amenable to any rational discussion) are 'sincere in their belief' and should be offered an 'amnesty' so that we can 'move forward'.(12) It would seem an impossibility for people with sincere beliefs to be expected to say: "Oh, phew, thanks for the amnesty, we now acknowledge we are wrong and sincerely give up our sincere beliefs." As a 'timid explanation' perhaps we could see that 'sincere belief' is not enough to answer the question 'why?'. Perhaps, behind the scenes the screening proponents feel free to freely work for a system that demands screening. And perhaps this system could be EBM operating as an Ideological State Apparatus operating under a repressive political regime. Perhaps also Welch's suggestions demonstrate what will always be the failure of the positivists' approach to the problem of overdiagnosis. The failure to confront and investigate and indeed resist the ideology that enables people to freely behave in such contradictory (and repressive) ways.

There are suggestions that women be told 'The Truth' so that they can make their 'own informed decisions'.(12) This signifies the results of science sufficient to enable a women to determine her own choices. Some scientists might feel this is as far as their responsibilities go. It ignores the failure of science to provide any solution to excessive overdiagnosis. It ignores the ideological construction of this knowledge, the research questions dominating the research agendas, and it's manipulation by what could be described as an ISA, EBM today. It also ignores the nature of our subjectivity as constituted by our alienation from our selves by language. Perhaps we are always struggling to fit in and yet resist repressive ideologies, not ever capable of totally free autonomous choice.

Further contradictions can be found in the discourse around the name cancer, is it a ‘real cancer’, an ‘actual cancer’, or a ‘pseudo cancer’. When is a false positive diagnosis a false positive diagnosis? Whose perspective counts, the histopathologist now or the patient after her mastectomy?

As Miriam Pryke, in her rapid response in this series, points out the task of the so-called ‘Citizen’s jury’ reveals a revealing inconsistency:

“The jury expressed preference for the term ‘over-treatment’ to ‘over-diagnosis’ on the basis that it was easier to understand, and felt that benefits should be stated in terms of ‘lives saved’ rather than ‘deaths avoided’ because it was more positive. They were unable though to reach agreement on whether the leaflet should give priority to accuracy or to reassurance; most felt that it should aim for both.” (15)

Reassurance and accuracy could not be agreed upon. Is this because they contain a contradiction , as Miriam Pryke points out. To know the accuracy, as Kirwan acknowledges, the uncertainty, may not be that reassuring, suggesting Kirwan’s and Richards’ conclusion that the programme should continue because of the uncertainty, might be problematic.(11,14)

Perhaps a new paradigm for EBM should include these somewhat anti-humanist and no doubt easily ignored or derided possibilities. But the contradictions are there for all to see. EBM as an ISA may be a fantasy dream promising immortality as a poisonous opium for the masses, so that they can ignore life's contingent nature, it's mystery and our 'being-unto-death', even whilst, disavowing how unhappy starving for immortality can make you, and how something like cancer is being fetishised as ' the enemy to be resisted, always already present, haunting us. (13)

References

1. Greenhalgh T. Why do we always end up here? Evidence-based medicine's conceptual cul-de-sacs and some off-road alternative routes. J Prim Health Care 2011; 4(2):92-97.
2. Althusser L. For Marx. Harmondsworth: Penguin books; 1969.
3. Parker I. Lacanian Discourse Analysis in Psychology - Seven Theoretical Elements. Theory and psychology 2005; 15(2):163-182.
4. Pavon Cuellar D. From the Conscious Interior to an Exterior Unconscious. London: Karnac Books Ltd; 2010.
5. Bewley S. The NHS breast screening programme needs independent review. BMJ [ 2013 Available from: URL:BMJ 2011;343:d6894
6. McPherson K. Screening for breast cancer-balancing the debate. BMJ [ 2013 Available from: URL:BMJ 2012;340:c3106
7. McPherson K. review breast cancer screening evidence. BMJ [ 2013 Available from: URL:http://www.bmj.com/rapid-response/2011/11/03/review-breast-cancer-screening-evidence
8. Gotzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database Syst Rev 2011;(1):CD001877.
9. McPherson K. review breast cancer screening evidence. BMJ [ 2013 Available from: URL:http://www.bmj.com/rapid-response/2011/11/03/review-breast-cancer-screening-evidence
10. Baum M. Re: Breast screening is beneficial, panel concludes, but women need to know about harms. Letter to BMJ
The Screening debate. BMJ 2013.
11. BBC radio 4 Today Programme. I was railroaded into cancer surgery. 30-10-2012.
Ref Type: Sound Recording
12. Gilbert Welch H. Cancer Survivor or Victim of Overdiagnosis. New York times 2012 Nov 22.
13. Gray, J. The Immortalisation Commission and the Strange Quest to Cheat death (2011)
14. Kirwan, C. Breast cancer screening: what does the future hold? BMJ 2013;346:f87
15. Hawkes, N. Citizen’s jury disagrees over whether screening leaflet should put reassurance before accuracy. BMJ 2012;345:e8047

Competing interests: undertaking a PhD "Overdiagnosis and Evidence Based Medicine - Positivism, Ideology and the Subject - A Lacanian/Althusserian Discourse Analysis"

Owen P Dempsey, GP

Manchester Metropolitan University, Manchester

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Proponents of informed decision-making should offer simple numbers for women to remember. We provide a transparent alternative supporting Dr. Baum’s benefit analysis in Box 1.1 Previously we estimated the screen-free breast cancer death risk from U.S. SEER data by comparing the 1980 and 2004 age-specific cumulative breast cancer death risks over 15 years.2 We adjusted for roughly equal contributions of screening mammography and modern therapy in decreasing the risk, including a 10-year window.3 However, it is now clear that mammography has contributed much less than therapy, given the rate of advanced cancers has not decreased in screened populations, and younger women not eligible for screening have had greater mortality decreases than older groups with screening.4

Assuming that 25% of the mortality decrease results from screening yields the screen-free death risk in column 5. A 50 year-old woman has a 995/1000 or 99.5% chance of not dying from breast cancer over 10 years without screening:

After calculating the absolute risk reduction, the number needed to invite for routine (multiple) screening mammograms to extend one life is 500-5000, depending on the assumed RRR and the follow-up time. Explaining that about 1000 women need to endure routine screening (about 3-4 mammograms each in the UK, double in the US) to let one woman win the screening lottery is easy to remember. The harm of overtreatment, about 5 women/1000 at 30% overdiagnosis, will increase with actual screening participation.5 Ironically, mammography results in massively increased breast cancer incidence and earlier death for some women, as Dr. Baum has calculated.

1. Baum M. Harms from breast cancer screening outweigh benefits if death caused by treatment is included. BMJ 2013;346:f385.
2. Keen JD, Keen JE. What is the point: will screening mammography save my life? BMC Med Inform Decis Mak 2009;9:18.
3. Keen JD. Promoting screening mammography: insight or uptake? J Am Board Fam Med 2010;23(6):775-82.
4. Jorgensen KJ, Keen JD, Gotzsche PC. Is mammographic screening justifiable considering its substantial overdiagnosis rate and minor effect on mortality? Radiology 2011;260(3):621-7.
5. Gotzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database Syst Rev 2011(1):CD001877.

Competing interests: None declared

John D. Keen, Radiologist

Cook County John Stroger Hospital, Chicago, Illinois, US

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An increased risk of cardiovascular and/or non cancer-related death early after the diagnosis of cancer has been recently discussed (1,2). Implication of surgery has been proposed as a possible explanation (3).

Systemic inflammation as an important link between cancer, surgery and cardiovascular outcome has been suggested. Indeed, inflammation is a causative event in many cancers (primary tumors), implicated in many, if not all, secondary localizations, and promoted by surgery. The Society for Immunotherapy of Cancer, supported by the National Institute of Health (NIH), recently emphasized the importance of the inflammatory monitoring in cancer (4). Concerning the link with postoperative cardiovascular outcomes, inflammatory response has been clearly implicated in early complications. Interestingly, an inflammatory score, the neutrophil:lymphocyte ratio (NLR) has been validated as prognostic factors of worse outcome after a coronary artery bypass grafting (5). The same score has been clearly associated to tumour growth (6). Knowing that systemic inflammation can be routinely monitored in cancer patients with the NLR, it could also be used to stratify their cardiovascular risk.

References
(1) Baum M. Harms from breast cancer screening outweigh benefits if death caused by treatment is included. BMJ 2013;346:f385
(2) Fang F, Fall K, Mittleman MA et al. Suicide and cardiovascular death after a cancer diagnosis. N Engl J Med 2012;366:1310-8.
(3) Voskoboynik M, Urban D, Mileshkin L. Early cardiovascular death in patients with cancer. N Engl J Med 2012;367:1572-3.
(4) Demaria S, Pikarsky E, Karin M, Coussens LM, Chen YC, El-Omar EM, Trinchieri G, Dubinett SM, Mao JT, Szabo E, Krieg A, Weiner GJ, Fox BA, Coukos G, Wang E, Abraham RT, Carbone M, Lotze MT. Cancer and inflammation: promise for biologic therapy. J Immunother. 2010;33(4):335-51.
(5) Gibson PH, Croal BL, Cuthbertson BH, Small GR, Ifezulike AI, Gibson G, Jeffrey RR, Buchan KG, El-Shafei H, Hillis GS. Preoperative neutrophil-lymphocyte ratio and outcome from coronary artery bypass grafting. Am Heart J. 2007;154(5):995-1002.
(6) Proctor MJ, Morrison DS, Talwar D, Balmer SM, Fletcher CD, O'Reilly DS, Foulis AK, Horgan PG, McMillan DC. A comparison of inflammation-based prognostic scores in patients with cancer. A Glasgow Inflammation Outcome Study. Eur J Cancer 2011;47(17):2633-41.

Competing interests: None declared

Patrice Forget, Anesthesiologist

Marc De Kock

Service d'Anesthésiologie, Cliniques universitaires Saint-Luc, Université catholique de Louvain, av. Hippocrate 10-1821, B-1200 Brussels

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