Cost of extending the NHS breast screening age range in England

10 April 2019

https://www.bmj.com/content/365/bmj.l1293.full

https://www.healthwatch-uk.org/projects/breast-cancer-screening-age-extension/122-age-extension-trial-of-mammography-screening-part-5-april-2019.html

Susan Bewley emeritus professor of obstetrics and women’s health, Mitzi Blennerhassett medical writer , Mandy Payne freelance editor  [i]

Context and concerns

AgeX is the acronym for the UK government inspired and funded, cluster randomised controlled trial of extending the NHS breast cancer screening age range in England. The trial aims to assess the risks and benefits of extending mammography screening for breast cancer outside the current 50-70 year age range by offering one extra mammogram to women between the ages of 47 and 49 and up to three to those over 70. Announced as “likely to be the largest randomised controlled trial ever undertaken in the world,”during 2010-16 AgeX randomised three million women into the extended age groups and screened one million. Concerns have been raised by Susan Bewley of the Health Watch observer group over the adequacy of the benefit-risk information provided to the women included in the study. According to Health Watch observers, there is a risk of harm through overtreatment by surgery and other risks to participants. Women learn of their inclusion in research through a letter with a screening appointment that has already been scheduled. There is a possible surgical over-treatment risk for women aged 47-49 years, and the authors question whether continued breast cancer screening is still appropriate, as the accumulation of evidence challenges its assumed benefits.

Breast screening policy and controversy in the UK

Mammography screening aims to find breast cancer before a lump is palpable, giving the opportunity to start treatment earlier. The current UK screening programme, started in 1988, offers triennial mammography to all women aged 50-70. Of the 2.85 million women invited in 2015-16, 75% attended. In common with programmes worldwide, the screening age range was defined based on evidence of when mammography is most effective at detecting tumours in the breast.

The programme has been estimated to prevent 1300 deaths from breast cancer each year. But evidence suggests improvements in breast cancer survival rate since the introduction of mass screening probably result from concurrent improvements in the adjuvant hormonal and chemotherapy used to treat breast cancer.

There is also evidence that screening does not reduce number of tumours reaching late stage and that it results in substantial overdiagnosis, with consequent radiotherapy, lumpectomies, and mastectomies.

Age extension trial in the UK (XAge Trial)

In 2007 the Labour government’s cancer reform strategy recognised late diagnosis as a factor contributing to poor cancer survival rates in the UK. The government’s proposals included extending the age range for breast cancer screening. By 2012, it promised, women would receive nine screens between the ages of 47 and 73, with a guaranteed first mammogram before age 50. Limited capacity forced a decision to phase in the proposed extension. According to the organisers, randomising would, “provide a unique opportunity to obtain unbiased evidence on the net effects of the new policy,” although the extension would “proceed regardless of whether the study goes ahead or not” . The Nationwide Randomised Trial of Extending the NHS Breast Screening Age Range was started by Public Health England [ii]  in June 2009 with an original expected participation of 1.1 million women over 13 years. The cluster design randomises batches of 1000 screening invitations normally sent to women aged 50-70 to be extended to comprise those aged either 47-70 or 50-73. Half of all women aged 47-49 and half of all women aged 71-73 are invited to screening, while all women aged 50-70 are invited to screening as usual. The trial compares breast cancer incidence and mortality between screened and unscreened participants in the studied population. In 2016, the Age Extension trial was renamed as AgeX. The recruitment target was raised to “at least six million.”

Shaky foundation

It is laudable to test government policy before it is rolled out. But the design of this trial does not meet standards for generating evidence that would be robust enough to inform future policy. It is good practice for scientific experiments to be preceded by a systematic review of the evidence to avoid wasteful research and repeating unnecessary harms.

Emerging concerns about the lack of efficacy and potential harms of screening were mentioned briefly as “so-called overdiagnosis” in AgeX’s seven page original trial protocol.The trial’s sponsor (University of Oxford), when asked whether the protocol had been subjected to independent scientific peer review, told authors only that it had been reviewed by the Department of Health advisory committee on breast cancer screening.

Results

AgeX’s primary outcome measure is death from breast cancer. Total cancer deaths are not recorded, and overall mortality was added in 2016 as a subsidiary outcome but will not be included in the primary analysis. Measuring breast cancer mortality alone excludes deaths resulting from side effects of treatment or cancers caused by mammography. This is relevant as suitably randomised trials of breast cancer screening find no effect on total cancer mortality.

Potential for bias

Estimates of breast cancer mortality in screening are particularly vulnerable to bias because large numbers need to be screened to see the small effect and there is a long lead time for outcomes to become evident. Bias in suboptimally randomised trials of breast cancer screening may have resulted in benefit being overestimated.

During the past decade, AgeX increased its planned duration and sample size, study outcomes were changed, and a proposal for statistical analysis was retrospectively appended.These factors, coupled with the protocol’s stated plan to continue the trial beyond a “fixed, predetermined sample size” until “clear answers emerge” all increase the likelihood of a biased assessment. (Editor’s note : Protocols are normally never changed afterwards).

Lack of explicit, fully informed consent

According to good clinical practice, trial participants must be told that they are in a trial and given details of all known benefits and harms in language they can understand.

When the age extension trial was first conceived, screening was already known to be associated with harms, but these were not believed to outweigh the benefits of early detection. Harms range from false positive results with associated psychological distress to overdiagnosis—with abnormalities that would not have harmed the woman in her lifetime being found, leading to potentially dangerous, painful, and disfiguring treatment.

Early AgeX trial documentation refers to “so-called overdiagnosis”. But the team’s assumption that overdiagnosis was unimportant was challenged in 2012 when the Independent UK Panel on Breast Cancer Screening, chaired by Michael Marmot [iii],, published a detailed review of the evidence. The report recognised and quantified overdiagnosis—for every breast cancer death averted, three “cancers” that would never have troubled women during their lifetimes would be found and treated.

The physical and psychological harms resulting from such treatment are substantial. Yet in 2016, when AgeX’s recruitment target was raised to six million, this increase—with corresponding potential for harm—was not referred to or justified in an accompanying application for ethics approval.

With Marmot’s publication, the confirmation that predicted benefits were accompanied by appreciable and quantifiable risks to participants should have triggered a reflective review of the research question and study design.

Crucially, this should have included whether participants should now be given full risk-benefit information and the opportunity for explicit, fully informed consent.

In AgeX, an early decision had been taken to forgo such consent. The original protocol said, “100% coverage is essential for the scientific validity of the study, and excluding participants for whom we cannot get consent could seriously bias the results ... consent is implied for those who attend for screening.”

Women in the invited clusters learn of their inclusion through a letter with a prebooked screening appointment, general mammography advisory notes with the sign-off, “Remember ... screening saves lives,” a brief leaflet describing the trial (but not the potential risks of participation), and the standard pink breast cancer screening booklet  written for women aged 50-70.  The trial participation leaflet was expanded in 2014 from one to four pages but description of risks is limited to »being asked to return for more tests.

Trial participants’ understanding that they are voluntary participants in research rather than routine NHS screening, and at risk of unnecessary surgery and other harms, is never explicitly checked.

Cluster randomised trials can be run without seeking individual participants’ explicit, fully informed consent. As participants are randomised in large groups to invitation batches for a local breast screening unit, obtaining prior consent from individuals in the cluster is normally unfeasible. International guidance on the conduct of such cluster randomised trials states that the requirement for consent may be waived when the study intervention(s) poses no more than minimal risk.

Authors believe that the level of risk to participants in AgeX necessitates a trial design that enables fully informed consent.

The public overestimates the benefits and has a poor sense of the harms of screening tests in genera so researchers have a responsibility to dispel misconceptions. Physicians themselves often do not fully understand the benefit:harm ratios and consequently are poorly equipped to counsel their patients.

Well designed decision aids could support doctors and their patients, but AgeX does not refer to any. Members of HealthWatch formulated a complaint to AgeX’s principal investigator about the paucity of participant information, which  was rebutted by saying the approach had been approved by ethics committee. A similar complaint to the ethics committee was in turn responded to by deferring to the principal investigator’s assurances.

Effects of extending age range

Information about the balance of risks and harms may be particularly relevant for women over 70. The risk of developing breast cancer increases with age. In 2014 a prospective nationwide population based study of breast cancer screening in women aged 69-75 in the Netherlands reported a steep rise in the numbers of “early” cancers in the screened group, without significantly reducing numbers of advanced cancer cases. Effectively, screening was leading to many more older women “living with cancer,” with little effect on actual deaths from breast cancer. [iv]

Although such observational evidence may not be as powerful as that from a randomised trial, a study of this size should have flashed a warning light. Instead, in 2016 AgeX was amended to further extend the programme for older women, who would now be invited triennially at ages 71-76, or 71-79 subject to funding. Older women are less able to tolerate surgery than younger women because of increased likelihood of comorbidities, so overdiagnosis and overtreatment have a greater effect on their quality of life and physical function. This information should be made available to women considering screening.

We cannot yet know the full effects—good and bad—of extending the age range for breast cancer screening, but a study from Devon, southwest England, sheds light on one aspect: the numbers of extra surgical procedures in the younger women screened.

In Devon, all women aged 47-49 are invited to screening because Inhealth, the region’s breast cancer screening provider, is not permitted to take part in clinical trials. The results from the first year show that 4250 (76%) of the 5624 invited women in this age group were screened, resulting in 125 surgical outpatient consultations and 53 operations. This gives an indication of the short term extra surgical workload from screening women under 50, although as the study authors point out, estimating the longer term surgical and financial effect is more complex.

Women participating in the AgeX trial must be given the opportunity to balance the possibility of lesions being detected earlier (with more opportunity for breast conserving surgery) against real risks of harm. Extrapolating the Devon figures to all women in England screened before age 50 over the duration of AgeX, we estimate that several thousand women would need surgery. Given what we know about overdiagnosis in breast cancer screening from sources such as the Independent UK Panel on Breast Cancer screening , we know that a substantial proportion of this surgery will be unnecessary. The full financial and human costs of AgeX will also include extra general practitioner visits and physical and psychological harms from diagnoses of cancer that otherwise would not have caused problems during the women’s lifetime. The trauma of living with cancer can be lifelong, including lasting effects of surgery or other treatments, fear of recurrence, and loss of self esteem and body confidence. Research shows that when women are fully informed of the risks and benefits of regular screening, fewer opt to be screened.

Despite pressures on NHS budgets, AgeX increases the workload for the already stretched NHS breast screening programme by 14%. The resultingextra treatment also creates a considerable burden on the NHS.

Author’s conclusion

The balance of benefits and harms from breast cancer screening remains contested. Three years after AgeX began, an architect of the NHS breast cancer screening programmes (Pr Michaël Baum) argued that deaths after treatment of screen diagnosed breast cancer may exceed those from breast cancer in an unscreened population (https://www.bmj.com/content/346/bmj.f385).

In 2014, the Swiss medical board advised its government to stop recommending mammography screening.

 In 2016 an open letter from French scientists [v] who had conducted a consultation into France’s breast cancer screening for their ministry for health called for a halt to breast cancer screening for low risk women under 50, and an end or thorough review of the programme for women over 50.

People must be given sufficient information to decide whether they wish to participate in research, particularly when the risks are unclear. We recommend the National Screening Committee uses high quality fact boxes and icon arrays20 to support patient consent in AgeX and all screening programmes. We call on the investigators and verifiers of any data resulting from AgeX to use all-cause death as the primary outcome. An independent inquiry into the scientific quality, governance arrangements, and ethical issues arising from the trial would inform future high standards for the design and conduct of government run trials.

On the Health Watch website

Observers, including Susan Bewley, say :

Thousands of unnecessary mastectomies could be the result of encouraging women to participate in the government's AgeX study. 

The study, announced as "the largest randomized controlled trial in history," has already invited more than a million women to undergo breast cancer mammography screening without first making sure they are aware that the test could do them as much harm as good.

https://www.healthwatch-uk.org/news.html

Comment by Cancer Rose:

Even if the design of trials is based on randomized groups, women should be informed through flyers, posters, press, radio, television, social networks, etc. In this era of communication, there is no reason why women's right of access to information should be limited by so-called scientific necessities. Indeed, a lack of transparency and information given to the public is quite often linked to bad science.

The same could be said of the MyPeBS trial [vi]: the problems are similar, in the low-risk screening group, mammograms will start at age 40, instead of age 45 or 50 in the usual screening group. Women at moderate risk will have more mammograms than women in the usual screening group. Some women over 50 will have fewer mammograms and some will have more.

Financial costs will be increased and, more importantly, there is an increased risk of over-detection for women. For which scientific result? We already know the result. The design of this non-inferiority trial, with a 25% threshold, means that if the new screening results in 25% more advanced breast cancers, the new screening will nevertheless be considered "not inferior" to the usual screening. Even if the new screening has no effect at all on the incidence of advanced breast cancer and mortality, it will be considered equivalent to the usual screening.

Is it a simple coincidence that in MyPeBS, as in AgeX, information to participants is minimal? In the MyPEBS leaflet given to women, over-diagnosis is greatly minimized and over-treatment, a tangible consequence for women, is not mentioned at all.

Bad information given to patients is also, in the Mypebs trial, related to bad science.

OUR RAPID RESPONSE BMJ

"Rapid response" published in the BMJ

To download below, BMJ2019-364-I1293

References

[i] https://www.healthwatch-uk.org/


[ii]  an executive agency of the U.K. Department of Health and Social Affairs, resulting from the reorganization of the National Health Service (NHS) in England, assuming the role of a health protection agency

[iii] Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet 2012;380:1778-86. 10.1016/S0140-6736(12)61611-0 23117178

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3693450/

[iv] https://www.bmj.com/content/349/bmj.g5410

See also our article : https://www.cancer-rose.fr/la-campagne-pour-le-depistage-de-la-femme-agee-par-le-college-national-des-gynecologues-et-obstetriciens-de-france-cngof/

[v] Organized screening of breast cancers by mammography: to evolve. Letter to the Minister of Health. Prescrire 2016 Oct 14.

http://www.prescrire.org/fr/3/31/52235/0/NewsDetails.aspx

[vi] http://mypebs.cancer-rose.fr/

The issues of My PEBS, for our english speaking readers

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The largest clinical trial in Great Britain on breast cancer screening was halted

https://www.bmj.com/content/370/bmj.m3337.full

Summary by C. Bour, MD

27 August 2020

A major UK breast cancer screening trial called AgeX [1], was halted, more exactly inclusion and randomization of new participants will not resume.
Age X is the acronym of the trial founded by British Gouvernment: it is a controlled randomized trial set up to expand the age bracket determined by NHS (National Health Service) for the breast cancer screening in UK.

The trial investigates the incidence and mortality from breast cancer in different groups and aims to evaluate the risks and benefits of expanding mammography screening for breast cancer beyond the current age range of 50 to 70 years by providing an additional mammogram to women aged 47 to 49 and up to 73 years of age. Announced as "probably the largest randomized controlled randomized trial ever performed in the world," AgeX has randomized 4.4 million women to date in the expanded age groups.
Normally, the goal was to recruit a total of 6 million women in the trial in order to ensure statistical significance and draw conclusions.

This trial had generated a strong scientific controversy on both methodological and ethical arguments when it was set up in 2009, as the women included in the trial were unaware that they were part of it.

The contesting was brilliantly led by the HealthWatch UK site under the chairmanship of Professor Susan Bewley, but also by medical author Mitzi Blennerhassett and independent scientific editor Mandy Payne.[2] [3]

Here we have summarized the entire issue [4], the authors pointing first and foremost to the omission of the informed consent of participating women.

They also denounced the fact that screening does not demonstrate sufficient evidence of effectiveness, but instead, it can be harmful for women who are not fully aware of all these risks, and that the number of mastectomies could increase with the inclusion of more women, which were also uninformed.

Finally, to make sure of the informed consent of women in the AgeX trial as well as in all screening programs, Susan Bewley, Mandy Payne and Mitzi Blennerhassett requested the National Screening Committee to use high-quality text boxes and charts with visual pictograms.
They asked investigators and auditors of all data resulted from AgeX trial, to use the rate of death for “all-cause” as main result. Then finally, they called for an independent investigation of the scientific quality, governance mechanisms and ethical issues arising from this trial in order to identify future high quality standards for the design and execution of future government-sponsored trials.

Discontinuation of the trial

The trial was halted alongside other screening services to allow the NHS to cope with covid-19 [5].
The researchers have announced that randomization will not resume.
However, they said that follow-up by electronic linkage to routine government records will continue “throughout the 2020s and beyond.”
The AgeX website [1] now says, “Following the suspension of routine breast screening throughout the UK in March 2020 due to COVID, and the substantial and prolonged overload on breast screening services to be expected when screening restarts, the AgeX investigators decided in May 2020 that further randomisation into AgeX should cease permanently.”
The trial’s team said : “Although the intent had been to continue until about 6 million had been recruited, 4.4 million will, with sufficiently long-term follow-up, suffice”

The contesting continues, an inquiry is requested

Commenting on the trial, M.Blennerhassett said, “Having sat on a local research ethics committee, I was shocked that this trial had been approved. When I raised concerns my questions were not answered. I was simply referred to the NHS Breast Screening Programme website which, at that time, had no information regarding the trial.”
Susan Bewley told The BMJ, “Although covid will be credited with ending AgeX, this trial would not have stopped prematurely with no fanfare were it actually answering a necessary research question that had been through proper channels of peer review and funding.
“This largest randomised controlled trial in history has been criticised for having no statistical plan or oversight at onset, and repeatedly changing protocol, numbers, and endpoints. Four million women have already taken part in this unethical human experiment, without having had their understanding checked and giving their explicit informed consent.”
Susan Bewley has called for an independent inquiry “to learn the lessons of this government funded research, sponsored by the University of Oxford, and approved by the Human Research Authority that rode roughshod over women’s rights for a decade … We need to ask the question: who approved this, and how much did it cost?”

Références

[1] http://www.agex.uk/
[2] https://www.healthwatch-uk.org/projects/breast-cancer-screening-age-extension/122-age-extension-trial-of-mammography-screening-part-5-april-2019.html
[3] Bewley S, Blennerhassett M, Payne M. Cost of extending the NHS breast screening age range in England. BMJ 2019;365:l1293. doi: 10.1136/bmj.l1293 pmid: 30971394
[4] https://cancer-rose.fr/2019/04/10/3924-2/
[5] National Health Service

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International reactions to attempts to cover up screening failure in a publication

24 August 2020 by Cancer Rose

We have previously reported on a publication by Stephen Duffy and al. about the final results of the UK Age Trial on breast cancer screening by mammography [1].
This is the "nth" publication by this author, which attempts to show the benefits of screening mammography for women, even at an early age, in this case from the age of 40.
We explained that, contrary to the result that Prof. Duffy is victoriously brandishing, the most important statement of his study was :
"After more than 10 years of follow-up, no significant difference in breast cancer mortality was observed in the intervention group compared with the control group, with 126 deaths versus 255 deaths occurring in this period (0-98 [0-79-1-22]; p=0-86). Overall, there was no significant reduction in breast cancer mortality in the intervention group compared with the control group, with 209 deaths in the intervention group versus 474 deaths in the control group by the end of follow-up (0-88 [0-74-1-03]; p=0-13). »

Therefore, no benefit can be expected from screening.


But what does the international scientific community think of this study?


1) Position paper by Professor Anthony MILLER [2], professor at the University of Toronto [3].


Professor Miller is a leading expert in breast cancer screening since many years, as evidenced by his publications. [4] [5]
For this scientist, the absence of a control group without screening in the study is critical for drawing any conclusions about the interest and possible benefit of screening.
This point is essential, because the omission of a control group without any screening is a major shortcoming that we highlighted in another ongoing trial on screening, namely the MyPeBS study [6], a European trial that aims to compare a personalized screening strategy to the standard screening in 4 European countries and Israel.

Again, the use of a control group "without any screening" was carefully omitted, which was the only way to know whether or not screening would be beneficial compared to women who had never been screened.

While no conclusions can be drawn from a medical intervention without a control group which is not affected by the process being tested, Duffy and al. nevertheless assert :
"There was a substantial and significant reduction in breast cancer mortality, of the order of 25%, associated with the invitation to yearly mammography between age 40 and 49 years in the first 10 years."
It should also be noted that the 25% reduction (Relative Reduction) put forward by the authors is far from being "substantial", since the absolute reduction is actually only 0.04% [7].
Anthony Miller also contests, with references [8], the minimization of over-diagnosis, which Professor Duffy persistently tries to minimize in his demonstration: "Results with respect to breast cancer incidence suggest at worst modest overdiagnosis in this age group, and that any overdiagnosed cancers would otherwise be diagnosed at NHSBSP screening from age 50 years onwards. Therefore, screening in the age group of 40-49 years does not appear to add to overdiagnosed cases from screening at age 50 years and older. There might have been some overdiagnosis in the intervention group and during the intervention period, which was balanced when the control group received screening in the NHSBSP. However, we cannot directly observe or estimate overdiagnosis in a trial in which the control group also receives screening, albeit later than the intervention group. »

Studies on over-diagnosis are numerous and attest to this phenomenon in all age groups [10].
However, authors Duffy et al. concede: “we cannot directly observe or estimate overdiagnosis in a trial in which the control group also receives screening, albeit later than the intervention group”.

We therefore again come back to the fundamental obstacle: without a group free of any screening, no reliable conclusion can be drawn either on the benefits in terms of mortality or on the evaluation of over-diagnosis.

2) Other scientists


Journalist Jacqui Wise [11] published an analysis of this study in the British Medical Journal, including remarks made by other scientists about the study.

A-Reaction by K-J.Jorgensen [12]


Karsten Juhl Jørgensen, acting director of the Nordic Cochrane Centre in Copenhagen, told the BMJ : “Since the trial was initiated, breast cancer mortality in the UK in the included age range has been cut by half due to major improvements in treatment, including centralisation and specialisation of care, as well as better systemic treatment.
“…we can be reasonably sure that any benefit in absolute terms will be less today, as there are simply substantially fewer lives to be saved ».

The trial was originally planned to include 195,000 participants, but the number was revised due to slow recruitment. Jørgensen said, Jørgensen said, “As the 160 000 women enrolled in this study was not enough to show any difference in overall mortality, the study really cannot be used to conclude that ‘lives were saved.’
“The study tells us very clearly that any benefit of breast screening in this young age group is very small in absolute terms, as you would expect due to the inherently low risk of breast cancer death before age 40 years.”
In other words, it is impossible, in a population with a very low incidence of breast cancer (young women) [13], to conclude that a reduction in deaths can be obtained through screening. This is another factor that the author of the study has not taken into account.
Jorgensen also pointed out the number of false alarms experienced by women in the test group, i.e. 18% of the women during the trial period.

B-Reaction of V. Prasad [14]


For Vinay Prasad, Associate Professor at the University of California, San Francisco : “It is disappointing to see the authors of this study continue to promote misleading rhetoric ».
”Saves lives” said V. Prasad “means that women, as a result of doing this, live longer than those who do not do it. That did not occur in this dataset. Quite the opposite.” He added “The authors note a very small reduction in death from breast cancer which is tiny, and so small it does not impact dying for any reason.” [15].

D-Reaction from scientists of Sydney University in the Lancet.

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30528-3/fulltext

"An earlier report on the trial (Moss SM Effect of mammographic screening from age 40 years on breast cancer mortality at 10 years' follow-up: a randomised controlled trial.Lancet. 2006; 368: 2053-2060), where mean follow-up was 10·7 years, did not find a significant difference in breast cancer mortality between groups, and there was no breast cancer mortality benefit in the trial overall (after a median follow up 22·8 years). "

E- Two additional responses, from eminent scientists, were made to Wise's article in the BMJ [16]

First of all, the opinion of Professor Michael Baum, Professor Emeritus of Surgery and Invited Professor of Medical Humanities at University College London.
For Professor Baum there are only two significant outcome measures in the practice of medicine for the patients we follow: length and quality of life. All other outcome measures should be considered, in his view, as surrogates.
M Baum comments :
« This trial claims that screening woman under the age of 50 for breast cancer, will save lives without having a detrimental impact on Qof (Editor note : quality of life). Starting with the first claim let us look at the raw numbers without any modelling or “mathemagic”, and here I acknowledge the help of Dr Vinay Prasad. The percent of deaths from breast cancer in the intervention and control arms were, 0.39 v 0.44, whilst deaths from all causes were, 6.5 v 6.5. Little evidence for screening as a “life saver”.

“As there was no formal assessment of QoL then we have to make the assumption that over-diagnosis or false positive results might impact on the woman’s psychological wellbeing to which can be added the toxicity of any surgery, radiotherapy or systemic therapy as the consequence of over-diagnosis”.

M. Baum estimates, based on available data, that 35% of women experience false alarms and over-diagnosis during the intervention period, with the consequent impact on their quality of life. According to Michael Baum, the authors' conclusions are unfortunately mainly driven by an ideological attitude that is not worthy of scientists.


Next, the opinion of Hazel Thornton, Honorary Visiting Research Fellow in the Department of Health Sciences at the University of Leicester who also comments.
« Recruitment of the 160,921 women in this study took place from 1990 to 1997. We learn that women in the intervention group were unaware of the study. In other words, they were denied their right to consider whether they wished to participate in the study. Screening by mammography is not without potential for harm: properly informed consent should have been sought from these asymptomatic citizens. The fundamental principle of the Declaration of Helsinki, of respect for the individual and the right to make informed decisions, was ignored.[17]

For H. Thornton, the problem with organized screening is that it focuses on the women who benefit from it, while neglecting the hundreds of women who go through this public health process and suffer harm, in some cases even psychological harm.

H. Thornton also refers to the current pandemic and its economic stakes.
« They (Editor note, those who talk about saving lifes) seem unable to see the wasteful disproportionateness of their stance at a time when currently, in the UK, for example, 1.85 million people are waiting for treatments put on hold in this time of pandemic. Only Covid-19 seems to have had the power to put a stop to breast screening when evidence, reason and clamours for distributive justice have not. »

In conclusion


We therefore see that many international scientific personalities are questioning Professor Duffy's conclusions.
This study and the sound analyses show once again, and this against the conclusions of the author, that breast cancer screening by mammography does not bring any benefit.
We remind that all published studies, and even the Duffy ‘s study presented here as "positive", demonstrate year after year, the ineffectiveness of screening in reducing mortality from breast cancer.
More and more voices are being raised calling for an end to this ineffective screening that has adverse effects on women.
It is quite disturbing to note that the scientific controversy, now almost swept away by ever-increasing evidence of the ineffectiveness of the program, is once again being renewed by the beliefs and ideology of scientists, as raised by Mr. Baum, and that these beliefs and ideology are leading these scientists to engage in manipulations of figures in order to erase the bitter failure of the results of an old trial, which was very well conducted, and whose conclusions on the failure of screening are nevertheless implacable.
Moreover, as Jorgensen and Thornton point out, all of these screenings have a cost that would certainly be better used elsewhere, especially in this epidemic period. Not to mention the cost of false alarms, both financial and psychological, that women have to face.

In addition, as Thornton points out, there is a lack of informed consent, as well as manipulative information which are often used with women.
In the next two articles, we will refer to this crucial issue of informing women about screening, and we will relate how screening promoters deliberately manipulate the information they give to women, when they give it….

References


[1] https://cancer-rose.fr/en/2020/11/30/absence-of-benefit-from-mammograms-in-women-aged-40-50-years-confirmed-by-final-results-of-uk-age-trial/
[2] https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30428-9/fulltext?rss=yes
[3] https://www.dlsph.utoronto.ca/faculty-profile/miller-anthony-b/
[4] https://pubmed.ncbi.nlm.nih.gov/24519768/
[5] https://cancer-rose.fr/en/2020/12/30/impact-of-screening-mammography-on-breast-cancer-mortality/
[6] Read : https://cancer-rose.fr/en/2020/11/30/letter-of-4-collectives-on-the-subject-of-mypebs-study/
[7] https://cancer-rose.fr/en/2020/11/30/absence-of-benefit-from-mammograms-in-women-aged-40-50-years-confirmed-by-final-results-of-uk-age-trial/
[8] references quoted by A. Miller :
Forrest APM Aitken RJ,Mammography screening for breast cancer. Annu Rev Med. 1990; 41: 117-132
Marmot MG Altman DG Cameron DA Dewar JA Thompson SG Wilcox M-The benefits and harms of breast cancer screening: an independent review. Br J Cancer. 2013; 108: 2205-2240
Miller AB To T Baines CJ Wall C-The Canadian National Breast Screening Study-1: breast cancer mortality after 11 to 16 years of follow-up. A randomized screening trial of mammography in women age 40 to 49 years. Ann Intern Med. 2002; 137: 305-312
Miller AB Wall C Baines CJ Sun P To T Narod SA-Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. BMJ. 2014; 348: g366
Baines CJ To T Miller AB-Revised estimates of overdiagnosis from the Canadian National Breast Screening Study. Prev Med. 2016; 90: 66-71
[9] National Health Service Breast Cancer Screening,
[10] See part "overdiagnosis" in this article: https://cancer-rose.fr/en/2020/12/17/mammography-screening-a-major-issue-in-medicine/
[11] https://www.bmj.com/content/370/bmj.m3191
[12] https://www.bmj.com/content/370/bmj.m3191
[13] Hill C. Screening of breast cancer. Presse med. 2014 mai;43(5):501–9

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An unexpected side effect of the covid epidemic-19

The following is the view of two researchers regarding the long-term contribution of suspending cancer screening, to the advancement of cancer knowledge.


Gilbert Welch (Centre for Surgery and Public Health at Brigham and Women's Hospital and author of "Less Medicine, More Health")
And Vinay Prasad (oncologist, Associate Professor of Medicine in Oregon Health and Science University et auteur de "Malignant: How Bad Policy and Bad Medicine Harm People With Cancer")
https://edition.cnn.com/2020/05/27/opinions/unexpected-side-effect-less-medical-care-covid-19-welch-prasad/index.html


Synthesis by Cécile Bour, MD, 28/05/2020


We had already recently reported the views of Judith Garber, a political and health policy scientist at the Lown Institute, and also whose of Susan Bewley, Professor Emeritus of Obstetrics and Women's Health at King's College London and President of HealthWatch.

According to the authors, due to the fact that medical care services were overwhelmed by the epidemic, some patients certainly suffered harm on their health.
For others, though, the two authors suggest that the delay may have been beneficial.
In addition to the effect of the decrease in surgical interventions, emergency room admissions, requests for additional biological and radiological examinations, and the increase in telemedicine, the two researchers review the impact of suspending cancer screening.
Previous research on the global effects of physician strikes has suggested a decrease in mortality concomitant with reduced medical consumption. It therefore seems relevant to carefully study mortality trends in 2020 and to disentangle Covid-related deaths from other causes of death. It would be just as important to look at inequalities according to socio-economic background: the interruption of medical care may reduce mortality among the over-medicated wealthy, but the opposite phenomenon is feared among the poorest.

The screening area

Suspending cancer screening is one of the areas to be studied according to Welsch and Prasad. For them, there is no doubt that the decline in mammography will lead to a decrease in the number of breast cancers diagnosed. But is this a bad or a good thing?
This is a good opportunity to study what will happen in American cancer statistics when screening resumes, in the opinion of these authors.
They expect one of two observations:

  • Breast cancer rates might "catch up" with the delay in diagnosis, meaning the deficit in cancer diagnoses during the pandemic would be matched for by a surplus of cancers in subsequent years. In other words, any cancers not detected in patients during the pandemic would eventually be found afterwards.
  • The alternative would be that breast cancer diagnoses would never catch up…
    Why ?
    Years ago, researchers observed this phenomenon in Norway. Welsch and Prasad refer here to the famous Oslo Institute study of 2008: in a group, women aged 50-64 years had three mammograms in six years, and at the end of six years it turned out that they had more invasive breast cancers detected than women in the comparison group, who had only one mammogram after six years. If all breast cancers were expected to become symptomatic, there would have been as many in both groups. There is no reason why there should be fewer in the group that was not regularly screened, except that breast tumors that never expressed themselves and even regressed spontaneously were detected in excess in the group that had more frequently mammography. This study was at the origin of the demonstration and quantification of overdiagnosis. (See our brochure).

A mammographic procedure done later and less frequently therefore leads to fewer breast cancer diagnoses. It could be argued that this deficit eventually manifests itself in undetected tumors appearing within a longer time frame, around 5, 10 or 25 years. However, this is not the case; this deficit is never caught up even after 25 years of follow-up, as Miller's study shows.
The results of the 2008 Oslo study suggest that some small cancers regress on their own. Question: could this be happening now during the Covid-19 pandemic? And could it be highlighted?

In the article the authors also look at the decline in heart attacks and strokes observed during this period. These diseases were either under-diagnosed or there were actually fewer of them?
Who benefited from this period of less medicalization, and who lost?

Conclusion of the authors

We won't find the benefits unless we look for them, say Prasad and Welsch. We need physician-researchers who are willing to ask hard questions about the services they provide - questions that may threaten their own professional/financial interests.

Covid-19 provides a once in a lifetime opportunity to study what happens when the well-oiled machine of medical care downshifts from high to low volume in order to focus on acutely ill patients. It will be comfortable for physician researchers to study what was lost. It will be courageous for them to study what was gained.

Our opinion

Here, the two researchers present and highlight the question of overdiagnosis and discuss its causes (spontaneous regression of a slow-growing/null tumor), rather than trying to quantify it.
Indeed, the period of suspending screening is likely to be too short for examining its impact reliably. For that it would require that the interruption last two or three years or more (as in the Oslo study comparison group, where the time period for mammography non-examination in the comparison group was 6 years), and that this interruption concerns people who would have been eligible within that time period, according to the initial schedule, as well as that there be no attempt to catch up with the delay.
In our situation, only a few months of over-diagnosed cancers will disappear.
Already in our country the INCa has been rushing, although the epidemic is not yet totally behind us, to send a note to the ARSs (Regional Health Agency) asking to set up a timetable to catch up with the screenings not carried out! (Page 2)
"A plan to catch up on screening not carried out will be established by each CRCDC (regional coordination centers for cancer screening), depending on the estimated number of screenings not carried out and on the epidemiological situation in the territories, its own resources and the methods for resuming activity".
It should be noted that there is an obsessively technocratic concern about the activity indicators of the screening centers, there is no question of reflecting on the possibility of a study based on the data collected during the suspension of screening period, no, it is a question of catching up on indicators that would have lagged behind schedule for the last three months.
A Danish physician colleague confirms that in Denmark, as well, the reactivation has also taken place, and it is not lagging behind….


Another reflection is that if we will find only a slight reduction in incidence due to the short duration of suspending cancer screening, it will be very difficult to detect reliably the eventual compensatory increase mentioned by the authors, or on the contrary the absence of a compensatory increase, not to mention the fact that tumors that disappear by themselves (the over-diagnosed) need nevertheless at least several months, if not years, to disappear.

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.