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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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.

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.

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