In the journal “Pratiques”, Dr Marc Gourmelon reviews the history of breast cancer screening in France, from the launch of organized screening campaign, through citizen consultation, until the current situation with the new 2021/2025 cancer plan endorsed by President Macron, in a climate of deafness of authorities to citizen demands and despite the failure of this screening. All of this is against women's right to fair information on the risk-benefit balance of this screening.
Here this article translated
Marc Gourmelon, Medical doctor, member of the Cancer Rose collective
Where are we today in France, regarding breast cancer screening by mammography in women aged 50 to 74 years old without an increased risk of breast cancer?
Historical reminder of the introduction of breast cancer screening by mammography in France
Mammography (breast X-ray) is a radiological examination for diagnosis of any abnormalities detected in breast. It became common practice in the late 1960s with the arrival of the first mammograph in 1965. [1] [2]
Two randomized screening experiments are believed to have proven the effectiveness of mammography on mortality reduction.
These are the New York HIP trial (1963) and the study of two counties in Sweden (1985, 1997).
The published results were identical: a 30% reduction in mortality in the screened group compared to the control group in women over 50 years of age. This resulted in great enthusiasm leading several countries (United States, Sweden, Finland, United Kingdom, the Netherlands and others) to the decision to launch systematic screening campaigns by mammography.
In France, systematic breast cancer screening by mammography was first launched in ten pilot departments in 1989.
Thanks to this screening, it is believed that women would no longer have to die of breast cancer and the disease would be defeated on the basis of an a priori intuitive concept: the smaller or "in time" a cancer is caught, the less serious it is and the quicker it can be removed, thus the more advanced forms of cancer will be averted for women.
Starting in the 1990s, an increasing number of doctors began offering this imaging technique to detect breast cancer, and many studies were carried out in parallel on the subject.
A report from the French National Agency for Health Accreditation and Evaluation (ANAES) dated March 1999 assesses relevance in general population. It recommends the breast cancer screening for all women between 50 and 69 years of age, to be performed every two years. [3]
Based on this recommendation, the cancer plan 2003-2007 in its measure 21, notes: "Fulfilling the commitment to generalize organized breast cancer screening by the end of 2003".[4] Organized screening of breast cancer by mammography, under the impetus of President Chirac, will then be generalized in France in 2004.
However, voices of national and international scientists have been raised, as early as 1987, urging caution, but inaudible in the climate of general euphoria. [5]
In 2001, the independent Nordic collective Cochrane published a meta-analysis, updated several times [6], which questions benefits of this screening.
Nevertheless, the French High Authority for Health (HAS), which evaluated this study in early 2002, refused to question the relevance of organized breast cancer screening. [7]
Despite the accumulation of studies and evaluations in recent years, today the organized screening of breast cancer by mammography is still recommended by the health authorities ( French High Health Authority, National Cancer Institute) on the basis of 2004 guidelines.
The objective is even to intensify it, because the participation targets for eligible women (50 to 74 years old) set at 70 or 80% have still not been reached.
In fact, participation in the organized breast cancer screening program represents only slightly more than 50% of women.
At the same time, the number of mammographers is constantly expanding and cutting-edge technology, such as tomosynthesis, a type of 3D imaging, is being studied to track down more and more small lesions, contributing to a surge in incidence of cancers without a significant reduction in mortality. (still 12,000 deaths/breast cancer/year).
Proponents of EBM (the concept of tripod-based medicine - scientific studies, physician's professional experience, and patient preferences and choices) advocate enlightened information and shared decision-making with the patient, who must be informed of the uncertainties of screening. This concept is defended in France by the independent journal Prescrire. In the United Kingdom and Canada, very detailed brochures are issued to patients, while in France this is not the case.
But what about the real effectiveness of this screening?
The effectiveness of cancer screening is defined by :
- a drastic and significant reduction in mortality from the disease,
- a reduction in incidence of advanced cancers,
- a lightening of treatments.
The meta-analysis of the Cochrane collective that we have just mentioned above alerts us of an unexpected guest of screening, namely overdiagnosis. This concerns the discovery of cancerous and pre-cancerous lesions which, undetected, would not have endangered the woman's health or life, but which will all be treated with the same determination.
Together with false alarms, that is, suspected cancers that are not confirmed after further examinations of the patients, the risk-benefit balance of screening does not appear to be favorable. For the Cochrane, for every 2,000 women screened over 10 years, for one life saved, there will be 10 overdiagnosed and overtreated women and 200 false alarms. In the years following this publication, international and national studies on the benefit/risk of breast cancer screening by mammography have multiplied and have highlighted an important issue: an increasing overdiagnosis of small lesions (<2 cm) and precancerous lesions responsible for overtreatment, and a parallel reduction in mortality that is very minimal, little or not perceptible. [8] [9] [10]
Indeed, when comparing populations of women subjected to different screening intensities, we find that among women screened, more cancers are found for identical survival in both groups. [11]
Overtreatment is the materialization of overdiagnosis for women, and it has destructive effects.
Women are doubly victims, in their body and in their illusions, convinced that they have been "saved" while they are suffering the stress of a ruined life and the potentially major adverse effects of treatment.
Treatments are primarily surgical, with an increase in total and partial mastectomies since screening, contesting the widespread myth of therapeutic lightening through screening. [12]
Women also undergo unnecessary radiation therapy with cardiac risks and an increased risk of hemopathy. [13] [14]
The quality of their lives is diminished; after being diagnosed with cancer, women suffer from anxiety and depression syndromes, some lose their jobs and become poorer. Their sexuality and self-image are altered, sometimes leading to suicide. [15]
Thus overdiagnosis leads to a number of deaths that are not reliably measured but which, when taken together, could be major, as a British study suggests. [16]
This problem of overdiagnosis took a long time to be recognized by health authorities in charge of organized screening.
Today, this has been done, but this crucial issue, which must be taken into account when assessing the risk-benefit balance of screening, is greatly minimized.
In the 2015 HAS document [17], overdiagnosis is well mentioned, but, taking up only a few lines of the nearly one hundred pages of the report, it is completely drowned out in explanations of the value of screening; therefore, it goes unnoticed.
Furthermore, when it comes to independent scientific studies questioning the value of screening, the HAS document uses the terms "controversy" and "polemical", which inexpensively discredits the debate on the subject.
The document is still in force today, and is very poor in terms of bibliography supporting the interest in pursuing organized screening.
This makes it a very partial document, contrary to what should be expected from a state agency.
The INCa (National Cancer Institute) has also continued throughout these years the same shortcomings in the information provided to women on the subject.
We have just seen that for health authorities, for politicians who decide on successive cancer plans, the question regarding effectiveness of breast cancer screening by mammography is not raised.
They do not question the effectiveness of this screening and they are aiming to intensify it, even though independent meta-analyses, international studies and epidemiological data from the countries where screening takes place tend to show that the objectives of screening effectiveness are not being met :
- Not only does screening significantly increase the incidence of cancer without significantly decreasing the risk of dying from breast cancer, -but also does not make it possible to treat less aggressively, or to reduce advanced forms of cancer that desperately remain at an unchanged rate, in all countries where screening is in place.
The citizen consultation on breast cancer screening by mammography in 2015
Several observations prompted the Minister of Health at the time, Marisol Touraine, to initiate in 2015 a scientific and citizen consultation on breast cancer screening:
- The stagnation of the participation rate of women, which does not exceed 50% instead of the initial 70% objective.
- The variability of participation according to territories and socio-economic groups.
- The growing extent of the debate on benefits and risks of screening, both within scientific and medical spheres and among general public, regularly covered by mass media.
The Cancer Rose collective, of which I am a member, was auditioned during two round tables, one with citizens and the other with health professionals.
Our collective, made up of doctors and a toxicologist, came together with the objective of providing women and healthcare professionals with all independent and recent scientific information available.
Thus, we have developed and launched an website that aims to convey information that will allow women to make an informed decision on the stakes of screening, in an objective manner, without being influenced by media and promoters of the pink campaign.
This collaboration has already led to the development of an information brochure as well as various informative and educational materials.
The report of the scientific and citizen consultation was published at the end of 2016. [18]
The conclusion is very clear: the organized screening program should be stopped based on the two proposed scenarios (see page 132 of the report [19]):
Scenario 1: discontinuation of the organized screening program, relevance of mammography being assessed in the context of an individualized medical relationship.
Scenario 2: Cessation of organized screening as it exists today and implementation of a new organized screening, profoundly modified.
Following the release of this report, INCa sent a letter to Minister Marisol Touraine, dated September 16, although we only became publicly aware of the report on October 2. Professor Ifrah, President of INCa, calls Scenario 1 in this letter a "textbook case" and dismissed it out of hand, thus reducing half of the work to a negligible amount. [20]
Voices were raised, scandalized by such a denial of health democracy. [21]
An action plan is then published by Mrs. Marisol Touraine who entrusts the renovation of the screening to... INCa, the same institute whose lack of information for women was heavily criticized throughout the consultation report.
Currently, in 2020, the citizens' demand of 2015 to stop the current screening is still unheard, the pink campaigns are going well, and this public health program is therefore continuing according to the 2004 plan.
The implementation of a "new, profoundly modified organized screening" based on individual risk is underway with the launch of the MyPeBS study [22].
This is a randomized, non-inferiority study comparing women randomly divided into two groups. One group will consist of women who are routinely screened according to current official recommendations, and the other group will consist of women who are individually screened based on an assessment of their personal risk of developing invasive cancer during their lifetime.
This study poses many problems, ethical (consent form given to women omitting overtreatment and minimizing overdiagnosis), and methodological (absence of a "no screening" arm of the study, recruitment of women as young as 40 years old with annual mammograms for risk groups without information on radiotoxicity), software for calculating individual risk without scientific validation .
And since 2015?
Nothing has happened, apart from continuity in the promotion of organized screening.
Breast cancer screening is still included in the Public Health Objectives Remuneration ( ROSP), but it must be recognized that the objective asked to the general practitioner (between 60 and 70% participation of patients) is very difficult to reach in order to get the maximum of this remuneration.
Every year, October month turns pink with multiple incentives for women to be screened. 2020 was no exception to the rule.
Broadcasts for general public (Stars à nues) on TV channels are making an unbridled and uncontrolled promotion of the screenings without any authority being concerned, nor the CSA Higher Council for Audiovisual that we had alerted.
What are the observations arising from these facts?
It was decided by the authorities to set up organized breast cancer screening by mammography in 2004 when already early warners were expressing their doubts. Fifteen years later, knowledge on the subject has been enhanced. A large number of studies have been published that are consistent on a perceptible lack of benefit from breast cancer screening by mammography, and on the presence of risks whose reality is tangible and accountable. According to the most recent studies, overdiagnosis now concerns one-third to one-half of the cancers detected by mammography [23].
According to the journal Prescrire, for every 1,000 women over the age of 50 participating over a period of 20 years, there are approximately 1,000 false alarms in France, leading to 150 to 200 biopsies, sometimes several on the same woman during her successive screenings [24].
So why is it important for the French authorities to continue this screening, since women who undergo it do not gain any conclusive benefit from it?
Several possibilities can be evoked.
- After having literally conjured up women, for three decades, to get screened, through slogans and media campaigns, it seems difficult for the health authorities and opinion leaders promoting it to disregard it.
- Conflicts of interest among certain actors in the field of screening cannot be denied and weigh heavily on the omerta that reigns over the scientific debate in France [25] [26].
- Beliefs based on intuitive concepts are often easier to anchor ("sooner is better", "finding earlier saves lives") than explanations of the much more complex natural history of cancers in real life. This requires a longer pedagogy and explanatory development, to make people understand why some cancers remain indolent for a lifetime, why people can die with their cancer but not because of it, why others are fast and kill their host no matter is done, screened or not.
- Obvious laziness in tackling true prevention contributes to the persistent buzzing of well-oiled pink campaigns.
- Primary prevention remains the weak side of public health in France. Smoking, alcohol, but also obesity and a sedentary lifestyle are among the risk factors for cancer in general.
In addition to many other social factors, such as poverty, night work, certain professional environments are well known as risk factors for developing breast cancer and other cancers.
But few resources are invested in massive campaigns to combat smoking, alcoholism, obesity and these socio-professional factors.
They would certainly be more relevant than Pink October campaigns or health fair shows that are inflicted on women with coercive and scary messages.
In this respect, the latest cancer plan 2021/2025 announced by President Macron on February 4, 2021 is symptomatic: even if it talks about tobacco and alcohol, it largely confuses prevention and screening, giving the latter a clear advantage at the expense of prevention policies worthy of this name [27].
Conclusions
It is particularly difficult for the public, faced with opposing opinions and a highly technical debate, to get a clear idea of realities at hand.
The health sector has seen in this year 2020, during the coronavirus crisis, medical "clashes" with diametrically opposed opinions.
How can one cope as a layperson who has no expertise on the subject?
This is exactly the problem that every woman who is asked to get screened has to face.
This is all the more difficult for her, since the authorities are "Blind" with regard to the scientific knowledge they have acquired, and "Deaf" to all questions on the subject.
This is why I think it is necessary that all women be aware of this simple infographics, based on the evaluation of the Cochrane review, in concordance with other audited evaluations, whose results have never been contested by the international scientific community [28].
This simple visual, summarizing the entire issue of screening, must be given to women BEFORE they undergo the organized screening test for breast cancer.
References
[1] Tabar L, VitakB, Chen HH et al.The Swedish Two-County Trial twenty years later. Updated mortality results and new insights from long-term follow-up, Radiol Clin North Am 2 000 ; 38:625-51.
[2] Efficacy of screening mammography : Kerlikowske K, Grady D, Rubin S M, Sandrock C, Ernster V L. Efficacy of screening mammography : a meta-analysis. JAMA 1995 ; 273(2) : 149-154.
[3] https://has-sante.fr/upload/docs/application/pdf/mamo.pdf
Recommendations :
Routine screening is recommended in the 50-69 age group.
In the general population, the benefit of breast cancer screening in terms of avoided mortality is demonstrated in the 50-69 age group. Therefore, in this age group, routine screening is recommended.
In the 70-74 age group, the incidence of breast cancer is high, but data on mass screening are scarce. Taking into account the large-scale organizational difficulties, extending screening to this age group currently seems premature in France. On the other hand, it is logical to recommend the continuation of screening between the ages of 70 and 74 for women previously included in the systematic screening program between the ages of 50 and 69.
[4] https://www.e-cancer.fr/content/download/59052/537324/file/Plan_cancer_2003-2007_MILC.pdf
5] In 1998, Professor Paul Schäffer of the Bas-Rhin Laboratory of Epidemiology and Public Health (faculté́ de médecine de Strasbourg), in charge of the evaluation of screening, published an article in the French Medical Council's Bulletin 19.
"Tumour screening campaigns: caution is needed. "Screening should not be harmful. If it can bring health benefits, its potential to harm individuals should not be forgotten.For reasons of efficiency and ethics, preventive action should not have major disadvantages.
[6] https://www.cochrane.org/fr/CD001877/BREASTCA_depistage-du-cancer-du-sein-par-mammographie
7] "Gotzsche and Olsen's meta-analysis challenges the consensus on the effectiveness of breast cancer screening. "and : "The evaluation of Gotzsche and Olsen's meta-analysis, carried out by ANAES with the help of a multidisciplinary group of experts, concludes that it is not legitimate to question ANAES' recommendations in favour of breast cancer screening. »
[8] Breast Cancer Screening, Incidence, and Mortality Across US Counties,Charles Harding, AB ; Francesco Pompei, PhD ; Dmitriy Burmistrov, PhD ; et alH. Gilbert Welch, MD, MPH ; Rediet Abebe, MASt ; Richard Wilson, DPhil, JAMAIntern Med. 2015 ;175(9):1483-1489. doi:10.1001/jamainternmed.2015.3043
The results of this 2015 study :
- An increase in the number of breast cancer diagnoses (+16% for a 10% increase in screening participation), mainly by tumors smaller than 2 cm.
- No reduction in breast cancer mortality.
- No reduction in the number of advanced breast cancers.
- No reduction in mastectomies.
[9] RevuePrescrire 2006 https://www.prescrire.org/aLaUne/dossierKcSeinDepSyn.php
"In terms of total mortality, a benefit of mammographic screening in the general population has not been demonstrated. If there is an effect (positive or negative) on total mortality, it is small. »
10] Mammography screening: A major issue in medicine, Philippe Autier, Mathieu Boniol, Eur J Cancer, 2018 Feb ;90:34-62. doi : 10.1016/j.ejca.2017.11.002.
The strong points :
- After 20 to 30 years of mammography screening, the incidence rates of advanced and metastatic breast cancer have remained stable.
Breast cancer mortality rates have not declined more rapidly in areas where screening mammography has been in place since the late 1980s.
- One-third to one-half of breast cancers detected by mammography are estimated not to be symptomatic during a lifetime (overdiagnosis).
- Randomized trials of breast cancer screening have adopted distinctive methods that have led to exaggerated screening effectiveness.
- The influence of mammography screening on mortality decreases with the increasing effectiveness of cancer therapies.
11] Twenty year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial, Miller AB, Wall C, Baines CJ, Sun P, To T, Narod SA, The BmJ, 2014 Feb 11;348:g366.
Conclusions :
- No difference in mortality between the two groups (mortality = number of deaths relative to the total number of people screened).
- Survival rates are identical, regardless of the stage of the tumour at the time of detection (by screening for some, by a symptom for others).
22% over-diagnosis
- No difference between the two groups in the rate of fatal cancers.
[12] Le dépistage organisé permet-il réellement d’alléger le traitement chirurgical des cancers du sein ?, Vincent Robert, Jean Doubovetzky, Annette Lexa, Philippe Nicot, Cécile Bour, Revue Médecine, Volume 13, numéro 8, octobre 2017.
https://www.jle.com/fr/revues/med/e-docs/le_depistage_organise_permet_il_reellement_dalleger_le_traitement_chirurgical_des_cancers_du_sein__310529/article.phtml
[13] Causes of death after breast cancer diagnosis : A US population‐based analysais, Ahmed M. Afifi MBBCh, Anas M. Saad MD, Muneer J. Al‐Husseini MD, Ahmed Osama Elmehrath, Donald W. Northfelt MD, Mohamad Bassam Sonbol MD, ACS Journal, 16 December 2019
https://doi.org/10.1002/cncr.32648
[14] Evaluation of the Incidence of Hematologic Malignant Neoplasms Among Breast Cancer Survivors in France, Marie Joëlle Jabagi, PharmD, MPH, Norbert Vey, MD, PhD, Anthony Goncalves, MD, PhD, Thien Le Tri, MSc, Mahmoud Zureik, MD, PhD, and Rosemary Dray-Spira, MD, PhD, JAMA Netw Open, 2019 Jan ; 2(1) : e187147.
Published online 2019 Jan 18. doi : 10.1001/jamanetworkopen.2018.7147
[15] Bouhnik AD et Mancini J, « Sexualité, vie affective et conjugale » In La vie deux ans après un diagnostic de cancer - De l’annonce à l’après cancer, collection Études et enquêtes, INCa, juin 2014, 454 pages.
[16] Harms from breast cancer screening outweigh benefits if death caused by treatment is included, BMJ, 2013 ; 346 doi : https://doi.org/10.1136/bmj.f385 (Published 23 January 2013). Cite this as : BMJ 2013 ;346:f385 - https://www.bmj.com/content/346/bmj.f385
Michael Baum, professor emeritus of surgery, Division of Surgery and Interventional Science, University College London, London WC1E 6BT, UK
[17] https://www.has-sante.fr/jcms/c_2024559/fr/depistage-et-prevention-du-cancer-du-sein
[18] https://www.e-cancer.fr/Institut-national-du-cancer/Democratie-sanitaire/Concertation-citoyenne-sur-le-depistage-du-cancer-du-sein
[19] http://www.concertation-depistage.fr/wp-content/uploads/2016/10/depistage-cancer-sein-rapport-concertation-sept-2016.pdf (read: https://cancer-rose.fr/en/2020/12/14/final-report-of-the-citizen-consultation-report-of-the-steering-committee/)
[20] https://www.atoute.org/n/IMG/pdf/Courrier-Ministre-concertation-depistage-cancer-sein---.pdf
[21] https://formindep.fr/cancer-du-sein-la-concertation-confisquee/
[22] https://cancer-rose.fr/my-pebs/ (read: https://cancer-rose.fr/my-pebs/2019/06/13/argument-english/)
23] Mammography screening : A major issue in medicine, Philippe Autier, Mathieu Boniol,
Eur J Cancer, 2018 Feb ;90:34-62. doi : 10.1016/j.ejca.2017.11.002.
[24] Revue Prescrire, février 2015/Tome 35 N°376.
[25] https://www.atoute.org/n/article308.html
[26] MitcHell ap, BascH em, Dusetzina sB. Financial Relationships With Industry Among National Comprehensive Cancer Network Guideline Authors, JAMA Oncology, 2016 Dec 1 ;2(12):1628-1631.
[27] https://cancer-rose.fr/2021/02/08/nouveau-plan-cancer-2021-2030-une-planification-sovietique/
[28] https://www.hardingcenter.de/en/early-detection-breast-cancer-mammography-screening