Perception and reality

3 jan. 2017

How women perceive the data from screening, influenced by optimistic slogans and presentations, versus reality:

When the authors of the report of the Swiss Medical Board (a Swiss medical commission independent from government authorities) evaluated the relevance of the mammographic screening program for breast cancer (see article), (PDF Article) they looked at one data that had been studied in several countries (4), namely how women perceive the benefits of screening according to what has been communicated about it and the information they have received, and that have made their beliefs on the subject.
The authors have presented a comparative table, with data gathered from the perception survey of American women in Part A, and real, objective data from the most probable scenarios, observed from the most convincing and among the most reliable studies in Part B (1-3)
The authors were astonished by the significant discrepancy between women's beliefs about the benefits of screening and reality.


The projected number of women in their fifties who would survive, develop breast cancer and die from other causes while doing regularly screening over 10 years, was compared to the expected number of women who would survive, develop breast cancer or die from other causes, and not doing screening.

71.5% of these interviewed American women estimated that screening mammography reduced by half the risk of dying from breast cancer, and 72.1% believed that at least 80 deaths would be prevented for every 1,000 women invited for screening.
The presentation of mortality risk reduction as a percentage embellishes the data.
A 20% reduction in mortality (a figure found on public institution websites, women committees websites and in the information brochures distributed to women) does not mean that 20 out of every 100 women will die of breast cancer, but that only one less woman will die of it in the best case (and without considering the other, more numerous women screened, who will at the same time suffer from overdiagnosis and false alarms).
The relative risk reduction of 20% corresponds to a comparison between the screened and unscreened groups. If, for example, 5 out of 1000 unscreened women die and 4 out of 1000 screened women die of breast cancer, the relative risk reduction resulting from the comparison of these two groups corresponds to this 20% ((5-4)/5=0.2 ), but in absolute terms it is only one woman who is saved. The data that the authors have collected for the Swiss population show also these optimistic expectations in a similar way.

The authors legitimately ask the question, how can women make an informed decision if the benefits of the screening program are overestimated?
We asked ourselves the same question…and tried to answer it (see the brochure on the home page).

REFERENCES

1-Gotzsche PC, Jorgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev 2013;6:CD001877-CD001877
Medline

2-Independent UK Panel on Breast Cancer ScreeningThe benefits and harms of breast cancer screening: an independent review. Lancet 2012;380:1778-1786
Medline

3-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-g366
Medline

4-Domenighetti G, D'Avanzo B, Egger M, et al. Women's perception of the benefits of mammography screening: population-based survey in four countries. Int J Epidemiol2003;32:816-821
Medline

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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.

Radiotoxicity and breast cancer screening: caution, caution, caution…

 Dr Annette LEXA (PhD Toxicology)

July 2, 2019

In October 2017, I published on this site, an informative article on the risk associated to radiotoxicity[1] explaining that 15 years of research performed by the Radiobiology Community UMR 1052 INSERM (a joint research unit within the National Institute for Health and Medical Research, Lyon) demonstrated that we are not equal when exposed to radiation. Moreover, this issue is not a new one in authorized environments, as the ASN (Nuclear Safety Authority) had already been concerned about it in 2003, calling for study and protection of populations at risk “through the evolution of medical practices with regard to ionizing radiation and an eventual evolution of regulations”.
We are now in 2019, the data is accumulating and nothing is moving. The main reason for this is the lack of disciplinary transversality: while radiotherapists and radiophysicists are regular collaborators, radiobiologists are rare and less involved in therapeutic choices.
Although radiotherapists point out problems with the physical doses received, biological factors are the ones that explain the dramatic reactions of patients, causing them to interrupt the radiotherapy, which is nevertheless necessary.

It should be mentioned that the current regulatory context[2] resulting from the amendments to the Labor Code and the Public Health Code introduced in 2002-2003, is based, in particular, on the monitoring of the 120,000 survivors of Hiroshima-Nagasaki. We are now facing a paradigm shift that is changing our view of radiation-induced events. Advocates of hubris around early cancer screening have not thought for a moment about this paradigm shift: early screening will induce even more medical imaging, overdiagnosis, overtreatment, and radiation-induced cancers in young and healthy women.

It is absolutely necessary that this new paradigm be implemented into legislation, good medical practice, population screening campaigns as well as all in clinical and epidemiological studies (such as the vast European study My PEBs, which enlists women as young as 40 years of age without the slightest precaution, without information or informed consent on this subject[3]). It's no longer a matter of the precautionary principle, it's a matter of prevention, because we can no longer say "we didn't know."

Mechanisms involved

Radiation induces chromosomal effects resulting in well-known anomalies (micronucleus, translocation, insertion) which are the manifestation of double-strand breaks (DSB) of poorly repaired DNA. Poor repair of DSBs is the most serious event that the double helix of DNA can undergo.

For the same dose of absorbed radiation, our cells undergo 40 DSB / Gy (Gray is the unit of measurement used in medicine to quantify irradiation). However, DBSs are already occurring at 1mGy and the effect is significant at around 100-300 mGy, so we talk about hyper-radiosensitivity to low doses. It is the persistence of unrepaired lesions that counts and it is on the signalling and repairing of our DNA that we are not all equal face to radiation.

In humans, there are two ways to repair DSBs: end-joining (predominant) and recombination. This is the model of a perforated sock, explained by Nicolas Foray: either we place the two pieces together and join them together (end joining) or we make a patch when the hole is too large, as our grandmothers used to do (recombination).The end-joining repair model is a source of error that can result in a high radiosensitivity and severe immunodeficiency. Recombination repair pattern necessarily causes breaks in other regions of DNA, as a piece of DNA has to be removed to repair the first break, resulting in DNA chain damage.

There is a distinct category of proteins known as 'tumour suppressors' which are involved in DNA signaling and repair. They function well in homozygous individuals [4] for these proteins such as BRCA1, BRC12, p53, Rb…

  • Heterozygous BRCA1+/- mutations in the BRCA1 protein, responsible for the majority of familial breast and ovarian cancers, increase the risk of cancer by a factor of 6 to 10. BRCA1 is closely related to the ATM[5] protein involved in the signaling of DSBs and would be indispensable for the action of the Rad51[6] protein involved in the repair by recombinant DNA.
  • The heterozygous BRCA2 +/- mutations are implicated in ovarian and male breast cancer. The BRCA2 protein interacts with the RAD51 protein for DNA repair.
  • Overexpression of the Rad51 protein induces hyper-recombinations, a source of high genetic instability leading to tumour processes. We are now aware that radio- sensitive individuals overexpress hyper-recombinations leading to radio-induced cancers.

The research carried out by the Radiobiology Group identified three population groups according to their resistance to radiation:

  • Radioresistant (Group I)75-85% of the population: ATM cytoplasmic protein in dimeric form, very good recognition of DBSs, no predisposition to cancer.
  • Moderate radiosensitivity (Group II) 5-20% of the population: delayed transit of the ATM protein in the nucleus, poor recognition of DBSs, poor repair, moderate radiosensitivity, high risk of cancer.
  • Hyper radiosensitivity (Group III) >1% of the population: mutation of the ATM protein, poor recognition of DBSs, poor repair, hyper-radiosensitivity, high risk of cancer.

Radiosensitivity of DNA to low doses of ionising radiation

We already know that the breast is a radiosensitive organ. Mammography, by performing successive images, results in a repetition of low doses of 2 mGy sent at 3 minutes intervals. These radiations will induce a tissue reaction in some women: cellular apoptosis [7], double-stranded DNA (DSB) breaks with late repair defects which can induce either secondary cancer from improperly repaired cells or cell death. When the control mechanisms are efficient, cell death is more likely than its transformation into an immortal cancer cell line.

This radiosensitivity has been known for a long time in radiotherapy, its late, long-lasting and very difficult to treat expected effects (burns, necrosis, fibrosis, apoptosis) affect 5-15% of patients treated for cancer (8,000-25,000 people per year).

Extreme radiosensitivity exists in several rare genetic deficiency syndromes (ataxia telangiectasia, progeria, xeroderma pigmentosum, Huntington's chorea, Fanconi anaemia, Li-Fraumeni syndrome, etc.): patients who are homozygous for the genes involved are unable to tolerate the doses used in medical imaging. Although these cases are rare but detectable, it is possible that in the general population a large number of heterozygotes may be observed, a source of genomic instability for these carriers and causing problems during repeated radiotherapy and medical imaging.

Radiosusceptibility signs a predisposition to radiation-induced cancers even at low doses

The effect is random, probabilistic and will concern 5% of patients who have received radiotherapy. They are likely to develop with a high probability a secondary radiation-induced cancer, knowing that these patients affected by cancer are already more radiosensitive than the majority of the population.
This radiosusceptibility is increased in mammographic conditions (images delivering 2+2 mGy at intervals of 3 minutes with immediate repetition, preventing the mutated genomes from setting up signalling and successful repair). Women at high family risk of breast cancer (15% of breast cancer cases) have defects in signalling and repairing of their DNA: this is the case of the BRCA1 protein, which is at the heart of the complexes formed to repair the DNA DBSs. But women carrying a mutation of this gene which has thus become defective, and who are therefore more likely to develop cancers because their DNA has not been properly repaired, are encouraged to undergo close monitoring at an early stage, with a combination of mammograms and even tomograms. Some doctors - who do not know anything about radiosusceptibility - require them to undergo examinations every 6 months or every year, while the greatest caution should be applied: spacing of at least ½h at 1 hour from the x-rays (50% of DBSs are normally repaired within 50 minutes), avoid contrast products and x-rays.

Time for conclusion

This knowledge implies a new screening strategy for women at high family risk (such as taking a single mammogram, proposing MRIs and ultrasounds that do not emit ionising radiation). It also calls into question the continuation of organised screening such as outlined in Law 2004-806 of 9 August 2004 on public health policy, consolidated version as of 16 April 2019. No one has ever thought of questioning French radiobiology specialists on this "point of detail".
Work is currently underway to validate predictive tests for radiosensitivity before any radiotherapy.

While awaiting the availability and reimbursement of easy and inexpensive predictive tests for all the tens of millions of women, young and not so young, but above all healthy women, enrolled in mammographic screening, this knowledge of the biological causes of radiosensitivity and radiosusceptibility requires, on the basis of the precautionary principle, that the project of extending mammographic surveillance of young women should be stopped. Radiologists, gynecologists and oncologists must be informed of the risks of radiation-induced cancers to that they are exposing their patients with this regrettable "life-saving screening". Don't we say that hell is paved with good intentions? Don't we also say that "error is human, stubbornness (by arrogance) is diabolical? ».

Read also, in the news :

  1. The Academy of Medicine warns that the risk linked to imaging examinations must be offset against the risks of the disease itself. http://www.academie-medecine.fr/wp-content/uploads/2016/12/16.11.15-DUBOUSSET-rapport-v-16.12.8-AK.pdf page 8 and 9

The incidence of cancer (breast and endometrial) is multiplied by 5 for adolescents treated for scoliosis 25 years earlier (with an average of 16 x-rays per case) in a Danish study in 2016 (26). This work led to the recommendation to take these images with a postero-anterior incidence rather than the reverse, in order to expose less the mammary gland. The new systems, which are unfortunately not widespread enough (EOS)(15), allow a reduction in dose by a factor of 6 to 40 compared with conventional radiographs. Complete monitoring of scoliosis can therefore be carried out for the equivalent of a single conventional radiography. Once the diagnosis has been specified on the initial radiography, the best protection is to monitor this scoliosis using non-irradiating means such as the scoliometer, or surface topography systems (27), with an X-ray check being carried out only if a significant change in surface topography is found.
c) The incidence of cancer in adulthood would be increased. Some populations have a particular radiosensitivity linked to DNA repair disorders (30,31). Obviously, the risk associated with imaging examinations must be weighed against the risks of the disease itself (e.g. mucoviscidosis) and the use of non-irradiating techniques (MRI, ultrasound) should be systematically favoured if possible.

2. https://www.francebleu.fr/infos/sante-sciences/les-nouveaux-cas-de-cancers-en-hausse-surtout-chez-les-femmes-1562060451
https://www.lemonde.fr/sciences/article/2019/07/02/les-nouveaux-cas-de-cancer-en-forte-hausse-en-france_5484200_1650684.html
No reduction in breast cancer despite screening, increase in lung cancer in women. We wonder about the proportion of lung cancers in women attributable to over-diagnosis and thus secondary to over-treatment by unnecessary radiotherapy.

Bibliography

Radiosensibilité et irradiation mammaire, Toxicité des polluants et cancers du sein , Nicolas Foray, Unité UA8 Radiations Défense, Santé et Environnement, Groupement de Recherche sur les Radiations de Lyon (GRRAL) , 2019, Communication personnelle à Cancer Rose
https://its.aviesan.fr/getlibrarypublicfile.php/cd704e89988a4e3bcf2e1217566876cf/inserm/_/collection_library/201800012/0001/J1-098ITS-2017.foray.lyon.ITMO.TS..21.nov.2017.pdf.pdf

La susceptibilité individuelle aux rayonnements ionisants, Pr. Michel Bourguignon Commissaire ASN, 2014
https://www.irsn.fr/GT-CIPR/Documents/15-05-2014/GT-CIPR_15-05-2014_3-Bourguignon.pdf

La radio-susceptibilité individuelle: 3 défis et une vision pour la radioprotection, Pr Michel Bourguignon, ASN, 2015
http://reseau-ramip.fr/wa_files/06-TOULOUSE_20RaMiP_20RSI_20-_204_20Dec_202015_20__5BMode_20de_20compatibilit_C3_A9_5D.pdf

Impact du transit cytonucléaire de la protéine ATM en réponse aux radiations ionisantes : notions de pro- et anti-episkévie, Melanie Ferlazzo, Thèse de doctorat de l’Université de lyon, 2017
https://tel.archives-ouvertes.fr/tel-01588173/file/TH2017FERLAZZOMELANIE.pdf

[1]Test prédictif des réactions à la radiothérapie : des femmes en grand danger, Annette LExa, 2017 .
https://www.cancer-rose.fr/test-predictif-des-reactions-a-la-radiotherapie-des-femmes-en-grand-danger/
[2] La Directive 2013/59/Euratom du Conseil du 5 décembre 2013 fixe les normes de base relatives à la protection sanitaire contre les dangers résultant de l’exposition aux rayonnements ionisants. Une directive regroupe les directives de 1989 à 2003

[3]https://cancer-rose.fr/my-pebs/2019/06/13/argument-english/


4] Homozygotes have 2 functional parental alleles such as BRCA1 +/+ for example. Heterozygous BRCA +/- carriers have a deficient mutated allele resulting in poorer break signalling and therefore poorer repair.

5] The cytoplasmic protein ATM, is a dimer with a signaling function to stimulate DNA repair - See the importance of the transit of this protein in the signalling mechanism for double-stranded breakage repair: https://www.cancer-rose.fr/test-predictif-des-reactions-a-la-radiotherapie-des-femmes-en-grand-danger/

6] In humans, the RAD51 protein plays an essential role in recombination during DNA repair following double-strand breaks.

7] Apoptosis, or programmed cell death, is the process by which cells trigger their self-destruction in response to a signal

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.

The over-diagnosis, in a graph and a table

December, 3, 2016

Here you will find a representation on a poster (home-made) of the results of meta-analyses from the independent French medical magazine Prescrire, the Cochrane Collaboration (a collective of independent Nordic researchers) and the US Preventive Task Force, the US public health program evaluation agency.

Despite some variations in the data, there are two standout points : on the one hand, the estimates are reasonably close, on a proportional basis, and on the other hand, for each of these three studies, there is a much higher proportion of overdiagnoses and false alarms compared to 'avoided' deaths, pointing out the disadvantages of screening. The benefit/risk balance is therefore far from being as optimistic as it is presented to women…
The Cochrane presents its results on 2000 women screened from age 40 onwards over 10 years,
Prescrire on 1000 women screened from 50 years of age over 20 years,
US Task Force on 1000 women also, screened from 50 to 74 years old, which corresponds most closely to the French situation (click to enlarge).

The brown dots represent the number of women screened and then monitored. The red dots correspond to over-diagnoses, the yellow dots to the number of cancers presumably prevented. The light blue dots are false alarms, and the dark blue ones are unnecessary biopsies.
Here we reproduce a very meaningful graph showing how over-diagnosis occurs, based on the idea of an American researcher, Gilbert Welch, adapted here by Dr. Jean-Baptiste Blanc and with his kind permission to reproduce this image.
Click on the link to read Dr Blanc's article "deconstruction of a manipulation".

Rapidly evolving cancer progresses fast between two mammography examinations and will be "missed" by screening. Often this cancer will have already spread to distant nodes and organs, even though it is not visible.

  • Slowly evolving cancer will certainly be anticipated by screening, but even without screening it will be detected a little later by the appearance of clinical symptoms that will lead the patient to consult in time, as the metastatic time is very long.
  • For the other three forms of cancer, the very slow, not evolving and regressing cancer, screening will detect them but this is a needless detection, the women in whom they have been diagnosed would have died with their cancer but not because of it.

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.

Less is more medicine

The challenge of implementing of Less is More Medecine : a European perspective

26 May 2020

https://www.sciencedirect.com/science/article/pii/S095362052030128X

Authors : Omar Kherad Nathan Peiffer-Smadja Lina Karlafti Margus Lember Nathalie Van Aerde Orvar Gunnarsson Cristian Baicus Miguel Bigotte Vieira António Vaz-Carneiro Antonio Brucato Ivica Lazurova Wiktoria Leśniak Thomas Hanslik Stephen Hewitt Eleni Papanicolaou Olga Boeva Dror Dicker Biljana Ivanovska Nicola Montano

Summary of the article : Cécile Bour, MD

The concept of Less is More [1] medicine emerged in North America in 2010. It aims to serve as an invitation to recognize the potential risks of overuse of medical care that may result in harm rather than in better health tackling the erroneous assumption that more care is always better.
In response, several medical societies across the world launched quality-driven campaigns (“Choosing Wisely”)[2] ) and published “top-five lists” of low-value medical interventions that should be used to help make wise decisions in each clinical domain, by engaging patients in conversations about unnecessary tests, treatments and procedures.

The purpose of this article is to analyze the conditions and obstacles to the launch of a similar European initiative aimed at reducing the overuse of medical procedures that are currently identified as unnecessary and even harmful in daily practice. Therefore, such a program may lead to a reduction in the cost of health care, although the authors emphasize in their conclusion that this is not the primary objective, but a beneficial corollary effect.

The authors of the article also identify obstacles and challenges to the implementation of Less is More in several European countries, where overmedicalization is culturally rooted and required by a society that demands health certainty at almost any cost.
High expectations of patients, medical conduct, lack of follow-up and pernicious financial incentives all have more or less direct negative effects on over-medicalization.

To implement the Less is More recommendations on a large scale, multiple interventions and evaluation efforts are needed.

These recommendations consist of a top-five list of actions:
(1) A new cultural approach from medical school graduation courses, up to
(2) patient and society education,
(3) physician behavior change with data feedback,
(4) communication training and
(5) policy maker interventions.
In contrast with the prevailing maximization of care, the optimization of care promoted by Less is More medicine can be an intellectual challenge but also a real opportunity to promote sustainable medicine.

This project will constitute part of the future agenda of the European Federation of Internal Medicine.

THE CHALLENGE

Access almost universal to quality health care is one of the hallmarks of the "European model", but how can we ensure the sustainability of European healthcare systems in an era of aging populations and budget restriction?
Financial aspects should be taken in account, as avoiding unnecessary practices have become a priority to ensure quality and access to care for everyone in the long term in both poor as well as wealthy countries!
A major concern has been not to miss a disease, to avoid problems of underdiagnosis and undertreatment. This has been supported by sustained and powerful technological growth and we are now facing the other side of the coin.
This results in: too many drugs, too many tests, too many screenings, eventually becoming a threat with accumulating evidence of over-diagnosis itself leading to damage from unnecessary treatment.
Following this dual perspective, with both qualitative (patient safety and avoidance of low-value, ineffective care) and quantitative aspects (costs), a new trend emerged in medicine: Less is More.

WHAT ALREADY EXISTS

Several medical societies across the world launched quality driven anti-waste campaigns such as Choosing Wisely in US, Smartermedicine in Switzerland, Slow Medicine in Italy, SMART Medicine Initiative in Israel, and Choosing Wisely in UK, France, Belgium, Portugal, Romania, Russian Federation and Poland.
These societies published “top-five lists” of low-value medical interventions which should be avoided [3]

But the concept of Choosing Wisely is applicable to the screening.
The article evokes the aspect of Less is More in this field.

REGARDING SPECIFICALLY THE SCREENING

The key mechanism for change lies in creating a shared decision-making process between physicians and patients during routine clinical encounters.
Physicians are often reluctant to speak about overdiagnosis. Most participants in a US cross-sectional online survey who underwent routine cancer screening reported that their physicians did not tell them about overdiagnosis and overtreatment [4].
The few who received information about overtreatment had unrealistic beliefs about the extent of that risk.

We have discussed this point here : perception and reality
Both benefits and harms of action or inaction must be discussed in order to help make better decisions about clinical situations in which care is needed.
Clinicians and patients must share the responsibility for the final decision, as both parties experience the potential consequences.

A 2015 article[5] shows the level of over-detection that people would find acceptable in screening for breast, prostate and bowel cancer, and attempts to see whether the screening acceptance is influenced by the magnitude of the risks.
This survey illustrates the varying level of acceptance depending on the level of information of individuals and suggests that clear information should be included in invitation letters for screening.
The whole Choosing Wisely campaign is patient-oriented and promotes shared decision making.
That means using personalized assessments of potential benefits and harms, as well as considering the preferences of patients who are well informed about possible options. The interaction between patients and doctors must be strengthened because a good therapeutic relationship can cause the decrease of the unrealistic patient expectations which can cause overconsumption.
The Choosing Wisely campaign can help “educate” patients (meaning an education for comprehension of medical data) and explain them why an unnecessary test may be harmful so that doctors and patients can have more constructive conversations about the tests.

The dimension of healthcare costs is addressed more widely in the Anglo-Saxon countries than in France[6], in a relevant manner, as savings from unnecessary medical care can be put to good use in other areas (Editor’s note).

THE BARRIERS

  1. Patients’s expectations
    For decades, the idea that seeking medical care is the key to maintaining well-being and that more medicine is better than less has been sold to patients.
    There is an enthusiasm for early diagnosis as part of preventive strategy, as this allows patients to feel heard and reassured.
    However, negative consequences of false positive diagnostic tests are underestimated. In addition, patients have huge expectations of their expensive health care system, and often bristle at recommendations that seem to limit their choice: any attempt to limit the access to doctors might be interpreted in relation to its economic dimension, raising fears about “rationing”.
    Moreover, the principle Less is More is frequently counterintuitive, too (for both physicians and patients), and because of this it is psychologically hard to accept.
  2. Physicians’s behaviour
    Some tests are ordered out of fear of missing a diagnosis. Cognitive biases, such as anticipated regret for missing a diagnosis, and commission bias, or the tendency toward action rather than inaction, lead to performing more tests. The fear of being sued for malpractice is of major importance, particularly in the US, where three-quarters of physicians report practicing defensive medicine, though “defensive” medicine is becoming more popular in Europe as well.
    An example is given [7] with the prescription of PSA test, despite the current non-recommendations for systematic screening of prostate cancer in men.
    In case of medical error, a physician who was exhaustive in patient care is less likely to be sued. This raises the issue of how physicians can balance the growing focus on patient satisfaction scores with the drive for evidence-based medicine. Some physicians are aware of the guidelines but disagree with the evidence and more broadly misunderstood the evidence-based medicine (EBM) approach. That’s true, some recommendations may rely upon biased studies or on experts opinion, thus far away from being “evidence-based” ….[8] We also have addressed this topic [9] [10].
  3. Other factors, which are barriers to reduce overuse of medical care, are detailed in the article, such as:
  • Sometimes insufficient evidence in some medical controversies,
  • Lack of research and lack of resources for research,
  • Fragmentation of care (e.g., moving from one care setting to another such as from a hospital to a specialized care facility, or simply from one physician to another increases the risk of care errors. New medications could be prescribed in duplicate or negatively interact with other treatments),
  • Difficult to measure the impact of less is more practice
  • Financial incentives (the fee-for-service system as in France, Switzerland or Belgium)
  • Lack of student education

In conclusion

There is substantial overuse of some common procedures that demonstrate no benefit and present potential harm in everyday practice, say the authors of this article. In order to reduce over-medicalization and maintain physician commitment and public confidence, it is necessary to avoid using cost as a motivating factor, and instead focus on unnecessary tests that may be harmful.
EFIM launched two years ago a “Choosing Wisely” project involving twenty- six national societies of Internal Medicine. The aim of this project is, first of all, to stimulate the dissemination of the low-value, high-value care concepts and the top-five lists from participating countries; secondly, to start educational programs for physicians, educators, residents and students using practical courses and publications, and thirdly, to design research tools to evaluate the effects of Less is More approach on appropriateness of care and cost reduction.


Our opinion


The approach described in the paper specifically concerns medication prescribing practices; we hope that the reflection on over-screening will also be widely included in the European program to reduce overmedicalization.

At present, unfortunately, the issue of screening, particularly for breast cancer, is much less scientific than it is cultural, social and political. Financial and ideological stakes burden this screening.
The process of choosing wisely, in terms of these abusively so-called "preventive" procedures, risks being very long and going through a patient public education, unfortunately countered regularly by a medical populism that is more and more present, like the deplorable and terribly deleterious for the science itself image, which we witnessed during the Covid-19 epidemic.

Références

[1] https://www.revmed.ch/RMS/2013/RMS-381/Less-is-more
[2] http://www.lessismoremedicine.com/blog/tag/choosing+wisely
[3] https://link.springer.com/article/10.1007/s11606-019-05050-2
[4] https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/1754987
[5] https://www.bmj.com/content/350/bmj.h980.full
[6] https://www.acpjournals.org/doi/10.7326/0003-4819-156-2-201201170-00011?doi=10.7326%2F0003-4819-156-2-201201170-00011&
[7] https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2753.2008.01024.x
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1939859/
[9] https://cancer-rose.fr/2017/06/07/adhesion-des-medecins-aux-recommandations-sur-le-depistage-du-cancer-du-sein/
[10] https://cancer-rose.fr/2017/01/15/vue-densemble-des-directives-et-recommandations-sur-le-depistage-du-cancer-du-sein-pourquoi-les-recommandations-different/

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.

30,000 cancers overdiagnosed in an Australian study

30,000 cancers overdiagnosed each year in an Australian study : a public health issue

Summary , Cécile Bour, MD
28 January 2020
https://www.mja.com.au/journal/2020/212/4/estimating-magnitude-cancer-overdiagnosis-australia
Authors of australian study published in Medical Journal of Australia
Paul P Glasziou, Mark A Jones, Thanya Pathirana, Alexandra L Barratt and Katy JL Bell
Med J Aust || doi: 10.5694/mja2.50455

The obsession of our modern societies to track diseases through ever earlier detection is leading to a public health crisis, according to Australian authors who published in January 2020 their evaluation of over-diagnoses for five different cancers.


Method

National data routinely collected by the Australian Institute of Health and Welfare (Australia's national agency for health and welfare information and statistics) were analyzed to estimate risks in population to have a cancer during lifetime by comparing the current period (2012 data) with the past (1982 data).
This allowed to measure changes in these risks over the last 30 years. An adjustment has been made to take into account the risk of death and changes in risk factors over time.
The five different studied cancers are: prostate, breast, renal, thyroid cancers, and melanoma.

The authors propose an estimate of the proportion of cancer diagnoses in Australia which are reasonably due to over-diagnosis.

Results


For women, an estimated 22% of breast cancers (invasive cancers, 13%), 58% of renal cancers, 73% of thyroid cancers, and 54% of melanomas (invasive melanoma, 15%) were overdiagnosed.

For men an estimated 42% of prostate cancers, 42% of renal cancers, 73% of thyroid cancers, and 58% of melanomas (invasive melanomas, 22%) were overdiagnosed.
Despite the relative uncertainty conceded by the authors themselves about these estimates, this result would be equivalent to an overdiagnosis representing about 18% of women's cancer diagnoses and about 24% of men's cancer diagnoses in Australia in 2012, i.e. about 11,000 women's cancers and 18,000 men's cancers overdiagnosed in Australia each year.

Absolute rates of over-diagnosis were highest for breast cancer and prostate cancer due to their higher baseline prevalence (rate of new cases + rate of cases already present).

Causes

The population is certainly aging, but screening programs are the big providers of overdiagnoses.
Cancer can also be overdiagnosed outside screening programs; for example overdiagnosis of thyroid cancer is attributable to incidental detection during imaging investigations of unrelated problems or the overdiagnosis of abdominal scans carried out for other causes.

Problems

Overdiagnosis is important to know and control because of the adverse effects on iatrogeny (pathology induced by treatments) and the associated additional costs.

Harms include the psychosocial impact of unnecessary cancer diagnoses, such as the increased suicide risk for men after being diagnosed with prostate cancer.
Cancer treatments such as radiotherapy, endocrine therapy and chemotherapy can cause physical harm, but the risks are considered acceptable if diagnosis is appropriate. Contrary, when someone is unnecessarily diagnosed with a cancer which would not be harmful for its health or life (overdiagnosis definition), this person will suffer harm as a result of the treatment, instead of enjoying the benefit of having been detected.

In other countries

This study is the first study to estimate overall cancer overdiagnosis on a national level.
A recent British analysis found that the “incidence of 10 of the 20 most common cancers in the UK has increased by more than 50% in both sexes since the 1980s.” These cancers included breast, kidney, prostate, thyroid cancers and melanoma, but also non‐Hodgkin lymphoma, oral, cervical, liver, and uterine cancers.
The authors therefore estimated overdiagnosis only for cancers with the typical epidemiologic signature of overdiagnosis: breast, prostate, kidney, thyroid cancers and melanoma (for which lifetime mortality has changed little in absolute terms).
UK cancer statistics released in January 2019 show very high survival rates for people with early stage cancers of these types, providing further evidence of probable overdiagnosis: 5‐year survival of 99% for stage 1 breast cancer, 100% for stage 1 prostate cancer, 100% for stage 1 melanoma, 89% for stage 1 kidney cancer, and 88% for thyroid cancer of any stage.

Editor’s note: Survival, often emphasized by INCa to justify the screening for breast cancer, is not an indicator of screening effectiveness, but a good over-diagnosis marker.
Survival measures the length of life with a cancer, If the cancer is not meant to kill its carrier, as is the case for cancers detected predominantly by screening, which are at low stage, survival can indeed be important since these cancers detected would never have led to the death.

The more over-diagnosis emerges, the more cancers that could have been ignored, and the better the survival rates, automatically.
The only appropriate indicator of the effectiveness of screening is mortality, or more precisely total mortality.

Author’s conclusion

Cancer overdiagnosis has important implications for health policy.
First, rates of avoidable overdiagnosis need to be reduced to the lowest level compatible with targeted screening and appropriate investigation, instead of mass screening.

Strategies to reduce overtreatment of low-stage, therefore low-risk prostate, breast and thyroid cancers should be addressed.

A second, and perhaps more important implication is that health services need to be alert to new areas of overdiagnosis and to detect them early.

Editor’s note: Australia has already initiated an over-diagnosis action plan : https:/cancer-rose.fr/2018/10/15/un-plan-daction-national-contre-le-surdiagnostic-en-australie/

Editor’s note: The Australian example should prompt us to look downwards, in particular to the pink October commercial campaigns that culpably promote and train crowds to practice mass screening, encouraging women to be screened even outside the screening age range.

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.

What if you would benefit from stopping screening ?

Cécile Bour MD, 15 June 2020


The question was asked by Quebec scientists in the newspaper Le Devoir.
https://www.ledevoir.com/opinion/idees/580791/et-si-la-covid-19-vous-avait-sauve-e

Not everyone benefits from screening, especially if it is a screening whose risk-benefit balance is increasingly questioned in view of the cumulative risks, and in view of the benefit that is less and less proven with the hindsight we now have on breast cancer screening campaigns.
This pause in screening could be an opportunity for research, to reflect on information for women without alarmism or threats towards them, to ask the right questions about the use of financial resources in health care towards procedures and tools that are proven beneficial to populations, as the Quebec signatories conclude:
"The current context must be used to question more broadly our choices in the offer of clinical services in order to prioritize interventions that have demonstrated effectiveness and concrete benefits for patients.”

Read also the analysis of :
-Welsch/Prasad https://edition.cnn.com/2020/05/27/opinions/unexpected-side-effect-less-medical-care-covid-19-welch-prasad/index.html
-Judith Garber https://lowninstitute.org/reduced-cancer-screenings-in-covid-19/
-Susan Bewley https://blogs.bmj.com/bmj/2020/04/14/susan-bewley-things-should-never-be-the-same-again-in-the-screening-world/
-John Horgan https://blogs.scientificamerican.com/cross-check/the-cancer-industry-hype-vs-reality/

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.

Reduction in the number of cancer screenings during the Covid-19 period, what are the expected consequences ?

Article by Judith Garber, May 9, 2020
https://lowninstitute.org/reduced-cancer-screenings-in-covid-19/
Abstract Dr. Cécile Bour MD

Judith Garber is a scientist in political science and health policy at the Lown Institute. (The Lown Institute based in Massachusetts, United States, is a non-profit organization, a "non-partisan think tank that advocates innovative ideas for a fair and caring health system").
Screening procedures and routine medical visits have declined since the Covid-19 pandemic. According to the author, this trend is not necessarily deleterious, as there will likely be a decrease in unnecessary and harmful care.

A recent analysis conducted by the EPIC* Health Research Network used electronic health record data from 2.7 million patients in the U.S. and compared the rates of cervical, breast and colon cancer in the pre-Covid period with the current Covid period. They found that screening appointments in March 2020 decreased by 86-94% compared to the average number of screening appointments that occurred monthly from January 1, 2017 through January 19, 2020.
*EPIC: The Epic Community is a global community of healthcare organizations.

What effect would this drastic decrease in screening have on patient health? The authors of the EPIC report claim that it will be disastrous….
But is this grim prediction likely? According to J.Garber, several points need to be considered.

Mortality by disease vs. all-cause mortality

Although there is some evidence that cancer screening can reduce specific mortality, i.e. mortality from specific cancers, there is much less evidence of benefit on all-cause mortality (the risk of dying overall).

Editor's note: In the above cited study, the effect of screening with fecal occult-blood testing on colorectal-cancer mortality persists after 30 years but does not influence all-cause mortality. 
( Note that the interest in all-cause mortality is that it includes both mortality from the disease and mortality from treatment of the disease.
If there is an impact with decreased all-cause mortality, it means that screening (and treatment) are effective. The overall mortality thus serves as a warning signal; e.g., if there is an abnormal offset between overall and disease-specific mortality, this should raise the question of whether an adverse effect of screening may have been insufficiently taken into account. Overall mortality is not generally used as a judgement criterion, which is regrettable because it implies a loss of information. Editor's note)

In 12 randomized screening trials, reviewed by Dr. Vinay Prasad and colleagues in an article published in the BMJ, seven failed to show a decrease in overall mortality, despite lower rate of disease-specific mortality. In some cases, overall mortality in the screening group was therefore higher than in the non-screened group. What is the reason for this?
The possible explanation is that the negative effects of screening, in these cases, may counteract the benefits. While cancer screening reduces mortality for some cancers, for others it leads to many more false positives with unnecessary biopsies, as well as over-diagnosis and over-treatment. Thus unnecessary surgery and complications of diagnostic and therapeutic tests and procedures have a negative effect on health in screened groups. See also [1].
The authors of the EPIC report should therefore have included in their alarming conclusion not only potential cancer deaths due to lack of screening, but also potential false positives and cascade of events avoided (over-diagnosis followed by over-treatment), and should also have taken into account the lack of evidence regarding the overall benefits of screening on overall mortality.

Not everyone benefits from screening


Not everyone is equally likely to benefit from cancer screening explains J.Garber. The likelihood of a young adult developing cancer is very low, making them more likely to be exposed to screening damage than actually helped.

At the same time, at a very advanced age, cancer screening also becomes less beneficial because older people no longer have the life expectancy to benefit from screening, but on the other hand are more susceptible to the harmful complications of testing and treatment that result from the detections. For example, the US Preventive Services Task Force (an independent US agency that reviews health devices) recommends colorectal cancer screening only between the ages of 50 and 75.

Yet many people are being screened for cancer outside the recommended ages, even though they are unlikely to benefit from it, the author explains.
In one 2014 study published in JAMA, among elderly patients with a very high mortality risk , 37.5% were screened for breast cancer, 30% were screened for cervical cancer and 40% were screened for colorectal cancer. Among women who had previously undergone a hysterectomy but did not have cancer, 34% to 56% still had been screened for cervical cancer within past three years.
Although cervical cancer screening is not recommended for young women aged 15 to 20, an estimated 1.6 million Pap tests (smears) are performed unnecessarily on women in this age group each year.
In the EPIC Network's analysis above, these are not considered. If most of the people who missed out on screening in March 2020 were those at lowest risk, then a reduction in screening participation may not be such a bad thing overall - especially if it was the number of obviously inappropriate screenings that was decreasing.
However, with the information we do have, we do not know which patients have avoided screening, making it impossible to estimate the real number of lives lost or damage reduced in this 'Covid pause' from screening.

An opportunity for research

The authors of the EPIC report explain the issues that seem clear to them, namely the 'lives lost' due to reduced screening. However, it is very likely that this number is overestimated, given the high rates of inappropriate screening in the real world, as well as the potential negative and unaddressed effects of screening on overall mortality.
Although the true impact of the sudden halt in screening due to Covid-19 remains unknown, according to J. Garber we have an opportunity to find out.
Such a drastic change in screening is unusual, so we must take advantage of this unique event and follow the results of this historical experiment to better understand the actual health effects - both beneficial and harmful - of cancer screening.

Editor’s note

A few cautions: this monitoring of data will depend on the evolution of the outbreak and whether or not screening is resumed. Two months of interruption, as is the case in France, may be insufficient to draw these conclusions or to discern real variations in cancer incidence and mortality rates. This can be made even more complicated and the conclusions even more hazardous if the resumption of screening is not carried out in a uniform and homogenous manner in all regions of France, depending on the persistence here and there of Covid clusters that curb the public's willingness to attend the various screenings. Only if the interruption of screening would continue for a few more months, either because of the persistence or resurgence of the outbreak, or because of public resistance (fear of going to the doctor's office or of having to undergo a colonoscopy in the context of an epidemic), the situation would be quite different and results could emerge.

Reference :

1] https://cancer-rose.fr/2019/08/08/synthese-detudes-un-exces-de-mortalite-imputable-aux-traitements-lemportant-sur-le-benefice-du-depistage/

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.

The cancer business

https://blogs.scientificamerican.com/cross-check/the-cancer-industry-hype-vs-reality/

February 12, 2020 Par John Horgan 12 février 2020
John Horgan is a science journalist who manages Stevens Institute of Technology 's Science Writing Center. We are going to try to summarize the key points of his article here. Summary by Cécile Bour, MD

Cancer medicine generates enormous revenues, but marginal benefits for patients.


According to the author, there is a huge gap between the sad reality of cancer medicine in the United States and the optimistic claims made by the cancer industry and its media catalysts.
Cancer has spawned a huge industrial complex, including government agencies, pharmaceutical and biomedical companies, hospitals and clinics, universities, professional societies, non-profit foundations and the media.
Cancer-industry boosters claim that research, screening and treatment investments have led to "incredible progress" and millions of "cancer deaths averted," as claimed on the American Cancer Society's home page, a non-profit organization that receives money from biomedical companies.
Cancer experts and the media often describe new treatments with laudatory terms such as "medical breakthrough," "revolutionary," "miraculous," ("innovative," often heard in France, Editor’s note).
Cancer centers “frequently promote cancer therapy with emotional appeals that evoke hope and fear while rarely providing information about risks, benefits, costs, or insurance availability.” (as in the French Cancer League and the numerous cancer institutes, Editor’s note). These highlighted therapeutic achievements concern particular forms or rare cancers, which, according to the author, are exceptional in the midst of a "litany of failures".

Mortality rate

The best way to measure progress against cancer is to look at mortality rates, the number of people who succumb to cancer per unit of population per year.

As the average life span of a population grows (because of advances against heart and respiratory disorders, infectious disease and so on), so does the cancer mortality rate. To calculate mortality trends over time, therefore, researchers adjust for the aging of the population.
With this adjustment—which, to be kept in mind, presents cancer medicine in a more favorable light — mortality rates have declined almost 30 percent since 1991.

This trend, according to cancer-industry boosters, shows that investments in research, tests and treatments have paid off. What boosters often fail to mention is that recent declines in cancer mortality follow at least 60 years of increases. The current age-adjusted mortality rate for all cancers in the U.S. is just under what it was in 1930!
Editor’s note: See the book "Dépistage du cancer du sein, la grande illusion" published by Thierry Souccar Editor[1] for a more detailed explanation of this mechanism concerning breast cancer.
In reality, the rise and fall of cancer deaths track the rise and fall of smoking, with a lag of a couple of decades. Smoking raises the risk of many cancers but especially of lung cancer, which is by far the biggest killer, accounting for more deaths than colon, breast and prostate cancer combined.
It was concluded that without reductions in smoking "there would have been virtually no reduction in overall cancer mortality in either men or women since the early 1990s.”

New treatments yield small benefits, big costs

Clinical cancer trials “have the highest failure rate compared with other therapeutic areas”.
Pharmaceutical companies keep bringing new drugs to market.
But one study [2] found that 72 new anticancer drugs approved by the FDA [3] between 2004 and 2014 prolonged survival for an average of only 2.1 months… A 2017 study concluded that “most cancer drug approvals have not been shown to, or do not, improve clinically relevant end points,” including survival and quality of life.
The authors worried that “the FDA may be approving many costly, toxic drugs that do not improve overall survival”.

Screening leads to overdiagnosis and overtreatment

The cancer industry, aided by celebrities who claim that tests saved their lives, has convinced the public that screening for cancer is beneficial. The earlier we can detect cancerous cells, the more likely it is that treatment will succeed, John Horgan explains here one of the most significant findings of the past decade which is overdiagnosis. Many people have cancerous or pre-cancerous cells that, if left untreated, would never have compromised their health. Autopsies studies shown [4] that many people who die of unrelated causes harbor cancerous tissue.

Tests cannot reliably distinguish between harmful and harmless cancers. As a result, widespread testing has led to widespread overdiagnosis, the flagging of non-harmful cancerous cells. Overdiagnosis leads in turn to unnecessary chemotherapy, radiation and surgery.

Gilbert Welch was one of the first who brought the overdiagnosis to the light and called it « unfortunate side effect of our irrational exuberance for early detection.”
Editors’s note : In France, Bernard Junod [5], an epidemiologist, teacher and researcher at the Ecole des Hautes Etudes de Santé Publique de Rennes, was, together with Dr Bernard Duperray, a whistleblower on over-diagnosis in France concerning breast cancer screening. Mammograms and prostate specific antigen (PSA) tests have led to particularly high rates of over-diagnosis and over-treatment of breast and prostate cancer.
Adding together the harmful and lethal effects of screening, any benefits of screening "are outweighed by the deadly damage due to over-diagnosis and false positives" according to breast cancer specialist Michael Baum [6], co-founder of the screening programme in the UK, who is currently calling for the discontinuation of these programmes, which he believes could shorten more lives than they prolong.

For one man whose life is prolonged, many others will experience false positive results with subsequent additional tests, eventual prostate biopsy, over-diagnosis and over-treatment, and treatment complications such as incontinence and erectile dysfunction.
The prostate specific antigen discoverer, pathologist Richard Ablin, called the PSA test a "profit-motivated public health disaster."

All-cause versus specific mortality and « torturing the data »

Studies of tests for a specific cancer generally look at mortality attributed to that cancer. Mammograms are thus deemed effective if women who get mammograms die less often from breast cancer than women who do not get mammograms. This method can overstate the benefits of tests, because it might omit deaths resulting, directly or indirectly, from the diagnosis. After all, surgery, chemotherapy and radiation can have devastating iatrogenic effects, including heart disease, opportunistic infections, other forms of cancer and suicide.

Rather, reference should be made to studies that measure "all-cause" mortality, as they account for the deleterious effects of treatment. A 2015 [7] meta-analysis by epidemiologist John Ioannidis (renowned for bringing the scientific replication crisis to light) and others found no reductions in all-cause mortality from tests for cancer of the breast, prostate, colon, lung, cervix, mouth or ovaries for asymptomatic patients.

In a recent editorial in the European Journal of Clinical Investigation, Ioannidis and four co-authors argue that cancer screening (especially mammograms and PSA tests) does more harm than good and should be abandoned. [8]

Survival rate

Often are pointed out improvements in survival rates, the length of time between diagnosis and death.
Survival rates for some cancers have indeed grown as a result of more widespread and higher-resolution testing, which detects cancer earlier.
But this doesn’t mean that people live longer as a result of early detection. They simply live longer with a diagnosis of cancer, with all its harmful emotional, economic and physiological consequences. (Explanation of survival rate here [9])
Using survival rates to promote tests is an example of what is have called “torturing the data» and for this article’s author, this a case of monstrous malpractice.

Corruption in the cancer industry


At USA, according to oncologist Vinay Prasad (@VPrasadMDMPH ; very active on twitter, Editor’s note) many cancer specialists accept payments from firms whose drugs they prescribe.
This practice "leads us to celebrate marginal drugs as if they were game-changers," Prasad argues. "It leads experts to ignore or downplay flaws and deficits in cancer clinical trials. ”
The desire of oncologists to produce monetizable findings might also compromise the quality of their research. A 2012 study of 53 “landmark” cancer studies found that only six could be reproduced.

Solution? Gentle cancer medecine?


The author pleads in favor of a medecine that adopt new therapies “when the benefit is clear and the evidence strong and unbiased.”
He pleads in favor of what some will call as conservative medicine that defines itself as a medicine that resists what is commonly and historically established, that knows how to say "stop" and arm itself with a lot of patience for those who want more medicine in a time where nobody is in favor of this attitude.
This meaning less testing, treatment, fear-mongering, military-style rhetoric and hype.
It would recognize the limits of medicine, and it would honor the Hippocratic oath: first, do no harm.
The patients must help these conservative physicians. We must recognize the limits of medicine and the healing capacities of our bodies, (dormant, non-evolving, spontaneously regressive cancers).
We must resist tests and treatments that have marginal benefits, at best.
We may never cure cancer, which stems from the collision of our complex biology with entropy, the tendency of all systems toward disorder.
But if we can curtail our fear and greed, our cancer care will surely improve.

According to Horgan, the fact to recognize the human body’s “inherent healing properties" and to acknowledge “how little effect the clinician has on outcomes” will make that physicians will thus protect themselves against their greatest foe—hubris, which is vanity.

References


[1] Extract from book of Bernard Duperray
Epidemiologists have the choice between two reference populations, the population of Europe or the world. The choice of the standard (“Europe” or “World”) induces wide variations in mortality.
“World” rates based on a younger population are generally lower than “Europe” rates reflecting an older population.
Depending on the standard chosen, the rate for the same population appears more or less high.

In France, the rates used most often by the InVs are the «Monde» rates (purple curve on the figure). The «Monde» standard tends to minimize the mortality rate for a country like France because it does not correspond to the structure of the French population. Moreover, according to Bernard Junod, age standardisation is subject to caution in describing a variation in mortality when the variations for the same age group are not uniform.
To assess the evolution of mortality in France in the fairest possible way, Bernard Junod chose to take as «standard» the age distribution of the population residing in France in 1992, that is to say in the middle of the period studied (1980 to 2005).
It thus obtained a standardized annual mortality rate by age in France per 100,000 women of 32.6 in 1980 and 32.9 in 2005, thus stable over this period.

In summary, here is what can be unquestionably retained from Figures 13 and 14:
• Between 1950 and today, the annual number of deaths and the crude rate of mortality from breast cancer have not decreased;
• Standardized rates “World” (purple curve fig 14) and “Europe” (blue curve fig 14) continuously increase in France until 1993 and then decrease while the crude rate stabilizes.

Let us now look again at figure 14. A surprising fact concerns us. The standardised “World” and “Europe” mortality rates of today, while falling, are still higher than those of the 1950s. Some would argue that comparing the current rates with those of 1950 is questionable because of the unreliability of the data at that time. It is possible, but then what about the fact that the standardized rates in 2006 were at the same level as those in 1970 according to the death registry which refers since 1968 (date of the creation of CépiDc, the Centre for Epidemiology on Medical Causes of Death)?

[2] https://jamanetwork.com/journals/jamaotolaryngology/article-abstract/1891387
[3] https://www.fda.gov/
[4] https://cancer-rose.fr/2017/12/14/frequence-des-cancers-latents-de-decouverte-fortuite/
[5] https://formindep.fr/apparence-et-protestation/
[6] https://cancer-rose.fr/2019/08/08/synthese-detudes-un-exces-de-mortalite-imputable-aux-traitements-lemportant-sur-le-benefice-du-depistage/
[7] https://www.researchgate.net/publication/271022752_Does_screening_for_disease_save_lives_in_asymptomatic_adults_Systematic_review_of_meta-analyses_and_randomized_trials
[8] https://onlinelibrary.wiley.com/doi/full/10.1111/eci.13062
[9] https://cancer-rose.fr/2019/05/21/peurs-et-croyances-histoire-naturelle-de-la-maladie-survie/

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.

HISTORY OF FRENCH CITIZEN CONSULTATION

In September 2015, the Minister of Health announces a "citizen and scientific enquiry" to evaluate organized breast cancer screening programme in France and appoints an independent steering committee to oversee it.

  • This committee brings together:
    -leading health professionals (oncology, general medicine, epidemiology, public health)
    -professionals in the social sciences (anthropology, law, economics, history of science and bioethics), all with no financial or academic interest in breast cancer screening.

This French inquiry is the third independent evaluation of breast cancer screening in Europe, following those done in Switzerland and the United Kingdom (1, 2). All of them emphasized the need for complete and balanced information, and all recognised over-diagnosis as a serious harm; two (the Swiss and the French evaluation) made a recommendation to stop screening as currently conducted.


The process is conducted as follows:

  • Examination of the review of evidence (by a technical committee of the French National Cancer Institute (INCa)),
  • The committee supervises "a civil dialogue", a concept inherited from the French Revolution of 1789 (round tables, working sessions…).

A website :
-provides information on the consultation
-invites the public to express its opinion.
Two consultations :
-a citizen consultation of a group of 27 women from different regions of France and different socio-economic groups
-a parallel consultation of a group of 19 health professionals with relevant professional experience, but with no link to breast cancer screening.
A final public meeting for :
-the presentation of the recommendations
-answering questions.

Conclusions

Two scenarios:

-Full cessation of organized breast cancer screening;
-Stop the organized breast cancer screening as it is currently being performed and fully reconstruct it

If the program should be continued, the main recommendations of the women citizens :
-Neutral, complete information for women, the public, doctors.
-Acknowledgement of the scientific controversy within the information given.
-Practitioner training for help women's decision-making.
-Research program on the natural history of breast cancer(s) and on the effectiveness of new therapies.
-Assessment of the program on the impact of screening on quality of life, mortality and costs.
-Cessation of screening for women at average risk under 50 years of age.
-Reflexion on a screening based on the level of risk.

-These conclusions are very different from those of other juries (US Task Force, American Cancer Society, International Agency for Research on Cancer) which concluded that the benefits outweigh the drawbacks and continue to recommend the organized screening.
-One explanation could be the conflicts of interest of some juries, which were deliberately avoided in the three European enquiries.

COUNTER-ATTACKS ARE LAUNCHED….

The president of INCa, Norbert Ifrah speaks on a Health television program on 4 October 2016.
The letter from the President of INCa to the Health Minister is meant to summarize the report.
In this letter, Norbert Ifrah violently denigrates the first scenario, which he rejects outright.
-He states that "… by the affirmation of the report's authors… it would be very risky, generating inequities and losses of chance".
-But no trace of these remarks can be found in the consultation report.


The new French Public Health Agency (Agence Santé Publique France) publishes a report written in collaboration with INCa highlighting the "quality" of the organized screening program.

(https://formindep.fr/cancer-du-sein-la-concertation-confisquee/)


The INCa president's preference goes to the second scenario, which he reinterprets, reducing it to a simple adjustment of current practices: "proposals for readjustments….. that are in line with the rationale of the 2014-2019 Cancer Plan".

CONFISCATION FOR THE WOMEN OF THEIR CONSULTATION

The Minister congratulates herself on the smooth running of Pink October in the media and expresses, in her press release, "The best chance of curing breast cancer is screening. However, still too few women used the organized screening. »


The 12-point action plan announced in the opening statement (April 2017) : "Breast cancer screening is therefore a major public health issue; to reduce mortality and morbidity related to breast cancer, but also to improve the quality of healthcare for those concerned. »

THE MINISTER'S MAIN PROPOSALS :


-creation of information tools for women for decision-making with the doctor.
-new medical consultation at the age of 50 to discuss options for cancer screening and prevention.
-information booklet accompanying invitations to screening and an online decision support.
-training to help doctors communicate about the risk/benefit balance and the limitations of screening.
-improving the technical quality of the program.
-establish a research program alongside the screening program.


The plan does not detail how these measures will be evaluated.

In reality

A downloadable booklet and a website created by the INCa, which are incomplete; this institute, strongly criticized by women citizens for its inability to provide good information, was entrusted with the revision of the screening.

Here are the contentious points:
-Underestimation of over-diagnosis.
-Over-treatment not mentioned.
-99% survival claimed.
-No visual support with real data.
-The effect on mastectomies not addressed.
A call for projects is launched among professionals to set up tools enabling them to inform women. This is in progress.
Screening remains in the ROSP (remuneration of doctors based on public health objectives).

Conflicts of interest :


Appointment of Ms. A.Buzin, former leader of the Inca, with the new Macron government, in May 2018.

All in all : a lot of movement, so that nothing changes.

But it is nevertheless going to change….

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.

Final report of the citizen consultation

15 Dec 2016

(Report of the Steering Committee)

In 2015, the Minister of Health has initiated a citizen consultation on breast cancer screening, with the creation of a website allowing everyone to express their opinions on screening, which is the subject of scientific controversy around the world.
Dr. Cécile Bour participated in two round tables for the Cancer Rose collective, one with citizens and the other with health professionals, which consisted of a 20-minute presentation followed by a half-hour debate.

The steering committee published its conclusions in October 2016


You will find them starting on page 128
(Role of Cancer Rose, page 72).


We list some of the comments before detailing the conclusions.


- Page 5
The committee raises the dysfunctions in the organization of screening: confusion about primary prevention, screening and early diagnosis, lack of information about risks and uncertainties in the letter sent to women, misleading and outrageous marketing and promotion.


- Page 38
We note that the committee raised the paradox of performance-based remuneration for physicians based on health objectives, with the objective that 80% of patients aged 50 to 74 years old should have screening exams, even though this is not a mandatory procedure. However, we note that this problem posed by ROSP is not subsequently included in the conclusions.


- Page 41-47
The committee takes up the characteristics of setting up a screening system.
Low cost: whether the cost is low for the individual, it is not low for the society.
This is published on page 46/47, it’s evaluated at 180 million in 2008.
Low variability between mammography readers (radiologists): low or not, if present, it has a major impact on the patient's future.
Reproducibility of the reading is not guaranteed.
Mammography has neither sensitivity nor specificity.
Regarding effectiveness: the benefit must be identifiable, this is where the controversy resides.

-Page 76
Analysis of the situation by the committee :

1-The natural history of cancer needs to be rethought in order to differentiate the types of cancers and their possible evolution.

2-Avoid confusion between prevention and screening

3-Saying that one in eight women will develop breast cancer is a misleading presentation, since this risk is a cumulative risk for all ages, calculated on a hypothetical population based on the risks observed in 2012. However, this risk should be considered by age group. With a follow-up of 20 years, for a 40-year-old woman this risk is 4%, for a 60-year-old woman it is 6%.

-Page 79
Requests that the absolute reduction in the risk of dying from breast cancer be presented in absolute terms, not in relative terms.
Even organizations that support organized screening recognize that the reduction in mortality is not solely attributable to screening.

-Page 81/82/83
Randomized studies are not conducted in France, nor are observational studies.
The risk/benefit ratio is not the expected one. The risks are more important in women without risk factors or symptoms.

The pink campaign, an incentive campaign, is out of date with the scientific uncertainty and even with the relevance of the organized screening.
It is therefore necessary to reinforce women's possibilities of choice with more balanced information. For the moment, the information is judged insufficient.
On the INCa website, the information is fragmented, difficult to locate, sometimes contradictory, and the over-diagnosis is addressed in an unclear manner.
The information on the french health insurance website is also criticized, without making concessions, as it is considered to be overly encouraging because it emphasizes the "advantages" of organized screening.


- Page 108
The committee is asking for information, not marketing. Women are misled by Octobre Rose in contradiction with their demand for fair information. Confusion between screening and prevention must be avoided.


- Page 109/110 /111-115
The benefit-risk balance must be addressed and the notion of uncertainty must be included, and we must talk about interval cancers and over-diagnosis.
The committee would also like to see information on side effects and the illusion of mammography as an ideal method for cancer detection should be corrected.
The invitation should not be a convocation, and should include information on benefits and risks.
Information and training should be offered to health professionals, and the information should not be inciting.

-Page 121
Tomosynthesis: its benefit-risk ratio remains to be confirmed and research protocols must be developed to evaluate its use in screening. Tools must be implemented for the assessment of the programme in real time.

-Page 123
The committee reiterates and emphasizes the urgency and importance of promoting studies on over-diagnosis and over-treatment.

-The report on page 125
A controversial risk/benefit ratio and inadequate communication.

-Page 132
1-Consultation dedicated for women on their 40s.
2-Strategy prioritized according to level of risk, identifying high-risk women who will benefit from special and adapted follow-up and "under-risk" women who could be exempted.

Conclusions

  • Consideration of controversy in the information provided to women and in the information as well as in the training of professionals.
  • Implementation of research projects to better study the natural history of cancer (some cancers are mildly aggressive or regressing, contributing to over-diagnosis), and to be able to identify biological or imaging factors to define tumors requiring only surveillance. (ARC proposal)
  • permanent evaluation of the system, in order to have epidemiological and economic data relating to screening in France
  • integration of the general practitioner
  • maintaining double reading (Cancer Rose draws attention to the fact that double reading certainly increases false alarms)
  • evaluation of the practice of ultrasound, which causes false positives, the increase of which is greater than the number of cancers effectively detected.
  • Stopping early screening in women under 50 years of age with no particular risk factors.
    Cancer Rose reminds that the official HAS recommendations for participation in screening are from the age of 50 onwards, and not before.
  • Adapt the screening and follow-up strategy according to the level of risk.

Two scenarios:


Scenario1: Termination of the organized screening program, the relevance of a mammogram being assessed in the context of an individualized medical relationship.


Scenario 2: Discontinuation of organized screening as it exists today and implementation of a new organized screening program, profoundly modified.

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.