Getting paid to be screened?

Cécile Bour, MD, February 13, 2021

That is the question asked in the JIM[1] of February 13 by a citizen, a participant in the INCA[2] citizen consultation organized to " put an end to cancers".

This woman gives here her opinion on an item proposed by the INCa which seemed to her to be particularly unethical.
She is an agri-food engineer with a PhD in Life and Health Sciences. 
She speaks jointly with two other scientists, Dr. Theodore Bartholomew, a physician at the Royal Surrey County Public Hospital in Great Britain and holder of a Master's degree in Bioethics, and Dr. Harald Schmidt, Assistant Professor at the Department of Medical Ethics and Health Policy and Research Associate at the Center for Health Incentives and Behavioral Economics, at the University of Pennsylvania, in the United States.

We have already expressed our concern about this citizen consultation supposed to support the next ten-year cancer plan, through two articles [3] [4] published at the time of its launch where we denounced the collusion with pharmaceutical industry and very low citizen participation despite the dithyrambic presentation of the INCa communicators.

Not only citizens have been able to vote just for fallaciously formulated items (see our articles), without prior information on the ins and outs of certain proposed measures, but the participation rate is in no way representative of the French population (2478 effective participants for 3. 8 million people affected by cancer in France, and 47 million French citizens registered on the electoral rolls...), thus denying the "adequacy" that would exist between "the objectives and measures presented and the expectations of our fellow citizens" proclaimed by the INCa communicators.

And we were already astonished by this item[5] in particular, which also retained attention of the three authors in the JIM :

Experimenting with material incentives to facilitate people's participation in screening :

Incentive mechanisms such as financial motivation or payment of expenses (transportation, childcare, work), which have been very little used to date, will be experimented with in order to evaluate their contribution to the development of participation in the program.

Adherence to screening programs or procedures also requires the mobilization of professionals, whether in the carrying out of the act or in the informing and raising awareness on screening, otherwise by incentivizing.

This is not without recalling similar measures already in place in the United States, where many private health insurance companies incentivize women to perform screening mammograms by offering compensation in various forms.

What do the authors denounce in the article?

This French citizen and the two co-authors denounce together the cynicism of this financial incentive measure proposed by the INCa, which ignores the demands of the true citizen consultation [6] dedicated to breast cancer screening and organized in 2016, that called, in addition to the cessation of this screening, for better information given to women on the benefit-risk balance of this breast cancer screening ("Taking into consideration the controversy in the information provided to women and in the information and training of professionals").


This is the point made by the three authors, who recall that the issue at stake is to inform women about the risk-benefit balance of screening, in particular the risks of overdiagnosis, in order to enable them to make a better choice, one that is optimal for each of them: "The risk of these incentives is that the decision-making process is short-circuited, that women make decisions they will regret and that they would not have made in the absence of incentives".

The authors point out the unethical nature of this item: "... the choice of screening should be made by properly informed women and not by their physicians, nor by health insurers, public health policy makers or other actors. This initiative should not be promoted, but rather ensuring that women have access to truly useful information on the advantages and disadvantages of screening. Rather, we advocate encouraging active and informed choice by encouraging women to use evidence-based decision support tools".

At the beginning of the article, the authors recall the Cochrane Collaboration review[7] and the risk of overdiagnosis inherent in this screening, which should be known by each woman before engaging in screening. And they ask a very logical question:  "Instead of trying at all costs to strengthen screening as foreseen in the new ten-year cancer plan, why not mobilise more resources for equal access for all women to informative materials and documents on the risk-benefit balance of this screening, to enable them to make a conscious decision on whether or not to participate in mammography screening"?

 Citizen's demands heard? Is informing the population a concern of the new plan?

No, not at all.

The proposed measure on financial incentives for women to increase their participation is further proof that the National Cancer Institute is doing just what it wants to do, promoting the pursuit of its obsolete objectives, formulating the items in such a way that citizens can only approve due to lack of explanation, and burying the demands of the citizens of 2016 in anti-democratic brutality.

We also noticed that in the small group of 24 people who concocted these items of the consultation, we find the representative of the drug companies (LEEM) Mr. Eric Baseilhac, director of economic affairs.

The sad consequence of all this is formulated in the new European cancer plan, published shortly after this "citizens' consultation" supposedly based on citizens' opinions but in advance elaborated a long time ago, and which proclaims the intensification of screening:

https://ec.europa.eu/commission/presscorner/detail/en/ip_21_342

« ...ensuring that 90% of the EU population who qualify for breast, cervical and colorectal cancer screenings are offered screening by 2025. To support achieving this, a new EU-supported Cancer Screening Scheme will be put forward ».

The pharmaceutical and medical imaging industry can rub their hands :

« In addition, to support new technologies, research and innovation, a new Knowledge Centre on Cancer will be launched to help coordinate scientific and technical cancer-related initiatives at EU level. A European Cancer Imaging Initiative will be set up to support the development of new computer-aided tools to improve personalised medicine and innovative solutions »

Everything continues as planned, all is going well in the best of all worlds.

Références

[1] https://www.jim.fr/medecin/debats/e-docs/des_incitations_financieres_pour_le_depistage_du_cancer_du_sein_sont_contraires_a_l_ethique_186433/document_edito.phtml?reagir=1#formulaire-reaction

[2] https://consultation-cancer.fr/

[3] https://cancer-rose.fr/2020/12/15/inca-une-consultation-citoyenne-pourquoi/

[4] https://cancer-rose.fr/2020/12/17/la-concertation-citoyenne-de-linca-sur-le-futur-plan-cancer-une-mascarade/

[5] https://consultation-cancer.fr/consultations/axe-1-ameliorer-la-prevention/consultation/consultation/opinions/12-ameliorer-lacces-aux-depistages/mesures-proposees/experimenter-des-incitatifs-materiels-pour-faciliter-la-participation-des-personnes-au-depistage

[6] https://cancer-rose.fr/en/2020/12/14/final-report-of-the-citizen-consultation-report-of-the-steering-committee/

[7] https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001877.pub5/full

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New French cancer plan 2021-2030, a “Soviet” plan

February 7, 2021
Cécile Bour MD

Emmanuel Macron has just launched on Thursday 4 February a decennial national strategy (for 2021-2030)  in fight against cancer, with a funding of €1.74 billion over 5 years, i.e. 20% more than for the three previous cancer plans. The aim is to reduce the number of so-called "avoidable " new cancers by 60,000 cases per year from now to 2040.
Several media are talking about it, but we rely on the rather exhaustive report made by the newspaper Le Monde [1] on February 4, 2021 and on the 6th report to the president elaborated by the INCa[2].

We are going to review the "plans" from their origin until today, and we will see the evolutions through ages, from great demagogic objectives of past times to ...great demagogic objectives of nowadays, complemented by the intrusion of drug manufacturers. Already in 2013, Roche laboratory was not far away from breast cancer screening and watchful when analyzing "women's compliance" with screening through the EDIFICE[3] study. And when a pharmaceutical company takes such a close interest in a controversial measure, it is often to find out how to protect its interests...

The more patients there are, the more pharmacopoeia is sold.

Focus on screening

Main axes of this new cancer plan are deployed in the article published in Le Monde newspaper and we will focus on screening, our core target, which the president promises to strengthen in the first axis called "prevention". 

  • "Every year in France," the article says, "9 million people participate in one of the three organized screening programs (breast, colorectal and cervical cancers). The goal is to increase this number to 14 million in 2025". "Every year, more than 157,000 people die of cancer in France. In total, 3.8 million people live with the disease. Four out of ten new cancers would be avoidable. That represents 153,000 new cancers per year that would be prevented if the population adhered to organized screening programs, had a balanced diet and regular physical activity".
  • The "urban legend" of "preventive" screening, so precious to the INCa correspondents, comes up against the very definition of prevention, which is to ensure that the disease does not occur. Yet screening aims to detect, to track down a disease, which is already there. Screening procedures, whether for colorectal, breast or prostate cancer, do not anticipate the disease but detect a lesion that is already present in the body.

This misleading confusion between "prevention" and "screening" is found in the "improving prevention" axis[4] of citizen consultation that the INCa (National Cancer Institute) proposed at the end of last year[5] [6].
However, French women citizens, during the 2016 citizen and scientific consultation on breast cancer screening, pointed out this dishonest confusion between the two terms.[7]

       Page 5 : The committee also noted dysfunctions, abnormalities in the current organization of screening and consequences it generates: inequalities of access, lack of understanding of stakes, confusion between primary prevention, screening and early diagnosis, lack of information on risks and uncertainties of screening in invitation letter sent every 2 years,

      Page 125 " Moreover, information provided about organized screening maintains confusion between prevention and early diagnosis. "

Difficult to admit a simple awkwardness this time, on the contrary, this amalgam of terms is maintained deliberately, serving to falsely attribute to screening a preventive power that it obviously does not have.

Review of previous cancer plans

We review what has been previously designed in different successive cancer plans, while following evolution of lung and breast cancer.[8]

1° Plan 2003-2007[9]

Heading

"The Plan allows to reduce tobacco consumption through a comprehensive tobacco control strategy combining price increases, a ban on sales to minors under 16 years old, information campaigns and actions targeted at youth and women, and the development of aids to help people stop smoking"."The organized breast cancer screening program was generalized in 2004, while the organized colorectal cancer screening program was the subject of an experimentation from 2002 to 2007 in 23 pilot departments".

Epidemiological results of the 2000s

Lung (Remontet Report 2013 page 79)[10]

"The incidence of lung cancer has been steadily increasing over the past two decades. This trend is more pronounced in women, although both incidence and mortality remain much higher in men. ... At the same time, mortality follows a similar trend.... The number of deaths has increased from 15,473 to 22,649 in men and from 1,997 to 4,515 in women".

Page 84 tables 5 and 6

Breast (Page 99 of the report)


"The incidence of breast cancer has increased dramatically over the past two decades. Between 1978 and 2000, the average annual rate of change in incidence was +2.42%. The number of new cases has almost doubled in 20 years, from 21,211 cases in 1980 to 41,845 cases in 2000. 
At the same time, mortality has remained stable (slight annual increase of 0.42%). The number of deaths rose from 8,629 in 1980 to 11,637 in 2000".

Table 5 page 104

All in total : What should be concluded from a review of these data? Duperray notes[11]: "For breast and prostate cancer, there is a stable mortality and an incidence that escalates as the screening intensifies, whereas for lung cancer which is not routinely screened, the number of deaths is proportional to the number of diagnoses.  Incidence of lung cancer increases in parallel with the real cause of the disease, tobacco consumption.

Table page 155

"Indeed, for cancers that are screened, such as breast and prostate cancer, the overdiagnosis generated by screening is expanding, resulting in a sharp increase in the incidence of cancer in 2005, with no impact on mortality, which remains comparable to previous years without screening. In comparison, lung cancer, which does not benefit from any screening, shows a comparable rate of death and diagnosis.

In this graph, we see that the rate of serious cancer remains unchanged, whereas it was expected to decrease with the introduction of screening.(Figure 9 in the book, page 121 [11] ).

Unbridled and ideological enthusiasm for screening, despite the warnings made by whistleblowers as early as 2000, makes this fact inaudible and encourages the continuation of programs, especially given the disappointing participation of women.

2° Plan 2009-2013 [12] [13]

Heading

P.56: "The actions taken have not led to increased participation in organized screening programs for breast and colorectal cancer. The "Pink October" and "Blue March" information and mobilization campaigns have been renewed annually by adaptation of messages... Participation in organized screening programs is not progressing for breast cancer (national participation rate of 52.7% in 2012 for a target of 65% set by the Plan) as well as for colorectal cancer (31.7% in 2012 for a target of 60%)".

In the face with this observation, it would seem important for health technicians to intensify participation, as we can read in the following pages; therefore, recommendations of the High Authority for Health (HAS) are aimed at maintaining the objective of organized screening while at the same time strengthening the conditions that allow women who are not at high risk of developing breast cancer to limit individual screening practices (page 81 of the report).

On the tobacco smoking aspect, the report states on page 47 :

Thus, while 76% of people surveyed consider the risks associated with tobacco smoking to be "certain", the prevalence of smoking is still 32% among 15-85 year olds. Sixty-five per cent of respondents also continue to believe that "breathing city air is as bad for your health as smoking cigarettes".

Results of epidemiological data

Lung[14]

We can read in the Remontet report on solid tumor incidence and mortality, page 176  "Lung cancer incidence and mortality are still twice as high in men as in women in 2018".

The report states:

"The evolution of mortality from lung cancer mortality is closely linked to the evolution of incidence in both sexes and for all ages...Mortality is still increasing in women for all ages and more significantly for those in the 50-60 age group..."

Breast

Remontet Report Page 204 tables 4 and 5

In relation to incidence, a slight inflexion of the specific mortality from breast cancer can be noted, but this, as we can see below, takes place as early as the 90s, well before the generalization of screening, and cannot be attributed to it.

The report states (page 207): "The introduction of organized screening is generally accompanied by a temporary increase in incidence and to some extent by overdiagnosis (cancer that would not have developed before the patient's death and which is more likely to be in situ cancer not included in this study)".

Regarding mortality, the report states:

"A decrease in the mortality rate has been observed since the mid-1990s, linked to major therapeutic advances (hormone therapy, taxanes, targeted treatments adapted to the molecular profile of the tumor) and an increase in the proportion of cancers diagnosed at an early stage, notably through screening. "

But this last point is strongly contested by several international researchers who object that overdiagnosis is increasing with more and more screening in an almost proportional way.[15]

Others suggest that screening may be providing unaccounted for excess mortality due to the effects of overtreatment. [16]
Disturbingly, there is no difference between screened and unscreened groups of women. [17]
And in any case, mortality from all causes is not reduced.

All in total :
When looking at and comparing all the data on lung cancer and breast cancer, we can see that tobacco consumption, the leading cause of cancer-related death in France, has not decreased and it contributes to inequalities, by progressing among women and unemployed. It is clear that measures banning the sale of cigarettes to minors under 18 years of age and graphic warnings on packages are largely insufficient.

Meanwhile, despite the observation of a marked increase in the incidence of breast cancer, still without a massive impact on the reduction in mortality expected from successful screening*, the Pink October campaigns for awareness and promotion of breast cancer screening, are going well and without saving resources  (city lighting, races organized by municipalities, placarding of slogans), without any questioning or reflection on the overtreatment generated in population.

*PS: (When there is such a marked discrepancy between increasing incidence (number of new cases) and non-proportionally declining mortality), this case inflation is due to one thing: unbridled screening activity).Once again, we can see that despite overabundance of resources for the Pink October campaign, breast cancer mortality, particularly in women, is only on the increase. And smoking alone kills more than breast and prostate cancer combined![18]

The fight against tobacco smoking is clearly not meeting its stated intentions, probably because tobacco generates a lot of revenue in the form of taxes[19]. It is clear that  emphasis on intensifying screening makes us forget that the fight against smoking and alcoholism is not up to what would be possible if politicians, instead of sparing lobbies, really intended to reduce cancers.

3° 2014-2019 Plan[20] [21]

This plan focused on facilitating access to breast cancer screening for women who are farthest away and by any means possible. 

As the women who were easily accessible seemed to be recalcitrant to this screening, the authorities decided that it was necessary to stimulate participation of women who were usually little solicited or geographically inaccessible.

And there is no shortage of ideas:

-To set up regional training courses for women to relay awareness of cancer screening (organized breast cancer screening) targeting women in precarious situations (partnership with IREPS2 ) (Picardie). 

-Favor access to screening for women furthest away from screening sites by organizing the payment of transportation costs for a mammogram in Cayenne (French Guiana) and fight against inequalities in access and recourse (Martinique). »

-Carry out an inventory of access to organized breast cancer screening for disabled people in social and medico-social establishments (Franche-Comté). 


-Facilitate access to screening for detainees by raising awareness among the teams of the Consultation and Ambulatory Care Units (Indian Ocean)

Pages 72 and 74:

"the objective of achieving 75% coverage of organized or spontaneous breast cancer screening for women aged 50-74 by 31/12/2018" "to increase the effectiveness of organized breast cancer screening programs".

There is a need to increase women's participation, again and again; this 2014-2019 cancer plan only addresses the technocratic side of the system and anticipates in its terms what the high authorities want to promote, in defiance of the information to which the female population is entitled and which it has demanded in the meantime during the citizen and scientific consultation on breast cancer screening and its harms[22]. The aim is to keep this screening program on the tracks set in 2013, directed towards intangible five-year objectives.

Epidemiological results

In 2017 (see on the official website of the INVS), in France, among the causes of cancer deaths in women, breast cancer, responsible for 11,883 deaths, comes first, followed by lung cancer (10,176 deaths) then colorectal cancer (8,390 deaths).

 All in total

Observation is still indisputable: In France, the decline in specific mortality (from breast cancer) is not significant, despite the fact that breast cancer has been made a public health priority and that more resources have been devoted to it than to other pathologies.

Mortality from lung cancer, on the other hand, remains a major concern, especially among young people, which the current plan aims to address once again .

One plan followed another, and none of the problems have been solved: smoking continues to take its toll, and cases of breast cancer have risen alarmingly to 54,000/year with an overdiagnosis acknowledged by the authorities, but largely minimized and appearing to these authorities, in no way to question our medical practices, while we still record, despite organized screening, between 11,000 and 12,000 deaths/year, a figure that has been stable since 1996.[23]

Additional remarks before concluding

1°The illustrative image in the article from Le Monde published online, is a skin cancer screening case.

We relay here an interesting podcast[24] in English, on the overdiagnosis of melanoma, a cancerous skin tumor.

Dr. Adewole Adamson's observation is alarming: no reduction in mortality and massive overdiagnosis due to a lowering of the tolerance thresholds used by dermatologists and anatomo-pathologists regarding skin lesions.

Dermatologists request increasingly and more quickly the use of biopsies, while anatomical pathologists prefer to upgrade their diagnosis of lesions examined under the microscope (i.e. to classify as malignant lesions that are simply dubious and that could only be monitored), giving rise to an apparent melanoma epidemic with even more artificial "survivors".

The vicious circle is endless, prompting patients and doctors to do more and more routine skin examinations.

2° specifically on breast cancer

We read in the 6th report to the President of the Republic published in March 2020 by INCa, page 7, prelude to the 2021/2025 cancer plan presented on February 4, 2021 [25]:

A strengthening of the quality of organized breast cancer screening.

"In terms of organization, according to a decree published on February 22, 2019, only digital mammography facilities are now authorized in the program. The decree confirms that the radiologist, as the first reader, must analyze the images on an interpretation console. »

Looking back at the changes imposed to radiologists throughout the history of screening, it is interesting to note that decision-makers have always opted to improve the form, but never to question, the very substance of this system. 
In the course of my career as a radiologist, and since the 1990s, I have witnessed the transition from two to three breast images per breast, to compensate for the problem of interval cancers, which occur between two mammograms and escape screening.

Then we had to complete this "mammotest" with the addition of ultrasound and clinical examination. We therefore went from a "test" to an individual examination in the face of the method's failure!

Then we witnessed the advent of digital mammography, a technology that at first coexisted with analog mammography depending on the radiology office, and now imposed on everyone.

There is no doubt that we will soon see the arrival of tomosynthesis[26] [27],, which is highly radiant and often performed in addition to mammography without the patient's knowledge in some practices, with the prospect of a surge in false alarms and overdiagnosis.

Support for a study experimenting with personalized breast cancer screening.

"An international experiment in targeted breast cancer screening has been initiated. Supported by the French National Cancer Institute, the ARC Foundation for Cancer Research and the Ligue contre le cancer, and funded by the European Union, the MyPeBS (My Personal Breast Screening) study intends to evaluate whether personalized breast cancer screening could be a better screening option for women aged 40 to 70. »

The best proof of the failure of the current screening system is that we are now trying an "individualized" screening, a real trap for women, especially in the younger age groups, since, if deemed at risk, they will have mammograms that can be annual and from the age of 40....

What better way, by means of a study of an arrangement that is as hermetic as it is pernicious[28], to extend screening to age groups that have not been concerned until now because of a benefit-risk balance that has proved harmful for these young women.

These are the continuous "improvements" made to breast cancer screening, a veritable absurd race instead of an in-depth questioning on: rethinking the fundamental relevance of screening.[29]

3°For prostate cancer,[30]

we had already mentioned the problem of overdiagnosis, and had also talked about the problem of thyroid cancer[31], the latter with a predominant impact on women's lives.

Surprising to read in the article from Le Monde "Another challenge: to intensify research to find new screening tests, particularly for lung and prostate cancer. »

A new prostate screening? It's precisely because the old one wasn't very brilliant in terms of efficiency....

And since critical questions are not asked in any media, medical information can shamelessly continue through the show "Stars in the Nude" on French Television, where stars strip to "raise awareness" about screening and for the "good cause", without any respect for scientific data. The presenter, Mrs. Sublet, states in an interview in a feigned modesty that her show is "of public utility"[32].

Last year, in the week following this TV show, our radiology consultations were literally assailed by young men finding "balls" in their purses (absolutely true), and young women in tears who also found various swellings in their chests.No diagnosis was made, all of them were fortunately healthy. All this useless excitement mobilized the already scarce doctor's time, to the detriment of a patient in real need of care.

Conclusion :

A "Soviet" planning that makes a mockery of scientific data

There is no question of providing better information to women or of reducing the number of screenings, we still find objectives set in advance, pre-decided, and built up in minds of technocrats centered on an inventory of figures to be reached.

We see the unfortunate results of the failure of real prevention campaigns (tobacco, alcohol, obesity), with lung cancer inexorably on the rise and deaths in parallel.
     

Why not give priority to health education with real large-scale campaigns instead of a waste of resources to promote screening, most of which, it must be admitted, has no perceptible impact on overall mortality, and on the contrary leads to overdiagnosis in healthy populations, plunging them into pointless situations of ill people?

Why? In a opinion column Annette Lexa, toxicologist, gives some clues[33]:

-"Destructive behaviors have been valued for a long time; hygiene and prevention are supposed not to be hedonistic;

-Curative sector is economically more interesting;

-Occupational cancers continue to be neglected and minimized by the health funds themselves (CPAM, MSA), forcing long, improbable and costly procedures;

-Society, which is so promptly in controlling its citizens when the political and economic system is in danger, pretends to fear that this is an attempt to reduce individual "freedoms" (freedom to smoke, to drink, etc.);

-Tobacco, alcohol, industrial food marketed by advertising bring in a lot of VAT;

-Contraceptive pill, a symbol of female emancipation, yet cancerogenic and endocrine disruptive as proven by the IARC (http://www.cancer-environnement.fr/479-Classification-par-localisations-cancereuses.ce.aspx#Seins), is still and always presented as the most popular means of contraception while skillfully minimizing undesirable effects, so great is the collective stake in sexuality.

-How many young women buy "organic" cosmetics guaranteed free of bisphenol A and parabens presumed to be carcinogenic while taking the pill and smoking?

-Our modern societies have not been able to reinvent the ritual of passage to adulthood, trapping adolescents in risky behaviors (addiction to tobacco, alcohol, drugs, trivialization and precocity of risky sexual practices ...).

-Finally, opportunistic marketing aimed at developing a connivance with women (cosmetics, mutual insurance companies, e-health professionals, "sports" events) symbolizes the power of manipulation and misinformation as well as the cynicism of an entire society busy developing business by giving itself a virtuous endorsement and sometimes even sincerely thinking of clumsily repairing the damage it has itself created, while it should put all its energy (albeit less profitable) into cancer prevention and provide everyone, from a very young age, with the keys to optimal life and health. "

Finally, this new cancer plan was developed under the supervision of the pharmaceutical industry.

And here is our colleague Dr. Gourmelon who explains:

"What is immediately striking in the two press releases, in addition to the means implemented, is the place that the cancer "lobbies" have taken in the prospective group that drew up the 220 proposals with Pr IFRAH. (See Annex 3 of the 29-page press kit).  In this small group of 24 people, we find the representative of the drug companies Mr Eric Baseilhac. He is the director of economic affairs".

Full article available here: https://cancer-rose.fr/2020/12/15/inca-une-consultation-citoyenne-pourquoi/

Broadly speaking, the objectives vary little, and neither do the epidemiological data, demonstrating the inanity of these large plans, which are invariable from one five-year plan to the next, from one president to the next.

In the end, only the easy and demagogic causes remain, giving the illusion of "doing", of grasping the problems, to the great delight of the firms and their "innovations".

Read here: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_342
"Early detection of cancer by improving access, quality and diagnostics and support Member States ensuring that 90% of the EU population who qualify for breast, cervical and colorectal cancer screenings are offered screening by 2025. To support achieving this, a new EU-supported Cancer Screening Scheme will be put forward.
......In addition, to support new technologies, research and innovation, a new Knowledge Centre on Cancer will be launched to help coordinate scientific and technical cancer-related initiatives at EU level. A European Cancer Imaging Initiative will be set up to support the development of new computer-aided tools to improve personalised medicine and innovative solutions."

Références


[1] https://www.lemonde.fr/planete/article/2021/02/04/une-nouvelle-strategie-nationale-pour-faire-reculer-le-cancer_6068728_3244.html

[2] https://www.e-cancer.fr/Presse/Dossiers-et-communiques-de-presse/L-Institut-national-du-cancer-publie-le-dernier-rapport-annuel-au-president-de-la-Republique-du-Plan-cancer-3-et-precise-les-echeances-de-la-strategie-decennale-de-lutte-contre-le-cancer

[3] https://www.roche.fr/fr/pharma/cancer/depistage-cancers-france.html

[4] https://consultation-cancer.fr/project/axe-1-ameliorer-la-prevention/consultation/consultation

[5] https://cancer-rose.fr/2020/12/15/inca-une-consultation-citoyenne-pourquoi/

[6] https://cancer-rose.fr/2020/12/17/la-concertation-citoyenne-de-linca-sur-le-futur-plan-cancer-une-mascarade/

[7] https://cancer-rose.fr/en/2020/12/14/final-report-of-the-citizen-consultation-report-of-the-steering-committee/

[8] https://www.e-cancer.fr/Plan-cancer/Les-Plans-cancer-de-2003-a-2013

[9] https://cancer-rose.fr/wp-content/uploads/2021/02/Plan_cancer_2003-2007_MILC.pdf

[10] https://www.santepubliquefrance.fr/maladies-et-traumatismes/cancers/cancer-du-colon-rectum/documents/rapport-synthese/evolution-de-l-incidence-et-de-la-mortalite-par-cancer-en-france-de-1978-a-2000

[11] B.Duperray "le dépistage du cancer du sein, la grande illusion" Ed Thierry Souccar, page 155

[12] https://www.e-cancer.fr/Plan-cancer/Les-Plans-cancer-de-2003-a-2013/Le-Plan-cancer-2009-2013

[13] https://cancer-rose.fr/wp-content/uploads/2021/02/2009-2013.pdf

[14] https://www.santepubliquefrance.fr/maladies-et-traumatismes/cancers/cancer-du-sein/documents/rapport-synthese/estimations-nationales-de-l-incidence-et-de-la-mortalite-par-cancer-en-france-metropolitaine-entre-1990-et-2018-volume-1-tumeurs-solides-etud

[15] https://cancer-rose.fr/en/2020/12/29/analysis-of-harding-american-study-2015/

[16] https://cancer-rose.fr/en/2020/12/29/excess-mortality-due-to-treatment-outweighs-the-benefit-of-breast-cancer-screening-synthesis-of-several-studies/

[17] https://cancer-rose.fr/en/2021/01/06/miller-study/

[18] http://www.unicancer.fr/le-groupe-unicancer/les-chiffres-cles/les-chiffres-du-cancer-en-france#:~:text=Cancer%20colorectal%20%3A%209%20294%20d%C3%A9c%C3%A8s,la%20prostate%20%3A%208%20207%20d%C3%A9c%C3%A8s

[19] https://www.who.int/tobacco/economics/taxation/fr/

[20] https://cancer-rose.fr/2016/10/10/a-propos-du-plan-cancer-2014-2019/

[21] https://www.e-cancer.fr/Expertises-et-publications/Catalogue-des-publications/Plan-Cancer-2014-2019

[22] https://cancer-rose.fr/2016/12/15/nouvelles-du-front-premiere-manche/

[23] https://cancer-rose.fr/2016/07/30/mortalite-donnees-de-la-base-cepidc-de-1996-a-2012/

[24] Podcast dermato https://www.youtube.com/watch?v=068KMIe-gys&feature=emb_logo

[25] https://www.e-cancer.fr/Expertises-et-publications/Catalogue-des-publications/Sixieme-rapport-au-president-de-la-Republique-Mars-2020

[26] https://cancer-rose.fr/2019/11/28/avis-de-la-haute-autorite-de-sante-sur-la-performance-de-la-mammographie-par-tomosynthese-dans-le-depistage-organise/

[27] https://cancer-rose.fr/2019/03/09/association-de-la-tomosynthese-versus-mammographie-numerique-dans-la-detection-des-cancers/

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

[29] l'étude dont on rêvait : https://cancer-rose.fr/my-pebs/2019/03/09/letude-dont-on-re%cc%82vait/

[30] https://cancer-rose.fr/en/2021/02/11/parallel-to-breast-screening-prostate-screening-overdiagnosis-as-well/

[31] https://cancer-rose.fr/en/2021/02/01/overdiagnosis-of-thyroid-cancer-another-womans-concern/

[32] https://m.youtube.com/watch?v=7NQOTNDeM1c

[33] https://cancer-rose.fr/2016/11/05/la-vraie-prevention-parent-pauvre-du-plan-de-lutte-contre-le-cancer-du-sein/

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.

Myths in medicine, but does their rebuttal make it possible to install the facts in a lasting way?

Cécile Bour, MD, May 24, 2020

During the Covid-19 pandemic that we have just experienced, science based on facts has been severely mistreated... General panic, mediocrity of the media combined with incredible assurance of a single researcher sounded the death knell of the serene search for facts, proclaimed as miraculous a treatment without having the proof, stepped on the principle of primum non nocere, (first do no harm), which is the foundation of our medical practice.

Independently of fundamental questions, which is not our subject, we can see that the urgency of a health situation facilitates drifts, sloppy studies, but also statements made by personalities who are not aware of scientific constraints, but who want to impose their convictions.

The interesting question is: does even strong evidence that can bury doubts and polemics have the power to put an end to myths and beliefs that are deeply rooted in medicine?

And above all, will they be tolerated in a context of serious illnesses, where public is asking for hope and where  scientific community and public authorities prefer to persist in a benevolent ideology, however fallacious?

Parallel of the epidemic situation with the myths conveyed during screening campaigns

Being a group focused on issues of public medical information and interference of non-medical stakeholders in scientific controversies, as we regularly experience during pro-cancer screening campaigns, we can draw parallels with history of breast cancer screening, where economic stakes and beliefs have prevailed over reasoning.

The public does not like uncertainty, and the tremendous desire to overcome major health threats enables the appearance and immoderate expression of promises of salvation and healing.

How was it possible to impose the mantra that screening is a preventive act, and that regular mammograms can drastically reduce the risk of dying from this disease?

To understand, a bit of history

At the very beginning of the history of screening, between the 1970s and 1980s and in various cities, counties and countries (Norway, Denmark, Canada, New York, Swedish counties, Malmö in Sweden,) women were included in so-called trials, meaning studies that consisted of simply comparing the outcome of screened women against that of unscreened women.

At that time this could be done, as women had never received an X-ray of their breasts before; they were what can be called "pure cohorts". And these early comparative studies claimed a tremendous decrease in mortality through screening, up to 30% reduction in the risk of dying from breast cancer.

 Presented in this way, this performance seemed very pleasing. In view of these results, it seemed intuitively obvious that breast cancer screening would allow earlier diagnosis, earlier treatment and thus a drastic reduction in mortality by eradicating the most serious forms.

But science is sometimes a colossus with feet of clay, and while some erected convenient convictions, other researchers, more scrupulous and suspicious, drove the stings of doubt into this base of certainties.

Indeed, it became quickly clear, (this is no longer contested by the scientific community), that these first trials had many biases, such as irregularities in method, in distribution of women between the two groups and in statistical analyses. The methodology of trials did not meet current quality criteria. For example, some of women "screened" by mammography had tumors that were already clinically palpable! Even the published results of the so-called trial in the two Swedish counties were incompatible with the data in the Swedish national file. The best results had been obtained with the less good mammograms, none of the equipment used then would be approved for use today.

While victorious publications multiply between 1992 and 2000, along with an important media and social relay on women, physicians and governments, Gotsche and Olsen, two independent Nordic researchers, proceed, in 2000-2001, to a meta-analysis according to the methodology of the independent Cochrane collective to which they belong.

And then it's a shock.

(Meta-analysis is a scientific method of combining the results of a series of studies on a given problem according to a reproducible protocol, here: does screening reduce mortality from disease. It allows a more precise analysis of the data by increasing the number of cases studied in order to draw a general conclusion. By grouping together the previous trials carried out, data on 800,000 women were obtained).

Gotsche and Olsen quickly realized that none of conducted trials were of high quality and that they all had biases, sometimes significant. By combining the best trials (the so-called Malmö 1, and the Canada 1 and 2 trials), it appears that there is no statistically significant difference in mortality between screened and unscreened women. Obviously, this is a colossal turnaround while enthusiasm for this public health procedure, which was supposed to solve the cancer problem once and for all, was in full swing.

Unfortunately for the researchers, they did not get authorization to publish their results in Cochrane reviews, and the powerful Cochrane "breast cancer group" forced them to include even biased trials in order to improve the results; after long negotiations, and with inclusion of the poorest trials, the authors still found only a very meagre and hypothetical benefit. They added at the end of their publication that the best trials show no decrease in mortality, and that the indicator "mortality from breast cancer" is unreliable.

About these negotiations that took place, read here : Trouble in the world of evidence

But in the end, the press preferred to retain the beautiful story of a life-saving screening, as did savant societies, women largely influenced by a glowing press, doctors, health authorities....[1]

However, other meta-analyses, the American USPTTF* in 2000 and the French independent review Prescrire in 2006 corroborate these equally disappointing results, even with different age groups studied, different observation periods and different cohorts.

* U.S. Prevention Services Working Group of primary care and prevention experts who review evidence of effectiveness to develop recommendations in the area of prevention.

The conflicts of interest that have plagued the whole history of breast cancer screening are very well documented on the Formindep website [2] [3], and are reported in the very complete report of the citizens' consultation (starting on page 63).

Conclusion

Science applies a method of doubt to beliefs and superstitions, and to itself as well, in well-done studies.

Uncertainty in the face of health dangers encourages beliefs and reassuring hopes, all the more so as this uncertainty is strong, not only on the magnitude of the threat itself, but also on the means of countering it.

The first bearer of good news becomes a hero, a savior. Any reasonable protester who applies his method of doubt becomes a public enemy.

With the history of screening we see how myths and intuitive ideas, simple to understand but false, once established, have a long way to go.

For three decades now, the myth of "preventive" screening, "life-saving for women", has been firmly anchored in people's minds, regularly promoted by the public authorities, the National Cancer Institute and the health authorities, valorized by public personalities who are committed to its promotion. Evidence of its ineffectiveness and, worse, of its deleterious effects, is little mediatized, has no right to be quoted; those who want to evoke it and warn women are called conspirators, incompetents, evildoers for the cause of women and are inaudible during the pink October campaigns.

Current Covid-19 crisis has revealed the fragility of science in relation to belief, and has highlighted all the possible excesses once we move away from the search for facts, act in haste, and adhere to convictions justified solely by their comforting character.

References

1] All of this is documented in the report of the citizen and scientific consultation on screening in 2016, starting on page 51, see also https://cancer-rose.fr/wp-content/uploads/2019/07/depistage-cancer-sein-rapport-concertation-sept-2016.pdf.

As well as in Bernard Duperray book "Dépistage du cancer du sein, la grande illusion" published by Th Souccar, starting on page 26.

2] https://formindep.fr/les-cinquiemes-rencontres-du-formindep/

3] https://formindep.fr/?s=Tabar%2C+Lancet

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.

High risk of breast cancer and mammography, in practice

JANUARY 18, 2021

(We have addressed this specific topic in two articles, below is a practical summary at the request of one of our readers. [i] [ii])

The first problem is to define a woman who is at high potential risk of developing breast cancer during her lifetime. And what is a "family at risk".
A family history alone, even a direct one, does not constitute the proof of being a person "at risk", contrary to what is often presented as a scarecrow to women.
We receive plenty of testimonials from young women who are unnecessarily alarmed and above all incited to unnecessary and dangerous over-medicalization.

What about the search for genetic mutations in women? When should it be done? 

This is the question that the independent French medical journal Prescrire addressed, Volume 36 N°388/February 2016.

Genetic mutations in the BCRA1 and BCRA2 genes are autosomal dominant, and women with these mutations are at higher but earlier risk of breast and ovarian cancer than the general population.

-The median age of onset is 40 years and the cumulative risk of cancer at age 70 is 51% to 75% for the BRCA1 mutation, 
-The median age is 43 years and the estimated cumulative risk is 33% to 55% for the BRCA2 mutation.

The journal Prescrire proposes the following criteria as significant backgrounds for proposing an onco-genetic consultation:

-Three people from the same branch, with breast cancer before the age of 70,

-Two people in the same branch, with cancer before the age of 50

-A person who has had ovarian cancer

-A person with breast cancer with a diagnosis before the age of 40, or a bilateral form, the first one before the age of 50, or a hormone receptor negative cancer that occurred before the age of 60.

Eisinger Score

The Eisinger score is a decision aid for requesting an onco-genetic consultation.(Click below to download) :

Several situations can arise in families with multiple cases of breast cancer:

A- Mutation identified in a woman in the family, presenting a breast cancer.

This search for genetic mutation brings valuable information to the women in the family: women who are carriers have a higher risk, women in the same family who do not have it, end up with the risk of the general population.

If a woman in the family decides to do a mutation search on the BCRA1 or BCRA2 genes because of a loaded genealogy, and finds herself carrying a deleterious mutation on these genes, then her risk of developing breast cancer appears to be high, and this risk is also very high for relatives.

B- No mutation found in women with breast cancer.

Either there is really no mutation and the patient has developed a form of cancer without a genetic cause, or there is a mutation, but it may be due to an unidentified genetic cause.

Therefore, there will be uncertainty for the women in her family regarding the hereditary nature or not of this cancer, the risk of the familial nature of this cancer is not as high as in the case of an identified mutation such as BRCA but probably slightly higher than in the general population.

Uncertainty makes it necessary to analyze genealogy, which also has its share of uncertainties and imprecisions…

C- The person with breast cancer has not done any genetic research.

For the women among the relatives, this gives useless information: either the ill person may have had a mutation that was not researched, or she is free of a mutation but the mutation possibly exists in the family members.

All overall, the following points should be kept in mind:

  • Either the person presents a family case carrying a mutation but she is free of any mutation herself, her risk will be close to that of the general population. 
  • Or the person has the mutation and can be estimated to have a higher risk of breast cancer than the general population.
  • But for other women there are still uncertainties about their family's risk of breast cancer:

-In women whose family members have had breast cancer but without a mutation found in only one of the family cases,
-In women with a personal genetic research of a mutation that is negative, with a genealogy presenting several cases of breast cancer, but without research done on the ill persons.

Proposals of conduct to be followed, different options depending on the situation

Who are the individuals with the highest theoretical risk?

-Woman with a case of breast cancer in a first-degree relative (mother, sister, daughter) before the age of 40.

-Two women with breast cancer in the family of first or second degree.

-Male relative with breast cancer in the family of the first or second degree

-First or second degree female relative with ovarian cancer.

Summary according to the Prescrire dossier published in the Revue Prescrire May 2016/Tome 36 N°391-p.355 to p.361

Here is a table summarizing the proposed courses of action according to the presence of mutation or not, and proposals for complementary imaging (downloadable table, click below):

TABLE

EXISTING RECOMMENDATIONS IN FRANCE

1°In 2014, the French National Authority for Health (Haute Autorité de Santé) issued recommendations that are still in force:

https://www.has-sante.fr/upload/docs/application/pdf/2014-05/depistage_du_cancer_du_sein_chez_les_femmes_a_haut_risque_synthese_vf.pdf

2° The recommendations of the National Cancer Institute, click (table p.10 of the doc)

As you will read, early and annual mammography is recommended, ignoring the greater risk of radiation-induced cancer, which can occur, depending on mutations, as early as the first mammogram. iii] [iv]

For these women at particular risk, recommendations are made without any objective data on the impact of different screening strategies, on overall mortality data, breast cancer mortality, mastectomies, treatment effects, over-diagnosis and false alarms for this at-risk population. In absence of data, these women and their caregivers are unsure of what to do and are struggling empirically.

While assessments are conducted on the general population, it is equally important to do them in these special populations, but they are not available.

General cautions

A thorough discussion should be undertaken with the patient because the knowledge of this high risk will condition for her, in addition to an important psychological burden:

-Permanent anxiety

-Numerous false alarms (false positives)

-Over-diagnosis is highly probable but not evaluated since no studies have been carried out to quantify it.

To quote the May 2016 issue of the journal Prescrire: "To ensure that screening has a favorable benefit-risk balance, it is not enough to determine the most effective detection method: earlier diagnosis does not always change the burden of treatment for patients, nor necessarily the prognosis of the disease".

"It is also necessary to establish the conditions where this translates into tangible clinical benefits for the people screened. It is also important to measure the undesirable effects to which all screening exposes people: over-diagnosis and over-treatment, sources of serious undesirable effects sometimes; iatrogenicity of the tests; false positives causing anxiety and useless tests; medicalization of the healthy person's existence. »

And further on, on the ethical aspect:

"Ethics. The magnitude of the risk of breast cancer in these higher-risk women compared to the general population does not make it unethical to conduct randomized clinical trials, on the contrary. Clinical trials comparing the effects of various screening strategies on clinical criteria such as total mortality, breast cancer specific mortality, frequency of breast amputations, frequency of cytotoxic treatments, would provide the answers that are lacking, instead of leaving women and caregivers without solid evidence for these important decisions". 

According to the journal Prescrire, a U.S. evaluation reports 125 cases of radiation-induced breast cancer per 100,000 women between 40 and 74 years of age screened by mammography every year, 16 of which are fatal. And for high-risk women, it has been shown that breast cancer was twice as frequent in women exposed to x-ray examinations before the age of 30 than in those not exposed.

Other complementary exams

Other exams than mammography, each having its limits, and an adapted follow-up can be proposed.


MRI

This exam has a higher sensitivity compared to mammography and is less radiating.

MRI + Mammography:
84% of cancers found

MRI alone:
75% of cancers found

Mammography alone:
32% of cancers found

These proportions are almost identical for women at high risk, but here the problem is the same, we do not know the proportion of overdiagnosis. It is not known whether there is a gain in survival for these women who are followed in this way, or whether, on the contrary, they are exposed to more overdiagnosis and invasive treatments.

The long-term effects of Gadolinium injected annually are also unknown. The assessment of this potential risk is all the more necessary as these women will be integrated into heavy surveillance protocols, with multiple repeated MRI scans.

This product has possible side effects during injection and some cases of allergic reactions have been described.

Ultrasound:


this examination increases overdiagnosis and exposes to false positives and multiplies unnecessary biopsies.

Clinical examination by a professional:


The authors of the Prescrire dossier did not find any study evaluating the performance of breast self-examination.

But according to all the studies examined by the authors, it seems that at least half of the cancers discovered by an imaging examination were not diagnosed by the clinical examination carried out at the same time. It is not known if a delay in clinical diagnosis would be life threatening, as this has not been evaluated.

References

[i] https://cancer-rose.fr/2016/11/20/observations-femmes-a-risques/

[ii] https://cancer-rose.fr/2016/11/20/depistage-et-risque-familial-eleve-de-cancer-du-sein/

[iii] https://cancer-rose.fr/en/2020/12/15/radiotoxicity-and-breast-cancer-screening-caution-caution-caution/

[iv] https://its.aviesan.fr/getlibrarypublicfile.php/cd704e89988a4e3bcf2e1217566876cf/inserm/_/collection_library/201800012/0001/J1-098ITS-2017.foray.lyon.ITMO.TS..21.nov.2017.pdf.pdf

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.

Hormone Replacement Therapy (HRT) and Breast Cancer

Synthesis by Cécile Bour, MD, 

December 29, 2020

The debate on the question of the link between HRT and breast cancer is long-standing, dating back to 2002 when an American study suggested an over-risk of cancer in patients on HRT. This first study resulted in great controversy. This WHI (Women Health Initiative) trial is a large randomized American study whose objective is to evaluate the risks and benefits of different dietary and medical strategies that can reduce the incidence of cardiovascular disease, breast cancer, colorectal cancer and fractures in postmenopausal women.

Planned to last more than 8 years, the trial was prematurely stopped in the first half of 2002 after a little more than 5 years, as the risks were deemed to outweigh the benefits, in particular due to the appearance of unfavorable and unexpected cardiovascular effects of HRT.

Indeed, the study confirmed a vertebral and femoral anti-fracture effect, a beneficial effect on the decrease of colon cancer rate, but found an increase in cerebrovascular accidents, myocardial infarction, phlebitis and pulmonary embolism, and breast cancer.

The results were contested in France on the basis that the products used in the study were orally administered and normodosed equine estrogens (whereas in France were used transdermally or orally estradiol), and medroxyprogesterone acetate which was not used in France. Great relief therefore when JAMA[1], in 2017, came back on these first rather frightening results and contested this excess mortality in the WHI study, the French gynecologists then considering HRT globally as a "good thing if the treatment is not standardized but personalized"[2].

However, in medicine, nothing is ever set in stone, and in 2003, another study, an English one[3] conducted from 1996 to 2001 including more than a million menopausal women between 50 and 64 years old, showed an over-risk of breast cancer under HRT, even with treatments commonly used in Europe. The result of the study was that the risk of developing breast cancer as well as the risk of cancer-related death was greater in treated women than in untreated women, and greater in women treated with combined estrogen-progestin therapy than in women receiving estrogen therapy alone. This English study examined many of the treatments used in Europe, both for the types of estrogen-progestin and for their means and routes of administration.

The controversy was such that the systematic prescription of HRT was drastically slowed down in 2004. And it is true that a decrease in the incidence of this cancer was observed around 2004, when HRT was stopped being prescribed on a large scale and for long periods of time. [4]

A 2019 study – an over-risk of cancer confirmed under HRT treatment

This is a review of 58 epidemiological studies on the subject of the association between HRT and breast cancer, mostly observational, involving more than 100,000 women in total. Published in 2019 in The Lancet [5], this review demonstrates an increased risk of breast cancer in women undergoing hormonal treatment for the effects of menopause. While this excess risk decreases well after stopping treatment, it persists for at least ten years.

The study is innovative in that it quantifies the risk for each type of treatment.

For example, a fifty-year-old woman who has been on HRT combining estrogen and progesterone continuously for 5 years has a risk of developing breast cancer within 20 years of starting treatment of 8.3%. The risk would be only 6.3% for women of the same age who have had no treatment.

The risk of developing breast cancer after 20 years would be 7.7% for women who have been treated with estrogen and progesterone but intermittently, and 6.8% for those treated with estrogen alone, according to the researchers.

What should be learned essentially from the study?

  • All hormonal treatments for menopause are associated with increased risk, with the exception of estrogen gels for local application.
  • The risk would also increase with the duration of treatment, the use of HRT for 10 years would result in an excess risk of breast cancer about twice as high as the risk of a 5-year treatment alone.
  • Conversely, using HRT for less than a year would result in a low risk.

Adapt according to the need

Currently the practice aims to individualize prescriptions, carefully considering the risks and benefits of treatment for each woman and taking into account whether or not to use HRT, depending on the woman's climacteric disorders (Climacteric refers to the years of hormonal change experienced by the woman before and after menopause).

The recommendation of the High Authority of Health (HAS-France)

In 2004 the French High Authority for Health (HAS) issued a recommendation[6] that is still in force: HRT should be prescribed for a short period of time. The HAS specifies that there is no need to prescribe additional or specific radiological examinations for women treated with HRT, but the HAS does request that all women treated be systematically included in the screening program. The following is recommended  [7]:

  •  In case of hormone replacement therapy or menopause hormone treatment in progress :

In case of prescription before the age of 50 and in the absence of sufficient data to determine the benefit-risk balance of mammography, no specific radiological monitoring is recommended.
In case of prescription after the age of 50, no specific radiological monitoring is recommended. The woman should be encouraged to participate in the national organized screening program.

Therefore, in the case of prescribing HRT, the prescribing physician cannot, at the risk of legal action, manage the treatment without recommending the systematic screening of his patient for breast cancer[8].

References

[1] https://jamanetwork.com/journals/jama/article-abstract/2653735

[2] https://www.lequotidiendumedecin.fr/actus-medicales/recherche-science/thm-letude-whi-montre-finalement-une-absence-de-surmortalite

[3] https://www.ansm.sante.fr/S-informer/Communiques-Communiques-Points-presse/Traitement-hormonal-substitutif-et-risque-de-cancer-du-sein

[4] Page 6 of the document: " STATUS AND KNOWLEDGE REPORT / GUIDELINE FILES".

FEBRUARY 2015

HORMONE TREATMENTS/MENOPAUSE AND RISKS OF CANCERS

Document written and coordinated by the Prevention Department, Public Health and Care Unit (PSPS)-INCa. "Although this hypothesis needs to be further explored, the decrease in breast cancer incidence has also been described in other countries where the drop in the prescription of THMs (hormonal treatment for menopause) has been spectacular, such as in Canada, Germany, the United States, Belgium and Australia".

[5] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31709-X/fulltext

[6] https://www.has-sante.fr/jcms/c_1754596/fr/traitements-hormonaux-de-la-menopause

[7] https://www.has-sante.fr/jcms/c_1741170/fr/depistage-du-cancer-du-sein-en-france-identification-des-femmes-a-haut-risque-et-modalites-de-depistage#toc_1_2

[8] https://cancer-rose.fr/2020/03/02/depistage-et-paradoxe-lors-de-lusage-de-certains-medicaments/

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DIABETES AND CANCER

By Dr. C. Bour, January 5, 2021

The link between diabetes and cancer in general and diabetes and breast cancer in particular is well known, as shown in a 2012 meta-analysis [1].

This meta-analysis revealed a significant increase in the risk of breast cancer in women with diabetes compared to non-diabetic women. However, the association between diabetes and breast cancer risk appeared to be limited to postmenopausal women. Type 1 diabetes and diabetes in premenopausal women were not associated with a significant increase in breast cancer risk.

People with type 2 diabetes have a higher risk of developing cancers of the breast, pancreas, liver, kidney, endometrium and colon. 
While patients with type 1 diabetes are more likely to develop cervical and stomach cancers.

Several studies have also shown that patients with diabetes and cancer have a poorer prognosis than those without diabetes. Diabetes and hyperglycemia are associated with higher infection rates, shorter remission periods and shorter median survival times, as well as higher mortality rates[2].

Several mechanisms might explain why type 2 diabetes could increase the risk of cancer are being implicated: hyperinsulinemia, hyperglycemia and inflammation. The increase in blood glucose levels is believed to have carcinogenic effects by causing DNA damage.

Particular case of breast cancer

The meta-analysis discussed at the beginning of this article was conducted using a random effects model to study the association between diabetes and breast cancer risk [3].

The risk of breast cancer in women with type 2 diabetes is increased by 27%, a figure that decreases to 16% after adjusting for BMI. Obesity is an aggravating factor as shown in other studies.  

No increase in risk has been observed in women in pre-menopausal age or with type 1 diabetes.

In addition to the over-risk of cancer in the diabetic patient, what about the management of the patient with both diabetes AND cancer? [4] [5]

The management of the diabetic patient requires treatment not only by hygienic and dietetic measures but also by a finely tuned medication protocol that may include insulin and one or more oral agents.

Chemotherapy and analgesics can affect glucose homeostasis[6] and insulin sensitivity; drug interactions can interfere with the patient's tolerance to diabetes drugs; decreased appetite, nausea, vomiting and weight loss resulting from both disease and cancer treatment can cause imbalances in blood glucose levels.

Chemotherapeutic agents

Several chemotherapies are known to cause or exacerbate these adverse conditions. For example, cisplatin is known to cause kidney failure, and anthracyclines can cause cardiotoxicity. Cisplatin, paclitaxel and vincristine may be neurotoxic. Unfortunately, many of these side effects may remain permanent.

For cancer treatment to be effective, at least 85% of the chemotherapy dose must usually be administered. Patients with diabetes should be carefully monitored before the start and during chemotherapy. Treatment decisions should be based on the patient's clinical picture, but always be aware that any change in dose, or alteration in the timing of administration, or substitution of another chemotherapeutic agent may compromise results by reducing the response rate to treatment.

Corticosteroids

They represent an important part of treatment in cancer pathologies and are widely used to improve nausea and vomiting associated with chemotherapy, as well as to suppress neurological symptoms when the cancer has metastasized to the spine or brain. And they cause significant hyperglycemia within hours after administration. 

The treatment of hyperglycemia resulting from glucocorticoids then depends on the type of diabetes, the severity of the hyperglycemia levels, the dose and the duration of therapy. Administering steroids in multiple doses throughout the day instead of a single bolus dose, or administering the entire daily dose of steroids intravenously over 24 hours, can help control hyperglycemia.

Patients with pre-existing diabetes can be maintained on oral hypoglycemic agents and closely monitored. However, these medications are generally unsuitable for managing hyperglycemia in this setting and insulin is used.

Patients using insulin prior to glucocorticoid therapy will typically require both basal and preprandial insulin. These patients may require two to three times their usual insulin dose. Insulin is the preferred drug for the management of steroid-induced or steroid-exacerbated hyperglycemia in patients with known diabetes.

Patients with type 1 diabetes will need to adjust their dose. Type 2 patients who are already taking oral agents at baseline will add insulin, but only during this period when their blood glucose levels are high.

Several studies of cancers as disparate as small cell lung cancer and breast cancer have found an association between poorly controlled hyperglycemia and poor outcomes in these patients with both diabetes and cancer. Hyperglycemia also increases the risk of infection.

In patients with active cancer, the management of hyperglycemia focuses on the prevention of long-term complications to avoid acute and sub-acute outcomes, such as dehydration due to polyuria, infection, catabolic weight loss, hyperosmolar non-ketotic states and diabetic ketoacidosis [7].

Analgesics

Analgesics can cause constipation that affects patients in two ways. It can make them want to not eat, but also, by slowing down intestinal motility, narcotics may delay the absorption of nutrients. This can lead to a mismatch between the administration of insulin and the absorption of glucose. The patient faces the risk of hypoglycemia.

Statins and chemotherapy [8]

Statins and chemotherapeutic agents are metabolized by the same enzymes in the liver. 

If the liver enzymes are all captured by statin therapy, this may result in less elimination of chemotherapy. Some research suggests that it also works the other way around. If you give a statin to a patient on chemo and then stop the statin, he or she will eliminate the chemotherapy drug much more quickly. 

In general, therefore, there is a reluctance to start statin therapy in someone just starting chemotherapy because of possible hepatotoxicity," says Lavis [9] . If patients are already on statins, it is important to be aware of their effects and monitor them carefully. 

It is appropriate to target therapeutic interventions according to the patient's prognosis. If the prognosis is poor, we should be less demanding about the goals and not overburden the patient's treatment based on excessive expectations.

Prognosis and comfort

Prognosis, longevity and quality of life are important considerations in setting blood glucose targets. A pragmatic approach to the management of hyperglycemia in these patients is necessary.

The interest of a very strict glycemic control is to try to prevent complications in 10, 15, 20 years. 

But in a person with a poor prognosis or a life expectancy of only a few years, one must be more concerned about comfort and quality of life in the remaining years.

The goal would then be to avoid the effects of acute hyperglycemia, such as dehydration and ketoacidosis.

Conclusion

There is strong epidemiological evidence that diabetic diseases are associated with an accumulated risk of several cancers. There is also growing evidence that the degree of hyperglycemia and the treatment modalities for hyperglycemia influence cancer risk. 

The risk of breast cancer in women with type 2 diabetes is increased and obesity is an aggravating factor. On the other hand, there is no over-risk observed in women in pre-menopausal age or with type 1 diabetes.

The management of blood glucose levels in patients with diabetes and cancer can pose a significant clinical challenge. As there is no clear evidence that tight glucose control improves cancer outcomes, hyperglycemia must be managed pragmatically to ensure that the patient remains asymptomatic and at low risk of acute decompensation. 

Proactive management of glucocorticoid-induced hyperglycemia can help reduce large fluctuations in glucose levels. 

Read also :

https://www.healthline.com/diabetesmine/living-with-cancer-and-diabetes#1

References

[1] Diabetes and breast cancer risk: a meta-analysis  British Journal of Cancer (2012) 107, 1608–1617 https://pubmed.ncbi.nlm.nih.gov/22996614/

P Boyle M Boniol A Koechlin .....and P Autier1/Prevention Research Institute, 95 cours Lafayette, 69006 Lyon, France

[2] Clinical Challenges in Caring for Patients With Diabetes and Cancer
Helen M. Psarakis, RN, APRN-Diabetes Spectrum Volume 19, Number 3, 2006

https://spectrum.diabetesjournals.org/content/19/3/157

[3] https://pubmed.ncbi.nlm.nih.gov/22996614/

[4] https://endocrinenews.endocrine.org/july-2014-double-jeopardy/

[5] Clinical Challenges in Caring for Patients With Diabetes and Cancer-Helen M. Psarakis, RN, APRN-Diabetes Spectrum Volume 19, Number 3, 2006

https://spectrum.diabetesjournals.org/content/19/3/157

[6]  Phenomenon by which a key factor is regulated to persist around a beneficial value for the body.

[7] https://www.cancernetwork.com/view/diabetes-management-cancer-patients

[8] https://endocrinenews.endocrine.org/july-2014-double-jeopardy/

[9] Victor Lavis, MD, professeur au Département de néoplasie endocrinienne et des troubles hormonaux à l'Université du Texas MD Anderson Cancer Center à Houston.( https://endocrinenews.endocrine.org/july-2014-double-jeopardy/)

 

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.

PRESS RELEASE, English version of Cancer Rose web site.

2021, January 7

After several months of dedicated work, time and energy, we are pleased to announce the launch of English version of Cancer Rose web site.

Cancer Rose is a Non-Profit Organization under French law made up of independent Medical Doctors, a Doctor in Toxicology and a patient representative, with the goal of providing fair, transparent and objective information for French women on mass screening for breast cancer, based on scientific evidence.

We participated in the French Citizen and Scientific Consultation on Breast Cancer Screening organized by French Minister of Health in 2015, following the controversy on this topic in France.

We founded Cancer Rose organization and created the website in 2016.

At the international level, we exchange and share information on medical issues including over-diagnosis and the resulting over-treatment, with members of different organizations such as HealthWatch Charity in the UK,  the Institute of Scientific Freedom in Denmark, Choosing Wisely health organization in Canada, Wiser Healthcare Group of collaborating researchers in Australia, as well as American patient advocate Donna Pinto, member of the Steering Committee of the International “Precision” Project.

Our aim with this English version is to inform international visitors about our activities, to create connections and share our views on mass breast cancer screening controversy with women and professionals around the world.

We will update our content with new information, posts, announcements, events.

We hope you can find this website useful and easy to navigate.

Please follow us on Twitter and Facebook for news.

If you have any questions, suggestions, feedback or comments, please contact us.

Members of Cancer Rose have no sponsorships, honoraria, monetary support or conflict of interest from any commercial sources. They dedicate their time to this activity on a voluntary basis. The funds necessary for the functioning of this website and production of information materials (educational films, brochures, posters) are generated by individual donations and members contributions.

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.

Cancer diagnosis: the bone of death or symbolic effectiveness

Annette LEXA, PhD Toxicology (Eurotox)

Expert Regulatory Toxicologist-Environmental Health Risk Assessor

22 February 2016

In today's health care system, a cancer diagnosis can be the most traumatic announcement that a patient will ever experience. And for some people, the announcement will be even more deadly than the cancer itself or its treatment. This is what a cohort study published in 2012 in the New England Journal of Medicine has masterfully demonstrated. The follow-up of this historical cohort of 6 million Swedes between 1991 and 2006, examined the link between cancer diagnosis and the immediate risk of suicide or death from a cardiovascular accident. In the first week after the announcement, the relative risk of committing suicide was 12.6 and the relative risk of dying from a cardiac accident was 5.6 compared to the control group without a cancer diagnosis. This indisputable result is observed equally in men and women.

According to the authors, a negative attitude from the healthcare professional, his or her beliefs around a diagnosis, will cause a deep distress to the patient, especially for cancers with a poor prognosis, leading to death within a week of diagnosis.

The major public health campaigns, the health system and the health professionals themselves, who are part of this dreaded particular colloquium, should be better consider this syndrome in their decision-making process based on the benefit-risk analysis, this potentially fatal psycho-physiological stress induced by the diagnosis itself.

Marcel Mauss and the death bone 

This study, which followed the standards of Evidence Based Medicine, confirms what ethnologists such as Claude Levy-Strauss in 1946 or Marcel Mauss in 1926 had already studied in the 20th century. This fatal syndrome is better known as "bone-pointing syndrome". This ancestral practice has been described among the first peoples of Australia, New Zealand and Polynesia. It consists in condemning a person to die after pointing towards to him a few meters away, a thin bone (often a kangaroo or emu femur of about 45 cm). This ritual is still at use today in Australia where health professionals are trained to face these fearsome situations, where the strength of beliefs prevails to the point of making the victim die from panic fear that disrupts the instinct of conservation, life itself. It is not a death of starvation where the individual would have let himself die of hunger and thirst, no, it is a panic fear that leads to a very rapid death that is not a deliberate choice of the individual or a death due to pre-existing psychological disorders, which the researchers verified in the Swedish study.

Marcel Mauss (1872-1950) wrote the following in 1926: "The Australians consider to be natural only those deaths that we call violent . (...) All the other deaths have a magical or religious origin (...). Mr. Mac Alpine employed a young Kurnai in 1856-57. This young boy was very healthy. One day, he fell ill. He explained that he had done what he shouldn't have done. He had stolen a female opossum before having permission to eat it. The old men had found out about it. He knew that he would not grow any more. He went to bed, practically under the effect of this belief; he never stood up again and died within three weeks. 

(…) Two recent observers, one of whom is a doctor, tell how people die from the death bone among the Wonkanguru: they are very scared. If this bone is found, the bewitched one gets better; if not, he gets worse. European medicine does not inspire confidence. It can do nothing (...) "

Mauss quotes Sir Barry Tuke, a physician who attests to having known "a healthy individual with a Herculean constitution". He died of this "melancholy" in less than three days. Another, "in excellent appearance, and certainly without any lesions of the thoracic viscera, was grieved by life: he said he was going to die and died in 10 days". In most of the cases studied by the doctor, the period was two or three days.

Marcel Mauss reminds us that sociology, like psychology, is only part of biology. Ideas that haunt the social body (death by cancer) have an immense capacity for development and persistence in individual consciousness. It is at the level of biology, of the psychophysiology of the individual that the collective suggestion crystallizes; the consciousness is entirely invaded by ideas and feelings that associate cancer and inevitable death and that are entirely of collective origin. Individuals die "by enchantment". Our human societies are animal societies, highly evolved indeed, but animal societies above all. And man is only a symbolic social mammal for whom language and symbols are powers that sustain his impulse of life and death.

Claude Lévy-Strauss and symbolic effectiveness

Claude Levy Strauss (1908-2009) later formulated the concept of symbolic effectiveness, based on the work of the American physiologist Waler Bradford Cannon (1871-1935). Cannon theorized the famous principle of the fight-or-flight response. In the face of a threat, if fighting or fleeing is no longer possible, physiological stress puts the organism in danger (illness, death). "An individual conscious of being the object of an evil spell is intimately persuaded, by the most solemn traditions of his group, that he is condemned: parents and friends share this certainty. From then on, the community retracts: one moves away from the cursed one, one behaves towards him as if he were not only already dead, but a source of danger for all those around him...".

Of course, there has to be a belief in "magic". This symbolic power implies a macabre ballet of three: the sorcerer, the victim and the group, all must share the same belief, the same trust and the same requirement. The fundamental problem is the relationship of a certain type of individual that we might qualify as easily influenced by certain requirements and beliefs of the group (cancer is an inexorably deadly and horrible disease that threatens and terrorizes us all).

Announcement consultation or "the pink bone".

The passive patient-victim and the active doctor-shaman then engage in this macabre dance orchestrated by the health care system around the panic fear of cancer: the doctor must at all costs fight this modern-day plague that threatens the entire community. His feverishness in making appointments for further tests and treatments reinforces the idea of imminent death. Some patients are convinced that they are already, in a way, banished from the world of the living. Society as a whole is threatened by cancer (how else to explain this collective obsession to "fight against cancer"?) and each new diagnosis is threatened with expulsion from the social body (work, family, insurance, bank...). Her stress is such that some of them can lose control of their lives, all choice. Their metabolic, psychophysiological and even vital functions are in danger. The victim succumbs without having been able to fight or flee: they die of a heart attack if their constitution allows it, otherwise they commit suicide under the effect of the dramatic collapse of their neurotransmitter balance.

The obsession with breast cancer screening, with its lot of over-diagnoses, stems from this hysterized macabre dance, linking women, doctors and the social body: terrified at the idea of being socially banished, how many pre-cancerous or cancerous women have already been victims of this disastrous fate by the collapse of their vital defenses? Nobody knows it and nobody wants to know it, the important thing is to fight cancer at all costs, isn't it? Without going as far as to the death, the announcement of the presence of a cancerous tumor can trigger in some women the collapse of their psycho-neuro-immunological defenses, making even more difficult the medical fight to be carried out during heavy treatments sometimes engaged in excess (surgery, radio- and chemotherapy) and accepted because they seem to be the price to pay to continue to keep its place among the living.

The society tries to exonerate itself and save face by multiplying "empathic" campaigns aiming to give "tips and tricks" on how to "live well with cancer while remaining feminine and keeping one's morale, energy and smile", but some victims, once they have received the ACR4 mark, are not as fortunate as others to have a mind of steel when faced with the symbolic effectiveness of the pink bone.

Bibliography

Cannon W.C., Voodoo death, American anthropologist, 1942, 44(2), 169-181.

Gaudard P.Y.,  Suggestion of the idea of death in Marcel Mauss, acute fatal catatonia, phobia and symbolic modalities, Journal français de psychiatrie, 2010/4 (n°39)

Marcel Mauss, Definition of the collective suggestion of the idea of death. In Sociology and Anthropology, 313-320

Suicide and Cardiovascular Death after a Cancer Diagnosis, Fang Fang et al, N Engl J Med 2012;366:1310-8.

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.

Cost of extending the NHS breast screening age range in England

10 April 2019

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

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

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

Context and concerns

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

Breast screening policy and controversy in the UK

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

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

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

Age extension trial in the UK (XAge Trial)

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

Shaky foundation

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

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

Results

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

Potential for bias

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

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

Lack of explicit, fully informed consent

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

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

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

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

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

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

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

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

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

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

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

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

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

Effects of extending age range

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

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

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

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

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

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

Author’s conclusion

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

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

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

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

On the Health Watch website

Observers, including Susan Bewley, say :

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

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

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

Comment by Cancer Rose:

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

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

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

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

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

OUR RAPID RESPONSE BMJ

"Rapid response" published in the BMJ

To download below, BMJ2019-364-I1293

References

[i] https://www.healthwatch-uk.org/


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

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

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

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

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

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

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

[vi] http://mypebs.cancer-rose.fr/

The issues of My PEBS, for our english speaking readers

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.

Manipulation of information provided to women on breast cancer cancer screening by mammography is a topic of interest for research studies

Marc Gourmelon, MD

Cécile Bour, MD

September 2, 2020

At the beginning of July 2020, a research article detailing how to successfully manipulate women in order to increase their participation in breast cancer screening programs by mammography,  was published under the title: 

The Good Outcome of Bad News.
A Field Experiment on Formatting Breast Cancer Screening Invitation Letters [1]. 

This article is published  by Italian authors in a journal which defines itself as follows: 

“The American Journal of Health Economics (AJHE) provides a forum for the in-depth analysis of health care markets and individual health behaviors. The articles appearing in AJHE are authored by scholars from universities, private research organizations, government, and industry. Subjects of interest include competition among private insurers, hospitals, and physicians; impacts of public insurance programs; pharmaceutical innovation and regulation; medical device supply; the rise of obesity and its consequences; the influence and growth of aging populations; and much more. The journal is published for the American Society of Health Economists (ASHEcon), which is a professional, non-profit organization dedicated to promoting excellence in health economics research in the United States. All ASHEcon members receive the journal as part of membership.”[2]

This article is not a scientific medical analysis about the relevance of screening by mammography  for women, but a health economics study, from the point of view of health economics carried out by economists. Screening is an integral part of the "health care market" and women behavior is evaluated, based on the manipulation of the information provided to them.

“We show that giving enhanced loss-framed information about the risks of not having a mammography increases the take-up. This manipulation is most effective among sub-groups with lower baseline take-ups, thereby reducing inequalities in screening.”

OBJECTIVE AND STUDY METHODOLOGY

The goal of this study is to evaluate the impact of the interplay between the "frame” of the invitation letter and the "level" of the information disclosed in it, on the rate of participation in the national breast cancer screening program.

There are four "manipulations" being evaluated, depending on the frame and the level of information. The frame of information refers in this case on how to deliver an information in the form of "gains" from being screened, or rather in the form of a grid of "losses" from not being screened.

The level refers to the quality and completeness of the information.

-The "benefit" of the screening procedure is valued by a high quality information 

-The "benefit" of the screening procedure is valued by a basic information

-The emphasis is placed  on the "loss" of not being screened by using a high quality of information

-The emphasis is placed on the "loss" of not being screened by using basic information.

“To the best of our knowledge, this is the first experimental study assessing how the interplay between the frame of the invitation letter and the information disclosed in it influences the take-up rates for a national breast cancer screening program” explained the authors.

MAIN RESULT

“Results show that the take-up rate in the group that received the letter combining the loss frame with enhanced information on the negative consequences of not taking the mammography is about 2.5 percentage points higher than in the baseline group.”

 According to the authors, “this is a sizeable effect”.

The authors congratulate themselves on these findings showing that that this manipulation “helps to decrease inequalities in screening”,   as it allows for a greater manipulative impact for subjects that, according to them, are “with low average education, with no recent screening experience, and for whom the available observable characteristics would lead us to predict a low likelihood of screening in the absence of any manipulation”.

IDENTIFIED ISSUES

A- THE ETHICAL ISSUE

 It seems to us the major one.

First of all, the aim to increase womens participation, at all costs, is clearly stated. Thus, these researchers claim that « the use of letters sent to women at their houses and the invitation for a free and pre-booked mammography increase take-up rates for breast cancer screening »

« In this respect, the present study aims ...at providing insights on how to design effective invitation letters to promote cancer screening activities. »

The intentions are clearly stated. The authors are well aware that providing the most complete information to women incited to be screened, will reduce their participation in screening:

« Previous studies have analyzed the impact of providing a rich amount of detailed medical information concerning the disease (for instance, as in Bourmaud et al. 2016 and Wardle et al. 2016, by including a booklet in the envelope of the invitation letter) on the take-up rate and generally found negative or zero effect ».

They hypothesize that  « ...invitation letters containing a loss-framed message (meaning « loss »to the woman or even risk if she declines to participate in screening, editor’s note) with enhanced information about the consequences of not taking part in the program are more effective at increasing take-up rates than letters with a gain-framed content or with a restricted informational content ».

Thus, this is about pure and simple manipulation, perfectly claimed since the term itself is used several times in the text, and the authors justify this manipulation as necessary for  « limiting women’s cognitive overload »

We wonder about the authors representation of women.

Cognitive overload is defined as follows: "Cognitive overload corresponds to a mental state in which an individual is engaged in the accomplishment of a task that is extremely demanding for him: he does not have sufficient cognitive resources for the easy implementation of this task. » [3]

If we understand correctly the authors, women would not have the mental state necessary to understand the comprehensive information on breast cancer screening. Isn't this a sexist and paternalistic attitude?

In any case, this runs contrary to the "shared medical decision"  that many medical actors claim.…

B- VALUATION OF THE SCREENING AND NEGATION OF ITS RISKS

Right from the introduction, despite the scientific uncertainty about the interest of screening, which has risen since the 2000s, the doubt about the relevance of breast cancer screening by mammography is swept away.

« Mammography screening programs at population-level are a key component of breast cancer control in many countries. The continuous implementation of these policies over the last decades mirrors the current consensus on the effectiveness of mammography screening. »

The authors are, however, forced to admit that there is « uncertainty about the magnitude of the effects of screening on mortality (see e.g. Welch et al. 2016) and the growing evidence on overdiagnosis » by citing a 2012 study and hurrying to downplay the level of overdiagnosis, which is the major adverse effect.

« However, to the best of our knowledge, the estimated extent of overdiagnosis in Italy is low, as it ranges between 1 and 4.6 percent (see the review by Puliti et al. 2012). These data lead us to consider the phenomenon as negligible for our population of interest ».

The authors deliberately disregard the numerous and more recent studies [4] which no longer demonstrate effectiveness of screening in reducing mortality in women, in reducing the rate of the most severe cancers, or to alleviating the treatment inflicted to them.

In addition to the lack of benefit, multiple adverse effects of screening, such as false alarms leading to over-medicalization of women and over-diagnosis, currently estimated at between 30% and 50% and indicating that one out of three cancers detected or even one out of two cancers detected is an unnecessary detection,  should not be ignored[5][6].

In this respect, here is a link to a recent additional study that we already discussed: this research (a review of cross-sectional studies) showed that mammographic screening did not reduce the stage of cancer, nor did it enable cancers to downgrade from the elevated stage to the early stage cancers. The results strongly suggest that it is the adjuvant therapy and not mammographic screening associated with the decrease in specific breast cancer mortality reported since the initiation of these therapies (1990s).

C –CYNISM AND CONFISCATED INFORMATION


Consequently, under no circumstances should women be properly informed or should the risks of participating in the screening be addressed, as the authors have demonstrated. Otherwise, this would decrease the participation in screening, as these Italian authors have well understood,  on the basis of a French study.

« Bourmaud et al. (2016) assessed the effect of providing a 12-page information leaflet on the take-up rate for breast cancer screening of a randomly selected sample of French women. They found a significant negative effect on the take-up rate. »
Later in the text, the authors intentionally skip over the details on disclosed information: « our baseline invitation letter contains no information on the consequences of screening ». And they add: « We show that a negatively-framed message, which adds “cheap” information in the form of brief and general statements about the consequences of screening to the original invitation letter, is able to enhance take-ups ».

In their conclusion, the Italian authors reach what seems to us to be the very height of cynicism by stating: « In addition, the effect of our proposed manipulation is stronger for subjects identified by the literature as being at higher risk of non-participation, such as those living farther away from the screening sites, the low educated and those with no recent screening experience. »

As a result, the less educated women are, the more effective it is to hide and manipulate information for them.

THE FRENCH PARALLEL

A– INVOLVEMENT OF MEDICAL DOCTORS

The potential influential role of the medical profession is not forgotten: « endorsement of the screening program by general practitioners on the invitation letter increased the overall take-up rate, while a letter of reminder was especially effective at increasing the take-up rate of subjects residing in socio-economically deprived areas »

The promoters of screening in France are also well aware of this, having included the "screening mammography" item in the performance-based remuneration of general practitioners [8].

B – THE LACK OF INFORMATION PROVIDED BY OFFICIAL BODIES

The authors of this Italian study state that « the use of letters sent to women at their houses and the invitation for a free and pre-booked mammography increase take-up rates for breast cancer screening »

It should be noted that this is exactly what is being done in France with the organized breast cancer screening program. The citizens' consultation clearly defined the unacceptable gaps in the information provided to women, and in France we are not outdone to regard patients as unworthy to receive quality medical information due to them[9]. In addition, we examined the lack of this information in the material provided by the INCa[10][11].

IN CONCLUSION

-Denial of the risks of mammography screening for breast cancer.

-Assertion against a large majority of clinical research on the effectiveness of screening.

-The manipulation of the letter of invitation to the screening.

-Sexism and paternalism.

This economic study published in July 2020 by Italian authors, with references to other similar studies, including French ones, leaves us with a deeply bitter taste,  on ethics, on the women representation in academic community or on the promotors behavior  of breast cancer screening through mammography.

It should be noted that the majority of those involved in screening justify the assumed manipulation of women for the sole purpose of raising their involvement in the public health system, which has not only failed to prove effective but is also harmful to women's health.

Références


[1]                              https://www.journals.uchicago.edu/doi/10.1086/708930

[2]                          https://www.journals.uchicago.edu/journals/ajhe/about

[3]                              https://www.universalis.fr/encyclopedie/surcharge-cognitive/

[4]                              https://cancer-rose.fr/category/etudes/

[5]                                 https://cancer-rose.fr/2019/09/06/le-depistage-mammographique-un-enjeu-majeur-en-medecine/

[6]                                 https://cancer-rose.fr/2020/01/28/30-000-cancers-surdiagnostiques-par-an-dans-une-etude-australienne-un-enjeu-de-sante-publique/

[7]                              https://www.oncotarget.com/article/7332/text/

[8]                               https://cancer-rose.fr/2020/04/20/la-nouvelle-rosp-quel-changement-pour-le-medecin-concernant-le-depistage-du-cancer-du-sein/

[9]                                 https://cancer-rose.fr/2016/12/15/nouvelles-du-front-premiere-manche/

[10]                               https://cancer-rose.fr/2017/09/17/analyse-critique-du-nouveau-livret-dinformation-de-linca/

[11]                               https://cancer-rose.fr/2018/02/11/2175-2/

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