Increase of cancers, an epidemic?

Dr. C.Bour, October 27, 2022

Marie Négré Desurmont is a journalist and lecturer who studied anthropology at École des Hautes Études in Paris in Social Sciences. She is a science journalist who has studied specifically on the subject of breast cancer after being affected herself and being struck, as Maëlle Sigonneau was, by the injunctions towards patients conveyed by language and that they have to face in their daily lives.

In a dedicated piece titled "Pink October or the Non-politics of the Breast," the author denounces what she calls the pink month's neutralization of social, environmental, and political issues. She advocates for a broader vision beyond the simple Pink October campaign to ensure a healthy future for the following generations.
"Let us have the courage to look beyond Pink October and require that we bring into the world little girls who won't have to waste so much energy trying to survive, cared for by the same world that made them sick," she writes.

She denounces:
"...rather than politicizing this serious disease, we prefer to repeat that it is best-treated cancer. We focus on individual behaviors by valuing the survivors who have learned so much from this difficult experience.."
The emphasis is placed, with a colorful and smiling veneer, on appearance and well-being "because," the author writes, quoting Audre Lordre (Cancer Journal*), "it is easier to demand that people be happy than to clean up the environment. Let's look for joy, shouldn't we, instead for healthy food, clean air, and a less crazy future on livable earth ."

*Audre Lorde, Journal du Cancer, translated from the American by Frédérique Pressman, Éd. Mamamélis, Geneva, 1998.

Cancer Politicization

In her book "Impatiente," Malle Sigonneau already called for a fight that must go beyond focusing exclusively on the particular behaviors of "survivors."
For her, it would be necessary to boycott Pink October, replacing pink messages with large posters on endocrine disruptors; we could imagine a month, she wrote, where we would 'sensitize' (to use an overused and meaningless word) on the carcinogenic effects of the environment, for example, pesticides...

Mrs. Desurmont sums up our society's attitude very well: "Our society has so much faith in its technological capabilities that it is more concerned with fixing the damage of growth than with creating another form of production and exchange, less mortifying."

Behavioral and environmental factors are responsible for almost half of all cancers. The author correctly points out that risk factors include not only tobacco, alcohol, or obesity but also endocrine disruptors, ionizing radiation (including mammography! ), air pollution, new chemicals (pesticides), exhaust fumes, occupational exposures, and general population exposure to chemical substances.

The pink campaigns and health authorities' messaging speak little about it. "By trying to make us believe that we are masters of our health, impenetrable to the surrounding conditions, and independent of our societal structures, we patients begin to anxiously seek the origin of our illness, psychologizing this sickness at any costs."

We talk about the injustice of a disease that hits women in their absolute femininity, but according to Desurmont, " What is unfair is what we have done to the world, not cancer that just can take advantage of the red carpet we roll out for it to thrive."
The reality is that by talking about injustice and little individual battles, we convince ourselves that cancer is anecdotal, that it's "poor luck," and that all it takes to beat it is a strong spirit. However, it is not a rosy epidemic and worsens as the environment deteriorates. Ladies, adopt a healthy lifestyle, but remember that while you jog, you breathe contaminated air."

Marie Négré Desurmont, like Malle Sigonneau, rightly condemns the guilt and responsibility put on cancer patients.

But what about the "epidemic"?

An epidemic?

What if the "epidemic" also came from medicine?

In his book "Dépistage du cancer du sein, la grande illusion" (ed.Souccar), Bernard Duperray explains:
"From the 1980s to the 2000s, the number of mammograms performed exploded. At the same time, the number of senographs, the devices used to perform mammograms, increased considerably: from 308 senographs in 1980 with 350,000 mammograms in 1982 to 2,511 senographs with 3 million mammograms in 2000. What was the result of this spectacular increase in mammography activity? 21,387 breast cancers were diagnosed in 1980, 42,696 in 2000, and 49,087 in 2005. An epidemic of breast cancer? Is epidemic independent of human activity or the result of uncontrolled human activity?
EPIDEMIC OR OVERDIAGNOSIS LINKED TO SCREENING ACTIVITY?
Two hypotheses can be considered to explain this surge of cancers:

-either it is a simple coincidence between the introduction of screening and the onset of a breast cancer epidemic

- or it is a plethora of breast cancer diagnoses linked to screening.

Let's look at the first hypothesis. If the continuous increase in new diagnoses each year corresponds to an epidemic of progressive cancers, the reduction in mortality due to screening would have to be considerable. There would be 1 cured cancer for every 1 death in 1980 and 3 cured cancers for every 1 death in 2000.
Neither the most optimistic results of randomized trials regarding mortality reduction, nor the therapeutic advances during this period, can support this hypothesis.

Let's look at the second scenario, in which screening is the cause of the increase in the number of new cases of cancer diagnosed each year.
Between 1980 and 2000, the incidence rate increased by an average of 2.7% per year. The increase affected all age groups but was most pronounced among women aged 50 to 75. This is the age group for which systematic mammography screening is performed (in the ten pilot departments). ......

The current epidemic of breast cancer is only apparent. Why apparent? Without screening, many of the cancers diagnosed today would not have occurred. With the overdiagnosis generated by screening, we are thus creating an only visible epidemic. When we admit to overdiagnosis, an increase in incidence does not imply an epidemic.
There is no concrete counterargument to the concept of increased overdiagnosis associated with screening. "Demonstrating its reality is based on indisputable epidemiological data and reliable facts."

I give a detailed explanation in my book "mammo ou pas mammo" (ed.Souccar), which I share with you here:
"A study has been conducted in France to allow this analysis of the situation: it is a survey conducted in 2011 by international epidemiologists, including a Frenchman, Bernard Junod, a prominent epidemiologist from the École des Hautes études en santé Publique de Rennes (EHESP) (Junod B, et al. S. An investigation of the apparent breast cancer epidemic in France: screening and incidence trends in birth cohorts. BMC Cancer. 2011;11(1):1-8. ).

Their observations are as follows:

- ✹ The number of mammography machines in operation in France increased steadily over 20 years, from 308 in 1980 to 499 in 1984, 1351 in 1990, 2282 in 1994, and 2511 in 2000. The number of devices has thus increased eightfold between 1980 and 2000. As a result, screening has intensified.
- ✹ When the incidence of breast cancer at different times in women of the same age group is compared, it increases over time. It is significantly higher when women are intensively screened. The most significant increase, 112%, occurred in 2005 for the 60-64 age group.
Thus, this increase in breast cancer incidence has occurred in parallel with the rise in screening intensity, as illustrated in Figure 1.

As screening increases, so does incidence. This increasing incidence rate as soon as the systematic screening is introduced is striking. It has been observed in all countries where screening has been introduced. "

The denunciation of the failure to consider environmental factors is entirely justified and relevant. Still, the role of medicine must be included and denounced in the same way.
We must ask ourselves the right questions in the face of an increase in new cases of cancer. The simultaneous absence of a reduction in serious cancers, the consequent lack of a reduction in these cancers that kill, that screening does not detect because they cannot be anticipated and evolve with a growth rate that makes them serious cancers. Incidence is increasing. Mortality is not falling in parallel with the intensity of screening.

At the same time, massive and systematic screening finds a plethora of tumors that would never have killed if undetected, a phenomenon known as overdiagnosis. Carcinomas in situ are a substantial source of overdiagnosed cancers and, according to some scientists, are wrongly labeled as cancers.

Why is overdiagnosis a real danger?

It excessively increases the incidence (the rate of new cancer cases) of breast cancer; as these are cancers that would never have been harmed, survival rates are artificially improved, leading to the reassuring slogan: "breast cancer is very well treated and often cured." Of course, it is cured all the better because we over-treat lesions that should never have been detected and would never have killed anyway. The medical profession cannot refrain from telling patients that they have been "saved," whereas screening may have harmed them.

Above all, overdiagnosis leads to overtreatment, which includes radiation therapy. Radiotherapy treatments, like breast surgery (partial and total mastectomies), which is not "lightened," contrary to what health authorities state, are only rising, contributing to what our two authors decry, namely exposure to ionizing radiation.
It is likely that the issue here is not so much the direct exposure during mammography (except for young, non-menopausal women under 50 years old who have an increased risk of radiation-induced cancer) as the treatment that a woman receives.
Speaking of "light" treatment, as the health authorities do, appears cynical because the issue is not one of the lightening therapies but of ensuring that women are not overdiagnosed and do not receive abusive therapy that they should not have had.

Radiation toxicity, downplayed in breast cancer screening, is a reality; radiation-induced cancer should not be ignored.
Radiation-induced heart disease is the biggest killer in survivors of treated cancer.
Hematological cancers can occur after radiation and chemotherapy.

Experiencing this is not harmless; sharing it abusively because a woman has not been alerted to the risk of overdiagnosis inherent in screening is ethically unacceptable.

Conclusion

So yes, let's return to Ms. Desurmont's conclusion: "Let's have the courage to look beyond Pink October and demand that we be able to bring into the world little girls who won't have to waste so much energy trying to survive, cared for by the same world that made them sick."

But this courage must include questioning medicine and how it makes healthy people sick by making them go through tests, they don't need.

This is what the public, the sick and the healthy, and especially the politicians need to be "made aware of." And this is done by telling women the truth about the risks and benefits of screening, not by using pink propaganda that wrongly makes women heroes when some of them should never have known they had this disease and others have this disease in its most serious form, which makes them invisible, impoverishes them, and isolates them from society.

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The irreversibility of screening

Dr. C.Bour, September 26, 2022

A short history

Whether useful or not, introducing screening into the population is irreversible. This is demonstrated by history.

1° Prostate cancer screening

The American doctor who developed the test in 1970, Richard Albin, was himself alarmed by the "public health disaster" caused by his discovery. In an op-ed published in the New York Times in 2010, he wrote: "I could never have imagined, four decades earlier, that my discovery would cause such a public health disaster, driven by the pursuit of profit. The improper use of this dosage must be stopped. It would save billions of dollars and millions of men from unnecessary and mutilating treatments."

PSA testing has been controversial since 1989 in France. A "consensus conference" was organized by three urologists, Professors François Richard, Guy Vallancien, Yves Lanson, and the economist Laurent Alexandre. This expert consultation already concluded that "the organization of mass screening for prostate cancer is not recommended.”
A new consensus conference was held in 1998. The same year a clinical practice recommendation was issued that ruled even more clearly: "Since screening for prostate cancer (whether mass screening, directed at the entire population concerned or opportunistic screening, on a case-by-case approach) is not recommended in the current state of knowledge, so there is no indication for proposing a PSA test in this context.

But things are not that simple. The majority of learned societies and professional groups around the world are against screening. Still, three American associations (American Cancer Society, American Urological Society, and American College of Radiology) do not agree. Gradually, the French Association of Urology (AFU) (specialists in the male reproductive system) is gradually drifting away from this position, and a campaign is being launched to promote PSA testing.

The problem with this screening lies in the fact that there is no established effect on mortality, but that, on the other hand, it detects a large number of very slowly progressing cancers that would never have been manifested (overdiagnosis), but which, once detected, will be treated, with disastrous effects in terms of impotence and incontinence.
Another problem is that radiotherapy treatments can lead to the development of secondary cancers.

In 2011, the US Preventive Service Task Force (USPSTF) recommended that PSA screening for prostate cancer be discontinued, emphasizing its side effects. For every 1000 people treated, there are 5 premature deaths one month after surgery. Between 10 and 70 patients have serious complications but survive. Radiation therapy and surgery have long-term effects, and 200 to 300 patients will become impotent and/or incontinent.

And the French High Authority for Health (HAS) concluded, "No new scientific evidence is likely to justify re-evaluating the appropriateness of implementing a systematic screening program for prostate cancer by PSA testing." Opinion renewed in 2016: 2016 HAS opinion
"The French National Authority for Health thus recalls that current knowledge does not allow for the recommendation of systematic screening for prostate cancer by PSA testing in the general population or in populations of men considered to be at higher risk."
The National Cancer Institute's conclusion is along the same lines.

Unfortunately, the recommendations and day-to-day practice are making a big gap, and biopsies, as denounced in 2013, are increasing.

Prescription habits have a hard time, but credit insurers also impose this test in the "formalities" requested to take out a loan, exposing people to seriously harmful effects on their health.

2° breast cancer screening

From 1970 to 1980, in various countries (Norway, Denmark, Canada, New York, Sweden), women were included in experimental studies, called trials, which simply compared the outcome for screened women with unscreened women. At the time, this was possible because the women had never x-ray taken on their breasts. These studies showed a supposedly tremendous reduction in mortality due to screening, up to 30% less risk of dying of breast cancer.

However, as we now know, these first experiments were subject to numerous biases in the method, the distribution of women between the two groups, and the statistical analyses. The methodology did not meet the current qualification criteria. The best results were obtained with the worst mammograms.

From 1992 to 2000, the number of victorious and enthusiastic publications multiplied with a colossal media echo.

Finally, from 2000 to 2001, voices were raised to warn about the irregularities of the first trials and to raise the alarm about the risks of this screening.

Peter Gøtzsche and Ole Olsen, two independent Nordic researchers, performed a meta-analysis according to the methodology of the Cochrane collaboration to which they belong. And there is a shock because even by combining the best trials, there appears to be no statistically significant difference in mortality between screened and unscreened women: "there is no reliable evidence that screening decreases breast cancer mortality," concludes the study [1].
This conclusion was later confirmed by the independent journal Prescrire in 2006 [2].

Unfortunately, these researchers were not allowed to publish their results in the Cochrane reviews, except on the condition that they would include even the most biased trials to improve the results.

Lengthy negotiations followed, and in 2009, researchers Peter Gøtzsche and Margrethe Nielsen estimated that if all the trials, including the worst ones, were included in the meta-analysis, then screening could reduce breast cancer mortality by 15%, which is still a minimal and supposed benefit [3].
Above all, a surprise “guest” emerges, and that is overdiagnosis, i.e., the detection of indolent lesions, unnecessary to detect, which would never have had an impact on the life or health of the woman, but which will all be treated like any other cancer, with surgery, radiotherapy, or even chemotherapy, leading to deleterious overtreatment for the person. These over-treatments have physical, psychological, economic (loss of job), trans-generational (descendants labeled as 'at risk'), etc., consequences.

In 2005, Norwegian statistician Per-Henrik Zahl, a member of the Cochrane Collaboration, raised the problem of discrepancies between studies showing a decrease in mortality and data from the official Swedish cancer registry. There would be more reported deaths in the unscreened group and missing deaths in the screened group. The researcher proposed an article on these discrepancies to the medical journal The Lancet, which was rejected.

One year later, Per-Henrik Zahl managed to have it published online in the European Journal of Cancer [4]. This article was censored and was finally published in a Danish journal shortly afterward [5].

In The Lancet, Peter Gøtzsche, co-founder of the Cochrane Collaboration, denounced the unacceptable pressure he had been subjected to [6].

But the machine had been launched, and European countries had started campaigns with much media coverage, with slogans, celebrity endorsements, and popular events colored in pink. And the press, as well as the learned societies, the women largely influenced by the media, the doctors, the health authorities, preferred to stick to the enchanting story of a screening that saves...

In 2004, under the presidency of Jacques Chirac, breast cancer screening was generalized in France.

In 2015/2016, under the aegis of Health Minister Mrs. Marisol Touraine, a citizen and scientific consultation on breast cancer screening was organized. The steering committee proposed two scenarios in the final report, both calling for the cessation of breast cancer screening in its current form because of a very uncertain balance of benefits and risks, with a non-significant reduction in mortality and, in parallel important adverse effects, such as irradiation, false alarms (see video at the bottom of this link) leading to stressful complementary examinations, and overdiagnosis of course. The citizens request better information.

Nowadays, screening is still conducted in its usual form, and women receive information on the benefit-risk balance that is still unclear and obviously unbalanced[7][8].

The scientific controversy about this screening is qualified as fake news by the National Cancer Institute[9].

3-Bronchopulmonary cancer screening.

Two trials essentially (there were several studies) were supposed to provide evidence of a significant reduction in specific mortality from bronchopulmonary cancer due to low-dose radiation thoracic scanner (LDRT) screening. These were the US National Lung Screening Trial (NLST) and the NELSON trial conducted in Belgium and the Netherlands.

Already in 2014, in a scoping note, the HAS noted, ".... it is likely that the low specificity of low-dose CT screening will remain a major obstacle to the implementation of screening in clinical practice and a screening program."
"Disadvantages and risks associated with FD CT (low-dose CT) screening include radiation exposure ranging from 0.61 to 1.5 mSv, some degree of overdiagnosis that varies among studies, and a high rate of false-positive exams, usually explored with more imaging."

When we look at the study published in the NEJM on the NELSON trial, the last line of table n°4 reads: "All-cause mortality - deaths per 1000 person-yr 13.93 (screening group) 13.76 (control group) RR 1.01 (0.92-1.11)". Clearly, there is no impact on all-cause mortality by this scan screening. (Remember that the "overall mortality" figure includes everything, cancer, its treatment, and its non-treatment, and is, therefore, a better reflection of "real life" data)

But the Academy of Medicine has retained this criterion and expresses its concerns in a published report here and there. It notes several problems for not generalizing this screening:

  • The two major lung cancer screening trials with low-dose CT scans greatly underestimated the potential harms (false positives, overdiagnosis, false negatives, radiation, and overtreatment). The magnitude of the benefit and the magnitude of the risks are unknown, and even if the 25% cure rate is achieved among the subjects included in the study, the majority of patients will die early from other smoking-related diseases (other cancers, heart disease, emphysema, etc.) without increasing their life expectancy.
  • For screening to be effective, it is necessary to have cancers with a sufficiently long latency to "catch up" during a screening (thus the least possible number of interval cancers); however, the proportion of long latency cancers in the lung is low.
  • These cancers are mostly due to active smoking and, marginally, to passive smoking: more than 85% of cases can be attributed to smoking. The progressive decrease of smoking among men (60% of smokers in the 60s to 33% today) is reflected in the reduction of incidence and mortality due to these cancers", which is equivalent to saying that this cancer is simply accessible to good primary prevention campaigns, and to incentives to stop the main risk factor, tobacco.
    "The natural and progressive history of the disease must be known and the various forms defined." Between the ages of 50 and 74, lung cancers are mainly composed of adenocarcinomas, which seem to be the most easily detectable. For example, in the European NELSON trial, 61% of PBCs in the screened group were adenocarcinomas compared to 44% in the control group, which could explain a better effect of screening in women", explains the Academy.
  • Unknowns: on the target population, the desirable participation rate, the frequency of scans, the therapeutic indications for cancers discovered during the scan, the acceptability by patients, the motivation and the respect of smoking cessation, etc...
  • The people who participate in the trials are not representative of the entire population eligible for screening at a later date, which may lead to an overestimation of the effectiveness in the Nelson study.
  • An economic evaluation is also needed, as the Academy rightly points out that primary prevention is certainly more effective and less costly.

To rebound on the arguments of the Academy of Medicine, one must keep in mind the economic stakes of this screening, not only of the initial examination but also of the importance of the expenses caused by the iterative examinations in case of intermediate nodules (which must be followed during the years to control their evolution). Screening for bronchial cancer by CT would be 4 times more expensive than screening for breast cancer and 10 times more costly than screening for colorectal cancer.

For academics, what is essential is the fight against the main risk factor: smoking, the acceptance of its reduction is the very condition for the candidates selected for a possible regular screening.

The reactions were not long in coming. An APM news release of February 24, 2021, tells us three learned societies have taken a position.
"The three learned societies are the Francophone Intergroup of Thoracic Oncology, the Society of Pneumology in the French Language, and the Society of Thoracic Imaging. In this text, which updates previous recommendations, the learned societies reaffirm their position in favor of individual screening, by low-dose thoracic CT scan without injection of contrast medium, for which they specify the modalities." ......
"Contrary to the French Academy of Medicine, which proposes a low-dose CT scan once during a smoker's health check-up, the learned societies envisage a recurrent examination. They believe 2 CT scans should be performed one year apart and then one every 2 years, except for risk factors or previous examinations with an intermediate result, which should continue every year. And this screening should be continued "for a minimum period of at least 5.5 to 10 years."

Three radiologists contest the opinion of the Academy of Medicine, which persists and signs: https://lequotidiendumedecin.fr/specialites/cancerologie/controverse-sur-le-depistage-du-cancer-du-poumon-lacademie-de-medecine-repond-aux-prs-revel-lederlin... with an argument that should prevail in any screening: namely that of the GLOBAL mortality.
"The authors mention that PBC (bronchopulmonary cancer) mortality is reduced in the Nelson and NLST trials, but without taking into account the general mortality of the smoking population, the only important parameter to consider organized screening and which does not change in the various trials."
This parameter, let's remember, includes PBC mortality but also mortality due to treatments and mortality due to other causes, smokers being exposed to other pathologies (emphysema, other cancers, cardiovascular diseases).
The Academy still says it does not want to return to the "irradiation controversy" the authors write: "... our report is factual on this point, and we encourage you to reread this paragraph. However, it is regrettable that in none of the trials was precise dosimetry performed."

The High Authority of Health, initially reluctant in 2016, completely changed its attitude and gave in 2022 its green light to an experiment on lung cancer screening, despite the ineffectiveness of this scannographic screening to reduce all-cause mortality.

"The HAS considers that the state of knowledge is still incomplete and insufficiently robust for implementing a systematic and organized screening of PBC (bronchopulmonary cancer) in France. However, the data shows a decrease in specific mortality and authorize the initiation of a pilot program to document: the modalities of screening, the performance/efficacy and efficiency, the organizational constraints, and the ethical and social dimensions by testing several possible scenarios and on several screening ranks.

Thus, the HAS recommends that experimentation be carried out in real life concerning the French healthcare system to answer the outstanding questions."

In its report on page 70, the HAS considers that "The meta-analyses do not show a significant reduction in all-cause mortality, whatever the procedures compared: this criterion of judgment is not very relevant because of the interference of age and chronic smoking on mortality, and the need for very long-term follow-up on a large cohort.

This means that the HAS does not recognize overall mortality as the primary efficacy criterion, puts specific lung cancer mortality ahead, ignoring other causes of smoking-related mortality and morbidity, and considers randomized studies with 10-year follow-up insufficient. This means that any unproven screening can be defended and maintained, as is the case with breast cancer screening, which is currently unable to prove its effectiveness.

A new study is published in 2022. This population-based ecological cohort study found that low-dose CT screening of low-risk, mostly nonsmoking Asian women was associated with significant overdiagnosis of lung cancer. Five-year survival is biased by the increased detection of indolent, early-stage lung cancers that would never have killed.
She concluded that unless randomized trials can show some value for low-risk groups, low-dose CT screening should remain targeted only at heavy smokers.

A HAS opinion on the relevance of screening

Dr. Catherine Rumeau-Pichon, Assistant to the Director of Medical, Economic and Public Health Evaluation, HAS, explained in this video from 5 years ago, that screening must meet the following six criteria:

1- A disease that can be detected early before the onset of symptoms

2- A reliable test

3- Effective treatments against the disease must exist

4- People at risk must be identifiable

5- Screening must be known to decrease cancer mortality.

6- The benefit/risk balance must favor a preponderant benefit over the risks.

Let's examine screening (breast, prostate) in the light of these criteria

1- Early detection of disease before symptoms.

For breast and prostate, not always...

Cancers with a long residence time in the breast, therefore not very progressive, are easily detected by screening before their symptoms because they are slowly progressive. They contribute to the overdiagnosis of many cancers.

On the other hand, cancers with a poor prognosis, with a high potential for progression and rapid growth, are 'missed' by screening because they are too fast to be 'caught' (these are the false negatives).

Their natural history is, therefore, not linear and predictable and is still not known at present. For prostate cancer, aggressive cancers often release their metastases from the start.

2- Reliability of the test

No

Mammography is a poor screening tool; it has good sensitivity for atypical lesions and in situ cancers, the least aggressive ones; it has poor sensitivity for high-stage cancers, triple negatives, and infiltrating forms.

The PSA level may be high in cases of simple benign prostate hypertrophy. A high level is not specific to cancer.

3-Effective treatments

Yes

For breast cancer, the effectiveness of treatments has improved significantly since the 1990s, and it is said that 9 out of 10 cancers are cured, even for those not detected.
For this reason, moreover, the usefulness of screening is diminishing.

Whether treated or not, prostate cancer rarely metastasizes (about 1 in 10 cases). When it does metastasize 90% of the time, it results in bone metastases.
While bone metastases usually have a poor prognosis for other cancers, this is not necessarily the case for prostate cancer. Whether it has metastasized or not, prostate cancer is often a slow-moving disease.
For this cancer, patient survival is improving year after year thanks to the appearance of new treatments and therapeutic combinations.

4-Identifiable persons at risk.

No

For breast cancer, risk factors predisposing to cancer can be identified, such as exposure to toxic substances, night work, and family history...
But not all women who smoke or work at night will automatically develop breast cancer, and there is no reliable link between a specific risk factor and breast cancer, not as clear-cut as smoking and developing bronchopulmonary cancer (and yet, here again, systematic screening of smokers is not recommended).

Only 5% of cancers are hereditary. This is too rare a phenomenon to impose screening on an entire healthy population with no family risk.

Women without risk, neither exposure nor intrinsic, can develop breast cancer without apparent 'reason.'

For prostate cancer, too, no risk factor has been identified and linked to this cancer.

5-Decrease in mortality

No

Impact studies have shown that mortality decline for several solid cancers has been effective since the 1990s and was not attributable to screening. This pattern of decline was also found for cancers not included in screening programs.

Breast: Norway study; impact study
Prostate: Ref: http://onlinelibrary.wiley.com/doi/10.1002/pros.20017/abstract; Labrie, Quebec, 2004

6-The benefit/risk balance in favor of the benefit

No

For the breast, this is no longer the case. Even in the most favorable hypotheses, such as the Marmot report, there is still more overdiagnosis than "lives saved."
M.G. Marmot, D. Altman, D. Cameron, J. Dewar, S. Thompson, M. WilcoxThe benefits and harms of breast cancer screening: an independent review Lancet, 380 (2012),. Marmot
Other independent reviews are even more severe; see our summary here: https://cancer-rose.fr/en/2020/12/15/the-over-diagnosis-in-a-graph-and-a-table/

When the three main disadvantages of systematic breast cancer screening are added: overdiagnosis, false alarms, radiation-induced cancers, and deaths attributable to overtreatment, the benefit/risk balance is always unfavorable.

For prostate cancer, really aggressive cancers release their metastases at the beginning of the disease. In this case, treatment will not protect against death. The treatments for this cancer have adverse effects that can be important (urinary incontinence, impotence). The patient's life will be altered more than "saved."
The elderly patient is more likely to die before from something other than his cancer.
Between 50 and 75, there is no proof that screening for this cancer would save people (HAS). The WHO does not recommend this screening either.

In the Canadian study, there is more mortality in the screened group because the risks of screening and the collateral effects of biopsies and treatments in screened men outweigh the benefit, which is minimal.

Overall all-cause mortality was almost the same in men who had surgery as in men who did not have surgery.

==> in total:

Of 6 requirements, breast and prostate cancer screening fail to meet 5 of them.

And nevertheless...

...the European Commission proposes at the end of 2022 an extension and/or a resumption of certain screenings and the implementation of new ones.
The objective is that by 2025, 90% of the EU population will be screened for breast, prostate, cervical, and colorectal cancer.
In addition, lung and stomach cancer screening will be included, although no conclusive studies exist for the latter.

Many media have copiously relayed this information without any further critical analysis...

The European commissioner Mrs. Stella Kyriakides issued in September the following speech
"Today, we know that it is estimated that one in two EU citizens will develop cancer during their lifetime."

However, the European Commissioner fails to mention that life expectancy in Europe continues to increase.
This is pure fear-mongering, creating a feeling of urgency, threatening the population, and must be addressed with great diligence.
This is a well-known technique to push for a change to be immediate and experienced as necessary, as is advocated in the business world.

John P. Kotter, Professor at Harvard Business School, outlines the elements for management of change:
"To succeed in a project or a change, it is important to demonstrate the need for it. The most effective way is to trigger a need that your project will meet by creating a sense of emergency among all your employees. Expose the risks the company is taking by not changing the way it operates."

Conclusion

Cancer takes a particular place, unlike other pathologies, even the most serious or deadly. It has replaced the scourges of the Middle Ages, tuberculosis, and syphilis of our elders. It symbolizes insidious evil and is always associated with the silent killer.

Despite all the knowledge accumulated over the last decades on the flaws and failures of screening, the fear of cancer is so deeply rooted in us, perpetually conveyed by societal, medical, and media messages, that any call for caution about the myth of saving early detection is vain.

Advances have been made, thanks to the failure of screening, our knowledge has progressed on the mechanics of cancer evolution, and we have learned about the complexity of the natural history of the disease.

But often, during the media communication of the pink October campaigns, it is enough for one or several "cancer-survivor" stars, television hosts, or politicians to claim to have survived thanks to a "saving" screening, feeling missioned to carry his experience as exemplary and emblematic, presumptuously setting himself up as a spearhead of a "noble cause," for everything to be reconsidered.
Or a blind decision by the European Commission...

There is nothing more powerful than the infusion of terror to suppress all reasoned, prudent, and scientific argumentation and to sweep away all efforts of neutral and objective information of the population.

We have not learned from past medical errors, the history outlined at the beginning of this article shows to what extent decisions taken too hastily and prematurely in the implementation of screenings lead to health disasters, carefully concealed from the public to whom only "benefits" are dangled.
These disasters and endangerment of people continue, and the media only communicate very sparingly on this subject.
Many screenings, especially for breast cancer, should never have been done and have resulted in resounding fiascos (like thyroid, neuroblastoma in children, and melanoma).
The European Commission even plans to implement a stomach cancer screening for which there is NO scientific evaluation...

The future seems quite dark because, at this frantic pace of repeated screenings, the only healthy individuals will be the ones who escape these macabre rituals, renewed during their life like a morbid litany, and which will propel healthy people into diseases they should never have known.

Read also the last post of Luc Perino-(in French)

References


[1] Olsen, O., & Gøtzsche, P. C. Screening for breast cancer with mammography. The Cochrane Database of Systematic Reviews. 2001; (4): CD001877.

[2] Mammographies et dépistage des cancers du sein : Pour un choix éclairé des femmes désirant participer au dépistage. In : Prescrire. [En ligne : https://www.prescrire.org/aLaUne/ dossierKcSeinDepSyn.php]. Consulté le 12 mai 2021.

[3] Gøtzsche P. C., Nielsen M. Screening for breast cancer with mammography. The Cochrane Database of Systematic Reviews. 2009 Oct 7; (4): CD001877.

[4] Zahl PH., et al. WITHDRAWN: Results of the Two-County trial of mammography screening are not compatible with contemporaneous o icial Swedish breast cancer statistics. European Journal of Cancer. 2006 Mar 9.

[5] Zahl PH, et al. Results of the Two-County trial of mammography screening are not compatible with contemporaneous o icial Swedish breast cancer statistics. Danish Medical Bulletin. 2006 Nov; 53(4): 438-40.

[6] Gøtzsche P. C. What is publication? The Lancet. Nov 2006; 368(9550): 1854-56

[7] https://cancer-rose.fr/en/2021/01/01/critical-analysis-of-the-new-inca-information-booklet/

[8] https://cancer-rose.fr/2018/02/11/10552/

[9] https://cancer-rose.fr/en/2021/06/24/press-release-cancer-rose/

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.

Why don’t we change our vocabulary?

May, 31th

https://philarchive.org/archive/LARCDS

This article argues that the phenomenon of overdiagnosis is linked to both our increasing knowledge of cancer and the fact that this new knowledge causes bias in cancer screening, but also to our approach to cancer and the associated medical vocabulary.

The authors selected two types of cancer as particularly exemplary: papillary thyroid cancer and carcinoma in situ of the breast.

The often militaristic semantics and abusive designations of "cancers" for lesions that are not life-threatening contribute to both an increase in societal anxiety and overdiagnosis, a real scourge of post-modern medicine.

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.

Why does INCa instrumentalize women’s fear of having breast cancer and dying from it?

November 5, 2021

By Dr. Alain Rauss, MD, Biostatistician, for the Cancer Rose collective

INCa and Cancer Rose have been at odds for years over the usefulness of breast cancer screening. Furthermore, Cancer Rose's criticism is directed at the INCa's failure to provide clear, objective, and neutral information to women, trapping them in a process initiated by the INCa based on successive cancer plans [1].
However, the question is not to favor or against screening but rather to allow each woman to make a personal decision based on her history and fears, rather than a decision guided by factors other than sanitary ones.
Finally, it appears that the issue is elsewhere. Why frighten people and use methods that are more akin to manipulation and propaganda?

Instrumentalization of fear

Today, if we look closely, we can see that INCa uses the fear of having breast cancer and dying to achieve its goals.

The fear of death has enabled us to live, save our lives, and arrive here. Despite all our societies' evolutions, we still have this fear in us. On the other hand, playing on fear is a shameful attitude because when fear is present, it becomes more difficult to use discernment, which is the problem. As previously stated, playing on people's fears is manipulation.

Awareness of all risks

There are numerous risks of dying throughout one's life, one of which is breast cancer. The INCa's hype of breast cancer causes at least a part of the population to lose sight of the fact that there are numerous other risks in life. This hype leads us to stop relativizing and consider that if screening is implemented, it will somehow make the woman "immortal."

The table below shows the total causes of death for men and women and changes between 2015 and 2016. Notably, of the 290,300 deaths observed in women in 2016, breast cancer is the 8th leading cause of death. Before the mortality from breast cancer, there were other causes, nervous system diseases, respiratory system diseases, cerebrovascular diseases, mental and behavioral disorders, external causes, and ischemic heart disease.

Thus, breast cancer mortality, although not negligible, represents only 4.27% of women's deaths. In contrast, the first 7 causes of death represent 48.5% of deaths (and we are not counting the other causes of death of the circulatory system that are not precisely individualized, representing 44,000 deaths per year, i.e., nearly 15% of deaths).

If women had to feel all their fears to the level that the INCa tries to bring out for breast cancer (as shown in the box in the latest INCa leaflet below), a woman's life would quickly become unbearable. With the risk of dying from another cause nearly 25 times higher, everyday life with this pressure on the risk of death would quickly become intolerable.

Taking advantage of a situation in which there is no consciousness of all the risks

We can see that INCa takes advantage of the fact that all other sources of risk of dying are absent from the media hype, leaving the field open for INCa on breast cancer and highlighting a fear that can stimulate irrationality in a woman's attitude toward breast cancer screening.

The INCA takes up 1 MONTH of the year in the media space for 4.2% of the deaths, with this month's "Pink October" being enormous. Imagine what life would be like if we had a particular month for one or another risk that kills more than breast cancer?

It is evident that if fields of cardiology, neurology, or pneumology put forward the risk of dying from cardiovascular disease, nervous system disease, or respiratory disease with tenfold means in light of the risks that may exist, the "noise" about breast cancer would be stifled.

However, on closer examination for these causes, which account for most deaths, prevention exists in many instances instead of screening. This means that it is possible to implement measures that will significantly reduce the risk, potentially saving hundreds of lives (as opposed to a battle over 1 or 2 fewer deaths over a 10-year follow-up in the case of breast cancer screening in 1000 women).

Thus, INCa takes advantage of a situation in France that could be described as monopolistic in terms of the fear of dying.

Reducing the fear of dying from breast cancer

All of this seems to indicate that it is critical to be aware of the numerous risks of death!

Women have multiple risks of dying in everyday life, not just from breast cancer, far from it. We accept risky behaviors that are responsible for many deaths, such as smoking and drinking. The rise and decline of cancer deaths follow those of smoking, with a few decades lag. Smoking increases the risk of many cancers, particularly lung cancer, which is by far the deadliest, accounting for more deaths than colon, breast, and prostate cancer combined. [2]

Is it reasonable to be afraid of dying from breast cancer and being manipulated but not be scared of dying due to our risky behaviors?

A return to common sense appears to be necessary to ease the stress that the INCa places on women, especially since it focuses on one single cancer.

The right to choose AFTER adequate information

Each woman must evaluate all the risks of death for her based on clear, reliable, complete, and honest information. Each woman must be able to determine which risks she is willing to accept and which she is not.

Her decision will then be in harmony with her history, her preferences, her environment... This choice is her own, and it should not be influenced by anyone, especially not by the medical profession or any other organization. This is what every woman should require from our health authorities:information and respect for her choices.

If there was only the fear of dying

In this screening propaganda, INCa is not only playing on the fear of death by cancer but also on the fear of developing breast cancer. The fear of losing her identity and her femininity is perhaps even more devastating for a woman. Without even thinking about death, the psychological consequences for this particular cancer are enormous. Many healthy women believe that by getting regular screenings, they will be able to avoid breast cancer.

Arguments such as "The earlier breast cancer is detected, the better the chances of recovery" or "I participate in organized breast cancer screening every two years. It has finally become a habit, and it reassures me and my family " are only there to instill the idea that by participating in screening regularly, healthy women will avoid damage to their bodies and of their identity as women. INCa lies to them exploits their naivety on the subject and especially their fear.

The appeal to fear is an influence technique used to increase screening participation, as detailed in an academic article outlining all the methods used to persuade women to undergo screening; we had discussed it[3] [4].

A culture of understanding risk

Living today without understanding the risk (as we have just seen with the INCa play without any notion of relativization) exposes the population to a climate of fear easily exploitable by unscrupulous people who want to achieve their goals.

 Because of this lack of explanation of what a risk is, these ultimately ill-intended people can use a kind of "hysteria" around risk.

As we mentioned earlier, without understanding the risk, fear arises, and discernment becomes extremely difficult to exercise.

Gerd Gigerenzer, a Berlin psychologist and author of "Thinking about Risk - Living with Uncertainty," denounces the misuse and torture of statistical data that occurs every pink October in every country.[5]

Let us defend the end of the use of fear to guide women's decisions, let us support clear information about the risks (without catastrophism)

References

[1] https://cancer-rose.fr/en/2021/02/08/new-french-cancer-plan-2021-2030-a-soviet-plan/

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

[3] https://cancer-rose.fr/en/2021/04/20/methods-of-influencing-the-public-to-attend-screenings/

[4]  https://cancer-rose.fr/wp-content/uploads/2021/04/Supplementary-Tables-Rahbak-et-al-210421.pdf

(summary table of institutions using influence methods).

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.

Bad statistic of the month October

https://www.hardingcenter.de/en/node/285

https://www.rwi-essen.de/unstatistik/120/

Translation by Cancer Rose, nov 5, 2021

Bad statistic of the month October: Breast cancer month October - Pink ribbons instead of information

Bad Statistic of the Month

Berlin psychologist Gerd Gigerenzer, economist Thomas Bauer from Bochum, and statistician Walter Krämer from Dortmund began publishing the “Bad Statistic of the Month” (“Unstatistik des Monats”) in 2012. Katharina Schüller, managing director and founder of STAT-UP, joined the team in August 2018. Every month they question recently published statistics and their interpretations. Their underlying aim is to help the public deal with data and facts more rationally, interpret numerical representations of reality correctly, and describe an increasingly complex world more adequately. Further information on this initiative can be found at www.unstatistik.de  and on the Twitter account @unstatistik.

October is Breast Cancer Awareness Month. You would think that women would be particularly well informed during this month. To do this, we typed "Breast Cancer Month October 2021" into Google and looked at the entries on the first page. All of them promote early detection, but none of them report what the scientific studies have found about its benefits and harms. Before we look at the entries, it's good to take a look at the results of scientific studies involving more than 500,000 women so far.

They show: When 1,000 women age 50 and older go for screening, 4 of the women die of breast cancer within about 11 years, and for women who don't go for screening, 5. So one fewer woman dies of breast cancer for every 1,000.

However, the total number of women dying from any cancer (including breast cancer) does not change; 22 in both groups. That is, one fewer woman in the screening group dies with a diagnosis of breast cancer, but one more woman dies of another cancer. So, overall, there is no evidence that screening saves or prolongs lives.

But women who go for screening face two harms. One in 100 out of 1,000 receive unnecessary biopsies due to false alarms, and 5 women have part or all of their breast removed unnecessarily. This information should be delivered in October, Breast Cancer Awareness Month, so that women can make an informed decision for or against early detection (see also the "Fact Box on Early Breast Cancer Detection through Mammography Screening"  „Faktenbox zur Brustkrebs-Früherkennung durch Mammographie-Screening“
by the Harding Center for Risk Literacy, led by "statistician" Prof. Dr. Gerd Gigerenzer).
https://www.hardingcenter.de/en/early-detection-of-cancer/early-detection-of-breast-cancer-by-mammography-screening

Google hit pages provide almost no information about the benefits and harms of screening

So what do the Google search results or web pages tell us? Euronews.com gives no information at all about the benefits and harms of screening. Instead, the website promotes pink ribbons and a pink duck parade. The womens.es website, on the other hand, gives a figure: Early detection "reduces the likelihood of death by 25 percent." Does that mean that for every 100 women, 25 fewer will die of breast cancer? No. This figure is found by reporting the reduction from 5 to 4 in 1,000 women as "20 percent less" and rounding it up to 25 percent. Here, I suspect readers are unaware of the difference between a relative risk (25 percent less) and an absolute risk (1 in 1,000). Indeed, studies show that many women (and men) do not see through this trick.

On their website, the Cancer League of Eastern Switzerland Krebsliga Ostschweiz encourages mammography screening, giving many figures (like the number of women and men who have breast cancer) but none about benefits and harms.  The Ministry of Social Affairs, Health, Integration, and Consumer Protection in Brandenburg Webseite again advises early detection on its website. It reports many figures, such as the average age at which women are diagnosed, but none that allows an informed decision - quite different from that in the fact box. Among other things, the company health insurer HMR advises self-testing of the breast by palpation, without mentioning that studies show that this does not reduce breast cancer mortality but can raise false alarms and unnecessary fears. The website also recommends mammography, again without information about benefits and harms.

Early detection is also mislabeled as "prevention," - which is widespread and one of the reasons why many people think that mammography prevents cancer. Vaccination is prevention and prevents diseases; early detection, on the other hand, means that an already existing disease is detected. On the rest of the web pages, it went on like this - entirely without information about benefits and harms, but with celebrities, pink ribbons, teddy bears, and flamingos.

Since different users get different results on the first page of a Google search, you should try it yourself. However, most of us find reliable information only on the later pages, and about 90 percent of all clicks reach the first page only.

In 2021, "Breast Cancer Awareness Month" still fails to provide balanced information

In October 2014, we had already reported on Breast Cancer Awareness Month's commercialization and the missing or misleading figures on benefits and harms. In October 2021, it's the same. In a society where people argue about gender stereotypes, at the same time, they tolerate the practice of withholding the scientific results about early detection from women. Women and women's organizations should be the ones to tear the pink ribbons and not tolerate this finally. Every woman should make her own informed decisions instead of being emotionally controlled by teddy bears and commercial interests.

Your contact for more information:

Prof. Dr. Gerd Gigerenzer Tel.: (030) 805 88 519

Sabine Weiler (Communications RWI), Tel.: (0201) 8149-213, sabine.weiler@rwi-essen.de 

Unstatistics author Katharina Schüller is also a co-initiator of the "Data Literacy Charter," which promotes comprehensive data literacy education. The charter is available at www.data-literacy-charta.de.

RWI - Leibniz Institute for Economic Research

https://en.rwi-essen.de/das-rwi/

RWI - Leibniz Institute for Economic Research (formerly Rheinisch-Westfälisches Institut für Wirtschaftsforschung) is a leading centre for economic research and evidence-based policy advice in Germany. 

Harding Center for Risk Literacy

https://hardingcenter.de/en/the-harding-center/about

University of Potsdam-Faculty of Health Sciences

Our aim is to study how people behave in risk situations. We believe that our work can contribute towards the ideal of a society that knows how to calculate risks and live with them.
Gerd Gigerenzer, Director

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.

Blind and Deaf

In the journal “Pratiques”, Dr Marc Gourmelon reviews the history of breast cancer screening in France, from the launch of organized screening campaign, through citizen consultation, until the current situation with the new 2021/2025 cancer plan endorsed by President Macron, in a climate of deafness of authorities to citizen demands and despite the failure of this screening. All of this is against women's right to fair information on the risk-benefit balance of this screening.

Cliquer sur image pour version française/click on image for french version

Here this article translated

Marc Gourmelon, Medical doctor, member of the Cancer Rose collective

Where are we today in France, regarding breast cancer screening by mammography in women aged 50 to 74 years old without an increased risk of breast cancer?


Historical reminder of the introduction of breast cancer screening by mammography in France

Mammography (breast X-ray) is a radiological examination for diagnosis of any abnormalities detected in breast. It became common practice in the late 1960s with the arrival of the first mammograph in 1965. [1] [2]

Two randomized screening experiments are believed to have proven the effectiveness of mammography on mortality reduction.
These are the New York HIP trial (1963) and the study of two counties in Sweden (1985, 1997).

The published results were identical: a 30% reduction in mortality in the screened group compared to the control group in women over 50 years of age. This resulted in great enthusiasm leading several countries (United States, Sweden, Finland, United Kingdom, the Netherlands and others) to the decision to launch systematic screening campaigns by mammography.

In France, systematic breast cancer screening by mammography was first launched in ten pilot departments in 1989.

Thanks to this screening, it is believed that women would no longer have to die of breast cancer and the disease would be defeated on the basis of an a priori intuitive concept: the smaller or "in time" a cancer is caught, the less serious it is and the quicker it can be removed, thus the more advanced forms of cancer will be averted for women.

Starting in the 1990s, an increasing number of doctors began offering this imaging technique to detect breast cancer, and many studies were carried out in parallel on the subject.
A report from the French National Agency for Health Accreditation and Evaluation (ANAES) dated March 1999 assesses relevance in general population. It recommends the breast cancer screening for all women between 50 and 69 years of age, to be performed every two years. [3]

Based on this recommendation, the cancer plan 2003-2007 in its measure 21, notes:  "Fulfilling the commitment to generalize organized breast cancer screening by the end of 2003".[4] Organized screening of breast cancer by mammography, under the impetus of President Chirac, will then be generalized in France in 2004.

However, voices of national and international scientists have been raised, as early as 1987, urging caution, but inaudible in the climate of general euphoria. [5]

In 2001, the independent Nordic collective Cochrane published a meta-analysis, updated several times [6], which questions benefits of this screening.

Nevertheless, the French High Authority for Health (HAS), which evaluated this study in early 2002, refused to question the relevance of organized breast cancer screening. [7]

Despite the accumulation of studies and evaluations in recent years, today the organized screening of breast cancer by mammography is still recommended by the health authorities ( French High Health Authority, National Cancer Institute) on the basis of 2004 guidelines.
The objective is even to intensify it, because the participation targets for eligible women (50 to 74 years old) set at 70 or 80% have still not been reached.

In fact, participation in the organized breast cancer screening program represents only slightly more than 50% of women.

At the same time, the number of mammographers is constantly expanding and cutting-edge technology, such as tomosynthesis, a type of 3D imaging, is being studied to track down more and more small lesions, contributing to a surge in incidence of cancers without a significant reduction in mortality. (still 12,000 deaths/breast cancer/year).

Proponents of EBM (the concept of tripod-based medicine - scientific studies, physician's professional experience, and patient preferences and choices) advocate enlightened information and shared decision-making with the patient, who must be informed of the uncertainties of screening. This concept is defended in France by the independent journal Prescrire. In the United Kingdom and Canada, very detailed brochures are issued to patients, while in France this is not the case.

But what about the real effectiveness of this screening?

The effectiveness of cancer screening is defined by : 

- a drastic and significant reduction in mortality from the disease, 

- a reduction in incidence of advanced cancers, 

- a lightening of treatments.

The meta-analysis of the Cochrane collective that we have just mentioned above alerts us of an unexpected guest of screening, namely overdiagnosis. This concerns the discovery of cancerous and pre-cancerous lesions which, undetected, would not have endangered the woman's health or life, but which will all be treated with the same determination.

Together with false alarms, that is, suspected cancers that are not confirmed after further examinations of the patients, the risk-benefit balance of screening does not appear to be favorable. For the Cochrane, for every 2,000 women screened over 10 years, for one life saved, there will be 10 overdiagnosed and overtreated women and 200 false alarms. In the years following this publication, international and national studies on the benefit/risk of breast cancer screening by mammography have multiplied and have highlighted an important issue: an increasing overdiagnosis of small lesions (<2 cm) and precancerous lesions responsible for overtreatment, and a parallel reduction in mortality that is very minimal, little or not perceptible.  [8] [9] [10]

Indeed, when comparing populations of women subjected to different screening intensities, we find that among women screened, more cancers are found for identical survival in both groups. [11]

Overtreatment is the materialization of overdiagnosis for women, and it has destructive effects.

Women are doubly victims, in their body and in their illusions, convinced that they have been "saved" while they are suffering the stress of a ruined life and the potentially major adverse effects of treatment.
Treatments are primarily surgical, with an increase in total and partial mastectomies since screening, contesting the widespread myth of therapeutic lightening through screening. [12]
Women also undergo unnecessary radiation therapy with cardiac risks and an increased risk of hemopathy. [13] [14]
The quality of their lives is diminished; after being diagnosed with cancer, women suffer from anxiety and depression syndromes, some lose their jobs and become poorer. Their sexuality and self-image are altered, sometimes leading to suicide. [15]

Thus overdiagnosis leads to a number of deaths that are not reliably measured but which, when taken together, could be major, as a British study suggests. [16]
This problem of overdiagnosis took a long time to be recognized by health authorities in charge of organized screening.

Today, this has been done, but this crucial issue, which must be taken into account when assessing the risk-benefit balance of screening, is greatly minimized.
In the 2015 HAS document [17], overdiagnosis is well mentioned, but, taking up only a few lines of the nearly one hundred pages of the report, it is completely drowned out in explanations of the value of screening; therefore, it goes unnoticed.

Furthermore, when it comes to independent scientific studies questioning the value of screening, the HAS document uses the terms "controversy" and "polemical", which inexpensively discredits the debate on the subject.

The document is still in force today, and is very poor in terms of bibliography supporting the interest in pursuing organized screening.
This makes it a very partial document, contrary to what should be expected from a state agency.

The INCa (National Cancer Institute) has also continued throughout these years the same shortcomings in the information provided to women on the subject.

We have just seen that for health authorities, for politicians who decide on successive cancer plans, the question regarding effectiveness of breast cancer screening by mammography is not raised.

They do not question the effectiveness of this screening and they are aiming to intensify it, even though independent meta-analyses, international studies and epidemiological data from the countries where screening takes place tend to show that the objectives of screening effectiveness are not being met : 

- Not only does screening significantly increase the incidence of cancer without significantly decreasing the risk of dying from breast cancer,  -but also does not make it possible to treat less aggressively, or to reduce advanced forms of cancer that desperately remain at an unchanged rate, in all countries where screening is in place.

The citizen consultation on breast cancer screening by mammography in 2015

Several observations prompted the Minister of Health at the time, Marisol Touraine, to initiate in 2015 a scientific and citizen consultation on breast cancer screening:

- The stagnation of the participation rate of women, which does not exceed 50% instead of the initial 70% objective.

- The variability of participation according to territories and socio-economic groups.

- The growing extent of the debate on benefits and risks of screening, both within scientific and medical spheres and among general public, regularly covered by mass media.


The Cancer Rose collective, of which I am a member, was auditioned during two round tables, one with citizens and the other with health professionals.
Our collective, made up of doctors and a toxicologist, came together with the objective of providing women and healthcare professionals with all independent and recent scientific information available.
Thus, we have developed and launched an website that aims to convey information that will allow women to make an informed decision on the stakes of screening, in an objective manner, without being influenced by media and promoters of the pink campaign.
This collaboration has already led to the development of an information brochure as well as various informative and educational materials.

The report of the scientific and citizen consultation was published at the end of 2016. [18]
The conclusion is very clear: the organized screening program should be stopped based on the two proposed scenarios (see page 132 of the report [19]):

Scenario 1: discontinuation of the organized screening program, relevance of mammography being assessed in the context of an individualized medical relationship.

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

Following the release of this report, INCa sent a letter to Minister Marisol Touraine, dated September 16, although we only became publicly aware of the report on October 2. Professor Ifrah, President of INCa, calls Scenario 1 in this letter a "textbook case" and dismissed it out of hand, thus reducing half of the work to a negligible amount. [20]

Voices were raised, scandalized by such a denial of health democracy. [21]

An action plan is then published by Mrs. Marisol Touraine who entrusts the renovation of the screening to... INCa, the same institute whose lack of information for women was heavily criticized throughout the consultation report.

Currently, in 2020, the citizens' demand of 2015 to stop the current screening is still unheard, the pink campaigns are going well, and this public health program is therefore continuing according to the 2004 plan.

The implementation of a "new, profoundly modified organized screening" based on individual risk is underway with the launch of the MyPeBS study [22].
This is a randomized, non-inferiority study comparing women randomly divided into two groups. One group will consist of women who are routinely screened according to current official recommendations, and the other group will consist of women who are individually screened based on an assessment of their personal risk of developing invasive cancer during their lifetime.
This study poses many problems, ethical (consent form given to women omitting overtreatment and minimizing overdiagnosis), and methodological (absence of a "no screening" arm of the study, recruitment of women as young as 40 years old with annual mammograms for risk groups without information on radiotoxicity), software for calculating individual risk without scientific validation .

And since 2015?

Nothing has happened, apart from continuity in the promotion of organized screening.

Breast cancer screening is still included in the Public Health Objectives Remuneration ( ROSP), but it must be recognized that the objective asked to the general practitioner (between 60 and 70% participation of patients) is very difficult to reach in order to get the maximum of this remuneration.

Every year, October month turns pink with multiple incentives for women to be screened. 2020 was no exception to the rule.
Broadcasts for general public (Stars à nues) on TV channels are making an unbridled and uncontrolled promotion of the screenings without any authority being concerned, nor the CSA Higher Council for Audiovisual that we had alerted.

What are the observations arising from these facts?

It was decided by the authorities to set up organized breast cancer screening by mammography in 2004 when already early warners were expressing their doubts. Fifteen years later, knowledge on the subject has been enhanced. A large number of studies have been published that are consistent on a perceptible lack of benefit from breast cancer screening by mammography, and on the presence of risks whose reality is tangible and accountable. According to the most recent studies, overdiagnosis now concerns one-third to one-half of the cancers detected by mammography [23].

According to the journal Prescrire, for every 1,000 women over the age of 50 participating over a period of 20 years, there are approximately 1,000 false alarms in France, leading to 150 to 200 biopsies, sometimes several on the same woman during her successive screenings [24].

So why is it important for the French authorities to continue this screening, since women who undergo it do not gain any conclusive benefit from it?

Several possibilities can be evoked. 

- After having literally conjured up women, for three decades, to get screened, through slogans and media campaigns, it seems difficult for the health authorities and opinion leaders promoting it to disregard it. 

- Conflicts of interest among certain actors in the field of screening cannot be denied and weigh heavily on the omerta that reigns over the scientific debate in France [25] [26]. 

- Beliefs based on intuitive concepts are often easier to anchor ("sooner is better", "finding earlier saves lives") than explanations of the much more complex natural history of cancers in real life. This requires a longer pedagogy and explanatory development, to make people understand why some cancers remain indolent for a lifetime, why people can die with their cancer but not because of it, why others are fast and kill their host no matter is done, screened or not. 

- Obvious laziness in tackling true prevention contributes to the persistent buzzing of well-oiled pink campaigns. 

- Primary prevention remains the weak side of public health in France. Smoking, alcohol, but also obesity and a sedentary lifestyle are among the risk factors for cancer in general.

In addition to many other social factors, such as poverty, night work, certain professional environments are well known as risk factors for developing breast cancer and other cancers.
But few resources are invested in massive campaigns to combat smoking, alcoholism, obesity and these socio-professional factors.

They would certainly be more relevant than Pink October campaigns or health fair shows that are inflicted on women with coercive and scary messages.

In this respect, the latest cancer plan 2021/2025 announced by President Macron on February 4, 2021 is symptomatic: even if it talks about tobacco and alcohol, it largely confuses prevention and screening, giving the latter a clear advantage at the expense of prevention policies worthy of this name [27].

Conclusions

It is particularly difficult for the public, faced with opposing opinions and a highly technical debate, to get a clear idea of realities at hand.
The health sector has seen in this year 2020, during the coronavirus crisis, medical "clashes" with diametrically opposed opinions.

How can one cope as a layperson who has no expertise on the subject?
This is exactly the problem that every woman who is asked to get screened has to face.
This is all the more difficult for her, since the authorities are "Blind" with regard to the scientific knowledge they have acquired, and "Deaf" to all questions on the subject.

This is why I think it is necessary that all women be aware of this simple infographics, based on the evaluation of the Cochrane review, in concordance with other audited evaluations, whose results have never been contested by the international scientific community [28].

This simple visual, summarizing the entire issue of screening, must be given to women BEFORE they undergo the organized screening test for breast cancer.

References

[1] Tabar L, VitakB, Chen HH et al.The Swedish Two-County Trial twenty years later. Updated mortality results and new insights from long-term follow-up, Radiol Clin North Am 2 000 ; 38:625-51.

[2] Efficacy of screening mammography : Kerlikowske K, Grady D, Rubin S M, Sandrock C, Ernster V L. Efficacy of screening mammography : a meta-analysis. JAMA 1995 ; 273(2) : 149-154.

[3https://has-sante.fr/upload/docs/application/pdf/mamo.pdf

Recommendations :

Routine screening is recommended in the 50-69 age group.

In the general population, the benefit of breast cancer screening in terms of avoided mortality is demonstrated in the 50-69 age group. Therefore, in this age group, routine screening is recommended.

In the 70-74 age group, the incidence of breast cancer is high, but data on mass screening are scarce. Taking into account the large-scale organizational difficulties, extending screening to this age group currently seems premature in France. On the other hand, it is logical to recommend the continuation of screening between the ages of 70 and 74 for women previously included in the systematic screening program between the ages of 50 and 69.

[4https://www.e-cancer.fr/content/download/59052/537324/file/Plan_cancer_2003-2007_MILC.pdf

5] In 1998, Professor Paul Schäffer of the Bas-Rhin Laboratory of Epidemiology and Public Health (faculté́ de médecine de Strasbourg), in charge of the evaluation of screening, published an article in the French Medical Council's Bulletin 19.

"Tumour screening campaigns: caution is needed. "Screening should not be harmful. If it can bring health benefits, its potential to harm individuals should not be forgotten.For reasons of efficiency and ethics, preventive action should not have major disadvantages.

[6https://www.cochrane.org/fr/CD001877/BREASTCA_depistage-du-cancer-du-sein-par-mammographie

7] "Gotzsche and Olsen's meta-analysis challenges the consensus on the effectiveness of breast cancer screening. "and : "The evaluation of Gotzsche and Olsen's meta-analysis, carried out by ANAES with the help of a multidisciplinary group of experts, concludes that it is not legitimate to question ANAES' recommendations in favour of breast cancer screening. »

(https://www.has-sante.fr/jcms/c_433803/fr/depistage-du-cancer-du-sein-par-mammographie-evaluation-de-la-meta-analyse-de-gotzsche-et-olsen)

[8] Breast Cancer Screening, Incidence, and Mortality Across US Counties,Charles Harding, AB ; Francesco Pompei, PhD ; Dmitriy Burmistrov, PhD ; et alH. Gilbert Welch, MD, MPH ; Rediet Abebe, MASt ; Richard Wilson, DPhil, JAMAIntern Med. 2015 ;175(9):1483-1489. doi:10.1001/jamainternmed.2015.3043

The results of this 2015 study : 

- An increase in the number of breast cancer diagnoses (+16% for a 10% increase in screening participation), mainly by tumors smaller than 2 cm. 

- No reduction in breast cancer mortality. 

- No reduction in the number of advanced breast cancers. 

- No reduction in mastectomies.

[9RevuePrescrire 2006 https://www.prescrire.org/aLaUne/dossierKcSeinDepSyn.php

"In terms of total mortality, a benefit of mammographic screening in the general population has not been demonstrated. If there is an effect (positive or negative) on total mortality, it is small. »

10] Mammography screening: A major issue in medicine, Philippe Autier, Mathieu Boniol, Eur J Cancer, 2018 Feb ;90:34-62. doi : 10.1016/j.ejca.2017.11.002.

The strong points :

- After 20 to 30 years of mammography screening, the incidence rates of advanced and metastatic breast cancer have remained stable.

Breast cancer mortality rates have not declined more rapidly in areas where screening mammography has been in place since the late 1980s.

- One-third to one-half of breast cancers detected by mammography are estimated not to be symptomatic during a lifetime (overdiagnosis).

- Randomized trials of breast cancer screening have adopted distinctive methods that have led to exaggerated screening effectiveness.

- The influence of mammography screening on mortality decreases with the increasing effectiveness of cancer therapies.

11] Twenty year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial, Miller AB, Wall C, Baines CJ, Sun P, To T, Narod SA, The BmJ, 2014 Feb 11;348:g366.

Conclusions :

- No difference in mortality between the two groups (mortality = number of deaths relative to the total number of people screened).

- Survival rates are identical, regardless of the stage of the tumour at the time of detection (by screening for some, by a symptom for others).

22% over-diagnosis

- No difference between the two groups in the rate of fatal cancers.

[12] Le dépistage organisé permet-il réellement d’alléger le traitement chirurgical des cancers du sein ?, Vincent Robert, Jean Doubovetzky, Annette Lexa, Philippe Nicot, Cécile Bour, Revue Médecine, Volume 13, numéro 8, octobre 2017.
https://www.jle.com/fr/revues/med/e-docs/le_depistage_organise_permet_il_reellement_dalleger_le_traitement_chirurgical_des_cancers_du_sein__310529/article.phtml

[13] Causes of death after breast cancer diagnosis : A US population‐based analysais, Ahmed M. Afifi MBBCh, Anas M. Saad MD, Muneer J. Al‐Husseini MD, Ahmed Osama Elmehrath, Donald W. Northfelt MD, Mohamad Bassam Sonbol MD, ACS Journal, 16 December 2019
https://doi.org/10.1002/cncr.32648

[14] Evaluation of the Incidence of Hematologic Malignant Neoplasms Among Breast Cancer Survivors in France, Marie Joëlle Jabagi, PharmD, MPH, Norbert Vey, MD, PhD, Anthony Goncalves, MD, PhD, Thien Le Tri, MSc, Mahmoud Zureik, MD, PhD, and Rosemary Dray-Spira, MD, PhD, JAMA Netw Open, 2019 Jan ; 2(1) : e187147.
Published online 2019 Jan 18. doi : 10.1001/jamanetworkopen.2018.7147

[15] Bouhnik AD et Mancini J, « Sexualité, vie affective et conjugale » In La vie deux ans après un diagnostic de cancer - De l’annonce à l’après cancer, collection Études et enquêtes, INCa, juin 2014, 454 pages.

[16] Harms from breast cancer screening outweigh benefits if death caused by treatment is included, BMJ, 2013 ; 346 doi : https://doi.org/10.1136/bmj.f385 (Published 23 January 2013). Cite this as : BMJ 2013 ;346:f385 - https://www.bmj.com/content/346/bmj.f385
Michael Baum, professor emeritus of surgery, Division of Surgery and Interventional Science, University College London, London WC1E 6BT, UK

[17https://www.has-sante.fr/jcms/c_2024559/fr/depistage-et-prevention-du-cancer-du-sein

[18https://www.e-cancer.fr/Institut-national-du-cancer/Democratie-sanitaire/Concertation-citoyenne-sur-le-depistage-du-cancer-du-sein

[19http://www.concertation-depistage.fr/wp-content/uploads/2016/10/depistage-cancer-sein-rapport-concertation-sept-2016.pdf (read: https://cancer-rose.fr/en/2020/12/14/final-report-of-the-citizen-consultation-report-of-the-steering-committee/)

[20https://www.atoute.org/n/IMG/pdf/Courrier-Ministre-concertation-depistage-cancer-sein---.pdf

[21https://formindep.fr/cancer-du-sein-la-concertation-confisquee/

[22https://cancer-rose.fr/my-pebs/ (read: https://cancer-rose.fr/my-pebs/2019/06/13/argument-english/)

23] Mammography screening : A major issue in medicine, Philippe Autier, Mathieu Boniol,
Eur J Cancer, 2018 Feb ;90:34-62. doi : 10.1016/j.ejca.2017.11.002.

[24Revue Prescrire, février 2015/Tome 35 N°376.

[25https://www.atoute.org/n/article308.html

[26] MitcHell ap, BascH em, Dusetzina sB. Financial Relationships With Industry Among National Comprehensive Cancer Network Guideline Authors, JAMA Oncology, 2016 Dec 1 ;2(12):1628-1631.

[27https://cancer-rose.fr/2021/02/08/nouveau-plan-cancer-2021-2030-une-planification-sovietique/

[28https://www.hardingcenter.de/en/early-detection-breast-cancer-mammography-screening

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 and the frightening abyss of death

The tree that hides the forest

Annette Lexa, PhD Toxicology

It is easy to see in this frenzy of screening and explosion of patient recruitment in clinical trials a fool's game that primarily serves industry.
However, it is almost certain that reality is more complex, and this angle of analysis is not only one that can explain this situation, it is only a consequence and not the primary cause.

It seems more and more certain that this much promoted early detection indiscriminately detects cancers with good and poor prognosis. The problem is just that treatments which follow don't discriminate either ("We are going to cure you of a disease that you don't have yet", says a doctor in the France 5 documentary, « In the name of all breasts »).

This leads to over-treating a number of patients with new supposedly "innovative" anti-cancer drugs, extremely expensive and no more effective than those already on the market and whose serious side effects (death, second cancer) are largely unknown to general public.

In terms of public policy, cancer is receiving a great deal of attention, with a certain tropism for women's cancers, partly due to a captive and docile clientele (see on this same site "Breast cancer screening, the latest avatar of medical misogyny").

There are equally serious deadly diseases such as multiple sclerosis, cardiovascular disease, AIDS, diabetes that do not receive the same attention as cancer through its major National Cancer Plans.  And we are not talking about nosocomial and iatrogenic diseases. It is not a question here of a silence of the body but of a societal silence or even of an indifference or a kind of fatality difficult to explain, assuming that the State' s vocation in health care is to reduce premature mortality and increase life expectancy of its citizens.

Unlike other pathologies, even the most serious and deadly, cancer is treated apart as if it was " the devil, the invincible predator ". Because cancer is more than a disease, it is a symbol of extraordinary power.

It replaced plague of the Middle Ages, tuberculosis and syphilis of our ancestors. It represents the devious evil, the silent killer, it seems to arise without any obvious cause (except the proven cases of smoker's cancer). For experts, it remains extremely difficult to prove causal link between exposure to a substance and appearance of a cancer, as environment and genetics seem to interfere and create favourable conditions for its development until metastasis and death.

Medical imaging tools have only been available for a few decades to confirm diagnosis. In the past, we would die without really knowing what caused the death. Now we still die, but we know from what, and the prognosis is even announced with a staggering techno-scientific coldness ("you only have 6 months to live").

Medicine has made great progress in oncology, that is not the point. What is important here is to recognize that this progress had little impact on what we modestly call cancers with a poor prognosis (lung cancer, gliomas, sarcomas, acute leukemia, certain skin cancers...). .

So why do we continue to focus so much on the "fight against cancer" all around? There are many equally deadly diseases where we could make huge progress through prevention alone or simply by focusing more on research and national plans.

The fear of the nothingness of death

Cancer collectively crystallizes all our thoughts and taboos about death. Yet our societies have "killed" death by killing God.
Existentialism and atheism (with secularism, which became the state religion in France) have become modern philosophies, markers of progress in the flow of History.

In a materialistic vision, when we consider that there is nothing after death, this death having lost all meaning; all that remains is the fight against this absolute "injustice". And the fight against cancer has become the latest eschatological fight (concerning the ultimate destiny of  human race) of the postmodern crusaders in a society that has lost any project and common sense.

There are even post-humanist currents of thought that promise disappearance of death (cloning, freezing, transfer of thought from brain to hard disk...).

The discussion about death is therefore now reduced to the "right to" and not to existential questions about meaning of death, whether individual or collective. The individual, the new Man, necessarily emancipated, is supposed to be sent back to himself in the name of his personal convictions about death. And the individual has not necessarily acquired the psychic tools enabling him to take up this personal challenge. He is alone and he is afraid, very afraid and wherever he turns, he no longer finds a satisfactory answer.

If he finds a religion that offers him a turnkey life path, he sometimes signs without hesitation. Is he right? Is he wrong? In any case, we can't blame him too much in front of sidereal void.

In a completely different vision, which we will call "spiritual" (and not religious) of existence, death is a passage and this deep conviction is lived serenely, calmly, with much less anguish. It creates another relationship of trust in relation to life and death. We may feel sorrow at no longer seeing those we love, of course, but we are convinced that something of ourselves survives beyond the disappearance of our body and our self and we attach extreme moral importance to it, for example. It is a 360° vision of Life from birth to death.

Today, terror, fear is no longer in front of the Last Judgment, like our ancestors from the Middle Ages to 19th century, but in front of the void, the nothingness of death: contemporary funerals are the result (absence of rites, ...). This is an unprecedented situation knowing that burial rituals, the first sepultures date back 100,000 years and are the first markers of civilization (even Neanderthal buried his dead).

Asserting that death is nothing like Epicurus, is not true collectively. Individually and collectively it has been the stumbling block to all human life on Earth since Man became aware of his own death. As long as our societies have not transcended this drama that death has become in contemporary societies, we will not be able to get out of this teenage individualism that wants everything right away and especially not to die. There will be no turning back (with the return of traditional religions as they are) but it will be necessary that our societies include and transcend the great monotheistic religions and the other world visions transmitted by the first peoples.

If we are in a position to make this observation, we have no collective answer to date, each one being sent back to himself in front of this dizzying existential question. Death has become a personal matter to which society tries to respond as best it can. And frantic screening for cancer is a technocratic and economic societal response to calm the fear of death.

Biomedicine is still a combat medicine that works on "masculine" war premises. The exorbitant price of anti-cancer drugs, the major cancer plans and their share of "innovative" actions tinged with totalitarian desires that sometimes become ridiculous through obstinacy in reality of death, are result of this vision of the world.

The excesses of obsessive screening aimed at tracking down the slightest allegedly cancerous cell in everyone and by all means of medical imaging in order to "fight" it; are the result of the domination of the small self of the possessive individual, who wants to control everything, anguished by death he cannot control. Worse, like immature teenagers, we have wrapped this too warlike, too virile "fight against cancer" in a dripping pink emotional and regressive marshmallow, aiming to mask the lack of preparation of individuals in the face of death, their daily occupations having totally exempted them from having to reflect on the meaning of their life and death.

Our lives, our distant descent from our Cro-Magnon ancestors, the challenges that await tomorrow's humanity on a planet that will soon reach 10 billion people, deserve better than that. If, instead of turning inward and allowing ourselves to be taken over by a paternalistic state and a monopolistic economy, each of us starts to find the meaning of our lives, the courage to live, common sense in the face of individual and collective destinies, our Western societies will emerge stronger and will know how to restore meaning in the face of death. Otherwise, scenarios such as The Best of the World await us. We still have the choice, it is up to us to choose today and without delay.

Bibliography guide: 

Bertrand VERGELY , Entretien au bord de la mort , 2015

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.

Breast Cancer Screening, the Latest Avatar of Medical Misogyny

ANNETTE LEXA - August 21, 2015

Value of breast cancer screening is not scientifically proven

Breast cancer screening seems obvious to women and we have all been lulled by these "evidences": breast cancer is the first cause of death in women, cancer is a horrible disease that threatens us all, the earlier a cancer is detected, the more it is cured, screening can detect small cancers that can be treated, if we do it early we will have fewer mutilating ablations.

However, contrary to what is asserted everywhere, and even on institutional sites when they intend to promote DOCS (organized breast cancer screening), women die much more in France from cardiovascular diseases 1. While breast cancer mortality has decreased slightly (from 4% to 3%), colon and lung cancer deaths have not changed over the same period [1] .

This small decrease is mainly due to the fact that women have become more attentive and better informed and that surgical and radiotherapy treatments have made great progress.

Since 2009, a scientific controversy (here, here, here, here) has developed around the risk/benefit balance of breast cancer screening, presented as the medical examination of choice that is supposed to reduce this mortality. This controversy has arisen from large epidemiological studies in various Western countries (not in France where epidemiology is a politically incorrect science to be avoided). This controversy is currently heating up with this recent American study (here) which demonstrates more masterfully that early detection not only did not reduce mortality that had become stable, but also did not reduce breast ablations.

Screening's 'assets' continue to be praised with its double reading (in France) in case of a negative result, which would be the top of the top of scientific rigor. Whereas no one seems to matter this simple question of common sense: "why not double reading in case of a positive result? ». What an arrogant and asymmetrical confidence in the infallible reading of the specialist! The risk of false positives (false cancers) with its heavy and disabling prescriptions and the risk of false negatives (with the recurrent discovery by women themselves of the famous "interval cancers" between two examinations) are systematically underestimated. And finally, the risk of developing cancer through an excess of examinations and radiotherapy (here) is most certainly underestimated, whereas recent work (here) should on the contrary incite the greatest caution with radiosensitive women.

But, obviously, the sacrosanct principle of precaution - especially when the risk-benefit balance is not proven - is much more scrupulously applied for chickens, steaks or cereals than for bodies of healthy women (not to mention the use of contraceptive pill, hormone treatment for menopause, breast prostheses, caesarean sections, periodical tampons, etc.).

Manipulative techniques to impose screening on a docile and captive female audience

 But then why have we been witnessing for years this veritable military operation of quasi-Stalinist national recruitment [2] of women to the depths of the most remote campaigns and by all means?  Doctors, institutions, associations, politicians, all enlisted for the Great National Cause with the numerical objective of bringing recruitment ideally to 70 or even 80%.  We go so far as to use "mammobiles" that travel around the Hérault department in the most remote villages to overcome the "reluctance" of "vulnerable" women and "women with a bad self-image" (I'm not exaggerating, go read here) and offer a free "useful" exam to women as early as 40).

Every year, we are entitled to the trickery of the Pink October campaign with the surge of indecent, manipulative, guilt-ridden, infantile messages, to reach women through the emotional supposed to be their main vector of communication and aiming to turn them all into cancerous ninnies ignoring themselves. Even if it means crushing individual lives, intimacy, and fulfilled sexuality, destroying couples and families (overtreating cancer is not a trivial event without risk, it is a personal drama) and leaving women in insurmountable financial difficulties because they are definitively labeled ex-cancerous (job loss, credit insurance...).

Treasures of imagination will be deployed to improve the self-image of the healthy women who are to be recruited by all means. But this does not really seem to be a priority anymore for a ex-cancer patient over 50 years old who must consider herself lucky to still be alive.

You will tell me that men also have their Movember to "fight prostate cancer". The PSA blood screening campaign was a failure and its interest was quickly questioned. It's true that men (including doctors), who care about their virility more than anything else, quickly understood the risk of overdiagnosis and overtreatment with its share of impotence and incontinence.... don't touch my virility.

Women's body control through medicine: a long history 

I will answer that this relentlessness to control women's bodies is not new in French medicine:

- The 19th century saw the invention of Charcot's hysteria, all feminine, which became the sexual neurosis of women who were believed to be deprived of a penis according to Freud.

André Brouillet, Dr. Charcot at the Salpêtrière

- With the praiseworthy aim of fighting syphilis, Pasteurian hygienism led to the control of captive prostitutes in brothels who had to undergo monthly degrading medical visits that clients never had to undergo, even though they were themselves just as vectors (of  transmission) of bacteria.

The medical visit , Toulouse Lautrec

- The control of childbirth by men from beginning of the 19th century resulted in a hecatomb of deaths in labour caused by the excessive hubris of hospital doctors who had taken over the childbirth. This hecatomb lasted until the 1930s. While 80% of pregnancies are normal, we then witnessed the increasing medicalization of pregnancy and childbirth, whose anxiety-provoking, cold and dehumanized nature did not escape any woman who experienced this event. In addition, there was an obsession with the control and normalization of this natural act with its share of episiotomies, epidurals and caesarean sections. It should be noted that this medical hypertechnicalization has not been accompanied by a decrease in maternal mortality in France.

- The invention of the oral contraceptive "pill" for women (why not for men?) became the symbol of female emancipation, of sexual liberation. However, for 4 decades, the medical profession has minimized and under-informed women about the side effects of this drug taken by women who are not ill. Yet this drug is a real endocrine disruptor classified as a group 1 carcinogen (definite carcinogen) by the IARC in 2012. The list of side effects that women docilely accept the risk of is as long as a poem à la Prévert: weight gain, cellulite, acne, headaches, depression, decreased libido, fatal venous and thrombo-embolic problems, slight increase in breast cancer and uterine cancer, etc. 

Yet no feminist, after the euphoria of the 70s and 80s, seemed to see the symbolic violence of this medicalization of women's bodies and sexuality.  In a terrible relational asymmetry, men were thus able to dispose of the bodies of women and very young girls brought by their own mothers in a irresponsible manner, and regularly complied with the medical visit to "their" gynecologist, demanding for the most scrupulous among them regular blood tests to monitor their cholesterol levels, accepting without flinching this control of their bodies and their sexuality, and sometimes serious undesirable effects of this constraining intake.

How can we speak of women's liberation ("my body belongs to me") with this passage from patriarchal submission to medical submission and to the desire of men since they are supposed to be 100% "available" from now on, and in case of a decrease in libido caused by taking the pill, they will blame themselves near their doctor-trust-sexologist? Recently, there has been concern about the urinary discharge of pill metabolites (17β-estradiol) present in aquatic environments at a concentration of around ng/L and responsible from this dose for fertility disorders and hermaphrodism in fish.

French society has not ceased to be worried about the impact of certain pesticides, brominated flame retardants, phthalates, glycol ethers, nonylphenol, Bisphenol A (a molecule that mimics estrogenic hormones) in food plastics, phytoestrogens, etc..,  on the reproductive system of humans and animals) but it continues to authorize the sale of oral contraceptives "under medical supervision" when it does not give them free of charge to teenagers who have just reached puberty in secondary school, prepared by official Natural Sciences classes where the pill is presented as a simple means of having regular periods [4] ... figure it out. Finally, how many women, struggling to start a pregnancy after 10 years or more of oral contraception, without asking themselves more than that, are complying with heavy methods of medically assisted procreation (MAP) whose violence and constraint have nothing to envy to what has just been described? What is to be thought of a Ministry of Health that advertises oocyte donation[5] without mentioning the heaviness of hormonal treatment and its possible consequences? What about companies such as Facebook and Google that encourage their employees to freeze their oocytes to fight against the biological clock by trivializing hormonal treatments of retrieval and reimplantation?

- In the aftermath, women were convinced that menopause was a pathology and medicalization of menopause was invented with hormone replacement therapy which was supposed to have a preventive role against a host of future diseases. Still today, TSH is too often given to treat simple transitory disorders sometimes felt at this time like hot flashes, night sweats, low libido or vaginal dryness, or even it is given (and claimed by some women) as a "preventive" with the promise of staying young.  Let us recall all the same that the treatment of menopause is classified as carcinogenic and that even  health authorities today encourage the greatest caution in its use.

Women were made to believe that, now that they lacked hormones, it was natural for them to suffer all sorts of inconveniences that needed to be corrected if they wanted to continue to appear socially young and sexually desirable (unless they naturally questioned at that age about their emotional life, the departure of their children, their desire and sexuality, etc.) . As each woman is unique and is her own witness, none of them can boast of the real effectiveness of TSH on her menopause and it is more than likely that a good part of effectiveness felt is a kisscool effect.

- As soon as craze for TSH waned, we witnessed the mass submission, sometimes from the age of 40, to mammography screening, a painful and anxiety-provoking examination of uncertain benefit to reduce mortality, and which only resulted in a dizzying increase in the number of small cancers that would not have developed, or very slowly or would have regressed, and the number of unnecessary and traumatic breast ablations.
It should be noted that these last two acts of violence against women's bodies concern the "not so-youngest" who no longer represent the ideal of youth and fertility of the young woman, the eternal object of male fantasy, and to which the 50+ woman must comply.

- The trivialization of heavy, painful and sometimes dangerous surgical procedures to have silicone breast implants in order to improve their self-image, to conform to a totally constructed social norm (the very thin woman with very large breasts) and to respond to male fantasies. Would we imagine for one moment 400,000 men in France undergoing surgery to inflate their penis or testicles?

- The submission to cervical cancer vaccines of uncertain benefit, with great reinforcement of campaigns blaming the mothers of young teenagers. Here again, why should women be the main vector of the papillomavirus in question? Why has a mixed campaign not been launched targeting both young heterosexual boys - and homosexuals particularly concerned - and young girls, if not because the medical world has a captive market with women and their daughters, docile, easy to make feel guilty and educated to obey?

Social control and submission to standards 

This docility of women with regard to medical world has changed little in spite of women's emancipation. And corporations and advertisers in charge of promotional campaigns are well aware of this, when they illustrate the importance of breast cancer screening by using images of young women with perfect bust, when they are not using guilty messages depicting family and "good friends". They continue to go running "against breast cancer" (who would be for, I ask you??) wearing a pink pin, dreadful gendered color, and don't hesitate to attend Tupperware meetings stamped Pink October to convince their reluctant girlfriends to go to the nearest mammobile.

Why this excessive relentlessness of medicine with the complicity of highest authorities of the State and their squads of civil servants in Regions to want to control the normality of breasts of women and to submit them down to their intimacy?

Why can we not find the beginning of an equivalent such control of the male body and such submission in men? Why doesn't medicine strive with same deployment of means to reduce mortality from cardiovascular disease in women, which represents almost 7 times more deaths per year than from breast cancer?  Or to lower female mortality from lung and colon cancer?  It is true that the heart, lung and colon are organs that are much less sexed. Women, contrary to what they claim, have not emancipated themselves from society's control over their bodies and sexuality. They have swapped one Master (father, husband, priest...) for another, representing the Promethean techno-scientific power supposed to watch over their bodies, which are inevitably disturbed, easily maladjusted, and which, if they are not careful, are the seat of all sorts of frightening feminine pathologies, this submission obscuring the perspective of a life as a woman, as a lover, as a mother in full bloom. Worse, women are women's worst enemies: making a daughter take the pill, recruiting her good friends is tantamount to making themselves accomplices in their submission, just as women are accomplices in the excision of the youngest in other cultures.

Some (here and here) have recently questioned the misogyny of the French medical profession, but paradoxically these theses have not seduced our journalists from women's magazines, who are nevertheless quick to liberate the sexuality of their readers.  This thesis did not seem to please the various feminist movements either, refusing to see in this pseudo-emancipation another form of alienation, as Marc Girard has very well demonstrated. There is in this submission an absolute unthought, a taboo, a blind spot that the struggle for women's emancipation has been unable to see.

Still today, the majority of women are not very curious and critical of recommendations that are made to them: submissive, constrained or outright exalted followers of the Church of Depistology (Europa Donna and other Pink October with the support of Sephora, Tupperware and Esthé Lauder), they do not go to critical blogs (to those previously mentioned, I will add here and there) to have another point of view and to reflect by themselves.

Control by Church 

Even though we live today in a secularized society, the past influence of the Church still unconsciously permeates our morals and mentalities. For centuries, the Catholic Church - like all monotheistic religious institutions - has sought to insist on the inferiority of women. She has sought to control the bodies and minds of women, for whom she has always had contradictory feelings: at once docile, submissive, modest and maternal, women remain for Church also a whore temptress, a witch or a fool incapable of judgment and decision by herself. Without going back very far, let's go back some 150 years. The few progressive women of the time are often put forward, but this is to forget that in the 19th century, while the predominantly male republican minds attacked the Church, the vast majority of women continued to be kept apart from the world, confined to their role as mothers, consolers, and social workers. Fear, restraint, modesty, devotion, virtue, these were the main qualities demanded of women who had only to please God and their husbands. Education was forbidden or very limited, and it was believed that she was incapable of intellectual life. Put aside from leisure, sport and study, women were considered weak and society had to protect them from themselves.

The adulterous woman was guilty when the man could act the most natural way in the world.  The woman was excluded from any religious function, unable to relate to transcendence and easily perverted by the Devil. For a long time, menstruation, the mystery of gestation, seduction and sexual attraction, the power of women over domestic life (where she had been locked up) frightened men terribly.

Still at the beginning of the 20th century, priests questioned young teenage girls about their violently prohibited masturbation practices (testimony of my own mother who lived through this in the 1930s at the age of 10).

Since the weakening of warlike societies and religious power, women have gradually been emancipated and immense progress has been made in recent decades. Has misogyny disappeared for all that? Nothing is less certain. Today, women study, divorce, work, have children they want, can have abortions, vote and know in theory the same rights as men. But differences still exist, reminiscent of a past, paternalistic, misogynistic world that still survives in the medical world where difference in treatment between men and women, although having taken a less coercive and more inciting form, remains glaring.

Medicine and Church  

For a long time medicine and religion were confounded, in the same fear of death .

The Age of Enlightenment saw the seeds of a new medicine that was meant to be rational. Did not the doctor with his new rites of medical examination replace the priest in his immense faith in medical progress and science, his interest in so-called ethical questions, his obsession with the control of female bodies from birth to death, whether in physiological, psychological, psychiatric or psychoanalytical field? Church saw woman of the 19th century as a layer, constantly pregnant or nursing. For the past 50 years, she has been put in a chemical straitjacket in a state of constant artificial sterility, now required to live a permanent sexual life where any drop in libido is experienced as suspect. She is also told not to complain about adverse effects ("it's in their head"). Any progress? In a sense yes, of course, but it is not certain that woman has not swapped her dependence for another alienation. And that male body of society is not yet consciously or unconsciously trying to control these bodies, so different from that of men, by their formidable cyclical capacity to seduce, to engender life.

Saint, whore, witch and Ninni, the four women of God, isn't that what contemporary diktats demand of women? At the same time to be a submissive and ignorant virgin, but also a temptress and seducer.

The era of biopower

Today we have entered the era of biopower, of state control of bodies from birth to death. Public health is a vast operation of planning, a series of recommendations that seeks to control any form of epidemic (with its vaccine obsession) or the development of aggressive factors (such as cancer); for this, it must also control medical power, doctors.

By necessity of management, the biopower has equipped itself with performance tools. There are no longer individuals, there are only medical images, protocols, populations, statistics. Worse, this biopower is tainted by cynical and soulless consumerism and it knows perfectly well how to talk to "health care consumers" under the guise of simplistic, soft and guilt-ridden arguments mixing fear, security and precaution and enjoining individual well-being as the only eschatological horizon.

The right to say "NO" 

Yet, no, we are not condemned to live our lives as women under a medical sword of Damocles, tetanized by fertility and menopause disorders, female cancers and medicalized pregnancies.

No, we are not condemned to live our lives after 50 years cahin-caha, depressed and petrified with anxiety between a mammogram and a biopsy, with the fear of one day finding ourselves mutilated (and rebuilt?), while swallowing our TSH with a glass of alcohol to pass.

We can re-appropriate our bodies in all their beauty and their fertile and erotic power.

We have the freedom not to accept to be a pre-cancerous woman who ignored herself, not to accept to give in to fatalism, fear and control, to the overbidding of long, painful, sometimes humiliating, sometimes dangerous tests, and we can build our lives with our companions in a complementary, responsible and respectful relationship without relying on misinformed doctors who have been trained only to answer our questions as normal and healthy women with tests and prescriptions.

We can demand respect for our values and preferences, in a dignified and respectful relationship with doctors.

For this, there is a wonderful natural remedy called trust in Life.

References

1] In France (latest available source: INSEE, 2011), where the life expectancy of a woman is 85 years, the main causes of mortality in women are as follows:

73,842 of cardiovascular diseases (28% compared to 36% in 1996)

16,106 lung diseases (6% compared to 8% in 1996)

10,286 of digestive diseases (4% versus 5% in 1996)

5,800 of infectious and parasitic diseases (2% compared to 2% in 1996)

and for cancers :

7,734 in respiratory tract and lung cancer (3% vs. 3% in 1996)

8,113 of cancer of the colon, rectum, anus (3% compared to 3% in 1996)

11,623 women died of breast cancer (2% compared to 4% in 1996).

2] the suppression of the Individual Screening has even been imagined by the High Authority of Health in 2011 (here)

3] France, with its 2.3 deaths per 1000 births is in 17th position in Europe in 2013.

4] http://svt.ac-creteil.fr/IMG/pdf/4emecauseregles-.pdf

5] Campaign of the Biomedicine Agency "Become a Happiness Donor".

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 chemotherapy: a fool’s market

ANNETTE LEXA , PhD in Toxicology

MARCH 8, 2016 

A priori, if we believe official messages communicated through the national cancer plan 2014-2019 (1) , we are witnessing real progress in the domain of anti-cancer therapies, and society (via patient associations) is ready to make it possible for everyone - in the name of the sacrosanct "equality of opportunity" - to have access to the best treatments, especially experimental ones. Otherwise, society and patient associations will even consider that this would be a "loss of opportunity".

Faced with the boom in oral chemotherapy, the 2014-2019 national cancer plan - which is silent on the origin of this boom - gives great importance (much more than to prevention) to improving "compliance (adherence to treatment) and management of adverse events" of new "innovative" anti-cancer therapies.

The term "compliance" (page 16 of the report) is scary and says a lot about the managerial necessity to make them accepted at all costs to the body and psyche of reticent patients by "securing" their care "pathway".

For the past 10-15 years, we have been witnessing an almost frenetic rush to bring new anti-cancer molecules to market. At the same time, the price of these new molecules is exploding. Patients are almost constrained to be enrolled in therapeutic trials.

What patients don't know is that there is no correlation between price, cost to market and efficacy in terms of survival rates. Moreover, these new molecules are not subject to rigorous clinical trials or to the search for proof of efficacy. Their efficacy - if it exists - is purely statistical and it is the standardization of treatments that prevails by type of cancer and not by type of patient. A careful reading of the scientific articles published on this subject in recent years even suggests that it is more important to put them on the market than to ensure their effectiveness and safety (3).

These drugs benefit from a fast-track marketing procedure. However, it has been proven that these drugs placed on the market prematurely have more serious adverse effects than those placed on the market more rigorously. Worse, once a molecule is placed on the market (such as bevacizumab), it is difficult to withdraw it from the market.

In the United States, of the 71 compounds approved by the FDA (Food and Drug Administration) between 2002 and 2014, the improvement in survival for all cancers combined is 2 months (5). For solid tumors, a review by the EMA (European Medicines Agency) shows an improvement of 1.5 months (3).

Currently, in Europe and in the USA, the regulatory agencies accept non-randomized trials, trials without controls, biased protocols, phase III trials when phase II was not convincing and they turn a blind eye to the quality of publications of these trials.
Worse, they accept as proof of "efficacy" new "innovative" molecules, "surrogate end points", measurements of biochemical sub-parameters, which are less costly to implement and which replace the only criterion that should prevail in oncology, survival, as a criterion of efficacy. It doesn't matter if you die in 10 days, the oncologist will look with satisfaction at your biomarkers rising.

The sky is getting a little darker when we learn (9) that a serious setback is announced in the new health law in the USA (21st Century Cures Act) whose stated objective is to make the best possible return on investment by reducing the time and number of patients in clinical trials, or even to abolish all clinical trials and replace them with "surrogate end points" (biochemical sub-parameters), in vitro and in silico studies. The USA is paving the way for a regression that is all the more serious since currently, in the USA, one third of drugs are approved after trials lasting less than 6 months and the average number of patients is 760. Underhanded negotiations around the future transatlantic treaty make this scenario increasingly likely as far as we are concerned.

In the USA, a number of oncology experts even believe that the moral red line between reasonable profits and profits has been crossed (3, 6). Partly because the poorest cannot afford to pay, as they no longer have medical insurance (a cancer treatment costs the insured about 20,000 to 30,000 dollars).

In France, costs are the same but we don't realize it because we are all covered by health insurance and optimal reimbursement.

In terms of "fight against cancer", it is also important to remember that 85% of the research is public and therefore financed by taxpayers and donations, the oligopolistic market (which relates to the oligopoly, a market characterized by a small number of sellers against a large number of buyers) of these pharmaceutical companies spending only 1.5% of its revenues on this research, between 5 to 13% on clinical trials and between 20 to 45% on marketing.

After this little clarification, we have a very different reading of the latest 2014-2019 cancer plan: the explosion of patient recruitment in early phase clinical trials of "innovative" drugs (do they really have a choice?), the public financial participation in this forced march, which is duly praised, leaves a strange bitter taste: is it the health of patients or the market that takes precedence? Not only are patients being lied to, but it is seriously damaging to both patients and research. For their safety alone, patients and physicians must demand greater rigour. Balanced health care budgets are also at stake.

Finally, it is questionable whether health agencies are serving the interests of patients or laboratories: in light of the appointment of Professor Agnès Buzyn as head of the Haute Autorité de Santé, it is reasonable to wonder (7, 8). Health agencies should regain their primary vocation, which is to ensure the protection of the public, and they should provide clear and transparent information to the public.

REFERENCES 

1. Plan Cancer 2014-2019 , LE RAPPORT AU PRÉSIDENT DE LA RÉPUBLIQUE , Février 2016

2. Au nom de tous les seins, documentaire France 5

3. Light D.W., Lexchin J., Editorials, Why do cancer drugs get such an easy ride? Rushed approvals result in a poor deal for both patients and cancer research , BMJ 2015;350:h2068

4. Prasad V et coll., The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses. JAMA Intern Med. 2015 Aug;175(8):1389-98

5.Fojo T, Mailankody S, Lo A. Unintended consequences of expensive cancer therapeutics

- the pursuit of marginal indications and a me-too mentality that stifles innovation and

creativity, JAMA Otolaryngol Head Neck Surg 2014;140:1225-36.

6. Hagop Kantarjian et coll., High Cancer Drug Prices in the United States: Reasons and Proposed Solutions J Oncol Pract 2014 Jul 6;10(4):e208-11.

7. Les petits arrangements de la nouvelle présidente de la Haute autorité de santé (7 mars 2016) https://www.mediapart.fr/journal/france/070316/les-petits-arrangements-de-la-nouvelle-presidente-de-la-haute-autorite-de-sante

8. Le professeur Agnès Buzyn nommée Directeur de la HAS. La victoire de big onco (8 mars 2016) http://docteurdu16.blogspot.fr/2016/03/le-professeur-agnes-buzyn-nommee.html 9. Avorn J and Kesselheim A.S., The 21st Century Cures Act — Will It Take Us Back in Time? N Engl J Med 2015; 372:2473-2475

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.

Loss of scientific rigor and scientific misuse, poor quality medical research

Cécile Bour, MD, May 14, 2020

In the era of EBM (proof-based medicine), the headlines of last few weeks during the Covid 19 pandemic have highlighted the drifts that undermine this approach of a modern medicine.

We should not only blame the recent context; over the last decade and perhaps more, there are three main problems in modern medicine that Jeanne Lenzer, an investigative medical journalist, and Shannon Brownlee, Vice President of the Lown Institute, « a nonpartisan think tank advocating bold ideas for a just and caring system for health in the United States », have denounced in "Issues" column of their site.

These three drifts seriously weaken evidence-based medicine and jeopardize the benefits owed to patients, and they are currently exacerbated in this period of crisis.

Three main drifts of today's medicine

  • The main drugstore in the city where I practice has the motto "primum non nocere" above the counters. But, according to Lenzer and Brownlee, doctors are insufficiently trained to discern good science from poor studies, and prefer to use molecules they know and whose effect appears biologically plausible. Fear and haste have sounded the death knell for the Hippocratic maxim, a pillar of medicine. Beliefs and unproven faith in medications used for other medical conditions have been considered, without concern for their real usefulness against an emerging and unknown virus, or their possible harmfulness.
  • The second pitfall identified by the authors is the prominent role of the media today. On the one hand,  convictions and opinions of non-physicians are following in the footsteps of politicians, to whom the floor is widely and generously given. On the other hand, many of media that echo this are ignorant and incompetent in scientific method or in search for evidence, and also have a commercial interest in hype around these well-known and popular, but null, town criers.

We can only agree with this observation, having ourselves been confronted with a very unpleasant episode of attacks from a TV host, who mediated his experience of prostate cancer at will to convince people who asked him nothing, to undergo prostate screening test, in spite of all the non-recommendations of such screening [1].
The naive crowds that "follow" these characters, fan clubs generally very well supported on social networks, do not facilitate the expression of cautious doctors or independent collectives like ours, which are inevitably a killjoy in the general hope. The word of the Cassandras is hardly a media-friendly one...

●The third calamity denounced by Lenzer and Brownlee concerns poor quality studies that do not include what is called a "control arm", i.e. inclusion in the study of a comparison group that has not been given the drug being tested. The control arm is the cornerstone of a strong randomized controlled trial. It aims to formally establish the true efficacy of a product, highlighting possible biases in the tested protocol. For example, a drug may appear to be effective in reducing the risk of a given disease when the population to which it was administered is already naturally less at risk, because they are younger, healthier or have easy access to medical care. A control arm with a wide range of subjects can show ineffectiveness of the test drug in certain groups of  population and thus point to errors in reasoning or biases that would go unnoticed. In hastily constructed studies, on the other hand, potential harms may be underestimated. 

But even outside of critical health periods, such as in the field of cancer for example, proclamation of "miracle" drugs has been legion in recent years, with questionable studies, selling hope of so-called "revolutionary" chemotherapies. On this subject read the post of Annette Lexa, our toxicologist.

We add to this last point on the poor quality of medical researchn a particular type of study that is currently spreading, it is the "non-inferiority" test, all the more fraudulent and perfidious that nobody understands a drop.

Doshi and all. 2] studied informed consent forms from non-inferiority studies on antibiotics. Their observations are generalizable, however, because there are many applications of this type of study, in diabetes, cardiology, infectiology and cancerology. Doshi et al. found that often neither the methodological experts nor the members of personal protection committees were able to define the true objective of the study from the information forms given. For the methodologists, only 1 out of 50 trials, according to them, correctly restituted the objective of the study; for the patients, 7 out of 50 studies succeeded in doing it. These results raise the question of whether consent is truly an informed one, and thus whether the trial is even ethical.

But what are we talking about?

Non-inferiority trials

We have given a summary explanation about the MyPEBS study for personalised breast cancer screening which concerns the theme of our site, a study that we have analyzed in depth here: https://cancer-rose.fr/my-pebs/.

In the non-inferiority trial it is a question of comparing two elements (two medical devices or two procedures, or two drugs) to check whether the device or procedure or treatment being tested would not be worse than what is already in use, accepting a certain loss of effectiveness within a certain tolerated margin, known as the non-inferiority threshold.

It is not a question of verifying whether the system, procedure or drug tested would be superior to former one. This is often how the press reports it and how doctors and public understand it, but it is not the case!

For example, for breast cancer screening, intended purpose is normally to reduce severe forms of cancer. In the MyPEBS non-inferiority study, if the new personalized screening tested does not appear to favor a rate above 25% (arbitrarily set threshold) for additional severe cancers, the trial will be declared a success. You have read correctly. There is no control group there either to test what would happen without screening, which would be legitimate though since recent studies on this screening no longer manage to demonstrate a positive benefit/risk balance.

It is true that in non-inferiority trials in cancerology the control arm is rarely considered, this being judged to be unethical given seriousness of disease, and patient cannot be deprived of any care. But here, in the MyPEBS study, healthy and non-complaining women are being tested, we should remember.

What must therefore be understood, in short, is that it is possible, with non-inferiority trials, that a new health procedure can be accepted as effective, even if its therapeutic or beneficial effect is slightly inferior to current standard. In a non-inferiority trial, the new procedure or drug is not supposed to make the participant healthier than she would have been outside the trial, since superiority of the procedure or drug is not sought.

The only assumptions are :

- In the best configuration, participants randomized into the study's test group could fare as well as if they had not participated in the trial,
-or then potentially worse within an arbitrarily accepted margin, in the wrong scenario.

And everyone is happy. The public because they are not well informed and believe that what was tested on them is 'superior', the journalists who did not grasp the subtleties of the methodology and write laudatory articles, and above all the designers of the study. Why is such an approach necessary? Because with this set-up, the study is subtly biased towards the result desired by the promoter, which is to obtain or safeguard a market share much more than to answer a scientific question whose stake is the well-being of the patient. For MyPEBS, the aim is to establish breast cancer screening, since women will only have a choice between two options: old screening or personalized screening, but screening in all cases.

To caricature, the patient or population will be worse or not less well, but the good news is that the study is a success..

Two interesting articles to help the practitioner in the critical analysis of the studies that published

Vinay Prasad, in an editorial in the JGIM[3] (Journal of General Internal Medicine) where he actually quotes the results of Doshi et al, refers to the publication of Aberegg, Hersh and Samore who analyzed 183 non-inferiority comparisons of 163 clinical trials published in the five major impact medical journals.

Aberegg and colleagues found that only 70% of the non-inferiority studies explicitly stated why new therapy would have an advantage, and in 11% of cases no advantage could be inferred. This suggests to these authors that many of these studies should not have been conducted.

What should the practitioner beware of and what trials of non-inferiority can he trust? According to V.Prasad, it is necessary to :

  • Consider whether new therapy is less expensive, more convenient, less invasive or less toxic than old one. If answer is no, stop looking, he says! There must be a positive compensation for the patient for loss of effectiveness of the new procedure or new drug being tested. If not, there is no point in learning about the "novelty".
  • Ask yourself how much loss of effectiveness of the new procedure or new treatment you would be willing to accept in order to adhere to it. 5% loss of effect, or 10%? More or less?
  • Be concerned about the margin of inferiority accepted. E.g. for MyPEBS the non-inferiority threshold is very generous. This means that if, at the end of the new screening, 25% additional serious cancers are found, the study is "successful". This margin would have to be justified, and this justification would have to appear at least in the study protocol, which is not the case.
  • Finally, consider whether the new intervention was in fact 'inferior', not 'non-inferior'.

The French independent journal Prescrire[4] examined  problems of these particular trials in 2006. Their advice is similar to that mentioned above. For the journal, one must be critical of the threshold of non-inferiority that is chosen a priori, arbitrarily by trial designers. For the patient, this threshold is equivalent to the loss that is consented to in relation to the reference treatment or device.  It is therefore necessary to be sure that the result is not in fact a true inferiority.

For Prescrire, in short, these tests are intended to simply exclude the possibility that a treatment or process is massively worse than what already exists. When the treatment or procedure is slightly less effective, and within a certain accepted margin, the new treatment or procedure is only of interest to the patient if it brings other benefits in compensation. And this is where the stick can hurt, as in this study we regularly criticize, and not just us.

To conclude:

The urgency and willingness to obtain results quickly justifies dispensing with well-conducted controlled studies and exposes us, because of flawed and poorly executed studies, to biased medical judgments and erroneous conclusions.

Improper, sometimes excessive, communication by lay people or ignorant media aggravates media coverage of drugs or procedures that we do not know what they actually induce, whether they do more harm than good.

These problems pre-existed before the context of the Covid19 pandemic which only brought them to light.

Research in science is important, yet it must meet quality standards, be done by scientists who are concerned about respecting proven methodologies and meeting standards, and this in a serene media environment.

This is currently not the case, as damage and physical inconveniences to health of populations are aggravated by misinformation and pollution of scientific debate by quarrels of opinion.

If we want to make good science that is useful to people, we must develop a critical spirit, constantly verify results of studies promoted as revolutionary by media, see by which methods conclusions have been reached.

We have come full circle; if we want to make good medicine we will always return to what is proclaimed at the front of the drugstore, the basic principle that must underpin our medical practice: "primum non nocere" .

References

[1] https://cancer-rose.fr/2020/02/06/ah-mais-quelle-aubaine-ce-cancer/

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710221/

[3] EDITORIAL
Non-Inferiority Trials in Medicine: Practice Changing or a Self-Fulfilling Prophecy?

Vinay Prasad, MD, MPH

Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA; Department of Preventive Medicine and Public Health, Oregon Health and Science University, Portland, OR, USA; Center for Health Care Ethics, Oregon Health and Science University, Portland, OR, USA.

J Gen Intern Med 33(1):3–5
DOI: 10.1007/s11606-017-4191-y
© Society of General Internal Medicine 2017

[4] La Revue Prescrire avril 2006/Tome 26 N°271, page 249

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


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

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