Mrs. PL, 22 years of shared life with breast cancer, or the fight from a fierce “NO” to a half-hearted “YES.”

Testimony from the practice of Dr. M. Granger, Senologist, October 2, 2021

February 1999: Mrs. PL, 58 years old, consulted for a nodule in her right breast, which had existed for two years, but which had recently undergone an inflammatory change. Clinically this nodule is typically a sebaceous cyst located on her right breast.

However, the mammogram showed, in addition to an oval subcutaneous opacity very well limited and in agreement with the clinical diagnosis, a cluster of punctiform and dusty calcifications, at a distance from this nodule, distributed in half a dozen small foci with numerous tight elements, without densification or associated architectural distortion. The conclusion of this first encounter, for a benign pattern, is the probable presence of a "right retro-mammary intraductal carcinoma, a histology is necessary."

As this lady was followed by a homeopathic doctor who was very close to his patients, no instructions for treatment were given, except for the conclusion reported above. Without any news during the following months, I wrote to my colleague: Mrs. PL was indeed undergone surgery, and the answer was "positive."

Having obtained the operative and histological reports, I learned that it was a 6 mm infiltrating ductal carcinoma, with more than 2 mm clean surgical margins. The peripheral intra-ductal contingent had fine regular calcifications, and it comes into contact with the limits of the excision. The second stage dissection (no initial extemporaneous examination, as this was a simple surgical biopsy of micro-calcifications [we were in 1999]), associated with the resection of the tumor bed, showed: no tumor residue and a negative dissection of the 3 layers (0/15).

September 1999: first postoperative follow-up at 6 months. This examination was satisfactory, with a trivial area of steatonecrosis at the surgical site. A new appointment is given at 6 months, classical surveillance.

June 2000: follow-up 14 months after the initial surgery.

Mrs. PL stated that she had not consulted an oncologist. She was afraid of radiation and would not do it, advised by her homeopathic doctor, who considered it useless to do radiation "for nothing" as the results of the tumour bed resection and curage were normal.

Mrs. PL will then scrupulously return, every year in June, for 12 years. In 2011, she informed me that she was getting divorced. The following year the imaging was transformed: a micro opacity, not significant until then, doubled in volume, appeared spiculated, and measured 6 mm on ultrasound. Same breast, close to the initial bed. The cytopunction immediately shows a cellular mass characteristic of carcinoma, and it is, therefore, a recurrence in situ. Reoperation is necessary.

July 2012: Mrs. PL chooses not to see her initial surgeon again and to consult a Parisian celebrity. The surgery performed in July 2012 will be limited to a "large quadrantectomy," as the patient refused the recommended mastectomy. Despite this, the histology of the surgical specimen is... negative: the pathologist did not find any tumor proliferation.

October 2012: when Mrs. PL comes back for a new postoperative check-up at 3 months, I discover this "discrepancy": I question - Mrs. PL also finds out, and I end up choking... Because I have absolute faith in my puncture method and the accurate reading of my cytopathologist, trained at the Zajdela school of the Curie Institute: where is the error? The MRI will show the persistence of an intense and early enhancement corresponding to the sought-after lesion. My ultrasound found the mitotic gap, unchanged, of 6 mm. The conclusion is evident with a sigh: the lesion has remained in place.

November 2012: the patient is then reoperated in the same Parisian clinic: "right hemi-mastectomy," taking away the spotting hook. One could see in this hemi-mastectomy either a certain " broadness " of the surgeon, perhaps embarrassed by this involuntary reoperation, or a poorly mastered spotting technique? What is certain is that the histological analysis still does not show the tumour lesion but rather ordinary inflammatory changes. This recurrent discordance still does not raise any metaphysical question.

April 2013: new control examination, difficult. The breast is disfigured, the scar is stuck after a very large postoperative hematoma. Doubt about the persistence of the initial anomaly, still at the union of the external quadrants of the right breast. A new MRI will, however, come back normal. OUF, the tribulations of this cancer seem to be over (?), but with the bitter taste of not having understood everything: where did this 6 mm tumor disappear?

October 2013: six months later, Mrs. PL reveals that she is being followed in Belgium and taking 2LC1-N to support her immunity. She will, however, accept my regular follow-up.

May 2016: I see her regularly, every year now. In May 2016, she reported a small intradermal granule at the union of the external quadrants of the right breast, thus always in the exact localization. The cytology is... stubbornly malignant. This time, a bit tired of all these missteps, I explain loud and clear that the choices made have not solved the problem and that it would be appropriate to do a "real" mastectomy associated with a radiotherapy of the chest wall. This opinion is confirmed by the Faculty (University Hospital of P...). However, Mrs. PL continues to refuse both the micro biopsy and the mastectomy.

September 2016: under pressure from another university hospital (T...), Mrs. PL will accept the biopsy removal of her nodule: the carcinoma is this time infiltrating ductal carcinoma is well stamped, the hormone receptors are strongly positive. A mastectomy was scheduled: it was refused, as was hormone therapy. As well as radiotherapy, once again.

March 2017: the nodule will recur again, after its localized removal, at the same place... A new puncture (malignant) will finally convince the patient... A simple mastectomy, without radiotherapy, will eventually be performed in May 2017, that is to say, 18 years after the first lumpectomy, and three "conservative" operations which had already largely damaged the breast...

October 2020: three and a half years later. After this (final?) episode, Mrs. PL is doing well; she is now 80 years old, she remains a gentle and pleasant person. She is getting used to her mastectomy scar. She never had a word of doubt about her Parisian surgeon or pathologist, nor about the successive disfigurements that were imposed on her.

This observation has several salient points, to say the least: what can we learn from it for the Defense and Illustration of Senology?

1- How can we respond to this homeopathic colleague who wonders about the interest of radiotherapy "for nothing"?

First of all: that there is no "nothing" since his patient has invasive cancer, certainly not very locally developed, at least in appearance. But can one know in advance and with certainty the evolutionary potential of cancer? History has proven its high potential for recurrence.

Secondly, the fact that the surgical margins were healthy at the initial surgery was undoubtedly good news. Still, it did not in any way prejudge the biological reality, which was inaccessible to the pathologist. The notion of the carcinogenesis field confronts us with this obvious fact: in 2021, we still cannot know the biological boundaries of a carcinogenesis process. Surgery is, therefore, necessarily approximate.

In the context of conservative treatment, radiotherapy is the preferred weapon to drastically reduce the incidence of local recurrence, which would otherwise be almost systematic. In summary: conservative surgical treatment should necessarily be associated with adjuvant radiotherapy.

Finally, we must agree with this colleague that the patients of a homeopathic doctor always have great "faith" in the method and that his doubts have fed, knowingly or unknowingly, the phobia of the X-ray of Mrs. PL.

2- Like everything else, this history must follow a logical pattern: if a diagnosis of malignant recurrence has been made and the histology of the operative specimen is normal, there is a contradiction and, therefore, an error somewhere, which must be resolved. This error can be the initial diagnosis (false positive of one of the techniques used...), the operative methodology (location of the area to be biopsied, topography/extent of the sample...), or the histological analysis itself (identification difficulties, number of slices taken... [cuts every 5 mm may miss the smallest tumors]).

Unfortunately, this investigation was not done after the first recurrence... This case was not the judiciary, so we will not know the end of the story.

A word about the initial diagnosis: it did not include a micro biopsy which, as we know, has become the grail of oncologists, because the patient refuses it. However, it must be admitted that fine-needle aspiration, a straightforward technique, usually provides very rich and unambiguous cytology for a trained cytopathologist. I do not know of any false positives in my experience. In this story, all the cytologies were characteristic, and the final diagnosis proved them correct. So it was not the initial diagnosis that was wrong.

3- The constant attitude of Mrs. PL questions us, the physicians, on the level of risk we place on our patients. A very anxious and/or very enterprising radiologist, who wishes to macrobiopsy the slightest grouping of microcalcifications (without waiting for the test of minimal surveillance, which would make it possible to judge their change), and Mrs. PL, who waited until the 4th local recurrence to be persuaded, merely to undertake the recommended treatment, are living in radically opposed and incompatible medical worlds.

4- It did come to your attention that Mrs. PL's first recurrence appeared the year after her divorce. In contrast, the first 12 years of her follow-up had gone smoothly, despite an incomplete initial treatment, radiotherapy having been rejected. Once again, cancer is shown in its true light, that of a psycho-somatic disease, the psyche being most often the initiator/accelerator of this process.

Cancer Rose Commentary

We would add another lesson from this observation, and that is "the lesson of humility."

Women are often made to feel the urgency of the situation as soon as a cancerous lesion is diagnosed as if every minute counts. Everyone is running, busy, panicking; we must act, react, operate as quickly as possible! However, in this case, the patient has been living with cancer for years, and she has reached the age of 80 without losing her life!

So it's never too late to do the right thing; it's never too late to treat and cure.

So, where is the urgency in which we propel the diagnosed women? If the cancer is metastatic, it is so immediately; in most cases, it is clear that there is no need to panic women as we do, and we are not a minute away. Yes, we can sometimes give ourselves time for surveillance (the ACR3 classifications (simple surveillance) have almost disappeared; in our emergency, we immediately consider taking samples and performing interventions).

Yes, we must treat, of course, but without panicking! Cancer does not metastasize in 5 minutes (unless it has already done so, and in that case, we are a step behind); it does not kill on the spot; we are not going to die tomorrow!

This case shows us the humility that the medical profession should have and shows us that it is necessary to leave the 'panic' and the 'emergency' that we inflict on women when we find them cancer, giving them the impression of imminent death, but that we are going to save their life because we have been quick.

The fate of the patients is not in our hands as great "saviors." It is never "too late" to treat and heal.

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Dream of a senologist

A testimonial from Dr M. Granger, Senologist, July 21, 2021

Mrs PS, 50 years old, from Paris, consulted in August 2010 for advice.

On June 23, 2010, she had a 3rd mammogram in a Parisian SENOLOGY CENTER, classified as ACR4 for a "poorly systematized zone of architectural distortion in the upper right quadrant." She had microbiopsies the same day, which resulted in the "diagnosis": "Proliferative fibrocystic mastopathy with atypia, ductal type (Atypical ductal hyperplasia)." She has an MRI appointment in a few days and is very concerned about the speed and bad turn of events: what is she supposed to do?

My findings:

After carefully inspecting the mammograms that were brought to me, I notice, with some initial concern, that this "zone of poorly systematized architectural distortion" escapes my sagacity.

The magnifying glass brings nothing: I see, in comparison with the left breast, which underwent a total adipose involution, only a banal aspect of a glandular remnant.

The appearance was identical on a mammogram done precisely seven years earlier.

Moreover, my clinical and ultrasound examination was strictly normal.

Surprised by the Parisian radiological diagnosis but reassured by the constant imaging, I advised this lady to wait for the MRI results and send them to me. These results arrived three days later, on the same evening as the examination.

"The zone of right superior-external architectural distortion is confirmed, with no suspicious morphological character on MRI." However, we are aware of the underestimation of MRI for intra-canal lesions. A surgical excision of the atypical area should be planned”.

The patient, caught in the "concordant" vise of 3 reports - mammogram, biopsy, and MRI - consulted a breast surgeon at the Gustave Roussy Institute (IGR).

A few days later, she sent me the following report: "I have received the result of your breast MRI, which confirms the elements described on the mammogram, i.e., a poorly systematized area of the upper right quadrant. However, given the histological findings of the biopsy, which revealed fibrocystic mastopathy with ductal atypia,  an excision surgery of this area is necessary".

I am sending this email back to Mrs. PS

Dear Mrs,

In response to your email, here are my conclusions:

- Your MRI is normal; the exact text is: "area of right superior-external architectural distortion that does not show, on MRI, any suspicious morphological character." As usual, the rest of the report ("however...") is just an umbrella formula.

- The letter from the IGR retains the negative part of this report ("poorly systematized zone" [which means what, by the way?]), opening the umbrella in turn: "an excision surgery is necessary...". A surgeon operates.

I warned you about this logic. I encounter it every day. It's not mine, given the mammograms you brought me, which haven't changed in seven years. This stability, in my opinion, is worth all of the umbrellas in all of the institutions on the planet, especially when the MRI is normal.

I remain in favor of simple surveillance, the specifics of which have to be determined for your moral comfort and safety: I would recommend a first X-ray and ultrasound control of the right breast within a year or less (contact my secretary), and then we will see.

You are thus confronted with choosing between following your new provincial senologist and the big Parisian machinery! Make this decision in your soul and conscience, discarding all Hierarchies and listening only to your deep feelings: the good answer will be found there.

Sincerely yours. M Granger

Mrs. PS finally chose to follow her provincial senologist.

She "comes from far away" but "knows why." I saw her until 2017, without noticing anything new, with clinical and X-rays and ultrasound examinations remaining unchanged for over 15 years. One who has been saved...

What can we learn from all this for the teaching of Senology?

Several observations, among many others, appear to be beneficial to me:

- The radiologist's initial description ("poorly systematized architectural distortion") was the starting point for a path that the patient had to climb alone... until the anxiety became too much for her and she decided to seek advice.

-This initial description was at no time questioned, and the radiologist's opinion was final.

However, it should be noted that the ACR classification can be easily "twisted" to achieve the desired result: if the radiologist accepts simple surveillance, he will grade the images as ACR2; if he wants close surveillance, he will grade them as ACR3; and if he wants a biopsy, especially if he can do it immediately, he will grade them as ACR4, as in this case.

A detached viewpoint will see things differently: simply comparing all of the mammograms taken, sometimes a dozen(!), will lead to a different conclusion, in this case normal (or ACR 2, if you are a fan of the Americas). That would have put an end to this lengthy diagnostic rambling.

-As previously mentioned, the initial description/classification was not discussed: because each professional works independently, without controversy, and is thus not directly accountable to the patient. In fact, this chain can be described as a vertical commercial agreement from which all parties have benefited. In the wild animal world, this is known as "horde hunting," and we know that if all of the subjects in the cohort are potentially targeted, only the strongest will escape .

Mrs. PS, a graduated lady working in the high public service, was able to get out of it by making the Cornelian decision to resist the IGR Institute... many others are not.

The remedy to this chain of medical control without counter-power is NOT to be found in the RCP (multi-disciplinary consultation meeting, editor's note): I have never seen a pathologist, a surgeon, or a radiotherapist oppose and break the chain biased from the start towards biopsies - micro, macro or surgical.

As a result, there is a de facto agreement not to question the initial diagnosis, and individual psychoanalysis of the "validated decisions" in RCP would be fascinating. The breast is a highly invested organ that everyone loves to argue about and share.

You may have realized that I am living the dream that our father (Charles-Marie Gros, from the Hospices Civils de Strasbourg) had in the 1960s: that the SENOLOGIST is recognized as that breast specialist, a little/lots/passionately a specialist in all the disciplines involved-from the various forms of imaging to anatomopathologist, to the relative interest of surgery and the oncologists' panoply... a specialist who coordinates and tempers everyone's enthusiasms and anxieties, a specialist ultimately accountable to the patient.

A communicator who is willing to take his time and sometimes loses it. But, as you're probably aware, the dream is still a dream, and SENOLOGY is a beautiful utopia. Mrs. PS and her struggle sisters occasionally awaken it.

 

A few comments from Cancer Rose

It is absolutely clear that screening has increased the number of unnecessary mastectomies.
We presented our study on mastectomies in France at the French Society of Senology's annual meeting in Lille.
It is undeniable that non-cancerous lesions are "over-operated," and this is yet another example of an over-detection drift, namely over-treatment.
Yet, this obviously explains why, as described in our study, there are increasingly more mastectomies in comparison to the incidence of invasive cancers.

The observation also confirms the ACR classification drifts: ACR3 hardly exists any longer, there is a tendency to classify very quickly in ACR4, and we voluntarily "upgrade" our examination classifications to have immediate access to a tissue sample, to avoid omitting anything, rather than taking time, settling down, and possibly rechecking at a later date.
The ACR4 becomes a catch-all for anything that appears "abnormal." More information can be found at https://cancer-rose.fr/en/2020/12/30/arc-classification/.


Finally, while there is a double reading during screening for cases classified as "negative" (see here: https://cancer-rose.fr/en/2021/03/30/what-is-a-screening-mammogram/), there is none for cases classified as "positive." This is not entirely logical.
But, even if there was, who would have the courage to "negate" an image previously classified as positive by another colleague...

 

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


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

The cat knew it

Cancer Rose offers you a forum for citizens. You can also testify.

Testimony of Dr Granger, Châteauroux, July 2021

Story of Mrs AH, 75 years old

My secretary stops me at the beginning of the afternoon:

"I have added a patient to your list at the end of consultation... "
- Well…

Nothing more to say, that's the rule: if a woman "felt something" and wants to see me, it’s right away...That's how it is with the breast. She hesitated... dared to call... she wants to talk, now. As much as possible don't stop that momentum.

- What brings you here today ?...
- You have seen a friend, she told me that I could... I had surgery for a very small breast cancer in 1991 [she was 45 years old at the time, no one in the family had been concerned]... I have been medically followed for a long time. And then I stopped the surveillance: I was told before the intervention that the cancer was not visible on the mammogram. So why continue to do it ? I have the impression that I feel something there (she holds her right breast, under the collarbone), it's not at all in the same place…My friend says he doesn't feel anything, but I think he wants to reassure me. He has glaucoma problems... I told him I was going to the cinema. 
-You're going to the cinema?
-... Yes

At first glance, the right upper-inner quadrant is as if filled, while the symmetrical area on the left side is empty. The hand perceives a large indurated plate, as if frozen. The diagnosis is obvious. The initial lumpectomy scar, at the union of the lower quadrants, is very small, thin and flexible. It is definitely not the same place at all. Upon contact with the ultrasonic probe, another evidence.

- Do you see something?... 
- Yes
-...
-...
- How big is it?...
- It's about 2 cm... (...) How long has it been since you had a mammogram?
- I stopped... It hurts. I saw my gynecologist...it's been maybe 3 years...she told me she didn't feel anything, she asked me for a mammogram, I didn't get it. I'm tired of being sick. I'm a former nurse, I won't go to the hospital anymore. I won't go for any more tests unless I'm sick.

When the examination is over, she gets dressed. We'll say more.
- I think it's a repeat of the original problem...
- I knew it. 

Her look is direct, clear. 

-That's why I said I was going to the cinema. I didn't want to tell him unless I was sure.
A nurse once told me: "Cats can sense when their owner is sick, they stick to him". For some time now my cat has been sticking to me, so I understood. Now what to do?...
- You had a conservative treatment, and a radiotherapy, right?... 
- Yes
- The radiotherapy can only be done once...
- Yes, I know
- We have only one thing left to do : surgery. You need to have the breast removed.
- Yes. The sooner the better. I don't want a biopsy, I heard that cells can leave

I did not insist on the interest of this biopsy for the surgeon, on the "procedure", I had neither the heart nor the certainty. On the doorstep her final words:

- Thank you. At least you didn't tell me it was my fault... 
- ?... 
- How could anyone say that?
- Oh you know I've heard so many things!

That was my last consultation. Nothing afterwards to remove these words, these impressions. What does this mean for the teaching of Senology?

  • A woman "knows" when she has breast cancer. All women fear it, all women fear to feel it. Only those who have it really "know". Cats also know, their sense of smell guides them. You should always listen to your cat, its cuddle is a sure guide.
  • In the surveillance loop, there is always someone other than the woman herself, someone else who motivates her or makes her reluctant. We must enter this loop if we want to be useful. First of all, by not saying anything that could be misinterpreted, so we have to be several steps ahead of her.
    For example, don't say that "nothing was visible on the mammogram" because 20 years later this will be a demobilizing argument. Then by telling it like it is: this "tiny little cancer" minimized will become another demobilizing argument one day.
    The initial mammogram, which she had brought to me, although in silver technique in 1991, showed perfectly the cancer, its spicules and the retraction of the sub mammary fold.
  • It is important to remain calm and factual in the announcement. The genius of cancer is infinite, so there is no such thing as a " small " or " good " cancer (don't mistake the enemy for a friend), nor a cancer " that often becomes bilateral " (don't mistake a friend for an enemy). What unjustified prophecies that mask our ignorance! There is no "emergency" either, cancer is always a long story. Things will be named, defined and explained as the consultation progresses. These consultations take time, they do not happen in a waiting room or on a table corner. Radiologists who no longer see their patients and refer them to their imaging site have paradoxically made a wise decision: it prevents them from saying what they don't know!...
  • It is necessary to offer an alternative to mammography for screening or surveillance. This examination is often painful, invasive, and not very informative, since it is usually completed by an ultrasound. Ultrasound which should explain what cannot be seen or understood with X-rays... Ultrasound is indeed an alternative, in trained hands: it could even be sufficient in most cases, for screening and monitoring, but this is another debate. The ultrasound alternative, which is widely implemented, would prevent clinicians and imagers from making women feel guilty by telling them that "it's your fault" or "you had it coming," "why didn't you get the mammogram you were asked for? ".
  • Remember the last words on the doorstep, they are the most important ones, the ones that could not be uttered earlier, and which are truly liberating: this woman, despite the shock of the announcement, was grateful: I had not accused her.

Cancer Rose Comments

This testimony has caused a lot of reactions, and we receive many questions and comments from our readers. Hence this short deciphering:

The patient's strongest message is that of being tired of surveillance, because to continue surveillance is to continue to be sick. 
The examinations are necessary when you are sick, that's what the patient expressed. 
This is an interesting point in the context of screening women with no symptoms, forgetting that screening is intended for healthy people, who have no complaints.
Here the situation is different in that the patient has been ill and has developed cancer, a situation for which annual monitoring is actually recommended, but this is her opinion, and the opinions, choices and preferences of patients must be heard.

The doctor's strongest message: refusal to accuse, refusal to make patients feel guilty. The patient liked that the doctor did not blame her ("you had it coming, you should have done your follow-up"; this is what women hear, although it cannot be said that this would have changed the situation much).
Gratitude of the patient for a too rare attitude of the medical profession: not to reproach a patient for a defect of a monitoring which she judged too long, tiresome, uncomfortable and distressing. 
This removal of guilt is extremely important, because we also see this feeling of guilt in healthy women who do not undergo screening, even though they are not suffering from anything.

On the substance, the doctor is right to point out that "the genius of cancer is infinite, so there is no "small" or "good" cancer". In fact, it is impossible to know if this is a recurrence of the disease, so long after, or if it is a new disease (another location in the breast than the first), if the mammo would have changed much (discovery of the mass immediately voluminous). It is also impossible to eliminate an induced disease (multiplication of mammograms, second radiation-induced cancer since it occurred in the same treated breast, long afterwards).

One will never know, hence the importance of respecting the choice of the patient, to leave the pattern "cancer, sooner taken better is", because, as the colleague writes it, the evolution of cancer does not work according to this automatismpre-...designed by an intellectually comfortable theory (read: https://cancer-rose.fr/en/2020/11/30/how-does-a-cancer-develop/)
Looking for alternatives to the sacrosanct mammogram in which so many hopes are based and yet which "misses" genuine cancers is also a line of reflection.

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.

Sophie’s testimony

June 6, 2021

By Sophie, testimony and point of view

Ethics of screening, information for women, training of professionals on breast cancer screening: what is the strategy of the new Cancer Plan?

A testimonial

...Before age of 50, I had a breast cancer screening test prescribed by my doctor as part of a health check-up, for no particular reason, just to be reassured. I showed up at the radiology center with a simple prescription, without the least information on the radiation, nor on the additional examinations, or the consequences of the test in case of abnormality, just as I would have a blood test for a general check-up. I was not given any information about what they were really looking for in the absence of symptoms, nor about the fact that they will be using a super-powerful tomosynthesis technology that detects the smallest anomaly of a few millimeters, for which no one can tell the outcome, nor on the doses of radiation delivered by the ten x-ray images with enlargements, with a total dose (16.5 mGy) of radiation four times higher than the dose delivered by a classic mammographic examination (3-4 mGy), and that I will have to repeat in 6 months, then 12 months and then 24 months. If all goes well, if not something else will happen?

If I were to draw a parallel with a drug, I would have had an information leaflet listing potential side effects.  But a mammogram is considered a harmless, banal examination.  I don't have any doubt about my doctor's good intentions, but unfortunately the tests and the anxious waiting were  overwhelming, then came the regret of having  this exam which should better not have been done.
I should have been able to decide, with the right information, but I didn't have it.

I may be told that this is a test done to save my life, although studies by independent researchers from the Cochrane organization have shown that for every 2000 women invited for screening throughout 10 years, one will avoid dying of breast cancer and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. 
Would I be that lucky one, although I did not feel in any imminent danger, I had no particular concern for breast cancer, nor any family history of it, I was not even 50 years old, which is the starting age for screening mammography in France? Or on the other side, could I be one of the other 10 women unnecessarily treated ? In any case, it was up to me to weigh the benefits and risks and choose. And it's not fair that I didn't get all this information in advance.

... Among close contacts of mine, a woman had a screening mammogram at her age of 72, without any information except invitation letters. She gave in to the reminder letters and decided to undergo the exam so that, she would be left in peace. Similarly, after the mammography followed additional tests and anxious waiting of results for the whole family, with regrets for having done this exam without being properly informed.

Once again, lack of honesty and transparency…

......Another woman I know, in her forties, with no particular risk factors, had pressure from her gynecologist to have a mammogram, with no particular reason, and  without receiving any information. She tries to hold on and hope to not upset her gynecologist, because it is difficult to find another one.

Where is the information?

And there are many such cases... Here, we are talking about healthy women with no symptoms suggestive of breast cancer. It’s not about women who have a symptom and who should consult, because in this case the mammography is necessary.

These cases show the lack of information and training of professionals, whether it is the GP, the radiologist or the gynaecologist, who focus on mammographic screening examinations to find existing, hypothetical or future breast cancers in healthy women, forgetting to inform them correctly and without taking into account their autonomy of decision.

And yet it could be done better. Information on the benefits and risks of breast cancer screening, in the case of a healthy woman with no particular symptoms, is a due to women: it is up to them to choose according to their own values and preferences if they wish to undergo it or not, especially since the benefits are not clear; the controversy between the benefits and the real damage has been going on for 40 years now.

This was also one of the first recommendations of the steering committee following the 2016 citizen and scientific consultation on breast cancer screening in France :  "The consideration of controversy in the information provided to women and in the information and training (initial and continuous) of professionals in this area, so that women concerned by breast cancer screening are provided with balanced and complete information, and that professionals involved in breast cancer screening are trained to acquire the relevant knowledge to accompany women, offering them adequate support to make their decision" (1).

Why women are not told the truth, why doctors do not humbly acknowledge their doubts about the appropriateness of this exam in the absence of any symptoms? They prefer to put forward benefits that they are not sure of, forgetting everything else, including informed consent and patient autonomy.

A new cancer plan, situation in France

The ten-year strategy of the new cancer plan has been adopted by decree (2).

We expected measures to improve information for women while respecting the autonomy of patients, as is done in Great Britain, Australia, Canada and Germany. Elsewhere, the objective is to inform and not to persuade, the emphasis is on the women's decision without making them feel guilty, by providing decision support tools, which correctly communicate risks in absolute numbers and not in percentages by minimizing them.

As for this decision aid in Canada (3) which states:

« Why is shared decision making important? 
Screening is a personal decision. It is important to understand and weigh the benefits and harms for women in your age group (as shown below) with your health care provider. This will help you get a better understanding of the issues so that you can decide what is best for you. Some women may wish to not be screened if they are concerned about potential harms. »

Click to enlarge

Instead of developing such tools, in France the focus is on the number of screenings and the participation rate, without the slightest concern for informed consent, the objective of the Cancer Plan being "to achieve one million more screenings by 2025 for the three screening programs, including organized breast cancer screening and to exceed the coverage targets recommended at the European level in terms of screening and join the leading group in terms of adherence with a participation rate of 70% for organized breast cancer screening, while today the participation rate announced for 2018-2019 is : 49.3% + 10-15% (organized + individual). "((2), action sheet I.12, p.20)

And yet the rate of participation in screenings should not be a goal of these programs. The real goal should be related to informed patient decision. As danish researchers (Rahbek et al, 2021) point out, instead of evaluating cancer screening programs on the basis of participation rates, the measure of engagement could be the rate of informed decisions, regardless of participation or non-participation (4). The authors note that authorities assume that for most citizens, participation is the right choice. This view is not necessarily shared by informed citizens. Indeed, current evidence suggests that the more informed citizens are, the less likely they are to participate in cancer screening (4). (see also : https://cancer-rose.fr/en/2021/01/24/objective-information-and-less-acceptance-of-screening-by-women/ )

Yet the 2020 WHO guide (5) on screening provides very clear information on the principles to be followed. The guide points out that the risk of these measures to increase participation rates is that people's autonomy to make an informed decision is threatened.

To avoid this, the guide recommends taking care to enable informed consent and to protect individual autonomy.

However, none of the actions in the roadmap of the Cancer Plan address the improvement of information to the population on the benefits and risks of screening, as recommended by the WHO 2020 guide. Similarly, there is no measure on the training of professionals in risk communication as recommended by the WHO. Yet the WHO guide gives as examples tools such as infographics, videos and decision aids can facilitate understanding and promote informed consent as well as evidence-based practices. And it points out that both lay people and clinical physicians tend to overestimate the benefits of screening and underestimate its harms. (see also https://cancer-rose.fr/en/2020/12/18/perception-and-reality-2/)

The WHO guide also indicates the principles that must be respected in a screening policy: 

« 1. Respect for dignity and autonomy. Autonomy is the capacity to make an informed and uncoerced decision. »

2.Non-maleficence and beneficence. Non-maleficence means doing no harm to people; beneficence aims to do good for people.

3.Justice and equity. In health care, justice concerns fair allocation of resources and that resources are allocated proportionate to the need.

4.Prudence and precaution. The precautionary principle requires foresight, planning for the potential outcomes of screening and making wise judgements based on these future concerns.

5.Honesty and transparency. This requires clear and transparent communica- tion, thus promoting accountability. » One may wonder whether these fundamental ethical principles will be respected in the new roadmap of the Cancer Plan, which focuses as much on the participation rate, with the ambition of exceeding the European objectives, but without worrying about information to the population and the training of professionals

How to make an informed decision when information is not provided or is incomplete and biased (see :

https://cancer-rose.fr/en/2021/01/01/critical-analysis-of-the-new-inca-information-booklet/ )?

The INCA booklet should be reviewed, particularly with regard to the targets for participation rates. It should be produced by an independent committee without conflict of interest and with the involvement of a panel of women as was done by the National Health Service in the UK and described by Forbes et al, 2014 (6). The 25 women on the panel, aged 47 to 73 years and recruited from the streets of London, came from a variety of professional and ethnic backgrounds. The NHS brochure does not seek to encourage screening or ask citizens to make decisions without guidance. And the committee that wrote UK brochure states that :  « policy of judging the performance of cancer screening only on measures of uptake is, arguably, inconsistent with the policy of supporting informed choice. » (6)

How can the principle of non-maleficence be respected when some women suffer the effects of overdiagnosis, without being properly informed of these risks beforehand?

Concerning the principle of honesty and transparency, danish researchers in screening (Rahbek et al, 2021 (4)) have cited the official INCA brochure as an example of presenting statistics in a misleading way, such as relative % reduction in mortality. And according to these scientists, this misrepresentation is an influence technique to increase participation in screening. The bias introduced by these relative mortality reduction values is also explained and criticized in the GIJN guide developed by RecheckHealth for investigative journalists reporting on health affairs and issues (7).

According to Rahbek et al, 2021 (4) insofar as patient autonomy and informed choice are important, the use of these types of influence remains ethically dubious in cancer screening programs where the benefit/harm ratio is complex and scientifically contested.

In addition, this INCA brochure, even if biased and incomplete, is not transmitted to all women, since it is sent only one time at age of 50, so women who were over the age of 50 in 2017, when the brochure started to be sent, have not received it.

Conclusion

Elsewhere than in France, efforts are being made to provide better information. Increasingly, the scientific literature emphasizes the need to inform citizens in order to make an informed decision about the benefits and harmful effects of screening for healthy people.

Especially this is the case in screening programs where the benefit/harm ratio is complex and scientifically contested and where the consequences of screening are complex and require personal choice, as in the case of breast cancer screening.

The ten-year strategy could have taken this into account in France as well, but it missed this opportunity, at the cost of a lack of information for women and training for professionals. 

References

  • (1) Citizen and scientific consultation, 2016

Report Key points Translated in English https://cancer-rose.fr/en/2021/03/16/citizen-and-scientific-inquiry-report/

https://www.re-check.ch/wordpress/en/projects/gijn-guide/

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 density, a viewpoint in JAMA

Synthesis by Dr. Cécile Bour, May 12, 2019

About https://jamanetwork.com/journals/jama/fullarticle/2733521

Foreword

With the emergence of predictive software [1] the radiological criterion of breast density, i.e., the predominance of fibroglandular tissue over fatty tissue in the female breast, has become, despite the lack of conclusive studies, a risk factor for breast cancer on its own. Breast density is generally high in young, non-menopausal women (but may persist after menopause), in leaner women with low body fat, and in women undergoing hormone replacement therapy during menopause.

As we said, it is a radiological criterion; whether this characteristic is really associated with an increased risk of cancer, opinions diverge and the question is far from being decided in the course of studies, which does not prevent opinion leaders from raising the scarecrow of dense breasts to terrorize women, if need be....[2]

What is established, however, is that with high breast density the discriminating power of mammography and the ability of the radiologist's eye to detect a lesion are greatly diminished, and it is only a short step from there to make a shortcut between breast density and cancer risk.

Available studies

Several studies are available, starting with the Wolfe study [3] on the relationship between breast density and breast cancer risk. This old study was strongly contested at the time, even by the supporters of screening.

Other studies have since been published, studying the relevance of linking this density factor with other risk factors, in order to develop models for calculating the risk of contracting breast cancer within 5 years. [4] [5] [6] [7] [8] [9] [10]

Today, there is no convincing evidence that high breast density is associated with risk of death from breast cancer.
Today, no tool for estimating the risk of breast cancer using breast density has yet proven its relevance.

The HAS(Higher Authority for Health in France), in a work on the identification of risk factors, writes:

 "High pre-menopausal breast density was not retained as a risk factor at the end of the work of part 1."[11]

The viewpoint published in JAMA on May 9, 2019[12]

The background is the adoption by the US Congress of legislation on breast density.[13]

More precisely this legislation requires the US Food and Drug Administration (FDA)[14] as part of the regulatory process to ensure that all mammography reports and summaries provided to patients include information on women' s breast density. This authority, which oversees the regulation of mammography facilities and quality standards, has previously required the reporting of breast density in radiologists' reports.

Based on published studies (see our bibliography), and according to the authors of this viewpoint published in JAMA, breast density as a risk factor for developing breast cancer draws attention to the fact that the associated increase in cancer risk is modest, and that for women diagnosed with breast cancer, increased breast density was not associated with an increased risk of poor-prognosis cancer or death from breast cancer.

Dense breasts are common (43% of women aged 40 to 74 years) and the majority of women with dense breasts will not develop breast cancer....

According to the editors of this article, notification of breast density may increase confusion and anxiety related to mammography and breast cancer, without providing clear recommendations on what women with dense breasts should do.

The USPSTF [15], in 2016, concluded that there was insufficient evidence to recommend additional breast imaging in women with dense breasts. This group raises several points of concern with this legislation requiring notification of breast density information to women.

  • Significant variability and limited reproducibility in the determination of dense breasts. This variability exists on an examination whether it is read by one radiologist or by different radiologists. The exam for a given patient may have different classifications and lead to misunderstandings leading to a reduction in a woman's confidence in screening in general, and confusion about her own breast cancer risk.
  • Uncertainty about initiatives undertaken by women who have been notified of significant breast density to reduce their risk of dying from breast cancer. 
    This refers to the request for additional tests for which there is no evidence to support the indication, as there is no evidence that the addition of imaging other than mammography in women with dense breasts will reduce cancer mortality; instead, these additions increase false positives, unnecessary biopsies, and overdiagnosis. The recall rate is significantly increased by the addition of ultrasound (by 14%), and by the addition of MRI (from 9 to 23%) with low PPVs[16] and an obvious additional cost. The authors remind us that MRI, often considered to be harmless, is likely to have a (small) excess risk of nephrogenic systemic fibrosis, and uncertain risks of gadolinium deposition in the brain when the examinations are repeated. Tomosynthesis (TS) is mentioned as an additional technique used, but the authors point out that longer-term studies are needed to determine whether the routine use of TS in women with dense breasts leads to a real improvement in breast cancer outcomes (mortality, decrease in the rate of serious cancers).
  • Difficulty in communicating information about breast density to patients. 
    Experts consider this communication difficult and dependent on the literacy level of the population. Study results show poor understanding and confusion and misinformation of patients when information about breast density is given.

Impact Analysis of FDA[17]

In this analysis the FDA claims that mandating breast density reporting would reduce breast cancer mortality in women, as well as costs through early detection of cancers .... But the authors of the viewpoint point to a troubling lack of evidence to support this arbitrary conclusion.

The FDA analysis failed to include in its calculation the costs associated with overdiagnosis, with overtreatment due to additional tests, and the costs of additional visits to primary care physicians.

In conclusion

The authors believe that breast density notification has implications for public health and that physicians, researchers, public health experts, and organizations should take a stand against this imposed rule.

Breast density notification could give clinicians and patients the opportunity to discuss a particular woman's risk of breast cancer, which depends on many factors other than breast density.

Predictive models of breast cancer risk include breast density, but its addition improves predictive estimates little. The addition of complementary imaging should be limited to high-risk women based on other risk factors to be included than breast density alone.

Discussions about the potential benefit of additional imaging for dense breasts should focus on the lack of evidence for a reduction in breast cancer deaths, and the well-known increase in false positives, unnecessary biopsies, and increased health care costs, as well as increased overdiagnosis and overtreatment.

In particular, when deciding on annual surveillance for high-risk women, these elements should be taken into consideration.

Clinicians should also engage patients in discussions about the importance of lifestyle (limiting alcohol, avoiding obesity, regular exercise) to reduce breast cancer risk.

Research will be needed to improve the coherence of reports on breast density and the quality of communication.

Additional research will also be essential to judge the long-term outcomes of complementary imaging to determine whether the benefits outweigh the harms.

But the authors point out that such studies will be increasingly difficult to conduct if the use of complementary imaging is routinely incorporated into screening mammography in women with dense breasts, which is currently the case (Editor's note).

Bibliography

[1]  see for example the software

Mammorisk http://mypebs.cancer-rose.fr/le-logiciel-mammorisk/

[2] http://sante.lefigaro.fr/article/les-seins-denses-un-risque-accru-de-tumeur/  itw du Dr Cutuli à propos d'une étude du NEJM de 2007( https://www.nejm.org/doi/full/10.1056/NEJMoa062790 )

[3] Wolfe JN. Breast patterns as an index of risk for developing breast cancer. AJR 1976;126:1130-9.

Breast patterns as an index of risk for developing breast cancer

JN Wolfe - American Journal of Roentgenology, 1976 - Am Roentgen Ray Soc

[4]  2011 Annals of Internal Medicine Personalizing Mammography by Breast Density and Other Risk Factors for Breast Cancer: Analysis of Health Benefits and Cost-Effectiveness- John T. Schousboe, MD, PhD; Karla Kerlikowske, MD, MS; Andrew Loh, BA; and Steven R. Cummings, MD
https://annals.org/aim/article-abstract/747009/personalizing-mammography-breast-density-other-risk-factors-breast-cancer-analysis?doi=10.7326%2f0003-4819-155-1-201107050-00003

"Mammographic screening should be individualized based on a woman's age, breast density, history of breast biopsy, family history of breast cancer, and knowledge regarding the benefits and harms of screening." 

[5] https://www.researchgate.net/publication/273154592_The_Contributions_of_Breast_Density_and_Common_Genetic_Variation_to_Breast_Cancer_Risk

The Contributions of Breast Density and Common Genetic Variation to Breast Cancer Risk
Article (PDF Available) in JNCI Journal of the National Cancer Institute 107(5) · May 2015 with 77 Reads
DOI: 10.1093/jnci/dju397 · Source: PubMed
Celine M Vachon

[6] McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006;15(6):1159–1169
https://www.ncbi.nlm.nih.gov/pubmed/16775176

[7] KERlikowske K, Cook AJ, Buist DS, et al. Breast cancer risk by breast density, menopause, and postmenopausal hormone therapy use. J Clin Oncol. 2010;28(24):3830–3837.
https://www.ncbi.nlm.nih.gov/pubmed/20644098

[8] https://link.springer.com/article/10.1007/s10549-011-1853-z

Breast Cancer Research and Treatment
May 2012, Volume 133, Issue 1, pp 1–10| Cite as

Risk prediction models of breast cancer: a systematic review of model performances Thunyarat Anothaisintawee, Yot Teerawattananon, Chollathip Wiratkapun

"Most (risk prediction) models have produced relatively low discrimination in internal and external validations. This low discriminative accuracy of existing models may be due to a lack of knowledge of risk factors, heterogeneous subtypes of breast cancer, and different distributions of risk factors among populations." 

[9] McCarthy AM, WE Barlow, Conant EF, et al; Consortium PROSPR. Cancer du sein de mauvais pronostic diagnostiqué après mammographie de dépistage avec résultats négatifs.  JAMA Oncol . 2018; 4 (7): 998-1001. doi: 10.1001 / jamaoncol.2018.0352 

ArticlePubMedGoogle ScholarCrossref

"Breast density has received much attention as a primary factor identifying the need for additional screening, but it may be more effective to consider both breast density and age to identify women at risk for poor prognosis breast cancer."

[10] Gierach GL, Ichikawa L, Kerlikowske K, et al. Relation entre la densité mammographique et la mortalité par cancer du sein dans le Consortium de surveillance du cancer du sein.  J Natl Cancer Inst . 2012; 104 (16): 1218-1227. doi: 10.1093 / jnci / djs327

"High mammographic breast density was not associated with risk of death from breast cancer or any cause after controlling for other patient and tumor characteristics. Thus, risk factors for breast cancer development may not necessarily be the same as factors influencing risk of death after breast cancer development."

[11] https://www.has-sante.fr/portail/upload/docs/application/pdf/2014-05/depistage_du_cancer_du_sein_chez_les_femmes_a_haut_risque_volet_1_vf.pdf

Page 53

[12] https://jamanetwork.com/journals/jama/fullarticle/2733521

May 9, 2019

New federal requirements to educate patients about breast density will help patients?

Nancy L. Keating, MD, MPH 1,2; Lydia E. Pace, MD, MPH 2,3

Dr. Nancy L. Keating is Professor, Health Care Policy, Harvard Medical School, Associate Physician, Medicine, Brigham And Women's Hospital

[13] Hoeven J. An Appropriations Bill Relating to Agriculture, Rural Development, Food and Drug Administration Appropriations, 2019, S 115-259, 115th Congress, 2nd Session (2018). https://www.congress.gov/congressional-report/115th-congress/senate-report/259/1?q=%7B%22search%22%3A%5B%22farm%22%5D%7D

[14] The Food and Drug Administration is the U.S. Food and Drug Administration.

[15] Melnikow J, JJ Fenton, Whitlock EP, et al. Supplemental breast cancer screening for women with dense breasts: a systematic review for the US Preventive Services Task Force. 

Ann Intern Med . 2016; 164 (4): 268-278. doi: 10.7326 / M15-1789PubMed 

(USPSTF, United States Preventive Services Task Force is an independent U.S. preventive services task force of primary care and prevention experts that systematically reviews evidence of effectiveness and develops recommendations for clinical preventive services).

16] Positive predictive value, which is the likelihood that the subject actually has cancer when he or she has a positive test.

[17] Office of Policy, Planning, Legislation and Analysis, Office of the Commissioner, Food and Drug Administration. Mammography Quality Standards Act; Amendments to Part 900 Regulations: File No. FDA-2013-N-0134.

Mammography Quality Standards Act; Amendments to Part 900 Regulations (Proposed Rule) Regulatory Impact Analysis

https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/mammography-quality-standards-act-amendments-part-900-regulations-proposed-rule-rule-regulatory-impact-


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.

An Indian study….ambivalent: breast cancer screening by clinical breast examination

Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai

https://www.bmj.com/content/372/bmj.n256

Dr C.Bour and

    - Contribution of Dr M.Gourmelon for the decoding the presentation of the risks of mortality. Appendix b

    - Contribution of Dr V.Robert for the statistical analysis. Appendix c

27/02/2021

Three randomized controlled trials were conducted in Russia, China and the United Kingdom [appendix a] involving a total of almost 400,000 women, which showed neither a decrease in breast cancer mortality nor a decrease in mastectomies. On the other hand, false positives were increased, leading to additional examinations and biopsies with normal results, and they also caused an increase in women's anxiety.

There was also a question of screening by trained professionals, the problem being the reproducibility from one practitioner to another which is not good. In short, clinical breast examination as a routine screening method has not been retained, as breast self-examination does not ultimately prove to be an effective method for the early detection of breast cancer. And it is still unclear whether screening by clinical breast examination can actually reduce breast cancer mortality

An Indian trial

A new study using the idea of clinical breast examination as mass screening is being conducted by a team of researchers in Mumbai, who are publishing the results of their 20-year randomized controlled trial.

The objective of the study was to test the effectiveness of breast cancer screening by clinical examination in reducing mortality from the disease and also in reducing the stage of cancer at diagnosis, compared with no screening.

151,538 women aged 35 to 64 years with no history of breast cancer participated in the study.
Women in the screening group (75,360) received four rounds of clinical breast examination screening (performed by trained primary care professionals) and cancer awareness information every two years. Women in the control group (76,178) received information on cancer awareness and eight rounds of active surveillance every two years.

It is examined whether, in the screening group, the cancer found is of a lower stage at the time of diagnosis compared with unscreened women, and of course whether mortality from the disease has decreased.

The main results of the study are as follows:

 -Clinical breast examination performed every two years by primary care professionals significantly reduced the stage of breast cancer at diagnosis.
-Clinical breast examination led to a non-significant 15% reduction in overall breast cancer mortality; BUT this is a relative reduction, i.e., for the screened group compared to the unscreened group (control group). See: [appendix b]
-The authors conclude that there was a significant reduction of nearly 30% in mortality in women aged ≥ 50 years. BUT This is a subset analysis done post hoc, not provided for in the original study protocol, so after the data were known; again, this is not an absolute reduction but a relative reduction in risk by comparing two groups. See: [appendix b]
-No significant reduction in mortality was observed in women under 50.

From the authors' perspective, what the Mumbai trial provides:

-In this 20-year study, clinical breast examination by trained health workers in Mumbai led to a reduction in breast cancer at diagnosis and a reduction in mortality from the disease by nearly 30% in women aged 50 years and older, but with no reduction in mortality observed in the group of women under 50 years.
-A 5% reduction in all-cause mortality was observed in the screening arm compared with the control arm, but this was not statistically significant.
-Clinical breast examination should be considered for breast cancer screening in low- and middle-income countries.

Review of the Study for Robustness

We present here the analysis of Dr. Robert, statistician of the Cancer Rose group, which you will find more exhaustively in the appendix at the end of the article [Appendix c].

In his opinion, the post-hoc analyses [1], which are included in the abstract and in the conclusion, are problematic.

We summarize his main conclusions about the study:

1-Post-hoc analyses raise suspicions of either a lack of scientific rigor or a lack of objectivity, with a propensity to want to demonstrate a posteriori, by an analysis not previously foreseen in the study protocol and made on the basis of the available data, at any price the effectiveness of screening by clinical breast examination.

2-The study is presented as randomized but in fact it is a cluster randomization (by groups of individuals and not by individuals). The authors do not give any information on the size of the clusters, nor on their characteristics. It is therefore impossible to know whether or not the randomization is sufficient to make the 'screened' and 'control' groups comparable.

3-The manner in which deaths are attributed (cause of death by breast cancer or other cause?) is debatable. When two physicians consulted to determine the cause are unanimous, the cause is retained, but if there is a disagreement a third opinion is required and the majority of opinions prevail; a rigorous process would require eliminating the disputed case.

Other remarks

Of course, there is a certain rate of over-diagnosis which dilutes the number of more advanced cancers in the total number of cancers found. This means that, as the results are expressed as a percentage, one has the impression that there are more cancers of an earlier stage in the screened group. It is surprising that the BMJ accepts this presentation in percentages which biases the results. And indeed, there are overall more women with breast cancer in the screening arm (198) than in the control arm (151).

(It is known that the presentation in percentages embellishes the data and gives a fictitious perception of reality.)

Thus, in Appendix 4 of the report of the citizens' consultation [Appendix d] (page 155) for example, since the citizens had asked for an honest rendering of the data, graphic representations are proposed of what the percentages represent "in real life").

The main point is that the overall result is not enthusiastic, since there is no statistically significant decrease in breast cancer mortality in the screened population as a whole.
And it is always problematic, as Dr Robert points out, to have the results of analyses carried out afterwards, once all the data are in hand, allowing one to "choose" what one wishes to put forward, thus leaving doubt as to the admissibility of the results.

Bernard Duperray[2], in his book "Breast Cancer Screening, the Great Illusion", mentions the Shanghai study where the results found are almost opposite to those of the Mumbai trial: "In a trial carried out in Shanghai from October 1989 to October 1991 on nearly 270,000 women, 130,000 were trained in breast self-examination under medical supervision and compared with a control group (not screened). Cumulative breast cancer mortality rates after 10 to 11 years of follow-up were similar in both groups ...... [3].

To conclude

It is important to keep in mind that this study took place in a very different setting than our Western populations. Initiatives to clinically examine women breast by trained personnel in a setting like Mumbai are likely to reduce the morbidity and stage of cancers for which women may be arriving too late for care.
The authors describe the difficulties[4] encountered in carrying out this trial, particularly from the point of view of financing, when Europe at the same time is capable of sacrificing 12 million euros for a study that failed before it even began, and which will not provide any usable information either on overdiagnosis or on the usefulness of mammographic screening.[5]

If this article lacks scientific robustness, and the interest of organized screening by clinical breast examination cannot be formally affirmed, the non-interest of this type of screening by clinical examination is not demonstrated either!
A more robust three-arm trial could be imagined, with a 'no screening' arm.

A 'rapid response' to the publication of this study[6] (Ismail Jatoi-Professor and Chief, Division of Surgical Oncology and Endocrine Surgery-University of Texas Health Science Center, San Antonio) is quoted here: ".... the risk of overdiagnosis will increase with the use of more modern screening technology (i.e., tomosynthesis, magnetic resonance imaging), which increases the rate of detection of more occult (non palpable) cancers."

... "Taken together, the results of the Mumbai trial and the CNBSS[7] suggest that a clinical trial randomizing women aged 50 years and older to mammography screening versus clinical breast examination (CBE) screening is now warranted. If such a trial demonstrates that there is no additional benefit to mammography screening beyond what is achievable with CBE screening, then CBE screening should replace screening mammography as the optimal method of breast cancer screening."

Ethically, a randomized clinical trial testing mammographic screening versus clinical screening would be justified, but in France it is unfortunately not possible, since the argument often put forward is that it is unethical to exclude women from mammographic screening. It seems to be considered more ethical to coercively and insistently call women to a radiological screening that has failed....

But the pandemic and future problems of health resource allocation may lead us to rethink this kind of testing around the world, especially for underprivileged populations, rather than furthering disappointing mammographic screening with technologies we know in the western world, which increasingly leads to overdiagnosis.

References

[1]  In a scientific study, post hoc analysis (from the Latin post hoc, "after this") consists of statistical analyses that have been specified after the data have been accessed. This usually creates a multiple testing problem because each potential analysis is in fact a statistical test. Multiple testing procedures are sometimes used to compensate, but this is often difficult or impossible to do accurately. Post-hoc analysis that is conducted and interpreted without adequate consideration of this problem is sometimes called "data dredging" by critics because the statistical associations it finds are often wrong.
(Wikipédia : https://en.wikipedia.org/wiki/Post_hoc_analysis )

[2] Bernard Duperray "dépistage du cancer du sein, la grande illusion"-éditions Thierry Souccar.

[3] THomas DB, gao Dl et al. Randomized trial of breast self-examination in Shanghai: nal results. Journal of the National Cancer Institute. 2002 Oct 2;94(19):1445-57.

Cox B. Variation in the effectiveness of breast screening by year of follow-up. Journal of the National Cancer Institute. Monographs. 1997;(22):69-72.

Retsky m. New concepts in breast cancer emerge from analyzing clinical data using numerical algorithms. International Journal of Environmental Research and Public Health. 2009 Jan;6(1):329-48.

[4] https://blogs.bmj.com/bmj/2021/02/24/the-story-of-the-mumbai-breast-screening-study/

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

[6] https://www.bmj.com/content/372/bmj.n256/rr-1

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

Annexes

[a]

b] Explanation of the misleading nature of risk presentations in terms of relative percentage reduction in risk of death. Dr M. Gourmelon

1-Clinical breast examination led to a non-significant 15% reduction in overall breast cancer mortality-

The 15% comes from the following relative calculation:

breast cancer mortality in the screening group 213 deaths, 251 in the control group.

251 -213 = 38

3800/251 = 15,13 %

This is how we obtain a 15% relative reduction in breast cancer mortality.

But what is it in absolute terms?

213 deaths for 75360 women in the screening group.

21300/75360 = 0.2826% is therefore the absolute percentage of deaths of women from breast cancer in the screening group

251 deaths for 76178 women in the control group.

25100/76178 = 0.3295% is the absolute percentage of women who died of breast cancer in the control group.

We therefore have: 0.3295 - 0.2826 = 0.0469% rounded to 0.05% fewer women deaths.

The relative percentage is therefore 15%, and the absolute percentage is 0.05%.

The absolute percentage represents the reduction in mortality of women between the screening group and the control group.

The relative percentage expresses the difference between the total number of deaths in the screening group and the control group, a reduction for a group not for individuals.

However, what is important to know for good information for women is the reduction that they can expect from screening and not how much of a reduction screening brings in the screening group compared to the non-screening group.

But to "promote" screening, it is better to put forward a figure of 15% reduction, which does not concern women directly but which they will interpret as such, than 0.05%, which is the real reduction they can expect by undergoing screening.

This is all the subtlety of presentation of the figures that most readers of the studies will not be aware of, but that the authors, yes. And that the French citizen consultation of 2015 had asked that such presentations are no longer accepted.

2-Second in the same way:

 The authors conclude that there is a significant reduction of almost 30% in mortality in women aged ≥ 50 years.

The 30% comes from the following calculation, in the same way:

64 women over 50 years of age who died of breast cancer in the screening group, 93 in the control group.

There is therefore a reduction in breast cancer deaths of : 93-64 = 29

so 2900/93 = 31.18% relative reduction in mortality in women over 50.

But what about the absolute reduction:

64 women died out of 20965 women over 50 in the screening group.

6400/20965 = 0.3053% absolute breast cancer mortality in the screening group

93 women died out of 21909 women over 50 in the control group

9300/21909 = 0,4245 %

or 0.4245-0.3053 = 0.1192

Therefore, in absolute terms, the reduction in mortality of women from breast cancer is 0.12%.

In the same way as before, calculating in absolute % expresses the mortality risk of women over 50 and therefore its reduction, whereas on the other hand, the relative % only expresses a reduction of one group in relation to another: the comparison between the group of screened women and the group of unscreened women and in no case the reduction of risk of women over 50 themselves.

3-Finally, the same is applicable:

A 5% reduction in all-cause mortality was observed in the screening arm compared with the control arm, but was not statistically significant :

11853 all-cause deaths in the control arm

11261 all-cause deaths in the screening arm

11853-11261= 592 fewer deaths.

59200/11853= 4.9945% so 5% fewer deaths between the screening group and the control group but not 5% fewer women who died, because for that you have to calculate in absolute percentage.

This gives:

1126100/75360= 14.94 %

1185300/76178= 15.56 %

15,56-14,94 = 0.62 %

c] Dr Robert's analysis

1. With each post hoc analysis (each subgroup comparison), we give ourselves an additional chance of arriving at a statistically significant result by chance.

Thus, to arrive almost certainly at a statistically significant result, it would be sufficient to create the subgroups at random 100x in a row. With the usual significance level of 0.05, there would be a little more than 99 chances out of 100 that at least 1 of the 100 subgroup comparisons would give (by chance, since the subgroups were formed on a random basis) a p.value <0.05 (in other words, a statistically significant result).
(Editor's note: Thus we keep this analysis which seems positive according to the criteria retained by the authors and we can ignore the other 99 studies which appear negative).

Thus the authors do not report 100 post hoc analyses but only 2 (one for the under 50s and one for the over 50s). But, with the 2 post hoc analyses + the main analysis (the one without subgroups), this still gives 3 "tickets" to try to have at least one statistically significant result. The risk of error in the conclusion is therefore no longer 0.05 but about 0.143.

More importantly, it is not known how many post hoc analyses were actually performed. The authors show results for subgroups under 50 and over 50. But in fact, we don't know how many subgroups they tried before arriving at a subgroup with a statistically significant result. Nothing says that they didn't try more than 36 years: no success; then more than 37 years: no success; then more than 38 years: no success; ...; then more than 50 years:  p.value = 0.02 we can publish.

The problem is that, in doing so, they would have given themselves 15 "tickets" to have a statistically significant result. The risk of error in the conclusion would therefore no longer be 0.05 but 0.537 (in other words, more than a 1 in 2 chance that the conclusion of a decrease in mortality in women over 50 years of age is due to chance and questionable statistical methodology).

The fact that the authors did post-hoc analyses (no matter how many) proves :
- a lack of statistical rigor or knowledge
- a lack of objectivity with a strong desire to demonstrate at all costs the effectiveness of screening by palpation (and from then on, one has the right to question the honesty of the study).

2. The study is presented as randomized but in fact it is a cluster randomization (by groups of individuals and not by individuals). The authors state that there are 20 clusters but give no information on the size of the clusters and the heterogeneity of risk factors between the different clusters. It is therefore impossible to know whether or not randomization is sufficient to make the screened and control groups comparable.

To understand the importance of the problem, let's take a caricatured situation:

2 clusters, one high-risk, the other low-risk.
In this situation, randomization does not change the comparability of the groups. One will receive the high risk cluster and the other the low risk cluster. Randomization or not, the 2 groups will not be comparable.
If the clusters are perfectly identical in terms of risk factors, randomization is unnecessary. No matter how the clusters are assigned to each group, there will be no problem of comparability anyway since all clusters are identical in terms of risk factors.
If there are an infinite number of clusters, it does not matter whether they are identical or not in terms of risk, the randomization will balance the distribution of the high and low risk clusters between the 2 groups.

In practice, we are always in an intermediate situation, with a number of clusters > 2 but not infinite and clusters that are not perfectly identical in terms of risk. In order to judge whether or not cluster randomization is likely to produce comparable groups, it is therefore necessary to know both the number of clusters and the heterogeneity between clusters.

3. The way to decide whether or not a death is attributable to breast cancer is rather curious.

Two doctors give their opinion. If the two opinions converge, these identical opinions determine the attribution (OK with that).

If the two opinions differ, a 3rd opinion is requested and the majority opinion determines the attribution. And there is a problem. The majority decision is democratic and well adapted to politics but it is not scientific. If the opinions of the first two doctors differ, the situation is ambiguous.

And it would be more honest not to take these cases into consideration than to want to remove the ambiguity at all costs by a 3rd opinion not necessarily more reliable than the first two.

It is difficult to know how many cases of disagreement there were. There were 17% in one group and 10% in the other where the cause of death could not be attributed; but figures on the frequency of cases where the attribution was made despite a contrary opinion from at least one of the physicians cannot be found. This is crucial information.

At the very least, the robustness of the conclusions should have been checked by a sensitivity study taking into account non-attributions and ambiguities in the attribution of the cause of death (curiously, this was done for the analysis of the staging (analysis of the stage of the cancer at the time of its diagnosis) of cancers and not for the analysis of cancer deaths; in the case of deaths, this removes all reliability from the conclusions)

d] Consultation report, see page 155

 

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Radiation-induced cancers after radiotherapy for breast cancer

ANNETTE LEXA

PhD Toxicology, EUROTOX

MAY 26, 2021

Adjuvant radiotherapy plays an important role in the treatment of breast cancer and its effectiveness has been demonstrated. However, we also know that for every 2,000 women screened for breast cancer after age 50, 10 will be over-diagnosed and one of them will have her life shortened by treatment (surgery, radiation, chemotherapy), a risk not taken by unscreened women. This over-treated woman will die either from chemotoxicity, or from radiotoxicity resulting in fibrosis of supporting tissues 6 to 30 months later (lungs, heart, coronary arteries...), or from radiation-induced cancer 3 to 20 years or more after the initial treatment.

What do we know today about these radiation-induced cancers (RIC)?

The Chernobyl accident showed significant excesses in the incidence of papillary thyroid cancer as well as sarcomas for which it has not been possible to find a specific genomic and transcriptomic signature (see box). Today, one of the main causes of radiation-induced cancers seems to be exposure to medical radiation, either in the form of radiotherapy for a malignant tumor or diagnostic radiography.

These tumors occur after a latency period that can extend over decades and the survival rate - in the cohort study of KIROVA et al, 2006 - was 36%. These are not recurrences of the original cancer but a cancer that affects the peripheral tissues in the irradiated area.

Generally speaking, the patients most at risk of IR cancer are those who were irradiated at a young age. In addition to secondary cancers of the lung, skin and hematological malignancies, sarcomas - rare tumors - representing 1% of cancers but overrepresented in IR cancers, have been the most studied. The latter are on the increase due to the lengthening of the survival time of patients.

Susceptibility is multifactorial: genetic predisposition, chemotherapy and radiotherapy are known to be risk factors for cancer.

More than 90% of angiosarcomas[1] occurring after radiotherapy for primary breast cancer are attributable to radiotherapy. One in a thousand women receiving such radiotherapy will develop angiosarcoma, with a latency of several years, a severe prognosis and a high recurrence rate. This figure may seem low, especially when, a priori, the benefit outweighs the risk.

Many uncertainties remain concerning the role of ionizing radiation in this type of carcinogenesis. The initial hypothesis evoked that cancers result from irreversible lesions of the DNA (mutations, deletions of genes), but they do not seem to be correlated with the level of energy sent.

Could such a risk be avoided by early detection? Do we have the tools to detect them earlier to improve survival?  

Click on image to enlarge

*A genomic signature of early hormone-dependent (HR+), HER2-negative (HER2-) tumors avoids adjuvant chemotherapy in postmenopausal breast cancer (https://www.lequotidiendumedecin.fr/specialites/cancerologie/une-signature-genomique-permet-deviter-la-chimiotherapie-adjuvante-dans-le-cancer-du-sein-post )

Chronic oxidative stress, an epigenetic signature of radiation-induced cancers

The scientific community has been investigating whether there is a genetic or epigenetic signature of IR cancers.

It has been shown[2] that radiation-induced sarcoma shows an increase in mutations in certain genes known to play a role in the development of cancer:

- TP53 gene of the p53 protein: it is the most important for the protection of the cell against cancerization. It is involved in the regulation of the cell cycle, autophagy and apoptosis. More than 50% of human cancers have an inactivated TP53 gene and if it is mutated, the cell becomes much more at risk of malignant transformation (this explains why in these cases of inactivated p53, chemotherapy may not work)

- RB retinoblastoma protein gene, a tumor suppressor gene that controls the cell cycle; a mutation in the pRB gene can lead to a tumor.

- PIK3CA gene and its associated oncogenic protein present in HER2 metastatic breast cancer,  observed in breast cancer associated to radiation

But these signatures are not specific to radiotoxicity.

Although it has not been possible to identify a genomic signature (DNA), a transcriptomic signature has been demonstrated and suggests that one of the characteristics of IR cancers is a mitochondrial dysfunction (see box) associated with a sign of chronic oxidative stress (see box) linked to an overproduction of reactive oxygen species (ROS) by these same mitochondria [3]. Moreover, a known direct effect of ionizing radiation, visible under the electron microscope, is the alteration of the structure of mitochondria which "shrivel".

Click on image to enlarge

These discoveries of the last decade evoke the old work of Otto Warburg (Nobel Prize in Physiology and Medicine, 1931) who demonstrated that cancer cells produce energy mainly by anaerobic glycolysis (see mitochondria box), followed by lactic acid fermentation, even if there is enough oxygen, with the consequence of producing H+ ions, which causes an acidification disrupting the metabolism of the cell.

According to Warburg, the development of cancer is due to a dysfunction of the mitochondria of cancer cells, which, instead of consuming glucose normally through the Krebs cycle, ferment this glucose. However, at present, the question remains whether this is the cause or the consequence of cell carcinogenesis and the scientific community is still debating the complex relation between the mitochondria and the nucleus.

The body often kills damaged cells by apoptosis - a self-destruct mechanism that involves the mitochondria - but this mechanism fails in cancer cells where the mitochondria malfunction and can no longer properly produce the energy necessary for the metabolic functioning of the cells, with a build-up of lactic acid, making the cellular environment unsuitable for certain enzymatic reactions.

Oxidative stress (see box) is an essential function of cells. It plays a major role in the elimination of pathogenic microbes and is essential for the functioning of mitochondria. However, like Janus, it has a negative side because it is involved in inflammation, cancer, autoimmune diseases, neuronal degeneration such as Parkinson's disease and aging. Oxidative stress has been maintained throughout evolution because it allows macrophages to eliminate pathogens, mitochondria to communicate with the nucleus, to initiate apoptosis and to send signals to other cells in the body to stimulate the influx of calcium (which blocks the functioning of mitochondria leading to an accumulation of ROS/NRS).

Click on image to enlarge

Several other genes involved in detoxification and antioxidant functions are also deregulated in this type of IR cancers. However, genes encoding enzymes important in ROS detoxification (catalase, glutathione reductase..) are not expressed differently in IR sarcomas or in primary non-IR sarcomas. These genes are known to be involved in the response to acute oxidative stress. It is therefore not the acute oxidative stress that is dysfunctional but the chronic oxidative stress that ultimately impairs the turnover and removal of oxidized proteins and lipids from the cell as well as DNA repair.

Ionizing radiation generates reactive oxygen species and oxidative stress promoting genotoxicity. An international team [4] has demonstrated the involvement of ROS/NRS in metastatic human breast cancer cells. In IR sarcomas, cells have been selected and adapted to survive chronic oxidative stress. The progeny of surviving cells after irradiation are characterized by genomic instability - acquisitions of genetic alterations promoting genotoxicity, mutagenesis and carcinogenesis - induced by chronic oxidative stress due to mitochondrial dysfunction. However, it is not yet known whether this signature is that of radiation-induced cancerogenesis in general (Chernobyl-type) or whether it is specific to radiation-induced sarcomas in radiotherapy.

Antioxidants have an anti-carcinogenic role

The reduction of oxidative stress is an approach to limit the development of radio-induced cancers, even if we do not know if this chronic oxidative stress is the cause or the consequence. In vitro studies (on cancer cell cultures) are studying this avenue but they are rather rare.

In the meantime, and considering the important role of oxidative stress in cellular communication processes, it may be useful to recall that a balanced intake of micronutrients is a path that should not be neglected, even if the epidemiological evidence is not yet indisputable: B vitamins but also antioxidants such as ß-carotene (provitamins A), ascorbic acid (vitamin C), tocopherol (vitamin E), polyphenols and lycopene from tomatoes, and the large family of polyphenols among which flavonoids[5] very widespread among plants (especially flavonols such as kaempferol, quercetin, myricetol, rutin, rutoside... ), tannins (cocoa, coffee, tea, grapes, nuts, etc.. ), anthocyanins (red fruits) and phenolic acids (in cereals, fruits, vegetables). As these substances are naturally found in plants, a healthy and balanced diet remains the best source of natural antioxidants.

At present, as with any dietary supplementation, and particularly in the case of people with cancer, it is important to not practice self-supplementation but to seek advice from a professional specialized in nutrition.

Conclusion

Radiation-induced cancer is a rare, serious and often fatal cancer. The main therapy is surgery when possible. However, these cancers are often detected too late and we do not know precisely the process of their development even if we have succeeded in highlighting some very interesting cellular mechanisms.

In the meantime, any unnecessary radiotherapy would need to be avoided or at least weighed up, especially in the case of in situ cancer, in order to avoid the risk of over-treatment with the admittedly rare but extremely dangerous consequences of radiation-induced secondary cancer, especially as there is no means of early detection to date.

In the meantime, and as a principle of caution, it is useful to ask for a predictive test of radiosusceptibility on which two articles have been written on the Cancer Rose website:

Predictive testing for radiation reactions: women at great risk

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

Additional bibliography used

Angiosarcoma associated with radiation therapy after treatment of breast cancer. Retrospective study on ten years, Verdin V et al, Cancer Radiother. 2021 Apr;25(2):114-118.  

Radiation-induced sarcomas after breast cancer:experience of Institute Curie and review of literature, KIROVA Y. et al., Cancer/Radiothérapie 10 (2006) 83–90

A little vocabulary ....

Autophagy: mechanism by which unwanted or damaged organelles are collected and transported for degradation. This process allows the recycling of proteins and is essential for the homeostasis of the cell. This natural process malfunctions in cancer cells

Deletion : Loss of a DNA fragment by a chromosome.

Homesotasia: process of maintaining the equilibrium of the internal environment (cells, organisms), whatever the external constraints. Thus cells and organisms maintain the concentration of glucose, sodium or potassium within a narrow range.

Hypoxia: lack of oxygen in the cells and tissues of the organism

Mutation: a rare change, accidental or provoked, of the genetic information (DNA or RNA sequence) in the genome (chemical agents, radiation, virus....)

References

1] Some sarcomas are specific such as angiosarcoma, osteosarcoma, fibrosarcoma, myosarcoma.... Angiosarcoma is a soft tissue sarcoma. A very rare cancer, it originates in an artery. It is characterized by the proliferation of abnormal cells in the vascular endothelium. It can be located in veins, arteries, but is usually found below the surface of the skin and in lymph nodes. This type of cancer can be due to exposure to toxic products such as thorium, arsenic, pesticides and vinyl chloride or to previous irradiations (radiotherapy for another cancer...).

[2] Behjati, S., Gundem, G., Wedge, D. et al. Mutational signatures of ionizing radiation in second malignancies. Nat Commun 7, 12605 (2016).

3] Reactive oxygen species ROS (superoxide anion, H2O2,...) often in synergy with reactive nitrogen species ERA (peroxynitrile..) produced by the cells attack the essential components of the cells (lipids, proteins, DNA, amino acids..)

Of exogenous origin (solar UV, IR) but also endogenous (nitrogen metabolites in immune reactions to kill microorganisms)

[4] Y. Li, K. Hu, Y. Yu, S.A. Rotenberg, C. Amatore, M.V. Mirkin., Direct Electrochemical Measurements of Reactive Oxygen and Nitrogen Species in Nontransformed and Metastatic Human Breast Cells, J. Am. Chem. Soc. 139, 2017, 13055-13062,& address correction in J. Am. Chem. Soc. 140, 2018, 3170−3170.

[5] https://fr.wikipedia.org/wiki/Flavono%C3%AFde

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.

Digital Mammography

Summary by Cécile bour, MD

April, 26, 2021

In the Journal of The National Institute Volume 113, Number 1, January 2021, is published an article of 2020 on an important meta-analysis. It discusses the contribution of digital mammography in breast cancer screening, a publication that we had relayed here: https://cancer-rose.fr/2020/06/28/la-mammographie-numerique-pas-plus-efficace-dans-la-reduction-des-cancers-les-plus-graves-selon-meta-analyse-australienne/

Digital mammography, approved in 2000 by the American FDA, is also widely used in France. 

Studies suggested that the new technology is equivalent to the old analog film technology for cancer detection.

A short technical description

Analog mammography produces an image printed directly on silver film. 

Digital sensor radiography (CR), which has now completely replaced the analog one, is an indirect mammography technique that captures the image on a reusable plate. This receptor of image contains a photostimulated luminophore, the X-rays cause an excitation of luminescent molecules which convert the X-rays to light. An analog-to-digital converter then produces a digital image that can be archived.

Direct Digital Radiography (DR) does not use reusable plates. Sensors convert the X-ray stream directly into an electrical signal which is then digitized and transferred to the screen. The image is visible and can be analyzed on the screen directly by the radiologist. The image can then be enhanced if it is over or underexposed for a better visualization. In this case too, the images can be stored as digital files in a computerized archiving system.

The article

In the article published in the National Institute's journal, authors Otis W Brawley (oncologist and epidemiologist in Baltimore, USA) and Channing J Paller (oncologist and urologist in Baltimore, USA) first recall the results of this important meta-analysis.

Digital mammography is certainly justified by easier storage and handling of images. There is also a possibility of computer-assisted diagnosis and better performance for the exploration of dense breasts. Digital mammography also has a lower radiation exposure than film mammography, provided that the number of images is not increased unreasonably... More on this later.

For effective screening, the authors point out, three objectives must be met: more localized tumors found at the same time as a decrease in interval cancers (tumors diagnosed between two screenings), and a decrease in the incidence of advanced cancers.

Regrettably, the Australian meta-analysis by Faber et al. (Sydney School of Public Health, Australia) confirms the problem of increased overdiagnosis with this method, which allows more detection of small lesions, particularly carcinomas in situ, the vast majority of which do not affect the life of the woman diagnosed, but there is no difference in the detection rate of invasive cancers. 

The study suggests that 11% of cancers detected by digital mammography are overdiagnosed. However, other analyses cited in the article are much more pessimistic about the rate of overdiagnosis attributable to the digital system [1].

The digital technique also has no effect on interval cancers, which are not reduced.

In the United States, the age-adjusted incidence rate (new diagnoses) of breast cancer increased by more than 30% from 1975 to 2000, while the incidence of advanced breast cancer at the time of diagnosis was stable for the 25 years, instead of decreasing as expected.[2]

Most importantly, the recall rate is significantly increased with digital technology because of the increase in false positives, which means that the claim of less radiation with digital technology is questionable, since these women recalled because of false suspicion of cancer will undergo, among other examinations, new X-rays.

Highlights from the article

Two interesting points are made by Brawley and Channing in relation to the results that can be extracted from the Australian meta-analysis:

1. The true measure of the value of effective screening at the population level is a reduction in cancer mortality and unnecessary treatment. 

Screening should not justify its apparent success on the discovery of more and more cancers, many of which are unnecessary detections, but rather on the detection of more cancers that are important to find because they are clinically dangerous to the women who develop them. But digital mammography is not more discriminating for these forms and overdetects a large number of cancers that would not have caused any consequence.

2. It is human nature to think that the new technology is always the best, and many experts felt that digital mammography would lead to better health outcomes. 

Sometimes we have to face the fact that the truth is different from what experts have put forward. These results demonstrate, according to the authors, the importance of post-marketing evaluation and open-mindedness. 

These results also show the biological variations of breast cancer, and confirm a non-linear natural history of the pathology: some cancers are useless to find because they regress or do not progress, others are immediately aggressive and develop between two screening mammograms without any possibility of stopping their occurrence.

Our commentary

We invite our readers to read the work of Bernard Junod and Dr Bernard Duperray on overdiagnosis. The natural history of cancer is of paramount importance, without this knowledge we will never be able to understand the problem of overdiagnosis and interval cancers.

References

[1] https://www.sciencedirect.com/science/article/abs/pii/S0959804917313850 "One-third to one-half of breast cancers detected by mammography would not have been Clinical over a lifetime (overdiagnosis)."

[2]Welch HG, Gorski DH, Albertsen PC. Trends in metastatic breast and prostate cancer–lessons in cancer dynamics. N Engl J Med. 2015;373(18):1685–1687.

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.

Media coverage of screenings

Global Media Coverage of the Benefits and Harms of Early Detection Tests

Mary O’Keeffe, PhD1Alexandra Barratt, MD2Alice Fabbri, MD3,4Joshua R. Zadro, PhD1Giovanni E. Ferreira, PhD1; Sweekriti Sharma, MPH1Ray N. Moynihan, PhD5

https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2778372

Synthesis by Cécile Bour, MD, April 22, 2021

This "researchers' letter" is from Australian scientists including Prof. A. Barratt, Professor of Public Health at the University of Sydney and Dr. Ray Moynihan, Australian researcher at Bond University and health journalist, focuses on the media coverage of screening tests. It was published in JAMA on April 5, 2021. The authors of the publication study the way in which the balance of benefits and harms of 5 tests are treated in the media.

Media is key to promoting testing of asymptomatic individuals in the population, and might play an important role in encouraging realistic reporting of the benefits and harms of screening, including unnecessary diagnoses.

But data suggest that medical media coverage tends to exaggerate benefits, minimize harms, and ignore conflicts of interest.

Methods

The authors studied all English-language narratives from 2016 to 2019 in LexisNexis (a publishing and professional information company), ProQuest (a global company providing tools for content search and management from dissertations, theses, books, newspapers, periodicals, etc.) and Google News.

All types of non-fiction articles from newspapers, blogs, magazines, and broadcast transcripts were included as long as they mentioned or implied benefit or harm from medical testing, with or without disclosure of conflicts of interest of the narrators involved.

The stories were reviewed for health benefits (early treatment, saving lives) and harms (false positives, overdiagnosis), and reflected views expressed by the commentators according to their agreement or disagreement.

Five early detection tests were targeted by this review: liquid biopsies, tomosynthesis also known as three-dimensional mammography (discussed on this site [1] [2]), electrocardiogram recording using the Apple Watch Series4 app, blood biomarkers for dementia, and artificial intelligence technology in dementia.

Results

Overall, media coverage focuses much more on the benefits of early detection testing than on the harms, and the risk of overdiagnosis was poorly covered.

Overall, 97% of the narratives reported benefits, 37% reported harms, and only 34% reported both benefits and harms.

63% of stories reported only benefits, while only 3% reported only harms.

Overdiagnosis was mentioned in only 57 of the 432 stories, making only 13% of all content that mentioned harms, or 5% of stories in the entire set.

In total

This study confirms the results of other similar studies on the subject of health media coverage[3] [4] [5].

The authors suggest that improved media communication would encourage a healthier skepticism about the health options available to populations, and reduce the problem of overdiagnosis (or overdetection).

They argue that strategies are urgently needed to improve media coverage so that professionals, patients and the public receive more balanced information about early detection tests.

Comments

In the past, we have repeatedly expressed our alarm at the biased reporting of scientific facts in the media.

In the case of screening mammography, easy slogans are used, facilitated by the impossibility for women to make an informed decision since they are fallaciously informed, as shown in a previous study[6].

A commentary published following the Australian study in JAMA was of particular interest to us[7].
It is that of Dr. Diamandis[8], head biochemist of the University Health Network and 'Toronto Medical Laboratories' and also division head of clinical biochemistry in the department of pathobiology at the University of Toronto in Ontario, Canada.

Indeed, we can remember the unbridled media hype and enthusiasm, as early as 2015, about "liquid biopsies"[9]. The "woman who would beat cancer", "the heroine of modern times" was presented on many television platforms and several more or less glamorous media. She was Mrs. Patrizia Paterlini-Bréchot, a scientist who worked on the development of liquid biopsies. [10][11] [12] [13] [14] [15] [16] [17]

But studies and publications that are less media-friendly[18] [19] dampen this enthusiasm about the possibility of using liquid biopsies more widely as routine population-based screening.
Indeed, in addition to its high cost and complexity, these tests on circulating tumor DNA seem to suffer from the same problems of low sensitivity and specificity as traditional biomarkers if we try to use them for screening in an asymptomatic and a priori healthy population. This means that we are heading for over-diagnosis, large numbers of false positives, with panic in the population and cascades of additional examinations for those who test positive (for a better understanding of these notions, see here: https://cancer-rose.fr/2016/11/13/cancer-du-sein-un-peu-de-technique/).

In his commentary to the Australian team's study, Dr. Diamandis writes:

"More recently, as the authors pointed out, we have seen a strong push by academic researchers and companies for DNA tests of circulating tumors for early cancer detection. However, our calculations showed that this test will only be able to detect large symptomatic tumors. We further stressed the need for newspapers to provide a space for healthy debate on such controversial issues. Since: biased reporting favoring the good news, but not the bad news..."

References

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

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

[3] MoynihanR,BeroL,Ross-DegnanD,etal.Coveragebythenewsmediaof the benefits and risks of medications. N Engl J Med. 2000;342(22):1645-1650.

[4] MoynihanRN,ClarkJ,AlbarqouniL.Mediacoverageofthebenefitsand harms of the 2017 expanded definition of high blood pressure. JAMA Intern Med. 2019;179(2):272-273.

[5] Walsh-ChildersK,BraddockJ,RabazaC,SchwitzerG.Onestepforward,one step back: changes in news coverage of medical interventions. Health Commun. 2018;33(2):174-187.

[6] https://cancer-rose.fr/en/2020/12/18/perception-and-reality-2/

[7] https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2778372

[8] https://www.aacc.org/community/merit-awards/hall-of-fame/bios/a-to-k/eleftherios-diamandis

[9]Liquid biopsy consists, schematically, in taking a blood sample to detect as early as possible material released into the blood by cancerous tumors. Three tools can be used: detection of circulating tumor DNA, circulating tumor RNA, circulating tumor cells.

For the moment, this is considered to be an interesting avenue for research. But a person who does not have cancer and is simply concerned about his or her health cannot, today, benefit from this type of blood test.

[10] https://www.letemps.ch/sciences/biopsie-liquide-parade-inedite-contre-cancer

[11] https://www.marieclaire.fr/,focus-sur-patrizia-paterlini-brechot-la-femme-qui-va-nous-sauver-du-cancer,819617.asp

[12] https://www.notretemps.com/sante/actualites-sante/patrizia-paterlini-brechot-oncologue-court-cancer,i119711

[13] https://www.hachette.fr/interview/patrizia-paterlini-brechot-combattu-avec-la-tete-et-avec-le-coeur-pour-y-arriver

[14] https://www.elle.fr/Societe/News/Patrizia-Paterlini-Brechot-la-femme-qui-fait-reculer-le-cancer-2859710

[15] https://www.dailymotion.com/video/x43u007

[16] https://www.youtube.com/watch?v=5AwzQ77r258

[17] https://da-dk.facebook.com/franceinter/videos/patrizia-paterlini-br%C3%A9chot-est-linvit%C3%A9-de-patrick-cohen-du-19/1230781260290325/

[18] Fiala C, Diamandis EP. Utility of circulating tumor DNA in cancer diagnostics with emphasis on early detection. BMC Med. 2018 Oct 2;16(1):166. doi: 10.1186/s12916-018-1157-9. PMID: 30285732; PMCID: PMC6167864.

[19] https://www.edimark.fr/lettre-cancerologue/biopsie-liquide-avantages-limites

"The use of CTCs or tcDNA as tools for early detection of primary tumor or recurrence remains a very active area of clinical research, but is not, in the absence of clinical evidence, routinely applicable."

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.

Methods of influencing the public to attend screenings

Categories of systematic influences applied to increase cancer screening participation: a literature review and analysis

Joseph Rahbek , Christian P. Jauernik, Thomas Ploug, John Brodersen
(more about the authors ==> see at the bottom of the article)

https://publichealth.ku.dk/staff/?pure=en%2Fpublications%2Fcategories-of-systematic-influences-applied-to-increase-cancer-screening-participation(2cfeab86-5b7c-47db-be7b-bdf04436a71f).html

https://academic.oup.com/eurpub/article-abstract/31/1/200/5902144?redirectedFrom=fulltext

April 20, 2021; 

Summary Dr C.Bour, with the help of our referent patient Sophie

Under this title the authors aim to analyze how health authorities can subtly influence citizens to participate in cancer screening programs.
The researchers identified and analyzed several "categories of influence", i.e. several methods of pushing the public to undergo screenings.
They point out that when influences become too severe, this is at the expense of citizens' ability to make a personal choice.

Methods of study

Two methods were chosen:

  • A systematic literature search was performed on three databases listing scientific articles and publications which are: PubMed, Embase and PsycINFO. In addition, a review of the so-called "grey" literature was carried out, i.e. information brochures and website content from regulatory authorities and patient organizations targeting general public.
  • Relevant experts were contacted via international email lists and asked to provide examples of systematic influences in cancer screening. These experts are members of independent groups and have expertise in cancer and the collateral damage of screening.

These include the following groups: EuroPrev (18 members),[1] Nordic Risk Group (24 members),[2] Preventing Overdiagnosis (27 members),[3] a Google group (breast-cancer-screening google group) with a special interest in screening mammography (42 members), and Wiser Healthcare (21 members).

Results

From the 19 articles included and the expert survey, six main categories of systematic influence were identified: (a) misleading presentation of statistics, (b) misrepresentation of harms versus benefits, (c) opt-out, (which consists in considering as passive consent the fact that a solicited patient does not object to the invitation to screen), (d) recommendation of participation, (e) fear appeals, (f) influence on general practitioners and other healthcare professionals. 

The authors provide examples for each category.

a) Misleading presentation of statistics

This involves presenting mortality reduction data in an embellished way by using percentages of relative reduction in the risk of dying, instead of raw figures.

Editor’s note : For example, in the case of breast cancer screening, a mortality reduction of 20% is presented. This is a reduction in the risk of dying when comparing two groups, i.e. one group against another.
With this kind of presentation, one might think that 20 out of 100 people screened would die of cancer. This is not the case, explanation:
If out of 1000 screened women 4 die of breast cancer, and out of a group of unscreened women 5 die of breast cancer, the passage from 5 to 4 constitutes mathematically a reduction of 20% of mortality, but in absolute figures it only makes a difference of one woman... This is why it is important to always require a presentation in real data, and not in percentages, which embellishes the situation.

Often physicians and patients have a limited understanding of the statistics, and exposing risk reductions in relative numbers is likely to increase participation especially because citizens overrate the benefits of screening.[5]

b) Misrepresentation of harm compared to benefits:

This method of influence can be applied by presenting the benefits in relative figures, as we have just seen, and the harms in absolute figures. Alternatively, certain types of harms can be minimized and even omitted altogether.

The authors cite as an example a British information brochure on mammography screening in which the reduction in breast cancer mortality was emphasized, but a major harm such as overtreatment was omitted [6]. In addition, the same British brochure showed the risk of overdiagnosis after one round of screening, and the cumulative reduction in mortality after five rounds of screening, thus minimizing the harm while exaggerating the benefit.

Failure to inform correctly also addresses the omission of harms such as overdiagnosis and overtreatment.[6]

Editor's note: We will detail in a dedicated paragraph the very same shortcomings in the information given to women in France, which were denounced in this study, and which were also mentioned during the public consultation on screening in 2016 in France. We will come back to this.

c) Opt-out systems

This consists of assigning citizens a pre-booked appointment at the point of the invitation. If the person does not wish to participate, he/she must actively opt out. The non-refusal of the patient is considered de facto as acceptance to participate.

Editor's note: In France, we do not have this system of prebooked appointments, but the system of reminders is widely used if a patient does not show up for a screening mammography appointment (reminders by mail and sometimes SMS).

d) Recommendations of participation

A recommendation to participate in a health procedure does not provide evidence about the effectiveness or appropriateness or benefit of a screening program. Instead, it promotes one option (to participate) as the smartest or best, based on the authority of the source from which the injunction emanates. This is the argument from authority.[7]

Celebrity staging is also widely used in different countries to increase participation. Humorous examples are given in the article by Rahbek et al. In an Icelandic government video, after examining a citizen's rectum, the doctor slaps him on the bottom and exclaims, "More men should follow your example and take care of their own ass" - a recommendation, unaccompanied by factual data.

e) Fear appeals

This is a well-tried lever. By relying on the uncertainty of life and emphasizing the human fear of dying, it is easy to convince.

All of the above levers are illustrated in an excellent and pictorial way in the Cortecs media article: https://cortecs.org/2016/05/ (Editor's note)

f) Influence on general practitioners and other healthcare professionals

The most obvious one is the system of reward by remuneration when the professional encourages a patient to participate, called P4P (Pay for performance) or ROSP (Remuneration on public health objectives) in France.

g) Others

It is not used in France but is in force in Uruguay, and it was almost introduced in Germany: it is the legislative influence.

In Germany, in 2007, a law proposal suggested that if an individual did not participate in a cancer screening program and was subsequently diagnosed with the type of cancer for which he or she had been called for screening, then that individual would have to pay double the health tax - a law proposal that was finally rejected.

In total

The authors' analysis shows that there is a common point between the six main categories of influence detailed in the article: they work through psychological biases and personal costs (i.e. time consumption or financial) on non-participation.

The article here focuses essentially on "nudging" populations, a term that refers to anything that predictably changes people's behavior by pushing them into what you want them to do, without any scruples, and even to the point of financial incentives.

Insofar as patient autonomy and informed choice are important, the authors say, the use of such influences is ethically questionable in cancer screening programs where the benefit/harm ratio is complex and scientifically contested.

Therefore, they argue, there is a need to find better ways to facilitate participation by willing citizens, without pushing reluctant citizens to participate. Instead of evaluating cancer screening programs on the basis of participation rates, programs should be evaluated on informed decision rates, regardless of participation or non-participation.

Key points

• This study finds six categories of systematic influences applied to increase participation in national cancer screening programmes.

• The categories of influences work through psychological biases and personal costs of non-participation and might not be compatible with the citizens’ informed choice.

• Research on how to properly implement informed decision models as not to complicate participation for otherwise willing citizens are needed.

Methods of pressure and manipulation by the sanitary structures in France, in particular for breast cancer screening by mammography

We will take up the six methods of influence described and analyse their application in France, specifically concerning breast cancer screening which is our subject of concern. The shortcomings of information in France have been very well identified and described in the report of the citizen and scientific consultation on breast cancer screening (2015/2016) which, let us remember, called for a halt to this screening[8] (observations of multiple failures in the information given to women).

It is important to underline the incredible cynicism of the National Cancer Institute which uses this same publication to improve the participation rate in screening!

Indeed, on the Institute's website, in the section intended for doctors (thematic access "health professionals") this publication is quoted as a basis for improving the participation rate, ignoring the denunciation of the unethical character of the influence techniques by the authors of the study.

https://www.e-cancer.fr/Professionnels-de-sante/Veille-bibliographique/Nota-Bene-Cancer/Nota-Bene-Cancer-460/Categories-of-systematic-influences-applied-to-increase-cancer-screening-participation-a-literature-review-and-analysis

"Conducted on the basis of a systematic review of the literature (19 articles) and with the help of experts, this study identifies different types of influence allowing to improve the participation rate in screening programs." 

The critical analysis of the Rahbek et al. study is not mentioned at all...

Let's look at the information given to women according to the 6 categories of influence analyzed in the article.

a) Misleading presentation of statistics

Rahbek et al. cite the INCa booklet[9] in Table 5 of the supplements section of their study (TABLE 5. GREY LITERATURE SEARCH RESULTS) as an example of misleading presentation of statistical data, and they denounce the French booklet's presentation of mortality in terms of relative risks. In fact, in the French booklet, the reduction in the risk of dying from breast cancer (this so-called gain in mortality) is announced by INCa to be between 15 and 20%. We have also analysed this booklet and made the same observations about the misleading and embellishing information concerning the supposed gain in mortality from breast cancer screening [10].

When we visit the INCa website[11], which is supposed to guarantee proper information to the population, we immediately come across the same flaw denounced by the publication, here: https://cancersdusein.e-cancer.fr/infos/pourquoi-les-autorites-de-sante-recommandent-de-realiser-un-depistage/ : "International studies estimate that these programs can prevent between 15% and 21% of deaths from breast cancer."

The same presentation can be found again and always on the French Health Insurance website, in spite of the citizens' requests to avoid this pitfall, superbly ignored and scorned by these authorities, which are nevertheless heavily pinned for their failings, as can be seen on the website,

Here: https://www.ameli.fr/assure/sante/themes/cancer-sein/depistage-gratuit-50-74-ans

b) Misrepresentation of harms versus benefits

On the French Assurance Maladie website, it is impossible for a patient to obtain information on overdiagnosis or overtreatment. In the search box there are no hits.

But in the tab "organized breast cancer screening" you will find a video made by the INCa and a reference to the page of the Institute.

The benefits, on the official site of the INCa, are largely developed, and the harms are called here modestly the "limits of screening". In the small paragraph 'DIAGNOSIS AND TREATMENT OF SLOW PROGRESSIVE CANCER', overtreatment, a direct consequence of overdiagnosis for women, is never mentioned.

Overdiagnosis is indicated at a percentage of 10 to 20%, figures that are completely obsolete and have been revised upwards for a long time[12].

Even lower numbers appear on the page for professionals: "Based on published studies, overdiagnosis could be in the range of 1-10% or even 20%. " 

https://www.e-cancer.fr/Professionnels-de-sante/Depistage-et-detection-precoce/Depistage-du-cancer-du-sein/Les-reponses-a-vos-questions The same observation can be made on the site dedicated to breast cancer screening (Prevention and screening of breast cancer) where you will find exactly the same wording[13].

We had also carried out ourselves a quantitative evaluation of the informative value of this site where the inciting for screening is obvious[14].

The French brochures are again cited in the "supplements" of the Rahbek et al study, item 'MISREPRESENTATION OF HARMS VS BENEFITS'; the authors denounce the omission of overdiagnosis in the official brochures. To be more accurate, overdiagnosis is mentioned in the booklet but very much minimized, and the description of overtreatment, a corollary of overdiagnosis, is completely missing.

Still in the same section, Rahbek et al. denounce the omission by the official French brochures of the risk of exposure to ionizing radiation. We had also noted this point in the analysis of the booklet (reference 11). But in fact this point is mentioned on page 12 of the INCa booklet, which states that: "the risk of death from radiation-induced cancer is of the order of 1 to 10 per 100,000 women who have had a mammogram every 2 years for 10 years."

This is true, but it should be pointed out that this risk increases with the repetition of examinations and incidences. Let us recall that 3 mSv are received on average with a mammography (between 2 and 3 images per breast depending on the needs), which corresponds to already 9 months of annual irradiation (which is 4.5 mSv per year for a French person). 

c) Opt-out system

As mentioned above, this system is not used in France. However, if a woman does not go for screening, she will be reminded several times, sometimes even by text message, giving women the impression that screening is mandatory. However, this is not the case, screening is not mandatory  and we have provided a pre-filled form on the home page that women who do not wish to undergo mammography screening can send to their departmental screening structure. 15]

At the end of the INCa booklet, it is clearly stated "You cannot or do not wish to be screened. Fill in the questionnaire in the invitation letter and return it to the address indicated. Please be aware that you can change your mind at any time. "

d) Recommendations for participation

The argument of authority is widely conveyed by opinion leaders, a radiologist speaks on the home page of the "breast cancer prevention and screening" website.

In the midst of the Covid pandemic, we saw a renowned oncologist calling on women to continue screening, scaring them and arguing loudly that breast cancer would kill more than the pandemic. When we read that the 100,000 mark was passed in one year (breast cancer causes 12,000 deaths/year), we realize how sordid these counts seem and especially how some media doctors do not hesitate to exaggerate in order to convey inciting and frightening messages.[16]

The stars in France are not to be forgotten, as shown by the TV show " Naked Stars " where celebrities unveil themselves for " the good cause " with messages that are intellectually indigent and insufficient in terms of scientific information.[17]

In 2011, Marie-Claire published multiple photos of French stars who let themselves be photographed naked to "raise awareness" of breast cancer screening, allowing this media a considerable and profitable increase in its sales.[18]

e) Fear appeals.

The organization Pink Ribbon, formerly 'Cancer-du-Sein-Parlons-en' , broadcast a spot in 2015 based on messages related to death (breast cancer, the most common, the most deadly).[19]

The INCa is not lagging behind and in 2018 was published this poster: "This cancer is at the same time the most frequent and the most deadliest in women. Yet if it is detected early, the treatments are generally less burdensome and the chances of recovery greater."

https://www.e-cancer.fr/Expertises-et-publications/Catalogue-des-publications/Depistage-du-cancer-du-sein-2018-Affiche-sans-zone-de-repiquage

Cancer is constantly associated with a verdict of death, so much so that the medical, societal and media messages are based on a military and bellicose jargon: cancer is an enemy that will inexorably invade the body. The patient either wins or succumbs, despite the "therapeutic arsenal" or the "fight" led by the patient. As soon as a cancer is diagnosed at the mammogram, the feverishness that the doctor shows in making appointments for his patient for other examinations and surgery reinforces the idea of imminent death for the patient. Each newly diagnosed woman feels banished from the world of "normality" and threatened with expulsion from the social system (work, family, insurance, bank, etc.). The stress that some women feel after the announcement is such that they lose all control over their lives, professionally, emotionally and in their families. And this is very well recognized by the other women in the family, friends or professional environment.

f) Influence on general practitioners and other health professionals

In France this is the ROSP system (remuneration on public health objectives)[20].

See here:

https://www.ameli.fr/seine-saint-denis/medecin/exercice-liberal/remuneration/remuneration-objectifs/medecin-traitant-adulte

Note that on the site dedicated to professionals [21], the risk of "unnecessary mutilation of women screened by excess" is well recognized, the controversy and the consultation of 2016 are mentioned, nevertheless the premium is maintained (according to web page of December 29, 2020).

But even worse is the financial incentive offered to the women themselves. Indeed, in 2020 the INCa organized a masquerade of consultation[22] where one item caught our attention, as it proposed to pay women this time in order to bring them to screening.

A citizen has expressed her concern in an article published in the JIM, denouncing the lack of ethical consideration in this proposal for "paid participation"[23].

The manipulation of women is a real scientific topic

To read here: https://cancer-rose.fr/en/2020/12/17/manipulation-of-information/

CONCLUSION

Rahbek et al have perfectly identified the shortcomings of the information provided to the public on screening in general, information that remains globally often inciting, which goes against the ethical objectives that we owe to the patient.

The shortcomings and failings of the official French brochures were noted, including those of the INCa, an institute that is supposed to protect the patient.

The booklet of the INCa, already quite imperfect, is sent to women eligible for screening only once at the time of their first convocation when they are 50 years old. In 2017, when the booklet was published, women aged 50 who were first called for screening received it, but women over 50 at that time will never receive it.

And what can be said about the INCa's multi-language brochure, which is even more succinct?

From our point of view, we can only be dismayed and distressed to see to what extent the demands of French citizens, who had, during the 2016 consultation, identified the same problems, have remained unheard and scorned by the French authorities.

ANNEX: 

You will find here a table annexed with the original publication, showing the research of the so-called 'grey' literature (brochures and information websites). French brochures are named in several items of misleading communication of data (yellow highlighting).

We have selected for presentation in our article only the examples concerning breast cancer screening, by mammography.

We found that these examples account for about 60% of the total number of examples for all cancers combined: prostate, breast, cervical and colorectal. We can conclude that there is a preferential communication, a hype around breast cancer screening, compared to other cancers.

Table here:

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

The authors

Joseph Rahbek

Master student Department of Public Health, Section of General Practice
Research Unit for General Practice, Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen K, Denmark

Christian P. Jauernik

The Research Unit for General Practice, Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen K, Denmark

Thomas Ploug

Thomas Ploug is Professor of ICT (Information and Communication Technology) Ethics at the Department of Communication and Psychology at Aalborg University in Copenhagen. He holds a Master of Philosophy from the University of Copenhagen and a PhD in ICT ethics from the University of Southern Denmark. His research interests and projects cover topics in different areas of applied ethics, such as ICT ethics, medical ethics and bioethics. He is currently involved in projects on online and offline consent behavior in the health context, and nudging in the health sector. He is head of the research group on communication and information studies, director of the Centre for Applied Ethics and Philosophy of Science, member of the Danish Council of Ethics and the clinical ethics committee of Rigshospitalet, Copenhagen.

John Brodersen, Professor, University of Copenhagen

https://publichealth.ku.dk/staff/?pure=en%2Fpersons%2Fjohn-brodersen(0f06ffbd-c5c4-4560-aac7-f0bfdf8e86e7).html

John Brodersen, the senior author of this article, is a general practitioner with more than ten years of experience in clinical practice. Dr. Brodersen holds a PhD in public health and psychometrics and works as an associate research professor in medical screening at the University of Copenhagen, Department of Public Health, Research Unit and Section of General Practice.

His work was used in the development of the 2020 WHO Screening Guide, which builds on the background papers written by John Brodersen for the 2019 WHO European Technical Consultation on Screening.

https://apps.who.int/iris/bitstream/handle/10665/330852/9789289054799-fre.pdf

He is also a co-author of the 2012 Cochrane booklet on mammographic screening.https://www.cochrane.dk/sites/cochrane.dk/files/public/uploads/images/mammography/mammografi-fr.pdf

He is a member of the Board and Scientific Committee of the non-profit organization "Preventing Overdiagnosis "https://www.preventingoverdiagnosis.net/?page_id=6

His research focuses on the development and validation of questionnaires to measure the psychosocial consequences of false positive screening results. Dr. Brodersen has published numerous articles in peer-reviewed journals.

In the area of self-diagnosis and screening, Dr. Brodersen specializes in the areas of sensitivity, specificity, predictive values, overdiagnosis, informed consent, and psychosocial consequences for healthy individuals when tested.

He also teaches nationally and internationally on evidence-based medicine.

PhD thesis:Brodersen, J 2006 , Measuring the psychosocial consequences of false positive screening results - breast cancer as an example, PhD thesis, Månedsskrift for Praktisk Lægegerning, Department of General Medicine, Institute of Public Health, Faculty of Health Sciences, University of Copenhagen. Copenhagen

REFERENCES

[1] European Network for Prevention and Health Promotion in Family Medicine and General Practice. Available at: http://europrev.woncaeurope.org/

[2] Nordic Risk Group. Available at: http://nordicriskgroup.net/

[3] Preventing Overdiagnosis. Available at: http://www.preventingoverdiagnosis.net/

[4] Wiser Healthcare. Available at: http://wiserhealthcare.org.au/

[5] https://cancer-rose.fr/en/2020/12/18/perception-and-reality-2/

[6] Gotzsche PC, Hartling OJ, Nielsen M, et al. Breast screening: the facts–or maybe not. BMJ 2009;338:b86.

[7] https://cancer-rose.fr/en/2021/04/02/screening-propaganda/ (part OPINION LEADERS AND MEDIA)

[8] http://www.concertation-depistage.fr/wp-content/uploads/2016/10/depistage-cancer-sein-rapport-concertation-sept-2016.pdf

  • page 125, le constat d'une information inadaptée.
  • page 57 : les incitations financières
  • pages 85, 92, 93, 115 : la communication "lacunaire" de l'INCa
  • pages 95, 96 jusqu'à 100 : la communication 'simpliste' de l'Assurance Maladie
  • page 133 : les deux scénarios proposés par le comité de pilotage pour l'arrêt du dépistage mammographique.

[9] https://cancersdusein.e-cancer.fr/infos/un-livret-sur-le-depistage-pour-sinformer-et-decider/ ou https://www.e-cancer.fr/Expertises-et-publications/Catalogue-des-publications/Livret-d-information-sur-le-depistage-organise-du-cancer-du-sein

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

[11] https://cancersdusein.e-cancer.fr/

[12] https://cancer-rose.fr/en/2020/12/17/mammography-screening-a-major-issue-in-medicine/

[13] https://cancersdusein.e-cancer.fr/infos/les-benefices-et-les-limites-du-depistage/

[14] https://cancer-rose.fr/en/accueil-english/

[15] https://cancer-rose.fr/wp-content/uploads/2019/07/Droit-dopposition_Mammos.pdf

[16] https://cancer-rose.fr/en/2021/04/02/screening-propaganda/

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

[18] https://cortecs.org/wp-content/uploads/2016/03/CorteX_mammo_sophie_davant.png

[19] https://www.youtube.com/watch?v=y7widbIFUb8

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

[21] https://www.ameli.fr/seine-saint-denis/medecin/exercice-liberal/remuneration/remuneration-objectifs/medecin-traitant-adulte

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

[23] https://cancer-rose.fr/en/2021/02/14/getting-paid-to-be-screened/

[24] https://www.e-cancer.fr/Expertises-et-publications/Catalogue-des-publications/Depliant-d-information-en-langues-etrangeres-sur-le-depistage-organise-du-cancer-du-sein

 

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


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