By ANNETTE LEXA, Toxicologist PhD
OCTOBER 20, 2019
Mass screening for breast cancer is a technocratic monster inscribed in the law by ministerial order.
It is supposed to be based on the 9 pillars of public health policies. In its wording itself, it flouts the principle of knowledge [1] according to which objectives and actions must take into account the best available knowledge and, conversely, knowledge must meet the need for information to enlighten decisions. However, to date no study has confirmed the effectiveness of screening, based exclusively on the dogma "the earlier a cancer is detected, the better it is cured", which has not been validated in reality as mortality has not decreased since the system was introduced more than 25 years ago.
But it is even worse. The ministerial decree strongly encourages healthy women aged 50 and over to be regularly exposed to ionizing radiation from medical imaging (mammography and synthetic tomography).
The International Commission on Radiological Protection (ICRP) has established principles and values of radiation protection in order to protect populations and individuals [2]. These major principles and values are based on the regulatory use of the linear no-threshold model, which remains a conservative but contested basis [3] in view of recent discoveries in radiobiology. This probabilistic model is based on the dose-response relationship, which postulates that the number of radiation-induced cancers varies linearly with the dose received in an irreversible and cumulative manner and "without threshold" below which an exposure could be considered as having no effect.
Each ionizing particle passing through an organism has a certain probability of hitting the DNA; each impact causes a mutation that has a probability of moving to a stage leading to the initiation of cancerous proliferation. Therefore, overall probability of observing a cancer can only increase linearly with the dose received. Today we know that there is a fundamental inequality between individuals. Each individual has his or her own specific threshold of tolerance to ionizing radiation. Delivering the same dose to all while a non-negligible fraction (5 to 20%) of population has a risk of radiation-induced cancer 10 times higher than the norm is not acceptable. [4]
What are the currently recommended doses?
The recommended doses were enacted in 1991 by the International Commission on Radiological Protection (ICRP). They are valid for entire human population and do not take into account invidual susceptibilities. The commission estimates natural irradiation (radon, telluric, cosmic) at 2.5 mSv/year, average medical irradiation at 1.2 to 2 mSv/year and civil nuclear at 0.2 mSv/year.
Not everyone is equal because there are radon regions and others are not, with radon alone representing 1.2 mSv/year.
In addition, the consumption of medical imaging procedures is exploding with 70 million procedures in France per year (3), and, again for France, the annual dose received for medical diagnosis is 1 mSv/ inhabitant/year on average but can reach 20 mSv/year according to the Academy of Medicine itself, which does not hide its concern [5]. Women undergo more than men, due to the societal obsession with the breast, an accessible but sensitive organ. In the context of breast cancer screening, a woman who is not ill and is still young can also receive a much more radiant tomosynthesis exam, in a doctor's office without being warned of the risk involved. And many women are exposed from the age of 25-30 years by careless practitioners.
For the population, the dose is limited to 5 mSv per year, the maximum tolerable lifetime dose is 70 mSv.
However, doses received during medical imaging exams can lead to an excess of this limit, without taking into account individual susceptibility. For example, the monitoring of scoliosis in young girls in the past generated a dose of 0.11 Sv to the mammary gland.
Perez A-F, et al. Low radiation doses: towards a new reading of risk assessment? Bull Cancer (2015), http://dx.doi.org/10.1016/j.bulcan.2015.03.019
Mammography generates 2 x 2 mGy images spaced 3 minutes apart. Double-strand breaks (DSB) - a source of gene instability leading to the development of cancer - appear as early as 1mGy and the effect is significant around 100-300 mGy. Radiosusceptible individuals with delayed transit of the ATM repair protein simply cannot repair or poorly repair these DSBs in less than 3 minutes, and thus DSBs accumulate during mammography. The risk is all the higher the younger woman is, the more she is unaware of her radiosusceptibility status, and the more the examination is repeated every year or every 2 years. 6] (see the bibliography of Nicolas FORAY's work).
THREE MAIN PRINCIPLES OF THE RADIATION PROTECTION SYSTEM
- The rationale that states that any decision to subject a person to even the weakest possible source of ionizing radiation should do more good than harm. A sufficient benefit must be obtained to offset any costs or negative consequences. Ionizing radiation sources should not be used if there are other alternatives (e.g., no radiography if similar results are obtained with an ultrasound, it is up to physician and radiologist to make the trade-off between benefit and risk, the benefit a person receives from examination must outweigh radiological risk). Practitioners remain primarily responsible for justifying procedures they request or perform.
- The optimization of exposures to these radiations which must be at the lowest possible level;
- The limitation stating that individual exposures must not exceed dose limits recommended by the ICRP in order to avoid occurrence of stochastic (= random) effects. Each country defines regulatory limits based on ICRP recommendations.
ESSENTIAL ETHICAL VALUES UNDERLYING THE RADIATION PROTECTION SYSTEM (2) [7] [7]
Beneficence and non-maleficence
Beneficence means doing good, and non-maleficence means not doing harm. These two related ethical values have a long history in moral philosophy, going back to the Hippocratic Oath, which requires a physician to do good and avoid harm. The use of radiation, although coupled with certain risks, can undoubtedly have desirable consequences, such as improved diagnosis and cancer therapy in medicine. But these must be weighed against harmful consequences. One of the main challenges in beneficence and non-maleficence is how to measure benefits versus harm and risks involved. Moreover, such an assessment must be done in a transparent manner.
Prudence
Prudence is the ability to make informed and carefully considered choices in full knowledge of the implications and consequences of actions. It is also the ability to choose and act on what is in our power to do and not do.
Justice
Justice is generally defined as fairness in distribution of advantages and disadvantages: fair compensation for losses (reparation), fairness of rules and procedures in decision-making processes. First, the principle of fairness in situations reflects personal circumstances in which individuals are involved. This is the role of regulatory dose limits, of compliance with protocols in order to reduce exposures in individuals subjected to the same radiation exposure (see the Toul irradiated persons case).
Inequality can also be seen as the inequity between the doses received by screened non-sick women, especially the youngest, compared to non-sick and unscreened women who are therefore less irradiated.
Dignity
Dignity is an attribute of human condition. It means that every individual deserves unconditional respect, regardless of age, gender, health, social status, ethnic origin, and/or religion. It is the principle of the Universal Declaration of Human Rights which states that all people are born free and equal in dignity and rights.
Personal autonomy is a corollary of human dignity: individuals have the capacity to act freely in order to be able to make informed decisions. This principle is found in "informed consent" in medicine, a principle that states that a person has the right to accept risk voluntarily and has an equal right not to accept it. This informed consent is of paramount importance when it comes to patients who are not seriously ill but are still young and healthy and who are being incited to be screened for cancer and the likelihood of being affected is very low.
PROCEDURAL VALUES OF THE RADIATION PROTECTION SYSTEM
- Responsibility: individuals responsible for making decisions are accountable for their actions to all those who may be affected by these actions. In terms of governance, this means the obligation of individuals or organizations to account for their activities, to take responsibility and to be prepared to be accountable.
==> The sponsors of the MyPebs study, which aims to recruit women aged 40 and over to compare mass screening with a personalized form of screening, will be accountable in terms of radiation protection and will assume their responsibility when the time comes (and we will make sure they do).
- Transparency means "openness to decisions and activities that affect society, economy, and environment and willingness to communicate them clearly, precisely, quickly, honestly".
Transparency does not simply mean communication or consultation, it means accessibility to information about activities, deliberations and decisions involved and honesty with which this information is conveyed. This transparency implies that all relevant information is provided to persons concerned.
Thus, informed consent has been developed in the context of medical ethics. The prerequisites of informed consent include :
- information (which should be appropriate and sufficient)
- understanding
- volunteering (avoid undue influence)
- all of this associated with the right of refusal and withdrawal (without any prejudice such as the idea that had germinated in the sick brains of a few in the 90s, to withdraw the social rights of women who would not get screened).
For vulnerable people with limited or diminished abilities (people with disabilities, in prison, interned in psychiatric hospitals, etc.), for weak people under the influence of extorting or threatening doctors, for pregnant women, additional protection both in terms of consent and strict evaluation of the benefit/risk ratio is doubly necessary.
However, the 2006 Order [8] (7) went so far as to incite territorial officials to recruit, without information on the radio risk involved, women living in the Guyanese forest, handicapped, in prison, in order to increase the percentage of participation in mass screening for breast cancer, which is an obvious abuse of weakness.
==> By not communicating with women concerned in an honest and transparent manner about the radiation-induced risk and the intrinsic inequality of associated individual risk, mass screening for breast cancer does not respect this ethical value.
Worse, the My Pebs study (https://cancer-rose.fr/my-pebs/), funded by public money at the European level, does not respect this elementary ethical value, since it is to date impossible to freely dispose of the protocol and women recruited are not informed of the radio-induced individual risk, all the more so as they are younger (inclusion planned from the age of 40).
-Inclusivity
This is stakeholder participation, which involves all parties concerned in the decision-making processes related to radiation protection.
==> The 2016 citizens' consultation obviously did not respect this fundamental value of radiation protection.
CONCLUSION
By exposing women who are not ill, to ionizing radiation (mammography, tomosynthesis...), mass screening flouts the principles of justification, optimization and limitation of the radiation protection system as they currently exist, i.e. without taking into account individual inequality.
So obsessed with the promise of a fantasized benefit, screening has become blind to the inconsiderate risk it poses to non-ill women by subjecting them to unnecessary examinations, dangerous technologies (tomosynthesis) and without taking into account other possible doses received during the year.
Mass screening - and its uncontrolled extension to young women - flouts the fundamental ethical values of the radiation protection system, which are non-maleficence, prudence, justice (individual inequality in relation to radiation), transparency (lack of communication about individual risk) and inclusiveness in the participation processes.
The same is true of the My Pebs study, which intends to recruit 85,000 so-called "volunteer" women without informing them faithfully of the radiation risk involved, in defiance of the most elementary values of the radiation protection system.
- But why so much malevolence and so little ethics, we can ask?
- Because nature hates emptiness,
- Because idea of doing nothing is unbearable in our mercantile society,
- Because France hates the idea of citizens having ability to act freely in order to make informed decisions,
- Because lure of gain ignores the principle of non-maleficence, prudence, dignity and equality regarding radio-induced risk.
- Because there are lobbies (Europa Donna, etc.)
- Because women have a propensity to subordinate themselves to medical authority from which they are struggling to emancipate themselves, and the market knows it.
Bibliography
[1] Plaidoyer pour l’abrogation de l’arrêté ministériel du 29 septembre 2006 encadrant le dépistage du cancer du sein , Annette LEXA, 2016.
[2] ICRP, 201X. Ethical foundations of the system of 37 radiological protection. ICRP Publication 1XX. Ann. ICRP XX(X), 1–XX.
http://www.icrp.org/docs/TG94%20Draft%20for%20Public%20Consultation%20(20April2017).pdf
[3] https://fr.wikipedia.org/wiki/Lin%C3%A9aire_sans_seuil
- Argument in favor of the linear no-threshold model: Epidemiological studies have shown an increased risk of cancer at doses of 10 mGy. The carcinogenic effect of doses of the order of 10 mSv is proven in humans. From 10 mGy, the linear no-threshold relationship correctly reflects the dose-response relationship in the Hiroshima and Nagasaki cohort. At doses below 10 mSv, the irradiated cells are crossed by only one trajectory and the effect of each trajectory is an independent stochastic event. The nature of the lesions thus caused and the probability of repair and elimination of the damaged cells do not depend on the dose or the flow rate. The probability that an initiated cell will give rise to cancer is not influenced by lesions in neighboring cells or adjacent tissues.
- Some of the arguments in its favour have lost some of their value, in particular due to numerous results from radiobiology laboratories: Even if ionizations are independent, there may be group effects via cellular communication mechanisms; The efficiency of chromosomal damage repair is directly dependent on the dose rate, with the possibility of hypersensitivity to very low rate radiation; The development of cancer depends not only on an isolated cell but also on the surrounding tissues, which may contribute to its evasion of the immune system; The effects of one irradiation at a given time may depend on previous irradiations (adaptive response).
To these arguments against, we must now add individual susceptibility (genetic and epigenetic) leading a non-negligible part of the population (about 20%) to a risk of radio-induced cancer according to its own tolerance threshold, previously neglected in studies mixing radio-induced and spontaneous cancer with age.
[4] MODULE NATIONAL D'ENSEIGNEMENT DE RADIOPROTECTION DU DES DE RADIOLOGIE, Principes et mise en œuvre de la radioprotection, Drs J.F. Chateil, H. Ducou Le Pointe et D. Sirinelli, 2010. http://www.sfrnet.org/data/upload/files/10_objectifs_et_principes.pdf
[5] De l’usage des Rayons X en radiologie (diagnostique et interventionnelle), à l’exclusion de la radiothérapie. Rapport et recommandations. Dubousset J., Académie Nationale de Médecine, 2016. http://www.academie-medecine.fr/de-lusage-des-rayons-x-en-radiologie-diagnostique-et-interventionnelle-a-lexclusion-de-la-radiotherapie-rapport-et-recommandations/
[6] https://cancer-rose.fr/en/2020/12/29/predictive-test-for-radiotherapy-reactions-women-at-high-risk/
[7] https://cancer-rose.fr/en/2020/12/15/radiotoxicity-and-breast-cancer-screening-caution-caution-caution/
[8] Arrêté du 29 septembre 2006 relatif aux programmes de dépistage des cancers
https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000000460656