Caution of the Council of European Union regarding screenings extension

By Cancer Rose, December 11, 2022

In September 2022, the European Commission issued recommendations for a new approach to screening.
We wrote about it here: https://cancer-rose.fr/en/2022/09/24/a-new-eu-approach-to-cancer-screening/

The European Commission proposed an extension and/or a reintroduction of some screenings and an implementation of new ones, some of which do not exist ( gastric cancer screening)...
The objective is that by 2025, 90% of the EU population should be screened for breast, prostate, cervical and colorectal cancer.
Lung and gastric cancer screenings would be added, although no conclusive study exists for the latter.
We are relieved that the Council of the European Union has not followed these recommendations and has been cautious. In this month of December is published the adopted text which we will analyze.

Comparison of press releases
Comparison of the recommendations between the initial proposal and the adoption of the final recommendations by the member states
Summary of breast cancer screening recommendations
Recap of the lung cancer screening controversy
Reminder of the prostate cancer screening controversy
Conclusion
Reactions
Reaction of WONCA

Comparison of press releases

Below is a comparison between the original draft from September 2022 and the one issued in December 2022, which presents the adopted final recommendations.

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Differences between the proposal and the adopted text are highlighted :

- For cervical and colorectal cancer, more moderate terms are used on the use of tests, described as a "preferred" tool for cervical cancer screening or as a "preferred screening" regarding immunochemical tests for colorectal cancer screening.

- For the three new screening tests (lung, gastric, prostate cancers), the Council invites to carry out research beforehand to study the feasibility and effectiveness of these tests and therefore refrains from introducing them as initially recommended.

- For breast cancer, the recommendation remains between 50 and 69, and screening is only suggested between 45-74 (not "recommended" as initially intended by the EC).
It should be noted that screening at 45-50 years was already initially only "suggested."

Comparison of the recommendations between the initial proposal and the adoption of the final recommendations by the member states

Caution: link modification for the new proposal for a Council Recommendation (CR) on Strengthening prevention through early detection: A new approach on cancer screening replacing CR 2003/878/EC https://health.ec.europa.eu/publications/proposal-council-recommendation-cr-strengthening-prevention-through-early-detection-new-approach_en

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Here are the main improvements in the final text and the precautions retained by the decision-makers:

  • The Junger and Wilson* principles are recalled, which should be applied as well as other criteria set out by the WHO to assess the feasibility of screening before its implementation
  • The risks of overdiagnosis (with a clear definition) and overtreatment were added, as well as the need for information.
  • Technical support for informed decision-making is mentioned
  • The notion of "screening effectiveness" is finally defined by mentioning that the decrease in specific mortality and the decrease in the incidence of invasive cancers defines it.
  • It is recalled that for lung and prostate screening, the evidence is limited
  • It is emphasized that aspects of the health system's capacity to support screening and the resources required must be considered.
  • "Screening should be offered when there is evidence that screening improves specific mortality" is replaced by "screening should be offered when the benefits and risks are well known, and benefits outweigh the risks."
  • Regarding cost-effectiveness, this should be considered at the national level
  • It is recalled that screening tests (for the 3 current screenings (cervical, colo-rectal and breast cancers) and for 3 new screenings (lung, gastric and prostate cancers) to be studied) should be offered only if it is proven that the Junger and Wilson criteria outlined by the WHO are met and that information on benefits and risks is reliable.
  • Emphasis is placed on considering national capacities and priorities when implementing new screening programs.
  • The objective of 90% of the European population to be offered all 3 screenings (breast, colorectal, and cervical) by 2025 is removed from the text (probably unrealistic).
  • In informing the population, the benefits and risks, including overdiagnosis and overtreatment, must be presented, potentially through an exchange between the patient and the health professional, for an informed decision made by the patient.
  • For new screening tests, the implementation should be considered only after randomized trials with scientific evidence of effectiveness.
  • It is also necessary to work and cooperate on predictive tests and algorithms to reduce overdiagnosis and overtreatment.
  • The need to have scientific evidence (evidence-based) is recalled, and the term "risks" is added next to "benefits" in the evaluation of screening programs,
  • Technical support with information activities, where relevant, for the general public and stakeholders about the benefits and the risks of participation in the screening programmes, taking into account the principles of health literacy and informed decision-making, could be provided.

*Junger and Wilson's principles for implementing screening:

What are the criteria used by the WHO to determine the appropriateness of screening?

The 10 criteria used by the WHO are:

- The disease studied must present a major public health problem
- The natural history of the disease must be known
- A diagnostic technique must be able to visualize the early stage of the disease
- The results of the treatment at an early stage of the disease must be superior to those obtained at an advanced stage
- Sensitivity and specificity of the screening test should be optimal
- The screening test must be acceptable to the population
- The means for diagnosis and treatment of abnormalities found in screening must be acceptable.
- The screening test should be repeatable at regular intervals if necessary
- The physical and psychological harm caused by screening should be lower than the expected benefit
- The economic cost of a screening program should be outweighed by the expected benefits

Summary of breast cancer screening recommendations

- 1) Current European guidelines for 45-50 and 70-74-year-olds

The current guidelines, published on the European website, do not recommend screening for women aged 45-50 and 70-74 but only "suggest" it.

https://healthcare-quality.jrc.ec.europa.eu/european-breast-cancer-guidelines/screening-ages-and-frequencies/women-45-49

https://healthcare-quality.jrc.ec.europa.eu/ecibc/european-breast-cancer-guidelines/screening-ages-and-frequencies#recs-group-70-74

These guidelines, which date from 2019, are published in the journal :https://www.acpjournals.org/doi/10.7326/m19-2125

The supplement provides the table with the current recommendations that "suggest" but do not recommend screening between the ages of 45-50 and 70-74.

https://www.acpjournals.org/doi/suppl/10.7326/M19-2125/suppl_file/M19-2125_Supplement.pdf

- 2) European Commission proposal to extend screening to the age range 50-69 to 45-74

In September 2022, the European Commission attempted an extension of the cut-off points with a proposal to change the guidelines

PROPOSAL:

Text, page 1: https://health.ec.europa.eu/publications/proposal-council-recommendation-cr-strengthening-prevention-through-early-detection-new-approach_en

“Extending breast cancer screening from women aged 50 to 69 to include women between 45 and 74 years of age and to consider specific diagnostic measures for women with particularly dense breasts;"

Annex page 1

https://health.ec.europa.eu/publications/annex-proposal-council-recommendation-cr-strengthening-prevention-through-early-detection-new_en

« Breast cancer: 
Breast cancer: Breast cancer screening for women starting aged 45 to 74 with digital mammography or digital breast tomosynthesis 1 , and for women with particularly dense breasts consider magnetic resonance imaging (MRI), where medically appropriate."

- 3) EU Council counter-proposal: no change to current guidelines, no extension to include 45-74 year olds, screening not recommended but only suggested for ages 45-50 and 70-74

In response to this proposal, the Council of the European Union, in the text published on 9 December 2022, did not adopt this extension.
The guidelines for the 45-50 and 70-74 age groups have remained the same (identical to the current guidelines)

Annex, page 21

https://data.consilium.europa.eu/doc/document/ST-14770-2022-INIT/en/pdf

“Breast cancer:
Considering the evidence presented in the European guidelines 9, breast cancer screening for women aged 50 to 69 with mammography is recommended. A lower age limit of 45 years and an upper age limit of 74 years is suggested. The use of either digital breast tomosynthesis or digital mammography is suggested. The use of magnetic resonance imaging (MRI) should be considered when medically appropriate."

Recap of the lung cancer screening controversy

We have reported on the lung cancer screening controversy and subsequent reactions and publications here, updated to March 2022: https://cancer-rose.fr/en/2021/02/24/being-a-woman-and-smoking-x-rays-in-perspective/

Reminder of the prostate cancer screening controversy

Here's a reminder about prostate cancer screening and why the French National Authority for Health does not recommend it:
https://cancer-rose.fr/en/2021/02/11/parallel-to-breast-screening-prostate-screening-overdiagnosis-as-well/

https://www.has-sante.fr/jcms/c_1238318/fr/cancer-de-la-prostate-identification-des-facteurs-de-risque-et-pertinence-d-un-depistage-par-dosage-de-l-antigene-specifique-de-la-prostate-psa-de-populations-d-hommes-a-haut-risque

"To date, there is no robust demonstration of the benefit of prostate cancer screening by prostate-specific antigen (PSA) testing in the general population, either in terms of reduced mortality or improved quality of life. Thus, no prostate cancer screening program is recommended in the general population, in France, in the United States, New Zealand, or the United Kingdom."

Conclusion

The Council stresses the need for further evidence on the effectiveness, cost-effectiveness, and feasibility of specific screening strategies in real-life settings.
Member States are invited to consider the implementation of the mentioned cancer screenings based on conclusive scientific evidence while evaluating and deciding at the national or regional level based on the burden of disease and available healthcare resources, the balance of benefits and harms, and the cost-effectiveness of cancer screening, as well as the experience from scientific trials and pilot projects

For breast cancer: a low limit of 45 years and a high limit of 74 years are suggested (not recommended as in the original proposal).(The inclusion of MRI for women with dense breasts is highly debated; see https://cancer-rose.fr/2022/04/26/grosse-deconvenue-pour-lirm-mammaire/)

The Council adopts a moderate position for the new screenings (prostate, lung, gastric cancers), inviting further research to assess the feasibility and including the notion of effectiveness.
For lung cancer, the program should also include primary (tobacco control) and secondary prevention strategies.
For gastric cancer, the proposal for immediate implementation is deleted, and feasibility tests are requested.

Reactions

The reaction of the European Commissioner who initiated the project of new recommendations:

Today’s adoption by the Council of new EU recommendations for cancer screening is a milestone for cancer care both at national and European level. 20 years have passed since the current recommendations were adopted and medicine has made incredible advances. It is high time that new, up-to-date, screening recommendations are rolled out across the EU and that the unacceptable disparities in access are addressed. Whilst I would have liked to see an even more ambitious approach, today represents a watershed moment for citizens in the EU and a key achievement for Europe’s Beating Cancer Plan.
Stella Kyriakides, Commissioners for Health and Food Safety - 09/12/2022

The protest letter of the European Cancer Organisation (gathering urologists, radiologists, gastro, oncologists, ...) 

https://www.europeancancer.org/screening

" Late interventions to insert excessive caution and reduced ambition

...However, following a closed meeting of Member State representatives on Monday 24 October we understand that significant rewriting of the Commission’s proposal has taken place to:

  • Undermine and contradict advice provided by the EU’s Group of Chief Scientific Advisors, particularly with regards to the addition of new cancer screening programmes and areas for update in respect to tumour types presently covered in the 2003 EU Council Recommendations;
  • Delete from the text the Beating Cancer Plan targets on screening uptake;
  • Insert whole new sections stating every potential and historic cited risk of cancer screening;
  • Impose specific criteria each EU member state should use in making decisions on cancer screening,
  • Insert exaggerated emphasis on national prerogatives for countries to exempt themselves of the recommendations;
  • Dilution of advice on meeting the psychological needs of those diagnosed with cancer as a result of screening; and,
  • Weakening of sections relating to the need for fit for purpose systems for recording and publishing information on screening performance. "

Members - European Cancer Organisation

Reaction of WONCA

EUROPREV Statement about European Commission announcement of a new EU approach on cancer detection

https://europrev.eu/2022/11/27/statement-about-a-new-eu-approach-on-cancer-detection/

November, 27, 2022

EUROPREV – the European Network for Prevention and Health Promotion in Family Medicine and General Practice

EUROPREV is one of the five network of WONCA Europe

WONCA Europe
The European Regional Branch, WONCA Europe, is the academic and scientific society for general practice/family medicine in Europe, that  represents 47 member organisations and more than 90,000 family doctors in Europe. 

WONCA World 
WONCA is an acronym comprising the first five initials of the World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians. The short name is the World Organization of Family Doctors. WONCA was established by 18 members in 1972. It currently consists of 122 member organisations in 102 countries, with a total of 500,000 family doctors. WONCA represents and acts as an advocate for its constituent members at an international level, where it interacts with world bodies such as the World Health Organization. It is comprised of seven regions: Africa, North America, Asia Pacific, Europe, South Asia, Iberoamericana-CIMF and WONCA East Mediterranean Region.

PDF version

In cancer screening, often less is MORE 

To the European Commission – Health and Food Safety
To Directorate-General Health & Food Safety
To European Union Health Authorities
To European Family Medicine and Public Health professionals

 Last September 20th, the European Commission announced: “A new EU approach on cancer detection – screening more and screening better”.(1)
Among others, the new recommendations include: 
– The extension of the target group for breast cancer screening to include women between 45 and 74 years of age (as compared to the current age bracket of 50 to 69);
– Lung cancer testing for current heavy and ex-smokers aged 50-75.
– Prostate cancer testing in men up to 70 on the basis of prostate specific antigen testing, and magnetic resonance imaging (MRI) scanning as follow-up.

Considering the best available scientific evidence, we call your attention to the following facts:

Breast cancer screening

– For every 2000 women screened with annual mammography for ten years, one death of breast cancer will be prevented. But, at the same time, 200 women will suffer the long-lasting consequences of having a false positive result, and ten women will be overdiagnosed and overtreated including all the harms from being labelled as a cancer patient to side-effects and late effects of cancer treatment. Therefore, the balance between benefits and harms is unclear, and every woman should be given this information.(2)

– The extension of the target group will relatively increase the harm and diminish the benefits associated with this screening. Increased harm: younger women have denser breast tissue, and this increases the rate of false positives and elderly women have a higher competing risk of dying from other reasons than breast cancer and thereby the risk of overdiagnosis will increase. Diminished benefits: the incidence of breast cancer is much lower among women aged 45-49 and thereby the reduction in mortality is in absolute numbers much smaller and in elderly women the expected benefit from a mortality reduction is much less likely due to their shorter expected lifespan.

Prostate cancer screening

– If best available evidence is used from two independent institutes: the Cochrane Collaboration and the USPSTF, then there is robust evidence of no mortality reduction from PSA screening. If cherry picking the evidence, than in best case scenario is has been shown that for every 1000 men screened with PSA, two avoid death from prostate cancer. But, at the same time, 155 men will experience a false alarm. Usually, this is associated with unnecessary tissue removal. And 51 men will be overdiagnosed and unnecessarily treated, with significant deterioration of the quality of life (urinary incontinence, erectile dysfunction).(3)

– The potential harm associated with this screen is of great concern, and this is why, until now, no population-based prostate cancer screening programs have been implemented in Europe.  

Lung, gastric and other cancer screenings

– The available evidence about the benefits and harms of this screening is still scarce. There are also concerns about false positives and overdiagnosis with these screening programs. No population-based cancer screening program should be implemented without adequately designed randomized controlled trials in European populations assessing the balance of benefits and harms related to each screening.(4)

The myth of early diagnosis

According to the European Commission, these new recommendations aim “to increase the number of screenings, covering more target groups and more cancers“. 

Although well intended, this will, in practice, translate into more healthy people unnecessarily transformed into patients – overdiagnosis. 

In addition, and again although well intended, this will, in practice, translate into more suffering, cancer, and costs to health systems that are already overloaded and with scarce resources.

Finally, and again, although well intended, in a perspective of the climate crisis, carbon emissions of such low-value care interventions, as the suggested screening programs, are not sustainable. Moreover, these programs will increase social inequity in health and promote the inverse care law.

The EU Commission’s proposal is based on a medical myth. According to the EU Commission statement, “The sooner cancer is detected, it can make a real difference by increasing treatment options and saving lives”. In screening, this is a myth. We now have data from population-based screening programs showing that the critical factor in reducing mortality of cancer is not related to early diagnosis but to good access to healthcare and new cancer treatments.(5–7)

In cancer, very often, early diagnosis means only more burden of disease, with more suffering. 

OUR RECOMMENDATION 

The current EU Commission proposal needs to be revised.

If we really want to improve the way cancer is handled in Europe, then the focus should be:

– Primary prevention: on a population level improve diet, increase physical activity, diminish smoking and lower the consumption of alcohol. Structural societal interventions has with robust evidence of high quality been shown to be effective, while primary preventive intervention on an individual level has been shown to have no – or only short-term effect.

– Good access to Primary Healthcare Care. Every European citizen should have the right to have their Family Doctor, and this means having the right to be cared for by doctors with a specialty in Family Medicine in a trustful relationship with continuity and where the general practitioner is trained in evidence-based medicine. 

– Tertiary prevention: when diagnosed with cancer, good and quick access to specialized oncological centres (or other relevant specialists) is key to improving the outcome. This also includes good access to novel evidence-based cancer therapies.

-Quaternary prevention: new screening programs should only be implemented when the benefits outweigh the harms.

References

1. European Health Union: cancer screening [Internet]. European Commission - European Commission. [cited 2022 Nov 8]. Available from: https://ec.europa.eu/commission/presscorner/detail/en/ip_22_5562
2. Gøtzsche PC, Jørgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev. 2013 Jun 4;(6):CD001877.
3. Harding Center for Risk Literacy. Early detection of prostate cancer with PSA testing [Internet]. Available from: https://www.hardingcenter.de/en/transfer-and-impact/fact-boxes/early-detection-of- cancer/early-detection-of-prostate-cancer-with-psa-testing
4. Heleno B, Thomsen MF, Rodrigues DS, Jorgensen KJ, Brodersen J. Quantification of harms in cancer screening trials: literature review. BMJ. 2013 Sep 16;347(sep16 1):f5334–f5334.
5. 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 Feb 11;348:g366.
6. Bleyer A, Welch HG. Effect of three decades of screening mammography on breast-cancer incidence. N Engl J Med. 2012 Nov 22;367(21):1998–2005.
7. Autier P, Boniol M, Gavin A, Vatten LJ. Breast cancer mortality in neighbouring European countries with different levels of screening but similar access to treatment: trend analysis of WHO mortality database. BMJ. 2011 Jul 28;343:d4411.

 

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