Good day, health colleagues, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week. In spite of the travails of coronavirus, and concerns about just what will happen at Christmas this year, there is still plenty of positive news in the health arena, writes EAPM Executive Director Denis Horgan.
With the launch of the European Beating Cancer, EAPM will be organizing a round table on lung-cancer screening in association with the European Respiratory Society, European Radiology Society as well the European Cancer Patient Coalition. The round table is entitled ‘Lung Cancer & Early Diagnosis: The Evidence Exists for Lung Screening Guidelines in the EU’, and the idea is to present a case for the coordinated implementation of lung-cancer screening across the EU Region.
Brexit and Christmas celebration may still be uncertain. The value of lung-cancer screening, however, is not.
One of the aims of the conference is to put forward an implementation action plan to facilitate the drawing-up of lung cancer screening guidelines by the EU. Comprehensive screening programmes have been in place for some time in respect of several other cancers, but not so lung cancer, the biggest killer of all, while guidelines and best practices shared across member states are urgently required.
A stage-shift related to lung cancer screening will allow EU countries to reduce the cost of treatment given that treating early-stage lung cancer has half the cost of treatment at an advanced stage. The Alliance and its stakeholders realize that, among other elements, what is required in Europe is: continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted,
For screening to be cost effective, it has to be applied to the population at risk. For lung cancer, this is not simply based on age and sex, as it is in the majority of breast or colon cancer screening. Europe needs to involve all key groups in developing recommendations and guidelines for implementation, adapted according to the healthcare landscape of individual countries.
All of the above will be discussed at the lung-cancer screening event on 10 December, and it is envisaged that a co-ordinated plan will emerge, which will make its way to Commission and Parliament policymakers and member state health system chiefs. You can check out the agenda of the conference here, and register here.
WHO envoy: ‘Cautiously optimistic, extremely concerned’
The World Health Organization (WHO) on Monday (16 November) said it was "cautiously optimistic" about encouraging news on the coronavirus vaccine. However, it added it was "extremely concerned" over surging cases in Europe and the Americas where health workers and systems are being pushed to the "breaking point".
"This is not the time for complacency," said WHO Director-General Tedros Ghebreyesus in a news conference from the organization's headquarters for the first time in two weeks since he self-quarantined after making contact with a person who tested positive for COVID-19.
"While we continue to receive encouraging news about COVID-19 vaccines and remain cautiously optimistic about the potential for new tools to start to arrive in the coming months, right now, we are extremely concerned by the surge in cases we're seeing in some countries, particularly in Europe and the Americas, health workers and health systems are being pushed to the breaking point," cautioned Tedros, who said he had not tested himself for the virus during his quarantine.
Looking to future of European Health Union
DG SANTE Director General Sandra Gallina made a brief appearance at an OECD webinar unveiling its Health at a Glance: Europe 2020 paper on Thursday (19 November), saying she hopes there will be new chapters to add next year after the European Health Union becomes reality.
Gallina highlighted various EU successes during the pandemic, including procurement of various items and the creation of a clearinghouse for medical goods. But she also warned there “remains significant scope to step up our effectiveness … not all things went well”.
Germany looks to health data developments
Germany has agreed to spend €3 billion to digitize its hospitals. This has been “discussed for years,” said Thomas Renner, head of directorate, digitization and innovation at the German health ministry. The country has also developed a single data protection supervising authority.
Interoperable coronavirus apps were developed within a few months. “This is a very good example that if we want to achieve something we can,” Renner said.
EU could approve two COVID-19 vaccines in December, says von der Leyen
The European Commission has agreed deals with several pharmaceutical companies to buy millions of doses of vaccines on behalf of EU member states. European Commission President Ursula von der Leyen has said that two COVID-19 vaccines could receive conditional market authorization as early as the second half of December.
Speaking after a meeting of EU leaders, von der Leyen said the vaccines developed by Moderna and Pfizer, which created its serum with German drugmaker BioNTech, could be approved by the end of the year by the European Medicines Agency (EMA) “if all proceeds now without any problem”. She added: “This is the very first step to be able to be on the market.”
WHO says lockdowns would not be needed if mask use reached 95%
World Health Organization Europe Regional Director Hans Kluge has said that if 95% of people wore masks, lockdowns wouldn’t be needed. Speaking at a briefing, Kluge said that mask use is currently at around 60% or less in Europe and that lockdowns should be “last resort” measures. However, he also said that mask use isn’t a panacea and needs to be done in combination with other measures.
UK leaders in talks over 'four-nation approach' to Christmas COVID rules
Health Secretary Matt Hancock has said the government hopes to implement “UK-wide” measures to allow people to see some family members from different households over Christmas “but still keep the virus under control”.
Hancock said the government was in talks with leaders in Scotland, Wales and Northern Ireland to agree a united front that would allow festive cross-border travel within the UK. Wales’s first minister, Mark Drakeford, said he had held discussions with the Cabinet Office minister, Michael Gove, and the other first ministers of the devolved administrations on Wednesday (18 November) about a UK-wide approach to Christmas restrictions, with another meeting planned next week.
He told BBC Radio 4’s Today programme: “We agreed some broad parameters on Wednesday (18 November) and remitted officials of all four administrations to work now on the detail, so I remain hopeful that it will be possible to reach a four-nation approach to Christmas.”
Drakeford said that an agreement on permitting travel across the UK during the Christmas season was “top of the list of things to agree”, even if a wider agreement was not possible. Hancock added: “I think it is important that we have an agreed set of rules over Christmas. It is the most important holiday for people in this country.
"What we are trying to do over Christmas is ensure we have a set of rules across the whole UK so there’s talks going on with the devolved authorities as well to try to agree a common set of rules over Christmas. I think that people would welcome that."
Lung cancer screening is ready to rescue thousands from death: Can the EU take action?
While Europe mulls multiple praiseworthy schemes to limit the damage inflicted by cancer, one of the most promising avenues is being neglected – and many Europeans are dying unnecessarily as a consequence. Lung cancer, the biggest cancer killer, is still on the loose, largely unchecked, and the most effective method for combating it – screening – is unaccountably being ignored, writes European Alliancce for Personalised Medicine (EAPM) Executive Director Dr. Denis Horgan.
Screening is particularly important for lung cancer because most cases are discovered too late for any effective intervention: 70% are diagnosed at an advanced incurable stage, resulting in the deaths of a third of patients within three months. In England, 35% of lung cancers are diagnosed following emergency presentation, and 90% of these 90% are stage III or IV. But detecting disease long before symptoms appear permits treatment that forestalls metastasis, drastically improving outcomes, with cure rates above 80%.
Over the last two decades the evidence has become overwhelming that screening can transform the fate of lung cancer victims. Disturbingly, however, EU member states still hesitate over its adoption, and it remains low on policy priorities nationally and at EU level.
A valuable opportunity to remedy this deficiency is in the offing. Before the end of 2020, the European Commission has unveiled Europe's Beating Cancer Plan, a major opportunity to guide national actions. It will be, in the words of Commission President Ursula von der Leyen, "an ambitious cancer plan to reduce the suffering caused by this disease.” Preparatory drafts suggest it will offer a powerful, coherent and almost comprehensive response to the havoc that cancer wreaks on lives, livelihoods and quality of life across Europe.
Almost comprehensive. Because on the potential for lung cancer screening to save lives, it has little to say. The document is commendably strong on prevention, where there is, as it points out, important scope for improvement, with up to 40% of cancer cases being attributed to preventable causes. It also highlights screening as a vital tool in colorectal, cervical and breast cancer. But screening for lung cancer – which alone kills more than those three cancers combined - receives only a few passing references in the draft text, and no endorsement commensurate with the impact of its implementation at scale. This threatens to leave LC screening in its current under-exploited status in the European Union, where although the disease is the third leading cause of death, there is still no EU recommendation for systematic screening, and no large-scale national plan.
The case for action
The most recent studies add to an accumulation of evidence of the merits of LC screening over the last two decades. A just-published IQWiG study concludes that there is a benefit of low-dose CT screening, and "the assumption that screening also has a positive effect on overall mortality seems justified." Some studies show it saves an estimated 5 in 1000 people from dying of lung cancer within 10 years, while others warn that 5-year survival among all patients with lung cancer is barely 20%. Every year, at least twice as many people die from lung cancer as from other common malignancies, including colorectal, stomach, liver and breast cancer. In Europe it causes more than 266,000 deaths yearly - 21% of all cancer-related deaths.
Late presentation precludes for many patients the option of surgery, which – despite continuing improvements in other forms of therapy – is currently the only demonstrated method to improve long term survival. The concentration of patients among smokers adds a further urgency to the introduction of systematic screening. Efforts to discourage and reduce tobacco use will have effects only over the longer term. Meanwhile, the best hope for the millions of smokers and former smokers – predominantly among the most disadvantaged populations of Europe – is in screening. But this is precisely the population that is hardest to reach – reflected in the fact that fewer than 5% of individuals worldwide at high risk for lung cancer have undergone screening.
The prospects for change
Europe’s Beating Cancer Plan (BCP) holds out the prospect of many improvements in tackling cancer, and its vision embraces admirable principles – including the merits of screening, technology and enlightened guidance. It foresees "putting the most modern technologies at the service of cancer care to ensure early cancer detection." But as long as it hesitates over endorsing screening for lung cancer, a major opportunity will remain neglected.
The BCP acknowledge that live are saved by early detection of cancer through screening. They speak approvingly of population-based screening programmes for breast, cervical and colorectal cancer in national cancer control plans, and of ensuring that 90% of the qualifying citizens will have access by 2025. For screening of these three cancers, they even envisage reviewing the Council Recommendation, and issuing new or updated Guidelines and Quality Assurance schemes. But lung cancer screening enjoys no such priority in the BCP, which are limited to allusions, to a "possible extension" of screening to new cancers, and to a consideration of "whether the evidence justifies an extension of targeted cancer screening."
As Europe enters the third decade of the century, significant evidence has already justified action to implement LC screening. It is not the time to be debating whether the evidence is sufficient. The evidence is in. "There is evidence of a benefit of low-dose CT screening compared to no screening," says one of the recent studies. The NLST study demonstrated a relative reduction in lung cancer mortality of 20% and a 6.7% reduction in all-cause mortality in the LDCT arm. 5-year survival in patients diagnosed early (stage I-II) can be as high as 75%, especially in patients who have a surgical resection. Earlier diagnosis moves the focus from palliative treatment of incurable disease to radical potentially curative treatment with a resultant transformation of long-term survival. LuCE claims that five-year survival rates for NSCLC could be 50% higher with earlier diagnosis.
Historic objections to LC screening – in terms of risks of radiation, overdiagnosis, and unnecessary interventions, or uncertainties over risk models and cost effectiveness – have been largely answered by recent research. And given the commitment of the BCP to put research, innovation and new technologies at the service of cancer care ("the use of technology in healthcare can be a lifesaver", says the latest draft), it might well provide for further studies to refine and clarify the areas where LC screening can be even further improved, and the necessary infrastructure and training be consolidated.
Maximizing the opportunities for diagnosis too
There are other aspects of BCP linked directly or indirectly to screening which could – and should – enhance early detection and accurate diagnosis of lung cancer. Draft texts already make mention of exploring "early diagnosis measures to new cancers, such as prostate, lung, and gastric cancer." By providing more precise information on tumours, lung cancer screening has opened the way to more personalized treatment for lung cancer and provides fertile ground for further innovations in technology, image analytics and statistical techniques, and future image interpretation will be increasingly assisted by computer-aided diagnostics. The EU's parallel Mission on Cancer is expected to generate new evidence on the optimisation of existing population-based cancer screening programmes, develop novel approaches for screening and early detection, and provide options to extend cancer screening to new cancers. It will also contribute to providing new biomarkers and less invasive technologies for diagnostics. The new ‘European Cancer Imaging Initiative’ will facilitate the development of new, enhanced diagnostic methods to improve quality and speed of screening programmes using Artificial Intelligence, and promote innovative solutions for cancer diagnostics. A new Knowledge Centre on Cancer will function as an ‘evidence-clearing house’ for early detection through screening. An upgraded European Cancer Information System will facilitate the assessment of cancer screening programmes through improved data collection on cancer screening indicators. The analysis of interoperable electronic health records will improve understanding of disease mechanisms leading to the development of new screenings, diagnostic pathways and treatments.
These are encouraging concepts, and could – if implemented – assist the refinement of early detection and diagnosis. But it would be even more promising if the recognition of improved access to biomarker testing on diagnosis and progression extended to treatment, and to advancing the emergence of personalised medicine. The BCP could be the context for a more systematic development of biomarker testing. Perhaps data on variations in testing rates could be included in the envisaged cancer inequalities registry.
Similarly, taking advantage of other technology advances in treatment could give patients still greater chances of survival and of quality of life. In addition to the critical role played by radiology in screening, radiotherapy itself has advanced substantially during the past two decades, with new technologies and techniques allowing ever more accurate, effective, and less toxic treatments, thus allowing shorter and more patient-friendly regimens. It is now established as an essential pillar in multidisciplinary oncology. And as with all the other opportunities in better screening, diagnosis and treatment, appropriate coverage in healthcare budgets and reimbursement systems is essential if good intentions are to be converted into action.
What is essential is that LC screening programs be implemented in a comprehensive and coherent and consistent manner, rather than arising as a by-product of sporadic ordering of scans by providers without a programme infrastructure in place. Given the potential for such a large number of lives to be positively impacted by a timely diagnosis of early-stage treatable disease, the initiation of these programmes should be given the highest priority by healthcare institutions and providers. The new EU Cancer Screening Scheme envisaged in the BCP should have its vision extended beyond breast, cervical and colorectal cancer screening to lung cancer. The Commission proposal to review the Council recommendation on cancer screening is a positive step forward.
The challenge now is to act, and to implement LC screening – and in so doing, to save lives and prevent avoidable suffering and loss across Europe. If the EU does not take advantage of initiatives such as BCP, long-overdue improvements in lung cancer care will be deferred again, with the worst impact felt in Europe's most disadvantaged populations. Policy makers should recognise this unexploited potential, and should respond by driving implementation.
Can we beat cancer? Europe’s Beating Cancer Plan moves forward
The only constant in public affairs is change and in cancer, it is no different: Policy formation everywhere and on every issue has to take account of this reality, or it will fail to deliver the best answers. And in beating cancer, of literally vital interest to European citizens, the best answers need to be sought right now if the future is to live up to expectations. The EU Beating Cancer Plan is tackling this issue holistically by optimizing a changing context for the benefit of patients and health-care systems in Europe, writes European Alliance for Personalised Medicine (EAPM) Executive Director Dr. Denis Horgan.
It is easy to demonstrate that change is a constant as in health and with COVID 19 now. But can Europe itself shift its dimensions and its character as it has for millennia – now much faster than ever, and often for the better to tackle the potential in science, the willingness of the healthcare community including industry with the support of patients, to curb the epidemic of cancer.
The potential is great for cancer patients and citizens. The benefits from advanced approaches to healthcare, such as personalised medicine as set out in the plan, will increase as the approach moves from single-test to multitarget profiling of the population, and ultimately to whole genome sequencing.
A more efficient allocation of health-care resources can be achieved through sharper focus on prevention and prediction of disease, as well as through improving disease management, and the avoidance or delay in more expensive care costs. An effective strategy allows a forward-looking perspective on the value of genomics to the healthcare system. It supports the testing infrastructure towards the development of whole genome sequencing, with benefits to a wide range of conditions, and particularly rare diseases.
But it requires policy decisions. Realising the potential requires a readiness to take a fresh look at challenges – and to run a fresh search for solutions. So for personalised medicine to get off the ground, for instance, it will be essential to move away from ‘trial-and-error’ prescribing and embrace the more considered initial prescription of optimal therapies. And for benefits of this sort to be delivered, the environment has to keep up with innovation.
With its policy objectives,
Key flagships will be launched, such as the new ‘Cancer Diagnostic and Treatment for All’ initiative, to be launched by end of 2021, which will help improve access to innovative cancer diagnosis and treatments. It will use the ‘next generation sequencing’ technology for quick and efficient genetic profiles of tumour cells, allowing Cancer Centres to share cancer profiles and applying the same or similar diagnostic and therapeutic approaches to patients with comparable cancer profiles. The initiative will ultimately help optimise cancer diagnosis and treatment and reduce unequal access to personalised medicine in cancer care, greatly benefiting patients.
These are key issues that we worked with our members such as the European Society of Medical Oncology as well as the broader agenda to put on the political agenda. Various academic publications supported this policy.
On imaging, it was announced that the European Cancer Imaging Initiative will be set up in 2022 to develop an EU ‘atlas’ of cancer-related images, making anonymised images accessible to a wide range of stakeholders across the ecosystem of hospitals, researchers and innovators.
This was the key issue that we have worked with the European Society of Radiology over the years to bring he attention to this unmet for more coordination at the EU level.
Lest we forget registries, in 2021, the Commission will establish a Cancer Inequalities Registry. It will identify trends, disparities and inequalities between member states and regions. Alongside regular qualitative assessments of the country-specific situation, the Registry will identify challenges and specific areas of action to guide investment and interventions at EU, national and regional level under Europe’s Beating Cancer Plan.
Of course, partnership will be launched and there will be a new Partnership on Personalised Medicine, due to be set up in 2023 and funded under Horizon Europe, will identify priorities for research and education in personalised medicine, support research projects on cancer prevention, diagnosis and treatment, and make recommendations for the roll-out of personalised medicine approaches in daily medical practice.
As a preparatory action to the Partnership, the Commission will establish a roadmap to personalised prevention, identifying gaps in research and innovation, and will support an approach to map all known biological anomalies leading to cancer susceptibility, including hereditary cancers.
This is a critical area that we have put on the political agenda since 2011 and engaged at the country level to make this a reality.
Building on this, the Commission will launch, the ‘Genomic for Public Health’ project. The project will complement the 1+ Million Genomes Initiative, which has cancer among its main use cases, and is expected to give secure access to large amounts of genomic data for research, prevention and personalised medicine purposes. Actions under the project, funded by the EU4Health programme, will also target the identification of genetic predisposition of individuals to develop cancers, opening new perspectives to personalised risk-assessment and targeted cancer prevention.
On disease specific issues such Lung Cancer: The Commission will make a proposal by 2022 to update the Council Recommendation on cancer screening to ensure it reflects the latest available scientific evidence. Extending targeted cancer screening beyond breast, colorectal and cervical cancer to include additional cancers, such as prostate and lung.
With the European Respiratory Society as well as with Lung Cancer patients, we have been advocating for this since 2015 with an EU Presidency conference supported by the Maltese Presidency of the EU.
Moving ahead in such circumstances will depend on the readiness of Europe's politicians and policymakers and prescribing physicians to open up to new ideas, to acknowledge that their way may no longer be the only way, and to contemplate a degree of voluntary collaboration that has until now been largely embryonic.
On the basis of the debate so far, with only limited progress towards cooperation even on health technology assessment, national sovereignty continues to reign supreme in many member states. Common work does already take place in a limited fashion in some areas and there are some enlightened spirits who are showing a more imaginative approach to the questions that have arisen. But overall it is proving difficult to establish the balance in which the merits of cooperation are seen to weigh as much as the desire for national autonomy.
The EU Beating Cancer Plan has the potential to allow us to move ahead.
The prize of adaptability will be better care. But it is a prize that will be won only if national authorities and traditional professionals are prepared to play. If they are not, they will not only lose the prize. They will condemn Europe's cancer patients and citizens to a declining share of innovation and the benefits that go with it in terms of economic prosperity and quality of life.
The choice is available now. But it will not remain available indefinitely. Europe is living in a changing world, and if it does not choose to change, the world will change around it.
The aim of Europe’s Beating Cancer Plan is to tackle the entire disease pathway structured around four key action areas where the EU can add the most value: (1) prevention; (2) early detection; (3)
However, the key will be translating the aims into actions.
EAPM and its members will be there to support the Commission and members through bottom-up policy support. The EU Beating Cancer Plan is available here.
Have the best weekend possible, and keep safe.
Beating cancer: MEPs react to the EU Plan for joint action
Today, on World Cancer Day (4 February), Parliament’s Special Committee on Beating Cancer (BECA) backs EU wide effort to beat cancer. BECA Chair Bartosz Arłukowicz (EPP, PL) said: “Over the past few years, fighting cancer has been high on the Parliament’s agenda, culminating in setting up our Special Committee on Beating Cancer. In the midst of the COVID-19 pandemic, we cannot forget about the disease that kills 1.3 million Europeans every year, and for which there is no vaccination that can eliminate it altogether.”
Responding to the Plan unveiled today by the European Commission: “We want to undertake the enormous task of beating cancer together, as a Union. Shared knowledge and databases, support for screening programmes, co-financing of HPV vaccinations, are among the many steps we will not hesitate to take on our path to finally beating cancer. We must embark on this ambitious project together. Our Union can beat cancer!” concluded Arłukowicz.
BECA Rapporteur Véronique Trillet-Lenoir (Renew Europe, FR) said: “Cancer is a disease underpinned by social injustice. We are unequal in terms of prevention, unequally protected against environmental carcinogens, unequally educated in what constitutes risky behaviour, unequally armed against disinformation. EU countries have unequal access to quality care. Finally, once we have recovered from illness, we are not all able to return to work, to be financially independent and to lead a harmonious social and private life. For all these reasons, I fully support the establishment of a Cancer Inequalities Registry to identify challenges and specific areas of action at EU and national levels.
“More than 40% of all cancers are preventable if individual, social, environmental and commercial health risk factors are addressed. Ambitious legislative proposals to reduce tobacco and alcohol consumption, to promote a healthy diet and physical activity are steps in the right direction. We should propose stronger measures and clear targets to fight against environmental pollution, to ensure health and safety at work, to limit the exposure to carcinogens and mutagens and to take into account the cumulative effect of hazardous chemicals,” Trillet-Lenoir added.
First debate on the Plan
Today, on World Cancer Day, 4 February, the Special Committee on Beating Cancer will discuss the plan with Health Commissioner Kyriakides from 16.45 to 18.45 (live streaming).
The EU Cancer Plan is structured around four key areas: prevention, early detection, diagnosis and treatment, and improving quality of life. There are multiple supporting actions, along ten flagship initiatives.
The EU budget has earmarked €4 billion to address cancer, including from the EU4Health programme, Horizon Europe and the Digital Europe programme.
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