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EAPM: Big plan on beating cancer set for big launch, coronavirus restrictions tighten

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Good morning, health colleagues, and welcome to the first update of the week from the European Alliance for Personalised Medicine (EAPM). It is a big week for health in general next week, as from 3 February the European Commission will be officially publishing its EU Beating Cancer Plan and there are still questions whether the EU Beating Cancer Plan will address lung cancer screening sufficiently, writes EAPM Executive Director Dr. Denis Horgan.

Lung cancer – transformation in local and country with the support of EU policies needed.  

In Europe, lung cancer (LC), is far ahead as the leading cause of death from the disease, and causes more than 266,000 deaths each year - 21% of all cancer-related deaths. 

That's not quite as high as COVID's death rate in 2020, but these lung cancer deaths are not a one-off crisis that has provoked an unprecedented mobilization to bring it under control. EAPM is pushing very hard for an increased focus on lung cancer (LC), which needs a transformation in national care pathways as well as local and country policies. LC care receives high priority within only a few national health strategies. 

But it is largely up to the member states – incentivized by the European Union – to recognize that reorganization and reallocation of health-care resources are justified by the current massive costs to individuals and to society of the growing incidence of this type of cancer. These are key issues that should be taken into account as highlighted by the multistakeholder engagement that EAPM has undertaken. 

 Screening is the most obvious route to arresting this destruction of life and is a question of looking for cancer before a person has any symptoms. This can help find cancer at an early stage. When abnormal tissue or cancer is found early, it may be easier to treat. By the time symptoms appear, cancer may have begun to spread.  

The same is true for lung cancer.

Over the past 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. In consequence, funding for it, and reimbursement of screening services, remain patchy and inadequate, and it is not yet integrated satisfactorily into the healthcare system.

The tools are there to improve the situation. As EAPM has highlighted with its members to policymakers: "Efficacy is proven. Don't waste more time! Now we have all the evidence we could be blamed for doing nothing." 

The EU Beating Cancer Plan should address this unmet issue. 

EMA expert unimpressed by the EU's COVID trials

The European Medicines Agency (EMA) has established dedicated task forces to deal with the scientific, regulatory and operational challenges created by the COVID-19 pandemic and initiated its business continuity plan. The aim of these measures is to safeguard the Agency's core activities related to the evaluation and supervision of medicines during the pandemic and to ringfence resources dealing with COVID-19.

However, the EMA’s Senior Medical Officer Hans-Georg Eichler has been unflinching in his assessment of the EU’s track record for clinical trials during the coronavirus pandemic: “When compared to other regions, the EU was not very successful in implementing large meaningful … trials for the COVID-19 medicines.” 

“If you look at what we have in terms of meaningful trial results, they come mostly from outside the current EU,” he added. 

If Europe wants to improve, Eichler said, it needs infrastructure and governance as well as funding for large, pan EU-trials. It also needs real world health-care data that can help answer questions, around, for example, the long term of vaccines and treatments. 

European Council president expresses doubt over vaccinating 70% by summer 

Charles Michel, president of the European Council, made his comments as the EU faces scrutiny over its slow rollout of coronavirus vaccines, weeks after Britain set the ball rolling. Speaking on Sunday (24 January), Michel told Europe1 radio: "There are difficulties in the production lines in the coming weeks and that will make the process more complex.But if we manage to mobilize the production lines, we may be able to succeed.It's going to be difficult.” The EU has not yet given the go-ahead to the Oxford/AstraZeneca vaccine.

'More deadly' UK variant claim played down by scientists 

Scientists say signs a new coronavirus variant is more deadly than the earlier version should not be a "game changer" in the UK's response to the pandemic. UK Prime Minister Boris Johnson has said there is "some evidence" the variant may be associated with "a higher degree of mortality". But the co-author of the study the PM was referring to said the variant's deadliness remained an "open question". Another adviser said he was surprised Mr Johnson had shared the findings when the data was "not particularly strong". A third top medic said it was "too early" to be "absolutely clear".

Brazilian variant raises concerns 

Paul Hunter, professor in Medicine at the University of East Anglia, said he believed it’s likely that the Brazilian variant will also show increased resistance to antibodies. “We are likely to see gradual accumulation of variants that are more and more able to escape vaccine induced immunity and indeed naturally induced immunity,” Hunter said. 

Commission proposes tougher coronavirus travel restrictions 

The European Commission has proposed ramping up coronavirus restrictions for travelers within the bloc as well as those coming from third countries. On Monday, Justice Commissioner Didier Reynders said: “There’s an urgent need to reduce the risk of travel-related infections to lessen the burden on overstretched health systems.”  

Monoclonal antibodies 

A study in US nursing homes has shown for the first time that monoclonal antibodies, mass-produced in a laboratory, can protect people from developing symptomatic COVID-19. Their manufacturer, Eli Lilly, hopes these antibodies will provide an additional way to protect people at risk of serious disease from the pandemic coronavirus. But given the success of COVID-19 vaccines and their increasing availability, it’s not clear that the expensive and somewhat cumbersome intervention will be widely used. 

Both Eli Lilly’s monoclonal antibody and a similar two-antibody cocktail from Regeneron Pharmaceuticals—famously used to treat former US President Donald Trump in October 2020—have already received emergency use authorization (EUA) as a therapeutic for those who have become infected and are at high risk of developing severe COVID-19. So far, they are not widely used because they must be given early in infection and infused in a hospital or clinic. But now that they appear effective at preventing even mild disease, Eli Lilly plans to ask the US Food and Drug Administration to expand the EUA to include use as a preventive.

And that is everything from EAPM for now – have an enjoyable, safe week, stay well, and see you on Friday for more updates.

European Alliance for Personalised Medicine

Spring is in the air as EAPM prepares for EU Presidency conference

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It is a hopeful time of year for the European Alliance for Personalised Medicine (EAPM) as spring finally unveils itself across the EU and  coronavirus vaccinations proceed apace, writes EAPM Executive Director Dr. Denis Horgan.

New newsletter, 9th EU Presidency Conference

The latest EAPM newsletter is now available for your attention, and it has much in there to grab your attention, such as a link to a lung cancer factsheet, news of the Europe Beating Cancer Plan, information and a link concerning tumour agnostics, and a link to the recent EAPM report on its serology round table. Click here to access the newsletter.

But, most importantly, on 8 March, EAPM will be hosting its 9th EU Presidency Conference. Naturally online, the conference will run from 9-16h, and is entitled ‘Forward together with innovation: The why, what and how of tackling the Implementation Gap for health care in the EU Portuguese Presidency’.

Many of the points raised in this update and in the newsletter will be discussed in the upcoming conference, which will feature a wide range of keynote speakers from across the EU, including Christine Chomienne, vice chairwoman of the Mission Board Cancer at the European Commission, Ortwin Schulte, Health Attaché, Permanent Representation of Germany to the EU, Ceri Thompson, Deputy Head of Unit DG CNECT H3: eHealth, Well- being and Ageing , Gilad Vainer, Molecular Pathologist, Hadassah Medical Center, Israel  and Stephen Hall, regional director, Precision Oncology (CDx), Oncology Region Europe, Novartis.

Registration is still very much open, click here to register, and click here for the agenda.

Commission to propose digital green pass for travel

The European Commission has announced that it will present a legislative proposal for a Digital Green Pass on 17 March. The certificate will contain proof that a person has been vaccinated, results of tests for those who couldn’t get a vaccine yet and may also consider recovery from COVID-19. The Digital Green Pass is aimed at enabling the safe movement of people across the European Union, or further afield.

Asked about the proposal, European Commission spokesperson Christian Wiegand said that if the passes were to be in place by the summer, member states would need to move quickly in their preparations and rollout. He said that countries had already agreed on basic data requirements. The European Commission would take a co-ordinating role ensuring high security standards and helping to connect different national health services.

EU to speed approval of variant-modified coronavirus vaccines

The European Union will fast track approvals of coronavirus vaccines adapted to combat mutations, Health Commissioner Stella Kyriakides has said.  “We have now decided that a vaccine that has been improved by the manufacturer on the basis of the previous vaccine to combat new mutations no longer has to go through the entire approval process. So it will be faster to have suitable vaccines available without compromising on safety.”

The European Commission has come under fire from EU member states over delays to deliveries of vaccines which has seen the bloc lag behind countries such as Britain, a former member, and the United States. Kyriakides is a member of a new task force, led by Industry Commissioner Thierry Breton, to eliminate bottlenecks in production plants and adjust output to new 
variants.

EU leaders face coronavirus ‘fatigue’

Despite the slow vaccine rollout in Europe, delayed by almost a month compared to former member the UK, Commission President Ursula von der Leyen said the bloc still aims to inoculate 70% of all adults — around 255 million people — by September.

“This is a goal that we are confident we will reach,” she said.

Border checks remain a sore point. Divisions among EU member countries, including Germany, Austria, Belgium and the Czech Republic, on restrictions to stave off transmission has again raised the specter of travel delays and long traffic backups in a bloc that prides itself on being a seamless market. Michel told reporters that “non-essential travel may still need to be restricted, but measures should be proportionate.”

The leaders were also updated on the movement of fast-spreading new variants of the virus within Europe, with the so-called U.K variant now present in 26 member countries. The variant first detected in South Africa has been identified in 14, while the Brazilian type is known to be in seven. This means that restrictions could well continue through coming months.  “There is a growing COVID fatigue among our citizens. It has been a very trying year, but we should not let up now,” said von der Leyen.

Choosing better lung cancer treatments with machine learning

Researchers say that machine learning could help guide health-care workers’ treatment decisions for lung cancer patients after developing a model that is 71% more accurate at predicting survival expectancy of patients. A team of Penn State Great Valley researchers conducted a study in which they developed a deep learning model that is more than 71% accurate in predicting survival expectancy of lung cancer patients, which is significantly better than traditional machine learning models that the team tested which have around a 61% accuracy rate. Deep learning is a type of machine learning that is based on artificial neural networks, which are generally modelled on how the human brain’s own neural network  functions. 

The team say that the information on a patient’s survival expectancy could help guide doctors and caregivers in making better decisions on using medicines, allocating resources, and determining the intensity of care for patients. The machine learning model is able to analyse vast amounts of data and can include information such as types of cancer, tumour size, the speed of tumour growth, and demographic data.

Next few weeks ‘difficult’ – Michel

EU leaders have discussed how to accelerate the production and rollout of vaccines, amid fears over more transmissible mutations triggering a new surge in cases across the bloc."We know that the next few weeks will continue to be difficult as far as vaccinations are concerned," said 

European Council president Charles Michel. “But we do have the means, we have the resources, we have the capability to succeed over the next few months," he added. More than 50 million doses have so far been delivered to EU member states, which have administered 29 million jabs (almost 7% of the bloc's population), according to the European Commission. The EU vaccine 
strategy has come under fire over the slow pace of immunization programmes in member states, compared to the UK, the US, or Israel. Brussels aims to vaccinate at least 70% of its adult population by the end of September but has struggled to receive the doses agreed with 
pharmaceutical companies. 

Following recent delivery delays, EU leaders stressed that predictability was crucial to organising national inoculation programmes, urging vaccine-developers to respect contractual deadlines.

Protecting European consumers: Safety Gate efficiently helps take  dangerous COVID-19 products off the market

The European Commission published its annual report on the Safety Gate, which is the EU rapid alert system helping to take dangerous non-food  products off the market. The report shows that the number of actions taken by authorities following an alert is growing year by year, reaching a new record number of 5,377, compared to 4,477 in 2019.9% of all alerts raised in 2020 concerned products related to COVID-19, mostly masks meant to protect but failing to do so. Other examples for dangerous COVID-19 related products notified in the Safety Gate are disinfectants containing toxic chemicals, such as methanol that can lead to blindness or even death if swallowed, or UV sanitizers that exposed users to strong radiation causing skin irritations.

And that is everything from EAPM at the start of the week – remember EAPM’s EU Presidency Conference on 8 March, click here to register, and click here for the agenda. Stay safe, stay well, see you later in the week.

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European Alliance for Personalised Medicine

Recruiting serology to the long fight ahead against pandemics

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Europe's ability to respond effectively to health threats has already been called into question by the coronavirus pandemic. Heroic collaboration between researchers and policymakers has made the first vaccines available at record speed, but Europe still stands before a major challenge that goes way beyond the current COVID crisis. There is a critical failure to develop and implement the testing technologies that not only can help protect citizens against COVID-19, but that will also be crucial in preserving public health over the longer term, in the face of future and even more deadly cross-border infections, writes European Alliance for Personalised Medicine (EAPM) Executive Director Dr. Denis Horgan.

To address these topics, EAPM hosted two webinars on the matter. The first virtual round table, 'Forward together with innovation: Understanding the need and framing the discussion for Serology testing for SARS-CoV', took place on 17 December 2020, and the on 'Recruiting serology to the long fight ahead against pandemics', on 3 February. Together they comprehensively highlighted the questions still needing answers and gathered input from European and international public health officials and organisations, academia, and industry.

As the experts concluded, action is needed to introduce meaningful testing strategies leveraging the comprehending strengths of the available testing technologies such as serology. This can contribute to more efficiency of vaccination programs.

Not the end of a battle - just the beginning

"We are only at the beginning now," Bettina Borisch, Executive Director World Federation of Public Health Associations, told a recent expert roundtable on serology testing, organised by EAPM to highlight the challenges and opportunities of making the best use of testing. "We are confronted with not just a short-term crisis but a long one, to ensure future capacity for protection." Testing and diagnosis have been Cinderella areas of medicine for too long, she said, urging the use of serology as a vital element in any pandemic strategy. The point was reaffirmed by Kevin Latinis, a scientific advisor for one of the US task forces to tackle Covid, at a follow-up EAPM roundtable in January: "The pandemic has demonstrated dramatically what an asset adequate testing would be, but the opportunity is being missed," he said. Or, as Denis Horgan, EAPM's executive director, who chaired both roundtables, expressed it: "More vaccines are now becoming available, but it is vital to ensure they are used effectively in clinical practice, and for that we need better understanding of which patients will respond to different vaccines and how the vaccines will tackle variants."

The confident but chilling scientific consensus is that the next decades will bring further and more virulent pandemics that threaten disruption and death on an even greater scale than the current outbreak. And while the hope is that vaccines now being created in extremis will overcome the immediate danger, Europe – and the world – can no longer afford to rely on hasty improvisation. The harsh reality is that much of the current vaccine development is shooting in the dark at moving targets.

As the first vaccines reach the general public at the start of 2021, it is still unknown for how long vaccination confers immunity (and, topically, how much flexibility in altering dosage schedules is justified), how it affects different population groups, or to what extent vaccination impedes transmission. As the European Medicines Agency observes in reporting on its first positive opinion on a Covid vaccine, Comirnaty, "It is not currently known how long protection given by Comirnaty lasts. The people vaccinated in the clinical trial will continue to be followed for two years to gather more information on the duration of protection." And "there were not enough data from the trial to conclude on how well Comirnaty works for people who have already had COVID-19." Similarly, "The impact of vaccination with Comirnaty on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus."

Sharper identification of the nature of the virus – and any of its mutated variants – as well as greater precision over the effectiveness of vaccines and measurements of immunity are still urgently needed.

Help is at hand – in principle…

The mechanisms are available to bring that precision and clarification. Notably, serology testing can help confirm the efficacy of vaccination, and could be used to establish a threshold for protection or immunity. It can also confirm an initial antibody response from vaccination, and provide subsequent tracking of antibody levels at regular intervals. Because data from initial vaccine trials will be limited to certain populations and exposure patterns, serology can provide additional data on antibody response and duration to help inform vaccine efficacy in larger, more-diverse populations, and to determine appropriate use in the context of variables such as ethnicity, level of viral load exposure, and individual immune system strength. Testing is vital also to distinguish successful from suboptimal vaccine responses and to detect antibody declines after natural infection.

How serology testing works...

Serology is the study of antibodies in blood serum. Serologic antibody tests help determine whether the individual being tested was previously infected, by measuring the person’s immune response to the virus—even if that person never showed symptoms. Antibodies are immune proteins that mark the evolution of the host immune response to infection, and they provide an archive that reflects recent or previous infection. If maintained at sufficiently high levels, antibodies can rapidly block infection on reexposure, conferring long-lived protection.

Serology tests are not the primary tool for diagnosing an active infection, but they provide information essential to policymakers. They help determine the proportion of a population previously infected with SARS-CoV-2, providing critical information on infection rates at a population level, and providing information about populations that may be immune and potentially protected. Accurate assessment of antibodies during a pandemic can provide important population-based data on pathogen exposure, facilitate an understanding of the role of antibodies in protective immunity, and guide vaccine development. Population-level surveillance is also critical to the safe reopening of cities and schools.

..but not always in practice

Serology testing is not being used systematically, and in many EU countries there is still hesitation over putting in place the organisation and infrastructure to make it possible.

The European Commission has already pointed out that short-term EU health preparedness depends on robust testing strategies and sufficient testing capacities, to permit early detection of potentially infectious individuals and to provide visibility on infection rates and transmission within communities. Health authorities must also equip themselves to conduct adequate contact tracing and run comprehensive testing to rapidly detect an increase in cases and to identify groups at high risk of disease, it has said in its guidance. But at present, European countries are in many cases falling short and functioning sub-optimally.

Charles Price of the European Commission's health department, DG Santé, admitted that despite the recent intensive collaboration among European Union institutions and the member states, "We are still short of consensus on the best serology tests for particular jobs – to assess the level of infection, to inform vaccination strategies, or to inform clinical decision-making on individuals." These all depend on good serology testing, and the EU is trying to coordinate additional observation at country level of vaccinated populations to feed into evaluation of vaccines by the European Medicines Agency, he told the round table.

Hans-Peter Dauben, secretary general of Euroscan, the international health technology assessment network, also admitted that authorities are often too slow: "We don't have a model to improve our understanding of what is going on," he said. Serological data can be collected within existing systems, he said, but there is no consensus on how it can be used.

He pointed out that while there are multiple settings and scenarios where a diagnostic technology can be used, ranging from clinical usage on treatment decisions in outpatient and inpatient care, and in public health interventions on isolation, tracing and tracking, and epidemiology, "Each scenario requires a unique approach with a set of validation criteria located in the relevant decision-making context."

Exploring the questions

Given the current uneven degree of readiness and capacity among European countries to utilize serology testing technology, and the current absence of plans for systematic serological testing for surveillance, Horgan queried how far public health professionals and institutes understand the barriers and enablers to adoption of serology testing in vaccination surveillance systems. And he questioned whether revised recommendations were needed from the EU on testing strategies and on adaptations to different types of vaccines. "We need to know who to vaccinate and how to vaccinate, and we need to allocate resources accordingly," he said.

Achim Stangl, Medical Director at Siemens Healthineers, was concerned that there is insufficient information about what subpopulations particularly benefit from vaccination, such as immunosuppressed patients, lymphoma patients, or very young children. His colleague Jean-Charles Clouet insisted that there are still open questions on vaccines that only testing will elucidate: "The importance has not been fully grasped of showing the impact of vaccination on the immune system, and of conducting long-term monitoring to define an optimal immunity threshold." Latinis focused on the need to understand not only the immunity conferred by vaccines, but also how far and fast it wanes. Or as Stangl put it, "The big question is how long antibodies are present and able to provide immunity

The questions come in the wake of many similar expressions of concern and counsel. The International Coalition of Medicines Regulatory Authorities warned in 2020 of the need for "stringent regulatory requirements for Covid-19 studies" and agreed to provide guidance on the prioritisation of clinical trials and on serology in order to promote a harmonised approach. The US Centre for Disease Control has issued serology testing guidelines listing important applications in monitoring and responding to the COVID-19 pandemic.

The World Health Organisation states clearly that the use of serology in epidemiology and public health research enables understanding of the occurrence of infection among different populations, and how many people have mild or asymptomatic infection, and who may not have been identified by routine disease surveillance. It also provides information on the proportion of fatal infections among those infected, and the proportion of the population who may be protected against infection in the future. Information that might impact serologic recommendations is rapidly evolving, particularly evidence of whether positive serologic tests indicate protective immunity or decreased transmissibility among those recently ill.

What can be done?

Serology is the scientific study of serum and other body fluids. In practice, the term usually refers to the diagnostic identification of antibodies in the serum.[1] Such antibodies are typically formed in response to an infection (against a given microorganism),[2] against other foreign proteins (in response, for example, to a mismatched blood transfusion), or to one's own proteins (in instances of autoimmune disease). In either case, the procedure is simple.

Serological tests are diagnostic methods that are used to identify antibodies and antigens in a patient's sample. Serological tests may be performed to diagnose infections and autoimmune illnesses, to check if a person has immunity to certain diseases, and in many other situations, such as determining an individual's blood type. Serological tests may also be used in forensic serology to investigate crime scene evidence. Several methods can be used to detect antibodies and antigens, including ELISA,[4] agglutination, precipitation, complement-fixation, and fluorescent antibodies and more recently chemiluminescence.

All this increases the chances of monitoring the spread of Covid-19 infection. Vicki Indenbaum of the World Health Organization told the round table that serology will become more important not only before vaccination, but after vaccination takes place, to let public health decision-makers know exactly what is going on, and what proportion of population has been infected. It is, she said, an essential element to ensure trust between policymakers, professionals and the public. Sarper Diler, a Faculty Member Istanbul University Istanbul Medical Faculty in Turkey, similarly urged a more rigorous schedule of serology tests, "before vaccination, and some months after to see whether a booster shot is needed or not, and to see the impact on wider populations." He also called for development of wider array testing to detect antibodies as vaccines – and virus variants – evolve.

What's needed now

A co-ordinated response across Europe – and beyond – is needed now to ensure that serology can play its part in defending citizens against pandemic infections.

Diler emphasised the importance of communication with citizens to minimize fear and anxiety and non-compliance with preventive behaviour: "We have to find a common language to communicate, and right now it is lacking in Europe," he said. His point was reinforced by Latinis and Daubens, who both warned that a confusion of voices is distracting for strategy formation and implementation. Boccia too urged building trust among public and professionals so as to minimise the likelihood of vaccine hesitancy – and for this, she indicated, clarity over the mechanisms of vaccination is essential.

Some consensus emerged from the roundtables on the need for testing itself to be refined and stepped up. Serology assays should have the appropriate characteristics for assessment of need to vaccinate and vaccine response: an automated, scalable serology assay used in the context of vaccination should include key technical features for effective use: measurement of spike receptor-binding domain neutralizing IgG antibodies, very high (≥99.5%) specificity, and quantitative results.

The requirements also extend to infrastructure. This applies to capacity as well as to physical facilities. Availability at a large and accessible scale is key to ensuring that the needs of the population can be met. This would allow for measuring antibodies in relation to vaccine use for establishing a threshold for protection or immunity, for confirming an initial neutralizing antibody response shortly (approximately 1 week to 1 month) after vaccination, and for tracking of antibody levels (at approximately 3, 6, and 9 months and annually) following vaccination. In the event of limited vaccine availability, antibody assessment can also support decision making for administration to the most vulnerable populations.

Strangl pointed out that the unprecedented speed at which COVID 19 vaccines have been developed leaves the scientific community with very limited data on duration of effective immunity and safety, and on the variability of responses among minority and underserved populations, children and the elderly, "many of whom may not develop antibodies to one or another of the vaccines," he added.

In these circumstances, serology testing can prioritize the use of vaccine resources and inform long-term vaccination strategy. Prior to vaccination, it can help prioritize individuals for vaccination , establish serological baselines and help ensure scarce supply reaches the most vulnerable. Testing one week to one month after vaccination can confirm an initial neutralizing antibody response, and help ensure that the antibody response clears the threshold for immunity. Further testing 3 six and nine months after vaccination can confirm persistence and duration of immunity , and can provide the means 2 agree on abridged trial requirements for additional populations. And testing annually after vaccination can assess persistence and duration of immunity and inform requirements for future vaccinations.

As Stangl summarized it: "Successful implementation of broad serological testing will require the right tools." This means quantitive considerations to establish a protective threshold, assess response and monitor antibody levels overtime. It means testing of specificity high enough for investigating responses in low-prevalence populations, and capable of minimizing false positive results. And it means capacity, reach and speed for sufficient production to address large populations, a large fleets of immunoassay analyzers installed worldwide, and high analyzer productivity and ease of use.

The European Commission's Communication ‘Preparedness for COVID-19 vaccination strategies and vaccine deployment’ notes that “to monitor the performance of the vaccination strategies, it is essential for member states to have suitable registries in place. This will ensure that vaccination data is appropriately collected and enables the subsequent post-marketing surveillance and ‘real time’ monitoring activities. Member states should ensure that …vaccination registries are up-to-date". Dauben suggested that all vaccinated patients should be included on a mandatory registry to allow proper study of the effects.

Stefania Boccia of Milan's Università Cattolica del Sacro Cuore quoted the recommendations of the EU expert panel on effective ways of investing in health, including integrating information and communication technologies across care levels and public health, and investment in comprehensive resilience testing of health systems and sharing of lessons. She also highlighted findings from EU surveys of member states over recent months that show the still incomplete status of monitoring systems for vaccine coverage, safety, effectiveness and acceptance. Survey conclusions also note that recommendations will be updated "as more evidence becomes available about COVID-19 disease epidemiology and characteristics of vaccines, including information on vaccine safety and efficacy by age and target group."

A serology-defined threshold (from either natural infection or vaccination) remains a key need, and this periodic testing would offer additional data on antibody response patterns to determine optimal serology testing utilization. Longer-timeframe quantitative testing for waning levels of protective antibody, such as through annual testing, would inform the need to revaccinate/boost.

To bring these changes into play, policymakers will need evidence, along with data points needed to substantiate that evidence. A framework of panels of experts will have to be created in which guidance can be offered to support decisions on the use of serological testing. And as Latinis remarked, "It is ultimately up to us who uses serology testing to convince politicians to implement it."

And where should this go?

The round table concluded that this was a key moment for the development of a new approach to pandemic preparedness. The current spread of infection – lamentable though it is in its human consequences – provides an unprecedented scientific opportunity for improving understanding of immunity, vaccination and related mechanisms. With adequate, and adequately rigorous, testing in place, it will be possible to evaluate without risk of bias different populations being treated with different vaccines across the world.

To allow the benefits to accrue from this situation, data will have to be collected and compared from a wide range of studies, and at a truly global scale. This in turn will depend on all stakeholders being ready to operate outside and across the customary siloes that characterise the health community, and to adopt a common language based on a new literacy. But by extension of the EU's new ambition to build a European health union, and taking as a model such international concords as the Paris climate agreement or the UN framework convention on tobacco control, what could and should emerge is a co-ordinated international response to future health crises of this scale, in an international pandemic treaty.

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Cancer

Lung cancer screening is ready to rescue thousands from death: Can the EU take action?

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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.

Conclusion

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.

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