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EAPM update: Lung-cancer screening round table, last chance to register, and news on launch of world’s first coronavirus vaccine

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Welcome health colleagues, and please find the European Alliance for Personalised Medicine (EAPM) monthly newsletter for December by clicking here. Time is ticking for EAPM’s lung-cancer screening event, and these past few days have seen the truly excellent news of the advent of a COVID-19 vaccine in the UK, so more of that below, writes EAPM Executive Director Denis Horgan.

Lung cancer screening round table

In the wake of several conferences on the subject in recent years and the launch of the European Beating Cancer Plan, EAPM is hosting  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 idea is to present a case for the coordinated implementation of lung-cancer screening across the EU Region. 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 co-ordinated implementation of lung-cancer screening across the EU Region.You can check out the agenda of the EAPM 10 December conference on lung-cancer screening here, and register here. In addition, a great deal of information can be found in EAPM’s latest newsletter, which is available here. 

Will health technology assessment (HTA) talks show Europe's countries can work together?

European health ministers met on 2 December to review what has been, and what can be, done to strengthen future defences to counter the COVID pandemic. It's a huge agenda—and in amongst the many components of the European Union bid to find common ground among its 27 member states on the way ahead, one less conspicuous and apparently incidental item may give a clue to how good the chances are of finding agreement on the big picture improvements that are necessary.

That secondary item is health technology assessment, and the discussion among ministers will turn on the proposal now three years old for co-ordinating evaluations at EU level, instead of conducting as many as 50 distinct regional and national evaluations among the member states on every new medicine. The logic behind the plan is obvious: avoiding duplication, saving time and resources, and arriving at the best decisions by pooling expertise from across the continent. But ever since the proposal emerged, other factors have intervened—and notably the reluctance of some countries to abandon their own approach and submit to a judgment reached by a committee. EAPM is working hard towards forward progress with HTA, and will keep you posted.

UK approves Pfizer-BioNTech COVID-19 vaccine, first in world

And, concerning dealing with the COVID-19 pandemic, Britain approved Pfizer’s COVID-19 vaccine on Wednesday (2 December), jumping ahead of the United States and Europe to become the West’s first country to formally endorse a jab that it said should reach the most vulnerable people early next week. Prime Minister Boris Johnson touted the medicine authority’s approval as a global win and a ray of hope amid the gloom of the novel coronavirus which has killed nearly 1.5 million people globally, hammered the world economy and upended normal life.

Elderly care home residents and their carers will be the first people in the UK to receive the vaccine, the government said on 2 December.

Wei Shen Lim, chair of the UK’s joint committee on vaccination and immunization, said that the vaccine rollout would prioritize those most likely to die from COVID-19 as well as protecting health and social care services.

The first phase of the UK’s vaccination programme will work through nine groups, beginning with residents in care homes for older adults and their carers. Next, all those over 80 years of age and other frontline health and care workers will be offered the jab.

Over 75s are in the third tier of prioritization, followed by the over 70s and extremely clinical vulnerable younger adults.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, in record time - just 23 days since Pfizer published the first data from its final stage clinical trial. The US Food and Drug Administration (FDA) is set to meet on 10 December to discuss whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and the European Medicines Agency said it could give emergency approval for the shot by 29 December. UK Health Secretary Matt Hancock said hospitals were ready to receive the shots and vaccination centres would be set up across the country but he admitted distribution would be a challenge given that the vaccine must be shipped and stored at -70C (-94F), the sort of temperature typical of an Antarctic winter.

EU eyes 29 December approval for virus vaccine, later than US

The European Union drug agency has said it may need four more weeks to approve its first coronavirus vaccine. The European Medicines Agency plans to convene a meeting by 29 December to decide if there is enough safety and efficacy data about the vaccine developed by Pfizer and BioNTech for it to be approved, as it was on 2 December in the UK. The regulator also said it could decide as early as 12 January whether to approve a rival shot by American pharmaceutical company Moderna Inc, which submitted its request to U.S. and European regulators this week. If its vaccine is approved, Germany-based BioNTech said the shot's use in Europe could begin before the end of 2020 — but that seems quite ambitious, given that the EU Commission usually needs to rubber-stamp the regulator's decision. Still, the agency has also left open the possibility that the date of that meeting will be brought forward if data comes in faster.

The European Medicines Agency has yet to receive any data from the Phase 3 AstraZeneca/Oxford vaccine trial and hasn’t received data on the quality of the vaccine, the EMA said in an email. It’s still waiting for data on the vaccine’s ingredients and the way it’s produced, as well as responses to questions that arose from the submission of initial laboratory studies. Meanwhile, in Belgium, Christie Morreale, health minister for the Walloon region in Belgium, said that the country would receive its first vaccines by mid-January at the earliest, according to the Brussels Times.

Commission’s new pharma strategy ‘has patients and collaboration at its heart’

Plans to cut the time it takes to gain regulatory approval for medicines and medical devices, and drive the development of new antibiotics and other products for treating rare diseases, have been outlined in a wide-ranging new pharmaceutical strategy for Europe. The strategy, developed by the European Commission, is patient-focused and seeks to build on the collaborative efforts of industry seen during the coronavirus crisis, said experts in life sciences at Pinsent Masons, the law firm behind Out-Law. The Commission hopes to deliver the strategy over a number of years.

Catherine Drew of Pinsent Masons said: "The strategy has patients at the heart and it recognises the need to ensure prompt access to high quality safe and effective medicines. In so doing the strategy recognises the value that both innovative and generic and biosimilar products bring to helping achieve that patient centric goal."

Nicole Jadeja, also of Pinsent Masons, said: "Importantly, the strategy recognizes the power and future role for health data and data infrastructures, the need for diverse sources of funding to support innovation, the role of new medicines and alternative uses for existing ones, the need for new business models as advanced therapy medicinal products and cell and gene therapies offer the potential of one-time treatments, and the need for the innovation for environmentally sustainable pharmaceuticals and manufacturing."

Team Europe: EU announces €20 million to support health systems in ASEAN

On 2 December, the European Commission announced a new €20 million programme to support the Association of South-East Asian Nations (ASEAN), as part of Team Europe's global response to COVID-19. The South-East Asia Pandemic Response and Preparedness programme will enhance regional co-ordination in responding to the coronavirus pandemic and strengthen the capacity of health systems in the region. The programme, with a duration of 42 months and implemented by the World Health Organisation, will also pay special attention to vulnerable populations and support timely communication about the COVID-19, its symptoms and risks, especially in rural and remote areas.

Fighting AMR paradoxes in age of COVID-19

Antimicrobial resistance (AMR) is one of the ten most urgent threats facing global health, and yet it remains totally underestimated by much of the population. AMR is more dangerous than car accidents and even cancer, but is still not being prioritised at either the EU or member state levels within public health policies. Furthermore, AMR is interlinked with the COVID-19 pandemic, a fact which has been all-but ignored by the media. The world is losing its most powerful health-care tool, antibiotics; by 2050, super bacteria could cause 350 million deaths. Meanwhile, the research sector is still waiting for EU incentive mechanisms as well as an overall strategy to integrate the development of – and access to – affordable and quality antimicrobials.

In the United States, some 70-80% of hospitalised COVID-19 patients received antibiotic treatment, according to one report, even though less than 10% actually had secondary bacterial infections In Italy, the Italian National Institute of Health affirms that of 3,335 patients who died from COVID-19, 86% of them had undergone antibiotic treatment, despite only 12% of them having had a superimposed bacterial infection.

A perspective on Alzheimer’s Disease (AD)

In addition, EAPM recently launched an academic publication on Alzheimer’s Disease (AD), with a multistakeholder perspective to tackle the issue of biomarkers, entitled Piercing the Fog of Alzheimer’s and Related Dementia. The paper is available here.

We will waive COVID travel restrictions for Father Christmas, EU confirms

Asked to reassure children that Santa Claus will be able to cross borders freely to bring them their gifts, Margaritis Schinas, the EU's Vice-President for Promoting our European Way of Life, said the European Commission "can offer this assurance". "We agreed with the religious leaders that this being an issue of trans-border movement — Saint Nicholas, Pere Noel, Babbo Natale, Reyes Magos, Agios Vassilis — they will all be able to deliver the gifts. Young Europeans of all faith should have the conviction that love and hope will never be absent from Europe in these days," he said.

And that is everything to end your first week in December – don’t forget, you can still check out the agenda for EAPM’s 10 December event on lung cancer screening here, register here, and the newsletter is available here. Have an excellent weekend.

 

Cancer

EAPM: Fears of new waves raised as lockdowns ease

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Good morning, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – with lockdowns easing across Europe, but fears of second or even third waves being raised globally, there is much to discuss in the health arena, writes EAPM Executive Director Denis Horgan.

COVID-19 in India

In India, a second COVID wave is wreaking havoc. Data suggests that this wave is proving to be more infectious and deadlier in some states, although India's death rate from the virus is still relatively low. But the county's healthcare system is crumbling amid the surge in cases - doctors say it's hard for them to "see the light at the end of the tunnel this time". Sharp rise in cases The rise in case numbers has been exponential in the second wave. On 18 June last year, India recorded 11,000 cases and in the next 60 days, it added 35,000 new cases on average every day. On 10 February, at the start of the second wave, India confirmed 11,000 cases - and in the next 50 days, the daily average was around 22,000 cases. But in the following 10 days, cases rose sharply with the daily average reaching 89,800. Chart showing cases in first and second wave Presentational white space Experts say this rapid increase shows that the second wave is spreading much faster across the country. Dr A Fathahudeen, who is part of Kerala state's Covid taskforce, said the rise was not entirely unexpected given that India let its guard down when daily infections in January fell to fewer than 20,000 from a peak of over 90,000 in September.

UK coronavirus: Boris Johnson warns of third wave

Pills taken at home to prevent severe Covid-19 infection could be available by the autumn, Boris Johnson said as he warned that a third wave of cases could hit the UK. The Prime Minister announced the creation of an “antivirals task force” charged with developing early-stage treatments for the disease. At a Downing Street press conference, he said that the UK’s “vaccination programme has demonstrated what the UK can achieve when we bring together our brightest minds”. It came as Mr Johnson acknowledged soaring cases overseas and warnings from scientists that there will be another wave this year. However, he said that he saw nothing that would cause the UK to "deviate" from its opening up schedule, and that we must "learn to live with the disease as we live with other diseases".

France launches digital health pass for air travel

France has launched an experimental digital health pass this week, becoming the first European country to allow air travel for those who have a negative coronavirus test or those who have recovered. The feature called notebook was introduced Monday (19 April) on the government’s TousAntiCovid app - allowing users to upload antigen or PCR tests by scanning a QR code on the test result form. A negative test result can be used for limited air travel to Corsica on Air France and Air Corsica flights and to overseas territories beginning at the end of May. Authorities are discussing the possibility of allowing the app to be used for entries to mass public events like music concerts, festivals, trade shows, but have ruled out its use for entry to "bars or restaurants," according to a report in Le Monde. “This system is more secure as there is no scope for fake paper certificates. It’s simple and can be easily shown at the airport,” Minister of State for Digital and Telecommunications Cedric O told France 3 news.

Commission probes biotech 'killer acquisition' thanks to new rule guidance

The European Commission has used new guidance on a key merger rule against so-called “killer acquisitions” to look into biotech company Illumina’s $7 billion deal to acquire cancer-test startup Grail. The takeover fell below the thresholds which normally trigger a merger investigation at the EU level. But Brussels was able to launch a probe at the request of France — subsequently joined by Belgium, Greece, Iceland, the Netherlands, and Norway — given the potential impact of the takeover on the market for cancer detection tests, the Commission said in a statement. The referral was possible thanks to new guidance from Brussels on a provision in EU merger rules, Article 22. According to the new reading, published on March 26, national regulators can ask Brussels to vet potentially harmful mergers that fall below the regulatory thresholds for a review. “A referral of this transaction is appropriate because Grail’s competitive significance is not reflected in its turnover,” the Commission explained. France’s competition authority, which first referred the deal to Brussels, took pride of having been the first to trigger the new tool. “This development has been called for by the authority for several years,” the French watchdog said in a statement.

The catch in Europe's 'green certificates' plan: COVID testing costs

New measures to allow Europeans to travel more easily this summer come with a hidden cost, say MEPs, who warn that the high-price tag of necessary coronavirus tests infringes on unvaccinated people’s right to free movement. The European Commission’s proposal for a so-called “digital green certificate” is intended to allow Europeans to move around more easily and safely despite the pandemic, and give a boost to the travel industry and tourism-reliant countries. The certificate, which will be issued free of charge, will indicate whether a person has been vaccinated, tested negative or recovered from the coronavirus. In theory, this ensures that unvaccinated people are not discriminated against. But coronavirus tests are expensive. That — in addition to quarantine measures demanded by some countries — creates an additional barrier to travel for unvaccinated people, said Dutch MEP Sophie in ‘t Veld.

Europe’s slow vaccine rollout means that most European adults are still waiting to receive their jabs, while high rates of vaccine skepticism in some countries suggest many may opt not to get vaccinated at all. “Many people can’t, or don’t want to, get a jab,” in ‘t Veld said in an interview. “Such a green certificate on the basis of a test must be a real alternative.” For that to be the case, tests have to be within reach for everyone, “and currently that’s simply not the case,” she added. The price for a PCR test varies wildly across Europe: France and Denmark offer tests free of charge, while a test costs 19,500 forints (€54) in Hungary and 520 złoty (€115) at Warsaw’s Chopin Airport.

According to data from travel association ABTA, Belgians are charged between €47 and €135, while Italians pay €63 on average and Portugal charges €75. It’s money travelers must be able to cough up several times, as countries often require two tests upon arrival, sometimes on top of a pre-departure test. In the Netherlands, tests cost between €70 and €140 — an “insurmountable obstacle” for many, especially for larger families or people who regularly commute across borders, such as truckers, according to in ‘t Veld. A divorced father who wants to visit his child in another country reached out to her, she said, because he couldn’t afford the tests. The difference in prices between countries also goes against EU treaties, which dictate that citizens should not be discriminated against on the basis of their nationality and that the single market should be free of disproportionate obstacles, in ‘t Veld said. The Dutch lawmaker, a member of the liberal Renew Europe group in the Parliament, has called on the Commission to put forward an emergency legislative proposal to cap the price of testing and suggested that EU citizens should have access to a number of free tests to allow them “to travel at least once during the holiday period”.

In ‘t Veld is not alone in seeing an issue with expensive testing. Greens MEP Tineke Strik said earlier this week that her group would put forward amendments to the green certificate proposal to ensure testing is free of charge. The Parliament is expected to nail down its position on the green certificates later this month, and in ‘t Veld is hoping to drum up support for a separate resolution — calling for Commission action on test prices — to be adopted at the same time. So far, the Commission’s response has been lukewarm. Making tests free of charge or capping their price “would constitute a serious interference in member states’ competence in the field of public health,” Commissioner for Justice Didier Reynders said Tuesday at a hearing of the Parliament’s industry committee. Such a proposal “would have to be carefully analyzed for its legality and feasibility,” he added. In ‘t Veld argues there’s “more than enough” of a legal basis for the Commission to step in, as the price of tests constitutes a “very clear obstacle to free movement” in the EU and the single market. She pointed at similar interventions to regulate credit card fees and bank transfer costs. “It’s as if this Commission is the lapdog of the member countries. They don’t dare to do anything without getting the green light from countries first,” she said.

Brexit to hit supplies of cancer, epilepsy and diabetes medicines to Northern Ireland, government warned

Brexit will prevent vital medicines to treat cancer, epilepsy and diabetes from reaching Northern Ireland, drug experts are warning. Firms making non-branded drugs are already starting to withdraw them because of costly new red tape, ministers are being told – threatening to cut the treatments available. The British Generic Manufacturers Association said planned new products being pulled before the rule changes come in next January included “treatments for epilepsy diabetes, and cancer”. “We need an urgent solution today,” said Mark Samuels, the trade body’s chief executive, adding: “If we don’t have a solution immediately, they will feel it in January.”

The threat has blown up because, at the end of a 12-month ‘grace period’, medicines made in Great Britain will require separate licences for use in Northern Ireland, as well as different safety inspections and other checks. The barrier is the latest to be put in the spotlight by the Northern Ireland Protocol, the 2019 treaty signed by Boris Johnson which has created a trade border in the Irish Sea. The new red tape emptied supermarket shelves in January, leading to the UK unilaterally shelving further checks – and a legal action launched by Brussels.

Johnson & Johnson to resume deliveries of COVID-19 vaccine to EU

Pharmaceutical company Johnson & Johnson is to resume deliveries of its one-shot COVID-19 vaccine to the European Union after the European Medicines Agency (EMA) confirmed its benefits outweighed the risks of blood clots as a very rare side effect. The vaccine leaflet is to be updated to include information on the diagnosis and treatment after the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed eight reported cases of unusual blood clots combined with low platelets among over seven million people who received the jab in the United States. It is likely to be several days before the National Immunisation Advisory Committee (Niac) will issue advice on the use of the Johnson & Johnson vaccine and the potential for spacing out between doses. Addressing an Oireachtas committee after the EMA announcement, Niac chairwoman Prof Karina Butler said it was awaiting further data from the European agency which may impact decisions on restricting access to specific age groups for some vaccines, and from the UK on dose intervals. This would be studied, along with projections on supplies of other vaccines and the potential impact of any decision on the wider programme, before recommendations were made to Government. On Monday (19 April), the National Public Health Emergency Team said it would not change its advice on extending the interval between doses of the Pfizer and Moderna vaccines until there was clarity on the Johnson & Johnson shot. Asked about the matter on Tuesday (20 April), Prof Butler said spacing out shots allowed to get “some vaccine into more people”, but that it could also favour the emergence of variants, and had to be balanced as it “will necessarily lengthen the time to get everybody fully vaccinated”.

And that is everything for now from EAPM – thank you for your company, stay safe and well, see you soon.

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Breast cancer

Europe Beating Cancer Plan can be a 'game changer' in tackling the deadly disease

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Every year, 3.5 million people in the EU are diagnosed with cancer and 1.3 million die from it. Over 40% of cancer cases are preventable. Without a reversal in these trends, it will become the leading cause of death in the EU, writes Martin Banks.

The European Parliament’s Special Committee on Beating Cancer is currently working on its own report by way of response to the recommendations contained in the new EU Cancer Plan on prevention.

The EU says Europe needs to stop cancer in its tracks by attacking it at source. 

That is why the beginning of 2021 has been marked by a significant milestone: the launch of Europe’s Beating Cancer Plan.

The Cancer Plan is Ursula von der Leyen Commission’s flagship initiative for EU health policy. The European Parliament reciprocated this ambition by setting up a special committee to develop concrete steps to fight cancer. 

Key to all this are the measures included in the Cancer Plan’s prevention pillar. The EU says that any potential gaps in terms of prevention must be urgently identified and addressed by actions in terms of legislation. 

One measure taken by some Governments across Europe are so-called "sin tax" policies to encourage better choices although  some question whether these have actually worked.

Most agree that the success of the Cancer Plan depends on understanding if regulation is working and what more can be done. 

The EU Plan was the focus of a special virtual hearing on Wednesday involving MEPs and a range of experts.

A keynote speaker at the online discussion included Deirdre Clune, an EPP member from Ireland and Member of the Committee on the Internal Market and Consumer Protection.

Clune is also a member of parliament’s special beating cancer committee, set up last September which will prepare parliament’s own report and response to the commission cancer plan proposals. 

It had hearings last year on lifestyle issues, including tobacco consumption.  

She said: “The plan is to cut consumption drastically by 2040 via measures such as taxation, education and plain packaging. The statistics on cancer are stark and these tell their own story but a lot can be done on a practical level, for example, via taxation.

“Yes, we will come up against many pushbacks a lot of the suite of the commission proposals, for example, in cutting down on eating red meat. But the point is that we must focus on preventable cancers.”

Europe’s Beating Cancer Plan seems to propose adopting the sin tax approach, especially for alcohol and diet. Ireland has previously been a driving force with its legislation on this with the Public Health Alcohol Act and now sugar taxes but some argue this seems to have backfired with poorer communities being hit the most.

When asked if she thinks this is the right approach, the MEP said, “A sin tax is always a sensitive issue but education is part of this too. In any case, I am not sure that it is just poorer communities that have been the only ones most affected. But even if you have higher taxes on alcohol you still need to do a lot about thing like low cost selling, for example, the 3 for price of 1 deals which have now been legislated against.

“But it has to be said that all such things at least raise a public awareness around alcohol harm and consumption and serves to maybe stop people in their tracks to think about these things.I accept the jury is still out though (on a sin tax).

She added: “During the crisis there has been more drinking done privately at home and increased taxation can be effective, be it on alcohol or tobacco.”

Tomislav Sokol, an MEP from the EPP and Member of the Committee on the Internal Market and Consumer Protection, said he was “surprised” to learn that up to 40pc of cancers are preventable.

He said: “The biggest problem is tobacco with 27percent of cancer deaths being attributable to tobacco compared to 4 percent due to alcohol.

“This is an enormous amount so this is a top priority for us.

“The European Cancer Plan is  the 1st systematic document which tries to cover all this and which also has a strong emphasis on prevention. it is a big step forward.

“The plan is very ambitious, for example, the aim to have less than 1pc tobacco use by 2040.”

The Croatian member said: “But we must have much higher taxation on tobacco and alcohol.This will be the silver bullet. But there will be a big backlash from interest groups in getting everyone on board.

Turning to harm reduction issues, he said alternative tobacco products had “more or less been put in the same basket for increased taxation as cigarettes.

“But this is divisive because the European Commission has taken a generally negative stance towards alternative products.”

He added: “Even so, much of the scientific evidence and the experts does not and do not share such negativity. They say that harm reduction measures can help while the ECJ says there is no certainty about  the effects of harm reduction. We must give consumers a real choice but I believe that the plan is a good starting point for these discussions.”

He said the special cancer committee was in process of preparing a report on prevention and a special study on vaping.

German member Michael Gahler, President of the Kangaroo Group which hosted the event, described the cancer plan as “ambitious” but that it was “top health priority”.

The MEP, who moderated the debate, said: “Up to 40% of us are likely to be affected by cancer so this presents a very serious issue. The WHO says 30-40" of cancers are preventable and there is clear evidence that  it can  help a lot when people  modify their lifestyles. That is why we need to invest in innovations that will help people change their lives and both the public and private sectors need to take joint responsibility here.

"Citizens should be motivated to choose to do regular exercise and avoid substance abuse, be it alcohol or tobacco. This, I believe, is better than,say, introducing a sin tax or just telling people what not to do.

“We should be following a science based approach - that will help us.”

Despina Spanou, Head of Cabinet for commissioner Margaritis Schinas, warned: “This (the cancer plan) is going to be a topic of tensions between governments and the  EU but these tensions have eased in recent years because people are more willing to talk about lifestyle changes.But the plan also looks not just at prevention but treatment, diagnose and  cancer survivors.

“The ambitious aim is for a tobacco-free Europe and this too will create tensions. There can be many government measures but at the end of the day we need an educated consumer who sees why tobacco consumption is harmful.

“Frankly, tobacco does not makes sense to me: it is an addiction and needs to be fought with a hardline approach. We need to tackle this at its heart: diagnosis and treatment.”

Dr Nuno Sousa, deputy director for the National Programme on Oncological Diseases, Directorate-General for Health in Portugal, said: “Lifestyle changes can promote a significant change in the growth of cancer but this will only become evident in a 5-10 year period. Past and current interventions to control tobacco consumption should be the roadmap for future proposals.

"Taxation is not the only issue and it is important to also explore controlling the marketing of, say, tobacco products.  That is the template to be followed. Education is also the key – if we provide the consumer about the pros and cons of different tobacco products we can make a change without the need for increased taxation."

The Portuguese Tobacco Control Law appears to encourage risk and harm reduction when it comes to smoking and using alternatives when conventional methods do not work. This, though, would seem at odds with the Cancer Plan which looks at regulating vaping (which the UK and France have both said helps with quitting smoking).

The Portuguese plan says that health services, regardless of their legal nature, such as health centers, hospitals, clinics, doctors’ offices and pharmacies, should promote and support information and education for the health of citizens with regard to the harm caused by smoking and the importance of prevention and smoking cessation.

Sousa, in a Q and A session, was asked about Portugal’s response to the Cancer Plan and if it supports the Commission’s approach of sin taxes.

He replied,: “Our approach is going to be in line with the commission recommendation, that is, that there should be no leeway provided for vaping or other forms of tobacco consumption. That is also part of our national tobacco control programme. This also states that tobacco alternatives should not be seen as being  any less harmful.”

Another speaker was Thomas Hartung, of the Johns Hopkins University Bloomberg School of Public Health.

Speaking via a link from Baltimore, he was asked about “gaps” in the cancer plan and if there should be more emphasis on harm reduction.

Hartung, who is on leave of absence from the commission, said that comparing the two systems, the EU and US was “interesting”, adding: “I hope the EU plan will also look at what is happening on this in the US and elsewhere.”

He said: “Put simply, people are afraid of chemicals but the good news is that this is starting to change.”

The WHO, he said, says that 40% of cancers are environment caused and tobacco will cause 1 billion early deaths this century. If someone starts smoking at the age of 18 they will live ten years less than those who don’t.

He believes e cigarettes can be a possible “game changer” saying that such products carry only a 3-5% risk of cancer.

“Tobacco is still a risky product but if some, by vaping, can get off cigarette smoking for good as a result that is good.

“A perceived problem is vaping kids although it is better they try e cigs than the real thing. I lost my dad to lung cancer so I am not a fan of any of these products.”

He said flavours of e-cigarettes was “one of the big problems”, not least as there are so many of them - 7,700 different flavours. Another issue is additives, he said: “Therefore we need to test flavours to identify all possible risks.

“There is a strong opportunity with the cancer plan but we need to do it carefully.”

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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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