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#EAPM – To mask or not to mask, that is the question



Welcome, one and all, to the first update of the week from the Euopean Alliance for Personalised Medicine (EAPM). The controversies of COVID feature largely as the week gets under way, writes EAPM Executive Director Denis Horgan.

As usual, a quick reminder about EAPM’s upcoming events - the ESMO conference arrives on 18 September, agenda here, register here, and there is of course the upcoming participation of EAPM at the German Presidency conference in October, see the agenda by clicking here.

The sessions in the Presidency conference of 12 October are as follows:  Opening Session: The Pharmaceutical Strategy of the EU; Session IRational allocation of resources to support innovation; Session II: EU coordinated action on prostate, lung, breast and cervical cancer; Session III: Biomarker testing: Alzheimer’s and related dementia; Session IV: Advanced therapy medicinal products (ATMPs) & Closing Session: Biomarker testing and molecular diagnostics

Phil Hogan replacement set to start

As previously, EAPM wishes resigned Irish Commissioner Phil Hogan well, and also offers its best wishes to First Vice President Mairead McGuinness, whom Commission President Ursula von der Leyen has  tapped for the role of financial services, financial stability and capital markets union commissioner. Commission Executive Vice President Valdis Dombrovskis is set to take over the trade portfolio vacated by Hogan.

World WHO chief calls for investment in public health, lauds Germany’s commitment 

It is important to learn from previous disease outbreaks and invest in public health to deal with future ones, said World Health Organisation Director General Tedros Adhanom Ghebreyesus, outlining successful initiatives by several countries, including a recent commitment from Germany. Lauding the announcement by Chancellor Angela Merkel over the weekend on her Government’s investment of €4 billion by 2026 to strengthen Germany’s public health system, Tedros said: “I call on all countries to invest in public health, and especially in primary health care, and follow Germany’s example.” Although Germany’s response was strong, it was also learning lessons, he pointed out. “This will not be the last pandemic. History teaches us that outbreaks and pandemics are a fact of life,” he said.

Review committee to start work in response to COVID-19

The Review Committee of the International Health Regulations (IHR) begin its work on 8 September to evaluate the functioning of the IHR during the COVID-19 pandemic so far, the chief of the World Health Organization (WHO) has said. "The International Health Regulations is the most important legal instrument in global health security. As a reminder, the review committee will evaluate the functioning of the IHR during the pandemic so far, and recommend any changes it believes are necessary," said WHO Director-General Tedros Adhanom Ghebreyesus at a virtual press conference. "It will review the convening of the Emergency Committee, the declaration of a public health emergency of international concern, the role and functioning of national IHR focal points, and will examine progress made in implementing the recommendations of previous International Health Regulations review committees," Tedros said. According to the WHO's website, the review committee is expected to hold its first meeting soon. 

Gallina under scrutiny in ENVI committee

On 7 September, ENVI Members debated with DG SANTE Deputy Director General Sandra Gallina, on the state of play of the EU vaccines strategy and the Vaccines Advance Purchase Agreements. The aim of the European Vaccines Strategy, adopted by the Commission last June, aims to secure for all European citizens high-quality, safe, effective and affordable vaccines within 12 to 18 months. To do so, and together with the member states, the Commission has started to enter into Advance Purchase Agreements with vaccine producers reserving or giving the member states the right to buy a given number of vaccine doses for a set price, as and when a vaccine becomes available. Advanced Purchase Agreements are financed through the Emergency Support Instrument. A first such contract was signed on 27 August for the purchase of 300 million doses for a vaccine against COVID-19.

Czech government unveils national coronavirus vaccination strategy

The Czech Health Ministry has released a draft national vaccination strategy for coronavirus, to be used in the event that a workable vaccine is developed. The document states that: “Despite the pressure and efforts to rapidly develop a vaccine, it is realistic to anticipate a registered vaccine possibly by the end of 2020 at the earliest, to become available in 2021.” According to the draft document, vaccination will be the most effective tool against the coronavirus pandemic. The main goal is to prevent deaths, complications and hospital overload. “Although we do not yet have a coronavirus vaccine on the table, we need to be ready when it becomes available. The vaccine is a key way out of the current situation. It will protect the population from disease and prevent the spread of the disease in the population,” said Health Minister Adam Vojtěch.

Addressing obesity

The pandemic has been the catalyst behind the UK government’s latest drive to tackle the rising level of obesity across the nation. This latest campaign, which is aimed at helping people lose weight, become more active and eat better, is hoping to make an impact on addressing a growing problem which more than ever poses an escalated threat to individuals’ health. Since the outbreak of COVID-19, there has been a significantly higher level of deaths amongst obese people who contracted the virus. A collaborative study between the University of North Carolina, Saudi Health Council and World Bank has now found a 48% increase in death amongst significantly overweight people who have been afflicted with the coronavirus. The study also reported that the risk of ending up in hospital with Covid-19 increases by 113% for obese people with a 74% increase in their chances of requiring intensive care.

EU unveils COVID-19 'colour-code' travel zones 

The European Commission announced on 4 September its recommendations for member states on how to co-ordinate travel restrictions due to the coronavirus pandemic, including a 'traffic-light' colour-coding system of affected areas. The proposal, based on ideas from the German EU presidency, includes common criteria on epidemiological risks, a shared 'colour-coding' of risk areas, as well as a joint approach on returning from high-risk areas. Until now, the European Centre for Disease Prevention and Control has been publishing these regularly updated maps showing 14-day Covid-19 case-notification rate per 100,000 population "The past few months have shown we can not take free movement for granted, but it is clear that we need more coordination," admitted Justice Commissioner Didier Reynders. Health Commissioner Stella Kyriakides, said this recommendation aims "to avoid further disruption of already fragile economies and additional uncertainty for citizens".

Germany’s Greens seek to toughen legislation on vaping over COVID-19

Vaping raises the risk of falling critically ill with COVID-19, experts have warned — despite a growing body of research showing the opposite. German scientists reviewed available evidence on the damage smoking and vaping inflicts on vital organs in the body. All three harden the arteries and raise the risk of developing lung and heart diseases — two risk factors for coronavirus — by up to seven-fold, they found. As a result, the team believes smokers and e-cigarette users would be more likely to suffer complications from COVID-19. They admitted smoking is more toxic on the body than vaping but warned research suggested vaping was 'not a healthy alternative'. The review — published in the European Heart Journal — did not actually analyse the hospital records of COVID-19 patients, however. One scientist said the methodology behind the review on how smoking and vaping damages the body was so sloppy 'it cannot be described as a study', while another described the findings as 'questionable'. 

That’s all for now. More later this week - and don’t forget to register in advance for the upcoming conference for ESMO as well as the 12 October Presidency Conference. (Links are above.)


EAPM: Why increasing trust between stakeholders must be way forward for health



Good morning, and welcome one and all to the first European Alliance for Personalised Medicine (EAPM) update of the week. We come off the back of a busy month for EAPM in October, following our 1 Million Genome meeting and German EU Presidency Conference, as well as engagement with the EU Beating Cancer Plan, which is aiming to set the framework to tackle cancer. And, a little later this week, there is the monthly EAPM Newsletter to look forward to, writes EAPM Executive Director Denis Horgan.

Trust and governance

Despite member state competence in many areas, there is undoubtedly a need for common European health legislation as much as possible, but it must be the right legislation. Unfortunately, experience has shown that having separate rules in every member state does not really work, for a variety of reasons. For example, it often leads to an R&D environment that is not competitive, slows the innovative dynamic and ultimately represents a barrier to the emergence of effective therapies for untreated disease. With more integration, collaboration, dialogue and increased trust among each and every one in the field, stakeholders can help mould the right frameworks, in the right place, at the right time. More about EAPM’s aims in this regard later.

Europe needs 'serious acceleration' in fight against coronavirus: WHO

Europe needs a “serious acceleration” in the fight against the coronavirus and a lack of contact-tracing capacity could drive the disease into the darkness, a top World Health Organization official said on Monday (26 October). In Europe the picture is unrelentingly grim as a string of countries reported record increases, led by France, which posted more than 50,000 daily cases for the first time on Sunday, while the continent passed the threshold of 250,000 deaths. The 46 countries at World Health Organization level accounted for 46% of global cases and nearly one third of deaths, said Mike Ryan, the WHO’s top emergencies expert. “Right now we are well behind this virus in Europe, so getting ahead of it is going to take some serious acceleration in what we do,” Ryan told a news conference.

Placing confidence in the hands of others

From man's earliest ventures into health care, when shamans, priests or medicine men ministered to the sick, trust has been at the centre of the compact between patient and carer. People at their most vulnerable moments choose to place themselves in the hands of others, in the confidence – or at least the belief – of benefit and relief. That compact remains just as valid in today's world of science and technology. The rapid development of medicine in the last 50 years, and more particularly the exponential leaps of the last 25, have created opportunities unimaginable only a couple of generations ago. Genomics is increasingly permitting a focus on the underlying nature of disease – and the underlying processes of health. As a result, at one end of the scale there is a growing ability to treat smaller populations – with orphan drugs for rare disease, or validated paediatric medicines, or advanced therapies, and with an unfurling range of possibilities as personalised medicine evolves. And at the other end of the scale health authorities begin to tap into a wealth of information about health trends, susceptibilities and the value of distinct treatment options that can radically improve health systems management.So the trust invested in the shaman is even more crucial today. The emergence of evidence-based medicine and organised health services that are overseen by governments entitle patients to a degree of certainty that their best interests are being attended to on the basis of reason and equity as well as of faith.

Council welcomes prospect of European health data space

The European Council has welcomed the European strategy for data, which supports the EUʼs global digital ambitions to build a true European competitive data economy. The European Council welcomes the creation of common European data spaces in strategic sectors, and in particular invites the Commission to give priority to the health data space, which should be set up by the end of 2021, and which is being cited as a means to strengthen the immediate response to COVID-19.

And it is not just the Commission that’s working on digital health, with the World Health Organization also presents its global strategy for digital health, which is set to be brought to the World Health Assembly in November. The WHO is currently putting together an investment case to implement this strategy, with member state approval being awaited, the WHO’s Chief Information Officer Bernardo Mariano Jr has said. But public trust is again a big consideration, with critics asking whether people will be willing to share their data on a pan-EU platform, and whether governance will be equired to ensure full participation.

Improving precision and power in randomized trials for COVID‐19 treatments

Time is of the essence in evaluating potential drugs and biologics for the treatment and prevention of COVID‐19. There are currently 876 randomized clinical trials (phase 2 and 3) of treatments for COVID‐19 registered on Covariate adjustment is a statistical analysis method with potential to improve precision and reduce the required sample size for a substantial number of these trials. Though covariate adjustment is recommended by the U.S. Food and Drug Administration and the European Medicines Agency, it is underutilized, especially for the types of outcomes (binary, ordinal, and time‐to‐event) that are common in COVID‐19 trials. In simulated trials with sample sizes ranging from 100 to 1000 participants, there have been substantial precision gains from using covariate adjustment–equivalent to 4–18% reductions in the required sample size to achieve a desired power.

EAPM to discuss trust and governance in early 2021 upcoming Presidency Conferences

In Europe, the interdependence of member states makes it both necessary and desirable that much of that task of oversight is organized at EU level. It is, inevitably, of course, a more complex compact nowadays. Each component of the systems on which people now routinely depend for their health has to fulfil its part of the bargain. These issues of trust will be discussed in EAPM’s two presidency conferences being planned for January and July 2021 that will address these elements of governance.

Health minister cites ‘strongest EU position on WHO in years’

German Health Minister Jens Spahn has recently spoken of “the strongest EU-level position concerning WHO at least in recent years”. Spahn added that he advocates “for a stronger role of the EU” in the WHO and in global health in general. “We should not leave [it] to the USA and China to call the shots,” he said. 

Public consultation on breast implants

On Friday (23 October) the European Commission launched a public consultation on a preliminary opinion on the safety of breast implants. The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) opinion is based on anaplastic large cell lymphoma (ALCL). Interested parties can submit their comments by 7 December.

Intensive care units ‘could be overrun in weeks’ warns WHO

The World Health Organization has warned that intensive care units in Europe could be overwhelmed in a matter of weeks and that immediate action was essential to prevent essential health systems collapsing and schools closing. In many cities around Europe, the capacity for ICU is going to be reached in the coming weeks,” said Maria Van Kerkhove, the WHO’s technical lead for COVID-19. WHO Director General Tedros Adhanom Ghebreyesus warned that the entire world, and particularly the northern hemisphere, was at a “critical juncture”.

And that is everything for now – do look out for the EAPM Newsletter, which will be available later this week, and stay safe and well.

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New French COVID cases could be 100,000 per day: Government medical advisor




France may be experiencing 100,000 new COVID-19 cases per day - twice the latest official figure - Professor Jean-François Delfraissy, who heads the scientific council that advises the government on the pandemic, told RTL radio on Monday (26 October), writes Sudip Kar-Gupta.

“There is probably more than 50,000 cases per day. We estimate, on the scientific committee, that we are more in the region of 100,000 cases per day,” said Delfraissy.

France, the eurozone’s second-biggest economy, is currently examining whether to tighten lockdown measures further to curb the resurgence of the COVID-19 virus, having already imposed night-time curfews on major cities including Paris.

The health ministry reported on Sunday a record 52,010 new confirmed coronavirus infections over the past 24 hours, as a second wave of cases surges through Europe.

The new cases took the French total to 1,138,507, with France overtaking Argentina and Spain in registering the world’s fifth-highest number of cases.

The ministry said 116 people had died from coronavirus infection in the 24 hours to Sunday, down from 137 a day earlier, taking total deaths to 34,761.

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Coronavirus: First rescEU ventilators dispatched to Czechia 



Following a request for assistance from Czechia, the EU is immediately sending a first batch of 30 ventilators from rescEU - the common European reserve of medical equipment set up earlier this year to help countries affected by the coronavirus pandemic.

As President von der Leyen (pictured) said: “Czechia is facing one of the most difficult situations in Europe right now. The number of coronavirus cases is rising rapidly. And it needs medical equipment to treat patients in hospitals. We do not leave our European friends alone in these hard times. The European Commission is mobilizing medical material through our Civil Protection Mechanism. I called the Prime Minister Andrej Babiš to tell him that we are dispatching rapidly to Czechia a set of 30 ventilators from our RescEU reserve. We created this reserve in record time in spring, to stockpile essential medical material that we can send to European countries in need. And we are in touch with other EU countries, to mobilize more ventilators for the Czech Republic. We are in this together.”

Crisis Management Commissioner Janez Lenarčič added: ”We have been working around the clock to avoid a repetition of the situation experienced at the end of February, when whole EU was overwhelmed in the fight against the pandemic. We created the rescEU medical reserve so no member state is left alone when dealing with the same challenge. After already delivering protective face masks across Europe, this will be the first time the European Commission is dispatching ventilators from the EU level reserve."

The EU's Emergency Response Co-ordination Centre is in constant contact with authorities in Czech and more EU assistance can be channelled in the coming days via the EU Civil Protection Mechanism, coming from member states. In order to give member states time to assess their response capacity and taking into account the gravity of the situation in the Czech Republic, the EU has proactively initiated the rescEU deployment of medical reserve. The full press release is available online.

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