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#EAPM – Confusion reigns over return to work and health-care systems prepare



Welcome, one and all, to the first European Alliance for Personalised Medicine (EAPM) update of September. As far as is possible, most are now back at either work or school, but the big return brings its own problems in the pall of coronavirus. On with the news, writes EAPM Executive Director Denis Horgan.

Chaos with la grande rentrée

Most MEPs have already gone back or are due back at work soon. But not necessarily here in Brussels. Since the coronavirus crisis hit, the Parliament has had to get used to remote working, and with the cases rising across Europe again, that doesn’t look like it will change anytime soon, and confusion reigns concerning rules for those who are returning to Brussels from abroad, with the prospect of thousands of Eurocrats returning to Brussels sparking concern. “The instructions regarding our working methods and those of our teams in Brussels, as in Strasbourg, are not clear,” French Renew Europe MEP Chrysoula Zacharopoulou said.

Health systems brace for viral overload 

Doctors are anticipating that the collision of COVID-19 and cold and flu season could bring a new host of health-care challenges when the cold weather sets in. Researchers have said there are significant similarities between the symptoms of COVID-19 and those of a cold or flu, including coughing, congestion and body aches. This diagnostic overlap can make it difficult for doctors to distinguish the sniffles from the deadly disease, and the only way to know for sure is through testing. As school resumes, scientists say it's unclear whether classes should be closed. Health agencies are helping hospitals prepare for an influx of patients with the flu and other respiratory illness, which could burden emergency rooms, acute-care units and the availability of beds. And the World Health Organization (WHO) states that 90% of countries from five regions have seen their health systems disrupted due to coronavirus. 

Scientists look to plasma treatment

Since early in the pandemic, scientists have said antibodies that the immune system makes to fight the coronavirus could be crucial in finding a cure for COVID-19. In the US, the Food and Drugs Administration (FDA) recently authorized one of these treatments — convalescent plasma, in which the antibody-rich portion of blood donated by recovered COVID-19 patients is given to people hospitalized with the disease. But the approval, which came soon after President Donald Trump accused the agency of moving too slowly on the treatment for political reasons, has prompted pushback from some in the scientific community, who say more research is needed to determine if and how plasma can be effective against COVID-19. Meanwhile, research on another therapy, involving antibodies cloned in the lab, is just getting underway in human subjects. The use of convalescent plasma in medicine dates back more than a hundred years. Early results from a Mayo Clinic study suggest convalescent plasma may reduce COVID-19 mortality rates. But the study, which is available as a non-peer-reviewed preprint, wasn’t placebo-controlled, and results from rigorous clinical trials with COVID-19 convalescent plasma have yet to be published.

UK antibody tests ‘stalled’

According to the FT, the UK government “has stalled the wider rollout of antibody tests, causing companies to voice frustration at being kept out of what was sold as an inclusive and ‘world-beating’ diagnostics market”. 

Hogan update

Following Phil Hogan’s regrettable resignation last week, the European Commission is set to gain a new commissioner, and certain portfolios may change hands as a result. The three key contenders toe take the role of trade chief are Ireland’s Foreign and Defence Minister Simon Coveney, European Parliament First Vice President Mairead McGuinness and MEP Frances Fitzgerald. It is also said to be likely that Ireland will lose the trade portfolio.

Breton speaks of common coronavirus rules and EU health data consultation

Speaking in an interview with POLITICO today, Internal Market Commissioner Thierry Breton spoke about Brussels proposing common rules to measure the spread of coronavirus, and to identify danger areas in red, yellow and green categories.. “You may see good proposals on this. It is important that at least we have the same rules … to harmonize when a region, a city or a country is red, and then take the same decisions,” Breton said, and also expressed his desire that the Commission launch a consultation on the use of health data, he said today. “We cannot compromise [on health data]. There is nothing more important than our health data. It really belongs to us. At the same time some data can be shared, only if clearly defined and anonymously. We have to discuss it. We want to launch a consultation,” he said.

Macron wants pharmaceutical production back in France

French President Emmanuel Macron said on Friday (28 August) that €15 billion ($18bn) will be made available in France’s post-coronavirus recovery plan to boost innovation, industrial relocation, and pharmaceutical production. Macron’s government wants to spur companies to relocate more production back to France after the coronavirus crisis laid bare its dependence on foreign Macron said: “We need to relocate and recreate production forces on our territories. Health and industrial sovereignty will be one of the pillars of the [post-corona] recovery plan.”

Commission confirms €400M guarantee for COVAX coronavirus vaccine 

The European Commission has confirmed its interest to participate in the COVAX Facility for equitable access to affordable COVID-19 vaccines everywhere, for everyone who needs them. As part of a Team Europe effort, the Commission is today also announcing a contribution of €400 million in guarantees to support COVAX and its objectives in the context of the Coronavirus Global Response. The COVAX Facility, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world.

UK ‘extremely close’ to coronavirus vaccination 

Scientists at both Oxford University and Imperial College London are said to be “extremely close” to developing and testing a vaccine. It could then be mass produced and given to the entire population in a matter of a few months, allowing life to rapidly return to normality in 2021. Ministers, however, are remaining cautious about developments and the “reopening” of the UK. 

And that is all from EAPM for now – a hearty welcome back to all, see you later in the week.


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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