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#EAPM – Phil Hogan faces Crucible-esque issues as COVID-19 political correctness holds sway and EAPM Newsletter available!

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Welcome, one and all, to the last European Alliance for Personalised Medicine (EAPM) update of les grandes vacances – August ends on Monday, so most (but decidedly fewer than usual) are getting ready fo the grand return to work next week, writes EAPM Executive Director Denis Horgan.

Before we get on with the main news, be sure and check EAPM’s monthly newsletter, which is now ready, click here. It covers the health news of the past month, and looks forward to key EAPM events that are just around the corner.

Hogan resigns

But first, a word on the sad demise this week of Irish Trade Commissioner Phil Hogan (pictured), who resigned on Wednesday evening (26 August), following controversy over alleged breaches of COVID-19 guidelines during a trip to his native Ireland, a spokesman for the commissioner said. 

Hogan attended a golf dinner last week that outraged the Irish public and led to the resignation of an Irish minister and the disciplining of several lawmakers. He had insisted on Tuesday (25 August) that he had adhered to all rules during the trip, and Commission President Ursula von der Leyen, while accepting his resignation, thanked Hogan for his work as trade commissioner and for his successful term as agriculture commissioner in the previous Commission, the Juncker Commission. Von der Leyen described him as a valuable and respected member of the College of Commissioners.  

Of course, COVID 19 is a very serious issue, but the question is how the guidelines are applied as well as the lowest common denominator in the application of standards.  If we go for the lowest commonest denominator and undermining our way of life, are we giving in to the disease in another way, and are we not losing our humanity in not seeing the issue, in this case the person that Phil Hogan is and the office he once represented?

For this part of the update, I want to highlight the good work that Hogan has done over the years as well as the work that he did on trade. The commissioner championed health care as well, and had spoken at EAPM events.

The fate of Phil Hogan is similar to the issue in the play The Crucible by Arthur Miller, in the sense that everyone acted hysterically about an alleged breach of rules, and political correctness won the day. The play is a fictionalized version of the Salem witch trials and tells the story of a group of young Salem women who falsely accuse other villagers of witchcraft. The accusations and ensuing trials pushed the village into a hysteria between February 1692 and May 1693. More than two hundred people were accused. Thirty were found guilty, nineteen of whom were executed by hanging (fourteen women and five men).

Of course, the former commissioner made a mistake, but the issue was blown into the stratosphere by those wanting to say that they are whiter than white, so as to protect the public good and score political points with the broader public. 

Clearly, public health guidelines must be adhered to but one must look to each case as UK Prime Minister Boris Johnson did, with Cummings. Hogan did have a COVID-19 test, was negative, checked with the relevant website as well as the department but to no avail, he had to bow out...as political correctness won the day. The controversy of what he did or did not do has now fallen silent, as there was really nothing to it in the end. There was no monetary fine, no punishment of any kind, but the fact was that he had to resign ....

By all accounts, he was the right person for the job and in his interaction with EAPM was a very considered and supportive member of the broader health-care community. 

A real shame. European Commission Vice President Valdis Dombrovskis will take over the trade portfolio temporarily after Hogan’s resignation, Commission President Ursula von der Leyen announced on Thursday. The Hogan saga was evidence writ large that von der Leyen has raised the European Commission’s ethical bar — and that may make it harder to clear in future. “As Europe fights to reduce the spread of the coronavirus and Europeans make sacrifices and accept painful restrictions, I expect the members of the College to be particularly vigilant about compliance with applicable national or regional rules or recommendations,” von der Leyen said on Thursday (27 August).

World Health Organization Pandemic Policy Committee meets

The World Health Organization (WHO) Pan-European Commission on Health and Sustainable Development met for the first time on Thursday. At its concluding press conference, chairman Mario Monti — former Italian PM and current president of Bocconi University — drew attention to the way COVID-19 has revealed weaknesses in current health systems. “The pandemic has illuminated with a rather dark light the stark inequalities in our modern world,” he said. “But it also has also underlined the truism that no one is safe until everyone is safe.”

Rethinking the PHEIC

And the WHO said on Thursday it was setting up a committee to consider changing the rules on declaring an international health emergency, following criticism of its COVID-19 pandemic response.  The World Health Organization declared a Public Health Emergency of International Concern (PHEIC) over the new coronavirus on 30 January 30 – at which time the respiratory disease had infected fewer than 100 people outside China, and claimed no lives beyond its borders. But under the current International Health Regulations (IHR) governing preparedness and response for health emergencies, there are no lower, intermediate levels of alarm beneath a full PHEIC, either on a global or regional scale. The WHO intends to interact with the new independent review panel looking at the broader response, as well as the WHO’s internal oversight panel, with plans to deliver an update at the World Health Assembly in November, and a final report at that gathering in May 2021.

Vaccination percentages

The EU, Britain and other EU partners such as Switzerland and Norway want a future vaccine to cover 40% of their populations, as opposed to the 20% initially set out by the global procurement mechanism COVAX. According to a document adopted in late July, the countries noted that at-risk groups account for around 40% of the population.

Back to school

According to a study by BMJ, COVID-19 has not caused the deaths of any otherwise healthy schoolchildren in the UK. Children's risk of needing hospital treatment for coronavirus is "tiny" and critical care "even tinier", they say. However, black children, those who are obese and very young babies have a slightly higher risk. The BMJ study looked at 651 children with coronavirus in hospitals in England, Wales and Scotland. It covers two-thirds of all children's admissions in the UK due to COVID-19 between January and July and confirms what is already known about the minimal effects of the virus on children. A "strikingly low" 1% of these 651 children and young people - six in total - had died in hospital with COVID-19 compared with 27% across all other age groups, the study found. Eighteen per cent of the children needed intensive care. And the six who had died had had "profound" underlying health conditions that had often been complex and themselves life-limiting. Children with such conditions remained vulnerable to the virus and must take precautions, the researchers said. But for others, the risk was extremely low. 

And that is everything for this week – enjoy your weekend, which is possibly your last before returning to work, here is our newsletter again and be sure to check in with EAPM again on Tuesday (1 September).

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

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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 clinicaltrials.gov. 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

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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 

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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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