#EAPM heads for grand depart with newsletter and imminent ESMO Roundtable

Welcome, one and all, to the final European Alliance for Personalised Medicine (EAPM) update before le grand depart– before you go, do be sure to check out the EAPM newsletter, which is available here. And be sure to register in good time for the ESMO Virtual Congress 2020, at which EAPM will be organizing a round table on 18 September, bringing its stellar cast of specialists from the patients network, as well as experts from the oncology community and the European Medicine Agency (EMA) and European Parliament, writes EAPM Executive Director Denis Horgan. 

The agenda is available here, and you can register already here.

Bringing innovation to patients – choosing the right time to investigate transparency

A major pillar in bringing new, targeted medicines to patients is, of course, innovation. This, in the realm of health, means the translation of knowledge and insight into what we can call ‘value’. And that value covers the value to patients but also has to take into account value to healthcare systems, society and, of course, the manufacturers.  

Transparency and good governance is of course essential, but it must be asked whether, with all resources stretched to near breaking point, now is a good time for European Ombudsman Emily O’ Reilly to be requesting the European Centre for Disease Prevention and Control (ECDC) to provide a number of documents to evaluate its performance during the coronavirus pandemic. 

A request was made during the summer of 2017 when, again, in a similarly unpopular move, the European Ombudsman asked the European Medicines Agency to provide more information about its early dialogue procedures. O’Reilly’s  raises the issue of what the EU is trying to do with its own health regulation in bringing innovation to the patient, but is now really the right time? On verras… O’Reilly suggested a meeting between her inquiry team and the ECDC staff to further clarify and discuss any outstanding issues.

Surviving the pandemic – how different countries have fared

The latest statistics now available have provided one of the clearest pictures yet of how different countries have fared during the pandemic. It demonstrates that while the most devastating short-term and localized spikes in COVID-19 and other deaths were seen in Spain and Italy, England and the rest of the UK endured a longer period of convalescence, with significantly increased excess mortality – England had the highest levels of excess deaths of any country in Europe from January to June, according to a new analysis by the European Office for National Statistics (ONS). 

While Spain saw the worst weekly spike in deaths from all causes during the coronavirus pandemic, England had the “longest continuous period of excess mortality,” the ONS said. By the end of May, England had the highest cumulative mortality rate of any of the 23 countries for which data was available, followed by Spain, Scotland and Belgium. The worst local spike in Europe was in Bergamo, Italy in the week ending 20 March, where an excess mortality rate of 847% — or more than nine times the 2015 to 2019 average — was seen. The major city with the worst spike was Madrid, with excess mortality of 432% in the week ending 27 March.

Dancing, with tears in their eyes

Initially, sad news for everyone planning to put their cares aside with a good boogie – the Romanian government was supposedly planning to ban dancing on public terraces. But, according to Digi24, the powers that be pulled back from this potentially unpopular decision, choosing instead to announce new measures this past week to make wearing a mask mandatory in certain outdoor spaces, such as markets and boardwalks. Local authorities were mandated to decide the spaces and the time slots when people will be required to wear a mask.

France sets out COVID-19 vaccination planning

As the coronavirus pandemic continues, there is hope that one or more of the vaccines in development will be successful. France has revealed its early planning for implementation of a vaccine.  The Haute Autorité de Santé (HAS – High Authority for Health) said: “At the request of the Ministry of Solidarity and Health, the High Authority for Health is making preliminary recommendations to anticipate the development of the vaccine strategy against COVID-19 with a view to the future arrival of one or more vaccines. 

Who to vaccinate? According to what scheme? By which professionals? To inform the public decision, the HAS draws the different possible vaccination strategies through four scenarios based on the level of circulation of the virus in the territory.”  

The strategy will be updated as the pandemic continues, ensuring the latest information is incorporated into the plan. In particular, the status and spread of the virus will be monitored.  What is clear now, however, is the need to prioritise medical and health professionals so that the risk of catching and passing on COVID-19 is reduced while essential work continues.

Dutch government not advising public to wear masks

On Wednesday (29 July) this week, the Dutch government said it will not advise the public to wear masks to slow the spread of coronavirus, asserting that their effectiveness has not been proven.The decision was announced by Medical Care Minister Tamara van Ark after a review by the country’s National Institute for Health (RIVM). The government will instead seek better adherence to social distancing rules after a surge in coronavirus cases in the country this week, Van Ark said at a press conference in The Hague. The decision bucks the current trend as many European countries have made masks mandatory in stores or crowded outdoor areas. Masks are currently required only on public transportation in the Netherlands and in airports.

WHO blames youth ‘letting their guard down’ 

Young people are relaxing on social distancing and other ant-coronavirus measures, and are part of the reason for the summer spikes in coronavirus, according to World Health Organization Director General Tedros Adhanom Ghebreyesus: “We have said it before and we’ll say it again: Young people are not invincible,” said Tedros. Countries across Europe are seeing increases in case numbers, with many fearing it’s the start of a second wave.

Coronavirus vaccine ‘not available this year’, WHO warns 

Hopes of a coronavirus vaccine before Christmas have been dashed by a World Health Organization (WHO) expert.   Mike Ryan, head of WHO’s emergencies programme, said the first use of a COVID-19 vaccine cannot be expected until early 2021. He noted that several vaccines are now in phase three trials and none have failed so far in terms of safety or ability to generate an immune response. His comments come after Oxford University — one of the frontrunners in a race for a vaccine —  claimed there was still a chance it could deliver its experimental jab by Christmas if tests keep going according to plan.     One of the researchers working on the project had said that people in the most at-risk groups could get the first jabs in the winter. 

A vaccine is considered crucial for getting out of the coronavirus pandemic because it would be the only way to secure protection against catching it. It would work by injecting either a tiny piece of the virus into the body –  which would not make someone sick – or a clone of its DNA. This triggers an immune response which has long-term memory, so if a person is exposed to the coronavirus in real life, their body knows how to fight it quickly.  

Here is the link the newsletter again for the ESMO Agenda and to register

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