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EAPM: How biomarker testing can pierce the fog of Alzheimer’s and related dementia

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Hello and welcome, health colleagues, to the second update of the week from the European Alliance for Personalised Medicine (EAPM). There is plenty of news today about a recent academic publication from EAPM, the evolution of the EU’s pharma strategy and updates on the ongoing COVID-19 crisis, writes EAPM Executive Director Denis Horgan.

A fundamental shift in Alzheimer's Disease (AD) health-care strategy

EAPM recently launched an academic publication with a multistakeholder perspective to tackle the issue of biomarkers entitled Piercing the Fog of Alzheimer’s and Related Dementia. This paper discusses the challenges, lists the achievements to date, and highlights the actions needed to allow biomarker testing to deliver more fully on their potential in AD. 

The paper is available here. Biomarker testing is improving the prospects for tackling Alzheimer Disease and other dementias, and holds the key to discovering new treatments. Early diagnosis and more personalised health care will have a central part to play in confronting this massive challenge to Europe’s citizens and its health-care systems. 

The EU is itself in constant evolution, both organically, as its competences are progressively refined, and in response to changes in the wider world. In health care, its evolution is marked not only by the emergency of the COVID-19 pandemic, which has largely monopolized the attention of all the major EU institutions throughout most of the  year, but also by the constant increase in morbidity, which now affects more than its ageing population.

With the initiation of a European Health Data Space and a new Pharmaceutical Strategy which will be discussed below, it is an appropriate moment also for it to review its approach to diagnostic testing as an intrinsic element in an integrated health strategy. 

In these straitened circumstances, a reappraisal of the significance and potential of biomarker testing in AD can provide the EU and its citizens with a much-needed immediate up-tick in quality and accuracy of care. 

The COVID-19 pandemic should also provide a warning of how vulnerable society is to inadequacies in healthcare preparation – and should serve to highlight the risk that dementia could, if unchecked, present a pandemic of similar or greater proportions within decades. Europe, with real foresight, can now make a change in policy that holds out the prospect of a radical transformation of care in the coming years as the full benefits of an optimum approach to the use of biomarkers begin to be felt.

EAPM lung-cancer screening event 

On 10 December, the EAPM will be holding on online conference on lung cancer screening. The Alliance and its stakeholders realize that, among other elements, what is required in Europe is continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted. 

You can check out the agenda of the 10 December conference here, and register here.

Kyriakides presents pharma strategy in Parliament 

On Thursday (26 November), access to safe and affordable medicines and supporting EU pharmaceutical innovation were debated in Parliament. Health and Food Safety Commissioner Stella Kyriakides presented the new Pharmaceutical Strategy as an important component of the new EU Health Union. 

A new strategy was already expected before COVID-19, but in the light of the pandemic, a more ambitious proposal is essential. Most MEPs welcomed the new strategy, which puts into effect Parliament’s requests to step up efforts to tackle medicine shortages – a problem exacerbated by COVID-19 – and to move towards a more sensible use and disposal of pharmaceuticals in order to prevent risks to the environment and public health. Several MEPs highlighted the need for all EU citizens to have equal access to high-quality medicines. 

They emphasized the need to decrease the EU’s dependence on imports of active pharmaceutical ingredients from non-EU countries, namely by increasing their production in Europe and supporting innovation in the EU pharmaceutical industry. The Commission has said that it wants to “work with the European Parliament and the Council towards the adoption of the Regulation on health technology assessment”. 

EPP MEP Peter Liese, while supportive of the Pharmaceutical Strategy, said, in an emailed statement: “The core of the current debate is how we can be less dependent on China and India when it comes to lifesaving pharmaceuticals. The coronavirus crisis has shown that the problem that has existed before is getting bigger and bigger.”

Advance funds for COVID-19 – Parliament seals its approval

On Tuesday (24 November), Parliament approved €823 million in EU aid in response to the coronavirus crisis in seven EU countries. The aid from the European Union Solidarity Fund (EUSF) will be distributed in advance payments to Germany, Ireland, Greece, Spain, Croatia, Hungary, and Portugal in response to the major public health emergency caused by the COVID-19 pandemic in early 2020.

Medicine supply to be prioritized in Portuguese Council presidency 

A secure supply of medicines will be a key priority for the Portuguese Council presidency — set to begin in 2021 — said Rui Ivo Santos, the president of Portugal’s drug agency Infarmed. Speaking at a panel organized by the European Public Health Alliance on Wednesday (25 November), Santos said he fully supported the Pharma Strategy’s goal of ensuring adequate availability of drugs.

NICE launches consultation on its methods of drug evaluation 

The UK’s National Institute of Health and Care Excellence (NICE) is set to review its methods of evaluation for drugs, medical devices and diagnostics. The health technology assessment (HTA) agency launched a public consultation last week on a proposal for changes to the methods it uses to evaluate potential medical treatments. NICE uses the Quality-Adjusted Life Year (QALY) measure to determine whether or not a treatment is cost-effective, with the current threshold set at around £30,000 per QALY. 

This formula weighs the cost of a potential drug for a year against the extension of life and improvement in the quality of life. In addition, new cancer treatments can be approved via NICE’s Cancer Drugs Fund (CDF) which was introduced in 2016. 

Through the CDF, NICE can appraise drugs while providing interim funding for up to two years to give patients access to drugs that have either a draft recommendation for routine use on the NHS or a draft recommendation for use within the CDF. While NICE regularly undergoes reviews of its processes, many industry experts have called for fundamental changes to the way in which it evaluates new technologies and medicines in an effort to improve patient access to the latest medical innovations.

EU must ease COVID-19 curbs slowly to avoid new wave, von der Leyen says

The European Union must only lift coronavirus restrictions slowly and gradually to avoid another wave of infections, the head of the bloc’s executive said. Ursula von der Leyen spoke after the 27 national leaders discussed stepping up joint testing efforts in the bloc, doling out vaccines and coordinating easing lockdowns as a second wave of the pandemic weighs on Europe. 

She said: "We will make a proposal for a gradual and coordinated approach to lifting containment measures. This will be very important to avoid the risk of yet another wave.”

Europe has had about 11.3 million confirmed COVID-19 cases and nearly 280,000 people have died, according to data from the European Centre for Disease Prevention and Control. The pandemic has also thrust the EU into its deepest recession.

And that is everything from EAPM for this week, don’t forget to check out the agenda of our 10 December conference on lung-cancer screening here, and register here, and EAPM’s multistakeholder paper on biomarker testing for dementia is available here. Have an excellent, safe weekend, and see you on Monday (30 November) for EAPM’s monthly newsletter.

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India records world’s biggest single-day rise in coronavirus cases

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Patients are seen inside an ambulance while waiting to enter a COVID-19 hospital for treatment, amidst the spread of the coronavirus disease (COVID-19) in Ahmedabad, India, April 22, 2021. REUTERS/Amit Dave

Patients are seen inside ambulances while waiting to enter a COVID-19 hospital for treatment, amidst the spread of the coronavirus disease (COVID-19) in Ahmedabad, India, April 22, 2021. REUTERS/Amit Dave

India marked a grim milestone in the COVID-19 pandemic on Thursday (22 April), reporting 314,835 new daily cases, the highest one-day tally anywhere, as its second wave and similar surges elsewhere raised new fears about the ability of health services to cope, write Sanjeev Miglani, Neha Arora and Alasdair Pal.

Hospitals across northern and western India including the capital, New Delhi, have issued notices to say they have only a few hours of medical oxygen required to keep COVID-19 patients alive.

More than two-thirds of hospitals had no vacant beds, according to the Delhi government's online data base and doctors advised patients to stay at home.

"The situation is very critical," Dr Kirit Gadhvi, president of the Medical Association in the western city of Ahmedabad, told Reuters.

"Patients are struggling to get beds in COVID-19 hospitals. There is especially acute shortage of oxygen."

Krutika Kuppalli, assistant professor at the Division of Infectious Diseases, Medical University of South Carolina in the United States, said on Twitter the crisis was leading to a collapse of the healthcare system.

The previous record one-day rise in cases was held by the United States, which had 297,430 new cases on one day in January, though its tally has since fallen sharply.

India's total cases are now at 15.93 million, while deaths rose by 2,104 to reach a total of 184,657, according to the latest health ministry data.

Television showed images of people with empty oxygen cylinders crowding refilling facilities in the most populous state of Uttar Pradesh as they scrambled to save relatives in hospital.

"We never thought a second wave would hit us so hard," Kiran Mazumdar Shaw, the executive chairman of Biocon & Biocon Biologics, an Indian healthcare firm, wrote in the Economic Times.

"Complacency led to unanticipated shortages of medicines, medical supplies and hospital beds."

Delhi Health Minister Satyendar Jain said there was a crisis over the shortage of intensive care unit beds, with the city needing about 5,000 more than it could find. Some hospitals had enough oxygen to last 10 hours, others just six.

"We can't call this a comfortable situation," he told reporters.

Similar surges of infections elsewhere around the world, in South America in particular, are threatening to overwhelm other health services. Read more

India has launched a vaccination drive but only a tiny fraction of the population has had the shots.

Authorities have announced that vaccines will be available to anyone over the age of 18 from May 1 but India won't have enough shots for the 600 million people who will become eligible, experts say.

Health experts said India had let its guard down when the virus seemed to be under control during the winter, when new daily cases were about 10,000, and it lifted restrictions to allow big gatherings.

Prime Minister Narendra Modi's government ordered an extensive lockdown last year, in the early stages of the pandemic, but has been wary of the economic costs of tough restrictions.

In recent weeks, the government has come in for criticism for holding packed political rallies for local elections and allowing a religious festival at which millions gathered.

This week, Modi urged state governments to use lockdowns as a last resort. He asked people to stay indoors and said the government was working to increase the supply of oxygen and vaccines.

Experts say new virus variants, in particular a "double mutant" variant that originated in India are largely responsible for the new spikes in cases.

"The double mutant ... is considerably more infectious than the older strain of virus," said Gautam I. Menon, a professor at Ashoka University.

Angela Rasmussen, a virologist at the Center for Global Health and Science Security at Georgetown University said the situation in India was "heartbreaking and awful".

"It's the result of a complex mix of bad policy decisions, bad advice to justify those decisions, global and domestic politics, and a host of other complex variables," she said on Twitter.

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Papua New Guinea: EU allocates €1 million to strengthen the resilience of the most vulnerable during COVID-19

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The EU has mobilized €1 million in emergency aid from the Epidemics Tool to assist those affected by COVID-19 in Papua New Guinea. The number of cases has skyrocketed in the last month, pushing the country's already stretched health system to the limit. The funding will support the International Committee of the Red Cross to implement a six-month intervention focused on the most urgent needs such as increasing treatment capacity of public health care system, supporting local health authorities to scale up the response and providing assistance to vaccination campaigns. This emergency Epidemics Tool allows the EU to provide rapid funding in case of an epidemic outbreak in a humanitarian context.

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How a WHO push for global vaccines needled Europe

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A nurse prepares to administer the AstraZeneca/Oxford vaccine under the COVAX scheme against the coronavirus disease (COVID-19) at the Eka Kotebe General Hospital in Addis Ababa, Ethiopia March 13, 2021. REUTERS/Tiksa Negeri
A man displays a vial AstraZeneca's COVISHIELD vaccine as the country receives its first batch of coronavirus disease (COVID-19) vaccines under COVAX scheme, in Accra, Ghana February 24, 2021. REUTERS/Francis Kokoroko
European Commission President Ursula von der Leyen delivers a statement on EU's coronavirus disease (COVID-19) vaccine strategy, following a college meeting at the EU Commission headquarters in Brussels, Belgium April 14, 2021. John Thys/Pool via REUTERS

Last April, at the start of the COVID-19 pandemic, European Commission President Ursula von der Leyen added Europe to a global effort to ensure equitable access to a vaccine, which she said would be deployed "to every single corner of the world", write Francesco Guarascio and John Chalmers.

But despite pledging billions of dollars for the scheme set up by the World Health Organization (WHO) and publicly endorsing it, European Union officials and member states repeatedly made choices that undermined the campaign, internal documents seen by Reuters and interviews with EU officials and diplomats show.

A year after its launch, Europe and the rest of the world have yet to donate a single dose through the vaccine scheme, which is part of an unprecedented effort to distribute vaccines, tests and drugs to fight the pandemic. Diplomats say Europe's ambivalence stemmed partly from short supplies and a slack start to the global campaign, but also from concerns that the EU's efforts would go unnoticed in a vaccine diplomacy war where highly publicised promises from China and Russia were winning ground, even in its own backyard.

The programme, co-led by international agencies and the Global Alliance for Vaccines and Immunization (GAVI), is a bulk-buying platform to share doses worldwide. But with the administration of former U.S. President Donald Trump having turned its back on the WHO, the plan, called COVAX, was slow to win support and focused on using funds from rich countries to buy doses for less-developed ones.

Von der Leyen presented Europe's support for the COVAX campaign as a gesture of international unity. EU officials privately cast the bloc's vaccine aims in a less altruistic light.

"It's also about visibility," that is, public relations, Ilze Juhansone, Secretary-General of the EU Commission and the Commission's top civil servant, told ambassadors at a meeting in Brussels in February, according to a diplomatic note seen by Reuters. Juhansone declined to comment.

A senior diplomat said many of those at that meeting felt Europe, which is by far the largest exporter of vaccines in the West, had goals that would be better served by plastering "more blue flags with yellow stars" on vaccine parcels and sending them out itself, rather than through COVAX.

Brussels, which is coordinating vaccine deals with its members, has reserved a huge surplus - 2.6 billion doses for a population of 450 million so far. It has promised nearly €2.5 billion ($3bn) in support to COVAX. That made the EU the biggest funder until the administration of US President Joe Biden pledged $4n this year to the plan, which aims to distribute 2 billion doses by the end of the year.

But supplies for Europe's own population are behind schedule, and despite giving funds, the EU and its 27 governments have also hampered COVAX in several ways. Like other rich countries, EU nations decided not to buy their own vaccines through COVAX, and competed with it to buy shots when supplies were tight. All except Germany offered the overall programme less cash than requested.

More than this, Europe promoted a parallel vaccine donation system that it would run itself, to raise the EU's profile.

"There is huge frustration because there is a feeling that right now the race is on but we're not really out of the starting blocks," a senior diplomat told Reuters.

"We're spending money on COVAX and the return in terms of political visibility is nil."

Russia says it wants to supply vaccines to countries directly. China has pledged support to COVAX. But both Moscow and Beijing have separate deals to deliver more than 1 billion doses to Africa, Latin America, and to EU partners such as Turkey, Egypt, Morocco and Balkan states that are candidates to join the bloc.

Most doses will take time to be delivered, but Russia and China have already exported about twice COVAX's deliveries of around 40 million doses.

COVAX was also hit in March by export restrictions on vaccines from India, which slowed supplies from its main provider of shots.

WHO chief Tedros Adhanom Ghebreyesus has repeatedly urged rich countries to set aside nationalistic impulses and share vaccines, calling the current situation "a shocking imbalance." Non-EU member Britain, for instance, has already injected about as many shots as COVAX has delivered to more than 100 countries.

COVAX officials told Reuters they received sufficient funds by the end of last year, but these came later than expected.

A spokeswoman for GAVI, the vaccine alliance that runs the scheme and speaks for COVAX on such issues, said EU support had been "unequivocal" and it expects doses to be donated soon. The WHO added that von der Leyen's personal support had been "invaluable."

An EU Commission spokesman told Reuters COVAX had been very successful in structuring global collaboration and securing millions of doses. He called the programme "our best vehicle to deliver on international vaccines solidarity" and the EU's "key channel for sharing vaccines."

Part of COVAX's difficulty is structural. Soon after it was set up, the wealthiest countries were sealing advance orders with drug companies to secure doses as they became available. The vaccination scheme has always relied on rich states for cash, which they have been slow to give.

COVAX aimed to be a platform for countries to buy vaccines, which would give it bargaining power and allow it to dispense doses among those most in need worldwide. Recognising supplies would be tight, its initial aim was to distribute doses for at least 20% of each country's populations to cover the people most at risk.

At an internal meeting last July, an EU Commission official told ambassadors that member states should not buy their shots through COVAX as they would come too slowly, diplomatic notes show. The Commission later set the target to vaccinate 70% of adults in the EU by the end of September.

COVAX changed some of its terms the next month to try to convince wealthy nations to join in, but no EU nations signed up to use the platform for their vaccination drives. The EU gave COVAX financial guarantees to pay for vaccines, but also made it harder for COVAX to do this, by arranging to buy far more doses than the bloc needed.

In November, the EU pledged more money to COVAX, but only after it had signed contracts with vaccine makers for nearly 1.5 billion doses - more than half Brussels' estimate then of global production capacity for this year, internal documents show.

Even though Europe had reserved such a large share, the Commission told diplomats in a meeting that month that COVAX was too slow in procuring doses.

That was when the Commission raised the possibility of setting up a mechanism of its own to send shots to poor countries outside the EU.

Within a month, France started to flesh out that plan. Shots would be sent directly from manufacturers - possibly before deliveries started through COVAX - and labelled as "Team Europe" donations, a draft plan said.

The move, revealed at the time by Reuters, caused an outcry among officials at COVAX. Read more

One told Reuters in April the plan was driven by France's desire to get shots to Africa, where France formerly had colonies, and smacked of colonialism. French diplomats said they never showed a preference for any country, and Africa was most in need.

EU Health Commissioner Stella Kyriakides said in mid-January the EU's own plan would go ahead - because COVAX was not yet fully operational. Countries to focus on would include the Western Balkans, the EU's southern and eastern neighbours and Africa.

The next month, having reserved more than 2 billion doses but with actual deliveries hit by production problems, the EU doubled COVAX funding to €1bn. Russia and China had already delivered millions of doses across the world. COVAX had yet to deliver any. And France's President Emmanuel Macron was publicly losing patience.

Europe and the United States should quickly send enough vaccines to Africa to inoculate the continent's healthcare workers or risk losing influence to Russia and China, Macron said in a speech at a security conference, without specifying how these donations should be made.

Unless rich countries speeded up deliveries, "our friends in Africa will, under justified pressure from their people, buy doses from the Chinese and the Russians," Macron told the conference. "And the strength of the West will be a concept, and not a reality." Read more

Despite Macron's urgency, France's cash support for the overall WHO programme - to cover tests and treatments as well as vaccines - was limited.

The WHO asked countries for contributions in proportion to their economic power. France has committed $190 million - about 13% of the $1.2 billion requested, a WHO document dated March 26 shows.

Other EU countries are also far below expected contributions; some have given zero. But Germany has helped offset this by publicly pledging $2.6bn, well above the $2bn requested.

French diplomats said the country's contributions are expected to increase soon.

On 24 February, COVAX shipped its first vaccines. The EU softened its criticisms.

At a meeting on 9 March, at the height of the European Union's own problems in procuring shots for its own citizens, a Commission official told diplomats COVAX was the main tool for donating vaccines to other countries.

But the official said Europe still needed its own mechanism, because COVAX had money, but only a tiny portion of the shots it needed. And the EU scheme would have "the advantage of giving us visibility," the official said.

At that same meeting, EU ambassadors were shown data compiled by the EU's foreign affairs service which those present said revealed how far the bloc's vaccine diplomacy was lagging behind its competitors.

They learned that Russia had orders for 645 million doses of its Sputnik V COVID-19 vaccine with dozens of countries, and that China was shipping millions of doses to EU neighbours, the data showed.

"We are completely out of this game," one of the diplomats who was there told Reuters.

Reuters could not confirm the data exactly. But figures assembled by the United Nations agency UNICEF, which works with COVAX on vaccine deliveries, show Russia has deals to deliver nearly 600 million doses, including to EU states. China has deals to sell about 800 million doses, including agreements with European countries such as Serbia, Ukraine and Albania.

Later that month the EU's top diplomat, Josep Borrell, made the point candidly: "The EU is the major driver behind COVAX," he wrote in a blog on 26 March. "But we do not get the recognition that the countries using bilateral vaccine diplomacy do."

On Tuesday, the EU Commission said the EU would share over half a million doses with Balkan countries from May through the EU scheme. That was two weeks after COVAX had delivered its first shots to the region. Read more

($1 = €0.8282)

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