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After Amsterdam high, EU drugs regulator feels the pain

The European Medicines Agency’s move to Amsterdam after Brexit was supposed to make for smooth saili..

The European Medicines Agency’s move to Amsterdam after Brexit was supposed to make for smooth sailing and a happy 900-member staff.

As the afterglow of winning the contest to host the EU’s drug regulator subsides, some unpleasant realities of the shift to the Dutch capital are coming to light.

The building that will eventually host the agency will not be ready until the end of 2019 or even early 2020, according to two Dutch officials. The EMA has to move out of London by the end of March 2019, so it faces using one or more temporary buildingsin different parts of Amsterdam for its sensitive work on drug approvals until the new permanent premises are ready.

An EMA official wrote that “each of the proposed temporary premises has weaknesses which raises concerns about EMA’s continuity of operation even if this is only for a period limited in time,” according to an internal email from November 28seen by POLITICO.

“We know that it will not be smooth, they know,” EMA Executive Director Guido Rasi said, pointing to Dutch officials at a meeting with all agency staff in London on November 24, according to a video recording of the meeting seen by POLITICO. “We already shared some common concerns, which means that we are realistic, we are not overpromising, but we are deeply committed to make it the best that can be done.”

Delivering on promises and expectations

Amsterdam topped the preferences of EMA employees in a September survey, with 81 percent of them saying they would move to the Dutch city if the agency relocated there.

“Amsterdam ticks many of our boxes,” Rasi said soon after the city was chosen to be the new host. “It offers excellent connectivity and a building that can be shaped according to our needs.”

Amsterdam won’t even settle on a contractor for the EMA’s new building until March 2018

The city has a major airport connecting it to the rest of the world and is just across the English Channel from London. The Dutch promised to ensure the agency could function seamlessly after its relocation. Amsterdam’s proposed transition plan included individual support for each agency employee and doing whatever it took to get the building site ready.

“We also have a very stylish queen and eat fish and chips,” boasted the video presenting Amsterdam as the perfect new home for the EMA.

The Netherlands made it clear when applying to host the EMA that the new offices wouldnot be ready by March 30, 2019, when the agency needs to move out of London because the U.K. ceases to be an EU member that day. It didn’t specify when the agency’s building would be fully ready, though, noting only that the offices would be made available throughout 2019.

The European Medicines Agency building in Canary Wharf | Neil Hall/EFE

What it did promise was critical conference facilities would be ready by April 1, 2019, the first working day after Brexit. The EMA relies heavily on experts from across the EU coming together to assess new drug applications, which is why those fully equipped conference facilities are the agency’s most urgent need.

Amsterdam says those meeting rooms in the new building will be ready by April 1, 2019. But that leaves no time to address any issues that come along with new construction. And while the Dutch bid promises to deliver meeting spaces, it’s not clear it will have the 4G internet connection, audio and video conference equipment, and a voting system per seat to satisfy EMA needs from Day One.

And it will be a further seven or eight months before the time the rest of the building is completed and all EMA staff are in one place, said Udo Kock, Amsterdam’s deputy mayor for finance and economic affairs.

Temporary workspaces for some staff could “have implications for the operational efficiencies during the transition period,” said one assessment published in September which was commissioned by the pharma lobby EFPIA. It’s not yet clear whether staffers would be split between multiple sites in Amsterdam.

One proposed temporary office building is two metro stops away or a maximum 10-minute walk from the EMA’s ultimate destination in Amsterdam, Maurice Galla, the project leader of the Dutch EMA candidacy, said at the EMA meeting.

“The biggest hurdle is that by the time we have to move, our new building in Amsterdam will not be ready for us,” Rasi told members of the European Parliament’s environment and public health committee Thursday. “We are working with the Dutch authorities to find another solution — the temporary building will be crucial for our business continuity as of March 2019.”

Winning strategy becomes Achilles’ heel

Constructing a new building was supposed to be a strength of the city’s bid, with the Dutch authorities wanting to give the EMA a fully customized new home similar to the one it has to leave in the Canary Wharf business district of London, Kock said.

For others in the 16-way race to win the agency that had a ready-made space, including Italy and Denmark, Amsterdam’s win may now seem especially bitter. The Italian and Danish cities competed head-to-head with the Netherlands in the three-round voting session on November 20.

The agency needs a minimum 850 workspaces and 15 internal meeting rooms.

Amsterdam won’t even settle on a contractor for the EMA’s new building until March 2018, Marcel van Raaij, a director in the Dutch health ministry, told EMA staffers at the November 24 meeting.

And an internal EMA email sent late November 28, after the EMA staffers in charge of the relocation visited the premises in Amsterdam, raised concerns that the proposed temporary premises had weaknesses, “especially in terms of the amount of workspaces, of internal meeting rooms, of facilities as regards reprographics, local archiving.” The agency needs a minimum 850 workspaces and 15 internal meeting rooms, with at least one of them able to host 30 people and the necessary space for reprographics and internal archives, preferably in only one building, the email said.

“Therefore due consideration should be given first at finding alternatives where not only these weaknesses can be addressed, but in addition also external meeting rooms could be provided (to minimize as much as possible travel time for staff for running and contributing to the external meetings),” the email said.

The EMA has to move out of London by the end of March 2019 | Robin Utrecht/EFE via EPA

This email is “completely outdated,” an EMA press officer said, adding that site visits are ongoing and that a first official step on the relocation process will be announced at the EMA Management Board scheduled for December 13 and 14. A spokesperson for the Dutch Health Ministry said it does not recognize concerns about the weaknesses of each of the proposed temporary premises because the EMA team is still visiting some of the potential temporary buildings.

A European Commission assessment in September said the office floors were expected to be ready as much as six months after April 1. The Commission did not inspect the building plans and said it was up to the country that won the agency to comply with the promises it made in its bid.

Asked whether the Commission can help speed up the building in any way, one Commission official responded: “Volunteer.”

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Monkeypox: First deaths outside Africa in Brazil and Spain

Brazil and Spain have reported their first monkeypox deaths.

A 41-year-old man in Brazil became the first fatality from the virus outside Africa. Spain announced two deaths soon afterwards – the first in Europe.

Last week, the World Health Organization (WHO) declared the monkeypox outbreak a global health emergency.

But infections are usually mild and the risk to the general population is low.

On Friday Brazil’s health ministry said the victim there had suffered from lymphoma and a weakened immune system, and “comorbidities aggravated his condition”.

Brazil has so far reported 1,066 confirmed cases and 513 suspected cases of the virus. Data from Brazil’s health ministry indicates that more than 98% of confirmed cases were in men who have sex with men.

Shortly afterwards, Spain’s health ministry confirmed Europe’s first death from the virus – a patient who suffered from encephalitis.

A second death linked to monkeypox was confirmed by Spanish authorities on Saturday.

The health ministry said that of 3,750 monkeypox patients with available information, 120 or 3.2% had been hospitalised.

According to the US Centers for Disease Control and Prevention, there are 21,148 cases worldwide.

The monkeypox virus is a member of the same family of viruses as smallpox, although it is much less severe and experts say chances of infection are low.

It occurs mostly in remote parts of central and west African countries, near tropical rainforests.

Health officials are recommending people at highest risk of exposure to the virus – including some gay and bisexual men, as well as some healthcare workers – should be offered a vaccine.

Last week, WHO director general Dr Tedros Adhanom Ghebreyesus said declaring the outbreak a global health emergency would help speed up the development of vaccines and the implementation of measures to limit the spread of the virus.

Dr Tedros said the risk of monkeypox is moderate globally, but high in Europe.

But, he added, “this is an outbreak that can be stopped with the right strategies in the right groups”. The WHO is issuing recommendations, which it hopes will spur countries to take action to stop transmission of the virus and protect those most at risk.


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Covid: Woman caught virus twice within record 20 days

A 31-year-old healthcare worker caught Covid twice within 20 days – the shortest-known gap between infections, Spanish researchers have claimed.

Tests show the woman was infected with two different variants – Delta in late December and then Omicron in January.

This shows that even if you have had Covid before, you can still be infected again even if fully vaccinated, the researchers say.

Reinfections in the UK require 90 days between positive tests.

Based on that definition, health officials say nearly 900,000 people have potentially been infected twice with Covid up to the start of April.

It is difficult to pin down an exact number, because only whole genome sequencing can confirm the infections are caused by different strains, and very few positive tests go through this process.

The Spaniard did not develop any symptoms after her first positive PCR test, but less than three weeks later she developed a cough and fever which prompted her to take another test.

When the tests were analysed further, they showed the patient had been infected by two different strains of coronavirus.

In a presentation at the European Congress of Clinical Microbiology and Infectious Diseases, study author Dr. Gemma Recio said the case highlighted that Omicron can “evade the previous immunity acquired either from a natural infection with other variants or from vaccines”.

She said: “In other words, people who have had Covid-19 cannot assume they are protected against reinfection, even if they have been fully vaccinated.

“Nevertheless, both previous infection with other variants and vaccination do seem to partially protect against severe disease and hospitalisation in those with Omicron,” added Dr Recio, from the Institut Catala de Salut, Tarragona in Spain.

She said monitoring reinfections in people who were fully vaccinated was important, and would help the search for variants which evade vaccines.

Covid reinfections rose sharply in December 2021 after the much more infectious Omicron variant emerged, and there was another increase when a slightly different version of it, called BA.2, appeared in early March.

Before that, 1% of all cases recorded in the UK were labelled as second infection – but that has now gone up to 11%.

Most are likely to be people infected by the Alpha or Delta variants and then infected again by the more contagious Omicron.

Scientists predict that eventually everyone will catch Covid twice, and probably many more times over the course of their lifetime.

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Poverty, crime linked to differences in newborns’ brains

Poverty and crime can have devastating effects on a child’s health. But a new study from researchers at Washington University School of Medicine in St. Louis suggests that some environmental factors influence the structure and function of young brains even before babies make their entrances into the world.

A study published online in the journal JAMA Network Open found that MRI scans performed on healthy newborns. At the same time, they slept indicated that babies facing social disadvantages such as poverty tended to be born with smaller brains than babies whose mothers had higher household incomes.

MRI scans of full-term newborns born to mothers living in poverty revealed smaller volumes across the entire brain — including the cortical grey matter, subcortical grey matter and white matter — than found in the brains of babies whose mothers had higher household incomes.

The brain scans, conducted only a few days to weeks after birth, also showed more miniature folding of the brain among infants born to mothers living in poverty. Fewer and shallower folds typically signify brain immaturity. The healthy human brain folds as it grows and develops, providing the cerebral cortex with a more extensive functional surface area.

A second study of data from the same sample of 399 mothers and their babies — this one published online in the journal Biological Psychiatry — reports that pregnant mothers from neighbourhoods with high crime rates gave birth to infants whose brains functioned differently during their first weeks of life than babies born to mothers living in safer neighbourhoods.

Functional MRI scans of babies whose mothers were exposed to crime displayed weaker connections between brain structures that process emotions and structures that help regulate and control those emotions. Maternal stress is believed to be one of the reasons for the weaker connections in the babies’ brains.

“These studies demonstrate that a mother’s experiences during pregnancy can have a major impact on her infant’s brain development,” said Christopher D. Smyser, MD, one of the principal investigators. “Like that old song about how the ‘knee bone is connected to the shin bone,’ there’s a saying about the brain that ‘areas that fire together wire together.’ We’re analysing how brain regions develop and form early functional networks because how those structures develop and work together may impact long-term development and behaviour.”

Babies in the study were born from 2017 through 2020, before the COVID-19 pandemic. Smyser, a professor of neurology, paediatrics and radiology, said that babies are fed when they arrive for scans because they tend to fall asleep after eating to scan newborns during the first few weeks of life successfully. They are then snugly swaddled into blankets and a device that helps keep them comfortable and still. The brain scans take place while they sleep.

In the study involving the effects of poverty, the researchers focused on 280 mothers and their newborns. First author Regina L. Triplett, MD, a postdoctoral fellow in neurology, had expected to find that maternal poverty — referred to in the paper as a social disadvantage — could affect the babies’ developing brains. But she also expected to see the effects of psychosocial stress, which includes measures of adverse life experiences and anxiety and depression.

“Social disadvantage

affected the brain across many of its structures, but there were no significant effects related to psychosocial stress,” Triplett said. “Our concern is that as babies begin life with these smaller brain structures, their brains may not develop as healthy as the brains of babies whose mothers lived in higher-income households.”

In the second study, which implicated living in high-crime neighbourhoods as a factor in weaker functional connections in the brains of newborns, first author Rebecca G. Brady, a graduate student in the university’s Medical Scientist Training Program, found that unlike the effects of poverty, the results of exposure to crime were focused on particular areas of the babies’ brains.

“Instead of a brain-wide effect, living in a high-crime area during pregnancy seems to have more specific effects on the emotion-processing regions of babies’ brains,” Brady said. “We found that this weakening of the functional connections between emotion-processing structures in the babies’ brains was robust when we controlled for other types of adversity, such as poverty. It appears that stresses linked to crime had more specific effects on brain function.”

Reducing poverty and lowering crime rates are well-established goals in public policy and health. And the researchers believe protecting expectant mothers from crime and helping them out of poverty will do more than improve brain growth and connections in their babies. But if social programs that aim to help people reach their full potential are to succeed, the researchers said the policies must focus on assisting people even before they are born.

“Several research projects around the country are now providing money for living expenses to pregnant mothers. Some cities have determined that raising pregnant mothers out of poverty is good public policy,” Smyser said. “The evidence we’re gathering from these studies certainly would support that idea.”


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