European drug regulation at risk of stalling as agency prepares to leave London

First published in Nature, 12.10.2017

Drug regulation in Europe could temporarily freeze if the European Medicines Agency (EMA) loses staff during its post-Brexit move from London. Up to 70 per cent of its 900 staff have said they would quit if the agency relocated to some of the cities bidding to host the organisation.

According to a battle plan drawn up by agency management, failure to retain enough staff would result in a shutdown of essential operations until more people could be hired. If fewer than 30% of the staff move with the agency to its new destination — to be decided next month — it would cease operation, Guido Rasi, the agency’s executive director, told Nature.

The EMA, an agency of the European Union, needs to leave London — where it has been headquartered since 1995 — as a result of Brexit. In addition to its permanent staff, the agency hires many other experts on a short-term basis. Following an internal staff survey undertaken in September, the agency urged European heads of state to pick a location to which at least 65% of staff would relocate.

Bids for a home

Some 19 cities across Europe have applied to host the prestigious organization. Last week, the EMA released its own assessment of the applications, and warned that several locations are entirely unsuitable for the agency’s location. Proposals for Sofia, Malta and Warsaw met almost none of the requirements put forward by the agency and could result in huge staff losses, Rasi warned. Amsterdam was the most popular alternative to London.

“The best case is, of course, a continuum of our activities, with only about 20% staff loss,” he says. “The worst case scenario we have come up with is 94% staff loss. For our business-continuity plan, we found three levels of activities we can delay, put on hold or stop completely.”

According to Rasi, the agency’s core mission — the regulation and monitoring of innovative drugs across Europe — would be the last thing to stop. But even with 50% staff loss, the agency would have to reduce advisory support to new research projects, which could stall work on innovative medicines, he says (see ‘European Medicines Agency chief raises alarm at forced relocation‘).

The agency assesses all medicines, including veterinary products, to be sold on the European market, and passes on recommendations to the European Commission for authorization. It evaluates reports of adverse reactions and, if necessary, works with national agencies to ban medicines that are suspected of being dangerous. The EMA also has in-house scientists who provide advice to drug developers on which criteria they need to fulfil to get a product passed.

In 2016, the agency recommended 81 new medicines for authorization and answered more than 450 requests for scientific advice.

Medication mediation

The European Federation of Pharmaceutical Industries and Associations, headquartered in Brussels, has called on member states to put the agency’s well-being first when choosing a location. “There are many cities that could have the right criteria for the agency to settle,” said a spokesman. “There is a potential for disruption, but also a potential for harmony. It all depends on what you choose.”

In the United Kingdom, pharmaceutical companies worry about how they will get their medicines approved after Brexit. The BioIndustry Association, a group of British life-sciences companies, has backed a UK government proposal to maintain authorizations for medicines granted before Brexit and the continuation of work with the agency during a transition period.

“The alternative — organizing and delivering a wholesale change — would be a gargantuan task for companies and regulators across the UK and Europe,” says Steve Bates, the association’s chief executive officer. “It would be extremely challenging to successfully deliver in the short amount of time left until Brexit in March 2019.”

Meanwhile, the uncertainty about the agency’s future is already causing problems. The agency has been unable to fill a position as head of veterinary medicine; all three potential candidates said that they would wait for the final location to be announced before deciding whether or not to take the job, according to Rasi.

Europe’s heads of state will meet on 18–20 October to begin hammering out an agreement. A decision is due to be announced on 20 November, at the next EU General Affairs Council meeting.

London soil pollution worst on former Blitz bomb sites

First published on Chemistry World, 15.01.18

Study links heavy metal enrichment to destruction of housing in 1940s

 

The UK capital’s soil bears a poisonous legacy from the Blitz bombing campaign – with calcium, lead and zinc pollution highest in the most heavily damaged areas.

Researchers from the British Geological Survey found that anomalous high calcium, lead and zinc levels in some parts of London were caused by the distribution of building dust and debris following the large-scale destruction of historic housing stock. These elements were widely used in paints, piping and mortar during the construction boom of the 19th century.

The presence of large quantities of calcium, the main ingredient of lime, in central London soil had been previously observed. Don Appleton, a geochemist at the British Geological Survey in Nottingham, and his colleague Mark Cave, were determined to find out why.

‘Traditional mortar contains a lot of lime, so if a building would be destroyed then the dust would spread in the surrounding area,’ Appleton explains. ‘We were thinking, was [the calcium enrichment] related to bomb sites?’

The team compared data on soil pollution with a map of the 31,373 sites bombed by the Luftwaffe – Nazi Germany’s air force – between October 1940 and June 1941. Areas bombarded in the 1940s had levels of calcium, lead and zinc that were up to 1.75 times higher than in areas built-up after the war or those that escaped the bombing.

(a) Number of bomb sites, (b) GM Pb (mg kg−1) 1km grid squares for sectors of the GLA with both soil chemistry and bomb site data underlain by Brickearth, River Terrace deposits or Thames Group clays

Source: © University of Portsmouth licensed under a Creative Commons Attribution- NonCommercial-ShareAlike

The bomb sites from the Blitz (left) correlate with the pollution of London’s soil with the poisonous metal lead (right)

 

Other built-up areas of London, however, also showed elevated heavy metal levels, if not quite as high as those bombarded during the Blitz. Appleton says that some of these metals, especially lead, are distributed by exhaust fumes from cars. The researchers found that lead enrichment in London soil increases with proximity to roads as well as bomb sites, hinting at a more complex pattern of pollution. ‘If you get closer to roads, that’s where the buildings are,’ Appleton says. ‘That makes it sometimes difficult to work out what exactly is the major cause.’

Heavy metal pollution is dangerous to human health, especially children who might ingest lead or zinc while playing on polluted land. Vegetables grown on such soil, for example in urban gardens, can also have enriched levels of toxic metals.

However, the chemical make-up of London’s soil provides some protection. London was built on large chalk deposits, which increases the pH of the soil and locks up heavy metals, says Mike Fullen, a soil technology professor at the University of Wolverhampton. ‘Even though these metals are there, it is not easy for them to get into the biological system.’

Many British cities are built on the most fertile land, as this is where ancient farming communities settled. The Thames terrace, for example, has some of the richest soil in England, but is now mostly covered by Heathrow Airport. As a result, even if land is subsequently freed, it loses much of its fertility due to urban pollution.

While the removal or chemical cleaning of soil is expensive, Fullen’s team are working on developing cheaper and environmentally friendly methods to remove heavy metals. In China, students from the University of Wolverhampton are planting carnations on soil polluted with cadmium. The plants act as so-called hyper-accumulators by drawing toxic materials into their roots.

Fullen says this method could be used on London’s brownfield sites, and even in parks created on former bomb sites. ‘If you are not looking to reuse the land straight away, the cheapest option is to plant something that will soak up the toxins, and that can then be burned in a safe place,’ he says.

 

Protest, diluted

This article first appeared in Research Europe, 27/04/17

Last week’s March for Science brought together scientists and their supporters in more than 600 world cities. In 2017, a year of political upheaval, this is reassuring. Scientists are starting to raise their voice as a community, protesting against government cuts and challenging alternative facts and the ever-increasing pressure on academia to prove its impact.

However, that researchers now feel they need to remind politicians and society of their value is frightening. It is a sign of dark times when academic scientists, usually detached observers, feel compelled to speak out and carry placards.

It could even be argued that the scientific community is still not protesting loudly enough. The marches, for all the cleverness of their signage, were polite affairs. About 10,000 people turned up in London. They marched quietly and sedately to Westminster, where they dispersed by 3pm.

Talking to marchers, it was clear there was no consensus on the message. In London alone, people protested against Trump, Brexit, climate change, stem cell research and sexism. Most are valid causes for concern, but protesters could neither say how any of these concerns could be addressed, nor make a case for the crucial role scientists could play in solving these problems, and why they currently feel they can’t.

Some protesters were more to the point. Individual posters called for more evidence in policymaking. Others voiced concerns about scientific independence and the continued assaults on research budgets.

And some were in it for the fun. Dressing like the mad scientist of cliché, with lab coats and out-of-control hair, they took a stab at public preconceptions about what science is. But in this mish-mash of causes and costumes, a clear message was lacking. The organisers stressed repeatedly that they wanted “those in power” to listen. But to what? Apart from a few chants about peer review, the London march was largely silent.

Any effort to highlight the growing pressures faced by the scientific community and show the public that scientists play a crucial part in democracy is to be welcomed. The marchers brought together communities of researchers scattered all over Europe and the world, and flagged up their concerns. But the next step up must be more concrete: we need proposals for governments to become more open to, supportive of—and reliant on—scientific expertise.

The risk, if this is not done, is that scientists will appear self-serving. Compared with health centres, primary schools and elderly care, universities seem well funded. If they cannot make their case, the public might condemn scientists as ivory-towered whiners.

The march organisers said they wanted to show the world that “lots of people care”. But to truly make things better for the scientific community, this care must be turned into proposals for action. Otherwise last week’s marches, and any subsequent protests, will remain little more than a photo opportunity.

Anger and discontent do not always have to express themselves through burning cars and flying rocks. But in attempting to bring everyone inside its tent, the March for Science risks not being heard at all.

UK scientists welcome changes to controversial research reforms

First published in Nature, 28.02.2017

UK scientists who had vigorously protested against a planned shake-up of the way their country’s research is funded say they’re largely reassured after the government announced amendments to the plans.

Science minister Jo Johnson announced a package of changes last week that look likely to smooth the way for the reforms to become law — although not everyone is satisfied.

The proposed reforms would bring the country’s separate research councils together under a single, central funder, called United Kingdom Research and Innovation (UKRI), and would create a government body to regulate what UK universities teach. The latest changes are designed to soothe fears of excessive government control over what gets funded and taught in British universities, policy experts say.

 

Most unusually, Johnson has suggested writing into law a long-held principle in UK science funding, termed the Haldane principle — that research-funding decisions should be protected from political interference. “Decisions on individual research proposals are best taken following an evaluation of the quality and likely impact of the proposals (e.g. a peer review process),” the revised law notes.

“We applaud the government’s intention to recognize that those best able to decide what should be funded are not always politicians,” says Naomi Weir, deputy director of the London-based Campaign for Science and Engineering. “It is such a difficult thing to put in legislation, and it’s good that the government is trying to do that.”

Among other amendments, the changes include promises to maintain the autonomy of universities and, according to government documents, “specify the freedoms of academic staff to question and test received wisdom, and to put forward new ideas and controversial or unpopular opinions”.

The changes show that the government has listened to scientists before “tinkering further” with the UK research-funding system, says James Wilsdon, who studies research policy at the University of Sheffield, UK, and who also chairs a lobby group, Campaign for Social Science. “This is a serious and substantial package of amendments that should go a long way to assuaging any lingering concerns,” he adds.

Point of principle

Many policy experts note that the government has not been quick to make amendments to its proposals. Criticisms were first heard in October 2016. The draft legislation passed easily through the country’s lower chamber of Parliament, the House of Commons, but has encountered fiercer resistance this year in the upper chamber, the House of Lords, many members of which have a science or education background.

“I am pleased with the amendments,” says John Krebs, a member of the House of Lords and a zoologist at the University of Oxford, UK, who last year had warned against adopting the reforms. He says that incorporating the Haldane principle is “a significant and welcome concession”, and that he is reassured by other amendments designed to protect the research councils’ autonomy and to make sure that the allocation of research funding to the various councils remains transparent.

But another House of Lords scientist, Martin Rees — an astrophysicist at the University of Cambridge, UK, who has criticized the idea of creating UKRI — says he still worries that the new body will have too much power over what gets funded.

The law will see its next hearing in the House of Lords on 6 March — and further changes might be suggested at that stage. After that, any changes have to be agreed again by the House of Commons. But the mood among UK universities is that the reforms will now go through, says Andy Westwood, director of the University Observatory in Wolverhampton, UK, a policy think tank.

Ironically, says Westwood, the writing into law of the Haldane principle could end up serving the government more than it does researchers, because it hammers out an agreed meaning for what has until now been a vague principle of independence that could be called upon whenever researchers felt threatened by government interference.

“Haldane was probably more powerful when it was not enshrined, because academics could always shape it to fit their argument,” Westwood says.