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CPR training should change, and maybe there should be an app for that

(Reuters Health) – To help more patients survive cardiac arrest, traditional CPR training needs an overhaul with more chances for practice – and instructions on social and digital platforms might help lessons stick, some doctors argue.

People learn CPR as part of a National Day of Service event on the National Mall in Washington D.C. January 19, 2013. REUTERS/Eric Thayer

Few Americans are trained in cardiopulmonary resuscitation, or CPR, and many people who do learn how to do this don’t practice or take refresher courses over the years to keep their skills fresh. Improving CPR training might help people retain these lessons longer and increase the long odds that cardiac arrest patients survive long enough to leave a hospital.

“The delivery of high quality CPR is one of the most critical components to improve survival from cardiac arrest,” said Dr. Adam Cheng, lead author of new CPR training recommendations from the American Heart Association (AHA).

Cardiac arrest involves the abrupt loss of heart function, breathing and consciousness. Unlike a heart attack, which happens when blood flow to a portion of the heart is blocked, cardiac arrest occurs when the heart’s electrical system malfunctions, disrupting the heart’s rhythm or halting it altogether. Cardiac arrest may occur with no warning and is often fatal.

Chest compressions or CPR can help restore circulation, increasing the odds of survival. Bystander CPR generally won’t restore a normal heart rhythm, but it can buy time by maintaining blood flow to vital organs.

“We need to do a better job of communicating the importance of high quality CPR, and working with policy makers to ensure CPR training becomes a mandatory part of school curriculum as kids are growing up,” Cheng, of the University of Calgary in Canada, said by email.

With new recommendations for CPR training, the AHA is striving to double survival rates from cardiac arrest to 38 percent when the arrest happens in a hospital and to 15.8 percent when it happens outside a hospital by 2020. They’re also trying to double the proportion of cases when bystanders perform CPR until an ambulance arrives to 62 percent by 2020.

The AHA argues that learners should get shorter, more frequent practice instruction sessions to help them retain knowledge, receive regular structured feedback, and training experiences tied to real world situations.

Beyond this, faculty coaching is key, and instruction might benefit from gamification, social and digital media to help learners retain what they’re taught, according to the guidelines published in Circulation.

Among other things, the guidelines stress that CPR learners should practice until they demonstrate mastery of skills, and be assessed using a variety of tools throughout their CPR course to make sure they’re grasping the material.

Instructors should also get continuous coaching and training to make sure they’re using the latest and most effective tools available to reach students.

The new CPR training approach should be used for all types of learners, whether they’re medical professionals or high school students or people in the community.

Doctors, nurses and other health professionals might benefit from better feedback in CPR training because clinicians often overestimate how well they have mastered new skills, said Dr. Lorrel Brown of the University of Louisville School of Medicine, who directs the CPR advocacy group Alive in 5 (www.alivein5.org).

For a layperson, however, the main issue with CPR training is that it’s too expensive to justify the cost when they don’t need to know CPR for work, Brown said by email.

“Of course, there is more research to be done on improving survival following cardiac arrest, preventing cardiac arrest in the first place, and early recognition of victims so they get help quickly,” Brown said. “However, the low-hanging fruit in the field is simply getting more victims to have higher quality CPR – that is the single most modifiable factor influencing survival.”

SOURCE: bit.ly/2Ldszua Circulation, online June 21, 2018.

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Cigarette use declines among U.S. young women, but marijuana blunt use rises

(Reuters Health) – Cigarette use decreased among young women – including pregnant women – during the past decade in the U.S., according to a new study. But, researchers found, use of marijuana blunts rose.

A blunt is a cigar that’s been hollowed out and filled with marijuana. Although researchers aren’t sure about the health implications of the increase, they want to know more given the rapid changes in state marijuana laws, the study authors wrote in the American Journal of Public Health.

“Everyone knows that smoking is bad for you. Everyone knows that women should not smoke while pregnant,” said lead study author Victoria Coleman-Cowger of the University of Maryland School of Medicine in Baltimore, in an email to Reuters Health. “But until recently, research in this area has focused primarily on the prevalence and impact of smoking tobacco cigarettes during pregnancy. We now recognize that use of tobacco products and multiple substances is not uncommon, and pregnant women who smoke tobacco cigarettes are often using other tobacco products as well.”

Coleman-Cowger and colleagues analyzed data from the 2006-2016 National Survey on Drug Use and Health to understand how women of reproductive age used cigarettes, cigars, and marijuana blunts during the past month. Altogether, they had survey responses from about 8,700 pregnant women and 162,000 nonpregnant women, ages 18 to 44.

Overall, cigarette use was more prevalent than cigar or blunt use for both pregnant and nonpregnant women, with higher prevalence of all products for nonpregnant women. About 15 percent of pregnant women smoked cigarettes in the previous month, as well as two percent who smoked blunts and one percent who smoked cigars. Between 2006-2016, the likelihood of smoking cigarettes decreased from 18 percent to 10 percent for pregnant women, and the likelihood of smoking blunts increased from less than 1 percent to 2.5 percent.

“It is promising to see less cigarette use during pregnancy because we know that it will positively impact public health,” Coleman-Cowger said. “However, this decline could mean pregnant women are turning to alternative tobacco products or marijuana due to perceptions of lower risk.”

Researchers don’t yet fully understand the implications of marijuana use during pregnancy, as well as the combined impact of tobacco and marijuana, she added. In a previous small study, Coleman-Cowger and colleagues found an association between birth defects and substance use, but many questions remain.

“We need to understand not only the health effects of blunt use during pregnancy but also why pregnant women are choosing to smoke them,” she said. “Could flavors available in cigars but not in cigarettes be a factor? Do pregnant women think that blunts are safer?”

Researchers also want to better understand which women of reproductive age are at greater risk for cigarette, cigar and marijuana blunt use, including age, socioeconomic status and racial/ethnic groups, said Qiana Brown of Rutgers University in New Brunswick, New Jersey. Brown, who wasn’t involved with this study, has researched marijuana use among pregnant and nonpregnant women.

Brown and colleagues reported last year in JAMA that between 2002 and 2014, marijuana use rose more among 18-to-25-year-old women than among 26-to-44-year-old women. They also found that insurance coverage was associated with a reduction in tobacco use among reproductive-age women, but not necessarily pregnant women. (bit.ly/2Lc3TlN)

“Tobacco use remains a major public health problem,” Brown told Reuters Health by email. “We must keep our fingers on the pulse of vulnerable populations to prevent health disparities.”

SOURCE: bit.ly/2L8v0hP American Journal of Public Health, online June 21, 2018.

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'Invisible' stool blood tied to increased risk of premature death

(Reuters Health) – A screening test for colon cancer that looks for “invisible” blood in stool may also predict a heightened risk of premature death from other causes, a recent study suggests.

Researchers examined data on 133,921 adults in Scotland who got screened for colon cancer using what’s known as a fecal occult blood test (FOBT). When these tests are positive for blood in the stool, it can signal cancer, but it doesn’t always mean people have tumors.

In the study, 2,714 people, or two percent, had positive FOBT results. Not only were these individuals almost eight times more likely to die of colon cancer than people with negative results, they were also 58 percent more likely to die of other causes during the study.

“Having blood in stool may be an early warning for a number of diseases, and could indicate the need for lifestyle change,” senior study author Robert Steele of the University of Dundee in Scotland said by email.

A positive FOBT result was associated with an increased risk of dying from respiratory, digestive, blood, hormone and neuropsychological diseases, as well as other types of cancer, researchers report in Gut.

Some previous research has linked stool in the blood to a shortened life expectancy, even when people didn’t have colon cancer, but results have been mixed and these studies often didn’t account for other underlying medical conditions and medications that might cause internal bleeding.

All of the participants in the current study had FOBT between 2000 and 2016. They were 50 to 74 years old when they joined the study, and they were followed from the date of their first test until death or the end of March 2016, whichever came first.

Men, older adults, and low-income people were more likely to have positive FOBT results, the study found.

People with prescriptions for aspirin or other drugs that boost the risk of digestive tract bleeding were also more likely to have a positive test result.

The study wasn’t a controlled experiment designed to prove whether or how blood in the stool might hasten death from colon cancer or other causes.

Still, researchers speculate that inflammation might contribute to bleeding in the gut as well as the development of certain cancers and other chronic diseases of advanced age like Alzheimer’s.

Inflammation is just a guess, however, and other explanations may also be possible, said Dr. Uri Ladabaum, author of an accompanying editorial and director of the gastrointestinal cancer prevention program at Stanford University School of Medicine in California.

“For colorectal cancer, we believe the cancer itself bleeds, and some pre-cancers can bleed as well,” Ladabaum said by email. “Other gastrointestinal tract lesions can also bleed – like stomach cancer, or benign conditions like ulcer, abnormal blood vessels, etc.”

“But we simply do not understand the mechanism linking hidden blood in stool to non-colorectal cancer death risk,” Ladabaum added.

Until this connection becomes clearer, there’s no need for patients to consider FOBT for purposes other than colorectal cancer screening, Ladabaum advised. “I would not advocate its use to screen for risk of other diseases.”

SOURCE: bit.ly/2LcjMcc Gut, online July 16, 2018.

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Virtual reality may help cure fear of heights

(Reuters Health) – A virtual reality program may work at least as well as one-on-one therapy to help people overcome a fear of heights, a UK study suggests.

Over four weeks of sessions, scores measuring fear of heights dropped by an average of two-thirds for volunteers who wore a virtual reality headset in anxiety-provoking situations, such as walking out on a platform over a large drop-off or rescuing a cat stuck in a tree, researchers said.

“In virtual reality, people can repeatedly enter simulations of the everyday situations that trouble them and be guided in the very best ways to think, feel and behave,” said the study’s lead author, Daniel Freeman of the University of Oxford. “The beauty is that the conscious awareness that these are simulations allows people to try things that they would be wary of in real life.”

While the method might apply to other phobias as well, Freeman and his colleagues chose to experiment with fear of heights because it is the most common phobia, with one in five people saying they’ve experienced it at some point.

The novel aspect of the new study is that no actual therapist was present during the sessions, just a “virtual coach” who walked each participant through the exercises, Freeman said. The animated coach asked questions that required yes/no answers or a rating of fear level, and then responded with suggestions.

One hundred people participated in the study, with 49 randomly assigned to get the virtual reality therapy in six 30-minute sessions and the others to receive no therapy for their fear of heights during the study period. (They were offered the VR treatment after the study was done).

On average, participants had experienced fear of heights for 30 years. To be included, they had to score between 30 and 55 on an acrophobia questionnaire, indicating a moderate fear of heights, or between 56 and 80, indicating severe fear.

As reported in The Lancet Psychiatry, at the end of the treatment period, half of the volunteers who got the VR treatment had scores at least 25 points lower than at the outset, while the group that didn’t get the treatment had little change in their scores.

“Afterwards, people even found they could go to places they wouldn’t have imagined possible, such as a walk up a steep mountain, going with their children on a rope bridge, or simply using an escalator in a shopping center without fear,” Freeman said.

Past research on the effectiveness of in-person treatment with a therapist has shown comparable benefits, but the current study did not compare VR treatment to any other therapy. Another limitation, the authors note, is that they can’t tell what aspects of the VR treatment were most effective.

Freeman and several other study authors are affiliated with Oxford VR, a company that partially funded the study.

Freeman doesn’t see virtual reality replacing real therapists. But it may fill a void caused by the shortage of therapists and also might help reduce the cost of treatment for people with phobias.

Programs like this might work well as a first step to getting people over their phobias, said Dr. Robert Hudak, a psychiatrist at the University of Pittsburgh Medical Center in Pennsylvania. “I could conceive of someone with fear of flying using virtual reality to get to the point where they could actually fly on a plane,” said Hudak, who was not involved in the study.

“I don’t think anyone is advocating this in place of a therapist, but it could be used as a step in many people’s treatment. With any kind of therapy patients are supposed to do homework. If they were doing a virtual reality program, then they’d be doing their homework,” Hudak said.

“When you’re working with an individual with anxiety you want to help them face the things they’re afraid of: that’s called exposure therapy,” said Lynne Bufka, a clinical psychologist and associate executive director for practice, research and policy at the American Psychological Association in Washington, DC.

Virtual reality therapy is not yet widely available, said Bufka, who wasn’t involved in the study. But with advances in technology making the programs more and more realistic, she can see it expanding. “It could help a lot of people,” she said.

SOURCE: bit.ly/2KR62U4 and bit.ly/2KPSHep The Lancet Psychiatry, online July 11, 2018.

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U.S. court rejects Allergan bid to shield patents through tribe deal

(Reuters) – A U.S. appeals court on Friday rejected a novel strategy adopted by drug company Allergan PLC to shield patents from review by an administrative court by transferring them to a Native American tribe.

The Allergan logo is seen in this photo illustration November 23, 2015. REUTERS/Thomas White/Illustration/File Photo

The U.S. Court of Appeals for the Federal Circuit said a tribunal run by the U.S. Patent and Trademark Office has authority to review the validity of patents covering Allergan’s dry eye drug Restasis.

Allergan spokeswoman Amy Rose declined to comment.

The company in September 2017 transferred the patents to New York’s Saint Regis Mohawk Tribe, claiming the tribe’s sovereign status meant the patents were immune from administrative review.

The tribe took legal ownership of the patents and licensed them back to Allergan in exchange for ongoing payments.

After announcing the deal, the tribe asked the U.S. Patent Trial and Appeal Board to dismiss a challenge to the validity of the patents brought by generic drug company Mylan NV , which was seeking to bring its own version of Restasis to market.

U.S. lawmakers from both political parties criticized Allergan’s move, saying it could be used by the pharmaceutical industry to prevent sales of lower-cost generic drugs.

Reporting by Jan Wolfe; Editing by Phil Berlowitz and Marguerita Choy

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Agios Pharmaceuticals leukemia drug gets U.S. approval

(Reuters) – Agios Pharmaceuticals Inc said on Friday the U.S. Food and Drug Administration approved its treatment for a type of leukemia, the first targeted drug for patients with a specific genetic mutation.

The company plans to launch the drug, Tibsovo, in the United States in about 48 hours, Chief Executive Officer David Schenkein told Reuters.

Agios would sell the treatment to drug distributors at $ 26,115 for a 30-day supply, he said.

Tibsovo is Agios’ first fully-owned drug and was approved on the basis of an early-stage trial in patients with acute myeloid leukemia whose disease has been resistant to treatment or has relapsed.

The drug’s label contains a boxed warning, the agency’s harshest, which flags the danger of “differentiation syndrome”, a fatal condition if untreated, with symptoms such as fluid build-up in the lungs and inflammation of the organ’s tissue.

In the United States, there are about 20,000 new cases each year of acute myeloid leukemia, a cancer of the blood and bone marrow, the company said in a statement.

Schenkein called the approval a milestone for the estimated 6-10 percent of AML patients with an IDH1 mutation, the specific form of the disease Tibsovo will target.

In August, the FDA signed off on another cancer drug from Agios, Idhifa, but its worldwide development and commercialization rights are held by Celgene Corp.

The company’s shares were marginally down at $ 90.15, having gained about 62 percent over the past year.

Reporting by Tamara Mathias in Bengaluru; Editing by Sriraj Kalluvila

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Bayer to phase out Essure birth control device in U.S.

NEW YORK (Reuters) – Healthcare company Bayer on Friday said it would discontinue the sale of its birth control product Essure in the United States, citing a decline in sales of the implantable device which made the business no longer sustainable.

FILE PHOTO: A logo of Bayer is seen next to dark clouds at Cologne Bonn airport
March 27, 2015. REUTERS/Wolfgang Rattay

Friday’s decision follows an announcement by the company in September 2017 to discontinue the sale of the contentious sterilization device in all countries outside the United States.

Bayer in a statement said the decision was not related to safety concerns.

“The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research,” the company said.

As of January, Ludwigsburg, Germany-based Bayer is facing some 16,000 U.S. lawsuits over Essure. The company said it was expecting additional lawsuits.

Plaintiffs allege that Essure, which is implanted in a woman’s fallopian tubes to permanently block an egg’s passage to the uterus, could pierce the tubes.

The women claim that metal parts of the device can become loose and migrate into other body parts, causing pain, injuries and severe bleeding. They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression.

The women who sued Bayer allege the German drugmaker knew of the risks associated with Essure, but failed to warn sellers, doctors and regulators of the dangers.

Steven Immergut, a Bayer spokesman, said the company had sold roughly two million Essure devices worldwide since the product came on the market in 2002.

The majority of those sales were in the U.S. Since then, the company has seen an average 40 percent annual decline in U.S. sales, Immergut said.

The U.S. Food and Drug Administration was not immediately available for comment.

Reporting by Tina Bellon; editing by Clive McKeef

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Honduras appeals WTO landmark ruling on Australia's plain tobacco packaging

GENEVA (Reuters) – Honduras has appealed against a WTO ruling won last month by Australia on its “plain” packaging requirements for tobacco, a WTO spokesman said on Friday.

In a landmark ruling, the WTO panel said Australia’s law improved public health by reducing the use of tobacco products, rebuffing claims that alternative measures would be equally effective.

It also rejected the argument that Australia had unjustifiably infringed tobacco trademarks and violated intellectual property rights.

The other plaintiffs – Cuba, Dominican Republic and Indonesia – have not yet said whether they plan to appeal. Australia’s law, introduced in 2010, bans logos and distinctively colored cigarette packaging in favor of drab olive packets with brand names printed in small standardized fonts.

Reporting by Stephanie Nebehay; Editing by Alison Williams

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Swiss, German drugmakers join U.S. price freeze

ZURICH (Reuters) – Roche, Bayer and Germany’s Merck KGaA became the latest drug companies to freeze prices in the United States, amid increased scrutiny by the Trump administration of medicine costs.

FILE PHOTO: The logo of Swiss pharmaceutical company Roche is pictured on the company’s headquarters in Basel February 4, 2009. REUTERS/Christian Hartmann (SWITZERLAND)/File Photo

Roche, Bayer and Merck KGaA all said on Friday they would not seek to lift prices this year in the world’s biggest drug market, following Novartis, Pfizer and U.S. drugmaker Merck which had already announced similar moves.

U.S. President Donald Trump made lowering prescription drug prices a top 2016 presidential campaign issue and has criticized drugmakers for raising prices, saying in a tweet this month that they “should be ashamed”.

“Last week on July 11, we communicated to the U.S. Department of Health and Human Services (HHS) that we will not be taking any price increases for the remainder of the year,” Switzerland’s Roche said in a statement on Friday.

“We take decisions related to the prices of our medicines very seriously and our commitment to patient access and investment in future breakthroughs are reflected in our actions.”

Germany’s Merck KGaA also relented to pressure.

FILE PHOTO: A logo of drugs and chemicals group Merck KGaA is pictured in Darmstadt, Germany January 28, 2016. REUTERS/Ralph Orlowski/File Photo

“We make our own independent pricing decisions and currently plan no price increases in the U.S. for the remainder of 2018,” the company said in an emailed statement.

Germany’s Bayer said it had also told U.S. health ministry officials that it will not raise prices this year.

THE BIG FREEZE

Novartis Chief Executive Vas Narasimhan called off price hikes in June, and this week cited the “dynamic environment” in the U.S. in tackling drug costs as a reason.

Trump called Pfizer’s boss, CEO Ian Read, after his company raised prices on July 1. The U.S. drugmaker reversed course after the president complained its hike was interfering with his administration’s drug pricing plan.

Trump, who has accused drugmakers of “getting away with murder”, thanked Novartis and Pfizer in a tweet this week.

New Jersey-based Merck & Co. announced price cuts on Thursday to some of its medicines, including a hepatitis C treatment and six medicines, though the overall impact may be muted since affected medicines have tiny market shares.

FILE PHOTO: U.S. Secretary of State Mike Pompeo and President Donald Trump listen during a cabinet meeting at the White House in Washington, U.S., July 18, 2018. REUTERS/Leah Millis

It also said it would not increase the average net price of other medicines in its portfolio of products by more than the inflation rate annually.

Roche said freezing prices this year was a measure to keep a lid on prices, saying its last seven new medicines were priced at a discount to rivals’ existing drugs.

In 2017 it priced Ocrevus at $ 65,000 annually, undercutting German rival Merck KGaA’s Rebif by a quarter even though Ocrevus beat Rebif in a trial. [reut.rs/2uBLGnC]

“We recently priced…Hemlibra at less than half the cost of the standard treatment for hemophilia A with inhibitors,” Roche said in its statement, adding that what was really needed were “long-term, system-wide solutions that lower costs, while sustaining scientific innovation.”

With his plan to cut drug prices, Trump has vowed to target “middlemen” in the drug industry – an apparent reference to health insurers and pharmacy benefit managers – but has retreated from ideas like letting the government’s Medicare plan for older Americans negotiate prices directly with drugmakers or allowing imports of cheaper drugs.

Drugmakers including Roche and Novartis favor reforms to Medicare’s discount drug program, saying the federal program originally designed to stretch resources has grown inappropriately. Some U.S. hospitals that benefit oppose changes.

Reporting by John Miller; additional reporting by Patricia Weiss in Frankfurt; Editing by Susan Fenton

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EU drug regulators step up work to prepare for 'no deal' Brexit

LONDON (Reuters) – Drug regulators across Europe are hiring extra staff and increasing their workload as the role of British experts in the EU-wide system of medicines supervision winds down ahead of Brexit.

FILE PHOTO: The headquarters of the European Medicines Agency (EMA), is seen in London, Britain, April 25, 2017. REUTERS/Hannah McKay/File Photo

Although the UK’s exit from the European Union is still eight months away, Britain has already stopped taking on new projects that will extend beyond March 29, 2019 and is preparing to hand over existing drug review work to other countries.

That leaves a major gap, since British experts carry out around a fifth of the work for the centralised European Medicines Agency (EMA), the EU’s equivalent of the U.S. Food and Drug Administration.

In addition, Britain’s Medicines and Healthcare products Regulatory Agency also plays a pivotal role in Europe’s decentralised system of drug supervision, which is based on mutual recognition.

“It’s a real pity that we are going to lose the UK expertise, which is certainly very strong,” said Hugo Hurts, executive director of the Netherlands Medicines Evaluation Board.

“It’s a real challenge, but I’m not going to say there is not enough knowledge to replace that in the rest of the network,” Hurts told Reuters.

FILE PHOTO: The headquarters of the European Medicines Agency in London, Britain, April 25, 2017. REUTERS/Hannah McKay/File Photo

Germany, Sweden and the Netherlands are among the other big contributors to the EU drug review process, alongside Britain.

The Dutch agency has already added more than a dozen extra staff, and drug regulators in other EU states are also hiring more people.

In addition, officials are exploring how more drug assessment work can be performed by multinational teams in future, rather than just one agency.

Despite a vote by UK members of parliament this week calling for Britain’s continued participation in the Europe regulatory network for medicines, there is no certainty that any such deal will be reached.

That reflects the wider lack of clarity over Britain’s future relationship with the world’s biggest trading bloc after it leaves the EU next March.

“At the end of the day, the network has to be prepared for the worst-case scenario. If we are not prepared by March 29, 2019 for a ‘no deal’ Brexit then we would have done a very bad job,” Hurts said.

CRITICAL FOR DRUGMAKERS

Maintaining timely approvals for new drugs is crucial for pharmaceutical and biotechnology companies, which have dozens of experimental medicines due to be assessed in the next couple of years.

The Brexit-induced disruption also comes at a time when regulators are having to grapple with oversight of a range of new health technologies, such as gene therapy, and a slew of big data on health outcomes.

Global drug companies, including UK-based GlaxoSmithKline (GSK.L) and AstraZeneca (AZN.L), have been vocal in calling for continued close EU-UK ties after Brexit. The issue is also important to many Japanese drugmakers that have made Britain their European base.

The EMA itself is being uprooted from London to Amsterdam, increasing the pressure on the system for overseeing drug safety. Although Amsterdam is more attractive than other locations that might have been chosen, the agency is still braced for significant staff departures.

A staff survey last year predicted 19 percent employee losses from the move to Amsterdam, and the EMA’s executive director Guido Rasi said this was based on optimistic assumptions.

Meanwhile, individual drug companies are taking steps to prepare their supply lines in the event of a disorderly or no-deal Brexit that could threaten the smooth flow of products across borders.

AstraZeneca said this week it was increasing stockpiles of those medicines in Britain and Europe that could be affected by around 20 percent.

Reporting by Ben Hirschler; Editing by Keith Weir

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