All posts tagged "health authorities"
Saudi health authorities announced Wednesday a new MERS death, bringing to 59 the number of people who have died from the coronavirus in the country with the most fatalities. The Saudi national, aged 60, died in hospital in the Riyadh region, said the…
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Scientists proposed developing a more potent strain of the deadly H7N9 bird flu on Wednesday to examine how mutant forms might spread among humans, a topic that has stoked global alarm in the past.
The announcement came a day after Chinese scientists reported the first likely case of person-to-person transmission of the H7N9 virus, which has killed 43 of the 134 people infected since March according to official figures.
US health authorities said any new H7N9 experiments that seek US funding would undergo a new, strict safety review, after concerns over such research on another bird flu, H5N1, in December 2011 raised fears that terrorists could unleash a virulent lab-grown strain and cause mass deaths.
Those concerns led to a year-long halt to the research being led by Ron Fouchier of Erasmus Medical Center in The Netherlands and US colleagues in Wisconsin.
That voluntary moratorium was lifted earlier this year by a group of 40 scientists around the world.
Fouchier told AFP that his lab has resumed work on an engineered H5N1 virus, but that US labs have not and are awaiting a final decision by American health authorities, expected in the coming weeks.
The latest proposal by Fouchier and 21 colleagues in Hong Kong, Britain and the United States is to examine how H7N9 may spread among mammals and may become more potent and drug-resistant.
This "gain of function" (GOF) research is "necessary and should be done" to better understand how the virus could act in the future, Fouchier and colleagues said in a letter published in the US journal Science and the British journal Nature.
"To fully assess the potential risks associated with these novel viruses, there is a need for additional research," said the letter.
"As members of the influenza research community, we believe that the avian A(H7N9) virus outbreak requires focused fundamental and applied research conducted by responsible investigators with appropriate facilities and risk mitigation in place."
US health authorities said any experiments that boost the virus's ability to spread would face "extra oversight" and "an additional level of review" by the Department of Health and Human Services.
The research is urgent because the H7N9 virus has some characteristics in common with human flu viruses and others like H5N1 that have adapted to transfer from birds to mammals, Fouchier and colleagues wrote.
H7N9 also shows signs of resistance to the main medical treatment, Tamiflu, and other neuraminidase inhibitors such as peramivir and zanamivir, which "could increase the risk of serious outcomes," the scientists wrote.
Adding to concerns about its spread was the announcement Tuesday that a 32-year-old woman in China appeared to have contracted the virus from her father, who had close contact with poultry, in the first known case of human-to-human transmission of H7N9. Both died.
Research published in Science in May showed that H7N9 could spread among ferrets in close contact, and may be able to transmit in people under certain conditions.
"Because the H7N9 virus has acquired the ability of limited airborne transmission under natural circumstances, many experts think the threat posed by H7N9 is higher than for H5N1," Fouchier told AFP in an email.
"As a consequence, it is possible that some people think that H7N9 research is more urgent."
Fouchier also said that no additional US funds were being sought for the experiments, since they would likely seek to use government money already provided under a seven-year contract to the high-security labs that are part of the US National Institutes of Health's Centers of Excellence in Influenza Research and Surveillance (CEIRS).
US health authorities said their review process would "consider the acceptability of these experiments in light of potential scientific and public health benefits as well as biosafety and biosecurity risks."
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A major US pharmaceutical company on Thursday issued a wide-spanning global recall of the fluid used to store organs for potential transplants over fears it could be contaminated.
Bristol Myers-Squibb (BMS) said it is recalling the fluid, called Viaspan, across much of Europe as a part of its investigation into the problem that was detected March 19 at a third-party manufacturing facility in Austria.
BMS issued the recall after tests found bacteria in the solution used to monitor the sterility of the storage fluid.
"We are urgently investigating the cause of this issue," the company said in a statement.
"BMS has notified all health authorities in countries where the product is distributed and will provide further updates as the investigation progresses."
Spokesman Ken Dominski told AFP the recall was being issued as a precautionary measure and no evidence of actual contamination had yet been found.
"No evidence has been found at this point (that this) manufacturing issue by our third party manufacturer could lead to a product contamination and therefore we are issuing the recall as a precautionary measure."
The recall applies to Viaspan 50mg/ml in Australia, Italy, Estonia, Slovenia, Argentina, Chile, Germany, France, Ireland, and the United Kingdom -- all places where there are available alternatives.
The company is working with health authorities in countries where a substitute is not available to find alternate solutions -- including Croatia, Finland, New Zealand, Switzerland, Latvia, Lithuania, Spain, Sweden, Norway, Denmark, Netherlands, and Belgium.
"BMS will be working with the local health authorities to find alternative solutions for patients, and sending a Dear Healthcare Provider Letter to physicians which includes a review of the benefit/risk for patients," a statement said.
The company does not sell the fluid in Asia or the United States, so those markets are unaffected, Dominski added.
The British government confirmed that there had been a global recall of the fluid used to store most of its donor organs over fears it may have become contaminated.
The bacteria Bacillus cereus was found in the production line of Viaspan, the world's "gold standard" organ storage fluid, a spokesman for Britain's Medicines and Healthcare products Regulatory Agency (MHRA) told AFP.
The British government stressed that no patients had reported any adverse reactions following transplants, and that it would still use organs currently stored in the fluid.
"Our priority is to ensure patients are safe," said Sally Davies, the government's top health advisor.
The bacteria can cause diarrhea, nausea, vomiting and stomach cramps, but patients can be prescribed antibiotics before their operation as a precautionary measure.
"There is currently no evidence of any problems in patients who have recently had transplants where Viaspan has been used.
"If we were to recall the product immediately it is clear that patients would suffer and some may die," she explained.
The last production-line tests were carried out in July, so any fluid produced since then is at risk of contamination.
The results of ongoing tests on batches on Viaspan are due within two weeks, according to the British health spokesman.
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US health authorities on Tuesday issued a warning to the maker of a new inhalable caffeine product sold in the United States and France, citing mislabeling and safety concerns.
"The Food and Drug Administration reviewed your website at www.aeroshots.com in February 2012 and has determined that the product AeroShot is misbranded," said the letter. "We also have safety questions about the product."
Because it is considered a dietary supplement, the lipstick-sized product did not have to gain FDA approval to hit the market. It is currently for sale in parts of the United States and France.
The FDA said the product's label "suggests in several places that AeroShot should be inhaled," raising concerns because little research has been done to assess the safety of inhaling caffeine into the lungs.
The product label also "states that AeroShot is 'not intended for people under 12' ... This suggests that the product is suitable for children 12 and over," the letter added, requesting data to back up its safety in youths.
US company Breathable Foods, which makes AeroShot, issued a statement saying that labeling changes are under way to make sure consumers know the product is for ingestion, not inhalation.
"AeroShot delivers a mix of B vitamins and caffeine to the mouth for ingestion and is not 'inhaled' into the lungs," the company's chief executive Tom Hadfield said in a statement.
"AeroShot is not recommended or marketed to persons under 18 or for use with alcohol."
The product was launched in Boston and New York earlier this year after first being introduced in Paris.
Its marketing materials claim to deliver as much caffeine as a cup of coffee along with "B vitamins in a fine powder that is dissolved quickly in the mouth and immediately starts working."
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A man in southwest China who contracted the bird flu virus died on Sunday, health authorities said, the second human death from the virulent disease in the Asian country in just under a month.
Concerns about avian influenza have risen across southeast Asia after China in late December reported its first fatality from the H5N1 virus in 18 months.
The latest victim fell ill on January 6 and was subsequently admitted to hospital in Guiyang -- capital of Guizhou province -- where his condition rapidly deteriorated, the provincial health department said in a statement.
Tests on the patient before he died confirmed he had contracted the H5N1 virus, it added.
"So far, 71 people who had close contact with the victim have not developed abnormal symptoms," the health department said.
He is the second man to die from bird flu in China in less than a month, after a bus driver in the southern province of Guangdong passed away from the disease on December 31.
The latest bird flu death brings to 28 the number of people in China who have died from the disease -- which is fatal in humans in about 60 percent of cases -- since 2003, out of 42 reported human cases.
The Hong Kong Department of Health said in a statement Sunday it had been notified of the case by the mainland's health authorities, which said the patient was 39 years old.
Authorities from Hong Kong and the mainland have been working closely together since three chickens in the Chinese territory tested positive for the H5N1 virus in mid-December.
The discovery prompted Hong Kong authorities to cull thousands of chickens in a bid to contain the spread of the virus among poultry.
Most human infections are the result of direct contact with infected birds, and the virus does not pass easily among humans.
The World Health Organization says it has never identified a "sustained human-to-human spread" of the virus since it re-emerged in 2003.
But according to health authorities, the man who died in Guizhou had not reported any obvious exposure to poultry before the onset of symptoms.
Chen, the Guangdong victim, had not had any direct contact with poultry either in the month before he was taken ill, nor had he left the bustling metropolis of Shenzhen where he lived.
Vietnam on Thursday reported its first human death from the virus in nearly two years, as the virus also claimed the life of a toddler in Cambodia.
Indonesia on Friday reported its second human death from bird flu this year, with the death of a five-year-old girl who recently lost her relative to the deadly virus.
China is considered one of the nations most at risk of bird flu epidemics because it has the world's biggest poultry population and many chickens in rural areas are kept close to humans.
In total, the avian influenza virus has killed more than 330 people around the world, and scientists fear it could mutate into a form readily transmissible between humans, with the potential to cause millions of deaths.
Highlighting those fears, the World Health Organization said last month it was "deeply concerned" about research into whether H5N1 could be made more transmissible between humans after mutant strains were produced in labs.
Two separate research teams -- one in the Netherlands and the other in the United States -- separately found ways to alter the virus H5N1 so it could pass easily between mammals.
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