FDA Approves First In-Home Test for Coronavirus
The Food and Drug Administration announced Tuesday that it gave the green light to the first in-home test for the coronavirus, a nasal swab kit sold by LabCorp, according to an FDA press release.
The agency said that LabCorp had submitted data showing the home test is as safe and accurate as a sample collection at a doctor's office, hospital or other testing site. The authorization is the first time the agency has issued emergency clearance for an at-home COVID-19 test, as STAT reported. It comes after weeks of back-and-forth between the FDA and companies trying to create their own versions of an at-home sample collection.
The FDA approved the LabCorp test after a previous spate of activity between the agency and companies including Nurx, Carbon Health and Everlywell. All of them sought to have their own COVID-19 tests approved for at-home use in March, as STAT reported.
The LabCorp test approved by the FDA will initially be available to health care workers and first responders who may have been exposed to the novel coronavirus. It will be more widely available in coming weeks.
To use the test, patients will swab their own nose using a testing kit sent by the company, and will mail it in an insulated package back to the company, as The New York Times reported. The Pixel by LabCorp COVID-19 test will be available to consumers in most states with a doctor's order, the FDA said. Patients also must first complete a questionnaire.
The test uses a specific Q-tip-style cotton nose swab. Other tests, like what's used in a flu test, use longer swabs that require patients to sample themselves deep in the back of the nose, which is uncomfortable when done properly, as STAT reported.
As the AP noted, allowing people to self-swab at home would help reduce infection risks for front-line health care workers and help conserve protective gear.
"Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," said FDA Commissioner Stephen M. Hahn, MD, in an agency press release.
"The FDA's around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers. Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor's office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home."
LabCorp said the test will cost $119 and consumers will have to pay out of pocket and then ask their insurer for reimbursement, according to The New York Times. The Trump administration has often said that diagnostic tests for the coronavirus will be covered so that consumers are not responsible for the bill.
Some of the hardest hit areas though will not have the test. The kits will not be available in Maryland, New Jersey, New York and Rhode Island, where laws prohibit testing with at-home sample collection kits, according to LabCorp, as the AP reported.
"This is not a game-changer, but it's potentially another piece of the large and rather messy puzzle we're assembling to test enough people to stop Covid-19," Dr. Sheldon Campbell, associate director of the Yale School of Medicine's Clinical Microbiology Laboratory, said of the at-home nasal self-swabbing kits, to The New York Times. "A home-collection testing procedure will support telemedicine and help patients with transportation difficulties and in hard-to-reach places to access testing."
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By Brian Bienkowski
Fish exposed to endocrine-disrupting compounds pass on health problems to future generations, including deformities, reduced survival, and reproductive problems, according to a new study.
Low Levels Lead to Generational Impacts<p>Researchers exposed inland silverside fish to bifenthrin, levonorgestrel, ethinylestradiol, and trenbolone to levels currently found in waterways.</p><p>"Our concentrations were actually on the low end" of what is found in the wild, DeCourten said, adding that it was low amounts of chemicals in parts per trillion.</p><p>Bifenthrin is a pesticide; levonorgestrel and ethinylestradiol are synthetic hormones used in birth controls; and trenbolone is a synthetic steroid often given to cattle to bulk them up.</p><p>Such endocrine-disruptors have already been linked to a variety of health problems in directly exposed fish including altered growth, reduced survival, lowered egg production, skewed sex ratios, and negative impacts to immune systems. But what remains less clear is how the exposure may impact future generations.</p><p>For their study, DeCourten and colleagues started the exposure when the fish were embryos and continued it for 21 days.</p><p>They then tracked effects on the exposed fish, and the next two generations.</p>
Inherited Problems<p>DeCourten said the altered DNA methylation is one of the plausible ways that future generations would experience health impacts from previous generations' exposure. Hormone-disrupting compounds have been shown to impact DNA methylation, which is an important marker of how an organism will develop.</p><p>"Methyl groups are added to specific sites on the genome, [the exposure] is not changing the genome itself, but rather how the genome is expressed," she said. "And that can be inherited throughout generations."</p><p>In addition, Brander said there are essentially different "tags" that exist on DNA molecules, which tell genes how to turn on and off. She said the exposure to different compounds may be "influencing which methyl tags get taken on or off as you proceed through generations."</p><p>The researchers said the study should prompt future toxics testing to consider impacts on future generations.</p><p>"The results … throw a wrench in the current approach to regulating chemicals, where it's often short-term testing looking at simple things like growth, survival, and maybe gene expression," Brander said.</p><p>"These findings are telling us we really at least need to consider" the next two generations, she added.</p>
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Poor eating habits, lack of exercise, genetics, and a bunch of other things are known to be behind excessive weight gain. But, did you know that how much sleep you get each night can also determine how much weight you gain or lose?
By Laura Beil
Consumers have long turned to vitamins and herbs to try to protect themselves from disease. This pandemic is no different — especially with headlines that scream "This supplement could save you from coronavirus."
Vitamin D<p><strong>What it is: </strong>Called "the sunshine vitamin" because the body makes it naturally in the presence of ultraviolet light, <a href="https://www.sciencenews.org/article/vitamin-d-supplements-lose-luster" target="_blank">Vitamin D is one of the most heavily studied</a> supplements (<em>SN: 1/27/19</em>). <a href="https://health.gov/our-work/food-nutrition/2015-2020-dietary-guidelines/guidelines/appendix-12/" target="_blank">Certain foods</a>, including fish and fortified milk products, are also high in the vitamin.</p><p><strong>Why it might help: </strong>Vitamin D is a hormone building block that helps strengthen the immune system.</p><p><strong>How it works for other infections:</strong> In 2017, the <em>British Medical Journal</em> published a meta-analysis that suggested a daily vitamin D supplement <a href="https://www.bmj.com/content/356/bmj.i6583" target="_blank">might help prevent respiratory infections</a>, particularly in people who are deficient in the vitamin.</p><p>But one key word here is <em>deficient. </em>That risk is highest during dark winters at high latitudes and among people with more color in their skin (melanin, a pigment that's higher in darker skin, inhibits the production of vitamin D).</p><p>"If you have enough vitamin D in your body, the evidence doesn't stack up to say that giving you more will make a real difference," says Susan Lanham-New, head of the Nutritional Sciences Department at the University of Surrey in England.</p><p>And taking too much can create new health problems, stressing certain internal organs and leading to a dangerously high calcium buildup in the blood. The recommended daily allowance for adults is 600 to 800 International Units per day, and the upper limit is considered to be 4,000 IUs per day.</p><p><strong>What we know about Vitamin D and COVID-19:</strong> Few studies have looked directly at whether vitamin D makes a difference in COVID.</p>
Zinc<p><strong>What it is: </strong>Zinc, a mineral found in cells all over the body, is found naturally in certain meats, beans and oysters.</p><p><strong>Why it might help: </strong>It plays several supportive roles in the immune system, which is why zinc lozenges are always hot sellers in cold and flu season. Zinc also helps with cell division and growth.</p><p><strong>How it works for other infections: </strong><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6457799/" target="_blank" rel="noopener noreferrer">Studies of using zinc for colds</a> — which are frequently caused by coronaviruses — suggest that using a supplement right after symptoms start might make them go away quicker. That said, a clinical trial from researchers in Finland and the United Kingdom, published in January in <em>BMJ Open</em> <a href="https://bmjopen.bmj.com/content/10/1/e031662" target="_blank" rel="noopener noreferrer">did not find any value for zinc lozenges</a> for the treatment of colds. Some researchers have theorized that inconsistencies in data for colds may be explained by varying amounts of zinc released in different lozenges.</p><p><strong>What we know about zinc and COVID-19:</strong> The mineral is promising enough that it was added to some early studies of hydroxychloroquine, a drug tested early in the pandemic. (Studies have since shown that <a href="https://www.sciencenews.org/article/covid-19-coronavirus-hydroxychloroquine-no-evidence-treatment" target="_blank">hydroxychloroquine can't prevent or treat COVID-19</a> (<em>SN: 8/2/20</em>).)</p>
Vitamin C<p><strong>What it is: </strong>Also called L-ascorbic acid, vitamin C has a long list of roles in the body. It's found naturally in fruits and vegetables, especially citrus, peppers and tomatoes.</p><p><strong>Why it might help:</strong> It's a potent antioxidant that's important for a healthy immune system and preventing inflammation.</p><p><strong>How it works for other infections: </strong>Thomas cautions that the data on vitamin C are often contradictory. One review from Chinese researchers, published in February in the <em>Journal of Medical Virolog</em>y, looked at <a href="https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.25707" target="_blank">what is already known about vitamin C</a> and other supplements that might have a role in COVID-19 treatment. Among other encouraging signs, human studies find a lower incidence of pneumonia among people taking vitamin C, "suggesting that vitamin C might prevent the susceptibility to lower respiratory tract infections under certain conditions."</p><p>But for preventing colds, a 2013 Cochrane review of 29 studies <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000980.pub4/full" target="_blank" rel="noopener noreferrer">didn't support the idea</a> that vitamin C supplements could help in the general population. However, the authors wrote, given that vitamin C is cheap and safe, "it may be worthwhile for common cold patients to test on an individual basis whether therapeutic vitamin C is beneficial."</p><p><strong>What we know about Vitamin C and COVID-19: </strong>About a dozen studies are under way or planned to examine whether vitamin C added to coronavirus treatment helps with symptoms or survival, including Thomas' study at the Cleveland Clinic.</p><p>In a review published online in July in <em>Nutrition</em>, researchers from KU Leuven in Belgium concluded that the <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000980.pub4/full" target="_blank" rel="noopener noreferrer">vitamin may help prevent infection</a> and tamp down the dangerous inflammatory reaction that can cause severe symptoms, based on what is known about how the nutrient works in the body.</p><p>Melissa Badowski, a pharmacist who specializes in viral infections at the University of Illinois at Chicago College of Pharmacy and colleague Sarah Michienzi published an extensive look at all supplements that might be useful in the coronavirus epidemic. There's <a href="https://www.drugsincontext.com/can-vitamins-and-or-supplements-provide-hope-against-coronavirus/" target="_blank" rel="noopener noreferrer">still not enough evidence to know whether they are helpful</a>, the pair concluded in July in <em>Drugs in Context</em>. "It's not really clear if it's going to benefit patients," Badowski says.</p><p>And while supplements are generally safe, she adds that nothing is risk free. The best way to avoid infection, she says, is still to follow the advice of epidemiologists and public health experts: "Wash your hands, wear a mask, stay six feet apart."</p>
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By Elliot Douglas
In early October, Britain's Prince William teamed up with conservationist David Attenborough to launch the Earthshot Prize, a new award for environmentalist innovation. The Earthshot brands itself the "most prestigious global environment prize in history."
The world-famous wildlife broadcaster and his royal sidekick appear to have played an active role in the prize's inception, and media coverage has focused largely on them as the faces of the campaign.
“Rather than a Moonshot 🌕, we need Earthshots 🌍 for this decade.” Watch Prince William’s @Tedtalks talk in full:… https://t.co/m5NCj6TQzH— The Duke and Duchess of Cambridge (@The Duke and Duchess of Cambridge)1602408749.0
But the pair are only the frontmen of a much larger movement which has been in development for several years. In addition to a panel of experts who will decide on the winners, the prize's formation took advice from the World Wildlife Fund, Greenpeace and the Jack Ma Foundation.
With more and more global attention on the climate crisis, celebrity endorsement of environmental causes has become more common. But why do environmental causes recruit famous faces for their campaigns? And what difference can it make?
'Count Me In'
"We need celebrities to reach those people who we cannot reach ourselves," says Sarah Marchildon from the United Nations Climate Change secretariat (UNFCCC) in Bonn, Germany.
Marchildon is a proponent of the use of celebrities to raise awareness of environmental causes. In addition to promoting a selection of climate ambassadors who represent the UN on sustainability issues, Marchildon's team has produced videos with well-known narrators from the entertainment world: among them, Morgan Freeman and Mark Ruffalo.
"We choose celebrities who have a lifestyle where they are already talking about these issues," Marchildon explains.
"Sometimes they reach out to us themselves, as David Attenborough did recently. And then they can promote the videos on their own social channels which reach more people than we do — for example, if they have 20 million followers and we have 750,000."
Environmental groups focused on their own domestic markets are also taking this approach. One Germany-based organization that uses celebrities in campaigns is the German Zero NGO. Set up in 2019, it advocates for a climate-neutral Germany by 2035.
German Zero produced a video in March 2020 introducing the campaign with "66 celebrities" that supported the campaign, among them Deutschland 83 actor Jonas Nay and former professional footballer Andre Schürrle. They solicit support as well as financial contributions from viewers.
"Count me in," they say, pointing toward the camera. "You too?"
"We are incredibly grateful for the VIPs in our videos," says German Zero spokeswoman Eva-Maria McCormack.
Assessing Success Is Complex
But quantifying the effectiveness of celebrity endorsement of campaigns is not a straightforward process.
"In order to measure effectiveness, first of all you need to define what is meant by success," says Alegria Olmedo, a researcher at the Zoology Department at the University of Oxford.
Olmedo is the author of a study looking at a range of campaigns concerning pangolin consumption, fronted by local and Western celebrities, in Vietnam and China. But she says her biggest stumbling block was knowing how to measure a campaign's success.
"You need a clear theory of change," explains Olmedo. "Have the celebrities actually helped in achieving the campaign's goals? And how do you quantify these goals? Maybe it is increased donations or higher engagement with a cause."
A popular campaign in China in recent years saw famous chefs Zhao Danian and Shu Yi pledge to abstain from cooking endangered wildlife. While the pledge achieved widespread recognition, both Olmedo and Marchildon say it's difficult to know whether it made any difference to people's actions.
"In life we see a thousand messages every day, and it is very hard to pinpoint whether one campaign has actually made a difference in people's behavior," she explains.
Awareness Is Not Enough
Many campaigns that feature celebrities focus on raising awareness rather than on concrete action — which, for researcher Olmedo, raises a further problem in identifying effectiveness.
"Reach should never be a success outcome," she says. "Many campaigns say they reached a certain number of people on social media. But there has been a lot of research that shows that simply giving people information does not mean they are actually going to remember it or act upon it."
But anecdotal evidence from campaigns may suggest reach can make an active difference.
"Our VIP video is by far the most watched on our social media channels," McCormack from German Zero says. "People respond to it very directly. A lot of volunteers of all ages heard about us through that video."
However, some marketing studies have shown that celebrity endorsement of a cause or product can distract from the issue itself, as people only remember the person, not the content of what they were saying.
Choosing the Right Celebrity
Celebrity choice is also very important. Campaigns that use famous faces are often aiming to appeal to members of the public who do not necessarily follow green issues.
For certain campaigns with clear target audiences, choosing a climate scientist or well-known environmentalist rather than a celebrity could be more appealing — Attenborough is a classic example. For others, images and videos involving cute animals may be more likely to get a message heard than attaching a famous face.
"We choose celebrities who have a lifestyle where they are already talking about these issues," says Marchildon from the UN. "You need figures with credibility."
McCormack cites the example of Katharine Hayhoe, an environmental scientist who is also an evangelical Christian. In the southern United States, Hayhoe has become a celebrity in her own right, appealing to an audience that might not normally be interested in the messages of climate scientists.
But as soon as you get a celebrity involved, campaigns also put themselves at risk of the whims of that celebrity. Prince William and younger members of the royal family have come under fire in recent years for alleged hypocrisy for their backing of environmental campaigns while simultaneously using private jets to fly around the world.
But Does It Really Work?
While environmental campaigns hope that endorsement from well-known figures can boost a campaign, there is little research to back this up.
"The biggest finding [from my study] was that we were unable to produce any evidence that shows that celebrity endorsement of environmental causes makes any difference," says Olmedo.
This will come as a blow to many campaigns that have invested time and effort into relationships with celebrity ambassadors. But for many, the personal message that many celebrities offer in videos like that produced by German Zero and campaigns like the Earthshot Prize are what counts.
The research may not prove this conclusively — but if the public believes a person they respect deeply personally cares about an important issue, they are perhaps more likely to care too.
"I personally believe in the power this can have," says Marchildon. "And if having a celebrity involved can get a single 16-year-old future leader thinking about environmentalist issues — that is enough."
Reposted with permission from DW.
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