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U.S. officials are preparing to battle two bad viruses circulating at the same time as the coronavirus outbreak runs into flu season next fall and winter.

The Covid-19 outbreak in the U.S. hit just as the flu season was ending this year, Robert Redfield, director of the Centers for Disease Control and Prevention, said at a White House press briefing Wednesday. But they won't have that benefit of using the country's flu surveillance system to track the Covid-19 pandemic when the next flu season hits, he said.

"Next fall and winter, we're going to have two viruses circulating and we're going to have to distinguish between which is flu and which is the coronavirus," Redfield said.

But Redfield noted that he didn't say the coronavirus itself would be "worse" in the winter.

Earlier in the press conference, President Donald Trump said Redfield was "totally misquoted" when he previously said challenges from the coronavirus could be "more difficult" in the winter.

"He was talking about the flu and corona coming together at the same time," Trump said, "and corona could be just some little flare-ups that we'll take care of."

Redfield told The Washington Post on Tuesday that the already daunting task of responding to the coronavirus outbreak could only become more challenging in the winter, when flu season begins.

"There's a possibility that the assault of the virus on our nation next winter will actually be even more difficult than the one we just went through," Redfield told the Post. "And when I've said this to others, they kind of put their head back, they don't understand what I mean."

"We're going to have the flu epidemic and thecoronavirusepidemic at the same time," the newspaper reported him saying.

The headline of the newspaper's story read: "CDC director warns second wave of coronavirus is likely to be even more devastating." Trump called that headline "ridiculous" and "fake news" at the briefing Wednesday evening.

"It's possible if the corona even comes back" in the winter, Trump said, "and [Redfield] doesn't know that it's going to and neither do I ... we may have some embers [of the virus] and we're going to put them out."

The CDC director, however, had been definitive that Covid-19 would still be present in the winter. "We're going to have two viruses circulating at the same," Redfield said at the briefing. Redfield also said that the Post's story quoted him accurately.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force, said later in the briefing that the disease would last beyond the summer.

"We will have coronavirus in the fall," Fauci said. "I am convinced of that."

Trump on Wednesday morning lashed out at CNN, which reported on the Post's interview with Redfield.

"CDC Director was totally misquoted by Fake News @CNN on Covid 19," Trump tweeted.

On Wednesday afternoon, White House press secretary Kayleigh McEnany said on Fox News that she had just spoken with Redfield on the phone and "the mainstream media has been taking him out of context, as they so often do with Trump administration officials."

McEnany added that what Redfield "was trying to" urge Americans to get a flu shot.

"The flu comes back in the fall. Be smart, American people," Redfield meant to say, according to McEnany.

"That's what he was saying. But leave it to CNN and some of the other networks to really take those comments out of context," McEnany said.

-- CNBC's Jacob Pramuk contributed to this report.

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US officials prepare for 'two viruses' next fall: coronavirus and the flu - CNBC

All these developments have taken place under pressure from Washington and Brussels. In hearings over the past few years, Congress has criticized the companiesnot always in consistent waysfor allowing harmful speech. In 2018, Congress amended the previously untouchable Section 230 of the Communications Decency Act to subject the platforms to the same liability that nondigital outlets face for enabling illegal sex trafficking. Additional amendments to Section 230 are now in the offing, as are various other threats to regulate digital speech. In March 2019, Zuckerberg invited the government to regulate harmful content on his platform. In a speech seven months later defending Americas First Amendment values, he boasted about his team of thousands of people and [artificial-intelligence] systems that monitors for fake accounts. Even Zuckerbergs defiant ideal of free expression is an extensively policed space.

Against this background, the tech firms downgrading and outright censorship of speech related to COVID-19 are not large steps. Facebook is using computer algorithms more aggressively, mainly because concerns about the privacy of users prevent human censors from working on these issues from home during forced isolation. As it has done with Russian misinformation, Facebook will notify users when articles that they have liked are later deemed to have included health-related misinformation.

But the basic approach to identifying and redressing speech judged to be misinformation or to present an imminent risk of physical harm hasnt changed, according to Monika Bickert, Facebooks head of global policy management. As in other contexts, Facebook relies on fact-checking organizations and authorities (from the World Health Organization to the governments of U.S. states) to ascertain which content to downgrade or remove.

Read: How to misinform yourself about the coronavirus

What is different about speech regulation related to COVID-19 is the context: The problem is huge and the stakes are very high. But when the crisis is gone, there is no unregulated normal to return to. We liveand for several years, we have been livingin a world of serious and growing harms resulting from digital speech. Governments will not stop worrying about these harms. And private platforms will continue to expand their definition of offensive content, and will use algorithms to regulate it ever more closely. The general trend toward more speech control will not abate.

Over the past decade, network surveillance has grown in roughly the same proportion as speech control. Indeed, on many platforms, ubiquitous surveillance is a prerequisite to speech control.

The public has been told over and over that the hundreds of computers we interact with dailysmartphones, laptops, desktops, automobiles, cameras, audio recorders, payment mechanisms, and morecollect, emit, and analyze data about us that are, in turn, packaged and exploited in various ways to influence and control our lives. We have also learned a lotbut surely not the whole pictureabout the extent to which governments exploit this gargantuan pool of data.

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What COVID-19 Revealed About the Internet - The Atlantic

SportRugby UnionHow the vote works, who the candidates are and why it matters so much to the sport

Friday, 24th April 2020, 6:16 pm

World Rugby will elect its chairman for the next four years in an online vote on Sunday, with the result declared on 12 May.

It is a straight fight between the incumbent Sir Bill Beaumont, standing for a second term, and Agustin Pichot, who has been Beaumonts vice-chairman since 2016.

How the vote will be carried out

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i's fantasy football tipsnewsletter: get ahead

There are 51 votes, made up of three each for England, Ireland, Scotland, Wales, France, Italy, South Africa, New Zealand, Australia, Argentina; two each for the regions of Africa, Asia, Europe, North/Central America, South America, Oceania; and an additional two each for Japan and one each for Romania, Georgia, Uruguay, USA, Canada, Samoa, Fiji.

One estimate is Beaumont will win with at least 26 votes from the Six Nations, Japan, Europe, Africa, Canada and Fiji but predictions are precarious and Pichot has been a media-savvy electioneer.

Bill Beaumont, 68

Played all his rugby as a lock in the amateur era, captaining England 21 times and the British & Irish Lions in apartheid-era South Africa in 1980. Has since been one of his sports most prominent administrators, as chair of the Rugby Football Union and then World Rugby, while holding down the day job, running a successful family textiles company.

There is nothing Sir Bill, aka Bo-Bo to his mates, does not know about schmoozing a rugby room, and since his days as a genial captain on BBCs A Question of Sport he has been getting things done in a collegiate manner.

He has a direct connection with the modern game through his son Josh, who plays for Sale Sharks, and his manifesto promise to review World Rugbys governance is backed up by the radical change he oversaw in 2017, when 17 female representatives were added to the Council taking it from 32 to 49, and subsequently up to the 51 who will vote tomorrow.

On the other hand (a phrase it is necessary to rehearse in rugby), the 50th and 51st Council members welcomed enthusiastically by Beaumont in 2018 included the Fiji Rugby chairman Francis Kean, who last week was stood down by his union over allegations of homophobia and violence in his role in charge of his countrys prisons. And the seven candidates for the seven vacant positions on World Rugbys powerful executive committee are all men.

So would it be fair to describe Beaumont as male, stale and pale? While the outwardly avuncular Lancastrian presided over last years hugely well-received mens World Cup in Japan, the decision to take it there was made back in 2009. And it was a previous World Rugby chairman, Bernard Lapasset, who did most to achieve the sports return to the Olympic Games. Similarly, the welcome surge in the womens game in recent years is only partly Beaumonts baby.

He can point to much-needed medical and injury initiatives, and he is promising a central voice for players but everyone says that, always. On the eternal question of who pays for what, Beaumont would advocate growing the overall pie more than taking a slice out of the Six Nations.

Beaumont also has a running mate, Bernard Laporte, the chairman of the French Rugby Union, whose country is hosting the next mens World Cup in 2023, having unexpectedly won the rights ahead of South Africa. And here is political murk: when you ask Council members if Laporte will work under Pichot if Beaumont loses, some say yes while others expect the Frenchman to step aside.

Agustin Pichot, 45

To those of us who remember meeting Pichot when he was a newly-capped scrum-half in Buenos Aires in 1997, the Argentinian has hardly changed the flowing black hair has shortened a little, but he remains a fast-talking polyglot who wears white trainers to black-tie dinners and answers a question about promotion and relegation in the Six Nations with a plea for the world to engage with his philosophy.

As World Rugbys Americas North rep Dennis Dwyer told this newspaper last week, Gus Pichot wants change now, if not sooner, and this election is a battle of personalities as much as it is of two broadly similar manifestoes.

Pichot is more aggressively progressive than Beaumont, and if it means speaking out against a policy he helped agree as World Rugbys vice-chairman, he will do it. His modus operandi can be unsettling. One Council member told i that half of World Rugbys staff would walk out if the 71-times capped Puma becomes top dog.

Both Pichot and Bill Beaumont say World Rugbys finances are not transparent enough. Where Pichot would differ is how the cash is doled out.

He is a businessman who has apparently softened on the idea of private equity taking a stake in rugby and, as long as everyone gains, he will put more pressure on the rich to help the poor. And as i understands that the regional federation of Africa, for instance, receives around 2 million a year in central surpluses compared with 7m for England, the scale of the challenge is clear.

Pichot has played all his rugby in the open era, for clubs in France and England, and in an Argentina team who turned over the French and the English in their back yards. He then helped persuade club owners in France to release Argentina players for the Rugby Championship, and he says he will reach out to the owners in England too.

Pichot does not fancy a world in which international rugby is second-best, and he was frustrated when a new Nations Championship to create an annual global Test competition stalled last year. He feels Beaumont should have pushed harder for it. Yet Pichot is more rigid on the question players representing one country and sticking to it.

Whichever of them is chair faces the thorny task of pulling a bunch of conflicting interests in the same direction: the Six Nations, the Rugby Championship, the Lions and the big club leagues in England, France and Japan.

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Battle for the control of rugby union: How World Rugby's chairman vote could change the face of the game - iNews

Selena Gomez is on the cover of the new issue of Interview magazine, and in an interview with Amy Schumer, which is published on Monday (13 may), the singer talked about his career, his purpose in life and trying to change the image that the media has created about her by being more open about his personal life.

You cant cough without the turn to news, it was given to the player at the beginning of the chat. The sad thing is, I dont recall a time when that was not so. The one that keeps me well, I know that eventually its going to be with the other person, and I dont mean this in a negative wayreassured her by explaining that, in spite of the hand is difficult, the exposure has also brought benefits.

At times it has been bad for my career, but it was, like, now I can talk to about things like my depression, my anxiety, the things which I have passed, and Im totally open to it, because, I believe, in the search for help. On top of that, the one that keeps me down-to-earth it is that I do my best to keep this from happening. Its not like I want to live my life.said the singer.

Selena explained that it was a fake image of her created by the media, which lead her to be more open about his personal life. My intention was never to turn into a tabloid. Then, when all the things in the middle, which took place in this way, it was out of control. And then I was like, For none of this is realrecalled to the star.

The way the media tried to explain some of the things that sometimes made them sound like they really, really, bad, when, in fact, there is nothing wrong with the fact that I had to tear myself away and I fell in love with. I had to get myself to open it because people were taking my story to me, and it was killing me. Im so new, Im going to continue to change, and no one has the right to tell me how my life is goingsaid she, decisively. Which is most certain, is it?

In spite of the difficult times through which it passed, in a relationship, and ending a very public, such as Justin Bieber, with a kidney transplant, Service has ensured that people do not need to worry about it. For the sake of those moments, like I have, or is not, a picture has been painted of my life. It was scary because I didnt want to [minha vida pessoal] to interfere with my career, vented.

Out-of-control that I had when I was younger. I think I showed people that I was weak at times, and I had no problems. Some people would make the best building, the people, and then trying to lower them.he lamented to herself, giving more details of what I wanted to say to you. People care about me, because Ive had problems in the past. And it is a kind gesture. But Ill be all right. I have read that I have to deal with, and I feel like Im having a bad week, or if you dont want to do something about it, I didnt do., he said.

In the end, Selena replied, if he believed that his calling in life was to help other people. I dont know if it was supposed to be my job, but I love the people. I care about you very much. I have been through many medical issues and I know that I can reach out to people who are going through things that are equally scary, whether it is an organ transplant, or to dialysis, or you have to take time off for treatmentyou described her.

A big part of the reason why I have to have a platform to help others. It is for this reason that I think that Im okay with the size. I mean, Im not really okay with it, but Im going to say yes, because its worth it. I know what Im doing, someone, somewhere, feel better, or to feel understood and heard, and its well worth it to me he told her. Super cute!

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Selena Gomez remembers when the media coverage of his life is 'out of control': 'Nothing is true' - Matzav Review

For Immediate Release: April 24, 2020

Today, the U.S. Food and Drug Administration issued a letter to Bayer outlining conditions for submitting additional postmarket information to the agency about Essurea permanent birth control device Bayer sold in the U.S. until 2018. The letter applies to reportable adverse events Bayer is or becomes aware of from social media information received in relation to ongoing litigation regarding Essure.

Because of the anticipated volume and nature of this information, the FDA granted Bayers request for a variance from some medical device reporting requirements but imposed conditions for reporting to ensure protection of the public health. Under the conditions, Bayer is required to start providing reportable adverse events to the FDA in July 2020 and continue submitting additional reportable events identified through review of the information on a monthly basis. The FDA will make these events publicly available on its Problems Reported with Essure webpage. The conditions the FDA developed for this particular variance also require Bayer to submit summaries of the reportable events that include information such as the type of event (death, serious injury or malfunction), a description of the reported patient events or device problems, and patient demographics. These summaries will be accessible through the FDAs Manufacturer and User Facility Device Experience (MAUDE) database. The FDA continues to require that Bayer submit Essure-associated reportable events, outside of the events specifically covered in this variance, in accordance with current medical device reporting requirements.

This variance will expire after one year, unless the FDA grants an extension, at which time, Bayer will be required to follow the regular adverse event reporting requirements for all Essure-associated reportable events.

Even though the device is no longer being manufactured or distributed, and hasnt for some time, the FDA continues its engagement with Bayer on postmarket safety monitoring of Essure, said Terri L. Cornelison, M.D., Ph.D., director of the FDAs Health of Women Program in the Center for Devices and Radiological Health. Bayer alerted us to the social media information it received in connection with litigation. We are committed to ensuring that all reportable adverse events identified from this information are submitted to the agency and that they are made publicly available.

In addition to providing summary information that will be available in MAUDE, Bayer is required to provide quarterly and final analysis reports evaluating the events reported under the variance and how the information compares to other medical device reports (MDRs) for Essure. Bayer will make each analysis report publicly available.

Today, the FDA is also updating the Problems Reported with Essure web page to include updated information on the MDRs the agency has received on the device since its approval. This update includes MDRs received in 2019. While the number of MDRs received in 2019 is the largest received for a single year, due to the continued volume of reports citing litigation and using terms related to device removal, the source and nature of the reports are consistent with recent years.

In addition, Bayer has reported to the agency that all unused Essure devices of which Bayer is aware have been returned to the company, and there should be no devices available for implantation in the U.S. Bayer voluntarily stopped selling and distributing Essure in the U.S. on December 31, 2018. In 2019, the agency reminded health care professionals and facilities to return unused Essure devices to Bayer by the end of that year.

Bayer has also submitted the most recent postmarket (522) study report for Essure to the FDA. The FDA will post the interim study results once its review of the data is completed. The FDA believes clinical data from the study will help patients, health care providers and the agency to better understand certain complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. Findings from the study may serve to inform future FDA actions.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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04/24/2020

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FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure - FDA.gov