Month: June 2021

Facebook’s recent decision to ban former president Donald Trump for two years sends a message to world leaders that Facebook is stepping up its role as sheriff on its service. Tina Trinh reports.Produced by Tina Trinh
…

The Senate overwhelmingly approved a bill Tuesday that aims to boost U.S. semiconductor production and the development of artificial intelligence and other technology in the face of growing international competition, most notably from China. The 68-32 vote for the bill demonstrates how confronting China economically is an issue that unites both parties in Congress. That’s a rarity in an era of division as pressure grows on Democrats to change Senate rules to push past Republican opposition and gridlock. The centerpiece of the bill is a $50 billion emergency allotment to the Commerce Department to stand up semiconductor development and manufacturing through research and incentive programs previously authorized by Congress. The bill’s overall cost would increase spending by about $250 billion with most of the spending occurring in the first five years. Supporters described it as the biggest investment in scientific research that the country has seen in decades. It comes as the nation’s share of semiconductor manufacturing globally has steadily eroded from 37% in 1990 to about 12% now, and as a chip shortage has exposed vulnerabilities in the U.S. supply chain. FILE – Senate Majority Leader Chuck Schumer, D-N.Y., speaks at the Capitol in Washington, March 6, 2021.”The premise is simple — if we want American workers and American companies to keep leading the world, the federal government must invest in science, basic research and innovation, just as we did decades after the Second World War,” said Senate Majority Leader Chuck Schumer.”Whoever wins the race to the technologies of the future is going to be the global economic leader, with profound consequences for foreign policy and national security, as well,” he added. FILE – U.S. Senate Minority Leader Mitch McConnell speaks during a news conference on Capitol Hill in Washington, May 25, 2021.Senate Minority Leader Mitch McConnell said the bill was incomplete because it did not incorporate more Republican-sponsored amendments. He nonetheless supported it. “Needless to say, final passage of this legislation cannot be the Senate’s final word on our competition with China,” he said. “It certainly won’t be mine.” President Joe Biden applauded the bill’s passage in a statement Tuesday evening, saying, “As other countries continue to invest in their own research and development, we cannot risk falling behind. America must maintain its position as the most innovative and productive nation on Earth.”  Senators slogged through days of debates and amendments leading up to Tuesday’s final vote. Schumer’s office said 18 Republican amendments will have received votes as part of passage of the bill. It also said the Senate this year has already held as many roll-call votes on amendments than it did in the last Congress when the Senate was under Republican control. While the bill enjoys bipartisan support, a core group of Republican senators has reservations about its costs. One of the bill’s provisions would create a new directorate focused on artificial intelligence and quantum science with the National Science Foundation. The bill would authorize up to $29 billion over five years for the new branch within the foundation, with an additional $52 billion for its programs. Senator Rand Paul said Congress should be cutting the foundation’s budget, not increasing it. He called the agency “the king of wasteful spending.” The agency finances about a quarter of all federally supported research conducted by America’s colleges and universities. “The bill is nothing more than a big government response that will make our country weaker, not stronger,” Paul said. FILE – Sen. Maria Cantwell, D-Wash., speaks on Capitol Hill in Washington, Feb. 5, 2020.But Senator Maria Cantwell noted that a greater federal investment in the physical sciences had been called for during the administration of President George W. Bush to ensure U.S. economic competitiveness. “At the time, I’m pretty sure we thought we were in a track meet where our competitor was, oh, I don’t know, maybe half a lap behind us. I’m pretty sure now as the decade has moved on, we’re looking over our shoulder and realizing that the competition is gaining,” said Cantwell, chair of the Senate Commerce, Science and Transportation Committee. The lead Republican on the committee also weighed in to support the bill. “This is an opportunity for the United States to strike a blow on behalf of answering the unfair competition that we are seeing from communist China,” Senator Roger Wicker said. Senators have tried to strike a balance when calling attention to China’s growing influence. They want to avoid fanning divisive anti-Asian rhetoric when hate crimes against Asian Americans have spiked during the coronavirus pandemic. Other measures spell out national security concerns and target money-laundering schemes or cyberattacks by entities on behalf of the Chinese government. There are also “Buy America” provisions for infrastructure projects in the U.S.  Senators added provisions that reflect shifting attitudes toward China’s handling of the COVID-19 outbreak. One would prevent federal money for the Wuhan Institute of Virology as fresh investigations proceed into the origins of the virus and possible connections to the lab’s research. The city registered some of the first coronavirus cases. It’s unclear whether the measure will find support in the Democratic-led House, where the Science Committee is expected to soon consider that chamber’s version. Congressman Ro Khanna, who has been working with Schumer for two years on legislation that’s included in the bill, called it the biggest investment in science and technology since the Apollo space flight program a half century ago. “I’m quite certain we will get a really good product on the president’s desk,” Schumer said. Biden said he looked forward to working with the House on the legislation, “and I look forward to signing it into law as soon as possible.” 
 
…

The head of UNAIDS said Tuesday that inequalities are a chief driver of the HIV/AIDS epidemic, just as they are with COVID-19. “Inequalities in power, status, rights and voice are driving the HIV pandemic,” said Winnie Byanyima, executive director of UNAIDS. “Inequalities kill.” Since the first cases were reported 40 years ago, UNAIDS says 77.5 million people have been infected with HIV, and nearly 35 million have died from AIDS. Byanyima told a high-level meeting of the U.N. General Assembly that nations must end the inequalities that perpetuate HIV/AIDS if they want to meet their target of ending the epidemic by 2030. “Today we are setting bold, ambitious goals to reach 95% of those in need with HIV treatment and prevention,” she said. “To get there we need to re-imagine HIV services, making them easy to access and designed around people’s lives.” Byanyima said the COVID-19 pandemic has shown how political will can help push science and that the same sort of push needs to be made for HIV/AIDS treatments, prevention, care and vaccines. FILE – Charlize Theron attends a movie screening in Los Angeles, California, July 31, 2020.U.N. Messenger of Peace Charlize Theron addressed the meeting in a video message Tuesday. The South African actress said it is often the most vulnerable people who are the least likely to have access to the services they need. “Because the fact remains, that whether you live or die from AIDS is still too often determined by who you are, who you love and where you live,” Theron said. U.N. member states adopted a political declaration on scaling up progress in order to reach the 2030 goal, but it was not without some controversy. Just before the adoption, Russia’s representative tried to get the assembly to agree to three amendments, which would have eliminated language on respecting the human rights of persons living with HIV/AIDS and ending discriminatory and restrictive laws based on a person’s HIV status. The amendments were overwhelmingly voted down, and the original draft text, which was the result of lengthy negotiations and compromises among member states, was adopted with 165 votes in favor, four against and no country abstaining. Belarus, Nicaragua and Syria joined Russia in voting against the declaration.  
 
…

The top executive for the biggest fuel pipeline operator in the United States told lawmakers he felt like he had no choice but to pay off hackers after a ransomware attack shut down operations along the East Coast. Testifying Tuesday before the Senate Homeland Security and Governmental Affairs Committee, Colonial Pipeline Chief Executive Joseph Blount took responsibility for agreeing to pay the Russian-based DarkSide Network approximately $5 million to minimize potentially disastrous delays to fuel delivery. “I know how critical our pipeline is to the country, and I put the interests of the country first,” Blount said. “It was the hardest decision I’ve made in my 39 years in the energy industry,” he added. “We wanted to stay focused on getting the pipeline back up and running. I believe with all my heart it was the right choice to make.” The May 7 DarkSide ransomware attack on Colonial Pipeline spawned fuel shortages and panic-buying across parts of the U.S., pushing prices higher as drivers hunted for gas stations that had not run out of fuel. FILE – A man with a gas container greets a motorist waiting in a lengthy line to enter a gasoline station during a surge in the demand for fuel following the cyberattack that crippled the Colonial Pipeline, in Durham, North Carolina, May 12, 2021.U.S. law enforcement, including cyber experts at the Federal Bureau of Investigation (FBI), routinely warn companies against paying ransoms to hackers. But Blount said that even though the company was in contact with the FBI, he felt paying DarkSide was the most prudent option. “It was our understanding that the decision was solely ours as a private company,” he told lawmakers. “Considering the consequences of potentially not bringing the pipeline back on as quickly as I possibly could, I chose the ransom.” Blount said Colonial did not deal with DarkSide directly and instead hired legal experts and negotiators to act as intermediaries. The payment was delivered May 8 to the ransomware network in the form of the bitcoin cryptocurrency.  In return, DarkSide provided Colonial with a decryption key that helped the company regain access to its systems and eventually resume operations, Blount said, noting that some systems are just now coming back online. Blount’s testimony comes just a day after the U.S. Justice Department and the FBI announced that they managed to track the ransom and recover the majority of the bitcoin, which was valued at about $2.3 million.  FILE – A Colonial Pipeline station is seen in Smyrna, Ga., near Atlanta, May 11, 2021.Other experts worry that companies, organizations and governments, like Colonial Pipeline, are putting themselves at a disadvantage. “With ransomware, the misconception is that there’s two options: pay criminals or don’t pay criminals,” said Raj Samani, co-founder of No More Ransom, an organization that distributes decryption keys for free. “Many of the decryptors that are developed by the ransomware groups are actually rubbish,” said Samani, who is also the chief scientist at McAfee, a U.S.-based cybersecurity company. “So, even if you pay a fee, you may not get your data back.” In the case of the Colonial Pipeline ransomware attack, the decryption key did allow the company to start getting some systems up and running.   “It’s not a perfect tool,” Blount told lawmakers Tuesday, adding that the company is working to further harden its cyber defenses. Blount said DarkSide was able to access Colonial’s systems by exploiting a virtual private network (VPN) that was no longer in use and which was protected only by a single password. CISA recommends using what is known as multifactor authentication, which requires users use a password and then complete a second step, such as replying to a text message, in order to access critical systems. 
 
…

The World Meteorological Organization, the United Nations climate agency, reported Tuesday that Europe saw its coldest March through May since 2013, with temperatures 0.45 C below the 1991-2020 average.During a briefing from the agency’s headquarters in Geneva, Switzerland, WMO spokesperson Clare Nullis cautioned that Europe’s cool start did not reflect any pause in the world’s climate change problems.In fact, data from the European Union’s Copernicus Climate Change Service show that the global average temperature for May was 0.26 C higher than the 1991-2020 mean, according to the U.N. News website.  Greenhouse Gases Threaten Ocean Ecosystems: WMOThe ocean absorbs around 23 percent of the annual atmospheric emissions of carbon dioxide and acts as a buffer against climate changeAlso according to U.N. News: “Temperatures were well above average over western Greenland, north Africa, the Middle East and northern and western Russia while below-average May temperatures were reported over the southern and central United States, parts of northern Canada, south-central Africa, most of India, eastern Russia, and eastern Antarctica.”  Nullis said there was also “quite a considerable rise” in carbon dioxide (CO2) in the atmosphere at the Mauna Loa Observatory, an atmospheric monitoring station operated by the U.S. National Oceanic and Atmospheric Association in Hawaii.She said, “The fact CO2 does have such a long lifetime in the atmosphere does mean that future generations — and we’re not just talking about one or two, we’re talking about many generations — will be committed to seeing more impacts of climate change.”  Nullis warned rising CO2 levels will also have a “very serious impact” on the planet’s oceans, which absorb almost a quarter of CO2 emissions. 
…

Pfizer says it will expand testing of its COVID-19 vaccine to children younger than 12.  The drug company, along with its German partner BioNTech, will enroll 4,500 children volunteers at more than 90 places in the U.S., Finland, Poland and Spain.  The children, ages 5 to 11, will be given two doses of 10 micrograms each, which is about a third of the dose used on teens and adults. Some will receive placebo shots.  Testing on infants as young as 6 months will start within weeks. They will receive 3-microgram doses. The Pfizer-BioNTech vaccine already has been given authorization for emergency use for those 12 and older in the U.S. and Europe. 
 
…

A number of major websites could not be reached early Tuesday following an outage at the cloud services company Fastly.The affected sites included news agencies CNN, the Guardian and the New York Times, streaming platform Twitch, and the U.K. government’s website.All were back online within a period of hours.Fastly said it identified an issue and that “and a fix is being implemented.”The company earlier said it was “investigating potential impact to performance with our CDN services.”
…

Apple on Monday said a new “private relay” feature designed to obscure a user’s web browsing behavior from internet service providers and advertisers will not be available in China for regulatory reasons.The feature was one of a number of privacy protections Apple announced at its annual software developer conference Monday.It will also be unavailable in Belarus, Colombia, Egypt, Kazakhstan, Saudi Arabia, South Africa, Turkmenistan, Uganda and the Philippines, Apple said.The “private relay” feature first sends web traffic to a server maintained by Apple, where it is stripped of its IP address. From there, Apple sends the traffic to a second server maintained by a third-party operator who assigns the user a temporary IP address and sends the traffic onward to its destination website.The use of an outside party in the second hop of the relay system is intentional, Apple said, to prevent even Apple from knowing both the user’s identity and what website the user is visiting.Apple has not yet disclosed which outside partners it will use in the system but said it plans to disclose them in the future. The feature will not likely become available to the public until later this year. 
…

The annual peak of global heat-trapping carbon dioxide in the air has reached another dangerous milestone: 50% higher than when the industrial age began.And the average rate of increase is faster than ever, scientists reported Monday.The National Oceanic and Atmospheric Administration said the average carbon dioxide level for May was 419.13 parts per million. That’s 1.82 parts per million higher than May 2020 and 50% higher than the stable pre-industrial levels of 280 parts per million, said NOAA climate scientist Pieter Tans.Carbon dioxide levels peak every May just before plant life in the Northern Hemisphere blossoms, sucking some of that carbon out of the atmosphere and into flowers, leaves, seeds and stems. The reprieve is temporary, though, because emissions of carbon dioxide from burning coal, oil and natural gas for transportation and electricity far exceed what plants can take in, pushing greenhouse gas levels to new records every year.”Reaching 50% higher carbon dioxide than preindustrial is really setting a new benchmark, and not in a good way,” said Cornell University climate scientist Natalie Mahowald, who wasn’t part of the research. “If we want to avoid the worst consequences of climate change, we need to work much harder to cut carbon dioxide emissions and right away.”Climate change does more than increase temperatures. It makes extreme weather — storms, wildfires, floods and droughts — worse and more frequent, and causes oceans to rise and get more acidic, studies show. There are also health effects, including heat deaths and increased pollen. In 2015, countries signed the Paris agreement to try to keep climate change to below what’s considered dangerous levels.The one-year jump in carbon dioxide was not a record, mainly because of a La Nina weather pattern, when parts of the Pacific temporarily cool, said Ralph Keeling, Scripps Institution of Oceanography geochemist. Keeling’s father started the monitoring of carbon dioxide on top of the Hawaiian mountain Mauna Loa in 1958, and he has continued the work of charting the now famous Keeling Curve.Scripps, which calculates the numbers slightly differently based on time and averaging, said the peak in May was 418.9.Also, pandemic lockdowns slowed transportation, travel and other activity by about 7%, earlier studies show. But that was too small to make a significant difference. Carbon dioxide can stay in the air for 1,000 years or more, so year-to-year changes in emissions don’t register much.The 10-year average rate of increase also set a record, now up to 2.4 parts per million per year.”Carbon dioxide going up in a few decades like that is extremely unusual,” Tans said. “For example, when the Earth climbed out of the last ice age, carbon dioxide increased by about 80 parts per million, and it took the Earth system, the natural system, 6,000 years. We have a much larger increase in the last few decades.”By comparison, it has taken only 42 years, from 1979 to 2021, to increase carbon dioxide by that same amount.”The world is approaching the point where exceeding the Paris targets and entering a climate danger zone becomes almost inevitable,” said Princeton University climate scientist Michael Oppenheimer, who wasn’t part of the research.
…

U.S. law enforcement officials say they have hit back at the Russian-based criminal network that caused gas pipelines to shut down across parts of the country last month, seizing much of the multimillion-dollar ransom payment before it could be used.The Justice Department announced Monday it recovered $2.3 million of the approximately $5 million Colonial Pipeline paid to the DarkSide Network following the ransomware attack, which resulted in fuel shortages along the U.S. East Coast.“We turned the tables on DarkSide,” said Deputy Attorney General Lisa Monaco, describing the seizure as a “significant development.”“Ransomware attacks are always unacceptable, but when they target critical infrastructure, we will spare no effort in our response,” she added.Tanker trucks are parked near the entrance of Colonial Pipeline Company, May 12, 2021, in Charlotte, N.C.Colonial Pipeline, the target of DarkSide’s May 7 attack, is the top fuel pipeline operator in the U.S., responsible for about half of the fuel supply for the East Coast.Following the attack, the company made the decision to meet DarkSide’s demands, paying out about $5 million in Bitcoin cryptocurrency. But U.S. government officials said Colonial also worked closely with law enforcement agencies, who were able to track the payment to a virtual wallet.Specifically, officials said they were able to obtain a virtual key that unlocked the contents of the wallet.As a result, the Justice Department said it was able to recover about 80% of the cryptocurrency, which has dropped in value in recent weeks, before DarkSide could access it.“We deprived a cybercriminal enterprise of the object of their activity,” said FBI Deputy Director Paul Abbate. “For financially motivated cybercriminals, especially those presumably located overseas, cutting off access to revenue is one of the most impactful consequences we can impose.”Officials said this is not the first time they have been able to recover ransom payment made to groups like DarkSide, and encouraged other companies to cooperate with the government if they are targeted.“The message we are sending today is that if you come forward and work with law enforcement, we may be able to take the type of action that we took today to deprive the criminal actors of what they’re going after,” Monaco said.But she added that this type of operation is a “significant undertaking” and “we cannot guarantee, and we may not be able to do this, in every instance.”The FBI has been investigating DarkSide since last October, blaming the network for attacks against 90 victims across critical sectors such as manufacturing, health care and energy.DarkSide and its affiliates have also been connected to ransomware attacks in at least 14 other countries. Last month, The Wall Street Journal reported the group made almost $60 million in seven months, including $46 million in the first three months of this year.In a statement late Monday, Colonial Pipeline President Joseph Blount said the company was grateful for the help from both the Justice Department and the FBI, calling them “instrumental in helping us to understand the threat actor and their tactics.”“Holding cyber criminals accountable and disrupting the ecosystem that allows them to operate is the best way to deter and defend against future attacks of this nature,” Blount added. “As our investigation into this event continues, Colonial will continue its transparency in sharing intelligence and learnings with the FBI and other federal agencies.”The Justice Department announcement also earned praise from some private cybersecurity firms, with one calling the seizure of the ransom payment a “welcome development.”“In addition to the immediate benefits of this approach, a stronger focus on disruption may disincentivize this behavior, which is growing in a vicious cycle,” John Hultquist, vice president of analysis at Mandiant, said in a statement. “Law enforcement agencies need to broaden their approach beyond building cases against criminals who may be beyond the grasp of the law.”U.S. President Joe Biden is expected to raise the issue of the DarkSide ransomware attack when he meets with Russian President Vladimir Putin in Geneva, Switzerland, next week.Biden has previously said Moscow bears “some responsibility” to deal with the attack.“The president’s message will be that responsible states do not harbor ransomware criminals, and responsible countries take decisive action against these ransomware networks,” White House press secretary Jen Psaki told reporters last week.National Security Adviser Jake Sullivan said Monday that Biden will also use meetings next week with G-7 leaders to discuss “increasing the robustness and resilience of our defense against ransomware attacks.”Sullivan said the U.S. also hopes to discuss ways to better share information about ransomware attacks.Information from Reuters was used in this report.
…

The U.S. Ambassador to the United Nations met Monday with the head of the U.N. Population Fund in the first such high-level engagement in more than four years.The U.S. Mission to the United Nations said Ambassador Linda Thomas-Greenfield highlighted the resumption of extensive support to the organization, which provides life-saving health care to millions of women and girls around the world.“I’m delighted to announce the resumption of U.S. humanitarian funding for UNFPA, including support for the Rohingya refugee crisis, Afghanistan, Sudan and those fleeing the Tigray region,” Thomas-Greenfield tweeted after the meeting. To mark our renewed commitment to @UNFPA, I met today with Executive Director Natalia Kanem. I’m delighted to announce the resumption of U.S. humanitarian funding for UNFPA, including support for the Rohingya refugee crisis, Afghanistan, Sudan and those fleeing the Tigray region. pic.twitter.com/aMJ9cAbgpL— Ambassador Linda Thomas-Greenfield (@USAmbUN) June 7, 2021In April 2017, the Trump administration withdrew funding to UNFPA, saying it “supports or participates in the management of a program of coercive abortion or involuntary sterilization” in China. For decades, China had a “one-child policy” for couples, which it revised in 2016 to a “two-child policy.” The country had been accused of using forced sterilization and abortions to enforce the restrictions. Last week, it relaxed the policy further, saying it would allow families to have up to three children, due to decreasing birth rates.The United Nations rejected the Trump administration’s accusation, but that did not persuade Washington to restore the nearly $76 million the U.S. contributed to the agency’s core operating budget. It was also the beginning of what many Western diplomats and activists said was the former Republican administration’s war on women’s health and reproductive rights at the United Nations.Since taking office in January, the Biden administration has offered the agency nearly $31 million toward its core operating budget. Washington has also resumed funding UNFPA’s humanitarian activities, including $2.6 million for the Rohingya refugee crisis and nearly $1.2 million for Ethiopian refugees in Sudan fleeing the conflict in the Tigray Region. The U.S. is also contributing nearly $1.5 million for international protection issues in Afghanistan and $1.3 million to assist Sudan in improving the response to gender-based violence for internally displaced persons and vulnerable communities.In 2015, UNFPA received $979 million in total contributions for its work in more than 150 countries. The United States provided nearly $76 million to the fund’s core budget and specific programs and initiatives, making it one of the top international donors. 
…

In a nationwide address Monday, Indian Prime Minister Narendra Modi said the federal government would take a larger role in obtaining vaccines for Indian states.“Government of India itself will buy 75% of the total vaccine production from vaccine manufacturers and give it free to the state governments.”FILE PHOTO: India’s Prime Minister Narendra Modi addresses a gathering in Ahmedabad, India, March 12, 2021.According to the New York Times, less than 4% of Indians have been fully vaccinated.India’s health ministry on Monday reported 100,636 new COVID-19 infections, the lowest tally in 61 days, and 2,427 deaths in the previous 24-hour period.In other COVID-19 news, Britain’s health minister Matt Hancock said Sunday the delta variant of the coronavirus, first identified in India, may be up to 40% more transmissible than the alpha variant.The delta variant has become the dominant strain in Britain, replacing the alpha variant first identified in Kent, Hancock told reporters. It is possible the delta variant could threaten plans to lift lockdown restrictions by June 21, he said.Hancock stressed the importance of Britons getting their vaccinations. Early data show the vaccine is effective against the delta variant after people have received both doses, he said.People queue outside a vaccination center for those aged over 18 years old at the Belmont Health Center in Harrow, amid the coronavirus outbreak, in London, June 6, 2021.Currently, 40% of the United Kingdom’s population has been fully vaccinated, according to the Johns Hopkins Coronavirus Resource Center. New cases of COVID-19, the disease caused by the coronavirus, have dropped dramatically since the United Kingdom began its vaccination campaign.Uganda began a 42-day pandemic lockdown Monday, including the closing of schools and universities, and suspended public gatherings, including in churches and mosques.Public transportation will be suspended starting Thursday.The country has seen an uptick in cases in recent weeks, and officials say the current wave is impacting people 20 to 39 years of age.The global count of COVID-19 cases reached 173.4 million Monday, according to the Johns Hopkins Coronavirus Resource Center.
…

Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.The Food and Drug Administration said it approved the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer’s patients.  It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.The decision, which could impact millions of Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks.Dr. Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision.”The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a medical researcher at Johns Hopkins University.The FDA’s top drug regulator acknowledged that “residual uncertainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain is expected to help slow dementia.”The data supports patients and caregivers having the choice to use this drug,” Dr. Patrizia Cavazzoni told reporters. She said FDA carefully weighed the needs of people living with the “devastating, debilitating and deadly disease.”Under terms of the so-called accelerated approval, the FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.Biogen said the drug would cost about $56,000 for a typical year’s worth of treatment, and said the price would not be raised for four years. Most patients won’t pay anywhere near that amount thanks to insurance coverage and other discounts. The company said it aims to complete its follow-up trial of the drug by 2030.The nonprofit Institute for Clinical and Economic Review said that “any price is too high” if the drug’s benefit isn’t confirmed in follow-up studies. About 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks. In the final stages of the disease, those afflicted lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s.Aducanumab helps clear a protein called beta-amyloid from the brain. Other experimental drugs have done that before but they made no difference in patients’ ability to think, care for themselves or live independently.The pharmaceutical industry’s drug pipeline has been littered for years with failed Alzheimer’s treatments. The FDA’s greenlight Monday is likely to revive investments in therapies previously shelved by drugmakers.The new medicine is manufactured from living cells and will be given via infusion at a doctor’s office or hospital.Researchers don’t fully understand what causes Alzheimer’s but there’s broad agreement the brain plaque targeted by aducanumab is just one contributor. Evidence suggests family history, education and chronic conditions like diabetes and heart disease may all play a role.”This is a sign of hope but not the final answer,” said Dr. Richard Hodes, director of the National Institute on Aging, which wasn’t involved in the Biogen studies but funds research into how Alzheimer’s forms. “Amyloid is important but not the only contributing factor.”Patients taking aducanumab saw their thinking skills decline 22% more slowly than patients taking a placebo.But that meant a difference of just 0.39 on an 18-point score of cognitive and functional ability. And it’s unclear how such metrics translate into practical benefits, like greater independence or ability to recall important details.The FDA’s review of the drug has become a flashpoint in longstanding debates over standards used to evaluate therapies for hard-to-treat conditions. On one side, groups representing Alzheimer’s patients and their families say any new therapy — even one of small benefit — warrants approval. But many experts warn that greenlighting the drug could set a dangerous precedent, opening the door to treatments of questionable benefit.The approval came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. The group voted “no” to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed the drug was effective.Biogen halted two studies in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer’s patients.Several months later, the company reversed course, announcing that a new analysis of one of the studies showed the drug was effective at higher doses and the FDA had advised that it warranted review. Company scientists said the drug’s initial failure was the result of some patients not receiving high enough doses to slow the disease.But the changes to dosing and the company’s after-the-fact analysis made the results hard to interpret, raising skepticism among many experts, including those on the FDA panel.The FDA isn’t required to follow the advice of its outside panelists and has previously disregarded their input when making similarly high-profile drug decisions.About 600 U.S. medical specialists already prescribe the drug through Biogen’s studies and many more are expected to begin offering it. Many practical questions remain unanswered: How long do patients benefit? How do physicians determine when to discontinue the drug? Does the drug have any benefit in patients with more advanced dementia?With FDA approval, aducanumab is certain to be covered by virtually all insurers, including Medicare, the government plan for seniors that covers more than 60 million people.Even qualifying for the drug could be expensive. It’s only been tested in people with mild dementia from Alzheimer’s or a less severe condition called mild cognitive impairment. To verify a diagnosis could require brain scans that cost $5,000 or more. Insurers, including Medicare, don’t cover the scans because their benefits are unclear, but that could change if the scans become a gateway to treatment.Additional scans will be needed to monitor potential side effects. The drug carries a warning about temporary brain swelling that can sometimes cause headaches, confusion and dizziness. Other side effects included allergic reactions, diarrhea and disorientation. 
…

Health professionals continue to see heart disease in some young people who have had COVID-19, those who have been vaccinated against the virus, and among student athletes, in general.Cardiomyopathy is an inflammation and weakening in the walls of the heart.  The Centers for Disease Control and Prevention (CDC) in Atlanta has reviewed vaccine safety data weekly since the start of the U.S. vaccination program and cautions that cases among those who have received the COVID-19 vaccine are “mild and few.” The agency says the condition appears in males more than females, more often following the second shot in a two-dose regimen, and usually around four days after the vaccination.Coronavirus-related cardiomyopathy was first observed last year in younger people when college athletes resumed play as the pandemic spread in the United States. College sport events generate significant revenues for colleges and universities, and some big schools that draw thousands into stadiums returned players to campus with the hope of public events resuming sooner than later.In a study of college athletes conducted since last September, a higher incidence of cardiomyopathy, also called myocarditis, has been seen in athletes who contracted the coronavirus, or SARS-CoV-2. Symptoms include shortness of breath, weakness, tiredness, dizziness and abnormal heart rhythm, according to the Mayo Clinic in Minnesota.   “Myocarditis is a leading cause of sudden death in competitive athletes,” researchers wrote in JAMA Cardiology in May, adding, “Myocardial inflammation is known to occur with SARS-CoV-2,” the medical name for the coronavirus. Another study published in the Journal of the American College of Cardiology in March found that more than one in three “previously healthy college athletes recovering from COVID-19 infection showed … resolving pericardial inflammation.”Resolving is the key word here: Researchers concluded that “no athlete showed … features to suggest an ongoing myocarditis,” or inflammation of the heart walls. Knowing when athletes should play or rest is important, and research has not nailed down the long-term effects yet, the researchers said.“Further studies are needed to understand the clinical implications and long-term evolution of these abnormalities in uncomplicated COVID-19,” they wrote.  Pediatric cardiologist Geoffrey Rosenthal has observed myocarditis in young people, specifically during the pandemic. He has been the team cardiologist for the University of Maryland, College Park since 2020.  “Myocarditis is one of the more common causes of sudden death in athletes,” said Rosenthal.  “If someone had myocarditis, it’s one of the standard recommendations that they not exercise strenuously for three to six months after their diagnosis to allow time for their heart to heal, and lessen their risk of a sudden event,” he said.  The residual health of athletes who have had COVID is being assessed to try to understand the risks.  Ohio State University (OSU) was one of the big universities that brought players back to campus amid the pandemic and detected heart changes in athletes who tested positive for the infection.It has led the effort to monitor athletes by overseeing a registry of nearly 1,600 COVID-19 positive athletes in the Big Ten sports conference, or a division of 14 colleges and universities among other divisions nationally.  Looking at a smaller sample of 37 athletes diagnosed with myocarditis, 28 didn’t exhibit symptoms, reported OSU.Rosenthal noted that research and cooperation among universities has advanced detection of myocarditis among young people and student athletes, who are largely asymptomatic, by using magnetic resonance imaging (MRI). The University of Maryland adopted cardiac MRI screening for athletes before almost all other universities in the country as the pandemic was starting, he said.“The EKG is normal, and their blood tests are normal, and their echo [cardiogram] is OK,” Rosenthal explained. “And then we get the MRI and find out that there’s an abnormality that we weren’t expecting, and that we never would have found out about had we not done the MRI.“There’s still a lot of cardiac work that’s going on in the younger student population,” Rosenthal said.  And this advancement in detection will help other athletes, younger and older.  “There’s also hope that it will inform our understanding of COVID in older athletes, in older and non-elite athletes. … the weekend warriors,” he said.But this research will also help non-athletes whose jobs demand physical labor.  “Other populations that these results might help inform is the military and other professions and occupations in which physical activity is part of what people are doing,” Rosenthal said.  “First responders, firefighters, policemen, you know, other people whose jobs have physical demands. In addition to gaining insight into the health of our student athletes what other populations can we help through this work?” 
…

Authorities on Greece’s most popular tourist island, Mykonos, will deploy more than a dozen drones to spot those who defy safety protocols aimed at preventing the spread and resurgence of COVID-19. 
 
The decision, known as “Operation Mykonos,” comes after a string of local so-called  “Corona-parties” organized by entrepreneurs at private villas and estates in recent weeks to bypass safety rules banning the operation of nightclubs. 
 
It also comes as the beleaguered government of Greek Prime Minister Kyriakos Mitsotakis scrambles to revive its battered tourism sector, luring foreign travelers — mainly from the United States, Europe, Israel, and Russia —  with the promise of a safe summer holiday stay under the Greek sun. 
 
Foreign travelers are required to abide by local lockdowns, curfews, and safety protocols during their stays. 
 FILE – People gather as the sun sets at the windmills on the Aegean Sea island of Mykonos, Greece, Aug. 16, 2020.Under “Operation Mykonos,” authorities will deploy 15 drones to fly over private villas or establishments in Mykonos that in recent weeks were host to parties packed with hundreds of locals and foreigners. Ten-member strong teams of officers will also be formed to raid the establishments upon notice, arresting and fining the offenders, authorities told VOA. 
 
Fines range between $365 to over $6,000. 
 
Officials tell VOA the measures, coupled with heightened police controls, inspections and added surveillance cameras across Mykonos, will serve as a blueprint for other popular hotspots among foreign travelers. These include Rhodes, Santorini and Paros, according to authorities. 
 
“Illegal parties spell a greater risk of seeing the virus spread, infecting more and more people,” warned Nikos Hardalias, the head of Greece’s Civil Protection Agency, on Sunday. “It spells a spike in COVID cases that can lead to fresh restrictions, leading businesses to shut down, causing major damage to tourist areas.” 
 
“It is high time,” he warned, “for everyone to size up to the challenge and take on full responsibility of their actions.” 
 
On Monday, government spokesman Aristotelia Peloni also criticized the mushrooming “corona-parties” gripping the country, saying she wished “Greece’s youth showed similar zeal and enthusiasm in the state’s nationwide vaccination drive.” 
 
“The country’s freedom,” she said, “can only come through comprehensive immunization.” 
 
Effectively in lockdown since last November, Greece started easing some of its sweeping restrictions, including curfews and travel bans, in mid-May when it re-launched international travel. 
 
The latest crackdown, however, underscores the paradox of what critics call a hasty and ill-thought-out strategy.  FILE – A waiter serves a group of people in a restaurant of Plaka district, as restaurants and cafes in Greece open after six months of lockdown, amid the coronavirus outbreak, in Athens, Greece, May 3, 2021.“You can’t say ‘restaurants and bars can open but no music playing in the background to block crowds from gathering,’” said Heracles Zissimopoulos, a leading entrepreneur on the island of Mykonos. “It’s absurd.” 
 
“The government should seriously rethink its policy, and provide locals and tourists with an outlet, instead. Otherwise, these types of parties will be difficult to stop,” he added. 
 
Greece recorded less than 3,000 cases during the country’s first bout with the pandemic. But as tourists streamed in last summer, infections and deaths sky-rocketed, making Greeks apprehensive to foreign travelers. 
 
But with 20 percent of the nation’s domestic output reliant on tourism, Greeks now know they can ill afford to lose a second summer tourism season in a row. 
 FILE – People wait at the reception hall of a COVID-19 vaccination mega center in Athens, Feb. 15, 2021.Under a campaign called “Blue Freedom,” the government wants to vaccinate all 700,000 or so adult residents of Greece’s islands in the Aegean and Ionian Seas by the end of June, hoping Greece can be included in Britain’s revised green-list of travel nations. All islanders are being offered the single-shot Johnson & Johnson vaccine to boost immunization. 
 
As of early June, Mykonos had vaccinated about four in ten of its residents, and Santorini over 50% — among the highest in the country. 
…