Month: June 2021

Categories
Entertainment

Within the ’80s, Submit-Punk Crammed New York Golf equipment. Their Movies Captured It.

In the ’80s, Post-Punk Filled New York Clubs. Their Videos Captured It.

In the summer of 1975, Pat Ivers filmed a legendary festival of unsigned rock bands at the CBGB, including Talking Heads, Blondie and Ramones. Ivers had unauthorized but easy access to equipment thanks to her work in the public access division at Manhattan Cable TV, and other members of her video collective, Metropolis Video, helped.

“I was the only girl,” Ivers said in a recent interview. “And all the boys were like, ‘You’re crazy. We don’t make any money with it. ‘ They wouldn’t do it anymore, so I pouted at the bottom of the bar at CBGB for about a year. Then I met Emily. “

Emily Armstrong was a sociology student at the City University of New York who had also accepted a position in public access with Manhattan Cable, sharing with Iver’s determination and punk rock penchant. The couple shot dozens of concerts and hosted a weekly cable show, “Nightclubbing,” which showed their videos. The bulky Ikegami camera they used was “like a Buick on my shoulder,” said Ivers. They shot bands until almost sunrise, rushed back to the Manhattan Cable offices and brought the gear back before anyone noticed it was gone.

Sean Corcoran, curator of prints and photographs at the Museum of the City of New York, graduated from college in 1996 and was in kindergarten when Ivers and Armstrong were putting their archives together. But he is fascinated by the heyday of new music, which took place in New York from the late 1970s. When a colleague proposed an exhibition to mark the 40th anniversary of MTV’s arrival on August 1, 1981, Corcoran took the opportunity to build a showcase for the music that followed in 1975 after the near bankruptcy of New York City and the subsequent economic hardship AIDS arose and crack epidemics.

When Corcoran began curating New York, New Music: 1980-1986, which comes out Friday, he knew most of the photographers who documented the era, including Janette Beckman, Laura Levine, and Blondie’s avid guitarist Chris Stein. While browsing the extensive Downtown Collection of NYU’s Fales Library, he saw a listing of the Ivers and Armstrong archives the library had acquired in 2010 and was delighted. Material from this duo as well as footage by Merrill Aldighieri and the team of Charles Libin and Paul Cameron provided Corcoran with an extensive, but rarely seen video catalog.

“New York, New Music” records a variety of genres including rap, jazz, salsa, and dance music, but the videos in the exhibit emphasize post-punk, the gnarled, joyously uncommercial cousin of the new wave who happens to have a moment. (An inevitable Apple ad campaign uses Delta 5’s spiky 1979 song “Mind Your Own Business,” which was considered so uncommercial that it wasn’t even released as a single in the US.) The sound of that era, Corcoran said : “Never gets the attention that disco and punk get.”

Thanks to the advent of portable (albeit Buick-sized) video cameras, these five dogged videographers documented this fertile music, which was politically progressive and races and genders involved. All of them were DIY self-starters, flush with Moxie, who made the most of borrowed equipment and Gothic lighting. Aldighieri even used videotapes retrieved from dumpsters outside the Time & Life Building. That dingy pants-of-pants aesthetic was the predominant language of music video until MTV spread across the country, turning videos into shiny advertisements for fame.

Like Ivers and Armstrong, Libin and Cameron rushed into the scene. The couple met as film students at SUNY Purchase, who had bonded through their love for Wim Wenders and Martin Scorsese. In 1979 they drove to the Hurray nightclub on 62nd Street in Manhattan and made a 16mm film for a colorful new band from Georgia, the B-52’s, playing a nervous surf rock song called “Rock Lobster”. They processed it with university equipment and then showed it to Hurray by projecting it onto a white bed sheet. Music videos were still a new idea, and “people got ballistic,” said Cameron.

The director of their film department went through for various reasons and expelled the duo for using equipment without permission. Free of academic distractions, they moved to New York, worked as a bartender at Hurray, and shot dozens of the best bands of the era; they contributed videos of the rugged funk bands Defunkt and James White and the Blacks to the museum show. After a few years, her video work led to thriving careers as cameramen, leaving no time for late nights in the clubs.

Filming this scene was stressful and sometimes risky. While working at Danceteria, an unlicensed club near Penn Station, Ivers and Armstrong were arrested along with other employees; they had also stolen a significant part of their archives. “It made us bitter,” said Ivers. In April 1980, after filming Public Image Ltd. “Nightclubbing”.

“The scene we loved was over. There was a new scene. I didn’t like Duran Duran, ”added Armstrong. More than a dozen of their videos, including recordings from punk bands The Dead Boys and The Cramps, and the Louche, Lounge Lizards’ chaotic jazz rock, are shown at the Museum of the City of New York Show.

Aldighieri, a fearless graduate of the Massachusetts College of Art and Design who had worked as a news camerawoman and animator for Sesame Street, was hired by Hurray to play video between sets and used the house camera to make bands. She filmed more than 100 different bands there, some more than once: “I was there five to seven days a week,” she says. But in May 1981, Hurray shut down, and a subsequent night robbery terrified her into retirement from the nightclub. Aldighieri created a short-lived series of VHS video compilations for Sony Home Video, worked in production and post-production, and then moved to France. Curator Corcoran used four clips from her archive, including jazz avant-garde Sun Ra and South Bronx sister group ESG, who played minimalist funk.

The five filmmakers’ footage forms “the core of the video content” in “New York, New Music: 1980-1986,” Corcoran said. It’s just a lucky coincidence that the show comes at a time when post-punk music is finally in the spotlight.

The vicious British band Gang of Four released a boxing set in March; Beth B’s documentary on the no-wave warrior Lydia Lunch opens in New York this month; and Delta 5, which can be heard constantly in this Apple commercial, has been cited as an influence by emerging corporations in the UK (Shopping), Boston (Guerrilla Toss) and Los Angeles (Automatic).

“Always surprised that there is still resonance after 40 years,” said Ros Allen, who played bass in Delta 5 and is now an animator and senior lecturer at the University of Sunderland in England, in an email. “’Mind Your Own Business’ has a catchy beat and bass lines and a crashing guitar break, and then there’s the ‘Go’ [expletive] even ‘texts. “

Gang of Four drummer Hugo Burnham, who is now an assistant professor of experiential learning at Endicott College in Massachusetts, said in an email, “This post-punk / pre-new romantic era became so much interesting and sustainable music made. “He added,” And maybe our own children are generous enough to like and bring us back to relevance. “

In the course of the 1980s, Corcoran said, New York had transformed from an unregulated, artist-friendly city to a strictly controlled, stockbroker-friendly city, which was the end of the era. Much of the footage he chooses has been rarely seen, and other important video documents of the era are frustratingly difficult or impossible to find.

Chris Strouth, a composer and filmmaker, spent years searching for the videotapes of M-80, a groundbreaking two-day music marathon from 1979 that was staged in Minneapolis. After he finally found it, he “spent four or five years,” he said, turning it into a full-length documentary. At the last minute, the singer withdrew permission from an obscure local band he did not want to name to use their footage, which Strouth described as “heartbreaking”.

Some filmmakers did not receive signed releases from the bands, which limits their commercial use. Some have received publications that have disappeared or did not anticipate the rise of digital media. In lieu of a contract, videos cannot be licensed without facing a bunch of opportunistic lawyers and moody band members. “It’s hell,” said Strouth with a hurt laugh. “Music licenses are hell.”

But it wasn’t always like that. Ivers was able to film almost every act of the late ’70s with the exception of Patti Smith and Television, which refused permission. Thanks to Ivers and others, an obscure era of music has been thoroughly memorialized. “The shows we saw – my god,” she said. “It was lightning in a bottle. It would only happen once. “

Categories
Health

High FDA advisor says children should be vaccinated towards Covid

Top FDA advisor says kids need to be vaccinated against Covid

U.S. Senator Bob Casey, right, watches as Dr. Paul Offit speaks during a press conference in Philadelphia on Friday, Feb. 13, 2015.

Matt Rourke | AP

Children need to be vaccinated against Covid-19, a top advisor to the Food and Drug Administration’s childhood vaccines told the agency on Thursday.

“It just seems silly to think that we don’t need to involve children,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and advisor to the FDA. “They can suffer and be hospitalized and occasionally die.”

He said 300 children had died of Covid so far.

Offit, a voting member of the Agency’s Vaccines and Related Biological Products Advisory Committee, spoke about the use of Covid-19 vaccines in children 6 months of age during the panel’s meeting.

“We have variants that are becoming more contagious, which means you need higher population immunity … for years, if not decades,” Offit said. He also said that we vaccinate children against polio every year, although we haven’t had a polio case since the 1970s.

Data from the American Academy of Pediatrics shows that nearly 4 million children have tested positive for Covid since the pandemic began. In the past week, the data said more than 16,000 new cases in children were reported, the lowest since June 2020. In states reported, less than 1% of all Covid cases in children resulted in death, the AAP wrote their website.

“I think in winter we will really see how well we do on population immunity,” Offit said. “I think the idea that we will no longer have to vaccinate children in the future is wrong.”

Categories
Politics

Apple, different China-linked corporations beneath strain

Apple, other China-linked firms under pressure

Apple, Cisco and other U.S. companies with deep ties to China are under increasing pressure to address Beijing’s “repression of human rights and democracy,” one of President Joe Biden’s key allies in the Senate said Thursday on CNBC’s “Squawk Box.”

The comments from Sen. Chris Coons, D-Del., came two days after his chamber passed a bipartisan bill to boost U.S. competitiveness with China.

Coons compared the U.S.-China relationship to America “decoupling” from the former Soviet Union during the Cold War.

While U.S. business ties now are far more robust with China than they were with the USSR, Coons said there is “some gradual distancing” taking place between the two economic superpowers.

Coons, who serves on the Senate Foreign Relations Committee, also made the case that Chinese conduct in its own country and around the world is growing increasingly hard to ignore.

Coons criticized what he called the “Great Firewall of China” that the government uses to “block off the internet in China and require censorship and use it to coordinate surveillance and repression of their own people.”

Coons also noted that both the Biden and Trump administrations called China’s treatment of Uyghurs in Xinjiang province a genocide.

CNBC Politics

Read more of CNBC’s politics coverage:

Companies that are trying to manufacture and operate in both countries “are facing increasingly difficult questions in the West about what you’re doing to help facilitate the repression of human rights and democracy in China and by the Chinese in other places around the world,” Coons said.

Asked what those companies should be telling China right now, Coons replied: “Stop stealing our intellectual property.”

“They force you to transfer technology to your Chinese operations and then frankly steal them from you,” he said. “They are competing with us in vaccine diplomacy and in fighting for the next generation of technology.”

Coons sang the praises of a $250 billion technology and manufacturing bill, which is aimed specifically at positioning the U.S. to better compete with China. The legislation, dubbed the U.S. Innovation and Competition Act, passed the Senate on Tuesday with rare bipartisan support.

The bill’s sizable investments in semiconductors, 5G, quantum computing and other industries “will make it far more likely that the United States and our close allies are ahead of the curve, rather than behind the curve, in the next generation of technologies that are dual use for both civilian and military,” Coons said.

Out-competing China will involve “coordinating our investments in new technologies,” Coons said.

He gave an example of then-Secretary of State Mike Pompeo urging U.S. allies not to use Chinese telecommunications giant Huawei due to security concerns.

“What a lot of our allies said was, ‘Well, that’s interesting. What is your alternative?’ And there wasn’t an American alternative,” Coons said.

“We need to invest in being competitive for this century with China.”

Categories
World News

America Might Be ‘Again’ in Europe, however How A lot Has Actually Modified?

America May Be ‘Back’ in Europe, but How Much Has Really Changed?

FALMOUTH, England – Few pictures have captured the rupture of the transatlantic relationship better than that of President Donald J. Trump in 2018, arms crossed over his chest, as he saw Chancellor Angela Merkel and other frustrated leaders in their doomed endeavors the rescue of their summit resisted in Canada.

When the same leaders meet again in Cornwall, England on Friday, President Biden will reverse body language and replace stagnation with hug. But below the pictures, it’s not clear how much more open the United States will be to Europe than it was under Trump.

The transatlantic partnership has always been less reciprocal than its proponents like to claim – a marriage in which one partner, the United States, held the nuclear umbrella. Now that China is overtaking the Soviet Union as America’s arch-rival, the two sides are less united than they were during the Cold War, a geopolitical shift that exposes longstanding tensions between them.

At the reunification of the group of 7 industrialized nations on Friday, the question arises: will this expression of solidarity be more than a diplomatic pantomime – reassuring for Europeans who are traumatized by Trump’s “America First” policy, but have to disappoint them if they do realize that? does the United States go its own way under Mr Biden?

“America’s foreign policy has not fundamentally changed,” said Tom Tugendhat, Chairman of the Foreign Affairs Committee in the UK Parliament. “It’s more collaborative and inclusive, but essentially it’s the same.”

“Like all leaders,” he added, “Biden puts his own country first. How he achieved this distracted many. “

Few Europeans question the sincerity of his efforts. Even more than his former boss, Barack Obama, Mr Biden is an Atlanticist who has been involved in European affairs from the Balkans to Belfast for decades.

On Thursday he and Prime Minister Boris Johnson presented a new Atlantic Charter based on the post-World War II draft signed by Franklin D. Roosevelt and Winston Churchill.

In their first face-to-face meeting, Mr Biden and Mr Johnson each projected unity, each promising that his country would provide hundreds of millions of doses of vaccine to the developing world.

“I will not contradict the President in this or anything,” said Mr Johnson after Mr Biden said that both he and the newlywed Prime Minister “got married over our station.”

But the president has made China the guiding star of his foreign policy more aggressive. While American officials seek European support for these efforts, analysts said their expectations are limited given the commercial interests of Germany and other countries and the fact that Ms. Merkel and other Europeans showed no appetite for a new Cold War with Beijing.

“The Biden administration is determined to be courteous, determined to hear them, and then they will do whatever it was up to,” said Jeremy Shapiro, who worked at the State Department during the Obama administration and is now the European Council’s director of research for foreign relations in London.

“It doesn’t matter what US policy is towards Europe,” said Shapiro, summing up the prevailing opinion in the government. “We’re going to get the same amount out of them in China.”

The skepticism goes in both directions. Many European officials view Mr. Biden’s statement that “America is back” with a yellowish look, even if it is well-intentioned, in the face of the attack on the US Capitol and other threats to American democracy, not to mention Mr. Trump’s iron influence on the Republican Party.

“We live in an era of loss of confidence,” said Wolfgang Ischinger, a former German ambassador to the United States who chairs the Munich Security Conference, at which Biden was a regular speaker.

The Germans used to think that the transatlantic alliance didn’t care much whether the president was a Democrat or a Republican. Now Ischinger said: “For the first time in 70 years we are confronted with a new question: What happens when a resurrected Trump appears on the stage?”

White House officials have carefully choreographed Mr Biden’s trip to make it a summer festival of Alliance repair. But back in Washington, analysts say its staff moves show a marginalized role for Europe.

Biden in Europe

Updated

June 10, 2021, 8:08 p.m. ET

The White House has appointed prominent officials to coordinate Indo-Pacific and Middle Eastern politics in the National Security Council. There is no equivalent for Europe, nor has the government made diplomatic appointments such as a NATO ambassador or an envoy for Northern Ireland.

Mr Biden has welcomed the leaders of Japan and South Korea to the White House, but has not yet welcomed a major European leader.

On the eve of his visit to the UK, a senior American diplomat spoke bluntly to Johnson’s chief negotiator for Brexit about how the UK is handling tensions over post-Brexit trade deals in Northern Ireland.

There is a similar sense of limited expectations of Russia on both sides, even if Mr Biden meets President Vladimir V. Putin in Geneva next week. Washington-Moscow relations quickly deteriorated in the early months of the administration as the United States faced a Russian hacking operation, evidence of continued Russian interference in the 2020 presidential campaign, and Putin’s masses of troops on Russia’s border with Ukraine.

Russia’s arrest of opposition leader Aleksei A. Navalny three days before Mr Biden’s inauguration set the tone for tensions to come.

Far from the “reset button” that Mr. Biden announced during his tenure as Vice President of Mr. Obama in 2009, his meeting with Mr. Putin appears to be primarily aimed at suppressing tensions with what is usually a divided Russia, so that both sides can use it avoid conflicts that could disrupt Mr Biden’s domestic political agenda.

Given what analysts are saying, Mr Putin’s calculation is that Russia will benefit from instability by sowing, they question how successful Mr Biden will be. Europe’s proximity to Russia – and Germany’s dependence on its natural gas – means that instability would pose a greater threat to Europe than it does to the United States.

“The problem with China is that it’s not our neighbor, it’s the US neighbor,” said Robin Niblett, director of Chatham House, a think tank in London. “Russia is Europe’s neighbor, and that reality complicates it, but only to the extent that the US wants to raise the temperature.”

The government’s zigzag course on Nord Stream 2, a gas pipeline that runs from Russia to Germany, has left some in Europe scratching their heads. Foreign Minister Antony J. Blinken said Mr. Biden publicly rejected the pipeline as a “bad idea”. But Mr Blinken recently declined to impose sanctions on those behind the $ 11 billion project, saying its conclusion was a “fait accompli”.

The reversal on the eve of Mr Biden’s European tour seemed designed to avoid a break with Germany, a critical ally. But in Britain, which is cracking down on Russia tougher than Germany, some officials said they were concerned that the decision would encourage Mr Putin and weaken Ukraine’s eastern border.

While the transatlantic differences with China are substantial, officials on both sides say Europe is gradually moving in Mr Biden’s direction. The European Parliament held up the ratification of a landmark investment treaty between Brussels and Beijing last month. This followed Beijing’s sanctioning of ten European Union politicians in what Europeans thought was an exaggerated reaction to the sanctions China had imposed for imprisoning Uighur minorities in Xinjiang.

The UK has leaned on the US on China, restricting Chinese telecommunications giant Huawei’s access to its 5G network. However, analysts warn that the change is motivated less by a change of heart about Beijing than by a desire not to get out of step with its most important ally after Brexit.

Some in Europe argue that Mr. Biden’s China policy is not fully worked out, noting that there was no shortage of diplomatic pantomime at Mr. Blinken’s stormy meeting with Chinese officials in Alaska in March.

Europe’s views could also develop further with the departure of Ms. Merkel, who firmly believes in a commitment to China, after 16 years in office and with French President Emmanuel Macron, who faces a difficult election campaign next year.

“The EU’s position on China has hardened over human rights issues,” said Simon Fraser, a former senior official in the UK Foreign Office. “I suspect there is a lot in common, even if different national interests come into play.”

Still, some Europeans have been put off by the way Mr Biden has portrayed competition with China in stark ideological terms – a fateful battle between democracy and autocracy in which the autocrats could win.

For leaders like Ms. Merkel, whose land sells millions of Volkswagen and BMW in China, the relationship is driven by trade and technology, not a possible military clash in the South China Sea.

“There’s a profound psychological problem at play,” said Thomas Wright, director of the Center on Europe and the United States at the Brookings Institution in Washington. “Some Europeans believe the US is too nostalgic for the Cold War and too ready to return.”

These are, of course, the early days of Mr Biden’s presidency. Analysts said he had recalibrated his message on China and Russia two months ago when he told Congress that Chinese President Xi Jinping believed that “democracy cannot compete with autocracies in the 21st century.”

Charles A. Kupchan, a Georgetown University professor who worked in the Obama administration on European affairs, said Mr Biden’s goal was to prevent the creation of a Sino-Russian bloc against the West. That requires the help of allies, which is why he predicted that Mr. Biden would not only listen to Europeans, but would also listen.

“This attempt to find geopolitical dividing lines will not find much support from the American allies,” said Kupchan.

Mr Biden appears to be sensitive to these concerns. In a column in the Washington Post last Sunday in which he outlined his travel destinations, he refrained from militant references to an autocratic China. Instead, he wrote about whether the United States and its allies might face a poor challenge: “Can democracies come together to deliver real results for our people in a rapidly changing world?”

Categories
Health

Three F.D.A. Advisers Resign Over Approval of Alzheimer’s Drug

Three F.D.A. Advisers Resign Over Approval of Alzheimer's Drug

In a strong rejection of the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, three scientists have stepped down from the independent committee that advised the agency on the treatment.

“This could be the worst regulatory decision the FDA has made that I can remember,” said Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, who resigned Thursday after six years on the committee.

He said the agency’s approval of the drug aducanumab, marketed as Aduhelm, a monthly intravenous infusion that Biogen has set at $ 56,000 a year, was incorrect “because of so many different factors, including the fact that there is no good evidence ”. that the drug works. “

Two other members of the committee resigned earlier this week and expressed dismay at the drug’s approval, although the committee overwhelmingly opposed it after reviewing clinical trial data in November.

The committee found that the evidence was inconclusive that Aduhelm could slow cognitive decline in people with the early stages of the disease – and that the drug could potentially cause serious side effects of brain swelling and hemorrhage. None of the eleven committee members thought the drug was ready for approval: ten voted against, one was unsure.

“The approval of an ineffective drug has serious potential to interfere with future research into new treatments that may be effective,” said Dr. Joel Perlmutter, a neurologist at Washington University School of Medicine in St. Louis, who first stepped down from the committee.

“In addition, aducanumab therapy will potentially cost billions of dollars to introduce, and those dollars could be better spent developing better evidence for aducanumab or other therapeutic interventions,” added Dr. Mother-of-pearl added.

Shannon P. Hatch, an FDA spokeswoman, said the agency does not comment on matters that affect individual advisory committee members.

Biogen plans to ship the drug in about two weeks. It expects more than 900 locations across the country, usually memory clinics that treat patients with dementia, to be ready to administer the drug soon.

The FDA’s green light decision, announced Monday, marked the first approval of an Alzheimer’s treatment in 18 years. Patient advocacy groups had pushed for approval because there are only five other drugs for the debilitating disease and they only treat dementia symptoms for a few months.

But since last fall, several respected experts, including some Alzheimer’s doctors who worked on the clinical trials of aducanumab, have said that the evidence available casts significant doubts on the drug’s effectiveness. They also said that even if it could slow cognitive decline in some patients, the proposed benefit – slowing symptoms down for about four months over 18 months – might be barely noticeable to patients and outweigh the risks of side effects on the brain would.

In addition to the high price of the drug, the additional cost of screening patients before treatment and having regular MRIs needed to monitor their brain for problems could add tens of thousands of dollars to the bill. Medicare is expected to cover much of that.

“Giving patients a drug that is not working and of course has great risks that require multiple MRIs costing $ 56,000 a year puts patients in a really challenging position and puts doctors in a difficult position.” said Kesselheim.

Aside from believing that the existing evidence of Aduhelm’s benefits is weak, the resigning advisory committee members – as well as several prominent Alzheimer’s experts – rejected two important aspects of the FDA’s approval decision.

One problem is that the FDA has approved the drug for a much broader group of patients – anyone with Alzheimer’s – than many experts expected. In the clinical trials, the drug was only tested in patients with early-stage Alzheimer’s disease or mild cognitive impairment from the disease.

The other problem is that a key part of the FDA’s rationale for granting the approval was that the drug’s ability to attack the amyloid protein in patients’ brains would help slow their cognitive symptoms.

“This is a big problem,” said Dr. Mother-of-pearl.

While amyloid is considered a biomarker of Alzheimer’s disease because its buildup in the brain is an important aspect of the disease, there is very little scientific evidence that reducing amyloid can actually help patients by relieving their memory and thinking problems.

Clinical studies of other amyloid-lowering drugs for more than two decades have shown no evidence that the drugs slow cognitive decline. As a result, many experts had said it was especially important to have solid evidence of Aduhelm’s ability to treat symptoms.

In November, FDA officials told advisory committee members that the agency would not count the drug’s ability to reduce amyloid as an indication of its effectiveness. But in Monday’s decision, the FDA announced that it did just that.

“The FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that reducing these plaques is likely to predict important benefits for patients,” said the director of the Center for Drug Evaluation and Research of the FDA, Dr. Patrizia Cavazzoni wrote on the agency’s website about the decision to make the drug available under a program called accelerated approval.

The advisory committee members said, however, that the committee was never advised that the agency would be considering approval based on amyloid reduction and that their opinion on this significant change was never sought. Dr. Perlmutter said the committee was “unaware of any additional information or statistical analysis to support approval.”

Dr. David Knopman, a clinical neurologist at Mayo Clinic, wrote in an email to FDA officials informing them of his resignation from the advisory committee on Wednesday: “Biomarker justification for approval in the absence of consistent clinical benefit 18 months of treatment is “unreasonable.”

Dr. Knopman, who stepped out of the November meeting for serving as the lead investigator for one of the aducanumab trials, added that “the whole aducanumab approval saga, which culminated in accelerated approval on Monday, is a mockery “The role of the advisory board.

Dr. Peter Stein, who heads the Office of New Drugs at the FDA Center for Drug Evaluation and Research, said in a briefing with reporters following the decision that the agency’s reviewers were convinced of what he saw as a strong relationship between plaque reduction and potential clinical benefit described by Aduhelm, which he said had not been seen in previous studies of amyloid-eradicating drugs.

Dr. Stein also defended the agency’s decision to approve the drug in such a broad patient population, saying it could be relevant beyond the early stages of Alzheimer’s.

“Since amyloid is a hallmark of the disease throughout its course, this drug is expected to provide benefits across this spectrum,” said Dr. Stone.

As a condition of approval, the FDA said Biogen would conduct another clinical trial and give the company approximately nine years to complete. These terms apply to some experts as well. They say the drug will be available without restriction during these years, and if the new study doesn’t prove the drug beneficial, the agency may, but is not required to, withdraw its approval and has not always done so for other drugs.

“The timeframe they gave for the so-called confirmatory study of nine years is problematic,” said Dr. Kesselheim, who also directs Harvard Medical School’s regulation, therapy, and law program. “During this time, the product will be used a lot.”

Categories
Politics

Bipartisan Group of Senators Say They Reached Settlement on Infrastructure Plan

Bipartisan Group of Senators Say They Reached Agreement on Infrastructure Plan

But the bipartisan group of senators are part of a broader coalition of moderates who have quietly met since Mr. Biden took office, in an effort to explore avenues of compromise on a number of issues. Moderate Democrats in particular have been resistant to immediately bypassing the need for Republican votes on an infrastructure package, long seen as a particularly ripe area for a bipartisan agreement.

The five Republicans are Senators Rob Portman of Ohio, Mitt Romney of Utah, Lisa Murkowski of Alaska, Susan Collins of Maine and Bill Cassidy of Louisiana. The Democrats are key moderates: Senators Kyrsten Sinema of Arizona, Joe Manchin III of West Virginia, Mark Warner of Virginia, Jeanne Shaheen of New Hampshire and Jon Tester of Montana.

“I think it’s important that there is this initiative, that again is a bipartisan initiative,” Ms. Murkowski said before the announcement. “What is happening now is as Republicans and Democrats, we are going out to folks within our respective conferences, talking about the contours of what we put together to see what that level of support might be.”

With razor-thin margins in both chambers, Democratic leaders have begun to quietly work on the legislation needed to use the fast-track budget reconciliation process, which would allow them to move a sweeping infrastructure package with a simple majority. But the maneuver would require near unanimity from the caucus and promises to be challenging, given the strict budgetary rules that govern the process.

“We either need to do it in a bipartisan fashion that gets 60 votes, which shows no sign of occurring given the substance of the ongoing bipartisan negotiations, or we need to be prepared to use the reconciliation process,” said Senator Sheldon Whitehouse, Democrat of Rhode Island and one of the most vocal proponents for the preservation of the climate provisions. “It’s got to happen.”

Senator Chuck Schumer of New York, the Democratic leader, refused to comment on the details from the bipartisan group as he left the Capitol on Thursday, telling reporters, “We continue to proceed on two tracks — a bipartisan track and a reconciliation track — and both are moving forward.”

Categories
Health

Bitcoin 2021 attendees report Covid instances after coming back from Miami

Bitcoin 2021 attendees report Covid cases after returning from Miami

Some of the 12,000 attendees who flew to Miami for the largest Bitcoin event in history last weekend have started testing positive for Covid.

Bitcoin 2021 attracted crypto enthusiasts from around the world to the Mana Wynwood Convention Center in the arts and entertainment district of Miami. For three days, conference attendees huddled in overcrowded lecture halls, happy and hugging. It was the first major conference since the pandemic began, and many attendees said they were relieved to be among colleagues sharing messages and updates.

There was no mask requirement and no proof of compulsory vaccination for participation. Covid was just a topic of conversation in connection with everyone’s excitement about being on the other side of the pandemic.

This is of course until some conference participants said on Twitter that they had tested positive for the corona virus.

For full disclosure, I attended the show after receiving two doses of the Moderna vaccine this spring. Vaccination isn’t a 100% guarantee of immunity, but at the moment I have no symptoms. A lot of my conversations with Uber and Lyft drivers started with a discussion about vaccination together.

It remains to be seen whether the conference will ultimately be billed as a super spreader event.

It is unclear how many people are affected and whether the city of Miami had a contingency plan for such an outcome. The mayor’s office and conference organizers did not immediately respond to CNBC’s request for comment.

On Tuesday, Florida said it would no longer report daily Covid cases and deaths as vaccinations increase and move into the “next phase” of the pandemic. Florida reported an average of eight new cases per 100,000 residents last week, well below its pandemic high of 84 per 100,000, according to Johns Hopkins University.

Categories
Entertainment

‘Within the Heights’ Premiere Celebrates the Neighborhood That Began It All

‘In the Heights’ Premiere Celebrates the Neighborhood That Started It All

In Washington Heights’ Plaza de las Americas, fruit and vegetable vendors typically sell their produce until dusk. But on Wednesday it was turned into a replica of another block in the neighborhood. There was a fake bodega adorned with three Dominican flags hanging from an awning, an artificial hydrant, and a plastic fruit stand. A yellow carpet ran under the entire set.

The reproduction served as a backdrop for the luminaries who attended the premiere of In the Heights, the theatrical adaptation of Lin-Manuel Miranda and Quiara Alegría Hudes’ Tony-winning Broadway show. The sunny carpet welcomed the cast and crew back to the Upper Manhattan area where it was filmed. The premiere, which also served as the opening night of the 20th Tribeca Festival, took place at the United Palace, a majestic 91-year-old theater with a projection system that had helped Miranda raise money, years before its success on Broadway, years earlier then helped with the installation.

As the actors, producers and executives flocked to the yellow carpet, pausing for photos with photographers and interviews with the news media, the real Washington Heights hummed behind them. Waitresses at the Malecon, a Dominican restaurant across the street from the square, peered out the window between the windows, serving rice, chicken, and beans, trying to figure out why crowds had formed outside their restaurant on a sticky 90 degree day.

Diners at El Conde Nuevo, another Dominican restaurant across the street, stood on the corner, also trying to decipher the hustle and bustle outside. And then Miranda – in a light blue long-sleeved chacabana, jeans, and the same Nike Air Force 1s, often called Uptowns in the City – that he wore to the Broadway opening of In the Heights – came with his family. and everyone burst out cheering.

Jorge Peguero, 71, was on his way home when he stopped and became a proud member of the crowd.

“I’ve lived here all my life and it’s fantastic,” said Peguero, who has lived in Washington Heights since 1969. “It’s a big deal that Tribeca represents the Dominican community, and it’s the first time we’ve seen something like this.”

Miranda, who still lives in Washington Heights, was hoping to premiere the film where it takes place.

“All I always wanted was for this neighborhood to be proud of itself and the way they are portrayed,” said Miranda, who was within walking distance of his home and his parents’ home. “I still walk around here with my headphones on, and they’re all just as fine as Lin-Manuel writes.”

“I feel safe here,” he added.

Many Washington Heights residents have never met Miranda in the neighborhood. Eglis Suarez, 48, wanted to change that.

“I want to see Lin,” she said. “We are so proud, this is progress for this community and for the city.”

Exuberant and critically admired, In the Heights, directed by Jon M. Chu, is a look at the changes taking place between first and second generation immigrants. The elders hope they can manage to get out of the neighborhood they left home for, while their younger colleagues plan to stay in the neighborhood they call home. It’s a story that happened a million times in the area and the Hudes, who also lives there, encounters daily during the filming.

“This is not about a hero or protagonist, but what happens when a community holds their hands together and life kind of pushes those hands apart,” said Hudes, who wore large hoops and a floral jumpsuit. “It’s about these blocks and these living rooms that you go to after school and do your homework or play bingo during a power outage, everything is here.”

Washington Heights has been home to middle and working class Dominicans since the 1960s. In the 1980s, like many others in the city, the neighborhood was inundated with cocaine and crack, making it unsafe for the community. Those days are over now and some residents say it is time to get away from a narrative in countless films and rap songs that no longer fits the neighborhood.

“I’m so proud of this movie,” said Sandra Marin Martinez, 67, a lifelong resident of Washington Heights. “Who wouldn’t be? At least there is no shooting. “

“Everyone dances, these are my people, I grew up dancing here,” she added while waiting for a look at the cast entering the theater.

Yudelka Rodriguez, 51, stood with her daughter, waiting for the cast to arrive. She was excited to see her hood represented in the film and herself.

“I’m so emotional,” said Rodriguez as she leaned against a metal gate. “It’s the best part to see your barrio involved; That’s the best feeling. “

Paula Weinstein, an organizer of the Tribeca Festival (which removed “film” from its name this year), hoped to reproduce this feeling across the city with this film.

“We dreamed of it – New York is back,” said Weinstein. “This is a tribute to the Dominican community, this is the best of New York. Each generation of immigrants is founded in one place and moves into the community. That’s the great thing about New York, that’s what we want to celebrate. “

In the theater, Robert De Niro, a founder of the festival, introduced Miranda, who then introduced the rest of the cast. The power was electric from the stage to the seats. When a title card labeled “Washington Heights” appeared on the screen, the crowd cheered and applauded.

When the star of the film, Anthony Ramos, arrived, the makeshift set was surrounded by a small crowd. When he came out in black and white cheetah print trousers, a matching shirt, and a jacket that he carried carefully on his shoulders, the crowd on the corner of 175th and Broadway thundered in applause and cheers.

“I didn’t even grow up on Broadway, and most New Yorkers didn’t grow up on Broadway,” says Ramos, a native of Brooklyn. “To tell a New York story about a community that is so familiar and special to the New York people is very special to me.”

Categories
World News

Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.

Sarah Silbiger | Getty Images

A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has learned.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.

“At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”

Shares of Biogen surged 38% Monday after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

The agency’s decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what it called an overly positive review of the data.

This is a developing story. Please check back for updates.

Categories
Health

OSHA Points Covid Office Security Rule, However Just for Well being Care

OSHA Issues Covid Workplace Safety Rule, But Only for Health Care

During the Trump administration, OSHA passed a policy to largely limit Covid-related inspections to a small number of high-risk industries such as healthcare and emergency aid. Meat wrap was not included in this high-risk group – studies showed it was a major source of virus transmission.

Some labor groups praised OSHA under President Donald J. Trump for enforcing health care safety regulations, including proposed fines of over $ 1 million for violations in dozens of health and nursing homes. However, critics accused the agency of largely failing to punish meat processors for lax safety standards, such as a lack of adequate distancing from workers.

Mr Walsh said the risks for most non-healthcare workers had decreased as cases decreased and vaccination rates increased. He also noted that the Centers for Disease Control and Prevention guidelines last month, telling vaccinated individuals that they generally do not need to wear a mask indoors, played a role in OSHA’s decision on one dispense with the broader Covid-19 standard.

“OSHA has adjusted the rule to reflect the reality on the ground, the success of the vaccine effort, as well as the latest guidance from the CDC and the changing nature of the pandemic,” Walsh said on the call.

David Michaels, an OSHA chief during the Obama administration, said the CDC guidelines made it difficult to implement a broader OSHA rule. “In order to justify an emergency standard, OSHA needs to demonstrate that there is great danger,” said Dr. Michaels. “To do this, the CDC should have clarified its recommendation and said that there is a great danger for many workers.”

Without such clarification, said Dr. Michaels, now a professor at the George Washington University School of Public Health, would have employer groups likely challenged any new OSHA rule in court, arguing that the CDC guidelines indicated that a rule was unnecessary.

Dr. Michaels said the new standard was an overdue move, but it was disappointing that no Covid-specific standard had been issued for industries such as meat packaging, corrections and retail. “If exposure is not controlled in these workplaces, they will continue to be major drivers of infection,” he said.