By Syndication Washington Post, Bloomberg · Robert Langreth · NATIONAL, BUSINESS, HEALTH, HEALTH-NEWS
The Food and Drug Administration approved Gilead Sciences Inc.’s antiviral therapy remdesivir on Thursday, making it the first drug to obtain formal clearance for treating the coronavirus.
Regulators had granted an emergency-use authorization for remdesivir earlier this year, and since then the drug has become a widely used therapy in hospitalized covid-19 patients. It was given to President Donald Trump this month when he was diagnosed with the virus.
The approval of remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to doctors, nurses, and patients. That could help solidify its position as a go-to medicine for covid-19 patients even as other drugs for the disease begin to reach the market.
“Veklury is now the first and only approved covid-19 treatment in the United States,” Gilead said in a statement. While the drug was in short supply initially, Gilead said that the medicine is now widely available in hospitals across the country as manufacturing capacity has rapidly expanded.
Gilead shares gained 3.6% in trading after the close of regular market hours on Thursday. Analysts estimate that remdesivir will have sales of $2.17 billion this year, according to 13 surveyed by Bloomberg.
The company said in June that it will charge U.S. hospitals roughly $3,120 for most patients who need remdesivir.
The approval is based on a U.S. government-sponsored trial involving more than 1,000 hospitalized coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo.
The overall side-effect rate was similar to the placebo in the government study. The most common side effects are nausea and elevated liver enzymes, according to the product’s label.
The drug hasn’t been proven to reduce deaths from covid-19. In a World Health Organization trial, the medicine failed to reduce fatalities, according to preliminary results that were posted on preprint servers last week.
Gilead has criticized the findings. In a letter posted on the company’s website, Chief Medical Officer Merdad Parsey said the WHO’s findings don’t negate other study results.
By The Washington Post · Miriam Berger · NATIONAL, WORLD, HEALTH, POLITICS The United States joined Brazil, Egypt, Hungary, Indonesia and Uganda on Thursday to co-sponsor a nonbinding international antiabortion declaration, in a rebuke of the U.N. Human Rights Council., which has enshrined abortion access as a universal right.
Secretary of State Mike Pompeo and Health and Human Services Secretary Alex Azar participated in the virtual signing ceremony. The Geneva Consensus Declaration aims to promote women’s health, “defends the unborn and reiterates the vital importance of the family,” Pompeo said at the ceremony.
Access to abortion is widely restricted in the other countries to co-sponsor the declaration. “There is no international right to abortion,” Pompeo said.
Though the document does not directly address same-sex marriage, the only co-sponsors to have legalized it are Brazil and the United States, while the text’s language affirming the family as “the natural and fundamental group unit of society” has clear meaning for countries that restrict LGBT rights. Among the co-sponsors, the Egyptian government targets LGBT people in a “systemic fashion,” according to a recent Human Rights Watch report, and in Uganda, gay sex is punishable by death.
The ceremony stood in contrast to Wednesday’s news that Pope Francis had expressed support for laws to protect same-sex unions.
Critics said Thursday’s declaration, less than two weeks ahead of the presidential election, marked the latest move by the Trump administration to build alliances with leaders accused of human rights abuses while working to promote abortion restrictions worldwide.
The Geneva Consensus formalizes a coalition united in opposition to the United Nations’ Universal Declaration of Human Rights, which forms the basis for the characterization of abortion and same-sex marriage as human rights under international law – a position that key U.S. allies, such as Britain and France, support.
Azar said Thursday that the coalition is intended to “hold multilateral organizations accountable.”
In addition to the six co-sponsors, 26 countries, including Belarus, Saudi Arabia and Poland, have joined as signatories.
“None of those countries [that have co-sponsored] at least currently have a strong commitment to women’s health and rights,” said Gillian Kane, a senior policy adviser for Ipas, a U.S.-based organization focused on abortion and contraception access around the world. “This administration is out of touch with the needs of women.”
The declaration is not legally binding and does not change any existing laws. But it is in step with the Trump administration’s repeated bypassing of traditional avenues of diplomacy to build parallel tracks.
“This will undoubtedly bring harm to LGBTQ people and roll back the established global consensus about the necessity of protecting the sexual and reproductive health and rights of women and girls in all their diversity,” said David Stacy, government affairs director of the Washington-based Human Rights Campaign.
In May, U.S. officials accused the United Nations of using coronavirus-related emergency funding for sexual and reproductive health services as a pretext to promote abortions, a charge that the global body denied.
One of President Donald Trump’s first moves in office was to reinstate a policy known as the global gag rule, which bans U.S.-funded health-care providers from providing or discussing abortions. Democratic presidential nominee Joe Biden has pledged to overturn it if elected, as President Barack Obama did shortly after taking office in 2009.
A 2019 study published in the Lancet found a global “pattern of more frequent abortions and lower contraceptive use” during periods when such U.S. restrictions have been in place.
The declaration could create “unnecessary legal, policy and service delivery hurdles that will obstruct interventions by Uganda to address the persistently high numbers of women and girls dying due to pregnancy-related complications,” a coalition of Ugandan civil society groups said Thursday in a statement opposing their government’s participation.
By The Washington Post · Seung Min Kim, Paulina Firozi · NATIONAL, POLITICS, COURTSLAW, CONGRESS
WASHINGTON – Judge Amy Coney Barrett moved one step closer to a seat on the Supreme Court on Thursday as the Senate Judiciary Committee advanced her nomination with solely Republican support after Democrats boycotted the vote in protest of what they viewed as an illegitimate confirmation process.
The vote was 12 to 0, with no Democrats present to officially register their objections. Senate Majority Leader Mitch McConnell, R-Ky., is expected to take procedural steps Friday to bring her confirmation to the floor, with Barrett being confirmed by Monday evening, putting her in position to hear key cases involving potential election disputes and health care.
Before then, Democrats are expected to throw up more procedural roadblocks – as they have been doing all week – and launch numerous floor speeches to frame what they say is the imminent threat Barrett poses to the future of abortion rights, gay rights and the fate of the Affordable Care Act.
Republicans, however, have been undeterred, vowing to swiftly install a 48-year-old jurist whose qualifications to serve on the Supreme Court have not been in dispute. Barrett’s installation would solidify a 6-3 conservative majority on the court and give President Trump his third successfully confirmed Supreme Court pick, just days before the Nov. 3 election.
“I could not live with myself if I denied her her day,” said Sen. Lindsey Graham, R-S.C., chairman of the Judiciary Committee. Of Democrats, Graham insisted that Republicans are “not going to allow them to take over the committee.”
Graham also defended Barrett’s personal beliefs after Democrats expressed concern during the confirmation hearings that her presence on the Supreme Court would result in further abortion restrictions. Both liberals and conservatives have suggested, based on her academic writings, personal beliefs and rulings as a judge, that she would support restricting or outright overturning the landmark 1973 abortion rights decision Roe v. Wade that guarantees a woman’s right to an abortion.
Barrett repeatedly declined to offer her legal views on presidential authority and voter intimidation, and insisted that she was not familiar with Trump’s positions on issues such as climate change and the health-care law.
“To all the people out there wondering about Judge Barrett I can tell you this: The law of Amy will not be applied to the case and controversy,” Graham added. “It will be the law as written in the Constitution or by statute or whatever regulatory body she is going to review. She will take her job on without agenda.”
Even though Democratic senators skipped the committee vote, they made their presence known. In their seats were 10 large portraits of constituents – Carrie from Delaware, Kenny from Illinois and others – who had benefited from protections mandated by the 2010 health-care law that ensures that millions of Americans with preexisting medical conditions cannot be denied coverage or pay more for insurance.
Each person’s story had been highlighted by Democrats during Barrett’s confirmation hearings last week, which centered on health care and whether she would be a vote to strike down the Affordable Care Act. The court will hear oral arguments Nov. 10 in the GOP-led challenge, backed by the Trump administration, to invalidate the law.
“No matter where you come down on this, this is personal,” Sen. Amy Klobuchar, D-Minn., said. “And this Republican majority and this president have chosen to make, as their closing argument, that they’re going to push through a nominee whose record shows us just where she’s going to come out on so many things.”
Trump injected his own thoughts as to what the Supreme Court should do on the health-care law in excerpts of a “60 Minutes” interview released Thursday. “It’ll be so good if they end it,” he said.
And on Barrett herself, Trump made his pleasure known in a tweet: “Judiciary Committee approves Judge Barrett. Moves to full Senate for final vote. Big day for America!”
Trump nominated Barrett, a judge on the 7th U.S. Circuit Court of Appeals, on Sept. 26, eight days after the death of liberal Justice Ruth Bader Ginsburg.
Rather than showing up for the committee vote, nine Democratic senators on the Judiciary Committee – all except Sen. Kamala Harris of California, the party’s vice-presidential nominee – and Senate Minority Leader Chuck Schumer, D-N.Y., gathered on the front steps of the Capitol to decry the confirmation process for Barrett and how they expect her to rule as a justice.
“The nomination of Amy Coney Barrett is the most illegitimate process I have ever witnessed in the Senate,” Schumer said. “Her potential confirmation will have dire, dire consequences for the Senate, for the Supreme Court and our entire country for generations to come.”
Schumer, who accused the Senate Republicans of “conducting the most rushed, the most partisan, and the least legitimate nomination to the Supreme Court in the nation’s history,” said the Democrats “will not lend a single ounce of legitimacy to this sham vote in the Judiciary Committee.”
Protesters on both sides of the debate made their views known. Some heckled the Democrats with obscenities as they spoke. Outside the Senate building, others dressed in the crimson robes and white bonnets of “The Handmaid’s Tale,” the television drama based on Margaret Atwood’s book, shouted “Trump-Pence, out now” and “Stop the confirmation.”
Republicans again warned the public that Democrats will surely move to expand the number of seats on the Supreme Court should they win the White House and flip control of the Senate in less than two weeks.
Democratic presidential nominee Joe Biden, facing pressure from the party’s base to embrace “court-packing,” said in his forthcoming “60 Minutes” interview that he would propose a bipartisan commission to study potential court changes but that the issue of expanding the Supreme Court was certainly a “live ball.”
Graham mused that the Democrats would be positioned to expand the Supreme Court to at least 13 justices. In a brief interview after the committee vote, Graham dismissed Biden’s commission proposal and said that if Democrats regain the levers of power in Washington, “they’re going to pack the court and Joe’s not going to be able to stop it.”
“As Ruth Bader Ginsburg pointed out, there goes the crown jewels of the American republic,” Sen. John Cornyn, R-Texas, said Thursday of the court proposals. “Our independent judiciary becomes nothing but another political body, a second legislative or political branch.”
In light of Biden’s comments, Democratic senators still tried to keep the focus on Barrett’s looming confirmation vote and the elections. Of the former vice president’s proposal, Schumer said that “everything is on the table when we get the majority.”
But “first job, get the majority,” Schumer said.
So Democrats continued to cast Barrett as a threat to health care and reproductive rights.
“Last week Democrats participated in the nomination hearings because we wanted to show what was at stake for America if Amy Coney Barrett is confirmed,” Sen. Dianne Feinstein of California, the top Democrat on the committee, said at the news conference. “We made our case about risks to affordable care, especially the Affordable Care Act, reproductive freedom, the right to vote and equality for all. We believe both the Affordable Care Act and Roe v. Wade could be lost.”
Democrats have lashed out at Republicans, calling them hypocrites based on their actions in 2016 when the court had a vacancy.
At the time, McConnell refused to consider nominee Merrick Garland, the choice of President Barack Obama, to fill the vacancy created by the death of Justice Antonin Scalia in February 2016.
McConnell and Senate Republicans, including Graham, insisted that the president chosen in November of that year, eight months after Obama’s nomination, should fill the seat.
Republicans argue that the circumstances now are different because Republicans hold the White House and the Senate majority.
Democrats also accused Graham of breaking committee rules to hold the vote, since the panel generally requires two members of the minority to be present to conduct committee business.
But Republican aides said that if a majority of the entire committee is present – which on Thursday it was – that means the Judiciary Committee can go ahead, under long-standing precedents. There have been more than six instances, including under Democratic control, since 2006 when the committee has conducted business without two members of the minority being there.
BBC รายงานการทดลองวัคซีนโควิด-19 ที่พัฒนาโดยมหาวิทยาลัยออกซ์ฟอร์ดและแอสตร้าเซนเนก้า ยังคงดำเนินต่อไปหลังตรวจสอบการเสียชีวิตของอาสาสมัครทดสอบวัคซีนเรียบร้อยแล้ว
จีนเตือนสหรัฐหยุดเลือกปฏิบัติต่อนักศึกษาจีน ลั่นจะดำเนินการต่อไปเพื่อปกป้องสิทธิพลเมืองจีน
การทดสอบวัคซีนของออกซ์ฟอร์ดและแอสตร้าเซนเนก้ายังคงดำเนินต่อแม้มีผู้เข้าร่วมเสียชีวิต
เวียดนามน้ำท่วมหนักสุดในรอบหลายสิบปี ตายทะลุ 100 ราย อพยพนับแสน
จีนยังคงคำสั่งห้ามกรุ๊ปทัวร์เที่ยวต่างประเทศกังวลโควิดระบาดอีกครั้งช่วงฤดูหนาว
รัฐบาลสหรัฐอนุมัติการขายขีปนาวุธมูลค่า 1,800 ล้านเหรียญสหรัฐให้ไต้หวันในช่วงเวลาที่ไต้หวันต้องเสริมสมรรถนะกองทัพเพื่อรับมือภัยคุกคามจากจีน
ไทย-ไต้หวันร่วมแถลงการณ์สนับสนุนการเรียกร้องประชาธิปไตยในไทย
ยอดขายเซ็กซ์ทอยจีนพุ่งผลพวงจากการล็อกดาวน์ช่วงโควิด
