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Health

In a Reversal, F.D.A. Requires Limits on Who Will get Alzheimer’s Drug

When the FDA approved Aduhelm a month ago, the original label said the drug was “for the treatment of Alzheimer’s disease.” The surprisingly broad label caused a storm of concern among many Alzheimer’s experts, even those who had supported the drug’s approval.

At a forum sponsored by the Alzheimer’s Association last month that urged Aduhelm to be approved, a panel of Alzheimer’s clinics with differing views agreed on whether the drug should have been approved that its use was strong should be restricted.

Many experts say the drug’s label should not only restrict Aduhelm’s use to mild disease stages, but also require two more stringent clinical trial conditions: that suitable patients have evidence of high levels of a key protein, amyloid, in their brain, and that people with certain diseases (so-called “contraindications”) should be prevented from taking the drug or at least classified as a high-risk group, as this can lead to brain swelling and bleeding.

At the forum, Dr. Stephen Selloway, director of the Memory and Aging Program at Butler Hospital in Providence, RI, who helped conduct the Aduhelm studies and is one of the drug’s most ardent medical advocates, when he saw the label had no contraindications to his The reaction was “oy”.

On Thursday, Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, who also worked on one of the Aduhelm studies and spoke out against the approval of the drug, saying that the new labeling was neglected.

The label should have said, among other things, that people with diabetes, high blood pressure and people who take blood thinners are not allowed to take part in the clinical trials and therefore “no extent is known”. of increased risk ”for these patients.

Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, said the new label was based more on what he and other Alzheimer’s experts believe should originally have been written. But the abrupt revision of the label so soon after a much criticized approval decision was worrying, he said.

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Politics

Biden, in Reversal, Raises Refugee Cap to 62,500 in Subsequent 6 Months

President Biden turned on Monday and said he would allow up to 62,500 refugees to enter the United States over the next six months, removing the sharp limits that former President Donald J. Trump had placed on those seeking refuge before war, violence or nature seek disasters.

“This erases the historically low number set by the previous administration of 15,000 that does not reflect America’s values ​​as a nation that welcomes and supports refugees,” Biden said in a White House statement.

The action came about two weeks after Mr Biden announced he would keep Mr Trump’s line of 15,000 refugees. The announcement was widely condemned by Democratic lawmakers on Capitol Hill and refugee lawyers who accused the president of failing to keep an election promise to admit the needy.

White House officials had insisted that Mr Biden’s intentions were misunderstood in mid-April. However, his decision to raise the refugee limit to 62,500 suggests that he felt pressure to act.

In his statement, Mr Biden admitted that the government is unlikely to relocate 62,500 refugees as the agencies suffered budget and staff cuts during Mr Trump’s tenure. Mr Biden did not say whether the government had already managed to take in the 15,000 refugees admitted by his predecessor.

“The sad truth is we won’t get 62,500 approvals this year,” he said. “We are working quickly to reverse the damage suffered over the past four years. It will take time, but this work is already under way. “

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Politics

In Reversal, Pentagon Publicizes Plane Service Nimitz Will Stay in Center East

WASHINGTON – The Pentagon said Sunday it had ordered the aircraft carrier Nimitz to remain in the Middle East over Iranian threats against President Trump and other American officials, just three days after the warship was sent home to ease mounting tensions Tehran.

Acting Secretary of Defense, Christopher C. Miller, abruptly overturned his previous order to reinstate the Nimitz, which he had done against the objections of his top military advisers. The military had been preoccupied with a muscle-building strategy for weeks to prevent Iran from attacking American personnel in the Persian Gulf.

“Due to the recent threats by Iranian leaders against President Trump and other US government officials, I have ordered the USS Nimitz to cease its routine redeployment,” Miller said in a statement on Sunday evening.

United States intelligence agencies have noted for months that Iran is attempting to target senior American military officers and civilian leaders in order to assassinate the death in an American of Maj. Gen. Qassim Suleimani, commander of Iran’s elite quds force in the Islamic Revolutionary Guards Corps avenge drone attack a year ago.

However, it was unclear what the new urgency of these threats led Mr. Miller to cancel his previous order to send the Nimitz home. In the past few days, Iranian officials have been stepping up their fiery news against the United States. The head of Iran’s judiciary, Ebrahim Raisi, said that anyone involved in the assassination of General Suleimani would not be able to “escape from law and justice” even if they were an American president.

It was unclear last week whether Mr. Trump was aware of Mr. Miller’s order to send the Nimitz to its homeport in Bremerton, Washington, after a longer than usual 10 month deployment.

Some Trump administration officials suggested on Sunday that with a controversial political week – the Georgia Senate runoff on Tuesday and the House and Senate meeting on Wednesday to win President-elect Joseph R. Biden Jr. confirm – the look of the aircraft carriers steaming from the Middle East did not match the White House.

Whatever the reason, the mixed news surrounding the aviation company’s movements is raising new questions about coordination and communication between an inexperienced Pentagon leadership and the White House in the dwindling days of the Trump administration.

Some current and former Pentagon officials have criticized the decision-making process at the Pentagon since Mr. Trump sacked Secretary of Defense Mark T. Esper and several of his top advisors in November and replaced them with Mr. Miller, a former counter-terrorism adviser to the White House. and several Trump loyalists.

Officials said Friday that Mr Miller ordered the redeployment of the Nimitz in part as a “de-escalation” signal to Tehran to avoid falling into a crisis at the end of Mr Trump’s administration that would land in Mr Biden’s lap in office.

In the past few weeks, Mr Trump has repeatedly threatened Iran on Twitter, and in November senior national security aides advised the president against launching a pre-emptive strike against an Iranian nuclear facility.

The Central Command of the Pentagon had published several violent demonstrations for weeks to warn Tehran of the consequences of an attack on American troops or diplomats.

The Nimitz and other warships arrived to protect American forces withdrawing from Iraq, Afghanistan and Somalia. The Air Force dispatched B-52 bombers three times to fly within 60 miles of the Iranian coast. And the Navy announced for the first time in nearly a decade that it had commanded a cruise missile submarine into the Persian Gulf.

American intelligence reports indicated that Iran and its deputies may have been preparing a strike last weekend to avenge the deaths of General Suleimani and Abu Mahdi al-Muhandis, head of the Iran-backed militia Kataib Hezbollah, who was last seen Killed in the same United States drone strike in Baghdad on January 1st.

American intelligence analysts have discovered Iranian air defenses, naval forces and other security units on high alert in the past few days. They also noted that Iran brought more short-range missiles and drones into Iraq.

But senior Defense Department officials admit they cannot say whether Iran or its Shiite proxies in Iraq are ready to beat American troops or prepare defensive measures if Mr Trump orders a pre-emptive attack against them.

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World News

In Abrupt Reversal of Iran Technique, Pentagon Orders Plane Provider Residence

WASHINGTON – The Pentagon abruptly sent the aircraft carrier Nimitz home from the Middle East and Africa to raise objections to senior military advisers. This marks the reversal of a week-long muscle building strategy designed to deter Iran from attacking American troops and diplomats in the Persian Gulf.

Officials said on Friday that incumbent Defense Secretary Christopher C. Miller had ordered the ship to be redeployed in part as a “de-escalation” signal to Tehran to avoid President Trump falling into crisis in the dwindling days of his term in office. American intelligence reports suggest that Iran and its deputies may be preparing a strike this weekend to avenge the death of Major General Qassim Suleimani, the commander of Iran’s elite Quds force in the Islamic Revolutionary Guards Corps.

Pentagon senior officials said Mr Miller believed that dispatching the Nimitz before the first anniversary of General Suleimani’s death in an American drone strike in Iraq would eliminate what Iranian hardliners see as the provocation justifying their threats against Americans could be military targets. Some analysts said the Nimitz’s return to her home port of Bremerton, Washington, would be a welcome relief in tension between the two countries.

“If the Nimitz leaves, it could be because the Pentagon believes the threat may lessen somewhat,” said Michael P. Mulroy, the Pentagon’s former chief politician in the Middle East.

However, critics said the mixed news was another example of the inexperience and confusing decision-making at the Pentagon since Trump fired Secretary of Defense Mark T. Esper and several of his top aides in November and replaced them with Mr. Miller, a former counter-terrorism adviser at the White House and several Trump loyalists.

“This decision sends a mixed signal to Iran at best and reduces our choices at just the wrong time,” said Matthew Spence, a former senior Pentagon leader in the Middle East. “It seriously questions what strategy the administration is pursuing here.”

Mr. Miller’s order canceled a request from General Kenneth F. McKenzie Jr., commander of the American Forces in the Middle East, to extend the Nimitz’s service and keep her formidable wing of attack aircraft ready.

In the past few weeks, Mr Trump has repeatedly threatened Iran on Twitter, and in November senior national security aides advised the president against launching a pre-emptive strike against an Iranian nuclear facility. It is unclear whether Mr Trump was aware of Mr Miller’s order to send the Nimitz home.

The Pentagon and General McKenzie’s Central Command had published several violent demonstrations over weeks to warn Tehran of the consequences of an attack. The Nimitz and other warships arrived to protect American forces withdrawing from Iraq, Afghanistan and Somalia. The Air Force dispatched B-52 bombers three times to fly within 60 miles of the Iranian coast. And the Navy announced for the first time in nearly a decade that it had ordered a Tomahawk missile submarine into the Persian Gulf.

On Wednesday, General McKenzie warned the Iranians and their Shiite militia representatives in Iraq against attacks around the anniversary of General Suleimani’s death on January 3.

On Thursday, senior military advisers including General McKenzie and General Mark A. Milley, chairman of the joint chiefs of staff, were surprised by Mr Miller’s decision on the Nimitz.

The Navy had attempted to expand the aircraft carrier’s already protracted use, but commanders believed the warship would remain for a few more days to counter what military intelligence analysts saw as a growing and imminent threat.

American intelligence analysts have discovered Iranian air defenses, naval forces and other security forces on greater alert in the past few days. They also noted that Iran brought more short-range missiles and drones into Iraq. But senior Defense Department officials admit they cannot say whether Iran or its Shiite proxies in Iraq are ready to beat American troops or prepare defensive measures if Mr Trump orders a pre-emptive attack against them.

“What you have here is a classic security dilemma where maneuvers on either side can be misunderstood and increase the risk of miscalculation,” said Brett H. McGurk, Trump’s former special envoy for the coalition on the defeat of Islamic State.

Some of Mr. Miller’s top advisors, including Ezra Cohen-Watnick, one of the White House loyalists newly appointed as Pentagon’s chief intelligence officer, have expressed doubts about the Nimitz’s deterrent value, especially when weighed against the moral cost of their expanding tour . Some aides also questioned the impending attack by Iran or its proxies, an assessment CNN had previously reported.

Pentagon officials said they had sent additional land-based warplanes and attack jets, as well as refueling planes, to Saudi Arabia and other Gulf states to compensate for the Nimitz’s loss of firepower.

On Friday, the commander in chief of Iran’s Islamic Revolutionary Guard Paramilitary Corps said his country was fully prepared to respond to US military pressure amid mounting tensions between Tehran and Washington in the waning days of Trump’s presidency.

“Today we have no problem, worry or concern about meeting any powers,” Major General Hossein Salami said at a ceremony at Tehran University to commemorate the anniversary of General Suleimani’s death.

“We will give our last words to our enemies on the battlefield,” said General Salami, without directly mentioning the United States.

Iranian Foreign Minister Javad Zarif said Thursday that the Trump administration was creating an excuse for war.

“Instead of fighting Covid in the US, @realDonaldTrump & Cohorts are wasting billions flying B52 and sending Armadas to our region,” Zarif said in a tweet. “Iraqi intelligence agencies suggest a conspiracy to create the pretext for war. Iran does not seek war, but will openly and directly defend its people, security and vital interests. “

In a further provocation from Iran on Friday, Tehran informed international inspectors that the production of uranium with a significantly higher enrichment was to begin in Fordow, a plant that lies deep under a mountain and is therefore more difficult to attack. The move appeared primarily to be aimed at putting pressure on President-elect Joseph R. Biden Jr. to re-join the nuclear deal with Iran. Little activity was allowed at the Fordow plant under the 2015 contract.

The message to the International Atomic Energy Agency in Vienna, the United Nations group that oversees the production of nuclear material, said Iran will resume production of uranium enriched with 20 percent purity. This is the highest level it produced before the nuclear deal, which the country justified at the time as necessary for the production of medical isotopes for its Tehran research reactor.

Fuel enriched to this level is not enough to make a bomb, but it is close. It requires relatively little further enrichment to reach the 90 percent purity traditionally used for bomb fuel.

The move wasn’t unexpected. The Iranian parliament recently passed a law requiring the government to increase both the amount of fuel it produces and the level of enrichment. But the decision to carry out this production in Fordow, the newest plant, was significant. The facility is located deep under a mountain in a well-protected base of the Islamic Revolutionary Guards. A successful attack would require repeated attacks using the largest bunker bomb in the American arsenal.

It would be months for Iran to produce a significant amount of 20 percent enrichment fuel, but the mere announcement could be another red flag for Mr Trump to rekindle the bombing options.

David E. Sanger contributed to the coverage.

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Politics

Trump Allies Eye Lengthy-Shot Election Reversal in Congress

Mr. Brooks tried to get support. He met with about half a dozen senators, including Utah’s Mike Lee, and separately with the conservative House Freedom Caucus last week.

“My # 1 goal is to fix a badly flawed American electoral system that is too easy to fraud and steal,” said Brooks. “A possible bonus for achieving this goal is that if you only count legitimate votes from legitimate American citizens and exclude all illegal votes, Donald Trump would officially win the electoral college, as I believe he actually did.”

It remains unclear how broad a coalition could be. More than 60 percent of Republicans in the House of Representatives, including the two top party leaders, joined a legal letter backing the unsuccessful Texas lawsuit and asking the Supreme Court to overturn the election results. But it is one thing to sign a legal mandate and another to officially challenge the outcome on the floor of the house.

Some Republicans, including Representative Scott Perry from Pennsylvania and Representative Matt Gaetz from Florida, have also signaled that they could support an appeal. Mr. Brooks said he had spoken to other interested parties. But prominent allies of the president who have plunged headlong into previous fights, such as representative Jim Jordan from Ohio or even the minority leader of the House of Representatives, representative Kevin McCarthy from California, have so far been publicly noncommittal.

“All eyes are on January 6,” Gaetz said Friday night on Fox News after the Supreme Court dismissed the Texas lawsuit. “I suspect there will be some debate and discourse in Congress as we go through the voter certification process. We still believe there is evidence that needs to be considered. “

Kentucky Republican Mr Paul said he would “wait and see how all legal cases play out” before deciding what to do.

Mr Johnson plans to hold a hearing this week “investigating the irregularities in the 2020 election,” and Ken Starr, the former independent attorney who is a right-wing favorite, and at least two attorneys who stand up for Mr Trump have pronounced introduces. Whether he will question the results on Jan. 6, he told reporters last week, “depends on what we find out.”

Maggie Haberman contributed to the coverage.