FDA Panel Backs First-of-a-Kind COVID-19 Pill From Merck

A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. 

A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. 

The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on the FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age. 

The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study and haven’t been shown to benefit. 

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The pill is already authorized in the United Kingdom. 

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant.

Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of the coronavirus. 

But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans. 

“With no data saying it works with new variants, I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug. 

Effectiveness, dangers

The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier. 

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results. 

That smaller-than-expected benefit amplified experts’ concerns about the drug’s toxicity for fetuses. 

FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.” 

FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options. 

Dr. Janet Cragan, who backed the drug, said that even with tight restrictions, some pregnant women would inevitably take the drug.

“I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”

Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely. 

Pfizer drug

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review. 

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug. 

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations. 

The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir. 

Both drugs require patients to take multiple pills, twice a day for five days. 

 

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Ex-Trump Chief-of-Staff Meadows Cooperating with Jan. 6 Panel, for Now 

The House of Representatives committee investigating the deadly Jan. 6 U.S. Capitol riot said on Tuesday that Mark Meadows, who served as former President Donald Trump’s chief-of-staff, has provided it with records and agreed to appear soon for a deposition. 

“Mr. Meadows has been engaging with the Select Committee through his attorney. He has produced records to the committee and will soon appear for an initial deposition,” Democratic Representative Bennie Thompson, chairman of the House select committee, said in a statement. 

Thompson did not rule out future action against Meadows. Noting that the panel expects all witnesses to provide all the information requested that it is lawfully entitled to receive, Thompson said: “The committee will continue to assess his degree of compliance with our subpoena after the deposition.” 

Trump has urged his associates not to cooperate with the committee, calling the Democratic-led investigation politically motivated and arguing that his communications are protected by executive privilege, although many legal experts say that legal principle does not apply to former presidents. 

On Jan. 6, Trump supporters stormed the Capitol in a bid to prevent Congress from formally certifying his 2020 presidential election loss to Democrat Joe Biden. Shortly before the riot, Trump gave a speech to his supporters repeating his false claims that the election was stolen from him through widespread voting fraud and urging them to go to the Capitol and “fight like hell” to “stop the steal.” 

‘An understanding’ 

Meadows’ lawyer George Terwilliger did not immediately respond to a request for comment. 

Terwilliger said in a statement to CNN that the two parties had reached an understanding on how information can be exchanged moving forward, stating that Meadows and the committee are open to engaging on a certain set of topics as they work out how to deal with information that could fall under executive privilege. 

Meadows was a Republican House member until he left in 2020 to join Trump’s administration. 

Trump’s former chief strategist Steve Bannon already has been criminally charged with contempt of Congress, pleading not guilty, after defying a committee subpoena. The select committee is meeting  on Wednesday to consider seeking similar charges against Jeffrey Clark, who served as a senior Justice Department official under Trump. 

Meadows was called to appear before the committee this month, but did not do so. 

Agreeing to appear for a deposition does not guarantee that Meadows will provide all the information requested in the committee’s subpoena. Clark appeared, but committee members said he did not cooperate with investigators. 

House Majority Leader Steny Hoyer told reporters on Tuesday that he expects the Democratic-led chamber to vote on Clark’s contempt recommendation this week, if the panel approves it as expected. 

 

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1st French Omicron Case on Indian Ocean Island of Reunion

Japan and France confirmed their first cases of the new variant of the coronavirus on Tuesday as countries around the world scrambled to close their doors or find ways to limit its spread while scientists study how damaging it might be.

The World Health Organization has warned that the global risk from the omicron variant is “very high” based on early evidence, saying it could lead to surges with “severe consequences.”

French authorities on Tuesday confirmed the first case of the omicron variant in the French island territory of Reunion in the Indian Ocean. Patrick Mavingui, a microbiologist at the island’s research clinic for infectious diseases, said the person who has tested positive for the new variant is a 53-year-old man who had traveled to Mozambique and stopped in South Africa before returning to Reunion.

The man was placed in quarantine. He has “muscle pain and fatigue,” Mavingui said, according to public television Reunion 1ere.

Japan on Tuesday confirmed its first case in a visitor who recently arrived from Namibia, a day after banning all foreign visitors as an emergency precaution against the variant. A government spokesperson said the patient, a man in his 30s, tested positive upon arrival at Narita airport on Sunday and was isolated and is being treated at a hospital.

Cambodia barred entry to travelers from 10 African countries, citing the threat from the omicron variant. The move came just two weeks after Cambodia reopened its borders to fully vaccinated travelers on Nov. 15.

The new version was first identified days ago by researchers in South Africa.

WHO said there are “considerable uncertainties” about the omicron variant. But it said preliminary evidence raises the possibility that the variant has mutations that could help it both evade an immune-system response and boost its ability to spread from one person to another.

The WHO stressed that while scientists are hunting evidence to better understand this variant, countries should accelerate vaccinations as quickly as possible.

Despite the global worry, doctors in South Africa are reporting patients are suffering mostly mild symptoms so far. But they warn that it is early. Also, most of the new cases are in people in their 20s and 30s, who generally do not get as sick from COVID-19 as older patients. 

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Why Trump Is Suing the ‘Nation’s Filing Cabinet’

Former President Donald Trump thrust the National Archives and Records Administration into the national spotlight after suing to keep the agency from releasing Trump White House documents to the congressional committee investigating the January 6 attack on the U.S. Capitol. 

A court is expected to hear the latest arguments in the case on November 30. 

Why are the call logs, drafts, speeches, handwritten notes and other documents from Trump’s term in office in the possession of the National Archives? 

“Presidential records are the property of the United States government and are administered by the National Archives,” says Meghan Ryan Guthorn, acting deputy chief operating officer of the agency. “So, all presidential papers, materials and records in the custody of the National Archives, whether donated, seized or governed by the Presidential Records Act, are owned by the federal government.” 

The Presidential Records Act of 1978 established that all presidential records are owned by the public and automatically transfer into the custody of the National Archives as soon as a commander-in-chief leaves office. All presidential libraries and museums are part of the National Archives. Former President Barack Obama’s presidential library will be the first to be fully digital. 

“The National Archives and Records Administration is the official record keeper for the United States government,” Ryan Guthorn says. “Only about one to 3% of the records are considered permanent records, and those are the documents that are essential to understanding the rights and entitlements of U.S. citizens, that hold our elected officials accountable for their actions, (and) document our history as a nation.” 

Presidential records weren’t always owned by the public. 

“From George Washington through Jimmy Carter, the papers of a presidential administration were considered the private property of a president to do with as they saw fit,” Ryan Guthorn says. 

Most commanders-in-chief have donated their presidential papers, a precedent started by President Franklin D. Roosevelt in 1940. That continued until the 1970s when President Richard Nixon fought to destroy his records, including secret tape recordings, during the Watergate scandal that eventually led to his resignation from office. 

Congress suspected the tapes contained evidence that could incriminate the president. Lawmakers passed the Presidential Recordings and Materials Preservation Act of 1974, which applied only to Nixon’s presidential materials and instructed that materials related to Watergate be retained by NARA.

During his lifetime, Nixon fought to keep his presidential records private. NARA received most of the recordings related to Watergate, but not all. After Nixon’s death, his family donated his presidential papers and other materials. 

“Julie Nixon Eisenhower calls me, said she wanted to meet with me, said the family wanted to settle,” says John Carlin, who served as archivist of the United States from 1995 until 2005. 

Nixon’s daughter reached out to Carlin during his first week on the job in June of 1995, more than 20 years after Watergate. 

‘“You have to remember that in those days, the president’s records were personal,” Carlin says. “Nixon was going to keep them, and he had the law on his side. … And so, when she called that day and said, ‘We’re ready to settle,’ that was good news. …When he (Nixon) was alive, he fought it. I mean, tooth and toenail. There wasn’t going to be any settlement.” 

Carlin says dealing with Nixon’s papers consumed most of his decade-long term at the helm of NARA. But now, with the Presidential Records Act in place, he does not expect the same complications to arise with Trump’s records. 

“I’m not a lawyer, so take that into consideration, but I don’t think he has a leg to stand on,” Carlin says. “The law is on the side of the government. The law is clear. Those are government records, presidential records that the government controls and has access to.” 

Among those who access White House records are presidential scholars like Shannon Bow O’Brien who are interested in documenting history. 

“The public can start making requests through the Freedom of Information Act five years after an administration ends, but also the president can invoke certain restrictions for public access for up to 12 years,” says Bow O’Brien, a professor in the government department at The University of Texas at Austin College of Liberal Arts.

“If we don’t have access to this material, we don’t have access to the truth. We only have access to curated truths, in many ways, which is what people want to tell us, or what people want us to see, and that’s not always the most accurate.” 

Bow O’Brien sees an upside to Trump’s fight to keep his presidential records out of Congress’ hands. 

“If nothing else, this Trump administration might be giving us additional clarity on some areas of the law that have never previously been challenged,” she says. 

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January 6 Panel Sets Contempt Vote for Former DOJ Official

A House committee investigating the January 6 Capitol insurrection will vote Wednesday to hold a former Justice Department official in contempt, demanding criminal charges against a defiant witness for a second time as lawmakers seek answers about the violent attack.

The committee on Monday scheduled a vote to pursue contempt charges against Jeffrey Clark, a former Justice Department lawyer who aligned with former President Donald Trump as he tried to overturn his election defeat. If approved by the panel, the recommendation of criminal contempt charges would then go to the full House for a vote and then to the Justice Department.

Clark appeared for a deposition November 5 but told lawmakers that he would not answer questions based partly on Trump’s legal efforts to block the committee’s investigation.

The vote will come as the panel is also considering contempt charges against former White House Chief of Staff Mark Meadows, who was Trump’s top aide the day that hundreds of his supporters violently attacked the U.S. Capitol and interrupted the certification of President Joe Biden’s victory. Meadows was subpoenaed in September but has not yet sat for an interview with the committee.

Members of the panel have vowed to aggressively seek charges against any witness who doesn’t comply as they investigate the worst attack on the Capitol in two centuries, and the Justice Department has signaled it is willing to pursue those charges, indicting longtime Trump ally Steve Bannon earlier this month on two federal counts of criminal contempt. Attorney General Merrick Garland said then that Bannon’s indictment reflects the department’s “steadfast commitment” to the rule of law after Bannon outright defied the committee and refused to cooperate.

Clark’s case could be more complicated since he did appear for his deposition and, unlike Bannon, was a Trump administration official on January 6. Trump has sued to block the committee’s work and has attempted to assert executive privilege over documents and interviews, arguing that his conversations and actions at the time should be shielded from public view.

A report issued by Democrats on the Senate Judiciary Committee detailed how Clark championed Trump’s efforts to undo the election results and clashed as a result with Justice Department superiors who resisted the pressure, culminating in a dramatic White House meeting at which Trump ruminated about elevating Clark to attorney general. He did not do so after several aides threatened to resign.

In a somewhat similar case, the Justice Department in 2015 declined to prosecute former IRS official Lois Lerner on contempt of Congress charges after Lerner delivered an opening statement at a hearing but then repeatedly declined to answer questions from lawmakers, citing her Fifth Amendment right to not incriminate herself.

This time, though, the Justice Department is considering the charges against a former administration official, not a current official. With little precedent to go on, it’s unclear what the department would do.

Clark is one of more than 40 people the committee has subpoenaed so far. The panel’s chairman, Mississippi Representative Bennie Thompson, wrote in Clark’s subpoena that the committee’s probe “has revealed credible evidence that you attempted to involve the Department of Justice in efforts to interrupt the peaceful transfer of power” and his efforts “risked involving the Department of Justice in actions that lacked evidentiary foundation and threatened to subvert the rule of law.”

After Clark refused to answer questions, Thompson said it was “astounding that someone who so recently held a position of public trust to uphold the Constitution would now hide behind vague claims of privilege by a former president, refuse to answer questions about an attack on our democracy, and continue an assault on the rule of law.”

Lawmakers on the committee have said that they will decide as soon as this week whether to hold Meadows in contempt, as well. Thompson said earlier this month that the committee “won’t rush the effort” to make it clear it has given the former North Carolina congressman multiple opportunities to cooperate.

Meadows’ lawyer has repeatedly made clear that he won’t comply with the September subpoena, arguing that Trump has said he will assert executive privilege over the testimony. The committee has rejected those arguments, especially as the White House has said that Biden would waive any privilege over Meadows’ interview and as courts have so far shot down Trump’s efforts to stop the committee from gathering information.

Members of the House panel have argued that they have questions for Meadows and Clark, as they did with Bannon, that do not directly involve conversations with Trump and couldn’t possibly be blocked by privilege claims.

In the committee’s September subpoena, Thompson cited Meadows’ efforts to overturn Trump’s defeat in the weeks prior to the insurrection and his pressure on state officials to push the former president’s false claims of widespread voter fraud.

Despite Trump’s false claims about a stolen election — the primary motivation for the violent mob that broke into the Capitol and interrupted the certification of Biden’s victory — the results were confirmed by state officials and upheld by the courts. Trump’s own attorney general, William Barr, had said the Justice Department found no evidence of widespread fraud that could have changed the results. 

 

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