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Biden needs to tell the FDA to stop blocking lifesaving COVID treatments

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Biden needs to tell the FDA to stop blocking lifesaving COVID treatments

Four years ago, influenza infected 41 million Americans in a matter of months. Imagine if we did mass testing for influenza and graphed daily cases. In fact, most winters, 10 to 25 percent of the US population gets infected with a respiratory pathogen, like RSV, rhinovirus, influenza and four other known coronaviruses that have circulated seasonally for centuries (COVID is the fifth seasonal coronavirus).

Testing is an important tool in protecting vulnerable people, but it is nearly impossible to contain a highly transmissible respiratory infection seeded throughout a population. We cannot outrun this lion. It’s time we bring attention to early treatment. We have lifesaving medications that public-health officials never talk about.

Fluvoxamine, a commonly available medication, reduced COVID deaths by 91 percent in a randomized controlled trial conducted with impeccable methodology and recently published in The Lancet. This study affirms another trial on the drug published last spring in the Journal of the American Medical Association. The drug is safe, has a plausible mechanism of action, costs $10 and has no contrary studies that might challenge the breathtaking results published. Yet I’ve never heard our public-health officials mention fluvoxamine.

An 8-year-old is swabbed for a COVID-19 test.
AP / Rebecca Blackwell

Instead, our leaders are pushing boosters for young, healthy people and masking 2-year-olds despite the documented harm. These responses lack supporting data and come in stark contrast to the federal government’s delinquency in authorizing drugs proven to dramatically save the lives of COVID patients. Merck and Pfizer’s antiviral pills designed to work against all variants are awaiting Food and Drug Administration action.

Merck’s lifesaving drug molnupiravir received an up-vote from the FDA’s external experts three weeks ago, yet the agency has not authorized the drug. Pfizer’s Paxlovid drug cut COVID deaths to zero (compared with 10 deaths in the control group), yet in the five weeks the FDA has been sitting on the application the agency has not even scheduled an advisory meeting to review it. Maybe functionaries don’t want to change their holiday plans.

The failure of public-health officials to talk about fluvoxamine and authorize molnupiravir and Paxlovid during a health emergency is medical malpractice. I can’t understand what kind of human being sits on the application of a lifesaving drug like Paxlovid — again, a safe drug that cut COVID deaths to zero — as 1,300 Americans die each day.

Our government bureaucrats have lost their sense of mission and become detached from sick patients having trouble breathing in emergency departments and fighting for their life in hospital ICUs. The Biden administration should immediately talk about fluvoxamine and demand that the FDA provide an up or down authorization or non-authorization of molnupiravir and Paxlovid within 24 hours.

DeMarcus Hicks, a recent graduate of nursing school, gives a person a COVID-19 vaccine booster shot.
DeMarcus Hicks, a recent graduate of nursing school, gives a person a COVID-19 vaccine booster shot.
AP / Ted S. Warren

Last week I testified before Congress that many COVID policies are no longer driven by science. Data are being cherry picked to support predetermined, political agendas, while lifesaving therapeutics are being sidelined and natural immunity is being ignored.

We also need straight talk when it comes to Omicron. Now 73 percent of new US COVID infections are from Omicron, a strain resulting in more mild illness. A University of Hong Kong study found that Omicron is one-tenth as infective in lung cells compared with the Delta variant. That explains why Omicron patients report far fewer cough and fever symptoms and far fewer people develop severe illness. Instead, the vast majority of Omicron-infected people get common-cold symptoms.

The fear headline is that Omicron partially evades antibody immunity. That’s true; so did Delta. But, also like Delta, Omicron does not escape existing T-cell immunity, according to a new Johns Hopkins study, which is consistent with mounting population data. Cases from the epicenter in Gauteng, South Africa, are plunging, down 44 percent Monday from the prior day. According to South African Health Minister Dr. Joe Phaahla, only 1.7 percent of COVID cases were hospitalized the second week of the Omicron-dominant wave, compared with 19 percent the same week of the Delta wave.

We now have laboratory data, epidemiological data and bedside observations to conclude that Omicron is a milder variant. We are witnessing how pandemics end — a virus mutates down and becomes endemic as population immunity increases.

COVID-19 tests on store shelves.
Biden announced plans to administer 500 million at-home rapid tests to Americans.
AP / Ted S. Warren

Omicron resulted in tremendous uncertainty when the news first hit. Our public-health officials took no action to study the virus in their many expensive labs. Instead, Pfizer officials put out a press release Dec. 8, saying they had conducted a lab experiment that demonstrated a booster shot increased antibody levels against Omicron. They didn’t release the underlying data but swiftly broadcast their headline findings. The next day, the FDA authorized boosters for 16- and 17-year-olds and the Centers for Disease Control officially cemented the recommendation. Is that what we’ve come to? Pharma tells people what to do in a press release, and the FDA and CDC just fall in line?

Imagine if I as your physician told you during a routine check-up that you are likely going to get a common cold this winter. You wouldn’t flinch. You probably wouldn’t go into social isolation or pre-emptively cancel your livelihood. If I told parents that kids typically come down with five or six common colds during childhood, they wouldn’t have them wear a mask in school K through 12. We’d simply tell them to not attend class if they are contagious.

The Merck logo on a stained glass panel at a Merck company building in Kenilworth, N.J.
Merck’s drug molnupiravir received an up-vote from the FDA’s external experts three weeks ago.
AP / Mel Evans

We should not downplay or ignore respiratory pathogens (it should never be acceptable to come to work coughing and slobbering on people as it was pre-COVID), but never before have we seen this level of medical and governmental paternalism to enact restrictions to make sure low-risk people have their risk of a mild infection reduced against their will.

The 20 to 30 million American adults who have not had COVID (and lack natural immunity) and have chosen not to be vaccinated have done so at their own individual risk. They have made a poor health decision, in my opinion, putting themselves at risk of the Delta strain, which is still sending approximately 7,000 of them to US hospitals each day.

Why are we closing society and destroying the economy for 300 million Americans who are at risk only of a mild common-cold illness?

Dr. Marty Makary is a professor at the Johns Hopkins School of Medicine and author of “The Price We Pay: What Broke American Health Care and How to Fix It.”

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Sports world reacts to John Madden’s death

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Sports world reacts to John Madden’s death

Legendary NFL coach and broadcaster John Madden died Tuesday morning at 85, the NFL announced. News of the football icon’s passing hit Twitter on Tuesday evening, and athletes, coaches and broadcasters from across the sports world reacted.

Fellow broadcasting legend Dick Vitale, who is currently battling cancer, called Madden “the greatest analyst of all time of any sport” in his Twitter tribute.

Former Yankees pitcher and notable Raiders fan CC Sabathia said “your legacy will live forever.” Madden coached the then-Oakland Raiders from 1969-78, a couple of years before Sabathia, a Vallejo, California native, was born. Lakers star LeBron James had similar words about Madden’s lasting legacy, adding an infinity emoji.

Former tennis star and social justice activist Billie Jean King recalled meeting Madden as a “privilege.”

Radio voice of the Rangers Kenny Albert, a five-sport broadcaster who’s been with FOX Sports since its inception in 1994, shared a photo circa 26 years ago to remember Madden.

ESPN’s Bomani Jones took a bit of a shot at current color commentators, noting that Madden “set an unreachable standard.”

Frank Caliendo, who’s made a career out of impersonations, including one for Madden, said he was surprised how emotional he felt.

Several football players, and others, including Saints running back Mark Ingram II and former Cowboys receiver Dez Bryant, credited Madden with being part of the reason why they love football.

Rams wide receiver and NFL MVP contender Cooper Kupp quote the late coach in his tribute: “The road to Easy Street goes through the sewer.”

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Miles McBride’s Knicks role will lessen with Kemba Walker’s resurgence

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Miles McBride’s Knicks role will lessen with Kemba Walker’s resurgence

MINNEAPOLIS — The Knicks got back another body in rookie point guard Miles McBride, who was cleared from protocols Tuesday and rejoined the team in Minnesota.

But there is no longer any hype for the rookie’s return. Kemba Walker is back as the starting point guard and coming off winning Eastern Conference Player of the Week honors with four standout games, including his Christmas Day spectacular. The Knicks have gone 2-2 since Walker regained the starting job.

“It’s great,’’ coach Tom Thibodeau said. “He had a great week. He’s playing great basketball. The team winning helps him get recognized and he was a big part of driving that winning. It’s great for the team.’’

McBride was also spectacular in his last outing before getting COVID-19, when he played the entire second half Dec. 16 in Houston and seemingly earned a spot in the rotation. In fact, McBride had strung together two decent outings before he was ruled out. But things have changed since his emergence and McBride is likely back to being a bit player.

Without a practice, McBride wasn’t even expected to see time when the Knicks faced the Timberwolves to kick off a four-game road trip.

Miles McBride
NBAE via Getty Images

Of course, with Walker’s arthritic knee, anything is possible. The Knicks play Detroit on Wednesday in a back-to-back, so it’s uncertain whether Walker will complete both contests. In addition, Immanuel Quickley is out of COVID-19 protocols but Thibodeau wasn’t sure he was ready for meaningful minutes.

That left Walker against the depleted Timberwolves, who were missing their three top players (Anthony Edwards, Karl-Anthony Towns, D’Angelo Russell), all because of COVID-19 .

Kemba Walker
Kemba Walker
USA TODAY Sports

When McBride got sidelined by the virus and Derrick Rose needed ankle surgery, Walker was resurrected by Thibodeau and it’s been a stunning comeback story.

Though Thibodeau has clear reservations about Walker based on his nine-game banishment due to his defensive malaise as an undersized point guard, he admitted after the Christmas Day triple-double against Atlanta that Walker is playing “much more aggressive.”

Walker’s triple-double that featured 10 points, 12 assists and 10 rebounds was a lot different than his prior outing, when he scored 44 points against Washington.

“I thought his passing was terrific,’’ Thibodeau said before the Knicks resumed their schedule.

“Kemba had control of the game. The game tells you what to do. That’s what I loved about the way he played. I don’t think he forced anything. They puts size on him and were aggressive in their pick-and-roll coverage. He didn’t fight it. He attacked pressure the way you like to attack pressure. You don’t fight pressure with pressure. Don’t try to split it. Get rid of it, go to the backside. Let the game tell you what to do.’’

The Knicks coach is finally seeing all the elements of what Walker can do. Before his demotion, Walker was nothing more than a no-defense, 3-point shooter whose plus-minus was an abysmal minus-122.

Thibodeau was also concerned about his durability in sitting out two of the three back-to-back sets. The last load management game in Atlanta in late November triggered Thibodeau’s decision.

But now it’s only superlatives from Thibodeau in judging the last four games.

“Sometimes it’s going to be his shooting, sometimes it’s his penetration and getting in the paint to force a collapse and sometimes they’re being aggressive with their traps get rid of the ball quickly,’’ Thibodeau said. “The overall play, his rebounding. When your guards rebound, those are key to fast breaks. The more guard rebounding we get the better we can be. ‘’

The Knicks still have three players in protocols — centers Nerlens Noel and Jericho Sims and the newly infected Wayne Selden. Quickley and Kevin Knox were cleared on Christmas but were held out for conditioning.

No matter. The Knicks go as Kemba goes.

“He’s much more aggressive,’’ Thibodeau said. “That was the challenge. At the beginning of the year he and Evan were two new starters. Sometimes guys are trying to fit in. he’s being very aggressive which is the way we want him to play. Not deferring at all. When he and Julius [Randle] are aggressive like that our team is different.’’

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Bar raises dramatically for Zach Wilson in matchup with Tom Brady, Buccaneers

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Zach Wilson and Tom Brady

When Zach Wilson stares across the MetLife Stadium field at the opposite sideline this Sunday, it won’t be Trevor Lawrence he’ll be looking at as his game-day counterpart.

Lawrence, drafted by Jacksonville one spot before the Jets selected Wilson at No. 2 overall last April, is a contemporary.

This Sunday at MetLife, the Jets rookie quarterback won’t be staring at a contemporary on the other sideline. He’ll be staring at the GOAT.

Tom Brady.

The bar raises dramatically for Wilson and the Jets, who are coming off of their feel-good, get-well win over the woeful Jaguars and Lawrence this past Sunday.

Brady and Buccaneers, who are 11-4, NFC South division champions and seeking to repeat as Super Bowl champions, play the Jets, who are 4-11 and seeking more signs of development from their rookie quarterback.

To say this is a step up in competition for Wilson and the Jets going from Lawrence and the Jags to Brady and the Bucs is as obvious as pointing out that Tampa Bay receiver Antonio Brown has had a few off-the-field incidents during his otherwise stellar NFL career.

There hasn’t been a lot to keep the interest of the Jets fan this season — other than watching Wilson’s development. That took an unfortunate pause for the four games Wilson missed with a knee injury, but he’s been back for five games and has looked like a better quarterback, throwing only two interceptions in those games (none in the last three) since returning from his injury.

The problem, though, is that Wilson hasn’t been producing enough touchdowns, throwing for three of them and rushing for four others in the past five games.

Zach Wilson and Tom Brady
Zach Wilson and Tom Brady
N.Y. Post: Charles Wenzelberg; AP

Baby steps, though.

Wilson was the better quarterback this past Sunday when matched up with Lawrence, who threw for more yards than Wilson did, but Wilson ran for 91 yards, including his electric 52-yard scoring jaunt, and made key throws when he needed them.

Wilson will not win Sunday’s game against Brady and the Bucs throwing for the 102 yards he had against the Jaguars. He and the Jets will need more.

Consider this: Brady enters the game having thrown 37 TD passes and for 4,580 yards this season and averages a league-high 305.2 passing yards per game.

Then this: The Buccaneers average 29.5 points per game this season, second most in the NFL.

And this: Wilson doesn’t have a single 300-yard passing game, averages 183 passing yards per game and has thrown seven TD passes in 11 games.

Seven TD passes is a pedestrian two-game total for Brady.

Wilson and the Jets are playing with house money anyway in what always has been a developmental season, so Sunday against Brady should, at its very least, be a great measuring-stick learning experience for Wilson, who’s studied Brady on tape.

Wilson revealed this month that he watched film of Brady before the Jets played the Eagles on Dec. 5 in an effort to pick up tips on how Brady worked against the Eagles defense when he played them earlier in the season.

“I thought it was really cool to see kind of how he went through his whole process, how he navigated the pocket, different things like that,” Wilson said at the time.

On Sunday, Wilson gets to see that process up close as Brady tries to dissect a Jets defense that has yielded 29.9 points per game this season, the most in the NFL.

That puts an added onus on Wilson to produce on the other side of the ball, because he knows Brady is going to get his. Wilson will likely need to produce four TDs — any way he can — for the Jets to simply remain competitive with the Super Bowl champs.

That’s a lot to ask of a 22-year-old kid who’s produced just 11 TDs in his 11 starts, up against Brady, who’s thrown 618 TD passes and for 83,784 yards in his remarkable career.

It, too, is a lot to ask playing against an aggressive Tampa Bay defense that’s ranked No. 9 in the NFL in points allowed (20.8 per game) and is led by former Jets head coach Todd Bowles, who’d surely like to send a holiday message to his former employer.

If you don’t think Bowles will be blitzing the bejesus out of Wilson, then you probably think Antonio Brown is a living saint.

The good news for the Jets is that Wilson has shown incremental improvements, particularly when it comes to his decision-making and quicker releases on his throws.

“He’s coming along, he’s getting more comfortable, he’s calmer back there,’’ Jets coach Robert Saleh said Monday. “He’s in a great headspace and it’s going to be fun to watch him grow, continue to grow.’’

A big part of that growth will take place this Sunday as he watches the GOAT operate from the opposite sideline at MetLife.

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