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Scientists worry FDA could be pressured to approve COVID vaccine before it's fully tested

Infectious Disease Society of America

After the Food and Drug Administration offered shaky data to justify its approval of blood plasma to treat COVID-19, some scientists are worried the agency could bow to pressure to approve a coronavirus vaccine before it's fully tested.

On Sunday, President Donald Trump announced that the FDA had issued an Emergency Use Authorization for blood plasma. The president, the Health and Human Services secretary and the head of the FDA all said the treatment reduced deaths in COVID-19 patients by 35%.

It did not, and scientists immediately questioned the FDA’s claims about the data.

“You saw FDA be bullied by the president of the United States into approving something that they didn’t want to approve earlier, because he wanted them to do that,” said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital in Philadelphia, in an online interview Monday with the editor of the Journal of the American Medical Association.

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Trump reportedly pushing new unproven coronavirus treatment that is also embraced by HUD Sec. Ben Carson and MyPillow's Mike Lindell

Oleandrin pushed by Trump as coronavirus cure

President Donald Trump is eyeing another unproven coronavirus "cure," at the recommendation of Housing and Urban Development Secretary Ben Carson, Axios reported Sunday.

Oleandrin — a botanical extract from the oleander plant — was suggested to the president by Carson in a meeting in the Oval Office in July, according to the Axios report.

MyPillow's founder and CEO, Mike Lindell, who's known to be well-connected with the president, also is said to have expressed support for the experimental extract. Lindell has a financial stake in the company developing the oleandrin product, Phoenix Biotechnology.

TVNL Comment:  Maniacs are charge of the asylum.  Not to believe.

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Vaccine makers including Moderna must hit U.S. timing goals for full payments

VaccineThe United States is tying payments for COVID-19 vaccines to timing milestones for production and approval, according to public documents and a Trump administration official, putting pressure on drugmakers including Moderna Inc (MRNA.O) to meet ambitious targets.

In a deal with Moderna announced this week, federal agencies negotiated a sliding scale of payments. The Cambridge, Massachusetts, biotech’s $1.5-billion deal pays out in full if its vaccine receives regulatory clearance by January 31, 2021, according to filings. It receives $1.2 billion, if it falls short of that timing goal.

Moderna also receives $600 million when it can demonstrate it has built out industrial-scale manufacturing capabilities for its vaccine, even if that happens before the drug is authorized by regulators, the filings show.

TVNL Comment:  Money talks.  Billions of dollars talk very loudly.  Be ready for an untested, very possibly unsafe, and surely premature vaccine.

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Florida Breaks Its Daily Coronavirus Death Toll Record Yet Again

Florida breaks virus rwcord againFlorida reported 276 coronavirus-related deaths on Tuesday, shattering its single-day death record. So far, a total of 8,553 have died as a result of COVID-19 in the Sunshine State.

Florida’s Department of Health reported an additional 5,831 coronavirus cases on Tuesday, bringing the state’s total to 542,792. Miami-Dade, Broward, and Palm Beach counties have been the hit the hardest by the deadly virus.

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Ohio governor says Covid-19 tests are reliable despite receiving false positive

Ohio Gov. DeWine

Ohio Gov. Mike DeWine wants Americans to believe that Covid-19 testing is reliable, despite receiving conflicting positive and negative results on the day he was set to meet with President Donald Trump.

“People should not take away from my experience that testing is not reliable or doesn’t work,” DeWine said Sunday on CNN’s “State of the Union” of his false positive Thursday. After the positive test, he subsequently tested negative three times.

He noted that the antigen test he took that day that revealed the false positive “should be looked at as a screening test,” and that 1.3 million Ohioans have taken a PCR test, which is “very very reliable.”

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Nancy Pelosi Tears Into Dr. Birx: ‘I Don’t Have Confidence’ in Her

Deborah Birx

House Speaker Nancy Pelosi (D-CA) didn’t mince words on Sunday morning, declaring that she has no “confidence” in White House coronavirus response coordinator Dr. Deborah Birx, whom she blamed for President Donald Trump peddling coronavirus disinformation.

Last week, during a closed-door meeting with White House Chief of Staff Mark Meadows and Treasury Secretary Steve Mnuchin, Politico reported that the speaker tore into Birx. “Deborah Birx is the worst. Wow, what horrible hands you’re in,” she reportedly exclaimed.

Pelosi also accused Birx of “spreading disinformation” while simultaneously praising top infectious disease expert Dr. Anthony Fauci—who has found himself in Team Trump’s crosshairs of late—as a “hero.”

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Bleak new record as 71,000 Americans died from drug overdoses last year

71,000 in US died of overdose in 2019

Nearly 71,000 Americans died of drug overdoses last year, a new record that predates the Covid-19 crisis, which the White House and many experts believe will drive such deaths even higher.

Preliminary numbers released Wednesday by the Centers for Disease Control and Prevention show the trend is driven by fentanyl and similar synthetic opioids, which accounted for 36,500 overdose deaths. Deaths involving cocaine and methamphetamine also are rising.

With billions of dollars devoted to ending the opioid epidemic, policymakers had hoped overdose deaths would continue to decline, or at least plateau, after 2018 showed a dip for the first time in three decades.

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