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Trump To Announce Covid Plasma Treatment Authorization At 5:30pm Press Conference

Courtesy of ZeroHedge View original post here.

Update (2:30pm): Well, we can forget the speculation, discussed just moments ago,  that Trump's 5:30pm news conference – conveniently 30 minutes before S&P futures open for trading - in which he will deliver "very good news" involves the fast-tracking of an AstraZeneca covid vaccine as an FT article hinted earlier…

… and instead both Bloomberg and StatNews report that Trump will announce that a new coronavirus treatment involving blood plasma from patients who have recovered from the disease, has received an emergency use authorization from the FDA, which is expected to clear for use with certain patients what’s known as convalescent plasma. The move, Bloomberg notes,  would make it easier for patients to get the product, which Trump has touted even though its effectiveness hasn’t been proved.

Blood plasma is among a host of potential therapeutics that have been undergoing testing in clinical trials, StatNews notes adding that the hope is that infusions of antibody-rich plasma from those who have recovered from Covid-19 can be injected into ill patients, kickstarting their immune system and allowing them to fight off the virus until they can generate their own antibodies.

Trump's decision to forge ahead is predicated by a study conducted by the Mayo Clinic and the National Institutes of Health which found that plasma treatments appeared to have a small but statistically significant impact on reducing mortality in hospitalized Covid-19 patients who received the infusions within three days of the onset of symptoms, compared with those who got plasma later.

Pouring cold water on Trump's major announcement, however, Statnews notes that the decision, which Trump’s press secretary heralded ahead of time as a “major therapeutic breakthrough," likely falls far short of that description, "and could generate intense controversy inside the administration and the broader scientific community."

Further indicating that the Trump announcement will lead to a firestorm of criticism among the scientific community, StatNews also adds that the move comes less than a week after officials at the National Institutes of Health staged a rare intervention to stop the FDA from issuing what is known as an “emergency use authorization” for blood plasma to treat Covid-19. NIH officials involved in the decision told the New York Times that more data, derived from randomized controlled trials, were needed.  

The announcement also follows sustained pressure from the president on his own administration. Trump told reporters last week that U.S. officials were slow-walking clearance of blood plasma until after the November election. He also took to Twitter on Saturday to criticize the FDA for making it difficult to test vaccines and therapeutics, though he didn’t specifically mention plasma.

As Bloomberg further notes, Mark Meadows suggested part of the reason Trump tweeted about the FDA on Saturday is that he wants to make federal health agencies "feel the heat" to deliver results.

On “Fox News Sunday,” Meadows said “the announcement that’s coming today should have been made several weeks ago.”

“It was a fumble by a number of people in the federal government that should have done it differently, and having been personally involved with it, sometimes you have to make them feel the heat if they don’t see the light,” he said.

As an aside, the FDA has previously issued dozens of EUAs during the course of the coronavirus pandemic, for both diagnostic tests and some drugs, but at times has been forced to reverse course. Most notably, the FDA revoked an EUA for the malaria drug hydroxychloroquine, which was personally touted by Trump as a treatment for Covid-19.

In any case, the fact that Trump's announcement is the fast-tracking of a treatment – and not a vaccinewill not lead to a Trump popularity hit within his core base, because as we discussed earlier there is a sizable contingent within the US population – at least 36% according to a recent Gallup, most of whom Republicans – who have said they would not take a covid vaccine even if it was mandatory by law.

* *  *

Update (9:05ET): President Trump is expected to hold a press conference Sunday evening regarding a major therapeutic "breakthrough" for treating COVID-19, the White House said late Saturday night. 

White House Press Secretary Kayleigh McEnany tweeted:

"News conference with President @realDonaldTrump at 6 pm tomorrow concerning a major therapeutic breakthrough on the China Virus. Secretary Azar and Dr. Hahn will be in attendance," McEnany tweeted. 

The press conference comes as the president on Saturday morning suggested the Food and Drug Administration (FDA) was 'deliberately' slowing down clinical trials for therapeutics and vaccines for coronavirus. 

House Speaker Nancy Pelosi responded to the president's comments, calling them "dangerous:" 

"This was a very dangerous statement on the part of the president," Pelosi said.

"Even for him, it went beyond the pale in terms of how he would jeopardize the health and well-being of the American people."

President Trump's planned press conference this evening begins as US equity futures open for trading. Is Trump trying to jawbone markets higher? Or is this another push for HCQ?

*  *  *

President Trump took a swipe at the Food and Drug Administration (FDA) in a pair of Saturday tweets, accusing the "deep state, or whoever, over at the FDA" of delaying human vaccine trials by "making it very difficult for drug companies to get people" (test subjects) so that trial results aren't known until after the 2020 election.

"Must focus on speed, and saving lives!" Trump concluded, tagging FDA Commissioner Stephen Hawn, who he appointed to the role.

Trump also slammed the FDA, rubbing the agency's nose in their June decision to revoke its emergency authorization of hydroxychloroquine (HCQ) for the treatment of COVID-19. 

"Many doctors and studies disagree with this!" tweeted Trump – resurrecting a June 15th 'Twitter moment' noting the revocation.

Hydroxychloroquine – used by many countries as both a front-line early treatment and a prophylactic against COVID-19 – saw sharp pushback from public health officials and Democrats after President Trump recommended it, almost as if the need to prove him wrong and push new treatments was more important than exploring whether HCQ was indeed effective if used early, particularly in conjunction with zinc and the antibiotic azithromycin.

Indeed, the first wave of studies on HCQ focused on mid-to-late stage COVID-19 infections, and found marginal improvement – or in one study, harm, from the use of the popular antimalarial drug. Since then, studies have emerged that HCQ is extremely effective when used early -

In July, the state of Ohio withdrew their ban on the use of HCQ to treat COVID-19.

he anti-HCQ push has infected Silicon Valley as well – as tech giants have been labeling pro-hydroxychloroquine content as 'misinformation' – most recently banishing a press conference by a group of doctors touting the drug from just about every platform.

To that end, Yale epidemiologist Dr. Harvey Risch has accused Dr. Anthony Fouci of waging a "misinformation campaign" against the drug – appearing on "Good Morning America" in late July where he further downplayed the drug – claiming that "the overwhelming prevailing clinical trials that have looked at the efficacy of hydroxychloroquine have indicated that it is not effective in [treating] coronavirus disease."

Wrong.

Several new studies have shown efficacy if used early, while countries that have deployed HCQ in just that manner have significantly fewer deaths per million residents (via c19study.com, which tracks HCQ studies).

HCQ's efficacy was known by mid-July, when the FDA removed its authorization:

Meanwhile, over 700 physicians from all 50 states have called on President Trump to issue another Emergency Use Authorization on HCQ


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