How good is the FDA at EUA approval for COVID drugs? Well, so far, to be honest, pretty shitty.
The first three Covid drugs approved under EUA were Remdesivir, Baricitinib, and Tofacitinib. All were EUA approved for inpatient use (in hospital) only, demonstrate dismal effectiveness and are replete with black box warnings and side effects such as organ failure, blood clots, serious infections and malignancy.
PAXLOVID was recently approved by the FDA without any external meetings or disclosure. There was no opportunity for public input. Essentially all done behind closed doors.
Dr. Ryan Cole on the drug’s mechanism of action after infection explains, the Covid virus enters the cell and commandeers the cell forcing it to produce proteins. Protease enzymes must be present for the virus to successfully complete the cycle before taking the cell over. PAXLOVID or any drug classified as a ‘Protease Inhibitor’ will inhibit or decrease the Protease enzyme interfering with the virus. Ivermectin is the most successful and proven protease inhibitor in production. Just as with Paxlovid, ivermectin decreases the protease enzyme but...the benefits of ivermectin in Covid treatment are obvious and not present in paxlovid. Additional actions of ivermectin include anti-coagulant action and anti-inflammatory actions, both observed in Covid infections. Hydroxychloroquine is also a protease inhibitor and also works against COVID.
So why PAXLOVID? Because it’s from big pharma, is less proven than other drugs in terms of safety, and was approved without input from the external committees and the public. If that doesn’t inspire confidence, then I don’t know what does.
You should ask your doctor to explain to you why the off-the-shelf protease inhibitors don’t work, while this one does. Let me know what he says.
PAXLOVID requires combination with an HIV/AIDS drug, Ritonavir, preventing the breakdown of the PAXLOVID so it may inhibit or decrease the enzyme interrupting the viral life cycle. Dr. Cole reports Ritonavir also has its own black box warning and side effects include life-threatening liver, pancreas and heart issues.
According to Pfizer’s press release, PAXLOVID reduces hospitalization/death by 89%. So in the treatment group we had 5 of 697 hospitalized with no deaths compared to 44/682 hospitalized with 9 subsequent deaths.
How does that compare with the Fareed and Tyson protocol? Well, Fareed and Tyson had 10 times as many patients taking the drug combo and yet they had fewer hospitalizations (4) and the same number of deaths (0).
So you’re way better off with the Fareed and Tyson protocol.
First, the efficacy when it works is poor, only 50%. There were two groups in the randomized trials and in the second group, the people who got the drug ended up worse. And then there is the problem of causing cancer and prion disease. For more, see the Molnupiravir section of this article and this article.
Avoid these drugs.
Early treatments using repurposed drugs have a track record that is safer and more effective than either of two drugs that the FDA likes.
But thanks to the NIH, you’ll never hear about early treatment protocols unless you live in Florida.