The FDA has refused to even explore approval of cheap, safe, and effective repurposed drugs for 20 months, despite mounds of evidence from studies vouching for their efficacy and safety. So, naturally, now that the agency is on track to issue an emergency use authorization to the first outpatient drug for COVID, this one must be the greatest thing since penicillin, right? Wrong! In fact, the drug is so dangerous and has so many known and unknown side effects that the FDA advisory committee members basically admitted this was a “difficult” decision and that they could rescind the authorization later on. This decision makes their rejection of ivermectin, fluvoxamine, nitazoxanide, and hydroxychloroquine all the more indefensible.
If you liked remdesivir, you will surely like Merck’s molnupiravir, which was developed with the help of the same entities guarding its approval based on flawed data produced by the company itself that is making over $1 billion off the federal government. No conflict of interest whatsoever!
Although the fix was in because no drug produced by Merck or Pfizer – no matter how dangerous – will ever be turned down, the approval was as revealing as it was appalling. The fact that the vote even by these compromised hacks was 13-10 demonstrates just how problematic molnupiravir likely is out of the gate.
Yesterday, the FDA’s Antimicrobial Drugs Advisory Committee voted 13-10 to approve molnupiravir at 800 milligrams twice a day for five days of COVID treatment for people in at-risk categories. It still needs official approval from the FDA and the CDC before it can be used, but the fix has long been in.
As CNBC reports, even those who voted for the drug admitted that it was a difficult decision and asked to revisit the authorization down the road. They conceded, as I have warned, that this drug can be mutagenic and cause birth defects, in addition to the fact that Merck’s own manipulated data show the efficacy is very modest.
“Given the large potential population affected, the risk of widespread effects on potential birth defects, especially delayed effects on the male, has not been adequately studied,” warned Dr. Sankar Swaminathan, an infectious disease specialist at the University of Utah School of Medicine, who voted no.
As CNBC reports:
The FDA and Merck both recommended against using the drug in kids and pregnant women. Molnupiravir was found to be lethal to embryos in pregnant rats, also causing birth defects and reducing fetal body weight. It also caused other defects that interfered with bone growth in young pups, along with other abnormalities, the data shows.
Just like the vaccines and remdesivir, this drug hits the triple crown – fails on efficacy, causes injury, and also induces mutants and viral escape, possibly making the virus worse. In the FDA’s briefing document on the drug for yesterday’s meeting, it states clearly that “there are potential safety concerns pertaining to MOV, including embryofetal toxicity, bone and cartilage toxicity, and mutagenicity.” They also observe that there is evidence molnupiravir “may increase the rate of changes in the viral spike protein, which, in theory, could enhance SARS-CoV-2 spike protein evolution.”
Fair use excerpt. Read the rest here.