Thursday, March 11, 2021 12:14:25 PM
Are government funds desired? More investors needed? This is an example of potential corruption in the drug development process overall.
Birth defects a concern? Not to worry. A law has been passed that lets drugmakers off the hook. But, what about the families experiencing birth defects and cancer by playing this game of Russian Roulette? Who cares about them?
Pushing forward a trash drug with problems as a therapy doesn't seem like a good idea. Unless, they have figured out a way to repurpose it safely which I've seen zero evidence of.
Too much focus on vaccines for covid instead of therapies since several billionaires are making huge amounts of dollars in every aspect of the process.
Leo bashing is ridiculous when looking at the big picture.
Message in reply to:
Controversy regarding Molnupiravir formerly EIDD-2801 now MK-4482
continues:
"This brings us to the controversy around the drug as explained by C&EN (emphasis ours):
" EIDD-2801 has been viewed as a potential competitor to remdesivir, although a contentious one, because similar compounds are mutagenic in animal studies, meaning they produce birth defects. Rick Bright, who was removed from his position as head of the US Biomedical Advanced Research and Development Authority (BARDA) in April, was reluctant to provide funding for the drug for this reason, according to an 89-page whistleblower complaint Bright filed after being fired. Merck’s investment in EIDD-2801 can be seen as a vote of confidence in the compound.
Bright’s concerns began in November 2019, more than one month before China disclosed the first COVID-19 cases in Wuhan — ScienceMag has that story:
Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient’s bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. “Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi says. “You don’t develop a drug that’s mutagenic. Period.”
" Merck’s Research Labs President Roger Perlmutter addressed the lingering questions about the drug’s mutagenic side-effects during the earnings call and explained what the company is doing to address safety concerns, a transcript of which is available at this link.
First of all, for the MK-4482, as you know, the compound is Ames positive. That’s, in a way, not unexpected given its mechanism of action. It is a cytosine analog so that — one could expect to see those kinds of things. The question is, does the compound have mutagenic activity that’s meaningful in mammalian cells and what do we want to do about this. Ordinarily, of course, we don’t want to take mutagens forward into clinical practice, although it has been done where the benefit/risk profile makes sense"
What does it mean to be Ames positive?:
The Ames test is a widely employed method... it is a biological assay to assess the mutagenic potential of chemical compounds.[1] A positive test indicates that the chemical is mutagenic and therefore may act as a carcinogen, because cancer is often linked to mutation. The test serves as a quick and convenient assay to estimate the carcinogenic potential of a compound...
THe positive Ames test and documented birth defects in similar compounds as document by Dr Bright must be thoroughly addressed.
GLTA, Farrell
https://bgr.com/2020/07/31/coronavirus-cure-merck-mk-4482-eidd-2801-rick-bright-controversy/
https://en.wikipedia.org/wiki/Ames_test
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