A Food and Drug Administration advisory panel on Tuesday narrowly endorsed the use of Merck and Ridgeback Biotherapeutics’ oral Covid treatment pill, despite questions about the drug’s effectiveness, safety and whether it would help the virus mutate into even more dangerous variants.
The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir, an oral antiviral drug initially hailed as a potential game changer in the battle against Covid since it can be taken at home instead of at a hospital like other treatments. It’s designed to treat adults with mild to moderate symptoms of Covid-19 who are at high risk of severe disease. The 800 milligram pill is taken every 12 hours for five days after symptom onset.
The drug needs final authorization from the FDA and Centers for Disease Control and Prevention before it’s available to the public on an emergency basis. The FDA doesn’t have to take the panel’s advice, but it often does.
It was always going to get approved. No matter how many concerns panel members may have, at the end of the day, Big Pharma just has too much money on the line for these drugs to get rejected.
Many members of the advisory committee described the vote as a difficult one, in which they had to carefully weight the risks and benefits of a drug that could help those most at risk but raised many unanswered questions. Several committee members recommended that Merck’s emergency use authorization be revisited and potentially withdrawn if another treatment becomes available later.
Normally you’d err on the side of caution and vote against the drug, I’d think. But apparently not.
“This was clearly a very difficult decision,” said Dr. Michael Green, a pediatric transplant specialist at University of Pittsburgh School of Medicine Division of Infectious Diseases, said in voting for the drug. He said the lack of available therapies to treat high-risk individuals with Covid swayed him to support Merck’s emergency application. He however recommended that the medication be limited to unvaccinated people most at risk for severe Covid.
Maybe if they hadn’t worked to actively suppress ivermectin they wouldn’t have to make their decision based on the availability of other treatments.
Plus, Biden is actively preventing states from getting access to monoclonal antibodies.
Dr. Sankar Swaminathan, an infectious disease specialist at the University of Utah School of Medicine, voted against endorsing Merck’s medication because the efficacy was “modest at best.” Swaminathan also said he worried that the drug’s potential affect on human DNA wasn’t adequately understood.
“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,” he said.
Well, at least Dr. Swaminathan has some integrity.
Merck originally said the drug was more than 50% effective in preventing hospitalizations and death, but a more full set of data presented to the FDA on Tuesday noted the drug is just 30% effective.
Weigh the risk-reward here, people.
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.
I am not a doctor so I cannot give out medical advice, but I will absolutely never consider taking molnupiravir; it’s poison.
Molnupiravir works by prompting the virus that causes Covid to mutate and produce errors inhibiting its ability to replicate and spread. However, some doctors and scientists worried that it could also enable the virus to mutate in a way that makes vaccines and treatments less effective.
Sounds like an absolutely idiotic plan to stop Covid, but that’s just me.
“Even if the probability is very low, 1 in 10,000 or 100,000, that this drug would induce an escape mutant from which the vaccines we have do not cover, that could be catastrophic for the whole world actually,” Dr. James Hildreth, CEO of Meharry Medical College in Nashville, Tenn., told the panel.
But on the other hand, if the drug isn’t approved, then just think of how much money Merck shareholders will lose! That’s what’s really important.
Nicholas Kartsonis, Merck’s senior vice president of clinical research, said the company does not have data on the chances such a mutation could evolve.
They don’t even have data on this?!
FDA: “What are the odds that this drug causes a vaccine-resistant mutation?”
Merck: “Uhh, idk lol.”
However, Kartsonis noted that Merck has not seen an increased rate of unusual changes to the spike protein, which the virus uses to attach to human cells, compared with a placebo group in clinical trials. Hildreth told Kartsonis that it is incumbent on Merck to estimate the likelihood of escape mutants.
No shit. But they haven’t, and the drug was still approved by the FDA advisory panel.
Patrick Harrington, the FDA’s senior virology reviewer, said its unclear whether changes in the the spike protein associated with molnupiravir could substantially impact the evolution of the virus more broadly.
“For molnupiravir to affect Sars-CoV-2 evolution beyond a treated individual, the variants would also have to be transmissible, and at this time we do not know if this is possible to a significant degree,” Harrington told the panel.
I’m seeing a lot of “It’s unclear…” and “We don’t know…”
Dr. Janet Cragan, a medical officer at the CDC’s birth defects division, said it wouldn’t be ethical to prescribe molnupiravir during pregnancy given the potential side effects, but denying the drug to a pregnant woman suffering from Covid is also problematic.
“I’m not sure you can ethically tell a pregnant woman who has Covi-19 that she can’t have the drug if she decided that’s what she needs,” Cragan said before voting yes, noting that her views do not represent the CDC.
“Pregnancy itself can be considered a risk factor for progression to severe Covid illness,” she said. “We know that respiratory illnesses increase in severity and can become life threatening as pregnancy progresses and that’s certainly true of Covid.”
I’m sure this lady is a hardcore abortion-lover.
But Hildreth isn’t, apparently:
Dr. Hildreth, the CEO of Meharry Medical College, was unequivocal in his opposition.
“Do we want to reduce the risk for the mother by 30% of harm, while exposing the embryo and fetus to much higher risk of harm by using this drug? And my answer is no,” Hildreth said. “And there’s no circumstance in which I would advise a pregnant woman to take this drug.”
Good for this guy.
Robert Heflich, director of the FDA’s genetic and molecular toxicology division, said the risk of molnupiravir altering human genes in a clinical setting is low. A study in rats showed no increased mutation frequency in the liver or bone marrow of rodents, according to Merck.
However, the study was conducted as a follow-up to a previous investigation using rodents that was inconclusive about whether molnupiravir affects the DNA. Molnupiravir was found to affect genetic material during in vitro investigations using bacteria and hamster cells.
That’s gonna be a no from me, dawg.