Perhaps the COVID vaccine that was brought to us at warp speed just isn't your cup of tea. Well, Merck has another option for you! It's the new COVID pill called molnupiravir! It works by wreaking havoc on the virus’s genes, though the FDA s
till isn't so sure it won't do the same to yours...
“What molnupiravir does is it disguises itself,” said Elizabeth Campbell, an expert in structural biology at the Rockefeller University who studies coronavirus antivirals. “It can propagate errors that are going to be sprinkled all over the genome.”
However, the problem is that the same compound that interferes in the replication of the virus’s genetic material can also be transformed into one that resembles a building block of DNA. Some scientists are concerned that could cause errors in a patient’s own DNA, or in that of a developing fetus.
Two weeks after a Food and Drug Administration expert committee narrowly voted to recommend authorizing the drug, the FDA is still weighing Merck’s application. One of the biggest questions the committee is weighing is whether the drug, in the course of wreaking havoc on the virus’s genes, also has the potential to cause mutations in human DNA.
Scientists are particularly worried about pregnant women because the drug could affect a fetus’s dividing cells, possibly leading to birth defects. Members of the FDA expert committee expressed these same concerns during a public meeting on Nov. 30.
“Do we want to reduce the risk for the mother by 30% while exposing the embryo and the fetus to a much higher risk of harm by this drug?” Dr. James Hildreth, president of Meharry Medical College in Tennessee, said at the meeting. “My answer is no, and there is no circumstance in which I would advise a pregnant woman to take this drug.”
The risk does not stop with pregnant women, however. Men who one day wish to be fathers should also stay clear of this drug if (likely when...) it becomes approved by the FDA. Through incorporation into sperm precursor cells, molnupiravir could alter a man's sperm and lead to birth defects. This has been brought to scientists' attention through a study that exposed molnupiravir to isolated hamster cells over 32 days, which found that the drug did induce mutations in DNA.
The mutations that the scientists discovered could “contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells,” the authors of that study wrote.
The reason while fetus and sperm cells are of particularly high concern is that these both have rapidly dividing cells, which the drug targets. In comparison, adults have a relatively sparse amount of actively dividing cells... in comparison. Ronald Swanstrom, an HIV researcher at the University of North Carolina at Chapel Hill who helped lead the hamster cell study, said that adults have enough dividing cells in areas like bones and in the lining of the gut — to cause concern. He also noted that men were constantly making dividing sperm cells that could carry potential mutations. Our mitochondria, aka the 'powerhouse of the cell', are also constantly dividing and therefore could become targets for molnupiravir.
"I don’t think anybody knows what this dose means in terms of human outcomes. I hope it’s trivial, but I don’t think anybody knows.”
— Ronald Swanstrom, an HIV researcher who helped lead a study of molnupiravir
Merch, however, claimed that the hamster study was flawed... In a letter objecting to Swanstrom’s conclusions, Merck scientists said that hamster cells were exposed to the drug for considerably longer than COVID patients would be. The company said that it tested the drug in rodents and found no signs of DNA mutations. “We see this molecule as having a very low risk for mutagenicity,” Dr. Roy Baynes, Merck’s chief medical officer, said in an interview. “This drug is used for five days, and the goal is to eradicate the virus quickly, and this is not a long-term treatment.”
If this is so, why hasn't Merch published the full findings of the rodent studies they are referring to? Dr. John Mellors, an infectious disease specialist at the University of Pittsburgh Medical Center noted that Merck has reported that high doses of the drug in pregnant rats could cause developmental abnormalities or the death of a fetus. Merch also did not include pregnant and breastfeeding women, as well as women likely to become pregnant from its clinical trial because they know that cells in a fetus are dividing all the time, heightening the risk of mutations.
Mellors goes on to say, “If I was pregnant, I wouldn’t take this. I probably would go so far as to say I wouldn’t give it to a child, a teenager, anyone whose cells are still dividing and differentiating at higher rates.”
“In those individuals who might have a particularly high risk of COVID disease, that risk might outweigh the risk of mutagenesis,” said Swanstrom. “Whereas in a younger individual who is planning to have kids or a younger individual who’s pregnant, they might want to take a different drug. Swanstrom said he had wrestled with whether to speak up about concerns that remain largely theoretical, given the drug’s potential to save lives.
Several experts also urged that researchers be allowed to study the long-term health outcomes of people who receive molnupiravir, therefore making us a real-time experiment... again. That data could indicate whether people who take the drug develop cancer or have children with birth defects at higher rates than would be expected. That seems to be the way the FDA and pharmaceutical companies like to do things; make a ton of money while they experiment on us and our children and THEN when a problem they knew was likely going to arise does occur, the drug is recalled/pulled.
Don't forget folks... every drug that has been recalled was FDA approved... let that sink in.