How messed up has the world really gotten that the New York Times can say that a new drug that the FDA approved can alter DNA and cause a host of issues—And no one bats a freaking eye?

If you haven’t seen this you really need to. NYT reported that Merck’s miracle Covid-19 drug could alter DNA, cause male infertility, and cancer and birth defects but still managed to pass through the FDA and into circulation. The report outlined how the drug molnupiravir could mutate healthy cells by accident, but it was ultimately buried in the chaos.

“A team of researchers at the University of North Carolina studied the use of molnupiravir in isolated hamster cells over 32 days and found that the drug did induce mutations in DNA.

Those mutations 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 drug targets only dividing cells, which are relatively sparse in an adult. That poses a narrower risk than other mutagens, like radiation, which can damage DNA in all types of cells.

Still, Ronald Swanstrom, an HIV researcher at the University of North Carolina at Chapel Hill who helped lead the hamster cell study, said that adults had enough dividing cells — in bones, for example, 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.”

Oh, and it could affect men wanting to become fathers.

The FDA advisers also noted that the risks could extend to other patients, including men wanting to become fathers, though those risks remain poorly understood and Merck said its own studies had turned up no evidence that the drug causes DNA mutations.

YIKES!

Why isn’t this bigger news? Because it doesn’t fit a narrative? I’m sorry but some things go beyond politics

Forbes reported that Molnupiravir has been tested for mutagenicity in animals before being moved to human trials, where it is being tested for safety. But that doesn’t mean the drug is fully in the clear.

The pool of participants in the clinical trial — around 1,500 patients — is too small to pick up on rare mutagenic events and the early nature of the trial is too short-term to provide a proper view of issues that may occur months, if not years, down the road.

Merck would do well to remember their experience with Vioxx, a painkiller that was deemed safe based on initial studies, but later proved deadly.

The FDA originally approved Vioxx based on a safety database that included around 5000 people. Five years later, the drug was recalled after a broader and longer term study found a definitive link between the drug and rare cardiac events. There is evidence that during the time the drug was on the market it may have killed up to 56,000 people and left up to 140,000 with heart disease.

theoneadmin

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