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FDA Panel Just Barely Recommends Molnupiravir. Data Show Birth Defects in Rats
Health advisors vote 13 for and10 against Molnupirivir for COVID-19 Patients. Issues with lack of evidence of efficacy against new variants and birth defects cause doubt.
The FDA may or may not take the weak recommendation by a health advisory committee. With 43% of the health advisors voting against recommendation, and the data on Molnupiravir lacking, the US awaits the decision by FDA on its recommendation position on Merck’s alleged “wonder drug”.
I had written early on the extraordinary hypocrisy of Molnupiravir, given that the press had advanced a press-release (not a peer-reviewed study) on the efficacy and safety of the drug. Even now, the peer-reviewed literature only includes studies with less than 20 patients for first-in-human and dose variation study.
Merck had decided to do an “interim analysis” of an ongoing clinical trial, and yet compared to the very strong evidence in support of Ivermectin in the reduction of hospitalization and risk of death (See https://ivmmeta.com).
So what made the 10 health advisors skeptical?
For one, data from studies in pregnant rats showed birth defects.
From CBS News:
“Given the large potential population affected, the risk of widespread effects on potential birth defects has not been adequately studied,” said Dr. Sankar Swaminathan of the University of Utah School of Medicine, who voted against the drug.”
With another example of hypocrisy, one panelist said that if the FDA restricts the use of molnupiravir in pregnant women, they would be denying women choice.
“I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” said Cragan, a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”
Read that again.
When FDA panelists start considering the level of evidence available for their favorites pharma partners, and start arguing for informed consent and health freedom when it comes to vaccines, we can start taking them seriously.
Until then, they are just going through the motions and abusing the public trust and they, and the FDA’s decisions, do not deserve our respect or attention.