- An advisory panel to the U.S. Food and Drug Administration voted to grant emergency authorization to Merck’s oral COVID-19 pill molnupiravir (Lagevrio) — by a narrow 13-to-10 margin
- Among those who received the drug, the rate of all-cause hospitalization or death was 6.8%, compared to 9.7% in the placebo group — a relative risk reduction of just 30%
- The full data showed more hospital admissions among patients taking molnupiravir (6.2%) than among those taking a placebo (4.7%)
- Molnupiravir works by triggering mutations that ultimately kill the virus; a risk of cancer and birth defects is possible, and the drug shouldn’t be taken by pregnant or breastfeeding women or children
- By driving mutations but not killing off all of the virus — such as if people don’t take the full course of the drug — new and deadlier variants could be unleashed across the globe
- The U.S. government is already on the hook for about 3.1 million courses of molnupiravir, which it bought for approximately $2.2 billion
(Mercola via LifeSite News) – An advisory panel to the U.S. Food and Drug Administration voted to grant emergency authorization to Merck’s oral COVID-19 pill molnupiravir (Lagevrio) — but only by a narrow margin. The 13-to-10 vote speaks volumes about the panel’s confidence in the treatment, as do the numerous concerns regarding efficacy and safety voiced by the panel.
Merck reported in a press release in October 2021 that their antiviral drug led to a 50% risk reduction in hospitalization and death among COVID-19 patients. That was based on data from 386 patients, however. When the full analysis was released, which included data from 710 patients, the effectiveness declined significantly.
Among those who received the drug, the rate of all-cause hospitalization or death was 6.8%, compared to 9.7% in the placebo group — a relative risk reduction of just 30%. Several panelists reportedly said that the change in data was poorly explained, and it represents just one concern voiced by experts that raise major red flags about Merck’s COVID-19 pill.
Placebo outperformed drug in second half of trial
In an addendum released November 22, 2021, the FDA stated that they became aware of the “topline safety and efficacy results from all 1,433 randomized participants.” The data showed that patients taking the placebo fared better than those taking molnupiravir.
As noted in a commentary in the BMJ, “The full data showed more hospital admissions among patients taking molnupiravir (6.2%) than among those taking a placebo (4.7%) and led Merck to revise the benefit of preventing admission downwards to 30%.”
Further, the trial was stopped early after interim results showed eight deaths in the placebo group compared to zero in the molnupiravir group. However, post-interim results painted a very different picture — one death was recorded in each group. The BMJ reported:
“When questioned why the trial’s later participants showed such different outcomes than those in the interim analysis, a physician representing Merck told the panelists that the later group contained older patients, were more likely to be female and recruited from Europe, and more likely to carry the delta variant. But, he said, the drop in efficacy at the end of the trial ‘doesn’t really add up to us.’”
Dr. Pierre Kory, who is part of the group that formed the Front Line COVID-19 Critical Care Working Group (FLCCC) to advance early treatments for COVID-19, has pleaded with the U.S. government to review the expansive data on the drug ivermectin to prevent COVID-19, keep those with early symptoms from progressing and help critically ill patients recover — to no avail.
Yet, the FDA went ahead and granted emergency use authorization (EUA) to Merck’s highly questionable drug. Kory tweeted his dismay at the decision:
No LOVE for Pharma given unconscionable behaviors now & historically. But I can HOPE. Hope now dashed: 2nd half of Merck’s trial: placebo outperforms drug. Ouch. Even FDA admits drug is weak & risky.. while approving? EUA for IVM please (I can also DREAM)https://t.co/3Pn3gFDclf
— Pierre Kory, MD MPA (@PierreKory) December 4, 2021
Fauci: Merck’s COVID pill ‘impressive’
In October, Dr. Anthony Fauci applauded molnupiravir, calling it “extremely important” and praising its results to date. “It’s a pill that’s given by mouth, so you don’t need anything special other than taking a pill the way you take any pill. And the results are really quite impressive,” he told CNN’s “State of the Union.”
It’s unclear if Fauci has changed his opinion given the less-than-stellar results now available, but the U.S. government is already on the hook for about 3.1 million courses, which it bought for approximately $2.2 billion. Officials have been touting the ease of the pill, which is taken at home, orally, every 12 hours for five days. Read Full Article >