Merck's (USA) Miracle Covid Drug (Molnupiravir)

[sharoncrayn]

Frankly, I was somewhat surprised by Merck's announcement by Dr. Gottlieb (BOD member and former FDA head, naturally). They (Merck and Ridgeback) tested a relatively small sample (775) of unvaxxed people. Supposedly, The people were all considered in the "high risk" category (actually they weren't) due to factors like age, and other characteristics from their "health profile". (Results published by Merck differ somewhat from Dr. Gotlieb"s presentation)

Per the results, 7% of volunteers in the group that received the oral drug were hospitalized, and none of them died, compared with a 14% rate of hospitalization and death (including eight who died) in the placebo group.

Unknown safety profile due to termination of trial (presumably moral grounds). Therefore no lag analysis is available. Viral sequencing was available only on 40% of the participants. Variants included delta, gamma, and mu (variants = 80% of participants). These %s don't make sense IMO.

Study Results not yet peer reviewed.

According to Dr. Gottlieb, "this is a phenomenal result". Dr. Gottlieb obviously did not major in statistics although the mortality rate statistic is somewhat startling in a std. deviation way given the high probability of comparable rates of hospitalization in a real world setting. Why the extreme disparity? Sample bias? Too many sites (n=170! anyone hear of lack of control)? Is the oral drug really that good?

Even more surprisingly the NYT's threw a curve ball at Merck's announcement --- "the Merck pill’s efficacy was lower than that of monoclonal antibody treatments, which mimic antibodies that the immune system generates naturally when fighting the virus."

Merck common stock was up as high as 10% in early US trading.

Sharon

[park_bear]

Link to Merck announcement:

merck.com/news/merck-and-ri...

" interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012."

This looks like an excellent P value to me. Am I missing something?

(Of course this efficacy does not come close to 90 percent efficacy of vaccines like Moderna and Pfizer)

[sharoncrayn in reply to park_bear]

The p value is fantastic but the sample size was far too small to be truly significant statistically, but who cares? In a phase III, they needed at least 4,000 in each arm and a duration of at least 12 weeks. Not even close.

We know the specifics of p value are heavily influenced by the make up of each arm. So, how closely were they matched? Details are missing probably because they used 170 sites and "washed" the data or "homogenized" it..

They terminated this CT very early on "moral" grounds, so they never developed a safety profile. Why not extend the trial to all participants out at least 12 weeks even though presumably the intervention lasted only 5 days? Does this mean we get a EA drug approval from the FDA without a published safety profile? Guess so because the CT ended at 29 days at least the way I understand it.

sharon

[Gioc in reply to sharoncrayn]

Everyone knows that after two years the pandemic runs out of strength; this too will end, in one way or another.