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New Merck data shows COVID-19 drug less effective


A pregnant COVID-19 patient is treated in an intensive care unit at St. Luke’s Boise Medical Center in Boise, Idaho on Aug. 31. Associated Press/Photo by Kyle Green

New Merck data shows COVID-19 drug less effective

The pharmaceutical company released new numbers on Friday on the effectiveness of molnupiravir, a pill that interim results in October indicated might cut coronavirus hospitalizations and deaths by half. The updated findings, based on nearly double the number of study participants, lowers the efficacy rate to 30 percent. The Food and Drug Administration posted an analysis on Friday ahead of an advisory committee meeting on Tuesday. The agency said the pill appears to be effective, but it wants outside experts to address pregnancy and birth defect risks. According to the FDA, Merck agreed not to provide molnupiravir to children over safety concerns.

What are the concerns? Molnupiravir inserts genetic mutations into the COVID-19 virus’s DNA to prevent it from reproducing. Federal regulators worried this could lead to stronger virus variants in the future. Merck’s study also did not include any pregnant women. The FDA analysis noted several potential risks, including birth defects in studies of the pill on animals. The agency also said Merck collected less safety data than researchers had for other COVID-19 therapies. The advisory committee will review the research and decide whether to recommend Merck’s pill and whether or not to recommend it specifically for pregnant women. The committee’s decision is not binding on the agency.

Dig deeper: Read my report in the Sift about Pfizer’s development of its own oral COVID-19 drug treatment.


Carolina Lumetta

Carolina is a reporter for WORLD Digital. She is a World Journalism Institute and Wheaton College graduate. She resides in Harrisburg, Pa.

@CarolinaLumetta

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DGAM9342

Just a few things seem off to me about this whole thing. This being one of them: "FDA asks for 55 years to release data on Pfizer's COVID vaccine. The FDA promised "full transparency" due to "tremendous public interest" in a drug that it approved after studying the data for just 108 days." "Responding to the FDA’s arguments, Aaron Siri of Siri & Glimstad said in a statement, “It was exactly 108 days for the FDA from the time Pfizer started releasing the licensing records to the time the FDA licensed the Pfizer vaccine. Taking the FDA’s word for it, it has conducted an intensive, reliable, thorough and complete review and analysis of these documents to ensure that Pfizer’s vaccine is safe and effective for licensing. While it can do a thorough review of Pfizer documents in 108 days, it now takes more than 20,000 days to make those documents publicly available.”'

According to the FDA they don't have the staff to process and release the documents in a timely manner. But they can insure that the product described in those documents is completely safe. Draw your own conclusions about the delay and safety of the product being forced on the population. https://www.israelnationalnews.com/News/News.aspx/317161

RKIM8631

I will raise a question to those who keep insisting hydroxychloroquine and ivermectin are being ignored as a solution. In the United States alone, there are about a million doctors, and a number of us are Christians. We have seen the value of immunizations over the years including this one, have seen the value of masks (like in the operating room and for things like tuberculosis), and value the scientific research process which over the decades has forced any scientific study into rigorous evaluation that even if politics come into play, eventually finds the gems and rather quickly.
If we as Christian physicians have overall supported and taken the vaccine, practice infection precautions (especially for those with weak immune systems for which the shot may be less effective) and demand rigor in looking at the big research picture (rather than cherry-picking studies, or relying on less reliable research/researchers or spokespeople), why do you suppose we are wrong? I suppose you can point out exceptions or maybe reasonable counters, but we see the overall picture and believe in the process recommended by most. We do the best we can in removing politics and other outside influences from our decisions, and I have seen conservative, liberal and moderate, Christian and non-Christian physicians on the same wavelength.
Are we less qualified? Doubtful. Do you think we can't see the medical studies out there and have come to some grievous error in our support of he vaccines and protective measures as best proven? Do you think we are suddenly dumb or blind or have some sort of agenda, especially Christian physicians? Are we suddenly or suddenly exposed as evil? Do you really think we are so blind to politics and outside influences that we cannot sort through that ourselves? Do you want to discount our own experiences with the virus, seeing patients trying ivermectin and failing to help, the risks we have seen with medications like hydroxychloroquine (and for a while, dealing with the problem of taking it away from those who take it for proven diseases) and seeing the unvaccinated get hurt for extended periods or die, time and time again (I still have not had a fully vaccinated patient end up in the hospital). Do you think that doctors are greedy, but don't see the doctors and other health care personnel that have burned out, gotten sick from treating covid patients, even committed suicide due to the emotional weight? Do you think that we want to put up with the hassles of masks, reconstructing offices and having quarantines of our own staff, and dealing often with arguments from patients who don't believe what we see everyday (and no, we don't earn more money from this pandemic)?
What I have seen, what I have heard, what I have experienced has shown me that some within the Body of Christ have been blinded by politics, by fear, by trusting what their itching ears want to hear. We excuse evil like trying to run a Christian Public Health official off the road for their Covid decisions, berating Public Health officials in general, allowing violent and evil threats against medical personnel like QAnon has without raising a voice. We justify evil and belligerent hearts for the sake of defending individual Christian rights.
Our primary goal is to glorify God, to carry out the Great Commission, to love God with all of our being AND to love our neighbors as ourselves. The fight (and I do mean at times literal fight it seems unfortunately) for individual rights and social causes is a part of being Christian as well in a society that is ours as well... as long as it does not hinder the more important principles above. We influence society by showing love, patience, understanding. We love those that are our "enemies", and when the situation calls for it, turn the other cheek, give them our coat, as living sacrifices. Paul and Jesus for example, never said you could not be in politics or political circles, but that is not the main focus. Our kingdom is in heaven, we should not fight as the world fights, we should win with a solid knowledge of the Bible and love that endures even attacks (physical and otherwise) that truly cares about our neighbor. They wanted Jesus to establish an earthly kingdom, but Jesus never had that in mind. His mission was clear. When Paul did decide to exercise his citizen rights, it was to further the Gospel.
Please consider who you listen to, if they have the credentials and experience, or if you are just listening to who you want to feed the narrative you want to hold onto, including this whole Covid issue. Consider that evil behavior and actions within those who call themselves Christians or who help with social causes has to be called out, not just those outside of those circles. Consider that we can engage in political and social issues without rancor but not as our primary focus, and trust the Holy Spirit with the Word of God to maybe step back and look at the big picture, of bringing others to Christ and glorify him in our lives. I have seen articles in the last 6 years, opinion polls included, showing that we are driving people away from the Gospel, and not just because of Covid. Please pray that we keep our priorities straight and glorify God and bring others to Christ, not at the exclusion of political or social issues, but above all else.

HHOO6560RKIM8631

Love this reply!

DWES4537RKIM8631

I agree with the statements you have made, but consider that there are many doctors that are Christians and who are also very concerned for their patients who are telling anyone who will listen that drug therapies work. One way is right and the other is wrong, either drug therapies work well or they should not be used. Cannot be both and there are intelligent, moral people on both sides of the argument. It seems there are many more doctors on the side of drug therapies don’t work and for sure those in positions of power are in the don’t use drug therapies camp. As for motive, many of the pro drug therapy doctors have been ridiculed or threatened with loss of medical licensing. We have heard that doctors at hospitals have been threatened with loss of employment if they prescribe a non-approved drug regime( I have only hearsay on this).
Perhaps the biggest disappointment was that early in the pandemic people who tested positive were sent home with nothing. Why not start a drug regime with few know side effects? In our county 2 doctors treated 7000 patients with only 3 fatalities(all 3 were in advanced stages of covid before treatment) Meanwhile 2 nurses at a local hospital watched all 65 of their patients die. These are anecdotal but they speak logically a more aggressive approach, I think you would agree.
I also agree that this has been over hyped by the media and I long ago learned that the media is a terrible source of accurate information. (World usually excepted) With the internet so much info is directly available from the source and I would urge everyone to do that. Ignore the media on this issue and go directly and prayerfully to the source.

SJS

"Unreal" is quite accurate as it applies to each statement that follows it in the pronouncement and comments that follow it below. (For some odd reason clicking on "Reply" only takes me to a new comment dialogue box.) I realize that Nanamiro's comments were sincere and well meaning. But, each statement is specious and misinformed. And before someone asks me to prove this, allow me to point out that that no data nor proof was presented to prove the "Unreal" propositions. But this is completely understandable as the public with no background in clinical trials or drug development are expected to sort through the politically biased CDC and NIH pronouncements. And even worse Fauci's silliness. Equally, if not more, challenging are the many purported challenges on social media and the internet. These are troubling times and I am not trying to defend these 3 public nuisances nor the opposition, that I just listed.

Nanamiro

Unreal. HCQ and Ivermectin both have shown in many studies to be more effective than this drug, and incredibly safe with decades of data. How is it that this new, sketchy drug is getting so much enthusiasm, while the aforementioned drugs have been all but banned in the US?
And pregnant women were also not included in vaccine trials, yet they don't seem concerned with pushing those on pregnant women.