FDA Approves Emergency Use of Coronavirus Drug
The FDA sped up the approval of a drug in order for it to be used on coronavirus patients. This drug, in tests, reduced the hospitalization days for those who took it. The new drug, remdesivir, will need to receive formal approval. It was approved for use, prior to formal approval, due to the current pandemic. If those involved with the drug provide enough verifiable information to prove that it is safe and meets the standard for formal approval, that approval would be given.
From Newsmax:
The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir’s effects could be rigorously evaluated.
Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far.
The National Institutes of Health’s Dr. Anthony Fauci said the drug would become a new standard of care for severely ill COVID-19 patients like those in this study. The drug has not been tested on people with milder illness, and currently is given through an IV in a hospital.
The FDA authorized the drug under its emergency powers to quickly speed experimental drugs, tests and other medical products to patients during public health crises.
Newsmax has the full article here.
Category: COVID-19
Not a lot out there on Remdesivir; doubtless this will change. I was able to glean some facts about it, though.
Rx List
Thanks, thebesig.
So, what happened to the hydrochloroquine, azithromycin and zinc drug cocktail. Too cheap?
Wireman, you might want to check this out:
https://tinyurl.com/y8vge57f
Plenty of politics and corruption around this, in my opinion. Studies that are positive about H+A+Z are “flawed”. But studies negative about it are equally flawed.
Trump had that meeting at the WH with some survivors of the virus. Two from my area were treated with H/A/Z and improved within hours. People who did not get the drugs did not improve. Somehow this doesn’t matter. In the VA “study” of H/A/Z the patients were in bad shape already. Start a trial of patients who are not near death? Why do that?
Remember, this is ‘Murica. Never use an inexpensive and proven solution when an untried, expensive one may be in development.
No double blind studies have been done yet (they take time), but one of the largest studies yet, looking at veterans hospitalized with it, showed no benefit:
https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v2.full.pdf
That said, there are some issues with the study – such as HCQ is typically given as a last ditch effort, which means the patients are already quite sick. That will, naturally, lead to a higher mortality rate. But between this showing no benefit, and other countries[1,2,3[ stopping it due to some heart problems in people receiving it, most are looking at things showing more promise, at least until the double blind experiments are done.
[1] Brazil: https://nationalpost.com/news/world/covid-19-brazil-trial-for-drug-chloroquine-touted-by-trump-stopped-after-11-patients-die
[2] Sweden: https://www.dailymail.co.uk/news/article-8199477/Swedish-hospitals-stop-prescribing-chloroquine-coronavirus-patients-adverse-effects.html
[3] France: https://www.newsweek.com/hydroxychloroquine-coronavirus-france-heart-cardiac-1496810
And yet they approved this really expensive crap.
I guess I posted too many links; my reply will show once the moderators can approve it.
Drug studies have to follow a whole bunch of rules, especially the double-blind phase III studies that can lead to approval of a drug for use.
There are also rules for “whoa! This stuff is working much better than we hoped!” also for “there is a huge unmet desperate need, and it seems to be working”.
A US phase III study can take several years, and anywhere from 30 to 100 million dollars plus.
The overall success rate (from ” this might be useful” to “here is your prescription” ) is about two approved drugs out of one thousand investigational molecules.
Those unsuccessful studies are one of the reasons the approved drugs cost so much. Also why illnesses with few victims to treat have so few drugs (“Orphan drugs”). No one typically spends fifty million dollars on studies for a patient pool of a few thousand people.
The off-label use arises when doctors observe benefit on other conditions in the approved use patients. This is also why post-approval studies are so important.
A study of a previously approved blood pressure drug noticed that a whole bunch of male recipients reported their partners getting pregnant. Turns out the prescribed blood pressure vasodialator also treated Erectile Dysfunction. Instant blockbuster drug called Viagra.
Post-market studies also find problems that didn’t crop up in the phase III studies. Vioxx turned out to have serious cardiac side effects, and was withdrawn.
I hope this drug works out.
Ditto. Since everything I want to do from Spring into Fall is either closed for the duration, or will be closed before long, I second that “hope” idea.
If it works quickly and stops the bug now, with no unfortunate side effects, I’m completely in favor of it. But if the CV19 bug is a shifting antigen virus that can adapt, absorb and overcome, we’re right back where we started. So let’s hope this works for REALZZZ and stops the bug in its tracks.
Let’s see. The choices are:
a. Drown in my own fluids.
b. Take some cheap combination of meds all of which have been used for decades, with known side effects. Like really bad if I am taking certain heart meds.
c. Be a guinea pig for a new, expensive med known to cause liver problems and who knows what else.
d. Let them intubate, causing even more misery as I drown in my own fluids.
Pardon me, but “b” seems like the only sensible option to me. And, yes, I want it early on, not two weeks after presenting symptoms.
Agreed
I’ll take “B” for $1000, Alex.
Connect the dots and follow the money. Saw a blurb the other day that said the patent holder on this med was tied to the Wuhan Lab.
It is ALWAYS about the money.