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1st results in on Gilead coronavirus
drug; more study needed

Original Article

Posted By: IowaDad, 4/11/2020 9:14:51 AM

More than half of a group of severely ill coronavirus patients improved after receiving an experimental antiviral drug, although there’s no way to know the odds of that happening without the drug because there was no comparison group, doctors reported Friday. The results published by the New England Journal of Medicine are the first in COVID-19 patients for remdesivir.

Comments:

Remdesivir is an inhibitor of the coronavirus enzyme that copies its genetic material (RNA). These results are quite encouraging, but not totally convincing. We'll get randomized trial results in a couple of weeks. Raoult's latest trial of hydroxychloroquine was much less promising, but again we'll get randomized data fairly soon.

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Reply 1 - Posted by: sanspeur 4/11/2020 9:24:03 AM (No. 376038)
isn’t the redoubtable Dr F connected with this company ?
0 people like this.

Reply 2 - Posted by: MickTurn 4/11/2020 9:56:15 AM (No. 376070)
"no comparison group"? This is medical double speak. If the freekin drug works that is all that counts.
7 people like this.

Reply 3 - Posted by: TLCary 4/11/2020 10:01:17 AM (No. 376079)
OP: "Raoult's latest trial of hydroxychloroquine was much less promising"?!? Want to provide some background on that? Sounds WAY more promising to me. Also, the missing "control group" in the Raoult study is the other 1.7 Million confirmed infected patients. "The investigators report a significant reduction in the viral load (83% patients had negative results on quantitative polymerase chain reaction testing at day 7, and 93% had negative results on day 8). There was a “clinical improvement compared to the natural progression.”
6 people like this.

Reply 4 - Posted by: DCGIRL 4/11/2020 10:02:59 AM (No. 376081)
#1, you are correct. Apparently, Dr. Fauci is in bed with the manufacturing company. Both he and this company are pushing this medication remdesivir. I have read that the manufacturer has an abundance of this medication and want to unload it on doctors for the virus. This medication apparently has a lot of side effects and is currently not recommended by most doctors. The anti malaria drug has minimal side effects and is working great. Just listen to Dr. Fauci concerning the anti malaria drug and this anti viral drug. This is a huge conflict of interest and he needs to be removed from the study/team. He is very dangerous and his so call recommendations for the virus treatment could harm the patient.
12 people like this.

Reply 5 - Posted by: curious1 4/11/2020 10:15:01 AM (No. 376094)
#2, not to mention these 'studies' appear to have a built-in bias that everybody is genetically the same - when we know they aren't. If it works for some and not for others, and you eliminate the placebo effect through further tests, then the drug ought to be passed with the proviso that it only works for some people with some specific genetic makeup, as far as is discernible with the current state of the art. I wonder if there is a significant effort underway to record that information?
2 people like this.

Reply 6 - Posted by: Chuzzles 4/11/2020 10:51:27 AM (No. 376114)
As long as it is working, I do wish that the lab rats would stop mocking and or brazenly interfering with that fact. Time enough for them to test their theories later when this is all finished. But for now, the lab rats need to just suck it up and be quiet and patient. These lab rats with delusions of godhood need to get over themselves and just let the meds work.
4 people like this.

Reply 7 - Posted by: Chuzzles 4/11/2020 10:55:12 AM (No. 376120)
Hit post too soon. #'s 4-5 are correct. Genetics play a huge part in how a drug will react to a person. Remember the MASH episode where Klinger had major problems taking a preventative drug? That was due to his Mediterranean background, him being Lebanese origin. To ignore that like Fauci is, is to bring more misery on innocent people that don't need it. This comes very close to medical malpractice on a huge scale, all for protection of his investment.
4 people like this.

Reply 8 - Posted by: rsgonner 4/11/2020 11:21:37 AM (No. 376151)
So let's see: according to the talking heads, hydroxychloroquine is unacceptable because there have been no "placebo controlled double blind studies" and the very high success rate seen in multiple countries are all "anecdotal". Remdesivir caused "improvement" (what is that actually?) in "over 50% of patients" in a study that lacked that same double blind placebo control but it is promising. Huh? Remdesivir costs a mint and hydroxychloroquine costs less than $20 for the whole treatment. Are we really idiots to accept this drivel? Follow the money and the politics and you will see why Fauci et al are pushing this. It has nothing to do with science at all. Or with ethics for that matter.....
9 people like this.

Reply 9 - Posted by: kono 4/11/2020 11:44:16 AM (No. 376187)
Remdesivir shows effectiveness in "more than half" of the patients who received it? Wow, that's got to be WAY better than hydroxychloroquine! Only about 98 percent improved. (s/o) The incidence of side effects severe enough to stop administering the Gilead drug sounds at least as awful as for the anti-malarial drug. Malignant TDS is already spinning the reporting of these comparisons to make it seem like remdesivir is a far superior option. Not sure where 98% became "much less promising" than "more than half". But I'll look for more info on that, because OP is a longtime contributor to this salon, and not known for trolling.
1 person likes this.

Reply 10 - Posted by: Skeptical1 4/11/2020 11:45:12 AM (No. 376189)
Gilead has been providing remdesivir for compassionate use, and sponsored this report on its efficacy. One very useful piece of information in the report was the inclusion criteria: It was provided only to patients who were severely ill, and needed oxygen support. The median age of patients was 64. There was no control group for this kind of study, but in the discussion, they point to some evidence that it was better than other treatments that have been tried. By contrast, Dr. Raoult's study of chloroquine seems to have included patients who had merely tested positive for COVID, and the median age was 49. His inclusion criteria were not spelled out in the abstract (which was all I could find online), but his intent was to demonstrate the effectiveness of starting treatment immediately after diagnosis. It is not a silver bullet, 4.7% of patients have a poor outcome, and at least 0.47% died. So at this point, you can't really do an apples to apples comparison of the two drugs. It could be that if you begin on chloroquine and progress to severe illness, it would make sense to treat with remdesivir. But of course, these aren't the only two drugs being looked at.
0 people like this.

Reply 11 - Posted by: Skeptical1 4/11/2020 11:52:04 AM (No. 376199)
Oops, Raoult's poor outcome was 4.3% of patients.
0 people like this.

Reply 12 - Posted by: felixcat 4/11/2020 12:13:49 PM (No. 376239)
Is there anyone on President Trump's team informing him of Fauci's conflicts of interests? Anyone???
1 person likes this.

Reply 13 - Posted by: kono 4/11/2020 12:16:10 PM (No. 376240)
Sitcom script as support for a point? Thanks for the reminder that this is not the same site as when i first joined in 2004.
0 people like this.

Reply 14 - Posted by: davew 4/11/2020 1:07:09 PM (No. 376317)
The real problem with this study is buried way down in the weeds. Unlike Raoult's study with Plaquenil that measured viral load at start and end, this study did not even measure the critical factor of effectiveness in reducing the reproduction of the virus. This should have been determined independent of the ultimate patient outcome which was dependent on multiple other factors like preconditions and use of mechanical ventilators. Unfortunately, our compassionate-use program did not collect viral load data to confirm the antiviral effects of remdesivir or any association between baseline viral load and viral suppression, if any, and clinical response. Moreover, the duration of remdesivir therapy was not entirely uniform in our study, largely because clinical improvement enabled discharge from the hospital. This should have been the primary study endpoint and this statement indicates the study was a waste of time. I appreciate compassionate use is concerned with patient outcomes and not other clinical metrics but they missed a major opportunity to make their case here.
0 people like this.

Reply 15 - Posted by: DVC 4/11/2020 1:07:28 PM (No. 376319)
So, this drug shows small effects, if any. This is the perfect example why you need large numbers of tests to tell if a drug which isn't a "miracle cure" is better than not having it. Based on 'sample size', all studies have a "margin of error", which is seen most commonly in polling. With 1,000 people polled, the margin of error is, IIRC, 3.5%. If the difference in the effectiveness of a drug is somewhere near the margin of error, you can't tell if the result is real, or random chance. Same with an honest poll. Of course, many polls aren't honest, but that's a different thing. Not a particularly impressive result, but it might be of some benefit. Not clearly obvious in this size of trial.
0 people like this.

Reply 16 - Posted by: DVC 4/11/2020 1:44:21 PM (No. 376363)
With 53 patients, the margin of error is plus or minus 10%, to a 95% confidence. So their calculated 68% could be as low as 58%, just a little bit better than a coin toss. This is why small tests, unless the results are overwhelmingly positive, like 90% are cured, are difficult to tell if there is much benefit. If 90% of 53 patients were cured in some hypothetical test, then the worst possible situation is that about 80% were really cured. THAT case would be worth doing, easily. This result is less clear. What are the side effects? This test certainly is not a negative result, so some good news. But clearly remdesivir is no magic bullet, but it seems like it may well be helpful. If it was the only thing out there....I'd take it - IF the side effects risk is reasonable, too. But like the headline says, "More study needed".
0 people like this.

Reply 17 - Posted by: Hermit_Crab 4/11/2020 4:39:56 PM (No. 376510)
There is NO balm in Gilead.
1 person likes this.

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