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Harvard Doctor: Slow Your Roll On That “Miracle Drug” Remdesivir
Hotair ^ | 04/18/2020 | AllahPundit

Posted on 04/18/2020 7:01:08 AM PDT by SeekAndFind

Can I not have one g-ddamned day of hope?

Just one day. In the middle of an endless waking nightmare.

Jeremy Faust is the doctor in Boston who wrote a couple of pieces early in the epidemic for Slate, arguing (presciently) that the true fatality rate for COVID-19 was probably far below the three-percent figure gleaned from China’s Wuhan data. If it were really that high, he reasoned, we would have seen more dead on the Diamond Princess cruise after a huge number of passengers became infected. He’s been commenting sporadically on Twitter since then and noticed the enthusiasm over yesterday’s exciting partial data about Gilead’s experimental antiviral, remdesivir.

That’s nice, said Faust, but there are two methodological problems with the data from the Chicago hospital that produced it. One: No control group. There’s no way to tell whether the drug is truly helping a particular class of patients in a particular location unless we can compare how they’re faring to how a similar group of patients is faring without it. There are some encouraging signs from remdesivir in other small studies that do involve control groups…

Scientists infected two groups of six rhesus macaque monkeys with SARS-CoV-2 (the new coronavirus which causes COVID-19 disease) so they developed a lower respiratory tract infection.

12 hours after the animals were infected, and once a day for six days thereafter, the team either gave the animals remdesivir intravenously or a control substance which didn’t contain the drug…

Compared with the control group, the animals given remdesivir “did not show signs of respiratory disease” and scans showed their lungs contained less substances linked to pneumonia…

Autopsies revealed the viral load in the lungs of animals given the drug “were significantly lower and there was a clear reduction in damage to the lung tissue,” according to the study.

…but no one’s going to draw any hard lessons about the drug’s benefits to humans based on what it did to six macaques. We need a clinical study of people involving a control group to feel more confident that it’s effective. That’ll come, but not yet.

Two: People — like, er, me — overestimated how dire the condition was of those who received remdesivir in the Chicago study. In my post yesterday I compared the sample of “severe” patients in Chicago to a sample of British patients receiving “critical” care. Biiiiiiig difference, said Faust.

You can read his full thread here but that’s the key bit. Critical patients are at death’s door; severe patients are, well, they’re having a bad time of it but they’re not at the ICU stage yet. Here’s the study he mentions from February, citing Chinese data on many thousands of patients, that found “No deaths were reported among mild and severe cases. The CFR was 49.0% among critical cases.” Patients who needed a ventilator were actually excluded from the Chicago study. Does all of that mean remdesivir doesn’t work in critical cases, or might work better if administered to patients before the severe stage? No, of course not. But it does mean we shouldn’t draw conclusions about the drug’s efficacy based on yesterday’s news.

Analysts are warier about the results than the general public too, as tends to happen when big money is on the line. “[I]t is difficult to interpret this new information without more data on the severity of illness in the patients discussed,” said one at Morningstar, declining to raise her forecast for shares of Gilead. Others noted the lack of a control group, while another was skeptical of the results on the merits, saying, “‘Rapid recovery’ of fever and symptoms seems like conjecture given in our view it is incongruent with the mechanism of remdesivir, a direct antiviral.” One analyst at Cantor Fitzgerald sniffed about last night’s surge in Gilead’s value, “We would have thought that kind of reaction would have been reserved for positive clinical trials.”

What they don’t understand is that Gilead’s not selling remdesivir. They’re selling hope. The scarcest commodity there is.

Anyway, I solemnly promise you that I won’t let this chastening deter me from wildly overreacting the next time we get another tiny crumb of good news about the drug. Until then, here’s the WSJ with its own version of a “slow your roll.”



TOPICS: Culture/Society; News/Current Events
KEYWORDS: covid19; gilead; harvard; remdesivir

1 posted on 04/18/2020 7:01:08 AM PDT by SeekAndFind
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To: SeekAndFind
The doctor who was overseeing the study remains cautious.

Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy about drawing too many conclusions.

“It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”

She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.

The placebo study involves using a control group, which is given a pill that looks exactly like Remdesivir, but is made of something inert -- what used to be called "sugar pills." It's one of the last steps before the FDA approves a drug.

With only two fatalities in treating 226 people with severe symptoms, this could be, if not a miracle drug, then certainly a major breakthrough in treating COVID-19. It's likely we'll see more results from other trials in the near future, at which time we'll have a better idea of the true potential of this drug.

2 posted on 04/18/2020 7:04:14 AM PDT by SeekAndFind (look at Michigan, it will)
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To: SeekAndFind
There was no control group!!!

TOTALLY, ANECDOTAL.

Has Fauci been silent on this VERY EXPENSIVE alternative which requires hospitalization for 10 days or more.

3 posted on 04/18/2020 7:06:01 AM PDT by Sacajaweau
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To: SeekAndFind

Ok so, remdesivir, masks itself as adenosine, so as to interrupt the coronavirus’ own near-perfect genetic repair machine. Kind of like gluing down the “A” key on the keyboard.

In most cases, it fools COVID-19’s proofreading & repair mechanism. My only concern is that in someone soon enough, COVID-19 mutation will overcome remdesivir’a adenosine spoofing, and then there will be a RNA chain-terminator-resistant version of COVID-19. That would likely acquire after herd immunity, though, so less of an immediate threat but still a threat.

Whereas, Prof. Raoult’s protocol of Plaquenil + Azithromycin is likely to still be effective against a mutated COVID-19, but there’s no money in it.


4 posted on 04/18/2020 7:08:46 AM PDT by StAnDeliver (CNN's Dana B: "Show of hands: Coverage for undocumented immigrants?" ***all Democrat hands raised***)
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To: StAnDeliver

RE: Whereas, Prof. Raoult’s protocol of Plaquenil + Azithromycin is likely to still be effective against a mutated COVID-19, but there’s no money in it.

Makes me wonder What if Zinc were added to Dr. Raoult’s protocol (as per Dr. Zelenko) ? Would the results be even better?


5 posted on 04/18/2020 7:15:49 AM PDT by SeekAndFind (look at Michigan, it will)
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To: SeekAndFind

https://www.managedhealthcareexecutive.com/news/5-takeaways-birx-fauci-remarks-white-house-covid-19-briefing


6 posted on 04/18/2020 7:16:34 AM PDT by Sacajaweau
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To: SeekAndFind

He has a point. All good scientific investigation some kind of negative control so you don’t fool yourself into thinking you’ve found something.

That said...

We’re not exactly in a position to do good science right now, especially when we still have people dying. IMHO, ethics dictates doing anything and everything that could help, unless the treatment you’re proposing harms the patient.


7 posted on 04/18/2020 7:16:46 AM PDT by MAexile (Bats left, votes rights)
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To: All

When politics overrule science and the public good. I have lost count of the number success stories but it will always be anecdotal.


8 posted on 04/18/2020 7:20:42 AM PDT by gibsonguy
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To: SeekAndFind

HCQ + Z-Pac = $
Remdesivir = $$$$$$$$$$$$$


9 posted on 04/18/2020 7:22:12 AM PDT by meyer (WWG1WGA, MAGA! The DNC virus is much deadlier than the Wu Han Flu.)
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To: All

Isn’t the whole point of the medications to not allow patients to get to “critical” in the first place? I get it. People with 17 failing organs probably won’t respond as well to a pill or IV.

The one thing I’ve been concluding from these studies is that the critical patients should have had access to the meds way sooner.


10 posted on 04/18/2020 7:23:43 AM PDT by mmichaels1970
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To: MAexile
-- ... ethics dictates doing anything and everything that could help, unless the treatment you're proposing harms the patient. --

Then there are the supply and cost variables.

11 posted on 04/18/2020 7:25:49 AM PDT by Cboldt
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To: StAnDeliver

There are areas of the world wherein hydroxychloroquine is no longer the preferred preventative medication for malaria due to strains of malaria becoming resistant. But, we’re talking decades of use here, not like a virus rapidly mutating. Covid-19 is a virus, however. It remains to be seen whether or not it can become resistant to hydroxychloroquine.


12 posted on 04/18/2020 7:36:16 AM PDT by RegulatorCountry
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To: meyer

Remdesivir also requires hospitalization...for 15 days.


13 posted on 04/18/2020 7:47:38 AM PDT by Sacajaweau
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To: Sacajaweau

The question is, would a control group have been condemned to potentially die in order to facilitate a full, proper test run?


14 posted on 04/18/2020 7:50:10 AM PDT by trebb (Don't howl about illegal leeches, or Trump in general, while not donating to FR - it's hypocritical.)
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To: trebb

absolutely agree


15 posted on 04/18/2020 7:59:40 AM PDT by Sacajaweau
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To: SeekAndFind

https://www.jci.org/articles/view/33692


16 posted on 04/18/2020 7:59:51 AM PDT by Sacajaweau
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To: SeekAndFind

What do doctors know? Idiots. We can read the Internet! We know everything they know and we know what’s best!

Idiocracy, “Cause it’s got electrolytes!”


17 posted on 04/18/2020 8:05:41 AM PDT by CodeToad (Arm Up! They Have!)
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To: SeekAndFind

What you never know about these studies is how many other trials didn’t come out as well and weren’t reported out.


18 posted on 04/18/2020 11:42:11 AM PDT by 9YearLurker
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To: 9YearLurker

RE: What you never know about these studies is how many other trials didn’t come out as well and weren’t reported out.

That would be dishonest. Regardless of how they turned out, they should report their studies so that we can all review their patient conditions, methodologies, drugs applied and results, etc.

That’s the only way we can determine the validity of their results.

Hiding the result would be like China trying to cover up the origins of the novel Coronavirus.


19 posted on 04/18/2020 11:55:05 AM PDT by SeekAndFind (look at Michigan, it will)
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To: SeekAndFind

https://www.google.com/search?q=pharma+companies+not+reporting+negative+studies&oq=pharma+companies+not+reporting+negative+studies&aqs=chrome..69i57.13439j0j7&sourceid=chrome&ie=UTF-8

Fauci, Birx and Redfield have already been caught with even worse misconduct, tied to their significant conflicts of interest.


20 posted on 04/18/2020 12:12:18 PM PDT by 9YearLurker
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