Posted on 03/26/2020 8:08:59 AM PDT by SeekAndFind
A recent paper reviewing the first 12 U.S. patients with COVID-19 is used by sell-side analysts to doubt the effectiveness of Remdesivir.
I review the paper and reach a different conclusion.
The patients that are treated with Remdesivir have a very different profile from those that were not.
There is a recent paper out on COVID-19 patients that were monitored and treated in the U.S. (3 among them received Remdesivir). This paper is used by several analysts to doubt the effectiveness of Remdesivir. Which in turn resulted in a flurry of articles (here's one example) in the media casting doubt on the antiviral. I've gone through the paper and although it is not a resounding victory for Remdesivir, I actually think it was fairly positive and mostly in-line with what I think I know about this treatment and I explain below why.
I'm long Gilead Sciences (GILD), the company that owns the rights to Remdesivir, and understand I'm likely biased because of that. But, from an investment perspective, I'd be thrilled to find evidence that disproves my inclination that there's a high likelihood the antiviral is effective. Exiting before it falls back to the levels it traded at before COVID-19 levels is very valuable too. The last thing I want is to sit around waiting for upside that never materializes.
I'm about as far from a MD or virologist as one can be. But I'm not scared to read about things I don't understand. A lot of reading, searching and common sense can definitely enrich your perspective on an unproven drug like this that's being given to COVID-19 patients in trials and as a last resort.
(Excerpt) Read more at seekingalpha.com ...
The patients are anonymous but numbered and I'll refer to them by number. About the patients that didn't see clear improvement:
Patient six is a male in his 30's and has cardiovascular complications. Gets supplemental oxygen day 10-11. Gets remdesivir day 11 no more supplemental oxygen and after the cure ends, he is out of the hospital.
Patient eight is in his sixties. Is a smoker, has one lung removed, hypertension, coronary artery disease, COPD, history of lung cancer status. He/she has been on oxygen for a few days before receiving remdesivir. After receiving it, he is symptom-free in 3 days. Continues to receive oxygen after COVID-19 symptoms are gone.
Patient nine is in his 30's with fatty liver and diabetes 2 and has been hospitalized for seven days before receiving Remdesivir. The next day patient nine is put in the ICU and on oxygen. Four days later this patient is out of the ICU and off oxygen. It still takes another nine days of hospitalization until all symptoms are gone. Hospitalization continues after that. I can't be sure but I read this timeline as one where it was truly given as a last resort (my information so far is that it is much more likely to be effective the earlier it is given; before it is a life or death situation).
Compared to the other patients:
Patient 1-5 did not get hospitalized. Perhaps these were not in the 20% that get the severe disease.
Of the patients that were hospitalized as well but not put on Remdesivir 3/4 were in their 50's and one patient in her 60's (patient 7). Only the latter had an underlying condition of heart disease.
The study specifically states that remdesivir was basically only given to the worst of patients.
Patient 7 is in frail condition but basically tests positive and then has no more symptoms a week later without receiving oxygen. This looks a little bit like the mild version of covid-19 contracted by a frail patient given hospitalization continues for a long time after symptoms are gone.
Patient 10 hospitalized and is symptom-free in three days. These are initial COVID-19 patients in the U.S. so I suspect they were aggressively admitted into the hospital but looks a bit like it may have been a mild case.
Patient 11 hospitalized in the second week and put on oxygen but free of oxygen three days later. Symptom-free after about a week. This is a patient in their 50's.
Patient 12 hospitalized in the second week but never put on oxygen. Symptom-free after a week. This is a patient in their 50's.
If I take the analysts' own words:
not a "clear temporal association" between treating patients with remdesivir and improvements in oxygen requirements, fever, and viral results, compared with hospitalized patients who did not receive the investigational drug
And I look at the population that did and did not receive Remdesivir does their analysis reflect positively or negatively on remdesivir?
I think positively.
There may not be a clear difference in the time it took for them to recover but the patients that received Remdesivir were clearly representative of the group that's generally considered much higher risk; people with underlying health issues.
I went through the paper and here are the things that jumped out at me:
All patients recovered or are improving, and three patients tolerated treatment with the investigational antiviral remdesivir.
Pretty good survival score especially given the profile of age, underlying conditions and percentage of hospitalizations.
Four of five patients with ≥1 underlying medical conditions were hospitalized (Tables 1 and 2).
Not new information but looking through the cases underlying conditions seem to be a very significant risk factor.
Two patients received a short course (≤3 days) of corticosteroids. Three, including one who also received corticosteroids, received the investigational antiviral remdesivir (Gilead Sciences, Foster City, California) under expanded access (compassionate use) for a duration of 4-10 days.
I think this is no longer standard practice as it is thought to increase bad outcomes.
Remdesivir was discontinued after improvement in each patient's respiratory symptoms.
Two patients were on it for five days and one for ten days. Trials are being conducted both for five and ten days.
Among the three remdesivir recipients, aminotransferase elevation developed in Patient 6 one day after starting remdesivir and in Patient 8 four days after starting remdesivir. Patient 9 had aminotransferase elevation at illness days 6-7 before starting remdesivir; aminotransferase levels started to decrease but increased again five days after starting remdesivir.
This is an important passage because aminotransferase elevation can indicate liver damage. This can be caused by drugs so could be indicative of a problematic side-effect. However, organ failure could also be one of the effects that COVID-19 ultimately has on patients that become very ill. As Gilead highlighted the Ebola trials with much higher N's did not attribute adverse side-effects like this to remdesivir. It is possible that the complications occur here because a new disease can make for a new dynamic. However, I think it's unlikely, for now, this is a remdesivir specific problem.
Patient 9, the most severely ill among this series, experienced sudden clinical deterioration late in the second week of illness. This was the only patient with SARS-CoV-2 RNA detected in serum, and detection in serum was temporally related to clinical deterioration. Similar observations have been described previously.24,25 Increased proinflammatory cytokines have been observed in patients with COVID-19,17 and it is possible that cytokine dysregulation and endothelial dysfunction contribute to both clinical worsening and SARS-CoV-2 RNA detection in serum.
If you ask me it is fairly miraculous that this patient made it if Remdesivir doesn't work. My understanding is that this is happening if your own immune system goes into overdrive and is causing more damage to you than the actual virus. I sometimes hear medical people talk about cytokine storms and it sounds very bad.
What I understand is that it can be caused by drugs. This is not that likely to happen because of Remdesivir given the Ebola trials (this is why these Ebola trials are such an enormous leg-up vs. the competition that has to prove safety from phase 1 up). Even if it is caused by Remdesivir this can sometimes be mitigated by using lower doses, infusing slowly or administering anti-histamines before and during administration of the drug (according to this paper).
Three hospitalized patients received the investigational antiviral remdesivir under expanded access (compassionate use) at the time of clinical worsening based upon a decision by each patient's clinician.
Well, I AM an MD with a background in virology, and a group of twelve people who received remdesivir is too small and too unorganized to say anything.
If and when I get COVID-19, I want it (among other things).
Remdesivir or the combination of Plaquenil and Azithromycin?
Given a choice, what would you treat with?
In which case, I will (temporarily) not be posting.
[However, organ failure could also be one of the effects that COVID-19 ultimately has on patients that become very ill.]
There is a patient in the ICU who is dying from coronavirus who has failed to respond to Remdesivir, hydroxychloroquine, and Zithromax. I doubt he will survive 24 more hours.
Why should we pay $1000.00 per dose of this vaccine when we do not know what the long term effects of this are when we can take $50.00 worth of known drugs with known side effects and obtain the same result.
We also know that vaccines have been modified with crap that is potentially more harmful than the disease they are intended to cure.
A friend of my SIL’s family has been in ICU in a drug induced coma b/c of Coronavirus. He is 27 (news reports have said 25 erroneously). They just transferred him to UPenn a couple of nights ago so he could get Remdesivir. I hope and pray it will help him. He is deathly ill.
Because the Pharmaceuticals can’t make any money of a $50 generic drug that is readily available and producible. Need to push the new $1,000 drug that is available through only one company.
Does he have any comorbidities?
The company is connected to Bill Gates and Soros.
https://civilianintelligencenetwork.ca/2020/02/12/george-soros-bill-gates-partner-with-china-on-coronavirus-drug/
The only thing they can point to is his allergies. He was a college athlete. Very healthy kid.
remdesivir is fascinating, in most cases, it fools COVID-19’s proofreading mechanism. My only concern is that in someone soon enough, COVID-19 mutation will overcome remdesivir and then there will be a RNA chain-terminator resistant version. That would likely acquire after herd immunity, though, so less of an immediate threat.
Three patients or twelve patients, neither is a powerful enough sample to conclude support or denial of a treatment’s efficacy (effectiveness).
The only thing that can be said for continuing such treatments is the treatment has not yet shown any harmful effect.
Afterall, we can cure cancer by killing the patient.
What is hopeful about Chloroquine-Azxithromycin combination treatment is that both agents are known for decades and decades to be ‘safe’. Thus, no harm is done in administering them. The jury is still out on the efficacy question but the rumors say the results are promising.
Back to the 3-patient or 12-patient sample size deficiency.
I play poker for the first time ever.
The first hand I take the pot with a full house. The second hand I take the pot with a royal flush.
People call me ‘genius’, ‘shark’, ‘prodigy’, ‘wunderkind’.
Others say I am cheating, I’ve somehow rigged or changed out the deck. They get the local press to blast that I’m a lying, cheating, con artist. I have people threatening to kill me as a result.
But there is a third explanation.
“Luck of the Draw”
Maybe I was just lucky.
If it was luck, then as I continue to play I should be as a beginner expected to start to losing and losing.
Expectation is a concept of probability that is made mathematical.
If it was genius, then perhaps I inherited a rare insight into poker psychology (poker is a game of psychology) that uniquely enables me to read my opponent’s tendencies and also to count cards in a way I know when to hold them and when to fold them. Maybe I am a genius.
There’s only one way to know for sure.
Continue the game.
But the pots are filled with chips bought with Monopoly money so no harm is done.
So it is with Chloroquine-Azithromycin.
When that smartass reporter addressed President Trump so disrespectfully charging that he was selling Hopium to the American people by touting promising results in the treatment of SARS-COV-2 using the Chloroquine-Azithromycin combination, he was technically right that at this stage it is Hopium and the President acknowledged that it is hopeful, that Americans are looking for answers, and there is no harm in trying. President was right, reporter was technically right but an ass about it.
But what the press moron did not see because he does not want to see or is not allowed to see is that this Hopium is NOT a vaccine. There’s an important backstory concerning the vaccine lobby that the fakes news press is barred from investigating. But going after Trump for mentioning Hopium is fair game.
Bottomline is we are dealing with some really nasty bad people who will do anything they can to confuse us, divide us, keep us from learning the real story.
In the meantime, we will continue to watch the game.
Meanwhile the leftist web pages are glorifying CUBA for using Interferon. I believe Interferon has been around since 1949, but to read the leftist web pages you would think it was discovered by Cuba in 1981.
I haven’t seen a response to the question of whether the young athletic patient vaped cannabis extracts, which seems to do really bad, and still undefined, health issues.
If you weren’t on a ventilator, would you want the hydroxychloroquine + azithromycin?
Yes to HCQ, mind not made up about azithromycin.
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