RIP Hydroxychloroquine
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This is from 2020 June 20:
https://www.nih.gov/news-events/news-releases/nih-halts-clinical-trial-hydroxychloroquine
NIH halts clinical trial of hydroxychloroquine
Study shows treatment does no harm, but provides no benefit
“A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) has been stopped by the National Institutes of Health. A data and safety monitoring board (DSMB) met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19. After its fourth interim analysis the DSMB, which regularly monitors the trial, recommended to the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, to stop the study. NHLBI halted the trial immediately.
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Why has hydroxychloroquine been disregarded?
First, as all know, the medication has become highly politicized. For many, it is viewed as a marker of political identity, on both sides of the political spectrum. Nobody needs me to remind them that this is not how medicine should proceed. We must judge this medication strictly on the science. When doctors graduate from medical school, they formally promise to make the health and life of the patient their first consideration, without biases of race, religion, nationality, social standing—or political affiliation. Lives must come first.
Second, the drug has not been used properly in many studies. Hydroxychloroquine has shown major success when used early in high-risk people but, as one would expect for an antiviral, much less success when used late in the disease course. Even so, it has demonstrated significant benefit in large hospital studies in Michigan and New York City when started within the first 24 to 48 hours after admission.
In fact, as inexpensive, oral and widely available medications, and a nutritional supplement, the combination of hydroxychloroquine, azithromycin or doxycycline, and zinc are well-suited for early treatment in the outpatient setting. The combination should be prescribed in high-risk patients immediately upon clinical suspicion of COVID-19 disease, without waiting for results of testing. Delays in waiting before starting the medications can reduce their efficacy.
Third, concerns have been raised by the FDA and others about risks of cardiac arrhythmia, especially when hydroxychloroquine is given in combination with azithromycin. The FDA based its comments on data in its FDA Adverse Event Reporting System. This reporting system captured up to a thousand cases of arrhythmias attributed to hydroxychloroquine use. In fact, the number is likely higher than that, since the reporting system, which requires physicians or patients to initiate contact with the FDA, appreciably undercounts drug side effects.
But what the FDA did not announce is that these adverse events were generated from tens of millions of patient uses of hydroxychloroquine for long periods of time, often for the chronic treatment of lupus or rheumatoid arthritis. Even if the true rates of arrhythmia are ten-fold higher than those reported, the harms would be minuscule compared to the mortality occurring right now in inadequately treated high-risk COVID-19 patients.
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What I find so distressing is how HCQ became a partisan issue.
you could peg a voter on his political views depending if one believed in or shunned HCQ while not caring to hold off until there was data.
now you will have people claiming the lancet is a main stream media rag with leftist leanings.
@bachophile said in RIP Hydroxychloroquine:
now you will have people claiming the lancet is a main stream media rag with leftist leanings.
Well, it is! And Eric Topol, the guy who said,“It’s one thing not to have benefit, but this shows distinct harm,” is probably a lefty Democrat and also black and gay hootchie-cooch to Jeffrey Epstein!
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@bachophile said in RIP Hydroxychloroquine:
now you will have people claiming the lancet is a main stream media rag with leftist leanings.
Well, it is! And Eric Topol, the guy who said,“It’s one thing not to have benefit, but this shows distinct harm,” is probably a lefty Democrat and also black and gay hootchie-cooch to Jeffrey Epstein!
@Catseye3 said in RIP Hydroxychloroquine:
@bachophile said in RIP Hydroxychloroquine:
now you will have people claiming the lancet is a main stream media rag with leftist leanings.
Well, it is! And Eric Topol, the guy who said,“It’s one thing not to have benefit, but this shows distinct harm,” is probably a lefty Democrat and also black and gay hootchie-cooch to Jeffrey Epstein!
What do you know about Plaquenil?
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https://www.washingtonpost.com/health/2020/05/22/hydroxychloroquine-coronavirus-study/
A study of 96,000 hospitalized coronavirus patients on six continents found that those who received an antimalarial drug promoted by President Trump as a “game changer” in the fight against the virus had a significantly higher risk of death compared with those who did not.
The study, published Friday in the medical journal the Lancet, is the largest analysis to date of the risks and benefits of treating covid-19 patients with antimalarial drugs. It is based on a retrospective analysis of medical records, not a controlled study in which patients are divided randomly into treatment groups — a method considered the gold standard of medicine. But the sheer size of the study was convincing to some scientists.
“It’s one thing not to have benefit, but this shows distinct harm,” said Eric Topol, a cardiologist and director of the Scripps Research Translational Institute. “If there was ever hope for this drug, this is the death of it.”
David Maron, director of preventive cardiology at the Stanford University School of Medicine, said that “these findings provide absolutely no reason for optimism that these drugs might be useful in the prevention or treatment of covid-19...”
The difference between patients who received the antimalarials and those who did not was striking.
For those given hydroxychloroquine, there was a 34 percent increase in risk of mortality and a 137 percent increased risk of a serious heart arrhythmias. For those receiving hydroxychloroquine and an antibiotic — the cocktail endorsed by Trump — there was a 45 percent increased risk of death and a 411 percent increased risk of serious heart arrhythmias.
Those given chloroquine had a 37 percent increased risk of death and a 256 percent increased risk of serious heart arrhythmias. For those taking chloroquine and an antibiotic, there was a 37 percent increased risk of death and a 301 percent increased risk of serious heart arrhythmias.
Cardiologist Steven Nissen of the Cleveland Clinic said the new data, combined with data from smaller previous studies, suggests that the drug “is maybe harmful and that no one should be taking it outside of a clinical trial.”
Jesse Goodman, a former FDA chief scientist who is now a Georgetown University professor, called the report “very concerning.” He noted, however, that it is an observational study, rather than a randomized controlled trial, so it shows correlation between the drugs and certain outcomes, rather than a clear cause and effect.
Peter Lurie, a former top FDA official who now heads the Center for Science in the Public Interest, called the report “another nail in the coffin for hydroxychloroquine — this time from the largest study ever.”
Here's what I don't understand: HCQ is a drug that's been around for decades being used as an antimalarial, in the treatment of lupus, and other diseases. Why is it dangerous now? What is it about the SARS-CoV-2 infection that makes it so.
The article suggests that it is because of a higher dose being used as well as the underlying pathology of the infection:
For years, hydroxychloroquine has been considered a generally safe and effective treatment for malaria, lupus and rheumatoid arthritis.
But those findings of safety were at lower doses than were being used at hospitals during the early days of the surge in patients in the United States and mostly in patients who were healthy.
@George-K
The Lancet article has been discredited.“After publication of our Lancet Article,1 several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication. We launched an independent third-party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper.
Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process.
We always aspire to perform our research in accordance with the highest ethical and professional guidelines. We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.
We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.“One rumor is that Surgisphere consists of a cryptocurrency trader, a science fiction writer, and an online sex performer. So much for peer reviewed.
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https://www.politico.com/news/2020/08/02/trump-health-official-hydroxychloroquine-390601
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official in the Trump administration's Covid-19 response effort said Sunday there is no evidence that hydroxychloroquine is an effective treatment for the virus, despite President Donald Trump's continued promotion of the anti-malaria drug.In an interview on NBC's "Meet the Press," administration testing czar Brett Giroir said he could not recommend hydroxychloroquine because trials "do not show any benefit."
"We need to move on from that and talk about what is effective,” Giroir, assistant secretary at the Department of Health and Human Services said.
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https://www.politico.com/news/2020/08/02/trump-health-official-hydroxychloroquine-390601
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official in the Trump administration's Covid-19 response effort said Sunday there is no evidence that hydroxychloroquine is an effective treatment for the virus, despite President Donald Trump's continued promotion of the anti-malaria drug.In an interview on NBC's "Meet the Press," administration testing czar Brett Giroir said he could not recommend hydroxychloroquine because trials "do not show any benefit."
"We need to move on from that and talk about what is effective,” Giroir, assistant secretary at the Department of Health and Human Services said.
— — — —@Axtremus said in RIP Hydroxychloroquine:
https://www.politico.com/news/2020/08/02/trump-health-official-hydroxychloroquine-390601
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official in the Trump administration's Covid-19 response effort said Sunday there is no evidence that hydroxychloroquine is an effective treatment for the virus, despite President Donald Trump's continued promotion of the anti-malaria drug.In an interview on NBC's "Meet the Press," administration testing czar Brett Giroir said he could not recommend hydroxychloroquine because trials "do not show any benefit."
"We need to move on from that and talk about what is effective,” Giroir, assistant secretary at the Department of Health and Human Services said.
— — — —Last I heard is that it was dangerous and could kill you. Did they back off that or ignore it? What’s the media position on harm?
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@Axtremus said in RIP Hydroxychloroquine:
https://www.politico.com/news/2020/08/02/trump-health-official-hydroxychloroquine-390601
— — — —
official in the Trump administration's Covid-19 response effort said Sunday there is no evidence that hydroxychloroquine is an effective treatment for the virus, despite President Donald Trump's continued promotion of the anti-malaria drug.In an interview on NBC's "Meet the Press," administration testing czar Brett Giroir said he could not recommend hydroxychloroquine because trials "do not show any benefit."
"We need to move on from that and talk about what is effective,” Giroir, assistant secretary at the Department of Health and Human Services said.
— — — —Last I heard is that it was dangerous and could kill you. Did they back off that or ignore it? What’s the media position on harm?
@Loki said in RIP Hydroxychloroquine:
Last I heard is that it was dangerous and could kill you. Did they back off that or ignore it? What’s the media position on harm?
Plaquenil
has been around for decades and has a good safety profile, when used as an anti-malarial, and when used in Lupus and rheumatoid arthritis. 400 mg seems to be a safe dose in those conditions. I'm too lazy to look up what doses were used in the treatment of patients with COVID-19. My understanding is that cardiac toxicity is one of the concerns.I'm also too lazy to look up the studies saying it's of no use - what doses were given? At what stage of disease?
"Now look here, you Baltic gas passer... " - Mik, 6/14/08
The saying, "Lite is just one damn thing after another," is a gross understatement. The damn things overlap.
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There are now 53 studies that show positive results of hydroxychloroquine in COVID infections. There are 14 global studies that show neutral or negative results -- and 10 of them were of patients in very late stages of COVID-19, where no antiviral drug can be expected to have much effect. Of the remaining four studies, two come from the same University of Minnesota author. The other two are from the faulty Brazil paper, which should be retracted, and the fake Lancet paper, which was.
Millions of people are taking or have taken hydroxychloroquine in nations that have managed to get their national pandemic under some degree of control. Two recent, large, early-use clinical trials have been conducted by the Henry Ford Health System and at Mount Sinai showing a 51% and 47% lower mortality, respectively, in hospitalized patients given hydroxychloroquine. A recent study from Spain published on July 29, two days before Margaret Sullivan’s strafing of “fringe doctors,” shows a 66% reduction in COVID mortality in patients taking hydroxychloroquine. No serious side effects were reported in these studies and no epidemic of heartbeat abnormalities.
This is ground-shaking news. Why is it not being widely reported? Why is the American media trying to run the U.S. pandemic response with its own misinformation?
>Steven Hatfill is a veteran virologist who helped establish the Rapid Hemorrhagic Fever Response Teams for the National Medical Disaster Unit in Kenya, Africa. He is an adjunct assistant professor in two departments at the George Washington University Medical Center where he teaches mass casualty medicine. He is principle author of the prophetic book “Three Seconds Until Midnight -- Preparing for the Next Pandemic,” published by Amazon in 2019.
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It clearly should never have been politicised in the way that it has.
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One of the criticisms I saw leveled against this article is that the articles that the author cites as showing a positive result were not double-blind studies.
So, from a practical point, let me ask this:
You start developing symptoms of COVID-19, and your doc sees that you test positive.
He says to you, "Hey, we're conducting a large study of people infected with SARS-CoV-2. It's a double blind study on the effectiveness of HCQ. We don't know, and you won't know, if you're getting a placebo or the medication. Can I sign you up?"
Who would say "Sure! I'd be thrilled to have a 50/50 chance of getting a placebo vs a drug that might work.?"
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One of the criticisms I saw leveled against this article is that the articles that the author cites as showing a positive result were not double-blind studies.
So, from a practical point, let me ask this:
You start developing symptoms of COVID-19, and your doc sees that you test positive.
He says to you, "Hey, we're conducting a large study of people infected with SARS-CoV-2. It's a double blind study on the effectiveness of HCQ. We don't know, and you won't know, if you're getting a placebo or the medication. Can I sign you up?"
Who would say "Sure! I'd be thrilled to have a 50/50 chance of getting a placebo vs a drug that might work.?"
@George-K said in RIP Hydroxychloroquine:
Who would say "Sure! I'd be thrilled to have a 50/50 chance of getting a placebo vs a drug that might work.?"
Most people who have ever participated in a drug trial do just that.
Only non-witches get due process.
- Cotton Mather, Salem Massachusetts, 1692
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I must admit my first thought when I read anything on HCQ is 'what's their agenda?', which is pretty sad.
I was only joking
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@George-K said in RIP Hydroxychloroquine:
Who would say "Sure! I'd be thrilled to have a 50/50 chance of getting a placebo vs a drug that might work.?"
Most people who have ever participated in a drug trial do just that.
@jon-nyc said in RIP Hydroxychloroquine:
@George-K said in RIP Hydroxychloroquine:
Who would say "Sure! I'd be thrilled to have a 50/50 chance of getting a placebo vs a drug that might work.?"
Most people who have ever participated in a drug trial do just that.
Most of those studies aren’t dealing with an illness with as much public hysteria as COVID-19.
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I must admit my first thought when I read anything on HCQ is 'what's their agenda?', which is pretty sad.
@Doctor-Phibes said in RIP Hydroxychloroquine:
I must admit my first thought when I read anything on HCQ is 'what's their agenda?', which is pretty sad.
Remember when they said that TRump had a financial stake in pushing HCQ?
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@Loki said in RIP Hydroxychloroquine:
Last I heard is that it was dangerous and could kill you. Did they back off that or ignore it? What’s the media position on harm?
Plaquenil
has been around for decades and has a good safety profile, when used as an anti-malarial, and when used in Lupus and rheumatoid arthritis. 400 mg seems to be a safe dose in those conditions. I'm too lazy to look up what doses were used in the treatment of patients with COVID-19. My understanding is that cardiac toxicity is one of the concerns.I'm also too lazy to look up the studies saying it's of no use - what doses were given? At what stage of disease?
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@Doctor-Phibes said in RIP Hydroxychloroquine:
I must admit my first thought when I read anything on HCQ is 'what's their agenda?', which is pretty sad.
Remember when they said that TRump had a financial stake in pushing HCQ?
@George-K said in RIP Hydroxychloroquine:
@Doctor-Phibes said in RIP Hydroxychloroquine:
I must admit my first thought when I read anything on HCQ is 'what's their agenda?', which is pretty sad.
Remember when they said that TRump had a financial stake in pushing HCQ?
NYT. What a bunch of putz’s. I never thought in my lifetime I would say that about them but hey that’s where they are.
