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Freddy
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And I don’t respect your attempt to make a medical emergency a political football. We shan’t be discussing this matter any further.Freddy:
I respect you comment about the need for America to “get your act together.”
Article: https://www.lifesitenews.com/opinion/a-safe-effective-outpatient-treatment-plan-for-covid-19-exists-why-arent-more-doctors-using-it
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Freddy
Guest
Most of the world doesn’t see ‘Make America Great Again’ as a bumper sticker. We look upon it as a plea. We need you guys.Thanks, @Freddy.
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Beryllos
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It’s gonna take a miracle. Lord, help us!
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Dovekin
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I posted a snippet from the FDA Press Release about the revocation of the EUA. The actual revocation, in a letter to the Biomedical Advanced R&D Authority, is accompanied by a 12 page memo that cites sources. The FDA did not leave them out, it just took a little digging to find them.
The FDA throughout calls attention to off label use of the drug, saying it is still allowed with the usual precautions. For hospital patients, the standards developed by the Infectious Diseases Society of America did not recommend HCQ for hospitalized patients; NIH incorporated that into their guidelines in June, which happened along with the revocation. All this is in the Memo mentioned above.
I suspect the original claim, that governors were forbidding off label use, was from some sloppiness by the governors, or more likely, LIfe Site News. LSN is not known for its careful journalism.
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AlbMagno
Guest
I think all persons should use favipiravir, not HCQ, because it’s less harmful to more patients, it’s waaaay easier to produce chemically, and has got good results.
But yes, I agree that scientific bureacracy (and scientific nationalism tbh) has delayed useful drugs to be mass-given here in the West. After all, if it’s not at all toxic to a Russian or a Japanese, why would it be toxic to us? Shouldn’t it be a lot easier to approve a drug when other countries have approved it already?
But yes, I agree that scientific bureacracy (and scientific nationalism tbh) has delayed useful drugs to be mass-given here in the West. After all, if it’s not at all toxic to a Russian or a Japanese, why would it be toxic to us? Shouldn’t it be a lot easier to approve a drug when other countries have approved it already?
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Joegrane
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Do you have the link to the 12 page memo you referred to? I’d like to read it.
I know better than to trust a post in a discussion group or even an article in corporate media. There is SO much deception and spin out there.
I know better than to trust a post in a discussion group or even an article in corporate media. There is SO much deception and spin out there.
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Dovekin
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My apologies. I usually include that kind of link.
The Press Release
The first link at the bottom is to the revocation, a 15 page pdf that includes the detailed memorandum.
The Press Release
The first link at the bottom is to the revocation, a 15 page pdf that includes the detailed memorandum.
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commenter
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LSN has done careful journalism in its specialty area, prolife. Sadly, its tangent work is much less reliable. But that’s not cause to ignore or question its prolife work.
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Beryllos
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What if the other country got it wrong? That happened in the case of thalidomide. At a time when it was already available in dozens of other countries, it’s approval was delayed in the US because the manufacturer did not submit adequate evidence of its safety.
Here is a story about the FDA scientist whose diligence averted a public health disaster.
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Funvod
Guest
Isn’t LifeSiteNews all but a conspiracy website, like Breitbart or something?
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AlbMagno
Guest
Thanks for the link, I didn’t think of birth defects. However, favipiravir is already known to be harmful to pregnant women, so it wouldn’t be used like that in this case, and I believe that even if we could treat with this drug all the population, except for the pregnant women, we would do much to defeat this disease.
Obviously, for that to work all doctors would have to prescribe well and be aware of the risks for a pregnant patient, which might be difficult enough considering the quality of some doctors
Obviously, for that to work all doctors would have to prescribe well and be aware of the risks for a pregnant patient, which might be difficult enough considering the quality of some doctors
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Beryllos
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The problem with thalidomide was birth defects. I didn’t mean to suggest that favipiravir would cause birth defects or that this side effect would preclude its use. Thalidomide was just the first example that came to my mind of a drug that was approved in other countries before its safety was adequately assessed.
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Beryllos
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No. While I would accuse LSN of a lot of things, like sensationalism, exaggeration, inaccurate or misleading quotations, failure to fact-check their sources, and sloppy journalism, I would not say that they deal in conspiracies or conspiracy theories.
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Joegrane
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Thank you for the link to the FDA documents about the emergency use authorization of HCQ, Dovekin. I read through them, including the FAQs.Joegrane:
I posted a snippet from the FDA Press Release about the revocation of the EUA. The actual revocation, in a letter to the Biomedical Advanced R&D Authority, is accompanied by a 12 page memo that cites sources…
A few things stand out that make me more confident than ever that the FDA was unethical–using a polite word–in its decision to remove emergency use of the US stockpile of HCQ.
By far the most important factor is the “Baseline severity of illness.” Notice that almost 2/3 of the patients were either in “serious” or “critical” condition.
I’ve never seen anyone present data from biochemistry suggesting that HCQ should be helpful in the later stages when the virus replication has already exploded and the cytokine storm is damaging a patient’s organs.
I’ve been hearing that HCQ is an “antiviral” that slows down replication of the virus. This buys time for the patient’s immune system and for doctors time to use other interventions as seen in the impressive “Time to Death” graph from Dr. Raoult’s study of over 3000 patients in Marseilles, France.
I’m not aware of any study of HCQ that was not encouraging when treatment was started on patients in the earlier phases of the virus–roughly before the 3rd day of hospitalization. I don’t know that the FDA based its decision on any studies of such patients. I did not notice any of those studies in the FDA documents. Unfortunately I’m fairly sure most of them were released shortly after the FDA’s decision.
Also notice in the FDA’s document that “The mean (SD) number of days patients received a dose was 4.1”
That seems to be an awfully short amount of time to expect treatment to be successful. Were they giving it to people on their death bed?!
Also notice that it includes chloroquine (CQ) not just hydroxychloroquine (HCQ). I heard one cardiologist who was prescribing HCQ to Covid patients say that no one uses CQ because it has more side effects. He also said heart problems are rare with HCQ. Why were researchers using CQ?
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Joegrane
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continued from above
The FDA document mentions the following about the Boulware study:
“…though with limitations that outcomes were largely self-reported with little opportunity for laboratory confirmation.25”
The Boulware study was essentially an internet survey. Few people were actually monitored in person. Given the political nature of HCQ who knows if politically motivated people signed up to present false information.
In contrast there is a more compelling study of HCQ for prevention from India.
Also I noticed that only 10% of the people in the Boulware study were black or Hispanic, yet they make up roughly 30% of the US population and have suffered disproportionately from Covid.
There was no mention of zinc in the FDA documents. Dr Chris Martenson expressed great disappointment about the lack of inclusion of zinc in almost all of the HCQ studies. He presents some information from a researcher suggesting that zinc might be more effective than a vaccine. There is more about zinc and HCQ here
The FDA document includes the following, “The potential drug interaction between remdesivir and HCQ/CQ is not the basis for the revocation of the EUA.”
Remdesivir is an expensive medication made by a US Pharma Co and I think is only administered via IV in a hospital. HCQ is a cheap, old drug taken orally.
Remember the important study of HCQ by the US NIH concluded that HCQ “treatment does no harm.”
In the three largest encouraging HCQ studies I’ve come across with over 4000 treated patients there were no sudden cardiac deaths
I’ve still not seen anything in this discussion that comes close to changing my view about the ethical problems surrounding HCQ. The views of Dr Fitzgibbons in the Lifesitenews article, Yale professor Risch and Dr Martenson seem quite compelling.
The restriction of access to HCQ by some US governors seems quite unethical and the rare nature of these actions by governors needs to be discussed.
Catholics and the general public need to be made more aware of the various ethical questions and problems related to HCQ in the US
The severe ethical problems exemplified by the awful, retracted Lancet study of HCQ can serve as a talking point as we try to reevangelize the culture.
Another member of our group mentioned the Boulware junk study/survey in the New England Journal of Medicine in support for governors to restrict access to HCQ.
The FDA document mentions the following about the Boulware study:
“…though with limitations that outcomes were largely self-reported with little opportunity for laboratory confirmation.25”
The Boulware study was essentially an internet survey. Few people were actually monitored in person. Given the political nature of HCQ who knows if politically motivated people signed up to present false information.
In contrast there is a more compelling study of HCQ for prevention from India.
Also I noticed that only 10% of the people in the Boulware study were black or Hispanic, yet they make up roughly 30% of the US population and have suffered disproportionately from Covid.
There was no mention of zinc in the FDA documents. Dr Chris Martenson expressed great disappointment about the lack of inclusion of zinc in almost all of the HCQ studies. He presents some information from a researcher suggesting that zinc might be more effective than a vaccine. There is more about zinc and HCQ here
The FDA document includes the following, “The potential drug interaction between remdesivir and HCQ/CQ is not the basis for the revocation of the EUA.”
Remdesivir is an expensive medication made by a US Pharma Co and I think is only administered via IV in a hospital. HCQ is a cheap, old drug taken orally.
Remember the important study of HCQ by the US NIH concluded that HCQ “treatment does no harm.”
In the three largest encouraging HCQ studies I’ve come across with over 4000 treated patients there were no sudden cardiac deaths
I’ve still not seen anything in this discussion that comes close to changing my view about the ethical problems surrounding HCQ. The views of Dr Fitzgibbons in the Lifesitenews article, Yale professor Risch and Dr Martenson seem quite compelling.
The restriction of access to HCQ by some US governors seems quite unethical and the rare nature of these actions by governors needs to be discussed.
Catholics and the general public need to be made more aware of the various ethical questions and problems related to HCQ in the US
The severe ethical problems exemplified by the awful, retracted Lancet study of HCQ can serve as a talking point as we try to reevangelize the culture.
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Dovekin
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I certainly agree. I think the FDA would as well. That is why I question whether it has happened.
IMO you and many others misunderstand a fundamental point about the EUA and its revocation. It is concerned with use in hospitals. If you want to say “patients on their deathbed” that is probably an accurate description. You agree that HCQ+ is unlikely to be helpful to these patients.
Patients at an earlier stage of the disease can get access to HCQ+ through clinical trials, or through an off label prescription by their physician. The decision on use in hospital patients should not persuade doctors to avoid HCQ, though it probably does have that effect. Even governors may have gotten that impression, though I still have have not seen anything about that except from LSN. Governors are probably obliged to follow the FDA, NIH, etc. but they do sometimes misunderstand what the guidance. There is no giant conspiracy against HCQ, probably just some reasonable misunderstandings.
It is also possible I misspoke in saying the governors were basing their decisions on this revocation by the FDA. My apologies if it was my mistake that led us off on a tangent.
Also, I am pretty sure they said somewhere that no CQ was sent out under the EUA, which is why they only discussed HCQ.
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Joegrane
Guest
Thanks for the reply. It may be true that the US government only sent hydroxychloroquine (HCQ) from its emergency stock, not Chlorquine (CQ) that has a more troublesome side effect reputation; however the FDA documents treat them essentially the same. From a quick review of the document, every time the document mentions one, the other is also mentioned.
They actually have a section of the document that explains why. They consider the pharmacokinetics to be essentially the same even though they admit there is some controversy about that.
“Similarity of CQ and HCQ and Rationale for Inclusion of Both Products in EUA 039” on page 3.
Since I’m suspicious about anything written about HCQ I’m always looking for something that may have been done to obscure the truth. This is one such issue.
Since CQ has a reputation for more side effects, making it equivalent to HCQ in their decision making process has a potential for changing their equation.
Rightfully they are considering the potential benefits and weighing those against the potential risks. When they add CQ to the equation they are increasing risk causing a higher bar for benefits. I suspect this is just another way they have been stacking the deck against HCQ.
We need a watchdog group made up of scientists from various religious groups and other groups focused on scientific ethics to call out those involved in crooked studies, especially in this time of crisis!
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commenter
Guest
Within their core area of expertise - prolife - they bring to light underreported developments. This includes advancement of the Culture of Death by government, media, and private organizations, as well as ambiguous or inadequate support for Life by some Dioceses and the Holy See since 2013.Funvod:
No. While I would accuse LSN of a lot of things, like sensationalism, exaggeration, inaccurate or misleading quotations, failure to fact-check their sources, and sloppy journalism, I would not say that they deal in conspiracies or conspiracy theories.
Sadly there’s no need to exaggerate to make their point.
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pnewton
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It is very seldom about conspiracies, just like it is very seldom about pro-life issues, and virtually never actual news, as in, journalism. It is a far-right op-ed blog. The articles posted here have also been anti-Catholic, frequently attacking the Pope.
To see for yourself, do a search here on LSN and see the titles used.
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Joegrane
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I came across an article at naturalnews.com similar to the article by Dr Fitzgibbons at LifeSiteNews. It actually mentions the Fitzgibbons article. This excerpt stands out.
There were previous reports out of Brazil that HCQ when given in the first week or so was working well to reduce the number of people admitted to the hospital.
The important study of HCQ done by the US NIH confirmed that they now know how to give HCQ safely. The NIH study, unlike the other studies mentioned in this post, did not emphasize early administration so it is not surprising that the study did not report significant benefits. Every study that I’ve seen reporting benefits from HCQ was giving it to patients in the early stages of the illness. That seems consistent with the hypothesis and evidence that HCQ is thought to slow replication of the virus, not treat the deadly cytokine storm in the later stages.
We hear reports that hospitals in some communities are being stressed. The use of HCQ by primary care physicians seems to be a good way to try to reduce the burden on hospitals in communities experiencing a spike in cases.
The protocol used by some primary care doctors in France seems reasonable.
Why are some governors restricting use of HCQ by primary care physicians as reported in the Fitzgibbons article? Are the deceptive studies of HCQ discussed elsewhere in this discussion still causing confusion, and/or providing cover for those with another agenda?
There were previous reports out of Brazil that HCQ when given in the first week or so was working well to reduce the number of people admitted to the hospital.
The important study of HCQ done by the US NIH confirmed that they now know how to give HCQ safely. The NIH study, unlike the other studies mentioned in this post, did not emphasize early administration so it is not surprising that the study did not report significant benefits. Every study that I’ve seen reporting benefits from HCQ was giving it to patients in the early stages of the illness. That seems consistent with the hypothesis and evidence that HCQ is thought to slow replication of the virus, not treat the deadly cytokine storm in the later stages.
We hear reports that hospitals in some communities are being stressed. The use of HCQ by primary care physicians seems to be a good way to try to reduce the burden on hospitals in communities experiencing a spike in cases.
The protocol used by some primary care doctors in France seems reasonable.
Why are some governors restricting use of HCQ by primary care physicians as reported in the Fitzgibbons article? Are the deceptive studies of HCQ discussed elsewhere in this discussion still causing confusion, and/or providing cover for those with another agenda?
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