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Offlinemorrowasted
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On the history and the thrill of medical practice and the processes that make it effective * 1
    #26900210 - 08/26/20 09:57 AM (3 years, 5 months ago)

This was written as a response to a specific user in another thread. I'm reposting it in a separate thread because I suspect a broader audience may enjoy/benefit from reading it. The choice to discuss certain medicines may seem odd given the lack of context, but I'm happy to answer and questions you may have about broader or different applications of the principles and processes discussed herein, to the best of my ability.



The first stage of learning about medicine and medical practice is exhilarating. Medicine is essentially the collection of the practices from what had been called "sorcery", "shamanism", "herbalism", and "alchemy" that actually turned out to be effective at ending or reducing the suffering, injury, and death of others- how could it not be exciting? It makes you feel powerful, because when medicine is done right, it is powerful. It isn't unusual to feel a kind of "manic excitement" when you embark on the journey of learning about medical practice.

For at least 2,000 years, those calling themselves doctors have had effective medicines for reducing suffering- primarily opium and alcohol. Prior to the advent of institutions that regulate the production and distribution of medicine, like the FDA, medical practice largely consisted of the sale of what were called "patent medicines". Although patent medicines rarely cured the illnesses they were purported to cure, they frequently made patients "feel better" because they contained things like alcohol, opium, and cocaine.

In the late 1800s, the discovery of microorganisms and their connection to diseases caused a revolution in medical practices: suddenly, the prospect of not only alleviating suffering, but also preventing death from disease, seemed to be within reach. For many decades thereafter, the discovery of effective medicines took place largely by accident and/or by conducting experiments that today would be considered highly unethical- for example, the cause of beriberi, the disease caused by a deficiency of vitamin B1 (Thiamin), was discovered by observing that prisoners fed a diet of white rice developed the disease far more frequently than prisoners fed a diet of brown rice.

The principles of the modern clinical were developed in the 1920s, but the first randomized, double-blinded, placebo-controlled clinical trial did not take place until 1946 to evaluate the efficacy of streptomycin in tuberculosis treatment. Increasingly widespread adoption of this clinical trial process in the decades that followed led to an explosion in the discovery of medicines that are both effective and safe at reducing or ending suffering and death resulting from injury and disease.

In the context of modern medicine, there are two broad categories of study used to evaluate the efficacy of a medical treatment:
(1) Observational studies involve simply observing subjects and measuring their outcomes.
(2) Interventional studies involve actively measuring the differences in outcomes between a group of people who are given a treatment and a group of people who are not.

With respect to SARS-CoV-2 and COVID-19, there are 4 relevant subtypes of study: observational studies, prevention trials, treatment trials, and compassionate use trials.

"In vitro" translates to "in glass": within the context of infectious disease studies, in vitro experiments involve culturing a pathogen (bacteria, virus, fungus, or protozoa) in a petri dish, and then adding in various chemicals to see what effect the chemicals have on the pathogen. In this stage, scientists simply use concepts from chemistry, human physiology, and microbiology to make their "best guess" about what sort of chemical will have the desired effect on the pathogen. For example, as feevers mentioned, scientists can guess based on the chemical properties of bleach that it is likely to destroy the SARS-CoV-2 virus. However, they can also guess based on human physiology that bleach is likely to destroy human tissues as well; therefore, they are unlikely to run an in vitro study of bleach on SARS-CoV-2.

Here is a non-comprehensive list of reasons that a chemical which is effective at destroying a pathogen in a petri dish may not prove to useful for treating the disease that pathogen causes in humans:
  • When the chemical passes through the liver, it is converted into different chemicals that are not effective
  • The absorption of the chemical is either very poor, or varies widely from human to human
  • Once the chemical is absorbed, it is not distributed effectively throughout the body. For example, it may be quickly absorbed by fat cells, or excessive amounts of it may bind to proteins in the bloodstream that make it incapable of exiting the bloodstream and penetrating human tissues
  • The undesirable effects of the drug on human tissues may outweigh the desirable effects of the drug on the pathogen

For these reasons, among others, it turns out that only a very small percentage of chemicals that are effective in vitro turn out to be effective in vivo.

The first studies released with respect to COVID-19 were observational studies. Because doctors were aware of in vitro studies conducted on SARS-CoV using HCQ, they made a reasonable guess that it might have similar effects on SARS-CoV-2. Furthermore, previously conducted clinical trials on HCQ provided doctors with useful information about the absorption, distribution, side effects, and toxicity of HCQ. Therefore, doctors determined that it was worthwhile to attempt HCQ treatment for COVID-19 patients without having conducted any in vivo (in life) studies, because patients were dying from COVID19 at an alarming rate. After having given HCQ to a reasonably large sample of COVID-19 patients, scientists used principles from statistics to conduct observational studies.

Having done so, there was no indication that HCQ was either overwhelmingly effective or overwhelmingly dangerous- a significant proportion of patients receiving it still died, and the number of deaths/injuries that could be attributed to HCQ was acceptably low. Therefore, doctors and scientists embarked on randomized, placebo-controlled clinical trials of HCQ to get more information about precisely how effective it was.

Here in the USA, concurrently with the HCQ clinical trials, trials on another drug called Remdesivir were being conducted. Since Remdesivir has no history of approved use, these were called "compassionate use" trials- the potential risks of giving the drug were considered to be acceptable given the severity of COVID-19.

In many hospitals- the one I work at included- these drugs were being given concurrently- some patients were receiving HCQ (and zinc/azithromycin), and others were receiving Remdesivir. Because of the randomization process, there were moderately ill patients and severely ill patients receiving each, there were early stage patients and late stage patients receiving each, and there were patients with various comorbid diseases receiving each. Within about 6-8 weeks, it became clear to medical practitioners that patients receiving Remdesivir were more likely to recover from COVID19 than those receiving HCQ, and that among recovered patients receiving either drug, those receiving Remdesivir had recovered more quickly. It also became clear while no patients appeared to be dying as a result of side effects of Remdesivir, occasionally patients were dying as a result of the side effects of HCQ. Among those who did not die, patients receiving HCQ required more careful monitoring and consideration with regard to other medical treatments being given than those receiving Remdesivir.

These results were communicated between medical practitioners around the world, and were corroborated. Hospitals/governments in other countries sought to- and did-  obtain as much Remdesivir as they were able to. Unfortunately for the citizens of those countries, the supply of Remdesivir is limited. Therefore, many of them resumed trials using what was available to them, which was HCQ. As cases accumulate and sample sizes grow, it may yet demonstrate some level of efficacy. They may be able to show that HCQ is more likely to help rather than harm the patient.

Depending on those results, hospitals in the USA may begin to re-consider the use of HCQ. For the moment, they have no compelling reason to do so. Remdesivir is not only clearly helping patients, it's helping them leave the hospital more quickly. A major problem with COVID-19 is that patients are not infrequently hospitalized for several weeks at a time. This creates logistical problems. The fact that hospitals are reimbursed a fixed amount of money for treating a COVID-19 patient- an amount that typically covers 2 weeks or less of expenses related to treating the patient- also creates a compelling reason for them to try to treat COVID-19 patients with the drug that helps them recover more quickly.

If you want the power to save lives, heal injuries, and reduce suffering, I understand, and I can relate. It is, again, an exhilarating experience. Being good at it takes dedication, critical thinking, focus, and patience. I don't know everything there is to know- not even close. But every day I learn how to do it just a little bit better. The exhilaration I feel from saving lives isn't reduced at all when someone else when someone else saves a life- it's not a competition. The better each person is at saving lives, the better off we all are. If what you truly care about is saving lives rather than "being correct", I'm willing to help you in any way I can. All you have to do is ask. 

:sun:Peace:mushroom2:


Edited by morrowasted (08/26/20 01:18 PM)


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Invisibletyrannicalrex
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: morrowasted]
    #26900222 - 08/26/20 10:06 AM (3 years, 5 months ago)

You really paid attention in nursing and are going to be a professional within a few years, kudos to you sir!


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Offlinemorrowasted
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: tyrannicalrex]
    #26900227 - 08/26/20 10:09 AM (3 years, 5 months ago)

Quote:

tyrannicalrex said:
You really paid attention in nursing and are going to be a professional within a few years, kudos to you sir!



Most of this information I either learned in my free time or on the job. School did help me learn how to think critically about medical practice. The purpose of this post is to be as informative as possible, not to impress anyone. But I do thank you for your kind words.


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Invisibletyrannicalrex
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: morrowasted]
    #26900233 - 08/26/20 10:13 AM (3 years, 5 months ago)

Yep, there's "NCLEX world, and then there's the real world" as the saying goes.


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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: tyrannicalrex] * 1
    #26901060 - 08/26/20 05:47 PM (3 years, 5 months ago)

:neat:  :threadmonitor:


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:heartpump::heartpump: :heartpump::heartpump:


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: pachoo]
    #26901226 - 08/26/20 08:08 PM (3 years, 4 months ago)

How many different drugs are given to someone in a coma with a tube lodged in their throat?

Are there any cross interactions with any of those drugs?

Do you prescribe any drugs yourself?

How long have you been a nurse?

Are you still in school?

If you were to travel to a different country where hydroxychloroquine is widely being used, would you argue with your superiors about their recommendations for use of HCQ?

Besides emergency use authorization, why do you think a drug with no FDA approval is being used over one that has been FDA approved?

Being a nurse, you will be required to take whatever new coronavirus vaccine becomes available first. How does this idea of taking an experimental vaccine shortly after trial completion make you feel?

What are your thoughts on those short observation periods those vaccine trials implement on their participants, sometimes as short as 5 days for adverse reactions to be recorded?

Care to discuss vaccine induced ADE?


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The Italian researchers’ findings, published by the INT’s scientific magazine Tumori Journal, show 11.6% of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

https://www.reuters.com/article/us-health-coronavirus-italy-timing-idUSKBN27V0KF

This online first version has been peer-reviewed, accepted and edited,  but not formatted and finalized with corrections from authors and proofreaders

https://www.icandecide.org/


Edited by HamHead (08/26/20 08:09 PM)


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: HamHead]
    #26901653 - 08/27/20 06:12 AM (3 years, 4 months ago)

https://populartimelines.com/timeline/Remdesivir

2019
GS-441524 was shown in 2019, to have promise for treating feline infectious peritonitis caused by a coronavirus. It has not been evaluated or approved by the US Food and Drug Administration (FDA) for the treatment of feline coronavirus or feline infectious peritonitis but has been available since 2019, through websites and social media as an unregulated black market substance as confirmed by the UC Davis School of Veterinary Medicine. Because GS-441524 is the main circulating metabolite of remdesivir and because GS-441524 has similar potency against SARS-Cov-2 in vitro, some researchers have argued for the direct administration of GS-441524 as a COVID19 treatment.

:whattefuck2:

Edit.

October 2015
In October 2015, the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) announced preclinical results that remdesivir had blocked the Ebola virus in Rhesus monkeys. Travis Warren, who has been a USAMRIID principal investigator since 2007, said that the "work is a result of the continuing collaboration between USAMRIID and Gilead Sciences". The "initial screening" of the "Gilead Sciences compound library to find molecules with promising antiviral activity" was performed by scientists at the Centers for Disease Control and Prevention (CDC). As a result of this work, it was recommended that remdesivir "should be further developed as a potential treatment."

So, Gilead is working with US military?

Can someone interpret what I'm reading on this site, I have to go to work.


--------------------
The Italian researchers’ findings, published by the INT’s scientific magazine Tumori Journal, show 11.6% of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

https://www.reuters.com/article/us-health-coronavirus-italy-timing-idUSKBN27V0KF

This online first version has been peer-reviewed, accepted and edited,  but not formatted and finalized with corrections from authors and proofreaders

https://www.icandecide.org/


Edited by HamHead (08/27/20 06:14 AM)


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Offlinemorrowasted
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: HamHead]
    #26901782 - 08/27/20 08:20 AM (3 years, 4 months ago)

Ill make you a deal, hamhead. You learn to read and I will answer your questions.

Other than that first highly loaded and completely irrelevant question, I have answered every single one of all of those questions at various times on this forum, and most of them directly in the course of conversations we have had. I am done saying the same things over and over. Either you are incapable of paying attention, choosing not to pay attention or youre hoping that one of the times I answer the same question, I accidentally contradict something I said previously. I do not "like" to argue. I am trying to be helpful. I like to save lives. I was under the impression that you might also have an interest in saving lives. Unfortunately- your lack of involvement in attempting to do so, even at a volunteer level completely aside- by asking the same questions repeatedly, you are making it abundantly clear that you simply want to argue. 

I have zero interest in discussing vaccines with you. If you want my position on vaccines, again, simply refer back to the other discussions we have had.


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: morrowasted]
    #26902071 - 08/27/20 10:39 AM (3 years, 4 months ago)

Quote:

morrowasted said:
Ill make you a deal, hamhead. You learn to read and I will answer your questions.

Other than that first highly loaded and completely irrelevant question, I have answered every single one of all of those questions at various times on this forum, and most of them directly in the course of conversations we have had. I am done saying the same things over and over. Either you are incapable of paying attention, choosing not to pay attention or youre hoping that one of the times I answer the same question, I accidentally contradict something I said previously. I do not "like" to argue. I am trying to be helpful. I like to save lives. I was under the impression that you might also have an interest in saving lives. Unfortunately- your lack of involvement in attempting to do so, even at a volunteer level completely aside- by asking the same questions repeatedly, you are making it abundantly clear that you simply want to argue. 

I have zero interest in discussing vaccines with you. If you want my position on vaccines, again, simply refer back to the other discussions we have had.




Dodgey I see. Simple questions, not so simple answers?

No comments on Remdesivir causing liver toxicity?


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The Italian researchers’ findings, published by the INT’s scientific magazine Tumori Journal, show 11.6% of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

https://www.reuters.com/article/us-health-coronavirus-italy-timing-idUSKBN27V0KF

This online first version has been peer-reviewed, accepted and edited,  but not formatted and finalized with corrections from authors and proofreaders

https://www.icandecide.org/


Edited by HamHead (08/27/20 11:02 AM)


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OfflinemndfreezeMDiscordReddit
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: HamHead]
    #26902162 - 08/27/20 11:20 AM (3 years, 4 months ago)

Why do I keep seeing your same posts pop up in different threads Hammy.


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Nothing says love like grannies prolapsed anus!

quote]Urb said:
I know... Its fucked up... Ill fix it minyana..[/quote]


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: mndfreeze]
    #26902616 - 08/27/20 03:50 PM (3 years, 4 months ago)

Quote:

mndfreeze said:
Why do I keep seeing your same posts pop up in different threads Hammy.




:shrug:

Which ones are those?


--------------------
The Italian researchers’ findings, published by the INT’s scientific magazine Tumori Journal, show 11.6% of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

https://www.reuters.com/article/us-health-coronavirus-italy-timing-idUSKBN27V0KF

This online first version has been peer-reviewed, accepted and edited,  but not formatted and finalized with corrections from authors and proofreaders

https://www.icandecide.org/


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OfflineIce9
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: HamHead]
    #26903045 - 08/27/20 07:52 PM (3 years, 4 months ago)

Quote:

HamHead said:
https://populartimelines.com/timeline/Remdesivir



Edit.

October 2015
In October 2015, the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) announced preclinical results that remdesivir had blocked the Ebola virus in Rhesus monkeys. Travis Warren, who has been a USAMRIID principal investigator since 2007, said that the "work is a result of the continuing collaboration between USAMRIID and Gilead Sciences". The "initial screening" of the "Gilead Sciences compound library to find molecules with promising antiviral activity" was performed by scientists at the Centers for Disease Control and Prevention (CDC). As a result of this work, it was recommended that remdesivir "should be further developed as a potential treatment."

So, Gilead is working with US military?

Can someone interpret what I'm reading on this site, I have to go to work.




Chemical companies make libraries of similar but slightly different chemicals usually off a base chemical that showed in vitro activity against a specific target.  They do this at pretty high though-put using combinatorial chemistry.  Most of these chemicals will never enter phase 1 clinical trials let alone make it to market, so they may enter into a contract with another company, or the Army in this case, which gives the contractor access to the library which they use to assess against totally different targets than these compounds were created for, call it a shotgun approach they are searching for a needle in a haystack in the hopes of making a break through discovery.


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The reasonable man adapts himself to the world; the unreasonable one persists in trying to adapt the world to himself. Therefore, all progress depends on the unreasonable man. -- George Brenard Shaw


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: Ice9]
    #26903161 - 08/27/20 08:47 PM (3 years, 4 months ago)

Remdesivir is one of those that made it to trials and failed. More than once. They tried it for Hep-C and for Ebola.

Studies were ceased due to evidence of liver toxicity shown in patients with no prior history of liver disease.

This is why I ask morrowasted about liver toxicity.

I guess I could be more specific and ask if he is witnessing liver toxicity in those patients he sees who are being treated with Remdesivir?

An honest question, really.

He's started this thread with a willingness to share what knowledge he has, so I ask questions. :shrug:


--------------------
The Italian researchers’ findings, published by the INT’s scientific magazine Tumori Journal, show 11.6% of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

https://www.reuters.com/article/us-health-coronavirus-italy-timing-idUSKBN27V0KF

This online first version has been peer-reviewed, accepted and edited,  but not formatted and finalized with corrections from authors and proofreaders

https://www.icandecide.org/


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: HamHead]
    #26904641 - 08/28/20 05:14 PM (3 years, 4 months ago)

https://cassingram.com/synthetic-drug-remdesivir-fails-in-clinical-trials-natural-medicines-would-have-done-better/

Synthetic drug remdesivir fails in clinical trials, natural medicines would have done better

April 25, 2020

The abrupt cancellation of the randomized clinical trial of the purported anti-coronavirus drug remdesivir is highly suspect. There must have been unanticipated toxicity; after all, it was highly touted and much hope was held for it. Otherwise, it would not have been cancelled. The claim is that there were not enough patients to enroll in the study. Most likely, instead, it was from side effects and lack of effectiveness. According to the summary of the China study, remdesivir was “not associated with a difference in time to clinical improvement” compared to a standard of care control. After one month, it appeared 13.9% of the remdesivir patients had died compared to over 12% of the untreated. Could the results have been fudged in order to alter the end-result? That could explain why it was terminated.

Regardless, with all the high expectations for the study, termination is no minor issue.

With this drug no one knows the extent of the toxicity. However, importantly, according to a Fox News report in some 18 people the drug was halted due to side effects. No wonder Gilead couldn’t find enough people for the trial. The exact quote is: “Remdesivir was stopped early in 18 patients because of side effects.” Therefore, the drug proved worse than the disease progression.

The results were reported by the WHO, which posted them on its Website. Then, rapidly, this was taken down. Clearly, this amounted to a major embarrassment to the drug-maker, causing a sinking of its stock value.

Since the study was run exclusively by the maker, drug company Gilead, the real reason for the cancellation is most likely being disguised. Why start the trial and then quit it? There may have been horrific results, including premature death. At the minimum the potential harm from the medication was greater than any benefit, so, ethically, it had to be halted.

Once such result was related to liver damage. In previous human studies elevated liver enzymes were reported. In China the drug has been found to also cause liver toxicity. In some cases the skin of Covid-19-afflicted doctors treated with remdesivir turned dark brown or blackish. This was from liver damage and the resulting deposition of iron in the tissues. The liver acts clear and store iron from dead blood cells and other sources, along with the spleen. If these are disturbed, that iron may be stored elsewhere, clearing upon the healing of these organs.

Here is further evidence of a cover-up. Dr. Li Shusheng, who is treating both physicians,  reported that the patients’ skin turned black “due to a type of medicine they were given…” He obviously refused to name it, though.  He then added that one of the drug’s side effects is the darkening of skin color, still refusing to list it.

Is that not bizarre to the extreme, hiding the name of the drug? According to China in Focus there is no issue. It reported, quoting a Chinese liver specialist, that liver damage and also this blackening of the skin is a known toxicity of the Gilead drug.

That’s all these people need is a poisoned liver. They have enough to deal with besides this. It is surprising that they even survive. Researchers had already previously documented liver damage in patients, this through elevated enzymes, a sign of cell death.

Drug companies cannot be trusted. They will do whatever is necessary to protect the bottom line, even if it means fabricating the results.

There is all sorts of pontificating, including here in the United States. ‘All the patients who took it survived,’ seems to be the best that can be said. Yet, according to involved physicians, for instance, Dr. Kali of Houston Methodist Hospital, “We are looking for not only a statistical difference, but also for a meaningful clinical improvement,” adding that most patients improve over time, drug-treated or not.

The drug, regardless, is a hopeless endeavor. It is nothing other than experimental at best. It already failed in Ebola. Why would it work here? Plus, like any other synthetic compounds based upon petrochemicals, it creates a burden on the body, which was obvious from the unsightly results of liver damage.

Only traditional, natural medicines must be used in this condition. Free of side effects the only possible result would be productive. Top examples include oil of wild oregano, raw garlic, raw onion, black seed oil, oil of cumin, cinnamon powder,  raw honey, royal jelly, ashwaghanda, and wild chaga. As well, tree resin extracts, especially those from spruce and pine, would also offer protective powers, especially for bronchial and lung tissues but also for liver health. Why not use such natural medicines to empower health and to create added strength to the immune system?

The medicines of nature are impressive. The fact is they are everywhere a person turns. As well, none of these can cause the slightest degree of liver or organ toxicity. Consider them as gifts from God. They do have their own complexities. Yet, unlike the man-fabricated types these natural medicines will not confuse the body and irritate the tissues, even causing poisoning and cell death. It is not possible for any of the natural medicines mentioned. Don’t even think about it. In fact, these natural complexes greatly aid in internal organ function, including the functional capacities of the kidneys and liver. The individual should search and find the highest quality of these supplements and foods and, at least, take them preventively.

Medical treatment of this disease is a nightmare. In dealing with this condition no drugs should be given. Treatment focus must be switched to natural medicine therapy immediately. There is no other way to resolve this pandemic.


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The Italian researchers’ findings, published by the INT’s scientific magazine Tumori Journal, show 11.6% of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

https://www.reuters.com/article/us-health-coronavirus-italy-timing-idUSKBN27V0KF

This online first version has been peer-reviewed, accepted and edited,  but not formatted and finalized with corrections from authors and proofreaders

https://www.icandecide.org/


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: HamHead]
    #26906509 - 08/29/20 07:14 PM (3 years, 4 months ago)

:popcorn:

Remdesivir causing liver toxicity?


--------------------
The Italian researchers’ findings, published by the INT’s scientific magazine Tumori Journal, show 11.6% of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

https://www.reuters.com/article/us-health-coronavirus-italy-timing-idUSKBN27V0KF

This online first version has been peer-reviewed, accepted and edited,  but not formatted and finalized with corrections from authors and proofreaders

https://www.icandecide.org/


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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: morrowasted]
    #26906559 - 08/29/20 07:49 PM (3 years, 4 months ago)

Quote:

morrowasted said:
This was written as a response to a specific user in another thread. I'm reposting it in a separate thread because I suspect a broader audience may enjoy/benefit from reading it.




This thread sucks. :smugjerry:


--------------------

Ephesians 6:12
For we wrestle not against flesh and blood, but against principalities, against powers, against the rulers of the darkness of this world, against spiritual wickedness in high places.
Psalm 12:6
The words of the Lord are pure words: as silver tried in a furnace of earth, purified seven times.
Hebrews 11:3
Through faith we understand that the worlds were framed by the word of God, so that things which are seen were not made of things which do appear.
Revelation 3:11
Behold, I come quickly: hold that fast which thou hast, that no man take thy crown.


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: HamHead]
    #26906592 - 08/29/20 08:08 PM (3 years, 4 months ago)

Here's a jama.

:shrug:

https://jamanetwork.com/journals/jama/fullarticle/2769871?guestAccessKey=03944cd1-64a7-43d2-83e1-ec7deaa0d285&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jama&utm_content=olf&utm_term=082120

Efficacy
Primary End Point
On day 11, patients randomized to the 5-day remdesivir group had significantly higher odds of a better clinical status distribution on the 7-point ordinal scale compared with those randomized to standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02) (Table 2 and Figure 2). The difference in clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not statistically significant (P = .18 by Wilcoxon rank sum test; the proportional odds assumption was not met for this comparison).

Exploratory Efficacy End Points
There were no significant differences between the 5-day or 10-day remdesivir groups and standard care for any of the exploratory end points—time to 2-point or greater improvement in clinical status, time to 1-point or greater improvement in clinical status, time to recovery, time to modified recovery, and time to discontinuation of oxygen support (eTable 3 in Supplement 3). There were no significant differences between the remdesivir and standard care groups in duration of oxygen therapy or hospitalization. The Kaplan-Meier estimates of all-cause mortality at day 28 were 1% (95% CI, 0.0%-2.6%) for the 5-day remdesivir group (log-rank P = .43 vs standard care), 2% (95% CI, 0.0%-3.6%) for the 10-day remdesivir group (log-rank P = .72 vs standard care), and 2% (95% CI, 0.1%-4.1%) for the standard care group.

Post Hoc Analyses
Sensitivity analyses of the primary end point adjusting for day 1 clinical status score, symptom duration, imputing patients with missing status as dead, and using the intention-to-treat population produced similar results (eTable 4 in Supplement 3).

By day 14, the clinical status of the 5-day and 10-day remdesivir groups was significantly different than that of the standard care group (P = .03 for both groups) (Figure 2 and eTable 5 in Supplement 3). By day 28, clinical status remained significantly different in the 10-day remdesivir group (P = .03) compared with standard care (eTable 6 and eFigure 1 in Supplement 3). No clear subgroup differences were noted between the remdesivir groups in proportions of patients with 1-point or greater improvement in clinical status (eFigure 2 in Supplement 3).

To explore the possible effect of the open-label design on study outcomes, rates of hospital discharge over time by treatment group were tabulated (eFigure 3 in Supplement 3). Peaks in discharge rates were observed in the remdesivir groups following the end of their assigned duration of treatment (ie, there were increased rates of discharge on day 6 in the 5-day remdesivir group and on day 11 in the 10-day group), suggesting that discharges were delayed for some patients to allow them to complete full courses of assigned remdesivir treatment.

Adverse Events (Secondary End Point)
Adverse events were experienced by 51% of patients in the 5-day remdesivir group, 59% in the 10-day remdesivir group, and 47% in the standard care group (Table 3). The difference in proportions between the 5-day remdesivir group and standard care was not statistically significant (4.8%; 95% CI, –5.2% to 14.7%; P = .36), but the difference between the 10-day remdesivir group and standard care was significant (12.0%; 95% CI, 1.6%-21.8%; P = .02). Adverse events that were more common in the remdesivir groups than in the standard care group include nausea, hypokalemia, and headache (Table 3).

Serious adverse events were less common in the remdesivir groups (5% in both) than in the standard care group (9%), differences of −4.3% (95% CI, −9.7% to 0.9%; P = .11) for the 5-day remdesivir group vs standard care and −3.8% (95% CI, −9.3% to 1.4%; P = .17) for the 10-day remdesivir group vs standard care. All 9 deaths through day 28 (2 [1%] in the 5-day remdesivir group, 3 [2%] in the 10-day remdesivir group, and 4 [2%] in the standard care group) occurred in patients aged 64 years or older, and none was attributed to remdesivir treatment.

Discussion
In this clinical trial of patients with moderate COVID-19 pneumonia, those who were randomized to remdesivir treatment for up to 5 days had significantly higher odds of having a better clinical status distribution on day 11 than those receiving standard care, but with an effect size of uncertain clinical importance. The difference in the distribution of clinical status on day 11 between the 10-day remdesivir and standard care groups was not significant.

Conclusions
Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.

Conflict of Interest Disclosures:
Dr Spinner reported receipt of personal fees from AbbVie and grants and personal fees from Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare/GlaxoSmithKline. Dr Gottlieb reported receipt of nonfinancial support from Gilead Sciences outside the current work. Dr Arribas López reported receipt of honoraria from Gilead for participating in an advisory board, and his institution has received grants from Gilead for an unrelated project; he also reported receipt of grants and personal fees from ViiV and personal fees from Janssen, Merck Sharp & Dohme, Teva, and Aelix. Dr Soriano Viladomiu reported receipt of honoraria as speaker or advisor from Pfizer, Merck Sharp & Dohme, Angelini, Menarini, and Shionogi. Dr Ogbuagu reported receipt of advisory board honoraria from Gilead and ViiV and speakers fees from Gilead. Dr Chai reported receipt of grant support from and advisership/consultancy for Pfizer, Gilead, Astellas, and Merck Sharp & Dohme. Dr Bernasconi reported that his institution has received fees for his participation in advisory boards and travel grants from Gilead, Merck Sharp & Dohme, ViiV, Pfizer, AbbVie, and Sandoz. Dr Bhagani reported receipt of research support and honoraria for lectures and advisory boards from Gilead Sciences and grants and personal fees from AbbVie, Merck Sharp & Dohme, Roche, and ViiV. Dr Sanyal reported being employed at Sanyal Bio; receiving royalties from Elseiver and UpToDate; holding stock in Exhalenz, Akarna, Genfit, Hemoshear, Durect, and Tozoama; receiving grants from Galectin and Bristol-Myers; consulting for Conatus, Gilead, Pfizer, Boehringer Ingelheim, Merck, Hemoshear, Lilly, Novo Nordisk, Ardelyx, Terns, ENYO, Birdrock, Albireo, Sanofi, Janssen, Takeda, Zydus, AMRA, Poxel, Servier, Second Genome, and General Electric; receiving grants and consulting for Mallinckrodt, Salix, Novartis, and Nimbus; being principal investigator of an ongoing trial for Genfit; receiving grants and being principal investigator of an ongoing trial for Immuron; receiving grants, consulting for, and being principal investigator of ongoing trials for Echosens-Sandill and Sequana; providing advice but receiving no personal remuneration for Intercept, Galectin, Fractyl, Durect, Indalo, Allergan, Chemomab, Affimmune, Teva, BASF, Perspectum, and 89bio; and being the inventor for a patent held jointly by OWL and Virginia Commonwealth University. Dr Huhn reported that his institution received grants from Gilead, GlaxoSmithKline/ViiV, Janssen, Bristol-Meyers Squibb, Proteus, Lilly, and the National Institute of Allergy and Infectious Diseases and that he received consulting fees from Gilead, ViiV, Janssen, and Theratechnologies. Dr Marty reported receipt of grants from Ansun, Chimerix, Gilead, and Merck and personal fees from AlloVir, Janssen, Kyorin, Merck, ReViral, and Symbio. Drs SenGupta, Hyland, Osinusi, Cao, Blair, Wang, Gaggar, and Brainard are employees of and own stock in Gilead Sciences. No other disclosures were reported.

Funding/Support: This study was sponsored by Gilead Sciences.

Role of the Funder/Sponsor: The sponsor, in consultation with the Food and Drug Administration and investigators, designed and conducted the study. Collection of data and management of trial sites were conducted by a contract research organization (PPD) with sponsor oversight. An independent data monitoring committee reviewed trial data. All authors contributed to interpretation of the data, including sponsor coauthors. A preliminary draft of the manuscript was prepared by a writer employed by Gilead. All authors reviewed the final version of the manuscript for approval and concurred with the decision to submit the manuscript for publication.


Just wanted to point out conflicts of interest in this trial that shows "uncertain clinical importance".

Pretty strong drug.

Intravenous only.

You get 200mg loading dose on day one. Then, 100mg per day for another 4-9 days.

Here it is.

"All patients randomized to a remdesivir group received 200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the subsequent days, infused over 30 to 60 minutes. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min (see eAppendix 1 in Supplement 3 for details). Patients who had sufficiently improved in the judgment of the investigator could be discharged from the hospital before finishing their assigned course of treatment."

So, if you add all those mg, that 200+400 for a 5 day and 200+900 for a ten day. 600mg and 1,100mg. What this means is, with a small doses, there are reports of evidence of liver toxicity. Says right there that treatment should belist.jontinued if any patients experienced severe elevations in liver enzymes.

It's a jama report and it reads no different than many other reports I have read over. One big one that stands out is that conflicts of interest list.


--------------------
The Italian researchers’ findings, published by the INT’s scientific magazine Tumori Journal, show 11.6% of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

https://www.reuters.com/article/us-health-coronavirus-italy-timing-idUSKBN27V0KF

This online first version has been peer-reviewed, accepted and edited,  but not formatted and finalized with corrections from authors and proofreaders

https://www.icandecide.org/


Edited by HamHead (08/29/20 08:10 PM)


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Offlinemorrowasted
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: HamHead]
    #26906596 - 08/29/20 08:11 PM (3 years, 4 months ago)

If anyone wishes to argue with HamHead, please do so in one of his threads.


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OfflineHamHead
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Re: On the history and the thrill of medical practice and the processes that make it effective [Re: morrowasted]
    #26906598 - 08/29/20 08:11 PM (3 years, 4 months ago)

Quote:

morrowasted said:
If anyone wishes to argue with HamHead, please do so in one of his threads.




You haven't looked into Remdesivir?

You are praising it.

:shrug:

You offered to answer questions, but not mine?


Edited by HamHead (08/29/20 08:13 PM)


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