Based on this, emergence of a super-variant seems unlikely, because these two functions — unlocking the host cell and evading the immune system — will always be in competition with each other, so neither will be able to achieve perfect efficiency.
This is also the point why CoV-19 must be lab made...we still miss 1600 intermediate forms of the virus and now see where it mutates...
Yes, it is at their discretion to administer drugs "off-label", but if they choose to do so, it comes with great risk to their livelihood.
No, it does not. They make the patients sign dozens of forms promising not to sue if the drugs don't work. Heck, they make me sign dozens of forms before giving me over-the-counter drugs. I am sure it is not a risk because 10% to 20% of prescriptions are for off-label use, according to various sources, such as:
https://journalofethics.ama-as…hysician-disclose/2016-06
Other sources give even higher numbers. It cannot be that ~20% of doctors are risking their careers. Not that many doctors are so brave -- or foolhardy.
KEY POINTS
Pfizer CEO Albert Bourla said people will "likely" need a third dose of a Covid-19 vaccine within 12 months of getting fully vaccinated.
He also said it's possible people will need to get vaccinated against the coronavirus annually.
If that turns out to be the case, it will be annoying. But not a serious problem. No worse than having to get a flu shot every year. The vaccines should be cheap after a few years. They are expensive now because they were needed on an emergency basis, in a hurry. If the booster shots can be staged all 12 months of the year, production should not be so difficult.
This statement effectively blocks doctors from prescribing ivermectin opening a direct route for civil matters and loss of license.
No, it does not. This and other statements from FDA explicitly give permission to use any approved drug off-label. The FDA has to say that, because that is the law. They don't get to decide. ~20% or more prescriptions are off-label, so if this could lead to the loss of license, a lot of doctors would be in trouble. Whereas in fact, over a ten-year period in the U.S. the total number of doctors who had their licenses revoked was . . . 27. Out of 540,000 doctors. That's 0.0005% per year. It is not something they will lose sleep over.
No, it does not. This and other statements from FDA explicitly give permission to use any approved drug off-label. The FDA has to say that, because that is the law. They don't get to decide. ~20% or more prescriptions are off-label, so if this could lead to the loss of license, a lot of doctors would be in trouble. Whereas in fact, over a ten-year period in the U.S. the total number of doctors who had their licenses revoked was . . . 27. Out of 540,000 doctors. That's 0.0005% per year. It is not something they will lose sleep over.
jed watch one of the flccc updates, I have posted a few on this thread. Frontline doctors explaining the suppression of ivermectin with regards to the FDA. Maybe hearing from over 3000 doctors working on Covid 24/7 might give you a better perspective.
This and other statements from FDA explicitly give permission to use any approved drug off-label.
It is obvious the people at the FDA oppose the use of ivermectin. They wish people would stop using it. But nowhere in this statement or any other will you find an implication that doctors will get in trouble for using it. The Congress and public would come down the FDA like a ton of bricks if they said that. As I recall, this fight was lost decades ago, when quack doctors insisted they be allowed to use non-working cancer cures, and the Congress agreed with them. The FDA cannot stop these quacks, who continue to rob desperate patients and their families.
The FDA people have an obligation to express their professional opinions about ivermectin. They may be wrong, but they have to tell the public they think the stuff does not work. It would be a dereliction of duty for them to say: "Meh. Why not? It may not help, but it can't hurt." Government regulators don't talk that way. They have to reach a conclusion, and they have to sound confident. Sometimes too confident, as we saw with the mistakes made by the CDC during the early stages of the pandemic. It turns out scientists are not omniscient Gods. I kinda knew that, but a lot of people blame them for being wrong about things that no one could possibly know for sure.
If you want to see the impossibly high standard scientists are held to, consider the fact that one researcher was forced to resign last year for quoting something like a 30% efficacy rate. It was 30%, but not in the sense the public took that to mean. He did not mean 30% of patients were cured. It was a 30% improvement, something like from 10% to 13%. Hardly measurable. That was a misunderstanding, but the guy was run out the job. It is the kind of misunderstanding I have been dealing with for decades, writing technical manuals and papers. Firing people for that is an outrage. There are always problems like that in a technical document. Along similar lines, people were much too hard on Fauci for sayings "masks are not needed" early in the pandemic. They were not yet needed, because there were so few cases outside of hospitals. Also, we needed to conserve supplies. Fauci did not explain this well. He should have corrected himself. But to blame him for confusing the issue is unreasonable. I wasn't a bit confused. I knew what he had in mind. You have to have some technical knowledge to understand these things, or you may be confused. Also, he tends to talk around the point. As they say of scientists, you ask what time it is and they tell you how to make a watch. He makes things hard for the layman to understand. He is an expect, but maybe not an expert in explaining things to the layman. His confrontation with Rep. Jordan yesterday was frustrating for me to watch. I felt like telling him: "Just give the man a number! Tell him that when we reach 1,000 cases a day and the numbers are declining, we can stop using masks. Draw an arbitrary line."
https://www.cnn.com/videos/pol…-exchange-hearing-vpx.cnn
Early in the pandemic, some ignorant reporters were badering Fauci about whether it is safe to gather in groups of five, or groups of 10. Which is the right number? He kept saying this or that study says this or that. He should have said: "Biology is not an exact science. The number is around 5 or 10, but there are circumstances such as where you are gathering and what you are doing, so it is just a general guideline." People demand more precision than the science can provide.
Maybe hearing from over 3000 doctors working on Covid 24/7 might give you a better perspective.
27 doctors losing their licenses in 10 years gives me a sense of perspective. Why would doctors be afraid of regulators when the chances of losing their job is about as high as winning the lottery? The FDA is toothless. All it can do is stop doctors from giving horse medicine. Which it does. There are mass media reports of doctors giving invermectin. The Congress passed an emergency law banning malpractice suits for COVID-19 treatments. Clearly, if you shop around, you will find a doctor willing to give you any damn thing in this pandemic. I suppose that is how things should be. It is a dire emergency, and the usual caution that doctors use should be put aside. I wish they would be less cautious about the J&J blood clot issue, and keep administering the vaccine while they work out standards to see who might be at risk for clots (if anyone).
If you want to see how powerless regulators are, and how poorly medicine is regulated in the U.S., look at the quack cures for cancer and other serious diseases. Even worse by far, look at all the doctors abusing opioid painkillers, handing out prescriptions like confetti. Of course that is against the law, but they get away with it, and they have addicted and killed hundreds of thousands of people. The NIH and the FDA know about this, and they have been yelling for years, but the drug companies and the Congress stopped them from taking effective action. See:
https://www.drugabuse.gov/drug…ds/opioid-overdose-crisis
(The NIH has absolutely no regulatory power. All they can do is talk, talk, talk.)
The "evil big pharma" trope is exaggerated, but it surely does have some basis. The opioid crisis is big pharam's fault. They killed people for profit. Of course the addicts themselves are also to blame. There is plenty of blame to go around.
Letter to the Editor
What about Ivermectin for COVID-19?
https://journals.lww.com/em-ne…ut_Ivermectin_for.25.aspx
found the article by James Roberts, MD, on COVID-19 a great read. (EMN. 2021;43[2]:12; https://bit.ly/2MMglKB.)
Why was Ivermectin not mentioned? In a pandemic, we emergency physicians don't have time to wait for validated studies before we try something. The oath we all took, do no harm, fits here.
In the war named pandemic, our ammo box should be full of whatever may help lessen the severity of infection and possibly save a life. That is, after all, what we do.
Douglas Nederostek, MD
Laurinburg, NC
Dr. Roberts responds: Ivermectin, an FDA-approved anti-parasitic agent, was found to be an inhibitor of SARS-CoV-2 replication in the laboratory. The drug has been minimally studied for a possible benefit in treating COVID-19 infections. Some clinicians support its use, and it has few adverse side effects, but it is not universally recommended.
The Infectious Diseases Society of America's typical conservative guidelines suggest against ivermectin use outside of a clinical trial in outpatients or hospitalized patients with COVID-19. The guideline states that additional sufficiently designed clinical trials are needed to support recommendations for routine use by clinicians.
Most of the published studies have incomplete information and significant methodological limitations. Many emergency clinicians would agree with Dr. Nederostek's argument for such a drug, but for ivermectin to be used in the ED, it likely would require support from a variety of hospital resources and an emergency clinician who has a personal interest in moving it forward.
Display More27 doctors losing their licenses in 10 years gives me a sense of perspective. Why would doctors be afraid of regulators when the chances of losing their job is about as high as winning the lottery? The FDA is toothless. All it can do is stop doctors from giving horse medicine. Which it does. There are mass media reports of doctors giving invermectin. The Congress passed an emergency law banning malpractice suits for COVID-19 treatments. Clearly, if you shop around, you will find a doctor willing to give you any damn thing in this pandemic. I suppose that is how things should be. It is a dire emergency, and the usual caution that doctors use should be put aside. I wish they would be less cautious about the J&J blood clot issue, and keep administering the vaccine while they work out standards to see who might be at risk for clots (if anyone).
If you want to see how powerless regulators are, and how poorly medicine is regulated in the U.S., look at the quack cures for cancer and other serious diseases. Even worse by far, look at all the doctors abusing opioid painkillers, handing out prescriptions like confetti. Of course that is against the law, but they get away with it, and they have addicted and killed hundreds of thousands of people. The NIH and the FDA know about this, and they have been yelling for years, but the drug companies and the Congress stopped them from taking effective action. See:
https://www.drugabuse.gov/drug…ds/opioid-overdose-crisis
(The NIH has absolutely no regulatory power. All they can do is talk, talk, talk.)
The "evil big pharma" trope is exaggerated, but it surely does have some basis. The opioid crisis is big pharam's fault. They killed people for profit. Of course the addicts themselves are also to blame. There is plenty of blame to go around.
You know nothing of the FDA and it's powers. I have worked in medical manufacturing and have witnessed inspections by uniformed FDA employees, they have the power to shut companies down for as little as dust in a manufacturing area and have the power to arrest and prosecute and have done so many many times. They have said ivermectin should only be used in a clinical trial. There are no clinical trials in the us for ivermectin. As a doctor would you go against that advisory?
No ivermectin for COVID, says EMA
https://www.raps.org/news-and-…mectin-for-covid-says-ema
The antihelmintic drug ivermectin should not be used for COVID-19 treatment outside of the clinical trial environment, according to a statement issued Monday by the European Medicines Agency (EMA).
The European regulator’s statement parallels the position of the US Food and Drug Administration (FDA), which issued a 5 March update for consumers in response to “multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.”
The consumer update reminded the public that ivermectin is not an FDA-approved treatment of preventative for COVID-19. FDA also warned consumers not to take veterinary formulations of medication.
In its statement, EMA acknowledged that high concentrations of ivermectin do block SAR-CoV-2 replication in vitro, but this effect was only seen at those extremely high concentrations. “Although ivermectin is generally well tolerated at doses authorized for other indications, side effects could increase with the much higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective against the virus. Toxicity when ivermectin is used at higher than approved doses therefore cannot be excluded,” wrote the agency.
Merck, known as MSD outside the US and Canada, markets ivermectin as Stromectol for human use to treat onchocerciasis and intestinal strongyloidiasis. In a 4 February press statement Merck noted that its own analysis revealed “No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies,” as well as a lack of “meaningful evidence” for clinical activity or efficacy in patients.
Merck also cited a “concerning lack of safety data in the majority of studies.” Both EMA and FDA noted that clinical trials are ongoing examining the use of ivermectin for prophylaxis or treatment of COVID-19.
Ivermectin has been touted on videos and reported by some media outlets as a potential treatment or prophylaxis for COVID-19 for months.
EMA’s COVID-19 pandemic task force has endorsed EMA’s statement and incorporated the recommendations into its public health advice.
The FDA people have an obligation to express their professional opinions about ivermectin.
When ever in the world did bribed folks express a professional opinnion???????
Main risk factor for death from Covid?? Missing sport!
https://www.archyde.com/low-ph…f-dying-from-coronavirus/
Full paper: https://bjsm.bmj.com/content/b…orts-2021-104080.full.pdf
Fully active people have about 1/4 death risk!
FLCCC weeonly update 4 /14/21
Big Pharma uses Big Tobacco's strategy to defeat Ivermectin
https://www.thedesertreview.co…eb-8c7b-633764c1bf9e.html
In the 1950's scientists Richard Doll and Bradford Hill published a study from the UK finding that the risk of lung cancer was related to the number of cigarettes smoked per day, and this risk was 25 times higher in those who smoked more than 25 cigarettes per day.
Other scientists, namely Ernest Wynder and Evarts Graham, found a strong association between bronchogenic carcinoma and smoking. 96.5% of men with bronchogenic carcinoma were heavy chain smokers compared to 73.7% of the general population. Several extensive studies within one year of each other found the same thing, cigarette smoking is strongly related to lung cancer, and the more one smoked, the higher one's risk.
The big problem was that the cigarette industry was a multibillion-dollar lobby by the mid- 1960s. And they were not about to allow a few renegade scientists to spoil their profits. The Marlboro Man, as Dr. Mukherjee wrote in his Pulitzer Prize-winning book, The Emperor of All Maladies, was the most successful smoking icon by 1955. Dr. Mukherjee describes how the Tobacco Industry fought back by twisting science against the public, first by arguing that an association does not prove cause and effect, and later by offering to perform the studies.
The tobacco scientists argued that lung cancer was caused by genetics: if you were born with cancer genes, you developed cancer, and if you weren't, you didn't get it. Cigarettes might be associated with cancer, but they argued that more studies were needed if one were to actually "prove a causal link" between cigarettes and cancer. The actual cause of lung cancer, the tobacco scientists concluded, was faulty genetics and not cigarettes.
To assist with these studies, the generous Big Tobacco even offered to fund the research by founding the Tobacco Industry Research Committee. The TIRC is described further in The Emperor of All Maladies, a book I strongly recommend everyone read. The author writes how this ingenious strategy kept the tobacco companies in business and record-breaking profits for the next 50 years despite causing many millions of lung cancer deaths.
Blurring or confusing the facts as a tactic proved remarkably effective. But by far, the craftiest ruse was for the Tobacco Industry to pretend to embrace the research and set up their own studies. Because by controlling the study design, they could control the outcome.
The same strategy is now used against the public in this pandemic.
Their first victim was Hydroxychloroquine, which proved easy to discredit given that Donald Trump sounded unhinged in his praise for the drug. Later studies seemed to reinforce the belief that HCQ was ineffective; however when academic misconduct was found, it threatened to expose the effort. Big Pharma successfully distanced itself when the fraudulent articles were retracted and blamed on lone scientists acting by themselves.
Dr. Tess Lawrie is a highly-respected and independent research consultant to the World Health Organization and NHS. Her work is routinely relied upon in the formation of International Practice Guidelines. She has found HCQ to have an effect against the coronavirus. Most tellingly, when Dr. Tess Lawrie performed her independent review of the data on Ivermectin, she removed the Fonseca study, which purported to show no benefit against COVID with Ivermectin use.
Dr. Lawrie explained, “They (The Fonseca Group) didn’t find that much of a difference between Ivermectin and the control arm. But the control arm received HCQ. So basically, there’s a comparison between two fairly active treatments.” Dr. Lawrie explained that there were many reasons to consider HCQ active against the virus. Thus, two patient groups were compared in Fonseca, both of which received effective drugs against COVID-19, and this was not considered a valid controlled trial of Ivermectin. Therefore the study was eliminated from the meta-analysis.
Doctors across the nation continue to employ both drugs in an antiviral cocktail comprised of HCQ, Ivermectin, Zinc and Vitamin D. In particular, former Harvard professor and NIH researcher Dr. George Fareed of the Imperial Valley has published on this approach and enjoyed remarkable success.
https://www.thedesertreview.co…eb-a59a-f3e1151e98c3.html
He and his associate, Dr. Brian Tyson, have treated over 5,000 COVID-19 patients with only two deaths. Dr. Fareed pioneered the first HIV clinic in Brawley, California, and notes that the cocktail approach was necessary and became the standard of care in such conditions as HIV and HCV. He feels it is also essential with COVID-19.
Today we know that the earlier Ivermectin is given, the lower the death rate. We learned in the 1950s that the more cigarettes one smoked, and the longer they smoked, the higher the death rate. We now have 50 studies all showing Ivermectin's benefits across all stages of COVID-19, with The World Health Organization finding an average of 81% decreased mortality.
Merck and the FDA came out against Ivermectin only after the US government contributed $356 million to Merck to develop MK-7110, an anti-COVID drug. This occurred after Merck purchased the rights to MK-7110 for $425 million in a deal announced on December 23, 2020. The chances of this drug receiving approval by the FDA are very high.
The chances of Ivermectin successfully competing against MK-7110, if Ivermectin is also approved, are also high. It is, therefore, logical that a multi-billion dollar industry will use its immense lobbying, media, and advertising power to prevent this. The smoking gun here is that Merck was the original developer of Ivermectin, but now that their old drug is generic and no longer profitable, it is being tossed under the proverbial bus.
Obfuscation and the "offer-to-fund-the-research" through a time-honored and proven strategy of manipulation is once again proving remarkably effective in swaying public opinion.
We have seen this movie before with Big Tobacco.
We already know how it ends. We have 50 studies, all showing Ivermectin's life-saving benefits. We do not need 50 more to tell that Ivermectin prevents COVID death and should be adopted immediately. The science is clear based upon numerous meta-analyses already performed by world-class and respected scientists Dr. Tess Lawrie, Dr. Andrew Hill, and Dr. Pierre Kory.
This brings me to the Washington Post's April 8, 2021 article which announced that the government planned to do their own Ivermectin study. Thanks, but no thanks, to the NIH, in their magnanimous offer to conduct more "research." We already know what they will find.
Merck and the FDA came out against Ivermectin only after the US government contributed $356 million to Merck to develop MK-7110, an anti-COVID drug. This occurred after Merck purchased the rights to MK-7110 for $425 million in a deal announced on December 23, 2020. The chances of this drug receiving approval by the FDA are very high.
Merck stopped (this week) the new drug as it in reality did not work and to much money would have been used for improvement...
But they certainly will deal in some money for not producing more ivermectin.
For the friends of "Gain of Research". An early paper: https://www.nature.com/articles/nm.3985.pdf
Using the SARS-CoV reverse genetics system2, we generated and characterized a chimeric virus expressing the spike of bat coronavirus SHC014 in a mouse-adapted SARS-CoV backbone. The results indicate that group 2b viruses encoding the SHC014 spike in a wild-type backbone can efficiently use multiple orthologs of the SARS receptor human angiotensin converting enzyme II (ACE2), replicate efficiently in primary human airway cells and achieve in vitrotiters equivalent to epidemic strains of SARS-Co....
ou know nothing of the FDA and it's powers. I have worked in medical manufacturing and have witnessed inspections by uniformed FDA employees, they have the power to shut companies down for as little as dust in a manufacturing area and have the power to arrest and prosecute and have done so many many times.
I did not say the FDA is powerless. I said the medical establishment has only taken licenses away from 27 doctors in 10 years. That's not the FDA. State Medical Boards are the ones who regulate doctors and revoke licenses. The FDA may be able to close down medical manufacturing facilities, but it has no power over doctors. Quote:
The FDA does not regulate the medical profession. The agency has no control over how doctors prescribe approved drugs to patients. So once a medication is on the market, it is up to physicians to determine the medically appropriate use of the drug.
https://www.drugwatch.com/health/off-label-drug-use/
I can see why doctors would normally fear malpractice suits, but the Congress exempted them for COVID-19 cases.
I also said the NIH is not a regulatory agency. Obviously the FDA is. However, it cannot stop off-label uses of drugs and it does not regulate the medical profession.
Merck and the FDA came out against Ivermectin only after the US government contributed $356 million to Merck to develop MK-7110, an anti-COVID drug. This occurred after Merck purchased the rights to MK-7110 for $425 million in a deal announced on December 23, 2020. The chances of this drug receiving approval by the FDA are very high.
The chances of Ivermectin successfully competing against MK-7110, if Ivermectin is also approved, are also high. It is, therefore, logical that a multi-billion dollar industry will use its immense lobbying, media, and advertising power to prevent this. The smoking gun here is that Merck was the original developer of Ivermectin, but now that their old drug is generic and no longer profitable, it is being tossed under the proverbial bus.
As I have pointed out before, this analysis makes no sense. Even if Merck opposes ivermectin because they want to sell something more expensive -- MK-7110 -- other drug manufacturers would be thrilled to sell a bunch of ivermectin instead, even at a much lower cost. They don't care if they cut into Merck's profit. On the contrary, they would love to do that.
The comparison to the tobacco industry fails because every company in that industry was selling the same thing: tobacco. There were no alternative products. No competing products, or better, or safer ones. It was not as if one of them could offer a safe alternative to tobacco. If there had been such a thing, and Phillip Morris had it, you can be sure they would have gone to the Congress and tried to outlaw the sale of everyone else's unsafe tobacco products. There was unity among the tobacco makers only because they had no choice. There is no unity among pharma companies. Or in any other industry. If Ford finds a dangerous problem in Toyota cars, they will not be silent out of professional courtesy. They will inform the authorities and the public, and they will hope that the revelation clobbers Toyota sales. When a computer software company finds a serious bug or security flaw in a competing product, they shout that from the rooftops and run big ads saying their competitor is endangering the public. If any other pharma company thought ivermectin was effective and they wanted to sell it, they would plaster the mass media with ads saying "Merck is stopping us from saving lives." There is no incentive for them to go along with a coverup. On the contrary, they would earn hundreds of millions of dollars in sales by exposing the coverup, plus they would get to take billions of dollars away from Merck, their competitor. A win-win proposition! Any sane businessman would do it.
Notice I am not saying they would expose the coverup because they are good people. Or because have a moral obligation. Or they care about the public. (Some surely do care, and other probably do not.) I am saying they would do it for money. Lots and lots of money. Some business people are good, and some are bad. Some are brave and some are cowards. What they all have in common is that given an opportunity to make hundreds of millions of dollars in easy money, in a legitimate business they are licensed to do, in which they are experts, every single one of them will take that opportunity. If it happens clobber their competition and take away even more money from the competition, all the better!
I can see why doctors would normally fear malpractice suits, but the Congress exempted them for COVID-19 cases
Reference?
Reference?
He read the headline but not the story or excemptions
Doctors’ Newfound Immunity to Medical Malpractice Lawsuits During COVID-19 Pandemic
https://attorneyatlawmagazine.…-during-covid-19-pandemic
The COVID-19 pandemic has created a healthcare crisis around the world. As governments continue to grapple with the pandemic’s immediate impact, the medical sector’s working conditions have experienced drastic changes. Healthcare facilities are overcrowded, critical equipment is scarce, and care providers are overworked.
For that reason, emergency declarations have been issued in all 50 states in the United States. Some of these protections pertain to acts of “good faith” healthcare, which means that a healthcare provider would receive additional graces or extended liberties.
However, these measures don’t cover reckless misconduct, intentional infliction of harm, willful criminal misconduct, or gross negligence. These changes also seek to address issues of COVID-19 patients and victims of healthcare malpractice.
If you or someone you love has been a victim of medical malpractice, you can consult reputable legal professionals like this to receive the justice you deserve.
We are all in this together????
J&J reportedly sought help from rivals after blood clot concerns emerged
https://amp.cnn.com/cnn/2021/0…pfizer-moderna/index.html
York(CNN)Johnson & Johnson sought help from its three rival Covid-19 vaccine makers to look into reports of blood clots, but Pfizer and Moderna both declined, the Wall Street Journal reported on Friday, citing people familiar with the situation. Only AstraZeneca agreed, according to the WSJ.
J&J also wanted to build an informal alliance with its competitors that it hoped would allow the industry to speak with one voice about the safety of the vaccines and address any public concerns about the blood-clot cases, the Journal reported.
In a statement to CNN on Friday, a Pfizer (PFE) spokesperson declined to comment on the specifics of the WSJ report. "Pfizer embraces opportunities for scientific exchange when we can make a meaningful contribution that is not being represented by other groups or regulators," the spokesperson said. "We have and will continue to collaborate with other vaccine makers as appropriate as we all fight against this deadly pandemic."
