As a background I'm a physician and I research a lot of related topics daily.
One of the major issues the pharmaceutical industry has run into is that it's getting harder and harder (and more expensive) for them to develop new medications, as most of the "easy" targets for the current model of drug development have already been found. It's for this reason that most of the drugs that come out now are basically just the same drugs as before but slightly tweaked and made out to be better than their predecessors (commonly known as me-too drugs) rather than any signs of general progress.
This general lack of new drugs to be developed has often been cited as the ticking time bomb that will destroy the drug industry.
mRNA vaccines represent a potential solution to this problem because they both make it possible to make a massive number of vaccines to a large number of conditions very easily (especially vaccines targeted towards cancer), but they also make it possible to treat a large number of genetic conditions or defects (ie. cystic fibrosis) by producing functional copies of whatever protein is missing. In effect if mRNA gene therapies are put on the market, they open up a multitrillion dollar market that will keep pharma going for a long long time.
The issue with this approach has bene that there have been major safety issues and concerns about utilizing mRNA gene therapies since their development which have prevented them from ever being used on human subjects.
Hence predictably, a large focus was put on developing mRNA vaccinations for COVID (even though other approaches also worked) and using the emergency nature of the situation to push through the vaccines (which were also the first ones to get on the market).
There are a lot of competing theories about why highly questionable vaccines with highly questionable justifications have been pushed so aggressively by everyone. Many of these are more conspiratorial and thus harder to argue to people. However, while it's debateable if more nefarious motives were at play, the need for opening up the gene therapy market to big pharma cannot possibly be overstated. In the past pharma has been willing to (and able to) do some pretty shady actions to push through products with a 0.01% profit potential of what the gene therapies open up.
My personal opinion is that this is the fundamental reason why the vaccines have been pushed so aggressively by everyone, and any other reason cited was a secondary concern. In addition, I also think this is the most persuasive means to explain the case to ordinary people.
You've heard of the Military Industrial complex? Well there's a pharma one too. Invested in "treatments" not cures so you continue to have the disease, but "manage it" so they keep selling you treatments you "need to survive" but never cure younro make you better, just sustain. Keeps you as a revenue stream. Same as the endless wars in the middle east and why they never want those to end.
Fraudulent paper to stop HCQ - paper in 2005 saying it works on coronaviruses from Fauci's agency - BY LAW, if there is a treatment, a vaccine CANNOT be approved. They totally stopped HCQ because if it's use had been embraced, the vaccines $1500/shot, remdesivir $3100/patient, regeneron $2800/patient would not have been necessary. Ivermectin $4 month >80% preventative with vitamin D and zinc. We have been living and funding a big pharma transfer of wealth.
So what should the average,fit,person do?im not getting the fucking vaccination..ive at least been touched by china virus
Vitamin D, zinc and ivermectin. Effective on all variants, flu, colds, west nile, zika, scabies and worms. https://covid19criticalcare.com/covid-19-protocols/i-mask-plus-protocol/
The moment they went after chloroquine, hydroxy chloroquine, and ivermectin, we knew it was a scam.
This post is right on. The potential for gene therapy is huge, but the results are very risky. This is why the only approved gene therapies are for rare diseases where the side effects and risks are justified.
By shoving this gene therapy over a large population, big pharma will have troves of data to push things along.
The sheep loving being subjects after all.
So, really, we should be grateful to all the suckers for testing out the new drugs for us.
In any case, I think you're correct. As an immunologist family member said to me recently "ackshully, COVID is probably the best thing that's happened for immunology in a really long time".
Animal trials well underway.
April 6, 2021
To Janet Woodcock, FDA head.This is the revised and edited letter I("Yanzi Lin") just sent.
Dear Dr. Wookcock:
As an ordinary U.S. citizen, I would like the FDA to answer some questions regarding its handling the drug Leronlimab from Cytodyn. The questions are based on the following facts:
On August 11, 2020, Cytodyn announced "the Top-line results from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms. There was no safety problem. The drug " is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.” And the drug is effective. " Patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).
On August 17, Cytodyn submited its Top-line Report from its Phase 2 COVID-19 trial to the U.S. FDA and requested an Emergency Use Approval (EUA)
Instead of granting an EUA, the FDA asked the company to conduct a Phase 3 trial for severe and critical Covid patients.
The company had to follow the FDA's order and completed the trial and reported the data on March 5, 2021. The company announced that the Phase 3 trial of leronlimab for the treatment of severe-to-critical patients with COVID-19 demonstrated continued safety, substantial improvement in the survival rate, and faster hospital discharge in critically ill COVID-19 patients." Specifically, the survival benefit was a 24% reduction in all-cause mortality; shortened time to recovery, 6 days, with a statistically significant p-value of 0.005; discharge alive at 28 days was 28% versus 11%, a 166% better rate than in the placebo group. The company filed an EUA request with FDA. Instead of granting an EUA, the FDA requested the company to do a Phase 4 trial.
On March 30, the company further analyzed the data and announced that Cytodyn’s Leronlimab decreased mortality at 14 Days by 82% with statistically significant P-Value of 0.0233 amongst critically Ill COVID-19 patients.
**With the above facts in mind, please answer the following questions:
a) In August 2020, there was no drug in the U.S. to treat mild and moderate Covid patients except Remdesivir which had a lot of side effects and a lot of studies showed that it was ineffective. At the time, 10 thousand Americans died. But now the figure reaches to 590,000. Had the FDA granted the EUA in August, 2020 at least 300,000 American lives would have been saved. American lost more lives in this pandemic than any other country in the world where the FDA played a major part. An excuse of negligence on the job cannot explain this slaughter. Three hundred thousand mothers, fathers, husbands and wives and children of the Americans died in a matter of several months. And millions who managed to be alive are weeping over the loss of their loved ones. Some say that the FDA has their hands with blood and tears. Please answer why the FDA refused to grant an EUA in August 2020 to save lives when they knew that Leronlimab was safe and effective.
b) Why the FDA requested the company to do a Phase 3 trial to see the result of treating the severe and critical patients? Common sense tells us that most severe and critical patients start with mild and moderate symptoms and then progressed to severe and then critical. Why not treat them in the early stage when there is a drug that can stop the progression? Why not FDA granted the EUA and at the same time ask the company to do the Phase 3 trial for sever and critical patients?
c) In the design of the Phase 3 trial, why FDA ordered the company to just have two doses at day 0 and day 7 while the company wanted four doses for four weeks to see the 28 day mortality rate. In most of the trials, one dose per week to see the result at day 28 is a norm. Because of the FDA, the 28 day mortality rate did not reach the statistical significance. However, the 14 day mortality rate of 82% is superb. And the company filed a new protocol for Phase 4 trial. Will the FDA grant this change? Can you predict the result? I believe that based the 14 day mortality rate. Cytodyn will prove that the death rate will be reduced by over 90% if they are allowed to dose the patient one dose per week for four weeks.
**These are the following sub-questions/issues below:
a). The criteria for granting an EUA is whether the drug is "safe" and "may be effective". Is Leronlimab safe? Of course. Is it effective? Of course. Who dares to say that a drug reduced a 82% deaths at 14 day is not effective?
b) Leronimab is the only drug to effectively treat critical Covid patients at this moment. And it is safe and effective. Why the FDA does not approve it immediately? We are in a pandemic. Americans are dying. To see the result of the Phase 4 trial another five months (as in the Phase 3 trial) will be needed. How many lives lost?
c) Which officer in the FDA insisted a two dosing regimens and what motivated him or her to do so. It is a norm to have four doses if the trial intends to see the day 28 result. Knowing such trials and Cytodyn's Phase 2 trial (8 weeks, one dose each week for eight weeks) the officer knew or had reason to know that with just two doses, the trial would not reach the primary endpoint. And the officer got the anticipated result. The day 28 mortality rate, though still good, was not statistically significant. Obviously, the officer wanted to kill the drug although he or she knew that the drug had the potential to save tens of thousands lives. I urge you to investigate the matter no matter the FDA grants CytoDyn's request for conditional EUA or not in the future. We simply cannot let such corrupt officials determine the life and death of so many Americans.
d) Why the FDA requests the company to do a Phase 4 trial? The criteria for granting an EUA is whether the drug is "safe" and "may be effective". Leronlimab has no safety issue and has proved the efficacy. Even with a 24% death reduction the benefits surely outweigh the risk. Will there be a 5th trial, a 6th trial and a seventh trial? FDA can invent all kinds of reasons to ask CytoDyn to do the trials indefinitely, each trial needing 5 months. Trials need money. The small company with only 20 employees may not have the money to do the trials. The FDA is slowly walking CytoDyn to death at the expenses of tens of thousands American lives. To get the Phase 4 trial result five more months are needed. Each day we have about 1,000 deaths. The number for five months is 150,000. With a 82% reduction, over 120,000 lives will be saved. But the FDA does not care about the lives. Killing the drug that has about 50 other indications and protecting big pharmacies is their priority.
e) Why the FDA wants the placebo volunteers to die in the 4th trial? They now know that the drug reduces death by 82% at day 14. A two arms trial is unethical and amoral. I would have to sue the FDA if my loved ones die in the placebo arm. What is the FDA's philosophy in not giving the volunteers the drug that will save their lives but instead putting them in a placebo arm and let them die?
f) What if other counties buy the entire stock from CytoDyn, leaving Americans without the drug at hand to save their lives? CytoDyn has applied EUAs from other countries. CytoDyn probably knows that the FDA is violating their due process rights of equal protection and fair dealing. In addition, and surprisingly, until now no government funds has been allocated to CytoDyn to support their trials.
Best Regards Yanzi Lin A U.S. citizen
Ivermectin and HCQ also very effective. HCQ totally banned and ivermectin being supressed. HCQ plants in India and Taiwan blown up in Dec. Ivermectin >80% as a preventative. https://covid19criticalcare.com/covid-19-protocols/i-mask-plus-protocol/
1000000%. I look at the vaccine very warily given that it’s a completely novel platform. Honestly I reallllyy hope the tech works out though. If it does it could drastically improve the human condition. In my field the majority of the malignancies we treat have absolutely no medical solutions other than cutting out Mets once they’ve metastasized. There are basically no sarcoma chemos (mostly) that are effective. Immune treatment of this is hugely promising to me. But we’ll see.
I too read this article earlier
You are missing one HUGE and GLARING aspect.....It's only been recently we've mapped the Human Genome....the medical industry is about to go through what the PC/Internet industry has been going through the past 20 years. Things are going to happen FAST due too what? NEW KNOWLEDGE! That's how technologies work fren...
Given the mapping of the human genome, can you identity the homosexual gene?
It’s not only been found but also photographed: https://kekpe.pe/i/6073a721b31a0.jpg