Weird that the "I-Believe-The-Science(TM)" crowd has completely given up on science
The NY Times announces that henceforth, clinical trials for Covid-19 shots must be abandoned because real world data makes the cartel look bad
I. Pharma is losing the game so they are throwing the chess board across the room
The NY Times published a vile piece of fascist Pharma propaganda today. Berenson flagged the online version of the article yesterday. As you know, I have been yelling about the FDA’s Orwellian “Future Framework” for weeks because it’s literally the worst idea in the history of public health.
It turns out that it’s even worse than I thought.
Pharma has already begun a PR offensive to get it across the line and Sharon LaFraniere of the NY Times was eager to do their bidding.
Here’s what’s happening. The mRNA shots are not working against SARS-CoV-2. Everyone knows this. So Moderna and Pfizer are racing to reformulate these shots. The reformulated shots are not working either. Just last week Moderna was touting a bivalent shot that combined Alpha + Beta, but now, apparently, they’ve abandoned that approach. The NY Times article hypes a Moderna shot targeting earlier Omicron variants (it does not say, but perhaps BA.2 and BA.2.12.1?). However evidence from South Africa shows that BA.4 and BA.5 are outcompeting the earlier Omicron variants and the reformulated Moderna shot probably won’t work against the new strains (the virus evolved for a reason — to evade vaccines).
So what are predatory pharmaceutical companies and their feckless government enablers supposed to do!? Abandon clinical trials altogether!
Here’s how the NY Times describes this scheme:
…many experts worry that the virus is evolving so quickly that it is outpacing the ability to modify vaccines, at least as long as the United States relies on human clinical trials for results.
See, it’s not that coronavirus vaccine have failed over and over again (even though they have). It’s that This Wily Virus(TM) is just evolving so quickly that we could not possibly allow human clinical trials of coronavirus vaccines ever again. The only way to beat This Wily Virus(TM) at this point is to abandon science.
Of course it gets worse. The NY Times elaborates:
The problem is that Moderna and Pfizer — the maker of the other main coronavirus vaccine in the United States — do not have enough time now to run more human clinical trials and still manufacture shots before the fall, when the Biden administration is hoping to be able to offer an updated vaccine to counter what public health experts predict will be a winter surge.
See, it’s not that rapacious pharmaceutical companies want to suck all wealth out of the world and put it into their own pockets while setting up a 1,000 year Pharma Reich. No, no, no, silly. It’s just that they “do not have enough time” to do actual science anymore so they are just going to skip all that. Don’t you worry your little head about it.
Furthermore, only a conspiracy theorist would believe that the FDA has abandoned all of its statutory responsibilities to protect public health in order to prostitute themselves to Pharma. The Correct Understanding(TM) is that the FDA is being forced by circumstances outside their control to abandon science. This is not a problem because the cartel is truth, the cartel has always been truth, and since the cartel has decided to abandon science altogether then that’s the new science.
Henceforth, quite literally, the peasants will be forced every six months to inject whatever they are told, with no questions asked, and “they will be [required by law to be] happy about it”.
Instead of human clinical trials the FDA will rely on a few test tube and mouse studies. In the article, Fauci describes this as, “alternative pathways of decision.” That guy just oozes totalitarianism at this point.
So if the “Future Framework” is approved on June 28 the new rules will be: a pharmaceutical company can claim that some new injection creates antibodies in a test tube or mouse (that no one else can see or audit). Done! Ship it and inject it! That’s it. Even though the FDA admits that there are no “correlates of protection.”
In the replies to my earlier articles about the Future Framework some astute readers have pointed out that the FDA has already abandoned human trials when it comes to Covid-19 shots in kids. None of the Moderna or Pfizer clinical trials in kids showed any real world health benefit at all. So they switched to looking at antibodies in the blood and use this tortured mental gymnastics called “immunobridging” to conjure up hypothetical future benefits that never materialize in the real world. Abandoning even the pretense of human trials and moving to test tubes and mice is the obvious next step in this complete abandonment of science.
When people say “I Believe The Science(TM)” what they really mean is “I Support The Genocide.” That’s what’s happening. The FDA has not done science in two years, probably much longer than that.
There is no left and right in politics anymore. Just, the FDA Pharma Fascist Party where members are expected to participate in self-genocide for “the good of society” (read: the profits of the cartel)
vs.
the Rebel Alliance where we practice actual science, critical thinking, logic, and reason, and work every day to protect human health and dignity.
Any politician who wants the 18 million votes of single-issue medical freedom voters in November needs to know that there must be hearings, arrests, and trials of the bureaucrats at FDA, CDC, NIAID, HHS, and NIH who did this to us.
II. What is to be done?
In the meantime, here are the email addresses for all of the public health political appointees, FDA staff, and VRBPAC members who have a say in connection with the “Future Framework”. Please contact them to urge them to reject this nonsense (proposed subject line and email text below — or share your own personal story).
Subject line: The “Future Framework” is the WORST idea in the history of public health. Please vote NO.
1. No Covid-19 shots for kids that failed clinical trials. According to the journal Nature Medicine, children and young people have a 99.995% recovery rate. According to the CDC, the overwhelming majority of children already have natural immunity. The harms from Covid-19 shots in kids are catastrophic.
2. The FDA and CDC must pivot to therapeutics. About twenty off-the-shelf treatments are more effective than vaccines (if used for prophylaxis or early intervention). Get these safe and effective medicines to people who need them and let doctors be doctors again and treat patients based on their own best clinical judgment.
3. Any reformulated Covid-19 shots MUST go through proper HUMAN clinical trials and FDA review. That means:
• large (50,000+ person) double-blind randomized controlled trials with inert saline placebos conducted by an independent third party;
• safety and efficacy studies for two years prior to any application; monitor the treatment and control group for the rest of their lives to record non-specific effects;
• must provide sterilizing immunity with greater than 90% efficacy and less than 0.1% Grade 3 Adverse Events; and
• proper monitoring for carcinogenesis, mutagenesis, and impairment of fertility.
[Contact list:]
sean.mccluskie@hhs.gov, commissioner@fda.hhs.gov, DeanofPublicHealth@brown.edu, Aux7@cdc.gov, Peter.Marks@fda.hhs.gov, Hong.Yang@fda.hhs.gov, Richard.Forshee@fda.hhs.gov, Huilee.Wong@fda.hhs.gov, Leslie.Ball@fda.hhs.gov, Doran.Fink@fda.hhs.gov, CBERVRBPAC@fda.hhs.gov, hanae@bcm.edu, paula.annunziato@merck.com, adam.berger@nih.gov, hbernstein@northwell.edu, acohn@cdc.gov, anc0@cdc.gov, hjanes@fredhutch.org, hgans@stanford.edu, david.kim@hhs.gov, asmonto@umich.edu, offit@chop.edu, spergam@fredhutch.org, Jportnoy@cmh.edu, erubin@hsph.harvard.edu, erubin@nejm.org, ashane@emory.edu, swamy002@mc.duke.edu, fullerao@umich.edu, bgellin@rockfound.org, RandyHawkins@cdrewu.edu, officeofthepresident@mmc.edu, JYLee@uams.edu, ofer.levy@childrens.harvard.edu, wayne_marasco@dfci.harvard.edu, cmeissner@tuftsmedicalcenter.org, mrn8d@virginia.edu, stanley-perlman@uiowa.edu, reingold@berkeley.edu, mhsawyer@ucsd.edu, mew2@cdc.gov
III. The FDA has opened the formal comment portal for the “Future Framework”
If you prefer the official route, you can lodge a formal comment with the FDA by following the instructions (here). Enter docket number FDA-2022-N-0905 at https://www.regulations.gov by June 22 to tell the FDA what you think of their proposed plan to abandon clinical trials for Covid-19 shots in perpetuity.
Blessings to the warriors. 🙌
Prayers for everyone fighting against Pharma fascism by reaching out to the FDA to tell them why they are wrong. 🙏
In the comments, please let me know what’s on your mind.
As always, I welcome any corrections.
Let’s freakin’ go!!!
By the way this is the standard playbook for toxic polluters -- they just never conduct a test if there is any chance that the data will show harms. https://www.amazon.com/gp/product/B01N5MDIQ0/
Thanks for your great work on this issue, Toby. As a Finance Professor, a father, a concerned citizen, I believe there cannot be reward without risk. In Finance, there is also rarely any risk without reward. And in Finance, if there is no risk there can be no reward. By freeing them from any legal liability under the EUA, the pharmaceutical companies have been granted a lucrative risk-free "call option" on the future cashflows of these vaccines, and all future variants of these vaccines. The shareholders of these firms reap all of the upside profit and bear none of the risk. This is un-capitalist, un-American, unethical and unconscionable. My letter to the committee: "If you insist that the pharmaceutical companies must be free from all risk, then please at least have the moral and ethical fortitude to demand that all profits be returned to the risk-bearers (which in this case is the children (US citizens) receiving the shots and their tax-paying families). Better yet, remove the liability shield and go back to Finance 101: there is never reward without risk. This cannot be any different. If they don't want to bear the risk, then get them out of the business and get them away from me and my family."