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“Real world evidence” vs. COVID-19?

Joel Hirschhorn argues that the feds should have used “real world evidence” per the 21st Century Cures Act to approve the use of hydroxychloroquine for COVID-19. It’s the same argument acupuncturists use to promote their quackery.

It’s been a while since I wrote anything about the use of hydroxychloroquine, but leave it to WND to give me a reason to revisit the topic. Hydroxychloroquine (HCQ), as you might recall, is an antimalarial drug that also has mild immunosuppressive properties that make it also useful to treat rheumatoid arthritis and other autoimmune diseases. Early in the COVID-19 pandemic, HCQ was portrayed as a “miracle” drug to treat COVID-19, even though the evidence supporting its use for this indication was slim to nonexistent. To some extent, I could understand trying HCQ. The early days of the pandemic were desperate times. COVID-19 was a new disease, and it was making patients very, very sick in large numbers. There were no known treatments other than supportive care, and, back then, no vaccine. A year ago, somehow HCQ seemed to find its way into pretty much every hospital’s protocol to treat COVID-19 based on anecdotal evidence. The FDA even granted it an ill-advised emergency use authorization (later rescinded). Meanwhile, the dedication to the use of this drug in many sectors became almost cult-like, and the cult continues today, as I saw in an op-ed in WND by Joel Hirschhorn entitled COVID scandal: Feds ignored 2016 law requiring use of real world evidence.

Before I get to Hirschhorn’s torturing of science and the law (not to mention “real world evidence”), let’s look at some history since last April. As we know, the use of HCQ didn’t pan out. Indeed, after initial enthusiasm, it wasn’t long before a drip-drip-drip of negative studies started eroding support for the drug as a treatment for COVID-19. Examples included a randomized controlled clinical trial of the drug as post-exposure prophylaxis that was entirely negative. This was followed by two more, first, a Spanish post-exposure prophylaxis trial that was also negative. Then there was the Recovery Trial from the UK. Then the New England Journal of Medicine published a clinical trial of 667 patients with mild-to-moderate COVID-19 randomized to receive placebo or HCQ (with and without azithromycin, the other “miracle drug” being pushed at the time by Didier Raoult), with the primary outcome being clinical status at 15 days. It was completely negative. Yet another randomized controlled trial of hydroxychloroquine was published in Clinical Infectious Diseases. It was a Spanish trial of 293 non-hospitalized patients with mild COVID-19. It was negative, too. No benefit was observed with hydroxychloroquine beyond the usual care. Basically, medicine did what medicine does as negative evidence accumulates and abandoned the drug as a treatment for COVID-19. Clinical trial evidence trumps “real world evidence.”

Unfortunately, by this time, the quacks and grifters up to and including Dr. Mehmet Oz had latched on to HCQ as the “cure” for COVID-19 that “they” don’t want you to know about, up to and including Donald Trump. Worse, like masks and “lockdowns,” HCQ had become a culture war issue, largely thanks to Donald Trump and his allies seeing the drug as a way out of the pandemic without public health measures that were harming the economy and (in his view) his chances of being re-elected. There’s a reason why in July I referred to HCQ as the Black Knight of COVID-19 treatments. No matter how many limbs you hack off of it, evidence-wise, its proponents kept insisting that it works and that it was being “suppressed.” It’s an effort that continues to this day, with the same astroturf group promoting not just HCQ but an anthelminthic drug ivermectin, which is normally used to treat parasitic roundworm infections, even though there is little or no good evidence to support the use of this drug in COVID-19 either.

This brings me back to Hirschhorn’s article, which starts out basically rewriting history:

Here is the scandal. In 2016 under the Obama administration, Congress with strong bipartisan support passed the 21st Century Cures Act. It required the Food and Drug Administration to use “Real World Evidence,” or RWE, for approval of drugs. During the Trump administration, this statute was not invoked by the White House task force under Dr. Fauci. But it should have been used early in the pandemic.

Starting a year ago, courageous front-line doctors generated RWE because they were curing COVID patients with protocols that kept patients out of hospitals. Real world data showed the effectiveness of cheap generics like hydroxychloroquine and ivermectin to cure and prevent COVID-19. Dr. Vladimir Zelenko used RWE language early on and this February, in light of over 2 million COVID deaths globally, noted: “The problem is that the medical world and governments ignored REAL WORLD EVIDENCE.”

I do so love the liberal use of all caps in an op-ed. It always persuades me.

This is a massive rewrite of history. First, you might recall that I wrote about the 21st Century Cures Act several times. Basically, I was not a huge fan, because I saw the potential for the law to turn the FDA into a puppet of the pharmaceutical industry. The first time I wrote about the 21st Century Cures Act, I thought there were some good provisions in it, such as increasing funding for the NIH, but that it had a fatal flaw—several, actually. However, those fatal flaws derived from the idea that, if we only relax the “stifling” regulations of the FDA that, if you believe proponents of the bill that’s soon to become law, the magic of the free market would unleash the creativity of private industry and academia to open the spigot and let the cures to all sorts of diseases flow. The bill didn’t go very far in 2015, but by summer 2016 it was still around, still containing the same flaws, still being pushed by the same characters. I discussed both times how the central premise of the bill, that the FDA is too strict, that its “out of control” regulations are hampering medical innovation and slowing drug approval unduly while (of course) people are dying in droves waiting for the cures that government is keeping from the people, is simply not true.

When the Senate linked the bill to the “Cancer Moonshot” initiative spearheaded by Vice President Joe Biden in the wake of his son Beau’s death from brain cancer, I knew the bill was definitely going to become law, much as I got the same sinking feeling that “right-to-try” would inevitably become law. The reason? The 21st Century Cures Act funded the “Cancer Moonshot” initiative. Ironically, the 21st Century Cures Act was arguably the last big piece of legislation passed with broad bipartisan support, and it was passed right before Donald Trump became president. As how the law mandates the use of “real world evidence,” I’ll get to that in a minute.

First, however, let me just point out that the EUA for hydroxychloroquine was based in “real world evidence,” in this case mainly anecdotal evidence and poor quality evidence from case series. If there’s an example of the widespread adoption of a drug to treat a disease based on “real world evidence” that’s more concrete than HCQ, I can’t think of one. HCQ was widely adopted all over the country (all over the world, actually) based on the thinnest of “real world evidence.” Indeed, the very “evidence” cited by Hirschhorn is a perfect example of what I’m talking about! Vladimir Zelenko’s case series that was being promoted a year ago got no better the more patients he added to it.

Indeed, even the scientific rationale for using HCQ to treat COVID-19 was pretty flimsy. Based on an observation of 80 patients full of confirmation bias, Chinese doctors in Wuhan noted that no patients with lupus erythematosis became ill with COVID-19 and hypothesized that the chloroquine or hydroxychloroquine that they were taking might be the reason. Of course, during a major outbreak of infectious disease, it is people who are immunosuppressed are the very people who most rigorously obey orders to practice social distancing and self-quarantine and thereby protect themselves from infection. Be that as it may, the Chinese doctors started using the antimalarial drugs, and anecdotal evidence of success was reported, leading China to incorporate these drugs into its recommended regimen. The World Health Organization followed suit, as did several countries, and thus was born a new de facto standard of care for COVID-19 based on, in essence, no evidence other than some in vitro evidence that the drugs inhibit replication of SARS-CoV-2, the virus that causes COVID-19, anecdotes, and incredibly weak and poorly reported clinical trial evidence.

But what is Hirschhorn talking about here? Here’s the relevant passage from the 21st Century Cures Act, “Utilizing evidence from clinical experience“:

(a) In General.—The Secretary shall establish a program to evaluate the potential use of evidence from clinical experience—

“(1) to help to support the approval of a new indication for a drug approved under section 505(b); and

“(2) to help to support or satisfy postapproval study requirements.

“(b) Evidence From Clinical Experience Defined.—In this section, the term ‘evidence from clinical experience’ means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.

Nowhere in the law is the term “real world evidence” used, actually, but “clinical experience” is close enough to the term. In any event, at the time, here’s what I wrote about it:

A homeopath would love this provision, and, I’m sure, so would drug companies. Why bother with the time, bother, and expense of those pesky clinical trials to get your drug approved for additional indications, when you can rely on clinical experiences based on therapeutic use, uncontrolled observational studies, or registries instead? If I were the CEO of a pharmaceutical company, I’d love it. Indeed, the one thing this provision most definitely does not do is to speed effective treatments to patients. Rather, it smacks of being a payoff to pharmaceutical companies.

More importantly, though, nothing in this particular law says that “real world evidence” should trump clinical trial evidence, only that it should be considered, which it most definitely was when the FDA issued an EUA for hydroxychloroquine. but to Hirschhorn, it’s all a conspiracy to suppress HCQ and ivermectin:

Other physicians and the organizations leading the cause did not invoke RWE, namely America’s Frontline Doctors, the Association of American Physicians and Surgeons, and the Front Line COVID-19 Critical Care Alliance. Nor have conservative and liberal media informed the public about the legal mandate to use RWE.

In my recent book, “Pandemic Blunder,” I used RWE to conclude that 70 to 80% of COVID deaths could have – and still can be – prevented by using the cheap and effective protocols.

This, too, was noted: “In a December 2016 article in the New England Journal of Medicine titled ‘Real World Evidence – What Is It and What Can It Tell Us?’ all twelve authors were from the FDA. A big point was that RWE would come from clinical care and home or community settings as opposed to research-intensive or academic environments. … In order to assess patient outcomes and to ensure that patients get treatment that is right for them, real-world data needs to be utilized.” Perfectly applicable for supporting use of hydroxychloroquine and ivermectin protocols.

It would be interesting to see Hirschhorn’s analysis of the “real world data” that led him to make such an amazing conclusion, but I’m not about to pay for his book in order to find out. I rather suspect that it’s probably an analysis as bad as what’s been featured on a widely cited HCQ website for many months. It’s also amusing to remind people who “America’s Frontline Doctors” are. Let’s just say that none of them appear to have been truly “frontline” doctors, and one of them, Dr. Stella Immanuel, was known for saying that  gynecological problems like cysts and endometriosis are in fact caused by people having sex in their dreams with demons and witches, leading to a large number of jokes about “demon sperm.” She also claimed that scientists were making a vaccine to to prevent people from being religious. Such is the quality of the doctors producing “real world evidence” for HCQ, a bunch of quacks from the dark underbelly of medicine.

In any event, what Hirschhorn wrote in this op-ed is very much like what, for example, acupuncturists write about their quackery. They dismiss randomized clinical trials and then cite “pragmatic” studies without placebo/sham controls as superior evidence. Indeed, take a look at this old post of mine, specifically the arguments acupuncture advocates make against randomized clinical trials, and see if they don’t sound very similar to the arguments made by Hirschhorn, before he goes even further into conspiracytown, because, don’t you know, Anthony Fauci and the CDC are all about pushing vaccines, lockdowns, and masks, not “cures” found by brave maverick doctors:

Now, we see pandemic hypocrisy because articles are appearing promoting use of COVID vaccines by invoking RWE.

Days ago, this was a headline: “Real-World Evidence Confirms Efficiency of mRNA COVID-19 Vaccines.” The article notes, “A CDC study used real-world evidence to find that both Pfizer and Moderna’s COVID-19 vaccines reduced risk of infection 90% two or more weeks after the second dose.”

Every time you see data on COVID deaths remember that most could have been prevented if the government had honored the statutory mandate to use RWE. Following the science legally means using RWE.

This is a disingenuous argument at best that is very simply refuted by pointing out one simple thing: Neither the Moderna nor the Pfizer/BioNTech mRNA COVID-19 vaccines were issued an EUA based on “real world evidence.” They were issued EUAs based on large phase 3 randomized clinical trials of their vaccines, with a total of over 70,000 participants between them. The “real world evidence” in the study cited by Hirschhorn is also only among the first of many studies planned to determine how effective the vaccines are at preventing infection by and transmission of SARS-CoV-2, the coronavirus that causes COVID-19.

Depressingly, but unfortunately not surprisingly, more than a year into the pandemic and 15 months after Chinese doctors first started trying HCQ to treat COVID-19 patients in Wuhan, HCQ is still being portrayed as the “cure” for COVID-19 that could prevent three-quarters of the deaths from the disease and would render masks, social distancing, “lockdowns,” and, of course, vaccines unnecessary but that “they” don’t want you to know about. The only difference now is that it’s been joined by ivermectin. I used to say that ivermectin was the new HCQ, but both are now equally at the heart of the conspiracy theories peddled by cranks like Joel Hirschhorn on the pages of WND.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

88 replies on ““Real world evidence” vs. COVID-19?”

This is just like the magic water quacks. When the trial data does not support efficacy of your quackery, make claims based on other evidence and contend that this other evidence is bigger and better than scientific trials.

Oh and lie about other competing treatments.

The real world evidence is when the Gates foundation a couple of years gave Africa 125 million vaccines for small pox some 95million people died. Then the culprits told the country don’t worry we have a cure and since you don’t have the money just let us put a central bank in your country. Problem+covid-19 not real Reaction+Masks Solution+ vaccines I’m ready to take them out of office.

Problem+covid-19 not real Reaction+Masks Solution+ vaccines I’m ready to take them out of office.

Could you rephrase that in English?

P.S. Your name link is broken.

Smallpox was eradicated before the Gates Foundation was founded.
Therefore your statement is highly suspect.
Which makes the rest of your statement suspect.

Haha, Snort.

“Having earned two master’s degrees in sacred theology from Mount St. Mary’s College and Seminary, Patrick Delaney’s professional background includes working for a presidential campaign, and later for American Life League: writing and speaking on Catholic moral teaching, interfacing with media, and lobbying at the state, national, and international levels.”

Who also writes for Children’s Health Defense.

His article as one might expect from someone with 2 master’s degrees in divinity is wrong on just about all the points of science.

As evidence for the efficacy of ivermectin it is pathetic.

In the real world, India is experiencing a massive surge in cases & deaths. This rather suggests that it doesn’t work there either.

Actually, & sadly, the current situation in Brazil is an additional case in point. HCQ & ivermectin are both promoted & used there, & today their daily death toll peaked at 4,000.

Yup. Pres. Bolsanaro believes in hydroxychloroquine and ivermectin and is promoting the drugs as near-miracle cures, but Brazil is on track to average more deaths per day that the US did at the height of its worst surge, with no end in sight.

Examples included a randomized controlled clinical trial of the drug as post-exposure prophylaxis that was entirely negative. This was followed by two more, first, a Spanish post-exposure prophylaxis trial that was also negative.

“But remember, antivirals should be used EARLY” – some nitwit on the internet.

The problem with the negative trials is that they did not test the hypothesis that hydroxychloroquine combined with zinc and an ionophore such as quercetin was effective early in the infection stage (before 48 hrs) or as a prophylaxis. Any study using hospitalized patients can be dismissed as not relevant to the question. As is the case in all anti-viral medications, the earlier the better. The mechanisms, based on science are as follows: HCQ alters the AEC binding site receptor and prevents binding of the virus. It also covers the grab hold areas that the virus uses to cling to the cell surface. HCQ directly inactivates RNA polymerase. Quercetin directly inactivates the NLRP3 inflammasome and thus mitigates any potential of developing a cytokine storm. It also binds to and inactivates the SARS-COV-2 3CLpro, which is essential for viral replication. Mutations in this enzyme result in a non-viable virus. Zinc directly inhibits RNA polymerase. It is difficult to get high enough zinc levels in a cells so an ionophore is also necessary. Proposed, but not clearly establish as an in vivo effect is alteration of the pH of the endoplasmic reticulum so that viral proteins do not fold correctly. The combination inactivates large swaths of virus, buying time for an immune response. If symptoms progress azithromycin needs to be added. Although azithromycin is thought of as an antibacterial it is also an anti-viral, as it induces interferon 1 production in respiratory cells. COVID-19 turns off the interferon 1 machinery of the cell, thus inactivating the most potent intrinsic antiviral processes of the cell. Restoration of production mitigates this. The immunological dysfunction of COVID-19, seen with hypercoagulability, likely requires LPS production by bacteria and thus the antibacterial properties of AZN are utilized at 2 levels.
To test the hypothesis the following studies are needed:
Placebo
Hydroxychloroquine alone
Hydroxychloroquine plus zinc
Hydroxychloroquine plus zinc plus azithromycin.
Corrected for the time from exposure.

Vitamin D levels correlate with disease severity so that there is also a question as to whether background vitamin D needs to be benchmarked.

The question is the endpoint:
As a prophylaxis it is symptomatic case reduction.
As an early treatment (prior to the onset of coagulopathy), it is reduction in hospitalization.

As far as I can tell, here to date, there are no scientific studies that have tested the hypothesis.

You bet! Also, what about hydrogen therapy? Don’t forget homeopathy. I’m sure people won’t mind playing guinea pig…not like we have safe, effective vaccines, after all….

Hell, why not thoughts and prayers? Those would work just as well as anything that idiot pathcoin pushes, and they are way cheaper.

“as anything that idiot pathcoin pushes, and they are way cheaper.”

I wish Pathcoin’s operators would reveal themselves. Wrong or not, the writing is impressive and in no way that I know of does that come without expense {at the current time}.

At this point, with no evidence showing HCQ works in any shape, you’d have to make quite a case to justify giving it as a treatment to people. You’re not coming in on a blank slate.

Arguing for denying people real preventives – like vaccines – in favor of something that repeatedly didn’t work in trials and has risks is problematic.

For what’s it is worth, the losing former President did not turn to HCQ when he was, apparently, seriously sick from COVID-19.

A large study in the UK tested that vitamin D hypothesis. The conclusion was that vitamin D levels make no difference to Covid-19 outcomes.

The secondary conclusion, based on having lots of blood samples of random people, was that if you live in the UK you should be taking vitamin D supplements anyhow, at least in wintertime, because almost nobody there is getting as much vitamin D as is recommended for other reasons.

The studies you say “are needed” have already been carried out, and are the basis of Orac’s, and other people’s, conclusion that hydroxychloriquine, with or without azithromycin and/or zinc, is not a cure or treatment for Covid-19. [Didt you read the post you’re commenting on?]

Whatcha gotta realise is that no one has tested sucking a sharks fin, on a Friday, between the hours of 03.00 and 04.30, whilst on a vitamin C drip and inside one of those pressurised chamber thingys. If you have tested using those criteria then you can’t say it’s not a miracle cure.

Oh. If you DID test the above and it didn’t work, maybe you weren’t playing the accordion loud enough.

The mechanisms, based on science are as follows:

Pathcoin, you damn idiot. Sources and other citations so much needed for this drek.

Based on science? Until specified, you are just pulling that out of your nether regions.
The mechanism of action of HCQ on the first SARS virus, as explained to me, only have a passing ressemblance to the logorrhea you are vomiting.

Pathcoin There is an actual theory about why HCQ should work against SARS CoV2;
Fantini J, Di Scala C, Chahinian H, Yahi N. Structural and molecular modelling studies reveal a new mechanism of action of chloroquine and hydroxychloroquine against SARS-CoV-2 infection. Int J Antimicrob Agents. 2020 May;55(5):105960. doi: 10.1016/j.ijantimicag.2020.105960. Epub 2020 Apr 3. PMID: 32251731; PMCID: PMC7128678.
Strange that you missed it. Theory explains why effect is weak (secondary binding site is involved),

Unfortunately, amongst the alties/ anti-vaxxers I survey, HCQ** is lauded as a great, life saving intervention for Covid which has been unfairly maligned by SBM/ “orthodoxy” because it is low priced and “well tested” and would counter their fevered efforts for vaccines.
This is interesting because they usually find fault with any med produced by pharma.

-btw-
as a J&J vaccine recipient, I can report no serious side effects and haven’t died yet ( see Mike Adams, NN)

** and sometimes ivermectin and usually, zinc, vitamin D etc.

I also got the J&J vaccine. I had a mild sore arm, which, you know, they stuck a needle in it and injected fluid, so that’s not shocking. That was it. A total non-event.

Yesterday I got my first dose of the AstraZeneca vaccine and I feel fine. A bit of a sore arm, as if someone punched me there, but I’m still very much alive.

Timmy:

Did you look at the number of adverse reactions in proportion to the number of vaccines given? People reported dizziness, lightheadedness etc. right after the vaccine. Concern in younger people.
None of this happened to me. Virtually no side effects. Ten days on.

I know, Denice. I was kind of joking because of the recent hold over 7 adverse reactions across 4 seperate states. I really want the Moderna one myself but whatever. It does appear that JJ may not be all that great for some of the variants.. BioNtech is buckling against the South African strain (as per early Israeli data with 8 infected peeps), my state dropped mask mandates and I’m surrounded by plague rats. I wouldn’t mind so much if the stores wouldn’t say “you can’t wear that here anymore.”

It’s crazy. In Mississippi, there are no-appointment drive-ins and the Moderna tents are empty whilst the JJ ones can’t keep up. I’m thinking about trekking over there as here they shut down operations at 10:30 in the morning because lunch break that never ends. I’m just really proud of my state right now and not just because of their stance on cannabis.

the cult continues today, as I saw in an op-ed in WND

I hope other RI readers, like me, didn’t know what WND is. I Googled. Wikipedia says:

WorldNetDaily is an American news and opinion website and online news aggregator which has been described as “fringe” and far-right as well as politically conservative. The website is known for promoting falsehoods and conspiracy theories.

We really do need to know who is pushing and circulating the BS Orac debunks, in order to understand the context of it’s production and dissemination.

And I do hope Orac landed at WND via some link to the HCQ op-ed, not that he’s a regular reader. ;- )

Silly, I’m on a number of antivax and quack mailing lists and have a list of websites that I regularly check out. It’s part of how I find blog fodder. 😏

Oh WorldNutDaily … reading that reminds me how much I miss Ed Brayton. He would have had a field day explaining the Jan 6th riot.

@ sadmar:

You might also take a look at Global Research. Or RT**.

Actually, I read ( skim) many of these horrendous websites to see how much overlap occurs with the usual dreck I survey. I think that sceptics should take a peek and see how the other half lives.
Worse than you imagine probably

** satellite tv has both RT and Scientology.

Usually lovingly referred to as World NUT Daily on the late Ed Brayton’s blog, Dispatches from the Culture Wars……..

Joel E. Hirschhorn has a B.S. in Metallurgical Engineering (1961), a M.S. in Metallurgical Engineering (1962), and a Ph.D. in Materials Engineering (1965), and it is claimed that he has written 150 papers, articles, guest editorials, and book chapters on environmental science and technology. He has no training in epidemiology, virology, vaccinology, or in even basic medicine. Consider the source.

Why should you even need “real world evidence” to make a Covid-19 related health claim? It’s an unfair requirement, especially when there are pills to be sold.

RI readers may be unaware that there is a dietary supplement that claims to restore humans’ ability to synthesize vitamin C, by switching on a defective gene.

Yessir, while you guys are nattering on about the need for “evidence”, Bill Sardi’s Encode Nutrition is changing medical history by marketing the “revolutionary” Formula-216.

Bill did have a spot of trouble with the FTC over the product.

“We have determined that you are unlawfully advertising that your “Formula 216” product, which you purport to cause humans to internally produce vitamin C, treats or prevents Coronavirus Disease 2019 (COVID-19).
Some examples of Coronavirus prevention claims on your website include:
 In marketing materials titled “Most Animals Can Harbor But Are Not Sickened by Coronavirus Because They Internally Produce Vitamin C 24/7,” you claim, “The animal kingdom is largely immune from the ravages of coronaviruses, even the deadly one that is now infecting human populations. There is strong circumstantial as well as scientific evidence that wild mammals exhibit immunity from coronaviruses and viruses in general because most animals internally produce vitamin C…. Below is a chart showing how much vitamin C non-vitamin C-secreting mammals (monkeys/gorillas, fruit bats) consume in the wild. It is no wonder why they remain free of symptoms from coronavirus exposure. . . . Human clinical trials using vitamin C for treatment of COVID- 19 coronavirus are now underway. But that is for treatment, not prevention…. A newly introduced nutraceutical, formulated by this author, Formula-216TM, is testing well in preliminary trials, to restore 24/7 vitamin C synthesis to humans. In the end, it may be the only hope for vulnerable human populations against a growing number of treatment- resistant pathogenic bacteria and viruses that now threaten humanity.”

https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_encode_nutrition.pdf

I am willing to believe that Formula-216 increases vitamin C levels in the body, mostly because the pill contains vitamin C*. It’s unclear why you’d need to add vitamin C to a product that claims to switch on endogenous production of vitamin C, but I guess it’s better to be safe than sorry.

*it’s basically a multivitamin plus zinc, going for $30 a bottle. It also contains a “proprietary herbal formula” including (naturally) resveratrol, Bill’s wonder molecule.

RI readers may be unaware that there is a dietary supplement that claims to restore humans’ ability to synthesize vitamin C, by switching on a defective gene.

But this would be gene therapy and we have all been told how bad gene therapy is when vaccines could be involved.

I’d rather take my chances with the Planequil and Ivermectin then destroying my immune system and worsening several autoimmune disorders. Did they ever solve these problems?

https://virologyresearchservices.com/2018/08/11/mrna-vaccines-go-into-humans/

“”The third is its high immunogenicity, which while potentially advantageous in vaccine settings, can be problematic if we don’t know how to control it. Accustomed to RNA virus invasions, cells have evolved an arsenal of sensors to detect different flavours of mRNA that don’t quite look like cellular. ”

https://pedsfirst.com/wp-content/uploads/2020/12/mRNA-vaccine-review.pdf

“Potential safety concerns that are likely to be evaluated in future preclinical and clinical studies include local and systemic inflammation, the biodistribution and persistence of expressed immunogen, stimulation of auto-reactive antibodies and potential toxic effects of any non-native nucleotides and delivery system components. A possible concern could be that some mRNA-based vaccine platforms54,166induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity167,168. Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken”

Were these problems solved or are millions going to be victims of a mass experiment?

It’s terrible. Millions of doses world.wide.and hardly any issues. I’m starting to wonder if Dr Evil is a real doctor.

Oh dear, Quisling, you linked to an anti-Semitic article at an anti-Semitic site and said the quiet part out loud. Your Nazi masters aren’t going to be pleased with you.

As for the article, it makes numerous false claims and omissions. First up is the “cytokine storm” falsehood. Also, the article forgets to mention the other primary method by which viruses and bacteria enter the body – breaks in the skin (cuts, scrapes, and punctures). Ironically, cytokine storms are implicated in severe CoViD-19 natural infection.

Also, vaccines aren’t injected directly into the bloodstream (there might be specific exceptions, but certainly not the CoViD vaccines). The description of what happens is false and non-sensical.

As far as animal trials, Moderna conducted at least 17 animal trials and Pfizer conducted at least 8 animal trials. Additional animal studies are being conducted in preparation for full approval. Further, I have been unable to find any study using mRNA transfected by lipid nanoparticles that had the effects described in the article. There have been dozens that didn’t have those effects, however. On the other hand, more traditional vaccine candidates, not using mRNA, did have the type of effect described in the article, though not nearly to the degree claimed.

Time to report back to your Nazi masters, Quisling. I hope for your sake the beating isn’t too bad.

From your first linked article, published two years before the mRNA Covid vaccines went into use:

“While more studies will be necessary to fully understand the safety and efficacy of mRNA vaccines in humans, in the almost 30 years from the first test of mRNA expression in vivo in 1990, scientists have made huge progress in understanding and ameliorating cellular responses, delivery routes, and manufacturing strategies.”

That progress has continued up through successful Covid-19 vaccine clinical trials that did not bear out those previous theoretical concerns.

I preferred to “take my chances” with the Moderna vaccine rather than being part of the Covid-19 disease mass experiment.

Is it really a safety concern, Quisling, if you have to invent studies that never happened and cherry-pick and misrepresent others?

Is it really a safety concern, Quisling, if animal trials weren’t actually skipped?

Is it really a safety concern, Quisling, if the mRNA is only transitory and quickly degrades?

@ Kevin

Whatabout the following then?
https://christiansfortruth.com/moderna-and-pfizer-skipped-animal-trials-on-mrna-covid-vaccines-because-they-already-knew-the-animals-would-sicken-and-die/
“All vaccines create a “cytokine storm” in the body because they short circuit the natural immune response when they bypass the natural way viruses and bacteria enter the body — through the mouth, eyes, and ears.

When viruses enter the body naturally, the body has a natural, healthy immune response to neutralize those bugs — and develop natural long-term T Cell immunity.

But when you inject those bugs directly into the bloodstream, you skip that natural response, confusing the immune system, creating a “cytokine storm” — precipitating an auto-immune response where the body is tricked into attacking itself.

This so-called “Operation Warp Speed” merely provides the pretext or excuse for the pharmaceutical companies to skip the crucial animal trials — the results of which they already know — but they don’t want you to know.

Christians for truth are lying:
Laczkó D, Hogan MJ, Toulmin SA, Hicks P, Lederer K, Gaudette BT, Castaño D, Amanat F, Muramatsu H, Oguin TH 3rd, Ojha A, Zhang L, Mu Z, Parks R, Manzoni TB, Roper B, Strohmeier S, Tombácz I, Arwood L, Nachbagauer R, Karikó K, Greenhouse J, Pessaint L, Porto M, Putman-Taylor T, Strasbaugh A, Campbell TA, Lin PJC, Tam YK, Sempowski GD, Farzan M, Choe H, Saunders KO, Haynes BF, Andersen H, Eisenlohr LC, Weissman D, Krammer F, Bates P, Allman D, Locci M, Pardi N. A Single Immunization with Nucleoside-Modified mRNA Vaccines Elicits Strong Cellular and Humoral Immune Responses against SARS-CoV-2 in Mice. Immunity. 2020 Oct 13;53(4):724-732.e7. doi: 10.1016/j.immuni.2020.07.019. Epub 2020 Jul 30. PMID: 32783919; PMCID: PMC7392193.
None of mice died, and vaccine was effective.
A hint: website with a name like somebody for truth is probably full of lies.

My doctor gave me the Moderna vaccine back in February (which was relatively early) precisely because I have an autoimmune disease.

I’m doing just fine–or, at least, as well as I was doing before being vaccinated. The Moderna vaccine prevents Covid infection. As far as I’ve heard, it doesn’t treat any autoimmune disorder, though there are hints that it may cure or at least alleviate Long Covid.

@ fivehundredpoundpeep

Both articles you refer to are from 2018 before clinical trials, the second was uploaded in 2020; but look at actual article, and there has been a mass of research since then. So, your question: “Were these problems solved or are millions going to be victims of a mass experiment?”

As for autoimmune diseased people, they are actually at much much higher risk for actual COVID, regardless of age, and there is a list of people, I’ll let you find it, who should either not be vaccinated or additional precautions taken. And if you actually took the time to collect info on mRNA, you would find that they change the mRNA capsid and use at least one nucleic acid analogue to severely reduce risk of antibody, or innate immune responses in the cell. In addition, the mRNA is short-lived, so believe what you want. It’s WRONG!

I was volunteer in Moderna COVID vaccine trial. Before I volunteered I took off my shelves several textbooks on cell immunology and reviewed chapters on mRNA, then went to PubMed and Google Scholar and found and downloaded every article/paper I could find on earlier attempts a making mRNA vaccines and, of course, how they severely reduced in cell immune reactions, etc. I am in mid 70s and since getting the vaccine, instead of donating whole blood every 8 weeks, donate convalescent plasma every four weeks (can help up to four patients hospitalized with COVID). According to blood bank, my COVID antibody titers HIGH.

You also fail to realize that there is NO absolutely safe intervention. One has to look at the risk from the actual disease vs from the vaccine. Even someone with an autoimmune disease would be at far far greater risk from the disease! ! !

Do you seriously think that the blood/plasma supply for transfusion isn’t tested?

Natalie, you astonish me.

@ Natalie White

First, it is estimated that 50% of u.s. population has HSV1 and another 20% HSV2. And herpes hides in the nerves of the spinal ganglia and outbreaks go directly following nerve to skin, not in blood. In any case I hope you someday need a blood transfusion or plasma. People in hospital for COVID are in serious danger, so you would prefer that everyone who might have HSV not donate blood. Oh, I forgot your absolute callousness towards others. I have been donating blood for over 40 years and my father did the same. As opposed to sickos like you.

So, your knowledge of blood transfusions as good as your thinking foxholes accord protection from mortars.

I love how you just continue to make a fool of yourself.

Most people would appreciate those willing to donate blood or plasma; but not you.

@ Natalie White

Blood banks ask one not to donate if have active case of HSV simply because could by accident somehow contaminate needle, etc, but not directly via blood. So, wrong again and again and again. But if you ever need a tranfusion, please refuse.

@ Natalie White

You probably don’t know, just one of many things you don’t know, that only about 5% of American population are regular blood donors.

So, if 50% have HSV 1 and 20% HSV 2, let’s assume some overlap, so 60% altogether and HPV: “During 2013–2014, prevalence of any and high-risk genital HPV for adults aged 18–59 was 45.2% and 25.1% in men and 39.9% and 20.4% in women, respectively.” Again assume some overlap, so, probably 70 – 80% of Americans have one or more. Let’s assume that a proportion of blood donors are among them, conservatively 50%, then we would have only 2 1/2 % of American population as regular blood donors. Given that from time to time we already experience shortages of blood, have you any idea of how many Americans would suffer and die? Maybe even someone you care about or you. Oops! You don’t care about others, so you could care less.

@ Natalie White

One more thought. Imagine a hospitalized COVID patient on a ventilator, that is, if you have any ability at all to imagine. Better interventions have reduced the number of patients on ventilators; but not ended it. First, given about 60% of population have HSV 1 and/or 2, likely they may already have it; but, for sake of argument, “imagine” this one doesn’t. And, as I explained above, herpes not transmitted by blood; but by touch, e.g., blood donor with cold sore could touch lip then touch arm of chair, etc. Though risk short-lived, if nurse, etc. should touch within short time and then touch lips, eyes, genitals, minuscule; but not impossible they could get it. In any case, imagine COVID patient on ventilator doesn’t have and, for sake of argument, imagine, goes against all medical knowledge, they have a small risk of getting HSV 1 or 2 from plasma; but plasma has good chance of shortening time on ventilator and the longer time on ventilator higher risk of long-term or permanent damage to lungs or even dying. In addition, there are excellent medicines for HSV, generic, inexpensive, very small risk of side-effects, e.g., acyclovir, vancyclovir. So, doctor explains above to patient and asks patient to blink once if willing to receive plasma and twice if not. I’m sure you would blink twice? But I imagine the vast majority of patients with common sense would blink once! ! !

There is almost nothing in live without some risk. People have gotten food poisoning both at home and in restaurants, some mild, some severe. Even if surgeons do everything perfectly, people have suffered strokes, etc. during even simple necessary operations. One can become infected at hair salons, even before COVID. Intelligent people using common sense understand that one looks at benefits vs risk and when it comes to plasma, well . . .

Please keep posting, given you represent a large, hopefully minority, segment of American population it is nice to see just how unscientific, illogical, and lacking of common sense they have and even when explained to you, literally spelled out, you refuse to change.

mRNA instructs the body to make the spike protein which then provokes immunity while this may sound frightening and invasive, it should be remembered that in nature you are being constantly assaulted by many viral proteins – including spikes- but these come with the other parts of the virus intact and those are the parts that allow replication and infection.

Denise – I had one plague enthusiast spend quite a bit of time trying to convince me that the mRNA in the Pfizer & Moderna vaccines is itself a virus. Because something something something (that showed she had no idea).

That would be an interesting virus if so!

I looked for some graphs I saw on television and couldn’t find them but here is a similar article- NYPost, Apr 7, Natalie O’Neill :
although the infection rate went up, deaths are decreasing because the most vulnerable, seniors, are the most highly vaccinated group. Younger people – less vaccinated- are hospitalised more than before

I wonder what anti-vaxxers/ Covid denialists will make of that turn of events?. Was there suddenly some magic that cured older people of the pre-existing conditions that were killing them in 2020?**
Did they all wake up and binge on vitamin D? Or is it just spring?

** sarcasm

Denise – “Younger people – less vaccinated- are hospitalised more than before” – I heard a news story yesterday saying that around half (HALF) of those in Brazil’s ICUs with covid19 are under the age of 50 🙁
Terrifying.

Yep, anyone who’s ever watched a baby falljng down and eating dirt should not be concerned with the challenges vaccines give our immune systems. One kid picked something off a hospital cafeteria floor and ate it before I could stop him; I nearly died of worry, but the kid was fine.

@ Heidi

A long time ago I was visiting a friend with a newborn. Pooped in crib and put in mouth. The mother freaked out.😀

I’m always fascinated how antivaccinationist worry about killed or attenuated microbes in vaccines; but not the real diseases. Like throwing a water balloon at someones head vs a brick. As for the other ingredients, e.g., aluminum, one of the most ubiquitous elements on planet. We get it from food, drink, air, and minor abrasions and amount in breast milk way more and formula even higher, etc. And on and on it goes.

They also play up the “profit” companies make; but latest statistics find worldwide sales of vaccines about 2 – 3 percent of total pharmaceutical sales. And they don’t criticize pharmaceutical companies for insulin, albuterol for asthma, etc. Yep, they are greedy; but convenient how antivaccinationist separate out the least profitable. They make more in a year on statins than all vaccines combined.

Don’t miss the Freedom Event going on today at the Crack’d Egg restaurant in Pittsburgh.

For those who haven’t followed this saga, the Crack’d Egg was cited for failing to follow Covid-19 regulations i.e. regarding masking and social distancing. The proprietor wound up challenging the restrictions in court. This was so successful that the place shut down. An attempt to reopen without restrictions pending outcome of an appeal was denied last week.

The following article on the case details testimony from a Crack’d Egg expert witness (familiar to regular RI readers), who apparently did not overly impress the county prosecutor or the court.

https://www.post-gazette.com/news/crime-courts/2021/01/29/crackd-egg-restaurant-covid-coronavirus-closure-rules-allegheny-county-health-department-brentwood-lawsuit/stories/202101290147

*there’s a statement on the restaurant’s website calling for people to refuse to give their business “to those that participate in the propaganda for the demise of Humanity”, which one assumes means restaurants that follow the dastardly Covid-19 regulations.
**other Freedom activities on the part of the Crack’d Egg include filing a federal lawsuit against Allegheny County (good luck with that) and stumping for a “full investigative and forensic audit” of the 2020 election in Pennsylvania.
***you can contribute to their legal defense fund if you like.

@ ALL

Just to follow up on what Denice wrote about the S-Spike protein. My analogy is rather sick/bizarre; but to make the point:

Imagine you need the fingerprint of a suspect to see if it matches those at several violent crime scenes. You could try to forcibly bring the subject to the station, him struggling the entire way, or cut off his finger. The fingerprint would be the same; but the finger would be completely harmless, incapable of doing anything as not attached to muscles, etc. This is the S-Spike protein. All it does is passively attach to ACE2 receptors on cells. The virus enters our bodies, just floating around until S-Spike protein passively attaches to cell receptor, e.g., bumps into; but it can’t do anything else. Without the cell which it just sticks out from, it is helpless, just a piece of protein. So, besides the mRNA from the vaccine that enters the cell, with a short-life time before disintegrating, the S-spike protein that the mRNA instructs the cell’s ribosomes to make, is just a piece of protein; but as with all proteins, it is configured in a specific way, so our immune system will recognize it as foreign, and react accordingly.

In many respects, probably one of the safest vaccines ever. Other vaccines the virus grown in embryonated eggs, so can elicit egg allergies, others live/attenuated so, on rare occasions can revert, and killed vaccines have several TRACE amounts of chemicals that could in rare situations, I repeat rare situations, elicit adverse reactions. Finally vaccines made out of subunits, actually similar to mRNA in that the subunit could be the S-Spike protein; but, also include some chemicals and the mRNA, though short-lived should produce more S-Spike Proteins to ensure enough for immune system to recognize.

I cut fingers off all the time so as to gain access to server rooms I’m not supposed to be in. I tend not to swallow them so that I’ve never really had an allergic reaction but I do worry about one being forced into me one day… That is just gross and could trigger all kinds of hyperemesis and general malaise which has a small chance of making me momentarily incapable of being part of an effective team.

@ Joel:
It may be macabre but it gets the concept across: the dangerous parts aren’t involved.

Here’s good news ( more sources than those which I include)
— Israel may have already achieved herd immunity with more than half of adults vaccinated and an additional 15% who were infected. Yahoo news
— California has vaccinated half of adults ( 22 million), has a very low positivity rate ( 1%) and plans re-opening in June. Mercury news.

We will be seeing more announcements like these in places having high rates of vaccination and other PH measures. Right here, outside of [ REDACTED!]. positivity is higher but Rt is below 1, vaccination is increasing beyond 35%, lower death rates, businesses are re-opening slowly.

I wonder what anti-vaxxers will make as more places join Israel and California?
Must be the sunshine and vitamin D?

“it’s true that if we could get our blood pH up above 8.5 we wouldn’t have to worry about SARS-CoV-2 any more.”

This is fairly easily accomplished with AC electrolysis between the right foot and inner thigh. Don’t skimp on the conductive gel though because 3.5 Amperes across a sloppy connection really stings a treat; especially though an abrasion or cut.

As a bonus, liberal amounts of sodium hypochlorite is generated fairly rapidly — no need for Trump’s dangerous injection.

A negative is that the back-fed 60 Hz arterial pulse plays havoc with the rest of the body. The heart should be safe, though.

@ JustaTech

You write to Natalie: “Do you seriously think that the blood/plasma supply for transfusion isn’t tested?”

The blood/plasma supply is tested; but not for herpes because as I wrote above, herpes hides in the nerves of the spinal ganglia, then follows the nerve to the skin, so not running around in the blood.

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