78 Comments

"nothing to do with the “investigational product”"

Very common dismissal.

Billions and decades of research later, doctors don't know the cause of autism, allergies, asthma, autoimmunity but they magically know trial adverse events are not related to this new mRNA vaccine?

https://vinuarumugham.substack.com/p/billions-and-decades-of-research?s=w

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Vinu! Well said. Nice to hear from you. How are you doing?

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Josh, good. How are you?

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Not sure. Haven't stopped to think about it. Busy, busy, busy!

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That Argentinian trial site keeps coming up.The first mystery was how they managed to get so many participants enrolled in such a short time. And now this. And you make an important point about these sub contractor sites wanting a positive outcome in order to get more work in the future. Surely Ventavia wanted the same. It would be so interesting to know the real AE numbers.

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What worries me is how common these (alleged) clinical trial fabrications are. While it's getting pretty obvious that the Pfizer trials were problematical, what about trials for other drugs or toxic substances? How much can we rely on those? Or, how reliable are meta analyses based on these trials? For example, if we are considering a medical procedure, and are given a risk number of specific adverse events, how much can we depend on the accuracy of such numbers? There are many procedures used today for diagnostic and therapeutic purposes that are commonplace, and large groups of people would lose their livelihoods if such procedures were shown to be far more harmful than is believed. Is the subject of this thread unique, or are we seeing the tip of the iceberg?

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I’m sure the trials for many drugs are subpar, but with c19 shots, the temptation to lie and cheat must have been mammoth. They were looking at creating a liability-free product that would be pushed on billions of people under threat of job loss.

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Been tracking this for over a decade. Peter Gotzche's excellent book "Deadly Medicines and Organized Crime" is a great place to start.

What he described there, pre-COVID, ramped up to blatancy with the COVID trials. Ruthless.

I've decided that's why they rolled them out so fast, and insisted that everybody take them quickly before anybody noticed....profits made, losses recouped. Viability for ModeRNA. Ruthless.

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Either has a large VERY large database or questionable recruitment. Wonder about quality, even more so how they screened and processed that volume. If enrolled 1500 a week that be almost 40 subjects enrolled every hour over 40 hour week. Each intake can take hours and they do them in under 2 minutes? Smells like another Surgisphere.

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Smells whiffy for sure. Like last weeks fish.

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They were able to get so many volunteers for the trial vax because argentines were paranoid about getting covid... more so than in the United States. Look at the data today argentine's STILL rush to get the third or fourth vax. While living here in Argentina I tend to be a good listener, people here have no idea that there could be a problem with the vaccines. The statistic I would love to know is how many argentines flew to Miami to get a free vax.... I know of so many.

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Hold up now folks. I agree that the recruitment for the vaccine trial in Argentina was incredible, perhaps unprecedented. But let's get a few things straight. Pollack was not alone. There is a document in the Pfizer dump that lists him as the PI, that's principal investigator. He was in charge but he was not alone. There is another document in the dump that lists him along with sub-investigators. Their names are blacked out but they take up 28 pages. Augusto Roux has said there were maybe 50 doctors working at the military hospital when he went there to enroll and perhaps 300-400 people on that day alone. Fitting it was at the military hospital because it was really like a military operation.

Yes each trial participant generates hundreds of pages of records over the course of the trial, which would have been over a million for that site alone, but it did not all fall on the shoulders of a single doctor. There were lots of doctors and staff.

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Having worked as a clinical trials assistant, copying paperwork, posting it out to principal site and recording follow up appointments, adverse events, etc. I can say the initial recruitment takes minimum 30 minutes to go through protocols and ensure no one is recruited who should not be. These facts are only discovered as the enroller progresses through the rigid enrolment process. It appears feasible that 50 doctors recruit 10 each per day but would probably interview a few more. Most trial recruiters in hospitals have to ask around to find possible subjects and then get 2 or 3 a week. Depends on type of trial of course with simple obvservational ones being easiest to recruit to. At the start of any trial everyone involved is listed as to their level of responsibility and involvement. I could not recruit but was authorised to handle paperwork. Anyone working on any medical trial has to have training and be tested and a copy of the certificate of competence for every person involved has to accompany the trial setup papers.

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I participated in a Lilly / IUPUI trial in 1990's. As an impoverished person, the $3000 was too hard to pass up (I got placebo). And what Markker describes is accurate. The trial I was in had hours of intake, pages of history, separate workups for organs, psych evaluations, etc. etc. Trial was 8 weeks active on the drug, prep for the trial took place for 3 months. I was inpatient for 48 very boring hours. (drug was olanzapine).

Sloppy is what comes to mind when I look at these COVID trials. Messy is another.

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Thanks for the clarification Josh. After everything that has happened I guess I see the worst in things. A spokesperson said the hospital had provided 70 staff in total, including doctors. Then there was Polack and his team. 28 pages is a lot of people though, but it's a pity they're blacked out. It was my understanding that the PI had to at least sign off each volunteer, but I guess that's unlikely.

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It's interesting to hear that people there are so keen to get it. It's similar in my country.. one young girl even dressed up as an old lady to try and get hers sooner! But it is important to note that the real obstacle to enrolling people in clinical trials is the process/paperwork etc. We are talking thousands in a few weeks which would amount to over a million pages of forms to fill out and thousands of hours of work at a site with only one listed doctor as enroller. To be able to achieve what they did, they'd need a huge team working round the clock...that is what is suspicious.

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Isn't the Pope from Argentina? Nothing to see here......

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It sure does! Lots of shenanigans happened down there. Read a Twitter thread the other day,

( https://threadreaderapp.com/thread/1523617233255436289.html ) which explained the mountain of paperwork required to enroll anyone in those trials. It was over 1 million pieces of paper. And we’re supposed to believe the one who enrolled these trial participants did all that in less than 3 weeks? All by themselves? Riiiiiiiight.

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I adore Jikky, but he pulled the trigger a little too soon on that allegation. See my comment here: https://jackanapes.substack.com/p/is-subject-12312982-the-key-to-proving/comment/7144987

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Appreciate the correction. Thank you.

This is what should happen when I (or anyone else) reply/post something with an error in it. No outrage on either end. Truth is advanced, and that is what all should want. Mistakes can happen to anyone.

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Absolutely. In this case if you aren't neck-deep in these documents and data like I am there is no way to know. I am in touch and working with Jikky, by the way and have the utmost respect for him. Brilliant dude. Itchy trigger finger.

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Checking it out now. Thanks!

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As a former CRA and clinical coordinator, I can tell you that this is an absurdly dirty business where every kind of corruption is inevitable and facilitated. CROs know their job is not to run a clean trial, but to get favorable results for the investigational product and to make it seem like there was a clean trial.

Every team has "cleaners" to tidy up little problems like this and to assess whether or not it's likely to ever be found out. They assumed there would be no digging into the database or that they could stop it from happening. In my experience, clinical trials, the FDA, and even NIH studies are completely unreliable. I've seen all data that undermined the desired outcome "cleaned" away and I have heard all manner of misconduct, one prominent researcher simply reversing all of the "no" answers.

Clinical trials and NIH studies are mostly high end public relations features.

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Les, can you please e-mail me? Augusto Roux wants to get in touch with you. joshg99 <at> gmail

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My apologies. I don't monitor this account closely. I can be reached at lestoolish@gmail.com or feel free to DM me at my Les Toolish Facebook account. Thanks.

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Thank you for your invaluable input.

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We need to contact you, could it be?

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An attempt to track down the 302/354 people in the vaccine arm that were removed or withdrew from the 1231 site seems like a good start. So Josh, does the recent Pfizer FOIA release specify the reasons for these 302? Or 354 if the files do not specify which arm of the trial they were in. All it took was hiding three heart attacks in Merck’s Vioxx trial to secure approval, leading to >50,000 dead in America alone. The precedent for Trial Fraud and regulatory capture/disinterest is well established in the courts

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Hi where did you see the numbers 302/354?

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The recent Healy article, and a prior article. The 354 was all withdraws in the trial, 302 were in the vaccine arm . He also states “ The clinical safety data for the Pfizer trial states 302 people on the active vaccine dropped out for protocol violations. A recently released document giving dropouts lists over 200 dropouts for the Buenos Aires site – but this does not include Augusto” ….suggesting an abnormally large portion of the vaxx dropouts we’re in Polack’s site. He references this info from the new FOIA data?

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Ah, ok. Thanks! I will look into it. I have been digging into the released data. They are fairly complex datasets with not documentation other than variable labels, so it is taking some time. I will contact him to see where he saw the 200 dropouts in Buenos Aires, because I didn't see that in the data. Maybe in one of the pdf files...

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Josh, being from the industry I’m pretty sure I know how this fraud is committed. Not that I’ve ever committed clinical trials fraud, but I’ve spoken to experienced people who are aware of others doing similar things.

If you want to disappear problematic subjects, here’s how to do it.

1. Make the trial protocol complicated, especially in the “visits” & “contacts” with the lowest level clinical trials staff. These people are not doctors. This is a nifty way of almost ensuring that there’s a “protocol violation” for every subject & it’s impossible to spot. An example might be to proscribe the time window for a contact call to happen such that it’s hard to get it right every occasion. If a call is made even 5min late, technically that’s a PV.

2. At some point in the trial, review and note subjects with the required characteristic, such as a positive Covid test. The cheat seeks to exclude the vaccinated who got infected. You do need to cheat overtly around this point because the blinding code is meant to be held by an unconnected organisation. Note though in the whistleblower case, treatment group was left unblinded in Ventavia trials, though this defeats the entire experiment.

3. A third party is meant to review clinical report forms (CRFs) and check if there are any reasons to exclude subjects prior to database lock (DBL). Once at DBL, nothing can be change & the numeric file goes off to the firm Pre-contracted to run the statistical plan. In the case of the Pfizer agent, they did the clean up. Quite simply, they removed many of the Covid positive subjects who’d been vaccinated themselves & they did it by citing “unspecified protocol violations”. We know they cheated because there’s huge imbalance in numbers removed from vaccinated vs control groups, without which the agent would have shown a negative result.

The entire “clinical benefit” of “vaccination” was accomplished this way. It doesn’t actually do anything except to poison, injure & kill people.

Cheers

Mike

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Mike, thanks for sharing your knowledge and expertise. I think the process you describe might be accurate for most normal clinical trials, however due to 'Warp Speed' and the novel nature of these vaccines, the Pfizer trial did not at all follow the blinding procedures you describe. I discuss this in my post on how the Pfizer trial was not double-blind, showing the blinding procedures in the trial were as opaque as Swiss cheese. Please read it if you haven't:

https://jackanapes.substack.com/p/the-pfizer-vaccine-trial-was-not

About the imblance in subjects removed from the efficacy analysis due to protocol deviations: The trial was "observer blinded" and Pfizer said this was mainly necessary because their product was so different from a conventional vaccine that the person administering it would have to know the difference between the IP and the placebo. Pfizer explains the protocol deviation imbalance (and FDA agreed it checked out) that most of the treatment subjects were excluded because there was something in the way the vaccine was administered that rendered them ineligible. Either the dosing was wrong or it was administered improperly, or the blind was ruined or something along those lines. "Perfectly innocent."

Now I am digging into the data from the trial on protocol deviations. The imbalance in deviations that did not lead to exclusion from the trial make it perfectly clear that the blinding was extremely imperfect. Just to give you an example, there are many more people in the treatment group (vs. control group) who had COVID symptoms but were either not PCR tested or not tested w/in the protocol time frame.

But we are unearthing even more interesting things related to the N-antibody testing they did on everyone. Stay tuned!

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Thank you, Josh.

Note that “FDA checked & agreed” doesn’t mean what it used to mean. Now it is more likely to mean “co-conspirators in crime looked the other way”.

There’s no way these agents passed even the extraordinarily low bar for regulatory authorisation. We had multiple lines of evidence of regulatory fraud. Manufacturing for example. Pfizer’s own filings showed they hadn’t attained batch to batch reproducibility.

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Just, Wow.

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I’m trying to find the withdrawals for the full 44000 study group, I recall they were skewed heavily to the vaccine arm and kind of suspect over a year ago too. Jessica Rose will know for sure!

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The only skew that was reported on are 'other protocol deviations' where there was a much larger number in the vaccine arm. Steve Kirsch and many others also pointed this out, claiming it was a sign they gamed the trial. Is that what you're referring to?

The response (and explanation in their reports to FDA) was that the person administering the vaccine was not blinded due to differences in the vaccine vs placebo -- either visual, preparatory or whatever (see my post on the trial not being double blind). They say that the majority of exclusions due to 'other protocol violations' in the vaccine arm were due to administration/preparation errors and that's why there is an imbalance. But I am looking at the data and finding many other sources of imbalance that indicate either lack of blinding or manipulation. More to come...

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It definitely needs review. For instance the VRBPAC briefing doc does not match the #’s in Polack’s NEJM paper on dropouts for each arm (post dose 2 is 48 in vax arm and 95 in placebo for NEJM article, compared to the 311/60 numbers in the document kirsch refers to, referred to as protocol deviations). The FOIA doc below summarizes dropouts, where the Healy article suggests 200 are from 1231/4444? https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf

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Good stuff. Thanks for all your hard work that benefits all of us!

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Josh, thank you for shining more light on this! I have come to know Augusto as well and can’t think of a better person to be called to testify in the Fraud of the Century. He needs a law firm that will represent him, and we all need to share this story!!! (The Brook Jackson lawsuit had a bizarre setback this week now that we know Pfizer didn’t need to follow ANY basic trial site protocols; as their contract was for a ‘prototype’ with the DoD😡. But fraud is not a protocol deviation….it’s simply fraud)

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i am so angry i actually accepted the two Pfizer vaccines. took me a while, but was visiting my family in California from Europe and everyone was so omg covid, nobody can meet until we're all vaccinated!! spent a week in a hotel in 2019 before anyone would see us and spent hundreds of dollars on tests. luckily my 12 & 15-year-old kids have managed to travel and live pretty normal lives with ZERO covid "vaccines". thank God.

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That's great about your kids!

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Thanks for covering this. This is sickening fraud. The people need to demand justice.

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Brilliant work here!!! 🙌

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TBH David Healy really deserves the credit. So does Augusto. Very brave soul.

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Thanks there's another bombshell coming from this site soon. Stay tuned

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Excellent write up. I will be checking against the data I have. We wrote Abstractor (https://vaccines.shinyapps.io/abstractor/) to search all the pdfs initially, but have plans are to extend it to be a front end onto the SaS (clinical trial) database. We've made good progress so far behind the scenes on this and I was eyeballing site #1231 last night.

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So, are these the ”suspected but not confirmed” covid cases that were reported in Pfizer’s trial, which I found strange especially due to their large number?

(in ref to the following quote)

”And that’s how Pfizer made cases of myocarditis and pericarditis disappear, by sweeping them under the rug of COVID-19. Moreover, the diagnosis of COVID-19 would not count against the efficacy calculations, since those required a positive PCR test to confirm diagnosis.”

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Yes! I presume they would be included in that count.

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"We know that Fernando did not visit the trial site on Sept. 12" Small point but don't you mean Augusto?

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Oops. Fixed it, thanks! Can you believe I proof read this thing at least twice?

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Someone who proof reads his Substack articles? You're a rarity. Congratulations!

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His blinding was compromised on October 9, 2020, as stated correctly elsewhere in the piece, not on Sept. 10 as stated near the end.

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Oops! Fixed, thanks! Switched month and day in my head.

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Wow

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Do you have Augusta’s contact? I organize Steve Kirsch’s shows and I would love to have him on as our guest. My email is Angela.wulbrecht@vacsafety.org.

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Great! Sending you is contact details now.

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