No wonder Alex Berenson had a few choice words to say about Pfizer’s clinical trials and posted them on Twitter (who quickly kicked him off). Other people have read the documents (you can too the link is below) and have found some interesting items of note aka RED FLAGS…
The Kunlangeta and Pharmaceutical Medicine
The last century of evolution of medicine in the West might be reasonably called "The Rockefeller Medical Era". After all, it was oil tycoon John D. Rockefeller---by many accounts the wealthiest man in the world, and first to be called "billionaire"---who set about reducing the influence of doctors, building a portfolio of petroleum-based patent medicines that did more to mask symptoms than cure ailments, and helped Hitler set up manufacturing of poisons and chemicals through an investment in I.G. Farben.
…"We took a perfectly useless, if not deadly vaccine like Pfizer's, and turned it into a successful product. And during the same time, we turned an inexpensive, highly effective medicine like hydroxychloroquine into a dangerous pariah and would-be killer!"
No wonder none of the vaccine manufacturers will release their raw data. The experiments are a success, so long as all participants remain blinded?
The vaccine campaign is no longer a regulated process. We should call it what it is: extralegal, with law makers turning blinded eyes, and a dysfunctional media running a full frontal assault on anyone who stands in the way while running the most sophisticated propaganda campaign in history against simple and effective alternatives. And what all else fails, the mob gets roused.
From Jon Rappoport
Pop quiz: During their clinical trial…
If Pfizer insists that certain unvaccinated persons who come into contact with a vaccinated person creates a…
SAFETY SITUATION that must be reported to Pfizer within 24 hours…
Would you say that implies…
The transfer of vaccine components from person to person can occur?
If you answered YES, you win four tickets to Oobladee, a little-known island nation where vaccines are forbidden and the people naturally remain healthy and live to a ripe old age.
Here is a Pfizer document, admitting and warning of person-to-person transfer of dangerous vaccine components : “A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS,” (see page 67).
I’m going to take this in small chunks, and translate the fake-speak clinical language as we go along.
“Exposure to the study intervention under study during pregnancy or breastfeeding and occupational exposure are reportable to Pfizer Safety within 24 hours of investigator awareness.”
The “study intervention” means the RNA COVID shot. That’s what the study is FOR—intervening with a jab. “Hi, I’m your intervener, you’re a volunteer in the clinical trial, and I’m going to hit you in the arm with this needle and inject you.”
“Exposure” to the shot doesn’t mean injection. It means somebody who hasn’t been injected gets physically close to somebody who has been injected. Or it could mean an un-injected person touches vaccine-liquid from a vial.
And that un-injected somebody would be a woman who is pregnant or breastfeeding. For example, she could be a lab worker, or a person who is giving the shots.
If THIS exposure event happens, it’s a safety situation, and it has to be reported within 24 hours.
A lab worker who is pregnant or breastfeeding gets physically close to a person who has received the vaccine and BANG, it’s serious, and it has to be reported.
Why? Because, obviously, there is a potential danger to the unborn baby. Or the mother, who is already breastfeeding her baby, could pass this danger to the baby through her breast milk.
The woman just came physically close to a person who already received the vaccine. That’s all. That’s all that happened. But it’s enough. It means THERE CAN BE A TRANSFER OF VACCINE COMPONENTS FROM PERSON TO PERSON, AND THIS IS NOT GOOD, THIS IS DANGEROUS TO PREGNANT AND BREASTFEEDING MOTHERS AND THEIR BABIES.
Here is the next piece of the Pfizer document. It’s crucial:
“An EDP [exposure to the vaccine during pregnancy] occurs if a male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception.”
This is a dangerous situation, too. A man who did get the shot then gets physically close to his female partner, who didn’t get the shot. This doesn’t necessarily mean sex. It means close physical contact. But the warning is obviously all about danger to the woman who is going to conceive a child or has just conceived, and the warning is also about a danger to that child. Some kind of severe injury. Or a miscarriage. Again, the document is obviously referring to the transfer of vaccine components from a vaccinated to unvaccinated person.
And then, in the Pfizer document, we find an example of this dangerous, immediately reportable situation: “A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact….”
Here, as plain as day, we see two meanings of “come in close contact with.” Inhalation, and skin contact. Do not assume this has to mean physically rubbing up against or breathing in the liquid in the vaccine vial. Go back and read the other quotes I gave you from the Pfizer document. They are clearly talking about something much different. They’re talking about close contact between PEOPLE, one of whom has ALREADY had the shot, and one who hasn’t.
They’re talking about vaccine components passing from the inside of one person’s body to another person.
Call it shedding, call it transfer, call it transmission, call it whatever you want to. Pfizer was clearly worried about it, because they insisted that any such occurrence had to be reported to company safety personnel.
They were aware that damage could be the result. Damage to mothers conceiving, mothers pregnant, mothers who are breastfeeding, and damage to babies.
Through person to person passage of components in the vaccine.
A person might object, saying, “Well, maybe the pregnant woman had skin contact with someone who was just vaccinated, and the vaccinated person has a small amount of vaccine on his skin, because that tiny amount of liquid somehow escaped from the needle during injection.”
That’s highly doubtful. And if you go back and read the Pfizer statement about the man who received the vaccine and then had close contact with his female partner, there is no time line mentioned. A) He received the shot and then b) at some point later, he came into close contact with his female partner. It could be days later, weeks later. There would be no amount of vaccine left on his skin.
We ARE talking about the passage of vaccine components from the inside of one person’s body to another person.
The Yupik Eskimos use the term kunlangeta to describe a man who repeatedly lies, cheats, steals, and takes sexual advantage of women, according to a 1976 study by Jane M. Murphy, an anthropologist then at Harvard University. She asked an Eskimo what the group would typically do with a kunlangeta, and he replied, “Somebody would have pushed him off the ice when nobody else was looking.”
Amusingly, in the opening paragraph of an article in Psychology Today, psychology professor Dale Hartley wrote,
The Inuit people of Alaska have a word, kunlangeta, for “a man who … repeatedly lies and cheats and steals things and … takes sexual advantage of many women — someone who does not pay attention to reprimands and who is always being brought to the elders for punishment.” Anthropologist Jane Murphy revealed this in a study published in 1976. When she asked how the Inuit people dealt with a kunlangeta, one man told her, “Someone would have pushed him off the ice when no one was looking.”
…there are people who, despite the basic societal structures and hierarchies that define and enforce boundaries, behave horribly toward other people. Psychopaths are rare people who neither feel empathy toward their fellow humans, nor care about societal norms.
…What most people understand less is how the same deviation of human psychology found perhaps 20 times as often among the hardest criminals coincides with perhaps similar proportions of corporate CEOs, lawyers, and media professionals. (image source: Lionsgate Films)
…Why would roughly 4% to 12% of CEOs be psychopaths (I've seen as high as 20% claimed, implying psychopaths might be statistically around 25 times as likely to become CEOs)?
Sloppy Pfizer Booster Clinical Trial Consent Form Provides Way to Exclude Reactions That Require Emergency Care
Bloomberg Law complained recently that the consent forms for Covid 19 vaccine clinical trials are larded with unimportant information and difficult to understand. Based on our reading of a Pfizer consent form for a trial of a third shot of its Covid-19 vaccine, those aren’t the biggest causes for pause.
We’ve embedded a Pfizer consent form for a Covid-19 booster vaccine clinical trial below, which as of posting time was available at careidresearch.com. We strongly encourage you to read it in full.
We’ll discuss first how the form does not appear to have been reviewed by the oversight body tasked by the FDA to do so, and then will discuss why key parts are troubling.
The biggest issue, flagged in our headline, is that the consent form allows for participants who need emergency care and go straight to their doctor or hospital to be ejected from the study. But it’s not the only one.
Red Flags in the Consent Form
While one has to assume that this Pfizer form is pretty typical, it’s alarming as a statement of the disdain Big Pharma and its hired hands have for clinical trial participants.
As IM Doc described, what has happened over time is that the major drug companies have turned the IRB watchdogs into lapdogs. The evisceration of independent oversight has the effect of elevating the importance of the consent form as a vehicle of informing and protecting study participants. But the consent form retains its apparent original form of being a user-friendly document describing the clinical trial process and risks. The teeth were intended to be at the IRBs, not in the consent forms.
Nevertheless, the consent form is clearly meant to have legal significance, as in most importantly to shield Pfizer from liability. Yet it is slipshod and incomplete. For instance, it fails to define terms and is inconsistent in the way it refers to concepts, does not specify governing law, and has no dispute resolution process.
The latter issue matters because Pfizer says the study doctor will “provide or arrange for” medical treatment for what is refers to as a “study-related” or “research” injury (it at least does define “research injury” on p. 17, if not all that crisply). But what if a study participant thinks he has suffered a “research injury” and the study doctor disagrees? Or the participant believes the level of care Pfizer provided is inadequate?
It’s not hard to wonder if the sloppiness of this document is deliberate, that it’s the Big Pharma answer to Nigerian scam letter. As professor of information and spam expert Finn Brunton put it:
By making them really obviously fraudulent, you’re weeding out the skeptics. You’re only getting truly gullible responses.
This consent letter looks designed to put off the legally savvy…who could be effective trouble-makers if anything went seriously wrong.
Below are some eyebrow-raising provisions. Note that these shortcomings have the potential of impairing the health of participants and their close contacts, by not giving them the most complete information about whether the participant has Covid, as well as the completeness and integrity of this Covid booster study.
1. Unlike the Moderna clinical trials, where participants were checked for Covid weekly, Pfizer participants are tested for Covid-19 only if they report symptoms to a study doctor and then the doctor deems they warrant testing. That assures asymptomatic cases will not be tracked.
Given that the CDC has raised its alert on the Delta variant to DefCon 1, based on evidence that asymptomatic patients carry Covid in their noses at the same level as symptomatic victims, the study data-gathering does not reflect current public health concerns.
2. Study participants, and importantly, their doctors, do not have access to any of their test information or samples from the trial, including if they report Covid symptoms and the study doctors run a test. Pfizer makes no commitment to tell them if they have a positive test result. They are instructed to get their own test from their MD if they think they have Covid. But participants agree to let Pfizer obtain information from their doctor and any medical provider about care the participant receives.
3. Pfizer can remove participants who seek emergency room care on their own. The document instructs participants repeatedly to contact the study doctor “immediately” if they suffer any of the listed Covid-19 symptoms. Note that the “immediately” means “Pfizer first”. That means if you contact your own medical professional first about one of the long list of Covid symptoms, you have violated Pfizer’s directives and can be removed from the study (p.16)
The study doctor or BioNTech/Pfizer may also decide to take you off the study vaccine and/or remove you from the study (even if you do not agree) in the following situations:
• You are unable or unwilling to follow the instructions of the study;
Now back to the issue of trial participants making emergency room visits after getting the third Pfizer injection. This is not a theoretical concern. We know of one participant who received a shot and in less than 24 hours had a high temperature plus debilitating digestive and neurological distress and went to the emergency room in haste. I am told this subject was escorted to the ER. That makes it unlikely the participant was alert enough to say “Oh, have Pfizer sort out my ER visit” even if that level of delay didn’t appear to be health-jeopardizing.
Thus thiis participant did not “follow the instructions of the study” if as I infer the individual didn’t have Pfizer “arrange for” care.
To put this more directly: the odds are not trivial that participants who had severe side effects would go to the ER and worry about Pfizer later. Any who behaved this way could be excluded from the study. In other words, Pfizer has the opportunity, and clearly already has the motive, to avoid reporting so-called Stage 4 (potentially life threatening) reactions by invoking this provision of their consent form.
4. The study is designed to minimize reporting of side effects. Remember that the study doctor is to be contacted only in the event of Covid-19 symptoms, and not other symptoms that have been attributed to the vaccines, like worsening of autoimmune symptoms or early and very heavy menstrual periods. From p. 8.
he consent form does not describe any mechanism for reporting side effects. And even if participants try using the “Covid Illness e-diary” for this purpose, weekly the weekly format will favor under-reporting of symptoms during first 1-3 days6
Other Issues with the Consent Form
These concerns are not as dramatic but are still worth logging:
1. This clinical trial is not double blind. Is Pfizer too broke to do the extra work to execute a study at the highest research standard?
This is an ‘observer-blind study’, which means that you and the study doctor will not know whether you are receiving the study COVID-19 Vaccine or placebo injection, but the person who gives you the injection will know because the COVID-19 Vaccine and placebo do not look the same. The person that gives you the injection will not be able to talk about it with you. In case of urgent need, the study doctor can learn quickly whether you have received COVID-19 Vaccine or placebo.
2. Not only are pregnant and at-risk-of-becoming pregnant women excluded, so too are men who might impregnate a woman. Tubal ligation, anyone? P. 14, emphasis original:
If you are able to have children and you are sexually active, you must use birth control consistently and correctly for at least 28 days after you receive your last vaccination. This applies to men and women who take part in this research study. The study doctor will discuss with you the methods of birth control that you should use while you are in this research study and will help you select the method(s) that is appropriate for you. The study doctor will also check that you understand how to use the birth control method and may review this with you at each of your research study visits.
Birth control methods, even when used properly are not perfect. If you or your partner becomes pregnant during the research study, or you want to stop your required birth control during the research study, you should tell the study doctor immediately. You may be withdrawn from the research study if you stop using birth control or you become pregnant.
If you are a male, you will not be allowed to donate sperm for at least 28 days after your last vaccination.
These restrictions seem at odds with a June 2021 of this New England Journal of Medicine article.. It starts by explaining that pregnant women are elevated risk for bad outcomes if they contract Covid compared to women who aren’t pregnant:
Therefore, clinicians relied on developmental and reproductive animal data from Moderna that showed no safety concerns, and there was no biologically plausible reason that the mRNA technology would be harmful in pregnancy…
If Pfizer wants to calm concerns about possible reproductive risk from taking its Covid vaccine, this is not the way to go about it.
Before you attempt to defend Pfizer, recall that it has a record before of playing fast and loose, including paying one of the largest criminal fines ever imposed on a drug company for the arthritis drug Bextra. It would not be hard for Pfizer to develop a legally sound and clearer consent form, or test all participants weekly for Covid, or inform participants if they test positive for Covid. But God forbid anyone interfere with Pfizer’s lock on the information flow, even if the result puts patients at risk.
And more generally, this consent form speaks volumes about the care in which Pfizer has placed people’s lives when evaluating these vaccines. It’s not hard to conclude this also represents the care Pfizer is taking to assure the vaccines are safe for you. Hire a bunch of local physicians at thousands of dollars a pop, and have an IRB rubber stamp the protective documents like an expense receipt. And set up the study so that if any participant sees a doctor they chose rather than Pfizer about Covid or a possible bad reaction, they can be excluded.
There is more info here, this is just an excerpt.
More background from IM Doc:
Big Pharma has hated this system since the beginning. They tried to sabotage it in any way they could. At the same time, an entirely different approach began to be more common. For Phase III and Phase IV trials, Big Pharma began to pull away from big academic centers and big hospitals, and employ local physicians to do all the patient recruitment and research work often right out of their offices. Initially, the same IRBs were used – however, the rapid turnover pace that Pharma wanted was just not happening, so large centralized IRBs came into existence. Big Pharma had also become very tired of what they felt was pesky interference in their trials.
These were national IRBs – for profit corporations – often approving hundreds of trials a week. I will leave it to the reader to ascertain for themselves how thoroughly these trials were evaluated for problems. The two biggest ones were known as Western IRB and Copernicus.
At the same time this was going on, the uptake of “research” grew into a big business for community physicians. Many often made hundreds of thousands a year on this type of work. Each patient recruited in a trial would be rewarded by Big Pharma of often 5-10 thousand dollars. The patients of course got nothing.They were enticed with the promise of being put on an awesome new study drug.
…On multiple occasions, when I was the chairman of the IRB, our hospital IRB got dragged into a fiasco because a patient had a bad outcome in one of these trials approved by a national IRB. And the hospital made it mandatory that for the community physician to retain privileges – he had to hand his disaster over to the local IRB. What was invariably found was sloppy work, virtually no records, and certainly no meaningful follow up with the patients. Indeed, an example of the sloppy work can even be found on this document presented by Yves. What kind of business would have a confidential document laying around on the Internet for all to see?
You can read all about this process here or in many other places across the Internet. The complete domination of these outside IRBs has now been assured.