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.
Pfizer Consent Form Too Obviously Not Reviewed, Let Alone Negotiated, by FDA-Designated Overseer, the Institutional Review Board
The FDA has tasked Institutional Review Boards, aka IRBs, to provide independent oversight of biomedical research projects to protect study participants, as you can see on the agency’s website.
Historically, academic medical centers and large local hospitals operated most IRBs. IM Doc, who was on an IRB for nearly two decades and its chairman for several years, explains how major drug companies have successfully shifted many over to private sector players to gut oversight:
In our IRB we oversaw usually between 250-400 active trials at any one time. There was a staff of 6 RNs dealing with all the documents, the patient contacts, and any other work needing to be done.
The Board itself consisted of a committee of LOCAL individuals. There were 15 people on ours. 3 were doctors, 3 were nurses, 3 were clergy, 3 were professional people from the community (lawyers, accountants, business owners) and 3 were blue collar workers. You notice the majority was ALWAYS NON-MEDICAL. We were tasked with going over any new research studies in our center, and coming up with a document called an “Informed Consent”. The researcher always had a template for this from either the NIH or other agency or Big Pharma. But the committee went over it with a fine tooth comb. To make certain that the patient was being informed exactly what the study was and how it was being conducted, what the risks and benefits were, what to look out for, and who to call if there were problems. A complete chain of command for problems was essential. It was also vetted to make certain that every person on the committee could easily understand the language. There were usually on average of multiple dozens of revisions made. The entire document was retyped and reformatted by our staff and then sent to the investigators for their approval. This process almost always took 2-4 weeks.
Over time, Big Pharma has obtained more control over IRBs by moving Phase III and Phase IV clinical trials over to more cooperative private sector operators. A big motivating factor is that if an IRB (and historically there would be multiple local/regional IRBs supervising a clinical trial) suspended a study, every other IRB involved would have to be informed of the suspension and the reason why. Needless to say, that would have the potential to generate other suspensions or calls for revisions of study procedures midstream….which would be tantamount to having to go back to the drawing board. 1
One of the side effects was to weaken, and as appears to be the case here, effectively end IRB review and negotiation of consent forms.
Have a look at this image, which is at the top of every page of the Pfizer consent form:
The document is on the website of a research company that has engaged a doctor as the investigator and is working with Pharma companies to recruit patients. What is striking is that there is no attempt to pretend that the consent form is anything other than a Pfizer document. IM Doc stresses that every IRB he was ever involved with would at a minimum rework the drug company templates and create their own documents.
Confirming IM Doc’s view that this document was simply rubber stamped: The Pfizer ICD date is July 2, a Friday. The IRB “approval” date is July 7, the following Wednesday, after the Federal July Fourth holiday on Monday July 5. There is no way a request for changes in language could have been developed, sent to Pfizer, reviewed, and approved (or a letter explaining the rejection generated) in such short period.
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.2/sup> But participants agree to let Pfizer obtain information from their doctor and any medical provide about care the participant receives.3
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;While we are harping on sloppiness, did you catch “The study doctor or BioNTech/Pfizer may also decide to take you off the study vaccine”? Huh? This is a one-shot trial. “Take you off the study vaccine” instead appears to contemplate withholding a shot from non-complaint participants. In other words, this looks like language from the consent forms from the clinical trial for the original two-shot regime that wasn’t cleaned up for this study.
And if this isn’t what Pfizer means, that language is still defective. “Take you off the study vaccine” is meant to be punitive. Trial subjects shouldn’t have to guess what that means.
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.4/sup>
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.5
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:
COVID Illness e-diary
At your first visit, you will either be given an “e-diary” (similar to a mobile phone), or you will download an e-diary application (‘app’) to your smart phone if you have one. You will also be given a thermometer. The study team will provide training on how to use the e-diary and thermometer.The e-diary has questions related to any potential COVID-19 symptoms that you have.
You will need to complete the COVID-19 illness e-diary once a week for the whole time you are in the study, or until your study doctor tells you that you no longer need to complete it, to report if you have any COVID-19 symptoms or not. You will also need to complete the COVID-19 illness e-diary if you have COVID-19 symptoms outside of the weekly question.You may receive alerts to the device or your own smartphone to remind you to complete the e-diary.
The e-diary is secure, and your confidentiality will be maintained.
In other words, the 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.
Clever Hans the horse could read unintended non-verbal cues plenty well.
2. Not only are pregnant and at-risk-of-becoming pregnant women excluded, so to 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…
Among 827 [V-safe] registry participants who reported a completed pregnancy, the pregnancy resulted in a spontaneous abortion in 104 (12.6%) and in stillbirth in 1 (0.1%); these percentages are well within the range expected as an outcome for this age group of persons whose other underlying medical conditions are unknown. A total of 712 pregnancies (86.1%) resulted in a live birth, mostly among participants who received their first vaccination dose in the third trimester. Among live-born infants, the incidences of preterm birth (9.4%), small size for gestational age (3.2%), and congenital anomalies (2.2%) were also consistent with those expected on the basis of published literature. There were no neonatal deaths. These are reassuring data based on reports from pregnant women mostly vaccinated in the third trimester.
…and with a March article in Nature that summarized other research.
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.
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1 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 – but as I found out so often – no one likely discussed with them the concept of a placebo – either the physician or the IRB. A practice would have hundreds of patients enrolled in trials, and often, the only employees doing any kind of follow up or paperwork on these patients were the same ones harried with all kinds of regular work in a physicians’ office. And unlike before in the academic IRB model, there was absolutely no follow up or concern given to the subjects by these national IRBs. NONE AT ALL. Eventually, many physicians doing this kind of work gave up clinical medicine and began to do this full time. It is highly lucrative and very little time is involved for them.
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.
2 P. 9:
The result from this nose swab will be provided to the study doctor once it is available, but this will take some time, and cannot be used to diagnose if you have COVID-19. This is why it is important that you contact your usual provider if you have COVID-19 symptoms and think you need medical care.
3 This qualifier on p. 27 is ambiguous and not satisfactory:
What are your rights to your personal information?
You may have the right to access your personal information that is held by the study site.However, by signing this authorization, you agree that your right to access certain of your information held by the study site will be suspended until after the study is over. After the study is finished, your right to access such information will be reinstated.
This section discusses “personal information” and “certain of your information.” Other parts of the consent form discuss “health information”. None of these terms are defined. This section can mean whatever Pfizer wants it to mean.
Oh, and there isn’t a clear duration of the study either. P. 5, emphasis original: “People taking part will be in this study who are given COVID-19 Vaccine (BNT162b2) will be in the study for about 1 year.
4 P. 17:
If you are injured or get sick because of being in this research, call the study doctor immediately. If you experience a research injury, your study doctor will provide or arrange for medical treatment. BioNTech/Pfizer will cover the costs of this treatment. A research injury is any physical injury or illness caused by your participation in the study.
5 As the post discusses shortly, Pfizer also requires sexually active men to use birth control methods approved by the study, review with the doctor that they know how to use them properly, continue to use them for 28 days after their shot, and “may” review the birth control practices at regular sessions with the study doctor. How many men do you think will be as compliant as the consent form requires? While the main point of these provisions is to make sure no way, no how can any pregnancy bad outcomes be pinned on Pfizer, non-compliance with the birth control requirements, even if they didn’t result in a pregnancy, could also serve as a basis for removal from the study.
6 This is a well-documented effect of the “empathy gap,” when individuals in “hot” agitated states can’t relate to what it is like to be in a “cold” detached state, and vice versa. One manifestation is people who are not currently in pain or discomfort typically do not fully recall how bad it was when they were miserable. From Wikipedia:
00 Pfizer booster shot clinical trial consent formHot-cold empathy gap is also dependent on the person’s memory of visceral experience. As such, it is very common to underestimate visceral state due to restrictive memory. In general, people are more likely to underestimate the effect of pain in a cold state as compared to those in the hot state.
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Good lord this is overt.
I’m seeing that a lot these days.
That and an angry response by many of the PMC’s in my life when I question AUTHORITAH!!
I’m seeing a lot of that angry response too.
This is pretty tame for a drug trial, probably since there is a lot of scrutiny on covid vaccine trials. Regular drug trials are typically much worse when it comes to data manipulation.
IIRC, probability of a drug trial success drops from 90% to 50% when parent company doesn’t control the trial. It’s not a very high bar either, just needs to be better than a placebo, nobody runs drug trials against old drugs for a good reason.
This is a question I’ve always wondered myself.
Why aren’t double-blind trials run against a similar existing drug rather than a placebo?
If something is better than nothing, than by default, almost anything is going to be better than nothing. Doesn’t really prove a lot.
Why don’t we see something vs. something else trials?
Just curious.
Actually this was the problem with Vioxxx https://en.wikipedia.org/wiki/Rofecoxib
The phase 3 trial was actually compared against a different drug rather than placebo. They found that vioxxx was way better for treating arthritis, the only problem was that it also increaseh the likelihood of having a heart attack. The study interpreted this finding as proof that the other drug actually prevented heart attacks. The FDA believed this (or pretended to).
I would argue that trials should be carried out vs both existing drugs and placebo.
This is so sad as the “avenues for escape” for Pfizer clinicians to manipulate clinical data is so blatant and no one is bothering to hide the regulatory capture. (But of course, management at Pfizer are saints and will never be tempted to, implicitly or explicitly, pressure their underlings to form-fit their data).
“trust the science” indeed.
All I would add is when I was on IRBs, someone like Yves was exactly who we were looking for to join the committee. Someone who could look through these documents and ask multiple important questions just like she has here. Non-medically trained insights were often critical.
The difference in our IRB then and this IRB now – the committee would have addressed these concerns, made changes to the documents as voted on by the majority and then submitted theses changes back to the the company like Pfizer.
If they did not want to address the issues, our answer would have been See You Later. Or at least some reasonable compromise would have occurred.
But that was a different era.
I’ve sat on IRBs in higher ed in my time as well. Earned my CIP from PRIM&R. Mostly social behavioral research but strayed into FDA sometimes. I don’t like the Western IRB/centralized for profit system either. Academic medical centers have their lumps but they’re also bound by mission.
It’s an INSTITUTIONAL review board, meaning you pull people from your institution to review protocols. This gives you local flavor while regs and internal policies are also empowering the board for independent work. The regs specifically look for non scientists (like myself) on the committee, as well as local community members. Outsourcing IRB activity is, at the least, not following in the spirit of regulation.
I’ve reviewed at least a few thousand consent forms in my career, again, mostly behavioral research. What I’ve always stressed, and what is in regulation and guidance, is clarity and maintaining a low reading level, grades 6-8. obfuscation as described in the post is something I’d crack down on.
The informed consent document is the most important ethical piece of any trial, no matter how benign. Screwing it up is tantamount to unethical behavior.
Unfortunately, IRBs have, at the level of this vaccine, become disempowered, whereas in non medical centers they’re far overpowered for the risk level of the studies they oversee. I’ve seen out of control boards in the small institution context.
Sorry to reply to myself, but the disempowerment of the most important IRB oversight and the draconian oversight of the smallest IRBs is going to hurt research and development in the long term, because of a lack of trust.
An IRB has to walk a delicate line of slowing down research for ethical review but also helping investigators understand risk. We are going in strange directions here.
The problem you allude to was a very important determinant in the development of the really bad research system we have created.
There were indeed way too many IRBs at way too many really small local hospitals. Some of these IRBs would have made Chairman Mao blush. And they were often way out over their skis with the research going on. The answer was not to ditch the entire IRB system. The answer would have been for the FDA to insure that criteria were in place for institutions only to do research they were capable of following and to have qualified people doing the research and the oversight. That was not done and here we are today with this mess.
The other issue you bring up that in my mind is absolutely paramount is TRUST.
In our world today we have dozens/hundreds of independent non-affiliated investigators. We have the Big Pharma rubber stamped IRB in another time zone across the country. FYI, many of these IRBs are owned by Guess Who – venture and vulture capitalists. And we have everyone involved knowing if too many problems happen or too many questions asked, Big Pharma will just erase you from their list of investigators (that is exactly what happens by the way). Your gravy train will end.
So, in that environment today, if there is a death or complication, there is no local IRB. Nope – in the case of these vaccines, it gets reported to a faceless computer program called VAERS. It may or may not be reported correctly, the employees may get around to it next year. Some inexperienced manager may decide it has no merit. And that is the nightmare we find ourselves in today. Everyone hears about complications all the time, but no one, not even the CDC seemingly, knows how to appropriately monitor or react with them.
Compare this to 20 years ago on my IRB. Any hints of complications were thoroughly documented by the research nurses. The patient’s charts were made available anonymously to every board member. Those board members were Lawyer Bob, Preacher Bill, Trixie at the Dairy Queen and your postman. There were enough real people to make a difference in getting questions asked. The local investigators and even sometimes the Big Pharma people were required to present themselves and explain the problems and offer solutions. There was no nebulous complication list on a vague national website. Only if the Board was satisfied would things continue. The entire process engendered trust.
Look around you now. What is horribly missing? I would say the majority of Americans have zero trust in our medical systems at this critical time. I understand that this is a national crisis. Rapid movement is essential. But the old system did indeed manage rapid movement and expedited reviews all the time. I was there.
I am going to make a prediction. When the roll is called up yonder and this has passed us by, the term “Operation Warp Speed” is going to enter the infamous lexicon of “The Gulf of Tonkin”, “Gallipoli” and “Dunkirk”. I am also very confident that my profession is going to get a long-needed reckoning not unlike the Flexner Report of a century ago.
100% agree with you. Baby and bathwater thrown out.
We cannot afford to have this system become dysfunctional. It is about the protection of human subjects, first and foremost. The benefits of research must arise AFTER the Do No Harm principle is applied.
This national conversation is inspiring me to finally undertake a project I’ve been meaning to work on: a sort of novelized look at the Belmont Report (link for those unfamiliar), delving into the drama that caused it, the players involved, and the eventual production of the report.
We’re straying from our source material in this country, and it’s scary. Maybe it’s time for a reminder of why we did all this in the first place.
I still remember when we were all awaiting DHHS’s reforms of the IRB review criteria for expedited and exempt studies. When the rule change came through, it was an absolute disaster and implementation took another two years. It’s leveled out somewhat, but that was under the Obama administration, which supposedly was forward-looking in terms of managing the bureaucracy. A local IRB I contract with for administrative purposes is STILL smoothing out the 2018 rule change.
There is a paper linked to by the Dark Horse folks, an investigation of the first 250 vaccine deaths reported into VAERS. Investigators tried to nail down what actually happened to these people (well, other than “they died”).
Most reports were from people associated with the health care industry, so it wasn’t random folks stuffing noise into the system. For the over 65 age group, 50% of deaths occurred within 48 hours of vaccination, so pretty clear what happened there. In fact, only about 20% of the deaths could be clearly found NOT to be from the vaccine. Also, the Doses Per Death has fallen from about 220million doses for one death, down to about 5million. Huh. This sudden drop began in 2018, so something other than COVID maybe going on there.
You would think data like that would lead someone at the FDA to see what might be going on there. Apparently not. According to the Dark Horse pair, even though only about 20% had either COVID positive tests, or symptoms, the reg agency has logged them all (all 250) as COVID deaths.
Way to make us believe in your data.
Paper is here
https://www.researchgate.net/publication/352837543_Analysis_of_COVID-19_vaccine_death_reports_from_the_Vaccine_Adverse_Events_Reporting_System_VAERS_Database_Interim_Results_and_Analysis
I appreciate the research and analysis presented here, and just have one question. As a layman trying to understand this and cut through all of Pfizer’s goal-seeking, weaseling and obfuscation, under what conditions should anybody get their vaccine? The disconnect between the mainstream discussion of the mRNA vaccines and what I’m learning on NC has become bewildering. Thanks.
We don’t give medical advice. And mRNA vaccines are not in the only choice.
Our beef is the overselling of the vaccines, not the vaccines per se.
Yes, makes sense. Alas, where I’m based mRNAs are the only option,
I’m a doctor from New Zealand, where mRNA vaccines are the only option. I’m not going to be vaccinated for the following reasons: (a) high numbers of deaths from vaccines recorded in UK yellow card, eudravigilance and VAERS reporting systems; (b) low death rate from Covid unless you are in certain age groups (i.e. very elderly / many co-morbidities); (c) safe and effective alternatives such as ivermectin. Since safety trials have not been completed and we have no idea on long term effects of these vaccines it’s just not worth the risk for me.
I just finished reading the book , Calling Bullshit, by Carl T. Bernstrom and Jevin D. West. I lost track of how many times while reading I would stop and my mind drifts back to articles posted on the NC website, the incredibly clear and thoughtful comments posted by IM Doc and so many others.
I cannot express enough my appreciation for this site in helping me (and many others I’m sure), cut, or at least be mindful of, all the Bulls**shit that is absolutely swamping us in all forms of media today. Especially that unleashed by our so called leaders.
Thanks again!!
I swear to god that as I was reading this and was about halfway through this post, a musical track started to kick off in the back of my mind-
https://www.youtube.com/watch?v=l8WMGBuNaus (2:50 min)
If I am reading this right, they are dangling the bait of being protected form a bout of Coronavirus in front of people to get them to join. Desperate people in fact. And they aren’t even offering them real money as an inducement either – just pocket money for expenses. And I am seeing the use of weasel words like ‘may’ to give themselves some wiggle room legally. Frankly I am surprised that they don’t have a passage that states that your d*** could fall off and they would not be liable. I have heard a lot of bad things about Pfizer so if this is the sort of stuff they used to have their vaccine tested, I am not surprised that they demanded that the Federal government give them full immunity in case of adverse side effects.
It’s interesting because exculpatory language is not allowed in an informed consent form:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/exculpatory-language-in-informed-consent-documents/index.html
This is old guidance. It’s an established bit of practice that if you’re the entity performing the trial, you’re responsible.
Coming to this very late. Was a lawyer for a decade before switching to tech over 20 years ago, so I couldn’t ignore it.
Stuff like this reinforces my belief that “free legal services as a right” should be a thing. The world has become too complex for to be left to muddle through on their own, especially when the results could be deadly.
As a lay person for so many years now, I’m finding the bare text of this document pretty shocking AND damning of our hopelessly captive regulatory system. That’s by comparison with the overtly self-serving language in most software licenses. Leads me to think that the anti-maskers aren’t the only threat to our survival out there. But I guess NC readers already knew that.
I’m wondering about something–could I just go in and get a third shot if I felt like it? Who would know I already had two shots?
My health system would know, since that is where I got the two shots, but if I went somewhere else, say Walgreens (and lied, of course), would they have any way to check my prior shot status?
Normally my health insurer would know and would not approve another shot, but I’m not sure the Covid shots were paid through my insurer–I never received a statement showing no balance due (can’t remember if I get statements from the insurer for the annual flu shot, but I think I do).
Not suggesting it would be a good idea, since side effects unknown, but how are providers being reimbursed for the free at point of delivery Covid shots?
WE DO NOT GIVE MEDICAL ADVICE! And the third shot clinical trials haven’t been completed. But we will learn something from Israel starting third Pfizer shots on old people.
When I went through the ridiculous process of getting a shot at Publix, it was weirdly easiest for the aide with no insurance, since they then would go to the Feds for reimbursement. If you have insurance, they will ask for that info and seek reimbursement.
I got the J&J shot back in april and I’ve been thinking of getting the Moderna shot too, if only to avoid long covid / to get a new vaccine card as I lost mine within an hour of getting it. You can always say you don’t have insurance and go to a drugstore that doesn’t have your info on file. Makes me wonder how many people have also done this.
I got the J&J vaccine and did this. I went to a public vaccine clinic in another state and put down that I didn’t have insurance. I did use my real name and address. No one knocking on my door the last few months.
Ethically, that “booster” Moderna vaccine I got was going to be thrown out anyway because it was near expiration and the state government was eager to get rid of them.
*This is not medical advice.*
Duh. Not surprised really. The drive to outsource the testing to private agencies is strong. Here in the CZ, it was quite a scandal few months back when the then health minister (fourth in a row, now we’re not on the fifth because we run repeats – the first one is back in) was found to made his fortune by taking the testing from the uni hospital he was CEO of to his private company, claiming it’s “not making money” when the uni before then made tons of money out of it.
The incentives there are just so f-ked up… One wonder when we’ll get the next thalidomide this way, because IMO it’s just a question of time, unfortunately.
I went to high school with a Thalidomide baby. Nice girl and smart as a whip.
However, as nice as she was, the other kids kept their distance. I suspect that they were creeped out by the fact that she only had one complete leg. She had arm stumps to which prosthetic limbs were attached, and a leg stump to which another prosthetic was attached.
This has all the earmarks of what happened between the big banks and the ratings agencies in the lead up to the financial crisis. There was really no independent review going on and the dreck was shoveled out the door rated AAA.
From IM Doc:
“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.”
Why are “for profit” entities even allowed to be involved in medical trials.
“If Pfizer wants to calm concerns about possible reproductive risk from taking its Covid vaccine, this is not the way to go about it….”
Less than a year of mass use. Is it really a good idea to give shots to all women of child-bearing age, and get rid of any possible control group, until more data about effects?
I voluntered for the Moderna study when they needed geezers in March 2020 when this all began. I got the placebo, but have since been fully vaccinated. I read the full consent doc and had no problems with it. Plus we got paid on a debit card and still fill out a weekly diary.
Maybe not perfect but much more homorable than Pfizer.
I heard from one source that when the study ended and the placebo people needed shots the gov (NIH? CDC?) told both Moderna and Pfizer to just “throw them back into whatever part of the line they belong in”. Pfizer said “OK” but Moderna objected on moral grounds – they had promised to give the vaccine to the placebo people as soon as possible. The gov said “Do what we told you”. Moderna said “OK, but I hope you don’t mind if we hold a press conference to explain this to are participants”. The gov changed its mind and we got the shots. I was very tired for two days after the second shot but no other side effects.
Thank you for this article. I sent it to my mother, and it finally clicked with her what I’ve been trying to explain/argue for months. It was like the balloon finally popped. She said to me “What’s the point of a review if the company throws out any data not favorable to their cause? Really scary. So who do you get a trustworthy vaccine from?”
Maybe she needed to hear it from someone other than me. As long as it got through, I guess.
It’s not “throws out” but “can throw out” and there does not appear to be any check to prevent them from doing that.
Survival of the Prickest?
It seems like this study will take one year to complete. So, around July 2022 is when they they will determine if a booster dose is needed and what potential side effects result. Meanwhile, Israel and other countries are already suggesting booster doses for at least the elderly and immuno-compromised. How are booster doses being given while the pharmaceutical company is just starting to research the need, effectiveness and potential side-effects of these additional doses? Are they also covered in the EUA? Doesn’t the pharmaceutical company at least have to apply for the need for additional doses? Like make some kind of argument or application to the FDA for approval? From a lay person’s perspective, it seems like these governments are making this decision on their own, and then telling the pharmaceutical company to research it to make sure it’s the correct decision in hindsight. Am I missing something?
No, you are not interpreting this correctly. Participants will be in the study a year. That is not the same as the time it takes for Pfizer to generate enough efficacy data to go to the FDA and get a booster authorization and flog study results.
As you can see from Dave in Austin’s comment above, he is still giving data to Moderna for a clinical trial that started in March 2020 and the results were presented to and accepted by the FDA before the end of 2020.
Thanks for the clarification! There is so much information to digest, and it’s also constantly changing. I think I’m suffering from information overload.
“I think I’m suffering from information overload.”
I know what you mean. I consider it an occupational hazard of being a regular reader of NC — a more-than-acceptable tradeoff, given that the overload would be totally incapacitating without it.
How can the timeline for this 3rd dose trial ethically ‘inform’ 3rd vaccinations for anyone who’s not part of the first 10,000 cohort (of which only 5,000 received the actual vaccine)? Hypothetically if the FDA gives full use authorization for Pfizer’s COVID-19 vaccine in September there will have been very little time for data collection and analysis for the 3rd dose. My concern is the full approval for doses 1 and 2 will be conflated with the booster dose. For anyone who was vaccinated in early 2021 there’s no way in hell that a 3rd dose should be deemed safe and mandated on September-October timescale. Also the 3rd dose trial size (5,000 vaccinated and 5,000 placebo) isn’t large enough to catch adverse reactions, e.g. “Rare (between 1 in 1,000 and 1 in 10,000 people): swelling of the face or lips”.
Huh? We wrote up the original Pfizer trial. There were nearly 40,000 participants, so >16,000 who got the shot.
Second, you don’t need to have been in the original trial to be in this study. You just need to have been previously vaccinated with two shots.