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.
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.
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.
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 form
Hot-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.