https://www.nakedcapitalism.com/2021/08/sloppy-pfizer-booster-clinical-trial-consent-form-provides-way-to-exclude-reactions-that-require-emergency-care.html"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."
"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."
"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 "
much more
https://www.nakedcapitalism.com/2021/08/sloppy-pfizer-booster-clinical-trial-consent-form-provides-way-to-exclude-reactions-that-require-emergency-care.html
