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--- covid-19_vaccines:covid-19_vaccine_trials [2022/03/31 08:49]
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+++ covid-19_vaccines:covid-19_vaccine_trials [2022/10/13 03:04] (current)
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 ==== Moderna Vaccine Trials ====
-[[Moderna]]
+[[:pharmaceutical_companies:Moderna]]
 [[https://www.nejm.org/doi/full/10.1056/NEJMoa2035389|Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine]]
 ==== Pfizer Vaccine Trials ====
 [[pharmaceutical_companies:pfizer|Pfizer]]
+  * Pfizer BNT162b2 mRNA vaccine [[https://restoringtrials.org/covid-19/|trial protocols and other details]].
+  * Pfizer trial [[https://t.co/4YJnjTfOyU|datasets in .csv format]].
 [[https://www.nejm.org/doi/full/10.1056/NEJMoa2034577|Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine]]
@@ Line 30: / Line 33: @@
 === Major Problems With Pfizer COVID-19 Vaccine Trials ===
-Though transparency was promised, Pfizer has never released the raw data from its trials. The FDA fought to keep the data collected by Pfizer that informed its decisions on vaccination hidden from the public for up to 75 years.
+Though transparency was promised, Pfizer has never released the raw data from its trials, which was called for in a Peter Doshi opinion piece in the BMJ. ((January 4, 2021 | [[:Peter Doshi]] | [[:BMJ]] | [[https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-we-need-more-details-and-the-raw-data/|Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data]]))
+The FDA fought to keep the data collected by Pfizer that informed its decisions on vaccination hidden from the public for up to 75 years.
   * Public Health and Medical Professionals for Transparency Documents ([[https://phmpt.org/pfizers-documents/|Pfizer documents released]])
@@ Line 67: / Line 71: @@
 The phase III COVID-19 vaccine trials were never set up to demonstrate reduction in serious outcomes or interruption of transmission of the [[:SARS-CoV-2]] virus.((October 21, 2020 | [[:Peter Doshi]] | [[:The British Medical Journal]] | Will covid-19 vaccines save lives? Current trials aren’t designed to tell us | [[https://www.bmj.com/content/371/bmj.m4037|doi: https://doi.org/10.1136/bmj.m4037]]))
-==== Regulator Concerns ====
+==== Problems in Animal Trials ====
+In a Texas Senate hearing, it was stated on record that animal testing of COVID-19 vaccines were stopped because too many of the animals were dying.((May 16, 2021 | [[Great Game India]] | [[https://greatgameindia.com/covid-animal-trials-stopped/|COVID Vaccine Trials In Animals Were Stopped Because They Kept Dying, Revealed In Texas Senate Hearing]]))
+==== Critical Data Concerns ====
+In a speech delivered at the [[:FDA]]'s Vaccines and Realted Biological Products Advisory Committee, [[:Mathew Crawford]] summarized flaws in both the COVID-19 vaccine trials by stating, "These trials never met basic standards of evidence."((April 6, 2022 | [[:Mathew Crawford]] | [[:Rounding the Earth]] | [[https://roundingtheearth.substack.com/p/vrbpac-presentation-the-ultimate?s=w|VRBPAC Presentation: The Ultimate Vaccine Red Pill Summary]]))
+=== Lopsided Data Exclusions ===
+The data exclusions in many of the trials (perhaps all that have been made public) outweigh all reported effect sizes calling into question the wisdom of ascribing any trust to the reports.((April 6, 2022 | [[:Mathew Crawford]] | [[:Rounding the Earth]] | [[https://roundingtheearth.substack.com/p/vrbpac-presentation-the-ultimate?s=w|VRBPAC Presentation: The Ultimate Vaccine Red Pill Summary]]))
+  * In Figure S3 of the J&J trial report, there were 96 participants prematurely withdrawn after receiving placebo as compared to 49 after receiving the vaccine, a statistically significant differential. There were 2101 other placebo recipients excluded from the placebo group relative to 2216 in the vaccine group.((June 9, 2021 | [[chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.nejm.org/doi/suppl/10.1056/NEJMoa2101544/suppl_file/nejmoa2101544_appendix.pdf]]))
+  * In Figure 1 of the Pfizer trial report, there were 95 participants in the placebo group who discontinued after receiving their second dose, but only 48 in the vaccine group.
+=== Lack of Transparency ===
+[[:Aaron Siri]] has documented how the [[:Food and Drug Administration|FDA]] has actively participated in obscuring data and documents related to COVID-19 vaccine trials.
+https://aaronsiri.substack.com/p/fda-doubles-down-asks-federal-judge?justPublished=true
+==== Regulatory Concerns ====
 An article was published in the British Medical Journal on March 21, 2021, 'The EMA covid-19 data leak, and what it tells us about mRNA instability' by Serena Tinari,((https://www.bmj.com/content/372/bmj.n627)) looking at some of the 40MB of data that was hacked from the European Medicines Agency and sent to the BMJ. Some of the leaked emails express significant concern, in late November 2020, about the stability of the mRNA found in the products, worrying about “truncated and modified mRNA species present in the finished product” that would compromise efficacy.
@@ Line 75: / Line 94: @@
 By late December, the Agency had decided that “the quality of this medicinal product (Comirnity), submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable.”((https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf))
-==== Lack of Transparency ====
-[[:Aaron Siri]] has documented how the [[:Food and Drug Administration|FDA]] has actively participated in obscuring data and documents related to COVID-19 vaccine trials.
-https://aaronsiri.substack.com/p/fda-doubles-down-asks-federal-judge?justPublished=true
@@ Line 91: / Line 105: @@
 ==== COVID-19 Vaccine Trials and Variants of Interest ====
 [[Mathew Crawford]] has [[https://roundingtheearth.substack.com/p/variant-roulette-evolution-and-immunity|noted the temporal and geographical coincidence]] of vaccine trial sites and emerging [[SARS-CoV-2 variants of interest]].
+==== Pfizer Informed Consent Documents ====
+Document Review by Naked Capitalism
+Sloppy Pfizer Booster Clinical Trial Consent Form Provides Way to Exclude Reactions That Require Emergency Care
+Posted on August 3, 2021 by Yves Smith
+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.((https://web.archive.org/web/20200929120116/http://www.careidresearch.com/documents/PoretzDonald_ConsentFormPhase23S3_37002669.pdf)) 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. ((https://web.archive.org/web/20220403034127/https://www.nakedcapitalism.com/2021/08/sloppy-pfizer-booster-clinical-trial-consent-form-provides-way-to-exclude-reactions-that-require-emergency-care.html)) {{ :covid-19_vaccines:pfizer_informed_consent_clinical_trial.png?800 |}}
+=== Pfizer Consent Form Too Obviously Not Reviewed, Let Alone Negotiated, by FDA-Designated Overseer, the Institutional Review Board ===
+Naked Capitalism con't
+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.
+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.
+=== 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.
+. 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.
+. 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((https://www.nakedcapitalism.com/2021/08/sloppy-pfizer-booster-clinical-trial-consent-form-provides-way-to-exclude-reactions-that-require-emergency-care.html))
+===== Meta-Analysis of COVID-19 Vaccine Trials =====
+==== Danish Study Comparing mRNA to Adenovirus-Vector Vector Vaccine Results ====
+In a study that went to preprint on April 5, 2022, researcher Christine Benn and colleagues point out that mRNA vaccines showed no reduction in mortality while adenovirus-vector vaccines showed substantial and statistically significant reductions in mortality.((April 5, 2022 | Christine Benn et al | preprint | Randomised Clinical Trials of COVID-19 Vaccines: Do Adenovirus-Vector Vaccines Have Beneficial Non-Specific Effects? | [[https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4072489|DOI?]]))