What Does It Take to Get a Harmful Drug Off the Market?
Over a million VAERS reports and evidence of incredible harm isn't doing the trick.
Please meet my friend Carolina Bourque, a Louisiana research scientist who was severely injured following covid vaccinations. During our conversation, Carolina tells us what life was like before and after the covid vaccines, how vaccine injury has affected her work, the financial burden her injury has caused, and the lawsuit recently filed by the Informed Consent Action Network (ICAN) on her behalf.
We recently shared interviews with two other Louisiana residents who have experienced severe vaccine injury following covid vaccination: Angelia Desselle and Alicia Smith. Alicia Smith is a plaintiff along with Carolina in the ICAN lawsuit, which challenges the constitutionality of the immunity from liability that the Public Readiness and Emergency Preparedness Act (PREP) provides to covid vaccine manufacturers, Pfizer, Moderna, J&J, and Novavax. ICAN states the PREP Act “basically provides a license to cause death with impunity” and the lawsuit “seeks to strike down portions of the PREP Act in order to reclaim Americans’ right to seek compensation with necessary procedural safeguards for their vaccine injuries.
The Plaintiffs demand, among other things, the right to due process protections such as adequate time limits within which they can sue, the right to see any evidence used against them, the ability to present expert witnesses, and the right to appeal an adverse decision. Basic hallmarks of the American justice system. If this suit is successful, the relief sought will apply to all COVID-19 vaccine injured individuals in the U.S.”
The PREP Act has compounded the devastation of covid vaccine injury by preventing just compensation for catastrophic injury AND it has allowed an incredibly unsafe product to remain on the market. If the responsibility of product liability remained with the manufacturer, this drug would have been removed from the market after only a few weeks, if not days.
We wish ICAN, Carolina, Alicia and all the plaintiffs in this historic lawsuit all the best!
A recurring theme in all of these tragic vaccine injury stories is how utterly broken the government programs are for recognizing and compensating vaccine injury. One of these programs is the Vaccine Adverse Event Reporting System (VAERS). The staggering number of covid vaccine injuries and deaths reported to VAERS has overwhelmed the already outdated and “clunky” reporting system intended to catch injury safety signals that otherwise go unnoticed when the free market indicator of product safety - litigation - is removed.
As a matter of fact, the British Medical Journal just published an investigational report detailing some serious concerns surrounding VAERS.
The report, titled “Is the US’s Vaccine Adverse Event Reporting System broken?” notes the CDC is profoundly understaffed to evaluate the formidable number of reports the agency has received.
“...The BMJ has learnt that in the face of an unprecedented 1.7 million reports since the rollout of covid vaccines, VAERS’s staffing was likely not commensurate with the demands of reviewing the serious reports submitted, including reports of death. While other countries have acknowledged deaths that were “likely” or “probably” related to mRNA vaccination, the CDC—which says that it has reviewed nearly 20 000 preliminary reports of death using VAERS (far more than other countries)—has not acknowledged a single death linked to mRNA vaccines.
Before the pandemic VAERS was receiving nearly 60 000 adverse event reports each year. A 2015 CDC article suggests that the agency had the capacity to request records for just a few thousand serious reports each year.3But in 2021 the total number of reports shot up to a million, and another 660 000 have been filed since. Nearly one in five meet the criteria of serious. This surge reflects the unprecedented campaign to vaccinate against covid-19—in the US alone some 675 million doses have been administered—and the vast majority of recent reports are related to covid vaccines. The CDC states that, “in the event of a significant increase” in VAERS reports warranting clinical review, the standard operating procedure requires additional CDC Immunization Safety Office staff to process cases.12
Freedom of Information Act documents seen by The BMJ suggest that Pfizer has around 1000 more full time employees working on vaccine surveillance than the CDC, despite the latter’s responsibility for handling adverse event reports on all products. The CDC didn’t provide The BMJ with specific numbers, instead stating that its staffing “reflects the needs of the office” at any given time and can range from “several dozen to hundreds,” including contractors and individuals reassigned “from across the agency.” The latest confirmed number of staff, as of November 2022—at the Immunization Safety Office, which houses VAERS—is 70-80 full time equivalent workers.
In comparison, a February 2021 Pfizer analysis of adverse event reports showed that the company had onboarded 600 additional full time employees to handle the volume and planned to employ a total of 1800.4 Pfizer didn’t respond to The BMJ’s requests for information on current staffing.”
Another revealing conversation about VAERS took place on Epoch Times’ American Thought Leaders when Jan Jekielek interviewed Jessica Rose, PhD., a research scientist who has been evaluating VAERS data since mid-December 2020. Watch the full interview HERE. Below is a short segment from the interview:
Dr. Rose states:
"If VAERS is a functioning pharmacovigilance database, then why isn't it being used as such by the owners of the data? Why is it independent scientists like me [that] are having to do this work and bring questions to the table? The onus is not on us to prove that these things aren't safe. The onus was never on us to do that. This is appalling. The onus is on them, the manufacturers and the regulators, to prove that they are. And they claim that they have done that, but they have not."
The V-Safe data mentioned in the interview was FOIA’d and evaluated by Del Bigtree’s Informed Consent Action Network (ICAN) and can be found on their website.
Just the data shown in the image above shows a cataclysmic number of reports to this V-Safe system which was also grievously inadequate for accurate reporting of vaccine injury in that it only provided a limited category of injuries to report. Untold numbers of injuries and deaths went unreported.
Are you wondering what it will take to get this unbelievably harmful drug off the market?
We are too.
We are hopeful that with the new Landry administration and very likely a new Secretary of Health at the Louisiana Department of Health in January 2024 that a common sense recommendation to avoid this drug will be made to all Louisianans.
And we are very hopeful that those injured by these “vaccines” will have a just verdict in the ICAN lawsuit and be allowed due process in a court of law instead of floundering in the abyss of a government compensation program.
I’m speaking in Lafayette at the Citizens for a New Louisiana’s “Secret Lunch” this Friday. Please join us! Get tickets by clicking the photo below.
Don’t leave your family and friends in the dark! Click the button below and share Braving Freedom! 🇺🇸
But wait, there’s more!
For a donation of $25.00, your name goes into a drawing for TWO fabulous autographed books: Lies My Government Told Me by Dr. Robert Malone (also authographed by Dr. Jill Malone) and I’m Unvaccinated and That’s OK! by Dr. Shannon Kroner.
Help us continue to help you! We are 100% volunteer, we do not get paid, but we volunteer our time and energy because we know it's critical to maintaining our liberties. We can't do it without your financial support!
Every $25 gets you one entry into the drawing, multiple entries allowed! (So a $100 donation would get you 4 entries.)