VRBPAC -- Is this the best that FDA can do in terms of Advisory Committee members and process?
There is a need for fewer self-congratulations, and more honest introspection
Background
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) specializes in vaccines. By vaccines, I do mean traditional vaccines like the influenza vaccine. They met on the 6th April 2022.
For those of you who are new to the regulatory sciences, the FDA has quite a number of Advisory Committees. They exist to assist the FDA in making the best decisions for the different types of therapeutics it regulates. The process of regulatory review in the US is supposed to be transparent, and for this reason, it is possible to watch the Advisory Committee meetings online at the FDA website and/or on YouTube.
There were about 20 advisors at the VRBPAC meeting on 6th April. I noted with surprise that there was not a single expert who had expertise in experimental genetic therapies. This had implications for the quality of the discussions, decisions and advice given to the FDA by the Committee.
As I watched the proceedings, I could not help thinking, it is not always what you know, but who you know. These experts all have very impressive titles, and all work for important hospitals, universities and other institutions. However, I could discern a mis-match between their considerable expertise in traditional vaccines, and the experimental genetic injections that they were discussing. Again, I stress that not one of the committee members had substantial expertise in gene-based injections. They consistently referred to the experimental genetic injections as vaccines. This is worrying, because they are approaching these experimental injections like they would approach the influenza vaccine. Indeed, many of them have experience with the influenza vaccine, and clearly consider the influenza vaccine an important point of reference, and template.
Here is the link to the meeting. I will show the link below a couple more times.
Here is the link to the briefing materials for the meeting.
Conflicts of Interests
Rules about Conflicts of Interests exist for a very good reason. There is a lot of research in the business world around the impact of conflicts of interest on decision making, and behavior. We have seen the adverse influence of conflicts of interest on medicines research in the past. When Jessie Gelsinger died while taking part in a gene therapy clinical trial, the investigation discovered that there were numerous conflicts of interest [1].
When clinical investigators are contracted to take part in, and oversee clinical trials, they have to declare conflicts of interest. Yet, approximately 50% of the Advisory Committee were given waivers for conflicts of interest. Furthermore, by the time individuals sit on this type of Committee, their children are usually old enough to purchase stock, yet they only have to declare conflicts for minor children. That a significant proportion of the Committee are conflicted puts into doubt the ability of the VRBPAC Committee to make decisions, and provide advice, in a non-biased way. Conflicts of interest matter. I know that. You know that. Why does FDA not know that?
Overview of the Committee Process
The meeting started out with FDA reviewers making slide presentations. If you like to watch and listen to speakers presenting in a monotone, without any energy, and reading a script, for fear of saying something that could get them into trouble, you will enjoy the start of the VRBPAC Committee meeting.
Unfortunately, a lot of what was presented was not necessarily up to date with the current understanding of what is taking place on the ground, in the US, and in other countries. It was far too retrospective. The presentations and discussions were therefore mis-matched to our understanding of the scientific literature at this current time. That was a missed opportunity for the FDA speakers and Committee members.
Another good aspect of an open FDA Advisory process is that we can hear the thought process of the Committee members. Now that I have heard their thought process, I can begin to understand why we are in the mess we are in.
In an 8 hour meeting (with breaks), they failed to address the lack of efficacy and safety of these experimental genetic injections, in any real way. They spoke about variants without addressing the fact that the roll out of these injections during an ongoing pandemic is what spawned the creation of the variants, and what will continue to spawn new variants [2].
Many of the Committee members are academics; that their discussion points could at times be theoretical and airy fairy was not a surprise. However, that they ignored so many aspects of what is going on in the real world was inexcusable.
They ignored the fact that people have been coerced into taking unsafe experimental injections to keep their jobs. They failed to make clear that no one should be coerced to take any medicine, much less one with such a poor track record on safety. The reason that they failed to make this clear, is that they consistently parroted the mantra that the injections are safe and effective.
There was no discussion of the article in the BMJ regarding the fraud in the Pfizer clinical trial [3]. If fraud occurred in the Pfizer clinical trial, and there is strong evidence that it did, then it likely occurred in other clinical trials run by other manufacturers. The clinical data produced from these clinical trials should be viewed as unreliable, yet they persistently referred to these clinical data. Any study that involved the unblinding of research subjects and/or staff should be thrown out, not put on a pedestal for evidence purposes.
Click on the link below to watch the video.
Link to the briefing materials for the meeting.
Statements from the General Public
As with other Advisory Committee meetings, the general public can apply to make oral statements. We therefore heard from external experts (see from 5 hours 12 minutes), including Dr. Jessica Rose, as well as a few of the people whose lives have been destroyed by the experimental genetic injections. All statements were powerful, but the statement made by Andre Cherry, a young man seriously injured by the injections, made my eyes tear up. Don’t miss his powerful call to the Committee and FDA to do their job and protect the public from these dangerous experimental genetic injections (6 hours 7 minutes in).
After all the statements from the injured, the meeting was handed over to Dr. Mantel, the Chair (6 hours and 24 minutes in). He continued with the meeting as though nothing had happened (6 hours and 25 minutes in). He did not even acknowledge the injured who had poured their hearts out. I had to watch that segment a couple of times to make sure I had not missed a statement from him. Nothing. Nada. Niente.
It is a travesty that Dr. Mantel didn’t even say he was sorry to hear of their suffering. The Committee members were going through the motion of listening to the public, but they didn’t hear a word that they said. Let’s face it, the injured are inconvenient, and they are telling an inconvenient truth.
Link to the briefing materials for the meeting.
Below I make some recommendations for the Committee composition, and the process. They should be obvious, but I will make them anyway.
Here are my concerns from yesterday’s meeting:
The VRBPAC members advise from within a bubble. They do not perceive that we are in a mess.
The meeting lasted 8 hours and 46 minutes including the breaks, and I am unclear on what, if anything at all, was achieved.
Meeting without addressing the real issues of safety and lack of efficacy was a waste of everyone’s time.
They failed to acknowledge the lack of safety of the injections, except to excuse away the carnage that these products are producing. That is inexcusable.
They believe that the issue is getting more people injected with the experimental genetic injections. They emphasized this even after hearing from the people whose lives have been destroyed by the injections.
They wrongly referred to the number of people injured as rare. This is not correct. The VAERS database is under reported by a huge factor. We know that physicians are not reporting the serious adverse reactions and death, and yet we see a huge overload of reports even under these conditions.
The injured were of no importance to them. They failed to acknowledge them even after they heard their powerful statements.
VRBPAC should be more than a cheerleading squad for the FDA. Committee membership appointments are prestigious, and are therefore highly prized. The members spent a lot of time during the meeting congratulating each other and the FDA, instead of addressing the need for an effective strategy.
An effective strategy MUST include removing these ineffective and increasingly unsafe products from the marketplace, as soon as possible.
Patronization of the Injured
It was highly offensive to note that the injured were ignored, that is, until Dr. Fuller referred to the statement made by the injured (8 hours and 17 minutes in), and stated words to the effect that, the serious adverse reactions are rare. Dr. Fuller indicated that the same types of serious adverse reactions occur with influenza and other vaccines, and that the reason we are seeing so many with the COVID19 injections, is that there is a higher uptake of these injections than for influenza injections.
Dr. Fuller, Do you think we are stupid?
Dr. Fuller actually said words to the effect that the general public has to be educated to expect and accept injuries, because they occur with other vaccines. That is not how drug safety works, and these aren’t vaccines. Unfortunately, the level of discussion on the VRBPAC Committee did not rise much higher than this.
Discussion regarding Boosters
The Committee discussed the potential need for a Booster every 8 weeks. Yes, they acknowledged that the public would not accept Boosters at that frequency, but the fact that they would even consider it is troubling.
To justify the risks of repeated Boosters, they kept making blanket statements about the injections protecting people from severe disease. They did not reference any studies. I am not aware of any such well conducted studies to demonstrate the reduction in death or severity of disease. There is a lot of publicity about failed studies for Ivermectin and Hydroxychloroquine. Where are the data showing these injections protect against severe disease and death? VRBPAC - please provide these well conducted randomized double blind studies for the statements you threw around yesterday, presumably for the uninitiated members of the general public. Such statements are nothing but propaganda.
They referenced the need for data from ongoing clinical trials. I am shocked that anyone would enter such clinical trials. This leads me to believe that the informed consent forms are as deceptive as they were a year ago. People are being duped into taking part in these clinical trials. They are not being informed consented.
This Advisory Committee meeting failed to address numerous issues, including:
Why approximately 40-50% of the population will not take these injections, at all. They are lay people, PhDs, lawyers, scientists, and engineers, etc. They are not sitting goggle-eyed watching and listening to conflicted Advisory Committee members spouting out propaganda.
Why the number of people taking these injections and Boosters, is dropping. The number is dropping due to injuries, lack of tolerability with increasing doses, and the fact that people have access to information that helps them to make up their own minds.
Why the percentage of people taking the Boosters is much reduced over those who took the first two injections. They kept referring to the need to educate the public. This type of statement is increasingly offensive and patronizing.
The illegality of mandating these products. They fail to acknowledge that one size is not appropriate for everyone. They failed to address the importance and imperative of informed consent.
The continuing, and increasing lack of efficacy of these experimental injections with repeated boosting. There is a clear tolerance effect (the efficacy is decreasing rapidly with repeated dosing). Ultimately, the injections would need to be administered frequently, and for what? Ultimately, the immune system would be wiped out, not to mention the destruction of organ systems due to autoimmune effects.
The need to provide support and help for the injured. Dr. Fuller also said the effects of COVID19 were worse than the effects of the experimental genetic injections. Even if that were the case, which it is not, for the vast majority of people, she has again missed the point. A medical product should not destroy the lives of the healthy. This has never been tolerated in the past, and should not be tolerated now.
The elephants in the room
The Committee failed to address the issue that the Sars-Cov-2 virus is a bioweapon, and that the Spike Protein in the experimental genetic injections is toxic to the human body.
The Committee members referred to COVID19 as a Pandemic. Many countries are now considering COVID19 to be endemic. The UK is living with the virus like the flu, but in the US, the FDA and other stakeholders appear to intend to keep this crisis ongoing into perpetuity. Consequently, they referenced the need to prepare for Autumn. As autumn approaches we can expect to face an onslaught of propaganda, with threats of lock-down, unless everyone is injected.
Fear will be ramped up to levels that will force the vulnerable and uninformed to comply to take the umpteenth injection, regardless of the consequences.
They even referenced the continuing efficacy of these injections in protecting people from severe disease. Where are the studies to demonstrate this protective efficacy? There aren’t any. These are like the statements that the injections are safe and effective. These statements are nothing more than propaganda, wishful thinking and lies, unless they are backed up with data from well controlled studies. They also perpetuated the lie that it is the unvaccinated who are ending up in hospital and dying. They provided no context or data for this.
The Committee members barely noted the failings of these products. Their focus was upon using influenza virus as a template for how to manage Booster doses. Yet, one of the elephants in the room is that these are experimental gene therapies, and not traditional vaccines.
Dr. Marks stated we want people to remain confident in the safety of the Boosters. It is a wonder no one laughed out aloud. He also stated that the goal is to reduce the toll of disease and death. What about reducing the toll of death from the experimental genetic injections, Dr. Marks?
My personal conclusions and recommendations
A Committee that does not raise and seriously consider the withdrawal of the experimental genetic injections based on the lack of efficacy, diminishing returns and safety concerns, is not fit for purpose.
The VRBPAC Committee lacks credibility due to the conflicts of interests of at least 50% of the members. Conflicts influence advice given to FDA, and that advice is not serving the American people well. The products that they have endorsed have destroyed, and are destroying, the lives of so many people, throughout the US, and the world.
Every single VRBPAC Committee member that has been involved with the disastrous roll out of these experimental genetic injections should be rolled off the Committee. They have failed in their duty of care to protect the American public.
A smaller Committee would be better to address the issues. Because the Committee is so large, each expert has a limited amount of time to raise issues. When issues are raised, they tend to be dismissed if they are inconvenient. What a waste of a Committee meeting!
Committee experts with no relevant experience in the development of experimental genetic therapies should be rotated off the Committee.
The Committee suffers from the lack of drug safety experience expertise, including how to review and analyze safety signals that are coming to light every day.
The Committee ignored the importance of natural immunity [4].
They missed an opportunity to invite experts who could present the analyses of the safety data in the VAERS database. Why are decisions being made without reference to these data, as well as data from other countries (UK - Yellow Card, EU - Eudravigilance)?
In my view this Committee has failed, and will continue to fail, not always because of the Committee, but because the CDC does not listen to them, and FDA uses the Committee like a cheerleading squad. They regard membership of this prestigious and high profile committee as too important to risk being removed by speaking truth to power.
References
Kim JS. Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology. J Korean Med Sci. 2017 Dec;32(12):1910-1916. doi: 10.3346/jkms.2017.32.12.1910. PMID: 29115070; PMCID: PMC5680487.
Dr. Geert Vanden Bossche’s statement - click below to read.
3. Paul D. Thacker, Investigative Journalist. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ2021;375doi:https://doi.org/10.1136/bmj.n2635(Published 02 November 2021)Cite this as:BMJ2021;375:n2635
4. Jennifer Block. Freelance Journalist. Vaccinating people who have had covid-19: why doesn’t natural immunity count in the US? BMJ2021;374doi:https://doi.org/10.1136/bmj.n2101(Published 13 September 2021)Cite this as:BMJ2021;374:n2101.
As always, you are encouraged to seek medical advice for your own personal situation. Whatever you read here, should not take the place of your own personal consultation with your qualified and competent medical advisors.
This is great. Thank you!!! 🙏🏽❤️
Having listened to these meetings, as well as the CDC ACIP committee meetings for several years, this is standard practice for them. I spent the time listening to the injured speak their statements and thinking to myself, “I bet they’ve all left the room and aren’t even listening since they’re not on camera.”
Not a single one of them represents the interests of the public. They’re in position to see how much they’ll benefit from holding the seat. It’d be laughable to think they actually care, if it wasn’t so damn obvious how sadly tragic it all is.