Hearing on the Hill Puts Feds on the Spot--Enormous Mistakes, Overreach & No Readiness for the Masses of Injured

The Select Subcommittee on the Coronavirus Pandemic hearing titled “Assessing America’s Vaccine Safety Systems, Part 1” examined the effectiveness of vaccine safety reporting and injury compensation systems after the rollout of the COVID-19 vaccine. Biden Administration officials from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Health Resources and Services Administration (HRSA) all testified that America’s vaccine injury and compensation systems have serious deficiencies related to inadequate staffing, lackluster surveillance, and overlapping programs.

Select Subcommittee Members were adamant of a false narrative: that rather than the safe and effective mantra touted over and over by health agencies, industry and the medical establishment, the efficacy of the COVID-19 vaccine was in question. They in some cases pressed witnesses aggressively to explain potentially politically motivated decision-making during the pandemic. In other ways, the event seemed like a COVID-19 kabuki.

TrialSite was one of the few media to announce the event in advance, one that Brad Wenstrup (R-Ohio) Select Subcommittee on the Coronavirus Pandemic Chairman, D.P.M., helped to organize.

Importantly, the Republican-led subcommittee sought out representation of patient groups. For example, Brianne Dressen, founder of React19, the largest COVID-19 vaccine injury group in the U.S. was in attendance and allowed to submit questions.

This first hearing was deemed part one of a two-part series of hearings. The second hearing focuses on the importance of the doctor-patient relationship in order to obtain public trust in vaccines during a future public health crisis.

Summary

In a nutshell, the Committee on Oversight and Accountability reports that the Biden Administration made the reckless move of mandating the COVID-19 vaccine less any kind of working system in place to compensate individuals injured by the policy.

Highlighting just how badly inadequate the government was to deal with any sort of vaccine-related injury HRSA Director at the Division of Injury Compensation Programs CDR George Reed Grimes: “At the beginning of the COVID-19 pandemic, we had not had a direct appropriation with the CICP. We also had only four staff.”

The hearing was also political kabuki for Republicans. They conveniently focus only on the Biden part of the COVID-19 history, excluding the Trump administration’s role in a reckless, relentless race to produce a vaccine first—TrialSite covered how various steps in the standard drug/vaccine development process were bypassed such as IND-enabling preclinical studies and the unreasonably compressed timelines (remember the AstraZeneca study) as examples.

In the hearing, the parties rather started with how the FDA accelerated the COVID-19 vaccine approval process to seemingly meet arbitrary mandate timelines set by the Biden Administration. This precedent was established by the Trump administration.

Executive branch officials from the CDC and FDA did express an accord that the federal government can never guarantee a vaccine is 100% safe. And of course, vaccines are public health tools involving tradeoffs, involving risk-benefit analyses.

Chairman Wenstrup asked: “Is any pharmaceutical 100% safe?”

FDA Director at the Center for Biologics Evaluation and Research, Dr. Peter Marks produced the honest answer: “No pharmaceutical is 100% safe.”

CDC Director at the National Center for Emerging and Zoonotic Infectious Diseases, Dr. Daniel Jernigan: “No medical intervention is risk-free.”

CDR Grimes: “There’s a reason we have a compensation program, and we’re dedicated to diligently carrying that out. I can’t say it any better than my colleagues sitting next to me have.”

Importantly, TrialSite has reported consistently how the U.S. federal government under both the Trump and Biden presidencies completely dropped the ball when it came to planning for the inevitable injuries that would present after the cranking out of a vaccine in such record time.

Is it a surprise to anyone that vaccine injury reporting and compensation systems were not prepared to handle what was described at the hearing as an “avalanche” of injury claims caused by the COVID-19 vaccine?

The FDA’s Dr. Peter Marks:“We tried to be prepared for that, but the avalanche of reports was tremendous. It, again, required re-tasking people on the fly…We had to usually staff up and had many meetings working to increase our ability to go through these reports.”

Not surprisingly, at times the politicians in the room used the forum for grandstanding, not intelligently delving deeper into what kinds of shortcuts the Trump administration allowed or looked the other way during Operation Warp Speed.

The Committee on Oversight and Accountability derived the summary: “Shortcomings in vaccine injury reporting and vaccine compensation systems, as well as ineffective government messaging during the pandemic, deteriorated public trust in vaccine safety.”

Dr. Peter Marks: “We probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus what’s in VAERS.”

Of course, not all reports in VAERS are related to the vaccines. However, the magnitude of problems associated with the system, given the “avalanche” of vaccine injury reports, necessitates its investigation plus call for reform.

Member Highlights

Brad Wenstrup organized this event and during the hearing, argued that advancing an accurate narrative about the COVID-19 vaccine through doctor-patient relationships during the pandemic would have decreased misinformation and disinformation.

Chairman Wenstrup: “I want everyone to understand, especially those serving on the government side that the public perception becomes reality. And because of that, words matter. Words matter that are coming out, you know. For those of us as Members of Congress or as physicians at home, we’re face to face with people. We are sitting face to face with somebody. We’re not just looking at data on a sheet and making decisions. It needs to be done, what you’re doing, but there’s a difference and that’s why I say words matter. Let me give you an example. When you say safe and effective, that’s relative in your mind. It’s relative in your mind, but it’s not to the person at home. They hear 100% safe and 100% effective. That’s what they hear. This is why words matter. Dr. Fauci, in his testimony, even said, you can never say that any treatment is 100% safe. Yet, in essence, that’s what people heard and are still hearing today. We’ve got to change that because the doctor on the ground or the Member of Congress on the ground is one one-on-one with somebody and explains that to them.

…

“Let me tell you, I’m grateful we live in a country that has these systems (vaccine injury reporting and compensation systems) in place because they’re there to protect the American people and to provide for better health in America. But there are ways we can do better.”

Committee on Oversight and Accountability Chairman James Comer (R-Ky.) pressed FDA Director Dr. Peter Marks to admit he ignored warnings from his colleagues about the dangers of accelerating the COVID-19 vaccine approval process. Chairman Comer further noted that the timing of the Biden Administration’s vaccine mandate and the FDA’s rushed approval of the vaccine appear to correlate. See the link.

Chairman Comer: “Why were you pressuring the doctors and then removing them from the approval process when they disagreed?”

Dr. Marks: “The approval process was one that needed to move as rapidly as possible.”

Chairman Comer: “Do you recall any conversations regarding the need to approve the vaccines in order for it to then be mandated?”

Dr. Marks: “There was an acknowledgment that an approval could allow vaccine mandates to occur.”

Chairman Comer: “So, Dr. Gruber wrote that you and Dr. Woodcock expressed your opinion that absent a license, states cannot require mandatory vaccination. Do you recall this conversation?”

Dr. Marks: “I don’t know what you’re what you’re referring to, but there’s probably, it’s just a statement of fact that once you have a license, vaccine and mandate could be placed.”

…

Chairman Comer: “Do you recall seeing safety signals regarding myocarditis in young men during this time?”

Dr. Marks: “There were yes. There were safety signals known and they were placed on the label.”

A notable admission given Marks was for accelerating the approval by August 20; the eventual approval came three days later on August 23 and coincidentally the Department of Defense’s vaccine mandate occurred according to the exchange on August 20, 2021. On the timing Comer declared, “And that is interesting.”

Rep. Rich McCormick (R-Ga.), M.D., argued that the federal government wrongly inserted itself in the doctor-patient relationship during the COVID-19 pandemic. In actuality the feds extended their reach much more than that, working to censor doctors indirectly via pressure on the National Association of Medical and Pharmacy boards as TrialSite chronicled.

Overall, this “overreach” created a lack of trust between Americans and their public health system.

Rep. McCormick: “When you insert yourself between a doctor and a patient, and some doctors contradict you and you censor them, even when you’re not a doctor treating patients, people are going to say, why does the government have authority to do that, to censor my doctor? And then secondly, when you start requiring people to do something instead of encouraging the natural resistance of a freedom-loving people that were founded on those principles, will be to resist what you’re requiring. So, it shouldn’t be any surprise to us when the people say, I’m not going to do what you’re telling me I have to do when my doctor may agree with me and not you. You’re the government. Why do they insert themselves in inappropriate ways?

“And really, when we talk about the evolution of science, when you have immunity and you’re still requiring a vaccination that can cause a hyper-immune response, which we’re all scientists, we can admit to, there’s risk versus benefit on every decision. When the government says we’re going to make a carte blanche requirement without taking science into account, it’s no wonder people are mistrustful of our recommendations.”

Rep. Debbie Lesko (R-Ariz.) demanded FDA Director Dr. Peter Marks explain why the publicly reported data on vaccine injuries differs significantly from the confirmed death and injury count available to FDA officials. See the link.

Rep. Lesko: “We spoke over the phone back on August 10th of 2021, and I was asking about VAERS because I had lots of constituents reaching out to me saying there were tons of adverse effects, there were thousands of deaths, etc., and they were very concerned. And I asked how many were confirmed. And at that time, you said four. There were four cases that you confirmed deaths that were caused by the vaccine. I suggested, at that time, that the CDC and FDA do a better job of telling the public not just how many cases were reported, but how many were actually confirmed. And just if I heard you right, just recently, you said, well, we don’t want to give out too much information because of privacy rights. But certainly, we could put out how many were confirmed deaths, couldn’t we?”

Dr. Marks: “I fully agree with you that we probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus what’s in VAERS. In fact, we just nearly fell prey to it here at this hearing.”

Rep. Lesko: “It seems very logical to me that if you’re saying the public shouldn’t count on VAERS because anybody can report to that, which they can, why wouldn’t you as actively report to the public — well, we confirmed this really low number of cases that actually were caused by vaccines. I mean, it’s been years now. Why? Why haven’t you done it?”

Dr. Marks: “We did present that in various settings, including at, I believe, at the Advisory Committee on Immunization Practices. It was mentioned at our vaccine advisory committee. It perhaps did not go as broadly.”

Rep. Mariannette Miller-Meeks (R-Iowa), M.D., uncovered evidence that the COVID-19 vaccine was mandated for healthy Americans and U.S. service members without a sufficient system in place to compensate those harmed by the coercive policy.

Rep. Mariannette Miller-Meeks: “I understand that there’s a current backlog of claims in CICP, by about more than 10,000. Why is there a backlog of claims for the COVID-19 vaccines?”

CDR Grimes: “At the beginning of the COVID-19 pandemic, we had not had a direct appropriation with the CICP. We also had only four staff. When we received our first direct appropriation in fiscal year 2022, we were able to ramp up quickly and now we have over 35 staff who are assisting to adjudicate claims.”

What have we learned from the COVID-19 pandemic? As healthcare itself became politicized and used by warring factions over access to power and money, the people generally suffer as a result. In a democratic society usurped by pecuniary interests, one normalizing the power of money over all else, little will likely change.

https://www.trialsitenews.com/a/hearing-on-the-hill-puts-feds-on-the-spot-enormous-mistakes-overreach-no-readiness-for-the-masses-of-injured-d5130c64

*************************************************

Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

*********************************************************