by Fed Up Texas Chick
The FDA has turned a simple and straightforward Freedom of Information Act (FOIA) request for Pfizer-BioNTech COVID-19 vaccine records into a 50+-year waiting game. To put it in perspective, Elon Musk would reach Mars way, way before the FDA would ever finish this task.
What was requested?
A Freedom of Information Act (FOIA) lawsuit was filed for documents tied to the approval of the Pfizer-BioNTech COVID-19 vaccine. The FOIA process gives the American public the right to request access to records from any federal agency. The law was put into place in 1967 to ensure that citizens remain informed about their government. Federal agencies must comply with the law by disclosing the requested information unless it compromises things like personal privacy or national security. There are nine exemption categories in all.
On an interesting side note, FOIA also requires federal agencies to post frequently requested information online, again unless it compromises one of the nine exemption categories.
Who requested the information?
The FOIA request was originally made by a group of doctors and scientists known as the Public Health and Medical Professionals for Transparency (PHMPT) group. PHMPT comprises an esteemed group of over 30 scientists and physicians, including Yale professor Harvey Risch, who has been a consistent voice of common sense during the pandemic. After the FDA denied the original request to expedite record release, PHMPT filed a lawsuit. Here’s the link to that lawsuit if you want to review it.
Like any federal agency, the FOIA mandate states that agencies should rarely withhold information unless it violates one of the aforementioned nine areas, or if for some reason disclosure of such records is prohibited by law. Federal agencies should always consider partial disclosure. In the case of the FDA’s holdings of Pfizer records, neither of these special cases applies.
Did FDA Comply with the FOIA request?
Well…sort of. While the FDA has no choice but to comply with the law and release these records to the American public, that doesn’t mean the agency wouldn’t try to use other tactics or perhaps slow roll the effort. And sure enough, that is what happened. The Department of Justice (DOJ) Office of Information Policy is in charge of FOIA and issues guidance to all other federal agencies.
As such, DOJ lawyers representing the FDA asked a federal judge to allow until 2076 to fully release the FOIA-requested documents. With the request, the FDA is effectively sealing the records. The agency’s defense is that 330,000 pages of material were requested, and they simply do not have the resources to fill the request in a timely manner. At a proposed rate of 500 pages per month, it will take 55 years, until 2076, to fulfill the request. Yes, you read that right. 2 0 7 6; the FDA will squeak in right under the deadline – 55 years from now.
As you can imagine, outrage ensued over the FDA’s “shameless effort to bury the information.”
Are 500 pages per month really too taxing for the FDA? The equivalent is Harry Potter books 1 and 2, so the FDA would have to review, redact exempt material, and copy the equivalent of two Harry Potter books each month. The FDA defended its position in their court filing, explaining that the 500-page-per-month rate is consistent with the pace of other federal agencies.
PHMPT attorney Aaron Siri isn’t buying the stall tactic, saying that “the FDA’s promise of transparency is, to put it mildly, a pile of illusions.”
By comparison, the FDA only took 108 days to license the Pfizer vaccine. In the FDA’s own words, the agency described the effort as “an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure.” Yet the agency is asking for more than 20,000 days to now make these documents publicly available.
PHMPT lawyers are asking for the FDA records by March 3, 2022, which is the same 108-day period it took to achieve the far more complex task of actually approving the vaccine. The argument was that FDA could conduct the same robust and intense document analysis this time around. If they did it for the actual vaccine, they should be able to easily do it to release those same records. The legal team continued by saying the records are important because the ability of Americans to participate in civil society is largely now contingent on receiving the COVID-19 vaccine.
According to the Epoch Times, “as of November 14, more than 256 million doses of Pfizer’s COVID-19 vaccine have been administered in the United States.”
What is the FDA hiding?
Pfizer has whistleblowers, and one of them told the British Medical Journal (BMJ), one of the oldest medical journals in the world, that the Pfizer clinical trials were fraught with issues. Whistleblower Brook Jackson worked for Ventavia Research Group which operated several of Pfizer’s clinical trial sites during the latter part of 2020. Jackson claimed that the trial issues included, among other issues, the falsification of data. At the time Jackson alerted the FDA, he was fired within hours of doing so. The BMJ now reports that the FDA never inspected Ventavia’s trial sites even after Jackson alerted them to the problems. The FDA told the Epoch Times that it nevertheless has “full confidence” in the trial data.
As if data falsification is not a big issue, there may be an even bigger elephant in the room. While the federal budget pays 55% ($3 billion) of the FDA budget, the remaining 45% ($2.4 billion) comes from industry user fees paid by manufacturers being regulated. Yes, you read that right – nearly half of the FDA funding comes from the companies it regulates.
Since its inception in 1938 as a new authority to protect Americans from unsafe food, medication and cosmetics manufacturing methods, the FDA was entirely taxpayer-funded.
The FDA has had some very public success stories, such as its refusal to approve thalidomide, a treatment for morning sickness that caused debilitating birth defects. The thalidomide-era FDA was driven by data, not by corporate interests. Then-President John F. Kennedy applauded their decision.
FDA funding changed in the AIDS era. When the first HIV case was identified 1981, it spread rapidly and affected many people, including well-known celebrities, so the disease was very visible to Americans. People were angry about how long it was taking to get medication treatments to the market, so in 1992, Congress passed the Prescription Drug User Fee Act which was signed into law by President George H.W. Bush.
This law provided the FDA with funding from prescription drug user fees that manufacturers paid when submitting applications to the FDA for new drugs. Companies pay annual fees, prorated per the number of approved drugs they have on the market. (You can only imagine how much money Pfizer pays the FDA). Over time, fees for generic drugs, over-the-counter drugs, medical devices, and even veterinary drugs were added to help fill FDA’s coffers, and today, nearly half of the funding comes from the industries it regulates.
Fee negotiations also occur between the FDA and manufacturers for performance measures. In other words, the FDA gets paid more if they do a better job for the drug companies. The most important performance measure is the time between the drug new submission and the time it takes FDA to get the product approved and to market. The FDA is also measured on how quickly the agency responds to meeting requests and other requests.
The FDA stands behind the fees, saying the funding allows them to much more rapidly approve new products. The agency says it is only fair to charge the manufacturers these user fees. After all, the manufacturers stand to make a lot of money from the approval and sale of these drugs, and the fees are a small “carving out” that provides viable relief for the FDA’s financial burden, and ultimately relief to the taxpayer.
Sounds pretty good, doesn’t it?
Indeed, the FDA has better performance with the fees, as the FDA now takes 10 months for approval (2018 data), an improvement from the 29-month timeframe in 1987. The FDA also states that these funds helped them respond to the COVID-19 emergency use authorization in a matter of weeks rather than months or even years.
However, even though the FDA has more rapidly approved more drugs, the number of drugs with serious safety issues after FDA approval has also increased. Today about 27% of drugs have issues (called black box warnings) or have been removed from the market, up from 21% before the user fee was initiated. As an example, here is Pfizer’s black box warning for its drug Celebrex.
It is critical that the American public understand how FDA is funded. Does the public benefit, or does patient safety take a back seat to corporate profits? By the way, Congress must reauthorize these user fee programs every five years; the next occurrence is September 2022.
Has the FDA released any of these FOIA records yet?
As a matter of fact, the FDA has released the first tranche of Pfizer records after being ordered by the court to comply with the FOIA release. First reported by the Gateway Pundit, the initial release is a bombshell.
In the first 90 days after the Pfizer vaccine Emergency Use Authorization (EUA) rollout, from December 2020 to February 2021, tens of thousands of adverse events were reported including 1,200 deaths. Here is the full report.
Furthermore, the report only included researcher-deemed serious cases, meaning thousands more adverse events were not included in the data. To put it a different way, there were so many spontaneous adverse events reported for the Pfizer product that the team had to prioritize the serious cases. Furthermore, the report only includes recorded events, so the number of actual adverse events is likely far, far greater.
The FDA says it best: “(Adverse event) reports are submitted (to VAERS) voluntarily, and the magnitude of underreporting is unknown.”
Worldwide, the number of adverse events over the first 90-day period totaled more than 42,000, with about 13,000 adverse event reports within the US and the UK, repectively. Women were three times more likely to experience a reaction than men, and just to reiterate, 1,223 fatal reactions (DEATHS) were reported within the first 90 days. The report goes on to elaborate on thousands of “special interest conditions” that could possibly develop after a person takes the vaccine. The Gateway Pundit list is astonishingly nine pages long – single-spaced.
Even more astonishing is that after the FDA review of the first 90 days of data, they concluded the data was satisfactory to move forward to release the EUA for the Pfizer vaccine.
Naturally, this begs the question: Why did the FDA not immediately pull this product? Why have they still not done it?
And there are 329,500 pages to go. Let that sink in. What else will this report reveal?
By the way, Pfizer is projected to make $36 billion in profit in 2021 from the vaccine alone. This amounts to $1,000 per second in profit.
Let that sink in too.
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Fed Up Texas Chick is a contributing writer for Vaxxter. She’s a rocket scientist turned writer, having worked in the space program for many years. She is a seasoned medical writer and researcher who is fighting for medical freedom for all of us through her work.