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The speaker explains that a series of laws allowed the military to take over vaccine distribution without any clinical trials or safety testing. The safety testing conducted by the pharmaceutical industry was just for show and had no regulatory implications. The FDA, which is responsible for regulating medical products, does not have the authority to regulate these countermeasures. The legal framework being used pretends that these are health products when they are actually in a different legal space.

Speaker argues that the majority of doctors lack the private-sector tools to "go outside the box"—no FDA portal to write INDs, no funds, no genetic sequencing labs, and no in-house scientists. They say doctors are "limited to what the guidelines are telling them to do" because stepping outside risks lawsuits; achieving this requires "'a regulatory board... FDA oversight... lawyers' costs." This isn't a field for all doctors. Cites examples like Peter McCullough and others (Pierre Corre, Paul Merrick, Jackie Stone, Mary Bowden). Peter McCullough is praised as "'published thousands of papers'"; most doctors merely receive data from sources and may miss data. During the pandemic, they faced rushed conditions and propaganda—"hydroxychloroquine was a bad drug, Ivermectin was a horse paste"—"they didn't get to see the data." The speaker notes three FDA-tracked trials and asserts FDA jurisdiction in off-label work, and that "'I had an FDA approval to run these trials.'"

The speaker explains that the COVID injections are not considered pharmaceutical products. They discuss the significance of a particular US code that states the use of emergency use authorized (EUA) countermeasure products is not considered a clinical investigation. This allows the government to remove these products from regulatory frameworks and operate in an extrajudicial space. The public health emergency announcement triggers this mechanism, and the government can make determinations without data or criteria. The speaker also mentions that the COVID pandemic was declared based on limited cases, and once a pandemic is announced, pharmaceutical regulations no longer apply. The products are classified as countermeasures, which is a vague term.

It is nearly impossible to publish data that goes against the national public health narrative, preventing doctors from finding solutions. The speaker has conducted clinical trials for pharmaceutical companies, including vaccine studies, and has brought vaccines and other drugs to market. Some drugs never made it to market because they killed people. Clinical trial guidelines ensure safe drugs, but these guidelines were not followed during the pandemic, affecting everyone. COVID should have been a time for doctors to unite, but interference with research occurred. Science evolves through experiments, skepticism, and an open mind. Challenging current knowledge must be allowed to move science forward, but what the speaker witnessed during the pandemic was not science.

In October 2020, the speaker was asked if Operation Warp Speed would use the expanded access use pathway to get on the market. The speaker responded that they would not be using that pathway because it requires an institutional review board (IRB) and informed consent, which they wanted to avoid due to the added complexity. The speaker expressed concern for the lack of informed consent in vaccine injuries and deaths. They mentioned that this scheme was designed to deceive professionals and took years to uncover. Both sides, including FDA staff, CDC staff, pharma staff, management, and lawyers, were aware of what they were doing.

The Emergency Use Authorization (EUA) regulation from the Clinton administration included safeguards. You can distribute a medication without approval, clinical trials, or safety testing, but only if no existing approved drug is effective against the target illness. To use the EUA for vaccines, any effective drugs against COVID needed to be discredited. Early on, it was known that hydroxychloroquine was effective against coronavirus. NIH studies demonstrated its effectiveness both as a preventative and as a cure. Ivermectin was also very effective. Acknowledging that these drugs worked would have eliminated the use of the emergency use authorization. So, they had to suppress them.

Due to drug shortages listed by the FDA, compounding pharmacies can create their own versions of drugs. These compounded versions are not FDA approved or reviewed. Because these pharmacies are regulated at the state level, there is no data available for how many people are taking compounded GLP-1s. This confusing environment makes it easier to take advantage of people. A researcher ordered compounded semaglutide from shady online sellers to investigate.

The FDA only approves emergency use authorization if there are no other alternatives. Ivermectin's effectiveness could have impacted vaccine approval. Powerful interests oppose Ivermectin due to financial reasons. Drug companies profit greatly from vaccines. Ivermectin is cheap and widely available. Merck's stance on Ivermectin changed after its patent expired. Paid articles may not always provide accurate information.

Before the pandemic, Dr. Fauci tested Remdesivir in an Ebola trial in Africa alongside four other drugs. However, the institutional review board (IRB), responsible for ensuring safety in clinical trials, intervened and removed Remdesivir from the trial due to its high fatality rate. Ebola typically kills 53% of those infected, but Remdesivir was causing even more deaths. It seems illogical to then administer this drug to individuals with a disease that has a much lower infection fatality rate of 1%. This decision appears questionable, but unfortunately, there is a history of similar actions being taken.

Clinical trials are essential to determine a product's safety and effectiveness, especially for vaccines intended for pregnant women. For a vaccine to be licensed for this demographic, specific trials must be conducted. A request was made to the FDA for the clinical trials used to license the flu shot for pregnant women, but after much delay, it was revealed that no such trials exist, as the flu shot has never been licensed for pregnant women. Consequently, promoting the flu shot for this group is considered off-label use, which pharmaceutical companies cannot legally advertise. Instead, the CDC handles this promotion.

After issuing full approval for the vaccines, they also authorized emergency use of remdesivir monoclonals. They claim that both the fully approved and emergency authorized vaccines should be distributed, which is unprecedented. It's like being a US citizen and a green card holder simultaneously, which is not possible. This whole situation is a charade.

There was a recent FDA rejection of an MDMA-based therapy for PTSD, a program that had achieved, on its own terms, two successful phase three studies. The speaker notes that the trials were designed exactly as the FDA told them to design, but the episode is tied to the rise of advisory committees—FDA panels of so-called experts who opine on data and recommendations. The FDA is not bound by their recommendations, but they often follow them, sometimes not. In the speaker’s view, the FDA uses these advisory committees as a cover for what they actually want to do, a dynamic the speaker has observed across years in biotech as an investor and company builder. He has sat in eight-hour advisory committee sessions in Maryland, taking detailed notes, and while he didn’t attend the most recent one, he believes it smelled like the briefing documents provided to the committee were used to guide the outcome. He suspects the advisory committee recommended against approval, and the FDA then moved to that outcome. The speaker argues this is a travesty for PTSD patients who have very few options. He focuses on the reasoning the FDA gave for denying approval: the trial was functionally unblinded. Typically, trials use placebo and active drug arms with participants unaware of which treatment they receive, to ensure that observed effects are not merely placebo. The FDA claimed that patients knew whether they were on the MDMA-based therapy because some experienced euphoria, a side effect of the treatment. Therefore, the therapy could appear to work due to unblinding and a placebo effect, rather than a true therapeutic benefit. The speaker emphasizes that the possibility of euphoria being part of the drug’s mechanism—and thus related to its therapeutic effect—was ignored in their assessment, and that this unblinding was, in his view, anticipated by the FDA before agreeing to the phase three protocol, which also added tens or hundreds of millions of dollars in development costs. The speaker criticizes the public record, including biotech press coverage, for focusing on “trial irregularities” or an unblinding issue rather than on the broader cost-benefit and mechanistic considerations. He asserts that the public is left with the notion that there were unblinding issues, not recognizing that the unblinding related to the drug’s therapeutic properties was anticipated and approved by the FDA. He concludes that the episode reveals how the bureaucratic machinery operates, with advisory committees and briefing documents shaping outcomes in a way that aligns with the FDA’s underlying aims.

Trump's quick release of vaccines eliminated the excuse for lockdowns, preventing the transfer of wealth from small businesses to large corporations. The vaccines also removed the need for lockdowns, forcing Democratic governors to reopen. Releasing the vaccines under emergency use authorization (EUA) prevented them from being legally forced on people. The original plan was to physically force vaccinations and quarantine those who refused, but the EUA made that impossible. The only FDA-approved vaccine is called Comirnaty, but it is not available in the US yet.

At the outset, a process was approved by the FDA for emergency use authorization. However, it was later discovered that the approved process was swapped out for one containing contaminants like DNA and a cancer-causing substance. Pfizer redacted 800 pages of the manufacturing process, hiding the fact that a carcinogen was included. This lack of transparency led to no informed consent and potential harm to individuals. The vaccine rollout included a trial with a 2.4 times higher adverse event rate, including the presence of a carcinogen.

**Italiano:** Un'indagine biennale condotta da giornaliste mediche rivela che la FDA statunitense ha approvato centinaia di farmaci senza prove di efficacia, e talvolta nonostante prove di dannosità. Su oltre 400 approvazioni tra il 2013 e il 2022, il 73% non soddisfaceva i criteri fondamentali per l'efficacia, come gruppi di controllo e studi replicati. La FDA ha spesso optato per percorsi accelerati, ma molti studi di follow-up non vengono completati o non dimostrano l'efficacia. Più della metà delle approvazioni si basava su dati preliminari. In oncologia, solo 3 farmaci su 123 hanno soddisfatto tutti gli standard. Esempi includono Kopictra, che ha ridotto la sopravvivenza, e Elmiron, ancora in commercio nonostante la mancanza di efficacia e gravi effetti collaterali. Tra il 2018 e il 2021, sono stati spesi miliardi per farmaci con studi di follow-up incompleti. Si stima che 128.000 americani muoiano ogni anno a causa di farmaci prescritti correttamente. Molti medici non comprendono il processo di approvazione della FDA. Si evidenzia la dipendenza dell'agenzia dai finanziamenti dell'industria farmaceutica. **English Translation:** A two-year investigation by medical journalists reveals that the U.S. FDA has approved hundreds of drugs without proof of efficacy, and sometimes despite evidence of harm. Of over 400 approvals between 2013 and 2022, 73% did not meet fundamental efficacy criteria, such as control groups and replicated studies. The FDA has often opted for accelerated pathways, but many follow-up studies are not completed or do not demonstrate efficacy. More than half of approvals were based on preliminary data. In oncology, only 3 out of 123 drugs met all standards. Examples include Kopictra, which reduced survival, and Elmiron, still on the market despite lack of efficacy and serious side effects. Between 2018 and 2021, billions were spent on drugs with incomplete follow-up studies. An estimated 128,000 Americans die each year from correctly prescribed drugs. Many doctors do not understand the FDA approval process. The agency's dependence on pharmaceutical industry funding is highlighted.

Normally, bringing a product to market involves proposals, clinical trial designs for efficacy and safety, years of trials, and FDA determinations on safety, efficacy, harm versus benefit, warnings, and inspections. All of this is abolished. Now, the HHS secretary only needs to decide, with or without evidence, that a product may be effective. Even if evidence shows ineffectiveness, they can still believe it's effective. This decision-making allows them to legally mandate the product for all Americans, regardless of evidence to the contrary. There are no stopping criteria, and the secretary never has to reconsider their decision because there were no criteria to begin with.

In 2012, DARPA initiated the ADEPT Protect P3 program for pandemic prevention using gene-encoded vaccines. The military had been working on mRNA vaccines since then, not as a response to COVID-19. Operation Warp Speed was not as rapid as claimed, with contractors like Moderna receiving funding in 2013. The military's involvement in developing vaccines and monoclonal antibodies predates the pandemic, with emergency use authorization primarily for military use. The FDA's lack of control over the process reflects its military origin, executed with military precision. No one is exempt from its reach.

Excitement surrounds the discussion of Pfizer's top-selling drugs as of 2019, which includes four medications and one vaccine. The clinical trials for these drugs involved long-term safety follow-ups, often lasting several years with placebo control groups to assess various health impacts. In contrast, the vaccine Prevnar had only a six-month safety review, using another vaccine as a control rather than a true placebo. This raises concerns about the thoroughness of safety evaluations for childhood vaccines, which are administered multiple times in the first six months of life. The disparity in study lengths suggests that economic interests may drive pharmaceutical companies to minimize safety testing to expedite market entry, raising questions about regulatory oversight.

The COVID-19 vaccines were rolled out under a series of laws that allowed the military to take over distribution, bypassing typical clinical trials and safety testing. The FDA's involvement was a "pretend authorization," as their mandate is to regulate interstate commerce of medical products, not countermeasures. The Department of Defense is fully in charge of the development, clinical trials, manufacturing, and distribution of the vaccines, utilizing "other transaction authority" (OTA), initially intended for NASA and weapons procurement. The vaccines are purchased under OTA as demonstration products, exempting them from FDA and CDC authority. Pharmaceutical companies were brought in largely for branding purposes, while the military oversaw manufacturing and distribution through military contractors.

The emergency use authorization (EUA) was crucial for normalizing the mRNA platform, which was seen as a significant advancement in vaccine technology. The fear surrounding COVID-19 helped facilitate acceptance of this new approach, despite existing treatments that could have mitigated the pandemic's impact. If doctors had been allowed to explore effective treatments, the reliance on mRNA vaccines would have been diminished, creating a control group that could reveal potential harms. While the EUA was important, it wasn't strictly necessary; they could have navigated around it. The rollout of the mRNA platform aimed to reshape public perception, and the legal complexities surrounding the EUA provided a layer of immunity for those involved. The backlash and discussions about vaccine injuries may complicate future implementations of this technology.

The FDA issues emergency use authorization for medical products when there are no approved alternatives. The effectiveness of Ivermectin as a treatment is questioned, as it would have affected the authorization of vaccines. Powerful forces with financial interests oppose Ivermectin, as it threatens global vaccination policies. Pharmaceutical companies like Pfizer, BioNTech, and Moderna have made significant profits from COVID-19 vaccines. Ivermectin is a cheap and widely available drug, but its safety is disputed by Merck, despite distributing it when it was under patent. It is important to be cautious of articles that may be biased or paid for.

Americans are programmed to trust only FDA-approved drugs, but Big Pharma buys the FDA's approval. The FDA stopped independently reviewing all drugs about 30 years ago. Drugmakers can pay a lump sum upfront, such as $10,000,000, to get immediate approval to sell their products. The approval is granted if the drugmaker believes and can prove through their own research studies that the drug is safe and effective.

Pfizer has been forced to release previously secret documents, including FDA approval packages, due to court orders and successful FOIA requests. These documents reveal that Pfizer tested different versions of their vaccine during preclinical and clinical trials, which goes against FDA guidance. The different versions included modified RNA, unmodified RNA, self-amplifying RNA, and Spike protein alone. Surprisingly, all these versions were tested under the same investigational new drug number, despite FDA guidance stating that multiple versions should have their own individual numbers. Additionally, the toxicity of the mRNA active ingredient in the COVID-19 vaccines was never studied. This raises concerns about the regulatory process and the lack of safety testing.

Speaker 0 discusses the origin and framing of pandemic prevention and vaccine development as a military-led initiative. He cites a 2012 DARPA program called the Adept Protect p three program, described as a pandemic prevention platform. The proposal outlined the use of gene-encoded vaccines based on RNA or DNA with the goal of stopping a pandemic within sixty days. He suggests that, by the time President Trump referenced “Operation Warp Speed” to develop vaccines, there should have been preparation and acknowledgement that this work dated back to 2012, making it not rapid innovation but a decade-long effort. He argues that the public narrative of rapid development and stunning innovation surrounding vaccines is deceptive and that contractors like Moderna had already secured multi-million-dollar contracts in 2013. He notes that the military operates programs addressing biological threats and also works on answers such as monoclonal antibodies and vaccines. The claim is made that the military originated the idea of messenger RNA vaccines, not Pfizer or Moderna, and not in response to the outbreak from Wuhan. According to the speaker, this is a military program in origin and administration. The speaker asserts that Health and Human Services, under Alex Azar, together with the Department of Defense, ushered the public into a vaccine era, framing Emergency Use Authorization as a mechanism to rapidly deploy new technology into the military rather than the public. He contends that this mechanism’s broad public application began with the COVID-19 pandemic, which is presented as evidence that the FDA lacks ownership or control over the process because the program is characterized as military in origin and execution. The overall claim is that the program operates like a military operation with universal reach and without exemptions, implying a deeply embedded military approach to vaccine development and deployment. Throughout, the speaker emphasizes the continuity from a 2012 program proposal through to the public health landscape observed during and after the COVID-19 pandemic, asserting that the military’s involvement, timeline, and governance underlie the current vaccine paradigm and its regulatory pathways.