Why is Emergency Use Authorization being used to increase big pharma coffers with no regard for patient safety?

Emergency Use Authorization provides windfalls for big pharma

The emergency use authorization (EUA) under which the Covid-19 jabs are being used to allow the world to be injected with hurriedly fashioned and minimally tested inoculations based on a new technology^[1] also provides the manufacturers with complete freedom from liability under the PREP Act.^[2] When Covid-19 countermeasures were included in the Prep Act, it covered vaccine manufacturers and anyone else involved in providing therapies for Covid-19. This means they can all avoid lengthy, expensive development and trial periods. Because there is no “FDA approved” therapy for Covid-19, they are, for the most part, the only show in town. The endeavor is all profit without risk to the company or any of its employees and for anyone who administers the vaccine or other therapies. The individuals who receive these therapies assume all responsibility and risk should they suffer any injuries or deaths, or even if the products just don’t work as claimed.

Other windfalls for pharma

As AFLDS has written previously, this is not the first time that the government and FDA have enabled pharma windfalls. In the mid-1980s when vaccine manufacturers threatened to stop manufacturing vaccines because they were being sued for injuries, the government was duly cowered and the 1986 Act, which absolved vaccine manufacturers of all liability for mandated childhood vaccines, was passed. That was the point at which the number of childhood vaccines increased at breakneck speed. From the 24 doses given to US children in 1983 to the 72 doses in 2016, pharmaceutical companies have made billions on vaccines without any responsibility for any injury or death their products may cause. In fact, it’s the taxpayers, in the form of a $0.75 tax on each vaccine dose that provides the funds for the “vaccine court”, an administrative procedure for compensating some of the many vaccine-injured children and adults and their families. The “court” was introduced with the 1986 Act.

AFLDS also showed how the FDA incentivized drug companies to manufacture orphan drugs (for illnesses that affect no more than 200,000 Americans) at, what was supposed to be, reasonable cost. This endeavor became a booming profit center for big pharma as they benefited from the incentives yet maintained exorbitant prices and offered the “orphan drugs” for illnesses that do not qualify for orphan status, replacing the less expensive drugs usually used.

The FDA gives EUA status to dangerous and under-tested drugs

Had the FDA approved hydroxychloroquine and ivermectin, two inexpensive off-patent medications with a long history of safe and effective use, for Covid-19, then they would not have been able to authorize or approve any vaccine. Vaccines are reserved for illnesses for which there is no other “FDA approved” remedy.

With hydroxychloroquine and ivermectin out of the way,^[3] the FDA was free to give Dr. Fauci’s Covid-19 drug of choice, Remdesivir by Gilead Sciences, Emergency Use Authorization. Since it was not an approved drug, it was not a problem to authorize the vaccines afterwards. Remdesivir costs about $3,000 per course of treatment.

The FDA also recently gave Emergency Use Authorization to three more drugs for Covid-19, Plaxovid by Pfizer, Sotrivimab by GSK, and Bebtelovimab by Eli Lilly.

Remdesivir has a history beyond its promotion as a drug to treat Covid-19. It had been investigated as a possible cure for Ebola but had to be discontinued because of its deadly effects. According to the manufacturer, it can cause liver and renal failure^[4] and the NIH acknowledges this as well.^[5] The World Health Organization (WHO) recommends against its use since ”there is currently no evidence that remdesivir improves survival and other outcomes” in the patients for whom it is prescribed.^[6]

In March, 2020, when the highly esteemed French professor of infectious diseases, Dr. Didier Raoult, demonstrated that hydroxychloroquine was an effective cure for Covid-19, he began receiving death threats. The French police traced the threats back to the doctor at Nante University Hospital who had received the most money from Gilead Sciences over the previous 6 years.^[7]

It’s virtually impossible that Fauci didn’t know about the dark history of remdesivir. Remdesivir was one of four drugs being tested in a 2018 Ebola clinical trial and was dropped because it had the highest death rate of all the drugs being tested. The National Institute of Allergy and Infectious Diseases (NIAID), of which Fauci is the head, sponsored the trial.

Dr. Bryan Ardis, speaking in front of an international group of lawyers investigating human rights violations related to the Covid-19 pandemic, said that

"Gilead’s “cohort study” conducted for “compassionate use” on patients with COVID-19 was only 28 days long. It reported that of 61 patients treated with the drug, eight were excluded for missing information, 32 (60%) of 53 remaining patients reported adverse events including increased liver enzymes, diarrhea, rash, and kidney function impairment. Twelve patients (23%) had “serious” adverse events including multiple-organ-dysfunction syndrome, septic shock, acute kidney injury, and hypotension (low blood pressure).

…

“Each of these symptoms – multi-organ failure, septic shock, acute kidney injury and hypotension – are described in medical literature as features of COVID-19 itself.”

Ardis said that many baffling symptoms that doctors began attributing to SARS-Co-V2, the virus that causes COVID-19, early in the pandemic, were in fact side-effects of the remdesivir used to treat it.

“Fauci “knew it for two years before he mandated this drug that it was deadly,” Ardis said. “I call it Fauci’s genocide.””^[8]

The NIH also funded a study to test remdesivir on pregnant women.^[9]

On January 24, 2022, Dr. Paul Marik, pulmonary and critical care specialist and founder of the Front Line Covid-19 Critical Care Alliance (FLCCC), in testimony before Senator Ron Johnson’s Discussion Panel on the “Deadly Approach to Covid-19 with Vaccine Mandates, Poisonous Protocols, and Restricted Therapeutics”, revealed that the Federal government will give a 20% bonus on the entire bill to hospitals that prescribe remdesivir for their Medicare patients.^[10]

Plaxovid is a combination of two medications, nirmatrelvir and ritonavir. According to Drugs.com

“Nirmatrelvir in combination with ritonavir is an experimental medicine being studied for the treatment of mild-to-moderate COVID-19. This drug is still being studied and all of its risks are not yet known.”

Plaxovid also comes with a number of warnings and contraindications for people taking certain medications, using birth control, or who have various medical conditions.^[11]᷾’^[12] It is not recommended for people with severe renal or hepatic impairment (impaired kidney or liver function), was found to cause hepatotoxicity in trial participants, and it comes with a potential risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection”.^[13]

Sotrovimab seems to be even more risky than Plaxovid, if such a thing is possible. Drugs.com explains that it is (emphasis added)

“... an experimental medicine being studied for use in treating conditions caused by coronavirus. It is not yet known if sotrovimab is a safe and effective treatment for any condition.^[14]

The patient fact sheet for Sotrovimab, a monoclonal antibody, includes the following (emphasis added):

It is possible that sotrovimab could interfere with your body’s own ability to fight off a future infection of SARS-CoV-2. Similarly, sotrovimab may reduce your body’s immune response to a vaccine for SARSCoV-2. Specific studies have not been conducted to address these possible risks.^[15]

Eli Lilly’s new monoclonal antibody, bebtelovimab, just approved under EUA, is sure to be a hit.  The federal government has agreed to purchase 600,000 doses for $720,000, with an option to purchase another 500,000 by July 31, 2022^[16]  even though they don’t know too much about the drug because the placebo-controlled phase 2 data only enrolled people without risk factors for progression to severe COVID-19, and the trial was not designed to determine a difference in the clinical outcomes of hospitalization or death between the placebo and treatment arms. The drug was studied in people with risk factors for progression to severe COVID-19, but the efficacy analyses are limited due to the lack of a concurrent placebo control arm for this population.

That's okay, however, because they say that “it is reasonable to believe that bebtelovimab may be effective for the treatment of patients with mild-to-moderate COVID-19 to reduce the risk of progression to hospitalization or death, This, depite warnings that there have been reports of clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment … and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19” (emphasis added).^[17]

In light of Eli Lilly’s newly authorized bebtelovimab that they claim works against Omicron, the FDA revoked the EUA for monoclonal antibodies Regen-Cov  by Regeneron and Eli Lilly’s bamlanivimab and etesevimab, which don’t. The EUAs can be restored if they are found to be effective for other variants in the future.

Regen-Cov had a warning similar to sotrovimab’s:

"It is possible that REGEN-COV could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, REGEN-COV may reduce your body’s immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks."^[18]

Bamlanivimab and etesevimab, like the other monoclonal antibodies, come with similar warnings of possible worsening of symptoms and interference with immune responses, among other issues. ^[19]

Be aware, as well, that monoclonal antibodies are developed and/or tested on aborted fetal cell lines, just like the Covid-19 vaccines and many of the childhood vaccines are.^[20],[21] AFLDS reported about that here.

Why would the government authorize drugs that weren’t tested properly and can even be deadly?

It’s all about money

To answer this question, one need look no further than the dollar signs.^[22]

“… As [Peter Daszak of EcoHealth Alliance, the company that received funding from Fauci’s NIAID to pass on to the Wuhan Lab for gain-of-function research] said in 2015, “we need to increase public understanding of the need for MCMs [Medical countermeasures] such as a pan-influenza or pan-coronavirus vaccine. A key driver is the media, and the economics follow the hype. We need to use that hype to our advantage to get to the real issues. Investors will respond if they see profit at the end of process.” (Emphasis added.)^[23]

Bribery and corruption run the industry

Pharma funds the NIH Foundation

The NIH Foundation, as per its 2020 Financial Report, received donations of

• between $1,000,000 - $2,499,999 from Gilead Sciences,
• between $5,000,000 - $9,999,999 from Pfizer,
• between $5,000,000 - $9,999,999 from GSK,
• varying amounts from other pharmaceutical companies, and
• over $10,000,000 from the Bill and Melinda Gates Foundation (BMGF)^[24],^[25].
• In 2019 The BMGF donated $100 million to the NIH for gene-based therapies for  HIV and sickle cell disease being conducted by Fauci’s NIAID.^[26] (Is it coincidental that NIH scientists and doctors, including Anthony Fauci, receive royalties on their experimental drugs, the trials for which are taxpayer funded.)^[27]’^[28]
  • According to Robert Kennedy, Jr., Fauci and the Bill and Melinda Gates Foundation will make billions from the Covid-19 vaccines.^[29]
• Gilead Sciences funded, in part, the NIH COVID-19 Treatment Guidelines Panel and the research promoting Remdesivir.^[30]
  • Seven members of the Treatment Guidelines Panel have financial ties to Gilead, three have ties to Pfizer and two to GSK.^[31]’^[32]
• Gilead Sciences received $70 million of taxpayer money to develop and test remdesivir,^[33] and $34.5 million from the Department of Defense.^[34]
• Eli Lilly gave the NIH $1.265 million to fund the U.S. – Russian Science Partnership.^[35]

The WHO and CDC Foundation are funded by big pharma

"The pharmaceutical industry enforces policy discipline through agency budgets. The World Health Organization (WHO) gets roughly half its budget from private sources, including Pharma and its allied foundations.  And CDC, frankly, is a vaccine company; it owns 56 vaccine patents and buys and distributes $4.6 billion in vaccines annually through the Vaccines for Children program, which is over 40% of its total budget. Further, Pharma directly funds, populates and controls dozens of CDC programs through the CDC foundation.  A British Medical Journal editorial excoriates CDC’s sweetheart relationship with pharma quotes UCLA Professor of Medicine Jerome R. Hoffman “most of us were shocked to learn the CDC takes funding from industry… It is outrageous that industry is apparently allowed to punish the CDC if the agency conducts research that has potential to cut into profits.”^[36]

• The BMGF, a major proponent of vaccines and investor in vaccine manufacturers, is the largest donor to the WHO, after the US. Non-state donors are able to earmark their donations for special projects, effectively moving the agency away from its mission.^[37]
  • Robert F. Kennedy Jr.: Bill Gates Vaccine Killed More Children in Africa Than the Diseases it Targeted^[38],  Unintended victims of Gates Foundation generosity^[39]
• The BMGF is a major contributor to the CDC Foundation. In 2013 the BMGF gave the CDC Foundation 3 grants totaling $13.5 million,^[40] and $29.9 million to the CDC Foundation in 2017.^[41]

The FDA is a captured agency

It can't fulfill its mission because much of its funding comes from the very companies whose products it is supposed to regulate.

"Until 1992, the FDA was funded entirely by the US government, but in 1992, the Prescription Drug User Fee Act was enacted, requiring drug companies to pay the FDA to have their drugs reviewed and approved. This, Wolfe said, influenced the FDA to consider the industry to be their client, rather than the public. Additionally, he said, there are many individuals in the FDA’s drug division who are reluctant to go against the pharmaceutical companies and Congressional oversight, which used to hold the FDA accountable, has dwindled.

“According to [Vice President for Health Sciences at the University of Arizona, Dr. Raymond] Woosley, the User Fee Act and pharma lobbying has skewed the balance of FDA activities away from safety.”^[42]

Not only is the agency itself captured, but so is Dr. Robert Califf, the newly appointed commissioner.

"Sen. Bernie Sanders, I-Vt., has criticized Califf for owning millions of dollars in pharmaceutical stock, accusing him of participating in a revolving door between industry and the FDA.

"Califf is as a senior advisor at Google Health and Verily, the life science arm of Alphabet. He received a salary of $2.7 million and up to $5 million in stock at Verily, according to an ethics disclosure form. Califf serves on the board of directors of Centessa Pharmaceuticals and biopharmaceutical company Cytokinetics. He has up to $5 million in unvested stock options at Centessa and owns hundreds of thousands of dollars in Cytokinetics stock. Califf also has stock in Amgen, Gilead Sciences and Bristol-Meyers Squibb.

"Califf has said he will resign from Verily, Centessa and Cytokinetics upon confirmation and divest his pharmaceutical stock holdings within 90 days.

“Sens. Joe Manchin, D-W.Va., and Maggie Hassan, D-N.H., opposed Califf’s nomination over his previous leadership of the the FDA during the opioid crisis. Overdose deaths from all opioids increased 12% to more than 47,000 during Califf’s tenure as commissioner from 2016 to 2017, while fatalities specifically from prescription opioids remained high with more than 17,000 people succumbing to overdoses, according to the Centers for Disease Control and Prevention.”[(Emphasis added.)^[43]

Is there any doubt that Califf will “act favorably” to the very companies that he is supposed to regulate?

The revolving door is standard policy in other agencies as well

Former CDC Director, Julie Gerberding, is one such example. Among the many ways in which she aided pharma, was her approval of the dangerous Gardasil vaccine.^[44] She also “… single-handily overhauled the agency’s entire organizational structure, causing many of the CDC’s senior scientists and leaders to leave, whilst replacing them all with individuals who had ties to the vaccine industry. After she resigned from the CDC she went on to work in Merck's vaccine division. "… Health Impact News reported that just two years later, Gerberding … had sold 38,368 of her shares in Merck stock for $2,340,064.32, leaving her with an impressive 31,985 shares of the company’s stock, valued at about $2 million. (Source) ”^[45]

Through lobbying big pharma has captured many of our representatives

• Four Republican senators who have received PAC contributions from and/or own stock in pharmaceutical companies switched sides to vote in Biden nominee for FDA commissioner, Dr. Robert Califf as the new FDA commissioner.^[46]  
  • Many of our representatives own shares in pharmaceutical companies. At least 75 federal lawmakers held shares of Moderna, Johnson & Johnson, or Pfizer and others traded shares of companies directly involved with the pandemic.^[47]
• Gilead Sciences spent $2.45 million lobbying the senate in the first quarter of 2020^[48] and $5.72 million to lobby representatives in 2019.^[49]
• Eli Lilly spent $7,515,000 lobbying in 2021 and $5,830,000 in 2020.^[50]
• Moderna spent $580,000 lobbying in 2021 and $280,000 in 2020.^[51]
• Pfizer spent $10,870,000 in 2020 and $11,000,000 in 2019 to lobby representatives.^[52] In 2020, $913,186 of PAC contributions to federal candidates.^[53]

From The Blaze:^[54]

“This is Pfi$er PAC's end-of-year message for 2020:

It has been a year like no other, and we are proud of the all [sic] the hard work and long hours our colleagues dedicated and continue to dedicate to develop and deliver the first COVID-19 vaccine. As if COVID wasn't enough, 2020 was also a big election year and Pfizer and the Pfizer PAC continued to support candidates of both political parties who support policies that impact our purpose: Breakthroughs that change patients' lives. We do not contribute to Presidential candidates or super PACs. In the 2020 cycle, Pfizer PAC and Pfizer Inc. supported 1,842 candidates and multiple political committees at all levels of the government. Forty-nine percent of the Pfizer PAC disbursements in the 2019-2020 cycle went to Republicans and 46% went to Democrats. We continue to advance our purpose to discover and deliver breakthroughs that change patients' lives, thanks to our PAC members and our Pfizer U.S. Government Relations team, who are on the ground educating and engaging elected officials about Pfizer's purpose.”

Pfizer CEO Albert Bourla is even attempting to shut down US citizen’s constitutionally guaranteed freedom of speech. In a recent interview he said “that those who spread "misinformation" about his product are "criminals" and "have literally cost millions of lives."^[55]

Bourla's accusation is ludicrous. Not only is his company responsible for the most deaths from a vaccine ever reported to the Vaccine Adverse Event Reporting System (VAERS),^[56] but over the decades most drug companies, including Pfizer, have paid heavy fines for a variety of illegal and harmful activities. They consider these fines a cost of doing business; no one goes to jail for these crimes that have even cost people their lives.

Here are a few headlines to make your blood boil, if it’s not already:

• Pfizer's History of Fraud, Corruption, and Using Nigerian Children as 'Human Guinea Pigs': How did Pfizer manage to rebrand itself as the savior of humanity?^[57]
• Gilead Sciences Settles Medicare Kickbacks Claims with DOJ for $97M.^[58]
• GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data: Largest Health Care Fraud Settlement in U.S. History^[59]
• Johnson & Johnson Lawsuits Every Person Should Know About ^[60]
• Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing^[61]
• Merck settles Vioxx lawsuits for $4.85 billion^[62] Merck manufactures many of the childhood vaccines which are part of the childhood vaccine schedule.
• GSK, Pfizer and J&J among the most-fined drug companies, according to study^[63]
• Eli Lilly: Corporate Rap Sheet^[64]
  Perhaps the company will best be remembered for its fraudulent study of thimerosal,^[65] after which the toxic ingredient was approved for use in vaccines.

“Eli Lilly faces hundreds of civil lawsuits from parents who blame thimerosal for their autistic children. But the pharmaceutical giant has powerful friends in the White House and in Congress. The elder George Bush sat on Lilly’s board of directors in the 1970s, and White House Budget Director Mitch Daniels was a Lilly executive. Lilly CEO Sidney Taurel was named by President George W. Bush to the Homeland Security Advisory Council.

…

“Eli Lilly may be determined to avoid liability for thimerosal, but that doesn’t mean it has abandoned children with neurological problems. This year, the FDA approved Straterra, a new Eli Lilly drug for the treatment of Attention Deficit Hyperactivity Disorder. The irony that Eli Lilly profits from damaged children is not lost on parent Robert Krakow: “When Eli Lilly is promoting Straterra on TV, saying up to 10 percent of children can be helped, you realize what we are up against.”” ^[66]

Moderna is not listed here, yet, since the company has never before had any product approved for use or even allowed to be marketed to the general public.^[67] Its Covid-19 vaccine is the only product that has been allowed for use by the general public, and this under EUA. But fear not, the NIH has ownership of intellectual property associated with the vaccine^[68] for which taxpayers funded the research and development to the tune of over $2.5 billion.^[69]

Are you outraged enough?

Don’t be outraged alone. That’s why I wrote this post and why you should forward it to your family, friends, and everyone else you know. Let your representatives know that this is no longer acceptable and that you will be holding them accountable. Tell everyone you know to contact their representatives, too.

P.S. If you no longer wish to rely on big pharma, protocols for truly safe and effective Covid-19 treatments have been developed by Dr. Marik and the FLCCC doctors, Dr. Zelenko, and others. Learn about them here.^[70]

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