Our kids are post-market data

Shouldn’t parents know when their children are part of a medical experiment?

In December 2021, the FDA granted an Emergency Use Authorization to Pfizer for its antiviral drug Paxlovid, for use in adults and children as young as 12 (with trials ongoing for younger children). Here’s what one primary care doctor from New York City has to say about its use:

“[T]he trial supporting Paxlovid is not directly applicable to the majority of Americans…I am left hoping and guessing and continue to prescribe Paxlovid to my high-risk COVID-19 patients without being sure if I am helping them.”[i]

The NYC primary doctor goes on, “The current situation with Paxlovid is reminiscent of an older antiviral medication, Tamiflu, which became the subject of controversy during the swine flu pandemic.”

The FDA has a history of taking risks with our children’s lives.

Tamiflu was another antiviral drug bought up and recommended by our government, especially during swine flu scares in the 2000s. The CDC issued emergency communications urging people to use Tamiflu at the slightest hint of a sniffle or sneeze and gave instructions on how to open the capsule and mix it into a sweet thick liquid for children who could not swallow pills.[ii] Tamiflu was approved for children as young as 2 weeks old. The U.S. stockpiled it after swine flu scares in 2005 and 2009.[iii] But U.S. regulators (and those from Europe and Japan) saw massive safety signals around psychotic episodes in children after use of Tamiflu. Like COVID drugs, Tamiflu’s safety signals were ignored and put off for years.[iv] [v]

The public had no knowledge of the data upon which the FDA based its decision to approve Tamiflu.[vi] The manufacturer, Roche (who partnered with U.S.-based remdesivir creator Gilead), did not readily share its trial protocols or results — the internationally renowned Cochrane Collaboration spent two years requesting data to piece together information to address safety signals for adverse events, and ultimately concluded there was minimal benefit and safety risks were ignored.[vii] [viii] Similar to COVID drugs, the antiviral Tamiflu was advertised to shorten the severity and duration of an infection. The U.S. and other countries built stockpiles at the recommendation of the World Health Organization.[ix]

Another flu antiviral, Relenza, was approved by the FDA just before Tamiflu. The now-disbanded Antiviral Advisory Committee of the FDA voted 13-4 against Relenza, but the FDA ignored that and approved it anyway.[x] One FDA investigator, a biostatistician Michael Elashoff, was berated for his presentation to the committee that Relenza was no more effective than a placebo and had safety concerns to boot. He was told that was his last presentation to the committee.[xi] The FDA stopped him from reviewing Tamiflu and then approved that drug on even less data. Both Relenza and Tamiflu became associated with serious adverse events including deaths and psychosis. It was well understood that taking a stand against a drug was not good for a career with the FDA and Elashoff ultimately left, joining others who had ethical concerns about approvals over the years.[xii]

In response to the declaration of swine flu as a public health emergency, the FDA granted rarely used (at the time) EUAs to Relenza and Tamiflu to expand their uses beyond what the FDA had approved, also granting an EUA to an RT-PCR test for the influenza.[xiii] Fifteen years later, we saw the same playbook used for COVID drugs and testing.

An eye-opening expose was published in December 2000 in the LA Times regarding the sudden withdrawal of seven FDA-approved drugs after reports of deaths. The report opens with the story of a father of a 3-month-old who died after being prescribed Propulsid for gastric reflux. The investigation revealed, “Parents and their doctors had no way of knowing that the FDA, in August 1996, had found Propulsid to be “not approvable for children.” The father stated, “To me, that means they took my kid as a guinea pig to see if it would work.” The LA Times reported, “By the time the drug was pulled, the FDA had received reports of 24 deaths of children under age 6 who were given Propulsid. By then, the drug had generated U.S. sales of $2.5 billion for Johnson & Johnson Co.”

The deadly drugs investigated were approved under the eye of Janet Woodcock, who at that time was head of the Center for Drug Evaluation and Research (CDER), the FDA’s drug-review center. In 2020, she oversaw therapeutics in Operation Warp Speed. In 2021, President Biden appointed Janet Woodcock to acting FDA Director during the declared COVID pandemic.[xiv] (Here is additional evidence that “embracing uncertainty” and helping unsafe drugs to market can’t hurt the careers of unelected FDA employees.)

A peer-reviewed article published in the Journal of the American Medical Association (JAMA) in May 1999, which included Janet Woodcock among its authors, noted “drug approvals are made on the basis of limited information, and more is inevitably learned as the drug becomes widely used…For this reason, post-market safety surveillance is an integral part of drug regulation.”[xv] The article did not even contemplate something like Warp Speed research and development, nor Experimental Use Authorizations for experimental drugs (the EUA law was part of Project Bioshield, passed by Congress in 2005, to make the loss of a military lawsuit over anthrax vaccines irrelevant.)

It was further noted that “the FDA and the community are willing to take greater safety risks due to the serious nature of the illness being treated.” In other words, the more serious the illness is considered, the more the FDA loosens safety standards and will declare that the stated benefits outweigh the risks of adverse events.

The FDA doesn’t trust doctors and knows doctors rely on their decisions.

Dr. Woodcock was quoted in that 2000 LA Times investigation of FDA drug withdraws under her watch:

“[S]ome of the withdrawn drugs were “very valuable, even if not lifesaving, and their removal from the market represents a loss, even if a necessary one.” Once a drug is proved effective and safe, Woodcock said, the FDA depends on doctors “to take into account the risks, to read the label. . . . We have to rely on the practitioner community to be the learned intermediary. That’s why drugs are prescription drugs.”[xvi]

She went on to say, however, “As medical practice has changed…it’s just more difficult for [doctors] to manage…They rely on us much more to make sure the drugs are safe.”

 Scott Gottleib, who held top roles at the FDA in the 2000s and joined the board of Pfizer in 2019, described the culture of the FDA in a 2012 article for National Affairs after a series of deadly drugs were withdrawn that had been approved by Dr. Woodcock through CDER, during his tenure with the FDA: “The agency’s senior management and staff lost trust in physicians — especially primary-care doctors – and d came to believe that doctors could not be relied upon to read drug labels and heed clear FDA warnings.” He summed up the culture by saying, “Simply put, the modern FDA is driven by a profound lack of confidence in the ability of doctors to make careful judgements.”

Dr. Gottleib stated that those with “less experience” at the FDA demonstrate “less willingness to embrace uncertainty.” The uncertainty he is referring to is the risk taken with public safety when putting a drug on the market. In his opinion, one of the FDA’s obligations is to protect consumers, but he thinks that leads to neglecting another obligation to “guide new medical innovations to market.” On the same wavelength, Dr. Woodcock wrote in the Food and Drug Law Journal early in her career, of balancing safety risks, “on the other hand, there are economic pressures to get drugs on the market as soon as possible, and these are highly valid.”[xvii]

The LA Times investigation exposed the lack of integrity at the FDA. One doctor said, “The FDA used to serve a purpose. A doctor could feel sure that a drug he was prescribing was safe as possible. Now you wonder what kind of evaluation has been done, and what’s been swept under the rug.” That was twenty years ago, before COVID ushered in experimental mRNA vaccines and the new normal.

Can we trust the manufacturer or the FDA?

Pfizer is the world’s leading manufacturer of the experimental mRNA COVID shots. But the safety and efficacy of those shots are nowhere near settled science. Like Roche with Tamiflu, Pfizer has been reluctant to share their science, even though it is truly a matter of life and death. It took a court order for Pfizer to start releasing information about its mRNA shots trials, and as the data is released, new information continues to come to light about suppressed safety risks and manipulations of the trials and data that inflate efficacy claims.[xviii]

The FDA has a troubling and quickly growing habit of ignoring advisory committee advice. We have seen it many times over the last two years, most notably when FDA would override and then exclude VRBPAC from COVID booster decisions. (The CDC has also ignored ACIP’s evaluation of COVID shots). A study published in 2022 found, “from the past decade, we found that the number of new approved drugs receiving advisory committee review decreased from 59 percent in 2011 to only 6 percent in 2021.”[xix] Without including COVID pharmaceuticals in the analysis, the researchers found the FDA went against advisory committee advice to approve a drug about once per year. “[F]or most of these drugs the committee involved cited excessive safety risks or lack of proven efficacy,” which are both concerns we have seen with the COVID shots and other drugs. Eight of ten committees would not recommend a drug due to insufficient data, also a concern VRBPAC has had when reviewing COVID shots (which would be expected for an experimental emergency drug.) It was very rare for the FDA to explain its decision to go against recommendations, and only two of the 10 drugs voted against by the advisory committee were subject to required post-market follow up for safety and efficacy concerns.

On the corporate side of these public-private partnerships, Kathrin Jansen, Senior Vice President and Head of Vaccine Research and Development at Pfizer told investors in December 2021 that Pfizer was “working on a regulatory pathway that would allow us to [sell] a vaccine with minimal additional clinical data.”[xx] She finished her presentation by boasting about Pfizer’s “ongoing and strong commitment to help transform the COVID-19 pandemic into a more manageable endemic.” At that same meeting, Nanette Cocero, Global President of Vaccines at Pfizer let investors know that even though it was early, in December 2021, Pfizer had “already set a significant foundation for 2023,” with the sale of 500 million doses of the COVID shot (a product that lasts only a few weeks in storage), and ongoing sales negotiations for more. COVID shot pre-sales continue for the coming years, but our government won’t stop authorization of this medical experiment despite safety signals from VAERS that are orders of magnitude higher than any vaccine in history.

Instead, the White House seems to have cut the brakes on the COVID shots train, pushing constantly for more boosters, annual shots, shots for younger and younger kids.

COVID pharmaceuticals

Paxlovid

Paxlovid was granted an EUA in December 2021 for adults and kids as young as 12 who are considered high risk. Pfizer has been planning for Paxlovid to become a large earner based on government contracts, multi-year agreements, and stockpiling for future pandemics.[xxi] The shots and the antiviral are meant to be “complimentary tools.”[xxii]

Clinical trials for children as young as 6 started in March 2022, giving only a scant few months of data. An infectious disease specialist from Yale Medicine points out, “While Paxlovid is authorized for use in adolescents and teenagers ages 12 and up who weigh at least 88 pounds, that age group wasn’t tested in the original clinical trial. But because many children reach 88 pounds — considered to be an adult weight — the FDA has allowed extensions of EUAs for medications such as monoclonal antibodies and remdesivir in younger age groups.”[xxiii]The doctor explains that the drug is thought to work similarly in children and adults.

The CDC’s Director Rochelle Walensky recently announced that the Pfizer COVID-19 pill causes people to get “rebound” symptoms after initial infection is treated with the pill, and during that time the virus can be transmitted again, after they have tested negative and believe they are safe.[xxiv] [xxv]

Remdesivir

 While Gilead was partnering with Roche to make and promote Tamiflu, it was also attempting, and failing, to get approval for its new drug, remdesivir, to treat Hepatitis C and Respiratory Syncytial Virus (RSV). The drug was eventually repurposed to treat Ebola, and repurposed again for COVID-19, despite observations of kidney failure after use of the drug in trials.[xxvi] Even the World Health Organization recommended against use of remdesivir for COVID-19. Regardless of its known safety concerns, storied history of repurposing, and recommendations against use by international organizations, the FDA approved remdesivir for children as young as 28 days old and included it in its COVID treatment protocol. Many doctors, experts, and parents have serious questions about this drug, especially for our youngest. Children have almost a 100% survival rate for COVID. Why would they need this drug now that the pandemic is winding down?

COVID shots

The Comirnaty Pfizer/BioNtech COVID shot has had ongoing or delayed post-market trials to test the safety and efficacy after authorization.[xxvii] Phase 4 of clinical trials are post-market data. The post-confirmation trials must show the drug’s efficacy or risk being pulled from market. According to the FDA, “[p]hase 4 trials are carried out once the drug or device has been approved by FDA during the Post-Market Safety Monitoring.”[xxviii]

Myopericarditis has been a huge concern about the mRNA shots, especially in young boys. Despite this being a topic of every CDC and FDA advisory committee meeting in the last couple of years, one independent researcher noted safety signals were not being calculated correctly in government data. While practicing medicine, Dr. Katie Sharff asked, “Why are we seeing more cases than the research is reporting?”[xxix] She was able to obtain the raw data from the Vaccine Safety Datalink to analyze with a team. “We identified additional valid cases of myopericarditis following an mRNA vaccination that would be missed by the VSD’s search algorithm, which depends on select hospital discharge diagnosis codes. The true incidence of myopericarditis is markedly higher than the incidence reported to U.S. advisory committees. The VSD should validate its search algorithm to improve its sensitivity for myopericarditis.” The Vaccine Safety Datalink (VSD) is a partnership between the CDC and private managed care organizations at nine sites through the country. They look for 23 prespecified vaccine safety signals. The ICD-10 code of 151.4 “myocarditis, unspecified” is not included in the VSD algorithm.[xxx]

 The FDA and the CDC both adjusted their recommendations on the Johnson & Johnson COVID shot after information about serious adverse events including thrombosis (blood clots) came to light. The recommendations for the mRNA vaccines from Pfizer and Moderna have not been adjusted in light of evidence of heart damage that strikes our health young males the hardest.

What does the FDA know about the risks of the COVID shots? If history is a teacher, we can guess that they know a lot more than they are revealing, and regulators are likely turning a blind eye to safety and efficacy data. The FDA approved drugs for blood clots in kids recently, ahead of the “unexplainable” rise in clots in children after the shots were introduced to younger kids and pregnant women. Now, ahead of the potential for the FDA to authorize the shots in kids under 5, there have been sudden breakthroughs in SIDS, which was claimed to be a complete medical mystery for many decades. The articles claim to have discovered a genetic mutation that predisposes children for SIDS, right before 18 million more children will be eligible for an experimental gene therapy being called a vaccine.

We cannot be left “hoping and guessing” that a pharmaceutical product will not harm our children!

Regarding COVID shots in children, one family physician from Hawaii has pointed out that it’s “worth noting that we are in somewhat uncharted territory here. Most vaccines employ the same dose in children as adults; only the exceptions use a higher dose in adults (like the Hepatitis A and B vaccines) or even a higher dose in children (as the one for Tetanus, Diphtheria and Pertussis). There was no playbook for Pfizer to follow here; the one thing quite clear is that the mRNA vaccines carry more adverse reactions at higher doses in younger people. Aware that an onslaught of social media posts of toddlers laid low with fevers after their Pfizer shot would not play well for vaccine uptake, Pfizer erred on the side of choosing a lower dose.”[xxxi] 

VRBPAC is scheduled to discuss expansion of the Pfizer COVID shots to kids under 5 on June 15, 2022. The meeting was initially scheduled for February 15, 2022, after the White House asked Pfizer to submit a rolling application to push the agenda for experimental shots on all of America, including our babies and toddlers.

Members of the US Congress addressed a letter on June 7, 2022 to FDA Commissioner Robert Califf and members of VRBPAC pointing out, “These mRNA vaccines lack long-term safety studies and may carry unknown long-term risks.”[xxxii] The lawmakers asked a series of very important and astute questions about the “one-size-fits-all” COVID shots, and their safety and necessity for children under 5.

You can join our lawmakers in holding the FDA accountable for their decisions. Read their letter for more inspiration in making your comment in the Federal Register at the link below!