Reasons to Dismantle and Reform the FDA

4 comments by Oskar Thorvaldsson

The Food and Drug Administration is the federal agency charged with protecting our food supply, including natural health supplements. However, as confirmed in a Politico.com invetigation, the FDA has increasingly de-prioritized monitoring the food supply, and increasingly shifted its resources to processing more medical products and designer drugs. A former acting FDA commissioner said that his number one problem is that the food program at the FDA was put on the back burner. Apparently the dysfunction has become so great, that even commissioners are powerless to re-shape the organization's priorities.

Let's look at the different types of problems with the FDA, ranging from the many substances it allows in the food supply, and why it got this bad in the first place.  

Failures to Ban Unsafe Chemicals

While there are many chemicals the FDA should ban, but hasn't, two of the most glaring examples are Perchlorate, and Thimerosal. Perchlorate, an increasing environmental toxin from rocket fuel, has been known about since the 1980s, and was recognized as a problem by the FDA since then. Unfortunately, the FDA lowered its restrictions starting in 2005, allowing the chemical to be used in food product packaging. Not unexpectedly, perchlorate contamination was found in high levels in baby food. Despite a petition by citizen advocacy groups to ban the chemical from food packaging, the FDA has repeatedly refused.

The FDA has also repeatedly refused to ban thimerosal, a mercury-containing preservative, for use in vaccines. Despite a plethora of evidence in human animal and cell studies presented in 2019, the FDA issued a canned response citing that it uses relative, as opposed to absolute criteria for determining safety, and that safety decisions are, “within the agency’s discretion” (FDA). They further make broad statements declaring vaccines safe and thimerosal, despite their own admission that it is not GRAS status, was banned from food products, and has never been the subject of any long-term safety studies. The FDA also falsely claimed that thimerosal was not widely used, despite it being in tens of millions of vaccines worldwide. If it has never been tested in infants, women and young children, why would it declare it a safe ingredient? The vaccine manufacturers themselves declare that the products such as the flu vaccine can cause seizures and Guillain-barre Syndrome, and further studies have found links to autism, miscarriage, and birth defects.  

Institutional Failures

There are several areas of institutional failures of the FDA, which we could categorize at both inadequate processes, and totally backward and counterproductive procedures. As far as inadequate processes, the central complaint is the lack of overisght. It not only does not respond to citizen inquiries, but also has been continuously reducing the number of inspections (by 45% from 2017-2022) despite the same number of drug applications being filed. They also have continued to use remote inspections, which were started in response to Covid-19, which allow manufacturers to hide information and tamper with data. In terms of the counterproductive processes, the FDA is set-up in a way that favors the highest bidders in the process, and appears to spend very little resources attending to both its legal obligation and citizen petition requests.

As noted by one author from the Children’s Health Defense (CHD):

“Here’s how the FDA-regulated pharmaceutical industry really works. The FDA judges all drugs as guilty until proven, to the FDA’s satisfaction, both safe and efficacious…The FDA waits for a deep-pocketed sponsor to present a comprehensive package that justifies the approval of a new drug or a new use of an existing drug.”

Events Indicating Internal Failure to Protect Citziens

Raid of Amish Farmers

A recent case that gained public attention was of a Pennsylvania Amish farmer who was raided by the FDA for selling raw milk without proper permits. The issue has become politicized, with some arguing that this is a classic example of overreach by government, and others arguing that everyone should comply with the laws to protect citizens from diseases from raw milk. The priorities do seem very misguided, and possibly indicate a threat to the big agricultural and big pharma industries which stand to lose profits from raw milk, as it has been used as an alternative to food and even drugs, as it has been prescribed for certain conditions and is known to contain probiotic species, and immune factors, destroyed by pasteurization. The extent to which the FDA sits idly by on truly dangerous compounds in the food supply, while going gestapo-style after one of the most natural foods, is a glaring example of misplaced priorities. 

Passing Rule to Disregard Informed Consent?

Perhaps most glaring of all, is the attempts by the FDA to change the established principle of informed consent. Recently, the FDA quietly passed a regulation that changed how patients must be provided informed consent. Exceptions to this have traditionally been only cases of incapacitated people. However, the new FDA rule allows exemptions based on "minimal risk", and that researcher do not need to obtain informed consent in these arbitrarily-determined situations.

Ignoring Petitions to Withdraw Dangerous Drugs

Another major failure of the FDA’s duties has been their denial of citizen-initiaited petitions, usually to withdraw a dangerous product. In 2021, the FDA was sued by a citizen advocacy group for ignoring a petition to withdraw from the market a drug for hair-loss called Finasteride, which was found to be associated with anxiety, depression and suicidal ideation. The FDA did not act for 4 years, and when sued, issued a decision in 9 months, refusing to withdraw the drug, but forcing companies to add warning labels.

The FDA has also been sued for ignoring known side-effects from SSRI use, such as “sexual dysfunction that persists for years after stopping the drug”, as explained by a former FDA psychiatrist, Dr. Josef Witt-Doerring who commented: 

“It’s not just the sexual dysfunction that persists for years after stopping the drug, they also feel totally dissociated from life, almost as if they’re watching their life play out on a screen. They can’t feel anything..."

Failed Responses to the Covid-19 Pandemic

During the early days of the pandemic, as vaccine manufacturers were developing and testing their products, the FDA was charged with oversight. However, as published in a BMJ journal in 2022, it’s oversight was found to be grossly inadequate, ignoring whistleblower claims of falsified data, inadequate training, and unblinded patients. The FDA responded by not

The FDA has repeatedly denied requests for release of information as required by the Freedom of Information Act, most notably when they said they wanted to keep the documents hidden for 75 years, and only release 500 pages per month until 2096. The agency did not explain how it was able to review over 300,000 pages of Pfizer documents required to expedite the approval of their product in a few months. Subsequently, the court ordered they would instead have to release 35,000 to 55,000 pages per month.

The most recent failure to comply with their legal obligations has been in regards to the request to provide their methods of analysis used to examine links between the VAERS system vaccine injury reporting system, and the Covid-10 injections. Why would they go to such great lengths to keep data hidden regrading the Covid-19 vaccine development and injuries? They may not have performed such analysis at all, or used such shoddy methods that releasing them would indicate fraud. The reason they gave for refusing? They said that they were, “overwhelmed by an increased number of vaccine-related FOIA requests since 2019” (CHD2).  Recently, in July of 2024, a court further ordered the FDA to actually prove it was having a difficult time in processing presently withheld documents by showing how many dedicated staff and procedures were currently in place to handle them.

According to a Reason.com article:

  • The FDA prohibited scientists from testing affected people in early 2020, preventing understanding of the virus and its effects on certain populations.
  • The FDA worked with the CDC to monopolize testing equipment and products
  • FDA staff, in charge of approving treatment options, took time off and delayed meetings

The FDA on Ivermectin

No sponsor wanted to pay the costs upfront needed for FDA to give its “new use” approval for ivermectin for Covid indications, especially when those costs would not be incurred by their competitors, who would still be able to benefit from the new classification without investing anything. Many other generic drugs have faced a similar fate, where they are highly effective for a new use, but they have no way to get through the FDA approval process.

And even though off-label prescribing is legal and widely practiced, it is illegal for pharmaceutical companies to promote off-label prescribing.

As explained by the CHD article,

“Ivermectin is an antiparasitic, but it has shown, in cell cultures in laboratories, the ability to destroy 21 viruses, including SARS-CoV-2, the cause of COVID-19. Further, ivermectin has demonstrated its potential in clinical trials for the treatment of COVID-19 and in large-scale population studies for the prevention of COVID-19. Contradicting these positive results, the FDA issued a special statement warning that “you should not use ivermectin to treat or prevent COVID-19.”

The FDA’s warning, which included language such as, “serious harm,” “hospitalized,” “dangerous,” “very dangerous,” “seizures,” “coma and even death” and “highly toxic,” might suggest that the FDA was warning against pills laced with poison. In fact, the FDA had already approved the drug years ago as a safe and effective anti-parasitic. Why would it suddenly become dangerous if used to treat COVID-19? Further, the FDA claimed, with no scientific basis, that ivermectin is not an antiviral, notwithstanding its proven antiviral activity.” (CHD)

Conclusion: Too Big to Not Fail

It's a bad sign when an agency has more FOIA requests than it can process in a lifetime, former commisioners and whistleblowers resigning and speaking out, countless failures to stop harmful substances while simultaneous using unneccesary agression against Amish farmers and physicians wanting to prescribe off-label use of ivermectin, and a general preoccupation with only what Big Pharma requests. There are many more controversial failures we could discuss, but suffice to say, they all point to the same sources: agency capture and conflicts of interest to the point that the agency works hardest for those gaming the system. At this point, the dysfunction is so great that nothing short of breaking the FDA up, and re-establishing equal resources for each division, while removing the revolving door between the FDA and Big Pharma, could reverse this trajectory. 

 


4 comments


  • Anonymous

    They seem to be feeding and protecting the “AI” movement – not taxpayers that help fund them.


  • Jenny Hatcher

    Thank you for putting this article out there. I’ve known about this corruption for some time now but the specifics are really scary. Just Thank You!!!


  • S

    Messages to reps every week or so and phone calls too.


  • Shirley

    This is spot on. Use readers can get behind this & make a difference


Leave a comment


Popular posts