The FDA's Conflicts of Interest

As noted in a 2017 article published in the Journal of Law and Medical Ethics, the pharmaceutical industry has exerted an extraordinary amount of influence over which drugs are developed, tested and studied. The FDA’s main clients are drug companies, whose pressure to shorten review times has resulted in an increased number of adverse events (1).

In addition to the capture of drug discovery and the entire FDA process, we are learning that simultaneously the FDA is not protecting Americans from the dangerous pathogens and toxins in our food supply. A Politico investigation, for example, discovered that the FDA has repeatedly failed to warn consumers about heavy metal in baby foods, and pathogens in water for growing crops, despite being aware of them for years (2). Far from being just another slow bureaucracy, the FDA is absolutely glacial, or as some former FDA officials anonymously commented, “broken”, impossible and “a joke”.

We need look no further for large scale failures than the history of “FDA-approved” food additives, like aspartame and sucralose, which had ample evidence of toxicity, while at the same time the FDA banned Stevia (3). How was a harmless herb banned when it has decades of safe usage? Surprisingly, it was not the drug companies, but the sugar industry, who lobbied the FDA because they were afraid that Stevia would reduce their market share (4). Between 1991 and 2008, stevia could not be used in any product.

Even though they eventually reversed their decision, the damage was done, and the health of the public was certainly held back and pushed towards worse alternatives.

Are FDA Inspections Broken?

A Kaiser Health News investigation discovered that 65 drug-making facilities recalled nearly 300 products within 12 months of the facility passing an FDA inspection. Including:

• 39,000 bottles of HIV drug Atripla laced with red silicone rubber particulates
• 37,000 Abilify mood disorder tablets that were mistakenly “superpotent”
• 12,000 boxes of generic Aleve (naproxen) that were actually ibuprofen
• Over-the-counter ducosate sodium, an anti-constipation drug, contaminated with deadly bacteria

Rulings Against the FDA

If terrible FDA quality control and recalls aren't bad enough, we can also get a flavor of the FDA’s crooked bent in previous suits they have lost.

In late 2000, the case of Pearson v. Shalala II involved a suit against the Food and Drug Administration (FDA) for suppressing health claims regarding the intake of folic acid by pregnant women and its potential to prevent neural tube defects. The FDA opposed this labeling of the simple B vitamin's benefits. The court found that the FDA failed to follow constitutional guidelines from the previous Pearson I case and the FDA was criticized for either “misunderstanding” or deliberately ignoring significant parts of the Court of Appeals Opinion: The FDA's conclusion was deemed arbitrary, capricious, and unlawful, and the court ruled in favor of the plaintiffs, highlighting the FDA's legal violations in suppressing the health claim.

In 2010, the Alliance for Natural Health USA (ANH-USA) was the lead plaintiff in a lawsuit against the FDA. The lawsuit challenged the FDA's denial of further health claims and the constructive suppression of others through disclaimers that negated the benefits. The court found that the FDA's decision to ban health claims related to colon and digestive tract benefits was unreasonable. The ruling emphasized that the FDA's ban was not supported by the available evidence nor the FDA's own Guidance Report. The court sided with the plaintiffs, reinforcing that the FDA's actions were unreasonable and unsupported by evidence.

FDA Settles on Ivermectin Disinformation

Another prominent case of FDA taking action unsupported by evidence is its official stance on ivermectin. Ivermectin was discovered by Satoshi Omura in 1973, from the soil microorganism, Streptomyces avermectinius (S. avermitilis). The drug became a  highly politicized topic, despite numerous experts and studies citing its efficacy. A 2017 article published in the Journal of Antibiotics, was titled, "Ivermectin: Enigmatic Multifaceted ‘Wonder’ Drug Continues to Surprise and Exceed Expectations", in which the author states that ivermectin continues to offer "promise to help improve global public health by treating a diverse range of diseases, with its unexpected potential as an antibacterial, antiviral and anti-cancer agent being particularly extraordinary." (5). 

It came as a surprise to many physicians when the FDA waged a false rhetoric-based campaign against ivermectin, telling people to stop using it. They promoted a social media post saying: "You are not a Horse. You are Not a Cow. Seriously, y'all. Stop it."

The lack of evidence to back up these claims, and apparent ignorance of the widespread use of ivermectin in human populations, led to Dr. Mary Talley Bowden, a Houston-based doctor, along with two other physicians, to sue the FDA for overstepping its authority. 

The appellate court ruled in their favor, rebuking the FDA's attempts to misinform the public about the uses and availability of ivermectin for human use. While the corrupt judge in the initial case, Jeffery Brown, claimed that the FDA had "soveriegn immunity", the appellate court judges held that the "FDA is not a physician" and only has the authoirty to inform, but not to "endorse, denounce or advise" (5).

Dr. Bowden believes that the damage done by the FDA will linger, but that this ruling will set a precedent for future attempts of federal agencies to thwart public health efforts by physicians.  

Conclusion

It's clear that the FDA is one of the most mismanaged, influence-peddling agencies in the U.S., and largely operates as an arm of big pharma. Hopefully, we will see attempts through congress, and not just court cases, that aim to improve regulations on conflicts of interest, as well as the prevention of drug companies from participating in, and managing their own safety trials.

Sources

1. Light DW, Lexchin J, Darrow JJ. Institutional corruption of pharmaceuticals and the myth of safe and effective drugs. J Law Med Ethics. 2013 Fall;41(3):590-600. doi: 10.1111/jlme.12068. PMID: 24088149.
2. https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/
3. Iuliano, J. (2021). Killing Us Sweetly: How to Take Industry out of the FDA. Journal of Food Law & Policy, 6(1). Retrieved from https://scholarworks.uark.edu/jflp/vol6/iss1/4
4. https://www.farrin.com/blog/4-fundamental-fda-failures/
5. https://thetexan.news/issues/healthcare/houston-doctors-lawsuit-forces-fda-to-remove-covid-19-related-ivermectin-posts/article_d62379ca-e875-11ee-9aa3-0b1840d4cc96.html