Most Americans would be appalled to know how many animals are stunned, electro-shocked, sleep-deprived, poisoned, vivisected and killed in the name of science at taxpayer expense. Believe it or not this sort of cruel animal testing is actually required by FDA law.
DAVID GORTLER: Recently the FDA scolded Americans interested in Ivermectin as a COVID-19 treatment by tweeting “You are not a horse. You are not a cow.” The FDA’s tendentious sarcasm is ironic given that the FDA mandates animal testing for all human drug development. Most Americans would be appalled to know how many animals are stunned, electro-shocked, sleep-deprived, poisoned, vivisected and killed in the name of science at taxpayer expense. Believe it or not this sort of cruel animal testing is actually required by FDA law…
In 1962, Congress passed The Kefauver-Harris Amendments (KHA) to “modernize” scientific methodologies under the Federal Food, Drug and Cosmetic Act and empowered the FDA to mandate animal testing requirements for new drug approvals. Of course, science has advanced tremendously in the last 60-odd years, but the FDA has not kept up. Following the FDA’s lead, neither have most other researchers…
The word “animal” is used specifically and repeatedly in this regulatory text for measures of pharmacology (how the drug exerts its effects) and toxicology (at what dose it causes adverse events), as well as for radiation absorption, the effect on pregnancy, fertility and effects on a developing fetus. Existing FDA regulations allow absolutely no flexibility to explore or implement newer methods that are more predictive for humans because they utilize human biology rather than that of other species. FDA alone holds the power to initiate change.
In the meantime, companies must follow these regulatory rules in order to move an investigational medication through the review process to obtain FDA approval… Recently, Vanda Pharmaceuticals sought to avoid conducting a 9-month study on dogs, stating the study — which would kill dozens of dogs— had no scientific justification, but FDA reviewers would not budge, referencing its own guidance documents…
After 60 years scientists have learned that the results of animal tests aren’t particularly useful or predictive in humans. Despite this, FDA requires animal tests to be performed for almost every investigational new drug it reviews, regardless of its utility. It’s noteworthy that approximately 90% of early-phase clinical trials fail after “passing” extensive animal testing.
The KHA and FDA’s ongoing failure to move away from animal studies has contributed to over tens of million mice and rats killed per year in the name of science in the US. Separate from that are the other animals killed including, monkeys, rabbits, pigs, guinea pigs, cats. That includes an estimated 20,000 dogs killed per year…
Many of the animal studies required by the FDA are rather nonsensical, including eye- and skin-irritation tests of drugs that are approved only for oral administration. The National Institutes of Health acknowledges “Approximately 30 percent of promising medications have failed in human clinical trials because they are found to be toxic despite promising preclinical studies in animal models.” Using animals to test human drugs not only hurts animals, it hurts people…
There have been rather dramatic advances in drug testing since the 1960s, including pre-clinical, non-animal testing methodologies… One of the things I proposed was advancing “Organ on a Chip” (OOC) technologies— which potentially could have done both. OOCs are made by programming or culturing human cells obtained from relevant human organs (heart, liver, kidney, brain, gastrointestinal) in a microenvironment “chip,” where micro-doses of experimental drugs can be applied…
Since human cells are used to populate these OOCs, this in vitro technology circumvents — and has the potential to reduce or eliminate — the cruelty and experimental limitations that have always been inherent in animal testing. The ethical and technological advantages are obvious. OOCs have the potential to predict safe doses more clearly and quickly than animal tests…
In 2020, both the House and Senate directed the FDA to “…review and modify regulations in 21 C.F.R. to clearly reflect the agency’s discretion to accept valid nonclinical approaches” to include changing references to ‘‘animal’’ data to ‘‘nonclinical,’’ (e.g., OOC) and report its progress by Sep 30, 2021. The FDA missed the deadline. To date, the FDA has no funding or dedicated staff to dedicate to these methodologies and no guarantee that in vitro or in silico methods (e.g., OOC) will be advanced or even explored.
Concerned scientists everywhere wait for the FDA leader to act, but the FDA continues to ignore the latest science, congress and the ongoing animal cruelty and suffering… Alternatives to animal testing such as OOCs already have bipartisan support. Replacing animals with state-of-the-art OOCs is not just an animal welfare issue, it is an issue of public health and reducing the time needed to bring investigational pharmaceuticals to market…
Over the past six decades, technology has dramatically progressed along with our view of the role of animals in society… Moral progress and ethics have guided retailers’ concern for animal welfare regarding the wearing of fur. Wearing animal fur is another thoughtless practice… Around the world we also see zoos closing their doors because common sense tells us that forcing wild animals to be placed in display behind bars essentially make all zoos an alternate form of animal cruelty…
Common sense and moral progress also dictate that the FDA is obliged to keep up with the latest technology to protect public health. That means reducing or eliminate its mandate and reliance on cruel and unnecessary animal tests.
Deep down we all know that it is particularly sinister to abuse domesticated animals and pets that we have bred to love, trust and completely depend on us as human beings. OOC technology has the potential to provide an avenue for a new kind of preclinical testing that doesn’t torture “man’s best friend” or any other animal.
America’s FDA deserves a forward-thinking, open-minded and scientifically nonpartisan generation of leaders who listen to scientific progress, congress, OOC technology and set positive examples against animal cruelty. In the meantime, animals everywhere will continue to suffer. SOURCE…
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