Perhaps the only thing Americans agree about today is that animals should not needlessly be tortured.  No matter their politics, Americans were upset to learn about the NIH's cruel animal experiments.  It turns out, though, according to David Gortler, a former FDA insider, that most of the most sadistic animal experiments in the U.S. are done under the aegis of the FDA — and are completely unnecessary.

In October, Americans were disgusted to learn that Anthony Fauci authorized horribly cruel and unnecessary experiments on dogs and monkeys.  And just this Monday, news emerged that the NIH "paid over $200,000 during the coronavirus pandemic for researchers to study why transgender women have high rates of HIV by injecting male monkeys with female hormones."

It turns out that the biggest culprit when it comes to animal cruelty is the FDA, which requires that all drugs submitted for its review must first have been tested on animals.  This is true even though these tests are often useless, given how different animal physiology is from human.

Dr. David Gortler, a former professor of pharmacology and biotechnology at Yale's medical school, as well as an FDA medical officer who served on the FDA's Senior Executive Leadership Team under Trump as senior adviser to the FDA commissioner for drug safety, drug epidemiology, FDA science policy, and FDA regulatory affairs, has written a detailed and very painful to read article explaining how the FDA's current leadership refuses to abandon these requirements — requirements that result in approximately 80% of all animal testing in America today.

Image: Dog and cat by wirestock.  Freepik license.

The article (which is behind a paywall) is entitled "Moral Progress Denied by FDA Leadership: New 'OOC' Technology Could Have Allowed the FDA to Abandon Its Cruel Animal Testing Requirements."  The opening paragraph sets the tone:

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.

Dr. Gortler explains that just one of the mandates is that animals be given toxic doses of experimental medicines, far exceeding anything a human would take, just to see how much it requires to kill the animal.  If you have the stomach for it, this PETA video (one of many) shows just one example of what's being done to dogs in these laboratories.

These testing requirements go back to 1962 when Congress decided to bring scientific methodologies to standardize drugs passing before the FDA for review.  The FDA's regulations rigidly enforce this sadistic animal research, even though it has virtually no predictive value regarding a drug's efficacy or safety.  The FDA truly is wedded to these guidelines:

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.

Thanks to these regulations, "over tens of million[s of] mice and rats [are] killed per year in the name of science in the U.S.  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."  What makes this all terribly ironic is that the tests are useless.  For example, rats can't vomit, so tests don't show whether drugs cause gastric problems, while thalidomide causes ghoulish birth defects in humans but does nothing to animals.

Moreover, things have changed since 1962.  Dr. Gortler describes tests that can be done by programming or culturing human cells to determine how they'll respond to experimental drugs.  The results would be more accurate, and no animals would be harmed.

Running trials to prove that these modern methods are effective should be a no-brainer in a government that spends $200,000 to make apes transgender.  However, Patrizia Cavazzoni, a psychiatrist whom Biden appointed to head the FDA's Center for Drug Evaluation and Research, refuses to budge.  By the way, if her name sounds familiar, it's because, in June 2020, she revoked emergency approval for hydroxychloroquine.  Multiple studies now prove its efficacy in treating COVID, but it's still unavailable.

Congress has been vaguely aware of this moral problem, but Dr. Gortler writes that the FDA refuses to move on it:

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. 

In other words, this is another federal agency ignoring congressional oversight.  Democrats are usually fine with this.  This time, though, the plight of tortured animals should move them, as it should move every moral person, to contact senators and House members and demand that they pressure the FDA to act.