Straight Dope on Medicine: End of Animal Testing?

Before human clinical testing can commence, animals must be tested.

In the search for a new drug, it will first be tested in the lab. Next, scientists must test those compounds that have shown at least some desired effects in living animals. In animal testing, drug companies make every effort to use as few animals as possible and to ensure their humane and proper care. Two or more species are typically tested because a drug may affect one differently from another. Such tests show whether a potential drug has toxic side effects and what its safety is at different doses.[i] 

At Pfizer, one of the most evil, corrupt, dishonest companies on the face of the Earth, “99% of the animals in our care are rats and mice. Other species include rabbits, hamsters, guinea pigs, ferrets, dogs, and non-human primates.”[ii]

“You’re protected most likely for longer since there was a natural response,” said Croce. He also expressed dismay at his company’s lack of ethics adding that the monoclonal antibody treatments had been “pushed to the side” because of greed and money. Croce said this was “disgusting”.

“I still feel like I work for an evil corporation because it comes down to profits in the end. I mean, I’m there to help people, not to make millions and millions of dollars. So, I mean, that’s the moral dilemma.”

He added: “Basically, our organization is run on Covid money now.”

The third Pfizer scientist, Rahul Khandke, admitted that his company demanded that its employees keep this vital information from the unsuspecting public. “We’re bred and taught to be like, ‘vaccine is safer than actually getting Covid.’ Honestly, we had to do so many seminars on this. You have no idea. Like, we have to sit there for hours and hours and listen to like — be like, ‘you cannot talk about this in public,’” Khandke explained.

Khandke also conceded that proof of antibodies was as good as proof of vaccination. “If you have [Covid] antibodies built up, you should be able to prove that you have those built up,” he said.

I will put it simply: Natural Immunity is far, far, far better than any mRNA injection.

Everyone should know that.

Getting back to the matter at hand….

How many animals are used?

Now, for the first time, someone has attempted to calculate this number using data from U.S. labs, and it's big: More than 111 million mice and rats are used annually in U.S. biomedical research, according to a new study. That represents more than 99% of all lab animals.[iii]

"It's a very thoughtful and reasonable analysis," says Sue Leary, president of the Alternatives Research & Development Foundation (ARDF), which seeks to reduce the number of animals in labs and find replacements. The figures are troubling, she says, because mice and rats are not covered by the federal Animal Welfare Act (AWA), which enforces the humane treatment of research animals. "If the numbers are anywhere near correct, the amount of pain and suffering that's occurring in these animals is completely unacceptable."

But many in the biomedical community say the figures, published today in Scientific Reports, are a gross overestimation, and that the study itself is deeply flawed. "It's a really disappointing analysis," says Allyson Bennett, senior editor at Speaking of Research, which advocates for the use of lab animals. The organization's own estimates—extrapolated from European labs, which do count mice and rats—put the number of rodents used annually in U.S. facilities at 10 million to 25 million. That would represent 93% to 97% of all U.S. research mammals. Bennett also disagrees with the idea that the animals are at risk of being mistreated because they are not covered by the AWA.

The Humane Society lands somewhere in the middle.

It is estimated that more than 50 million animals are used in experiments each year in the United States. Unfortunately, no accurate figures are available to determine precisely how many animals are used in experiments in the U.S. or worldwide.

The U.S. Department of Agriculture (USDA) does compile annual statistics on some animals used in experiments, including cats, dogs, guinea pigs, hamsters, pigs, primates, rabbits and sheep.[iv]

The 50 million figure does not include rats and mice.

Chimpanzees have thankfully not been subjected to invasive experiments in the U.S. since 2015, when federal decisions were made to prevent their use. Despite this, hundreds of chimpanzees are still languishing in laboratories while they wait to be moved into sanctuaries.

What kinds of experiments are animals used in?

Animals are used in many different kinds of experiments. These are just a few examples:

  • Dogs have their hearts, lungs, or kidneys deliberately damaged or removed to study how experimental substances might affect human organ function.

  • Monkeys are taken from their mothers as infants to study how extreme stress might affect human behavior.

  • Mice are force-fed daily doses of a chemical for two years to see if it might cause cancer in humans.

  • Cats have their spinal cords damaged and are forced to run on treadmills to study how nerve activity might affect human limb movement.

  • Ferrets are deliberately infected with extremely painful, potentially fatal diseases (such as RSV, COVID-19 or Ebola) and not given pain relief or treatment before their death to study how humans might be affected by the same disease.

  • Pigs are implanted with various devices (such as pacemakers and dental implants) to study how human bodies might respond to such devices.

  • Pregnant rabbits are force-fed toxic pesticides every day for several weeks to study how human mothers and babies might be affected if they were exposed to the pesticides.

  • Sheep are subjected to high pressures (such as those experienced deep underwater) for hours at a time and then returned to normal pressure so that their response can be observed.

  • Rats are placed in small tubes and are forced to inhale cigarette smoke for hours at a time to study how humans might respond to cigarette smoke.

  • Baboons are injected with endometrial tissue to induce painful symptoms of endometriosis and study how humans might be affected by the disorder.

  • Horses are infected with a potentially fatal virus (such as hepatitis) and their symptoms monitored to study how humans might be affected by the same virus.

Drawbacks to Animal Testing

Researchers have warned for years that animal drug tests aren’t as reliable as they’re made out to be. Aysha Akhtar, a neurologist and animal ethicist, published a paper in 2015 discussing the dangers associated with assuming a product is safe or effective on humans just because it was on mice, rats, dogs, or monkeys.

Or vice versa.

There is no one-to-one correspondence between humans and any animal.

MORE THAN 90% OF DRUGS ENTERING CLINICAL TRIALS FAIL, DESPITE POSITIVE RESULTS IN PRECLINICAL ANIMAL TESTS.

Animal Alternatives

Akhtar mentions, “human organs grown in the lab, human organs on a chip, cognitive computing technologies, 3D printing of human living tissues, and the Human Toxome Project.”

What kinds of institutions use animals in experiments?

Chemical, pesticide and drug companies (as well as contract laboratories that carry out tests for those companies), public and private universities, community and technical schools, government facilities, Veterans Affairs (VA) facilities and hospitals all use animals in experiments.

Animal Welfare Act

The Animal Welfare Act is a federal law that sets minimal standards for the treatment of certain warm-blooded animals used in experiments. The law also requires that unannounced inspections of all regulated research facilities are carried out annually. In addition to purpose-bred mice and rats, animals such as crabs, fish, frogs, octopuses and turtles as well as purpose-bred birds are not covered by the Animal Welfare Act. The failure to protect these animals under the law means that there is no oversight or scrutiny of their treatment and use in the laboratory. These animals aren’t even counted.

Why?

Requirements and data.

the Environmental Protection Agency (EPA) requires that a new pesticide be fed to dogs for 90 days as part of its evaluation and approval process. The Food and Drug Administration (FDA), which regulates various products such as drugs, medical devices, food, fragrances, and color additives, will not approve potential drugs unless they are first tested on animals, which usually includes dogs. In addition to tests on dogs, mice and rats, rabbits, birds and primates are also used to test pesticides and drugs.

In addition, pharmaceutical companies want information like dose-response, immunogenicity, volume of distribution and toxicology.

The News

Pharmaceutical Companies Are No Longer Required to Test Drugs on Animals[v]

Beginning this year, the US Food and Drug Administration (FDA) will be required to comply with a new law that waives animal testing requirements for pharmaceutical companies. Drug makers will now have the option to shift directly toward human trials without first testing their products on mice, rats, rabbits, or other animals.

The change is courtesy of the FDA Modernization Act 2.0, a bill Senator Rand Paul’s (R-KY) and Senator Cory Booker’s (D-NJ) first introduced back in October 2021. Nearly a year later, the bill unanimously passed through the Senate and then the House of Representatives. The FDA Modernization Act 2.0 made its way to President Biden’s desk last month and cleared its final hurdle just days before 2022 came to a close.

The law eliminates an animal toxicity testing mandate implemented in 1938. Rather than having to test medical treatments on rodents and other non-human animals, companies can now skip directly to the human trial step toward commercialization. Companies will still have the option to test their products on animals if they so choose.

Animal testing for cosmetics is illegal across the European Union, as well as in many other countries.[vi]

Will Pharmaceutical companies stop?

No.

But they may cut back.

Time will tell. Some animal testing can be expensive. It also matters if the direct to human avenue develops some turbulence. Sticking an investigational drug into humans for the first time with no animal information may lead to unexpected morbidity and mortality. If so, there may be a backlash against that.

In May of 2019, the Wellcome Sanger Institute announced it was closing its animal facility in line with its “scientific strategy”, which will transition towards the use of alternative technologies.[vii]

We can’t edit out all risk, and progress does have a price. Is it one we are willing to pay or not? That is the question. Also, are the testing companies doing all they can to minimize damage to animals and humans alike?

References

[ii] https://www.pfizer.com/science/clinical-trials/integrity-and-transparency/animals-used-in-research#:~:text=What%20Kinds%20of%20Animals%20Are,%2C%20and%20non%2Dhuman%20primates.

[iii] https://www.science.org/content/article/how-many-mice-and-rats-are-used-us-labs-controversial-study-says-more-100-million#:~:text=Now%2C%20for%20the%20first%20time,99%25%20of%20all%20lab%20animals.

[iv] https://www.humanesociety.org/resources/animals-used-experiments-faq

[v] https://www.extremetech.com/extreme/342310-pharmaceutical-companies-are-no-longer-required-to-test-drugs-on-animals

[vi] https://pharma.nridigital.com/pharma_oct19/are_we_nearing_the_end_of_animal_testing_in_pharma