FDA no longer needs to require animal tests before doing human drug trials. Science 1-23-2023.
The FDA no longer requires all drugs to be tested on animals before human trials. NPR 1-12-2023.
This change in policy is the result of years of effort by groups like
PETA and
CAARE.
It has shaken the vivisection industry. The notion that zillions of animals might not be bred, hurt, and killed could translate into a significant financial loss for them. Even those not directly involved in safety testing are worried that this could be the camel’s nose; it could lead to less public funding for the harmful use of animals in college and university labs across the country.
A June 23, 2023 editorial in
Drug Discovery Today (Volume 28, Number 6) caught my eye because of the title: “The ethics of animal research and testing: A US perspective,” and because one of the authors’ unethical behavior is the subject of Chapter 16 “Michelle Basso” in my book
“We All Operate in the Same Way.” The Use of Animals at the University of Wisconsin-Madison. (Virginia Smith Books: 2017)
Basso had numerous problems involving her use of monkeys while she was at the University of Wisconsin-Madison. The numerous written concerns by senior veterinary staff led to her suspension, which led to her departure and move to the University of California, Los Angeles, notable for being the homebase of the radical anything-goes vivisectors’ club,
Speaking of Research. She is currently the Director of the University of Washington, Seattle’s tax-payer-funded Washington National Primate Research Center. It may not be a coincidence that the management of the Washington National Primate Research Center’s monkey farm in Arizona deteriorated after she took the job. See:
Report: NIH probing UW primate center in Arizona. Dec. 20, 2021.
Seattle Times.
The
Drug Discovery Today article includes this humorous claim:
Declaration of Competing Interest.
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
The authors’ livelihood is dependent on hurting and killing animals.
The article starts off with an oddly ignorant assertion:
The burgeoning field of adjunct and complementary methods for animal research and testing, including computer simulations and micro-physiological systems, has given rise to a debate about the ethics of animal research and testing.
In fact, the debate has been going on since at least the late 1800s. In 1875, the National Anti-Vivisection Society was started by Frances Power Cobbe. The American Anti-Vivisection Society was founded in 1883. What the authors could have said, more accurately, is that technological advances have made it harder to defend the cruel things done to animals in the labs in the name of human health.
(A nice overview of some of those advances is available from
Citizens for Alternatives to Animal Research and Experimentation.
The authors’ argument that the use of animals is still needed starts with an appeal to two cases of new drugs harming users. The first was “The Elixir Sulfanilamide disaster of 1937,” which led directly to the Federal Food, Drug, and Cosmetic Act, or FFDCA, in 1938.
They paradoxically seem to believe that the science of toxicology has not progressed in the ensuing 86 years. They are clearly wrong, as the CAARE link above and a Google search for “nonanimal toxicology” both demonstrate.
The authors continue: “The 1960s brought about greater FDA oversight over preclinical animal research… Ethical considerations and new scientifically validated animal behavior insights led to the passage of the 1966 Animal Welfare Act (AWA).”
But, again, they are wrong. Do they know they are wrong? The plain facts are an embarrassment to the animal research community. The impetus behind 1966 Act was an article in the November 29, 1965
Sports Illustrated by Coles Phinizy about a dog who was stolen and sold to a laboratory and killed. (“The Lost Pets That Stray to the Labs.”
Sports Illustrated, 29 Nov. 1965.) Scientists in labs across the country knew they were buying stolen and lost dogs.
In fact, the USDA reports:
August 24, 1966
Passing of the (Laboratory) Animal Welfare Act (Public Law 89-544)
Rep. Resnick's efforts lead to the passage of the (Laboratory) Animal Welfare Act, [AWA] of which the stated intention is "…to protect the owners of dogs and cats from theft of such pets, to prevent the sale or use of dogs and cats which have been stolen, and to insure that certain animals intended for use in research facilities are provided humane care and treatment…". The new law establishes licensing for dog and cat dealers and authorizes the Secretary of Agriculture to regulate the transport, sale, and handling of animals pre-research or “for other purposes”. The Act covers six species: dogs, cats, nonhuman primates, guinea pigs, hamsters, and rabbits.
How is it that Basso et al don’t know this? Or, maybe they do, are embarrassed by it, and are knowingly misleading their readers? Either way, ignorant or willful, this error of fact demonstrates one of the reasons it is best to question the claims of those who make their living hurting and killing animals.
They continue with a citation that an uncritical or uniformed reader is likely to interpret as evidence of progress or researchers’ concerns for the animals they use:
“The 1985 AWA Amendment instituted federal requirements for enriching the lives of research monkeys and established the federal Animal Welfare Information Center (AWIC). Along with the 1985 Public Health Service Act for federally funded research, it also required the establishment of an Institutional Animal Care and Use Committee (IACUC) at every institution that conducts animal research and testing in the USA to ensure the humane and responsible use of animals.”
But, in fact, the 1985 Amendment was a direct response to
documentation of hideous conditions at the City of Hope in Duarte California and videos of extreme cruelty to monkeys at the University of Pennsylvania.
Basso et al write:
In the 1980s and thereafter the scientific and veterinary communities gave renewed attention to the ‘3Rs’ principles: reduction, refinement and replacement, established in 1959. Professional research societies like Public Responsibility in Medicine and Research, the American Association for Laboratory Animal Science and the AAALAC International published position statements on the importance of improving animal welfare, minimizing pain and distress and developing adjunct methods.
But the history and current activities of these organizations strongly suggests that they were intended to be (and in practice are) public relation tools for entities like colleges, universities and contract laboratories that become members. Animal welfare violations don’t result in a loss of membership.
Basso et al write: “In a June 2022 meeting of its Science Board, the FDA’s Alternative Methods working group said the agency is reviewing micro-physiological systems, cellular assays and computer models to complement and in
some cases reduce animal use (my emphasis) in drug safety and efficacy research and testing.”
But, the FDA’s Alternative Methods working group
actually said: “I am proud to highlight in this report some of the activities in which FDA is engaged that are moving us closer to the goal of replacing, reducing, and refining the use of animals in medical product development while continuing to advance disease modeling, toxicology, and pharmacology in support of FDA’s mission.” Stephen M. Hahn, M.D. Commissioner of Food and Drugs
And, the FDA says in its
Predictive Toxicology Roadmap: “Breakthroughs in many areas of science are generating new tools and methods that are being incorporated into the science of toxicology. … Also critical is the potential of these advances for replacing, reducing, and/or refining animal testing.” It seems that replacing the use of animals remains one of their goals. This seems to be what is worrying vivisectors.
Basso et al also appeal to the National Academies’ 2022 workshop series
"Nonhuman Primate Model Systems: State of the Science and Future Needs"’ https://www.nationalacademies.org/our-work/nonhuman-primate-model-systems-state-of-the-science-and-future-needs
The fact that a group of primate vivisectors and others with a vested interest in the continuation of animal use concluded that we will just have to keep using monkeys doesn’t seem too surprising. I don’t see how it bolsters the authors’ claim that the use of animals is genuinely needed. Whether or not it is, of course, says nothing about whether it is moral.
Evidence to support their claims is hard to find, this might be why they cite
a webpage produced by students, who, it seems, aren’t too up to date either. For instance, the author says, “Chimpanzees, which share 99% of their DNA with humans respectively, also serve as reliable models for researching diseases due to their similar genetic makeup. Studying them enables scientists to explore how the disease affects the body and the kind of immune response that is triggered, which then makes it possible for scientists to develop potential therapies.” [Cites 2 articles from 2014.]
Maybe the students haven't heard that chimpanzees are no longer used in medical research anywhere in the world. Basso et al must know this, and yet they try to bolster their asserions with an appeal to these out-of-date or poorly researched claims.
Basso et al are ethically blind, money can do that to a person. They write:
When it comes to research leading to understanding and treating neurodegenerative and neurodevelopmental diseases, nonhuman primates are essential because they are the only animal species with a prefrontal cortex similar to humans. Their central nervous system is more complex than other mammals and they experience similar cognitive and sensory symptoms of disease.
To paraphrase: They suffer like we do.
