Revising FDA Testing Mandates Will Spare Animals and Save Human Lives
Proponents of civil society no longer accept the moral premise that’s it’s okay to conduct painful or harmful experiments on their human brethren without their consent or understanding, even if insights we’d glean from them could in theory benefit the larger community.
The Tuskegee experiments that started in the 1930s and persisted through the early 1970s dramatize this moral problem that the ends cannot justify the means. At a time when there was no known treatment for syphilis, a coterie of physicians from the U.S. Public Health Service and the Tuskegee Institute enlisted several hundred impoverished African-American sharecroppers from rural Alabama who had been infected with the disease and elected not to treat them so they could track the disease’s full progression. Men died, went blind or insane or experienced other severe health problems due to their untreated syphilis, even after a promising treatment had been developed.
It was a case of some scientists running amok.
While the debate about forced testing on people is a morally settled matter, a roiling debate persists about the use of animals in science. Score one for the animals just a few years ago when the United States put a stop to the use of chimpanzees in invasive experiments, partly because their physical and psychological similarities to humans raised moral questions about subjecting them to painful and even lethal treatment. A National Academy of Sciences panel, called together by National Institutes of Health director Frances Collins, M.D., concluded that scientists had other ways to address research needs for Hepatitis, AIDS, and other disease modeled in chimps.
Still though, private companies, universities, and the federal government use vast numbers of primates, dogs, and other mammals in testing regimens. And it was with that in mind that last week U.S. Senators Rand Paul, R-Ky. Cory Booker, D-N.J., Mike Braun, R-Ind., Ben Ray Lujan, D-N.M., and John Kennedy, R-La. introduced the FDA Modernization Act to move our nation forward both morally and scientifically. Their bill, S. 2952, would eliminate a Depression-era requirement for animal testing for all new drug development protocols and to allow for alternative methods when validated.
It’s a companion to a bipartisan House bill, H.R. 2565, led by U.S. Reps. Vern Buchanan, R-Fla., Elaine Luria, D-Virginia, Nancy Mace, R-S.C., Mikie Sherrill, D-N.J., and Brendan Boyle, D-Pa., that seeks to spur innovation and open the door to the use of New Approach Methodologies (NAMs) with the goal of improving the science that is the basis for public health protection.
Alternatives to animal tests
The bill does not seek to settle the debate over animal testing, but to apply the widely accepted view that where alternative methods exist, they should be put to use.
It’s not a controversial notion, and it’s enshrined in the broad accept of the “3Rs” approach – Reduction, Refinement, and Replacement -- developed more than a half century ago by Drs. William Russell and Rex Burch and described in their book, Principles of Humane Experimental Technique.
In recent decades, almost all major research organization, pharmaceutical company, academic institution, and even government agencies have embraced the principle. But it’s the application of that principle that has been more difficult.
The existing drug development paradigm, established by statute in 1938 under the Federal Food, Drug, and Cosmetics Act (FFDCA) – about the same time the Tuskegee experiments were getting rolling – is that animal tests are required for every new drug development protocol.
While that statutory framework has limited acceptance of alternative methods in drug development for 83 years, there’s been progress in other categories of testing.
When it comes to testing of cosmetics for safety purposes, most major corporations by law or by preference, have ended animal testing of cosmetics. As a consumer, you often find a “no animal testing’ logo on packaging of cosmetics and other household products. The European Union bans cosmetic testing on animals, and Mexico just adopted a similar policy.
In 2016, the Congress looked to modernize the scientific approach to testing of chemicals, which are present in in so many aspects of our lives. An amendment to the Toxic Substances Control Act, led by Senator Booker, strengthened federal oversight over the use of tens of thousands of chemicals in commercial use and contained provisions to minimize animal testing by requiring the use of alternatives where they exist.
This kind of progress should be happening in the domain of drug development, too.
An exclusive reliance on animal tests undercuts good science
The Federal Food Drug and Cosmetics Act (FFDCA) requires drug sponsors to submit reams of animal testing data before investigational drugs are used in human trials even though animals have proved poor predictors of the human response. Between 90 and 95% of drugs found safe in nonclinical tests fail during human clinical trials due to toxicities not predicted by traditional animal tests or because they simply don’t work in their human subjects.
That kind of failure rate imposes onerous financial burdens on companies. Those costs are invariably passed on to consumers in the form of higher drug prices. Drug sponsors are hamstrung because they have no choice but to follow the archaic regulations that prescribe their work. When costs are added for withdrawn and restricted drugs, along with failures during development, for a new drug, the cost is an estimated average of $1 billion to $6 billion.
European drug makers have faced the same dynamics, and animal advocates took note of the same data. That triggered the European Parliament to vote in September to phase out animal experiments and invest in Non-Animal Methods (NAMs) that are grounded on human biological responses. The FDA Modernization Act would move us in that same direction.
“The FDA Modernization Act would accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science,” said Senator Paul. “It would also prevent the needless suffering and death of animal test subjects—which is something I think both Republican and Democrats can agree needs to end.”
No sector of the economy should be exempt from beneficial forces of innovation and moral progress
Think of the changes to the workings of society and civilization that have occurred in the last century.
In terms of land transportation, we got off the backs of the horse and moved people and goods on trains, cars, trucks, and planes.
When it came to remote interpersonal communications, we moved from the telegraph to telephone to the cell phone and the smart phone and Skype, Teams, and Zoom.
We still have robust publishing in printed form, but now access unlimited amounts of digital information in our homes and workplaces available through the internet.
Modernizing the FFDCA to include 21st-century science would improve the success rate in clinical trials and break the decades-old logjam in bringing life-saving treatments to Americans.
In doing so, drug developers and the FDA can improve clinical trial attrition rates, cut time to market in half, and substantially reduce R & D costs which could cut drug prices fivefold.
The global race for a COVID-19 vaccine – and the delivery of that vaccine to people throughout the world in record time – reminds us about the need for urgent action to pandemics and other crises. Delivering treatments for other health scourges is also an imperative, and we can get there without leaving a trail of animal victims in our wake.
This is our chance to end unnecessary animal testing in drug development in America. TAKE ACTION using our secure form to contact your Members of Congress and encourage them to co-sponsor the FDA Modernization Act of 2021.
Additionally, securing protections like this for animals in the halls of Congress requires significant resources. So please, donate $25, $50, $100 or whatever you can to help us get this important legislation across the finish line!
Wayne Pacelle is a New York Times bestselling author and President of Animal Wellness Action and the Center for a Humane Economy. He has led efforts to pass 1,500 state laws for animals, more than 100 federal laws and amendments, 30 ballot initiatives, and 500 corporate agreements. He is a graduate of Yale University