From Wayne Pacelle <[email protected]>
Subject With FDA Modernization passed, time to halt using primates in testing
Date May 27, 2023 1:30 PM
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​# [#]
The Inhumane, Wasteful, and Often Illegal Use of Primates
in Laboratory Testing and Research

Government and Contract Labs Clamor for More Primates in Labs
Even After FDA Modernization Act Clears the Path for Alternative Test Methods

By Tamara Drake and Wayne Pacelle

In what seemed a coordinated two-step, the National Academies of Science recently issued an alarmist report about animal testing and the [[link removed]] decline in the supply of nonhuman primates, followed by contract breeding labs and their allies in the animal research industry sphere pulling the fire alarm about the supposed problem. “We need more breeding of primates for use in labs,” cried the industry voices.

In the wake of the December passage of the FDA Modernization Act — a law that eliminated the requirement for animal testing in drug testing — that’s precisely the wrong instinct. With the new landmark law, now is the time for the research community to wean itself from using our primate cousins and turn toward 21st-century nonanimal testing methods that are cheaper, more reliable and less freighted with ethical defects.

The use of primates, mainly for drug testing, has been big business. The United States uses about 70,000 monkeys a year [[link removed]] , compared to about 5,000 in the larger economic market of the EU and just 2,000 in the United Kingdom.

For a practical example of why the current rate of primate use is excessive and unwarranted, look no farther than the example of the Moderna COVID-19 vaccine. The Moderna vaccine entered human clinical trials 66 days after the virus was mapped by Chinese scientists and then immediately went into human clinical trials. Given the global medical emergency, researchers leap-frogged the primate testing at the outset and it worked fine. The primate tests would not have given us anything we didn’t already know from human trials.

The primate shortage occurred after China — which supplied 60 percent of the 70,000 primates — stopped exporting primates for research once COVID-19 became a pandemic. The United States — which used several species, including Cynomolgus macaques (monkeys) — turned mainly to Cambodia and Mauritius to make up for the deficit. The United States, it turns out, is the largest importer of the animals globally. [[link removed]]

Illegal Smuggling of Endangered Nonhuman Primates into the U.S.

There’s more to this than the invasive use of our primate relatives. According to government data, Cynomolgus macaques, which are endangered, accounted for 96 percent of the nonhuman primates imported into the United States in 2022. In a word, that’s illegal.

In February, the stock market shares of primate-importer and supplier Charles River Laboratories dropped by 10 percent when they announced they had received a subpoena from the Department of Justice (DOJ) regarding trafficked endangered long-tailed cynomolgus macaques from Cambodia. The medical-research contractor was the second-worst performer in the S&P 500 Index that month. Forget the high-minded rhetoric of “research saves lives” — these folks were directly involved in trafficking endangered wildlife.

The DOJ indicted eight people [[link removed]] last November who were at the center of an international monkey smuggling ring tied to another U.S. contract research organization. That company, Inotiv, also supplies primates to pharmaceutical research companies and contract testing labs doing drug development work. Inotiv houses approximately 9,000 monkeys to sell for experiments to drug developers and other players who do animal testing.

These companies knew a crime was being committed. Passing off endangered macaques as captive-bred rather than wild has been going on for a long time, and the cases involving Charles River and Inotiv blew the lid off the wildlife-trafficking scheme. From 2000 to 2020, the research industry and its enablers States imported approximately 482,000 primates [[link removed]] , mostly for laboratory use.

Disappointing Report on the Shortage of Nonhuman Primates for Research is Shortsighted

That report [[link removed]] from the National Academies recommends expanding U.S. nonhuman primate breeding programs without opining on their relevance to human disease. The report also calls for qualification and validation efforts that are needed to realize the full potential of nonanimal methods (NAMs) but gives short shrift to their value.

The new report didn’t consider critical issues surrounding the use of nonhuman primates (NHPs) such as:

*
the
impact
of
biomedical
research
on
NHP
populations
in
the
wild;
*
the
ethical
standards
or
disputes
regarding
the
value
of
primate
research;
and
*
the
development
of
criteria
for
determining
the
scientific
necessity
of
using
NHPs
in
biomedical
research.

According to PETA, even the NIH was guilty of “33 violations of federal animal protection guidelines” just between May 2022 and January 2023,” showing that even the primate grant-maker for animal testing couldn’t even do its job properly.

Moving Toward Human-Relevant Science

A decade ago, the former NIH Director, Dr. Elias Zerhouni, acknowledged the problem with primate research, saying [[link removed]] we “have moved away from studying human diseases in humans … We need to refocus and adapt new methodologies for use in humans to understand disease biology in humans.”

A few years later, NIH Director, Dr. Francis Collins predicted in testimony (at 33.47 of the video) [[link removed]] before the U.S. Senate that the use of animals in drug development and safety testing would be mostly replaced by 2026. This replacement would be due to increasing adoption of non-animal technologies “giving results that are more accurate, at lower cost and with higher throughput.”

Yet despite these views of leaders at NIH, we are still stuck on the animal-testing treadmill.

*
Approximately
47
percent
of
all
NIH
research
funding
goes
toward
animal
experimentation.
*
We
have
no
cures
for
major
diseases,
such
as
Parkinson’s,
multiple
sclerosis,
Alzheimer’s,
congestive
heart
failure,
stroke,
pancreatic
cancer,
brain
tumors,
amyotrophic
lateral
sclerosis,
and
psychiatric
disorders
like
schizophrenia,
depression
and
more.
*
The
failure
rate
of
new
drugs
developed
using
animals
in
certain
disease
research
areas
exceeds
95
percent
for
Alzheimer’s
disease,
cancer,
sepsis,
and
stroke.

For HIV/AIDS and Hepatitis C, it’s the same story. Out of 85 potential AIDS vaccines that were tested in 197 human trials, only seven reached Phase III trials, and not one vaccine was successful [[link removed]] after passing muster in chimpanzees. The failure rate for vaccines for HIV/AIDS is 100 percent and nonhuman primates are the model of choice for safety and efficacy.

Foolhardy to Expand Primate Breeding

Even if government funding materialized tomorrow to expand breeding at the National Primate Research Centers, it would take at least a decade and hundreds of millions of dollars to accomplish. The federal government invested $30 million to expand NHP breeding in 2021 — and the shortage of primates has only become more acute.

It’s time to move away from using NHPs and shift to ethical, practical, cost-effective, and human-relevant research models that will better predict human outcomes. Continuing the unsustainable practice of using millions of animals for research and testing, including endangered animals, is a treadmill that conditions us only to cruelty and wastefulness.
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