Dosing puppies with drugs designed for humans won’t make people safer. In fact, it poses serious risks to human health.... Francis Collins, the director of the U.S. National Institutes of Health, wrote last year that 90 percent of drugs entering human trials fail to gain FDA approval, many because they show dangerous side effects not predicted by the animal trials.
Ben Mason, via Flickr
The U.S. Food and Drug Administration (FDA) is slowing the search for
treatments and cures for COVID-19 and other illnesses by forcing
pharmaceutical manufacturers to conduct unscientific and outdated drug
safety tests on puppies. The FDA asserts these tests are necessary because
they help screen out toxic drugs before they reach people, but the evidence
shows they’re inaccurate and inefficient. The FDA has the power to fix this,
but hasn’t, and I’ve joined a new #CutFDARedTape effort to change that.
I am a pathologist, with expertise in diagnosing human disease, and can say
with certainty that dosing puppies with drugs designed for humans will not
make people safer. In fact, it poses serious risks to human health.
As advocacy group White Coat Waste Project recently revealed, these drug
tests on puppies are being carried out to comply with 80-year-old FDA
regulations that are not based on modern medical science.
Right now, to get a drug approved for sale in the U.S., the FDA requires
companies to undertake extensive animal testing. Among these tests are
deadly experiments on beagle puppies. Every day, for up to a year, each
young dog is forced to swallow or breathe doses of experimental drugs. At
the end of the tests, the puppies are killed and cut apart for examination.
There are many problems with this model, including the cruelty, the time
(the process can take up to a year to complete) and the expense; some of the
dog tests cost hundreds of thousands of dollars.
Perhaps the greatest problem with the FDA’s required dog testing is that it
just doesn’t work. Francis Collins, the director of the U.S. National
Institutes of Health, wrote last year that 90 percent of drugs entering
human trials fail to gain FDA approval, many because they show dangerous
side effects not predicted by the animal trials.
This number may seem shocking, but it shouldn’t be. Animal testing’s
fundamental flaw is that puppies aren’t little humans. There are core
biological differences between humans and dogs (and other laboratory
animals) that help explain the failure of animal testing. Just to take one
obvious, everyday example: We humans are fortunate enough to be able to eat
chocolate safely, while small amounts of chocolate are toxic for dogs.
If it’s clear how the thousands of dogs experimented on and killed to comply
with this FDA red tape are harmed, what may be less obvious at first glance
is how people are harmed, too — primarily by keeping safe and effective
drugs from patients who need them, allowing dangerous drugs to reach the
market and significantly increasing medical costs.
Meanwhile, companies challenging these outdated and counterproductive rules
in favor of high-tech methods that are more accurate, humane and
cost-efficient aren’t allowed to pursue this better path but instead are
punished by the FDA.
One recent example is Vanda Pharmaceuticals, a Washington, D.C.-based global
biopharmaceutical company developing the drug tradipitant, primarily to
treat gastroparesis — a common stomach disorder — but which also shows
potential as a treatment for COVID-19-related pneumonia.
In 2018, right in the middle of human trials — and despite a mountain of
evidence from testing in animals and humans that showed the drug is safe for
use in humans — the FDA demanded that Vanda conduct long-term testing on
puppies, who would then be killed. When Vanda pushed back on the
unscientific, expensive, slow and unnecessary dog-testing demands, the FDA
blocked the human studies of tradipitant and the drug was put on hold
indefinitely as the company appealed the testing request. Tradipitant has
now emerged as a potential COVID-19 treatment and may have already been
available to sick patients if not for the FDA’s bureaucracy.
Our patients deserve the best biomedical research that brings them safe and
effective cures and treatments as efficiently as possible, but the FDA’s
dog-testing mandate is hampering medical progress, not helping it.
Luckily, there are still reasons for optimism. The FDA has recently
reevaluated its dog-testing mandate for food additives and veterinary drugs
and found viable alternatives. Polls show two-thirds of Americans support
eliminating the FDA’s dog-testing requirement for drugs, too.
Forward-thinking lawmakers are also taking notice and taking action. Rep.
Brendan Boyle (D-Pennsylvania) recently spearheaded a letter to the FDA
signed by 17 of his House Democrat and Republican colleagues seeking to
reform these archaic rules. “Science has come a long way and there are now
better ways to assess the safety of drugs than conducting deadly experiments
on dogs,” he recently said in a statement.
The bottom line is that abolishing the FDA’s blanket dog-testing mandate
will not just spare thousands of puppies from abuse in the lab, but it would
also help us improve human lives. Especially now, while we all struggle with
the health and economic effects of COVID-19, this is the relief we need.
Tiffani Milless Tiffani Milless, M.D., is a board-certified pathologist based in Des Moines, Iowa.
This article first appeared on Truthout and was produced by Earth | Food | Life, a project of the Independent Media Institute.
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