In 1937, an American pharmacist introduced an elixir to treat pharyngitis—and unwittingly sparked a public health disaster. The product, which had not been tested on humans or animals, contained a solvent that was found to be toxic. More than 100 people died.
The following year, the United States Congress passed the Federal Food, Drug, and Cosmetic Safety Act, which required pharmaceutical companies to submit safety data to the US Food and Drug Administration (FDA). before offering new medicines, helping usher in an era of animal toxicity testing.
Now, a new chapter in drug development could be beginning. The FDA Modernization Act 2.0, enacted late last year, allows drugmakers to gather initial safety and efficacy data using new, high-tech tools instead of animals. Other countries are making similar changes. In 2021, the European Parliament called for a plan to phase out laboratory testing on animals.
These moves have been driven by a confluence of factors, including changing views on animals and a desire to make drug development cheaper and faster, experts say. But what is finally making them feasible is the development of sophisticated alternatives to animal testing.
Many of these technologies need to be refined, standardized and validated before they can be used routinely. But momentum is growing for non-animal approaches, which could ultimately speed drug development, improve patient outcomes and reduce the burdens on laboratory animals.
“Animals are just a surrogate for predicting what’s going to happen in a human,” said Nicole Kleinstreuer, director of the National Toxicology Program’s Interagency Center for Evaluation of Alternative Toxicological Methods. “If we can get to a point where we actually have a fully relevant model for humans, then we won’t need the preliminary animal stage anymore.”
Animal rights groups have been pushing for a reduction in animal testing for decades.
In recent years, scientists have been able to get human stem cells to assemble on their own to form a small, three-dimensional mass, known as an organoid, that exhibits some of the same basic features as a specific human organ, such as a brain, lung, or heart. kidney. Scientists can use these miniature organs to test treatments.
Another approach relies on “organs on a chip.” These devices contain tiny channels that can be lined with different kinds of human cells. Researchers can inject drugs through the canals to simulate how they might move through a part of the body.
There are also computer models that can predict whether a compound is likely to be toxic and how quickly it will be metabolized.
For now, these alternative methods are better at predicting relatively simple short-term outcomes, such as acute toxicity, complicated long-term consequences, for example, whether a chemical might increase cancer risk when given for months or years, they said. the scientists.
Nicole zur Nieden, a developmental toxicologist at the University of California, Riverside, said the new strategies could help weed out ineffective and unsafe compounds before they get to animal testing.
“We will be able to greatly reduce the suffering of the test animals,” he added.
By: Emily Anthes
BBC-NEWS-SRC: http://www.nytsyn.com/subscribed/stories/6611821, IMPORTING DATE: 2023-03-14 22:00:06
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