The implications of the new bill are profound. Enshrined into law, it would eliminate an 85-year-old requirement that pharmaceutical companies must test drugs on animals before starting clinical trials in people.
EMILY SOHN: The list of people and organizations celebrating a potential new law modifying a longstanding FDA mandate on animal testing is long, broad, and bizarrely eclectic. It may be unprecedented for a proposal in Congress to make bedfellows of Rand Paul and Bernie Sanders, People for the Ethical Treatment of Animals (PETA) and the Cato Institute, and famed primatologist-turned-conservationist Jane Goodall and Texas congressman Marc Veasey, the former vice-chair of the pro-hunting Congressional Sportsmen’s Caucus.
The proposed new law, known as the FDA Modernization Act 2.0, does just that. This obscure legislative change basically swaps a few words in the existing section of U.S. Code that governs the development of new drugs in the United States. In one place it changes the word “preclinical” to “nonclinical,” and in another it replaces the word “animal” with the more anodyne “nonclinical tests or studies.”
That may not sound like a lot. But experts say the implications of the new bill are profound. Enshrined into law, it would eliminate an 85-year-old requirement that pharmaceutical companies must test drugs on animals before starting clinical trials in people and would usher in a new era of cell-based or computer-based testing instead…
A rare consensus across bipartisan lines represents a scientific tipping point into an era where new technologies can now outperform animal studies for many indications, says cell biologist Don Ingber, the founding director of the Wyss Institute for Biologically Inspired Engineering at Harvard University in Boston. Animal research continues to benefit people in a variety of ways and is unlikely to disappear altogether, he says. But given a strong preference for alternatives on both sides of the aisle, the change could potentially be a win for animals, people, and science.
“Everyone knows the animal models are terrible,” says Ingber, who has founded several companies including Emulate, which creates versions of a technology known as organ chips for research studies. “The drug companies know it. FDA knows it. It’s been known for years. Nobody has ever questioned that. But there has been no alternative”… Now as other options are showing greater proof of principle, he says, there is enough momentum to make regulatory changes…
However much things change within the pharmaceutical industry, the advance of the bill to the floor of the U.S. House of Representatives is a huge win for animal rights groups, many of which have been campaigning for years to sway public opinion against the use of animals in laboratory experiments.
Those efforts finally appear to be paying off. In 2001, 65 percent of people said that animal research was morally acceptable in a Gallup poll. By 2017, approval rates were down to 51 percent. Opposition to animal research grew from 25 to 44 percent in the same time frame. That societal shift, Van Norman says, probably helps explain the wide support for new regulations in Congress, which tends to bend where the wind blows.
Besides that, animals are a cute and easy photo op for politicians. “I was unaware until the last couple of months that it was required to do animal testing before you got to human testing,” Rand Paul said, announcing his co-sponsorship of the bill in his puppy press conference last year, which took place on a grassy lawn with barking dogs, wagging tails, and drooling onlookers. “I think sensibilities change over time,” Paul said…
The ultimate fate of the bill still depends on getting approval of the House and then being signed into law by the president. The House has not announced a timeline for a vote or whether that will happen before next month’s midterms. But it appears to be popular in the House as well…
Evidence has been accumulating for years showing that animal studies often only weakly predict the safety or efficacy of drugs in people, Van Norman reported in a 2019 analysis. One 2007 review of 221 animal experiments found that results in animals predicted results in people just 50 percent of the time. A 2015 study on the toxicity of 37 chemicals in rats and people showed the same kind of coin-flip results.
As many as 90 percent of new drugs fail in human clinical trials, according to some estimates, and animal studies don’t seem to be helping enough to improve a drug’s chances of being tolerated or effective in people. When scientists looked at 93 serious adverse reactions to approved drugs, they found that animal studies predicted only 19 percent of them. Even when drugs make it to store shelves, a quarter of them get removed within four years, she says, often because of safety reasons. “We’re really approaching 50 percent of the drugs that are safe in animals not being able to continue in the market because they are toxic to humans,” Van Norman says. “Fifty percent is random chance”…
Over the last decade, scientific developments have started to offer new and better ways of mimicking human biology, Ingber says. With a breakthrough paper in Science in 2010, he pioneered the development of organs on chips, one of the key technologies that could replace animal studies for understanding the function of drugs in the human body. The specific organs on chips he has produced are clear silicone rubber devices, about the size of pink school erasers, that contain tiny hollow channels and a membrane lined with human cells, and they are designed to mimic the structure and physiology of human body parts.
That’s the advantage of organ chips over just studying human cells: They can mimic real processes—breathing in the lungs, peristaltic movements in the intestines, and uniquely human microbiome communities. The chips can analyze the way drugs change in concentration over time in the human body depending on dosing regimens. Their humanlike qualities can produce more relevant results, and the fact that they are mounted on a transparent chip makes them easier to observe, Ingber says. “You get insight into the mechanism of drug action, the mechanism of drug toxicity, the mechanism of disease,” he says. “Animals are kind of a black box”. SOURCE…
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