FDA no longer requires animal testing for new drugs. Is that safe?

Published

2 years ago

February 16, 2023

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The U.S. Food and Drug Administration (FDA) no longer requires new drugs to be tested in animals before being approved. Thanks to a law passed in December 2022 (opens in new tab) , the agency now has the option to approve drugs that are tested in only non-animal studies, including those that use lab-grown tissues or computer models, before being tested in clinical trials with humans.

But is that safe, and will it happen any time soon? For now, no one should expect a dramatic shift in how drug developers bring medicines to market, experts told Live Science.

“I think it’s going to be a while before this actually gets implemented in full force,” Vivek Gupta (opens in new tab) , an associate professor of industrial pharmacy at St. John’s University told Live Science. Gupta is also the scientific founder of PulmoSIM Therapeutics, a subsidiary of VeriSIM Life that develops therapies for rare and progressive respiratory diseases.

That’s because, although promising non-animal models have recently been developed, these technologies are “still in their infancy,” Jim Newman (opens in new tab) , communications director at Americans for Medical Progress, which advocates for the use of animal research, wrote in a Feb. 1 statement (opens in new tab) .

Related: Why do medical researchers use mice?

Previously, the FDA typically required drugs be tested in one rodent and one nonrodent species, before they were moved into human trials, Science reported (opens in new tab) . These animal tests help reveal how drugs break down in the body, whether they reach the tissues they’re intended to target and whether they exert the intended effects on those tissues — without having harmful side effects. But they’re not perfect: more than 90% of drugs that pass initial animal tests end up being unsafe or ineffective in humans, according to a 2019 review in the journal Translational Medicine Communications (opens in new tab) .

Research groups developing alternatives to animal testing aim to find different models that capture this same information, or better yet, ones that accurately predict exactly how a drug will behave in people.

Dr. Donald Ingber (opens in new tab) , the founding director of the Wyss Institute for Biologically Inspired Engineering at Harvard University, agreed with Gupta’s assessment that the implementation of the new law will be gradual. “It’ll still be a while, I think, before we really see the impact of this,” Ingber told Live Science.

One of the biggest hurdles will be convincing drug developers to adopt new, non-animal testing methods, he said. The companies will want to see evidence that the models show equivalent or superior performance to animal testing, and reassurance that the FDA views the tests as robust before they heavily invest in new technology. Once they do, that will provide the FDA with more evidence that these tests can replace animal testing.

“I think it’s going to happen over the next couple years, one by one, drugs including data from these models,” said Ingber, whose lab develops “organ chips” — small devices that contain living human tissues and flowing fluids that mimic the inner workings of full-size organs. These organ chips, which can be used in drug testing, are being commercialized by Emulate, a biotech company of which Ingber is a board member.

This is an example of the “Organ Chip” platform developed at the Wyss Institute and subsequently licensed to Emulate, Inc. (Image credit: Harvard’s Wyss Institute)

Still, replacing animal models with organ chips will “occur gradually,” as each system will have to be validated for a specific purpose, to show how a drug is absorbed by the colon or whether it damages heart cells, for example, Ingber wrote in his review.

What’s more, “true validation of their use as animal replacements will require large-scale evaluation involving hundreds of devices of the same design carried out using the same protocols,” a feat that will require regulatory agencies and drug companies to work together to standardize their validation methods and performance criteria, he added.

Related: Tiny ‘hearts’ self-assemble in lab dishes and even beat like the real thing

Other promising alternatives to animal testing are organoids, or 3D clusters of lab-grown cells that can mimic key biological features of full-size organs. These organized clumps, often derived from stem cells and grown on physical scaffolding, are especially useful for observing cell- and tissue-level drug responses, as well as assessing how well drugs latch onto their molecular targets, Ingber said.

“In the same ballpark” of organoids are spheroids — simpler 3D clusters of cells that are often used to model cancerous tumors, Gupta said. Gupta, who studies lung cancer, works with spheroids grown from primary cell lines, which are populations of cells sampled directly from human patients and can only replicate a few times; that’s in contrast to so-called immortalized cell lines, which can be grown indefinitely.

Although often more difficult to obtain than immortal cells, primary cells better capture what happens in a human patient, Gupta explained. RELATED STORIES—Fatal ‘brain-eating’ amoeba successfully treated with repurposed UTI drug

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Alongside these models constructed from cells are those built using computers. For instance, scientists have built computer models to assess drug toxicity — one model, described in a 2018 report in the journal Frontiers in Physiology (opens in new tab) , predicts whether a given drug could have toxic effects on the heart.

“As the AI-based models become more and more robust, as more and more data gets fed into them, I think they are able to provide a fairly accurate prediction,” Gupta said. Perfecting these AI-based models will be essential in getting rid of the early stage animal tests that assess how drugs get broken down in the body and interact with different tissues, he said.

As more drug developers invest in and perfect organ chips, organoids and AI-based models the need for animal studies may gradually shrink. In the meantime, “I think the FDA will be happy to review the data,” Ingber said. “If they see data that they believe are convincing, they can use it,” he said.

US

Virginia Giuffre, who accused Prince Andrew of sexual assault, has died, her family says

Published

53 mins ago

April 26, 2025

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Virginia Giuffre, who accused Prince Andrew of sexual assault, has died, her family says

Virginia Giuffre, who accused Prince Andrew of sexual assault, has died aged 41.

In a statement to Sky’s US partner network NBC News on Friday, her family said she took her own life in the Perth suburb of Neergabby, Australia, where she had been living for several years.

“It is with utterly broken hearts that we announce that Virginia passed away last night at her farm in Western Australia,” her family said.

“She lost her life to suicide, after being a lifelong victim of sexual abuse and sex trafficking.

“Virginia was a fierce warrior in the fight against sexual abuse and sex trafficking. She was the light that lifted so many survivors.

“In the end, the toll of abuse is so heavy that it became unbearable for Virginia to handle its weight.”

Police said emergency services received reports of an unresponsive woman at a property in Neergabby on Friday night.

“Police and St John Western Australia attended and provided emergency first aid. Sadly, the 41-year-old woman was declared deceased at the scene,” a police spokeswoman said.

“The death is being investigated by Major Crime detectives; early indication is the death is not suspicious.”

Sexual assault claims

Ms Giuffre sued the Duke of York for sexual abuse in August 2021, saying Andrew had sex with her when she was 17 and had been trafficked by his friend, the billionaire paedophile Jeffrey Epstein.

The duke has repeatedly denied the claims, and he has not been charged with any criminal offences.

In March 2022, it was announced Ms Giuffre and Andrew had reached an out-of-court settlement – believed to include a “substantial donation to Ms Giuffre’s charity in support of victims’ rights”.

She stuck by her version of events until the end

Of the many dozens of victims of Jeffrey Epstein, it was Virginia Giuffre who became the most high-profile.

She was among the loudest and most compelling voices, urging criminal charges to be brought against Epstein, waving her right to anonymity in 2015.

She told how he and Ghislaine Maxwell groomed her and “passed around like a platter of fruit” to be used by rich and powerful men.

But her name and face became known around the world after she accused Prince Andrew of sexually abusing her when she was 17 years old.

The picture of her together with the prince and Maxwell at the top of a staircase, his hand around her waist, is the defining image of the whole scandal.

Prince Andrew said he had no memory of the occasion. But Giuffre stuck by her version of events until the end.

‘An incredible champion’

Sigrid McCawley, Ms Giuffre’s attorney, said in a statement that she “was much more than a client to me; she was a dear friend and an incredible champion for other victims”.

“Her courage pushed me to fight harder, and her strength was awe-inspiring,” she said. “The world has lost an amazing human being today.”

“Rest in peace, my sweet angel,” she added.

Dini von Mueffling, Ms Giuffre’s representative, also said that “Virginia was one of the most extraordinary human beings I have ever had the honour to know”.

“Deeply loving, wise, and funny, she was a beacon to other survivors and victims,” she added. “She adored her children and many animals.

“She was always more concerned with me than with herself. I will miss her beyond words.

“It was the privilege of a lifetime to represent her.”

Ms Giuffre said at the end of March she had four days to live after a car accident, posting on social media that “I’ve gone into kidney renal failure”. She was discharged from hospital eight days later.

Raised mainly in Florida, she said she was abused by a family friend early in life, which led to her living on the streets at times as a teenager.

She said that in 2000, she met Ghislaine Maxwell, a British socialite who was convicted in 2021 on federal sex trafficking and conspiracy charges and was sentenced to 20 years in prison.

Ms Giuffre said Maxwell then introduced her to Epstein and hired her as his masseuse, and said she was sex trafficked and sexually abused by him and associates around the world.

‘A survivor’

After meeting her husband in 2002, while taking massage training in Thailand at what she said was Epstein’s behest, she moved to Australia and had a family.

She founded the sex trafficking victims’ advocacy charity SOAR in 2015, and is quoted on its website as saying: “I do this for victims everywhere.

“I am no longer the young and vulnerable girl who could be bullied. I am now a survivor, and nobody can ever take that away from me.”

:: Anyone feeling emotionally distressed or suicidal can call Samaritans for help on 116 123 or email jo@samaritans.org in the UK. In the US, call the Samaritans branch in your area or 1 (800) 273-TALK.

Politics

Crypto banking rule withdrawal by Fed ‘not real progress’ — Senator Lummis

Published

1 hour ago

April 26, 2025

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Crypto banking rule withdrawal by Fed ‘not real progress’ — Senator Lummis

United States Senator Cynthia Lummis suggests the crypto industry may be celebrating too soon over the US Federal Reserve softening its crypto guidance for banks.

“The Fed withdrawing crypto guidance is just noise, not real progress,” Lummis said in an April 25 X post. Lummis called the Fed’s April 24 announcement — withdrawing its 2022 supervisory letter that had discouraged banks from engaging with crypto and stablecoin activities — “just lip service.”

Lummis’ tone was different from the rest of the crypto industry

Lummis, a pro-crypto advocate known for introducing the Bitcoin (BTC) Strategic Reserve Bill in July 2024, pointed out several flaws in the Fed’s announcement, even as Strategy founder Michael Saylor and crypto entrepreneur Anthony Pompliano suggested it was a step forward for banks and crypto.

Cryptocurrencies, United States — *Source:* *Anthony Pompliano*

She argued that the Fed continues to “illegally flout the law on master accounts” and still relies on reputational risk in its bank supervision practices. It comes as the Federal Insurance Deposit Corporation (FDIC) is working on a rule to stop examiners from considering reputational risk when reviewing a bank’s operations, according to a recent Bloomberg report.

Lummis also highlighted the Fed’s policy statement in Section 9(13), which hasn’t been withdrawn, stating that Bitcoin and digital assets are considered “unsafe and unsound.”

She also reiterated many of the same staff behind Operation Chokepoint 2.0 are still involved in crypto policy today.

“We are NOT fooled. The Fed assassinated companies within the industry and hurt American interests by stifling innovation and shuttering businesses. This fight is far from over.”

“I will continue to hold the Fed accountable until the digital asset industry gets more than a life jacket, Chair Powell — they need a fair shake,” Lummis said.

Custodia Bank founder and CEO Caitlin Long seemed to share a similar view to Lummis.

“THANK YOU for seeing this for what it is,” Long said.

However, many crypto executives praised the Fed’s announcement as a positive development for the industry. Saylor said in an April 25 X post that the Fed’s move means that “banks are now free to begin supporting Bitcoin.”

Anastasija Plotnikova, co-founder and CEO of blockchain regulatory firm Fideum, said the Fed’s decision “is a significant development, as it will simplify the path to institutional adoption.”

Magazine: Ethereum is destroying the competition in the $16.1T TradFi tokenization race

Science

Water on Ancient Mars? New Study Challenges the Cold Planet Theory

Published

1 hour ago

April 26, 2025

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Water on Ancient Mars? New Study Challenges the Cold Planet Theory

Despite being a vast and inhospitable planet today, scientists believe Mars, the Red Planet, used to look much like Earth, the Blue Planet. Over the last four years, NASA’s Perseverance rover has wandered across an area of Mars where researchers believe a powerful river once poured into a crater, forming a sizable delta. According to computer models, ancient Mars most likely had frequent snowfall and rain, which shaped the enormous networks of lakes and river basins. In the Journal of Geophysical Research: Planets, a recent study found that the distribution of these land characteristics is more consistent with precipitation models than with only the consequences of melting ice caps.

Investigating Early Martian Climate Through Modeling

The researchers published their findings April 21 in the Journal of Geophysical Research: Planets. According to the research by geologists at the University of Colorado in Boulder, our planetary neighbour, on average 140 million miles away in space, was warm and wet billions of years ago. This challenges a long-held belief that early Mars was mostly cold and icy. However, there’s a vital mystery buried in the story: It’s unclear where Mars’ water could have come from, and most climate models predict the world exhibits surface temperatures that are far too cold to sustain liquid water, raising questions about how those visible geological features could have formed.

“It’s very hard to make any kind of conclusive statement,” Amanda Steckel, a postdoctoral researcher at the California Institute of Technology’s Division of Geological and Planetary Sciences, said in a statement. “But we see these valleys beginning at a large range of elevations. It’s hard to explain that with just ice,” she further added in the official blog posted by University of Colorado.

Through computer simulations, Steckel and her team explored what Mars might have looked like during the Noachian epoch, when water may have drastically shaped the planet’s surface, some 4 billion years ago. Initially created for Earth, their model was modified to simulate how Mars’ landscape changed near the equator, where expansive channel networks extend from the highlands and drain into ancient lakes, possibly even an ocean. NASA’s Perseverance rover is currently exploring one of these sites, Jezero Crater, where a once-powerful river poured into the basin.

Comparing Climate Models and Implications for Planetary History

The group explored two major simulation models, the ice-melt model and the wet and warm model for how precipitation might have created the valleys on Mars: one in which the planet was warm and humid, and another in which ice briefly melted at the edge of a huge ice cap, signifying a cold, arid climate. With valley roots showing up in radically diverse places, each scenario produced a very different Mars.

Their goal was to determine whether ancient Mars may have had a more Earth-like climate, at least for a while. While more evidence is needed and answers to questions, such as how the planet stayed warm enough for rain or snow, are part of an ongoing investigation. Still, Hynek said the study offers valuable clues, not just about Mars, but about the early history of Earth as well.