FDA No Longer Needs To Require Animal Tests Before Human Drug Trials (science.org) 78
New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. Science Magazine reports: "This is huge," says Tamara Drake, director of research and regulatory policy at the Center for a Humane Economy, a nonprofit animal welfare organization and key driver of the legislation. "It's a win for industry. It's a win for patients in need of cures." In place of the 1938 stipulation that potential drugs be tested for safety and efficacy in animals, the law allows FDA to promote a drug or biologic -- a larger molecule such as an antibody -- to human trials after either animal or nonanimal tests. Drake's group and the nonprofit Animal Wellness Action, among others that pushed for changes, argue that in clearing drugs for human trials the agency should rely more heavily on computer modeling, "organ chips," and other nonanimal methods that have been developed over the past 10 to 15 years.
But pro-research groups are downplaying the law, saying it signals a slow turning of the tide -- not a tsunami that will remake the drug approval process overnight. Jim Newman, communications director at Americans for Medical Progress, which advocates for animal research, argues non-animal technologies are still "in their infancy" and won't be able to replace animal models for "many, many years." FDA still retains tremendous discretion to require animal tests, he notes, and he doesn't expect the agency to change tack anytime soon. In order for a drug to be approved in the United States, FDA typically requires toxicity tests on one rodent species such as a mouse or rat and one nonrodent species such as a monkey or dog. Companies use tens of thousands of animals for such tests each year. Yet more than nine in 10 drugs that enter human clinical trials fail because they are unsafe or ineffective, providing grist to those who argue that animal experiments are a waste of time, money, and lives. [...]
Now, that requirement is gone. In eliminating it, Congress seems to have responded to the emergence of nonanimal methods and growing public sentiment against animal research. Senator Rand Paul (R-KY) and Senator Cory Booker (D-NJ), who both call animal research inefficient and inhumane, introduced the changes, which the Senate passed by unanimous consent in September 2022. In December, Biden signed them into law as part of the Consolidated Appropriations Act, which funds the government through this fiscal year. [...] Still, it remains unclear just how much the new law will change things at FDA. Although the legislation allows the agency to clear a drug for human trials without animal testing, it doesn't require that it do so. What's more, FDA's toxicologists are famously conservative, preferring animal tests in part because they allow examination of a potential drug's toxic effects in every organ after the animal is euthanized.
But pro-research groups are downplaying the law, saying it signals a slow turning of the tide -- not a tsunami that will remake the drug approval process overnight. Jim Newman, communications director at Americans for Medical Progress, which advocates for animal research, argues non-animal technologies are still "in their infancy" and won't be able to replace animal models for "many, many years." FDA still retains tremendous discretion to require animal tests, he notes, and he doesn't expect the agency to change tack anytime soon. In order for a drug to be approved in the United States, FDA typically requires toxicity tests on one rodent species such as a mouse or rat and one nonrodent species such as a monkey or dog. Companies use tens of thousands of animals for such tests each year. Yet more than nine in 10 drugs that enter human clinical trials fail because they are unsafe or ineffective, providing grist to those who argue that animal experiments are a waste of time, money, and lives. [...]
Now, that requirement is gone. In eliminating it, Congress seems to have responded to the emergence of nonanimal methods and growing public sentiment against animal research. Senator Rand Paul (R-KY) and Senator Cory Booker (D-NJ), who both call animal research inefficient and inhumane, introduced the changes, which the Senate passed by unanimous consent in September 2022. In December, Biden signed them into law as part of the Consolidated Appropriations Act, which funds the government through this fiscal year. [...] Still, it remains unclear just how much the new law will change things at FDA. Although the legislation allows the agency to clear a drug for human trials without animal testing, it doesn't require that it do so. What's more, FDA's toxicologists are famously conservative, preferring animal tests in part because they allow examination of a potential drug's toxic effects in every organ after the animal is euthanized.
Mixed feelings (Score:4, Insightful)
Its hard, emotionally, to read studies where they inject rodents with cancer causing agents etc. At the same time, maybe an animal test makes a breakthrough that saves countless lives. For example, these researchers found that transportation stress, from the rodents being shipped in a Fedex box, drove cancer. https://youtu.be/DOXTxpEZ_yw?t... [youtu.be]
Its sad what happens to the animals being tested on, at the same time, how else are we going to find some things out? Maybe researchers can find a way to run tests that is more ethically sound. Some of the tests sound like the animals go through torture.
Re:Mixed feelings (Score:5, Insightful)
Animal testing is not prohibited, its just not required any longer. You still have to show the FDA evidence your drug is safe, that evidence could still include animal tests. Its LIKELY to still include animal tests for a large range of drugs, medical products, and food additives where that is best way to show safety.
What this does is allow experts in industry who think they can show what they are working on is safe without using animals the ability to try to convince FDA of safety without including an animal test. Animal testing when its not actually necessary was abusive. I am not against animal testing at all if there is actually a human welfare objective that is being met by it. I also hold the position subjecting animals to pain, misery, and fear, because someone put box on a form sixty years ago was immoral.
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>You still have to show the FDA evidence your drug is safe
How do you propose that will happen without actually testing it?
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Testing is still required. Animal testing is no longer required. There has always been human testing... I'm sure you have heard of those ad's... "are you between the ages of 40 - 60 with a heart condition? If so, you may be eligible for up to $5000 compensation to participate in a clinical drug test." Only difference is now, that drug doesn't need to pass animal tests before moving on to humans.
Are you suggesting to go straight to human trials without evidence that the drugs can be safe and effective? Is giving money to people somehow makes experimenting on the ethical? What kind of ethics is that?
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Are you suggesting to go straight to human trials without evidence that the drugs can be safe and effective? Is giving money to people somehow makes experimenting on the ethical? What kind of ethics is that?
Yeah. That's EXACTLY what's being said.
Welcome back to the Bad Old Days of snake oil.
The Tuskeegee study and Thalidomide babies say "Hi!"
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If you RTFS, you'll see an answer to your question:
"Drake's group and the nonprofit Animal Wellness Action, among others that pushed for changes, argue that in clearing drugs for human trials the agency should rely more heavily on computer modeling, "organ chips," and other nonanimal methods that have been developed over the past 10 to 15 years."
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Of course not, the idea is that study in cultures and computer modeling can be adequate. Notably, testing of immune modulators on animals is practically worthless anyway, the receptors are all different.
Meanwhile, we've all seen how many drugs with amazing results "in mice" fail to work out for humans. I wonder how many drugs that failed utterly in mice might have been quite useful in humans.
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It depends a lot on what you're doing.
There are lots of cases where you could show a drugs effect on some cells cultured in a dish. You can show what a Protein will do with a computer simulation. You can show your thing is chemically and physically similar to what already is naturally present or already widely accepted as safe. Once you establish a margin of safety you then you do human trial with consenting participants.
There are certainly situations where you can't do that or you are in new enough territ
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"There are lots of cases where you could show a drugs effect on some cells cultured in a dish. You can show what a Protein will do with a computer simulation."
I haven't worked directly in pharma R&D in years so what I'm saying below is no doubt out of date. With that caveat, traditionally, the cell line work is exactly what you would do before you would move into animal models. It was not uncommon for you to observe very different results in animals than you observed in cell lines. It was and is stil
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If you're Pfizer, all you has to do is say "shit's cool" and the FDA will break out their little rubber stamp of approval for you.
Mixed feelings only about the testing (Score:2)
I assume you mean mixed feelings only about the testing, not about the FDA change which was a no-brainer. I agree, sometimes animal testing can be beneficial, even though I personally would not like to harm animals at all, but we definitely know now that animal testing is not needed in many cases (it can be completely irrelevant to humans), so FDA removing the archaic rule requiring it has long been overdue. The ethics and benefits of some animal testing during drug development is a whole other, and definit
Necessary Data not Provided (Score:3)
I assume you mean mixed feelings only about the testing, not about the FDA change which was a no-brainer.
Is it a "no brainer"? The data needed to show that is how many drug trails did not happen because animal trials showed adverse reactions? This really should have been included in the article because nobody (I hope) wants to stop requiring animal trials if the result is an increased risk to human lives. However, if animal trials are not catching dangerous new drug candidates then they absolutely should no longer be required.
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In those cases that you speak of where animal trials showed adverse reactions they would still require animal testing after this change
Hang on you are assuming here that there will be animal testing required otherwise how will anyone know that animals show an adverse reaction? Is there some specific interpretation of "animal testing" that is implied here because, in normal English usage "animal testing" would include any testing on animals.
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So in many of those cases that you bring up where it turned up that the drugs where killing animals....
Yes, but how will they know that the drug kills animals if there has never been any animal testing performed? If this change is simply that drugs that have already been tested on animals don't need to be tested on animals a second time then it has been very poorly explained.
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Is it a "no brainer"?
Yes, only people with no brain think that they know better than the experts whether animal trials are always necessary.
The data needed to show that is how many drug trails did not happen because animal trials showed adverse reactions?
What you need to know, besides the difference between your ass and a hole in the ground, is how often human trials show very different results from animal trials.
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Yes, only people with no brain think that they know better than the experts whether animal trials are always necessary.
In my experience, it is only people with no brains who blindly accept what they are told without asking questions. Not being an expert does not mean that you just turn off your brain, stop thinking and blindly accept whatever you are told. If you reread my post you'll find that I am asking questions that should be obviously relevant to understanding whether or not this change is a good idea. How did you manage to interpret that as me disagreeing with the experts? I am literally saying "I do not know if thi
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Well, certainly lab mice with evolutionary bias towards long telomeres aren't useful (since they downplay acute dangers, and overplay cancer risks), but this essentially turns humans into the animals for testing.
I think the bigger problem is that we no longer have any sort of informed consent. We're willing to allow children to consent to castration and mastectomies when they can't possibly consent. We're willing to lie to the public about safety and efficacy of drugs that have no long term data (doesn't
Cruelty to animals Cruelty to Humans (Score:3)
Re: Cruelty to animals Cruelty to Humans (Score:2)
Re: Alternate test subjects (Score:1)
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Hey look, a Nazi.
Re:Alternate test subjects (Score:4, Insightful)
We can use them, too.
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You can become them, too.
So.... (Score:4, Insightful)
Now, when a drug has unexpected side effects, it gets discovered in humans first? Yup, you got it. People will die because the farma's didn't test on animals. But oh well, at least the animals are saved.
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Politicians won't be volunteering and they think there are far too many people as it is, so from their perspective it makes sense. Mengele felt the same way.
I know a woman whose brain got rekt in a Phase II she volunteered for.
After mice.
She didn't survive long.
The researchers need to be on the hook for damage caused. Then they'll use mice.
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Unexpected results happen. Would they have happened in animals? Currently we don't know what unexpected results would have happened in the test animals...well, currently the answer is zero.
Unfortunately, just because an unexpected reaction happens in a test animal is not proof that it would have happened in a person. Even among people the sensitivity and reactions to most drugs differs. E.g. acetaminophen doesn't do anything for me, though I expect strong doses would still damage my liver.
Whether this i
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E.g. acetaminophen doesn't do anything for me, though I expect strong doses would still damage my liver.
In randomized trials acetaminophen only worked slightly over 50% of the time, while a placebo was effective about 30% of the time. So not only is it provably less than twice as effective as imagination, but we can assume that at least part of the time its purported success was actually the placebo effect, and it actually works less than half the time. 100% of the people who take a whole bottle are going to suffer serious health effects and probably die if they don't receive care, but it's still available OT
Re:So.... (Score:4, Insightful)
It's like you didn't bother reading to the end of TFS.
Animal testing is of questionable value (Score:5, Insightful)
A significant percentage of the time, the test results don't carry over to humans [nih.gov] anyway. And these days we should be able to guess with some accuracy when the animal testing should be worthless for this reason. We don't need to do animal irritation testing any more because we can guess fairly accurately which compounds will be irritants or not before we even synthesize them. And we don't need to do as much pharmaceutical testing on animals partly for that reason, and partly for the other reason I mentioned.
Animal testing was required because it was believed to be the best solution for all situations, but it isn't. We shouldn't ban it outright, because sometimes it still is, but we also shouldn't require it when it's not useful.
Computer models often better (Score:2)
I heard a talk by a researcher from the FDA who worked on computer modeling of drug toxicity. He showed very conclusively that computer models could better predict toxicity in rats better than mouse testing could predict toxicity in rats.
It makes one really question how useful mouse and rat testing is for predicting toxicity in humans.
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My problem with this data is that it only goes in one direction. The data shows lots of drugs which pass animal testing are still harmful. That is a good case for ALSO using computing modeling. A good case for using ONLY computer modeling would require establishing that nothing that fails the animal tests is actually dangerous (ruling out safe drugs) or at least that computer modeling has a 100% overlap and not just on backtesting.
It isn't worth having to face a grieving mother to explain that you killed he
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My problem with this data is that it only goes in one direction. The data shows lots of drugs which pass animal testing are still harmful.
Right, it doesn't show the drugs which aren't harmful to humans even though they failed in animal testing, because they were abandoned at that point. But that's because they terminated the studies at that point, so we don't know which they are.
It isn't worth having to face a grieving mother to explain that you killed her child to save some quantity of rats, especially when rats show no sign of self-awareness or higher order thought.
False [bharmless.com]
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"It isn't worth having to face a grieving mother to explain that you killed her child to save some quantity of rats, especially when rats show no sign of self-awareness or higher order thought.
False [bharmless.com]"
No, it really isn't worth facing a grieving mother to explain you killed her child to save some quantity of rats. It wouldn't be worth it regardless of the capabilities of rats, it will always be the case that it is better for non-human to be the 'canary' than human to anyone who is human and has
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"Right, it doesn't show the drugs which aren't harmful to humans even though they failed in animal testing, because they were abandoned at that point."
It doesn't matter WHY that data isn't there. That data is the data needed to establish if computer models are a safe replacement for animal trials. Otherwise all you are establishing is that animal trials alone aren't enough or need revised protocols, not that something is able to substitute for them.
Proceeding to human trials with toxic drugs is expensive. I
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It doesn't matter WHY that data isn't there.
In fact, it does matter. That data hasn't been collected for protectionist, anticompetitive reasons.
That data is the data needed to establish if computer models are a safe replacement for animal trials.
Comparison of computer model results to existing animal testing results and eventual human trials/use can tell us that.
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"In fact, it does matter. That data hasn't been collected for protectionist, anticompetitive reasons."
It does not matter for the purpose of determining the computer models (or anything else) are a safe replacement for animal trials. And the reason that data hasn't been collected is obvious. It isn't SAFE or ethical to test things that kill rats on humans! However, thanks to the extermination industry we do introduce substances which kill rats/mice into environments where humans are exposed to them. Last I c
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No one here is suggesting that we skip a step arbitrarily. There are better things we can do here that don't involve killing rats for no reason. Animal models are generally a bad proxy period.
If you want to go torture animals for fun, go do that. I don't care much for animals but don't pretend you're aiding science using a think of the children of the grieving mother excuse.
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"No one here is suggesting that we skip a step arbitrarily."
But that is exactly what is being suggested.
"There are better things we can do here that don't involve killing rats for no reason."
That isn't proven by the data available. The data establishes that there are plenty of things which are toxic or ineffective in humans. It does not establish that there are many things which are toxic to rats which aren't also toxic to humans, nor does it establish over a long term and range of new unexpected variations
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A significant percentage of the time, the test results don't carry over to humans anyway.
I was expecting a paper that provided useful comparative statistical evidence to support a case. What I actually read is parody of anecdotes by a partisan organization with an axe to grind.
This opinion piece just cites other sources, offers no new information or insights and resorts to one sided anecdotes and emotional appeals.
Some of my favorites:
"In 2004, the FDA estimated that 92 percent of drugs that pass preclinical tests, including âoepivotalâ animal tests, fail to proceed to the market. Mo
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This opinion piece just cites other sources, offers no new information or insights
There is substantial scientific work done which falls into this category. How do you propose to put yourself forwards as an expert when you don't even know that?
What I find priceless is commentary like this "We don't need to do animal irritation testing any more because we can guess fairly accurately which compounds will be irritants or not before we even synthesize them."
You see this > 90% failure rate is just a function of people people really not bothering to guess properly in advance.
I was making a comparison between irritation testing and drug efficacy and safety testing. If you found that confusing, congratulations! You're a functional illiterate.
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There is substantial scientific work done which falls into this category. How do you propose to put yourself forwards as an expert when you don't even know that?
Who said I was an expert in anything? Whether or not I'm an expert what difference does that make?
I was making a comparison between irritation testing and drug efficacy and safety testing. If you found that confusing, congratulations! You're a functional illiterate.
Why bother when the full context of your statement is readily available?
"A significant percentage of the time, the test results don't carry over to humans [nih.gov] anyway. And these days we should be able to guess with some accuracy when the animal testing should be worthless for this reason. We don't need to do animal irritation testing any more because we can guess fairly accurately which compounds will be
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The article you cite is BS. Here is a quote from the article describing its premise:
As medical research has explored the complexities and subtle nuances of biological systems, problems have arisen because the differences among species along these subtler biological dimensions far outweigh the similarities, as a growing body of evidence attests. These profoundly important—and often undetected—differences are likely one of the main reasons human clinical trials fail.63
The statement that subtle differences between species outweigh the similarities between them is patently false. They claim "growing body of evidence" but fail to cite a single reference. The lie is mixed with a half-truth, that clinical trials fail because of the subtle differences between species. This is indeed the case in some trails, but it is far from being a main cause for clinical trail failure. The logic appears to b
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The statement that subtle differences between species outweigh the similarities between them is patently false.
[citation needed]
How can you ethically give a drug to humans without the evidence gathered in animal trials?
Tell us you know nothing about this subject without telling us, thanks
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This is where Trump and Faux News comes in!
They can be paid to recruit human volunteers to try out new drugs. They will have no trouble finding test subjects; just never call it a vaccine.
Keep in mind you can never survey the test subjects because they'll claim it still is working on their death bed as the placebo fails them.
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A significant percentage of the time, the test results don't carry over to humans anyway.
I've always wondered about the inverse... how many treatments that would have been effective in humans never advanced because they were ineffective in animals?
It was required?! (Score:1)
wrong question (Score:5, Interesting)
Yet more than nine in 10 drugs that enter human clinical trials fail because they are unsafe or ineffective
What you really want to know is how many drugs fail to enter human trials because they harmed an animal.
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Well, but you also want to know how many of the drugs that failed because they harmed and animal would also have harmed a human had the human taken them. It's pretty well guaranteed that the answer isn't either "all of them" or "none of them".
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I remember a lawsuit (which I heard of because a friend was in the represented Class) about contact lens solution, which the company proudly proclaimed had "never been tested on animals" (in this case, meaning rabbits as their eyes have sensitivity similar to human eyes).
The lawsuit happened because the never-tested-on-animals product blinded several humans.
Target: Poor and Developing country people (Score:2)
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Or undocumented immigrants.
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Worked for Margaret Sanger
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Different countries already have different rules. E.g. in the UK melatonin is a prescription drug.
What's wrong with the legislative process? This. (Score:2)
Hopefully the rule changes agreed upon in the new Congress will help prevent this BS, but it won't stop the next Congress from deciding the Speaker's policy
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I agree: it should be debated and discussed. The FDA did that - this rule change didn't just come out of nowhere on a whim from some assistant-to-the-deputy-administrative-liason-on-making-stuff-up.
How is it that the FDA has the power to do this, rather than in Congress where it constitutionally originates? Because Congress gave it to them.
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The FDA didn't do this, Congress did.
From TFS:
New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022.
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Note, however, that the FDA can still require animal testing. Now it's up to them. And they are the "experts in the field". Unfortunately, recently they've shown an unfortunate tendency to be swayed by corporations when the evidence isn't really very good...or even is actually that they shouldn't approve the drug.
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Unfortunately, recently they've shown an unfortunate tendency to be swayed by corporations when the evidence isn't really very good...or even is actually that they shouldn't approve the drug.
Very true, but what they've just moved away from is exactly the kind of protectionism that Big Pharma likes to purchase to raise the barrier to entry. There are lots of other rules they love, like how you don't have to prove efficacy of a derivative of an existing drug, you only have to show that it doesn't kill significantly more people than the old version.
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Congress did this, not the FDA.
"And, frankly, it's probably better for a lot of this stuff to be hashed out by subject matter experts in agencies than by elected officials."
In some cases that may be true but there is FAR too much power given to unelected bureaucracy. The problem is they and their policy is poorly accountable to the people which leaves that guy who was good enough to get a degree but not good enough to hack it in a high paying private sector gig making decisions. That isn't always going to b
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It's also worth noting that technocrats are horrible at crafting policy. Te
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Agreed. The new single subject bill requirement the Freedom Caucus demanded alongside demanding 72hrs (which is pretty minimal imho) to actually read bills and amendments before they are voted on should at least help for awhile.
With multiple issue bills, riders, amendments, 1hr to read them before a vote and suspension of the quorum requirement put in under Pelosi there was NO chance.
I've heard this line before... (Score:2)
"Companies use tens of thousands of animals for such tests each year. Yet more than nine in 10 drugs that enter human clinical trials fail because they are unsafe or ineffective, providing grist to those who argue that animal experiments are a waste of time, money, and lives."
My question isn't how many of the drugs which pass the test fail in humans but rather how many of the drugs which fail the test turn out to be safe for humans. The question is not computer modeling vs animal testing but rather computer
Skipping animal testing will be rare. (Score:4, Informative)
I've done animal and human testing with surgical products. We work hard to minimize animal testing (and human) because it is slow and expensive. The goal is to get better data from fewer tests. Even worked one place that had a policy of publishing any techniques we discovered that could reduce animal testing.
That said, it's very hard to avoid any animal testing. If nothing else, it's required by the regulatory agencies of some countries. But more so due to perceived liability.
Doing human testing is harder both to justify, enroll, and sometimes even design without some animal data. "Has this ever been used before?" "Nope." "How about in animals?" "Nope." "What testing did you do." "Benchtop and theoretical."
And bad things happen to patient while taking a drug. Someone will get injured or die. Maybe due to the drug, maybe it's a coincidence. This leads to lawsuits. And the likelihood of a lawsuit will increase, as well as a payout, when lawyers have the emotional argument handed to them on a platter. "They were so greedy they skipped doing animal testing and went straight to experimenting on people like my client."
Source proves itself wrong (Score:2)
We Minimize Testing! (Score:1)
insanity (Score:2)
Thanks to PETA and similar idiots, now YOU are the animals on which it's tested.