Testing Drugs On Animals Could End. When Will The Technology Be Ready?

On today's 5 Things podcast:

A bill that took effect late last year could spell the end of veterinary drug testing. It's called FDA Modernization Act 2.0. The bill has bipartisan support. The bill is sponsored by seven Republican senators, Sen. Rand Paul of Kentucky, and three Democrats, Sen. Cory Booker of New Jersey and Sen. Bernie Sanders of Vermont. Beta is also enthusiastic. But is the technology ready?

5 Things Sunday host James Brown and USA Today's Patient Safety Foundation reporter Karen Weintraub discuss the implications of this new law, what's possible, and if untested drugs end up in stores.

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Animal testing is not required for drug licensing. But high-tech options are not yet ready

FDA Update Press Conference - October 7, 2021

Paul's bipartisan FDA Amendment Act 2.0 to end animal testing mandates contained in the 2022 Act

Persuasion! The President signs the Food and Drug Administration (FDA) Modernization Act 2.0.

NABR press release on FDA Modernization Act 2.0

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Karen Weintraub on Twitter

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James Brown: Hello and welcome to Five Things. I'm James Brown. Today is Sunday, January 22, 2023. Go Bills. Each week we take a question or idea and dig deeper. This week we begin the fall 2021 press conference. Several US senators stand behind a dog podium on the lawn.

Rand Paul: It's great to see so many dogs here and bring their people.

James Brown: This is Republican Senator Rand Paul from Kentucky. He led the charge at that Cubs press conference and yes, that's what they called him.

Rand Paul: I knew there was animal testing, but I only learned a few months ago that the Food and Drug Administration requires testing on animals before testing on humans.

James Brown: Before becoming a US Senator, Paul was an ophthalmologist.

Rand Paul: We are in a world of trials and tribulations. I think sensibilities change over time and horrible things happen. I think most people think their dogs and cats are close to people. Anything we can do to make it easier to find replacements isn't limited by our bill, but our bill goes a long way toward making a difference.

James Brown: The law he's talking about went into effect a few weeks ago. It's called FDA Modernization Act 2.0. It has bipartisan support. Seven Republican senators, three Democrats sponsored the bill, including Sen. Cory Booker of New Jersey, as well as independent Sen. Bernie Sanders of Vermont. It was one of several bills signed by President Joe Biden as part of a massive omnibus bill. This means that the Food and Drug Administration can now approve drugs that have not been tested on animals, but will they be allowed? My colleague Karen Weintraub is trying to find out. She is a USA Today Patient Safety Foundation reporter. I have contacted the FDA several times over the past few weeks and reported this rule. I came back on Wednesday. A spokesperson responded via email. They wrote that the agency will implement all applicable provisions of the general guidelines and will continue to encourage alternative testing methods with stakeholders, and that the law will not change the drug regulatory process or eliminate animal testing.

The FDA continues to ensure that clinical trials of drugs intended for first human use are sufficiently reliable. PETA considers this decision a victory. In the blog, they celebrate it as a victory and move on to the next challenge. "Now let's get a dinosaur from the agency, the National Institutes of Health, to join the program." They urge Congress and the National Institutes of Health to get people to change their testing habits. Regardless of what you think about the ethics of animal testing, ending it has the potential to make a big difference. More than 131 million Americans, or nearly two-thirds of all adults in the country, take prescription drugs. According to Georgetown University's Health Policy Institute. As we can see, almost all new drugs, with a few exceptions, begin with some kind of animal testing, usually in mice. But are we ready for it? And is the technology good enough for the future? We're not there, at least not yet, say some experts Karen Weintraub spoke to. I will discuss this and more with Karen in a moment.

Karen, welcome to Five Things.

Karen Weintraub: Thank you for inviting me.

James Brown: Help me understand exactly what's going on here.

Karen Weintraub: In order for a drug to be approved, it has to be tested on animals, usually two animals. Rats, as you said, are then a higher order animal, a rabbit or ape primate. It then moves on to human clinical trials. The idea is that the most serious problems are seen in animals. It's not 100% perfect, but it's a safety measure. We don't want to kill people so let's try the animals first. About 40 years ago, we did not have a movement to protect animals. This is the culmination of that effort.

James Brown: Let's slow things down a bit and look for something basic. Do you know how long it takes on average to pass the exam?

Karen Weintraub: It takes 10 or 15 years for a drug to go from just a bubble in the world's mind to your medicine cabinet, and at least a billion dollars, 90% of them fail. There is a large margin of error in this process, many of which are tested by many people in the later stages. So this is an attempt to partially solve this problem.

James Brown: Let's put it in context. The drug is likely to enter the market this year...

Karen Weintraub: She's been in business for 15, 10, 15, 20 years. Yes, except for minor modifications of existing drugs that are among the drugs approved today.

James Brown: Well, there are two streams that I see. It's the new drugs that take time and so do I with a little modification. I think these will pass the testing process very quickly.

Karen Weintraub: That is. For example, let's say you get a flu shot. It is published annually. New strains are first tested on mice before being tested on humans and released. It's not a year-long process because we need a new flu shot every year.

James Brown: Since when are we talking about abandoning animal testing?

Karen Weintraub: Animal rights activists have been asking for more than 40 decades. But the flag was not there. Here too, animals were used for security purposes. I wasn't necessarily comfortable taking a drug that hadn't been tested on animals before it was tested on me, but now science is catching up. What was not possible in the past is conceivable today.

James Brown: To be honest, I'm not sure I'm comfortable with drugs that haven't been tested on some animals. How close are we to technology?

Karen Weintraub: In recent years, there have been many advances in animal welfare. One of them is computer technology. Now with machine learning and artificial intelligence we can simulate what might happen in the body. Again, none of these are perfect, but they're all close, and animals aren't perfect either, which I'll explain in a bit. The second big advance is something called stem cell biology, where you can extract certain cells from my skin or use blood or urine and take that adult cell and make it into an embryo that has the potential to become a cell.

And so it is used, for example, I know a case with ALS. A terrible, deadly disease, and they took their adult cells, reshaped them into childhood, then made motor neurons from them, damaged cells, then made thousands of them and tried drugs on each one. Petri dishes contain cells and you can show what happened to those cells. What happened to them and medicine can help. It makes more sense to do something like this and say, "Yeah, this drug brought the problem back to those cells," than making a mouse model of a human disease and then trying to treat it. The assumption and possibility here is that instead of trying to mimic that disease in an animal, it may make more sense to use human cells in a dish taken from a patient who actually has the disease.

James Brown: If we're always talking about potential, why do we do something like this?

Karen Weintraub: I think it will be a gradual process. If it's Dope Me Too or something similar that's already on the market, you can skip the mouse test and go straight to people because it won't change much. You can try it on cells first. And with this computer technology, I think we'll have to use animals in the future, a new approach to a theoretical medicine.

James Brown: Who is pushing this camp? I wanted to fantasize about drug companies, but I think it's a little more complicated than that.

Karen Weintraub: Yes, pharmaceutical companies are interested. In theory, it could save them money if they didn't...as mentioned it could take years to go through the vetting process. In theory, if you just type something into a computer, it will take much less time. Another example I came across is that I wonder if you have ever heard of botulinum. botulinum toxin. You may know it better as Botox. It is used as an injection for facial blisters and migraines. It is a terrible poison. It is one of the most toxic substances known to man. Canned foods and other foods can produce botulinum toxin. So it is very dangerous. You have to prepare properly. Now we think we kill millions of mice every year to test these botox kits and food products to make sure we're not killing people using these products. And I talked to a gentleman in the federal government who was working with the Food and Drug Administration to replace those millions of mice in experiments on plates. And in a way that makes it easy to demonstrate safety without killing millions of animals.

James Brown: I just want to share with you my concerns about this concept. As I read your article I found myself thinking about Vioxx and I know it's a great example but there are many cases where pharmaceutical companies have been fined millions and millions of dollars for bringing drugs to market. Hastily or sometimes knowingly it is not completely confirmed. I am concerned that drugs are not tested at the same level as they are now. Is this a reasonable concern?

Karen Weintraub: Animal rights activists are now saying that many of our drugs, as you said, only make it to market about 10% of the time they pass through the testing process. And some, like Vioxx, end up being pulled from the market because they're dangerous. They say these tests are actually better in human cells than in animal cells, and they are actually more realistic and representative of our experience.

And I think it varies a little bit depending on the situation. Mice, for example, do not develop autism. Therefore, it is very difficult to know whether a drug is effective when tested for the basic features of autism. You can test the safety on animals, but the effectiveness is impossible. Therefore, a drug tested in these cells may be more realistic in organoids in a dish than in mice and may be more predictive and therapeutic. That's why we got 20% success instead of 10%. And animal rights activists say it couldn't be any less safe. I don't think it's decided yet. I think, and again, that's why the regulators are probably going in that direction with the human cells in the dish or the computer to make sure there aren't any red flags or concerns that we're finding. . Technology. But in our current system, even with animal testing, things come through Vioxx that are dangerous to humans.

James Brown: For those of you who don't know, Vioxx was a painkiller, a painkiller that caused heart problems and killed a lot of people when it first came out. There were severe penalties for this.

Karen Weintraub: And there are anti-obesity drugs that work that way. Finland/Finland I think if you remember the early 90's. The classic example, though more complicated than I thought, is thalidomide, a drug used in the United States in the 1950s and 1960s for morning sickness, pregnant women, and nausea. They took this drug and had terrible birth defects, flailing arms, missing limbs, which has been tried but not done... Animal rights activists use this as an example. Others use it as an example of when animal testing fails to prevent such horrific outcomes. In fact, before people started using this drug in the United States, they were not strictly tested on animals as there was research.

I don't know if this is a good example, but early animal testing did not show the dire consequences seen in humans. Again, animal testing is not perfect. Ship cells are not perfect and computer experiments are not perfect. The overlap of the three assures us that things will be safer. I think it's more reliable and probably more efficient, but convenient. We will learn more over time.

James Brown: What do you think? Are we ready for this?

Karen Weintraub: Not tomorrow, no. Again, not verbatim... my favorite example to think of since I wrote about it extensively is "The Seed of Zeno." The idea of taking an organ from a pig. If I need a new heart or kidney, I can get one from a pig. I don't want to have this. Research is currently underway to test these organs in monkeys, for example, it is scary to think that monkeys would give their lives to humans. But of course I think that if I were an organ recipient, I would want to know if another animal had played with this organ for some time before being directly adopted by a pig. So I think there are cases where patients feel safer if this product is tested on animals first. Again, no guarantees. The only person who received a pig's heart died a few months later. Science is a process. The first time is not perfect.

James Brown: A Famous Last Word?

Karen Weintraub: I hate to sound like a cliché, but I think it's one of those things that happens. I don't think animal testing will disappear in the next five, 10, 15 years, but I think it will... I hope this will make researchers think twice about using animals, and it won't be there, there are millions of rats or primates in the world. These animals are bred for research purposes. But surely no one wants to kill the animal if he can get rid of it.

James Brown: If you like the show, be sure to leave a comment on Apple Podcasts or wherever you listen. And do me a favor, share it with a friend. What do you think about this episode? Email me at jabrown@usatoday.com or text me at 5-8-5-4-8-4-0-3-3-9. We can join the show. Karen Weintraub thanks me and Alexis Jostin and Shannon Ray Green for their help with the production. To all of us at USA TODAY, thank you for listening. I'm James Brown and be nice as always.

This article originally appeared on US TODAY: Animal testing could end. When will the technology be ready?