On today's episode of the 5 Things podcast:
A bill became law late last year that could mean the end of testing drugs on animals eventually. It's called the FDA Modernization Act 2.0. The law has bipartisan support. Seven republican senators led by Senator Rand Paul of Kentucky, three democrats including Senator Cory Booker of New Jersey and Senator Bernie Sanders of Vermont co-sponsored the bill. PETA is thrilled about it too. But is the technology ready.
5 Things Sunday Host James Brown and USA TODAY Patient Safety Enterprise Reporter Karen Weintraub discuss the implications of this new law, what makes it possible and if or when drugs not tested on animals will make it on the market.
If you have a comment about the show or a question or topic you'd like us to discuss, send James Brown an email at email@example.com or firstname.lastname@example.org. You can also leave him a voicemail at 585-484-0339. We might have you on the show.
Animal testing no longer required for drug approval. But high-tech substitutes aren't ready
FDA Modernization Act Press Conference - October 7, 2021
Dr. Paul's Bipartisan FDA Modernization Act 2.0 to End Animal Testing Mandates Included in 2022 Year-end Legislation
Victory! President Signs Groundbreaking FDA Modernization Act 2.0
NABR's press statement on the FDA Modernization Act 2.0
Podcasts: True crime, in-depth interviews and more USA TODAY podcasts right here.
James Brown: Hello and welcome to Five Things. I'm James Brown. It's Sunday, January 22nd, 2023. Go Bills. Every week we take a question or idea and go deep. In this week we begin at a press conference in the Fall of 2021. Several US senators are standing on a lawn behind a podium with puppies.
Rand Paul: It's great to see so many dogs here and that they also brought their humans with them.
James Brown: That's Republican Senator Rand Paul of Kentucky. He led the charge at this puppy press conference, and yes, that's what they called it.
Rand Paul: I knew animal testing was done, but I was unaware until the last couple of months that it was actually required by the FDA to do animal testing before you got to human testing.
James Brown: Before Paul was a US senator, he was an ophthalmologist.
Rand Paul: And look, I've been involved in medicine, I've been involved in science, I've been around the testing world. I think sensibilities change over time, and there were some horrific things done. I think a lot of people feel their dogs and cats are close to humans as well. And so anything we can do to make it easier to find alternatives, our bill doesn't forbid it, but our bill goes a long way towards allowing it to change.
James Brown: The bill, he's talking about just became law a few weeks ago. It's called the FDA Modernization Act 2.0. It received bipartisan support. Seven Republican senators, three Democrats, including Senator Cory Booker of New Jersey, co-sponsored the bill as did Senator Bernie Sanders of Vermont, who's an independent. It was one of the many bills signed by President Joe Biden as part of the massive omnibus bill. It means the FDA can now approve drugs that were not tested on animals, but will they? My colleague, Karen Weintraub, has been trying to find out. She's Patient Safety Enterprise Reporter for USA Today. She reached out to the FDA multiple times over the last few weeks as she reported on this law. I reached out again on Wednesday. A spokesperson responded by email. They wrote that the agency will implement all applicable provisions in the omnibus and will continue to work with stakeholders to encourage the development of alternative testing methods, and that the law does not change the regulatory process for drugs and does not eliminate animal testing.
The FDA will continue to ensure clinical investigations of drugs are reasonably safe for initial use in humans. PETA sees this step as a triumph. In a blog post they hailed it as a victory and that they're moving on to the next challenge. "Now, let's get that dinosaur of an agency, the National Institutes of Health to get with the program." They're encouraging people to lobby Congress and the NIH to change their testing habits too. Whatever you think of the ethics of testing drugs on animals, moving away from it even gradually is potentially a massive change. More than 131 million Americans, or roughly two thirds of all adults in the country, are on some type of medication. That's according to Georgetown University's Health Policy Institute. And just about every new medication starts the same way, with some kind of animal testing, usually on mice with some exceptions as we'll discuss. But are we ready for this? And is the technology good enough to proceed? Some of the experts Karen Weintraub spoke to say we're not there, at least not yet. I'll discuss that and more with Karen in just a few moments.
Karen, welcome back to Five Things.
Karen Weintraub: Thanks so much for having me.
James Brown: Help me understand what exactly is happening here.
Karen Weintraub: To get a drug approved, it has to go through animal testing, usually two animals. Mice, as you mentioned, and then a higher order animal, a rabbit or a primate monkey. And then it goes into clinical testing, into people. And the idea is that really bad problems would show up in the animals. It's not a hundred percent perfect, but it's a safety precaution. We don't want to kill people, so we try it on animals first. There's been a 40 year or longer movement to protect animals, to not use animals for our purposes, and this is sort of the culmination of that effort.
James Brown: Let's slow things down a bit and ask something really basic. On average, do you know how long it takes to get through the testing?
Karen Weintraub: Drugs take 10, 15 years to get from the basic light bulb goes off in a scientist's head to your medicine cabinet, and at least a billion dollars, 90% of them fail. There's a huge failure rate in that process, many of them, even in the later stages when they're tested in large numbers of people. So this is in part an attempt to address that problem as well.
James Brown: So let's just put this in context here. Odds are the drugs that will come on the market this year...
Karen Weintraub: Have been in the works for 15, 10, 15, 20 years. Yes, unless they're just slight modifications of existing drugs, which many drugs today that are approved today are.
James Brown: Wow. Well, there are two currents there that I see. There's the new drugs which take a while and there's the me-too drugs, the ones with a slight modification. I'm assuming those go through the testing process faster.
Karen Weintraub: It does. So let's say, take the flu vaccine, for instance. It comes out annually. The new strains are tested on mice first before being tested in a few people and before being widespread. That's not a year's long process because we need a new flu vaccine every year.
James Brown: How long have discussions been going on about moving away from animal testing?
Karen Weintraub: Animal rights activists have been pushing for this literally for decades, for 40 plus years. But the science hasn't been there. Again, the animals have been used for safety. I wouldn't necessarily be comfortable taking a drug that hadn't been tested on an animal before it's tested on me, but now science is catching up. That is conceivable now, which it hasn't been in the past.
James Brown: Frankly, I'm not sure I'm comfortable taking a drug that wasn't tested on some animal. How close are we in terms of the technology?
Karen Weintraub: So a couple of advances have happened in recent years that have made this even imaginable, thinkable, to do without animals. One is computer technology. We can now simulate what might happen in the body using computer machine learning, artificial intelligence. Again, none of these is perfect, but all of them are getting closer and animals aren't perfect either, which I can explain in a second. The second big advance is in so-called stem cell biology where you can scrape some cells off of my skin or use blood or urine and take that adult cell and make it like it would've been in an embryo with potential to become any cell at all.
And so it's used say for, I know of a case with ALS. Terrible, awful fatal illness, and took their adult cells, reverted them back to infancy in a sense, and then made motor neurons out of them, the cells that are damaged, and then made thousands of them and tested drugs in each one of those Petri dishes with cells, and could show, then, what happened to those cells. What was going wrong with them and whether the medication could correct it. It's much more realistic to do something like that and say, "Yes, this drug did reverse the problem in these cells," than it is, say, to try to make a mouse that has something similar to the human disease and then treat it. So that's where the thinking is and the potential here that it may be more realistic to use human cells in a dish coming from a patient with an actual disease than it is to try to mimic that disease in an animal.
James Brown: If we're still talking about potential, why make this kind of move?
Karen Weintraub: I think that it's going to be a gradual move. If it's a me-too drug or something similar to what's already on the market, maybe you can skip that mouse testing and just go right into people because there's not a lot of difference. You can test it in the cells first. And with this computer technology, I think for a radical new drug, new approach, we're still going to have to use animals for the foreseeable future.
James Brown: Who's in the camp of pushing for this? I would imagine the drug companies, but I'm assuming it's a bit more complex than that.
Karen Weintraub: Yes, drug companies are interested. Theoretically, this could save them money if they don't... It can take, as we mentioned before, it can take years to go through the animal testing process. Theoretically, if you're just plugging something into a computer, that takes a lot less time. Another example that I came across that I thought was really interesting is if you've ever heard of Botulinum. Botulinum toxin. You may know it more familiarly as Botox. It's used as an injection for facial fillers, also for migraines. And it's a terrible poison. It's one of the most poisonous substances known to man. It can generate, canned foods and other foods can breed Botulinum toxin. So it's very dangerous. It has to be prepared properly. Right now, apparently, we kill millions of mice a year testing these batches of Botox and these food supplies to make sure we're not going to kill people in the process of using these products. And I spoke to a gentleman in the federal government who's working with the FDA to try to replace those millions of mice with tests in a lab dish instead. And so that could be an easy, in a sense, way to prove safety without risking, without killing millions of animals.
James Brown: I just want to share with you one of my misgivings about this concept. As I read your article, I found myself thinking about Vioxx, and I know that's an extreme example, but there are many instances of drug companies being fined millions and millions of dollars for putting a drug on the market. Whether it's prematurely or sometimes knowing that it's not fully vetted. It concerns me that drugs may not be tested on the same level that they are now. Is that a rational concern?
Karen Weintraub: The animal rights people would say right now that a lot of our drugs, as I mentioned, only 10% of drugs that start in the testing process end up on the market. And some of those like Vioxx end up being taken off the market as unsafe. They would say that these testing in human cells instead of animal cells is actually better, is actually more realistic, more reflective of our experience.
And I think to some degree it also varies by condition. A mouse doesn't get autism, for instance. So a drug tested for basic aspects of autism, it's very hard to know whether that's effective or not. You could test safety in animals, but not likely effectiveness. So a drug tested in these cells, in these organoid cells in a dish could actually be more realistic than in a mouse and might predict and save. Maybe we'd get 20% success instead of 10% success because of that. And the animal rights activists argue that it wouldn't be any less safe. I think that's yet to be determined. I think, and again, that's why the regulators are likely to move very slowly in this direction to make sure that there aren't red flags or concerns that crop up, gaps that we find, either with the cell human cells in a dish or with the computer technology. But even with our current system, even with animal testing, things do get through Vioxx that end up not being safe in humans.
James Brown: And just for those listening who don't know, Vioxx was a painkiller, a painkiller that caused heart problems and a number of people died when it got on the market. There were massive penalties for that.
Karen Weintraub: And there have been anti-obesity medications that have gone that route. Fen/phen, if you remember that in the early nineties, I think. The classic example, although it was more complicated than I realized, is thalidomide, the drug that was used in the fifties and sixties in the US for morning sickness, for women who were pregnant and feeling nauseous. They would take this drug and it caused horrible birth defects, flippers for arms, missing limbs, and that was tested, but not... The animal rights activists use that as an example. Other people use that as an example of where animal testing did not prevent such horrible outcomes. They were not, in fact, as I did the research, tested thoroughly in animals in the US before people started using that drug in the US.
So I don't know that it's a great example, but the early testing in animals did not show these horrible problems that cropped up in people. So again, animal testing isn't perfect. Cells in a dish aren't perfect, computer testing isn't perfect. The overlap between the three does reassure us that things will be hopefully safer. Safer and potentially more effective, but I think it's a process. We'll learn more as time goes on.
James Brown: What's your take on this? Are we ready to do this?
Karen Weintraub: Not tomorrow, no. And again, not in term... So one example I like to think about, because I've written about this a lot, is xeno-transplantation. The idea of getting an organ from a pig. If I need a new heart or a new kidney, I could get one from a pig. I don't want to get that. There are studies now going on testing those organs in baboons, for instance, and it's horrible to think about baboons giving their lives for people. But the security, I do think that if I were that organ recipient, I would want to know that another animal had survived for some period of time with that organ before accepting it directly from a pig. And so I think there are cases where it would make the patients feel a lot safer if this product had been tested in animals first. Again, there are no guarantees. The one person who's received a heart from a pig died a few months later. Science is a process. It's never perfect the first time.
James Brown: Any famous last words?
Karen Weintraub: Hate to be cliche, but I think that this is one of those things that's an evolving process. I don't think animal testing is going to go away in the next even 5, 10, 15 years, but I think it will... Hopefully it'll make researchers think twice before using animals and it's not like there're going to be millions more rats or primates in the world. These animals are bred for research. But certainly nobody wants to kill an animal if they can avoid it.
James Brown: If you liked the show, write us a review on Apple podcasts or wherever you're listening. And do me a favor, share with a friend. What do you think of this episode? Email me at email@example.com or leave me a message at 5-8-5-4-8-4-0-3-3-9. We might have you on the show. Thanks to Karen Weintraub for joining me, and to Alexis Gustin and Shannon Ray Green for their production assistance. From all of us at USA Today, thanks for listening. I'm James Brown, and as always, be well.
This article originally appeared on USA TODAY: Testing drugs on animals could end. When will the technology be ready?
the magazine pro(2023-01-23 12:14:11Z)
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