Many inside and outside of the pharma industry think so. Now, one group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development
Transcript
Meagan Parrish: Animal testing, it's kind of a dark side of drug development the pharma industry would generally prefer not to talk about. But because of FDA regulations, it's also a part of early drug testing that the industry can't avoid, yet momentum to reduce and eventually replace animal testing and drug development is growing both from within the industry and outside of it. And recently, a watchdog group focused on tracking government spending on animal testing in science released a new report detailing the FDA's required use of dogs in pharma, calling it ''wasteful, misleading, and expensive.''
I'm Meagan Parrish, and you're listening to Off Script, Pharma Manufacturing's podcast that goes beyond the pages of our magazine, to discuss the issues that matter to the industry most. In the May issue of Pharma Manufacturing, I wrote a cover story focused on emerging technologies that could one day replace the use of animal models in drug development, including organ on a chip, new cell-based assays, and an innovative computational modeling platform.
While all of these technologies are already helping the industry cut down on the use of animals, pharma is still years away from widely adopting different tests. Part of the holdup is the FDA's requirement of animal testing, which was created in 1938 to help ensure that drugs are safe before moving into human-based clinical trials. Still, although many acknowledged the important role animals have played in bringing vitally needed drugs to the market, the chorus of critics who call it an inefficient way of gauging a drug's efficacy continues to get louder.
For that reason, an outspoken watchdog group called White Coat Waste Project recently released an analysis of nearly 200 new drug applications submitted to the FDA between 2000 and 2020 to describe the impact of animal modeling. In particular, the organization took aim at the use of beagles coming away with these findings. Around 11,000 puppies and dogs were used to satisfy the FDA's testing requirement during that 20-year period.
And as we know, the cost of drug development is also high, and the report cites a researcher who estimated that switching to non-animal models, such as organ on a chip, could save pharma companies as much as 26% in R&D. And of course, a commonly cited statistic to argue against animal modeling is that about 90% of drugs fail in clinical trials, despite passing animal tests.
In the report, White Coat Waste Project calls on the Government Accountability Office to audit the FDA for its animal mandate and asks Congress to pass legislation that would allow drug companies to bypass animal testing. Today, White Coat Waste Project's vice president of advocacy and public policy, Justin Goodman, is here to talk more about the group's findings, the regulatory changes it's pushing for, and the story behind what happened to one drug company that fought back against the FDA's animal rile.
Meagan: Thank you so much for joining, Justin.
Justin Goodman: Thanks for having me.
Meagan: I thought we could start with you just telling me a little bit of history about your organization and give me a bit of background about your mission.
Justin: Sure. So White Coat Waste Project is a taxpayer watchdog group, we're not an animal rights group, and we were started in really in earnest in 2015 by Republican political strategists who were looking to bring in the center and the right into discussions about wasteful animal testing, but not necessarily from the animal rights perspective, but from the waste perspective and the government waste perspective, because a lot of people don't realize cosmetics testing is not the No. 1 issue animal testing is facing right now. That's been largely ended. And really the biggest problem is government-funded animal testing, two-thirds of all animal testing is funded by the federal government in the United States to the tune of about $20 billion a year. That's just what the government funds. That is in addition to government-mandated testing that the government imposes on pharmaceutical companies and other fields.
Meagan: Yeah. This is something that I find interesting about your organization because typically you don't think of animal rights as being an issue the Republicans are very interested in, and it seems like wasteful spending is something that's obviously a big issue for Republicans. So this is almost like you've found an angle that resonates with Republicans, but also with Democrats as well.
Justin: We like to say that we're uniting liberty lovers and animal lovers. We have 3 million members, and they are from all across the political spectrum: left, right, and center. The truth is a majority of Americans oppose animal testing. The most recent Pew poll from 2018, national polling shows that 52% of the public opposes animal testing and only 47% supports it. So the majority of the public is on our side.
Now, when you start adding in the government waste component of it, that not only are these practices cruel and inhumane, but they're incredibly wasteful and inefficient, those numbers start to go up because people who aren't motivated by the animal issue are often motivated by the fact that we're wasting so much time and money and resources on wasteful animal testing while patients continue to suffer from diseases that can be cured more quickly if we cut the animal testing out of the equation. So there's really something for everyone when it comes to those issue, whether it is the government waste of it that they're concerned about, or the animal testing component of it, or both, and we'd found 3 million people who are motivated by both of those things.
Meagan: Great. And you mentioned that you guys launched in about 2015. Since then, what have been the biggest wins for your organization so far?
Justin: So we've had big wins at a number of different federal agencies. One of the things I'm most proud of is, in 2018, we shut down a laboratory inside the FDA that was addicting squirrel monkeys to nicotine, and then forcing them into withdrawal. Not only did we shut those experiments down, but we were able to get those monkeys retired to a sanctuary in Florida. We've also ended experiments on dogs and cats inside the Department of Veterans Affairs. And a couple of years ago, we also shut down the government's largest kitten lab at the USDA.
USDA was actually going to the so-called wet markets in China and other countries, buying dogs and cats, and having them slaughtered, and then bringing their body parts back to the U.S. and force feeding them to cats in cannibalism experiments. And that had been going on for decades, and it cost $22 million to taxpayers. And we were able to shut that down and get over a dozen of those cats adopted out, two of whom are now living with our organization's president.
Meagan: Wow. Well, obviously you can't see it, but my eyes are very wide hearing about cannibalism experiments with dogs and cats. That's not something I knew the government was doing, and I'm sure a lot of people don't hear about many of these kinds of tests.
Justin: They don't. And that's why we like to use the acronym for it that describes our work as FED. Not only because we work on federal policy, but because we find, expose and defund animal testing. That's our mission.
Meagan: Okay. And like you mentioned, most of your work so far has focused on government-funded projects, but for this recent report that you did called "Broken Bureaucracy," you focused on the FDA and testing requirements happening in the pharma industry. So you did look at the private sector for this report. Can you tell me why you decided to tackle this issue happening inside the pharma industry?
Justin: Well, because whether it's taxpayer-funded animal experiments inside of government labs, or at colleges and universities, or it's pharmaceutical testing, the government is the problem. Whether they're funding it or they're mandating it like they do for pharmaceutical companies, we need reform at the federal level to fix the problem. So for us, it's just two sides of the same coin.
Meagan: Yeah. And in your report, you called out for several changes to happen on the regulatory level at the FDA. Has the agency responded to your report in any way so far?
Justin: Not yet, but this new administration hasn't really said anything about the issue yet. And we are waiting to see where they fall on it. We are cautiously optimistic given that under Donald Trump, we had some of the best progress, I would say, on this issue inside the FDA, particularly with Scott Gottlieb at the helm. He was the one who personally shut down those monkey experiments and was really making great progress to curb wasteful animal testing. Stephen Hahn was supportive of the issue and said a lot of good things, but wasn't really there long enough to, I think, see changes through. So we haven't heard from the FDA yet, but, again, we're cautiously optimistic that we'll see some progress.
Meagan: Yeah. And that brings up the interesting issue of the fact that they still haven't named a commissioner yet, or a permanent commissioner, and many considered Janet Woodcock to be the No. 1 candidate for that position. Do you have any read on where she would fall on this issue?
Justin: She's been there a long time, and there have been positive changes that have happened under her leadership of the agency over the years. So she's certainly, probably, well-versed on the issue and someone who knows the culture of the FDA well, and those are two important ingredients for making positive changes there. So, again, we don't know who is going to end up taking the helm, but if it is her, I think we would see some progress.
Meagan: Great. And in your report, you focused on beagles, which you say for 99% of the dog testing that happens in pharma, beagles are used. I'm wondering why just focus on the dog testing mandate, given the range of animals that are required to be used by the pharma industry?
Justin: Well, you know, one thing about our organization is that we like to widen the tent on this issue and meet people where they're at. And we're a nation of dog lovers, and pharmaceutical testing is probably, I would argue, maybe the largest consumer of dogs for painful testing in the United States because of government-mandated testing requirements. So we'd like to look at what the biggest part of the problem is. And so in terms of animal testing, we focus on federal spending because that's funding two-thirds of animal testing.
In terms of dog use in the United States, pharma testing represents a huge chunk of it. In the United States, we don't really know exactly what proportion of dog use is for government mandates. In other countries like Canada or the U.K. or the E.U., they break down dog use in federal reporting by the purpose. And the ranges in those countries is from about 25% of dog use being for regulatory purpose, to as much as 75% of dog use being for regulatory purposes. So we're being conservative and saying probably a third of the dog use in the U.S. just for pharma testing, but it could be more than that. So it's practical for us. It's a way to bring in new people to the issue and it's a way to save a lot of dogs.
Meagan: Yep. As a case, in point, you described the situation with Vanda Pharmaceuticals and how they challenged the FDA on its requirement for a nine-month dog study. I'm wondering, can you just summarize that situation for our listeners and give me an update if you have one about where that situation is at?
Justin: Sure. Vanda Pharmaceuticals, which is based here in Washington, D.C., was developing a drug called Tradipitant that treats GI disorder called gastroparesis. And they had conducted some animal testing to fulfill the FDA's requirements, submitted their new drug application, and were actually allowed to start human clinical trials that were going very well. And they wanted to extend those trials to be long-term. And the FDA said, ''If you want to do that, you're going to have to conduct a nine-month toxicity study in beagles. And at the end of the study, those dogs are going to be killed. And not only do you have to go and kill these dogs, but it's going to cost you close to a million dollars. And unless you do that, you're not going to get approval to expand your drug trial.'' So they were basically holding, the FDA was holding Vanda, was and is holding Vanda hostage, unless they would kill these dogs.
So Vanda decided that it was going to stick his heels in, to its credit, and they filed a lawsuit against the FDA saying that the decision was arbitrary and that they hadn't provided any scientific justification for requesting the dog use, which they still haven't to this day. Unfortunately, the court ruled that the FDA has the authority at the moment to do whatever it wants and ask for whatever animal testing it wants. So the lawsuit wasn't successful, but we saw an opportunity here to use Vanda's situation as a lightning rod to show that they're not the only ones who don't want to test on animals or dogs specifically, or other animals for that case, because it's incredibly expensive, it's cruel, shareholders don't like it, and it's not getting them any useful data in a lot of cases. You have situations where companies are testing drugs with the wrong administration route, the problems are vast. And a lot of it is because there's not clear guidance from the FDA on what is and isn't actually required. And there isn't clear guidance from the FDA about how you can actually go about requesting to use alternatives to animal testing and what the requirements are for meeting whatever standards the FDA has. It's just a black box right now.
Meagan: And aside from the Vanda incident, are you aware of any other pharma companies pushing back against the FDA on this issue?
Justin: Not in the way Vanda has publicly. You know, it's probably no surprise to you or your listeners or readers that the industry has long bemoaned the FDA's archaic animal testing mandates, but Vanda was really the first company with the, I'd say, the determination, the compassion and the courage to on the fight publicly. And they paid for it both literally and figuratively. As soon as they filed their lawsuit, their stock tanked, and they lost tens of million dollars in market capital, and as a result of the fight they had with the FDA, the drug that they had in clinical trials, which was very promising for treating gastroparesis, was put on a permanent clinical hold until they did the dog testing. The kicker here is, is that they were able to repurpose that drug and it actually turned out to be a promising treatment for COVID-related pneumonia. And it would have been more readily available for clinical trials had the FDA not put up those roadblocks because of the dog testing.
Meagan: Wow. And one of those steps that you're hoping Congress will take is pass the AARF Act, that's the Alternatives to Animals for Regulatory Fairness Act. I've seen some support for that online. It looks like right now that that act is being tied up in committee right now, in the House. But I was wondering if you could just give me an idea of what's in that act and where you see it going.
Justin: Sure. The Alternatives to Animals for Regulatory Fairness Act, or the AARF Act, basically would amend 80-something-year-old law, the Food, Drug and Cosmetic Act, to clarify that companies have the freedom to use alternatives to animal testing to meet regulatory requirements. Right now, the Food, Drug and Cosmetic Act states that drugs need to be tested in animals and then humans, and they don't have any language in the actual law to facilitate the use of alternative methods that are not either clinical testing or animal testing. This bill would include language in that law that says companies can use alternatives to animal testing.
It's bipartisan, introduced by Brendan Boyle, a Democrat from Pennsylvania, and Brian Fitzpatrick, a Republican from Pennsylvania. And currently the bill is in the Energy and Commerce Committee. It was introduced not too long ago, but we're hoping that some version of this bill, whether that's the bill itself or some version of this bill in another vehicle, can make its way to the President's desk this Congress.
Meagan: Do you have any sense of what could happen to that bill in the Senate?
Justin: We don't have a Senate companion yet, but we have been working with Senator Susan Collins, a Republican from Maine, on this issue. And she wrote to the FDA at the end of last year, asking them to prioritize the consideration and approval of alternatives that would eliminate and reduce the use of dogs in pharmaceutical testing. So while the bill has not been introduced in the Senate yet, there is bipartisan support on the Senate side for these reforms.
Meagan: Now, from what I can tell the FDA does seem to be opening its arms, to some extent, to alternative testing platforms that are emerging in the drug development space. In fact, the FDA recently launched a program called ISTAND, and this lays out a three-step process for qualifying new testing technologies. Do you think that the agency with that program is going far enough to promote alternatives to animal testing?
Justin: I think it's a step in the right direction, but it's hard to get too excited about it. First of all, it's just a pilot program and it's only going to accept between two and four submissions per year to review. And additionally, as far as I can tell, there's no transparency about what the reviews will entail and how long these reviews might take. So while they're going to accept two to four new submissions a year, how long are these reviews going to take, a year, five years? And with the FDA, you really never know.
Also looking at looking at ISTAND's scheduled reviewing as few as two new alternative tests a year, it would take over a decade just to test a few alternatives that the FDA itself has working on, never mind all of those that are being developed and already used internally by industry. So I find that to be unacceptable in terms of a timeline, that it would take a decade just to test the ones that the FDA is working on while the industry has lapsed the FDA many times over, developing these methods over the last several decades. So it certainly concerns me that the program is not more aggressive.
Meagan: Okay. And aside from the AARF Act, what other changes would you like to see happen at the FDA?
Justin: We'd like to see some independent scrutiny of the FDA's process for accepting and considering alternatives. Vanda is not alone. You know, we know that definitely there have been other companies that have tried to avoid animal testing, but ended up having to do it anyway. And the FDA is not transparent again about what steps companies need to take to get their alternatives approved currently. So we're calling on the Congress to ask the Government Accountability Office, the GAO, to do an audit of FDA drug applications and find out how often they are actually letting companies use alternatives to animal testing, because I don't think it's very frequent.
Meagan: And in terms of alternative...emerging alternative technologies right now in the drug development space, are there any in particular that you guys have looked at closely that you think hold the most promise for replacing animal models?
Justin: Well, I'm probably not alone in thinking that organs on a chip are really exciting. You know, there's a lot of comparative studies that have already come out, showing that organs on a chip, whether they're lungs or livers or other organs, are better at modeling human diseases and predicting drug outcomes in humans than animal tests are, whether it's dogs, rats, or other species. And we'd love to see that the regulatory approval of those technologies expedite as much as possible. You know, the big problem here is that FDA policies have really failed to keep pace with scientific advancements. And we have a situation now where, as a result, animals and humans are suffering unnecessarily because of bureaucracy at the FDA.
Meagan: And I'm just curious, do you think that there's actual support at the FDA for maintaining animal models in drug development, or is this just sort of a situation where it's a bureaucracy, and so implementing change, especially to a longstanding policy, is just a slow process?
Justin: I think there's probably... I don't think there is. There's definitely a support. There are definitely FDA scientists right now co-authoring papers endorsing the use of alternatives to animal testing. I do think there's a lot of bureaucracy at the FDA that's standing in the way. And I think there's a lot of institutional inertia where regulators get comfortable looking at a particular set of data. They know what dog data looks like. They know what rat data looks like. They're less comfortable with alternatives. And as a result, they make it easier for companies to use animal testing because that's what they're familiar with.
So I think there needs to be not only a regulatory change, but there needs to be cultural change at the FDA where you get people in there who are more open and less biased towards animal testing and more open to the use and the consideration of a regulatory use in alternatives.
Meagan: Great. Well, thank you so much for taking the time to explain all this to me. I really appreciate it.
Justin: No, you're the expert. I'm grateful that you had me on.
Meagan: Yeah. You've been listening to Off Script. Stay safe, everyone, and be well.
For more, tune into Off Script: A Pharma Manufacturing Podcast.
