Intro 0:00
Welcome to the Naturally Healthy Pets podcast. Let's get to it.
Dr. Judy Morgan 0:04
Hello everyone and welcome. I'm Dr Judy Morgan, your host for the Naturally Healthy Pets podcast. My guest today is another brilliant veterinarian. I don't know, I don't know where we find all these brilliant people to talk to on this show, but I guess we're just really lucky. So my guest is Dr Terry Fossum, and she is a highly respected board certified veterinary surgeon, widely recognized and admired within the veterinary community. She is best known for authoring the best selling textbook Small Animal Surgery. I'm pretty sure it's on my bookshelf, a foundational resource in veterinary education and practice worldwide. In addition to her contributions to academia, Dr Fossum owns and operates a Natural Pet wellness company offering products designed as a first line of defense against common ailments, supporting pets health through science backed nature powered solutions. Terry, thank you so much for being my guest today.
Dr. Terry Fossum
Oh, thank you so much for having me Dr Judy, it's really an honor.
Dr. Judy Morgan 1:05
So I'm sorry to everyone who's listening, but she's suffering with allergies, and I've got a head cold. So between the two of us, we're very sniffly today. Just makes it more fun.
Dr. Judy Morgan 1:16
So we want to talk today about something that I think is is a really cool topic, because I just read a book on this, and the title of the show is, are dogs a better predictive model for drug approval? Now, interestingly, I got this book at the library called the First Cell, and it was written by an oncologist, a brilliant she's from Pakistan. She's got a huge practice in New York City, and she specializes in bone marrow and blood cancers, and has been doing research. Has this huge bank of samples that she's been collecting for 30 years, and she talked in that book about how all cancer research and drug research is done using a mouse model. And interestingly, mice are nothing like us, and so it's a really bad model. So for instance, we have a lot in our white blood cell distribution. We have mostly neutrophils and some lymphocytes. It's about a two to one, two and a half to one ratio. Mice are the opposite. They're like all lymphocytes and some neutrophils. So the lymphocytes are really responsible for the immune system and how it works. So they're going to respond a lot differently to drug models than we would.
Dr. Terry Fossum
Oh, yeah,. Well. And take that one step further and figure that when we test, like, say, a tumor in a mouse, we usually use, uh, immunosuppressed mouse that we put a human tumor in, so that they all accept the tumor and then we treat it. It's not, it's not a real world setting. So, I think this is a great topic. It is one I have been passionate about for 30 years, because I think drug development in this country is absolutely not sustainable the way that we do it.
Dr. Terry Fossum 3:26
You know, our healthcare in the US in 2027 is going to be, I think 19.7% of our GDP.
Dr. Terry Fossum 3:33
We're almost at 20% I mean, how can we sustain that? I don't think we can. And so we have to figure out how to be more efficient at drug discovery, and we have to figure out how to make it cheaper. So, yeah, one of the things that I wanted to talk to and I'm going to give you some numbers here, so I'm putting on some glasses,
Dr. Terry Fossum 4:02
but here's, here's just some numbers why people need to understand why this is such an important topic. If you look at 2022 what drug development costs were in the US in billions of dollars, it was $100.8 billion that we spent in 2022 on prescription drugs globally, we spent $1.3 trillion
Dr. Terry Fossum 4:32
and that was that's gone up about 4-6% a year. But it gets even worse, if you talk about cancer drugs globally, we spend about 150 billion, but it's increasing. Has increased over 10% a year for each of the past five years. So it the numbers are just absolutely incredible.
Dr. Terry Fossum 5:00
Medicare spending is in 2018 it was 107 billion. By 2028 it is going to be 223 billion, not knowing what's going to happen. Maybe between with the new administration, they're restoration,
Dr. Judy Morgan
that that is part of the problem. I mean, if we would clean up our food supply and stop promoting chronic inflammation, chronic disease. I mean, it's just it's in our pets, in ourselves we I mean, we just know,
Dr. Judy Morgan 5:43
one of my huge things for our animals is we're feeding them pesticides purposely, flea and tick pesticides. They're neurotoxins. Yeah, no problem there.
Dr. Judy Morgan 5:54
You know, we, we're making no inroads on cancer. It takes seven to nine years to get a drug to market, and millions or billions of dollars to get a drug to market. And then some of the drugs, they make it to market, and then the side effects are so horrendous that they get dumped very quickly. So we need a different model.
Dr. Terry Fossum 6:19
We absolutely do. So let's talk about that. 50% of our healthcare dollars go to 5% of our population. That's chronic disease for you right there. And if we don't get a handle on chronic disease to your point, which is largely inflammation, that number is just going to go up and up and up and again, I, I just don't think that's affordable.
Dr. Terry Fossum 6:46
So, if, if it's that expensive, and we'll talk more about the expense of getting a drug to market in the time. Why? Why did, why does big pharma do it? Let's look at some numbers.
Dr. Judy Morgan
Oh, because they're making billions and billions,
Dr. Terry Fossum
billions. Okay, so here's some numbers
Dr. Terry Fossum 7:07
in 2021 worldwide sales, both prescription and over the counter drugs in billions of dollars in 2021 in oncology was 176 billion
Dr. Terry Fossum 7:21
In 2026 it's going to estimated to be 320.6 billion, right? And almost every category is going up in somewhat similar except for, guess what? Vaccines. Vaccines are going to go down over the next few
Dr. Judy Morgan
that would be nice,
Dr. Terry Fossum 7:43
They are definitely going down. But I mean, on the other hand, if you look at the once you start a phase one trial for a human drug, if you look at your odds of actually getting approved, if you're an oncology drug, is 3.4%
Dr. Terry Fossum 8:04
Yeah. So what people don't understand is that, Hey, Big Pharma is not eating those costs. Every drug that they try to get through the pathway that doesn't make it is something we pay for, right? I mean, they're not going to going to pay for it. So if you look that the difficulty is that there's no set requirement for reporting of what drug companies spend on R&D. But if you look at through pre launch so research and development to get a new molecular entity to the market, you're somewhere between at the low end, 161 million, and at the high end, 4.5 billion dollars,
Dr. Terry Fossum 9:03
and you're and you're absolutely right. It's 12-14 years to do that. So you know, we don't know the exact numbers, because companies don't all report the same numbers. Some don't report their preclinical they only start once they enter into phase one. Others report everything. Therapeutic class obviously makes a big difference.
Dr. Terry Fossum 9:31
There's just a lot of issues. So these are estimates that we have. But however you look at it, the numbers are just incredibly high. So here's, here's a bit more. If you look at drug discovery and the timeline. So let's say that you have this big funnel, and you start with 10,000 compounds. So that's your drug discovery, and that's generally going to take you three to five years.
Dr. Terry Fossum 10:07
And then you're going to get down to from that 10,000 compounds, you're going to weed it down to maybe 250. those 250 compounds are ones that you're going to look at pre clinically, you know, do some more testing, and then you're going to get into your clinical development. So that's another five to seven years. You're going to test in phase one, safety, phase two, safety and efficacy. Phase three, you're going to do a large scale efficacy study, and then in Phase four, you're going to do long term safety. So that's going to take you another two to three years at the very least. So yeah, you're talking 12 to 14 years, starting with 10,000 compounds and coming down to a single one that will actually make it through the approval process.
Dr. Judy Morgan
So if you're a pharmaceutical cancer researcher. You've literally spent your entire life trying to come up with that one compound that is going to be effective. And you may spend your entire life and never come up with that compound that's going to be effective. Sounds great.
Dr. Terry Fossum 11:22
So, you know, I guess, what do we do when you know we're at this point where it's really if you're a small so as you mentioned, I have a small company. We can talk more about this in a second, but I have a drug that I actually think could have really interesting implications for cancer in dogs.
Dr. Terry Fossum 11:44
But, you know, I don't have $8 to 12 million to take a drug through even the CVM FDA, and that's a lot of money to raise. So there are a lot of very promising compounds that never get brought to market. So, so, first off, so, why? Why is it so expensive? Well, I mean, part of it is that, I think that there's planned obsolescence of a lot of drugs these days. Pharmaceutical companies definitely plan on these drugs lasting through their patent life, and then they've got to have their next drug ready to go. We're treating, particularly in dogs, and you know, this Judy, much as I do, we're treating a lot more serious diseases, a lot more dogs with cancer, a lot more people that really want to go to the furthest extent that we can possibly go, which is, you know, almost at the same level of human care at this point, for cancer and that's costly. Development costs a lot. I don't think we can discount how good at lobbying pharmaceutical companies do. I think they are the biggest and best paid lobbyists that we see in Washington, DC, and
Dr. Judy Morgan
Oh, absolutely. They also are the biggest contributors to media advertising, and so they pretty much own the media as well. We need to take a break to hear from our sponsors. We'll be right back to continue this fascinating conversation. Stay tuned.
PRODUCT SPOTLIGHT #1
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PRODUCT SPOTLIGHT #2
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Dr. Judy Morgan 14:35
Welcome back. You're listening to Dr Judy Morgan's Naturally Healthy Pets. And today I'm talking with Dr Terry Fossum, and we're talking about how dogs may be a better predictive model for drug approval. And, you know, tons of facts and figures. So why are dogs a better predictive model? I mean, we already talked about some of the fallacies with mice. I mean, they're They're specially bred. We're not using anything natural here. We're using very specially bred mice. They're injected with these tumors. They grow the tumor, and then we give them a drug and see if it kills it. And sometimes it works great in the mice, and then you try it on a person and nothing.
Dr. Terry Fossum
And most of the time it doesn't work, most of the time, right? So to your point you mentioned earlier, most studies are done in mice.
Dr. Terry Fossum 15:26
It's actually 95% of the early preclinical work is done in mice. And I'm going to give you an example of why that doesn't work in part. So I'm studying a botanical that has some very interesting characteristics. At one dose is toxic, and at another dose, it is a medicine with really interesting properties. I don't know if you've looked much at but we're talking about sort of longevity and stuff and chronic aging. And a lot of people these days believe that chronic aging is associated with a buildup of senescent cells. So senescent cells, for those of you aren't looking in the longevity literature, cells are not meant to divide forever, because when they get old, they start making mistakes. So they're supposed to divide a certain number of times, and then they're supposed to go down this program cell death pathway. Well, we have a certain number of cells in our body that say, Nope, ain't happening. I am not dying. What I'm going to do instead is I'm going to quit dividing. So now you've got this non dividing cell that secretes very inflammatory substances, and that's why most people think that we age. And the drug, this natural botanical that I'm now studying is the most potent senolytic that has ever been identified. So it should be interesting for anti aging, but even maybe more importantly, there's some recent evidence that those senescent cells might be what cause metastases. So for example, Judy, you take a dog with osteosarcoma, and you amputate the leg. We give them chemotherapy, but we know that within three months to a year, they're all going to die of Mets, right? Those, I think, and there's getting to be some increasing evidence and literature to support this. I think those are those senescent cells that reanimate, that we didn't kill with the chemotherapeutic. In fact, we give chemotherapeutics. We drive cells to senescence. Those are the cells that are becoming our meds. And guess what? So we know that this particular botanical that I'm looking at
Dr. Terry Fossum 17:58
on the sodium potassium ATPase pump. The normal isomer that's expressed is the alpha one, but this botanical actually binds to the alpha three. So stress cells, senescent cells, some cancer cells over express this alpha three isomer, and that's where this botanical binds.
Dr. Terry Fossum 18:24
Guess what? Mice and rats don't express that isomer. And yes, the studying was done in mice and rats. They're totally immune to the effects at any level. And in our studies, we found out that chickens are too. So you know, what a waste, you know? But, yeah, but there's still a desire for to do these early, pre clinical studies in mice, a total waste of money and time. So, yeah. So why? Let's, let's talk about dogs. And one thing I want to make really clear is we are not talking about giving dogs disease.
Dr. Terry Fossum 19:05
We are talking about taking dogs that have naturally occurring disease and using them as a more predictive model for human disease.
Dr. Terry Fossum 19:22
So that's for cancer, for osteoarthritis, for any seizures, for any number of diseases. One of the big ones is Alzheimer's. Dogs get canine cognitive dysfunction, which is Alzheimer's, and it's essentially the same disease in people and dogs, but we can treat dogs a little more readily, and they don't live as long, so we're going to get data a lot faster. So we're talking dogs with naturally occurring disease that we have safety data on a product, and then we get efficacy in dogs, because that efficacy data is Going to translate to efficacy in people much more commonly than going from mice. Mice to man doesn't work. Dog to man should be highly predictive. So we need to use naturally occurring animal disease,
Dr Judy Morgan
right. And I like that model. That brings me back to the Keto Pet Sanctuary, where they were going to shelters and getting dogs with cancers and then putting them on their ketogenic diet, giving them exercise, like doing everything that you're supposed to do to keep an animal healthy. And you know, they had a huge success rate with getting those dogs turned back around and getting the cancers to disappear and so and it didn't take 18 years,
Dr Judy Morgan 20:49
you know, we can, we can do things. And I love, I love starting with dogs that are already in that natural state. I mean, nobody wants, you know, this is one of the problems with laboratory studies, you know, keeping beagles and monkeys and rats and mice in lab settings and doing horrible things to them, and then having to sacrifice the animals to to do the autopsy at the end.
Dr. Judy Morgan 21:16
I think I love the model of, look, we're taking dogs who who naturally have this problem, and then using whatever the compound is to try to see what results we can get with that. So that's very cool. So do you have ongoing studies using this dog model?
Dr. Terry Fosssum
I do several, actually. So the one that one that I have going right now. So the compound I was just speaking of, the senolytic, is from the Oleander plant, which we all know is toxic, but again, we micro dose it, and we have figured out very safe doses, which are 100 times lower than what you would ever see
Dr. Terry Fosssum 22:01
serious you know, adverse event with and we haven't seen any. We've dosed quite a few dogs.
Dr. Terry Fosssum 22:10
Interestingly enough, this Oleander product, when we extracted it, looked to me very much like Apoquel for anti itch. So we did a head to head in cells with the extract, with the the active ingredient, which is oleanderin, and then with Apoquel. And what we saw is that we actually reduce the inflammatory cytokines more than Apoquel did, but we don't suppress the immune system,
Dr. Judy Morgan
which would be wonderful.
Dr. Terry Fosssum
Which, yeah, which is amazing, because we all know, like, we can't give it to a dog with cancer, they're going to get worse. Some people are concerned it may actually cause cancers. I don't know that's true, but definitely any Veterinary Oncologist that I have talked to, when they get a dog that is on Apoquel that has neoplasia, they're off of Apoquel immediately. You can't give it to a dog less than a year of age. We've given ours to newborn puppies without any problem. So so here's my dilemma, and and it's kind of sad when I think in that we're going to sell that product for anti itch internationally, because
Dr. Terry Fosssum 23:29
I'm in talks with the FDA, but it's going to be difficult to get it approved here, and I don't want to go down the FDA drug approval pathway, because that will make the drug too expensive. And I want a drug that, you know, Apoquel and the new one from Elanco they're going to cost you 90 bucks, 100 bucks a month. A lot of people can't afford that, so our product is going to be about 45 a month, unless we go down the FDA pathway, and then we'd have to add on all those costs, and it would be too expensive, so we're not going to do that. And that is the reason, I think, you know, there really are no supplements in veterinary medicine. It's not really a category, but there are unapproved drugs that the FDA just looks the other way. And we've got many, many of those. I mean, chondroitin is a good example. You know, it's not an approved drug, but it's used in multiple products. I think there are something like 400 drugs that national, the National Animal Supplement Council has that are unapproved animal drugs that, again, the FDA doesn't mess with so, yeah. Well, we'll see. But it's very interesting trying to take a drug
Dr. Terry Fosssum 24:53
and get it approved that one does have some issues with toxicity at one level, but that I don't want to Go through the FDA. So we're selling internationally.
Dr Judy Morgan
I don't blame you. So on your website, which is DrFossumsPetCare.com
Dr. Judy Morgan 25:13
You have some surveys. And what are those surveys about?
Dr. Terry Fosssum
Yeah, so you know what we found? So we have a product for canine cognitive dysfunction. It's a combination of eastern and western ingredients. And what we realized when we talked to people is that so many people thought the signs that their dogs were showing were just normal aging, but they're not like these dogs that go stand in a corner and they're confused, or the dogs that their sleep wake cycle reverses and they're now awake all night and keeping their owners awake, or they stand at the hinge side of the door, because they forget how a door opens. That's cognitive dysfunction that is not normal aging.
Dr. Terry Fosssum 26:12
like I said, we treat them and they actually we've seen about 38% improvement within 30 days. But the reason we put the surveys in there was so that people could do a baseline survey of where their dog is, and then come back in 30 days or 60 days and reassess their dog and see if there's a change. And then we actually wrote a book recently.
Dr. Terry Fosssum 26:40
Let me grab one. It's for people with older dogs. So this is Senior Dogs: Maximizing Time With Your Best Friends. And we've got those same surveys. So if you're not gone on our website, you can go into this book, and it has the same surveys in it and but we've got them also for osteoarthritis, for dental disease and for other diseases also, cardiac disease, again, just so that people can assess your dogs and follow them a little more closely.
Dr Judy Morgan 27:25
Amazing. We are out of time. This was fascinating, and I applaud you for the research and the work that you're doing making a difference in the lives of so many dogs around the world. And I wish you the best of luck with this. I'm sure you're going to be successful. So thank you very much for being my guest today.
Dr. Terry Fosssum
Thank you for having me. And this went so fast. It was such a pleasure.
Dr Judy Morgan
I know it does.
OUTRO
Thanks for listening to another great Naturally Healthy Pets episode. Be sure to check out the show notes for some helpful links. And if you enjoy the show, please be sure to follow and listen for free on your favorite podcast app. We value your feedback and we'd love to hear from you on how we're doing. Visit DrJudyMorgan.com for healthy product recommendations, comprehensive courses, upcoming events and other fantastic resources. Until next time, keep giving your pet the vibrant life they deserve.
DISCLAIMER
The purpose of this podcast is to educate and to inform. It is no substitute for professional care by a veterinarian, licensed nutritionist or other qualified professional. You're encouraged to do your own research and should not rely on this information as professional medical advice, diagnosis or treatment. Dr. Judy and her guests express their own views, experience and conclusions. Dr. Judy Morgan's Naturally Healthy Pets neither endorses or opposes any particular view discussed here.
