He Practiced Rheumatology, Then Spent 25 Years in Biotech. Now He's Smelling the Roses.

Welcome to Work Unscripted. I'm your host, Savannah. And today I've got Wayne Jack Wallace, one of the most, one of my most favorite people in the world. Wayne, how are you?

I'm good, thank you for having me.

Of course, course, of course, lots to catch up on today, Wayne. We can start at a bunch of different places, but where I want to start with you today is if you were at a dinner party or a ski trip and you met a group of strangers, how would you describe yourself?

yeah, that's a good question. So, I'm a sort of middle to late age physician and a parent of some lovely kids and who has worked in biotech for about 25 years. And before that was in practice in rheumatology. And now I'm,

Yeah.

basically consulting with a lot of different companies and trying to be semi-retired and smelling the roses.

Yeah, yeah, that's a great life, that semi-retired life. Wayne, I want to maybe start a couple years back. I've known you literally my whole life and we've gone through a lot of things together and you've taught me a lot of things throughout the years. But I want to start in the beginning because I don't think even after knowing you for 40 years, probably over 40 years now, I actually don't know the story of where you grew up and what that looked like. Tell me about Wayne Jack when he was a kid. What were you like?

okay. Yeah, so I grew, I was born in White Center, which is a part of Seattle that I know you're aware of, but it's, yeah, it's also known as Rat City, not a very distinguished place. And my parents lived in public housing. My mom was a homemaker and my dad.

Yeah, Rat City.

Right? Right?

worked at a machine shop and then later became a school teacher in junior high math. We later on moved to West Seattle. And so I was really a sort of public school, both parents, great people, but not terribly sophisticated or achieved in some ways. then, you know, went to public school, did very well in school, was, you know, president of the class, captain of the football team, and then later went to university and

Yeah.

Did reasonably well there. And then one of the things that happened to me along the way was when I was a kid, I was, we were at a summer weekend out on ocean shores, which is, I don't know, a hundred miles from Seattle. And there was a, I was on my bike as a kid. I was probably about 10 years old. There was a car where

Mm-hmm.

Right?

The driver was very drunk and drove into a hillside where the car was full of people and the car got totally smashed up and a bunch of the people died and some were dying. When I got there on my bike as a 10 year old where I couldn't really open the doors or do anything to help these people and it really made me want to try to help people when they were sick.

Wow. Wow.

you

a

That was a very powerful experience for me, not being able to do anything. then later on when I was an adolescent, my older brother became schizophrenic. And then he...

wow, I didn't know that.

became suicidal and jumped into a construction pit and broke his neck. And so he became not only schizophrenic and refractory to most medications, but then he was paralyzed in a way that was really devastating for our family. was my parents always wondered like, what did we do to make this happen? It was like this really horrible thing to navigate.

Wow.

Yeah.

Right.

which kind of further made me want to try to acquire skills to help. In his case, both problems were somewhat intractable and he passed away when he was very young. But anyway, that's a big part of my growing up story. then I went to school in, well, I basically volunteered at some clinics in northern New Mexico where they were cooperatives, meaning that they were sort of run by the town's people to serve the people locally, where the politics were very exemplary, a very, nobody was seeking big reward systems, it was very idealistic.

Mm-hmm.

Mm-hmm.

And they achieved a lot of really good things. So after having done that, I went to medical school in New Mexico and had a lot of experience there working on the Navajo Nation with Gallup, Tuba City, and then trained at UCSD in La Jolla for three years. And then was at the University of Washington for three years in a fellowship in rheumatology.

Thank

Mm-hmm.

And it was during that time where I really learned that you could have the best politics in the world, but if you weren't really skilled or sophisticated as a doc, you really couldn't help people as well as those who had better training. know what mean? So I was at one time, I was going to work for the Indian health service and really provide service to groups that were previously not served very well.

So.

Yeah. Yeah.

.

Right.

But I came around to the idea that I could contribute in other ways and got into more of an academic path.

Yeah. How did you get the inspiration? You talk about your parents and growing up in White Center. I know White Center very well as well. But the drive to exceed in school and to do well, where was that from? Was that just seeing sort of like the situation around you and wanting to escape that or was there something else that was

Yeah, no, I don't. I mean, I was There was, yeah, was, know, the schools were, there was lots of opportunity and I was just able to, I was fortunate to be able to do well in where school was relatively easy for me.

Yeah.

But in hindsight, the schools weren't as rigorous or demanding as some other settings as well. So I don't know if it was me as much as the setting, but I just was energetic and interested in lots of different stuff and was able to do well in school. then, yeah, I think a lot of it was just good fortune as well.

Yeah, yeah.

Right. And did you want to move away after high school was done? Was that in the cards for you?

Well, yeah, I got it. You know, so I got accepted to some colleges that were elsewhere, some some of them very fancy. But I got a scholarship from the West Seattle Lions Club. But I had to but I had to go to college within the state of Washington in order to access those funds. And and frankly, my family wasn't really sophisticated enough to know how to access

Yeah.

wow, okay. Wow.

scholarship money or additional support at some of these other schools that were super, you know, more prestigious, but also very expensive. So the whole thing of like getting, accessing support for education was we were pretty poorly informed or really not very clued into what was possible that way. So I ended up going to school at the University of Washington.

Right.

Right.

for the first two years and then a place called Huxley College in Bellingham, which was a school for environmental science for the final two years. Yeah.

Holy smokes, awesome. So what was your major then in undergrad?

Well, I started out doing pre-med and I did all those things and then I got interested in biochemistry. And so I ended up creating my own degree, which was called life science, which

Yeah.

I think that's an official degree now, right? Like you can get...

I don't know. know. At the time I just sort of invented it because I thought it could include anything that, that I wanted it to. There wasn't any pushback when I proposed it. I, it, sounded logical given the training and I had done some work in plant biochemistry that was for, because of the environmental thing with Huxley and was able to get a couple of publications as a kid.

And they took you up on that? Like, how did you pitch that?

Yeah.

Right?

that was helpful for later going on and doing stuff. yeah, it was, there was no plan. It was more just like trying to adapt to whatever new situation I was in. Yeah.

And did you go to New Mexico right after that, after you finished?

Well, worked, you know, I worked for Seattle Transit. was a bus driver for three months, summer after I graduated from college. Then I went down there. Sorry.

Wow, I didn't know that. I didn't know you were a bus driver. That's interesting.

Yeah, I worked for Seattle Transit. There was one trip where I was driving a bunch of school kids and a kid, while I was driving the bus, a kid came up behind me and said, put their hands over my eyes. He said, can you see bus driver? Can you see? There was another one where the kids in the back of the bus lit this

Was that the end of your career there?

lit the back seat of the bus on fire while I was driving and it was pretty wild. It was very, very funky time. Learned a lot of, a lot of great lessons from that job.

man. What year was this?

Holy smokes. And what year was this then? Like, 80s?

This is 72.

Oh, okay. Okay. When you could bring matches onto a bus and it'd be okay. I understand. Oh, man. What was the...

73, yeah.

Yeah.

Yeah, so but then I went to New Mexico, based I had some friends that were there who told me about, you know, I had said I was interested in medicine and they knew these docs that were in a couple of clinics. One was Tierra Maria in northern New Mexico and the other one was the checkerboard health system in Cuba, New Mexico.

Right.

Mm-hmm.

okay.

So I did some, I went down there and volunteered and did some work there and really, I was hooked, really wanted to carry on.

Yeah, what was, when you were in med school, what was the hardest thing about going through that process? Because I've got friends now that have either just finished or is reinventing their life and they're like, okay, I want to go and take a chance at making it through medical school. What was the hardest part for you when you were going?

Well, so one of the challenges I had was that when my brother broke his neck, he had actually been at the emergency department at the University of Washington when that happened. And so as a result of that, there was litigation with the university about his pretty tragic situation. So because of that, I really wasn't comfortable.

wow.

Yeah.

pursuing medical training, which at the local medical school and really wasn't clued into kind of the national scene. So that's what led to the, partly led to why I went elsewhere. And yeah, and was at the time, I was sort of a communist. really wanted, I was sort of sold on the thing about healthcare should be a right and not a privilege.

Right.

Yeah.

for people, I saw a lot of people who couldn't access care who really needed it because of cost and really was, yeah, I was actually in a little study group, communist study group with a little red book and the hats and stuff.

Wow. Wow. What was that like? That amazes me that, well, it doesn't amaze me knowing you, but like just in terms of being alive at that time and having that stance, which is, it sounds to me very counter to where America was going in the eighties with Reagan and all these things. Did you get a lot of pushback and like, what was that community like?

Yeah.

Well, I mean, it was an emerging movement where there were, you know, marches and periodicals and meetings and, it was developing, but it was also, you know, was not terribly powerful or terribly resourced. And so, you know, and it was during the Vietnam War and the Nixon

Yeah.

Right.

So there was a, it was a very, you I was a child of the late sixties, whereas you, you know, you're aware it was like on a major revolution in terms of music and culture and, and politics. And it was just, you know, you only got the news from the TV or the newspaper. you'd read, you were getting these really minimal slices of what was going on. And then just trying to do the best you could with navigation. So, you know, there.

Right?

Mm-hmm.

But it was hard to build up enough cohesive power to be effective politically.

.

Yeah. Yeah.

So anyway, that's how I, in these, the clinic in Tierra Maria was actually run by a guy from Stanford who was a communist and who had been to China actually and was in a,

Wow.

was in a study group there and brought a lot of his teachings back. And yeah, it was really a big force for developing kind of the co-op structure in northern New Mexico that was actually really effective and helped a lot of people.

Mm-hmm

Right, right, Did you take anything away from your experiences with that group going into when you started practicing medicine and becoming a doctor?

Well, that's where, you know, had the political point of view and the resolve and desire to get trained, but also to change the world. of at the end. So, but then what I also saw was the guys that had some of the people that had the best politics were the worst doctors. In other words, they were committed and focused and loved their patients, but at the same time, they didn't have as much skill or...

Yeah.

training on a scientific level to understand as much as one might for practicing sort of higher order medicine. So that for me, I got into medical school and I was very, I really loved the whole thing. I really scarfed it up. was four years of just really exciting, really interesting.

Yeah.

All right.

It's like, there's no problem that I'll just study my brains out because I was so into it.

Yeah, yeah. What is what's what's the one thing about medical school that most people don't know that that that you want to like tell people that are potentially going into it right now? What would that be?

you

well, you just, basically have to sign off on having much of a personal life. In other words, you know, it's really, it's really, it's a way of life. So you basically are choosing to blow off a lot of recreational or, after hours. Where you go to school all day and then you study all night and then you get up and do the same thing again the next day. and then.

Yeah.

Yeah.

When you're done with the first two years where it's at least in most medical schools, it's very didactic that way. Then the second two years you're in clinics or working in the hospital.

Yeah. Yeah.

And my experience was one where we were, you know, living, we were sleeping in the hospital every third night and up really late. And, you know, it was just very consuming. Really, basically took over my whole identity. But it was regrettable too, because I didn't keep up as much with old friends because I was just super busy. And, you know, the whole thing of trying to become a good doc, you

Yeah. Yeah.

You study hard, you do the best you can, but you still have blind spots and you still need experience and you still need to hang out with wise people who know how to sort of shape you in the correct direction. So you have to pick mentors, know, people that you trust and can relate to to teach you how to practice with the highest professional standards. So yeah, you really have to be prepared to let go of a lot of outside.

Right.

Yeah.

stuff.

Yeah, I mean, did you know those sacrifices you were making like when you when you walked into it when you started?

Yeah, I didn't have any trouble with it that way though, because I was sort of ready for a new chapter where I felt like I'd had a lot of great life experiences and was really sort of primed to kind of throw myself into something where I could acquire skills and contribute in a more substantial way. And it had a lot of emotional passion related to those prior

Yeah.

sort of childhood experiences with my brother and the accident that I told you about. It was like a sort of guiding light to maintain your commitment and passion even when things were really difficult.

Right, right. How was your first couple years actually practicing medicine? What you specialize again in anyway?

Yeah, so I trained in internal medicine for three years, and then I trained in rheumatology for three years. Rheumatology is like arthritis and rheumatic diseases, lupus, autoimmune diseases. And then I was on the faculty at the University of Washington as junior faculty. And then I got recruited by a group that was a cooperative. It's a large sort of Kaiser-like

Right?

well.

institution locally that had about 400,000 people and they wanted, they didn't really have a rheumatologist in the whole Seattle area. So they offered me a position where I thought I could do that, make a living, but where I wouldn't be, and that group was designed where they had both the insurance and the care in the same institution, was quote unquote integrated.

wow. Okay.

So they were, it was basically using the resources wisely to take care of the most people in the best way. But, I worked there and it was fantastic. I learned a lot and really associated with a lot of really great docs, saw a lot of really difficult medical problems and really had deep relationships with patients for almost 20 years. And, but I also,

Thank

Wow.

The specialty that I was in treating people with these pretty disabling diseases, many of them, the field was changing where there were new therapeutics that were coming out that were really powerful and effective compared to what we could do in the past. And because they were super expensive, the organization really didn't want to have a lot of people taking those things or they would break the bank.

Mm-hmm. Right.

So there was this sort of pressure to not prescribe or do things that would be expensive in a way that after a while just became sort of unacceptable for my, yeah, just for the work I was doing. I was troubled by the incentives. Like there were a lot of times the incentives were to not do as much care or spend as much money on.

and

on patients than you might otherwise given that the way that the system was worked, put together. And then I subsequently worked at another large fee for service. I left that place and went to a large fee for service group practice again with, you know, hundreds of docs, but where I was one of very few rheumatologists. but there I saw the opposite problem where it was fee for service work, which means

Right.

there was this incentive to do more stuff with every patient so you could bill more to make more money, both for yourself and for the institution in a way that was also really discouraging. It just seemed like it was very a distortion of kind of ideal medical practice, taking care of people doing the right thing. yeah, so anyway, then I got recruited.

you

Yeah.

Right?

Yeah, yeah.

to biotech with a company locally called Immunex that was making one of the first biologic there called proteins that you administer as a shot to treat certain forms of inflammatory disease. There was like this big revolution where it was very exciting.

Yeah.

Yeah, I remember it when it IPO'd like probably, what was that like early 2000s? Wasn't there a big IPO on it? Like it grew really quickly, right?

Well, they had no, they became public like in the like 10 or so years earlier, but they, but they, you know, but the value of the company was skyrocketing. And so when I joined, I very passively got involved with that, where I was like, suddenly they give you a certain amount of stock when you join these things. And then you just passively that because the company's growing in value, you end up being rewarded in this way. was.

Okay, okay.

Right?

Yeah.

very, it was instructive, you know, like it was good to own a piece of the rock and make money and try to contribute to the success of the program, still doing their, always trying to do the sort of patient centered values. So I became head of what they call drug safety or global safety, which means you look at all the stuff involved with the medications, all the findings from clinical trials, and then you evaluate what were the,

Yeah.

Okay.

adverse events or things that happened to people that weren't expected or like toxicity to try to figure out what was the drug and what was other stuff. And then you represent that to the FDA and other worldwide regulatory authorities to try to get the best representation of how to help docs use the medicine most effectively where it's safe and effective. So I was involved with a lot of that stuff and it was a real steep learning curve.

Mm-hmm.

Right. How did?

Yeah, I bet.

Really exciting to work in. I'm sure you went through this too. Were you working teams for the first time? And it's like very high performance, really fast, very well-resourced, accomplishing all kinds of stuff really quickly, meeting lots of really interesting and idealistic people. So that was, that was a major shift for me in a way that was, yeah, a real eye-opener, really, really.

Yeah.

So then after that, I, Amy and X got bought by another, by the world's largest biotech company in Southern California.

Mm-hmm.

And then they asked me to become head of their safety group where they had like 30 different products with all kinds of different patient populations and different ways of treating people. in a way that was, you know, really a big, I was way over my head in terms of experience and stuff, then really learned quite a lot very quickly just by digging in on their huge portfolio.

Right.

of products and issues and so forth and managed a lot. I also managed like a couple hundred people as the senior guy, where the whole thing of like management training in a large complex institution was a new learning thing as well. With all the attendant bumps and bruises that go along with that. but anyway, that was also very exciting.

Right, right.

Yeah.

Right, Wayne, what made you, you know, this podcast is about transitions and we try to sort of like dive into the reasons behind why people make certain decisions, but going from medical practice, it sounded like you were a bit disillusioned after being at these two different places that are, sounds like very opposite of each other in terms of how they run their business. to then going into biotech at Immunex, like that jump is really interesting to me. What were some of the reasons why you made that versus going to maybe another hospital or another clinic or even opening up your own specialty and running a business yourself? Like why did you make that decision?

Yeah.

Yeah, well, so I was the group that I was working with, I've been there long enough where I was able to coordinate a sabbatical, meaning that if you can find a person to replace your practice, a doc who can fill in for you while you're away, then you can go for a year and do essentially whatever you think is helpful or useful for your own training or career.

Right.

Mm-hmm.

And so I chose to go to Immunex under that umbrella, which made it, it is still sort of like jumping off a cliff because you don't know what the heck you're getting into and you're way over your head with all kinds of things. But then after I landed there and got settled, I liked it enough where I decided to continue doing that and make that my core work. But even then I was able to still see patients because I was

Mm-hmm.

I had a clinical appointment at the University of Washington and was working in the clinics there, you know, but not very much, like just a couple months a year, just a few days a week, something like that.

Right, right.

Yeah. So were you like detailed there? mean detailed is you know in the military it's like when you quote unquote volunteer, officially volunteer for another group organization. Were you still an employee of the University of Washington when you went to Amunex for that first year?

Well, so when I left the university, that's when I went to the first group that had the Kaiser-like entity. Yeah, so when I left that, that was really difficult because it was meant leaving sort of academic life with publications and laboratory and doing sort of high science. So I left the university, but I retained this clinical appointment, meaning they stay on as a

Right, right, right.

Right.

I was at that time a clinical assistant professor. And then with the stuff I was able to do over time, I became a clinical associate professor and then a full clinical professor, still just helping with residents and fellows who were in training with teaching. And then I made the move from the Kaiser Light Group to the fee for service group.

Mm-hmm.

Right.

Yep.

And then, I didn't really want to be a small businessman, which is really what it means to start your own practice. You know, I really, yeah. Well, there's just, yeah, that it's just not part of my, it's just, I'm not wired that way, you know, I'm more of a service or science based person. So, yeah, anyway, that was, it was just that simple. There wasn't a lot of, I really was ready for a change.

Yeah.

And I was kind of in a unique position where things lined up, but I was also, I had written a review article about the biologics that were in development for treating rheumatic diseases. And part of that was positioning to make me more visible to people. So I would be available for other opportunities. Cause it was really hard to make that change while you're, you know, we had bought a house, we had two kids.

Yeah.

Right.

If you leave your job, suddenly all that cash flow disappears, you've got all these bills. It was very high risk to make a change in that setting.

Yeah.

Did you feel like at the time, what was the calculus going on in your head when you finally pulled the trigger and made that change? Was there something that pushed you over the edge? Because that's a lot of stuff to juggle all at once. And taking a risk like that is not a light decision. What was going on in the back of your head?

Well, I just knew I didn't like the other two models and the other one looked exciting and interesting. Yeah, it wasn't more complicated than that. I figured that even if I failed, I could always find a job or join a practice as a practicing rheumatologist.

Yeah.

Right. Right.

make a living and then to pay the bills and so forth. So I figured I was secure in that sense. But I think, you know, after those biotech jobs, I went serially to lots of different companies over time where I would be there for a while and then something would happen and I'd switch. Where I do think there's kind of a restlessness thing in me where I, if you're doing the same stuff,

Yeah.

Yeah.

for a long time, you sort of want to do, you want to take on new challenges or new opportunities for learning. For me, it's always about the people and the products and the patients, you know, trying to put yourself in a setting where you can have a big impact and do good deeds to help more people. So, yeah, those have been kind of my

Mm-hmm. Right.

Guidelines, guess.

Yeah, that's a great North Star and it seems like that's probably through line across your entire career, Wayne. I want to maybe go back a little bit and talk about when you were practicing medicine, one of the things my wife and I talked about actually yesterday was we'd switched from our local hospital here in Longview to a smaller clinic that's further out, but the way they've approached practice in her opinion was significantly better in that they were less averse to risk in many ways. Like they'll talk to you about certain things, they'll prescribe the right things that they feel like will get you to a place where you can be healthier. The hospital we have here, in many ways we feel sort of air on the side of being significantly risk averse in what they are prescribing you and the treatment and medications they do. In your opinion, I mean, you've worked across a bunch of different settings. What would be sort of the perfect scenario for you if you could like wave a magic wand and say like, this is the perfect place for a patient to get treated? What would that look like, Wayne?

that's a really good question. yeah, I mean, really what you want is for people to be comfortable and to have enough time to be able to tell their story in a way that's comfortable for them. And where the providers, the doc or the nurse or whoever, the pharmacist, aren't in such a hurry where they have the time to listen.

Yeah. Yeah.

and take notes. And then to do the homework it takes to figure out like what's the best solution for this individual. So the key is individualized care rather than guideline or conveyor belt sort of high throughput care, which is oftentimes what's promulgated by many of the health systems.

Mm-hmm.

Right.

So, and I, frankly, I think, some of the things that are breaking now with AI, like where they have scribes basically record the discussion and transcribe it where the doc doesn't then have to dictate or, write down all everything that happened just saves you more time. So you have more time to be human with your patients. and then there's more stuff with AI around decision support. In other words, somebody has something.

Yeah.

Right.

Another thing is like some people in my specialty, people would come in with years and years and years of history with very complex conditions where people were wanting to know like what do we do here? What's this all about? What's the key issue? And the only way I could do that was by reviewing the six charts that were each four inches thick to figure out what has been happening with this.

the

Yeah.

person, basically would shoot, you know, a couple hours at least. And you don't have two hours for per patient in a clinic. You know what I mean? So that's where, again, where I think some of the work that's being done for AI to reduce these complex databases into a problemless

Yeah, for sure. Mm-hmm. Mm-hmm.

in medications and medication exposures and prior surgeries, where you really can understand the whole constellation of issues with the patient. And then you want people that are kind and not burnout, you know, who are still committed to practicing excellent care and who care about details and who follow through and can interact. Yeah. Yeah.

Right.

Yeah, I agree. agree. Wait, like one of the things that I've been thinking about a lot is I've gone through a couple of different providers, Pam has as well. I've taken my mom to a significant amount of doctor visits over the last couple of years as well, is I've been thinking about how do we instill more empathy in providers so that they don't get burnt out. And I know part of that workload and maybe a lot of it is stress, but from your perspective, how can maybe the medical schools or how they're actually learning how to practice health and be a good provider, how do we instill more empathy so that we don't burn people out and we get better? sort of overall practice across the nation. Because I feel like it's one of these systemic problems that I'm seeing regardless of which hospital I'm going to.

Yeah, I do think it's important as a provider to not be, have your whole schedule booked every moment, every day with being a provider that you really, you need to break it up with other stuff that gives you more diversity and it helps kind of enrich your, what you bring to bear as both a person and as a doc, you know.

Right

Right.

And so having doing research or doing other stuff, teaching, those are things that help people preserve their passion for the work. But you'll find there's, you know, there's, it's really interesting, like some people are just wired to be infinitely giving and warm and supportive and

Right.

Thank

attentive and other docs just pretty quickly get into kind of business mode where they just want to like churn, get people through the clinic and then get off to what they really love, whatever that is, you And I don't think it's entirely predictable. I think that's what they do when they interview people for medical school, like which are the guys that are going to really retain their humanity.

Yeah, you can tell.

Yeah. Yeah.

most consistently or longest and which guys are going to just want to do it as a business thing or something. I think those are really key things that aren't always entirely predictable.

Right.

Yeah, and I would imagine like even for people that are going through medical school, they don't probably know if they're the get in and get out type or if they're very passionate about patient care until they jump into the deep end and all of a sudden they're like, shit, I've got a packed schedule and I've got to be concerned about every single one of these patients versus just a bunch of numbers in front of me and notes.

Yeah.

Yeah, I mean, you really want to work in a setting where you're provided with the. the tools you need to do sort of high quality care and where the volume of patients isn't such that you can't keep track of stuff, you know, or you have support to keep track for you of a lot of things. So I do think the systems are improving and will continue to, but as you know, it's a very slow process for medicine to change. And

Right, right.

Mm-hmm.

Yeah, a lot of it has to do with the incentives in the different clinics. know, some of them have under have had litigation like somebody sued somebody. So thereafter they're constantly thinking, how do they manage risk for not for the patient, but for the institution or for the doc or the clinic, you know, in a way that really gets obstructs the real connectivity between docs and patients, you know? So it's it's very mixed.

Yeah.

Mm-hmm.

Right, right.

It's very diverse.

Wayne, wanna, you mentioned that there aren't a lot of people, at least when you were in the space, that were rheumatoid specialists. Why is that? Because I feel like arthritis, and I don't know anything about this, I'm not a doctor and I don't know much about the space, but I feel like that's such a pervasive thing. You'd think there's more people that would be leaning into that, but you'd mentioned a couple times that

Yeah.

There aren't a lot, like why is that?

Well, the whole thing about how people go into different areas of medicine, know, family medicine or orthopedics or surgery or ophthalmology or, you know, every, you know, some of those, some of those are people that, you know, wanted to be an eye doctor as long as they can remember, you know, some of them are family docs that just want to help people. I got interested in,

Mm-hmm.

Rheumatology, one of my professors was a rheumatologist who had really profoundly sick patients from that. And people saw, would come to his clinic from all over the world where I was sort of inspired. It was also a very primitive area where there weren't a lot of tools. And I thought, well, if I get in on this thing, maybe I can have sort of like, low, sell high, know, sort of maybe could have more impact by helping bring the, this around.

Right

But anyway, there's a whole bunch of different considerations. mean, you have to get accepted into whatever program you want to train in. Like right now, I think the hardest one to get into is dermatology because everybody wants to just look at people's skin lesions, do cosmetic procedures, and then go home.

Yeah.

Yeah. Yeah. I feel like that one also probably pays a little bit better if you had your own practice and it didn't.

Yeah, a lot of it has to do with money, know, people positioning for the biggest. Yeah. So there it's, you know, it's again, it's extremely diverse. Yeah.

Yeah.

That's wild. That is wild. When I want to switch a little bit and talk about the biotech space, I don't know much about that space either. Based on your experience with Aminx and all the places that you've consulted with, what are some of the things that happen in biotech company that most people don't realize? What's the day-to-day like there?

Well, so you've got, yeah, that's a good question. So you've got different sectors within the company. So it depends on the stage of the company. like early stage, well, like, you know, let's say you've got a scientist who discovers a molecule that he puts into an animal and the animal, you can cure some infection or something from it.

What does a stage mean? What is that for people that...

Okay, cool.

So the thought is, well, maybe this would be useful in humans. Let's get some money to do the studies that it takes to do human studies and then get the people in place to coordinate all that where it's approved by the regulatory authorities, that it's safe and effective and so on. So you basically, you have to have a discovery of something and then you have to have money to do what's called development.

Okay.

And then development includes putting it in, putting the product, you have to show that you can manufacture it in a stable way. You've got to show that you can put it into animals and that the animals don't get sick. And then when you put it into people, you have to do it in a very safe and gently escalating way to show that it doesn't hurt people. And then, by the way, does it still work for the, for the thing that you invented it for? You know, like

Mm-hmm.

what happens to infections. So it takes a long time to get from what they call discovery to the clinic in patients or humans, first in normal volunteers typically, and then to patients. So you've got, in larger companies, you've got a whole group called the discovery group, and then you've got the preclinical group doing the animal stuff, and then you've got the manufacturing group.

Right.

.

And then you've got the clinical group, the guys that put together the studies where you start putting it into human beings and then into patients, and then getting the readouts and negotiating with the regulators for what would it take for us to get approvals to actually put this on the market and let people buy it to use as part of their care, or the doctor to prescribe it.

I see. Right, right. That's wild. Wayne, what does that funnel look like? You know, I would imagine that a big biotech company probably has a bunch of these different ideas or inventions, I what the correct terminology is, in the beginning where people are doing research and stuff like that, but let's assume that maybe there's 100 of those. Of that 100, how many eventually will then end up on a store shelf and get sort of like sold to people that have those problems? Is it a significantly small amount or what does that look like?

Yeah.

Yeah, no, it's like 10 % or something, you know, really, really small. So it takes a lot of money upfront to get it all the way into patients. And then even then a lot of them fail. It's partly why everything costs so much with drugs, new drugs is because people are trying to get their investment back. But they also want to make money, healthy profit on stuff. But you'll find that startups just

Okay.

Yeah.

Mmm.

Right?

are usually just one or two things where they want to just get enough money to get those going. And then if they're successful, often they get acquired or bought by a larger company that's trying to have a broader portfolio of products. So they talk about startups and then the big pharma, they buy lots of companies and pull them all together into.

Hmm Right, right.

So that's kind of what happened to me. was in a startup and then when I went to the big company, I saw this whole array of products in different stages of development. So it goes discovery phase one, phase two, phase three and phase four, where each one has its own sort of rules and regulations on how to get to the next step. And they'll have, let's say 30 products in different stages of development. So you quickly learn kind of what

Right.

what the different stages require for different kinds of molecules or different types of therapeutics. So there's vaccines and then there's cell therapy and there's protein therapy and small molecule therapy, lots of kinds of ways of affecting targets for benefit. So does that answer your question?

It is.

Wow. Yeah, no, that's, it did and it gave me a few more questions. Your role as the chief drug safety person, that's probably not the official title name, but let's just say it is. What does a person like that do? And the question I have in my head whenever I see a new medication come out,

Okay, sure.

That's okay. Yeah.

is two things. The first is there's always the, hey, this thing's gonna solve these things, but then there's a list of things that it could do, like eventually potentially kill you, end of it. So that's my first question is, why do we have that? And this, my second question is, what's the threshold for safety? Because everybody's different, we all have different compositions, and the medication probably won't work the same way, and there's gonna be different reactions.

Yeah.

Yeah.

Yeah.

How do you sort of baseline what's acceptable that goes out? What does that even look like?

Yeah, so it's a highly regulated sector. So when you're doing the development, you discover along the way, what are the side effects that you see with this product? And then how do you figure out what's sort of what you'd expect? Let's say you're treating a bunch of cancer patients that have lung cancer. Well, a lot of those guys are going to have lung problems because the cancer is affecting their lungs.

Mm-hmm.

So sometimes you have to figure out what's the drug doing versus what's the underlying disease doing. And you represent that in dialogue and through dossiers and documents with the regulatory authorities. So one is the FDA and then there's others in Europe and Japan and China, all over Australia, who basically look critically at your information.

Mm-hmm.

and then decide what do you need to say about it with you. They may say you need to show that so many percent of people develop pneumonia or something. And then you basically negotiate what are the things that you have to put in the, it's called the approved product label, meaning the packaging information that goes with the drug.

Mm-hmm.

Okay.

and sort of what are the big things that are important and then what are the little details that are less important. And the stuff you see on TV is really kind of the highlights of some of the big things that are there. It's called fair balance. So the ads are promotional. So the idea, which means benefit, they're showing you people in rock bands and dancing and, know, and what the other stuff is.

Right. you

Fair balance, meaning here's the potential side effects that you might get as well, which they're obliged to represent. But you have to be aware, we're the only country in the world that permits TB advertising of drugs, which is sort of a marker for how peculiar the US sort of.

Mm-hmm.

Really? Fuck!

Why is that, Wayne? Why is the United States the only one?

It's just this freedom to advertise or freedom to represent whatever you want to do. Frankly, I'm against it. actually think having patients exposed to stuff where they don't really understand the full story is oftentimes not in their best interest, you know what I mean? Where it's promotional. A lot of it's pushing people to take drugs that are way more expensive than alternatives.

Wow.

Right.

Right, right, right.

But anyway, yeah, that's what the work of drug safety is. You collect the safety information and then you represent it in a way that's consistent with sort of established standards. And then you propose how you want to represent it. And then they propose back like, well, we think you should do this or that. And that ends up appearing in the approval information. It's actually on the website for each product. It's called prescribing information.

and

where the docs are supposed to go there and then look to see what the FDA permitted the company to say, how to represent things. But very few docs actually look at that. It's the sort of harsh reality. They learn a lot about drugs through promotion and through being detailed by marketing folks to a great extent.

Right. Right.

Yeah, there's, you know, the commercials that I see on TV and the internet, I feel like they're targeting consumers so that the consumers then will tell their providers like, hey, I need Rogaine. I may not know exactly the extent, but you know, heard that that was a great thing to take and I want you to prescribe it to me. That to me is just so backwards in the way that

Yeah.

Yeah.

Yeah, I mean, and the thing is, you know, it works. That's why they do it. It's called marketing and they market, it's called direct to consumer DTC. so you'll have patients asking for something and then the doc is in a hurry. It doesn't have a lot of time to debate. you say, okay, fine, let's just do it. And then they do it. But in the meantime, we've got all this healthcare craziness where you can't afford to.

Yeah. Yeah.

know, healthcare costs are so ridiculous now for just routine things. It's partly because of stuff like that. So it's one of many low-hanging fruit that could be regulated more effectively, you know.

Right?

Yeah, what's the, what's one of the things about working at a big biotech company that really made you nervous or made you scared? Was there what's a bit working at a biotech company? What's one thing that made you nervous or scared there that you saw that maybe most people know about?

I'm sorry, made me nervous about what?

well, you know, I think in the work that I do, it's really very patient centered. And so you see all the good things and bad things that can happen to patients when they're sick. And clearly a lot of times the senior people in these companies are, many of them are sort of business focused where their objective is to

Yeah.

make money for the company and for shareholders. And so sometimes when you're the guy that has to represent the fact that this product is causing harm, it's not like direct pushback, but there's tension in representing that because the fear that this might erode or diminish the value of the product, you know what I mean, for public consumption.

Yeah.

Thank

Yeah. Yep.

So you sort of have to learn how to be, you know, very high integrity, but also diplomatic in a way to get the correct representation of these things on the table. And you'll, you know, it's like any company is composed of real people, some of whom are very ethical and some people, you know, would really like to corners to, to, optimize some other aspect of the business. So you're always having to kind of read the ethical environment where, you know, it really all boils down to individuals and how they're wired and how they want to run their company. the great majority of cases, people want to do the right thing where safety really has to come first, you know.

Right.

Yeah, I would have met

Yeah, I would imagine that in your role, so the comparison I'll make is in the software development world, you have the product managers and you have the engineers and then you have the QA people and there's, and the designers and you always have this healthy struggle, sometimes not healthy, of wanting to get things pushed out the door that may not be ready, but people are asking for it.

Yeah.

because we'll sell more units. In your part of the world, I would imagine there's a similar struggle there where you want the safety to be at a certain level, but then maybe the shareholders or the chief marketing officer or whoever wants to get this thing out the door as fast as possible. Talk to me a little bit about maybe some of that tension, that struggle, like what happens there.

Yeah.

Well, yeah, no, there's tremendous urgency in the whole process. It costs so much to do this kind of work that even days of shortening the timeline for getting stuff approved and commercialized has a big impact. So yeah, people really want to go fast. And sometimes that means...

Yeah.

taking risks with the programs. But again, usually it's in dialogue with the regulators where the regulators can say, look, unless you guys do the following, we're not gonna approve this for you to put it on the market. And so then there'll be pushback and you'll read accounts of these debates in public between the FDA and other groups that are trying to market something.

Yep.

Mm-hmm.

is it public filings when you're engaging with the FDA and stuff like that?

So some of them are, yeah, like there's a document called a refuse to file letter that outlines why the FDA doesn't approve your product now. You can go back and work on it and come back. But a lot of it, as you're implying, is proprietary, where it's not public domain.

Right, yeah I would imagine they're probably guarding that behind lock and key because they've spent hundreds of millions of dollars on that drug or that research and

Yeah.

Yeah, no, it's, yeah, it's very high stakes and yeah, lot on the line with all of this stuff.

Yeah.

Yeah, it happens where people want to go fast and it's really not appropriate, you know.

Yeah. Wayne, I want to ask you maybe a tangential question and you could tell me you don't know anything about it, but I'd love to get your opinion on it either way. I would love to know about your thoughts on how the FDA has changed even since you were a kid here in America and our ability to, maybe not even just the FDA, but just the governing boards that we have in the government to make sure that the things we were producing are at an acceptable level for the citizens. Have you seen the changes that have been happening and what does that look like since the, you know, early to mid 60s? Like what is sort of the evolution look like to you?

Yeah. Yeah, so, you know, back in the sixties, there wasn't really as much structure to how they would evaluate products. There could just be claims which were verified or validated. And then so they evolved in the FDA's case, this very formal dogma on thou shalt perform clinical studies that are

Right?

blinded and placebo controlled and where the science, the science of what constitutes the truth to support approvals has really been elevated to a very high place. So it's still difficult when you're treating very rare diseases where it's really hard to have a control group or a group that isn't getting the treatment or especially for a life-threatening disease. It's hard for, tell someone you're gonna get the placebo rather than the real drug when they're

the

Right? Absolutely.

know, so, but on a lot of levels, it's really probably one of the most successful regulatory actions in the United States that I'm aware of. In other words, I would like to see things like, they're called nutraceuticals or like. these things that you can get off the shelf that are like vitamins or supplements, know, health food things, like most of those are completely unstudied where there's no science behind them at all. They're just somebody makes a claim and then.

Right.

Yeah, how do they even get that pass weight? the GMC and all these like vitamin and fitness stores have to...

No, it's political. So some of the senators in Utah are basically supported in large part by one of the largest supplement producing firms. When they haven't permitted regulations to evolve to regulate that industry, basically they describe it as sort of tampering. in what is otherwise a very healthy or helpful world of therapies. But I think it's really horrible.

Yeah. What is that, what is categorized as? I don't like, I'll tell you, I've taken a couple pre-workout supplements over the years and man, it's made my face tingle and it's done really weird things to my body where, you know, in the back of my head I'm thinking this can't be legal. But yet here it is, right? And I just bought it. What is that categorized as and how the hell?

Yeah.

You

Yeah.

does it get pushed out without the FDA tracking down on it?

Yeah, it's just this whole area that isn't regulated. There's no third party oversight over what's going on. They'll prevent them from selling stuff if they find that it's contaminated or actively doing harm. If there's reports or outbreaks of an epidemic of some problem occurring as a result of an exposure to some agent.

Okay.

But otherwise, there aren't criteria for allowing people to put things on the market. And it really is the Wild West. It's really primitive. I think it's clear that it does as much harm as it does good, I think, in a lot of situations. So that's one area.

Interesting.

Right. Would that be anything in this vitamin category, Wayne? Or is that like, I just don't know what falls under medicine that you, you know, when you were working at those biotech companies are producing versus some of these other things that are enhancing you, quote unquote, enhancing you in some ways. What is that? Where's that line drawn?

Yeah, well, there are certain formulations or preparations of vitamins that are said to be more pure and more safely prepared. But it's mostly by reputation that if you're working with a group that says they do high quality work and they have some evidence for that, that's, and their product is active in some

you

system, some assay or some animal that shows that it does shows benefit, where the science is pretty good, then you know, then you're on reasonable footing. But there's just so much stuff that that hasn't really been evaluated at all. I mean, that's just one sector, one area that's your bigger question was, do where should we have better regulation or not? There's always this tension between

Mm-hmm. Mm-hmm.

Right.

You know, they say that in the US we innovate and in Europe they regulate, meaning they don't crank out as much new stuff, but they put boundaries on what the stuff can do or how you can use it. So there's always this tension between the innovation people and the regulation people and the innovation people want to deregulate as much as possible. But, you know, that goes for environmental stuff. It goes for buildings, you know, in every

Absolutely, yeah.

it.

domain, you know, there's this whole thing of when do you have freedom to operate and when do have to do things in accord with the rules? And it's lot of it's just historical. What did they used to do? And then political, like what if what are the politicians support or get paid to ignore, you know, it's it's really the Wild West all over. So

Right.

Yeah. Yeah.

I'm sure that's a big part of it. And actually, is a good segue to my next question, which is around when you were doing research, especially gathering feedback from the efficacy of certain drugs and how that's positioned over the last couple years. I don't even know what year it was, but we've had companies like Theranos and all these other ones that have sort of supposedly been a golden child of being a very effective drug, but the CEO was found to be either hiding or misrepresenting certain figures and all of a sudden you get pinched for that. I don't know much about the industry, talk to me a little bit about sort of like why companies would want, one, want to go to that extent of

yeah, yeah, yeah.

maybe exacerbating some of these numbers. Like what does that get them? But two, how does that even happen? Because I would imagine if you had a sheet of data and you run it, at least in my head, it's like, okay, this drug did these five things, here's the data, and I'm gonna show it, and it's pretty straightforward, but that's definitely not the case. Like, maybe explain.

Yeah, no, so like the Theranos example, they said that you could take a drop of blood and then do all these tests from that that were predictive of all sorts of health outcomes. And when I first heard about it, knew it wasn't real because, know, we're just, medicine's just not at that stage where you can do those kinds of essays with that much precision, you know, that are predictive. So.

Right, yeah, yeah, yeah.

Mm-hmm.

But as you know, a lot of very sophisticated people, think Kissinger and Schultz, for whatever reason, they were taken by the aura of these people being on the cutting edge and representing their product with a lot of certainty and implying that it was going to blast off and become even more valuable over time.

Yeah, yeah, it was good.

Right?

I mean, part of it's driven by greed and part of it's driven by people just assuming that people know what they're doing if they're hanging out with other people that already have been achieved in some area, you know, their pedigree. So, but you know, especially in the early stages with biotech, you'll find that the venture capital people, the people that have the money to invest, they oftentimes don't really understand what the product is or what's going on. They're really doing it more.

Great.

based on have these guys done anything important in the past? And you know what I mean? Where they're not scientists or they don't really understand in any real depth what's going on. So they have to depend on others for their assessments of when to invest or not. But there's a saying that the truth will always out. In other words, over time, once you do

yeah.

promote transparency with the studies and the data that you'll ultimately find out that it works or it doesn't in accord with really well-established standards. The beauty of science is if it's not reproducible, it's not true.

Mm-hmm.

Yeah, yeah.

Yeah, I mean, I think like with Theranos, it's a lot of it is just this hamster wheel that gets started by a couple people and then you just get more people on this wheel and the next thing you know, it's going too fast for people to jump off. But the impact of a company like that, especially in the biotech space, if it is a fraud, is significantly greater than a startup that is making a widget.

Yeah.

that raised $100 million but the widget doesn't work, right? I wonder what, within that space or within that industry, are there checks and balances so this type of stuff doesn't happen again? What does that even look like?

Yeah. So like I get involved in a due diligence meeting, like when one company is considering buying another company, because that, that company has a product that they think they could take and through their expertise, develop it into a more commercially successful product to help a lot of patients. And so they ask you to go in and look at the information about the product and

Mm-hmm.

Sometimes it's very clear early on that there's all sorts of warts or problems with the product. And sometimes the data set is very limited where you really don't know completely how this thing is going to behave. But it's very urgent because the company that's purchasing is in a race with another company with a similar situation. And so they have to decide how much risk do we want to take with this uncertainty?

Right.

And then sometimes there's a little bit of fibbing on the part of the selling company. You know, they may not represent stuff that's already known, that this doesn't work in certain experiments that they're not showing you. You know what mean?

for sure. Yeah.

It's like lying by omission, right? Like you're or just flooding people. Right. Right. Right.

Yeah. They call it selective representation of data. Yeah. So there's, I've seen, you know, really million, multi-million dollar and even billion dollar things where they buy something and then learn later that the, there wasn't, some of it wasn't necessarily true or some of it was misrepresented. And then they have to decide, it worth litigation?

Mm-hmm.

Right.

And then the lawyers get involved and it really becomes this big mess. So, yeah. But on the other hand, I think the US leads the world in innovation. We have more people that are willing to bet their money to make more money and at the same time develop products that might help people. There's sort of an infinite demand for human problems that warrant potential therapies.

Yeah.

.

Yeah, absolutely.

So you could make an argument that if you're going to waste your money, wasting it on health care isn't a bad way to go.

No, absolutely not. not. Wayne Jack, I have two more questions for you. The second to last question is you've got three wishes. Your first wish, you wish for pizza. Your second wish, you wished for beer. And you get one more wish. And if you only have that one wish left on how to improve

Okay.

the space that you're in, the biotech space of going from stage one to stage four, what one thing would you do to make that whole process more efficient and efficient?

That's a really good question. I guess I would make just heighten the transparency even further, both for when people are purchasing things, but also developing things that there be sort of full disclosure of all of the information, that there's more resource to evaluate the information.

Mm-hmm.

But yeah, I don't think it's straightforward how one can improve that process. It takes a lot of time. It's already very cumbersome and burdensome. People don't want you to put stuff in animals because we love animals. On the other hand, we're reluctant to put stuff in people before we know that it might have some problems. So I do think animal studies remain appropriate because of that.

the

Right.

I don't know, it's a really good question. I don't have a snappy reply. I may be too close to it, where it's too complex. I think this thing where they're resourcing the regulators more is to facilitate faster reviews and turning things around more quickly. I think that's a good investment.

Yeah.

So I'm sorry, I don't have anything more colorful to offer.

No, that's great. Well, at least you've got the pizza and you've got the beer from the first two wishes. So we've got that. All right, Wade Jack, last question for you, my friend. In 30 years, your grandkids, they end up stumbling upon our conversation today. What is the one thing that you hope they get out of our conversations today?

you

that I hope to get out of it or they, I'd want them to, I hope that they are inspired or encouraged to be brave and to take risks and to try to contribute and do important things, you know, and really help the larger human community. Yeah.

that they'll get out of it after they watch you and I talk today.

Yeah, love that. I love that, I love that. Wayne Jack, it's been fantastic, my friend. You are and have been an inspiration to me for so many years. And I thank you so much for coming on the show and dropping all this knowledge on me and all the listeners. So I appreciate you.

Thank you for having me. We'll see you down the road. Okay, bye-bye.

All right, we'll talk soon. See ya. Bye bye.