Russ Johns 0:02
Welcome to the #piratebroadcast, where we interview #interestingpeople doing #interestingthings where you can expand your connections, your community. #Kindnessiscool and #smilesarefree. Let's get this party started.

It's a beautiful day for the #piratebroadcast where we bring #interestingpeople doing #interestingthings. I'm grateful for your being here and participating in a community, sharing little kindness along the way. #smilesarefree. Share one pass it along and enjoy your day. I also want to introduce you to another pirate. Deirdre pirate Deirdre the pirate is in the house today. How are you today?

Dr. Deirdre Clark 0:52
I am fantastic. I'm so happy to be here with you and be part of the pirate crew. Thank you for having me. Yes!

Russ Johns 1:01
Yes, we were talking before the show, and we actually started a little bit late because we were having such a great cover. I know there's gonna be a dynamic conversation today.

Dr. Deirdre Clark 1:13
Yes, yeah.

Russ Johns 1:15
I was telling her a story, a long sad story about breaking my hip, and how time just flies by and you're young, you're 19 and you're thinking, I'm never gonna hit 50 I'm never gonna get old and feel like little aches and pains here and there. However we do. We know life happens in the next thing, you know, you're there. And

Dr. Deirdre Clark 1:41
You're there. You're there.

Russ Johns 1:43
I know that some of your background is around research in the medical profession and some of the things are happening in and around our world right now. There's a couple things I wanted to Talk to. One was, I think about this this morning, Dr. Deirdre is one. Research is one of those professions that it's a lot of test and evaluate. It didn't work exactly how I imagined. It's almost like your failures are part of the process. It's a failure as much as you tested something that didn't actually end up exactly the way you wanted to work it or didn't provide the results you were looking for.

Dr. Deirdre Clark 2:37
Correct

Russ Johns 2:38
or try to frame it in a way. I wanted you to kind of speak to that because I think a lot of people in life are so fearful of testing things and not knowing what the outcome is in your business of not knowing what the outcome is in a lot of ways. Kind of broadneck thought process and and let's talk about how that impact so many people's lives.

Dr. Deirdre Clark 3:02
Okay, so research is like the silent machine that runs a variety of therapeutics that are designed to give us a longer lasting life to treat conditions that were either ineffective or did not have treatments for them for rare diseases, new, more aggressive cancers that are coming out. With research comes many years of development. You have to come up with the molecule, you have to go through animal testing, you have to go through a variety of stages before you even get to the point where you're actually testing a drug in a human. Okay?

The drug has to be proven to be safe. It has to go through a whole bunch of testing and I'm not going to get into a lot of scientific words here. Because I think it just It gets lost in the meaning. I think people just want to sound really smart. Basically, research is there so that we can actually improve the longevity of our lives. What's happened in the current climate is that we have a whole bunch of different experts spewing out information that is confusing the population. You have people that are talking about this therapeutic drug, you got people talking about this therapeutic drug, you've got every day, a new article of people saying shave your beard off, you're more likely to get COVID if you shave your beard off, you're more likely to get COVID if you're over six feet tall, and do all of these different things is absolutely, everybody's kind of going, what is this?

What is it that you want us to do? Basic infection control, okay? is to just be clean, okay? Keep your hands clean, keep your face clean, and just just be clean, okay? That's really sums it up. When it comes to research, okay, it takes a lot of work to get a drug or vaccine ready for development, you have to go through many stages of development, four stages, four stages, to get it to the, to the place where it's ready for the population to mass receive it. With that being said, I don't think we're anywhere close to having a vaccine because it takes a lot of trial and error, practice Case in point and I'll wrap it up is that if I develop compound a, okay, and it does well in animal testing, and it does well and healthy volunteers.

When we tested in the actual population that actually has the condition, you might pick up some, we call it as Okay, as Now use, I'm not going to name the company, but one of the side effects of a medication was Hello, good morning. It was actually used as a hypertensive drug and it actually produced a side effect that made men really really, really happy. That was that was the side effect. Okay, but that wasn't the intention. That wasn't the intention of the drug. That was a happy side effect, but then you have some side effects that are more undesirable. Then you have to go back to the drawing board and see what you know what's causing this And then you have to re tweak it. It's a lot of trial and error to get it to the point where it's more beneficial than detrimental to the population.

Russ Johns 7:12
Yeah. That is such a challenging process. It has to be challenging. The amount of patience that you have is probably tremendous, is practicing every day.

Dr. Deirdre Clark 7:24
It's a lot because they're global trials. They happen. You're there global trials. You when you have a global trial, the global trial takes place in the United States, it takes place in Europe, it takes place in Asia, it takes place in Australia, it takes place in Africa, it takes place in South America, so that you are seeing how people are responding from different locations, to

Russ Johns 7:51
A broad demographic of India, to really get enough data back to to know what The side effects?

Dr. Deirdre Clark 8:01
That's correct. That's correct.

Russ Johns 8:05
I'm here in Arizona care for mom now. When she's watching television and some of these commercials Come on, for drug use and it's mostly geared and focused to the geriatric community. The side effects, the list of the side effects are tremendous. I'm thinking to myself, I don't know if I would rather have the symptom or the side effect because some of these may or may not happen. I happen However, it's a process, and I want to bring it up because somebody that is unaware of the process, unaware of the system that we have to go through in order to accomplish this goal, saying, Hey, why don't you just go to the lab and mix something up and make it happen?

Why can't they just and they don't realize that There's a large machine that has to be moved. Everything has to go through this machine and testing and evaluation and several layers of testing, excuse me. Just to bring awareness to #thepiratecommunity and everybody around you, because it's not that everybody's dragging their heels. It's not that they're getting anything that you're not doing what you need to do, but it's really about how you can actually generate real tests and real results and come back to

Dr. Deirdre Clark 9:42
okay. So, basically, to answer your question, we generally use a guidance. It's called the Code of Federal Regulations. Okay, this is our guidance book, okay. This is what we call the research Bible. Okay, and in here It tells us basically all the requirements of conducting a trial. It tells us all of the regulatory documents that are required to conduct a trial. It tells us the IRB requirements and IRB is the institutional review board that approves a protocol. A protocol is designed to conduct a study of a new drug, okay? and participate in a new drug study. All participants must be able to sign an informed consent where they actually give consent to participate in the trial. Okay, so we follow what we call I ch GCP guidelines.

In this book, this is the old version, but in this book, it has so much information that we utilize that tells us all the requirements and guidance does ad that have been initiated by the FDA. There's no like shortcutting to get to where you want to go, you have to follow the process of research and development, there is no way to, to over look that. During the conduct of the trial, you'll have what we call interim analysis, okay? where they actually look at the data and determine what's happening with the data. Let's just say for example, during the interim analysis for quarter one and quarter two or interim analysis, one interim analysis to it is determined that 20 people have had a heart attack.

Okay. All right. Across all the sites spread out, okay, when people have had heart attack, so they're going to say, Wait, wait a minute. 20 people have had a heart attack. We got to stop and reevaluate this because people shouldn't be having a heart attack, taking this drug. Okay? We've got to stop. We've got to see what's happened and reevaluate. Is it this drug is something else is how we enroll people who were sick, have someone enrolled people who were unhealthy and should not be on this trial? Is someone taking a drug that is interacting with the drug, we have to actually look at every single aspect of the trial to determine Is it the drug, it may not even be the drug? It may be people enrolled in the trial that shouldn't be in the trial.

Russ Johns 12:46
Not only you do the research, you have to do the forensics,

Dr. Deirdre Clark 12:49
yes, yes, we have to do a lot of a lot of investigation. There's a lot of moving parts. When you are conducting a trial, you have Researchers, you have biostatisticians you have medical affairs, you have data managers, you have pharmacovigilance, you have clinical monitors, you have project managers, you have so many people that are feeding into the success. We're always hoping for success success of the trial in the therapeutic.

Russ Johns 13:22
That's why I can take years. I mean, because you can make some adjustments and go back. Do you do you start multiple trials simultaneous? Or is it just like, you start with one and you go through the whole process? And then you say, okay, that that outcome isn't what we would like to see. So you start another one, or are there multiple trials going on at the same time?

Dr. Deirdre Clark 13:45
most companies Yeah, they will start multiple trials and they may have like one compound, and they may start multiple trials, once is deemed that the compound is safe and it's stable. Let's just say Crohn's disease, okay. If the compound is safe, they may try multiple compounds, multiple protocols to use the compound and different trials with people with moderate to severe Crohn's or maybe, very mild krones or very extreme chromes to see how it works in very various, populations with Crohn's disease, and in my find it's very effective in those with moderate to severe Crohn's, but ineffective in those with mild Chrome's.

Okay, so that's why you'll see those differences and say, Okay, well it's effective in those words and that's most what mostly with like, biosimilars or things like biosimilar drugs or bio The name is just Left my head right now, because I work on so many things in my head, I'm like a, like Emerald or what's the other way humera those type of drugs that you actually inject, okay? They have targeted things that they are actually targeting. Okay. That's happening then you kind of have to look at it. Even though they use you know those particular drugs for RA, and psoriatic arthritis, they also use them for Crohn's disease.

Russ Johns 15:41
Okay. So there might be a drug that could be used for like the side effects of some drugs you know, you could use drugs or alternate medical conditions in It's a wide range of these things. It's just like one thing I was thinking about the other day and I was thinking about we have the whole DNA sequence mapped out, in our bodies are always changing, our cells are dying and new cells are growing. I'm thinking to myself, do you ever see us getting to a point where we can do go like, what's the gene? What's the DNA? Is it a slicer? Where the DNA where you actually modify the DNA, they just had a cow was born as a result of this process.

Dr. Deirdre Clark 16:44
Genetic mutation

Russ Johns 16:46
Well it's genetic. However, I was thinking to myself, it's like, well,

Dr. Deirdre Clark 16:53
Cloning?

Russ Johns 16:53
Well, it's not cloning. It's where you modify the outcome of Gene behavior. If you're known to have cancer cells, you can actually modify the DNA to change the way cancer behaves. Instead of expanding it would contract or something along those lines. It's not necessarily chemical changes, but changes the DNA level.

Dr. Deirdre Clark 17:27
Well they do have target therapies

Russ Johns 17:27
Yeah, well, it's, I have to believe that there's probably something along those lines being studied. It's fascinating to me. Because if you're at the DNA level, your DNA is is mapped out to say, Okay, I have no hair is suck.

Dr. Deirdre Clark 17:50
Yeah,

Russ Johns 17:50
okay. That's in my DNA of who I am is in my DNA. So if you're actually modify that DNA at some point in time. It's kind of sci fi a little bit maybe. However, it's like for disease and disease control and blindness or, different kinds of conditions like Crohn's disease it's okay. If you could see the DNA and say, Hey, this individual is prone to have Crohn's. Here's the trick that we can add to the DNA or prevention that we can add to the DNA diversity that taking place or how does that fit into the current existing infrastructure that we have for drug study.

Dr. Deirdre Clark 18:39
It is taking place, okay. There's a fine line. It's called bioethics, right. There's a fine line of what is ethical and what is too far, right. How far can we go with out actually going too far. Right. That's the debate that they have in the medical ethical community. They'll talk about altering the genetic structure there. There are targeted therapies, there are targeted oncology treatments that are very specialized for the individual right now as we speak, okay.

There is stem cell therapy, there are a variety of targeted therapies that are designed to help us live longer, healthier lives, and they're mostly available to those who are very wealthy now. Okay, so I'm gonna say On the flip side, that if you want to have hair because you are vain. Okay? Right. That's not medically necessary for people to have hair. Okay. If there is a reason, and then there is a genetic mutation that they can correct so that babies are not born with mitral valve prolapse. Okay, all right, that's a life saving condition or a life saving, alteration that would be beneficial. Okay. But when you start having designer babies

Russ Johns 20:28
That's a different.

Dr. Deirdre Clark 20:30
That's different. It's like, you know, there goes that ethical question, what's medically necessary versus things that are desirable? Okay. I want to be taller.. But is that actually necessary? No. Then, you got the mad scientist people, right. It'd be better if we could be No great taller people in the world? No, no, no, no. That's why we need to create a bunch of committees to keep people in check. Because once you start going down the rabbit hole of all we can do this and oh, we can do that. We need to check ourselves and say, Okay, well, is this something should we do? This is the question and let's just pause.

Russ Johns 21:26
Yeah. Just because we could doesn't mean we should. Right.

Dr. Deirdre Clark 21:30
Right. Right. So that's, yeah, yeah, that's right.

Russ Johns 21:36
I think the tool was called CRISPR. So CRISPR,

Dr. Deirdre Clark 21:40
yes, yes. Yes. Yes. Okay. Yes. Okay.

Russ Johns 21:46
I just want to give a shout out. This is a fascinating conversation that I could have for a long time because it's, it's really amazing. Some of the technologies that's going into this so Wendy. Good morning. It's Eddie Shuman. Good morning everyone. How are you? Here?

Dr. Deirdre Clark 22:17
Hi Oliva!

Russ Johns 22:17
It says on fire. He says Wendy Good morning. Wendy. Jeffrey Good morning all these people this is so interesting

Dr. Deirdre Clark 22:29
Hi Angie!

Russ Johns 22:29
then we got Gabriel Gabriel is in the house yeah

Dr. Deirdre Clark 22:33
Hi Gabriel!

Russ Johns 22:34
Everything wonderful Community Olivia saying everything looks great out and thank you everyone for being here and if you're watching the replay you can always go to russjohns.com and sign up for notificationsto get new

Dr. Deirdre Clark 22:51
Russ is awesome! He is an awesome host.

Russ Johns 22:54
We're talking about some amazing things with Dr. Clark pirate Deirdre

Dr. Deirdre Clark 23:01
Yes. I am a pirate now!

Russ Johns 23:04
It's fascinating. I want to go back and shift gears before we take off is, so this is a long process to get to where you are today. What was the point in your life or you decided I want to be a research scientist or I want to be a doctor working in research for drug. Was this a choice? Or Wasn't it a series of decisions or opt opportunities that presented themselves or what was the what was the challenge in the opportunity that you saw on this journey?

Dr. Deirdre Clark 23:41
Well, I'll tell you quickly, how much minutes do I have to two minutes? Okay basically I went to school, I became a chiropractor, and I really started falling in love with research because started reading research, and I was going to go to medical school. I was really tired. I had already went to school for like eight years. I was like, I'm really tired. I entered research, the different realm, I became a clinical research associate and Britain moved in through that space and became like a project manager and did QA and medical affairs and things like that.

I went in that realm, even though most people don't go into clinical research because chiropractors don't believe in medicine or anything in that in that manner. What I've learned from that is that you can combine. I know a lot about research, I know a lot about wellness and know a lot about prevention. Just kind of combine that knowledge and see that you can combine the three and make it work to be able to help the the group Good. That was how I ended up in this space.

Russ Johns 25:05
Wow. You have a broad knowledge of a lot of different subjects that you're probably always curious, you're always looking for something up and you say, I wonder how that works, then you go down the rabbit hole and figure out how it works, right?

Dr. Deirdre Clark 25:23
I wake up in the middle of the night and I get my glasses and I'm like, I'm starting to like googling stuff. I'm researching stuff. I'm like, give me sleep at night. I'm always looking up different things because it's so important. It's been a really, really interesting time. I want to say thank you so much for having me on the show. Thank you so much for your wonderful guests that chimed in and said hello. Anytime you only had a short time but anytime you want to delve into health care and prevention and and what have you, because it's it's all a great space.

I don't want people to think depend on drugs. That's not what I want them to take away from this, but I want them to take away that there's a lot of work that goes into research and development of new therapeutics that are available for them, and to them, but you still have to do your part. Meaning like, you still have to do your exercise, you still have to eat right? You still have to take control of your health, and not depend on your doctor to say, here's a script, here's a script because all those drugs in your body are just building up. Do the best that you can so that you don't have to have a shelf full of drugs, okay, so that you can maintain your life.

Russ Johns 26:43
Yeah. The more you can maneuver through life without drugs, the better.

Dr. Deirdre Clark 26:49
Yes,

Russ Johns 26:50
yes, yes. It's about a healthy lifestyle as well. It's like, Okay, well, I broke a bone. There's a process for that shortcuts. You can't give me a pill for it's like, I can't heal overnight. It would be nice.

Dr. Deirdre Clark 27:07
It'd be nice, you will heal you get and get that hit and move in. And it will heal, it will heal, all of those bone cells will come together heal that bone. I don't know. Did you get a steel plate or anything in there?

Russ Johns 27:23
Both of you back together will be rebuilt.

Dr. Deirdre Clark 27:30
Yes. Yes.

Russ Johns 27:33
The other thing I want people to understand is that you Everything is a process and personal responsibility is important because we all have a responsibility for our own bodies, our own minds, our own thoughts and research, understand what it is that you have to work with, when and where what kind of outcomes are you looking for? Because life is research. We're testing wherever Evaluating we're learning. I often tell people, life is like an instrument we have to learn how to play our instrument.

Dr. Deirdre Clark 28:08
Yes. Yes, yes.

Russ Johns 28:11
Good.

Dr. Deirdre Clark 28:12
Yes. Be advocates for our parents, because our parents just like we say your parents see, see things on TV, they see different therapeutics on TV, do your due diligence, see, is this the right drug for you? It might help you, but it might not be the right drug for you. Because when your physician is prescribing a medication for you, they have to they have to evaluate Is this the right truck for you based on your age, your race, your weights? So many things that they have to go through? Just because you see it on TV doesn't mean it's for you.

Russ Johns 28:44
Yeah, exactly. Exactly. Well, I have thoroughly enjoyed this conversation. We were able to connect and share this information with the community. Thank you so much for being here. Thank you so much for your work you're doing If there's anything we can do to add value to your day, let us know and let me know. I'm more than happy to share it out and promote it. So if you're not connected with Deirdre, pirate dierdre reach out and tell her Sencha.

Dr. Deirdre Clark 29:26
Captian Russ ! I love it. Yes, yes, yes, yes, yes.

Russ Johns 29:30
start this conversation, keep this conversation going, keep it positive, keep it productive, educating inform other people around us that, you know, there are options for us, there are things that are going on around the world that are positive. And there's people working hard to come up with outcomes and results that we need help with.

Dr. Deirdre Clark 29:51
There are a lot of hard working people out here working so that we can be healthy. So just keep that in mind. Just don't turn off the noise. Turn off the noise and then listen to the silence. Turn off the noise. Listen to the silence.

Russ Johns 30:12
We have to learn how to play it.

Dr. Deirdre Clark 30:13
Yes, it is. I love that. That's a great saying.

Russ Johns 30:18
Yes, the more you can live your life without drugs, the better. So,

Dr. Deirdre Clark 30:23
yes, yes, yes, yes, I agree. We all just kind of do our part, and kind of support one another. Post if you learn something new post it, share it. Well, yeah.

Russ Johns 30:38
Yeah. Let's have a dialogue. Let's have a conversation about it.

Dr. Deirdre Clark 30:42
Yeah.

Russ Johns 30:43
This is another wonderful episode. We've got another pirate in the community. I want to wrap it up and thank everyone for being here. Thank you, Deirdre for your presence and your work and your efforts and all Also, as you know, everyone, #kindnessiscool, #smilesarefree, and you #enjoytheday. Take care of it. See you soon.

Dr. Deirdre Clark 31:11
Thank you.

Russ Johns 31:13
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