Interview with Dr. Grant Pagdin about his BHRT POC
February 5, 2025
Interview with Dr. Grant Pagdin about his BHRT POC
Nick Tierney: Hello! This is Nick Tierney with RegenMed Circles, and I'm joined by Dr. Grant Pagdin, who's a regenerative medicine and anti-aging expert located in Kelowna, British Columbia. Dr. Pagdin, thank you for your time.
Grant Pagdin: Yeah, thanks, Nick. It's a pleasure to be here.
Nick: Please tell us a little bit about yourself.
Grant Pagdin: Well, I got involved with bioidentical hormone replacement back in around 2009 - 2010, and I got certified through the American Academy of Anti-Aging Medicine with their board exams. So, I have expertise in bioidentical hormone replacement, and also in the regenerative procedures involving PRP and stem cells along the way. I also was involved with clinical research that was pharmaceutical, sponsored, and I have my name on about 39 research papers using pharmaceutical medications and trying to get those things to market. In 2019, Health Canada intervened in the stem cell space in Canada and insisted that if we were going to use stem cells to treat osteoarthritis, we had to register a clinical trial. So, I put my own trial together. It's sort of self-funded, self-initiated. I'm the sponsor and the investigator, and I stick handled all through the Health Canada regulations to put my clinical research trial as the pioneering trial in Canada using stem cells for osteoarthritis.
So, I have a fairly extensive background in research as well as my background in bioidentical hormones and regenerative procedures.
Nick: Excellent. And today's topic is going to be bioidentical hormones in particular. So, tell us a little bit about what those are, what they're used for, and a little bit more about some of the challenges and or misconceptions about them.
Grant Pagdin: The big challenge in this field is that some of the drug companies are now producing bioidentical options so that you can get a pharmaceutical drug. That's a prescription, and it's available from any pharmacy, and it's standardized. It has a DIN number. It goes through your extended healthcare plan.
But some of these products are not available, or not always suitable. So, we ask the compounding pharmacy to make up a special cream, or a lotion, or a recipe, according to the doctor's prescription, and they will use the exact hormone that would be normally present in the body. So, a bioidentical form, and it's formulated in some sort of a method of delivery.
So, the challenge for us really is to show that these things are safe and effective, that they work as they ought to, and that they would provide important, meaningful clinical improvements on a par with what the standard prescription pharmaceutical versions might do. That evidence is really lacking in the marketplace right now.
And some of the regulatory bodies or the oversight bodies, for instance, Women's Menopause Society, aren’t really coming out strongly in favor of these compounded hormones, because they're not really validated, and the standards of manufacturing are not necessarily uniform across the board. So, we do have some challenges when it comes to showing the safety and the efficacy of these compounded bioidenticals.
Nick: So, in the field of stem cells, you mentioned that you self-organized a clinical trial which you brought to Health Canada, and are now conducting. Probably, the rare practitioner that can put all of those pieces together, and afford to be able to run a clinical trial. What are the other options for generating clinical evidence. How else can we start to collect data on BHRT?
Grant Pagdin: As you've alluded there, Nick, putting together a registered clinical trial, is a very onerous proposition. But an emerging way of achieving some meaningful data is what's called real-world data collection. So, what we do is rather than having a registered clinical trial where patients are randomized either to receive a placebo or an active drug, what we do is we take a cadre of patients that have similar symptoms and similar presentation. We put them on some treatment, and we track their outcomes with patient-reported outcome tools. I don't have to register that as a clinical trial. I don't have to have ethics oversight. We just have to have the patient that consents to, first of all, the treatment with the hormones and participation in the data collection.
Nick: So, you're doing this real-world data collection already, it sounds like, and what are the types of patients that you're tracking after prescribing BHRT?
Grant Pagdin: So, in my testosterone replacement Circle, these are males that are registering with us for the onset of testosterone replacement. They've been deemed to be suitable candidates based on their symptoms and their blood test results.
They do a questionnaire at baseline that gives us an idea of some validated symptom scores that they are dealing with. Then we initiate testosterone replacement. It could be done either as an injectable pharmaceutical substance, or as a compounded topical transdermal substance. And so, I record that at the beginning of the Circle of which sort of approach we're using for hormones, and then the individual is prompted to repeat the symptom score 1 month, 3 months, and 6 months into the treatment. And that way we can track how well they're doing.
Nick: And on the clinical side, what is the type of data that you're really interested in entering and then correlating against those outcomes?
Grant Pagdin: Sure. So, as the provider I'm going to be entering into the Circle the data around the severity of the symptoms, the nature of the prescribed treatment, whether it's going to be an injectable testosterone, and the exact dose or transdermal testosterone, and the dose as well as the baseline lab levels. You know the total testosterone, free bioavailable testosterone SHBG, - some of the parameters that we want to track. So, it's the responsibility of the provider to enter some of that basic data information at the baseline and then again at follow up. If we have follow-up lab tests, I typically do my follow-up labs at 3 months and 6 months. So, I would have a little bit of data to enter at those time points. But it's not particularly onerous for the provider. There's just some basic information that we want to register in that data set.
Nick: So, that's great, Dr. Pagdin. So, you're collecting a lot of great patient data. You're spending the time to enter in a lot of specific prescription and other data related to formulations. What are you doing it for? What will you be using the data for?
Grant Pagdin: Well, there're really 3 benefits that are obvious that I can think of, Nick.
The 1st is the benefit for the patient themselves to feel engaged in the program, to be able to track their progress and have some objective numbers that they can see that helps them to track their outcome.
The 2nd is for the provider. So, I want to know, am I, you know, am I hitting the mark? Do I need to make some adjustments, you know? And how is this particular patient doing compared to the overall cohort? So, it helps me to refine my prescribing and optimize the treatment of the patient.
And the 3rd is that these API suppliers that produce these ingredients to make the compounded hormones, they're very interested in the efficacy and the outcomes, and that data would be very valuable to them.
So, if there's a way that we can monetize this in a licensing way to be able to make that data available to these manufacturers and suppliers, that would be just, you know, an extra bonus.
Nick: And so, Dr. Pagdin, so far, you're describing something you've already started, are doing yourself have been doing for over a year now with us. Is there a way for other doctors to participate?
Grant Pagdin: Yes, I've established these Circles for some time now, just a little over a year. In the Hormone Replacement Circle for men I have over 300 registered subjects. In my Bioidentical Hormone Replacement Circle for women, I have over 250. So, what I would do is - I would invite other providers that are working in this field to contribute their cases to these Circles, so that we can have even more data available. So, for instance, if I had 10 providers, all contributing 100 patients each over the next 6 months to my Circle, well, we'd have, you know, thousands of patients in the Circle, and that data just becomes so much more powerful when it gets to those kinds of numbers.
Keep in mind that it's anonymized data. So, you don't get to see the names of the patients. But you get the power of this amalgamated data from a number of providers as a contributor. Then also the other benefit, if you are contributing as a provider, you would be able to avail yourself of some of the financial rewards that could come from the licensing of the data to the manufacturers and the pharmacies.
So, if there are any colleagues out there working in this bioidentical field, you could join the team of providers contributing data to the Circle, have access to that data for your own patients, for your own purposes, and also have access to the potential for licensing this data.
Learn more about Dr. Pagdin's Circles below:
Interview with Dr. Grant Pagdin about his BHRT POC
February 5, 2025
Nick Tierney: Hello! This is Nick Tierney with RegenMed Circles, and I'm joined by Dr. Grant Pagdin, who's a regenerative medicine and anti-aging expert located in Kelowna, British Columbia. Dr. Pagdin, thank you for your time.
Grant Pagdin: Yeah, thanks, Nick. It's a pleasure to be here.
Nick: Please tell us a little bit about yourself.
Grant Pagdin: Well, I got involved with bioidentical hormone replacement back in around 2009 - 2010, and I got certified through the American Academy of Anti-Aging Medicine with their board exams. So, I have expertise in bioidentical hormone replacement, and also in the regenerative procedures involving PRP and stem cells along the way. I also was involved with clinical research that was pharmaceutical, sponsored, and I have my name on about 39 research papers using pharmaceutical medications and trying to get those things to market. In 2019, Health Canada intervened in the stem cell space in Canada and insisted that if we were going to use stem cells to treat osteoarthritis, we had to register a clinical trial. So, I put my own trial together. It's sort of self-funded, self-initiated. I'm the sponsor and the investigator, and I stick handled all through the Health Canada regulations to put my clinical research trial as the pioneering trial in Canada using stem cells for osteoarthritis.
So, I have a fairly extensive background in research as well as my background in bioidentical hormones and regenerative procedures.
Nick: Excellent. And today's topic is going to be bioidentical hormones in particular. So, tell us a little bit about what those are, what they're used for, and a little bit more about some of the challenges and or misconceptions about them.
Grant Pagdin: The big challenge in this field is that some of the drug companies are now producing bioidentical options so that you can get a pharmaceutical drug. That's a prescription, and it's available from any pharmacy, and it's standardized. It has a DIN number. It goes through your extended healthcare plan.
But some of these products are not available, or not always suitable. So, we ask the compounding pharmacy to make up a special cream, or a lotion, or a recipe, according to the doctor's prescription, and they will use the exact hormone that would be normally present in the body. So, a bioidentical form, and it's formulated in some sort of a method of delivery.
So, the challenge for us really is to show that these things are safe and effective, that they work as they ought to, and that they would provide important, meaningful clinical improvements on a par with what the standard prescription pharmaceutical versions might do. That evidence is really lacking in the marketplace right now.
And some of the regulatory bodies or the oversight bodies, for instance, Women's Menopause Society, aren’t really coming out strongly in favor of these compounded hormones, because they're not really validated, and the standards of manufacturing are not necessarily uniform across the board. So, we do have some challenges when it comes to showing the safety and the efficacy of these compounded bioidenticals.
Nick: So, in the field of stem cells, you mentioned that you self-organized a clinical trial which you brought to Health Canada, and are now conducting. Probably, the rare practitioner that can put all of those pieces together, and afford to be able to run a clinical trial. What are the other options for generating clinical evidence. How else can we start to collect data on BHRT?
Grant Pagdin: As you've alluded there, Nick, putting together a registered clinical trial, is a very onerous proposition. But an emerging way of achieving some meaningful data is what's called real-world data collection. So, what we do is rather than having a registered clinical trial where patients are randomized either to receive a placebo or an active drug, what we do is we take a cadre of patients that have similar symptoms and similar presentation. We put them on some treatment, and we track their outcomes with patient-reported outcome tools. I don't have to register that as a clinical trial. I don't have to have ethics oversight. We just have to have the patient that consents to, first of all, the treatment with the hormones and participation in the data collection.
Nick: So, you're doing this real-world data collection already, it sounds like, and what are the types of patients that you're tracking after prescribing BHRT?
Grant Pagdin: So, in my testosterone replacement Circle, these are males that are registering with us for the onset of testosterone replacement. They've been deemed to be suitable candidates based on their symptoms and their blood test results.
They do a questionnaire at baseline that gives us an idea of some validated symptom scores that they are dealing with. Then we initiate testosterone replacement. It could be done either as an injectable pharmaceutical substance, or as a compounded topical transdermal substance. And so, I record that at the beginning of the Circle of which sort of approach we're using for hormones, and then the individual is prompted to repeat the symptom score 1 month, 3 months, and 6 months into the treatment. And that way we can track how well they're doing.
Nick: And on the clinical side, what is the type of data that you're really interested in entering and then correlating against those outcomes?
Grant Pagdin: Sure. So, as the provider I'm going to be entering into the Circle the data around the severity of the symptoms, the nature of the prescribed treatment, whether it's going to be an injectable testosterone, and the exact dose or transdermal testosterone, and the dose as well as the baseline lab levels. You know the total testosterone, free bioavailable testosterone SHBG, - some of the parameters that we want to track. So, it's the responsibility of the provider to enter some of that basic data information at the baseline and then again at follow up. If we have follow-up lab tests, I typically do my follow-up labs at 3 months and 6 months. So, I would have a little bit of data to enter at those time points. But it's not particularly onerous for the provider. There's just some basic information that we want to register in that data set.
Nick: So, that's great, Dr. Pagdin. So, you're collecting a lot of great patient data. You're spending the time to enter in a lot of specific prescription and other data related to formulations. What are you doing it for? What will you be using the data for?
Grant Pagdin: Well, there're really 3 benefits that are obvious that I can think of, Nick.
The 1st is the benefit for the patient themselves to feel engaged in the program, to be able to track their progress and have some objective numbers that they can see that helps them to track their outcome.
The 2nd is for the provider. So, I want to know, am I, you know, am I hitting the mark? Do I need to make some adjustments, you know? And how is this particular patient doing compared to the overall cohort? So, it helps me to refine my prescribing and optimize the treatment of the patient.
And the 3rd is that these API suppliers that produce these ingredients to make the compounded hormones, they're very interested in the efficacy and the outcomes, and that data would be very valuable to them.
So, if there's a way that we can monetize this in a licensing way to be able to make that data available to these manufacturers and suppliers, that would be just, you know, an extra bonus.
Nick: And so, Dr. Pagdin, so far, you're describing something you've already started, are doing yourself have been doing for over a year now with us. Is there a way for other doctors to participate?
Grant Pagdin: Yes, I've established these Circles for some time now, just a little over a year. In the Hormone Replacement Circle for men I have over 300 registered subjects. In my Bioidentical Hormone Replacement Circle for women, I have over 250. So, what I would do is - I would invite other providers that are working in this field to contribute their cases to these Circles, so that we can have even more data available. So, for instance, if I had 10 providers, all contributing 100 patients each over the next 6 months to my Circle, well, we'd have, you know, thousands of patients in the Circle, and that data just becomes so much more powerful when it gets to those kinds of numbers.
Keep in mind that it's anonymized data. So, you don't get to see the names of the patients. But you get the power of this amalgamated data from a number of providers as a contributor. Then also the other benefit, if you are contributing as a provider, you would be able to avail yourself of some of the financial rewards that could come from the licensing of the data to the manufacturers and the pharmacies.
So, if there are any colleagues out there working in this bioidentical field, you could join the team of providers contributing data to the Circle, have access to that data for your own patients, for your own purposes, and also have access to the potential for licensing this data.
Learn more about Dr. Pagdin's Circles below:
