As the name suggests, New Frontiers is about staying ahead of the curve in functional medicine, continually asking critical questions, and being open to self-critique. This couldn’t be more true than when it comes to advanced functional testing. Today I’m pleased to talk with a familiar face and renowned hormone testing expert, my friend Mark Newman. Mark created the DUTCH test based on his decade-long experience in novel test development, and joins New Frontiers to talk about all things hormones: from cortisol & thyroid health to estrogen, progesterone and androgens, the importance of analytical and clinical validation of tests, and his upcoming research on various hormone replacement therapy methods. If you’re like me, you’ll be blown away by Mark’s passion for delivering functional tests that offer meaningful differentiation and his commitment to publishing peer-reviewed data. Settle in, and be sure to check out the shownotes for tons of ancillary info, plus special offers from Precision Analytical. Listen, learn, and leave us a comment wherever you find New Frontiers! Thank you! ~DrKF
Ever wondered how to recognize a good, evidence-based laboratory-developed test? You would be surprised to learn the amount of research that certain functional testing companies have put into correlating patient data with peer-reviewed literature to deliver clinically relevant results. In this episode of New Frontiers, we are joined by Mark Newman, founder of Precision Analytical Incorporated, recognized expert and international speaker in the field of hormone testing. With a decade-long experience of developing novel lab tests, Mark Newman shares with us his expertise on testing methodologies, specimens, metabolites, and hormone replacement therapy monitoring. Listen in to find out how results can be overlayed with clinical findings to create a rich health story.
In this episode of New Frontiers, learn about:
- Functional hormone testing
- Hormone metabolites
- Testing methodologies
- Comparing specimens
- The cortisol curve
- Monitoring sex hormones
- Understanding laboratory-developed tests
- Correlating test results, clinical findings, and research
- Hormone replacement therapy
- Precision Analytical’s dedication to research & innovation
Mark Newman is a recognized expert and international speaker in the field of hormone testing. After over 10 years of developing several hundred novel tests at multiple laboratories, Mark began his own lab, Precision Analytical Inc., where he developed the latest innovation in hormone testing, the DUTCH Test ® (a Dried Urine Test for Comprehensive Hormones).
Mark is committed to helping healthcare practitioners find the answers they need in their hormone testing and has educated thousands of physicians on the different hormone tests available and best practices, especially in HRT/BHRT monitoring.
Evaluating urinary estrogen and progesterone metabolites using dried filter paper samples and gas chromatography with tandem mass spectrometry (GC–MS/MS), Mark Newman, Suzanne M. Pratt, Desmond A. Curran, Frank Z. Stanczyk
- DrKF FxMed Clinic: Patient consults with DrKF physicians
- Clinician Professional Development: DrKF FxMed Clinic Immersion
- DrKF FxMed Nutritional Residency Program
Dr. Kara Fitzgerald: Hi everybody and welcome to New Frontiers in Functional Medicine where we are interviewing the best minds in functional medicine and of course today is no exception. I am back with Mark Newman. He and I have been podcasting really for years. I think he was one of the first podcasts I did when I started back in 2016. I love talking to him. Let me give you his background so you know who he is and then we’ll just jump right into our questions. He’s a recognized expert and international speaker in the field of hormone testing. After over 10 years of developing several hundred novel tests at multiple labs Mark started his own lab, Precision Analytical Incorporated where he developed the latest innovation in hormone testing, the DUTCH test which stands for dried urine test for comprehensive hormones. I know many, many of my listeners use DUTCH and are familiar with this. Then of course new folks will be listening today as well and you’ll learn about some of the cool work Mark is doing and don’t let me forget that there’s actually a really good deal that we’ll let you know at the end of this.
Mark is kind of a great lab geek and committed to furthering the science in the field of functional medicine and he is committed to helping healthcare practitioners find the answers they need in their hormone testing and has educated thousands of us on the different hormone tests available and best practices especially relating to hormone replacement therapy monitoring. Mark, once again welcome to New Frontiers.
Mark Newman: Always great to be with you Kara. Thanks for having me.
Dr. Kara Fitzgerald: It’s always great to be with you. I was just reflecting on the podcasts we’ve had over the years and we’ll put all of those in the show notes folks so if you want to go back and you can see the various topics that we covered and sometimes different studies that he had been working on or when they moved into organic acids we talked about that, we talked about creatinine if you really want to geek out but all of that will be in the show notes but for people who are new to Precision Analytical, just give me the background on the DUTCH test and also what was your inspiration for it?
Mark Newman: Inspiration, let’s see. The inspiration for the name came from an 11 hour flight to Sydney when we were just starting and I had a scratch paper and I was like, “This thing needs some sort of acronym or something,” so my motivation for the name was 11 hours on a plane with this piece of paper. I need to find that somewhere.
Dr. Kara Fitzgerald: Yeah.
Mark Newman: The test itself, I love data and I’m trying to figure out what’s going on with someone in terms of their hormones. I’ve been really narrowly focused my whole career on just hormones and things peripherally related to them but kind of same topic and not very broad. Just doing that for me I’m a pretty skeptical guy so when it comes to what’s going on with somebody as it relates to a particular hormone, seeing the most information always makes me feel like I have a better handle. I talk a lot about uncertainty so I always feel like there’s some uncertainty and it’s good to understand that but the more of that I can reduce then the “guess” you’re making as a provider, because we never know everything about what’s going on with a patient, is way more likely to be right and you’re likely to help them better and I think the vision for me came from digging through the literature and through data as it relates to cortisol and going, “Okay, I think I know what’s going on with a particular patient as I look at their free cortisol pattern because the literature’s pretty clear that that’s important.”
It actually started with this obesity thing of there’s this very general correlation in our minds about cortisol and obesity and a lot of people that were using the testing at the time were running to these conclusions of, for example, my salivary cortisol must be related to obesity. I’ll go along with that. Then in digging through the literature and digging through the data I realized that’s not actually true, that the relationship with cortisol is a little bit more complicated than that. It’s kind of this three-dimensional picture and there was this big missing piece in what we were doing in terms of understanding that which was the metabolites of cortisol.
When we started messing around with looking at cortisol and its metabolites and then overlaying the clinical picture and seeing some really fascinating cases. Early on I had a friend of mine who was taking thyroid medication and she had this picture of having her free cortisol low and her metabolites high. She says, “What causes that?” I, well usually that picture tends to correspond with obesity because your fat sucks up the cortisol and it gets metabolized and it goes in the toilet as a metabolite and your adrenal glands keeping up with this and you get this weird picture of your cortisol at one level and your metabolites at a much higher level and she’s this skinny little thing. I’m like, “Oh crap. I guess I don’t look so smart this time.”
Then she called me back later that night because one of the things I had said is that one of the things that can lead to this pattern, at least in the literature, is hyperthyroidism. She said, “Well that’s not me either because I’m hypothyroid,” and now I’m pretty confused. She calls me back that night and said, “I re-looked at my doctor’s notes and he told me to take my thyroid medication once and I’ve been taking it twice a day. She had induced this hyperthyroid situation which led to this really interesting pattern that lined up with the literature if you dug enough into… A lot of it honestly was like really old papers where they were connecting the rate at which you clear cortisol with your thyroid status and there was this wonderful picture emerge of the fact that she was chewing through her cortisol too fast because of a thyroid situation because she… It wasn’t her doctor’s fault in this situation. She just didn’t follow the instructions and those types of moments were what inspired me to go, “Okay, this patient cannot know what’s going on as it relates to cortisol unless I have as much of a picture as I can see.” That’s kind of where it began and then you move to the estrogens and then you get the same thing-
Dr. Kara Fitzgerald: Wait, let me just… I want to just tease this out. You started looking at salivary cortisol, realized that that was inadequate. You needed to look at the metabolites so then you moved to urine and you were able to see a broad sweep of the metabolites and realize that was essential to the story. Then you moved into sex hormones to kind of round the picture out so talk about the sex hormone story but then also just touch on using four dried urine specimen.
Mark Newman: Right. For us where we are now is we have a couple different ways you can look at it. You can look at your free cortisol picture in saliva which is the very best way to do that. We developed the urine test as an alternative to that. You could look at the up and down pattern of free cortisol instead of saliva and we published our data showing the correlation between the two just this last year I think actually. Which was actually a really big moment for us because when you’re breaking new ground with something you really need to, and that’s what our conversation today is about, is to go to the lengths of validating that so that people can have confidence in what you’re doing, particularly if it’s different than what people have done historically.
We started off going, okay, there’s an interesting message in the metabolites but we don’t want to lose the free cortisol pattern. That’s where I got so frustrated, it’s like, “Well crap. If I do a 24 hour urine on this patient and a saliva test and, and, and, now I can put the picture together but the patient’s broke and it’s hard to do, right? That was one of the primary motivators for us is like, “What can we get under one umbrella?” If you go home and collect four times these dried samples throughout the day, does it work? There was this big process of how we did it initially and the timing of it wasn’t quite right. We found that if you collected the second urine sample at one hour, it was really variable so we settled in on two hours because it caught like that whole awakening curve that happens in the morning you caught in that two hour sample so we’re collecting at waking, two hours after waking, dinner time and bedtime and creating this cortisol curve.
Then the question is okay, well now if I’ve got a reasonable alternative for the cortisol curve do I also or how do I also get a reasonable alternative to the 24 hour urine using these four samples? Some of the details for that are probably too in the weeds to go into detail but it was a pretty complicated process of figuring out how concentrated each sample is and taking sort of a weighted average of those four samples, putting that together and saying, “Are we getting correlation with the 24 hours so we don’t have to collect it.” We got pretty good data on that and then we kept kind of critiquing it and optimizing it so one of the things that we did that was I think pretty clever was that everything in urine is reported in spot samples relative to creatinine which we went into the deep dive with last time-
Dr. Kara Fitzgerald: We did.
Mark Newman: It has a relationship to how big the person is. We found that if we corrected for that based on the known relationships, that that 24 hour correlation went from good to even better. At the end of the day what we had was a simple way to collect and just more data. A broader picture of cortisol and then to start diving into the sex hormones. To go okay, what’s the story to be told with estrogen? You can do a serum test, you can do a saliva test, you can do a urine test and figure out what your estradiol status is, right? Then if it’s high you got to ask why. I think this test is good at that because asking why could be well, maybe I make too much estrogen and I need more fiber in my diet and calcium d-glucarate and reduced inflammation or whatever. Good. That’s great.
What if the problem is you’re not metabolizing it appropriately and I’m seeing… Early on it was that same case of like, test a friend and estrogen’s high and the metabolites are low and hey, functional medicine knows how to manipulate that and so a little DIM or IC3 later and you get this more balanced picture and she feels better and you go, “Hey, this is a pretty good tool at not just saying what’s your status as it relates to a hormone because there are a number of options for that but also getting to pick at that a little bit and go, “Okay, where’s that dysfunction coming from and does it have a more complicated story than just too much or too little hormone or whatever.
We found that with each family of hormones there’s a broader story to be told and over the 10 years that we’ve been doing that here, we’ve learned a lot about some of those stories like how does thyroid tie in with cortisol and all of those stories that are told that every patient has a story and it’s your job as a provider to figure it out. That’s what we wanted to do is say we want to give you a tool to be able to look under as many rocks as you can in an efficient way so that you can get them moving in the right direction and that’s kind of I guess the genesis of where our testing came from.
Dr. Kara Fitzgerald: It’s a pretty exciting story. I know it’s a little bit in the weeds for some of our listeners but the end result is this really useful test that provides a broad snapshot. If anybody gets prescribed a 24 hour urine or who’s… If anybody’s had to collect a 24 hour urine unless you’re at home it’s really kind of a pain. It’s just a pain. The ease that you can collect this with is really important I think for patient adherence and the fact that you’ve been able to really figure out how to make it reliable is just, it’s a real stroke of brilliance so we can look at all of the metabolites plus you have the cortisol awakening in there as well. It’s a story of inspiration.
The other piece that I want to say and this folks will be in the show notes is that Mark is pretty interested in publishing on the DUTCH and looking at and we’ll talk about this in relation to serum testing and some of the gold standard tools that we’re using but I just… He’s got three publications since 2019. 2019, 2020, 2021 and all of those will be linked too in our show notes. Talk about the difference between the DUTCH and more standardized tests. You can actually dip into some of your publications. We’re all using serum. We’re trained to use serum and just speak to that.
Mark Newman: Yeah, it’s an important distinction and there are benefits to either world, either the conventional world or this world that we… You have to be in both worlds. I think if you’re going to use functional medicine it doesn’t mean you’re only using functional labs, right? You’re still going to run a lipid panel or whatever. The thing with those tests is for me as a lab guy they’re super, super boring, they’re easy to do and as a provider that’s a nice thing in terms of reliability. When you send up a blood sample to the lab and they’re doing a lipid panel, literally all they’re doing is putting it into an analyzer and pushing the right buttons and then it does all the work. It’s wonderful technology. It doesn’t take very much sample, it’s fast as can be and there’s no reason to deviate from that. You need to be… This is one of my mantras is you need to be compelled to leave gold standard methodology. There needs to be a compelling reason to do it.
It just so happens then with hormones there are a lot of wrinkles there where these functional labs can really be helpful but with standardized lab tests you get the advantage of FDA approval in that the FDA is governing over the manufacturing of those things. The labs aren’t actually making the tests. The labs are set up appropriately to take these tests from external sources and then to just run them and to report those values and hopefully to make some sense of them for you. We live in a little bit of a different space, laboratory developed tests so LDT’s are things that aren’t as standardized that you kind of have to do yourself as a laboratory.
There are pros and cons to both worlds and it really depends on what you’re testing; estradiol is a tough thing to test and that’s always a really good example for me when I’m trying to contrast those because it starts to dip into that space where you actually have the potential for improved accuracy by moving away from those standardized FDA approved methods. The literature’s pretty full of this nerdy little conversation about what’s the best way to test estradiol and you can go do this test where they stick your sample into an instrument and push the E2 button and it works and you get a number. What you find is that you’re often in serum other than that is to send it to a lab that’s going to do LCMS on it. That is liquid chromatography mass spectrometry. That’s a more sophisticated way to do the test. That doesn’t tend to be FDA approved because you’re not buying it for someone who says, “I made this test. Here you can use it.” It’s more an issue of like this is the way that this test is done best but you’ve got to figure it out yourself. You need to have-
Dr. Kara Fitzgerald: That’s right. Let me just tease it out a little bit. FDA, a lot of us put a lot of stock into things that are FDA approved and lab is no exception and these are often very simple kits as Mark has pointing out and the laboratory purchases these kits and runs them and yeah, they’re reproducible, they’re quite standardized. The reference ranges are created by the kit manufacturer so anybody using that kit is going to have that same thing. I think there’s utility in those but if we’re going to move the field forward we do have to have these lab developed tests and moving into LC kind of mass spec, as Mark is talking about, is moving into the more sophisticated technology that’s going to let us see more and there is a… It’s a very important piece of moving lab science ahead and so go ahead. Where were you on that?
Mark Newman: Well and if I was to offer you an LCMS test for hemoglobin A1C you would be wise to say no thank you because it’s internationally standardized, it’s an easy test, you don’t need that sophistication and you just pay your few bucks and you get your test and it’s interchangeable between labs. When you get into hormones you kind of get into the split world where some of the higher level hormones are more forgiving for those standardized methods but when you get down to… Estradiol’s the one I always use because it’s the lowest level. There’s about between 1,000 and 10,000 less estradiol in a sample than there is for cortisol. Cortisol’s a lot easier to measure and if you’re measuring cholesterol it’s even way higher than that. It’s a really easy test without all that much sophistication. When you get down to estradiol now we’ve got more of a challenge.
If you look in the literature and say, “Which method works best?” Those FDA approved tests are quick and easy and inexpensive. When you get down to the post-menopausal range so that means low level women, that means men, that means kids, you have to have those more sophisticated methods that have to be developed by the laboratories themselves and so you’re in a little different space. It’s not space that’s governed by the FDA directly because they’re directing a group selling a lab a test that they can use whereas these LDT tests, which is that’s a space I’ve always lived in, is it’s a little bit different and you’re more as a provider dependent on the competence of the lab-
Dr. Kara Fitzgerald: That’s a very good point. Yeah you can’t compare results across labs. If you’re doing a DUTCH LCMS analysis you want to have your follow up also be with DUTCH and you definitely… I call you guys DUTCH. Everyone calls you DUTCH but it’s Precision Analytical.
Mark Newman: Yep. Either way works.
Dr. Kara Fitzgerald: Just keep that in mind if you’re new to using lab testing and you’re kind of teasing this through that even kits. I mean, if you do a kit test through Quest, you want to follow up with Quest. You don’t want to go over to Lab Corp or AURP, you know? I would argue even with those FDA approved you should probably whatever your baseline test is you want to stick with the same lab for your follow up. If you’re using lab developed tests yeah, you want to make sure that you’re trusting the lab that you’re working with for sure.
Mark Newman: Yeah, it’s nice to stick with the same methodology when you’re looking at a before and after and that sort of thing because lab comparisons get kind of complicated when you switch between two labs but also between two methods and heaven forbid between two samples so moving from urine to serum. I’m also a big proponent of when it comes to hormones as complicated as they are that serum and urine complement each other really well because there are things in serum that you just can’t measure in urine like SHBG, things like that. That’s a different topic. For us, it was to research this method and figure out the specifics of how to do it in terms of collection, how to do it in terms of instrumentation and then of course the never ending game of figuring out what some of these different patterns mean.
Then it was a really important step for us to say, “Listen, if people are going to trust this we need to take first the validation data and get into the peer reviewed literature so that you know that it’s being scrutinized in terms of looking at accuracy and reproducibility and for us then it goes of course beyond that in that for estradiol as I mentioned we needed to show that over menstrual cycles and between different people that when you look at the gold standard which for estradiol is a particular method of serum when we correlated those two we got really nice data that we were able to publish to show that this is a reasonable alternative to that for estradiol. That’s where it begins.
Or you go fishing in the metabolites. Let’s make sure that the parent hormone that we’re trying to tell a story about actually lines up with gold standard methodology.
Dr. Kara Fitzgerald: That’s what they showed and again this will be in our show notes that for estradiol, the DUTCH actually correlates with serum which is really cool. Just talk to me about… define validation and just briefly what validation is and what you guys did.
Mark Newman: In my mind I sort of split it into two categories and they’re not cleanly defined categories but there’s an analytical validation side of things and the clinical side of things. Analytically I want to know am I getting the numbers right? After you develop a test you need to be really rigorous about accuracy, do things interfere with your test? Do we know that the numbers are right? That’s kind of the first level of validation is obviously if I test the same sample on Monday and Tuesday and I get a very different story then you have nothing to work off of. First thing you need to do is make sure that there’s stability and accuracy in what you’re doing and then, especially when you’re in this world of non- standardized types of tests, then there’s a matter of like well what do the numbers mean? Because a phrase that I like to use is meaningful differentiation. That’s what a lab test really offers you is meaningful differentiation.
We wanted to go through a pretty rigorous process there too which is really never ending because with each family of hormones you’ve got all these different questions that you want to ask. We start simple. The first thing we had to show is the thing that we’re doing correlates through 24 hour collection. The thing that we’re doing correlates the serum measurement for sex hormones but then when you shift to cortisol, it’s like okay now the question’s different. The question is does my urine free cortisol match up with my salivary free cortisol. The clinical validation, some of it’s been done. If you want to test salivary cortisol, you don’t need to prove that it matters. You can go into the literature and it’s-
Dr. Kara Fitzgerald: There’s lots of it.
Mark Newman: There are thousands of papers that say that this is meaningful. Here’s how we want to do it, the timing. Let’s include the cortisol awakening response, so we went through all of that but that’s relatively easy because it’s so established that we just need to establish that our test is accurate and reproducible and all of those things whereas with our DUTCH panel it’s breaking new ground so we’ve got a lot more work to do in terms of validation which is why it was so important for us to publish that which has become a passion of mine. We’ve got multiple people who are digging through our data and we’ve got some papers actually that just got submitted… Well actually the last thing we got accepted was we got three abstracts accepted from the North American Menopause Association-
Dr. Kara Fitzgerald: Right.
Mark Newman: Which was really exciting for us because that’s conventional world and we said, “Hey, here’s our data as it relates to different doses of estradiol patches, different doses of estradiol gels and different doses of estradiol cream. What we’re able to show is that the people that are testing with us in real time, just patient data, are getting the relationship that you’d expect to see and what’s fun for me then is you can overlay that with the clinical data that’s out there on patches and gels and say, “Okay, we know which doses of these are actually clinically effective so is there coherence between what’s going on clinically and what we see in our results and we’ve found some really, really encouraging things with those which again we were able to publish in abstracts and then those are then followed up with full manuscripts, the first of which just got submitted yesterday I think. Then we’ve got several behind them.
I think it’s what we owe the industry to say if we’re making claims that are provable that it’s really incumbent upon us to go and put those to the test and then when the data falls the way that it’s expected to we get to celebrate, and when it falls in a way that’s unexpected then we all get to learn something and we just have to be big enough to put that out there too. There are always some surprises along the way where we as industry make assumptions and sometimes we learn otherwise when we get into the weeds on some of this stuff.
Dr. Kara Fitzgerald: Well, I want to ask you about some of those surprises but I just want to kind of back up and corral together some of what you said. The DUTCH panel is four different dried urine spots and it’s looking at metabolites and it’s looking at sex hormones and metabolites and cortisol metabolites et cetera, but as a part of it you also do this salivary cortisol awakening so I just want to distinguish that there’s two different specimen collections if people didn’t capture that but he did say it and there’s plenty of data on saliva as you pointed out.
Mark Newman: Okay, to clarify that for us it’s the DUTCH Complete is an all urine panel. The DUTCH Plus is where we say, “Okay, I want all that same stuff but I want my cortisol pattern from saliva because the literature has taught us that there’s one variable in saliva that you cannot get in urine and that is this as you referred to, the cortisol awakening response which is to get the salivary cortisol right as you wake up and 30 minutes later and what the literature teaches us is that that’s a really good mini stress test. The chemistry that goes on when you wake up is the same chemistry that goes on when the bear chases you and so isn’t it nice to have a way to say before and after that to see if your stress response is exaggerated which puts you at higher risk for depression and things like that, or if it’s flat then you’re obviously going to be struggling with energy and things like that and that’s a unique variable that we wanted to add. DUTCH Complete is everything else and the DUTCH Plus is exactly the same except we’re getting the cortisol pattern from saliva which includes the diurnal pattern which is similar but adds the cortisol awakening response.
Dr. Kara Fitzgerald: I think we really pretty much here just get the DUTCH Plus but yeah, it’s a great tool. If you haven’t done the cortisol awakening you’ll find it not only clinically useful for you but also really motivating and powerfully impactful for our patients. That’s been my experience especially if it’s imbalanced. It can really motivate people to make some broad lifestyle changes. In fact, honestly, I’m just thinking of someone who, a hedge fund guy, just this young amazing hedge fund guy. I really liked him a lot but he was really kind of living in hedge fund hell and given his family history and his cortisol awakening response it was like he really looked like a heart attack waiting to happen. You could just sort of see the stress impact in his numbers and we talked about it frankly and he had other inflammatory patterns going on. It just warranted a good kind of sit down conversation and he ended up leaving. Moving to Africa and starting some micro funds. He transformed his existence. It’s just a really neat story and moved more into his own sort of calling. I had some updates from him. I haven’t heard from him in a while but maybe if he’s listening send me an update.
Mark Newman: Yeah, people like that tend to have sometimes a pretty wild cortisol awakening response that correlates with all that stress that they’ve got going on and quite frankly I think of that as a doctor pattern because most of the doctors that test with us have that extra bounce in the morning which is fine short term but it’s something that we want to address because we know that it carries with it increased risk for things that you don’t want to be experiencing long term and that can be a helpful tool that way for sure.
Dr. Kara Fitzgerald: Yes, yeah it really… It’s just one of the cooler stories. Surprises, I’m just curious what may have been unexpected in your analytical exploration and prompted you to switch directions if you have anything?
Mark Newman: Yeah, there’s so many interesting things to dig into in this field and I think somewhere along the way there definitely have been some things that surprised me. They go in both directions. Sometimes you go into something with the assumption that something’s not going to be a useful tool for particular situations… So the topic we were just talking about, I had been so entrenched in my mind that saliva was the better way to monitor topical hormones. That was something that surprised me along the way that may be too long of a story for today but seeing the way that the dosage in urine scaled up in an intuitive way in urine was something we started the company, I told people, I don’t think this is the best tool for measuring transdermal estrogen and after analyzing all of the data, the literature data, looking at the clinical picture and also looking at the kinetics which is really something that is hard to find data on is that for example if I take an estrogen gel you actually get a response that correlates with clinical change to bone mineral density, whatever but it’s fast. It goes up and down really fast so you’re shooting at a moving target.
What we found in urine is it actually tracks really well with the dose, it averages out that up and down throughout the day and when we hit values where you expect to see clinical change and you look at the clinical studies, there’s a correlation there that says, “Oh, okay this is tracking not only with dosage but with the clinical changes that the literature shows and when you hit those lower doses, when you hit clinical failure you can see that the results-
Dr. Kara Fitzgerald: You can actually see it.
Mark Newman: Actually make a lot of sense there. That’s was something that surprised me on the positive side to say, “Hey, this is better than I think. Let’s publish the data because I think this is going to be a really terrific tool for people with compounded estrogens and things like that.
Dr. Kara Fitzgerald: Let me just say, I think that you were nudging people away from using it for trans dermal, you know in our previous conversations so that’s a really cool shift and this is probably some of the content you’re going to present at the North American Menopause Society Conference, these findings?
Mark Newman: Yeah the data there is patches, gels, and creams because you would be shocked at how little data there is on creams. We have so many people in our industry that love compounded creams because they’re so convenient. Zero outcome studies and there’s only one published study in serum, one that shows this little up and down pattern that’s probably too fast to catch. Wow, this is an area where if our data aligns with the dosages… There’s a lot more work to be done in terms of we get into that a little bit later about what’s sort of on the horizon but it’s a great starting point to show the clinical utility of the test for that. I probably should just mention so I’m not misleading people, you have to ask these questions about specific hormones because what I just said about transdermal estrogen is actually not true about transdermal progesterone and that’s a whole longer story about whether you should be using it to balance estrogen anyways but the urine levels don’t scale like they do with estrogen because it’s so lipifilic. All these stories are complicated. That was an example for me-
Dr. Kara Fitzgerald: People are going to want to know your… Then in which case what’s the best specimen for progesterone?
Mark Newman: This is where we fall into this assumption, right that for every scenario there is a lab test that gives you useful information, that gives you meaningful differentiation. I would argue that the data tells me that progesterone when given transdermally there’s not a lab test that’s going to give you meaningful differentiation. The clinical data which I know you’ve discussed before with Dr. Saltiel would also tell us that it’s not proven to protect the endometrium if you’re on estrogen. I’m more interested in pushing people away from topical progesterone when you’re on estrogen, not because my test doesn’t work with it, which is also true but because it’s not proven to work. There isn’t a test that has been shown to give meaningful differentiation between no therapy and therapy between one dose and another dose and it’s a long, complicated story that I’ve written about a fair amount and it’s a long story but I don’t think the data supports the wildly high, variable numbers you get in saliva or the numbers that lag way behind in serum or in urine.
I don’t think there…. That’s an assumption that was really important for me to break out of it to say, “One, my test is not useful in every scenario. And two there isn’t a test for every scenario that speaks to the clinical picture to ask the most relevant information which gets into answering your question as well on the negative side with a surprise that I found with our tests that I’m not so sure works as well as I thought it did initially which is when you take vaginal progesterone. When you take vaginal progesterone it’s actually a really strategic way to take progesterone because it actually hops into the uterus at a really high level. You get this uterine first pass effect. As it turns out, what’s going on in your body fluids, urine included doesn’t actually represent that. There’s no fluid that represents what’s going on in the uterus. When we started off I, in error told people, “Hey, I think this is an effective way to test vaginal progesterone,” and then after digging into the literature more and digging in our data more we steer people away from that to say, “The best marker for systemic exposure when you take it vaginally happens to be serum.”
The best marker for what’s going on in the uterus, which is the primary reason you’re taking it is nothing is to follow the literature that says these doses are proven to work and the lab testing is not super helpful to tell you you’ve got it right. Making that concession-
Dr. Kara Fitzgerald: Maybe an ultrasound periodically or something.
Mark Newman: What you actually do as a provider in that sense is probably not an area I should be speaking into as a chemist but yeah, you need to be asking those types of questions and understanding that the limitations of the laboratory testing are such that we can’t really tell you what’s going on in the uterus when you’re taking progesterone that way. That’s an example of something where I led off with a steam of confidence thinking, “Oh, this is good also for this,” and the data has corrected our thinking to us discouraging its use for monitoring the appropriate dose of progesterone when taken that way.
Dr. Kara Fitzgerald: Okay. Got it. That’s really interesting. All right, so I mean I think we’re coming back to the DUTCH Plus with the cortisol which is what we use here all the time but is helpful and we still, particularly depending on route of delivery, want to include serum in our analysis for some of these or at least for progesterone and I think you would still agree that testosterone is probably the case but estrogen, you’re solid in urine.
Mark Newman: The collection has to be what hormone are you taking, what route of administration and I’ve got a little testing matrix that I have made for people to say, “Here’s where I prefer this test, here’s where I prefer that test. I think for progesterone monitoring I think urine works really well for oral and I think for vaginal hormones nothing really monitors the uterine exposure very well. It’s a complicated thing but for testosterone serum is always the gold standard I think for testosterone and that’s one of the areas where in doing the validation as you creep into the clinical validation, we’ve learned a lot about both the utility of the urine test but also the limitations of the urine test when it relates to the androgens.
There’s kind of a complicated story there that it took a while quite frankly to understand at a high level and then to try to disseminate that to people to where it’s a really useful test but again has some limitations where in a lot of cases where that’s a focus is that using the serum and urine to complement each other is probably the strongest position that you can be in, particularly when you’re talking about male TRT therapy. There’s a really fascinating story in urine that has a number of layers to it that really can help with therapy. When it comes to “did I get my testosterone dose right?”, serum has still got a leg up when it comes to testosterone, and I think that that’s important for providers to know that-
Dr. Kara Fitzgerald: But I don’t know though. I would challenge that that’s not where the buck should stop. I think it is useful and I think most of us do obtain it but having the metabolites again has been useful. I’m just thinking of PCOS patients and how it’s really helped us discern intervention, you know to have both pieces of the puzzle.
Mark Newman: Right, so speaking of testosterone replacement therapy I think that that’s where serum I think is a really essential-
Dr. Kara Fitzgerald: Yeah.
Mark Newman: When you start talking about PCOS that’s where I think the DUTCH test really shines is you get a look at not only your androgens but how it’s being metabolized because we know at the heart of PCOS is insulin and insulin is going to push those androgens down that 5-alpha pathway towards those more androgenic metabolites. DHT is three times as potent as testosterone and we want to see that pattern. How is it flooding down that pathway or down the non-androgenic pathway and that adds to the story of PCOS pretty significantly so I think it’s a really strong tool for that to be able to see progesterone, estrogen, testosterone and the metabolism pathway.
Dr. Kara Fitzgerald: Sure.
Mark Newman: And the metabolism pattern along with the rest of it as well. That’s part of the thing that makes functional medicine so complicated is when you start looking at what does a person who has low or high levels of a particular hormone look like and there’s a lot of overlap, right between having high cortisol or low cortisol and imbalances in some of these other hormones which is why we tried to make this test as broad as possible so that you can see dysfunction in each of those families of hormones and try to really identify what’s driving the dysfunction in a particular patient.
Dr. Kara Fitzgerald: Yeah, so there is a little bit of a learning curve. I think you have good educational resources. You’ve got a good clinical team that people can access, that clinicians can access to walk through their laboratory data and you can do that as much as you need until you’re comfortable with it. The testing matrix, I mean anything that we’re referencing in this we’ll gather for show notes or link to the appropriate page at the DUTCH website. Let me just ask you, so piggybacking on this conversation common mistakes the functional medicine world has made because we’re not working with tests that are adequately validated?
Mark Newman: I don’t know about common mistakes but I do think the functional… One other thing that’s great about functional medicine is that-
Dr. Kara Fitzgerald: Yeah
Mark Newman: Being out ahead of the curve, right? I think if you’re going to get ahead of the curve, one of the things that you need is to have a high level of self-critique. I think the thing that’s hard is nobody knows the cracks in what somebody’s doing better than that person. It’s so tempting to build something and then build this sort of information bubble around it and wait for your critics or your competition to start poking holes in it and I think we can do a much better job of being I think open to self-critique and continuing to grow in some of those areas. I think of like there was a day where you could test thyroid in saliva and you can still test thyroid in urine and so you can make this story about relevance but again I’ll go back to my statement that if you’re going to do something that’s non-conventional you need to have a compelling reason. When I do serum testing. Not I, when serum testing is done in thyroid you get a really nice comprehensive panel. You can see… You can have a conversation about that, right? It’s a really nice way to look at that.
Then to move into doing thyroid by a different manner is interesting and it’s kind of fun if you’re a research guy but again, there needs to be a compelling reason. It was developed in saliva which was then discontinued. You run into these little surprises like in the renal system, T3 and T4 interconvert in the local environment. If you’re going to base your thyroid therapy on a urine thyroid, there’s just no reason to jump out of your conventional way of doing that with thyroid testing because there isn’t anything additional that we can see that adds clarity to the picture. I think-
Dr. Kara Fitzgerald: Yeah, and it’s not like you’re getting… You need to get multiple blood draws. Cortisol moving into a different specimen is… Or is super smart because you can’t get endless… Or if you get blood… There’s all sorts of issues with getting multiple blood draw assessments with cortisol, lots. The fact that we can do it in saliva is awesome. The fact that we can look at analytes in urine is awesome and so there’s a point to that, yeah. Doing a single blood draw for thyroid, it just isn’t a big deal. We don’t need-
Mark Newman: Kind of the example I use in my own mind for a cautionary tale was when we used to, or the industry used to do iodine loading test and it was this whole concept was created and it was an interesting theory that was based on poor fundamentals and poor self-critique because it was this idea if I take 50 milligrams of iodine and I catch a 24 hour urine, gosh people who are iodine deficient seem to have less in their urine. That was an observation that somebody made. There was this really basic fundamental problem that you don’t spill out in 24 hours all your iodine. About 20% of it is just in day two and nobody bothered to look at the kinetic of that and scrutinize that and go, “Oh wait a minute, it may not be that you’re iodine deficient, it may just be…” There was a fundamental problem in the way that it was set up and what you ended up getting was anecdotal evidence to affirm that it was working and when people really went in and scrutinized the model, it didn’t need tweaked, it was like-
Dr. Kara Fitzgerald: Did that happen?
Mark Newman: What’s that?
Dr. Kara Fitzgerald: It was scrutinized and published on?
Mark Newman: Well, I know DRT developed iodine testing and I was there at the time so I know that was the direction that we were headed was well this iodine loading test, people love it. I was actually the first one to go, “Okay, I’m going to go down the hatch with 50 milligrams of iodine and then I collected each sample and what I expected to see is a curve that went way up and way down but that it came down within 24 hours so then you could say, “Okay, you excreted this much and the theory is the rest of it you’re holding onto it based on how iodine deficient you were.” We looked at that first curve and went, “Oh no.” The whole thing just crumbled instantaneously. We repeated it with a bunch of people and went, “Oh wow, this is based on an assumption that evidently has never really been scrutinized and so the whole thing kind of just fell apart and they went on to develop a spot iodine test which is an interesting way to see if your diet is deficient in iodine or whatever but that concept of load up with iodine and it will give you a window into something and will be meaningful differentiation actually ended up being I think fundamentally flawed and is been largely discarded-
Dr. Kara Fitzgerald: Not only that, thank God. It’s interesting that you were behind sort of eroding that because it did change people’s practice. People were mega dosing iodine and I moved people… I treated multiple patients with iodine toxicity who developed hyper or hypo or auto immune thyroid disease as a result.
Mark Newman: Well it’s a scary world if you have a test that you can fail that’s fundamentally flawed and you can take literally 100 times more iodine than you need and still fail that test. As a provider puts you in a pretty odd spot. Anyways, not to sort of rail on that, it was just a really good example of-
Dr. Kara Fitzgerald: No, it’s interesting.
Mark Newman: Where you get out ahead of the curve and you say, “Iodine deficiency is an issue, absolutely.” This tool was created without enough scrutiny and it created a problem. In my industry I’ve seen the same thing with HRT monitoring. It’s easy to throw stones in 2021 because when you go clear back to 2001 or whenever when these sort of concepts were coming out and we needed evolution in that topic. We were not there yet but as the studies have rolled out it really has reshaped our thinking in terms of which specimen really gives you the best information when it comes to HRT and it really centers around this weird thing that who would’ve ever predicted that if you put a hormone on your foot on the skin that your salivary levels will go sky high and your urine and your serum lag behind and it created this weird paradox of okay, we’re getting a very different message. Which one is right? People theorize a lot about that and now in 2021 there are dozens and dozens of studies to ask the question which value actually correlates with the clinical picture and when it comes to transdermal testosterone and transdermal estrogen, it’s not saliva.
That value that goes so high, there’s not a single study that affirms that that is actually speaking well for tissue. It’s created this kind of weird thing in our industry where people think that serum testing is bad whereas the issue with some of that is just sometimes that value goes up and down so fast that it’s hard to measure but it still is the fluid that your hormones swim around in all day, right? It still is telling typically a story that when you look at clinical change if you can measure it well it correlates with what’s going on clinically and that’s where the urine testing has become this interesting option because it tends to parallel serum in most of those situations but it allows you to capture over time so if you have this up and down that’s rather hard to sort of grab onto with a single test that you can actually see those changes happening and again for the estrogen that’s become… I think that’s where we’re sort of headed with the estrogen but there needs to be further testing done and more research and that’s what we’re trying to involve ourselves in to say, “Hey. We can tell this story that makes a lot of sense with the research that’s been done when we overlay it.”
That’s what we want to continue to invest in is to say, “Listen, to take our confidence level up higher we want to be investing in studies where they’re comparing people on different dosages of therapy and then looking at actually monitoring directly that clinical change while measuring those lab tests of serum and urine and maybe even saliva to better establish correlation with lab values so there’s even more confidence in using those to adjust someone’s therapy to provide again meaningful differentiation between people whose status level is different based on absorption or whatever.
Dr. Kara Fitzgerald: Right. What would be fabulous would be to have a relatively straightforward reference guide to the type of HRT being used, the route of delivery and the appropriate laboratory tests to evaluate. Just having those sort of broadly all those that document-
Mark Newman: Right. That’s kind of testing matrix because I’ve spent 20 years putting that thing together. The thing that’s really hard and that’s sort of been I hope part of my contribution to this industry is to be the guy to spend hours and hours and hours in the literature going, “Okay, no one’s done this in one clean step. We have to go look at studies on estrogel and bone mineral density and then they don’t always report serum levels so you have to look at different studies to see serum levels and then I can look at my urine levels and we can see what happens in these different body fluids and with clinical change and to say, “Now I have a conclusion I’m pretty confident in but as soon as I change to progesterone instead of estrogen-
Dr. Kara Fitzgerald: It shifts.
Mark Newman: It behaves differently. Going through that has been something that’s been a passion of mine over the last 20 years is to try to figure out what are the best answers for different routes of administration, different hormones and where are the holes where we don’t really have laboratory testing like sublingual hormones, people like to use sublingual hormones sometimes. You can, but the lab testing, none of them really work very well so knowing that might change your use of that therapy but the worst thing you can do is to use a tool that doesn’t work. Use something that’s a bad match for the particular therapy you’re doing and then you can end up really doing a disservice to your patients-
Dr. Kara Fitzgerald: Your patient.
Mark Newman: It also feeds into this traditional medicine critique of functional medicine as it relates to hormones which most of them would say, “Well you don’t even need to measure hormones and it doesn’t really matter. That’s why for me it’s so important that we get it right because there is value in leveraging those numbers but only if we get the lab part right and from the clinical aspect of using the right tests at the right time.
Dr. Kara Fitzgerald: That’s very interesting. When I was at Metametrics laboratory many, many moons ago I was charged with writing in our laboratory evaluations textbook, minerals. How do we best assess minerals and I haven’t dedicated my entire career to it as you have in the hormone world but the conclusion that I drew was very similar to your own so we had to pick a best specimen for minerals and the data leaned towards red blood cells being the best or whole blood being because you were getting some idea of what’s happening in a tissue. My conclusion on reading insane amounts of papers was you wanted to really actually look at multiple specimens and sometimes you would look at surrogate markers like sex hormone binding globulin for testosterone, obviously for iron we look at ferritin but it’s complex but you do have to kind of lean into what’s the best specimen. We can’t order endless amounts of labs.
Mark Newman: Right, yeah, and having trusted laboratories that are going to give you the best information that they can but also help to educate on when to leverage that test and when to leverage another test and when it’s best to have some sort of combination because you’re right. We have obviously practical limitations in terms of how much information you can take in and how much laboratory testing people can afford. That’s become a passion of ours is to not just become good at the lab testing but on the education side is there’s so many layers to the complexity of hormones and we have a team of 10 or 12 clinicians on staff here that use the testing for practice and they’re really well studied and they sit there ready to help walk somebody through some of those complex cases. At first when you’re talking about something that’s comprehensive as our testing they’re all kind of complicated. Then eventually those reports really start to tell a story that the providers can really leverage I think to treat their patients in a meaningfully different way and that’s pretty exciting when people start to pick up some of those patterns to help them to really solve some of those complicated problems.
Dr. Kara Fitzgerald: Sure. Yeah, again I go back to my PCOS cases and patients with very high DHEA versus folks with high dihydrotestosterone or just the different patterns that we can see with women and then also layered into that of course a lot of our PCOS patients surprisingly have imbalanced estrogen metabolism and I can kind of see that in my mind’s eye just looking at doing a pattern analysis with DUTCH and it’s true that the clinicians, the on staff clinicians are helpful and walked our staff here through many a test over the years. Just going back to this whole your broad vision for our field, what are some areas of functional medicine that you would like to see progress further towards evidence based. I know this has been a passion project of yours for a long time and I got to say that I’m thrilled you’re putting your time and your team and your money behind investing in doing research. There’s a lot of effort involved in it but you’re doing it. What would you like to see in general?
Mark Newman: I think as a general improvement I would say that anytime we’re using provable claims that haven’t really been proven I think there’s motivation for us to continue to push into that. Outside of my area of expertise whether it’s food allergy testing or stool testing, you look at the diversity of the ways that people are doing stool testing both in what they’re measuring and how they’re doing the measurements. All those areas of functional medicine I think there needs to be pressure on us as an industry to continue to push into that. I have a particular passion but I only have one piece of the story for the hormone replacement therapy as I mentioned. There are zero interventional studies done on compounded estrogen. You have an entire industry flying a little bit blind. We learn what we learn from the literature and from the laboratory and there’s a lot of extrapolation that goes on there and those claims are provable, right? I think that’s something that we would like to continue to be involved in and there are multiple layers to that. For us, there’s a lot of clinical data in the literature so for us to just show the patterns that we see with our test and given doses of different things and then to overlay it and to see that there’s a correlation there with things like transdermal estrogen, that’s really exciting because that kind of fires the engine here.
Then again, there are different levels to which we can show correlation. We’re trying to really partner with other people in the industry. Compounding pharmacists as an example when it comes to compounded estrogen that there should be motivation on all of us that are related to that to show at what doses do you get particular clinical outcomes because it’s a complicated story and it’s based on a lot of conjecture at this point and we know that there are a lot of really talented providers helping a lot of people but there’s also some uncertainty about best practices still because we haven’t pushed far enough into that so on the hormone side I think the HRT and that, it’s just a really a great area to continue to invest in. We’ve complemented our testing with other things so we started with hormones and then we added melatonin so if you want to look at cortisol pattern, gee wouldn’t it be nice to see melatonin and since we have individual samples we’re able to grab the ideal sample which is the wake up and grab a urine sample and that represents all that urine that’s collected over the night, the literature shows that it correlates well to the melatonin that’s made at night, which is when you want to be measuring it.
We also added an oxidative stress marker so 8-Hydroxy-2-deoxyguanosine (8-OHdG) because that relates to the story that we’re trying to tell. We’ve added nutrient deficiencies so deficiency markers so MMA for B12, B6 markers and glutathione markers, all of which are involved directly or indirectly in how your hormones are metabolized. Now, that story, the organic acid story gets broader than that and I know there are labs that are doing broader panels of those. That’s an area where I would love to see an investment in the functional medicine space because some of those connections are not that well established in the literature. I know we’ve talked before about β-hydroxy-β-methylglutaric acid (HMG). There’s this theoretical connection between your CoQ10 status and how elevated that marker might be in urine. Well, like we pedal in the industry of fatigue, right? As a cortisol testing lab we get a lot of people that have fatigue issues and wouldn’t it be nice to compliment that with a marker that moves meaningfully when your CoQ10 status changes. But there aren’t any studies that have actually measured that marker and CoQ10 status simultaneously and that’s a doable thing.
There are other markers in there that are conceptually B vitamin markers that are when you look through the literature it’s like, “Well, here are some newborns that have genetic problems. When they have those genetic problems they have this really overt deficiency for B vitamins and these markers get elevated. We go, “Oh, okay.” There’s a potential connection between these things getting elevated and your status for these particular vitamins. It really hasn’t been… No one’s really pressed into that and said, “Well, we have the ability to measure the status of those individuals in just adults that may have mild deficiencies in these things to see if it does push those same markers.
Some of those areas where I would love to see our industry again be internally skeptical to continue to push into taking claims that we’re depending on that are provable and really continue to invest. That’s what we’re trying to do on the hormone side is that if we’re leaning on something for how we treat our patients and it’s not something where you can point to the literature and say, “This is known,” then I think that’s our job to keep investing in that area to take our confidence in using these types of connections that are well laid out conceptually but can be proven at a higher level. I think that’s a really good encouragement for us as an industry to just keep leaning into that.
Dr. Kara Fitzgerald: Yeah, that’s right. It’s possible. All of the labs have loads and loads of data and they just need to maybe hire a PhD candidate to do serious data mining projects, you know?
Mark Newman: It’s threatening too though because if you’re making 10 claims and one of them falls away as you scrutinize the data, that’s I think part that we have to be open to is taking the wins and the losses as you continue to scrutinize the claims that we’re leaning on in terms of interpretation of complex laboratory tests.
Dr. Kara Fitzgerald: How does a clinician who’s not going to be doing the dive that you’re doing on a daily basis is going to recognize a good lab? Somebody with a lot of evidence behind them?
Mark Newman: I think the first thing is to recognize when you’re moving into this unconventional space. You don’t want to treat hormone testing in urine or saliva or whatever the same way you would treat your hemoglobin A1C. I think that’s the first thing is to know when you’re moving into this space where you’re into sort of an unconventional space and some of the things that we do as functional tests is laid out well in the literature, so salivary cortisol would be an example of that. I think the lab can present that type of data but it’s when you get into things that haven’t been that well established in the literature that I think one of the real keys is why we’re pushing in this area is peer-reviewed published literature because it takes the claims that you make and it puts them in the hands of a neutral expert to be an arbiter of whether what you’re saying actually makes sense and whether the data’s actually falling as it should and it doesn’t allow us as an industry to put something forward as a concept without asking the right critical questions and showing supporting data. I think that’s a really big key I think in terms of having confidence in what you’re doing.
Dr. Kara Fitzgerald: So just ask.
Mark Newman: Yeah.
Dr. Kara Fitzgerald: Just ask what they’ve published on and yeah, ask them for the evidence on the analytes that they’re measuring. I think that’s reasonable. Just as we started this conversation off with a discussion on laboratory developed testing and there’s a lot of laboratory developed testing going on and it’s ridiculously important that it’s happening. It’s extremely important and what is that technology and what have they published on? I think it’s fair to ask.
Mark Newman: I think that’s a good key to knowing that you’re working with someone that’s really invested in doing what they do well and continuing that sort of continual improvement of not only what you measure but how you measure it and then what we can conclude from the data because it’s complicated.
Dr. Kara Fitzgerald: And don’t dismiss it. I know that it’s an easy seat to take that oh, that’s not a FDA approved test, forget it. You can’t. I remember when Quest moved from using the… I think it was called the DiaSorin kit for vitamin D that was like the gold standard FDA approved kit to using LC-tandem mass spec. People wanted to just… It’s no longer FDA approved. It’s a lab developed test that Quest did.
Mark Newman: And it’s better.
Dr. Kara Fitzgerald: Yeah, it’s absolutely unequivocally better test and it’s not an FDA approved kit and so you just have to pay attention to it and with something like vitamin D of course there’s plenty of evidence that LC-tandem mass spec is better. Don’t throw away, absolutely don’t throw away lab developed testing. It’s essential I think for the life of the industry but yeah, I think it’s reasonable to ask what they’re doing and what they’ve published on and what the evidence is behind it for the method. In fact, we do that here at our clinic people. When there are these new tests that we’re curious about we’ll often have one of their experts come on and not dissimilar to this conversation with Mark and really talk about it. What is next? What are you guys working on now? You have this NAM’s conference coming up which is pretty exciting but what’s in the future?
Mark Newman: I think continuing to push evidence and then continue to explore other markers that might be helpful for people in… We want to give as much meaningful and useful information as we can so we have kind of have a two-pronged effort of taking the things that we do now and proving the clinical utility and fine tuning the clinical utility of that. As I mentioned kind of the next horizon for us is one to continue to publish the data that we have. You mentioned PCOS and we actually had a really interesting statistical analysis on looking at people who are diagnosed with PCOS and the androgen markers that we have and that correlation is really fascinating and very affirming of what we’re doing on that front. There’s an effort to get that out into the literature in terms of what we’ve already done that needs some of the dots connected and written up into manuscripts. Then there’s that next horizon of evidence as we mentioned which for me, my passions for that is the hormone replacement side of things is can we connect with the right groups to show actual specific correlation between values of laboratory testing and the… As an example the increase of bone mineral density as women take estrogen. That’s something that’s on my list of things to get done in the future.
That’s complicated because we are a lab test and we have to connect with partners really to make those things happen because our area of expertise is not in compounding hormones or in some of the other aspects of that and then researching new things that we want to measure to complement the story that we’re already telling. There are a couple other markers that we’re chasing down and it’s the same process of how well does it work from an analytical standpoint, scrutinizing the literature to say is this just conjecture or is there actually evidence that this is a marker of what we hope that it is, and then to push again to that next level of showing correlation between those markers and the things that should be changing as they change or vice versa.
Dr. Kara Fitzgerald: Anything you can tell us you’re looking at or do we have to just like stay tuned? You’re ending with a teaser.
Mark Newman: I don’t have anything to the degree yet where we want to get out ahead of it but there’s some really exciting stuff in the literature and in that we can be exploring to again to just complement the picture that we’re already telling with the markers that we have so that’s pretty exciting. The other front that we’re pushing on is just the education side itself because the honest truth is I’m a chemistry nerd so I like that new stuff but the biggest missing piece is probably people’s ability to leverage the information that we’re already giving them because there are so many nuances to that and that’s where we’ve invested in this clinical team and we’re investing in educational resources that we want to create for people so that they can use and leverage the testing for all that it has there because that’s probably one of the biggest opportunities out there I think is just to educate people who happen to be new to hormones, don’t know how to necessarily work with cortisol and its metabolites and the androgen metabolism and the estrogen metabolites and some of these complimentary things. Those are some of the efforts that we’re making.
Dr. Kara Fitzgerald: Yeah, and so important and doable and very empowering for the clinician to be able to really see that broad sweep. Listen, I just Mark want to really thank you for this fun dive into what’s going on over there in your world and what you would like to see for our industry. I think it’s a bar that should be set high and we should all go for it. I also want to remind people, this will be on the show notes that you can access a significant discount on DUTCH testing if you go to Dutchtest.com\Fitzgerald you’ll get some kits at I think 50% discount.
Mark Newman: Yeah, that’s our offer for you if you’re new to DUTCH. What we love to see people do is say, “Listen, this is a tool you probably need to have in your toolbox.” For some providers it’s their go to, let’s screen all our patients for this because there’s so much good information. For some providers it’s more of a tool for their complicated cases. For some it’s more of an HRT tool but it’s a good thing to have in your toolbox and the easiest way to get to where you can use that when the situation calls for it if you haven’t used our testing before is as Kara mentioned go to Dutchtest.com\Fitzgerald and you can get up to five tests at half off and what I always encourage people to do is if you do that and set up a phone consult with our clinical consults… What’s the word I’m looking for? Clinical consultants they really do a marvelous job of being able to walk people through what does this mean and what are the next steps and that’s generally the process that people use to kind of again put this in their toolbox so that you can use it for those patients where it’s really going to be helpful.
Dr. Kara Fitzgerald: Yeah, and run one on yourself. I mean, we walked through the same thing. I remember the journey of sort of ingesting and metabolizing the test and now it is pretty straightforward for us. Anyway, Mark it’s just great to talk to you as always. You’re up to some really cool stuff over there and we’ll look forward to seeing what analytes you’re looking at. I will say, and then I’m going to hush when you did add the organic acids onto the test you actually didn’t increase the price point which was really nice.
Mark Newman: Yeah well we’re working on keeping things affordable as well. Part of the challenge for us too is we don’t want this for the 1% we hope that our testing is available to everyday people. Literally the way we set our test is I was asking myself, “What can my mom afford?” That’s kind of where our pricing structure started and as we’ve increased the efficiency of the testing we’ve been able to add those other tests while keeping it cost competitive which has been really encouraging for how many people have been able to use the test.
Dr. Kara Fitzgerald: Yep. Well thanks again for joining me today.
Mark Newman: Dr. Fitzgerald, it’s always great to chat with you. I appreciate the time.
Dr. Kara Fitzgerald: Absolutely.