Announcer:
0:00
Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts Hosted by cardiologist and top medical researcher, Dr. Michael Koren.
Dr. Michael Koren:
0:11
Hello, my name is Dr. Michael Koren and I'll be leading a unique program of our MedEvidence podcast today, in that, instead of speaking with another medical professional, I'll be speaking with one of our patients. And this was an interesting opportunity for me because one of our patients, who has a little bit of background in media, was keen on talking about what his experience was like when he signed up for a clinical trial, and he's actively participating in a clinical trial. And I'm going to depart from our usual protocol by not using your name, because when I talk to another medical professional, it makes sense to use their name. But because you're a patient, I'm going to give you the respect of privacy and let you introduce yourself to show that it was uncoerced and that you're willing to talk to the community about what it was like to be in our clinical study.
Andy Munsey:
1:04
Thank you. I appreciate that my name is Andrew Munsey I go by Andy usually and I'm happy to put that out there and advocate for studies like this. It's something that I was actively looking for a solution for my particular issues and it's nice to be here to talk about it.
Dr. Michael Koren:
1:27
Sure. So one of the things that we do in medicine is we like to know a little bit about the background of our patients and if you're willing to just share a little bit about your background, where you grew up and your profession and how you ended up here in North Florida.
Andy Munsey:
1:40
I grew up outside Washington DC. My parents were in politics and very much an industry town, and I did not follow them into politics and got bitten by the writing bug and went out to Hollywood to become a television writer, wrote for a couple of different shows a comedy called Late Line with Al Franken that actually just had a lot of politics in it, and an HBO show called Arliss but then fell into a marketing career out there doing trailers for movies and then ending up at NBC working as a promo producer doing the marketing for Friends, Frasier, Seinfeld, Will Grace shows like that had to move on to move up to and went over to, ABC and worked for them for a while, went back to NBC for a stint and did the Office and a number of 30 Rock.
Andy Munsey:
2:37
A number of shows like that Ended up back at ABC and where I finished up my career just a couple of years ago when, uh, I retired, um and uh. My medical history is that, uh, my background, uh, my father had uh quadruple bypass late in the sixties. Uh and uh. Sometime late in my forties, my cholesterol was testing high and started lipitor and statin drugs that brought it down. Some diet and exercise had some effect but wasn't doing enough .
Dr. Michael Koren:
3:21
So let's drill into that a little bit, and I'll mention the fact that you're involved in a study here treating the cholesterol molecule called lipoprotein little a, and it's actually a cholesterol-containing particle, but we use the term lipoprotein to describe these things. And lipoproteins are these molecules that circulate in our bloodstream that are combinations of fat and protein, and that has to be the case, because cholesterol is a fat and it's not soluble in our blood, which is mostly fluid, mostly water. So we have these lipoproteins and we know that certain lipoproteins are more dangerous than others. There are favorable packages of lipoproteins, for example HDL, or high-density lipoprotein, and then we have the less favorable packages LDL, or low-density lipoprotein, but particularly lipoprotein little A.
Dr. Michael Koren:
4:13
And you mentioned a very common scenario for people with lipoprotein little A, which is a family history. And lipoprotein little A is a particle that is inherited at high concentrations in an autosomal dominant fashion, meaning that if one of your parents has this problem, there's a 50-50 chance they'll pass it along to the kids. So it sounds like you had this gene, and tell us a little bit. What was your lipoprotein little a level? Did you know about it before you got involved in the trials?
Andy Munsey:
4:42
I did. I didn't know about it when I first started on a statin drug and I ended up having some chest pains playing tennis, and that's when I first started, or that's when they increased. They doubled the dose of the Lipitor and then, a few years after that, I had more chest pains and I had my first angiogram. They found blockages. Three stents were put in. I tried to be more concerted about the change of diet, exercise and that sort of thing had a second angioplasty and a third angioplasty for a total of eight stents in the end, and it was only after the third one that the lipoprotein A was tested and found to be 555.
Dr. Michael Koren:
5:34
Ooh, okay, very high,
Andy Munsey:
5:36
Over five times higher than it should be
Dr. Michael Koren:
5:38
.
Andy Munsey:
5:39
Yeah, and sometime after that, in April of 2022, I began on Repatha
Dr. Michael Koren:
5:48
On top of the Lipitor
Andy Munsey:
5:50
Correct , yes, and that has actually worked Better than the drop by a third that it has usually done, getting me down to 311. Still three times higher than it should be, but happy for some reduction. And then I had a fourth angiogram last December.
Dr. Michael Koren:
6:15
Keeping the interventional cardiologist busy? Yes, unfortunately for you,
Andy Munsey:
6:21
And that time it was just an angiogram, because they were not able to drill out anything or put in any stents. The blockages were too far down in the branches and I always thought, because my father had the quadruple bypass, that that was sort of my lot in life and would eventually be what happened, of course, as you would know, I came to find out well, a bypass wouldn't help that issue and
Dr. Michael Koren:
6:52
we call that distal vessel disease and cannot be treated with bypass correct.
Andy Munsey:
6:54
So you know my concern continued to grow for how do I get on top of this and you know what else can be done. And that's when I began pursuing the issue of lipoprotein A and found out about some studies at the Cleveland Clinic and the effectiveness of the new drugs, and I reached out to them and I said I think I might be the perfect candidate for you.
Dr. Michael Koren:
7:18
You are
Andy Munsey:
7:18
, and they let me know about the continuing studies going on a list of them in the various states, including Florida.
Andy Munsey:
7:27
And so.
Andy Munsey:
7:28
I reached out to see if I was the right candidate?
Dr. Michael Koren:
7:33
Yeah, and you screened and you got in the study. Yes, and how long have you been in the study?
Andy Munsey:
7:38
Since June. Late June I got my first shot.
Announcer:
7:41
Okay.
Andy Munsey:
7:42
And I have had no side effects. Beautiful, everything's been great.
Dr. Michael Koren:
7:46
So I'm going to explore a few things Fascinating history, a common history.
Dr. Michael Koren:
7:51
We see this quite a bit in cardiology and something that a lot of people in the public sector aren't really aware of. Most people know about cholesterol, of course, and I think the majority of people know about LDL, but very few people know about lipoprotein little a, and one of the reasons they don't know about it is because we really haven't had a treatment specifically for it. You mentioned Repatha, which lowers its some. We actually did that work here in Jacksonville and I was very involved in that work, and we showed that we can lower that lipoprotein delay 25 or 30% with something like Repatha, which is called the PCSK9 antibody. Evalocumab is the generic term for Repatha, but that's still not going to help that much, quite frankly, if somebody's starting out with Lp(a) level level of 500, and it should be 25. So we obviously have a lot of work to do and we've had to develop other molecules.
Dr. Michael Koren:
8:47
But before I get into that, I'm curious about a couple of things. What was your total cholesterol or your LDL cholesterol before you were on any drug? Do you remember what it was?
Andy Munsey:
8:57
I think about 230
Dr. Michael Koren:
8:58
. Was your total or your LDL Total
Andy Munsey:
9:02
Total?
Dr. Michael Koren:
9:08
Do you remember what your LDL was?
Andy Munsey:
9:09
I don't,
Dr. Michael Koren:
9:09
okay. And then, after you got to Lipitor, it sounds like they started at a lower dose and titrated up. How high was the dose that you got to? Do you recall?
Andy Munsey:
9:13
I think it went from 10 to 20,.
Dr. Michael Koren:
9:15
Lipitor. What was the highest dose you were ever on for?
Dr. Michael Koren:
9:17
that
Andy Munsey:
9:21
I think that's the highest. It was 20.
Andy Munsey:
9:23
Now I'm on rosuvastatin Rosuvastatin
Dr. Michael Koren:
9:25
yeah, How much of that 20 or 40 milligrams
Andy Munsey:
9:32
20, yeah,
Dr. Michael Koren:
9:32
okay.
Dr. Michael Koren:
9:35
So interestingly, your doctors chose not to put you on the highest doses. Statins don't affect LP little a lipoproteotein, little a so that piece of the puzzle wouldn't be improved by those drugs. But you remember how much your LDL dropped, or your total cholesterol dropped,
Andy Munsey:
9:46
I think went down to 160 in the end.
Dr. Michael Koren:
9:49
So from 230 total cholesterol to 160. Okay, because the reason I'm bringing this up is one of the clues to people who haven't had Lp(a) tested tested is to see a less than expected drop in LDL when you put on a statin.
Dr. Michael Koren:
10:06
So a drug like atorvastatin, lipator or rosuvastatin or Crestor can lower your LDL cholesterol between 40 and 50% and some people will only see maybe a 25% reduction.
Dr. Michael Koren:
10:19
And the reason for that is that when you get a standard measurement of your LDL or your bad cholesterol, Lp(a) portion portion is in that and Lp(a) portion portion is not lowered by the statins, so you get less than expected drop in your LDL when you have a situation like yours. So that's an important learning feature for people that may be listening to this. If you have less than an expected drop in your cholesterol, or particularly your LDL, with a statin drug, there's a chance that this is because of lipoprotein little a and if you have a family history and that phenomenon of less than expected drop, please get your Lp(a) checked. Some people would argue Lp(a) should should be checked for anybody with coronary disease, which is my standard for my patients, but certainly another clue would be this concept of less than expected drop. So let's change subjects just a little bit and talk about what the experience was to get involved in a clinical trial.
Dr. Michael Koren:
11:15
Must have been scary
Andy Munsey:
11:18
Actually, no, I looked at it as an opportunity, knowing that it would be several years before these drugs would reach market, and the study I read said it had dropped Lp(a) down down by 95%. I thought that's what I want, sure, and from what I read, there weren't side effects to be concerned about. And so I had no fear going into it. I looked at it as an absolute opportunity.
Dr. Michael Koren:
11:49
Well, you'd be the exception rather than the rule. Yeah, so you hadn't done a clinical trial before that?
Andy Munsey:
11:53
I had not
Dr. Michael Koren:
11:53
. Okay, yeah, so I would think that most people that have not been involved in a clinical trial would be nervous. You did a lot of research and obviously you looked at this very intelligently, but the truth is that when you're using products that are relatively new, that there may be some concerns. There may be even some fear.
Andy Munsey:
12:14
You know, once you've exhausted all of the options you have of changing your diet, increasing your exercise, reducing stress by retiring from a stressful job and moving to the Florida coast, and life is good and you still have another angiogram your mind opens up.
Dr. Michael Koren:
12:34
Well, unfortunately, all those lifestyle issues will not touch your LPLA Right? It's interesting. We certainly advocate lifestyle changes and diet and exercise can do wonderful things. They have modest effects on cholesterol in general, Lp(a)is is one of these genetic concerns, or diseases if you want to look at it as a disease. But it's a risk factor. That's because of your parents and your genes and it's very, very difficult to change, short of some of these new drugs and these really breakthroughs that we're working with now in research.
Andy Munsey:
13:14
It's extraordinary fact that medicine is advanced in this way. To be able to stop the generation Lp(a) that that your body is naturally doing is a wonderful opportunity, especially since it seems to have no side effects.
Dr. Michael Koren:
13:27
Yeah Well, we'll talk about that. I would never say something has no side effects. Just to be clear.
Andy Munsey:
13:31
My experience
Dr. Michael Koren:
13:32
, but a couple of things is one is that I liked, one of my quips that I like to share with patients is that one of the most important things about your own personal health is to choose good parents.
Andy Munsey:
13:43
Great, well, I have that
Dr. Michael Koren:
13:46
.
Andy Munsey:
13:48
Maybe a few select genes.
Andy Munsey:
13:49
Maybe
Dr. Michael Koren:
13:50
Right. So with every choice there may be a thing or two that you can make issue with, but nonetheless, in your case, you have this gene and standard therapies have very little ability to affect this gene, and so you look to clinical trials as a great option and you're the perfect candidate. So thank you for being part of the study and hopefully work out for you. Now, in fairness, we like to be very upfront. There's a chance you're not on an active drug when you're in a study. Did that concern you Sure?
Andy Munsey:
14:20
Sure, but I figured once. I realized that I didn't have to change anything about my current medications and that, you know it, either I got lucky and was on the drug or you know it's just doing everything I could otherwise right, so why not?
Dr. Michael Koren:
14:38
right. So one of the things we talk about in our MedE vidence platform is the truth behind the data and for things in medicine, things in life, quite frankly, but particularly in medicine there's things that we know for sure, there's things we definitely don't know, and then there's a way, a process to figure out the stuff we don't know. And that's what we do in clinical trials is we figure out the stuff we don't know. So we do know that LP little a or lipoprotein little a, is a very potent risk factor for heart disease, and there are many families like your family, where this is probably what's driving your cardiovascular complications. You know, you're a thin guy, you're a fit guy. I'm sure even in your previous life, before you had your stents, you were relatively conscientious about your health, is my guess. Nonetheless, you still had these complications, as did your parents. I didn't get into brothers and sisters, but they would have a 50-50 chance of having the gene as well, assuming it's just coming from one parent. And you know, you don't have to go into their whole story, but they would certainly be people I would want to screen for this particular problem. So if they haven't been screened, I would encourage them to do so, but the point I'm making here is that we don't know if lowering lipoprotein little a is going to make a difference, and that's why we do the studies. So another thing that we do know is, as you mentioned, we have products that can now Lp(a) by by 90, 95, close to 100% in some cases. It's remarkable, and the product that has been the most successful is the product that you're participating in study.
Dr. Michael Koren:
16:18
The product you're participating in called a small interfering RNA, and this is now Nobel Prize winning technology that shows that our body has the natural ability to suppress certain gene expression. As you go back to your old high school or college biology days, you probably remember is that the genes are in the nucleus of the cell and they send an RNA signal out to the cytoplasm of the cell which allows our body to produce these proteins. And, of course, in a lipoprotein there's a protein, and we now have learned again through scientific exploration that we can block the transcription of that protein in the cytoplasm of a cell. And this is the concept of small interfering RNA, where we send a signal to the liver cells that make this bad protein and prevent that from occurring. And if you don't make the protein, you can't make the particle All right, and so hopefully that made sense to you. It does, and that's how these things work.
Dr. Michael Koren:
17:14
And we know with this small interfering RNA technology and there are products on the market, particularly one product that lowers PCSK9 using this mechanism that's now been on the market. We've done a lot of research with it, very effective at lowering LDL cholesterol and appears safe. So this is a really exciting new area where we can intervene and have a huge impact. But we don't know yet if that lowering of the lipoprotein little a will result in fewer heart attacks and strokes, and you're helping us figure that out. So we appreciate that and hopefully along the way, you glean some nuggets of information so that, whether or not you're on the medication that we're testing, you'll get some benefit from what we're doing. So talk to me a little bit about that. Tell people what it's like to come into a clinical trial center and be part of this. Is it like a doctor's office or different? Just a little bit of your experience.
Andy Munsey:
18:07
It's been very easy, you know, because I had so many cardiovascular events and procedures. I'm fairly used to having to go for various appointments and things and so, uh, it was all very easy to come in, take the survey, answer the questions. Uh, had to go back and do some family medical history and check in with with relatives about some of the the specifics. Um, but, uh, you know there was, there was nothing to it.
Dr. Michael Koren:
18:41
And is? Is it enjoyable? Do you feel when you leave, when you leave the office after a visit? Do you feel uplifted? Do you feel depressed, confused?
Andy Munsey:
18:50
I'm very excited to be part of the study and, and obviously I, you know, I'm very hopeful that it stops this pattern of needing some intervention because of a blockage. You know, and beyond that, you know, I'm aware of the. Well, what about the rest of me? What about my carotid arteries? And their blockage and they've been scanned and they're in good shape now. Good, but you know, I would hope that being part of this study wouldn't keep that, yeah being the case yeah, it's interesting when we do surveys of patients like you.
Dr. Michael Koren:
19:29
obviously you're driven. The value proposition for you is to get a treatment that you can't get elsewhere. You say that other people do it for different reasons. Some people just like the socialization of being part of this. Most people will say that when you go to a physician's office these days, the physicians are so stressed for time that they run you in and out as quickly as possible, whereas in a clinical trial setting it's much more relaxed, much more comprehensive. It's actually more social.
Andy Munsey:
19:57
I definitely agree with that.
Dr. Michael Koren:
19:59
Yeah, and you know, for some people they're driven by the fact that they get compensation for what they do in the studies. That's a driving factor for some people, not for everybody. In a case like yours, it's really access to the product and trying to change your disease course.
Andy Munsey:
20:14
Yeah, I didn't realize that that was part of this, but it's a nice little bonus yeah.
Dr. Michael Koren:
20:20
And then the other item that I think is relevant in your case, and correct me if I'm wrong, but there's a legacy issue. I don't know if you have children or not.
Andy Munsey:
20:27
One daughter
Dr. Michael Koren:
20:28
, yeah. Has she been tested for Lp(a)?
Andy Munsey:
20:30
Not yet
Dr. Michael Koren:
20:30
, okay.
Andy Munsey:
20:32
No, but she knows that she needs to on their next checkup.
Dr. Michael Koren:
20:39
Well, let's test her.
Dr. Michael Koren:
20:40
We'll, we'll do it for free here.
Andy Munsey:
20:41
Oh, thank you. Okay, that'd be great.
Dr. Michael Koren:
20:41
Yeah, so it's actually a relatively simple test, but it probably would not be recommended by her primary physician because, again, it's not part of national guidelines yet for somebody that doesn't have coronary disease, right. But given the family history, why not?
Dr. Michael Koren:
20:53
and again, uh, siblings of yours should also be tested, if they have not already
Andy Munsey:
20:57
yeah, and even after it took the third angioplasty for mine to be tested a few years ago.
Dr. Michael Koren:
21:07
Well, hopefully that's going to change. Part of this is to educate physicians as well as patients about this particular problem, and we're in that zone where we don't have all the answers yet. So we do think that interventions of lipoprotein little a will be important. We know that lowering LDL in patients like you is very, very important, but you're going to be part of this process where doctors and patients around the world can help us figure this out. So I thank you for your participation. It's really, really important. And the other thing I was very pleased to hear that Cleveland Clinic kind of guided you along the way.
Dr. Michael Koren:
21:44
We work with Cleveland Clinic on a number of projects. Steve Nissen is head of cardiology at Cleveland Clinic and he and I have published together on multiple occasions Terrific guy, just evidence-based guy. So we have great conversations and the fact that we all work together, as a fraternity, if you will, of people that run clinical trials is a neat part of what we do. So we share data with each other and, interestingly, people in Europe and around the world will learn from your experience, and the flip side is, I'll learn from the experience of patients that are in Asia and Europe that are part of these trials as well. So again, we thank all of you for your participation.
Andy Munsey:
22:24
Happy to do it
Dr. Michael Koren:
22:29
so any final words that you want to share with the audience that may be considering doing a clinical trial?
Andy Munsey:
22:32
Just, I agree with everything you've said. It's easy, a specific issue that my cardiologist and primary physician were aware of and knew that it needed to be tackled, but weren't in a position to take advantage of these new advances. So I just think the clinical trial is a wonderful opportunity to do that and hopefully I'm getting the drug and if not, then hopefully it will come to market at some point.
Andy Munsey:
23:13
It will help me down the line
Dr. Michael Koren:
23:14
and in many cases the manufacturer will make that drug available if it's proven to be successful. Again, we can't guarantee that, but I'm lobbying for it as we speak.
Dr. Michael Koren:
23:23
So one of the things that I do for all my patients is to make sure that the manufacturers know how important that is. So you mentioned Repatha, and that was an example where we successfully lobbied Amgen to make Repatha available for the people participating in clinical trials, whether or not they were assigned to the drug during the course of the study. So, Andy, thank you for being part of the study, thank you for being part of MedEvidence and thank you for being part of the process of making healthcare better.
Andy Munsey:
23:53
Thank you for the work you're doing.
Announcer:
23:55
Thanks for joining the MedEvidence podcast. To learn more, head over to MedEvidence. com or subscribe to our podcast on your favorite podcast platform.
