On precision medicine and pharmacogenomics - Dr. Ron Leopold

Guest Dr. Ron Leopold, Chief Medical Officer at Lockton discusses the impact of genetic testing on employee benefits as well as the ins and outs of precision medicine and pharmacogenomics.

Download the whitepaper referenced in the conversation here.

This episode brought to you by:

Nate:               
I am very excited about my guest today, Chief Medical Officer at Lockton, frequent speaker, health outcomes guru and my friend, Dr. Ron Leopold. Welcome to Illuminate HR.

Dr. Ron Leopold:   
Thanks, Nate. Happy to be here. How are you?

Nate:               
You know, I'm doing good. It's a rainy day here, so it's a perfect day to be inside recording something like this.

Dr. Ron Leopold:   
On my end, we had an awful lot of technical variables to get to this point where we can have a clear conversation, but I'm happy we're here, and I'm ready to hit the ground running.

Nate:               
There are a number of topics that you and I could discuss obviously. We've known each other for quite a while, but for this conversation, I wanted to focus in on the sort of four-part white paper series which you were a coauthor. 'Precision medicine and pharmacogenomics; new frontiers and genetic testing for employee benefits providers.' That is a long name, but extremely interesting read.

Dr. Ron Leopold:   
I'm happy to do so. I think it's a great topic. I will say that any time this topic comes up, it always stokes the fires, gets people excited. Really what we're talking about here, I wanna try and keep it as plain and comprehensible as possible for your listeners. So we're talking about genetic testing, but what we're really looking at these days is, what are new things that we can do with genetic testing that have value based on our stakeholder position? And so I'm coming at this, and I think you are too, as folks that are looking at an employee benefits program on behalf of an employer, and thinking through what do I have to know, what do I have to think about, what should I consider, what are some of my options, and what should I be on the lookout for in the future when it comes to genetic testing? Does that sound reasonable?

Nate:               
Yeah, absolutely. And I think, for me, when we first talked about this topic, precision medicine was a word that I've heard sort of bandied about in the vernacular of the public consciousness. Pharmacogenomics was completely new to me, so maybe you can set the stage for us by just, what are we talking about when we say precision medicine and pharmacogenomics? What are these things?

Dr. Ron Leopold:   
Okay. So precision medicine refers to the capability of ... we'll call it medical science, to do at least two things. One is look at your genetic code, and we map the entire human genome now and see what are you, Nate Randall, predisposed to based on your DNA. And then second, the second part of all of that is the pharmacogenomic piece. So how will you, Nate Randall, based on your DNA, respond to certain classes of drugs? And what we've learned is that different people, based on their genetic type for a particular gene or series of genes, will respond differently to different medicines. Does that make ... does that track?

Nate:               
It does, yeah, and what I learned from the whitepaper, it's pretty exciting for some of the possibilities and treatments of, it looks like anyway, specifically cancer. And so, if I'm understanding correctly, you can really start to dial in what may and may not work for an individual. Not give false hope, but maybe get yourself towards a more accurate not only diagnosis but treatment plan for that individual. Individualized medicine, if you will.

Dr. Ron Leopold:   
In theory, that's the broad horizon. What's really important to understand is that we can do this for some medical conditions, for some cancers, but not all of them. And we can do this for some drug treatments but not all of them. So to put it a different way, where we are able to recognize that a particular gene gives an individual a predisposition to a certain kind of cancer or a certain medical condition, we have to think and evaluate whether or not it makes sense to test people for that gene. Likewise, for pharmacogenomics, the same sort of thing. Where we know that there is a genetic component to how somebody responds to a medicine, is it worth tapping into that and understanding that?

Dr. Ron Leopold:   
And so the reason I say that is it's not all medical conditions that genetics can give us insight to. And there's a lot of ways that we may or may not be able to get a little bit of information, but that information may not be actionable. So with all of this, it becomes very complicated. It's changing rapidly. If you can tap into where it makes really good sense, it can be extremely important to the lives and welfare and the health of people that we're looking out for as we think about employer-sponsored plans.

Dr. Ron Leopold:   
So it's understanding what we can do today, but also what we cannot do. It's thinking through where should that be applied and then tracking through the 'so what' with all of this. Does that follow?

Nate:               
Yeah, yeah, absolutely. And taking us a couple years back, we started to see a bit of impact on employee benefits and some questions coming up with news that was circulating around BRCA gene mutations or BRCA and-

Dr. Ron Leopold:   
That's right.

Nate:               
Famously Angelina Jolie had her double mastectomy based on her genetic testing results. That, if I'm remembering correctly, my career resulted in a bit of a blip of questions around coverage levels and are genetic tests covered, should I do this? How do you see the future of genetic testing in employee benefits unfolding?

Dr. Ron Leopold:   
Okay, so let's take ... I think there's two spheres for us to look at. The first is, based on my genetic testing, what am I predisposed to? Second will be, based on my genetic testing, what drugs might I respond well or poorly to? Let's take that first thing.

Dr. Ron Leopold:   
So the first questions is, what's already covered? Doesn't my carrier already pay for it? And the fact is that all of the carriers that have published clinical policies for instance do have criteria that include things like family history, in some cases ethnicity, in some cases, personal history, that are required in order to do some of this genetic testing. So that's one, is what is my carrier doing?

Dr. Ron Leopold:   
The second is are there vendors out there, which there are, are there additional medical tests that could be tested for and if I do test positive, I need to heighten my awareness. So some examples that I gave in the whitepaper ... so certain colorectal cancers, certain stomach cancer, breast, melanoma, pancreatic, ovarian and uteran, certain ones of each of those types of cancers do have a genetic predisposition. So is it worth it for an individual to have that done? Well, an individual could say, "I wanna know as much as possible," and they can get tested for those particular genes. And what that will tell them is whether or not they have the gene for a certain type of colorectal, certain type of stomach, certain type of breast, et cetera, cancer.

Dr. Ron Leopold:   
So if they do test positive, then they do know, like Angelina Jolie, that they are predisposed to that certain type of cancer and, for instance, if it's a melanoma predisposition, you might be far more vigilant in terms of your own self-inspection of skin and seeing the dermatologist on a more regular basis. Some of the danger, though, is if you don't test positive for that gene, that doesn't mean that you can't get the very cancers that those genes are markers for, and it certainly doesn't mean that other types of cancers for each of the body parts that I named, you may be as susceptible as anybody else.

Dr. Ron Leopold:   
So this new capability has a lot of misinformation around it or the potential for people to misinterpret. A perfect example is, well, I don't have the BRCA gene, so therefore I won't get breast cancer, which is not an assumption that anybody should make if they get BRCA testing.

Nate:               
Yeah, and you from your end, in your role and what you see around you, consulting with employers and their benefits and health outcomes, are you seeing an increased interest from employers in offering precision medicine, pharmacogenomics? Are these things that they're pushing the medical plan for, or are you seeing an interest in being offered as a voluntary benefit or a supplemental benefit? What does that look like?

Dr. Ron Leopold:   
I think there are two tracks, and you kind of nailed both of them. The first one is, we wanna do something a little more cutting-edge. So Nate, I know you've spent a lot of time in Silicon Valley, and a lot of the tech companies there are struggling for talent. And so, it would not be unusual for a white collar company that are tapping into a millennial workforce, a specific one that has high skills, constantly looking for what can we do to retain talent? And so some of those are looking to offering genetic testing capabilities, whether or not the employer pays for it or they wanna offer it at a discounted basis, on a voluntary basis. That's one sphere.

Dr. Ron Leopold:   
And then the second is, as companies continue to monitor what is happening in the day-in and day-out approval and payments of claims, in some cases genetic testing does pop out, where we see that a provider may have suggested or prescribed a certain set of genetic tests, and the carrier pushes back. There's a lot of things that happen there. One is that the provider is looking to do a much broader spectrum of genetic testing, which can run very expensive, and the carrier can only approve a subset of that. In other cases, it might be a mismatch between what the provider's looking to do and what the test actually does. And I'll stop at those two examples. Those are a couple of areas that we see as incidents that could escalate for an employer as they're managing their plan.

Nate:               
And so, in your thought process, ultimately let's say once the medical carriers catch up to science, which sometimes can take a little while, once employers are in a space where we become comfortable with what is covered and what should be covered and all of these things, does precision medicine, is part of the promise of this that it could ultimately make the healthcare system more efficient and affordable for everyone? Is that some of the benefit that we could be seeing as employers?

Dr. Ron Leopold:   
Well, I'm a skeptic on the issue. So I do think that there are opportunities for efficiency. I'm not so sure that I, in the end, fully believe that cost reduction will be the endpoint. So you know, I think that brings us to the second sphere, which is ... if we're looking at efficiency and we're thinking about cost, where I think efficiency can play is in pharmacogenomics. Pharmacogenomics, again, we take your genetic sequence and there are certain genes that will tell us how you will respond to certain medicines. Some examples are psychiatric medicines, antipsychotics, antidepressive, cardiovascular medicines in some cases, inflammatory disease and chemotherapeutics.

Dr. Ron Leopold:   
And it used to be that the drug manufacturers would test drugs and they would just test everybody and hope that more than 50%, more than two thirds of people, would respond positively. And now what we know is that there are certain drugs where certain people respond very well and others don't. So pharmacogenomics allows us to analyze your DNA or my DNA and determine what would be the best antidepressant for you verses what would be the best one for me. What might be the better hypertensive medicine for you, and what would be the better for me. And what we might find is if there are choices A, B, C, and D, A and B may work great for you, C you may be a fast metabolizer for and so it won't work, and then D will work but we have to double the dose for me. And for me, it might be the opposite. It might be that A and B I'm a fast metabolizer for, C I'm so slow that it could end up being a toxic experience for me, and then D is the only choice for me.

Dr. Ron Leopold:   
So the science around all of this is getting pretty complex. And so if you step back, I think the real challenge is how can you leverage this new capability on behalf of our plan? To make sure that the right people are getting tested, and when they're tested, the right things are happening as a result of that testing.

Nate:               
Yeah. And so let's just say I'm a high growth white collar tech company. I'm challenged with talent, like you said. Maybe I'm on one of the coasts. I really want to offer something different. What are some of the things that I need to think through? There's probably obviously GINA, which is the Genetic Information Non-discrimination Act. That's probably a big one. But what are the things I need to think through if I want to get on the leading edge of this to be able to provide what sound like some pretty amazing benefits to my employees and their families?

Dr. Ron Leopold:   
So first and foremost, and I think where you're going with this question is the employer's plan sponsor, and as a company that might offer an ancillary benefit, a voluntary benefit or a supplementary benefit to allow people to get genetic testing, there needs to be secure privacy, secure firewalls between what the tests reveal and the employer. So the employer should never know, and for any of the third-party vendors that are approaching employers, this is table stakes. If you're offering genetic testing for an employee, the results of what the employee gets tested is never revealed, never made known, to the employer. But what the employer has to assure is, are we testing things that make sense? We don't want to introduce some marginal testing or even some junk science in there. We wanna make sure that everything that is being tested makes sense to be tested, because there's something that the person can do.

Dr. Ron Leopold:   
And then the second piece is that, as part of the process, when they get their results, they have the right action steps. So that can be anything from a full written explanation in their results to an online capability with Telephonic to actually make sure that everybody tested does get to talk to a genetic counselor. So you want to make sure that the right things are tested, and you also want to make sure that people are given the right level of support to do what they find out from this testing.

Nate:               
Yeah, it's fascinating. I think where this space is going and what we're going to see in medical care over the next 15, 20, 25 years is probably going to be be very staggering. Is that the sense you get? Is this something that you think it's just sort of the beginning of space exploration, and we don't know what's out there in the universe yet? Are you as excited about it as I think you are?

Dr. Ron Leopold:   
Yeah, I am. And I think the analogies are good. I think that we're just at the beginning of the capabilities and five years from now, 10 years from now certainly, what we'll be able to tell in terms of what a person is predisposed to, how they respond to different therapies, is going to make significant leaps, possibly even quantum leaps. I do think that, for many of classes of drugs, it's going to change the way that clinical trials happen, and there will be a proliferation of research, and what we're gonna start to find are much ... precision medicine type drugs. Smart drugs that are targeted for how you, as an individual, respond to medicine.

Nate:               
Fascinating. Yeah, that's good stuff. I want to make sure that we're able to link to the whitepaper, because it was a fascinating read, so we'll make sure to figure out a way to include that-

Dr. Ron Leopold:   
Beautiful.

Nate:               
In the show notes. And then, yeah, exactly. And keep up the good work. I'm hoping we can have you back for another interesting topic in the future, and thank you very much for your time. I really appreciate it.

Dr. Ron Leopold:   
​Thanks, Nate. This was great. I enjoyed this.