Transcript
Two Docs Talk Allergies and Asthma Part 4
Recorded Date: April 14, 2023
[Narrator] Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts. Powered by ENCORE Research Group and hosted by cardiologist and top medical researcher, Dr. Michael Koren.
[Dr. Koren] Hello, I'm Dr. Michael Koren here hosting another episode of MedEvidence where we discuss the Truth Behind The Data. It's been a pleasure. We’ve had multiple sessions and a great conversation so far. This is Dr. Sunil Joshi. He’s an allergy immunologist and is also very involved in organized medicine. Thank you for your service as past president of the Duval County Medical Society and Foundation.
[Dr. Joshi] Thank you.
[Dr. Koren] We do appreciate that, on behalf of all Physicians. Dr. Joshi is a community leader and somebody that's interested in clinical research so he’s a soul mate in that area. We've been having a really fabulous discussion about allergy and Immunology new drugs, the evil eosinophil, and how we calm that evil eosinophil, and also alluded to some of the clinical research that we're doing. We actually left off our last session talking about how eosinophils can have effects in different organ systems. You shared with us a great case of somebody that you were treating for eosinophilic asthma who also got tremendous benefits from her eosinophilic esophagitis.
[Dr. Joshi] That's right!
[Dr. Koren] What a cool case.
[Dr. Joshi] Yeah and there's so many more like that too. That one stands out because I wasn't even sure it would work. She was the first patient I was using one of these agents on and it worked in multiple areas.
[Dr. Koren] So more broadly this gets the idea of the immune system and its impact on different diseases that we don't necessarily consider immune diseases, but maybe they are. We were just talking about diabetes. Type 1 diabetes is probably autoimmune based.
[Dr. Joshi] Oh it is absolutely autoimmune based.
[Dr. Koren] What's interesting is that there's some theories that get into your hygiene theory that you're talking about that suggest that people that are more exposed to pathogens and viruses, including southern people, are less likely to have type 1 diabetes than people who grew up in the north. Do you want to comment?
[Dr. Joshi] That's the perfect example. As we talk about a hygiene hypothesis, some autoimmune diseases are actually driven by the part of the immune system that fights off viruses and bacteria, but type 1 diabetes is actually not. It's actually down that same path similar to allergies and igG4 processes. It makes perfect sense that people who are exposed to more viruses in warmer climates, who may even have some parasitic infections in the mountain regions, versus folks who are not as exposed in the colder regions (at least traditionally before climate change) would see that difference in overall disease processes. This includes autoimmune diseases such as type 1 diabetes.
[Dr. Koren] In my area of cardiology there's a lot of talk about inflammatory cells and how they affect atherosclerosis. It's believed at this point in the atherosclerosis hypothesis that macrophages in particular and other inflammatory cells are very very important in terms of progression of a coronary heart disease and other forms of atherosclerosis.
[Dr. Joshi] Oh, absolutely. It makes sense, too. That's why in cardiology you guys now have markers of inflammation that help you determine somebody's risk of heart disease like the CRP and things like that. Again it all comes back down to inflammation in the immune system.
[Dr. Koren] We know for example that folks that have rheumatoid arthritis have a higher risk for cardiovascular disease and other things where your immune system and your inflammatory system are revved up over extended periods of time.
[Dr. Joshi] The overdrive of the immune system. We probably don't even know half of what it is doing to our bodies.
[Dr. Koren] We're just really in the infancy of this. The other thing you mentioned in the previous segment that I thought was fascinating is that we actually have a fair number of drugs already out there that target the eosinophil and other elements of the whole inflammatory cascade. There are drugs that will tame that eosinophil. I'm very curious, with a lot of these new drugs they're very expensive and I'm sure there's some sort of prior authorization process. Tell me how you decide to go from sort of standard antihistamine steroids to these more sophisticated therapies and then go into a little bit of the process.
[Dr. Joshi] Okay, great question! When the standard therapies have been working for 30 or 40 years why do we jump to biologics? We don't jump to biologics! If a patient is doing well with a standard of care that we would typically do for an asthmatic; if they're able to have a good quality of life, if they're not having exacerbations two or more times a year; or they're not needing systemic steroids, there would be no reason to jump to a biologic. It's when they're not doing well with that standard of care and continuing to fail that we start thinking about biologics. Based on certain biomarkers, certain biologics would be more likely to be the ones that we would go after. Those biomarkers might be the eosinophil count, something that we measure called exhale nitric oxide in a breathing test, or even an allergy antibody level. These help us decide what biologic agent we choose. There is definitely prioritization needed for all of this. In our office, we have a full-time employee whose only job is to try to get these medications approved for these patients. The reason for that, and you can't blame the insurance companies, is that these medications are in the three to four thousand dollars a month range - maybe even higher than that for some of the newer agents. It's very very expensive, so they want to have proof as to why the patient needs the drug. We have to provide that proof to them and then they approve it. Further, just because the insurance company approves it doesn't mean the patient doesn't have to pay for it. The patient may have a high copay, they may have a high coinsurance or they might be a Medicare patient who's now in their donut hole. So suddenly patients, even with a 20% coinsurance, are paying $800 a month for this drug.
[Dr. Koren] Wow.
[Dr. Joshi] It becomes cost prohibitive. Then we have to go through all of the processes to see if we can have them qualify for some rebates from the drug company, etc. to make it more cost effective.
[Dr. Koren] So it's become complicated to get these new sophisticated, wonderful drugs. They do things that we couldn't even imagine a few years ago, but they are very costly. There's been a lot of research and development of course that has to be recaptured by the companies that develop them and it's tough on some patients.
[Dr. Joshi] It is, and it's tough on us as providers too because we know we've got this potential treatment option. It takes us time to have that discussion with a patient to the point where they're now ready to do a biologic. It takes a while to convince them they need to take that step, but then after that the cost comes in and it's another battle we have to fight, unfortunately.
[Dr. Koren] Right, right. That actually gets into one of the rationales for participating in clinical research. There are a lot of reasons why people like clinical trials. One of my favorite things to quote is if you ask the random person on the street whether or not they'd be interested in a clinical trial 40% say yes, both in North America and Europe. That's the general sense of being supportive of clinical trials if they've had no exposure. Once they've been exposed - if you've been in a clinical trial - and you ask the patient “would you do another one,” the positive rate is 97 to 99.
[Dr. Joshi] Wow!
[Dr. Koren] So there's something about the process that people really enjoy, that makes them feel fulfilled.
[Dr. Joshi] Yeah, yeah.
[Dr. Koren] Part of that could be getting access to medicines that they wouldn't have access to otherwise. This could be either because they're not exactly available for them, because they don't quote “meet the indication” for that medicine, or because they can't afford it. I'm sure you've had that experience in the clinical research realm.
[Dr. Joshi] Oh, absolutely! I think there are multiple factors. I definitely thought that it would be lower than 40%, to be honest with you.
[Dr. Koren] Europeans are actually a little bit lower than Americans.
[Dr. Joshi] Okay, very interesting!
[Dr. Koren] Americans tend to be a little bit more optimistic.
[Dr. Joshi] That's good, that's good! When people actually enroll into a trial I think they realize how easy it is. Number one: they just show up. Number two: in most of these trials just because they're actually interacting with a nurse or healthcare provider or professional about health in general, they focus on their own health a little bit more. So the placebo effect of these trials is pretty high just by the fact that they are interacting with someone who's now talking to them about their health and they don't have to pay for it. Not having to pay for a drug that could cost up to three thousand dollars a month also would make me want to be part of that clinical trial network as well. There's that percentage of patients who want to contribute to science of course on top of that. If you could do all of that, get that benefit and feel better at the end of the day, of course that would be a great way.
[Dr. Koren] Legacy is a big issue also. A lot of people do it because they don’t want their kids to have to deal with the same thing. There's probably some genetic components to some of the things that you deal with.
[Dr. Joshi] Yes there are. So if patients can help us understand what treatments and diagnostic factors can make a difference then it does help other people coming behind them; in particular their offspring.
[Dr. Koren] Absolutely, absolutely. Talk to us a little bit about the clinical trial that's going on here in Northeast Florida using an oral agent to knock off those evil eosinophils. tell us a little bit about it.
[Dr. Joshi] We've been talking about agents to treat eosinophils that are injection therapies. Most patients would want something simple, something oral. There's a drug that has been studied for ALS amyotrophic lateral sclerosis, otherwise known as Lou Gehrig's Disease. It’s a horrible disease and there's so much research looking for ways to prevent progression of that disease. There was a drug that was out there aimed at it and unfortunately, it didn't work for ALS. But what they noticed as they were checking blood on these folks is their eosinophil accounts were dropping
[Dr. Koren] Interesting.
[Dr. Joshi] This is without very many other side effects of note. The eosinophil counts were dropping. So here we have disease processes where we're targeting eosinophils with injection therapies and now there's this potential drug that decreases eosinophils too. The question is, if we are able to decrease the eosinophils in the bloodstream, will that help them with their asthma? It's helping them with these other biologic agents, but if it's an oral agent it certainly would be more convenient for the patient. It’d be something they could do at home with a relatively low side effect profile. Wouldn't that be amazing! One study led to another that might help us with another debilitating disease.
[Dr. Koren] That's interesting. When it was first being proposed as a treatment for a neurological disease was it through the eosinophilic mechanism?
[Dr. Joshi] No! I think it was through a mechanism to reduce a certain protein that's involved with ALS and the eosinophils somehow got implicated as something that was dropping as a result of this drug. We don't 100% understand the mechanism of how this drug reduces eosinophilia like we do with these other agents (when talking about IL-5, etc.) we just know that it does. So we’ll see what the outcomes are.
[Dr. Koren] Interesting. That's one of my favorite parts of clinical research when you discover something you had no idea that you would discover.
[Dr. Joshi] Right!
[Dr. Koren] You're going down one road and if you keep your eyes open you'll find something that may help people in another area.
[Dr. Joshi] That's what makes research fascinating.
[Dr. Koren] One of you know one of the classic examples of that is Viagra.
[Dr. Joshi] Yes!
[Dr. Koren] Viagra was developed as a treatment for coronary artery disease, and with the concept that it was a phosphodiesterase inhibitor and it helped dilate arteries and all this sort of thing. It didn't work very well for angina, but they couldn't get the study drug back from the men that were in the trial. They tried to figure out “what the heck is going on here?” One thing led to another and they found out their sexual function got better. It went from a possible cardiac drug to a drug for erectile dysfunction.
[Dr. Joshi] Amazing.
[Dr. Koren] So you never know how things will twist and turn.
[Dr. Joshi] That's right! Then you have to go down that road if it can help people. You go down that road, it's all about quality life, and in this case it may be about disease progression too.
[Dr. Koren] Yeah. Well Sunil, I've learned so much from you. Thank you very much for being here, thank you for being a guest on MedEvidence and it's fascinating. We'll definitely have you back on another topic and thank you for sharing your wisdom with our audience.
[Dr. Joshi] My pleasure, I love talking about allergic diseases! Like I said, I could talk about this for two or three days straight.
[Dr. Koren] Absolutely. That will be our marathon session, stay tuned.
[Dr. Joshi] (laughing)
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