10 May 2021

Lindi Hayes, MD of Palomar Pomerado Health’s Escondido Monoclonal Antibody Resources Center

 

Lindi Hayes  00:11

Some places in the country they’re opening very carefully and strategically and with smarts, but some places they are not. Those are the areas that have us the most concerned is the opening, not using the medical expertise that’s available. We have to be smart about this.

Gregg Masters  00:29

PopHealth Week is brought to you by Health Innovation Media. Health Innovation Media brings your brand narrative alive via original or value added digitally curated content for omni channel distribution and engagement. Connect with us at www.pop upstudio.productions. And welcome everyone. I’m Gregg Masters, Managing Director of Health Innovation Media and the producer and co host of PopHealth Week. Joining me as always in the virtual studio is my partner, colleague and lead co host of PopHealth Week Fred Goldstein, President of Accountable Health, LLC. On today’s show, our guest is Dr. Lindi Hayes of Palomar Pomerado’s Health Escondido, Monoclonal Antibody Resources Center, otherwise known as MARC. Dr. Hayes is a decorated emergency medicine physician achieving fellow status with the American College of Emergency Physicians, the American Association of Emergency Medicine and is certified by the American Board of Emergency Medicine. So Fred with that introduction over to you. Help us catch up with Dr. Hayes and the innovative work at Palomar Pomerado’s Monoclonal Antibody Resources Center.

Fred Goldstein  01:49

Thanks so much, Greg. And Lindi, welcome to PopHealth Week.

Lindi Hayes  01:52

Thank you so much for it. I really, really appreciate you all inviting us on today. We are so honored. And really grateful that you all have received and seen this information and want the community hear more about it. It’s awesome. Thank you.

Fred Goldstein  02:11

Yeah, fantastic. And we will definitely get into that. But first, why don’t you provide our audience a little bit of your background and experience?

Lindi Hayes  02:18

Yes, absolutely. I am going on my 20th year as an emergency medicine physician. I born and raised in Chicago, Illinois, and did my residency in Chicago, Illinois, actually at my undergrad at Xavier University in New Orleans. love it love it miss it so much. And I went on from Xavier to go to medical school in Chicago. And after medical school, I did my emergency medicine residency and training in Washington DC at the Howard University, Hospital Medical Center. And ever since then, I have been working in and practicing in level one trauma centers, critical access hospitals as an attending emergency physician. And that is that’s the gist of what I’ve been doing.

Fred Goldstein  03:17

That’s great. I know that over the past year, obviously the COVID pandemic, you’ve actually been around the country working in ERs in various places. Give us some sense of what you’ve seen.

Lindi Hayes  03:25

Oh, wow. Well, this has actually turned into a almost a whole other career for myself and my colleagues, especially those of us that in addition to having a a quote unquote regular group or a permanent kind of home base where we practice, those of us who do like to travel, practice independently as independent contractors or locum tenens medicine. It has really turned into a whole secondary specialty actually. So we first started out in Michigan, in Detroit, which was very close to Chicago, Indianapolis, which is where I practice both mostly full time in Chicago in Indianapolis. In Detroit, we had two field hospitals that I was Chief Medical Officer over and helped to set up along with the Army Corps of Engineers. One was in downtown Detroit, and the other was in town called Novi, just outside of Detroit, which was at the is a large convention center right outside of Detroit. And we had between the two sites, a couple 1000 patient bed capacity at those sites. And so that is where outside of my home emergency departments and taking care of those patients outside of that and in the field in my deployment is what as I call it, I feel like I’ve been on deployment and I told my husband, this is the closest to the military, I think that I’ve I have ever been, of course, outside of that. Those are the two places. Those are where we that’s where we started this journey.

Fred Goldstein  05:08

And now I understand you’re at Palomar Health. And tell us a little bit about what’s going on there.

Lindi Hayes  05:13

Palomar health health has partnered along with the San Diego County Health Department as well as EMSA and Cal Mac and various other medical organizations in the state to provide a treatment for patients who are already COVID positive. And so we are so honored and grateful. And we want to share the information with as many folks as possible within the community.

Fred Goldstein  05:46

And this treatment is a monoclonal antibody, can you explain what that is?

Lindi Hayes  05:51

So monoclonal antibody is a medication that’s genetically engineered in a laboratory, it is it is not COVID, it is not, from patients who have had COVID even. It is, again, a genetically engineered product made in the lab, the product that we use, I can tell you more about that later. But the product that we use is from manufacturered by Eli Lilly, which is located in my second home in Indianapolis, and it is infused into patients to help their body combat this disease to help their body basically get a immune boost, in order to begin to kind of attach to these protein particles and the protein spikes that are on the COVID molecule. So we instead of your body producing it when you get a vaccine, we try to give it to you

Fred Goldstein  06:51

got it and understand this has any EUA there are certain which is obviously an emergency use authorization from the FDA that allows it to be given to certain people and who qualifies for receiving this type of treatment.

Lindi Hayes  07:04

So the patients who qualify for this treatment, are patients that we would say are at higher risk than the general population of the general public from becoming severely severely sick from COVID. Patients who are high risk of being hospitalized, being intubated, etc. Those are the patients that we really want to get this medication.

Fred Goldstein  07:35

And what are some of those indications for high risk status versus a normal person? And I guess also, they obviously have you been infected with COVID? Early infection? Correct. So that is correct. So one of the first things that we want to make sure is that yes, that the patient does have COVID. That is the first criteria. And one of the things that we’re trying to do is partner along with our test taking sites, both not just through Palomar, but across the county, our test taking sites and partners along with the laboratories that produce and distribute their testing, so that we can know as soon as possible, the patients who are COVID positive, and then we go on to find out about those patients. That’s the kind of the that’s the number one criteria that we are looking for. And then of course, there’s other good else another basically list that we need to go through after that.  So those individuals be like I know, one of the criteria is over 65, obesity is another one things like that, and that that  lends to those individuals having a higher risk of having a much more severe impact by being infected, correct?

Lindi Hayes  08:48

Yes, that is correct. So we could just kind of go through and you can tell me when to stop, we’ll just start with the kind of the first top five things that we screen. So of course, the first thing is making sure that we do know that the patient is COVID positive, not you have been around someone who is COVID positive, not you think you are COVID positive not you feel like you’re COVID positive, we need to have a laboratory study that corroborates your COVID positive status for the patient. That’s number one. And then from there, we get some general criteria once that is met and you’ve had also you’ve had symptoms, typically 10 days or less is what we use as our quote unquote short term timeframe for being symptomatic from COVID. Symptomatic can be a vast array of things cough, shortness of breath, wheezing, weakness, fatigue, diarrhea, nausea, vomiting, body aches, malaise, any of those things, mild headache, so it does not have to be a severe side effect or a severe side effect but a severe symptom. So as a matter fact, we really don’t really want patients who actually have severe symptoms are actually not candidates for us. So it’s mild to moderate symptoms of all those that I listed above.

Fred Goldstein  10:08

Got it. And really, this is one of the few treatment approaches out there, isn’t it?

Lindi Hayes  10:13

Yes, it is. Now we use a product again, engineered by Eli Lilly, there is another product Regeneron, which is there also a combination of two monoclonal antibodies, but that is not the product that we use at our facility. But it is some it is a product that other places use. And so there are, again, in terms from a symptomatic standpoint that those are very, they’re very specific criteria, particularly symptoms that need to we need to just kind of discuss to make sure the patient is experiencing those.

Fred Goldstein  10:46

Right now. The whole COVID pandemic is you know, everybody’s talking vaccines, vaccines, vaccines, obviously, right now. And we’re getting millions of people vaccinated every day now in the country. But it’s really an issue that we still have 60 some odd 1000 people getting infected, you know, in the United States every day. So this is something that people really need to understand that there is something out there for those that meet the criteria. What sort of efforts are there others this clinic? Are there others around the country that have been set up now to do something similar?

Lindi Hayes  11:18

Yes. So just want to go back. So in terms of your and it’s so important that you, you know, talk about that Ferd? So the the number of positive patients that we are seeing every day? So now the numbers that you mentioned, keep in mind that is considering that we really have not had the testing? Like we really probably should? And I’ll be I’ll be quite honest with you. Do we think we are probably vaccinating COVID positive patients? Yes, we are because there is no negative COVID test required. When you present for your vaccine, we ask you a set of a series of screening questions. And that’s all that is required. And so the testing is something that we really need to get back, make get some attention back on and how important that is because we do have patients that come into our infusion center, who have had one dose or sometimes both doses, and are still COVID positive or have found to be COVID positive, and then have the symptoms and need infusion.

Fred Goldstein  12:27

And so those individuals, obviously a breakthrough patients that they’re talking about now, we’re getting much more information on those as well. And bebeginninging to learn more about it. I would I would think and I don’t know, you know where this clinic may be located. But obviously, as we’ve seen this, this disease impact, proportionally, a higher rate of people of color, and others having something available is that some area that’s being focused on now to try to bring this out to those communities that associate with social determinants of health or other issues that have less access to services?

Lindi Hayes  12:58

Yes, yes Fred, so we are really, really trying to do everything we can to ramp up the information and a basically a media campaign about this medication. Some facilities actually have medication distributed or infused in an area in their emergency department. We here we have our site here at Palomar downtown Escondido in San Diego County. And there’s a new facility opening up south of us in Chula Vista through San Pedro, I believe it’s pronounced it excuse me, if I’m pronouncing correctly. But there is going to be another facility opening on the 20th there. But hospitals, facilities docs, we are really, really trying to get this information out. We are sharing different documentaries throughout our health systems about this infusion. And really just trying to every patient that we have even that comes in our facility, we give them documents and a pamphlet flyers to please you know, share with your family and friends. Because who knows other COVID positive patients COVID positive patients, so they know their family, they know their friend, they know where they got it. And so we do get a lot of referrals in from that route as well. But yes, there is a huge and unfortunately along with the CDC and from the health and human services on a federal level there is developing as we speak a mass campaign to really  let patients know about this medication.

Fred Goldstein  14:34

I know you’ve not been doing it for that long, I guess but have you began to see some results from that that are similar to some of the studies.

Gregg Masters  14:40

And if you’re just tuning into PopHealth Week, our guest is Dr. Lindi Hayes of Palomar Pomerado Health’s, Escondido Monoclonal Antibody Resources Center, otherwise known as MARC

Lindi Hayes  14:55

Yes, we are seeing results. We are still of course databasing in kind of gathering and compiling all of our data. But from an anecdotal standpoint, and just in conversation with our patients, we do a, we do us a next day follow up. And we do a seven day follow up with our patients and asking them any symptoms. Are you feeling better? Do you did you have, how did you feel going home? All of those things, and we are definitely seeing patients who are telling us, you know, I felt great. As a matter of fact, I felt great even before the infusion was done. So we are definitely seeing patients who are responding wonderfully well to this medication.

Fred Goldstein  15:40

And about how many patients could you see in a day, if you were fully functioning? Yes, if we were fully functioning, we can see between 50 and 55 patients. And we have that’s with our current setup. And of course, there is room to expand, but that has to be discussed, you know, with the those higher up decision makers and shakers. But from where we are right now, in our current facility, we do have capacity to infuse 50 patients a day. And I understand that the is this funded by the government for the medication, etc. So it’s not charged the patient. That is correct. It is a free service, we do take insurance information, but that is primarily as a documentation follow up type thing. And it’s not because the medication but because you do have nurses, we have our our particular facility is staffed with ICU nurses. So these are nurses who are highly skilled and qualified. Now keep in mind, we are in an office setting, although we are in a hospital building, it is set up as an office setting. So it’s not set up in an emergency department or anything like that, we have the obviously we have the medical expertise to handle any situation that might arise, we make sure that we have great communication with our 911 teams, etc. For any extended or more involved medical care that might need to happen. But again, our facility we’re staffed with ICU nurses, myself, board certified in emergency medicine, my PA, emergency medicine, emergency medicine physician assistant, and so so patients can feel, you know, completely safe and cared for. And we make sure to monitor very carefully all of our patients, in addition to all the follow up that I mentioned earlier,  and what is the process, I know you know having  gone through a vaccine, and I’m actually my second dose now, you know, go through the process, get the vaccine, sit for 15 minutes, I know with a monoclonal antibody, there are some potential issues. So how does that process work?

Lindi Hayes  17:50

So the process works. So you know, you first come in and we kind of almost like you got to go to pre op, you know, if you’ve ever had an outpatient procedure, you know, you get it gets real official, when you drive up to the hospital, we come and get you in a wheelchair and we will get to the room and you know, talk to yet make sure you feeling okay, and your days been fine. You get to the treatment area, and we get your prepared for your infusion. We do some initial again, screening questions, we make sure that everything that we received on your initial screening document is correct, we make sure that we have any other information, you know, family who brought you those kinds of things if we need to call a family member for some reason. And then myself or my physician assistant goes in as well and assesses the patient clinically, they get a physical examination, and then we go on and give the okay to for the patient to get infused. And then our nurses get the medication which does have to arrive there’s a there’s a special time window, it has to be at a certain temperature. There’s all kinds of particulars before it actually is infused, physically infused into the patient. So once that is is ready, the patient IV is  is established and the nurse gets IV in ya, and you go on and get the medication. There is approximately it’s about a two hour long process from beginning to end as support for people to know. Although the actual window for the infusion is just say 16-20 minutes, but because of the time on the front end and the monitoring on the back end to make sure that the patient does well. It’s overall it’s about a two hour process.

Fred Goldstein  19:32

Got it so they wait to see if they have any effects or things like that.

Lindi Hayes  19:36

Absolutely

Fred Goldstein  19:37

confusion. Got it.

Lindi Hayes  19:38

Absolutely.

Fred Goldstein  19:39

Do you see any other newer other therapies potentially coming out or down the pike? Have you heard of any others?

Lindi Hayes  19:45

I haven’t really heard of any other therapies. There is some discussion about this medication being administered to high risk patients as a precaution as a pre treatment to actually even becoming COVID positive. That is something that is still being studied, evaluated. That actually was actually a there’s a study that has been done. And there’s some numbers out that does show that this medication did prevent was a preventative measure for patients getting COVID, particularly patients who are around lots of COVID positive patients who are already in that setting, nursing home, those types of things. So it has been shown to prevent even COVID from developing. So that I think is where we’re going next with the monoclonal antibodies.

Fred Goldstein  20:38

So perhaps people who are in the high risks exposure situation who maybe can’t get vaccinated or may do something like this thinking,or they’re thinking

Lindi Hayes  20:47

that that is that is correct. Because this medication and this infusion there is it is not exclusive, it does not exclude you, if you have been vaccinated. So fortunately, you know, the again, we’ve had patients who have been vaccinated and subsequently test positive or develop symptoms, and we infuse them anyhow. So again, we are really looking at ways to optimize this therapy and this treatment because it is, I would say to say that it’s underutilized is is just this most significant understatement. It is so underutilized overall, nationally, but I definitely think there are regions in the country where it’s really pretty severely underutilized. And we just really want to make sure that our not only our patients know about it, but because yes, sometimes the patient is the one who refers to himself, and we allow them to, we want to make sure our patients know and also the medical community is more aware.

Fred Goldstein  21:46

Yeah, that makes sense. Because you know, it’s typically been, oh, you’re infected, well go, go ahead and isolate yourself for your 10 days, your 14 days and not thinking through from your physician, maybe we need to refer them over they may be an appropriate candidate for this monoclonal antibody treatment.

Lindi Hayes  22:01

Absolutely, absolutely. So So if it’s okay, if I could just kind of go down some of the criteria, is that okay with your audience. So the very first first criteria that we list is a body mass index, which the BMI that we use is over 35. So if you come up positive with COVID, and you think you’re a little bit portly, go on and give us a call, or wherever you might be located across the country, search monoclonal antibodies, you can even find sites. There are links on CDC’s website, as well as Health and Human Services website for the local monoclonal antibody infusion center near you. Second thing, chronic kidney disease, okay, third, having diabetes, okay, it doesn’t matter what kind of medication you’re on, you know, insulin or pills, it doesn’t matter. We don’t get you know, we asked just for medical history standpoint, and just to make sure we know your medications, but having diabetes, it can even be where you’re not on medication as of yet. It could be that you are have diabetes, and you are being controlled with diet, okay, so it doesn’t mean just because it, you know, you are not on medication that does not exclude you. The other thing is have an immunosuppressive disease, having an immunosuppressive disease, for example, would be something like lupus, or something like sarcoidosis. And we get it we get all into that when patients call and they think they’re a good candidate, we go into possibly what their immunosuppressive disease might be. And then 65 years of age or older, those patients are without any, they don’t have to have any medical, any disease at all, just be 65 or older. And that patient can not only be infused by us, but they can also actually self refer, we’d like to have a doctor to communicate with for any patient that we see just sometimes patients forget things or, you know, they say oh, no, I don’t have any medical problems. I don’t take any medications. And then we go into talk with them. And then we log on and we find out they’ve been the Palomar or whatever other hospital in our area, you know, 10 times and they’ve had all these, you know, they have hypertension, diabetes, and you know, high cholesterol. So sometimes it’s good if we can get a physician contact. If we cannot, we do not delay treatment with this medication. We still go on to get the medication although we would love to have a physician referral and a physician connection for that patient.

Fred Goldstein  24:35

Are you seeing you know what percentage of folks do you have actually coming in and using up if you could do 50 a day how many you’re seeing now?

Lindi Hayes  24:42

Oh, we need more. You know we are at our high number 10 maybe 12 a day. I think at our peak. We are we really want to get this information out. We have an amazing staff that is ready and waiting and willing to get these patients seen we, we have myself included, we have kind of been out on the, on the pavement, hitting the pavement a little bit and handing out, you know, flyers and trying to call our different physicians and hospital systems within an area to make sure that they are aware. But like I said, I believe from my observation, our biggest and most popular way of getting patients in is by other patients.

Fred Goldstein  25:32

word of mouth

Lindi Hayes  25:32

They go, yeah, word of mouth, they, they call Matter of fact, they call their family and friends while they’re there.

Fred Goldstein  25:38

Oh that’s great

Lindi Hayes  25:38

They’re like, Hey, you won’t believe what I’m getting right now. You know, and I’m feeling so much better even as I’m talking to you. So we love that we love it, love it, love it. Um, but yeah, we just need all of all parties involved to, to kind of get on board and know that there’s something available, we are going to need to learn to adjust and move within this new world, there are things we’re going to have to guidelines that we’re going to just going to need to follow, we’re going to need to get used to it and continue to feel comfortable using our mask wearing our mask and washing hands and, and staying distant from as much as possible, physically distant, even with our our vaccination numbers going improving, etc. We’re not going to be anytime soon to the point where we can let our guard down with this, we’re going to still have to continue to be very careful. Now we are going to be able to do again, as things are opening some places in the country. They’re opening very carefully and strategically and with smarts, but some places they are not those are the areas that have us the most concerned is the opening, not using the medical expertise that’s available. We have to be smart about this.

Fred Goldstein  26:55

Well, I think that’s a fantastic way to end this. I want to thank you very much for coming on and the work you’re doing. It’s fascinating and also fantastic to have some sort of a treatment option for individuals. So thank you so much for joining us Lindi.

Lindi Hayes  27:07

You’re so welcome Fred. Thank you all so much for having me.

Fred Goldstein  27:11

And back to you, Greg.

Gregg Masters  27:12

Thank you, Fred. That is the last word on today’s broadcast. I do want to thank Dr. Lindi Hayes for her time and insights today. For more information on the Monoclonal Antibody Resource Center. So known as MARC at Palomar Pomerado Health go to www.PalomarHealth.org and search for monoclonal antibody therapy or follow them on Twitter via @PalomarHealth. And finally, if you’re enjoying our work here at PopHealth Week, please subscribe to our channel on the podcast platform of your choice. And do follow us on twitter via @PopHealthWeek. Bye now.

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