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Sounds of Science is a monthly podcast about beginnings: how a molecule becomes a drug, how a rodent elucidates a disease pathway, how a horseshoe crab morphs into an infection fighter. The podcast is produced by Eureka, the scientific blog of Charles River, a contract research organization for drug discovery and development. Tune in and begin the journey.
Mary:
I'm Mary Parker and welcome to this episode of Eureka's Sounds of Science. In September 2012, the CDC in collaboration with state and local health departments and the FDA began investigating a multi-state outbreak of fungal meningitis and other infections. The infected patients had received contaminated injections from a compounding pharmacy in Massachusetts. The ensuing criminal investigation ended in charges against several employees and executives of the pharmacy, and sparked changes in FDA oversight of compounding pharmacies. Looking back over a decade, what have we learned about what happened and what has changed in the industry? Here to discuss these questions are Charles Rivers, Doug Botkin, Technology and Marketing Development Manager, and Abby Roth, founder of consulting and training company Pure Microbiology. Welcome, Doug and Abby.
Doug:
Thank you, Mary.
Abby Roth:
Thanks for having me.
Mary:
Thank you for being here. This is a fascinating topic and I can't wait to hear what you guys have to say. So to start us off, can we define some terms? I'm a bit of a noob in this. So like what is a compounding pharmacy and what are some of the differences between like a 503A and a 503B pharmacy?
Abby Roth:
I’ll start off just by saying that when it comes to a compounding pharmacy, the whole idea is for that for pharmacy to be able to prepare a medication that is totally tailored to a patient's individual needs. So it's something that's going to be made specific for that patient in the right strength dose that they need for that medication to be effective for them.
Mary:
Yeah, the only experience I have with a compounding pharmacy is actually getting medication for my cat. It was like some pre-surgery medication they wanted her to take before she had surgery. So, I mean, speaking of range of doses, it's a pretty wide range between, you know, full-size adult human and small animal. I guess they cover a lot of bases.
Abby Roth:
That's very true and you'll have some pharmacies that specialize in just human, some that will do just veterinary, some that will do a mix of both. And the other interesting part about that is some do sterile compounding and others will do non-sterile compounding. So it really comes down to the medication that's needed.
Mary:
Does, just out of curiosity, does pure microbiology do any consulting for compounding pharmacies?
Abby Roth:
Yeah, I do. A lot of what gets done is related to the microbiology aspects of things, but I also do help quite a bit with USP 797 chapter compliance.
Mary:
Okay. And Doug, from your experience, what is supposed to be the difference between a compounding pharmacy and say a regular drug manufacturer?
Doug:
The difference comes down to the regulations that they're held to. And so if you think about a 503A, those are more we consider traditional pharmacies. Those are permitted to compound for individual prescriptions only, meaning if there's a specific patient need for a medication, they can compound that. They're not permitted to produce medications in bulk like a... drug manufacturer would. The 503A's have to comply with state boards of pharmacy. So that's our primary regulatory body is the state boards of pharmacy and also comply with 795 for non-sterile medication and 797, as Abby mentioned, for the sterile medications. And they're also not required to comply with the good manufacturing processes as outlined in the Code of Federal Regulations here in the US.
Mary:
Okay, so how do these different definitions determine the amount of oversight required by the FDA? Doug, you wanna start?
Doug:
Yeah, so the 503As typically don't have oversight by the FDA. The FDA may be brought in for a cause. In other words, if the state boards of pharmacy find an issue, if there's adverse events reported from certain medications compounded by a 503A, the FDA may come and investigate. 503Bs, on the other hand, are... a relatively new classification of pharmacy, those are subject to oversight by the FDA, and they're also subject to the CGMP regulations in 21 CFR parts 210 and 211. And so they're more like traditional drug manufacturers in that regard than the traditional 503A's compounding for individual prescriptions. The 503B's can be compounding drugs for bulk distribution across state lines.
Mary:
Abby, anything to add?
Abby Roth:
One of the big things that everybody has to keep in mind when it comes to the FDA oversight in these cases with both the traditional compounders and the outsourcing facilities is that the FDA still does potentially have some purview over those traditional pharmacies, particularly in the event that they’re not in compliance with what is required within the 503A regulations. So at any point that they're found to be out of compliance or in violation of the 503A regs, they kind of then default to being reviewed according to the CGMPs. So the FDA still does have some stronghold over them depending on certain situations.
Mary:
Okay, and CGMP is.
Abby Roth:
That's the current good manufacturing practices.
Mary:
Right. But that usually would only apply to larger manufacturers and not necessarily to compounding pharmacies?
Abby Roth:
Correct.
Mary:
OK.
Abby Roth:
Not the compounding pharmacies in the traditional sense. They're out of that purview and as Doug said, they're going to fall under state boards of pharmacy. Some also might fall under the jurisdiction of the Department of Health. Some are also under the state drug control. So it really depends on how those states are configured and who has oversight of what happens within those pharmacies.
Mary:
Okay. So can you both tell me about your personal experiences in this industry and your opinion of the regulations controlling compounding pharmacies in particular? Abby, do you want to go first?
Abby Roth:
Sure. So I'm a microbiologist by background, and that's, I think, one of the interesting things on how I got sort of all wrapped up in what goes on with sterile compounding. And this all started in 2008, 2009, when USP 797 was first requiring viable air and surface samples for these sterile compounding pharmacies. were certification companies who are going in, doing sample collection, and then sending their samples to my lab for analysis. And initially, we were seeing crazy growth, really high counts, exceeded action levels. And I got involved by getting on the phone with the pharmacies and the certifiers, and essentially doing microbial excursion investigations over the phone.
So that's really how I got involved in, you know, this industry and was a part of these conversations of, well, what garb are you wearing and what are you using to clean? And that sort of then transitioned into me leaving the lab and finding myself doing more consulting and training in this field.
Mary:
Hmm. So you would be on the phone with them. And would you even be like walking them around? Because I'm sure in your experience, you know the most common places for contaminations to get into a lab. Were you like checking the air vents with them? And you know, seals on doors, things like that.
Abby Roth:
And initially I had done some visits early on with these sterile compounding pharmacies and in these clean rooms. And like, mind you, I've been in clean rooms, but my background had been GMP and I had visited more medical device and aseptic manufacturing and places that were doing some other like biologic type work. So coming into these sterile compounding pharmacies at the time, I was like, wow. not necessarily what you would have expected to see from the greatest clean room behavior, design, like workflow. They just used the space as they need to, and there wasn't seemingly a whole lot of thought going into the clean room behavior piece of things. They were always great when they worked in the ISO class 5s about really good... you know, aseptic technique to a point and thinking about first air and those sorts of things. But, you know, the whole like clean room expectation of like the slow and controlled movements or like walk like you're on the moon, like that didn't exist. People were rushing through that space, trying to get medications out the door because at the end of the day, particularly like in a hospital, sterile compounding clean room. it's just trying to get those medications to those patients as quickly as they can. And some of them are there because it's a life or death situation.
Mary:
That makes perfect sense. What about you, Doug? What are some of your personal experiences in this industry?
Doug:
Yeah, so I like being a microbiologist by training, perhaps by birth as well, I think.
I've been doing microbiology for a very long time in different areas and my first entry into pharmaceutical micro, about I guess 11 years ago, 12 years ago, was in a 503B company. And again, similar to Abby, the observations that I had, I never worked in industry before, there's a lot of It's very different, no clean rooms yet. And so that was my first look at the challenges that these compounding pharmacies have in terms of microbiology. I was brought in for to do endotoxin testing and kind of start heading up the EM program. Yeah, like Abby said, I didn't necessarily know what the right answers were at the time, but I was pretty sure what was happening wasn't maybe correct type of situation. So... It was early learning experience though. I did learn a lot there, but the challenges are significant to overcome because there's not a lot of core microbiology knowledge. There's not a lot of knowledge of, yes, you have a clean room, but it's not, it's not this magical box that can keep things sterile or clean or aseptic. It takes, you have to be proactive. And a lot of that. It's the understanding is not there in the industry quite yet because traditionally, you know, compounding pharmacies and pharmacies in general are run by pharmacists and it's just not part of their training. They're not expected to know or have deep microbiology experience.
Mary:
So, well, I mean, let's get into it. So can you tell me about the incident in 2012? What happened and who was at fault? Abby, you wanna start?
Abby Roth:
Sure, so when we look back to the New England compounding center incident in 2012, I mean a high level of this, there ended up being... total of 700 and I think 93 patients identified throughout the country that had received contaminated medication. And ultimately then more than 100 patients had died. So when you take a look at this, this was the turning point for I think some of these the FDA and we're essentially manufacturing medications and why we see the regulations that we do today.
Mary:
What do you think, Doug? What do you think happened from your perspective?
Doug:
There's a couple of things going on here. There was at the time, like Abby said, there's a regulatory gray area. So at the time, most pharmacies were regulated at the state level. State boards of pharmacy had oversight and you have New England Compounding Center operating essentially like a drug manufacturer. They were producing medications in bulk. They were shipping across state lines. During that outbreak, it was three contaminated lots of methylprednisolone that were responsible for the outbreak and they were distributed to 76 facilities across 23 states that resulted in meningitis and primarily meningitis outbreaks and some other illnesses as well because these medications were injected inside the body. And so the other part of it is that the company and there's some of the executives are now in prison. So they were convicted of various crimes, conspiracy and fraud. transporting these fraudulent drugs across state lines. They were intentionally writing prescriptions for these to appear like they were compounding for individual people. But if you look at who they were compounding for, the records indicate they were compounding for people such as Michael Jackson, Freddie May, and Diana Ross. These are people that were intentionally doing this to thwart the regulations at the time. So there was some, there was ill intention on the part of the executives at the company to do this because they knew they couldn't do this legally. And the FDA didn't really know what was happening. They didn't have oversight. It wasn't until a lot later until the outbreak where then the FDA was brought in, they investigated, they found that the conditions in the facility were poorer, to say the least. They were unsanitary conditions. And so for those not familiar, the FDA issued a form 483, which is a notice of inspectional observations. This is, these are issued to pharmaceutical companies as well. This is just after the FDA comes in, they'll make some observations about what can be improved with an issue of 483. Our listeners can find the NECC 483 online. If you type in NECC. The number is 483. It should be one of the first items that comes up. And you can read it. And it is, for those in pharmaceutical microbiology facilities, it's frightening to read, to be honest. They kind of made notes of some things that they did. The firm personnel stated that the firm shuts off the air conditioning from 8 p.m. to 5.30 a.m. nightly in the clean room. Now there's probably two reactions to this. Those of us that know about clean rooms are probably, our eyes are probably wide open or our jaws hit the floor just now to know that they shut the environmental control off. But for those that don't know about clean rooms, if you operate a clean room, that thing runs 24 seven 365. You have to maintain certain environmental parameters, microbial parameters, particulate parameters in the clean room. And so I mean, you're allowed to... turn it off, shut it down for construction, but there has to be procedures to bring it back under a state of control. And this just wasn't being done at the facility. So they had quite a number of unsanitary conditions. They weren't investigating their microbial counts. So they have alert and action levels. They found micro certain places that exceeded their internal standards. They weren't investigating. They weren't notifying customers. There was a lot of things going wrong. And so like Abby said, this is the reason that we have stricter regulations and stricter guidances now for these companies is to control for this and prevent people from doing this either intentionally or unintentionally.
Abby Roth:
Yeah, well, and at the end of the day with particularly what happened at NECC, it was all about making money. It wasn't about patient safety.
Doug:
exactly.
Abby Roth:
It wasn't about the product going out the door. It was, well, we can make a ton of money by shipping these medications out that other sterile compounders don't want to or aren't able to prepare. a lot of what they were doing is it wasn't just straight up sterile to sterile easy compounding.
Doug:
No, it wasn't.
Abby Roth:
They were doing a lot more with complex manipulation starting with non-sterile ingredients. So there's a lot more risk to it. And I think too Doug with your background of starting out with working at a 503b from a micro standpoint. I mean, even for you that had to be kind of eye opening.
Doug:
Oh, definitely.
Abby Roth:
What are they doing? Does this make sense? Like I've never seen this before. Is this right? And I think my experience and I'm sure yours too, and I think you mentioned it was the fact that the pharmacies that are, were operating at the time and are now operating today as these outsourcing facilities, these 503Bs. they have to have a pharmacist that oversees operations.
Doug:
Right.
Abby Roth:
And in my experience and probably yours too, the pharmacist that oversees these operations has no background in good manufacturing practices.
Doug:
Mm-hmm, right. Exactly.
Doug:
Yeah, and they're responsible a lot of times for, as like director of pharmacy, would be overseeing, I mean, pharmaceutical operations, which they should be, that's their area of expertise, but right, the, like the environmental monitoring program, the microbial control, the gowning program, the cleaning and disinfection, all these things that go into making sure that whatever they formulate and compound is compounded aseptically and stays that way. is yeah, there's just a big gap there. And it was interesting because there's misunderstandings about microbial control and what's needed for it. And it's just a big gap in the industry that still needs to be addressed. I mean, regulations and guidance doesn't only go so far. There has to be a push to really show the compounders that they need internal microbiology support. And so you bring in that support, you bring in something that's experienced in microbial control at the same time, leveraging these companies that you can outsource assays to. You know, if you have to do endotoxin testing, you can bring it in a house or you can outsource it. I mean, running an ID program has a lot of work. It's sometimes easier to outsource that as well. And so there's a lot of resources out there to help the compounders, consultants also. I mean, there's tons of consultants out there to have conversations as well. I mean what you don't want to happen is a compounder to get a 483 or a warning letter because at the end of the warning letter they're going to suggest you find a consultant.
Abby Roth:
Yeah.
Doug:
At that point it's you always want to if you know better you do better but at that point it's getting a little bit late in the game. There's always room for improvement but that's things are bad at that point. It's hard to come back.
Abby Roth:
Will also add to you know you mentioned the idea of them either having microbiology experience on staff or outsourcing. There's different types of microbiologists out there right? So there's
Doug:
That's true.
Abby Roth:
you know you look at Doug and myself and we have that pharmaceutical micro background but then there's the whole world of food microbiology and the whole world of indoor air quality and then clinical. So like It is important that when you are looking for micro help, that you are going to the right place and that those microbiologists either as a 503B hiring microbiology help that they have the right microbiology background. Cause you couldn't put me in a food lab. I'd have no idea what I'm doing.
Doug:
exactly.
Abby Roth:
Ha ha ha.
Doug:
Neither. That's a good point because it's tough too because a lot of times I imagine these compounders are looking for, you know, like, oh, we need to do EM so we need EM technicians. Well, that doesn't require, you know, you can get people younger in their career, earlier in their career to come in and do EM sample collection and processing. But what they actually, you're not going to find people at that level with extensive experience in microbiology, let alone pharmaceutical microbiology. So the focus, you're right, needs to be on bringing in people that are mid to higher level initially to then build out your microbiology group or your environmental monitoring group or however it's structured within the company.
Mary:
Well, you mentioned, you know, it was fungal meningitis. And, you know, even as someone who's not a microbiologist, you know, I have a fridge, I can imagine unsanitary conditions and turning a fridge off leading to a fungus or a mold growing. So that does seem pretty obvious.
Doug:
Yeah, and I think it's what Abby said, it's, I mean, we'll be frank, it's about making money. And everyone, everybody wants to make money, but they took advantage of a regulatory gray space. And they, I mean, they knew what they knew what they were doing. They were operating in these, these areas and they're obscuring what they were doing as well, which demonstrates intent. And so they took advantage of it to make money and they were cutting costs at every turn. For example, turning off the clean room at night. which to me sounds absolutely insane crazy, but... That's what they were doing to cut costs. And, you know, working with non-sterile ingredients, I'd read in the 43, they, you know, when you do that kind of thing, working in the clean room, you have to sterilize equipment, whether you're sterilizing goggles or, you know, your forceps or tools or whatever. None of their cycles were validated. They couldn't even demonstrate that what they were autoclaving was actually coming out sterile. So they obviously, there's just a, it's just reckless behavior. I'm just trying to get it done without regard to why they're producing drugs and who these drugs are going to.
Mary:
Yeah. And of course, anything would have a cascade effect because something that's not sterile at the beginning of the process doesn't matter how sterile things are later on, it still would have been contaminated from the start.
Doug:
Yeah.
Mary:
So, so this incident was obviously an extreme case, but what are some of the more common problems with places like this? I mean, you mentioned staffing for one, maybe not having the right people on staff.
Abby Roth:
Well, right now we're in a situation where staffing is difficult across the board and
Mary:
Mm-hmm.
Abby Roth:
I predominantly work with a lot more of the 503A organizations that are based out of hospitals and they're having a very difficult time getting pharmacy technicians and even pharmacists to be able to staff their compounding operations. So that's definitely one of the challenges right now. But looking at some of the 483s that the FDA has put out for, and for particularly on my side of things, more of the 503A organizations, it's the same issues over and over again, where we don't have a good environmental monitoring program in place. We also see issues where they are having, let's say, microbial excursions, or they had possibly an issue during certification where it's not being thoroughly investigated, and then they're not closing out the investigation. So there's a lot of issues with failure to investigate. The other one with that too would be like failure to investigate stability test failures. That's usually a big one with the outsourcing facilities. And then just things like insanitary conditions. And those unfortunately pop up so frequently. And I don't know about you Doug, but I feel like those are like the low hanging fruit a lot of the time. Like we shouldn't be coming across insanitary conditions in these facilities.
Doug:
Yeah, yeah, it's not the insanitary conditions is definitely some that's why FDA issued a guidance on them as well as like here's, here's what we found by looking at these facilities. Let's not repeat the same mistakes, even though, and to be fair, we see this in pharma too, I mean if you look at the 43 is warning letters recalls we see repeat observation, not from the same companies, sometimes, but. Repeat observations industry-wide of, okay, failure to investigate, your water system wasn't maintained, you've got brokawdaria contamination everywhere or similar waterborne organism. So we see it in pharma too. It's not a compounding industry specific thing. It's just an industry specific thing, but you're right. I would say it's easy to mitigate if you know how to mitigate it and take the time. I think that maybe highlights one of the critical problems in the industries is that these companies don't realize how to mitigate it, so how to correct it for one, and also how to prevent it from happening again. And these investigations take time. Microbiology investigations are a different breed. It's very difficult to determine root causes a lot of times. Sometimes all you end up with are process improvements, which are good. I mean, there's always room for process improvements. But at the same time, you also don't want to be making unnecessary improvements to a process if you don't know what the cause is. So it takes a lot of time, a lot of energy, a lot of people, not just a microbiology group, but facility wide to investigate these things. And a lot of these companies, especially with staffing issues, don't have the time to devote to it, not realizing that this is more of a business longevity question. There's a lot of resources out there, though. We can always learn from learning from the past is always helpful. I encourage every one of the listeners to look up the NECC tragedy. There's a lot of information online about it. Read more about that and how that came to be and lessons learned. Performing risk assessments in your facilities, you know, find your areas, find your gaps, find your areas of improvement and compliance. Consultants, which I mentioned before. And I also think we need to break down the barriers between compounding industry and the pharma industry. I see a lot of times that they're somewhat treated as two separate entities, or two separate silos. And if you look at the 503Bs being subject to the CGMP regulations, so are pharma manufacturers. So the question becomes, how do you implement these regulations in your specific facility? And there's probably not a lot of unique problems. A lot of the problems are probably common and there's gonna be solutions out there. So I think breaking down the barriers between compounders and their counterparts in pharma is gonna be important.
Abby Roth:
So And Doug, there was one other thing I wanted to mention because you were talking about the, you know, microbiology aspects of things and some of those investigations can be really challenging.
Doug:
Mm-hmm.
Abby Roth:
And I like to equate microorganisms to toddlers, right?
Doug:
Yeah.
Abby Roth:
We're working with living things who have a total mind of their own, and they're not gonna behave the same way every time we run into those particular bugs. So, That's one thing that the people out there that are working within these sterile compounding organizations kind of have to keep in mind is that it's not chemistry, right? A lot of the sterile compounders, your pharmacists, your pharmacy technicians, you have more of that chemistry type science background where you're not dealing with living things. And when we try to investigate living things, it gets to be very, very challenging. And you might not have a defined outcome or a defined source when you go and do an investigation. So it's hard.
Doug:
no, it absolutely is. That's right. It's not chemistry. And I've run into that in my career too, is that you try to explain microbiology to chemists a lot of times and they understand it. But at the same time, it's when you're dealing with living systems, they're ultimately variable. There's no there's no absolutes in biology. And so it's challenging to think like that. Because when you're doing investigation, somebody asks you where an organism came from or is it harmful? It's, you know, you just, the old microbiology answer of it depends because it really does. Every situation is unique and there's no absolute answers. And when you're writing an investigation and you have to have something on paper defendable, that's hard to write around when you don't have a root cause.
Mary:
We've already covered some of this, but what in your opinions are some of the solutions to these issues? I mean, more oversight or is there other things that people can be looking into?
Abby Roth:
is looking within your own organization and ensuring that internal training is in place covering kind of all the topics that are needed. All of that's built into SOPs and probably the biggest one that I am seeing currently and have run across the last couple of years is staff retention and obviously people aren't going to stick around forever. But what's been happening is that those individuals that know the ins and outs of the regulations, the standards, the guidances that are out there, they're walking out the door with that information and there's nothing kind of left in the organization. So there really does need to be multiple people need to hold and be responsible for ensuring compliance with, whether it's going to be the USP chapters, the state board of pharmacy laws, you know, even like the Insanitary Conditions document. That's been my biggest challenge at least me from a consulting standpoint is that Every couple of years we have a new crop of pharmacists that are taking over sterile compounding operations and they are brand new and have no background, no guidance, no insight. And now like they're managing these operations. So for me, it's ensuring that there's a really good foundation built into the facility's SOPs and that there's some knowledge transfer within these organizations.
Mary:
Mm-hmm. What do you think Doug, any other advice?
Doug:
And there has to be. I don't know what the answer is. There has to be, I mean, the knowledge transfer is important, but I think it's getting that knowledge in-house to begin with and realizing that, the comp hunters have to realize that if you look at, I mean, if they have friends in pharma, I suggest you go to a clean room, a pharma clean room, and just, I'm guessing they're gonna have the same observations that Abby and I have experienced of comparing and contrasting maybe their clean room. the compounding area to a pharmaceutical grade clean room in terms of operations and just processes and personnel. And it's your facility, you can't have pharmacists running all the operations. They're operating outside of their knowledge base, which is okay to an extent. You know, you always wanna learn new skills, but at the same time, it's not necessary. It's too much. And so you need to bring in facilities people, you need to bring in, you know, experienced microbiologists or sterility assurance experts, microbial control experts, all the way down to experienced technicians. And if you don't have if you have turnover on your technician level, there's going to be usually an uptick in deviations, there's going to be, you know, you're not going to be following your SOPs exactly. The training burden is huge with lack of retention. it puts undue stresses on companies. And that's not just for compounders, that's industry-wide for pharma too. And so it's very important to figure out how to retain people, how to train them. And training is not just a, you know, read an SOP and then go off and do some stuff. It's re, if it's, you know, yearly years, every six months, recounting qualifications. It's making sure that they're trained, making sure that they have practical experience and are cleared to do what they're supposed to do. and do it repeatedly and do it accurately.
Abby Roth:
And that stratification of knowledge that you kind of mentioned and experience, that works great in the outsourcing facilities. They're more structured and built for that. But when you look at some of the 503As, whether it's within a hospital or even some of these community compounders particularly,
Doug:
Hmm, that's
Abby Roth:
like
Doug:
good.
Abby Roth:
they're gonna struggle getting a hold of microbiologists or facilities people.
Doug:
That's true.
Abby Roth:
The hospitals have a little bit of an upside to that because you do have facilities, people in the hospital, you have infection prevention
Doug:
That's true.
Abby Roth:
that you can lean on and ask for help. But even there, I've done a lot of work just educating infection preventionists on how what happens in the clean room is different than what happens in the rest of the hospital.
Doug:
Mm-hmm.
Abby Roth:
So, there's gonna be challenges across the board as we continue to try to work towards solving some of these issues. But Doug, you've mentioned it a couple of times, get help.
Doug:
Yeah.
Abby Roth:
There is a ton of people out there that can help you, whether they are consultants and they serve either facility design, they have environmental monitoring backgrounds, contamination control. There's a lot of resources out there and if you are struggling, ask for that help.
Mary:
Well, certainly hiring consultants would be cheaper than the hit to your reputation that you'll take if you do those
Doug:
Absolutely.
Mary:
these types of sorts of things incorrectly.
Doug:
Yeah, it's
Mary:
So.
Doug:
an investment. I mean, that's how they can frame it.
Mary:
Yeah, yeah, absolutely. Oh, well, thank you both so much for talking with me about this. This has been really fascinating and I'm glad that there are definitely people out there who are looking into these things more carefully, you know, not just for me and any future medications I get, but in case I ever need more medications for my
Doug:
Exactly.
Mary:
cat.
Abby Roth:
I'm sorry.
Mary:
It affects a lot of people and animals,
Doug:
Yes.
Mary:
so it's very important stuff. But thank you both for sharing your expertise.
Doug:
Thank you for having me.
Abby Roth:
Yep, thanks for having me.