The Toxpod

Emerging Risks in Toxicology (live at FACTA2019)

August 21, 2019 Season 2 Episode 3
The Toxpod
Emerging Risks in Toxicology (live at FACTA2019)
Chapters
00:00:35
Are our systems helping us?
00:09:02
The black box mentality
00:13:05
Are validation guidelines becoming too onerous?
00:23:01
Deuterated medicines
00:32:04
Expanding our scope of analysis
00:34:12
Hazardous new drugs
The Toxpod
Emerging Risks in Toxicology (live at FACTA2019)
Aug 21, 2019 Season 2 Episode 3
Tim Scott & Peter Stockham
Emerging risks in toxicology (with Marc LeBeau)
Show Notes Transcript Chapter Markers

TIAFT President Marc LeBeau joins The Toxpod for a special episode recorded live at the FACTA conference in Adelaide. We discuss some of the emerging risks in the field of toxicology.

Find out more about FACTA at www.facta.org.au

You can read the available OSAC toxicology guidelines here


Contact us at thetoxpod@sa.gov.au


The Toxpod is a production of Forensic Science SA and the South Australian Attorney General's Department. The opinions expressed by the hosts are their own and do not necessarily reflect the views of their employer. 

Tim:
0:01
Hello and welcome to a very special episode of The Toxpod. We are recording live at the FACTA conference here in Adelaide. I'm Tim Scott, and with me as always...
Peter:
0:20
I'm Peter Stockham
Tim:
0:21
And we're fortunate to have a special guest here with us today. Marc LeBeau is senior scientist at the FBI, current president of TIAFT, and keynote speaker here at the FACTA conference. Marc, thanks for joining us.
Marc:
0:33
Yeah, very happy to be here.
Tim:
0:36
So today we're going to be talking about some emerging risks in toxicology. So we'll probably hit a few different topics, but we'll see where the conversation takes us. And Marc, you've given a few, couple of keynotes already talking about some of the big picture issues in toxicology. So in terms of the systems that we have, which can either help or hinder us in doing toxicology, what's your perspective on that, are the systems that we have helping us to succeed or are they in some ways hindering us from succeeding?
Marc:
1:09
I think it's a little bit of both, quite honestly. I think it's helping us in regards to try to ensure that the work that we're producing is going to be solid work, that there'll be less holes that will ultimately ensure that we can get our work into the proper settings, whether it be into court or, and then we, we make the right decisions when it comes down to a cause of death, helping with cause of death determinations, but at the same time, these things take work and time and, and that ultimately means that there's less time to do the actual case work.
Tim:
1:51
And a lack of funding, lack of staff is always an issue for everybody.
Peter:
1:57
So are the expectations of the general public maintained by the amount of funding, do you think, is there enough R and D funding going into forensics in America?
Marc:
2:05
Uh, there's never enough money for anything, but yeah, I think it's absolutely improved over the last 10 years. We know that there's been upwards of $230 million that has been put towards forensic science research since the NAS report was issued in 2009. So that helps a lot. And the good news is it's not just being pumped towards DNA, which is what we had been seeing prior to that.
Peter:
2:36
That's novel.
Tim:
2:37
Yeah. DNA gets a lot of the attention I suppose, in the media.
Marc:
2:39
It does, it sure does.
Tim:
2:40
More than toxicology.
Peter:
2:41
And from your talks yesterday when you were talking about the systems in place in various committees you're on, I'm just wondering, do you actually do any tox work besides being on these committees? There seems to be so many of them.
Marc:
2:52
Uh, no I don't. [laughter] Uh, but certainly I think in my position at the laboratory, it's a senior scientist position, so I'm an advisor for the government and for the FBI and probably in a good role to actually take the time to, uh, to serve on these committees. But, point well taken.
Peter:
3:17
Yeah. At least you can drive where you're going in the future from the committees, that's good.
Marc:
3:19
Exactly.
Tim:
3:20
So in terms of these systems, we've, there's been a lot of publicity about the system in the UK, Forensic science system, you were talking about some of the reports and things that have come out in the US, we've obviously got our own issues here in Australia, but maybe not as well publicized as those. What do you think are the differences in terms of different regions in dealing with funding, access to research, I think that's been something that's come out of the UK that the lack of funding for research and new method development.
Marc:
3:50
I'm not sure I'm following you.
Tim:
3:52
Do you think there's any differences in terms of, let's say the US to the UK, to Australia, to Asia, around the world in terms of whether the systems are helping us to succeed or not as forensic toxicologists?
Marc:
4:06
Well, I think that, uh, quite honestly, if we work together on all of these things, I think we're going to be much more successful than to, you know, if each group is trying to create their own widget, if you will, or fixes, it takes a lot of resources as we've already said and it would certainly make more sense if we could do this in a more collaborative effort. We're certainly trying to introduce that with our approach in the US, we've, as I talked about in the talk earlier this week, the effort with the organization of scientific area committees where we are allowed to have affiliates come in and assist us in the development of these different documents. And those affiliates don't have to be from, from the US or North America. We've, we have quite a few affiliates representing other countries that have particular subject matter expertise. And that's I think really critical so that we're not sitting there developing these things with blinders on without an appreciation of the bigger picture.
Tim:
5:13
You talked about, I think yesterday as well, about mandating certification of labs and obviously there are some large labs, some small labs, you know, wherever you go, it's the same issue. Some labs are more well resourced than others. Will this create other problems in terms of these smaller labs not being able to meet the requirements of that certification or, you know, validation guidelines, whatever? And is that necessarily a bad thing if they can't?
Marc:
5:41
Yeah, we've had that discussion actually as we've developed some of the documents and we realized, well this is gonna take some effort to implement, but I think your point's well taken and we've had it, that debate as well. Is it right to essentially drive laboratories out of business? But at the end of the day, I think if a laboratory cannot be funded appropriately to do the quality of work that's required to give the entire field a positive image, then perhaps they do need to consider shutting the doors. We've seen it in a number of jurisdictions in the US where, particularly in the area of post-mortem toxicology, where laboratories are, or the medical examiners offices are deciding to shut down the toxicology portion of the laboratory and sending all of their samples to private laboratories in order to ensure that a) the cost is reasonable, but b) that they are getting a quality result without investing all of that money into trying to maintain instrumentation and a quality control program. So it's, it is happening, but, ultimately it's how much money does a jurisdiction want to put into ensuring that they're getting quality results out of the laboratory?
Peter:
7:05
And where a laboratory's not compelled to be accredited, the commercial laboratories are more likely to be, aren't they? So you'd prefer to go to an accredited laboratory rather than a smaller...
Marc:
7:16
Yeah, I mean it's almost a requirement for the commercial laboratories to have that accreditation to, to justify why you should send your samples there.
Peter:
7:24
Exactly.
Marc:
7:24
Yeah.
Tim:
7:25
It's interesting what you were saying about collaboration between different regions. Obviously TIAFT is heavily involved in promoting that kind of collaboration, and I think conferences like TIAFT, like the FACTA conference are really vital to keep promoting that kind of interaction between toxicologists. It's a really eyeopening experience I think when you... I remember going to my first TIAFT conference and Frank Peters was giving a lecture about validation and that was kind of my welcome to the NFL moment. You're an NFL fan, right?
Marc:
7:52
Yeah I am absolutely.
Tim:
7:53
Yeah. You realize there's so much that you don't know and so many people who know more than you and who are willing to teach you as well. That's the great thing about it.
Speaker 3:
8:01
Yeah it really is, I mean, I think it's the amazing thing about TIAFT and FACTA and a number of the professional organizations around forensic toxicology is, you know, everybody's very approachable I think throughout toxicology. I remember my first meeting as well, and the, the gods of toxicology were there and you walk up to them and you have a drink in your hand and everybody's talking to each other without any titles being thrown around or, or any reason to feel uncomfortable. And so it, it makes the youngest toxicologist feel comfortable right from the getgo, and I think it makes those of us that are more, shall we say, uh, have more experience now, makes me feel young that young people are coming up to me and asking me questions still and, you know, want to grab a drink or something with you. So I think it's, it's really a nice field to be in. And we're lucky quite honestly, because most fields aren't that way. There's a hierarchy.
Peter:
9:01
That's right.
Tim:
9:02
So let's talk about another potential risk then, which, I've sort of noted here as the use of laboratory instruments as a black box. You know, it's, I remember seeing an episode of CSI once, I don't usually watch that show, but where they brought in a sample and they said, let's just run it through the mass spectrometer. They fed it in and out the other side, it spat a piece of paper and they said, "Yep, it's lipstick alright". This kind of use of instruments as just a black box that we don't really understand what's going on inside, but we just feed something in and get a result spat out. There's a pressure, I think, as we're talking about before with lack of funding, to become more and more efficient in our work, which does force people a little bit maybe down that route. Do you have any thoughts on the potential risk of that?
Peter:
9:50
Well, there is risk, particularly if you don't demonstrate that it works right? You can have the magic box, but, uh, and say that it does x, y, z, but just because the manufacturer says it does x, y, z , I think we're still obligated to validate that it works the way we need it to work, that it produces the end result that is required by our customers. So, you know, in a way everything to me is a little bit of a black box. So I don't understand everything in every single instrument. I don't understand the electronics, but I do understand the theory behind the instrument and how it works and I think that is important for everybody to know. But at the same time, things are getting much more complicated today, aren't they? And we are expected to know so much more today than we needed to know just five years ago, 10 years ago, and at some point we're going to be overloaded. So...
Tim:
10:49
Already feeling overloaded.
Marc:
10:50
Yeah, exactly. And anything that can help us do a better job, maybe faster,. is a great thing, but it has to work
Peter:
11:00
In the clinical world, maybe not for the toxicology side of things, but for biochemical analyzers, they may be accredited and they may come out under a standard method or something like that, but nothing exists correct, to the level that we need yet in toxicology.
Marc:
11:13
Yeah. But to the credit of the manufacturers, they're trying, they are trying to help us out. And, but you know, I think it has to be a collaborative effort with us to ensure that that the end product is actually something that's going to be useful to all of us.
Peter:
11:32
Well the manufacturers don't often have access to the authentic samples that we have, so they can't actually validate it to the level that we need to.
Marc:
11:40
That's right.
Tim:
11:40
And speaking of how much there is to know, you know, for a toxicologist to be an expert in all aspects of toxicology, pharmacology and analysis on the instruments, all the different things we've heard about here at the conference so far. It's just impossible for one person to be an expert on all that. Which goes back to those small labs where you don't have many people, can you really develop the expertise that you need? I mean in my lab we've got a reasonably large team and I still feel like there's things that we don't specialize in.
Marc:
12:09
You're absolutely right and there's positions now that maybe didn't exist before. You know, to have a full time quality manager in many laboratories where before it just, it was an auxiliary duty for people to take on and it just means more and more staff is needed. Maybe you need somebody more dedicated to maintaining the instruments today than what you needed before. And then it's being on top of all the current trends of the things we have to look for, understanding the new instrumentation. What do we want to bring into our laboratory? Uh, but it goes back to what you said earlier, it's the importance of these kind of meetings that where we're able to come in, meet people, learn from each other, talk about the challenges that you have in your lab versus my lab versus your lab, Peter and then say, hey, you know what? At the end of the day, we're all kind of in this boat together and we can learn from each other. So it's vital.
Tim:
13:05
So what about validation guidelines? Validation has become quite complex and there's lots of different guidelines around about how to do validation and they seem to be getting ever longer. People want to do more and more, which is good because people are discovering problems, then they want to insert things into validation guidelines to make sure that people aren't going to suffer from those problems. Is there a risk that validation becomes so onerous that some labs may just throw up their hands and say it's too hard to do that kind of validation?
Marc:
13:37
Well, I hope not. I'll say that I still, I think we are still in our field much better off than in the clinical field. Uh, I think it's much more difficult to validate in that arena. But, you know, validation doesn't just end because you said, I've completed my experiments and now it's time to put this method online. We continue to validate every time we use the method and we have to realize that, keep that in mind when we are storing validation records, that we maintain that type of information to further support it. Most of the validation documents that are written right now I think should be considered as a minimum. It's enough to get you by so that you can put that online and start using it, but continue to maintain documentation that it's a useful method that it is fit for purpose as we say.
Peter:
14:32
So there is a danger with the minimum guidelines that people are just going to tick the box without doing any extra maintenance of their method validation. So that's not how it is, is it?
Marc:
14:42
No, it's not, if you're just checking the box without fully understanding what it is you're doing, why you need the method to perform a particular way, it's a little bit foolish. You need to start with a plan, the validation plan that says on paper, this is what I need the method to do. At its worst, it needs to perform this way and then demonstrate that you can, you can actually have it work that way.
Peter:
15:08
And so by that way you're saying this is validated to, to the standard that we've set.
Marc:
15:13
Exactly. Exactly.
Tim:
15:15
So what about, in terms of methods, they're becoming much more diverse now I think, we are analyzing a lot, much wider scope of drugs and so, and there's a much broader range of instrumentation now I think, new manufacturers are getting in the game all the time. Is there, there has been some efforts I guess to sort of make people do things in the same kind of way. Maybe not to use the same kind of instruments, but part of the problem is if you're using a different instrument, it means that you can't actually do it in the same way as someone else who's got a different instrument. So do you think we should be trying to head towards getting people to do things in the same way? Or is it okay that everyone just does things in their way, as long as it's validated and everything?
Marc:
15:59
Yeah, I think you're absolutely right. It's fine. We don't have to button our shirt the same way every day. I can start with the top button, you can start with the bottom button. Who cares? If at the end it's buttoned up, that's what we're looking for. Same thing with our methods. The critical part is that we check the boxes, appropriate boxes, to demonstrate that the method is working right. And that's why in the US with the OSAC process that we're following, we're not telling people how to do anything other than the standard method that we're gonna develop is with blood alcohol, and why? Because everybody is pretty much doing it the same way. So this to us made sense, but once you leave that arena, you know, it's, there's just too many variables in place to say this is, we're going to follow this standard method using this particular technique, and before long you end up with, in the US we have the EPA methods for environmental samples and it's, it's a little bit ridiculous how many different methods there are to analyze for the same analyte at the end of the day.
Tim:
17:07
So what about unusual drugs that you encounter? I mean, if you're trying to do broad screening as a forensic toxicology laboratory, especially, you're going to encounter some things that you don't have validated methods for. Now in Australia, we do have some sort of guidelines about what to do in those cases, which is limited validation and it really is limited. It's not anywhere close to the scope that you'd normally go to in validating. Is that a risk that these methods aren't fully validated? Should people be quantifying drugs where they don't have a validated method? And if not, how do you ever quantify these drugs because most people aren't gonna be able to do it?
Marc:
17:46
Um, I, well I think that's two questions there. First we're talking about screening for analytes that maybe you don't have a validated method for. And we've written our validation document now so that we're only talking about targeted analytes, things that we have taken the time to validate for. And if you stumble across some, a new analyte that you weren't expecting, then you can report it out. You can do good lab practices to ensure that the result that is going out the door is acceptable, but if it's going to become a routine thing that you're going to look for, then you need to take the effort, make the effort to validate it, to understand what your detection limit is, to understand what types of interferences may create a problem for you in the laboratory. And then certainly if you're going to put a number on it, a number that you or your customer believes to be a true and accurate number, then you need to do the full validation for bias and precision and things like that. That's our view on it, but it takes work and we understand that, but at the end of the day, that number has to have some meaning for all of us. If we just put a number out and then publish it on a method that that really wasn't well validated, somebody else is going to pick up that number and say, well look, this is what a lethal number, lethal level looks like and it may be a number that has just absolutely horrible precision to it.
Tim:
19:07
Absolutely. You see that a lot actually in papers with NPS and...
Marc:
19:10
Absolutely.
:
19:11
There's lots of numbers. What do the numbers really mean? Not sure.
Speaker 3:
19:14
Exactly. Exactly. And we see this as well, we see a lot of people claiming that they're following some of these validation guidelines, but then when you really look deep, they've conveniently decided, well, I'm not going to do the matrix effect study or I'm not going to do the appropriate number of samples to assess precision. So it's, you know, something as a reviewer, I always look at and make sure if they say they're following SWGTOX method validation guidelines, that they've actually followed it and not taken shortcuts.
Tim:
19:45
Yeah. And that things have passed as well because if something doesn't pass the guidelines, I'd like to see more discussion of it in papers. Just, it's okay if it doesn't pass the guidelines I guess, but discuss it, you know, talk about what that means for the results.
Marc:
19:58
Yeah, that's absolutely right. Uh, it's a limitation then. You know, so what if you have an interferent, you know about it now and you can then make sure that that information is known to your customer. At the end of the day that's, that's really what it's all about.
Peter:
20:13
And the customer comes into it as well because it also has to be fit for purpose for them. If, I mean publishing data in a journal is one thing, but maybe information that you giving to a pathologist on a specific drug, there's just not the resources to fully validate that drug. But you can still qualify your report that you give out that this was done not on a validated, with limited validation.
Marc:
20:33
That is an excellent point and something again that I think a lot of people overlook is, all right, so what if you don't have the resource to validate for that particular analyte, just make sure your customer knows that. That it's not, it was done on a method that wasn't fully validated for that particular analyte and then they can make a decision as to whether or not they want to go with it or if they want to take it to another laboratory.
Tim:
20:57
So in your experience though, do do your customers understand that? Because you know, we deal with a lot of different clients, I suppose if you want to call them that. Lawyers, uh, judges, police officers, et cetera, and in my experience, often they find it hard to grasp even the fundamental aspects of what we're doing. Like the fact that we've analyzed a sample twice and got two different results and they struggle to understand, what does that mean? Why are there two different results? So that's even going a level further then in talking about whether a level is approximate and then how approximate it is.
Marc:
21:33
Yeah. So your question as to whether the customer understands it, I'd say the documents that we're producing at the OSAC are definitely going to ensure that the customer will understand because we have a document out about opinions and testimony that go into reports as well as uh, oral testimony. We have to put limitations in those according to this document. Additionally, we have a document out about reporting and that also makes it clear that you have to let your customer know all the significant limitations to the assay that you did in the results that you're reporting to them.
Peter:
22:11
And speaking of these OSAC reports. Um, they are available aren't they, when they get past a certain stage of approval, for anyone to look at and not just in America?
Marc:
22:19
Yeah. You're right. And, uh, we've started something new in the process in that we realize that some of the documents are putting out newer concepts to individuals and we want to introduce them to the public earlier in the process so they have a chance to actually review, try to use it before it goes to the Standards Development Organization and they put it out for 30 days for comment. So we want it out there and so we've put it up on our OSAC toxicology subcommittee website. As we finished the documents, they're there and they are freely available for anyone to look at and try to put into practice.
Tim:
23:02
All right. Let's shift gears and talk about another very practical risk, which is the development of deuterated drugs for use as therapeutic agents. So we as toxicologists used deuterated internal standards all of the time. It's best practice, but the pharmaceutical companies are developing deuterated drugs to use as medications. And you could argue cynically that it's all about patents and making money and so on. But in the studies that they've done on some drugs, they have found that they do have some better effects. Like they're longer lasting because they don't metabolize as quickly or maybe they don't form as many of the toxic metabolites if they exist for a particular drug. So there seems to be some benefit for it, and just a couple of years ago, deuterated tetrabenazine was approved by the FDA, so that's the first one that's actually been approved and released to the market. But it seems like it's going to be something that continues. How should we deal with that as toxicologists?
Marc:
24:00
Yeah. It'd be funny if we started now having to buy undeuterated internal standards, right? Uh, yeah, it's going to be a challenge and I think, uh, one of the solutions is going to be looking for other ways to further label it with more deuterium or other labeling compounds to allow us to do these analyses, uh, or, you know, maybe some new technology that's developed in just a few years will make it very simple for us. I don't know.
Tim:
24:30
Yeah, I guess you never know what's around the corner in terms of new technology. Actually, I remember seeing some work coming out of the US, I think maybe New York, where they were, rather than using a deuterated internal standard, they were spiking the samples with the drug itself. I guess it's kind of like standard addition. It's basically standard addition, but they'd kind of, you know, streamlined it in a way. So that's another approach. The problem with it is it seems to take quite a long time, usually, standard addition.
Marc:
24:57
And if you're going to do it with multiple samples, right, you're gonna use up a lot more sample than you would normally.
Peter:
25:03
So these are obviously going to be pretty expensive if we have to get either more and more deuteriums put on our molecules or whatever?
Marc:
25:09
Yeah, you would think so. But again, with mass production then the cost comes down. So maybe it won't be so bad.
Peter:
25:17
Or maybe we could ask the pharmaceutical companies that if you're going to release chemicals into our community, you have to provide us the internal standards and the authentic standards that are going to help us determine why your drug killed someone.
Marc:
25:29
Yeah. That's actually an idea I had about 15 years ago, I thought in the US that when a drug was released on the market that we as forensic laboratories should be provided a sample of the drug itself and any metabolites that had been developed and that there could be a central repository that, somebody that would be responsible, whether it be us at the FBI laboratory or the FDA or whoever. And then labs could come to us and ask for a sample instead of all the legal problems we go through in order to get a reference material from the pharmaceutical company or having to pay sometimes quite a bit of money in order to have somebody synthesise it.
Peter:
26:12
And in this world that you are imagining there'll be unicorns that we'd be able to ride to get our standards?
Marc:
26:17
There were, yeah...
:
26:17
Rainbows?
Marc:
26:18
It was... and then I woke up. So... [laughing]
Tim:
26:22
I mean it's already too expensive really to buy all the standards that we need, including internal standards. It's always a struggle and you're always having to compromise when you're developing new methods. You know, you're, just like you're saying you have this ideal in your mind of what you want it to be, but it always comes back to what can I afford to do?
Marc:
26:41
That's true. That's very true. And it's just the nature of the beast right now. And then, you have to weigh whether or not it's worth making that investment, is this a method, an analyte that you're predicting you see enough of that it justifies the cost or is it a onetime thing and you're gonna purchase an internal standard that's going to expire before you use it again.
Tim:
27:07
Yeah. It's very hard to find that balance, isn't it, between when to say yes and when to say no to your clients who are asking for, you know, you to analyze all sorts of different things all the time.
Marc:
27:17
Yeah.
Tim:
27:18
How do you draw that line of saying yes and no? Some labs probably have no control over it.
Marc:
27:22
That's right. I think sometimes we can't say no. Right, you're told you will do this and uh, and you will. But when you do have the option, I think you just have to be honest with the customer up front and say, if we do this, this is what it's going to cost you in time or money or this is what's going to cost us as a laboratory to pull this off.
Tim:
27:43
Does your lab get involved with a lot of new method development?
Marc:
27:46
We do. We're somewhat lucky, uh, as our laboratory is a resource to all state and local laboratories in the US and even international laboratories can use us if you go through the right channels. So we're funded by Congress to assist state and local criminal investigations and international investigations, if the local resources can't handle the, the local laboratory can't do the analysis or when there are, you know, high profile cases, huge cases where it would essentially shut down a laboratory if that's all they had to do, we can put a ton of resources to it and actually assist them.
Peter:
28:27
What about labs in developing countries? How do they keep up?
Marc:
28:33
Well, yeah. That that's an even bigger issue, isn't it? Because, you know, our problems talking about not being able to get a deuterium labelled standard for a deuterium approved drug, is, you know...
Peter:
28:48
A fat world problem.
Marc:
28:49
Yeah, exactly. Yeah, this is an ongoing issue, but I think that if we look at standards that are being developed, even developing countries can try to meet them. They can, they can try to validate their methods to the same level that we're validating ours at without any problem. But, uh, you know, they might not be able to afford a deuterium labelled internal standard. They might have to go with another internal standard that's much more affordable. But then if they do the validation and it works, if they demonstrate it's fit for purpose, it's absolutely fine to do.
Peter:
29:24
And so there shouldn't be a separate minimum standard?
Marc:
29:27
I don't think so. I don't think so. For, look, at the end of the day, if our laboratory makes a mistake and puts a black eye on forensic science, that affects everybody. And if your laboratory does it, it affects me, if your laboratory does it, it affects anybody's laboratory here. So that's true in the developing countries too. Now the question is, is it going to be uncovered in a developing country? I don't know. You know, is the media strong enough to grab onto a laboratory in a small country? Is that what their focus is on or not? But certainly in our countries where the media loves to attack forensic science, at times, they're just looking for the next case to, to essentially make us look bad. I don't know why that is, but other than it seems to sell papers or gets people to watch the TV.
Tim:
30:17
Presumably those labs, especially in developing countries, then would have to have a smaller scope of analysis if they're going to, if they're going to be held to the same standard and they're not as well resourced, they're not gonna be able to do as many things.
Marc:
30:31
That's probably fair, yeah. But I think it depends, and they may have fewer things to look for, you know? It's hard to say though, globally, it'd be nice if we all had the exact same drugs that we had to look for and we could, we could have standardized methods that we all use the exact same method for everything we do. But it's not realistic is it?
Tim:
30:51
And TIAFT does have a role here. TIAFT has promoted, you know, sending scientists to, especially developing countries to help with method development and so on. Has that been a successful program or do you see that there's more that TIAFT could do in that space?
Marc:
31:05
I think it has been successful, but I, it's also been underutilised, and that's maybe something we can improve on, on making sure people are more aware of it. But we do have what we call our method development grant, that a laboratory can apply for. And it's not just for developing countries. It can be any country can ask for a method development grant. But what we do is, uh, if they make the case, TIAFT will pay for the cost of a scientist to travel to their laboratory. The laboratory then is responsible for funding their stay, basically their lodging, cover their meals and in exchange that scientist will sit there and help them develop a method and begin the validation process with them.
Peter:
31:53
Gotta be a good program.
Marc:
31:54
Yeah, it is a nice program. But again, we've only actually had a couple laboratories apply for it. And it's been successful though where it's been used.
Peter:
32:04
So moving on to another risk might be the rapid increase in new drugs that are coming out. So there's continually pressure to expand the scope of analysis. How do you think we're going to deal with this coming threat?
Marc:
32:17
Uh, well I think we're going to continue to struggle quite honestly. You've heard in talks this morning of how people are trying to overcome some of the challenges of not having reference standards and how we go about identifying things that, uh, you know, maybe aren't so easy to identify. So this is just, it's gonna continue and continue and we just have to keep at it. That's the best we can do.
Tim:
32:42
Where do you sort of, um, when do you make that decision about when to include things in your routine screen? Most labs have a broad screen that they do on most cases or all cases, and then they have some other peripheral type analyses. It's hard to know when to make that decision to bring things into your routine screen.
Marc:
32:57
It really is. I think it depends. If you start seeing the request a lot or seeing it in cases, that's the big clue that you probably need to put it in. But maybe, an interesting idea that we've toyed with a little bit in the US, and going back to your question earlier of smaller labs shutting down and things, is to have more of a regional approach, where you have a lab that's considered an expert on certain types of analyses. I think you called it a Centre of Excellence before Peter, but basically that we could farm certain types of cases to a lab over here because that's what they're well known to do, and if you think you have a case of this type it goes to another laboratory that's almost an expert at it. But that concept to me would have to almost be at the federal level in order to pull it off. I can't imagine that, at least for us, that you could have a state lab in, for us, in Utah, doing samples for New York state, just because of the expense that we'd be talking about in moving things around. But the federal government could probably handle that.
Tim:
34:13
So just in the last couple of minutes as we finish up, one more perceived risk that I want to ask you about is the impact of highly potent drugs, particularly opioid agonists, the fentanyls especially, we've heard some talks this morning about them. There has been a lot of, uh, media publicity especially about the potential risks of people coming into contact with these, first responders, but also people in the lab. Is this overhyped, is this a real risk or is this just a media beat up?
Marc:
34:46
Uh, it is overhyped, it's a media buildup, but they are dangerous as we know. So you don't want to let your guard down, but if you just follow standard lab safety practices, we're going to be perfectly fine, I mean, yeah. But I think it's been a lot of, scare people to get somebody to watch the news that night. And it's, a lot of the first responders that are reporting symptoms, you know, there's enough of these cases that you know that it's psychosomatic. The effects that they're reporting, it's the same effects they report when they open up a letter that has white powder in it and they suddenly have a metallic taste in their mouth, some part of their body becomes numb and it's all just, you know, the fear, the threat of I don't know what this is and I'm scared now.
Peter:
35:34
Because these are being handled by dealers, that, they don't wear PPE I guess.
Marc:
35:38
Exactly, yeah. They're packaging it in their homes and they're managing to survive.
Peter:
35:44
But on the other side, we've got the Russian hostage crisis back, earlier 10 or so years ago, where they did die from, they suspect it was volatilised fentanyls, maybe remifentanil and carfentanil. So they can be used in that manner apparently, but they were probably specially prepared for that purpose rather than being the hydrochloride salt. They might've been the bases that were floating around.
Marc:
36:08
Well, I don't think it's ever been fully acknowledged what the substance was, but you're right, there is good suspicion that it was a fentanyl analogue. One of the unfortunate aspects of that event was that nobody was told, the first responders weren't told. Uh, so a number of the hostages actually died from the substance that was introduced. But yeah, and they are incredibly effective for that purpose. But again, that's a different situation isn't it? It's aerosolized, purposely put into a ventilation system at what dose we don't know, right? And, versus somebody just touching somebody else that happened to have used the drug and suddenly they're exhibiting symptoms
Tim:
37:04
Alright, well I think that's all we have time for today. Thanks very much, Marc for joining us. It was a pleasure to have you on.
Marc:
37:09
Absolutely. Thank you very much for having me.
Tim:
37:11
And thank you all and I hope you enjoy the rest of the conference.
Peter:
37:28
Thank you.
Delegates:
37:28
[Applause]
Are our systems helping us?
The black box mentality
Are validation guidelines becoming too onerous?
Deuterated medicines
Expanding our scope of analysis
Hazardous new drugs
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