I'm Barry Sample. Wanted to give you what I think is a fun presentation. I think we'll all have a little bit of fun with this. Looking at ways that donors try to beat the drug test by dilution, substitution, and adulteration. First, I'd like to start with the disclosure. Currently, I'm self-employed. I retired recently after 40-plus years in the drug testing industry, and I'm now working as a consultant with a variety of laboratories and IDD companies. So the problem is, how do we know that we have a valid specimen from that donor? Particularly with urine drug testing and in the federal program, only urine is currently permitted. It's not an observed collection, it's scheduled. Because of that, donors may have an increased opportunities to subvert their workforce drug test. Either by diluting it, the specimen, substituting it, adulterating it, or attempting to use some sort of cleansing agent. Observed collections in federal urine program is only used when specimens are collected under reasonable suspicion or specific recollection circumstances. And obviously, when that collection is observed, there's much less opportunity to tamper with the specimen. I want to start off now with a quote from the former director of workplace programs at SAMHSA. This came from testimony he gave in 2005 in the U.S. House of Representatives. Every one of those adulterated, substituted, and invalid tests represents a potential threat to national security and or public safety. This is why it's important that specimen validity testing be performed, particularly for urine collections, when there's the opportunity for a potential subversion of the specimen. So if you were to Google either beat a drug test or pass a drug test, and I would put that in the phrase in quotes. It's not just quoted there because that's what you're typing in. You can actually put it in quotes. You can see how at the beginning, there were far fewer, much less information out there, far fewer hits on how to beat the drug test. And for beating the drug test was 58,000 hits in 2002. Really exploded in 2006, by the time 2006 rolled around for both beat a drug test and pass a drug test, and it has gone down progressively since then, although it's interesting that when I Googled just the other day, pass a drug test is back up to 2.2 million. And if you don't put that phrase in quotes, you'll get at least 10 times more hits in roughly the same period of time. So some states, this is just an example of one state like South Carolina, actually have state laws pertaining to the sale or use of products that are designed to interfere with drug and alcohol tests. There are, I think, about 15 states at this point that have passed a variety of laws regarding this, but it's not uniform from state to state, and there's still no national policy, even though Congress held a hearing back in 2005. So what are some of the ways that donors are trying to beat the bladder cops? For those of you that remember Abbie Hoffman, steal this urine test, fighting drug hysteria in America. You can see the names of some of the products on this slide. We'll go into those in more detail, but people have been trying to beat drug tests probably for about as long as drug tests have been around. So some of the older technology that was used, bleach, vinegar, ammonia, salt, baking soda, even WD-40, Vyzene, so there were, you know, a variety of products that were used, I'll say the olden days, but, you know, in the more historically and in the past. It doesn't mean that people still don't try and use those products, but the newer products have a number of catchy names. You can see some of them here. We'll go through them again in a little bit later, but there are all types of products that are marketed to try and beat the test. So in 2003, in the magazine High Times, more than 10% of the magazine was devoted to products that were designed to help subvert the testing process. By 2010, it was down to five ads on five pages in a magazine that had 135 pages. Part of that is as a result of federal law enforcement efforts, not agents, law enforcement efforts to stem the sale and distribution of these products. And as you can see, in 2010, there were a variety of products advertised. Additives, substitution products, detoxification drinks, as well as some products designed to help subvert oral fluid and hair testing. So broadly, you can classify these products as either being dilution products, cleansing products, adulterants, which are additives that are added to the specimen, as well as devices, which are used to substitute the urine. And they may also have delivery devices and more on that later associated with that substituted urine. So when we look at dilution, there are two types you can think of. One would be physical dilution, in vitro, where fluid is added to the urine specimen in the privacy of the restroom. That one can be a little more problematic because temperature is measured when the donor exits the restroom, the temperature of the specimen, that is. And depending upon how much fluid they add, it may be difficult to have a specimen within the specified temperature range. But there could also be in vivo. And you can think of two different types of in vivo dilution. One could be pharmacologic through the use of xanthines, diuretic, alcohol to enhance excretion of fluid, or just simply water loading. You know, drink 120 ounces of fluid in a short period of time. Sometimes it may have substances like calcium carbonate included. Then there are cleansing products that could act as a colonic or metabolic. Some examples there would be golden seal or psyllium. Cleansing drinks, which would be a combination of colonics or metabolic as well as water loading. And we'll talk a little bit about that in a second. So what impact does water loading have on urine production? So as we look at urine production, and, you know, flow rate is on the y-axis, and the time frame is on the x-axis. You can see after water loading, a profound diuresis increase in urine production occurs after about half an hour, which is sustained for over two hours and then falls off back to normal about three hours after the intake of that water. So clearly, just drinking a lot of water, you have increased urine production and therefore dilution of the specimen. When we look at the impact on urinary creatinine, which is used as one of the measures that's used for assessing specimen validity, and whether the donor drinks half a liter of water or one liter of water, it falls from, in this study, from 175 or so or 185 down to levels. And if it's one liter of water, it actually would go into at least half of the definition of dilute by two hours. But within an hour, the creatinine is significantly depressed, slowly comes back, and still hasn't returned back to its pre-water intake, even five hours later. In a study that we performed a number of years ago, where we looked at the distribution of creatinine concentration in positive and negative general workforce specimens, in the blue bars, you have the distribution of creatinine values in positive specimens, those that are reported positive. In the red bars, those that were negative, reported negative by the laboratory. If you look at those negative results, the median value is around, you know, 130, 140. With, you know, only about 5%, 6% of the specimens having a creatinine less than or equal to 20. However, in those positive specimens, that distribution is shifted significantly to the left. In the range of 10 to 20 milligrams per deciliter, more than 10% of the specimens had a creatinine less than 20. And nearly 3% of the specimens had a creatinine less than 10. You know, perhaps you could think of these as the donor maybe trying to dilute their specimen, but was unsuccessful. We have data, which I'm not going to show here today, that where we looked at specimens that were close to the immunoassay cutoff for cocaine and marijuana, but were administratively negative on the screening test, but we subjected them to confirmatory testing. A significant number of those specimens were found to contain drugs. So you could, you know, think of those potentially as people that had tried to dilute their specimen and had succeeded. So one of the early products that was used to try and subvert the testing process was Goldenseal. Goldenseal by itself really isn't that effective as a cleansing agent. You know, it's been marketed as a popular digestive remedy. It may have some diuretic impact, but it really doesn't have much effect on the ability to pass a test or not. In fact, maybe one of the ways that it's most effective is to actually dump it in the urine specimen as it seems to interfere with the analysis. But it's rather obvious because you have all this unusual yellow floating material in that urine specimen, so not typically utilized in that manner. More modern types of products, and this is from one manufacturer, Clear Choice. You can see a variety of the products that they were offering, and this is quite some time ago, although the prices probably haven't changed significantly from then to today. For reference, there's a quarter in the two pictures on the left, so you can see how small these products are, which would help facilitate being able to, you know, smuggle that in to the privacy of the bathroom, even by emptying and displaying of the pockets and removing outer garments. You can clearly see that a product that small may be easily hidden by the donor prior to going into the restroom. Some of the other products would be, you know, cleansing and detoxification products, which are designed to be consumed. Either they're powdered and they're diluted in water, or they come in liquid form to begin with. But at the end of the day, by themselves, they're probably not very effective. Most of those products, whether they're diluted with water or they're liquid to begin with, in addition to taking their product, which may be 100, 200 milliliters, the donor is also instructed to drink water before they take the product and after they take the product. So rather than spending the $35 to $50 on the product, they may achieve the same benefit simply by drinking that much fluid. So they're mostly effective by diluting the urine, not by any innate property that these substances have. For products that are added to a specimen, the adulteration products, they could include surfactants, in other words, soap, oxidizing agents, acids, aldehydes. And as we look at some of the earlier products, such as, you know, prior to 2001, you see some of the trade names there. Amber 13, which is really just hydrochloric acid. Clear Choice, which is glutaraldehyde, one of those aldehydes that we mentioned. Clear, which was a nitrite product. Mary Jane's Super Clean, which is nothing other than soap. Clear, which is a nitrite product, or the pyridinium chlorochromate. Stealth, and we'll talk a little bit more about stealth in just a bit. One of my all-time favorite names, Urinaid, which originally was a glutaraldehyde product. And Urine Luck, which has also gone through a number of generational changes. And again, you can see pictures of some of these products and marketing material that goes with them. You know, look at how small some of those are relative to the quarter. Again, very, very easy to smuggle into the privacy of the restroom. So, Clear was one of the first nitrite products. Nitrites, as well as other oxidants, oxidized cannabinoids, particularly cannabinoids and opiates, under certain conditions. And the way laboratories identified that this was going on is that it takes some time for these to become fully effective. So, the specimen might screen positive, but when it went to confirmatory testing, it would confirm as negative. But it also has, from the seller's perspective, an unwanted side effect of also destroying the internal standard that is used as part of the confirmatory assay. So, these Maspec, UC Maspec, or LC Maspec confirmation assays utilize a deuterated internal standard. So, in the case of marijuana and the carboxylic acid, it's a deuterated carboxylic acid. And what laboratories were finding is not only was there no THC acid there, there's also no THC internal standard there. So, clearly something unusual was going on. And the nitrites were fairly easy to detect and identify. Many laboratories added nitrite detection assays to their testing panel. And, you know, now for a number of years, oxidant testing has been required in the federal testing programs. Urine luck, you see some of the marketing information for, you know, urine luck in the past. It is, you know, one of the innovators, the purveyors of this product, I think in some ways are some of the innovators. And, you know, they have, their product has evolved over time. Initially, it was just a simple acid solution. Then it was pyridinium chlorochromate, which also had a low pH. So, as laboratories developed assays for pyridine and then later on for the chromium-6, they changed the product again to be more of a mix of oxidants and acid. So, a little bit of this, a little bit of that, enough to impact the laboratory's ability to either detect or confirm the drug or drug metabolite that they're trying to mask, but not enough to put it into the adulterated range. Laboratory might report it as invalid, but an invalid is not the same as an adulterated or substituted. While the donor may have to be subjected to an observed collection, following the reporting of an invalid test on a, an observed collection on a subsequent test, they've essentially bought time, bought time to abstain from using drugs. They've gained their 48 to 72 hours, maybe more, and then are able to test positive, sorry, test negative when they are recollected. And we talked about this aspect of urine luck and how we discovered it from a laboratory perspective just a bit ago. Stealth is another interesting product. So, each packet contains two plastic vials. One is a tan solid, which doesn't melt. The other is a small amount of a liquid solution, pH 4.5. So, the user is instructed to pour the powder into a collection cup, add their urine, probably swirl a little bit, and then they add the liquid activator. So, I don't know how many of you were Mission Impossible fans when it came on, but remember what it said at the beginning at the end of the tape. So, the tan solid contains peroxidase, the liquid contains peroxide, it destroys THC metabolites very, you know, relatively quickly, and then it self-destructs because all of the peroxide is consumed by the peroxidase. So, it's a very clever type of product that can be difficult to detect in laboratories. Some of the other products, bacon shakes, sort of reminds you of shake and bake, but no, this is not something you would cook your chicken with. It's something that you would use to try and subvert the testing process. So, how effective are these urine adulterants? It really depends upon the drug and the product. Some of the products are effective and detectable. You know, others like Stealth are going to disappear on their own. Other products aren't effective at all. They're still marketed and sold, but quite frankly, they simply don't work that well. So, the effectiveness of each product may also be different between the initial or screening test and the confirmatory drug test, as well as what may be detected during using the standard panel of specimen validity tests. They're also clearly not effective across all the various drug products. So, several studies have been performed in order to try and assess the effectiveness of these various products. So, you know, the first test would be to look at those new adulterants, test them against each of the analyzes mandated in the federal urine panel under realistic conditions, and then perform routine specimen validity testing. And The second is once those effective adulterants are identified to analyze their composition and try and determine exactly what they are. So in this study, drug-free urine that were spiked with analytes at two times the cutoff were developed. The product was used according to its package insert, package instructions, incubated for 24 hours, and then shipped via FedEx. So trying to simulate somewhat of a normal collection process. So that's one of the designs. In the second experimental design, four laboratories performed the initial or screening drug test on those specimens that were prepared, and one laboratory performed both initial as well as confirmatory tests. So these are the results of studies between 2001 and 2008, looking at a variety of the products. So clear choice was found to be effective on initial test, on the screening test, in blocking the detection of amphetamines, opiates, and THC, or THCA more specifically, on the confirmatory test against morphine and the carboxy-THC. The diamond purifying liquid, some similar compounds, but also, you know, a bit of an oxidant, but really not very effective. Nuclear, that's not nuclear, that's nuclear, or new, it contains ethanol, benzaldehyde, and toluene. It effectively wiped out all of the initial tests, so it impacted the ability of the immunoassay to function properly, but had no impact on the confirmatory test, and it also had an abnormal pH. Purifies it, which is an oxidant, chromium-6, effective on initial tests for cannabinoids as well as the carboxylic acid confirmatory assay. UrinLuck, version 6.8 of UrinLuck. UrinLuck's sort of interesting in that it's a product we talked about that's evolved over time, and they've actually given it version numbers. Today they're on version 8.0, and, you know, one of the clever things, you know, particularly with the UrinLuck marketing, is that they have a money-back guarantee if you fail your drug test. All you have to do is send in the result of your positive urine drug test and proof of purchase, and they'll happily either refund your money or send you the latest version at no charge. There you can see, you know, pictures of the various UrinLuck products as it's evolved over time. The instructions for use, I'll go back to that for a second. So in addition to using their product, you see that they tell you to urinate two to three times before use, eat or drink normally, don't drink more than 10 ounces of fluid per hour per hour on day of use. I don't know how many people generally drink 10 ounces of fluid every hour. Yes, they're warning you not to over dilute your urine specimen, and then obviously you add it to the urine specimen. So this is one product that that's also evolved over time, and, you know, different formulation dates, and you can see that they, for certain drugs, they have different relative effectiveness depending upon the version of the specific adulterant product. And this would be an example of a product that has little to no effect. One of the problems, at least for the manufacturers of UrinLuck, and something that laboratories were able to quickly notice, was the effect of version 6.5 on the appearance of the urine. So as noted as the NLCP and HHS was preparing samples using UrinLuck 6.5 to assess effectiveness, that the adulterated urine turned red-brown after standing or storage, and looked significantly different from the unadulterated paired control, which caused them to do some additional studies looking at 15, 45, and 90 milliliters of normal urine, and adding UrinLuck 6.5 and then taking images at various times between 5 and 1,440 minutes. So there's the visual comparison. You can see the color of the control urine on the far left, and as the concentration of the relative concentration of the adulterant decreased based on being diluted into increasing volumes of fluid, you can see the color gradation there. So that's at time zero, 15 minutes, 24 hours later. So all very dark and clearly different colors, and you can see the impact. So that's in addition to laboratories being able to detect that impact on color, maybe one of the things that prompted them to come out with 6.8, not too, version 6.8, not too long after 6.5 was developed. So what are laboratories seeing? This is all the data from Northwest Toxicology from 2003, but it gives you an idea of the percentage of specimens that were reported as adulterated, substituted, or invalid. So in total, it was a point about 0.15 percent or 15 in every 10,000 specimens. So that's a pretty good percentage of specimens. Unsuitable or invalid led the pack at 0.07, substituted 0.04 percent. So where are we today? This is from our drug testing index data, and to me, it's rather interesting that, you know, while the relative failures for the specific reason for failing the test for specimen validity, whether it be due to acid base and oxidizing adulterant, substituted, or invalid, has changed a little bit over time. It's not that much different today than it was 20 years ago. Although, you know, the relative amounts of change and invalid is the most common reason for failing specimen validity these days. And similar data in our general U.S. workforce testing. As we look at the relative amounts of the reasons for failing, or sorry, for being reported as invalid in federally mandated testing, the vast majority, over half of them, in 2017, 2018, were due to an immunoassay interference. We believe that that is primarily because of the use of synthetic urine. There was a specific formulation, or manufacturer of synthetic urine, that had a characteristic of interfering with the immunoassay test for 6-acetylmorphine, and with the introduction of the prescription opiates, hydrocodone, hydromorphone, we believe, and what it appears is that there was an uptick in invalid specimens due to this immunoassay interference, perhaps because of the use of synthetic urine. So, we believe that there was an uptick in synthetic urine because donors that had previously been able to use other opiates, other than codeine and morphine, that would not have been detected or reported in the earlier federal panel, were using that at least initially. Invalid results due to pH has been a leading cause of invalid specimens for quite some time in the federal testing, and creatinine and specific gravity, as we talked about in the earlier lecture about the basic lab testing for the five-panel test, represents half of that two-legged criteria for reporting a specimen as invalid. So, either an abnormal creatinine, very low creatinine, without meeting the specific gravity criteria, or a very low specific gravity without meeting the creatinine criteria. And outside of the immunoassay interference, which, as I described previously, we're attributing to the inclusion of the prescription opiates in the federal panel, similar data in our general U.S. workforce testing. And I thought I would also throw in our experience with dilute. And it's been remarkably stable, the prevalence of dilute specimens over the course of really almost the last 10 years, but certainly over the last six or seven years. And it's down significantly from where it was going back in 2001. So, how effective is specimen validity testing? To a certain extent, it's been effective, but it's also been limited. Why? Because as laboratories identify and take countermeasures, the product change, it's really as a moving target. A great example is nitrite. You know, that was one of the earlier ones. You know, going from nitrite, changing the concentration of the nitrite, going to the chromium six products as an oxidant. As, you know, chromium was identified by laboratories, then they changed to nitrite chromate mixtures. And then they added acids such as hydrofluoric acid or periodate or other halogens, all designed to try and change the makeup of those products to avoid, if not being detected as invalid, but certainly to avoid being detected and reported as an adulterated specimen. Switching now to devices. Really talking about substituted urine and delivery mechanisms. So, you know, substituted urine could either be in liquid form or lyophilized, just add water, to reconstitute. And it may either be synthetic urine or mammalian urine. So, the synthetic urine is designed to pass the standard test of specimen validity, pH, creatinine, oxidants. Now, while some laboratories have proposed adding urea and have done so as an additional marker, the problem is newer formulations of those products, synthetic urine products, also include urea. So, it would be a continual cat and mouse game. The problem of substituted urine adulteration is not necessarily going to be solved by chemistry. And this is one of the main reasons why the federal regulators have now published final guidelines for oral fluid. Again, not yet implemented, no laboratory certified for performing oral fluid tests in federally mandated specimens. But it will come at some point in the future. And while they're also considering hair. And the thing to remember with urine, no matter how good the laboratory's technology or testing is for detecting synthetic or adulterated urine, at the end of the day, if the donor has the opportunity to smuggle in a fluid, a urine specimen or some other fluid, they certainly could actually smuggle in urine, you know, mammalian urine, human, animal urine, which would pass all tests of specimen validity. So, again, it's not a problem that will be solved by chemistry. It's one that would require alternate testing technologies or specimen types such as oral fluid or hair. So, some of the substitution products also come with delivery devices. You can see some pictures of them. Only $79.95 plus shipping and handling to have your synthetic urine product as well as a delivery bag. Switching now to other specimen types such as hair. There are certainly shampoos that are marketed to help cleanse the hair. Clear Choice makes products for all specimen types. They're not restricted just to urine. One of the products is Afterburner. They claim it's a revolutionary new way to rid the hair shaft of toxins. I always like how they refer to these drugs that people are taking into their body as toxins, whether it be marijuana, cocaine, amphetamines, opiates, etc. Well, you know, what they're saying is that it penetrates the core of the hair shaft. So, it would be very harsh on hair, not detected in any hair analysis, leaving no residue traces. And they claim to have a 99.8% success rate and they'll happily refund your money if you test positive following the use of their product. In our testing of the various, certainly the various shampoo products, we haven't found any to be effective, however. And here are some pictures of some of the hair shampoo products that have been marketed. Oral Fluid, you know, also has its share of products. On the left, you see Spit and Clean, and on the right, Quick Fizz. So, all specimen types have products. Again, we've not found any to be effective, at least not in the case of Oral Fluid. Although, I would expect that as more and more tests are performed using either Oral Fluid and or hair, we'll continue to see development and evolution of these products. And at some point, they may become effective. So, it's, you know, one of the advantages of having a variety of specimen types available for employers is that they may, if they design their program appropriately, they may have the ability to keep donors guessing. So, it may be easy to study for one test, but it may be quite difficult to study for all three tests simultaneously. So, what's happening at the federal level with, or what has happened at the federal level with some of these sellers of these products? So, there are two operations, Operation Pipe Dreams and Headhunter, which was led by the DEA with the assistance of other federal agencies. So, in February of 2003, the DEA, sorry, the U.S. Department of Justice announced the indictment of 27 people on charges of trafficking in illegal drug paraphernalia. There were 10 indictments against national distributors of these products and seven indictments specifically involving businesses located in western PA. One of the headlines was they put 55 illegal drug seller paraphernalia sellers out of the market. Some of the websites they seized are listed here, and they literally did seize them, as you can see on these screenshots of the message that the government put up on those URLs. So, a second Operation TrueTest, which followed a two-year investigation, came to light in mid-2008, involved raiding nine locations, U.S. businesses selling masking products that were designed to help people pass drug tests. Ultimately, one of the results of this is they shut down Puck Technology, one of the larger purveyors of these products, who surrendered $300,000 and all other assets as part of a plea agreement against their president and vice president. No other arrests were made in this, and Mary Beth Buchanan was the U.S. attorney for the Western District of Pennsylvania who handled the prosecution, and she argued that the Whiz-O-Mator, as well as the Puck product number one, were, quote, sold to customers around the U.S. and the Western District of Pennsylvania for the purpose of defeating federal and federally regulated employment urine drug tests overseen by SAMHSA for marijuana, cocaine, and other controlled substances, and those indictments were handed down in October of 2018. So, Willis was sentenced to six months in prison, followed by three years of supervised release. Catalano received a sentence of three years probation, and two locations of Spectrum Laboratories, one in Ohio and one in Kentucky, were also raided that year. So, the Urinator, this is one of the more famous or infamous urine substitution devices. It's a little simpler, has a bag to hold the urine in and a tube, so it's really a, you know, it's partially a delivery device here, but obviously Urinator, even if being observed, doesn't look anything like the real thing here. But the Whiz-O-Mator, on the other hand, is one of the devices that is, you know, certainly more realistic. It's a prosthetic device, and it even comes in a variety of skin tones to better match the ethnicity of the individual who is using the device. And this is one of the products that was involved in that 2008 raid. Thank you very much. I hope you've enjoyed this presentation, and have a good day. Thanks. Bye.

drug test subversion

urine drug tests

dilution

substitution

adulteration

specimen validity testing

UrinLuck

Operation Pipe Dreams