Agenda Item: Welcome
MR. STEPHENSON (Chairman, HHS): At this time I'd like to convene the open
session of the Drug Testing Advisory Board Meeting. I'm very happy that you all
could join us this morning. It's an abbreviated open session, but we're going
to cover some important things. I want to remind everybody to sign in so we'll
know who all was here.
At this time I'd like to ask Dr. Donna Bush to introduce our new members.
DR. BUSH (HHS): As you may know, our board is composed of ten members who are
nominated and approved by the administrator of SAMHSA. There are cycles of
terms that these members serve.
We have Paula Childs, Prentiss Jones, Tai Kwong, and Barry Sample. They are some
of our old members. Then we have our new members for whom this is their first
board meeting. They are Dr. George Jackson, Dr. Sue Brown, Dr. Matt Slawson,
and Dr. Mahmoud ElSohly who is not here because of an emergency.
In the spirit of always identifying ourselves around the room, which I'm sure
we'll get to, I want to take a minute to give a couple of sentences about our
new board members.
I'll just start with how they are in my little stack here, and that's with Dr.
Sue Brown. She has an extensive career in working in an HHS-certified forensic
laboratory. She has quite a background in clinical chemistry and publications
in journals and book chapters, and she comes to us as an eagle eye data auditor
with the attention to detail on data that we need. Dr. Sue Brown is a
consultant. That's the position she has right now.
Dr. George Jackson is technical director for product integrity at National
Medical Services and he has a background in clinical chemistry. He has been a
director of analytical laboratories in the past, and he inspects for the
national laboratory certification program. He is board certified in forensic
toxicology and brings a lot of diversified laboratory experience to this board.
We have Dr. Matt Slawson from the Center for Human Toxicology. He is a research
assistant professor at the center. He has much experience and a lot of skill in
developing analytical methods for analyzing drugs in various biological
matrices. He has expertise in method development, especially in the use of
different mass spec techniques; hence, as we move into alternative matrices he
will serve as quite a resource for us, and he's got a lot of experience with
the national laboratory certification program, also.
Dr. Mahmoud ElSohly, who is not here this time, but will be the next time, is
president and laboratory director of ElSohly Laboratories in Oxford,
Mississippi. He is a research professor at the University of Mississippi, and
is one of the best-published authors that I know in our field. He has over 170
articles in scientific journals, and is considered a foremost supplier of
high-purity drugs, metabolites, and drug analogs that are used as standards and
controls for drug testing analyses -- and this is all legal.
MR. STEPHENSON: I had the great honor of being one of the contract reviewers
many years ago on the contract that approved Dr. ElSohly's growing marijuana
for the federal government, and it was really quite interesting to see the
concerns that they had at the time about the purity and the security of the
small acreage. I think since then, with so many of the other things that we're
facing with the pro- legalization, as well as the medical marijuana issues, Dr.
ElSohly brings a very special resource to the board. We're looking forward to
having him work with us more closely.
Agenda Item: HHS Update
DR. VOGL (HHS): For those who are new to the Board and perhaps some of the
public attendees who may not be familiar with what we have been doing over the
last few months, last summer we published a proposed guideline for
incorporating specimen validity testing into our Federal mandatory guidelines.
There was a public comment period in which 23 separate commenters submitted
their comments and concerns with the proposed policy. We put those comments on
our website for anyone who was interested to actually review what was
submitted.
After the public comment period ended, we began revising the policy and
preparing the preamble. For those who are familiar with Federal Register
notices, there is always what is called a "preamble." It is a discussion of the
public comments with background information, justification for accepting or
rejecting comments, things like that. It gives you our thoughts behind the
final policy. Then you have the Federal Register notice itself.
When we published the proposed policy, we focused on the sections of the
guidelines which would need to be changed in order to incorporate specimen
validity testing into the guidelines. What we have done since that time, when
we publish the final Federal Register notice, is to revise the guidelines in
their entirety so that it will be easier for someone to see exactly how
specimen validity testing fits into the guidelines, as opposed to everyone
taking the current version and trying to insert the changes.
We completed our draft of the preamble and the revised guidelines around the end
of January. A couple of days ago we received a review from our Office of
General Counsel on the draft that we prepared. I think I can say that none of
their comments would delay our going forward with our effort to actually
publish a revised policy. Hopefully, we will be able to start the process of
getting the Federal Register notice signed by the Secretary, and by the next
board meeting we would have that document available and it would be published
in the Federal Register. We will put it on our website so everyone can see what
the policy is.
When we publish it, however, there will be some implementation date several
months after the date it is actually published. We need to give laboratories
the time to implement the policy because not all laboratories are doing all the
different types of validity tests at this time and they will need time to get
those methods in place.
I would anticipate, if we do get the notice published by the next board meeting,
to implement the policy by early next year.
MR. STEPHENSON: Before we move on, one of the things that I think is worthy of
at least comment from my perspective, not only as a person who has tried to
help facilitate improved safety and decreased opportunities for people to game
our systems that we think are fairly effective out there and important
nationally. We've seen a change in behavior that has been documented through
the laboratory data sets that have come into us over the last two years. This
has been probably the most problematic hard science area that a group of
established laboratorians have had to address. We all know well how to do drug
testing, per se, and we've had to learn several new things and incorporate
knowledge and interpretation skills from the clinical area when we began to
look at specimen validity testing.
What I am very pleased about is that we have -- because we have tried the very
best that human beings can to do the best job based on science and skill and
knowledge, we have actually changed human behavior. We have seen the numbers of
adulterated and substituted specimens fall almost in half each time we've
looked at a data set from one year to the next, and in one lab that focuses a
lot of their efforts on doing highly-technical and difficult adulteration
testing, we've seen it drop by half in maybe six months time from one time
slice to the next.
This is something that's very important to remember as we go forward, because it
isn't so much a case of catching people as it is to deter people, and if we can
drive the science in such a way that improves the quality of the test, the
integrity of the system, the safety of the public, and provide safeguards to
those that are being tested simultaneously, we've done the best that we can
possibly do, and I think that's kind of where we are growing and developing as
this SVT testing moves along.
Now, an update on the alternative specimen guidelines?
DR. VOGL: For those who are unfamiliar with what we have been doing, we have
been looking at alternative specimen testing, which includes hair, sweat, oral
fluid, and on-site testing for the past five years. It is not a fast process,
but it is steady and we are moving forward.
We have four drafts that we worked on as far as proposed guidelines, and they
are all on our website. Hopefully, you can find them. We actually have a fifth
draft which was prepared late last year. Again, it is a typical Federal
Register notice. It includes an extensive preamble, which goes into the
background and all of the reasoning and justification for us to expand our
urine drug testing program and to incorporate the testing of alternative
specimens and on-site testing into our program.
The notice, itself, the guidelines, are in a totally different format. We call
it "plain language" or "plain English." It's a question and answer format
following DOT's Part 40 revision. Hopefully, it is easier for people to go
through the document and to understand what the proposed policies are.
We have had the notice reviewed by our Office of General Counsel and they
submitted extensive comments on both the preamble and the guidelines,
themselves. I have been working on addressing those comments, and it is moving
along quite nicely, but we do have to keep one thing in mind. We cannot publish
this notice until we actually get the SVT notice published, because all of what
is in the SVT notice is actually in the alternative specimen version of the
guidelines. So until we get our final policy established, we cannot publish the
alternative specimen guidelines.
Hopefully, it would be published within a reasonable period of time after the
SVT Federal Register notice is published. There will be a long public comment
period. Obviously, it is such a big difference from just urine testing,
incorporating all these other specimens and on-site testing. It would probably
be at least a 120-day public comment period and we expect to receive a
significant number of public comments on a number of issues that would be with
the testing of these alternative specimens.
That's where we are with that notice. Again, there were no comments from our
General Counsel's office that would stop us from going forward. It's just we
need to address the comments, add more discussion in the preamble on certain
issues, and keep going forward.
We started five years ago and it looks like we are actually getting to a point
where we are going to have proposed guidelines published some time this year. I
am very optimistic. I hope everyone else is.
MR. STEPHENSON: In regard to this whole issue, this is not something that the
Drug Testing Advisory Board, by itself, was able to accomplish. It took true
active partnering with our industry-lead working groups and with the industry,
in general, to look at the technology, the gaps, the questions that the members
of the Board had, and how they addressed them. I would say that all of the
technologies are significantly better and stronger today because of the process
that collectively we have gone through to get to where we are.
This is very important. This has moved the United States technologically so far
ahead that when this kind of new technology is incorporated fully as
alternatives or as complementary testing in the current environment, we will be
able to look at added controls for specimen integrity and to deter those who
would cheat on the drug test or try to suborn the process of testing, choosing
a drug use lifestyle rather than avoiding it or seeking treatment.
This is a very powerful part of our whole process. This is a living system. It's
not a static set of rules and regulations. We get reminded of this every time
we look around and see a new drug show up or some new test that is being
offered on an alternative lifestyle website or magazine on how to beat a test,
and we never have a chance to settle down and just learn to do something in a
routine manner, but I think that is the nature of where we are in our society
and in our times.
I'm really very pleased. I want to thank everybody who has participated in this
process, because I think we've finally gotten it to a point where we can take
it to the next step, put it out for formal public comment to the general public
who have not had a chance to see this and work with it, and to fully understand
the concerns that could be out there from a lot of different people that
haven't had a chance to work with us yet.
DR. BUSH: One more thing. Just to follow up with what Bob just said right now,
no pressure here or anything, but the world is watching. We get phone calls
from overseas. We certainly get e-mails from overseas. We get visitors from
overseas who want to take a look at the process and are fascinated by this
process. Many of the countries that we speak with, the representatives of the
countries realize their countries have not had workplace drug testing in place
and realize that their needs for workplace drug testing that may be exemplified
by tragic accidents are in their future. They take a look at where we are and
where we have been and they see themselves behind us, but, nevertheless, they
see themselves moving along.
So not only do we serve for the Secretary of Health and Human Services. That is
what we all are doing here. Yet, we stand as a glowing beam of what a process
is about in moving that technology forward. That's the rest of the complement.
Agenda Item: DOT Update
MR. EDGALL (DOT): Under the Federal Advisory Committee Act (FACA), a plan has
been approved by Secretary Mineta to approve establishing an advisory committee
to look at the Electronic Transfer and Storage of Drug Testing Information. The
Secretary is currently in the process of selecting the members for that
committee.
The responsibility of the committee or the goal of the committee is to establish
specific criteria for the transmission and storage of drug testing information,
specifically concentrating on the security of that information. Secondary,
additional items are formats around the drug testing information as it flows
from the laboratory to the medical review officers, and also electronic
signature technology. The members will represent the affected industries. There
will be laboratories, medical review officers, other service agents, employers,
associations, and labor.
The anticipated date of the selection of those members, hopefully that will
occur in March, so we are looking at our first meeting to be held approximately
two months after the selection of the members. It takes time to schedule rooms,
and things of that nature, and to notify the members. There will probably be
about three meetings.
Also, at the last meeting, I announced that we were working on a one DOT MIS.
Currently, there are a multitude of MIS formats that stretch across the six
operating administrations for DOT, and we are in the process of putting out a
notice of proposed rulemaking to drop this down to one form to report both drug
and alcohol information. This would be anticipated for use in the next
reporting year, 2003, or in 2003 for the reports for 2002. That is in process.
Also, as you know, we put out our Part 40 in December of 2000, technical
amendments in August of 2001, and since then we have -- even though we also use
the plain English approach to our rules, have had a series of questions and
answers that we have placed on our website. We had round one in September, and
we added round two in January. That is on our website at WWW.DOT.GOV/OST/DAPC.
If anybody missed that, I can give it to them offline later.
A feature that we have is that you can register your e-mail address with DOT,
and future rounds of Q&As will be sent to you automatically.
We do have one item of especially good news for the Department within the drug
and alcohol testing area. DOT hired a new employee assigned to the U.S. Coast
Guard Operating Administration. Robert Schoening is the drug and alcohol
program manager. Bob is here with us today. He is no stranger to the Drug
Testing Advisory Board, but since he was hired in January he attends his first
DTAB as a DOTer. It's no under-statement -- Bob was a tremendous addition to
DOT. He comes with a wealth of experience from the private sector and will help
DOT greatly.
MR. STEPHENSON: And one other comment, for the general public. What is his phone
number?
MR. SCHOENING (DOT): My phone number is 202-267- 0684.
MR. STEPHENSON: Now, somebody might suggest that this is irrelevant in a meeting
like this, but I can't tell you how many thousands of phone calls we get a year
because the Coast Guard had previously published on their form to call our
number whenever they need to find anything.
So for those of you who didn't get it -- 202-267-0684. Now, in case you don't
get it, we'll make sure it is incorporated into the public minutes of the
meeting that will be posted on our website. Thank you very much, Bob.
DR. BUSH: Actually, I want to take a minute and talk about the issue that has
been such a -- I mean, we know we're SAMHSA customer service, but we didn't
realize that we were advertised as SAMHSA customer service in a lot of the
material that was on Coast Guard's web and handed out to them. But, you know,
when we think about companies, drug-free workplace, you know, you think about a
workplace. You probably have a few people there. Well, there's many, many, many
independent mariners who need to comply with DOT drug testing rules and
regulations, and they need drug testing, and they know they need drug testing,
and so many of these individuals call us for the lab list or find it on the web
and then show up at the lab or to provide a drug test. "Hey, I'm here. Can I
please give you my drug test?"
Then, if perceived sufficient help from the laboratorian or laboratory site
isn't provided to these individuals, they call us back and say, "Your
laboratories aren't helping us." And it's, like, oh, my god, then you realize
you have individual donors going. Many of them do not understand or realize
that they need a medical review officer in the process. What's going to happen
to the result? How about the billing? I mean, there's all kinds of issues with
individual people showing up at laboratories.
I tell you this to let you know there are different dimensions to workplaces.
This is one prime example that is focused on a Federal workplace, and this is
the job that Bob Schoening has stepped into, to try to get systems set up to
help these people who are trying to get a drug test.
MR. STEPHENSON: It is truly a global process. Donna said some of these people
don't know they need an MRO. Some people I don't think know they need a
specimen container, either. But, anyway, you'll be able to bring all of that
into focus, and I'm sure with your background the kind of information and tools
which are public education and awareness will be particularly useful in helping
do the outreach and getting the information to these folks.
Agenda Item: Cycle 4 PT Results
DR. MITCHELL (RTI): We're going to go through these tables. I was trying to
prevent us from having the task of trying to go through the tables. I think
what I'll do is I'll give you some information that is on the slides and at
your leisure I'll let you go through these.
For those who have been involved in the hair PT program, they realize that last
August we had a fourth cycle of PT samples that was sent to laboratories. There
were some notable things about this that we'll go through a little bit later.
Note: The tables for Cycle 4 are on the DWP website:
http://workplace.samhsa.gov
Next slide, please.
The parameters for this particular cycle was that we had 20 samples. Eighteen of
the strand samples were spiked at RTI. The other two were actually strands from
drug users. All the instructions to the laboratories were that all the samples
were to be subjected to initial testing by amino assay, and then confirmation
analysis was to be conducted under two protocols: one, if they had a wash in
which they went through and washed the hair prior to analysis by MS, and also
we would like to see the samples not washed, analyzed without the wash.
Next slide.
In this cycle, we were attempting to fill in some holes that we had and to look
at the proposed cutoffs for amphetamines and opiates, so this cycle was
primarily directed toward amphetamines and opiates and the analytes within
those drug classes. Some of the hairs also contained some marijuana, and one
contained cocaine in its metabolites. I'm not going to say anything about that
today, but I will cover the amphetamines and opiates.
Just to remind you of what the cutoffs are for the amphetamines, it is 300
picograms per milligram, and for the opiates it is 200 picograms per milligram.
The labs were sent, since we had asked them to test by confirmation, washed and
unwashed or not washed, we sent them 200 milligrams of hair, so we sent double
the amount that we normally send to the laboratories.
Next slide.
Now, what I'm not going to do is I'm not going through these tables. For those
of you who have been here in the past, you know what a task that is, and I
think that today what we'll try to do is go through some of the highlights and
some of the things that we saw and some of the things that we were looking at,
and if you're interested in the individual results for each of the samples,
that information is in this packet.
Very quickly, let's go through the packet and see what is contained in here.
Table one, as it has been in the past, is the results of initial testing by
amino assay of the 20 samples.
Table two is actually divided into four parts -- A, B, C, and D. A and B -- 2A
and 2B are test results that were conducted as a result of amino assay
positives, so if a lab did not screen a sample positive, then they would not
have results in this particular table. This was done, both information for hair
not washed and hair washed, as you can see.
Table C and D are essentially a summary or the gathering together of all the
results for not- washed hair and washed hair. So what we did, if there were
analytes that a laboratory did not detect by amino assay, then we would go back
and ask them to do additional testing, so this is the directed phase.
This gives us an idea of what we can do if we are directed and what we may need
to look at or what we're looking at if we're dealing only with amino assay
results, what type, so it gives us some idea of what type or what percentage of
the positives we will see.
Now, this first slide is kind of a summary of the initial testing for
amphetamines. As you can see, I set the scale so that we have 300 as being the
first bar. You can see that at around 300 we got around two- thirds of the
samples were screened positive. It wasn't until we got up to about 900 that we
started seeing 900 to -- about 800 to 900 we started to see 100 percent. This
was primarily the -- it seemed like one of the amino assays that was used by
one of the laboratories did not quite have the sensitivity that the other
laboratories did, and that's the explanation for those results.
Next slide.
With the opiates, when the morphine was at 200 you can see that we got
approximately two-thirds of the samples positive or screened positive. As we
went on up double or twice the cutoff, then we saw that we approached 100
percent as far as screening those analytes which were there.
It would appear from these results that there is not an additive effect of the
analytes. They primarily seem to be directed for morphine.
Next slide, please.
Looking at the confirmation of the spiked hair samples and the type of results
we got for both the washed and not-washed samples, the not-washed being blue,
the washed samples being in the red, you can see that for amphetamine the
results were comparable down below the cutoff, but when we got up above the
cutoff we saw that there was considerable loss of material as the wash was
conducted, and the amount or the means of those wash cycles was somewhat
variable. I couldn't make a lot of sense of the results. It seems like that the
amount probably is -- this is due to the amount of analyte that's removed by
the different wash materials or wash procedures is different or is going to
differ.
Next slide.
Same thing with methamphetamine. We saw a similar pattern, and especially when
we got on up to the higher concentrations well above the cutoff, about three
times, two to three times, then we saw great variability in the difference
between the washed and the not washed.
Next slide, please.
Morphine -- seemed like we lost a lot of morphine. The procedures were pretty
good at removing morphine from the samples. As you can see, it almost looked
like above twice the cutoff -- the cutoff is 200 for these -- that you reach
some type of plateau in which the -- for the morphine. We don't have enough
data at this time to really tell what's going on because of variability that we
see.
Next slide.
With the 6-M we see a lot of variability, and, again, we see the loss with the
washing procedures.
Next slide will be the codeine. I'm just trying to run through these. Codeine we
see something similar to morphine. We see a great loss, and we see this kind of
a plateauing out here in the analysis for the amount that remains after
washing.
Variability -- as a measure of variability, we use a thing called a "CV," which
is nothing more than the standard deviation divided by the mean expressed as a
percent, and it gives us a general feel of what the variability is.
Now, if you remember, the last time I presented this I was showing the
variability between the different matrices, the type of variability they were
seeing versus what we see in urine. In urine, except for THC, the variability
is usually well below 20 percent, the CV is. Normally it's 10 percent or less.
THC will get into this range. But we're still dealing with a great deal of
variability in these assays.
It didn't appear that -- I really can't say that the variability seen in the
washed or in the unwashed samples was any different. I would expect the
not-washed samples to have less variability, but I did not see that, as you can
see, because the not washed are in the blue.
In this pattern -- next slide -- we see the same type of pattern in the
methamphetamine. Keep going to the opiates' variability and the morphine
ranging anywhere from 20 to 80 percent. This is between labs, values reported
by the laboratories.
And 6AM, this represents the sample that had 6AM in it. It was a user's hair,
and the variability there did not appear to be as great as it was in some,
which is a measure of the spiked samples, but still there's not enough data
because we have one right next to it that has similar variability, so I'm not
sure that we see any difference. At this time I can't say that we'd see any
difference in hair that was from a user versus hair that has been spiked with
the analytes.
Next slide, please.
As I said, the purpose of this was to look at the -- to fill in some holes. The
light blue bars are the means that we had gotten from previous analysis in
previous cycles for amphetamines. As you can see, the dark ones are the means
that we obtain from amphetamine or methamphetamine concentrations,
methamphetamine challenges on this cycle. You can see that now we have gone all
the way from well below the cutoff of 300 for methamphetamine all up to about
nine times, almost ten times the cutoff, and we've been able to look at the
laboratories and their ability to analyze around the cutoff.
Next slide, please.
Same thing for amphetamine. The reason I put methamphetamine, that's the one
most of the labs are focusing on. Amphetamine is a minor metabolite of
methamphetamine and can appear as a result of methamphetamine metabolism, but
amphetamine is still used by some people. It's not that great any more, but it
still can be used, and so we did look at that.
The concentrations of methamphetamine, as we might expect, even in users' hair
tends to fall below the 300 cutoff.
Next slide.
Morphine concentrations -- again, we're filling in the holes and we've gone all
the way up to about seven times the cutoff.
I think I've got two more slides.
Six-Acetylmorphine, same way. You can see that we've really concentrated around
the cutoff in this one on either side of it. This would be a metabolite that
would be indicative of heroin use, and so it is a very important one and would
be the one that would be attacked in court cases, this particular analyte, and
so it looks pretty good. We've been able to go across a wide range of
concentrations in six-acetylmorphine.
Last slide, I believe, is the codeine concentration. Codeine is a minor
metabolite, would be found in heroin, but would also be found in the use of
codeine. You would find it in the hair. But we did cover the concentrations
around the cutoff and fill in the holes.
So it looks like we have provided enough data across the range that we would be
interested in for the Drug Testing Advisory Board to assess the abilities of
the laboratories to analyze at concentrations on either side of the cutoff.
This data does present some -- and I'll say this from my part -- it would
present to me, as a PT or managing a PT program from hair, the variability of
these assays causes a big problem, because then what standard do you use to say
whether or not a laboratory is meeting the criteria that are a set criteria,
because when we have variability between laboratories of plus or minus 40, 50
percent, in urine a 50 percent error is a major error and gives the possibility
of the laboratory being removed from the program.
From a standpoint of PT, it presents a problem in that, with the variability
being that great, it would also indicate that that is not a valid sample if we
use the urine criteria because the CVs are too high for that particular sample.
I don't know what the answer is. Maybe there needs to be additional
standardization within the industry, standardization of procedures and
standardization of the equipment that's used and standardization of the wash
procedures or non-wash procedures that are used, so these are issues that the
industry needs to consider, as well as the Drug Testing Advisory Board.
DR. SAMPLE (DTAB): You show the bar graphs with the coefficients of variation.
DR. MITCHELL: That's correct.
DR. SAMPLE: Could you speak to what the concentrations were in those samples,
because they were just labeled one to seven. There was actually no
concentration associated with those.
DR. MITCHELL: Right. The concentrations are increasing. I do not have those
values with me right now. But it is increasing from left to right.
DR. SAMPLE: They were ordered from low to high?
DR. MITCHELL: That's correct. I should have said that. I'm sorry, Barry.
DR. SAMPLE: And will you be providing that data for us?
DR. MITCHELL: Yes, I will provide that data for you.
DR. SAMPLE: Okay. In looking at the washed versus the unwashed, at least in the
user hair population, did you see any differences on these as part of the
variability of function of the fact that they're spikes versus a real sample?
DR. MITCHELL: I have looked at that, and no, I do not see a difference in the
variability, but one of the problems in assessing the data is that many times I
obtain values which were ten times what the mean of the labs were from a single
lab or two labs, and so you wonder is it an administrative error where it is
expressed incorrectly, a dilution was not taken into account. And when we went
back to laboratories and queried them, we didn't get an answer. And so I can
only go with the values that I've got.
This type of thing makes it extremely difficult to determine where I am, and
that's why I said we need some additional type of standardization. Within the
industry I know that there are different ways of reporting the concentrations
other than what HHS is currently proposing, and so I wonder if we don't have
problems in converting from one unit, one set of units to another. It has been
somewhat difficult, and I haven't gotten answers to those questions.
DR. SAMPLE: Were any of these samples paired? In some of the previous PT sets
there were some duplicates to assess intra-laboratory variation.
DR. MITCHELL: Not in this set.
MR. EDGALL: I have a question. On your hair PT samples, do you submit hair
samples of different colors -- light hair, dark hair? And are there any
variations in the results?
DR. MITCHELL: I have not looked at that. No. I tried to -- the difficulty that I
have with the PT is that I try to use a single -- whenever I do or make
concentrations I try to use hair from a single source, and those experiments --
that is, with different-colored hair -- have not been conducted at this point
in time.
MR. EDGALL: Is that something that's planned?
DR. MITCHELL: I'd like to do it.
MR. STEPHENSON: This is an issue that has kind of grown up with this whole
process. The PTs and the issues of PT value are instructive for us, not only
for hair but for all of the other alternative matrices, too, because this is an
area, again, we have to learn, we have to access sample material, we have to
look at the ability to either spike it or obtain it from real users to develop
collaborations with those that are involved in treatment programs and have
access to populations that, in the living laboratory of life, individuals have
chosen to expose themselves and produce specimens that contain the targets that
we're looking for.
These are things that are going to have to be undertaken over time. One state
who tried to do this -- I think it is the State of Florida -- had abandoned the
process for hair because it was too difficult for them to sustain on their own.
We can't stop this process, but we desperately need the additional funds and
commitment to long-term, developmental research. It doesn't mean we have to
have all the answers before we start, but it underwrites the primary forensic
responsibility of each and every laboratory to validate their own methods and
to be able to forensically defend them in court.
When we look across labs and look at intra- lab variability, the consistency of
being able to get the same test result on the same specimen, these are things
that are going to have to be demonstrated not to us but in court, and every
time we do one of these PT samples we are sending a message that we are trying
the best we can and that we are learning something each and every time we do
it.
All I can say is help support the process of getting the funds that are
necessary to do this kind of thing from the industry. Look for grant
opportunities. Look for process issues where we can get some in-kind
contributions, maybe access to hair from various treatment provider resources.
Think about it. Think outside the box, and we'll be glad to talk to you about
any constructive way we can try to help make this better over time.
DR. MITCHELL: I'd like to have two acknowledgments. One is that at RTI, Andy
McDaniel and Dale Hart have been instrumental in this work in providing these
samples and getting them ready for the PT samples. Also several laboratories
have been involved in initial testing of these samples, and we've had a lot of
help from Psychemedics Corporation, from APL, and also the Center for Human
Toxicology in trying to determine, after we did a spike, what was the
approximate concentration, because you've got to remember it's not like spiking
a urine. Hair will absorb the material, some of it is on the outside, some of
it is on the inside, and you wash it, and there's all types of things, so it's
not an easy process. It's not one that you can easily predict as to the results
that you're going to get under the current methodologies that we're using.
We're looking at new methodologies at this point in time to give us an
independent assessment without destruction of the hair or extraction of the
hair for the analyte, so we're trying to use some other newer methods to try to
determine the amount of material that's within the hair.
DR. CHILDS: Were the samples exposed to an environment, for example, of cocaine
vapor or smoke and then sent through the process or were these all soaked in a
liquid solution?
DR. MITCHELL: These are all in a liquid solution.
MR. STEPHENSON: I again apologize for the delay in getting this information out
onto the screen, but I think it was worthwhile because it was a good
presentation.
DR. BUSH: Like John said, it's a lot easier than reading those tables.
Agenda Item: Public Comments
CAPT. MORRIS: I am Captain Robert Morris, executive vice-president of the Air
Line Pilots Association, International.
ALPA remains concerned with the integrity of our nation's regulated drug testing
system. Specifically, we find the due process afforded an individual accused of
violating validity testing standards woefully inadequate. Furthermore,
limitations on access to test related information severely compromise the
ability of individuals to challenge results they view as unfounded. The
combination of these factors continues to draw intense judicial, congressional,
and media attention. Labor will not retreat until our concerns are adequately
addressed.
The Drug Testing Advisory Board fulfills a critical role in formulating policies
directly impacting millions of American workers. Let us not overlook that, in
addition to the profitability of drug testing, your recommendations directly
influence workers' continued employment, professional certification, and
personal reputations. Although DTAB is at the nexus of policy development,
seasoned observers sometimes question the comprehensiveness of information
presented to your distinguished panel. In this light, a brief review of recent
development is in order. There are a number of current cases which deserve your
particular attention.
Siotkas v. FAA is the landmark case in terms of validity testing. ALPA's
discovery of egregious behavior by the laboratory involved resulted in a
nationwide inspection of NLCP-certified processing facilities. This inspection
resulted in the cancellation of over 300 individual tests. ALPA believes that a
more-thorough consideration of the issues we raised in this cast doubt on all
substitute findings during that period of time.
Drake v. FAA is presently before the D.C. Federal Court of Appeals. In this case
involving an alleged adulterated sample, the plaintiff challenges a "whitewash"
investigation conducted by the agency charged with ensuring the integrity of
airline testing. The circumstances surrounding this incident are so serious as
to demand widespread attention. The FAA recently announced a $100,000 fine
against the employer in an apparent attempt to shift the public's focus. A
probing report by the DOT Inspector General is evidence of a range of problems
with the testing process and confirms a number of serious concerns previously
raised by ALPA.
The Bosela decision by the National Transportation Safety Board firmly
establishes that this distinguished panel will not accept testing done under
less than forensic standards. An airline pilot was stripped of his licenses
based on a single-step nitrite determination. Hopefully, this ruling puts to an
end ruining a person's career by dip-stick. This ruling emphasizes that two
separate, independent tests are the forensic standards that should apply in
validity testing.
The Nelson case involves a petite flight attendant charged with substituting her
urine sample. Multiple SAP interviews concluded she had no dependency problems
or history of any drug usage. Simply, she is a small woman who consumes a
healthy amount of water. To retain employment, she accepted follow-up testing.
Predictably, again she tested below the substitute thresholds during an
observed follow-up test. The individual then arranged two additional observed
tests sent to separate certified labs. One of those samples was also judged as
substituted. For over nine months, the DOT's acting director of drug and
alcohol policy and compliance attempted to block the MRO's cancellation of her
tests. Today she remains on an extensive program of follow-up testing.
Jones is another flight attendant terminated for substituted who won, through
the Colorado courts, an order to test her split sample over the objections of
the lab, MRO, and her former employer. The split was not found substituted by a
respected certified lab. The DOT's acting director of drug and alcohol policy
and compliance has refused to cancel her tests and no longer responds to
inquiries from her counsel.
Due process can be measured by the progress of real, live cases. Do paper rules
protect the lives of actual workers when they are invoked? As above cases show,
we have a long way to go before obtaining a meaningful balance in our
administrative procedures.
How does anyone clear his or her name? What proof establishes a replication of
results under observed condition? Is DOT and Health and Human Services more
interested in protecting individuals or in protecting the status quo?
Confidence in any system grows through openness, as opposed to restrictions on
information. We can improve drug testing by facilitating challenges and taking
corrective actions when warranted. Unfortunately, the controlling authorities
in this system choose to stonewall legitimate inquiries into the current
rulings and procedures. Freedom of Information requests go unanswered. Calls
from accused individuals lay unreturned. Requests for investigations are
routinely dismissed. This situation is an injustice not only to accused
individuals, but also the entire drug testing community.
I'd like to thank you for the opportunity to address you.
MR. STEPHENSON: Are there any other public comments that individuals wish to
make at this time? (No response.) I'm going to conclude this session of the
Drug Testing Advisory Board. Thank you very much.
