A little over a year ago, while in the midst of a civil custody case
against the government of Missouri, despite years of clean urine test
results, I incurred a false positive hair test for drugs. I began
writing a Trial Brief on the subject of hair testing for drugs
preparatory to fighting this element of the case. The brief turned out
to not be needed because the court declared the test results
inadmissible as evidence. So I never finished writing the Trial Brief.
(I eventually lost the case on other grounds, by the way.)
Anyway, my research, although incomplete and unpolished, may be helpful
to somebody else. I'm posting what I finished, a rough draft of the
Trial Brief. If you can use it, modify it to suit your purposes.
And I'll always be willing to answer any questions regarding this
_What follows is NOT in final presentable form_.
* ROUGH DRAFT * Not a completed work * ROUGH DRAFT *
REGARDING THE RELIABILITY OF THE RESULTS OF HAIR TESTS FOR DRUGS
[I briefly described the case and the reason for the brief.]
Are the results from hair drug tests used in this case reliable in
determining cocaine use?
The reported inventor of the technique to find cocaine in hair, Dr
Svetla Balabanova, reported that in 1992 that she had found cocaine in
the hair of three-thousand-year-old Egyptian mummies that were in German
museum. The find was remarkable because the plant that yields cocaine
only grows in the New World, and pre-Columbian trans-oceanic trade had
never been recorded in history. Her reports sounded convincing though.
She said she was mystified at first, repeated her tests, and had other
labs do confirmation tests. Her procedure was to first do an immunoassay
and to follow it up with "chromatography/mass spectrometry". Discovery
Channel ran a piece on her work in 1996 and so did BBC. All major news
outlets also carried the story. Balabanova was famous - for fifteen
Most of the mass-media accepted her work without question, and carried
articles with such titles as "Pharos on Crack" and "The Stoned Age".
The focus of the articles (other than to sensationalize) was to try to
explain the fact that cocaine was found. Some suggested a trans-Pacific
trade route via the Silk Road through China. Some speculated about
unknown extinct plants that might have contained cocaine. Some disputed
the idea that cocaine was available in ancient Egypt and focused on the
possibility the mummies weren't genuine or that contamination was
responsible. The common perception was that laboratory tests don't lie,
so the cocaine must have come from somewhere.
Nonetheless, the scientific community wasn't persuaded. Dr Sandy Knapp
of the Natural History Museum, London, expressed a polite view:
"Finding cocaine in these Egyptian mummies - botanically speaking - is
almost impossible. I mean, there is always a chance that there might be
some sort of plant there, but I think there is some sort of mistake.
There is something wrong there. I can't explain it from a plant point of
view at all."
Other people, like columnist Cecil Adams, were less charitable:
".right now the general feeling is that it's not the ancient Egyptians
who were on drugs."
Before Balabanova faded back into the woodwork, she found yet more
cocaine in other mummies, some of them a millennium more recent than her
previous group, and some of them were from as far away from China. But
no other published researchers were ever able to duplicate Balabanova's
discoveries. Consequently, mainstream historians disregarded the
discoveries, and the tenets of history regarding early trans-oceanic
trade remained unchanged.
Nonetheless, many books and articles (particularly those from the
pro-cocaine camp) written since Balabanova's announcements continue cite
the discovery as if it were fact. It's an engaging story, and the
concept of the Egyptian rulers using cocaine is appealing. But there's
something else that makes this story acceptable to many: it's the
misguided perception that laboratory tests are infallible and reports of
these tests are made by scientists - impartial truth tellers. Many
simply say something like, "laboratory results have shown".
There's a misguided perception in most of us that laboratory tests are
infallible, and we also believe a reporter of such tests is
automatically credible. Science has had amazing, even mystical,
accomplishments. Science is impartial. We equate laboratories with
science. Thus, hair tests tell the truth. are In our minds there is
something capturing about concept of hair holding hidden information,
and also in our minds, there is an almost religious regard for
laboratory work. Laboratory work is presumably science, and science
deserves respect. But the essence of science is to not have blind faith.
New technologies often masquerade as science, but until they've earned
their stripes by proving themselves under scrutiny and debate, they
cannot be deemed true science. The burden here is solidly on the
affirmative: hair tests must demonstrate their reliability before the
courts, or anybody for that matter, can accept them.
Confusion with Other Tests
Hair testing for drugs should not be confused with other kinds of tests
that have a more established record of reliability.
Hair testing for particular DNA, despite using the same sampling
material as a hair test for drugs, is altogether different. For one
thing, the analyte in the actual detection phase of the test is present
in millions of times the quantity as would be the analyte in a drug
Hair drug testing should not be equated with urine drug testing either.
Urine tests, although still not perfect, have several advantages in
terms of reliability:
? The mechanism of drug deposition in urine is reasonably understood.
With hair it is not clear if the blood, sweat, or sebum is the
? The analyte, if present, would be there in larger quantities in urine
than in a hair test.
? The sample does not need to be washed. The washing step may introduce
contamination and is controversial for other reasons.
? The probability of environmental contamination is less. Urine comes
from inside the body.
? With urine, there is no cutting step. Hair needs to be chopped into
small pieces. This is another place where contamination can occur.
? There is no liquefaction step. Apparently there are three different
ways to liquefy hair. Comparative benefits and hazards do not appear to
be clearly established.
? The relationship between levels of detected analytes and usage has not
been established with hair tests. There have been no large-scale
controlled dosage studies. Consequently, so-called cutoff levels do not
have a scientific basis and are not standardized.
? With urine testing there is a great deal of experience: the procedure
is established and is legally certified. Hair tests are not legally
certified. There is no oversight whatsoever.
Hair tests for drugs are closely related to hair tests for heavy metals
(used for nutritional tests or environmental contamination tests). The
medical establishment currently regards these as unreliable.
The Uncertainty of Hair Analysis for Trace Metals
Steven J. Steindel, PhD; Peter J. Howanitz, MD, JAMA Editorial
Physicians and other health care professionals who are considering
ordering hair analysis to assess nutritional status or who are basing
nutritional counseling or therapy on hair analysis results, should
reconsider this approach unless and until the reliability of hair
analysis value is established and evidence becomes available that
clinical recommendations based on hair analysis improve patient
Reliability of a test for drugs cannot simply be expressed in a
percentage number as Ashley Hern used in testimony to describe the
accuracy of the urine "instant" (a dip test) test he had used. Part of
Ashley Hern's testimony:
Question: How accurate is that [dip or instant urine] test?
Answer: Ashley Hern testified, "Ninety-nine percent accurate."
All laboratory tests are less than perfect. They produce false positives
and false negatives, and sometimes tests are not conclusive one way or
A false positive is when the test shows a positive for a drug when no
drug was present. A clean person getting a positive result would be a
victim of a false positive.
A false negative is when the test shows a negative for a drug when the
drug was actually present. A lucky drug user getting a negative result
would be getting a false negative.
An inconclusive result would be perhaps when a test is unreadable or if
it gave results that were obviously false.
I offer these descriptions to facilitate the discussion of hair tests. I
was unable to find any studies of a statistically significant scale
giving a direct assessment of hair test reliability.
Hair test are not regulated, certified, nor accredited. There also
doesn't seem to be independent scientific assessment of their
Laboratory certification does not in itself guarantee a reliable test,
but a lack of certification for a lab for a test shows that the test
hasn't even reached that level of respectability.
For urine testing, there are two nationally recognized FUDT
certifications: CAP (College of American Pathologists) and SAMSHA.
Neither of these agencies give certifications for hair testing. CAP
currently has nothing to do with hair testing and SAMSHA is in the
process of developing guidelines.
If SAMSHA develops guidelines, one of the proposed guidelines certain to
make it to the final draft is one to require that the test be FDA
approved. The Quest/AML hair test is not FDA approved.
Status of SAMHSA certification for hair drug tests
SAMHSA currently is not certifying laboratories for drug hair tests.
SAMHSA is developing a draft for guidelines for such testing and is now
asking for public comment.
STATEMENT FROM SAMHSA
Presently, urine is the only specimen collected for Federally
regulated Workplace drug testing programs and for most private sector
programs. Urine drug testing in the Federally regulated Workplace is
currently recognized as the "Gold Standard" because of its proven
accuracy, reliability, and fairness. This "Gold Standard" status is
Use of Forensic Custody and Control Procedures from specimen collection
to the final analytical procedure in the laboratory
Exhaustive quality assurance procedures for both the initial and
continuing certification of the laboratories in the National Laboratory
Analytical procedures to ensure no false positive results and minimize
false negative results
Review of laboratory positives by a trained Medical Review Officer (MRO)
for alternative explanations and as another quality assurance reviewer
of the entire process
Procedures to ensure confidentiality of the donor throughout the process
including the reporting of results to the employer
There are a number of different biological specimens that can be
collected and tested for drugs, although urine is the only specimen
collected for Federally regulated Workplace drug testing programs and
for private sector programs that use the Federal standards. Testing hair
specimens is becoming more common in some unregulated, private sector
programs. Oral fluids and sweat are also used in some testing programs
and non-instrumented, on-site test devices are available for screening
of both urine and oral fluids.
Although the technologies of hair, oral fluids, sweat and
non-instrumented, on-site drug testing are not currently approved for
use in Federally regulated Workplaces, the Substance Abuse and Mental
Health Services Administration (SAMHSA) through its Division of
Workplace Programs and Drug Testing Advisory Board (DTAB), is actively
appraising, in partnership with industry, the eligibility of these other
biological specimens and devices.
The FDA has not granted approval to the hair test that Quest/AML used.
And since the FDA regards hair tests as medical devices under its
jurisdiction requiring pre-market approval, Quest/AML possibly sold the
FDA'S PROPOSED POLICY FEBRUARY 6, 1997
WILLIAM B. SCHULTZ, DEPUTY COMMISSIONER FOR POLICY
FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
COMMITTEE ON COMMERCE
U.S. HOUSE OF REPRESENTATIVES
companies seeking to market a system that uses a hair test or any other
test that has not been recognized by FDA would need to establish the
validity of the test with FDA prior to marketing.
DFS and the GAL go to significant lengths to elicit testimony from its
urine testing contractors saying that the urine tests are SAMHSA
approved or certified. Ashley Hern made two statements to this regard
(in previous testimony in this case) to promote the veracity of his
urine tests. DFS&GAL are, by extension, arguing that such approval is
important in judging the reliability of the urine tests.
Pathway of Entry
It's not clear by what mechanism drugs enter the hair. The sebum, blood
or perspiration could each be responsible for delivery.
ANALYSIS OF HAIR FOR COCAINE
Gary L. Henderson, Martha R. Harkey, and Reese T. Jones
..the mechanism of how drugs enter the hair remains unknown (Cone and
Wang 1995; Kidwelland Blank 1995). Understanding the pathway of drug
entry into hair is important for interpretation of results, i.e., if
drugs get into hair only from blood there is less risk of contamination
and more likelihood of dose-concentration and time-location
relationships existing; however, if sweat or sebum are important
contributors, then these relationships are expected to be much less
reliable and introduce the risk of environmental contamination.
Current RIA (radioimmunoassay) techniques were developed for urine,
which comes from inside the body. Hair is a different medium that is
contaminated by a wide variety of substances, and the potential for
cross-reactivity of the test to other substances, perhaps substances
that might enter the hair form the air, has been established.
ANALYSIS OF HAIR FOR COCAINE
Conclusion, Analytical Methods
However, because cocaine is the primary analyte in hair, the antisera
should be directed at cocaine rather than BZE, as is the case with many
RIA kits used in urine drug screening. Analysts also should be aware
that most commercially available RIA kits are designed for urine
specimens and therefore have not been evaluated for possible matrix
effects from different hair digestion techniques or for cross-reactivity
to other possible components in hair, such as cosmetics.
On those drug tests that give results in terms of numbers, the results
are usually given in a ratio (picograms per milligram or nanograms per
milligram) of the
analyte to the substance as a whole. This can be called a concentration
of that analyte.
The cutoff is a pre-designated concentration, above which the sample is
declared positive, and below which the sample is declared negative.
Currently, there is no government established cutoff levels with hair
tests, and different companies have different notions of what is
ANALYSIS OF HAIR FOR COCAINE
Conclusion, Dose-Response Relationships
The correlation between the dose of cocaine and the amounts of drug and
metabolites detected in hair is unclear at the present time and remains
controversial. Most studies have shown few correlations between dose of
drug and concentration found in hair.
When cocaine is metabolized, it results in several higher metabolites in
addition to the parent drug cocaine itself:
Ecgonine methyl ester (EME) (aka anhydroecgonine methyl ester)
Cocaethylene (a.k.a. ethyl cocaine)
Ecgonine ethy ester
N-desmethyl benzoyl ecgonine (norBZE).
The testing company in this case cast its results as a "pg/mg" level of
"Cocaine/Metabolite(s)". It's not clear if this results indicated the
concentration one or the other or both combined, and Quest/AML didn't
indicate which metabolite it was referring to.
Benzoylecgonine (BZE) is the most common tested-for metabolite with
urine RIA tests. But characterization or BZE as a metabolite shouldn't
force the conclusion that BZE had to be the product of cocaine
metabolized by the body. BZE is simply cocaine with a methyl group
(-CH3) replaced with a simple hydrogen. In other words, BZE is cocaine
with a part hydrolyzed, that is, reacted with water.
This reaction can easily take place outside the body. BZE, thus, may
technically qualify as an in vivo metabolite, but it also can develop
from cocaine in any environment, and finding BZE is not indicative that
the original drug passed through the body. Other metabolites, such as
EME, are believed to arise solely from in vivo metabolism. A credible
test for the use of drugs would at least check for EME or some of its
The presence of EME in a sample would tend to show that someone had
actually ingested the drug. This is not foolproof, of course, because a
contaminant could be from someone else's sweat that contains EME.
(Remember, we are discussing exceedingly small amounts.) Nonetheless,
testing for EME would eliminate many false positives in a hair test for
The Quest-AML test results gave no indication of which metabolites it
tested for (if indeed it tested for any). And considering the way
Quest-AML presented the results, it appears that Quest-AML only
performed an immunoassay with antibodies that had an affinity to at
least both cocaine and BZE. Results form gas chromatographic-mass
spectrometric procedure would have given separate numbers for each
substance and would have identified the substance. And there would be a
ratio between these two concentrations.
Reference: Simultaneous GC-MS analysis of meta- and
para-hydroxybenzoylecgonine and norbenzoylecgonine: a secondary method
to corroborate cocaine ingestion using nonhydrolytic metabolites
Klette KL, Poch GK, Czarny R, Lau CO
Navy Drug Screening Laboratory,
J Anal Toxicol 2000 Oct; 24(7):482-8
Passive or Involuntary Exposure, External contamination
A decent drug test only tests positive for voluntary ingestion (by
whatever means). If the test is testing for involuntary exposure, then
anybody could test positive. Since hair is on the outside of the body
and since the amount needed to yield a positive result is infinitesimal,
involuntary exposure is a recognized problem.
Hair samples are particularly susceptible to environmental
contamination; hair will become tainted by drug residue in the air from
drugs which are smoked (marijuana, crack, heroin) or by physical,
external contact with the drug. Thus a hairdresser or girlfriend, with
residue on their hand, could unwittingly contaminate a test subject's
hair. Tests with a high threshold, designed to screen out environmental
contamination, will also screen out many users. Washing the samples
prior to testing may also wash out the substance which was absorbed into
the hair through the subject's body, thereby defeating the purpose of
the test. Furthermore, samples may reveal a substance use history dating
back months or years, defeating its use, for example, as a probation
Robert O. Bost, Hair Analysis -Perspectives and Limits of a Proposed
Forensic Method of Proof: a Review, Forensic Science International 63
The Validity of Self-Reported Drug Use: Improving the
Accuracy of Survey Estimates
Lana Harrison and Arthur Hughes
..Research has demonstrated that passive contamination occurs, and that
procedures to remove external contamination are not effective (cf.,
Kidwell and Blank1995). The basic pharmacological relationship between
drug dose and concentration in hair has not been demonstrated; the
amount of drugs incorporated into the hair depends on a variety of
factors (Kidwelland Blank 1995). The relationship between time of drug
exposure and location of drug in the hair strand has not been clearly
established. Studies with labeled cocaine have found only a limited dose
and time relationship (Cone 1994a; Henderson et al. 1993; Kidwell and
+ Finale Argument
Because of the unproven reliability record of the test in question and
of hair tests in general
..and because of the lack of standardization of hair test procedures,
..and because of the lack of certification of the process used to test
..and because of the lack of governmental oversight for the testing
..and because of the lack of additional supporting evidence to the
inference produced by the hair test results - i.e., there is no evidence
nor history of [...] taking cocaine.
Hair tests for drugs in this case should not be given a picogram of
credibility. The court should not rely on hair test results whatsoever.
Laboratories accredited by the College of American Pathologists meet
exacting standards set by the College's Commission on Laboratory
Accreditation and approved by the College's Board of Governors.
American Medical Laboratories, Inc.(AML) http://www.aml.com/
Associated Pathologists Laboratories Division, now part of Quest
[I may add here, that these hair testing companies were evasive when I
asked in detail about the reliability of their tests. Call them
yourself, or call the particular company involved in your case. You'll
get some good quotes.]
4230 Burnham Avenue
Las Vegas, NV 89119
The substance being measured in an analytical procedure.
Human or animal serum containing antibodies that are specific for one or
Ashley Hern (816) 868-0500
The de facto owner of DRAGNET and the person who collected the hair
samples. His company contracts for the Division of Family Services (DFS)
A cocaine metabolite with the molecular weight of 289
College of American Pathologists (CAP)
http://www.cap.org/html/general.html (800) 323-4040, EXT. 6065
The College of American Pathologists (CAP) is a medical society serving
more than 15,000 physician members and the laboratory community
throughout the world. It is the world's largest association composed
exclusively of pathologists and is widely considered the leader in
providing laboratory quality improvement programs.
A pre-designated concentration of an analyte, above which the sample is
declared positive, and below which the sample is declared negative.
Ecgonine methyl ester (EME)
Also known as anhydroecgonine methyl ester; an in vivo metabolite of
U. S. Food and Drug Administration
FUDT (Forensic Urine Drug Testing) CERTIFIED laboratory
[CAP (College of American Pathologists) or SAMSHA]
A tubular infolding of the epidermis containing the root of a hair.
The chemical reaction of a compound with water, usually resulting in the
formation of one or more new compounds.
In the living organism, as opposed to in vitro (in the laboratory).
JAMA Journal of the American Medical Association
A substance produced by metabolism. For the purposes of this paper, a
breakdown product from the body's metabolism of a drug.
one billionth of a gram; 0.000,000,001 gram; 10-9 gram
NIDA National Institute on Drug Abuse http://www.nida.nih.gov/
SAMHSA Substance Abuse & Mental Health Services Administration
http://www.samhsa.gov/ , part of HHS
Office of Policy & Program Coordination (OPPC) 443-4111
Center for Substance Abuse Prevention 301 443 0365
Division of Workplace Testing 301 443 6780 Charles L Mrs. Hersh
one trillionth of a gram; 0.000,000,000,001 gram; 10-12 gram
Psychemedics Corporation http://www.psychemedics.com/
A company that sells and performs hair tests for drugs
1280 Massachusetts Ave.
Cambridge, MA 02138
Quest Diagnostics Incorporated http://www.questdiagnostics.com/
The company that now owns AML
An abbreviation used in this document to describe the company formed by
the combination of Quest and AML
A type of assay technique that uses radioactive antibodies to attach to
target antigens in the sample. A gamma counter is then used to quantify
the amount of antibodies that have found and attached to antigens
The fatty lubricant matter secreted by sebaceous glands of the skin
Society of Forensic Toxicologists, Inc. (SOFT) http://www.soft-tox.org/
* ROUGH DRAFT * Not a completed work * ROUGH DRAFT *
* Nehmo Sergheyev *