Pathology laboratories in Australia that want to be eligible to
access the Medicare Beneits Schedule (MBS) must be accred-
ited by the National Association of Testing Authorities. NATA
accreditation is a rigorous process that assesses laboratory
management, quality systems and analytical performance, and
also requires the tests performed to have characteristics demon-
strating clinical utility. As an example, there must be an asso-
ciation between a genuine clinical condition and the
interpretation of the test, and the results of the test must be
useful to the individual patient or the broader population.
If laboratories do not access the MBS and bill the full cost
of the testing to the client directly, they are not required to be
NATA-accredited. Hence none of the complementary and
alternative medicine (CAM) laboratories in Australia are. In
other words, there is no external oversight of what happens in
these laboratories, and they offer a variety of tests that don’t
meet the clinical utility requirements required by NATA.
This situation allows alternative practitioners and alterna-
tive laboratories to use dodgy tests to make dodgy diagnoses.
Some examples are:- the use of salivary hormone proiles to diagnose “adrenal
fatigue”; - unvalidated tests to diagnose Lyme disease;
- IgG antibodies and “cytotoxic” tests to diagnose food and
other “allergies”; and - post-chelation urine heavy metal analysis to diagnose “heavy
metal poisoning”.
The Therapeutic Goods Administration (TGA) has insti-
gated changes to the system that will have a limited effect in
improving this situation. All in-house developed tests must be
NATA-accredited by the middle of 2017. Laboratories are
likely to be asked to provide the evidence base to demonstrate
clinical utility of the results and the way they report such tests.
If there is no evidence that tests have a relationship to a genuine
disease or that the results have genuine clinical utility, then
such tests should be denied accreditation and thus laboratories
will not be able to provide them on a commercial basis.
All commercially supplied diagnostic testing devices must
by now be listed on the Australian Register of Therapeutic
Goods. ARTG listing is a sponsor-driven process where the
sponsor (the supplier) submits a dossier of documents to support
its case for listing on the ARTG.
The TGA does a good job at regulating and scrutinising
high-risk medical devices, but its record in regulating what it
classes as low-risk devices is poor at best. The TGA appears to
lack the will and the resources to properly scrutinise low-risk
devices before registering them.
Even worse is the decision to accept conformity assessment
by recognised bodies in other countries, such as the European
Union’s CE Marking. An example is the ALCAT testing instru-
ment, which automates a form of cytotoxic testing to detect
sensitivities to foods and other environmental substances. This
machine has a CE mark obtained in Germany, where it is manu-
factured, and it is used in Australia. Cytotoxic testing using the
ALCAT device for food and other sensitivities has been
condemned as useless and misleading by nearly every profes-
sional allergy and immunology body in the world, including
the Australasian Society of Clinical Immunology and Allergy.
The TGA, however, is happy to list this device. If the TGA
looks at anything at all, it will only look at the dossier provided
by the instrument supplier, and the TGA staff involved lack
the expertise to evaluate whether this is incomplete or biased.
CAM practice and CAM laboratory testing are not a risk-
free and harm-free zone. The large amounts of money spent
on CAM laboratory testing is wasted in most cases. False-posi-
tives or false diagnoses lead to further unnecessary treatment and
cost. Also, management of chronic and sometimes serious condi-
tions such as arthritis, diabetes, thyroid disease and cancer may
be unethical and dangerous if the only beneit to the patient is
via the placebo effect, and effective management strategies are
delayed or prevented.
Bruce Campbell is a retired chemical pathologist and the Editor ofLab Tests Online-AU.46 | JUNE 2016
THE BITTER PILL Friends of Science in MedicineDodgy Tests and Dodgy Diagnoses
Lax regulation of complementary treatments is allowing alternative laboratories to peddle
expensive and useless diagnostic tests.