Australasian Science: Australia's authority on science since 1938

Dodgy Tests and Dodgy Diagnoses

By Bruce Campbell

Lax regulation of complementary treatments is allowing alternative laboratories to peddle expensive and useless diagnostic tests.

Pathology laboratories in Australia that want to be eligible to access the Medicare Benefits Schedule (MBS) must be accredited 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 demonstrating clinical utility. As an example, there must be an association 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 alternative laboratories to use dodgy tests to make dodgy diagnoses. Some examples are:

  • the use of salivary hormone profiles 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 instigated 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 instrument, 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 manufactured, 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 professional 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-positives or false diagnoses lead to further unnecessary treatment and cost. Also, management of chronic and sometimes serious conditions such as arthritis, diabetes, thyroid disease and cancer may be unethical and dangerous if the only benefit 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 of Lab Tests Online-AU.