Pharmacy Daily | DTC medical test concern

DIRECT-TO-CONSUMER (DTC) health and medical tests are risking people's health and wellbeing, argued a team of Australian and international experts in a paper published yesterday in the BMJ.

Better information and regulation are essential to protect consumers from potential harms of these tests, the authors of the paper said.

The tests, including hormone tests and food sensitivity tests, may cause harm from unnecessary worry, providing a false sense of security or leading people to use supplements and treatments they don't need and that may themselves cause harm.

Tests that claim to detect over 50 cancers before symptoms appear are currently being marketed in the US, but are more likely to detect cancers at an advanced stage, thereby limiting their benefits.

In Australia, more than 40% of DTC tests marketed online were sold as "health checks", and while these tests may tell people if their one-off reading is not within the "normal" range, they don't tell you if this means anything clinically.

One example the paper highlighted was testosterone tests, which are often targeted at male bodybuilders for "optimising" testosterone levels and can be misused to justify unsafe supplementation.

Hormone tests for women that claim to indicate menopause or chance of conceiving have poor accuracy and may provide incorrect or misleading information to women about fertility or symptoms, they pointed out, adding that the accuracy of HIV self-testing is also problematic.

On the other hand, there are tests such as the self-test kit for chlamydia and gonorrhoea recently approved by the TGA (PD 21 Nov) that can potentially lead to better outcomes by increasing the likelihood of earlier detection.

The researchers said that information provided with the product or in marketing material is sometimes incomplete, misleading or false, giving consumers a false basis for health decisions.

"Clearly, current regulatory frameworks are inadequate in responding to the new ways in which DTC tests are being sold and used," noted the authors.

The report called for more accountability on the part of suppliers, and for regulators to broaden concepts of harm to include financial burden, psychological and physical harm, overdiagnosis and ineffective diagnosis associated with DTC tests.

Read the paper HERE. KB