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December 5, 2024

Researcher raises concerns over easy-to-access consumer health tests

Dr Patti Shih says consumers are at risk of buying products that do more harm than good

A ÁñÁ«ÊÓƵapp of ÁñÁ«ÊÓƵapp (UOW) researcher is calling for better information and regulation to protect consumers from the potential harms of health tests advertised directly to consumers.

Sociologist from UOW’s Australian Centre for Health Engagement Evidence & Values (ACHEEV) warns that consumers are at risk of buying self-testing products that do more harm than good.

“The public needs high-quality information and effective communication to protect consumers from unbalanced and misleading marketing,” said Dr Shih.

Dr Shih’s calls come on the back of a new paper published today in leading health and medical journal, , which found no dedicated regulatory framework exists to govern the appropriate use of direct-to-consumer (DTC) products. DTC tests are sold commercially and don’t require a doctor’s consultation. 

Dr Shih and her coauthors’ new paper, titled , reveals advances in diagnostic technology and digital health have increased the variety and volume of DTC tests, ranging from self-test kits and multicancer detection tests to testosterone tests and food sensitivity tests. 

“Diagnostic home self-testing kits are increasingly available for consumers to purchase at pharmacies, supermarkets and online,” said Dr Shih.

“The sales of these tests are surging in many countries, including Australia, but regulatory frameworks aren’t keeping up to govern the appropriate use of these products.”

The paper is a result of international collaboration by researchers from Australia, the United States, Denmark and the United Kingdom. They found similar issues across many countries.

One example the researchers point to is poor accuracy of tests to indicate menopause or chance of conceiving, which may provide incorrect or misleading information to women about fertility or symptoms.

They explain that that, while the availability of self-testing kits may encourage undertested communities, such as key affected populations of sexually transmitted infections, to better access testing, inaccurate tests may not be sufficient to rule out infection. Any false positive results can cause unnecessary follow-up consultations and further testing, while false negative results would provide false reassurance, and therefore delay treatment.

Dr Shih highlighted other significant concerns of DTC tests including poor instructions and packaging problems.

“Sometimes information provided in instructions, on packaging and advertising is incomplete, misleading or even false and this can lead to consumers making ill-informed decisions about their health,” said Dr Shih.

The researchers also revealed that clinical tests marketed for assessing ‘wellness’, such as hormone levels, may also spark mental and physical health concerns.

“Results may trigger over-testing, distress associated with abnormal results that are not clinically important, or lead to unnecessary use of non-evidence based supplements and treatments, which can carry significant health risks such as fertility and cardiovascular problems,” said Dr Shih.

The researchers say marketing of DTC tests also target healthy people, who are least likely to benefit from testing. They acknowledge these tests may be beneficial in some cases, but say studies are yet to demonstrate that their use leads to better health outcomes.

To address potential consumer harms, professional organisations are calling for tests to have clear interpretations and results, and for patients to have clear information about when self-testing is recommended and when it is not. However, without official policy directives and regulation of commercial suppliers that operate outside the healthcare system, these changes are slow to happen.

Dr Shih said it’s clear current regulatory frameworks are inadequate in responding to the new ways in which DTC tests are being sold and used.

“Commercial suppliers should prove product benefit for their consumers, including clearly defining appropriate targeted populations of tests to avoid harmful misinterpretation,” said Dr Shih.

“In addition, industry and regulatory bodies should engage in broader concepts of harm such as financial burden, psychological and physical harm, overdiagnosis, and ineffective diagnosis associated with DTC testing.

“We also believe more research on consumers’ perspectives and values in self-testing is critical for improving user centred practice, benefit, and safety.”

More information

was published in (4 December 2024) DOI: 10.1136/bmj-2024-080460

It is authored by Emma Grundtvig, Tessa Copp, David F Ransohoff, Annette Plüddemann, Barnett S Kramer, Steven Woloshin and Patti Shih.