The direct-to-consumer medical testing industry is booming, with the global market predicted to reach more than $9bn by 2033, but many screening tests sold to the public would not be conducted within a formal health system, an editorial in The Lancet warns.
Genetic tests are increasingly available, with 10 new ones entering the market every day, as well as biochemical tests for markers associated with health or disease, devices for monitoring parameters such as blood glucose, and even so-called wellness tests, all of which can be performed without a health professional involved.
Some have no medical purpose. Weak regulation has enabled the direct-to-consumer medical testing industry to flourish, but its growth is fuelled by the exploitation of consumers’ fears and commercial interests that do not have our health at heart.
Fear about what lies in our future is fundamental to being human, so the rise of direct-to-consumer genetic testing is no surprise.
However, tests for genetic risk of diseases like cancer, frequently offered as an add-on to ancestry testing, often report on only a small fraction of known pathogenic variants – for example, in BRCA genes.
Such tests can provide false reassurance to those testing negative. Conversely, the psychological effects of receiving a positive test result can be enormous. Some consumers informed of their APOE4 homozygosity, and therefore increased risk for Alzheimer’s disease, report feeling overcome with anxiety, are left without post-test support, and turn to unapproved drugs in the hope of preventing dementia.
The industry washes its hands of consumers once the result is delivered. The workload associated with confirmatory testing and follow-up care falls on the health-care system.
Regulators should mandate that companies provide post-test genetic counselling, including advice on evidence-based strategies to mitigate disease risk, and that they objectively report how useful a test really is.
A recent Australian study found that, of several hundred direct-to-consumer tests evaluated, the vast majority had limited clinical utility, were non-evidence-based, or used methods or tested for conditions not recognised by the medical community.
Companies advertise ‘‘fear nothing’’ and ‘‘free if we don’t find anything’’ tests. The likelihood is that most people will have at least one result that is outside the normal range when a panel of biomarkers is tested, and biomarker abnormality alone is not a disease.
Another emerging trend, the promotion of continuous glucose monitors to people without diabetes, with monthly subscriptions sold at great cost, lacks an evidence base and will create undue anxiety about diet. Medical testing should be grounded in evidence, not an opportunity to capitalise on the worried well.
The direct-to-consumer testing industry is disruptive to the classic model of health care, and changing attitudes towards conventional healthcare might be one factor underlying the industry’s success.
The relationship between patients and healthcare providers is an increasingly fractious one, as patients struggle to obtain appointments or fear that their concerns are not taken seriously.
Self-testing provides not only convenience but also empowerment and autonomy. The industry promises to give consumers control over their health. However, empowerment can only come through access to accurate tests that give actionable results, as well as reliable health information and linkage to care.
The industry exemplifies the commercial determinants of health in action, with companies using several tactics straight from the corporate playbook. They rely on aggressive advertising campaigns emphasising individual responsibility for health and social media influencers, some of whom are academics and physicians, to lend credibility to a company’s claims.
Conflicts of interest often go undeclared.
Generating high-quality clinical evidence is not a priority; instead, claims on the necessity of tests, or their performance, are exaggerated or misconstrued. While regulators such as the FDA oversee tests that make overt diagnostic claims, some companies exploit loopholes allowing tests marketed as lifestyle or wellness products to face less scrutiny. Lobbying also occurs on issues such as consumer rights to genetic privacy.
Tighter regulation of the industry is urgently needed, but so is an honest conversation within the public sphere about the benefits, risks, and value for money of asymptomatic screening tests.
Direct-to-consumer testing is no substitute for formal health-care evaluation. Data must be collected systematically on individual consumer harms arising from direct-to-consumer testing, as well as its wider effects on health systems.
Those working within the industry must ask themselves whether they are promoting products that are in their consumers’ best interests.
Study details
Direct-to-consumer tests advertised online in Australia and their implications for medical overuse: systematic online review and a typology of clinical utility
Patti Shih, Pauline Ding, Stacy Carter et al.
Published in The BMJ Open, Volume 13 Issue 12
Abstract
Objectives
The objective of this study is to map the range and variety of direct-to-consumer (DTC) tests advertised online in Australia and analyse their potential clinical utility and implications for medical overuse.
Design
Systematic online search of DTC test products in Google and Google Shopping. DTC test advertisements data were collected and analysed to develop a typology of potential clinical utility of the tests at population level, assessing their potential benefits and harms using available evidence, informed by concepts of medical overuse.
Results
We identified 484 DTC tests (103 unique products), ranging from $A12.99 to $A1947 in cost (mean $A197.83; median $A148.50). Using our typology, we assigned the tests into one of four categories: tests with potential clinical utility (10.7%); tests with limited clinical utility (30.6%); non-evidence-based commercial ‘health checks’ (41.9%); and tests whose methods and/or target conditions are not recognised by the general medical community (16.7%). Of the products identified, 56% did not state that they offered pretest or post-test consultation, and 51% did not report analytical performance of the test or laboratory accreditation.
Conclusions
This first-in-Australia study shows most DTC tests sold online have low potential clinical utility, with healthy consumers constituting the main target market. Harms may be caused by overdiagnosis, high rates of false positives and treatment decisions led by non-evidence-based tests, as well as financial costs of unnecessary and inappropriate testing. Regulatory mechanisms should demand a higher standard of evidence of clinical utility and efficacy for DTC tests. Better transparency and reporting of health outcomes, and the development of decision-support resources for consumers are needed.
The Lancet article – Direct-to-consumer medical testing: an industry built on fear (Open access)
See more from MedicalBrief archives:
Genetic risk scores a poor measure to predict disease – UK study
Continuous glucose monitoring improves glycaemic control versus finger-prick
Swedish study changes guidelines for genetic breast cancer tests
Device to detect breast cancer at home wins British design award
UK's home finger-prick antibody test passes first clinical trial