Abstract
Objectives
Unsupervised online direct-to-consumer (DTC) access to medical services has rapidly expanded to medical screening tests, which have not been critically evaluated for their evidence basis. The objective of this study is to identify the scope of online-advertised DTC screening tests, outline the evidence for use of available DTC testing and suggest regulatory reform to address the relevant issues.
Methods
An observational study of website advertisements, testing services and counselling/follow-up services for DTC testing was conducted. Data were collected from websites between 4 April and 1 June 2011. Each website was assessed for tests offered, advertised indications and availability of counselling/follow-up services. Advertised testing indications were compared with US Preventive Services Task Force recommendations and/or specialty guidelines and categorized as Supported, Against, Insufficient Evidence or No Guidance.
Results
Of 20 companies identified as offering DTC screening tests, 95% (19/20) do not clearly offer pretest counselling, post-test counselling and/or test follow-up. One hundred and twenty-seven different tests were identified. Only 19/127 (15%) could be Supported for screening in a target group selected for testing; 38/127 (30%) were given recommendations to avoid use in specific target group(s) selected for testing (‘Against recommendations’); 29/127 (23%) had Insufficient Evidence of value, and for 64/127 (50%) No Guidance could be given. Only 4/127 (3%) tests were Supported for general screening use.
Conclusions
Virtually all identified medical tests advertised and offered DTC are not recommended for use in screening by evidence-based guidelines. Limited oversight may lead to inaccurate self-diagnosis, treatment and wasted health resources.
INTRODUCTION
Direct-to-consumer (DTC) availability of medical products is expanding rapidly. DTC marketing has broadened beyond traditional television, print and radio media onto the Internet. Consequently, DTC advertising potentially reaches millions of consumers searching online for health-care resources. 1 Whereas pharmaceutical advertising has traditionally dominated the DTC medical marketplace, online DTC advertising has now expanded to include medical tests of questionable efficacy, safety and utility for disease screening and diagnosis. Previous studies have highlighted the controversial marketing and sale of genetic susceptibility testing, 2 but little attention has been paid to the plethora of non-genetic medical tests available DTC that are being offered for ‘screening’ purposes.
The medical community defines disease screening as ‘the systematic application of a test or inquiry, to identify individuals at sufficient risk of a specific disorder to benefit from further investigation or direct preventive action, among persons who have not sought medical attention on account of symptoms of that disorder’. 3 This definition necessitates a pretest evaluation with screened individuals to ensure the absence of symptoms as well as a quantification of each individual's risk of disease.
There are generally nine factors that contribute to the usefulness of a specific screening test: (1) the disease being screened for is well defined; (2) the incidence/prevalence of the disease being screened for is known; (3) the disease being screened for will lead to morbidity and/or mortality; (4) early management of asymptomatic individuals is more effective than management at clinical presentation of disease; (5) the screening test is simple and safe; (6) the test performs well with acceptable rates of false-positive and false-negatives; (7) the health benefit of screening justifies test costs; (8) there is access to resources for further diagnosis and treatment; (9) follow-up management after diagnosis is agreed upon and acceptable to both medical professionals and patients. 4 To ensure safety, meeting these criteria requires screening outcomes evaluation and evidence-based support for screening test use before making testing widely available for screening purposes.
Companies advertising online and offering DTC medical tests for screening purposes are creating unique safety risks for any person, nationally and globally, with access to the Internet. While aiming to empower consumers by providing private medical testing without professional consultation, these companies may be marketing unproven or harmful medical testing, resulting in poor health outcomes. By definition, where a pretest evaluation with consumers is absent, these DTC medical tests cannot be properly identified as ‘screening’ tests despite their advertised purpose and consumers are at risk for making ill informed decisions regarding medical care. 5 Furthermore, similar to online DTC drug advertising, medical test risk and benefit information given to consumers may be misleading, inaccurate or incomplete. Several studies examining DTC medical tests for cardiovascular disease, genetic testing and imaging services have highlighted the potential risks involved in offering medical testing DTC without medical professional oversight. 6–8
The DTC medical testing industry is fueling medical consumerism growth, unnecessary medical interventions and downstream resource waste. For example, a recent study reported 22 clinical cases of patients arriving self-referred or physician-referred to geneticists due to results of DTC genetic testing. 9 The costs of initial genetic testing for each of these 22 patients was as high as US$3120, while the cost of subsequent follow-up care (including visit to genetic counselor, referrals to specialists and referrals for additional diagnostic testing) ranged from $40 to $20,604 per patient. 9 Not surprisingly, with the exception of BRCA 1/2 testing for breast cancer susceptibility, 64% of DTC genetic tests performed in these case reports were considered not clinically useful by genetic health-care professionals seeing these patients in follow-up. 9
In response to powerful concerns related to DTC availability of genetic testing, the Food and Drug Administration (FDA) issued warning letters to companies offering DTC genetic testing. 8,10 Further, recent recommendations for DTC genetic and cardiac testing have appropriately included requiring that testing be FDA approved before use/marketing, outcomes research be conducted before public availability, that testing be offered through health-care professionals and that counselling be offered pre-test and post-test to guide consumers toward appropriate care and follow-up. 6,11 Despite these efforts, concerns remain regarding the ability of the FDA to regulate the DTC industry, given its limited mandate, inadequate funding and staff, and reluctance of US legislatures to infringe on commercial rights of free speech. 12
It is important for global health, health-care cost containment and public safety that DTC medical testing be critically evaluated, the scope of the problem outlined and further policy pursued to regulate a currently unfettered industry that may be exploiting unproven medical testing at the expense of patient and consumer safety. In this study, we identify medical tests advertised online and available DTC, outline the evidence-base for use of available DTC testing, evaluate the availability of counselling and follow-up offered by DTC testing companies related to DTC testing services, and suggest regulatory reform and coordination among various stakeholders to address the relevant issues.
METHODS
Google searches were performed to identify medical tests advertised online via DTC medical testing company websites. ‘DTC Medical Testing Company’ was defined as a company offering medical testing direct-to-consumer without prior physician consultation/prescription. ‘Medical tests’ were defined as any imaging test or any tests advertised as measuring any serum, saliva or urine analyte. The company websites were evaluated for information including: whether the companies offer pre-/post-test counselling or follow-up for abnormal results. Where the companies did not explicitly address these issues on their websites, they were coded ‘unclear from website’.
Google searches were run using US Department of Health and Human Services-focused health categories beyond ‘general health’, 13 i.e. heart health, diabetes, prostate health, reproductive health, colorectal health, eye and ear health, breast health, and oral health. Terms were searched with the term ‘screening’ added (for example, ‘heart health screening’). To provide a general sense of the scope of offered DTC medical testing while limiting the number of identified medical tests to a manageable data-set, organic and sponsored search results of pages 1 and 2 were evaluated to identify DTC Medical Testing Companies, medical tests offered, availability of pre-/post-test counselling and follow-up care provisions. ‘Organic search results’ are listings on search engine results pages that appear because of their relevance to the search terms, as opposed to appearing as advertisements. In contrast, ‘sponsored search results’ are paid-for listings that appear on the results page for a fee to the search engine company. Indeed, consumers may be confused regarding the difference in these search results, with studies indicating that only 38% of US users could make a distinction between organic and sponsored results. 14 Searches were completed between 4 April and 1 June 2011.
After identifying medical tests, we evaluated the evidence-base for medical test use via US Preventive Services Task Force (‘USPSTF’) guidelines or relevant specialty society guidelines where USPSTF guidance was unavailable. We chose this method primarily because all identified DTC medical tests were advertised specifically for ‘screening’ purposes. We chose to evaluate the usefulness of each identified medical test according to the evidence-base relating to the advertised testing purpose. Medical tests were stratified according to whether evidence-based guidelines support screening (Supported); advise against screening (Against), do not offer definitive recommendations because of conflicting, poor, or incomplete data (Insufficient Evidence), or do not address the medical test for screening purposes (No Guidance). The ‘Insufficient Evidence’ category is based on USPSTF ‘I Statements’, which signify ‘current evidence is insufficient, … of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.’ 15 Because screening guidelines generally provide recommendations for specific populations, any given medical test may have ≥1 recommendation, coded ‘multiple recommendations.’
RESULTS
Identified direct-to-consumer testing companies and parameters of offered services
Identified direct-to-consumer medical tests
CT, computed tomography; ALT, alanine transaminase; ANA, antinuclear antibody; AST, aspartate transaminase; BRCA, breast cancer; MRI, magnetic resonance imaging; HS-CRP, high sensitivity C-reactive protien; DXA, dual-energy X-ray absorptiometry; CA, Cancer Antigen; CEA, Carcinoembryonic Antigen
Of 127 medical tests, 63 (50%) have USPSTF or relevant specialty society screening guidance, 19/127 (15%) have ≥1 Supported recommendation for screening use; double this number (38/127, 30%) were given recommendations to avoid use in specific target group(s) selected for testing (‘Against recommendations’); and 27/127 (21%) carry ≥1 statement of Insufficient Evidence of value.
A detailed review revealed that only 4/127 (3%) are Supported without any Against or Insufficient Evidence recommendations (Table 2). The remainder (N = 123, 97%) had only recommendations Against (N = 23, 18%), statements of Insufficient Evidence (N = 15, 12%), multiple recommendations (N = 21, 17%), or No Guidance (N = 64, 50%). Virtually all DTC medical tests are not clearly supported for screening in the general population.
Direct-to-consumer medical tests with guideline support for use in screening
USPSTF, US Preventive Services Task Force; yo, years old; GC, Gonnococcal
Direct-to-consumer medical tests with guidelines against use in screening
USPSTF, US Preventive Services Task Force; BRCA, breast cancer; CEA, Carcinoembryonic antigen
Direct-to-consumer medical tests with insufficient evidence for use in screening
US Preventive Services Task Force; TSH, thyroid-stimulating hormone; HS-CRP, high-sensitivity C-reactive protien
Table 4 lists the 38 medical tests with ≥1 recommendation Against use in screening; 19/38 tests (32%) carry specific recommendations Against use in all target population groups, while another 10/38 tests (37%) are advised Against for all low-risk patients. For example, guidelines recommend Against carotid artery stenosis screening for all persons, while AAA screening is Supported for men age >65 who have smoked but recommended Against for all women. Within this group of tests, most (N = 29, 69%) are recommended Against for either all individuals or all low-risk individuals.
Of the 127 medical tests, 29 (23%) medical tests carry ≥1 recommendation of Insufficient Evidence to inform use in screening (Table 5). Some may have arguable clinical utility but evidence-based guidance suggests that the available data are insufficient to determine whether screening benefits outweigh risks (e.g. osteoporosis screening in men, hyperlipidaemia screening in young persons and diabetes screening in persons without hypertension).
Direct-to-consumer medical tests with no guidance for use in screening
USPSTF, US Preventive Services Task Force; ALT, alanine transaminase; ANA, antinuclear antibody; AST, aspartate transaminase; SM, Smooth muscle; HS-CRP, high-sensitivity C-reactive protein
DISCUSSION
Though recent commentary has focused on the implications of DTC cardiac and genetic tests, the patient safety threat posed by the breadth of available DTC medical tests has not been adequately addressed. Furthermore, probably due to recent FDA warnings targeting DTC genetic testing companies, access to DTC genetic tests has become much less appreciable. In fact, most companies we identified did not specifically advertise or offer the range of DTC genetic susceptibility tests previously reported in the literature. However, we have identified a large scope of non-genetic DTC medical testing and, as such, regulatory oversight in combination with non-governmental and professional society intervention is critical in future efforts.
Principal results and implications
Of the 127 identified DTC medical tests advertised online, virtually all (97%) have clear guidance advising against use, insufficient or conflicting evidence to inform use, or no guidance at all regarding use for screening purposes.
The relative lack of evidence-based support is alarming, but in addition the 3% of tests with unopposed recommendations of Support were all limited to very specific target populations. In fact, where tests are Supported, they are supported for a narrow range of individuals, and where tests are advised Against, they are advised against for target populations. This means that not a single identified DTC screening test has evidence-based guidance to support general population screening. Ultimately, traditional medical care uses evidence-based guidelines based on outcome data to restrict screening test recommendations to narrow target populations in order to improve the risk/benefit ratio of testing. However, DTC medical testing companies do not limit their testing according to evidence-based guidelines, and are therefore exposing the general population to tests that likely pose more risk than benefit to many of these consumers. In general, no screening tests are recommended for broad use in the general population, yet these tests are offered to the public without any mechanism to filter consumers who may benefit and those who may not. Indeed, medical testing offered to the general public without adequate pretest evaluation cannot even be properly identified as a ‘screening’ test. Consumers searching online are therefore confronted with a quagmire of medical tests that are generally not evidence-based and in all probability not applicable to their specific circumstance.
Online advertisements for DTC medical tests generally fail to offer evidence-based screening information, informed consent and potential risks of testing. This information is necessary for informed acceptance or refusal of test risks and benefits. Informed consent provides a mode of evidence-based patient selection and accountability for advising use of various medical tests for screening purposes and direct questioning with a qualified health professional allows determination of whether a consumer is truly seeking screening for asymptomatic disease or if he/she has symptoms requiring diagnostic testing and follow-up.
In addition to a lack of informed consent and pretest counselling, consumers are generally not offered post-test counselling or follow-up. On the basis of misused testing and/or misinterpreted results, patients may choose to self-diagnose and self-treat, including purchasing pharmaceuticals online. 26 Inappropriate self-interpretation may prompt patients to seek unnecessary care, or worse, erroneously preclude them from seeking needed care because they believe a single test has precluded a positive result. Pre- and post-test counselling, even if offered, has its own limitations, and may not promote patient safety without adequate referral services to a medical professional. The vast majority of identified sites offered no pre- post-test counselling and consequently also did not offer any referral services following a test result. This lack of adequate patient follow-up and continuity of care could have significant adverse impact.
In general, abnormal results from DTC medical testing lead to further care for repeat testing, treatment or further investigation. Consequently, medical testing that is promoted in a fashion inconsistent with evidence-based medicine is highly likely to lead to unnecessary resource waste, iatrogenic harm from downstream treatments or management, premature labelling of patients and excessive anxiety over testing results, while not improving health outcomes.
Legally, given that nearly all identified medical tests lack evidence to support use in the general population, online DTC advertising and/or sale of this testing as ‘screening’ or otherwise may be construed as false or misleading where it does not adequately reflect the risk versus benefit of use. This may represent violation of FDA regulations regarding advertisement and sale of DTC medical products. 27 Moreover, advertisements for DTC medical tests that include potentially fraudulent or misleading statements regarding efficacy and/or utility 6 also implicate US state and federal consumer protection laws. 28,29
Recommendations for reform
Collectively, the limited scientific support, lack of patient/consumer safety protections and legal concerns necessitate multistakeholder actions to address this burgeoning industry. Like illicit online pharmacies, unregulated online advertisement, sale and administration of DTC medical testing poses a threat to public health and inappropriately fuels health expenditures. 1,6–8 Yet medical screening tests, if evidence-based and used appropriately with patient safety safeguards, can promote and inform health and education. Hence, efforts to collect outcomes data, create public awareness, highlight best practices for the DTC medical testing industry and implement a robust regulatory regimen to promote responsible access to DTC medical screening tests should be explored.
Collecting outcomes data are an essential first step in addressing the DTC medical testing industry. As seen via evidence-based guidelines based on outcome data, unnecessary screening with many of these medical tests will lead to downstream harms within traditional medical practice. In addition to known harms from false-positive/negative results and iatrogenic harms from widespread testing, it is probably that there are additional harms related to a lack of informed consent and follow-up in the DTC medical testing industry. While there are few case reports detailing severe anxiety and hopelessness of consumers after being given results of DTC genetic screening tests, 30 larger outcome based studies evaluating DTC testing harms, downstream intervention harms and costs are needed.
Secondly, DTC medical testing companies should be limited to offering medical screening as a public health service, in an organized manner, according to a specified protocol, requiring medical professional oversight, appropriate pre-test evaluation, post-test counselling for people with positive testing results, availability of diagnostic services and diagnostic support and treatment, and service monitoring. 4 Indeed, where medical testing is being advertised and offered DTC without appropriate medical professional oversight, it should be prosecuted by US state Attorney Generals and organized medical associations as the unauthorized practice of medicine. DTC medical testing companies should be limited to offering only outcomes proven medical screening tests endorsed by professional screening bodies. In addition, where online advertisements could be construed as fraudulent, misleading or lacking appropriate evidence-based risk/benefit information, companies should be sanctioned.
Because of the national scope of this DTC medical testing industry, the FDA should be a primary driver for regulation and oversight in the US FDA involvement here is consistent with draft guidance indicating oversight of tests that: ‘might use measured or observed values of multiple variables, such as a patient's age, weight, metabolite level, and gene expression levels.’ 31 FDA oversight could include guidance and surveillance of websites advertising and selling DTC screening tests, 12 including requiring DTC testing companies be FDA-registered under a programme verifying federal certification for engagement in medical testing sale and administration.
The combination of these safeguards would ensure companies selling DTC screening tests in the US are legitimate, tests are evidence-based, patients are informed, counselling is available, and that marketing is responsible, monitored by regulators, and appropriately reflects screening test risks and benefits. Importantly as well, providing accessible consultation by a medical professional would alleviate the burden on patients in interpreting confusing (especially abnormal) results, and would allow patients to make more informed decisions regarding health care and screening test purchase and follow-up care. DTC medical testing in combination with the unprecedented increase in Internet access and illicit pharmaceutical activity has now moved the health-care arena into uniquely troubling waters. Society now faces unfettered diagnosis and treatment completely peripheral to professional guidance, creating the potential for a medical delivery system promoting patient self-diagnosis and self-treatment that may be inaccurate, ineffective, potentially harmful and resource wasteful. This safety risk is growing as DTC sale and online advertisement of medical resources expands and regulation lags.
Study limitations
There are several limitations to this study. First, our study methodology did not capture various previously identified DTC tests such as genetic testing and fetal ultrasound imaging. 7,32 This implies, however, that there are probably more suspect DTC tests available than those identified here. In addition, our methodology did not address actual utilization of online DTC screening test services, making it difficult to quantify the public health and patient safety impact; however, the continued existence of these companies offering such a spectrum of medical tests implies that there is a lucrative market keeping companies financially viable and tests available. Finally, the Internet is a rapidly changing, dynamic environment, and our assessment was limited to data from the specific time periods when we performed searches.
CONCLUSION
Online advertising and access to DTC medical products has made screening tests readily available to consumers without the need of a prescription or medical consultation and without adequate clinical follow-up. The scope of DTC medical testing advertised online is broad and most available medical tests have limited evidentiary support. Companies offering DTC medical tests fail to provide for informed consent, pre-/post-test counselling or follow-up care, creating substantial risks to patient safety and legal concerns. Reform is needed to address this growing public health risk.