Kimberly M. Lovett

Risks of Online Direct-to-Consumer Tumor Markers for Cancer Screening

Kimberly M. Lovett, Kaiser Permanente; University of California San Diego School of Medicine; and Institute of Health Law Studies, California Western School of Law, San Diego, CA Bryan A. Liang, University of California San Diego School of Medicine; and Institute of Health Law Studies, California Western School of Law, San Diego, CA Timothy K. Mackey, University of California San Diego School of Medicine; San Diego State University; and Institute of Health Law Studies, California Western School of Law, San Diego, CA See related article in J Oncol Pract doi: 10.1200/JOP.2011.000513

Direct-to-Consumer Cardiac Screening and Suspect Risk Evaluation

DIRECT-TO-CONSUMER (DTC) GENETIC TESTING HAS generated much concern due to nonstandardized products, unproven utility, and potential harm from testing results. Recommendations indicate that genetic testing should be US Food and Drug Administration (FDA)–approved, supported by predictive value and outcomes research, and offered only through qualified health care professionals. However, many companies offer DTC cardiac screening tests under auspices of patient empowerment and cardiac risk evaluation. DTC cardiac screening tests have been largely ignored in these discussions. Yet because cardiac disease is a leading cause of death, DTC cardiac testing has tremendous potential reach and is equally important to critically evaluate. Although concerns regarding quality control and unproven utility of DTC genetic testing are valid, cardiac screening tests have been evaluated, and under evidence-based guidelines, these tests likely pose more risk than benefit to patients. Despite the known risks of offering this DTC service, there is no requirement of these companies for full disclosure in advertising, informed consent, pretest evaluation, or posttest counseling.

Evaluating the evidence: direct-to-consumer screening tests advertised online

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.

Emerging Dangers from Direct Botulinum Access and Use

Botulinum toxin (BTX-A) is the most deadly substance known. Yet it has clinical applications, particularly cosmetic uses. With the latter’s exploding popularity, unauthorized BTX-A is emerging from suspect sources. In combination with the Internet as a virtually unregulated marketplace, BTX-A is available for direct purchase and use. This represents a safety threat against individuals and civil society. Since extant technology and Internet marketing can easily target individual consumers by changing BTX-A concentration and pose risks for society by scaling up production for terrorist purposes, BTX-A availability is a homeland security threat. To address this, BTX-A should be deemed a controlled substance subjecting it to track-and-trace and other requirements. Simultaneously, this categorization would subject it to federal law requiring Drug Enforcement Agency registration and state licensure for sales. This relatively simple step can be a strategy adopted for other high risk materials and an international approach to limit the availability of potentially harmful materials.

Accountable Care Organizations: Updates and Issues

Abstract The implementation of health care reform includes the development of Accountable Care Organizations (ACOs). Although the precise forms these entities will ultimately take are not known, the Department of Health and Human Services has recently published final regulations that may help define the ACO construct. As ACOs are implemented, physicians of all specialties will be influenced by these new entities, their new markets, and the financial performance incentives created under these rules. However, questions and concerns remain that will need further elucidation in the future.

Online, Direct-to-Consumer Access to Insulin: Patient Safety Considerations and Reform

The online, direct-to-consumer (DTC) medical marketplace is proliferating more rapidly than regulation is evolving to ensure proper patient safety and public health controls. Along with this growing body of unrestrained medical testing and pharmaceuticals offered DTC online, most types of insulin and insulin administration products may now be purchased without prescriptions or physician guidance. Given the relatively significant risks of insulin use, the abuse potential, the high prevalence of diabetes mellitus, and the rising population of uninsured and underinsured, it is imperative to reform the online DTC medical marketplace to ensure that patient safety and public health are protected.

Direct-to-Consumer Disease Screening with Finger-Stick Testing: Online Patient Safety Risks

The direct-to-consumer (DTC)6 medical industry (i.e., medical testing and treatment outside of physician oversight) is growing rapidly as the Internet becomes more accessible globally. As several studies have highlighted, this industry offers unproven medical testing, provides testing for unapproved indications, and uses suspect advertising claims (1,–,5). Furthermore, given the prevalence of illicit pharmaceutical marketing (6), consumers are confronted with systemic online self-diagnosis and self-treatment risks that have emerged as a global patient safety and public health issue. One particularly troubling practice DTC companies commonly use is finger-stick (capillary blood) testing for disease screening and diagnosis. Although useful in some clinical point-of-care applications, finger-stick testing carries substantial risks when offered to the consumer for screening, diagnosis, or disease monitoring without professional oversight. Although other nonvenipuncture alternative-site testing carries many of the same risks, we focus specifically on the dangers of finger-stick testing because of its widespread use by DTC vendors. Because of the present situation and the unique patient safety risks we outline below (e.g., low diagnostic sensitivity, strip factors, logistics of testing), creating a regulatory framework for finger-stick testing could ensure legitimate evidence-based applications, patient safety protections, and responsible advertising that accurately reflects risks and utility. Offering DTC finger-stick medical testing in conjunction with information suggesting potentially abnormal results may in fact constitute unauthorized medical practice. According to the Federation of State Medical Boards, medical practice includes “offering or undertaking to prevent or diagnose … by any means … or devices any disease, illness, pain, … or abnormal physical condition of any person … .” (7). Many DTC medical-testing companies seem to fit squarely within this definition. Indeed, a simple Google search for “home testing kits” yields a panoply of DTC finger-stick tests: lipids (total, LDL, and HDL cholesterol; triglycerides), high-sensitivity C-reactive protein (hs-CRP), aspartate …

Reply to Stanback et al.'s "Suspect online sellers and contraceptive access".

authors mention that many experts, including the American College of Obstetricians and Gynecologists [2], support over-the-counter (OTC) access to oral contraceptives (OCs) in the US. There is a growing body of evidence documenting the safety and effectiveness of OTC access to OCs that is not reflected in the article by Liang et al. In fact, the US is among the minority of countries that still requires prescriptions for OCs [3,4]. Far from jeopardizing public health, removing the prescription barrier to hormonal contraception and making high quality contraceptives available from more sources — including the internet — could help to reduce the very high rate of unintended pregnancy in this country.