Objective To investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people. Design Quasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends. Setting Automated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network. Participants Study cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million). Main outcome measures Rates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides. Results Trends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were −31.0% (95% confidence interval −33.0% to −29.0%) among adolescents, −24.3% (−25.4% to −23.2%) among young adults, and −14.5% (−16.0% to −12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100 000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, −6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100 000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group. Conclusions Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.

Background: Suicide is a public health concern, but little is known about the patterns of health care visits made before a suicide attempt, and whether those patterns differ by race/ethnicity. Objectives: To examine racial/ethnic variation in the types of health care visits made before a suicide attempt, when those visits occur, and whether mental health or substance use diagnoses were documented. Research Design: Retrospective, longitudinal study, 2009–2011. Participants: 22,387 individuals who attempted suicide and were enrolled in the health plan across 10 health systems in the Mental Health Research Network. Measures: Cumulative percentage of different types of health care visits made in the 52 weeks before a suicide attempt, by self-reported racial/ethnicity and diagnosis. Data were from the Virtual Data Warehouse at each site. Results: Over 38% of the individuals made any health care visit within the week before their suicide attempt and ∼95% within the preceding year; these percentages varied across racial/ethnic groups (P41%) within 1 week of suicide attempt. Asian Americans were the least likely to make visits within 52 weeks. Hawaiian/Pacific Islanders had proportionally the most inpatient and emergency visits before an attempt, but were least likely to have a recorded mental health or substance use diagnosis. Overall, visits were most common in primary care and outpatient general medical settings. Conclusions: This study provides temporal evidence of racial/ethnic differences in health care visits made before suicide attempt. Health care systems can use this information to help focus the design and implementation of their suicide prevention initiatives.

Pharmacogenomics (PGx) is a key subset of precision medicine that relates genomic variation to individual response to pharmacotherapy. We assessed longitudinal trends in US FDA approval of new drugs labeled with PGx information. Drug labels containing PGx information were obtained from Drugs@FDA and guidelines from PharmGKB were used to compare the actionability of PGx information in drug labels across therapeutic areas. The annual proportion of new drug approvals with PGx labeling has increased by nearly threefold from 10.3% (n = 3) in 2000 to 28.2% (n = 11) in 2020. Inclusion of PGx information in drug labels has increased for all clinical areas over the last two decades but most prominently for cancer therapies, which comprise the largest proportion (75.5%) of biomarker–drug pairs for which PGx testing is required. Clinically actionable information was more frequently observed in biomarker–drug pairs associated with cancer drugs compared to those for other therapeutic areas (n = 92 (59.7%) vs. n = 62 (40.3%), p < 0.0051). These results suggest that further evidence is needed to support the clinical adoption of pharmacogenomics in non-cancer therapeutic areas.

Globally, genetic testing has become increasingly used over the last two decades. As a result of the rapid development of genetic tests, the Genetic Testing Registry was created in the United States to provide transparent information on genetic tests and the corresponding laboratories. Using publicly available data from the Genetic Testing Registry, we analyzed trends in the availability of genetic tests in the United States over the last decade. As of November 2022, a total of 129,624 and 197,779 genetic tests in the US and globally, respectively, including updated versions of previously existing tests, have been made available and submitted to the genetic testing registry. Over 90% of tests submitted to GTR are for clinical rather than research purposes. Worldwide, 1081 and 6214 new genetic tests had been made available in 2012 and in 2022, respectively. In 2012, only 607 and in 2022, 3097 new genetic tests were made available in the US, with 2016 seeing the biggest increase in availability of new tests during the study period. Over 90% of tests can be used for diagnosis. In the US, 10 of >250 laboratories account for 81% of new genetic tests in GTR. As more genetic tests become available, further international collaboration is required for a comprehensive understanding of the available genetic tests worldwide.

Direct-to-consumer genetic testing (DTC-GT) companies are engaging health consumers in unprecedented ways and leveraging the genetic information they collect to further engage health companies. This has produced controversy about DTC-GT consumer expectations, standards, and perceptions of privacy. In this commentary, we highlight recent events involving DTC-GT companies and controversy about privacy that followed those events and discuss recent studies that have explored DTC-GT consumer concerns about privacy. We discuss DTC-GT company standards of upholding consumer privacy and the general accessibility of DTC-GT company terms of use agreements and privacy policies that are written at reading levels above that of many consumers. We conclude that broader discussions and more research are needed to identify DTC-GT consumer concerns about and expectations of privacy. We anticipate that our recommendations will advance discussions on consumer privacy expectations and protections in an era of increasing engagement in DTC-GT.

Patient access (or risk-sharing) schemes are alternative market access agreements between healthcare payers and medical product manufacturers for conditional coverage of promising health technologies. This study aims to identify and characterize patient access schemes to date in the Asia-Pacific region. We reviewed the literature on patient access schemes over the last two decades using publicly available databases, Internet, and grey literature searches. We extracted key features of each scheme identified, including the drug, clinical indication, stakeholders involved, and details of the scheme. We categorized schemes according to a previously published taxonomy of scheme types and by country. We identified 3 schemes in South Korea, 5 in New Zealand, and 98 in Australia. Most (97.2%; n = 103) schemes focused on pharmaceuticals, few on medical technologies. More than half of the schemes related to treatments for cancer and inflammatory diseases such as rheumatoid arthritis. The majority (77.4%; n =82) involved pricing arrangements. Evidence generation schemes were rarely used. About half (41.8%; n = 41) of schemes in Australia were hybrid by nature, consisting of pricing arrangements with a conditional treatment continuation component. Australia has the most experience with patient access schemes and its experience may provide useful insights for other Asia-Pacific countries. The main targets are pharmaceuticals likely to have high budget impact (due to high per-patient costs and/or large volumes of use), and pharmaceuticals that may be adopted more widely than indicated. With the proliferation of high-cost medicines, the use of schemes may increase to address rising cost pressures, consumer demands, and uncertainties, while attempting to provide patient access to innovative care within finite budgets. Future research is warranted to evaluate the performance of patient access schemes.