Mary K. Olson

The risk we bear: the effects of review speed and industry user fees on new drug safety.

Drug review speed has increased substantially in the 1990s, largely due to industry-funded user fees. Following several drug withdrawals, however, new questions have emerged about the effects of this change on drug safety. This article examines the impact of review speed and user fees on counts of serious adverse reactions among drugs approved in 1990-2001. The analysis controls for the influence of drug utilization, patient conditions, drug novelty, black box warnings, foreign drug launch, US launch lags, patient age, and gender on drug reactions. Results show that drugs receiving faster reviews are associated with increased counts of serious adverse drug reactions. Other results show that novel drugs, drugs with black box warnings, drugs first launched abroad, and drugs with shorter US launch lags also have increased adverse drug reactions. Although any increase in risks must be weighed against benefits, the results show a trade-off between review speed and drug safety.

Pharmaceutical Policy Change and the Safety of New Drugs

Policy reforms in the Food and Drug Administration (FDA) have led to substantial increases in the speed of new‐drug review. While data show that FDA review times for new drugs have fallen as much as 50 percent, other data show that several new drugs have been withdrawn from the market for safety reasons. This flurry of new‐drug withdrawals raises a question. Have increases in the speed of new‐drug review had an adverse effect on new‐drug safety? This analysis uses adverse drug reaction (ADR) data from the FDA’s Spontaneous Reporting System to examine this question. Specifically, ADR counts for newly approved drugs are estimated as a function of drug characteristics, patient characteristics, and regulatory factors (such as the speed of new‐drug review) using negative binomial regression analysis. The primary result is that reductions in new‐drug review times are associated with increases in both ADRs requiring hospitalization and ADRs resulting in death.

Managing Delegation in the FDA: Reducing Delay in New-Drug Review

This article examines the effects of the user fee reform on the speed of drug review in the U.S. Food and Drug Administration. The results show that even after controlling for increased agency resources, the reform reduced review times among new-drug approvals by 34 percent (95 percent confidence interval, 11 to 51 percent, p = .01). The results suggest that increased agency resources alone cannot explain the reductions in drug-review times. Evidence suggests that other reform-specific factors facilitated the change. Such factors may include the agencys desire to obtain program renewal and secure future fee revenues as well as heightened industry monitoring. Additional results show that there were significant increases in the speed of review for novel drugs in the reform era and for drugs in certain classes that have historically experienced longer delays. The results suggest that the user fee reform has helped politicians manage delegation and reduce delay in new-drug review.

When Free Is Not for Me: Confronting the Barriers to Use of Free Quitline Telephone Counseling for Tobacco Dependence

Remarkable disparities in smoking rates in the United States contribute significantly to socioeconomic and minority health disparities. Access to treatment for tobacco use can help address these disparities, but quitlines, our most ubiquitous treatment resource, reach just 1%–2% of smokers. We used community-based participatory methods to develop a survey instrument to assess barriers to use of the quitline in the Arkansas Mississippi delta. Barriers were quitline specific and barriers to cessation more broadly. Over one-third (34.9%) of respondents (n = 799) did not have access to a telephone that they could use for the quitline. Respondents reported low levels of knowledge about the quitline, quitting, and trust in tobacco treatment programs as well as considerable ambivalence about quitting including significant concerns about getting sick if they quit and strong faith-based beliefs about quitting. These findings suggest quitlines are not accessible to all lower socioeconomic groups and that significant barriers to use include barriers to cessation. These findings suggest targets for providing accessible tobacco use treatment services and addressing concerns about cessation among lower income, ethnic minority, and rural groups.

The effects of improved auditory feedback on the verbalizations of an autistic child

ConclusionsAllowing autistic children to control the volume and direction of their auditory inputs apparently affects their language behavior. Further studies are needed, however, to determine the extent that use of devices such as the Phonic Ear will be of value in increasing vocalizations in these children.

The Process of Adapting the Evidence-Based Treatment for Tobacco Dependence for Smokers of Lower Socioeconomic Status.

INTRODUCTION Tobacco use is the leading cause of preventable death and disease and contributes significantly to socioeconomic health disparities. The prevalence of smoking among individuals of lower socioeconomic status (SES) in the US, many of whom are African American (AA), is three to four times greater than the prevalence of smoking among individuals of higher SES. The disparity in tobacco dependence treatment outcomes between lower and higher SES smokers contributes to tobacco-related health disparities and calls for adapting evidence-based treatment to more fully meet the needs of lower SES smokers. AIMS We sought to adapt the evidence-based treatment for tobacco dependence using recommended frameworks for adapting evidence-based treatments. METHODS We systematically applied the recommended steps for adapting evidence-based treatments described by Barrera and Castro and Lau. The steps included information gathering, preliminary adaptation design, preliminary adaptation tests, and adaptation refinement. We also applied the PEN-3 Model for incorporating AA values and experiences into treatment approaches and a community-engaged approach. RESULTS/FINDINGS Findings from each step in the process contributed to the results. The final results were incorporated into a revised treatment called the RITCh Study Tobacco Dependence Treatment Manual and Toolkit. CONCLUSIONS To our knowledge, this is the first adaptation of evidence-based treatment for tobacco dependence that has systematically applied these recommended frameworks. The efficacy of the treatment to reduce treatment outcome disparities is now being examined in a randomized controlled trial in which the revised treatment is being compared with a standard, individualized cognitive-behavioral approach.

Addressing Mental Health Needs: Perspectives of African Americans Living in the Rural South

OBJECTIVE Rural African Americans are disproportionately affected by social stressors that place them at risk of developing psychiatric disorders. This study aimed to understand mental health, mental health treatment, and barriers to treatment from the perspective of rural African-American residents and other stakeholders in order to devise culturally acceptable treatment approaches. METHODS Seven focus groups (N=50) were conducted with four stakeholder groups: primary care providers, faith community representatives, college students and administrators, and individuals living with mental illness. A semistructured interview guide was used to elicit perspectives on mental health, mental health treatment, and ways to improve mental health in rural African-American communities. Inductive analysis was used to identify emergent themes and develop a conceptual model grounded in the textual data. RESULTS Stressful living environments (for example, impoverished communities) and broader community-held beliefs (for example, religious beliefs and stigma) had an impact on perceptions of mental health and contributed to barriers to help seeking. Participants identified community-level strategies to improve emotional wellness in rural African-American communities, such as providing social support, improving mental health literacy, and promoting emotional wellness. CONCLUSIONS Rural African Americans experience several barriers that impede treatment use. Strategies that include conceptualizing mental illness as a normal reaction to stressful living environments, the use of community-based mental health services, and provision of mental health education to the general public may improve use of services in this population.

Community Engagement in Health-Related Research: A Case Study of a Community-Linked Research Infrastructure, Jefferson County, Arkansas, 2011-2013.

Background Underrepresentation of racial minorities in research contributes to health inequities. Important factors contributing to low levels of research participation include limited access to health care and research opportunities, lack of perceived relevance, power differences, participant burden, and absence of trust. We describe an enhanced model of community engagement in which we developed a community-linked research infrastructure to involve minorities in research both as participants and as partners engaged in issue selection, study design, and implementation. Community Context We implemented this effort in Jefferson County, Arkansas, which has a predominantly black population, bears a disproportionate burden of chronic disease, and has death rates above state and national averages. Methods Building on existing community–academic partnerships, we engaged new partners and adapted a successful community health worker model to connect community residents to services and relevant research. We formed a community advisory board, a research collaborative, a health registry, and a resource directory. Outcome Newly formed community–academic partnerships resulted in many joint grant submissions and new projects. Community health workers contacted 2,665 black and 913 white community residents from December 2011 through April 2013. Eighty-five percent of blacks and 88% of whites were willing to be re-contacted about research of potential interest. Implementation challenges were addressed by balancing the needs of science with community needs and priorities. Interpretation Our experience indicates investments in community-linked research infrastructure can be fruitful and should be considered by academic health centers when assessing institutional research infrastructure needs.

Engaging Underrepresented Minorities in Research: Our Vision for a "Research-Friendly Community"

This article introduces our “Research-Friendly Community” vision, placing research in the arena of social justice by giving citizens a voice and opportunity to actively determine research agendas in their community. The mission of Tri-County Rural Health Network, a minority-owned, community-based nonprofit serving 16 counties in Arkansas’ Mississippi River Delta region, is to increase access to health-related services and opportunities to both participate in and shape research. Tri-County has built trust with the community through the use of Deliberative Democracy Forums, a model devised by the Kettering Foundation and through a community health worker program called Community Connectors. Over time, a partnership was formed with investigators at the University of Arkansas for Medical Sciences (UAMS). Tri-County serves as a boundary spanner to link community members, other community organizations, local politicians, policy maker, and researchers. We describe our experience for other nonprofits or universities who might want to develop a similar program.

Rural African Americans' Perspectives on Mental Health: Comparing Focus Groups and Deliberative Democracy Forums

Abstract:A number of approaches have been used to obtain community members’ health perspectives. Health services researchers often conduct focus groups while political scientists and community groups may hold forums. To compare and contrast these two approaches, we conducted six focus groups (n = 50) and seven deliberative democracy forums (n = 233) to obtain the perspectives of rural African Americans on mental health problems in their community. Inductive qualitative analysis found three common themes: rural African Americans (1) understood stresses of poverty and racism were directly related to mental health, (2) were concerned about widespread mental illness stigma, and (3) thought community members could not identify mental health problems requiring treatment. Deductive analyses identified only minor differences in content between the two approaches. This single case study suggests that researchers could consider using deliberative democracy forums rather than focus groups with marginalized populations, particularly when seeking to mobilize communities to create community-initiated interventions.