Daniel M. Cook

Reporting Science and Conflicts of Interest in the Lay Press

Background Forthright reporting of financial ties and conflicts of interest of researchers is associated with public trust in and esteem for the scientific enterprise. Methods/Principal Findings We searched Lexis/Nexis Academic News for the top news stories in science published in 2004 and 2005. We conducted a content analysis of 1152 newspaper stories. Funders of the research were identified in 38% of stories, financial ties of the researchers were reported in 11% of stories, and 5% reported financial ties of sources quoted. Of 73 stories not reporting on financial ties, 27% had financial ties publicly disclosed in scholarly journals. Conclusions/Significance Because science journalists often did not report conflict of interest information, adherence to gold-standard recommendations for science journalism was low. Journalists work under many different constraints, but nonetheless news reports of scientific research were incomplete, potentially eroding public trust in science.

Political Time Reconsidered Unbuilding and Rebuilding the State Under the Reagan Administration

This article addresses the claim that the thickening of institutions in American national politics has reduced the capacity of partisan governing coalitions or regimes to introduce fundamental changes. We seek here to clarify what partisan regimes can accomplish under contem porary conditions. We find that in certain respects, regimes have acquired increased capacity for change by making use of the tools of the administrative presidency. In the two cases we study, the Reagan administration disrupted enforcement of pollution laws and transformed the national education agenda. The record of lasting accomplishments by the Reagan Republican regime, although underappreciated in the political science literature, indicates that regime builders in the modern era do not face intractable obstacles in the form of a thickened institutional context. What emerges from this analysis is a portrait of partisan regimes operatingin the modernpolitical environment that depicts them as effective, flexible but not omnipotent governing instruments.

Risk Management Policy and Black-Box Warnings: A Qualitative Analysis of US FDA Proceedings

AbstractBackground: The US FDA increasingly applies risk management to drug safety policy. Little is known about the process by which the FDA approves labelling changes. Although advisory committees can recommend any of the risk management tools, including the use of ’black-box warnings’, it is unknown whether they deliberate on these questions or how they apply the principles of risk minimization or management during their considerations of drug licensing. Objective: To examine the process by which risk management is considered by the FDA, including the role of FDA advisory committees. We also aimed to identify and describe drug labelling changes and additions, including the prevalence of black-box warnings. Methods: We electronically obtained publicly available information regarding drug approvals, drug revisions and advisory committee meetings over 3 years (2004–6) from the FDA. Data in the form of meeting transcripts and full histories of labelling changes were collected on drugs discussed by advisory committees. We then searched and qualitatively analysed the meeting transcripts to identify themes in the discussion. We also created a database of all prescription drug labelling changes for 3 years and examined which drugs have had the most changes. We describe the risk management consideration process and report the frequency and characteristics of labelling changes. Excerpts from the transcripts are selected to illustrate both typical and atypical features of the discussion. Findings: A total of 174 black-box changes were made in the 3-year period of our study, of which 77 were new black-box warnings and 97 were revisions in black-box warnings. Of 77 new black-box warning additions, only 11 drugs were discussed by the advisory committees. Of the 17 most frequently revised drug labels in these 3 years, two were discussed in the advisory committee meetings. Advisory meeting discussions revealed confusion about black-box warnings and emphasized potential consequences of the warnings rather than their content. Conclusion: The safety labelling of drugs on the market is changed often. Panels of advisors consider only a few drugs, rarely discuss the labelling requirements, and display confusion about applying black-box warnings. The creation and application of black-box warnings on prescription medications should receive closer attention from the FDA and its advisors.

The decision-making process of US food and drug administration advisory committees on switches from prescription to over-the-counter status : A comparative case study

BACKGROUND The US Food and Drug Administration (FDA) and FDA advisory committees have been under increasing scrutiny as a result of media attention to safety concerns. OBJECTIVE This article compares the decision-making process of the FDAs Nonprescription Drugs Advisory Committee (NDAC) in 3 cases of a proposed switch from prescription to over-the-counter (OTC) status involving a nicotine replacement therapy product, 2 statins, and an emergency oral contraceptive. METHODS This comparative case study reviewed written transcripts and slides from 4 NDAC committee meetings and a digital video disc recording of a later meeting held to reconsider one of the proposed switches. The focus was on the committees discussion and deliberation processes. Content analysis and iterative coding were used to assess the level of participation by committee members and the extent to which committee discussion adhered to both the key draft list questions provided by the FDA and the published DeLap criteria for switches from prescription to OTC status. Other major themes and discussion topics were identified, and the voting process was analyzed. RESULTS In the absence of clearly defined meeting procedures, the advisory committees developed their own procedural standards. There were major differences between meetings in terms of the extent of discussion of the key draft list questions and adherence to the DeLap principles, discussion of other themes and topics, and voting methods. In each case, at least 1 major topic of discussion was not directly related to safety, efficacy, or self-use. Additional identified themes were the public health significance of a switch to OTC status, costs, and access. CONCLUSIONS Variability in processes created discrepancies in the decision-making criteria used by the NDAC committees. There is a need to establish structured procedures to achieve an optimal level of uniformity and transparency in advisory committee processes.

New cooperative medical financing policy and hospitalization in rural China: multi-stage cross-sectional surveys

BACKGROUND In 2003 China began to implement the New-type rural Cooperative Medical System (NCMS). This provided enhanced funding for hospital-based medical services among farmers. We examined self-reported utilization data for evidence of changes following the new policy. METHODS We conducted a multistage stratified random cluster sampling method for Jiangxi Province, China. Data were collected via five surveys in 2003-4, 2006, 2008, 2010, and 2012. The study compared the rates of hospitalization, early discharge, and hospital avoidance as descriptive indices after weighting the data. Weighted multiple logistic regression analysis was used. Multi-stage cross-sectional analysis was used to explore the reasons for early discharge and for avoiding the hospital during illness. RESULTS We found that the rates of hospitalization, early discharge and hospital avoidance showed upward, downward and downward changes respectively. The logistic regression analysis showed that, controlling for other factors, the financing level significantly affected the changes of the three indexes (p<0.05). The proportion of finance-related early discharge and hospital avoidance dropped significantly (p<0.05). CONCLUSIONS NCMS improved the utilization of in-hospital services step by step as time went on, and greatly alleviated cost-related barriers to accessing health services. Even so, because costs continue to restrict access to services we should continue the NCMS policy and improve its guarantee levels.

Sexual behavior, stages of condom use, and self-efficacy among college students in Taiwan

Abstract The purposes of this study were: (1) to assess sexual behaviors and condom use behaviors; (2) to compare sexual behaviors and condom use behaviors between gender groups; and (3) to explore differences in specific items of self-efficacy to practicing condom use by the transtheoretical model stages of readiness to change among college students in Taiwan. A survey of students at two universities yielded 996 valid responses. The survey questions collected reports of demographic information, sexual history, condom use in general, and likely condom use in specific situations in relation to self-efficacy. Only 27.8% (n=277) reported ever having had sex, of these only 31.4% used condoms every time (those in action and maintenance). Condom use among women was lower than among men with men 5.1 times more likely to use condoms to prevent sexually transmitted infections (OR=5.1, 95% CI: 2.14–12.16, p=0.0002). The stages of change model with reported attitudes (self-efficacy) toward condom use in specific situations. The Tukey–Kramer multiple comparisons showed that participants in the maintenance stage reported significantly higher scores than those in the pre-contemplation, contemplation, and preparation stages for all 10 self-efficacy items (p<0.0001). Circumstances that are the most challenging for condom adherence across the stages are: partner preference to forego use, situations involving alcohol and drug use, and perceived low-risk scenarios. College students in Taiwan would benefit from targeted interventions that link risky sex to alcohol, and that address the interpersonal pressure within relationships that compel women students to practice unsafe sex.

Condom Use and Stages of Change Among College Students in Taiwan

OBJECTIVES To explore the correlates for nonuse of condoms and the factors that affect stages of change for regular condom use among college students in Taiwan. DESIGN AND SAMPLE Cross-sectional, quantitative survey design. A total of 996 college students were recruited from two universities in Northern Taiwan. MEASURES Questionnaires collected data on demographic information, condom use, HIV/AIDS knowledge, confidence in using condoms in different situations, and perceived benefits and barriers to using condoms. RESULTS The common reasons for not using condoms were trust in the partner (21.30%), partner dislike for condoms (19.49%), and perception of low risk (18.77%). Most sexually active students (52.4%) were in the earliest 2 stages of readiness to change (i.e., precontemplation, contemplation). Participants in action/maintenance were (a) 43.4% less likely to show a high knowledge score, (b) 4.08 times more likely to present high self-efficacy, and (c) 2.24 times more likely to be more religious than those in contemplation/preparation. CONCLUSIONS Among a highly literate group, college students, condom use is inconsistent and readiness to change is not imminent. This study reveals that preventive steps targeted at young adults should address other concerns related to condom use such as trust in partners and the alleged appeal of unprotected sex.

Papanicolaou Screening in Taiwan: Perceived Barriers and Self-Efficacy

Cervical cancer remains a leading cause of death in Taiwan, and frequency of screening remains low. We surveyed Taiwanese women about beliefs and practices related to cervical screening, searching for perceived barriers and self-efficacy using the transtheoretical model. We assessed demographics, 12 perceived barriers, and seven self-efficacy measures for 222 Taiwanese women. Data were analyzed descriptively and with multiple linear regression. Barriers related to worry, embarrassment, stigma, and the lack of female physicians were significant in the relapse stage. All self-efficacy measures were significant across various stages of change. Interventions should focus on relapsers and on information related to self-efficacy.

Elderly hospitalization and the New-type Rural Cooperative Medical Scheme (NCMS) in China: multi-stage cross-sectional surveys of Jiangxi province

BackgroundStudies assessing the impacts of China’s New-type Rural Cooperative Medical Scheme (NCMS) reform of 2003 among rural elderly have been limited.MethodMultistage stratified cluster sampling household surveys of 1838, 1924, 1879, 1888, 1890 and 1896 households from 27 villages in Jiangxi province were conducted in 2003/2004, 2006, 2008, 2010, 2012 and 2014. Data from older adults age 65 and above were analyzed. Weighted logistic regression was applied to find factors of elderly hospitalization services.ResultsSince 2003, hospitalization rates for elderly increased, while rates of patients leaving against medical advice and patients avoiding the hospital decreased (P < 0.05). Factors associated with a higher likelihood of reporting hospitalization in the past year for elderly were the per-capita financial level V in 2012 for NCMS (Adjusted Odds Ratios [aOR]: 2.295), the level VI in 2014 (aOR: 3.045) versus the level I in 2003 and chronic disease (aOR: 2.089) versus not having a chronic disease. Lower rate of elderly left against medical advice was associated with the financial level V in 2012 (aOR: 0.099) versus the level I. The higher rate of hospital avoidance was associated with chronic disease status (aOR: 5.759) versus not having a chronic disease, while the lower rate was associated with the financial level VI in 2014 (aOR: 0.143) versus the level I. Among reporting reasons for elderly hospital avoidance, the cost-related reasons just dropped slightly over the years.ConclusionsNCMS improved access to health services for older adults. The utilization of hospitalization services for rural elderly increased gradually, but cost-related barriers remained the primary reporting barrier to accessing hospitalization services.

HIV Knowledge and Behavior Among Chinese College Students in China and the United States

Disease prevention can be improved with a better understanding of student–environment interactions. The purposes of the study were (a) to compare HIV/AIDS-related knowledge, attitudes, sexual behaviors, and sources of HIV/STI information and (b) to investigate the association between sources of HIV/STI information and HIV/AIDS-related knowledge, attitudes, and sexual behaviors among Chinese college students in China and the United States. Comparative, correlational analysis of survey data from 608 students in two countries was conducted. Chinese students in the United States scored higher on knowledge questions. More students in the United States received HIV/STI information from the Internet and family members than did students in China. Traditional media and schoolteachers had a stronger association with participants’ HIV-related knowledge, age at first intercourse, and number of sexual partners in both samples than did other sources. The survey revealed incomplete knowledge within both groups. Prevention programs should focus on risky misconceptions and should teach about strategic utilization of media.