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1.  Primary prevention and precaution in hazard identification in the NIEHS/NTP: body in the morgue approach. 
Public Health Reports  2002;117(6):564-573.
In the spirit of stimulating reevaluation of the methods of public health science, this article explores the methods of cancer hazard identification at the National Toxicology Program (NTP) from the perspective of primary prevention and precaution. The NTP is a cooperative effort of three federal agencies: The National Institute of Environmental Health Sciences (NIEHS, the lead government institute); the National Institute for Occupational Health (NIOSH), in the Centers for Disease Control and Prevention; and the National Center for Toxicology Research (NCTR), in the Food and Drug Administration. NTP coordinates toxicological research and testing programs within the Department of Health and Human Services (DHHS), and through its annual Report on Carcinogens (RoC), identifies and characterizes cancer hazards-the first step in quantitative risk assessment-for the federal government. The foundation of NIEHS policies, for environmental health research, is quantitative risk assessment (QRA). The author examines the opportunities for primary prevention and precaution, and the extent to which the policies of NIEHS in general, and the NTP in particular, do and do not realize that potential. Special attention is paid to the issue of cancer hazard identification. Critical comments on the process of classifying carcinogens in the Ninth and Tenth Reports on Carcinogens are presented, based on the minutes of the Board of Scientific Counselors Subcommittee meetings.
PMCID: PMC1497487  PMID: 12576536
2.  ONE Nano: NIEHS’s Strategic Initiative on the Health and Safety Effects of Engineered Nanomaterials 
Environmental Health Perspectives  2013;121(4):410-414.
Background: The past decade has seen tremendous expansion in the production and application of engineered nanomaterials (ENMs). The unique properties that make ENMs useful in the marketplace also make their interactions with biological systems difficult to anticipate and critically important to explore. Currently, little is known about the health effects of human exposure to these materials.
Objectives: As part of its role in supporting the National Nanotechnology Initiative, the National Institute of Environmental Health Sciences (NIEHS) has developed an integrated, strategic research program—“ONE Nano”—to increase our fundamental understanding of how ENMs interact with living systems, to develop predictive models for quantifying ENM exposure and assessing ENM health impacts, and to guide the design of second-generation ENMs to minimize adverse health effects.
Discussion: The NIEHS’s research investments in ENM health and safety include extramural grants and grantee consortia, intramural research activities, and toxicological studies being conducted by the National Toxicology Program (NTP). These efforts have enhanced collaboration within the nanotechnology research community and produced toxicological profiles for selected ENMs, as well as improved methods and protocols for conducting in vitro and in vivo studies to assess ENM health effects.
Conclusion: By drawing upon the strengths of the NIEHS’s intramural, extramural, and NTP programs and establishing productive partnerships with other institutes and agencies across the federal government, the NIEHS’s strategic ONE Nano program is working toward new advances to improve our understanding of the health impacts of engineered nanomaterials and support the goals of the National Nanotechnology Initiative.
PMCID: PMC3620765  PMID: 23407114
consortium-based research; health effects; nanoparticles; nanotechnology
3.  NIEHS Extramural Global Environmental Health Portfolio: Opportunities for Collaboration 
Environmental Health Perspectives  2008;116(4):421-425.
Global environmental health has emerged as a critical topic for environmental health researchers and practitioners. Estimates of the environmental contribution of total worldwide disease burden range from 25 to 33%.
We reviewed grants funded by the National Institute of Environmental Health Sciences (NIEHS) during 2005–2007 to evaluate the costs and scientific composition of the global environmental health portfolio, with the ultimate aim of strengthening global environmental health research partnerships.
We examined NIEHS grant research databases to identify the global environmental health portfolio. In the past 3 fiscal years (2005–2007), the NIEHS funded 57 scientific research projects in 37 countries, at an estimated cost of $30 million. Metals such as arsenic, methylmercury, and lead are the most frequently studied toxic agents, but a wide range of stressors, routes of exposure, and agents are addressed in the portfolio.
The portfolio analysis indicates that there is a firm foundation of research activities upon which additional global environmental health partnerships could be encouraged. Current data structures could be strengthened to support more automated analysis of grantee information.
PMCID: PMC2291017  PMID: 18414621
global health; partnerships; science assessment
4.  The NIEHS Environmental Health Sciences Data Resource Portal: Placing Advanced Technologies in Service to Vulnerable Communities 
Environmental Health Perspectives  2007;115(4):564-571.
Two devastating hurricanes ripped across the Gulf Coast of the United States during 2005. The effects of Hurricane Katrina were especially severe: The human and environmental health impacts on New Orleans, Louisiana, and other Gulf Coast communities will be felt for decades to come. The Federal Emergency Management Agency (FEMA) estimates that Katrina’s destruction disrupted the lives of roughly 650,000 Americans. Over 1,300 people died. The projected economic costs for recovery and reconstruction are likely to exceed $125 billion.
The NIEHS (National Institute of Environmental Health Sciences) Portal aims to provide decision makers with the data, information, and the tools they need to a) monitor human and environmental health impacts of disasters; b) assess and reduce human exposures to contaminants; and c) develop science-based remediation, rebuilding, and repopulation strategies.
The NIEHS Portal combines advances in geographic information systems (GIS), data mining/integration, and visualization technologies through new forms of grid-based (distributed, web-accessible) cyberinfrastructure.
The scale and complexity of the problems presented by Hurricane Katrina made it evident that no stakeholder alone could tackle them and that there is a need for greater collaboration. The NIEHS Portal provides a collaboration-enabling, information-laden base necessary to respond to environmental health concerns in the Gulf Coast region while advancing integrative multidisciplinary research.
The NIEHS Portal is poised to serve as a national resource to track environmental hazards following natural and man-made disasters, focus medical and environmental response and recovery resources in areas of greatest need, and function as a test bed for technologies that will help advance environmental health sciences research into the modern scientific and computing era.
PMCID: PMC1852670  PMID: 17450225
community-linked research; cyberinfrastructure; disaster; environmental justice; GIS; grid; health disparities; integrative research; Katrina; telescience
5.  The NIEHS Superfund Basic Research Program: overview and areas of future research directions. 
Environmental Health Perspectives  1995;103(Suppl 1):3-5.
The National Institute of Environmental Health Sciences' Superfund Basic Research Program is currently funding 142 separate research projects within 18 programs encompassing 29 universities and institutions around the United States. The research under this program covers a wide range of interdisciplinary science from both the biomedical and nonbiomedical perspectives. This is a unique program of technology-driven research. Nonetheless, there are some areas of research that should be investigated or investigated further, should funds become available. Environmental health risk posed by the location of Superfund sites may be distributed inequitably across socioeconomic status and racial groups. Since one in five children now lives below the poverty line, an important aspect of environmental equity must be the investigation of the health effects of environmental factors on children. The multidisciplinary investigation of the effects of hazardous substance exposure on children is an area that needs much research due to the fact that most of the toxicologic data available are based on adults and animals. This program is funding 27 projects on ecologic damage posed by hazardous wastes. Much more research is needed in the investigation of toxic effects on natural succession of ecosystems as well as on their effects on biodiversity to further our understanding of the food web in the role of bioavailability in human health, and to examine the bioaccumulation of these chemicals as it relates to their fate and transport. This program is researching and developing many innovative technologies for detecting, assessing, and reducing toxic materials in the environment.(ABSTRACT TRUNCATED AT 250 WORDS)
PMCID: PMC1519329  PMID: 7621795
6.  Consortium-Based Science: The NIEHS’s Multipronged, Collaborative Approach to Assessing the Health Effects of Bisphenol A 
Environmental Health Perspectives  2012;120(12):1640-1644.
Background: Bisphenol A (BPA) is a high production volume chemical used to make polycarbonate plastic and is found in many consumer products. Some studies using animal models have suggested that BPA exposures may have adverse health effects. However, research gaps have precluded a full understanding of the effects of BPA in humans and engendered controversies surrounding the chemical’s potential toxicity.
Objectives: The National Institute of Environmental Health Sciences (NIEHS) and National Toxicology Program (NTP) have developed an integrated, multipronged, consortium-based approach to optimize BPA-focused research investments to more effectively address data gaps and inform decision making.
Discussion: NIEHS/NTP BPA research investments made over the past 4 years include extramural research grants, establishment of a BPA Grantee Consortium, intramural research activities on BPA’s mechanisms of action, the launch of two clinical studies and an occupational study, development of a round-robin experiment to validate BPA measurements in human serum, and, in collaboration with the Food and Drug Administration (FDA), formation of a consortium to design and execute a chronic toxicity study of BPA in rats. The NIEHS’s new consortium-based approach has led to more integrated, collaborative efforts and should improve our ability to resolve controversies over the potential human health effects of exposures to low levels of endocrine-active agents.
PMCID: PMC3548284  PMID: 23052487
bisphenol A; consortium-based research; endocrine disruptor; low dose; NIEHS
7.  Mixtures Research at NIEHS: An Evolving Program 
Toxicology  2012;313(0):94-102.
The National Institute of Environmental Health Sciences (NIEHS) has a rich history in evaluating the toxicity of mixtures. The types of mixtures assessed by the Division of the National Toxicology Program (DNTP) and the extramural community (through the Division of Extramural Research and Training (DERT)) have included a broad range of chemicals and toxicants, with each study having a unique set of questions and design considerations. Some examples of the types of mixtures studied include: groundwater contaminants, pesticides/fertilizers, dioxin-like chemicals (assessing the toxic equivalency approach), drug combinations, air pollution, metals, polycyclic aromatic hydrocarbons, technical mixtures (e.g. pentachlorophenol, flame retardants), and mixed entities (e.g. herbals, asbestos). These endeavors have provided excellent data on the toxicity of specific mixtures and have been informative to the human health risk assessment process in general (e.g. providing data on low dose exposures to environmental chemicals). However, the mixtures research effort at NIEHS, to date, has been driven by test article nominations to the DNTP or by investigator-initiated research through DERT. Recently, the NIEHS has embarked upon an effort to coordinate mixtures research across both intramural and extramural divisions in order to maximize mixtures research results. A path forward for NIEHS mixtures research will be based on feedback from a Request for Information (RFI) designed to gather up-to-date views on the knowledge gaps and roadblocks to evaluating mixtures and performing cumulative risk assessment, and a workshop organized to bring together mixtures experts from risk assessment, exposure science, biology, epidemiology, and statistics. The future of mixtures research at NIEHS will include projects from nominations to DNTP, studies by extramural investigators, and collaborations across government agencies that address high-priority questions in the field of mixtures research.
PMCID: PMC4232209  PMID: 23146757
combined exposures; cumulative; multi-pollutant; co-exposure; stressors
8.  The NIEHS Predictive-Toxicology Evaluation Project. 
Environmental Health Perspectives  1996;104(Suppl 5):1001-1010.
The Predictive-Toxicology Evaluation (PTE) project conducts collaborative experiments that subject the performance of predictive-toxicology (PT) methods to rigorous, objective evaluation in a uniquely informative manner. Sponsored by the National Institute of Environmental Health Sciences, it takes advantage of the ongoing testing conducted by the U.S. National Toxicology Program (NTP) to estimate the true error of models that have been applied to make prospective predictions on previously untested, noncongeneric-chemical substances. The PTE project first identifies a group of standardized NTP chemical bioassays either scheduled to be conducted or are ongoing, but not yet complete. The project then announces and advertises the evaluation experiment, disseminates information about the chemical bioassays, and encourages researchers from a wide variety of disciplines to publish their predictions in peer-reviewed journals, using whatever approaches and methods they feel are best. A collection of such papers is published in this Environmental Health Perspectives Supplement, providing readers the opportunity to compare and contrast PT approaches and models, within the context of their prospective application to an actual-use situation. This introduction to this collection of papers on predictive toxicology summarizes the predictions made and the final results obtained for the 44 chemical carcinogenesis bioassays of the first PTE experiment (PTE-1) and presents information that identifies the 30 chemical carcinogenesis bioassays of PTE-2, along with a table of prediction sets that have been published to date. It also provides background about the origin and goals of the PTE project, outlines the special challenge associated with estimating the true error of models that aspire to predict open-system behavior, and summarizes what has been learned to date.
PMCID: PMC1469687  PMID: 8933048
9.  Scientific and Public Health Impacts of the NIEHS Extramural Asthma Research Program – Insights from Primary Data 
Research Evaluation  2009;18(5):375-385.
A conceptual model was developed to guide evaluation of the long-term impacts of research grant programs at the National Institutes of Health, National Institute of Environmental Health Sciences. The model was then applied to the extramural asthma research portfolio in two stages: (1) the first used extant data sources, (2) the second involved primary data collection with asthma researchers and individuals in positions to use asthma research in development of programs, policies, and practices. Reporting on the second stage, this article describes how we sought to broaden the perspectives included in the assessment and obtain a more nuanced picture of research impacts by engaging those involved in conducting or using the research.
PMCID: PMC3171697  PMID: 21921976
10.  Interlaboratory Evaluation of Rodent Pulmonary Responses to Engineered Nanomaterials: The NIEHS Nano GO Consortium 
Environmental Health Perspectives  2013;121(6):676-682.
Background: Engineered nanomaterials (ENMs) have potential benefits, but they also present safety concerns for human health. Interlaboratory studies in rodents using standardized protocols are needed to assess ENM toxicity.
Methods: Four laboratories evaluated lung responses in C57BL/6 mice to ENMs delivered by oropharyngeal aspiration (OPA), and three labs evaluated Sprague-Dawley (SD) or Fisher 344 (F344) rats following intratracheal instillation (IT). ENMs tested included three forms of titanium dioxide (TiO2) [anatase/rutile spheres (TiO2-P25), anatase spheres (TiO2-A), and anatase nanobelts (TiO2-NBs)] and three forms of multiwalled carbon nanotubes (MWCNTs) [original (O), purified (P), and carboxylic acid “functionalized” (F)]. One day after treatment, bronchoalveolar lavage fluid was collected to determine differential cell counts, lactate dehydrogenase (LDH), and protein. Lungs were fixed for histopathology. Responses were also examined at 7 days (TiO2 forms) and 21 days (MWCNTs) after treatment.
Results: TiO2-A, TiO2-P25, and TiO2-NB caused significant neutrophilia in mice at 1 day in three of four labs. TiO2-NB caused neutrophilia in rats at 1 day in two of three labs, and TiO2-P25 and TiO2-A had no significant effect in any of the labs. Inflammation induced by TiO2 in mice and rats resolved by day 7. All MWCNT types caused neutrophilia at 1 day in three of four mouse labs and in all rat labs. Three of four labs observed similar histopathology to O-MWCNTs and TiO2-NBs in mice.
Conclusions: ENMs produced similar patterns of neutrophilia and pathology in rats and mice. Although interlaboratory variability was found in the degree of neutrophilia caused by the three types of TiO2 nanoparticles, similar findings of relative potency for the three types of MWCNTs were found across all laboratories, thus providing greater confidence in these interlaboratory comparisons.
PMCID: PMC3672912  PMID: 23649427
carbon nanotubes; inflammation; lung; nanoparticles; titanium dioxide
11.  Interlaboratory Evaluation of in Vitro Cytotoxicity and Inflammatory Responses to Engineered Nanomaterials: The NIEHS Nano GO Consortium 
Environmental Health Perspectives  2013;121(6):683-690.
Background: Differences in interlaboratory research protocols contribute to the conflicting data in the literature regarding engineered nanomaterial (ENM) bioactivity.
Objectives: Grantees of a National Institute of Health Sciences (NIEHS)-funded consortium program performed two phases of in vitro testing with selected ENMs in an effort to identify and minimize sources of variability.
Methods: Consortium program participants (CPPs) conducted ENM bioactivity evaluations on zinc oxide (ZnO), three forms of titanium dioxide (TiO2), and three forms of multiwalled carbon nanotubes (MWCNTs). In addition, CPPs performed bioassays using three mammalian cell lines (BEAS-2B, RLE-6TN, and THP-1) selected in order to cover two different species (rat and human), two different lung epithelial cells (alveolar type II and bronchial epithelial cells), and two different cell types (epithelial cells and macrophages). CPPs also measured cytotoxicity in all cell types while measuring inflammasome activation [interleukin-1β (IL-1β) release] using only THP-1 cells.
Results: The overall in vitro toxicity profiles of ENM were as follows: ZnO was cytotoxic to all cell types at ≥ 50 μg/mL, but did not induce IL-1β. TiO2 was not cytotoxic except for the nanobelt form, which was cytotoxic and induced significant IL-1β production in THP-1 cells. MWCNTs did not produce cytotoxicity, but stimulated lower levels of IL-1β production in THP-1 cells, with the original MWCNT producing the most IL-1β.
Conclusions: The results provide justification for the inclusion of mechanism-linked bioactivity assays along with traditional cytotoxicity assays for in vitro screening. In addition, the results suggest that conducting studies with multiple relevant cell types to avoid false-negative outcomes is critical for accurate evaluation of ENM bioactivity.
PMCID: PMC3672931  PMID: 23649538
cell viability; inflammation; in vitro; MWCNT; nanotoxicology; round-robin testing; TiO2; ZnO
12.  Animal Models used to Examine the Role of the Environment in the Development of Autoimmune Disease: Findings from an NIEHS Expert Panel Workshopa 
Journal of autoimmunity  2012;39(4):285-293.
Autoimmunity is thought to result from a combination of genetics, environmental triggers, and stochastic events. Environmental factors, such as chemicals, drugs or infectious agents, have been implicated in the expression of autoimmune disease, yet human studies are extremely limited in their ability to test isolated exposures to demonstrate causation or to assess pathogenic mechanisms. In this review we examine the research literature on the ability of chemical, physical and biological agents to induce and/or exacerbate autoimmunity in a variety of animal models. There is no single animal model capable of mimicking the features of human autoimmune disease, particularly as related to environmental exposures. An objective, therefore, was to assess the types of information that can be gleaned from the use of animal models, and how well that information can be used to translate back to human health. Our review notes the importance of genetic background to the types and severity of the autoimmune response following exposure to environmental factors, and emphasizes literature where animal model studies have led to increased confidence about environmental factors that affect expression of autoimmunity. A high level of confidence was reached if there were multiple studies from different laboratories confirming the same findings. Examples include mercury, pristane, and infection with Streptococcus or Coxsackie B virus. A second level of consensus identified those exposures likely to influence autoimmunity but requiring further confirmation. To fit into this category, there needed to be significant supporting data, perhaps by multiple studies from a single laboratory, or repetition of some but not all findings in multiple laboratories. Examples include silica, gold, TCE, TCDD, UV radiation, and Theiler’s murine encephalomyelitis virus. With the caveat that researchers must keep in mind the limitations and appropriate applications of the various approaches, animal models are shown to be extremely valuable tools for studying the induction or exacerbation of autoimmunity by environmental conditions and exposures.
PMCID: PMC3465484  PMID: 22748431
autoimmunity; animal model; environmental factors; chemicals; biological
13.  Health and social support services to HIV/AIDS infected individuals in Tanzania: employees and employers perceptions 
BMC Public Health  2014;14:630.
HIV is a major public health problem in the world, especially in sub-Saharan Africa. It often leads to loss of productive labour and disruption of existing social support system which results in deterioration of population health. This poses a great challenge to infected people in meeting their essential goods and services. This paper examines health and social support services provided by employers to HIV/AIDS infected employees in Tanzania.
This was a cross-sectional study, which employed qualitative and quantitative methods in data collection and analysis. Structured questionnaires and in-depth interviews were used to assess the health and social support services provision at employers and employees perspectives. The study participants were employees and employers from public and private organizations.
A total of 181 employees and 23 employers from 23 workplaces aged between 18–68 years were involved. The results show that 23.8% (i.e., 20.4% males and 27.3% females) of the employees had at least one member of the family or close relatives living with HIV at the time of the study. Fifty six percent of the infected employees reported to have been receiving health or social support from their employers. Employees’ responses were consistent with those reported by their employers. A total of 12(52.2%) and 11(47.8%) employers reported to have been providing health and social supports respectively. Female employees (58.3%) from the private sector (60.0%) were more likely to receive supports than male employees (52.6%) and than those from the public sector (46.2%). The most common health and social support received by the employees were treatment, and nutritional support and reduction of workload, respectively.
HIV/AIDS infected employees named treatment and nutritional support, and soft loans and reduced workload respectively, as the most important health and social supports they needed from their employers. This study provides baseline information for further studies on provision of health and social support services by employers to HIV/AIDS infected employees in the context of a developing economy like Tanzania.
PMCID: PMC4074831  PMID: 24950701
Family member; Treatment and nutritional support; Workload; Workplaces
14.  Profiles in Leadership: Donald E. Francke, MSc, DSc (Hon) 
Hospital Pharmacy  2013;48(9):778-782.
The Director’s Forum series is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems. August 2013 marked the 50th anniversary of the publication of the Mirror to Hospital Pharmacy, the results of a federally funded comprehensive study of pharmacy services in the United States. The late Don E. Francke, MS, DSc, was the lead author of the Mirror and the principal investigator for the US Public Health Service grant W-45. To celebrate the anniversary of the Mirror, the Director’s Forum is profiling the leadership styles of Drs. Latiolais and Francke. September’s article highlighted Dr. Clifton J. Latiolais; this month’s Director’s Forum reviews Dr. Francke’s biography and key career accomplishments, describes his leadership philosophy, and translates that philosophy to today’s health care challenges. Don’s influence on health system pharmacy serves as an example of effective leadership. This historical perspective provides directors of pharmacy a valuable leadership view as they develop strategies to enhance patient-centered pharmacy services.
PMCID: PMC3857116  PMID: 24421553
15.  A prostaglandin E2 receptor antagonist prevents pregnancies during a preclinical contraceptive trial with female macaques 
Human Reproduction (Oxford, England)  2014;29(7):1400-1412.
Can administration of a prostaglandin (PG) E2 receptor 2 (PTGER2) antagonist prevent pregnancy in adult female monkeys by blocking periovulatory events in the follicle without altering menstrual cyclicity or general health?
This is the first study to demonstrate that a PTGER2 antagonist can serve as an effective non-hormonal contraceptive in primates.
The requirement for PGE2 in ovulation and the release of an oocyte surrounded by expanded cumulus cells (cumulus–oocyte expansion; C-OE) was established through the generation of PTGS2 and PTGER2 null-mutant mice. A critical role for PGE2 in primate ovulation is supported by evidence that intrafollicular injection of indomethacin in rhesus monkeys suppressed follicle rupture, whereas co-injection of PGE2 with indomethacin resulted in ovulation.
First, controlled ovulation protocols were performed in adult, female rhesus monkeys to analyze the mRNA levels for genes encoding PGE2 synthesis and signaling components in the naturally selected pre-ovulatory follicle at different times after the ovulatory hCG stimulus (0, 12, 24, 36 h pre-ovulation; 36 h post-ovulation, n = 3–4/time point). Second, controlled ovarian stimulation cycles were utilized to obtain multiple cumulus–oocyte complexes (COCs) from rhesus monkeys to evaluate the role of PGE2 in C-OE in vitro (n = 3–4 animals/treatment; ≥3 COCs/animal/treatment). Third, adult cycling female cynomolgus macaques were randomly assigned (n = 10/group) to vehicle (control) or PTGER2 antagonist (BAY06) groups to perform a contraceptive trial. After the first treatment cycle, a male of proven fertility was introduced into each group and they remained housed together for the duration of the 5-month contraceptive trial that was followed by a post-treatment reversibility trial.
Quantitative real-time PCR, COC culture and expansion, immunofluorescence/confocal microscopy, enzyme immunoassay, contraceptive trial, ultrasonography, complete blood counts, serum biochemistry tests and blood lipid profiles.
Several mRNAs encoding proteins involved in PGE2 synthesis, metabolism and signaling increase (P < 0.05) in the periovulatory follicle after administration of an ovulatory hCG bolus. PGE2 signaling through PTGER2 induces cumulus cell expansion and production of hyaluronic acid, which are critical events for fertilization. Moreover, chronic administration of a selective PTGER2 antagonist resulted in a significant (P < 0.05 versus vehicle-treated controls) contraceptive effect without altering steroid hormone patterns or menstrual cyclicity during a 5-months contraceptive trial. Fertility recovered as early as 1 month after ending treatment.
This is a proof-of-concept study in a non-human primate model. Further investigations are warranted to elucidate the mechanism(s) of PTGER2 antagonist action in the primate ovary. Although PTGER2 antagonist treatment did not produce any obvious undesirable effects, improvements in the mode of administration, as well as the efficacy of these compounds, are necessary to consider such a contraceptive for women.
Monitoring as well as improving the efficacy and safety of female contraceptives is an important public health activity. Even though hormonal contraceptives are effective for women, concerns remain regarding their side-effects and long-term use because of the widespread actions of such steroidal products in many tissues. Moreover, some women cannot take hormones for medical reasons. Thus, development of non-hormonal contraceptives for women is warranted.
Supported by Bayer HealthCare Pharmaceuticals, The Eunice Kennedy Shriver NICHD Contraceptive Development and Research Center (U54 HD055744), NIH Office of the Director (Oregon National Primate Research Center P51 OD011092), and a Lalor Foundation Postdoctoral Basic Research Fellowship (MCP). The use of the Leica confocal was supported by grant number S10RR024585. Some of the authors (N.B., A.R., K.-H.F., U.F., B.B. and B.L.) are employees of Bayer Healthcare Pharma.
PMCID: PMC4059334  PMID: 24781425
prostaglandin E2 receptor; cumulus oocyte expansion; contraceptive trial; primates
16.  Improving retention and performance in civil society in Uganda 
This article is the second article in the Human Resources for Health journal's first quarterly feature. The series of seven articles has been contributed by Management Sciences for Health (MSH) under the theme of leadership and management in public health and will be published article-by-article over the next few weeks. The journal invited Dr Manuel M. Dayrit, Director of the WHO Department of Human Resources for Health and former Minister of Health for the Philippines to launch the feature with an opening editorial to be found in the journal's blog.
This article – number two in the series – describes the experience of the Family Life Education Programme (FLEP), a reproductive health program that provides community-based health services through 40 clinics in five districts of Uganda, in improving retention and performance by using the Management Sciences for Health (MSH) Human Resource Management Rapid Assessment Tool.
A few years ago, the FLEP of Busoga Diocese began to see an increase in staff turnover and a decrease in overall organizational performance. The workplace climate was poor and people stopped coming for services even though there were few other choices in the area. An external assessment found the quality of the health care services provided was deficient.
An action plan to improve their human resource management (HRM) system was developed and implemented. To assess the strengths and weaknesses of their system and to develop an action plan, they used the Rapid Assessment Tool. The tool guides users through a process of prioritizing and action planning after the assessment is done.
By implementing the various recommended changes, FLEP established an improved, responsive HRM system. Increased employee satisfaction led to less staff turnover, better performance, and increased utilization of health services. These benefits were achieved by cost-effective measures focused on professionalizing the organization's approach to HRM.
PMCID: PMC2440376  PMID: 18570658
17.  Profiles in Leadership: Clifton J. Latiolais, MSc, DSc 
Hospital Pharmacy  2013;48(8):697-702.
The Director’s Forum series is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems. August 2013 marks the 50th anniversary of the publication of the Mirror to Hospital Pharmacy, which was a comprehensive study of pharmacy services in the United States. The late Clifton J. Latiolais, MS, DSc, served as the assistant program director for the study and was a co-author of the Mirror. The late Don E. Francke, MS, DSc, was the lead author of the Mirror and the principal investigator of the federally funded study that reviewed hospital pharmacy services across the United States. The next 2 articles in Director’s Forum profile the leadership of Drs. Latiolais and Francke. This article highlights Dr. Latiolais (“Clif”) by briefly reviewing his biography and key career accomplishments, describing his leadership philosophy, and translating that philosophy to today’s health care challenges. Clif’s influence on health system pharmacy serves as an example of effective leadership. This historical perspective on Clif’s leadership, as seen through the eyes of those who knew him, provides directors of pharmacy a valuable leadership viewpoint as they develop strategies to enhance patient-centered pharmacy services.
PMCID: PMC3847978  PMID: 24421540
18.  Life in a Fishbowl: Accountability and Integrity in Pharmacy Leadership 
Hospital Pharmacy  2014;49(7):671-676.
The Director’s Forum is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems by providing practical information on various leadership topics. Pharmacists are bound to practice in the best interest of the patient and are obligated to act with integrity and in an ethical manner. Pharmacy directors and their leadership staff are additionally bound to manage their department with integrity. Staff often scrutinize the pharmacy director’s actions, giving the director a feeling of “life in a fishbowl.” Every action of the leader is judged in the context of personal integrity or their individual commitment to moral, spiritual, and ethical values. The objective of this article is to describe how a pharmacy leader manages this responsibility. This article addresses the pharmacy leader’s obligations to act with integrity, reviews key integrity concerns in pharmacy leadership, and provides guidance for leading and managing in the context of ethics and integrity. Pharmacy directors must always be aware that they are open to both department and public scrutiny if they do not conduct themselves in a professional manner. Being accountable for their actions and maintaining a high standard of integrity, leaders can keep the focus of their departments on the goal of patient-centered pharmacy services.
PMCID: PMC4252238  PMID: 25477587
19.  Is housing a public health issue? A survey of directors of public health. 
BMJ : British Medical Journal  1991;302(6769):157-160.
OBJECTIVE--To determine the views of directors of public health on the importance of housing for public health and their departments' and health authorities' participation in housing issues. DESIGN--Postal self administered questionnaire survey. SETTING--All district health authorities in England and health boards in Wales, Scotland, and Northern Ireland. SUBJECTS--All 221 district directors of public health in England and chief administrative medical officers in Wales, Scotland, and Northern Ireland. MAIN OUTCOME MEASURE--Response to questionnaire consisting of fixed and open ended questions on housing issues. RESULTS--The response rate was 89% (196/221). Housing was perceived as a major health problem by 33% (65/196) of directors. Positive responses were most likely from inner city districts. In 47% (93/196) of departments there was a formal time commitment to housing issues with a median time of one session/week (range one per month to 10 per week). The main function was allocation of medical priority for public sector rehousing. Overall, 73% (144/196) reported some participation in this process. Reported participation in joint care planning and links with non-statutory housing organisations were uncommon. 53% (104/196) of directors had included housing issues in their annual health report. In 16% (32/196) of districts specific services for the homeless had been set up. CONCLUSIONS--Although concern about the impact of current housing policy on public health was shown by a substantial number of directors, the main activity was still allocation of medical priority despite a background of increasing housing need and homelessness. The underlying need is for greater advocacy to produce a healthy housing policy for all, and the annual public health report could be used to promote this objective.
PMCID: PMC1668824  PMID: 1995137
20.  Successfully Matching Into Surgical Specialties: An Analysis of National Resident Matching Program Data 
We explored the impact that attributes of US medical school seniors have on their success in matching to a surgical residency, in order to analyze trends for National Resident Matching Program (NRMP) match outcomes in surgical specialties between 2007 and 2009.
Using Electronic Residency Application Service data and NRMP outcomes, we analyzed medical students' attributes and their effect in successfully matching students into residency positions in surgery, otolaryngology, orthopedic surgery, plastic surgery, and obstetrics and gynecology. Attributes analyzed included self-reported United States Medical Licensing Examination (USMLE) Step 1 and Step 2 scores, Alpha Omega Alpha (AOA) Honor Medical Society membership, research experience, additional graduate degree status, and graduation from a top 40 National Institutes of Health (NIH)–funded medical school. Odds ratios were calculated for each criterion, and 95% confidence intervals were used to determine significance.
Between 2007 and 2009, the number of surgical specialty residency positions increased by 86, and the number of applicants increased by 34. Membership in AOA, USMLE Step 1 and Step 2 scores, research experience, and graduation from a top 40 NIH-funded medical school frequently had a significant impact on residents successfully matching into many specialties, while additional graduate degrees had no effect on matching into surgical specialties (range 0.64 to 1.2).
Although the statistical significance varied across specialties, higher USMLE Step 1 and Step 2 scores, AOA membership, research experience, and graduation from a top 40 NIH-funded medical school generally had a positive impact on match success to surgical residency for US allopathic seniors. Test preparation and seeking research experience during undergraduate medical education may be effective approaches for increasing the likelihood of success for US seniors matching into a surgical specialty.
PMCID: PMC2951766  PMID: 21976075
21.  C.-E.A. Winslow Day: Proceedings of the June 3, 1977 Centenary Celebration 
Sponsored by Yale University, the City of New Haven, and the John B. Pierce Foundation, the C.-E.A. Winslow Day program consisted of speeches by Mr. Leonard Woodcock, President Emeritus, U.A.W., the Honorable Kenneth Gibson, Mayor of Newark, and Dr. Hector Acuña, Director, Pan American Health Organization; reminiscences of Ira Hiscock, Anna M.R. Lauder Professor Emeritus of Public Health, Mary Elizabeth Tennant, Associate Professor Emeritus of Nursing (Public Health), A. Pharo Gagge, Emeritus Fellow, John B. Pierce Foundation, and Mrs. Harriet Welch, Former President of the VNA of New Haven. The proceedings also included the presentation of gifts and the official C.-E.A. Winslow Day Proclamation.
PMCID: PMC2595576  PMID: 345631
22.  Public health week: marketing the concept of public health. 
Public Health Reports  1992;107(1):110-112.
The Public Health Programs and Services (PHP&S) Branch of the Los Angeles County Department of Health Services began a strategic planning effort in January 1986 to meet new disease trends, curb rising health care costs, consolidate limited resources, and handle shifting demographics. A strategic plan was designed to assess the opportunities and challenges facing the agency over a 5-year horizon. Priority areas were recognized, and seven strategic directives were formulated to guide PHP&S in expanding public health services to a changing community. Health promotion was acknowledged as a critical target of the strategic planning process. Among the most significant results of the health promotion directive was the establishment of an annual Public Health Week in Los Angeles County. Beginning in 1988, 1 week per year was selected to enhance the community's awareness of public health programs and the leadership role PHP&S plays in providing these programs to nearly 9 million residents of Los Angeles County. Events in Public Health Week include a professional lecture series and the honoring of an outstanding public health activist and a media personality who has fostered health promotion. Other free community activities such as mobile clinics, screenings, and health fairs are held throughout the county. With intensive media coverage of Public Health Week, PHP&S has been aggressive in promoting its own services and accomplishments while also educating the community on vital wellness issues. The strategic methodology employed by PHP&S, with its emphasis on long-range proactive planning, is receiving national recognition and could be adopted by similar agencies wishing to enhance their image and develop unique health promotion projects in their communities.
PMCID: PMC1403611  PMID: 1738801
23.  The employee high blood pressure program of the National Institutes of Health. 
Public Health Reports  1982;97(2):122-126.
Adequate control of high blood pressure remains a significant problem for many hypertensives detected through screening programs. The worksite is an ideal place in which to help workers control their high blood pressure. The Occupational Medical Service (OMS) at the National Institutes of Health developed and implemented a protocol to screen, refer, follow up, and monitor hypertensive employees. Approximately one-half of the workers were screened at a cost of $1.70 per employee. Alternative approaches to improving the effectiveness of a building-to-building screening program were suggested. Of the employees screened, 85.3 percent had normal blood pressure, 7.8 percent had borderline blood pressure, and 6.9 percent had high blood pressure. The two-steps screening process reduced by one-third the number of persons referred for evaluation of persistently high blood pressure. Among the hypertensive employees on treatment, 53.7 percent had normal readings. Of the 263 newly diagnosed and poorly controlled hypertensives who were referred to their private physicians for care, 73 percent were actually evaluated. Measures to increase the likelihood of a successful referral and followup included providing a list of medical resources in the community and assigning a nurse rather than a clear to contact employees for a repeat blood pressure check. Monitoring and education services are being provided to 70 percent of the known hypertensives. Adequate blood pressure control in NIH employees has improved by one-third as a result of the program.
PMCID: PMC1424316  PMID: 7063592
24.  Communicating with the Workforce During Emergencies: Developing an Employee Text Messaging Program in a Local Public Health Setting 
Public Health Reports  2014;129(Suppl 4):61-66.
Short message service (SMS) text messaging can be useful for communicating information to public health employees and improving workforce situational awareness during emergencies. We sought to understand how the 1,500 employees at Public Health – Seattle & King County, Washington, perceived barriers to and benefits of participation in a voluntary, employer-based SMS program. Based on employee feedback, we developed the system, marketed it, and invited employees to opt in. The system was tested during an ice storm in January 2012. Employee concerns about opting into an SMS program included possible work encroachment during non-work time and receiving excessive irrelevant messages. Employees who received messages during the weather event reported high levels of satisfaction and perceived utility from the program. We conclude that text messaging is a feasible form of communication with employees during emergencies. Care should be taken to design and deploy a program that maximizes employee satisfaction.
PMCID: PMC4187308  PMID: 25355976
25.  Tightening Conflict-of-Interest Policies: The Impact of 2005 Ethics Rules at the NIH 
To determine both the intended and unintended effects of the National Institutes of Health (NIH) 2005 ethics rules by examining changes in publishing rates and the frequency of external relationships among NIH scientists.
After identifying eligible intramural scientists and administrators from institute’s web pages and central directories, a mailed survey was administered to 900 NIH research faculty between October 2008 and January 2009 (response rate 70.1%).A
Eighty percent of respondents believed the NIH ethics rules were too restrictive. While nearly half (45%) of respondents believed the rules positively impacted the public’s trust in the NIH, over three-quarters (77%) believed the rules hindered the NIH’s ability to complete its mission. Implementation of the ethics rules significantly decreased self-reported GIRs among NIH faculty (from 51.8% to 33.2%, P<.01), including significant drops in consulting (33.1% to 7.8%, P<.01) and scientific advisory board membership (31.5% to 16.0%, P<.01). The policy had limited impact on NIH faculty participation in non-industrial professional service roles and had no detectable change in publishing behavior (5.29 articles per researcher per year from 2002–2005 vs. 5.26 from 2005–2008, P = .88).
The NIH ethics rules accomplished much of what they were intended to do, limiting relationships with industry while maintaining NIH researchers’ association with external scientific and professional organizations. However, the rules negatively affected personnel morale and the perceived progress of research.
PMCID: PMC3767378  PMID: 20852402

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