The University of Kansas ergraduate esearch Fall 2011 — Spring 2012 The Journal of Undergraduate Research University of Kansas Fourth Edition | Fall 2011 — Spring 2012 © Copyright 2012 | Lawrence, KS Snow in Kansas By: Michael S. Vitevitch, Ph.D University Honors Program Although the title of this brief introduction to the 2011-2012 issue of the Journal of Undergraduate Research may sound poetic, it is an allusion to the Rede Lecture delivered in 1959 by C P . Snow at Cambridge University entitled "The Two Cultures and the Scientific Revolution." His lecture focused on the disdain that those in the arts had for the sciences, and that those in the sciences had for the arts. Over 50 years later, it is all too easy to find an English major who can't balance his checkbook, and a major in Physics and Astronomy who thinks Titian is an alternate spelling for one of the moons of Saturn. Ignorance—of the Pythagorean Theorem or of the influence that Edgar Allan Poe had on literature—should not be worn proudly, like a badge of honor. Instead, one must strive to know both cultures. Indeed, being familiar with both cultures is the only way to truly understand the world around us. Fortunately, the rise of fields like the Digital Humanities can be interpreted as a sign that the gap between the arts and the sciences is decreasing. In an effort to continue to reduce the gap between the two cultures, we made a conscious effort in this issue of the Journal of Undergraduate Research to include not just "traditional" or "stereotypical" research from the physical and social sciences, but to also include creative and scholarly works from the arts and humanities. Despite the differences in methodologies used in the arts and sciences, both fields strive to answer the same questions: Who are we? What does it mean to be human? Why do we do the things we do? We hope you enjoy the answers to these and many other questions in the pages that follow. Thank you to all of those who have contributed in some way to this issue of the Journal of Undergraduate Research. The electronic version of this issue, along with previous issues of the Journal of Undergraduate Research can be found online at: http://web.ku.edu/~kujur/ Contents Undergraduate Research The James K. Hitt Award for Outstanding Undergraduate Research 6 Toward an Environmental Assessment of Social Determinants of Health: Direct Observations of Latino Neighborhoods in Kansas City 7 Cara Smith, 2012 winner of The James K. Hitt Award for Outstanding Undergraduate Research (Faculty Advisor: Stephen Fawcett, Applied Behavioral Science] Regulatory Oversight of Foreign Clinical Trials: An examination of the industry's influence on FDA pharmaceutical regulation and the implications for enforcement activity both domestic and abroad 21 Beeta Kashani (Faculty Advisor: Gary Reich, Political Science] Taste and Odor Problems in Clinton Lake Reservoir's Drinking Water 54 Diana L. Restrepo-Osorio, McNair Scholar (Ecology and Evolutionary Biology] Evaluating the use of DNA Sequences for Species Identification in Medusozoans (Phylum Cnidaria) 72 Rhea Richardson (Faculty Advisor: Paulyn Cartwright, Ecology and Evolutionary Biology] A New Stabilization Approach to Cadaveric Shoulder Joint Testing 84 Cole Bittel (Co-authors: Jessica Witherspoon & Jared Vanlandingham Faculty Advisor: Terrance Mclff, Orthopedic Surgery, University of Kansas Medical Center] Underground Economies: Infrastructure, equity, and access in Kansas City 1871¬ 1939 94 Julia Barnard Pavement Through the Prairie, Wheels in the Wetlands: The battle over a road in Lawrence, Kansas 102 Kelly Heiman (Faculty Advisor: Leslie Tuttle, History] Effects of Weight Cue Reactivity on Self-Report Measures of Body Dissatisfaction..142 Marshall Beauchamp (Faculty Advisor: Ric Steele, Clinical Child Psychology] Islamabad: The struggle for Pakistan's identity 156 Eman Siddiqui Social Factors that Encourage Post-High School Education: What Works Across Racial and Socioeconomic Divides 173 Beth O'Neill Scapegoat Theory and the Discursive Representations of Immigration And the Migrant Body 188 Kenneth Stowe (Faculty Advisor: Donn Parson, Communication Studies) The National Socialist Courtship of the Arab World: 1938-1943 200 Joe Siess Biomimicry: Finding Inspiration for Innovation in Nature 208 Brittany Hodges Humanities in the Field: Enhancing learning through Community Service 213 Hannah Vick (Faculty Advisor: Cheryl Lester, English and American Studies) Undergraduate Scholarship and Creative Works Ich bin nicht ein Berliner: A Reconsideration of Marsden Hartley's Portrait of a German Officer 236 Sean Kramer (Faculty Advisor: Marni Kessler, Art History) Time Capsule (A collection of poems and short story excepts) 249 Timothy Barta Letters Between Fools or (Words.) 281 Jon Prapuolenis Chapter One: Friday 284 Jon Prapuolenis Madagascar? 288 Jon Prapuolenis Chapter 3 or 4 or something: Schedules 292 Jon Prapuolenis Musings in a Cold Store on a Warm Night 294 Jon Prapuolenis Chapter 9: Smooth orbs, clean slates, and rough beginnings 295 Jon Prapuolenis Eye c a b 298 Jon Prapuolenis The James K. Hitt Award for Outstanding Undergraduate Research The year 2012 marks the inaugural year of the The James K. Hitt Award for Outstanding Undergraduate Research. This award was presented at the 2012 Undergraduate Research Symposium to three students who engaged in outstanding research and scholarship. These students—Cara Smith, Jessica Ludwig and Santiago Ferreira—presented the keynote addresses that kicked-off the Symposium on April 28, 2012. A written report of the research presented by Cara Smith also appears in this issue of the Journal of Undergraduate Research. The James K. Hitt Award for Outstanding Undergraduate Research was established in October, 2011 by his son Alan B. Hitt and his daughter and son-in-law, Nancy Hitt Clark and David Clark. James Hitt was born in 1914 in Everest, Ks and raised in the small town of Hamlin in northeastern Kansas. Hitt first came to the University of Kansas in 1930 and graduated in 1934 with a bachelor's degree in mathematics. He continued his education at KU, earning his master's in mathematics in 1936. As an undergraduate, Hitt was a Summerfield scholar, ROTC member, and a member of several honors societies including Phi Beta Kappa. He was a member of Kappa Sigma fraternity. Hitt first served as a staff member in 1940 as Assistant Registrar, and left on military leave as a second lieutenant for active service in the Army during World War II from 1942-1946. He returned to KU and served in several positions over the next 32 years, including University Registrar, Director of Admissions, Director of the Office of Admission and Records, Associate Director of Institutional Research and Planning, and finally as a Special Assistant to the Chancellor. Hitt's leadership and dedication at the University of Kansas were evident as a student and continued during his 32 year career as an influential and innovative administrator. Following his retirement in 1977, Hitt continued to engage in his love of music through his piano playing and remained a die-hard KU basketball fan. He spent many years as a loving care-giver to his wife Bernadine and co-founded the Caregiver Support Group for individuals caring for family members with Alzheimer's disease. James Hitt died in January 2011. Hitt's son, daughter, and son-in-law, all of whom are KU alumni, wished to commemorate Hitt's achievement and dedication to the university. They felt that his sincere attention to KU students and faculty was truly exceptional and well- known across campus. As Hitt was involved both as a Summerfield Scholar and the head of the Summerfield committee, his son and daughter were keenly aware of their father's respect for academic excellence and research. Both felt their father's values are reflected in the University Honors Program's focus on scholarship, research and innovation, and felt that an Award for Outstanding Undergraduate Research would be an appropriate way to honor their father. We thank the Hitt family for their generous support of excellence in the domain of undergraduate research and scholarship. 6 Toward an Environmental Assessment of Social Determinants of Health: Direct Observations of Latino Neighborhoods in Kansas City CaraSmith (FacultyAdvisor: Stephen Fawcett) Applied Behavioral Science ABSTRACT The environment - including exposure to social determinants - is a major influence on health outcomes and health disparities. Direct observation may be useful in identifying factors related to disparities in health across neighborhoods. This study explored the question of whether environmental features - exposures related to social determinants - can be assessed by direct observation. A checklist and measurement protocol was created for this purpose. This two-page environmental assessment was used to document the occurrence or non- occurrence of specific features or measures in six domains: housing (N=5), safety (N=11), recreational spaces (N=5), transportation (N=5), economic factors (N=2), and access to services (N=17). Each feature (e.g., broken windows, illegal dumping, and sidewalks) was measured in selected neighborhoods in urban areas of Kansas City with higher populations of Latino residents. After pilot testing was completed, ten neighborhoods of similar population densities were selected for study. These included five neighborhoods from census tracts of higher median annual income and five from census tracts of lower median annual income. Trained coders independently recorded the occurrence or non-occurrence of environmental features while walking through the ten neighborhoods. The assessment of each neighborhood took approximately one hour to complete. Results showed that there was a higher percentage of some negative features (e.g., broken windows, vacant houses) in lower income neighborhoods than higher-income neighborhoods. The higher-income neighborhoods had a greater percentage of some positive environmental features (e.g., childcare centers, schools, security systems etc.) that did the lower-income neighborhoods. The lower-income neighborhoods also had a higher percentage of some positive features (e.g., places of worship, parks) than did higher-income neighborhoods. Reliability of observations between independent observers suggests that the checklist may be an accurate tool for assessing environmental features related to social determinants of health. INTRODUCTION Research on social determinants of health suggests that physical health is affected by much more than access to primary health care (WHO Commission on Social Determinants, 2008). Only about 20% of overall health outcomes can be attributed to access to quality health care; by contrast, as much as 50% of the contribution to overall health outcomes can be attributed to the social, economic, and environmental conditions in people's lives (County Health Rankings, 2012). These social determinants - often related to income inequality - are seen as major determinants of health outcomes for populations (WHO Commission on Social Determinants, 2008). 7 Mechanisms by which social determinants produce health disparities include unequal exposure to environmental factors such as poor housing and living conditions (WHO Commission on Social Determinants, 2008). These differential exposures may be related to unhealthy housing, dangerous working conditions, low food availability and quality, social exclusion and barriers to adopting healthy behaviors and other risk factors (WHO Department of Ethics, Equity, Trade and Human Rights, 2010). Differential exposures to unequal health conditions are linked to health disparities, particularly for groups experiencing social exclusion such as Latinos and other racial and ethnic minorities (Braveman, 2006). Observable indicators of social determinants of health may be useful in distinguishing environmental features that may influence disparities in health across communities. This study explored the question of whether environmental indicators that may affect health can be assessed by direct observation. The experimenter created an environmental assessment tool to test this question. The tool was used to survey higher- and lower-income Latino neighborhoods in Wyandotte County, Kansas. METHODS Context: Latino Health for All Coalition This research project was conducted in support of the Latino Health for All Coalition, a community-academic partnership working with a low-income and primarily first-generation Latino community in Kansas City, Kansas. The mission of the Latino Health for All Coalition (LHFA) is to decrease rates of heart disease and diabetes in the Latino population and to increase the proportion of Latinos who engage in healthy lifestyle choices such as physical activity and nutritious eating habits in the Kansas City area. These objectives were selected because of the need that has been documented within the community. In the Kansas City region, Latinos experience an average life expectancy 11 years shorter than whites (Farakhan and Thompson, 2000). Specifically, Latinos in the Kansas City area are slightly less than 1 U times more likely to die from diabetes - the second leading cause of death for Latinos in Kansas City, Missouri (Kansas City Missouri Department of Health, 2004) - than their white counterparts (Farakhan and Thomas, 2000). Even as the mortality rates due to cardiovascular diseases among whites and African Americans in Kansas City decreased between the years 1994 and 2003, the mortality rates due to cardiovascular diseases among Latinos continued to rise (Kansas City Health Department, 2004). The Latino Health for All Coalition has set out to empower community members to positively impact their health and the health of their community in order to create greater community change. In doing this, LHFA aims to promote health equity by identifying and addressing the social determinants that affect Latinos and other minorities in Wyandotte County while also remaining culturally sensitive (Latino Health for All, 2008). In order to accurately identify social determinants, the Latino Health for All Coalition has engaged in extensive community health assessment efforts through a grant from the Centers for Disease Control and Prevention, the Racial and Ethnic Approaches to Community Health (REACH). This environmental assessment is one of many efforts intended to learn more about 8 factors affecting the overall health and health disparities among socially disadvantaged groups in Wyandotte County, Kansas. Neighborhoods Ten neighborhoods, each within a different census tract in Wyandotte County, Kansas, were selected for this research project. Census tracts were used to identify areas with differences in median annual income and relatively high population density overall and higher Hispanic population. Each of the census tracts had a population of 900 individuals or higher and Hispanic populations of 200 individuals or higher. Census tracts with Hispanic populations of 1,000 individuals or higher were selected when there were census tracts that also fit both the income and population density requirements. Five of the neighborhoods were selected from a lower median annual income range to serve as a lower-income group, and five of the neighborhoods were selected from a higher median annual income range to serve as a higher-income group. The five census tracts selected for the lower-income group had median annual incomes in the range of $9,694 - $24,999, and five of the census tracts selected for the higher-income group had median annual incomes in the range of $35,000 - $49,999. For each census tract, the street intersection closest to the centermost geographic point of the tract was selected as the center of the data collection area. From this point, observations were conducted for one-half mile outward in each of the four directions, North, South, East and West or the closest possible approximation thereof. Each of these half-mile radius zones within a census tract served as the operational definition of a neighborhood for the study. Appendix A provides a map of the neighborhoods involved in this study. Measurement System Table 1 displays the environmental assessment domains, measures and behavioral definitions used in this study. Environmental indicators for measures of social determinants were selected through literature review and social validation ratings by researchers with experience in the area. Lists of possible measures of social determinants of health were compiled from existing reports that used windshield surveys and other related methods. They included a number of domains as related candidate indicators; for instance, housing (e.g., broken windows, signs of eviction, etc.) and social order (e.g., parks, organized game courts, etc.) (Furr-Holden, Campbell, Milam, Smart, Ialongo X Leaf, 2010). These lists of candidate measures were then presented to several experts in public health and community health. They evaluated each candidate measure using three criteria: a) its relevance to the construct of social determinants of health, b) its likelihood for feasibility of data collection, and c) its likelihood for accuracy or reliability between independent observers. Measures that scored high in all three of these categories were then selected for inclusion on the environmental checklist. Appendix B provides a data table of the candidate measures' evaluation. A simple environmental assessment instrument (Appendix C) was then created consisting of these measures. This tool is a two-page checklist used to document the occurrence or non-occurrence of environmental features related to the domains of housing (N=5), safety (N=11), recreational spaces (N=5), transportation 9 (N=5), economic factors (N=2), and access to services (N=17). Observers scored for occurrence or non-occurrence of each indicator for each block surveyed within a particular neighborhood. There is also space for additional comments and qualitative description of neighborhood attributes. Before the study took place, observers received training to help assure the accuracy of their recording. This consisted of a PowerPoint presentation that included behavioral definitions of each measure (e.g., housing - vacant dwellings) with examples and non- examples (e.g, photographs of what is by definition a vacant dwelling and what is not by definition a vacant dwelling). Table 1 contains a summary of the measures and corresponding behavioral definitions. 10 Table 1 - Environmental Assessment Domains, Measures, and Brief Definitions Domains Measure Definition Housing Broken Windows Dwelling where any window has unrepaired cracks or missing glass as visible from the street Boarded Up Windows Dwelling where any window has signs of makeshift repair [e.g., plywood, plastic sheets, etc.] Vacancies Dwelling that appears to be without occupants (e.g., eviction sign, no furniture inside) For Sale/Rent Dwelling with a posted sign that says "for sale" or "for rent" Fire Damage Dwelling that shows signs of smoke or fire damage Safety Barred Windows Any window that has two or more metal bars on the exterior side of the building Graffiti Any words or symbols spray-painted onto surfaces Security Systems Signs or other markers posted on a dwelling that indicate a security system is present Illegal Dumping Any waste material that is larger than 1 foot by 1 foot [e.g., tires, appliances, equipment) Street Lights Any public light on a post with as a source for illuminating the area Crosswalks Any signage on pavement indicating where pedestrians are permitted to cross a street Police Presence Any sighting of a police officer or a patrol vehicle Fire Stations Any facility with a sign designating it as a fire station Guard Dogs Signs or other markers posted that indicate the presence of dogs (e.g., "beware of dog") Trash Any waste accumulated; must be at least 5 pieces of 2 inches by 2 inches Hazardous Materials Harmful chemicals or refuse or sites where waste is dumped Transportation Bus Stops Location with signage for bus stop Potholes Any hole in the street pavement the size of a dinner plate or larger Sidewalks Presence or cement or brick paths adjacent to the road Bike Lanes Presence of a lane in road for bike traffic Taxis Presence of a vehicle identified as a taxi Economy Vacant Store Fronts Any retail or business building that is not currently occupied Payday Advance Stores Operating business that has signage labeling it as a payday loan or advance store Recreational Spaces Parks Space for communal interactions and/or recreation for the general public Parks with Amenities Any man-made item or aspect that enhances the quality of the park (e.g., playground equipment, basketball courts, water fountain, etc.] Public Recreational Facilities Enclosed building visibly designated as open to the public or as a "community center" Recreational Facilities with Amenities Any item or aspect that enhances the quality of the community center Private Recreational Facilities Enclosed building that is not designated to be open to the public Services Schools Building with sign indicating it is a school Elementary Schools Building with sign indicating it is an elementary school Childcare/Daycare Building with sign indicating it is a childcare or daycare Primary Health Care Building with sign indicating it is a primary care facility or clinic Safety Net Clinics Building identified as a "Federally Qualified Health Center" [FQHC] or "Community Health Center" Social Services Building identified as a government or government supported services office Food Stores Any building that sells food or groceries Corner Stores/Tiendas Food store that sells mainly food and household goods Supermarkets Food store with additional services available [e.g., clothing retail, auto services, eye care, etc.] Bars Any facility that serves alcoholic beverages (e.g., bar, tavern, pub, etc.] Restaurants Any store where one can purchase or eat a meal [e.g., fast food, dine-in, carry-out] Liquor Stores Any building marked as a liquor retail outlet Places of Worship Any operating church or other religious building 12 Gas Stations Building that has at least one gas pump Hospitals Health care institution with signage indicating it is a hospital County Dental Clinics Building providing dental care that has signage identifying it as a "County Dental Clinic" Farmers Markets Any set of stands selling produce and/or meat products 13 Several undergraduate students affiliated with the KU Work Group for Community Health and Development were trained using the observer codebook found in Appendix D. The students piloted the checklist in a different county that served as a test location for feasibility and accuracy. The first author (primary observer) then conducted observations of environmental features in the 10 selected neighborhoods within Wyandotte County. A random sample of two lower-income neighborhoods and two higher-income neighborhoods were concurrently observed by a second independent observer, an undergraduate student not the first author, so that accuracy of scoring could be assessed using measures of inter-observer agreement. Development of Observational System This measurement process was designed using an observational system framework outlined in the Community Tool Box (2012). First, the experimental question was identified: Are there differential levels of exposure to environmental conditions in lower and higher-income neighborhoods for the Latino community of Kansas City, Kansas? Second, the method chosen to address this question was direct observation of environmental features. Measures to be included were compiled through literature review and social validation of measures by researchers with experience in observational studies. The neighborhoods within Wyandotte County would be each observed one time during the course of the study. Third, codebook was devised for observers that provided behavioral definitions and scoring instructions for each measure as well as examples and non-examples. Observers were individually trained on the codebook regarding what to record and what conditions would be observed. Fourth, a second observer simultaneously to the primary observer yet independently assessed four of the ten neighborhoods to check the reliability of the environmental assessment tool. Finally, suggestions for adjustment in the measurement system were included in this study after data on inter-observer agreement were collected and analyzed. RESULTS Table 2 displays the overall results obtained using this measurement system. Table 2 - Mean Percent and Range of Occurrences of Measures in Each Block Per Area of Selected Lower-Income fN=5} and Higher-Income fN=5} Neighborhoods Domains Measure Lower-Income Higher-Income Positive (+)/Negative (-) Measures Mean fBlock/Areal Range Mean fBlock/Areal Range 7ousing Broken Windows (-] 2 1 % 7-39 5% 0-19 Boarded Up Windows f-> 24% 18-48 19% 0-32 Vacant Dwellings f-> 18% 6-25 15% 11-20 For Nale/Rent f-> 15% 8-29 20% 11-38 Fire Damage (-] 1% 0-4 0% 0-0 NaQety Barred Windows f-> 35% 19-47 12% 0-22 GraQQiti f-> 2 2 % 10-35 4% 0-10 Necurity Nystems f+> 4 3 % 7-71 6 2 % 50-83 Illegal Dumping (-] 13% 0-19 13% 0-50 Ntreet Lights f+> 96% 82-100 100% 100-100 Crosswalks f+> 12% 0-34 11% 0-33 Police Presence f+> 2% 0-7 2% 0-13 Fire Ntations (+> 0% 0-0 2% 0-17 Guard Dogs (+> 15% 3-27 15% 0-25 Trash f-> 29% 17-52 39% 11-60 7azardous Materials f-> 0% 0-0 0% 0-0 Transportation Bus Ntops (+> 2 1 % 0-48 11% 0-39 Potholes f-> 7% 0-17 6% 0-16 Nidewalks f+> 87% 69-100 8% 0-50 Bike Lanes (+> 0% 0-0 0% 0-0 Taxis (+> 0% 0-0 1% 0-5 Economy Vacant Ntore Fronts f-> 20% 0-46 2% 0-6 Payday Advance Ntores f-> 0% 0-0 0% 0-0 Recreational Npaces Parks f+> 9% 0-35 4% 0-17 Parks with Amenities (+> 6% 0-35 2% 0-17 Public Recreational Facilities f+1 2% 0-7 0% 0-0 Recreational Facilities with Amenities f+> 2% 0-6 0% 0-0 Private Recreational Facilities f+1 1% 0-4 1% 1-17 Nervices Nchools f+1 2% 0-7 7% 0-50 Elementary Nchools (+> 2% 0-7 6% 0-17 Childcare/Daycare f+> 0% 0-0 5% 0-33 Primary 7ealth Care (+> 2% 0-7 0% 0-0 NaQety Net Clinics f+> 1% 0-3 0% 0-0 Nocial Nervices f+> 3% 0-10 0% 0-5 Food Ntores (+> 10% 0-21 1% 0-5 15 Corner Stores/Tiendas (+) 8% 0-21 1% 0-5 Supermarkets (+] 1% 0-4 0% 0-0 Bars (-] 4% 0-19 0% 0-0 Restaurants (+) 9% 0-21 2% 0-17 Liquor Stores (-) 2% 0-7 0% 0-0 Places of Worship (+] 15% 4-38 6% 0-10 Gas Stations (+] 2% 0-4 0% 0-0 Hospitals (+) 0% 0-0 0% 0-0 County Dental Clinics (+) 0% 0-0 0% 0-0 Farmers Markets (+] 0% 0-0 0% 0-0 The results show a higher percentage of some negative environmental features to which residents were exposed in the lower-income neighborhoods than the higher-income neighborhoods. Negative environmental features occurred at a higher percentage in lower-income neighborhoods than in higher-income neighborhoods for these measures: broken windows, boarded up windows, vacant dwellings, fire damaged dwellings, barred windows, graffiti, potholes, vacant storefronts bars, and liquor stores. Higher-income neighborhoods had higher percentages of positive environmental factors than did lower-income neighborhoods for some features: security systems, street lights, fire stations, taxis, schools, elementary schools, and childcare or daycare centers. Other environmental indicators showed little or no difference across neighborhoods. For instance, the percent of blocks per neighborhood in lower- income communities was equal to that of higher-income neighborhoods for the measures of illegal dumping, police presence, guard dogs, hazardous materials, bike lanes, payday advance stores, private recreational facilities, hospitals, county dental clinics, and farmers markets. For other measures, lower-income neighborhoods had lower instances of negative environmental features and higher instances of positive environmental features. Lower-income neighborhoods had lower percentages of "for sale" and "for rent" signs than did higher-income neighborhoods as well as a lower percentage of blocks with trash per neighborhood. Additionally, lower- income neighborhoods had higher percentages than higher-income neighborhoods of several positive environmental features: crosswalks, bus stops, sidewalks, parks, parks with amenities (e.g., parks with playgrounds1, public recreational facilities, recreational facilities with amenities (e.g., recreational facilities with outdoor basketball courts1, primary health care centers, safety net clinics, social services, food stores, corner stores or tiendas, supermarkets, restaurants, gas stations, and places of worship. Figures 1-6 present some illustrative graphs of selected measures. Figure 1 shows that the percentage of occurrences of broken windows, a measure of housing, was higher in the lower-income neighborhoods (21%) than in higher-income neighborhoods (5%1. Figure 2 shows that the percentage of occurrences of graffiti, a measure of the safety domain, was higher in lower- income neighborhoods (22%) than in higher-income neighborhoods (4%). Percentage of occurrences of sidewalks, a 16 measure of transportation, was higher in lower-income neighborhoods (87%) than in higher-income neighborhoods (8%), as shown in Figure 3. Figure 4 shows that a measure of the economy, vacant storefronts, were found to occur at a higher percentage in lower-income neighborhoods (20%) than in higher- income neighborhoods (2%). The percentage of blocks per neighborhood containing parks, as shown in Figure 5, was higher in the lower-income neighborhoods (9%) than in the higher- income neighborhoods (4%). Figure 6 shows the percentage of blocks with places of worship, an example of the services domain, was higher for lower- income communities (15%) than it was for higher-income communities (6%). Figure 1 - Housing: Broken Windows Figure 3 - Transportation: Sidewalks Housing: Broken Windows Lower-Income Neighborhoods (N=5) Higher-Income Neighborhoods (N=5) Figure 2 - Safety: Broken Windows Figure 4 - Economy: Vacant Store Fronts Figure 5 - Recreational Spaces: Parks 17 Figure 6 - Services: Places of Worship Figure 7 - 89:er;<=server > g r e e ? e 9 t Services: Places of Worship Lower-Income Neighborhoods (N=5) Higher-Income Neighborhoods (N=5) There was also variability between the neighborhoods surveyed within each group. For example, the low-income neighborhood in census tract 420.02 had places of worship on 4% of the blocks observed whereas the lower-income neighborhood in census tract 418 had places of worship on 38% of the blocks observed. The higher-income neighborhood in the census tract 437 had 11% of blocks with "for sale" or "for rent" signs while the higher-income neighborhood in census tract 405 had "for sale" or "for rent" signs on 38% of the blocks. Inter-observer agreement was high overall with the primary observer (first author) and secondary observers (undergraduate students) agreeing on 98% of total opportunities, as shown in Figure 7. Inter-observer agreement was higher for some indicators than for others. Inter-observer agreement was above 80% for the following measures: all measures in the services domain; all measures in the housing domain; all measures in the transportation domain; all measures in the economy domain; and the measures graffiti, police presence, fire stations, street lights, crosswalks, security systems, guard dogs, barred windows, illegal dumping, and hazardous materials. For the measure of trash, it was below 80%. DISCUSSKN Findings from this study indicate that residents of the lower-income neighborhoods had greater exposure to some environmental features associated with health disparities than those living in higher-income neighborhoods. The higher-income neighborhoods had greater percentages for some positive features such as schools, childcare and daycare centers, and streetlights; and fewer negative features such as broken windows, vacant dwellings and store fronts, and bars and liquor stores. This was consistent with the hypothesis that differential exposures (to social determinants) were related to differential income. Many measures did not show marked differences between lower- income and higher-income communities. For instance, percentage of neighborhoods with police presence, crosswalks, evidence of guard dogs, and illegal dumping were equivalent across income levels. This was not consistent with the hypothesis. Also not consistent with the hypothesis, greater percentages of many positive environmental features occurred in lower-income communities than in the higher-income communities, such as 18 blocks per area containing sidewalks, parks, and places of worship. These higher percentages of positive environmental features occurred in especially high number for the domains of recreational spaces (e.g., parks and recreational spaces) and services (e.g., restaurants, places of worship). This suggests that lower-income communities may not be as resource-poor as predicted by the hypothesis. These factors are assets upon which lower-income neighborhoods can build and may serve as important environmental features to leverage toward improving community health and the health outcomes of community residents. A limitation of this approach was the minimal adaptability of this measurement protocol to different neighborhood conditions such as population density. For example, some of the neighborhoods surveyed contained fewer houses set farther apart whereas other neighborhoods contained houses that were much closer together. The neighborhood observed in census tract 418 contained 29 blocks while the neighborhood observed in census tract 438.03 contained 6 blocks. Additionally, this study was limited by the sampling method for each neighborhood area of only surveying four one-half-mile lengths out from the central point as opposed to the entire circular area with a radius of one half-mile. As an example, several neighborhoods were known to contain features such as schools or parks that were within the circular one half-mile radius, but these features were not observed or consequently scored because they were not along any of the four lengths surveyed. These are factors that should be considered in future research. This study also had several strengths. One strength is the practicality of conducting the assessment. The only supplies used in observation were printed copies of the environmental assessment and clipboards. The average time spent in observation for an individual neighborhood was one hour, with a range of forty minutes to 1.5 hours. Further, this study attempted to identify and directly observe environmental features that may be related to differential exposures that contribute to health inequity, an area on which the experimenter was able to find only limited prior research. Finally, the environmental assessment was shown to have high levels of inter-observer agreement. The findings of this study support the growing body of research connecting environment with health. The results suggest that indicators related to environmental features can be studied through direct observation. Future research should explore the question of which environmental features have the greatest correlation to social determinants and the greatest impact on health. Further research and collaborative action is also needed to establish and verify successful methods of eliminating health disparities. A potential future use of this environmental assessment is as a pre-test of neighborhoods before community organizations implement initiatives to improve health followed a second use of the assessment as a post- test of the neighborhoods after this work has been put into action. Use of this assessment in this way would serve to measure the broad effects of the community organization's work on the neighborhood residents' exposure to social determinants of health. The Latino Health for All Coalition is taking part in such efforts to create conditions that promote health equality for Latinos in the Kansas City area. 19 Collaborative public health research actions should attempt to limit exposures in low-income neighborhoods. For instance, this might include community programs and policies that support access to services, places that assure opportunities for physical activity, safety improvement efforts, and economic improvement efforts within low-income areas with populations experiencing health disparities. The higher occurrences of service resources found by this study to exist in the lower-income communities support this recommendation and may be built upon for future health improvements. The goal of these efforts is to learn more about and act to reduce health inequities that prevent people from living healthy lives. We can work together to create more equitable conditions so that all people are able to live healthy lives. REFERENCES Blas, E., & Kurup, A. S. [2010]. Equity, social determinants and public health programmes. Geneva, Switzerland: WHO Press. Braveman, P. [2006). Health disparities and health equity: concepts and measurement. [Review]. Annual Review of Public Health, 27, 167¬ 194. doi: 10.1146/annurev.publhealth.27.0 21405.102103 CSDH [2008). Closing the gap in a generation: health equity through action on the social determinants of health. Final Report of the Commission on Social Determinants of Health. Geneva, World Health Organization. Commynity Tool Box. [2008). Latino health for all: about us. Retrieved from https://www.myctb.org/wst/latin ohealth/about_us/default.aspx County Health Rankings. [2012). Our approach. Retrieved from http://www.countyhealthrankings .org/our-approach Farakhan, C., & Thompson, F. [2000). Minority Health Indicators. In C. Farakhan & F. Thompson [Eds.). Kansas City, Missouri: Kansas City Health Department. Fawcett, S. B., & Rabinowitz, P. [2012). Data collection: Designing an observational system. Retrieved from http://ctb.ku.edu/en/tablecontent s/chapter37_section3_main.aspx Furr-Holden, C. D. M., Campbell, K. D. M., Milam, A. J., Smart, M. J., Ialongo, N. A., & Leaf, P. J. [2010). Metric properties of the neighborhood inventory for environmental typology [nifety): An environmental assessment tool for measuring indicators of violence, alcohol, tobacco and other drug exposures. Eval Rev, 34(3), 159¬ 184. doi: 10.1177/0193841X10368493 Kansas City Missouri Department of Health. [2004). The Community Speaks About Health. Kansas City, Missouri: Kansas City, Missouri Department of Health 20 Regulatory Oversight of Foreign Clinical Trials: An Examination of the Industry's Influence on FDA Pharmaceutical Regulation and the Implications for Enforcement Activity Both Domestic and Abroad Beeta Kashani (FacultyAdvisor: Gary Reich) Political Science ABSTRACT 9: rece:t decadeS; the 1 1 T e s s a T a n - T o r r e s Edejer . "North-South R e s e a r c h P a r t n e r s h i p s : the Ethics of Carrying 0 u t R e s e a r c h in D e v e l o p i n g Countries ." British Medical Journal 319 (1999) : 4 3 8 - 4 1 . French Section of Medicins Sans Frontieres, warned of the dire need to address the gaps between research realities and the global disease burden: "In most cases, [the company's] objective is not to do research on illnesses affecting poor countries." 1 2 Of the 1,556 new drugs developed between 1975 and 2004, only twenty of them targeted the diseases responsible for fifteen million deaths annually. Not even 10% of clinical research focuses on the conditions that cause 90% of deaths worldwide. 1 3 Not only is foreign clinical research often exploitative, it can also be scientifically unsound. Because the standard of care in the developing world is usually second-rate and local facilities lack adequate clinical infrastructure, health care professionals, and standard treatments and drugs, many patients who suffer from illnesses are often untreated or undertreated. 1 4 When these patients participate in a clinical trial, the experimental treatment is being tested on individuals who have had little to no previous exposure to drugs, and thus might have an entirely different effect than it would on a patient who has been medicated, vaccinated, and treated for their entire life, as is common in the first world. 1 5 These trials do not always take into account how the drug would interact with other treatments that might be administered or present in the bloodstream simultaneously, or the effect of environmental factors. 1 6 In many cases, 1 2 J e a n - H e r v e Bradol . "Clinical Trials in Africa: Ethical R e s e a r c h N e e d e d on Diseases ," Doctors W i t h o u t B o r d e r s , 7 June 2 0 0 7 . W e b . 1 3 Ibid. 1 4 G l i c k m a n , "Ethical and Scientific Impl icat ions of the Global izat ion of Clinical Research ," 8 1 9 . 1 5 Ibid , 8 2 0 . 1 6 F D A Cardiovascular & Renal D r u g s A d v i s o r y 23 attention to social ecology and genetic diversity takes a backseat to the convenience of the test subjects' lack of education or poverty. Researchers have found divergence among the genetic profiles of populations according to geographic location; accordingly, some treatments may differ in how they respond to the particular genetic makeup of different people. 1 7 One study of 42 genetic variants related to pharmacologic response found that more than two-thirds had substantial differences in frequency between persons of African descent and European descent. 1 8 This has serious implications for trials involving cardiac, circulatory, and neurologic disorders. 1 9 CASE STUDIES In order to illustrate the serious implications of the ethical negligence routinely exhibited by pharmaceutical industry sponsors when conducting research, I will describe the clinical development of several controversial treatments. TROVAN In 1996, Nigeria experienced the largest epidemic of meningococcal meningitis 2 0 t h century Africa had ever seen. Between January and June of that year, 109,580 cases were reported, resulting in more than 11,000 deaths. 2 0 For clinical investigators at the most profitable American pharmaceutical C o m m i t t e e . 2 0 0 7 M e e t i n g d o c u m e n t s . ( w w w . f d a . g o v / o h r m s / d o c k e t s / a c / 0 7 / t r a n s c r i p t s / 2 0 0 7 - 4 3 2 7 t - 0 2 - p a r t 2 . p d f ) 1 7 G l i c k m a n , "Ethical and Scientific Impl icat ions of the Global izat ion of Clinical Research ," 8 2 0 . 1 8 Ibid. 1 9 Ibid, 8 2 1 . 2 0 Idris M o h a m m e d , et al . , "A severe e p i d e m i c of m e n i n g o c o c c a l meningit is in N i g e r i a , 1996." Transactions of the Royal Society of Tropical Medicine and Hygiene (2000) : 2 6 5 - 7 0 . company, Pfizer, these statistics fell upon eager ears. Earlier that year, Pfizer had developed a potentially lucrative antibiotic called Trovan. Before they could make it available on the market, it had to be approved by the Food and Drug Administration through a process of clinical trials and toxicity testing to demonstrate the efficacy of the treatment. 2 1 To nullify concerns that Trovan causes joint damage and other dangerous side effects in children, Pfizer sought to prove its usefulness to the medical community by using it to treat bacterial meningitis. However, there were not enough cases of meningitis in the United States for Pfizer to conduct a statistically significant trial. Upon finding out about the outbreak across the Atlantic, Pfizer promptly opened up an unauthorized clinic in the Nigerian city of Kano. 2 2 Two hundred children were selected from an epidemic hospital; half of them were administered an untested oral dose of Trovan and the other half were given the standard treatment, a dose of intravenous ceftriaxone. None of the patients' parents were told that their children were receiving an experimental and potentially risky drug. Although Trovan proved fatal for eleven children and had detrimental side effects such as deafness, lameness, blindness, brain damage, and paralysis, Pfizer stated in its reports that the death rate was significantly low, and never attempted to conduct follow up examinations on the children to confirm long-term effects of 2 1 " H o w D r u g s A r e D e v e l o p e d and A p p r o v e d . " U.S. F o o d and D r u g A d m i n i s t r a t i o n , 23 Apr . 2 0 1 0 . W e b . 2 2 W i l l i a m D u B o i s . " N e w Drug R e s e a r c h , T h e Extraterritorial Appl icat ion of F D A R e g u l a t i o n s , and the N e e d for International Cooperat ion ." VanderbiltJournal of Transnational Law 36 .161 (2003) : 1 6 1 - 2 0 7 . 24 the treatment. 2 3 After FDA approval was obtained in the U.S., Trovan was introduced to the market in February 1998 as an antibiotic with fourteen different uses. That year, Trovan was one of Pfizer's top-selling drugs, bringing in $160 million and expected to bring in $1 billion the following year. Within months, reports of liver toxicity in patients with Trovan prescriptions were submitted to the FDA, and the FDA responded by asking Pfizer to include liver toxicity in the list of possible side effects. The next year hundreds of reports of liver problems piled in. By the time the FDA issued a statement recommending that Trovan be used only in hospitals and in rare cases, fourteen patients experienced acute liver failure, and six died. 2 4 As accusations of unethical research practices began to crop up in 2000, Pfizer's researchers were blamed for not obtaining informed consent, keeping inaccurate records, and not explaining to the parents of the test subjects that their children were receiving an experimental and potentially risky drug. 2 5 Despite the clear violations of research ethics, the deceitful exploitation of children during a public health emergency, and the lack of authorization by the Nigerian government, the lawsuit filed against Pfizer was dismissed twice in U.S. Courts, and a Pfizer spokesman stated that the 2 3 Ibid, 164. 2 4 M e l o d y Petersen. "Unforeseen Side Effects R u i n e d O n e Blockbuster ." The New York Times. A u g u s t 17, 2 0 0 0 . < h t t p : / / w w w . n y t i m e s . c o m / 2 0 0 0 / 0 8 / 2 7 / b u s i n e s s/unforeseen-s ide-ef fects-ruined-one- b l o c k b u s t e r . h t m l > 2 5 Anjal i Kamat , " W i k i L e a k s Cables: Pfizer T a r g e t e d Nigerian A t t o r n e y General to U n d e r m i n e Suit over Fatal D r u g Tests , " D e m o c r a c y N o w, 17 Dec. 2 0 1 0 . W e b . trials were "sound from medical, scientific, regulatory and ethical standpoints." 2 6 SYNFLORIX Between 2007 and 2008, GlaxoSmithKline (GSK) conducted a trial in rural areas of Argentina, Colombia, and Panama on approximately 24,000 children between the ages of 6 and 16 weeks to study the efficacy of a pneumococcal vaccine, Synflorix. 2 7 This vaccine was developed to prevent both pneumococcal diseases, which includes meningitis, sepsis, pneumonia, and otitis media, as well as bacterial respiratory infections. 2 8 Most of the parents of trial subjects were under-age, illiterate, or did not understand the implications of the treatment received. "They are vulnerable sections of society," Jorge Yabkowsky, president of the Argentine Federation of Health Professionals, explained, "They were unable to read any kind of consent form." 2 9 Researchers received $350 from GSK for each subject they enrolled. 3 0 Fourteen babies who were randomly assigned to the placebo group died during the trial. 3 1 In 2011, Argentinian courts 2 6 "Nigeria sues drugs giant Pfizer." BBC News, 5 J u n e 2 0 0 7 . 2 7 A n d r e a Gerlin. "Glaxo to A p p e a l Fines in A r g e n t i n a Case O v e r Synflorix Trial ." Bloomberg. J a n u a r y 3 , 2 0 1 2 . < h t t p : / / w w w . b l o o m b e r g . c o m / n e w s / 2 0 1 2 - 0 1 - 03/glaxo-to-appeal- f ines- in-argent ina-case-over- synflorix-trial .html> 2 8 "Glaxo m a y not launch Synflorix v a c c i n e in U.S." Reuters. F e b r u a r y 5, 2 0 0 9 . < h t t p : / / w w w . r e u t e r s . c o m / a r t i c l e / 2 0 0 9 / 0 2 / 0 5 / g l a x o - s y n f l o r i x - i d U S L 5 7 7 0 8 5 2 2 0 0 9 0 2 0 5 > 2 9 " G l a x o S m i t h K l i n e fined over trials on the b a b i e s of A r g e n t i n i a n poor ." The Telegraph, 11 J a n u a r y 2 0 1 2 . 3 0 Ibid. 3 1 Natal ie Fuertes . " W o r l d Report : G S K malpract ice case raises quest ions about trial s tandards ." The Lancet. 379 (2012) : 508. < h t t p : / / w w w . i a p c o i . c o m / h p / p d f / G S K % 2 0 m a l p r a 25 sued GSK $92,000 for "administrative irregularities" in obtaining informed consent. GSK is currently in the process of appealing the decision, claiming they "[conduct] clinical trials to the same high standards irrespective of where in the world they are run." KETEK In the 1990s, French company Aventis Pharmaceuticals (later Sanofi- Aventis) began conducting clinical trials of a new antibiotic, Ketek (telithromycin), developed to treat bacterial respiratory infections such as sinusitis, bronchitis, and pneumonia. 3 2 Most of the trials were done in Hungary, Morocco, Tunisia, and Turkey. 3 3 Several weeks before FDA approval of Ketek, an American researcher who had enrolled more than 400 subjects in one of Ketek's key clinical trials was sentenced to 57 months in prison for fabricating 9 1 % of her trial data. 3 4 It was later revealed that she collected $400 from Aventis for every subject she enrolled. Even after her sentencing, the FDA approved Ketek as safe in 2004, primarily based on foreign clinical data, and it was introduced to the market. 3 5 By 2006, the FDA received fourteen reports of liver failure, 23 reports of serious liver injury, and numerous other reports of liver damage, c t i c e % 2 0 c a s e % 2 0 r a i s e s % 2 0 q u e s t i o n s % 2 0 a b o u t 0 /o20trial°/o20standards.pdf> 3 2 K D Clay, JS H a n s o n , SD Pope , R W Rissmiller , et al. "Brief c o m m u n i c a t i o n : severe hepatotoxic i ty of te l i thromycin: three case reports and l iterature review." Annuals of Internal Medicine 144.6 (2006) : 4 1 5 - 2 0 . < h t t p : / / w w w . n c b i . n l m . n i h . g o v / p u b m e d / 1 6 4 8 1 4 5 1> 3 3 D o n a l d L. Barlett and J a m e s B. Steele . " D e a d l y Medic ine ." Vanity Fair, J a n u a r y 2 0 1 1 . 3 4 H e a r n , "The Rise of U n r e g u l a t e d D r u g Trials in South A m e r i c a . " 3 5 Ibid. including four deaths. 3 6 A study done that same year examined three previously healthy patients who had taken Telithromycin. Within days, all three of the patients had acute hepatitis, jaundice, and "markedly abnormal results on liver function tests." 3 7 One of the patients recovered, one needed orthotropic liver transplantation, and the third died. Further examination of the second and third patients revealed "massive hepatic necrosis," or the premature death of cells in living tissue. 3 8 Dr. David Graham wrote an email in 2006, obtained by the New York :i;es, revealing he thought approving Ketek was a mistake and strongly advised its withdrawal. He explained, "We don't really know if the drug works; no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin is uniquely more toxic than most other drugs." 3 9 He went on to write, "For FDA to refer to its being assured by post-marketing data from Latin America and Europe as a basis for declaring 'Ketek is safe' is in my opinion a great abuse of such surveillance data." Several weeks after these emails were made public, the FDA added to Ketek's warning section to include adverse events such as "visual disturbances, loss of consciousness, and hepatic toxicity." 4 0 3 6 G a r d i n e r Harris . " A p p r o v a l of Antibiot ic W o r r i e d Safety Officials." : 3 7 C lay , "Brief c o m m u n i c a t i o n . " 3 8 Ibid. 3 9 Harr is , "Approval of Antibiot ic W o r r i e d Safety Officials." 4 0 F o o d & D r u g A d m i n i s t r a t i o n . "FDA A n n o u n c e s Label and Indication C h a n g e s for the Antibiot ic Ketek." F e b r u a r y 1 2 , 2 0 0 7 . < h t t p : / / w w w . f d a . g o v / N e w s E v e n t s / N e w s r o o m / P r 26 It was not until February 2007, when more than 5 million Ketek prescriptions had been written, that the FDA announced that Sanofi-Aventis had to include a black box warning with the medication, as well as a Patient Medication Guide, and restrict its use for two previously approved conditions - acute bacterial sinusitis and acute bacterial bronchitis. 4 1 For these conditions, the FDA concluded that the risks of Ketek greatly outweighed the potential benefits. Iowan Senator Charles Grassley, a chairman of the Finance Committee who was involved in investigating Ketek, said, "It's no surprise to learn that the F.D.A. didn't listen to Dr. Graham on the dangers of Ketek. The F.D.A. has made it their business to discredit Dr. Graham and others who aren't willing to cater to the drug companies." 4 2 DEVELOPMENT OF GLOBAL STANDARDS In the past century, international efforts have been made to develop global standards of conduct for human experimentation. Current regulations for clinical research are derived from a series of international documents that form the foundation of research ethics. In this section, I will outline the historical contexts, important contributions, and fundamental gaps of each of these international documents to demonstrate why they fail to complement national regulations by reining in the pharmaceutical industry on a global scale. e s s A n n o u n c e m e n t s / 2 0 0 7 / u c m 1 0 8 8 4 2 . h t m ? u t m _ c a m p a i g n = G o o g l e 2 & u t m _ s o u r c e = f d a S e a r c h & u t m _ m e d i u m = w e b s i t e & u t m _ t e r m = k e t e k & u t m _ c o n t e n t =2> 4 1 Ibid. 4 2 Harris , "Approval of Antibiot ic W o r r i e d Safety Officials." Before World War II, no universal ethical document existed to guide research involving humans. When Allied troops moved to liberate Nazi concentration camps, they were horrified to discover that scores of prisoners had been subjected to ghastly medical experiments, carried out by Nazi researchers in an attempt to test the limits of the human body, develop weapons of warfare, and test experimental antibiotics. None of the prisoners gave consent or willingly volunteered to be exposed to diseases such as malaria, jaundice, and typhus, or to be operated on in a variety of dangerous surgical procedures. 4 3 The subsequent Doctors' Trial (United States of America v. Karl Brandt, et al.), the first of twelve trials for war crimes held by American authorities before American military courts in Nuremberg between October 1946 and August 1947, illuminated the dire need for an international consensus on bioethics. 4 4 Of the twenty-three defendants, twenty were medical doctors charged with crimes against humanity, such as performing medical experiments without the subjects' consent on prisoners of war and civilians of occupied countries. 4 5 Sixteen of the accused were 4 3 M a t t h e w L i p p m a n . "The Nazi Doctors Trial and the International Prohibi t ion on M e d i c a l I n v o l v e m e n t in T o r t u r e . " L o y o l a of Los Angeles International and Comparative Law Journal 15.2 (1993) : 3 9 5 - 4 4 1 . 4 4 U n i t e d States of A m e r i c a v s . Karl B r a n d t , et al. 1946. 4 5 O p e n i n g S t a t e m e n t of the P r o s e c u t i o n b y Brigadier G e n e r a l Teleford T a y l o r , 9 D e c e m b e r 1946. < h t t p : / / w w w . m a z a l . o r g / a r c h i v e / n m t / 0 1 / N M T 0 1 - T 0 2 7 . h t m > 27 indicted and sentenced to execution or imprisonment, despite their protests that there was no law that differentiated between legal and illegal human experiments. 4 6 In response, Dr. Leo Alexander, an American physician and medical advisor to the trials, proposed a set of principles to define legitimate and ethical medical research. Four more principles were added and adopted by the trial verdict, creating the Nuremberg Code. This code was the first established set of ethical principles for research involving human beings and prompted international dialogue regarding the development of international standards for research on humans. It emphasized, above all, informed and voluntary consent, as well as the absence of physical and mental suffering of the patient, an analysis of risks and benefits, scientific validity, and beneficence of the researcher with regards to the subject. 4 7 However, as the interest in medical research and advancement of new research methods grew, the need for more developed guidelines grew as well. Physician-researchers found that the Nuremberg Code was too stringent and inflexible and hindered their research. It made no provisions or guidelines dealing with children or the mentally impaired as research subjects and overemphasized 4 6 Federal R e s e a r c h Division. L ibrary of Congress . "Trials of W a r Criminals Before the N u r e m b e r g Mil itary Tr ibunals U n d e r Control Counci l Law." O c t o b e r 1 9 4 6 - Apri l 1 9 4 9 . < h t t p : / / w w w . l o c . g o v / r r / f r d / M i l i t a r y _ L a w / N T s _ w ar-cr iminals .html> 4 7 Ibid. informed consent. 4 8 In 1964, the World Medical Association presented the Declaration of Helsinki. Rather than a list of uncompromising principles, the Declaration was intended to be a more versatile ethical model, which would serve as guidelines for physicians. American researcher Henry Beecher explained: "The Nuremberg Code presents a rigid act of legalistic demands... The Declaration of Helsinki on the other hand, presents a set of guides. It is an ethical as opposed to a legalistic document and is thus more broadly useful than the one formulated at Nuremberg." 4 9 The President of the Council for International Organizations of Medical Sciences (CIOMS) stated that the Declaration of Helsinki improved upon the Nuremberg Code's "circumstantial" guidelines by placing them "more correctly in the context of generally accepted medical traditions." 5 0 The Declaration accomplished this versatility by isolating therapeutic and non-therapeutic, or scientific, research. 5 1 4 8 G e o r g e J. A n n a s . "The C h a n g i n g L a n d s c a p e of H u m a n E x p e r i m e n t a t i o n : N u r e m b e r g , Helsinki , and b e y o n d . " Journal of Law and Medicine 92.2 (1992) : 119. < h t t p : / / c o n n e c t i o n . e b s c o h o s t . c o m / c / a r t i c l e s / 9 6 0 9 0 4 2 7 0 3 / c h a n g i n g - l a n d s c a p e - h u m a n - e x p e r i m e n t a t i o n - n u r e m b e r g - h e l s i n k i - b e y o n d > 4 9 Q u o t e d in W . R e f s h a u g e , T h e Place for International S t a n d a r d s in C o n d u c t i n g R e s e a r c h for H u m a n s , 55 Bull . W o r l d Health Org. 133-35 (Supp. 1977) 5 0 R e f s h a u g e , supra note 5, at 137. 5 1 A n n a s , "The C h a n g i n g L a n d s c a p e of H u m a n E x p e r i m e n t a t i o n : N u r e m b e r g , Hels inki , and b e y o n d . " 28 While therapeutic research is utilized strictly for the benefit of the patient, scientific research is done to acquire scientific data. The patient's consent is valued differently according to which type of research they are exposed: if it is therapeutic, the physician may make decisions for the patient without their consent, assuming that the physician has the patient's best interests in mind. It was thought that acquiring consent in these instances would be too cumbersome and would create unnecessary difficulty in caring for the patient. 5 2 If the patient is involved in scientific research, their complete informed consent is absolutely necessary because there may be no direct benefit to the patient at all . 5 3 But when it comes to types of research like drug trials, they may be difficult to label as strictly therapeutic or scientific. Experimental treatments may be given in a therapeutic treatment, but they may not be proven to be safe or effective and are therefore not expected to necessarily benefit the patient. 5 4 In the 1975 revision, another provision was added, pushing for formal peer review of research protocols, which would give institutional review boards the responsibility to consider and comment on proposed experimental procedures. 5 5 During the 1990s, a series of trials were conducted in developing countries that incited international controversy and illustrated serious deficiencies in the 5 2 D a w n Joyce Miller. "Research and Accountabi l i ty : T h e N e e d for U n i f o r m Regulat ion of International P h a r m a c e u t i c a l Drug Testing." Pace International Law Review 13 (2001) : 204. 5 3 Ibid, 204. 5 4 Ib id , 204. 5 5 A n n a s , "The C h a n g i n g L a n d s c a p e of H u m a n E x p e r i m e n t a t i o n : N u r e m b e r g , Helsinki , and b e y o n d . " newly revised global standards. In 1994, trials were conducted in Uganda to determine if zidovudine (AZT), an antiretroviral drug, would decrease the likelihood of mother-to-child transmission of HIV. Researchers found that administering the drug during pregnancy and labor reduced transmission to infants by two-thirds, and that it had the potential to save one out of every seven infants born to HIV-positive women. 5 6 These studies proved to be controversial because a number of study participants were randomly assigned to placebo control groups. Although the use of placebos allows for quicker and more accurate results than equivalency studies, which are done to determine efficacy of a treatment in comparison to a pre- established level of efficacy, it deprives those unfortunate enough to be randomized into the control group of any kind of treatment, even if one exists. 5 7 Placebo-controlled studies were justified because research subjects were not being denied a treatment they would have otherwise received. This logic proved to be problematic because it created an incentive for researchers to conduct studies in parts of the world with the least access to medical care, where locals would more willingly risk being put into the placebo group out of desperation for 5 6 Peter Lurie, S i d ney M. W o l f e . "Unethical Trials of Intervent ions to R e d u c e Perinatal T r a n s m i s s i o n of the H u m a n I m m u n o d e f i c i e n c y Virus in D e v e l o p i n g Countr ies . " New England Journal of Medicine 337 ( 1 9 9 7 ) : 8 5 3 - 8 5 6 . < h t t p : / / w w w . n e j m . o r g / d o i / f u l l / 1 0 . 1 0 5 6 / N E J M 1 9 9 7 0 9 1 8 3 3 7 1 2 1 2 > 5 7 B r o o k s J a c k s o n , et al. " I n t r a p a r t u m and neonata l s ingle-dose nevirapine c o m p a r e d with z i d o v u d i n e for p r e v e n t i o n of mother-to-chi ld t r a n s m i s s i o n of HIV-1 in K a m p a l a , U g a n d a . " The Lancet 362 (2003) : 8 5 9 - 8 6 8 . < h t t p : / / w w w . t h e l a n c e t . c o m / j o u r n a l s / l a n c e t / a r t i c l e / P I I S 0 1 4 0 - 6 7 3 6 ( 0 3 ) 1 4 3 4 1 - 3 / a b s t r a c t > 29 even a 50% chance of receiving treatment. Following these incidents, the Declaration's revisions in 2000 contained a provision that stated, "A new method should be tested against those of the best current prophylactic, dialogistic, and therapeutic methods," and that a placebo (no treatment) is acceptable only in cases where no proven method exists. 5 8 Another provision stated that all study participants, on the completion of a clinical trial, must be provided with the "best proven diagnostic and therapeutic methods." 5 9 Before the codification of this principle, most research participants in the developing world were not provided with the proven treatment after the conclusion of the study, while participants in wealthy countries were supplied with the proven treatment until their death or the end of their illness. Although these provisions were well intentioned, they failed to fully address the root problems. The banning of placebos or experimental treatments when a proven treatment already exists is meant to promote a global standard of care, granting every trial subject the same treatment they would have received anywhere else in the world. This principle does not consider the extremely high cost, sophisticated equipment, and advanced medical training that is necessary to provide many standard treatments or perform standard procedures. Thus, it effectively bans the development of more practical treatments that would be cheaper and easier to implement or administer in the less advanced 5 8 W o r l d M e d i c a l Associat ion . "Declaration of Helsinki : ethical principles for medica l research involving h u m a n subjects ." Journal of Postgraduate Medicine 4 8 . 2 0 6 (2002) . 5 9 D i s m a n t l i n g the Helsinki Declarat ion 30 , 2 0 0 3 . healthcare systems of developing countries. 6 0 In 1949, the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) founded the Council of International Organizations of Medical Sciences (CIOMS), an international non-governmental organization designated to maintain "collaborative relations" with the UN, UNESCO, and WHO. In the late 1970s, CIOMS and WHO teamed up to establish bioethics as an integral part of medical research. They sought to develop an ethical framework "to indicate how the ethical principles that should guide the conduct of biomedical research involving human subjects, as set forth in the Declaration of Helsinki, could be effectively applied, particularly in developing countries, given their socioeconomic circumstances, laws and regulations, and executive and administrative arrangements." 6 1 In 1982, WHO and CIOMS published International Ethical Guidelines for Biomedical Research Involving Human Subjects. The document is intended to guide research that involves human subjects, which includes "studies of a physiological, biochemical or pathological process; the response to a specific intervention... in healthy subjects or patients; controlled trials of diagnostic preventative, or 6 0 David W e n d l e r and EJ E m a n u e l . "The S t a n d a r d of Care D e b a t e : Can R e s e a r c h in D e v e l o p i n g Countr ies be Both Ethical and R e s p o n s i v e to T h o s e Countr ies ' Health n e e d s ? " American Journal of Public Health 94.6 (2004) : 9 2 3 - 9 2 8 . 6 1 Counci l for Internat ional O r g a n i z a t i o n s of M e d i c a l Sc iences in col laborat ion w i t h the W o r l d Health O r g a n i z a t i o n . " International Ethical Guidel ines for B i o m e d i c a l R e s e a r c h Involving H u m a n Subjects ." Geneva , 2 0 0 2 . 30 therapeutic measures; studies designed to determine the consequences of specific preventative or therapeutic measures; studies concerning health-related behavior". 6 2 The guidelines call for research to adhere to basic principles: 1) respect for persons: respect for autonomy and protection of those with impaired autonomy; 2) beneficence: the obligation to maximize benefit and minimize harm; 3) justice: the treatment of each individual subject with the utmost respect and dignity, the equal distribution of burdens and benefits between those involved in the research, and sensitivity to the specific needs of subjects. 6 3 Research protocol should clearly elucidate "the aim of the research; the reasons for proposing that it involve human subjects; the nature and degree of any known risks to the subjects; the sources from which it is proposed to recruit subjects; and the means proposed for ensuring that subjects' consent will be adequately informed ad voluntary", and the protocol should be scientifically and ethically reviewed by independent investigative bodies. 6 4 However, due to the spread of HIV/AIDS, biotechnological advancements, and new research practices, CIOMS was obligated to publish two revisions: International Guidelines for Ethical Review of Epidemiological Studies (1991), and International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993). Ethical issues that arose after 1993 exposed gaps in the revisions that were connected to clinical trials done in developing countries. Some argued for local decision- 6 2 Ibid, 19. 6 3 Ibid, 18. 6 4 Ibid, 18. making, the avoidance of paternalism, and the development of low-cost public health solutions in communities where research was done. After much deliberation and re¬ drafting, CIOMS published the latest revision in 2002, which is comprised of general ethical principles and twenty-one guidelines. Just like the first draft, the current document is intended "to be of use, particularly to low-resource countries, in defining national policies on the ethics of biomedical research, applying ethical standards in local circumstances, and establishing or redefining adequate mechanisms for ethical review of research involving human subjects." The actual guidelines and their respective detailed commentaries consist of rules such as ethical justification and scientific validity of biomedical research involving human beings, ethical review committees, ethical review of externally sponsored research in the country sponsoring the research, individual informed consent, obligations of sponsors and investigators, benefits and risks of study participation, choice of control treatment, equitable distribution of risks and benefits, research on children, right of injured subjects to treatment and compensation, and more. 6 5 At the 2001 Conference on Ethical Aspects of Research in Developing Countries, participants compiled a set of developed criticisms of the CIOMS guidelines. In particular, they focused on the idea of reasonable availability, explained in Guideline 10: "The sponsor and investigator must make every effort to ensure that: 1) the research is responsive to the health needs and the 6 5 Ibid, 2 5 - 8 2 . 31 priorities of the population or community in which it is to be carried out; and 2) any intervention or product developed or knowledge generated, will be made reasonably available for the benefit of that population or community." 6 6 This guideline was criticized because of its reliance on a "mistaken conception" of exploitation - it focuses on the products of the research rather than the level of benefit. 6 7 While benefits are provided (i.e. "the fruits of the research"), they may not be necessarily fair or appropriate for the community. 6 8 Reasonable availability not only "embodies a very narrow notion of benefits," it makes the benefit reliant upon the success of the clinical trial, ignoring other potential benefits such as "the training of health care or research personnel, the construction of health care facilities and other physical infrastructure, and the provision of public health measures and services beyond those required by the research trial." 6 9 Furthermore, it is not applicable to Phase I and II drug and vaccine testing, or to genetic, epidemiology, and natural history research. 7 0 The Conference ultimately contributed a few constructive recommendations, including "providing collateral health services unnecessary for the research itself; public health measures for the country or community; long-term research collaboration; and sharing of financial rewards from research results, including intellectual 6 6 Ibid, 51 . 6 7 2 0 01 C o n f e r e n c e on Ethical A s p e c t s of R e s e a r c h in D e v e l o p i n g Countr ies . "Moral S t a n d a r d s for R e s e a r c h in D e v e l o p i n g Countries ." Hast ings Center Report . ( 2 0 0 4 ) : 17. 6 8 Ibid, 19. 6 9 Ib id , 21 . 7 0 Ib id , 21 . property rights", as well as advocate for transparency of the research process, extensive deliberative dialogue with the subject community, and a publicly available record of research protocol and benefit agreements. 7 1 Existing international guidelines have had a global impact. The Nuremberg Code set the precedent for an internationally accepted set of bioethical principles to guide human experimentation. The Declaration of Helsinki has been characterized as the "cornerstone of biomedical research for the past 30 years" and the indisputable foundation for ethical decision-making in research. 7 2 The CIOMS guidelines proposed suggestions for the application of ethical principles specifically for research conducted in developing countries. Although none of these ethical guidelines are legally binding under international law, they have in some part influenced or been integrated into numerous international, regional, and national legislation on human experimentation.7 3 The Code of Federal Regulations, consisting of guidelines directing federally funded research in the U.S., is partly based on the Nuremberg Code. 7 4 In 1981, the U.S. Courts cited the Nuremberg Code when stating, "The 7 1 Ruth Mackl in . Double Standards in Medical Research in Developing Countries. C a m b r i d g e Universi ty Press . (2004) : 152. 7 2 Francis C r a w l e y & J o s e p h Hoet. Ethics and Law: The Declaration of Helsinki Under Discussion. 150 Bulletin of M e d i c a l Ethics 9.10: (1999) . 7 3 Delon H u m a n and Sev S. Fluss . "The W o r l d M e d i c a l Associat ion's Declarat ion of Helsinki : Historical and C o n t e m p o r a r y Perspect ives ." 2 0 0 1 . < h t t p : / / w w w . w m a . n e t / e n / 2 0 a c t i v i t i e s / 1 0 e t h i c s / 10hels inki/draft_histor ica l_contemporary_perspe ctives.pdfg 7 4 Protect ion of H u m a n Subjects , 45 C.F.R. § 46 (2009) . 32 international consensus against involuntary human experimentation is clear." 7 5 The Belmont Report, the foundation of the Food & Drug Administration's duties and functions, is based on the Declaration of Helsinki. While all have been widely accepted and recognized worldwide, they have been criticized for being devised in reaction to particular events, such as the Nazi experiments or the Tuskegee and Willowbrook scandals . 7 6 , 7 7 , 7 8 As a result, they inadequately or unevenly address certain principles according to the context of the document's conception: the Nuremberg Code relies too much on informed consent, while the Declaration is too ambiguous to allow for pragmatic application, and CIOMS does not fully address the needs of research participants from the developing world. Furthermore, the guidelines are almost entirely oriented towards the "integrity and judgment" of the researcher, and have no real methods of enforcement.7 9 7 5 United States v. Jaffe, 663 F.2d 1226 7 6 E m a n u e l , " W h a t M a k e s Clinical R e s e a r c h Ethical?" 2 7 0 2 . 7 7 T h e T u s k e g e e syphil is e x p e r i m e n t w a s a 4 0 - y e a r - l o n g study c o n d u c t e d b y the Public Health Service to observe and record the p r o g r e s s i o n of syphil is in Afr ican A m e r i c a n m e n , w h o w e r e never i n f o r m e d of the real p u r p o s e of the study and w e r e deprived of effective t r e a t m e n t , penici l l in , even w h e n it b e c a m e available in 1947. See "The T u s k e g e e T i m e l i n e , " Centers for D i s e a s e Control and Prevent ion . 2 0 1 1 . 7 8 B e t w e e n 1 9 5 6 and 1970, s tudents h o u s e d at W i l l o w b r o o k State S c h o o l , a g o v e r n m e n t - f u n d e d school for chi ldren with intel lectual disabil i t ies , w e r e intentional ly infected with the hepatit is v irus in order to help r e s e a r c h e r s develop a vacc ine . See Medical Ethics and Humanities b y Frederick Paola, et al. (Jones & Bartlett Learning, 2 0 1 0 ) . P a g e s 2 8 5 - 2 8 6 . 7 9 D o m i n g u e z - U r b a n , " H a r m o n i z a t i o n in the The inability of global standards to act as effective regulatory mechanisms for foreign clinical trials place the burden of supervision on states. T H E ROLE OF THE F D A In 1938, U.S. Congress passed the Food, Drug, and Cosmetic Act (FDCA). 8 0 This law gave the Food and Drug Administration the responsibility to guarantee: the safety and efficacy of human and veterinary drugs and medical devices, safety and proper labeling of food and cosmetics, and protection of public health from electronic product radiation. 8 1 The FDA is mandated to protect public health through product regulation and supervision. The FDCA endows the FDA with the authority to inspect and approve new drugs and medical devices before they may be made available to the public, including the clinical trials required to develop them, as well as the duty to promptly withdraw a product if it proves to be unsafe after being introduced to the market. FDA restrictions apply to: research involving human subjects that is conducted, funded, or bound to regulation by any federal agency, as well as research conducted, funded, or bound to regulation by the federal government outside the U.S. 8 2 Research that is not conducted or funded by the federal government, but subject to federal regulations, is required to be evaluated and given approval by an institutional review board according to Regulat ion of P h a r m a c e u t i c a l R e s e a r c h and H u m a n Rights: T h e N e e d to T h i n k Globally," 274. 8 0 Federal F o o d , D r u g , and C o s m e t i c A c t of 1 9 3 8 , 21 U.S.C. C h a p t e r 9. 8 1 F o o d and D r u g A d m i n i s t r a t i o n , 21 U.S.C. § 3 9 3 ( b ) ( 2 0 0 9 ) . 8 2 Protect ion of H u m a n Subjects , 45 C.F.R. § 4 6 . 1 0 1 (2009) . 33 the same regulations. 8 3 Because all drugs must be approved by the FDA before being introduced into U.S. markets, any pharmaceutical corporations that conduct clinical trials to develop drugs to sell in the U.S. fall under the umbrella of restrictions as put forth by the Code of Federal Regulations. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established after the Tuskegee Syphilis scandal, was Congressionally mandated in 1974 to investigate all federally sponsored human subject research and review ethical research principles. The most prominent of their published reports is the Belmont Report, which is based on the Declaration of Helsinki and focused on three basic principles - respect for persons, beneficence, and justice - which were then applied to modern FDA research regulations. 8 4 , 8 5 "Respect for persons" is actualized through the rule of informed consent. The FDA requires that research may be done only under the condition that "the legally effective informed consent of the subject or the subject's legally authorized representative" is obtained. 8 6 Informed consent is defined as disclosing to the patient information regarding the study's purposes and methodology, potential 8 3 Ibid. 8 4 David P e r l m a n . "Ethics in Clinical Research: A History of H u m a n Subject Protect ions and Practical I m p l e m e n t a t i o n of Ethical S t a n d a r d s . " T e m p l e Universi ty School of P h a r m a c y . 2004. < h t t p : / / w w w . s o c r a . o r g / p d f / 2 0 0 4 0 5 _ E t h i c s _ C l i n i c a l _ R e s e a r c h _ H i s t o r y . p d f ] 85 h t t p : / / w w w . h h s . g o v / o h r p / p o l i c y / b e l m o n t . h t m l # xbenef i t 8 6 G e n e r a l R e q u i r e m e n t s for I n f o r m e d Consent , 21 C.F.R. § 50.20 ( 1 9 9 9 ) . risks and intended benefits, other alternative treatments, and the patient's right to withdraw from the study at any time, presented in a way the patient can understand. 8 7 The patient may not be coerced in any way. Informed consent may be bypassed only if the physician demonstrates that the patient was in a life threatening situation, the patient was unable to give consent, there was no time to obtain consent from another legitimate source, and there are no alternative treatments available. 8 8 "Beneficence" involves respecting the integrity and autonomy of the individual, as well as promoting their well being and protecting them from harm. This principle is the basis of the researcher's obligation to maximize benefits and minimize harm to the study participants. A clinical trial may only be conducted if it is supported by a positive risk/benefit analysis and the subject is not exposed to an unreasonable level of risk. "Justice" involves the equitable distribution of research benefits and burdens, and calls for a fair and appropriate method of selecting research subjects. This principle gives rise to the researcher's responsibility to select research populations based on the relevance of the study to their specific conditions, and to avoid taking advantage of economic, social, racial, or sexual vulnerabilities. These three principles are fulfilled by research protocol inspection by institutional review boards (IRB). IRBs, also called independent ethics committees or ethical review boards, are 8 7 E l e m e n t s of I n f o r m e d Consent , 21 C.F.R. § 50.25 (2011) . 8 8 Except ion from G e n e r a l R e q u i r e m e n t s , 21 C.F.R. § 50.23 (2011) . 34 committees officially assigned by the FDA to review biomedical research proposals, approve, disapprove, or require modification of research protocol, and monitor clinical trials involving humans. IRBs provide, in theory, broad protection of the health and safety of clinical research subjects. In order to approve research proposals, IRBs must ensure: (1) risks to subjects are minimized by using viable research design; (2) anticipated benefits reasonably outweigh risks to subjects; (3) choice of research subject population is justified and valid, and vulnerable populations are not being taken advantage of; (4) informed consent will be obtained; (5) informed consent will be officially documented; (6) data collection monitoring techniques will ensure the safety or research subjects, and (7) subject privacy is ensured and data is kept confidential.8 9 Furthermore, additional precautionary measures will be taken to ensure ethical research protocol if the research population is "vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons." 9 0 When clinical research was still done primarily in the U.S., these regulations for the most part effectively protected trial subjects, ensured the scientific validity of research protocol, and verified the accuracy of trial data. 9 1 But as sponsors began to submit foreign trial data, the FDA had to scramble to adapt methods of supervision. The FDA 8 9 Criteria for I R B A p p r o v a l of Research , 21 C.F.R. § 56 .111 (2001) . 9 0 Ibid. 9 1 D o m i n g u e z - U r b a n , " H a r m o n i z a t i o n in the Regulat ion of P h a r m a c e u t i c a l R e s e a r c h and H u m a n Rights: T h e N e e d to T h i n k Globally." gives sponsors conducting clinical trials abroad two options. First, they may submit an Investigational New Drug Application (IND) and be supervised by an IRB, just as they would be required to if the research were conducted in the U.S. An IND must contain pharmacological and chemical information about the drug, the objectives and duration of the clinical trial, background information on previous human and animal testing, foreign investigational or marketing experience, and manufacturing information. 9 2 It must also include a comprehensive outline for the clinical investigation, detailing the motivation behind the study, the components being studied, names and qualifications of all clinical investigators, research methodology, detailed protocols and procedures, the number of subjects to be enrolled, any anticipated risks and side effects, and information on the drug's safety and effectiveness based on previous studies. 9 3 The second option is the most commonly used - the clinical trials must be done in accordance with the Declaration of Helsinki, or the regulations of the host country, whichever provides more extensive protections of the research subjects. 9 4 If host country guidelines are used, the clinical investigator must explain the differences between the standards used and those put forth by the Declaration of Helsinki, and their reasoning in choosing those guidelines. To gain premarket approval based only on foreign clinical data requires that the data is relevant to U.S. markets and medical practices, the 9 2 Invest igat ional N e w D r u g Appl icat ion , 21 § 3 1 2 . 2 3 (2002) . 9 3 Ibid. 9 4 R e s e a r c h c o n d u c t e d outside the United S t a t e s , 21 C.F.R. § 8 1 4 . 1 5 (1986) . 35 clinical investigators are competent, and the understanding that the FDA may conduct on-site inspections if deemed necessary. 9 5 However, the FDA is often not aware that a clinical trial is being conducted abroad until the drug application is being submitted for market approval, after the completion of research, preventing field inspectors from supervising trial sites. 9 6 Foreign regulatory bodies may also monitor and inspect trials, but they are not obligated to share information or collaborate with the FDA. 9 7 The FDA is responsible for ensuring that these regulations are followed and is allowed to cooperate with foreign governments and agencies to "reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements." 9 8 While this does not explicitly imply extraterritorial jurisdiction, it certainly necessitates some amount of inspection to ensure the validity of the scientific data that will be used to determine the safety and efficacy of that drug. In 199O, only 271 clinical trials were conducted abroad to develop drugs for American markets. But by 2OO8, the number of foreign trials escalated 2,OOO%, to 6,485. 9 9 That same year, 80% of approved marketing applications for new drugs involved clinical data from 9 5 Ibid. 9 6 Daniel Levinson. "The F o o d and D r u g A d m i n i s t r a t i o n ' s Overs ight of Clinical Trials ." Office of the Inspector General . 2OO7. < http://oig .hhs .gov/oei/reports/oei-O1-O6- OO16O.pdf> 9 7 L e v i n s o n , "The F D A ' s Overs ight of Clinical Trials ," 5. 9 8 Interagency col laboration, 21 U.S.C. § 393(c)(2OO9). 9 9 L e v i n s o n , "The F D A ' s Overs ight of Clinical Trials ." foreign sites. The FDA inspected only 1.9% of domestic trial sites and O.7% of foreign trial sites in 2OO8.1 O° Without conducting onsite inspections, the FDA cannot consistently and fully ensure that clinical investigators, sponsors, and independent review boards are adhering to the proper regulations while completing research. In many instances, a failure to adhere to ethical guidelines coincides with the falsification of data. For example, in 1995, South African researcher and professor Werner Bezwoda conducted clinical trials to test a new treatment on of women with Stage 4 (metastatic) breast cancer. 1 ( ) 1 In the 1999 meeting of the American Society of Clinical Oncology, he reported extremely favorable outcomes as a result of an expensive treatment of high-dose chemotherapy combined with bone marrow or stem cell transplants. 1 O 2 When an on-site investigative team reviewed the trial data to verify Dr. Bezwoda's findings, they found "substantial evidence of scientific misconduct." 1 0 3 One-third of the trial subjects had not been officially enrolled and lacked any paperwork to verify their informed consent had been obtained or their eligibility to participate in the trial . 1 O S Many other patient files were incomplete or inconsistent with medical 1 0 0 L e v i n s o n , "The F D A ' s Overs ight of Clinical Trials ," ii. 1 0 1 R ichard Horton . "After B e z w o d a . " The Lancet 355 (2OOO): 9 4 2 - 9 4 3 . 1 0 2 Chr istopher W e i r and G o r d o n M u r r a y . "Fraud in clinical trials: Detect ing it and p r e v e n t i n g it." The Royal Statistical Society. D e c e m b e r 2O11. 1 0 3 R a y m o n d B. W e i s s , Robert M. Rifkin, et al. "High-dose c h e m o t h e r a p y for high-risk p r i m a r y breast cancer: an on-site review of the B e z w o d a study." The Lancet 3 5 5 (2OOO): 999-1OO3. 1 0 4 Ibid. 36 records. 1 0 5 Furthermore, Dr. Bezwoda never su;m 0' s=onsored to re=ort three deaths that occurred as a resu>t of h rates of those rece had been established in Sudan in 1979. 1 0 9 Because many African countries lack the infrastructure and resources to provide medical care to their citizens, in many cases the absence of regulation is deliberate. In efforts to supply their populations with health support and beneficial research, the governments of these nations often seek to attract pharmaceutical companies by stripping regulations and restrictions on research, or intentionally not enforcing them. 1 1 0 Today, 40% or more clinical trials are taking place in Asia, Eastern Europe, and Latin America, where there are no required registry systems in place to keep track of the research conducted. 1 1 1 This makes it easy to exploit the lax regulation and minimal supervision. Research subjects from developing countries are also increasingly vulnerable due to the flexible informed consent guidelines of CIOMS, adjusted in an effort to cater to the communal realities that exist in parts of the developing world. Additionally, regional agreements fail to represent shared values and a streamlined system of regulation. 1 1 2 In April 2008, the FDA announced that they would no longer require clinical research conducted 1 0 9 D E Elsayed and NE Kass . " A s s e s s m e n t of the ethical r e v i e w p r o c e s s in Sudan." Developing World Bioethics 7.3 (2007) : 1 4 3 - 8 . 1 1 0 B e n j a m i n M a s o n Meier . " International Protect ion of P e r s o n s U n d e r g o i n g Medical E x p e r i m e n t a t i o n : Protect ing the Right of I nformed Consent ." Berkeley Journal of International Law 513.20 (2002) : 5 3 2 - 3 3 . 1 1 1 K e y a A c h a r y a . "India: P r i m e Dest inat ion for Unethical Clinical Trails ." Inter Press Service. D e c e m b e r 14, 2 0 0 7 . < h t t p : / / w w w . c o m m o n d r e a m s . o r g / a r c h i v e / 2 0 0 7 / 1 2 / 1 4 / 5 8 3 8 > 1 1 2 M e i e r , " International Protect ion of P e r s o n s U n d e r g o i n g M e d i c a l E x p e r i m e n t a t i o n , " 534. 37 abroad to comply with the Declaration of Helsinki. Rather, they must follow the Guideline for Good Clinical Practice, a standard "for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate, and that the rights, safety, and well-being of trial subjects are protected." 1 1 3 The motives behind the shift were based on the idea that GCP provides more specific instructions and guidelines on how to responsibly monitor the trials and report harmful incidences, as well as ensures data quality and reliability by necessitating the submission of detailed information regarding adherence to protocol. Furthermore, since the Declaration of Helsinki is a document that is international by nature and privy to change independent of FDA authority, future revisions might conflict with U.S. laws and regulations, and GCP avoids this potential conflict. 1 1 4 The FDA is the oldest, and one of the most powerful, regulatory agencies in the U.S., wielding authority over almost a quarter of Gross National Product and supervising more than one trillion dollars worth of consumer goods and one-third of all imported products . 1 1 5 , 1 1 6 Considering the vast number of economic and political interests affected by the practices of the FDA, the degree to which 1 1 3 Foreign Clinical Studies Not C o n d u c t e d U n d e r an Invest igat ional N e w D r u g Appl icat ion . 21 C.F.R. § 312.120 (2008) . 114 h t t p : / / w w w . r e g u l a t i o n s . g o v / # ! d o c u m e n t D e t a i l ; D = F D A - 2 0 0 4 - N - 0 0 6 1 - 0 0 0 2 ; o l d L i n k = f a l s e 1 1 5 F o o d and D r u g A d m i n i s t r a t i o n . "Operat ions in a Global E n v i r o n m e n t . " 2 0 0 8 . 1 1 6 Gardiner Harris . "The Safety Gap." The New York Times. O c t o b e r 31, 2 0 0 8 . they may influence policymaking and regulatory decisions requires examination. Capture theory, a model put forth by Samuel Huntington (1952) and Marver Bernstein (1955) in the 1950s, suggests that older and established members of industry are better able to make political connections, and thus more capable of influencing regulations that benefit them and restrict smaller f irms. 1 1 7 The theory pertains to members of an industry sector whose dealings are affected by certain policy decisions, who then attempt to influence the process in pursuit of favorable policy outcomes. Regulatory capture occurs when these interest groups succeed in influencing public officials in "identifying with the interests of a client or industry." 1 1 8 There are two types of capture. The traditional form is "entry-barrier" capture, which strengthens regulation so that one section of industry is more privileged than the rest and market entry is more difficult. The other, more recently prevalent, form is called "corrosive" capture, which involves industry members pushing for deregulation and weaker enforcement. 1 1 9 In recent years, industry capture 1 1 7 Daniel P. Carpenter . "Protection w i t h o u t C a p t u r e : P r o d u c t A p p r o v a l b y a Polit ical ly R e s p o n s i v e , Learning Regulator ." American Political Science Review 98.4 (2004) : 6 1 3 . 1 1 8 G a r y A d a m s , S h a r o n H a y e s , Stuart Weierter , John B o y d . "Regulatory C a p t u r e : M a n a g i n g the Risk." Austral ian Publ ic Sector A n t i - C o r r u p t i o n C o nf er enc e . Sydney, 2 0 0 7 . < h t t p : / / w w w . i c e a u s t r a l i a . c o m / a p s a c c 2 0 1 1 / p d f X p a p e r s 0 7 / d a y 1 _ 2 4 o c t 0 7 / S t r e a m A 2 / R e g u l a t o r y C a p t u r e M a n a g i n g T h e R i s k s _ J o h n B o y d . p d f > 1 1 9 Daniel P. Carpenter . "Corrosive C a p t u r e ? T h e Duel ing Forces of A u t o n o m y and I n d u s t r y Inf luence in F D A P h a r m a c e u t i c a l Regulat ion." In Daniel C ar pente r and David M o s s (Eds .) , Preventing Capture: Special Interest Influence in Regulation, and How to Limit It. T h e T o b i n Project , 2 0 1 1 . 38 has shifted to the corrosive direction. In Washington, the eagerness to deregulate has resulted in lax consumer and environmental standards, freeing the private sector from government oversight of food safety, controls on greenhouse gas emissions, offshore drilling, and drinking water qual i ty . 1 2 0 , 1 2 1 Some argue that the promotion of the idea, "most regulation is unnecessary at best and downright harmful at worst," has reinforced the public's distrust of governmental involvement in industry, and delegitimized the idea of regulation itself. 1 2 2 Dr. Marcia Angell, former editor-in- chief of the New England journal of Medicine, wrote that the pharmaceutical industry specifically targets the FDA and exerts its influence by pushing legislation drafted by industry lobbyists, as well as through the administrative management of agencies "that are beholden to industry, and sometimes...openly hostile to the very idea of regulation."1 2" This has created a political environment in which agencies are pressured to cooperate with, rather than supervise, the industries they are obligated to regulate. As recently as a couple of decades ago, pharmaceutical companies relied on academic researchers and physicians to 1 2 0 Jeffrey Smith . "A Last Push to Deregulate . " The Washington Post. O c t o b e r 31, 2 0 0 8 . 1 2 1 D a n a Milbank. "Budget cuts as b a c k - d o o r regulation." The Washington Post. Apri l 2, 2 0 1 2 . 1 2 2 J a m e s S u r o w i e c k i . "The Regulat ion Crisis ." The New Yorker. 2 0 1 0 . < h t t p : / / w w w . n e w y o r k e r . c o m / t a l k / f i n a n c i a l / 2 0 1 0 / 0 6 / 1 4 / 1 0 0 6 1 4 t a _ t a l k _ s u r o w i e c k i > 1 2 3 M a r c i a Angel l . "FDA: T h i s A g e n c y Can Be D a n g e r o u s . " R e v i e w of Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, b y Daniel Carpenter . T h e N e w Y o r k R e v i e w , 2 0 1 0 . < h t t p : / / w w w . a h r p . o r g / c m s / i m a g e s / s t o r i e s / a r t i c l e s / a n g e l l _ f d a _ d a n g e r o u s . p d f > conduct clinical drug trials. This reliance was based on the pharmaceutical companies' lack of expert staff and resources to design and execute the trials. Academic medical centers were able to supply their patients as research subjects, and the reputation of academic publications was needed to market the drugs. 1 2 4 But academic researchers, with many responsibilities (including teaching, research and patient care) in addition clinical drug trials, found it increasingly difficult to carry out trials and produce medicines at the rate pharmaceutical companies wanted. Academic research offices and institutional review boards continued to delay the commencement of trials due to their slow review process of proposals. A drug manufacturer, on average, loses $1.3 million every day a drug's FDA approval is delayed. 1 2 5 Once the pharmaceutical industry found that it was more cost effective to employ their own research physicians to design and oversee clinical trials much faster, their reliance on academia decreased considerably. 1 2 6 Before 1980, the pharmaceutical industry had minimal influence on those who were recruited to research their products. Academic institutions that were paid to conduct studies had full responsibility and control over designing research procedure, analyzing and interpreting trial data, writing up results, and deciding where and how to report them. This allowed researchers and the institutions they worked for to have minimal ties to the companies that 1 2 4 T h o m a s B o d e n h e i m e r . " U n e a s y A l l i a n c e — Clinical Invest igators and the P h a r m a c e u t i c a l Industry ." New England +ournal of Medicine 342 (2000) : 1 5 3 9 - 1 5 4 4 . 1 2 5 Ibid, 1540. 1 2 6 Ibid, 1540. 39 sponsored them. Butrecently, pharmaceutical sponsors have strengthened their authority and input regarding product research; they often design the studies, analyze the data, write the report, and decide how and where to publish them. Recent studies have demonstrated that the industry's increased influence on the research of its products has created conditions in which sponsors may alter or frame trial data in order to make them appear safer and more effective. 1 2 7 While academic researchers had minimal financial ties to their sponsors before, now they often "serve as paid consultants and members of speakers' bureaus and advisory boards and sometimes even have equity interest in the companies." 1 2 8 Another study demonstrated that approximately two- thirds of academic medical institutions hold equity interest in pharmaceutical companies that sponsor research in those institutions, two-thirds of medical school department chairs receive departmental income from drug companies, and three- fifths receive personal income from those companies. 1 2 9 In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), renewable every five years, which necessitates that pharmaceutical companies pay fees for regulation of their products. Companies pay around $300,000 to apply for drug approval, an annual fee of $145,000 for each manufacturing base, as well as a fee per product. 1 3 0 In return, the FDA must 1 2 7 Marc ia Angel l . " Indust ry-Sponsored Clinical Research: A B r o k e n Sys t em. " JAMA 300 .9 (2008): 1069-1071 . 1 2 8 Ibid, 1070. 1 2 9 Ibid, 1070. 1 3 0 R a y M o y n i h a n . "Science, industry, and polit ics at the FDA." British Medical Journal 327 .160 adhere to stricter approval deadlines and improve responsiveness to companies during the drug development process. The new law was passed to help the FDA accelerate its costly monitoring and reviewing operations. In the late 1980s, drug approval times averaged at 30 months. In 1999, the median approval time was 11.6 months. 1 3 1 Marcia Angell, in her article "Taking Back the FDA," criticizes the law, which she says "puts the FDA on the payroll of the industry it regulates... [And] makes it more likely that drugs will be reviewed favorably." 1 3 2 Smaller pharmaceutical companies are put at a disadvantage; one British producer protested that the new user fees were even greater than revenue from U.S. markets. 1 3 3 Although user fees increased over the years, faster approval times are financially beneficial to the industry in the long run—"if you pay $500,000 in user fees and get your [New Drug Application] approved one month earlier, you make more money... [It's] one of the few examples of paying the government an outrageous amount of money and you get back more than you pay." 1 3 4 In 2002, the FDA was estimated to receive $162 million in user fees, which is nearly half the cost of reviewing drugs. 1 3 5 Because PDUFA is a renewable law and the FDA now relies so heavily on funding from (2003) . 1 3 1 P u b l i c Cit izen. " P r o b l e m s in the N e w D r u g A p p r o v a l Process : A Case S t u d y of Lotronex ." 2 0 1 0 . < h t t p : / / w w w . c i t i z e n . o r g / c o n g r e s s / a r t i c l e _ r e d i r e c t . c f m ? I D = 7 4 4 2 > 1 3 2 M a r c i a Angel l . "Taking B a c k the FDA." The Boston Globe. F e b r u a r y 26, 2 0 0 7 . 1 3 3 Fran H a w t h o r n e . Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat. John W i l e y & Sons . (2005) : 152. 1 3 4 Ibid, 152. 1 3 5 M o y n i h a n , "Sc ience , industry , and polit ics at the FDA." 40 pharmaceutical companies, industry is in a prime negotiating position and can threaten to challenge the PDUFA renewal and withdraw funding. David Williams, in his 2001 Pulitzer Prize-winning Los Angeles Times article, revealed that the FDA was mounting enormous pressure on its drug reviewers to work more quickly. An anonymous pharmacologist working in the FDA's scientific investigations division admitted, "the devil is in the details, and detail is something we no longer have the time to go into." 1 3 6 William Schultz, the FDA deputy commissioner from 1995¬ 1999, explained: "You can meet the goal by either approving the drug or denying the approval. But there are some who argue that what Congress really wanted was not just decisions, but approvals. That is what really gets dangerous." 1 3 7 Kathleen Holcombe, a former FDA legislative affairs staffer and congressional aide, pointed out that while historically, the FDA operated according to the motto, "'Regulate, be tough, enforce the law, and don't let one thing go wrong,'" the FDA more recently "sees itself much more in a cooperative role" with the pharmaceutical industry. 1 3 8 In 1998, Public Citizen, a nonprofit, consumer rights advocacy group, surveyed FDA Medical Officers in charge of reviewing drug applications and found that out of the fifty-three who responded to the survey, nineteen officers recalled twenty-seven market-approved drugs 1 3 6 David W i l l m a n . " H o w a N e w Policy Led to Seven D e a d l y Drugs ." Los Angeles Times. D e c e m b e r 20, 2 0 0 0 . < h t t p : / / w w w . l a t i m e s . c o m / n e w s / n a t i o n w o r l d / n a t ion/la-122001fda ,0 ,4840718, fu l l . s tory> 1 3 7 Ibid. 1 3 8 Ibid. they believed should not have been approved. A study done in 2005, by Edmund Pezalla, revealed that that more than 51% of market-approved drugs may have had severe adverse effects that went undetected before approval. 1 3 9 In 2009, the FDA recalled 1,742 prescription medications from the market, growing 309% from just 426 in 2008. 1 4 0 Most criticism directed at the FDA rests on its perceived inability to efficiently respond to the safety concerns surrounding already approved drugs and their failure in post marketing safety surveillance. This is perhaps due to the FDA's lack of "clear and effective processes for making decisions about, and providing management oversight of, post market safety issues." 1 4 1 Dr. David Graham, an epidemiologist working as the Associate Director of the FDA's Office of Drug Safety, condemned the FDA for dealing with safety concerns in a perverse way that makes consumer welfare a peripheral responsibility. He wrote that the FDA refuses to act on safety concerns and alarming evidence during the preapproval process that may point to potential complications unless there is "complete certainty" of an increased risk due to the medication. This practice fails to protect consumers, is partial to industry interests, "rewards drug companies for not aggressively pursuing safety questions, and guarantees that 1 3 9 E d m u n d Pezalla . "Prevent ing adverse drug react ions in the general populat ion ." Managed Care Interface 18.10 (2005) : 4 9 - 5 2 . 1 4 0 Parija Kavi lanz . " D r u g Recal ls Surge." CNN Money. A u g u s t 2 0 1 0 . 1 4 1 B M Psaty , SP B u r k e . "Protect ing the health of the public : Institute of M e d i c i n e r e c o m m e n d a t i o n on drug safety." New England Journal of Medicine 3 5 5 . 1 7 (2006) : 1 7 5 3 - 5 . < h t t p : / / w w w . n c b i . n l m . n i h . g o v / p u b m e d / 1 7 0 3 0 8 4 3> 41 some drugs with major safety problems will be approved, and, once approved, will remain on the market, even in the face of extensive patient harm." 1 4 2 This serves as evidence that the FDA is more interested in getting drugs on the market, rather than thoroughly evaluating the drugs, especially once they have already been market-approved. 1 4 3 In a report prepared for Rep. Henry Waxman in 2006 by the Committee on Government Reform, the FDA's enforcement record was examined over the course of a 15-month investigation. The Committee reported that FDA enforcement in every sector had declined by over 50% since 2000, during the Bush Administration. 1 4 4 The FDA issued 50% less warning letters for regulation infringements, and confiscated 44% less mislabeled, defective, or dangerous products. Furthermore, FDA officials failed to act on the recommendations of agency field inspectors reporting violations in 138 cases. The report also mentioned the decline in FDA enforcement was not a result of manufacturers' increased level of adherence to regulation, and that FDA field inspectors found no decrease in 1 4 2 Russel l G. T h o r n t o n . " P r e e m p t i o n , tort reform, and p h a r m a c e u t i c a l c la ims." Baylor University Medical Center 21.1 (2008) : 8 2 - 9 2 . < h t t p : / / w w w . n c b i . n l m . n i h . g o v / p m c / a r t i c l e s / P M C 2 1 9 0 5 5 9 / > 1 4 3 Jerry A v o r n . "Paying for D r u g A p p r o v a l s - W h o ' s Using W h o m ? " New England Journal of Medicine 356 ( 2 0 0 7 ) : 1 6 9 7 - 1 7 0 0 . < h t t p : / / w w w . n e j m . o r g / d o i / f u l l / 1 0 . 1 0 5 6 / N E J M p 0 7 8 0 4 1 > 1 4 4 C o m m i t t e e on G o v e r n m e n t R e f o r m , Special Invest igat ions Division. "Prescription for H a r m : T h e Decl ine in F D A E n f o r c e m e n t Activity." June 2006. violations from years before. 1 4 5 In response to these statistics, Dr. Jerry Avorn, an expert consultant, characterized the FDA as "an agency unwilling to exert its regulatory authority in defense of the public's health." 1 4 6 The only measure of FDA enforcement that increased in the five-year span was the number of drug recalls. In 2000, 3,716 FDA-regulated drugs were recalled. In 2005, the number of recalls increased by 44%, to 5,338. 1 4 7 This increase indicates the FDA's serious neglect of adequate pre- approval measures. Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group for more than thirty years, laments the unprecedented rise of health complications and deaths due to unsafe prescription drugs, emphasizing the number of clear warning signs that surface before and immediately after unsafe drugs come on the market. "In all cases, once they came on the market, there was a very dangerous and reckless slowness to respond to the signals that came after marketing." 1 4 8The failures of the pre-approval phase as well as of the post-market safety surveillance phase contribute to delays in pulling drugs off the market - delays that cost thousands of lives. The U.S., compared to other first world countries like France and the United Kingdom, has an ineffective system of reporting adverse events of prescription drugs. Dr. Wolfe approximates that only between 1-10% of adverse reactions from prescription 1 4 5 Ibid, i. 1 4 6 Letter from Dr. Jerry A v o r n to Representat ive H e n r y A. W a x m a n (May 2 5 , 2 0 0 6 ) . 1 4 7 C o m m i t t e e on G o v e r n m e n t R e f o r m , Special Invest igat ions Divis ion , "Prescription for H a r m : T h e Decl ine in F D A E n f o r c e m e n t Activity," 9. 1 4 8 S i d ne y W o l f e interview. 42 drugs are reported to the FDA. This increases the time it takes to pull the drug from the market or enforce a black box warning. 1 4 9 Dr. Wolfe goes on to claim that post-market surveillance analyses are often received poorly or with hostility by FDA officials, who "are wedded to the idea that when they approved the drug, it must have been OK or we wouldn't have approved it... [They] tend to take very, very negatively the criticism that comes from those people that do post-market surveillance." 1 5 0 Jim Dickinson, an established columnist and the editor of FDA Review, has tracked FDA policy developments and deregulatory shifts for the past three decades, wrote in 2010: "It has taken almost a generation, but by now, the pro-industry infiltration of FDA's culture is firmly entrenched. Not only is collaboration in product reviews officially encouraged, but good relationships across the regulatory fence hold the prospect of a possible future career in a well-paid industry job - a connection that is less likely to be publicly noticed in news media that now have to line up for information that has been filtered through agency press offices. The arm's-length relationship that formerly ruled every contact between agency and industry has become a 1 4 9 Ibid. 1 5 0 Ibid. fading memory." 1 5 1 The FDA and pharmaceutical industry collaborate in other harmful ways - a phenomenon dubbed "the revolving door," which occurs in every regulatory agency and level of government. Many FDA employees find themselves working as consultants for pharmaceutical companies after their stint at the agency. 1 5 2 This is a concern especially when drug reviewers, still employed by the FDA, but looking to apply for jobs at large pharmaceutical companies in the near future, are hesitant to give unfavorable reviews. The Center for Responsive Politics published a report in 2006 listing fifty-three individuals who at one time worked for various government agencies, and had either before or afterwards worked for a private sector employer in the health industry. 1 5 3 Billy Tauzin, a member of the House of Representatives (1980-2005) and the Chairman of the House Energy & Commerce Committee, which was highly influential in drafting the Medicare drug benefit, went on to become the President of the Pharmaceutical Research and Manufacturers of America (PhRMA) in 2005. 1 5 4 Michael Friedman, the Acting Commissioner of the FDA (1997-1998), 1 5 1 Merri l l G o o z n e r . " F D A M o r e Pro Industry than A n y T i m e in 35 Y e a r s . " T h e Health Care Blog. J a n u a r y 16, 2 0 1 0 . 1 5 2 H a w t h o r n e , Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat, 150 . 1 5 3 C o n s u m e r Project on T e c h n o l o g y . "Revolving door b e t w e e n the U.S. G o v e r n m e n t and Industry." February , 2006. < h t t p : / / w w w . c p t e c h . o r g / i p / h e a l t h / p o l i t i c s / r e v o l v i n g d o o r . h t m l > 1 5 4 W i l l i a m M. W e l c h . "Tauzin switches sides f r o m drug industry o v e r seer to lobbyist ." USA Today. D e c e m b e r 15, 2004. < h t t p : / / w w w . u s a t o d a y . c o m / m o n e y / i n d u s t r i e s / h e a l t h / d r u g s / 2 0 0 4 - 1 2 - 1 5 - d r u g s - u s a t _ x . h t m > 43 later became the Senior Vice President of the Pharmacia Corporation, and PhRMA's Chief Medical Officer for Biomedical Preparedness. 1 5 5 Gerald J. Mossinghoff, the former Assistant Secretary of Commerce and Commissioner of Patents and Trademarks from 1981-1985, became a registered lobbyist for PhRMA in 1998. Susan K. Finston, who formerly worked at the State Department in the Office of Intellectual Property and Competition, now works as the Assistant Vice President for Intellectual Property and Middle East/African Affairs at PhRMA. Edward Allera, the Associate Chief Councel for Enforcement at the FDA from 1974-1978, later became a partner at a law firm with clientele including Pfizer and PhRMA, and a lobbyist for Johnson T Johnson in 1998. These are only a few examples of high-level state officials who later would go on to work for the very industry they worked for years to regulate. Daniel Carpenter, a professor of government at Harvard, published a study in 2002 in which he reviewed 450 drugs approved by the FDA between 1977 and 2000. He concluded that the most prominent sources of influence were "the number of times a disease was mentioned in The Washington Post, the budget of the Center for Drugs, and the budgets of patient advocacy groups." 1 5 6 In other words, FDA approval rates are spurred by public pressure and available resources. Although Carpenter's study did not look at industry influence, he admitted, "Firm attributes undoubtedly sway the FDA's decision making in drug approval 1 5 5 "Michael A. F r i e d m a n : Profile." Forbes. < h t t p : / / p e o p l e . f o r b e s . c o m / p r o f i l e / m i c h a e l - a - f r i e d m a n / 6 8 5 0 7 > 1 5 6 H a w t h o r n e , Inside the FDA, 154. cases." 1 5 7 Also, the pharmaceutical industry is known to make direct contributions and giving support to patient advocacy groups, which are often the parties that attract media attention. Carpenter also studied the bias against small companies that permeates the approval process. It is an accepted fact that large, established companies face fewer obstacles in obtaining drug approval. Carpenter studied 766 drugs submitted between 1979 and 2000, and analyzed review times, political contributions from companies, the ownership of companies, and the budgets of patient advocacy groups. He found that large companies often complete the approval process much faster. After a 15- month review process, more than 40% of products submitted by large companies were approved while only 15% of products from small companies were given approval. He attributed this to "the greater regulator familiarity that large firms enjoy," explaining that having a prior relationship with the agency can result in a 55% advantage in approval t imes. 1 5 8 To illustrate how the FDA appeases the pharmaceutical industry in regulatory practice, I will take closer look at the development, approval process, and post marketing surveillance measures of a drug called Lotronex. This case study epitomizes the FDA's heavy reluctance to act on the recommendations of its drug reviewers and in the best interest of the consumer population, 1 5 7 Ibid, 158. 1 5 8 D a n i e l C a r p e n t e r , Br ian Feinstein , Col in M o o r e , et al. " W h y D o Bigger F i r m s Receive Faster D r u g A p p r o v a l s ? " Harvard Medical School. (2004) : 29. < h t t p : / / p e o p l e . h m d c . h a r v a r d . e d u / ~ d c a r p e n t / w h ybigfast1 .pdf> 44 prioritizing industry interests over safety concerns. In July 1999, GlaxoWellcome (now GlaxoSmithKline) submitted a New Drug Application for Alosetron (Lotronex), a drug developed to treat irritable bowel syndrome in women. Irritable bowel syndrome is not a fatal condition, but Lotronex was given an accelerated review. Although 27% of the women in the clinical trial experienced constipation and 10% had to withdraw from the study, Glaxo labeled constipation an "infrequent side effect," even though constipation can cause severe complications in women with IBS . 1 5 9 The medical officer reviewing the drug noticed that there were four cases of ischemic colitis, a serious and rare condition, which occurred in the experimental group during the trials. 1 6 0 The review noted that this "[represents] a signal of a potentially serious problem that should be anticipated, perhaps even more severely expressed, if the drug is approved for clinical use ." 1 6 1 Despite the fact that only 10-20% of trial subjects reported improvement due to Lotronex and women in one trial group reported a level of relief between 0.12-0.14 (on a scale of 0-4) higher than women in the 1 5 9 S idney W o l f e , M.D., Director of Public Citizen s Health R e s e a r c h G r o u p , in t e s t i m o n y before the U.S. Food & Drug A d m i n i s t r a t i o n ' s Gastrointest inal D r u g s A d v i s o r y C o m m i t t e e and the Drug Safety and Risk M a n a g e m e n t S u b c o m m i t t e e of the A d v i s o r y C o m m i t t e e for P h a r m a c e u t i c a l Science, Apri l 23 , 2 0 0 2 . 1 6 0 Public Citizen's Health R e s e a r c h G r o u p , "Petition to the F o o d and D r u g A d m i n i s t r a t i o n to r e m o v e Lotronex from the market ," Publication # 1 5 3 3 ; A u g u s t 31 , 2 0 0 0 . 1 6 1 John R. Senior, M.D. , "FDA Medical Review: Lotronex , N D A 2 1 - 1 0 7 , 9 0 - D a y Safety U p d a t e " N o v e m b e r 30, 1999, p. 22 . placebo group, the drug was approved in February of 2 0 0 0 . 1 6 2 , 1 6 3 Less than two months later, a multitude of adverse events were reported, including eight cases of ischemic colitis and six hospitalizations. 1 6 4 The FDA reconvened to review its decision, attempting to label Lotronex with a black box warning. Glaxo protested, and they agreed instead to include a Medication Guide with each prescription to describe symptoms of dangerous side effects. 1 6 5 But by November, five patients were dead and there were many more reports of adverse effects. 1 6 6 In November 2000, FDA Medical Officers rejected Glaxo's risk management proposals and insisted, "the sponsor has not identified a subset of women who will respond to Lotronex therapy safety... a risk management plan cannot be successful that will eliminate deaths, colectomies, ischemic colitis, and complications of treatment that were never seen previously in the management 1 6 2 Joseph S h a p i r o , "A pill t u r n e d bitter: H o w a q u e s t for a b l o c k b u s t e r drug w e n t fatally w r o n g , " U.S. News & World Report, V o l . 129, Issue: 23: D e c e m b e r 11, 2 0 0 0 . 1 6 3 Public Citizen's Health R e s e a r c h G r o u p , "Petition to the F o o d and D r u g A d m i n i s t r a t i o n to r e m o v e Lotronex from the market ," Publication # 1 5 3 3 ; A u g u s t 31 , 2 0 0 0 . 1 6 4 Ibid. 1 6 5 Ibid. 1 6 6 D e p a r t m e n t of Health and H u m a n Services . Lotronex ( a l o s e t r o n ) safety and risk m a n a g e m e n t s u m m a r y . M e m o r a n d u m P I D [ D 0 0 0 6 7 4 , 16 N o v e m b e r 2 0 0 0 . < w w w . c i t i z e n . o r g / d o c u m e n t s / 1 5 6 6 . p d f > 45 of IBS." 1 6 7 Despite this, the FDA proposed the "restricted distribution" of Lotronex, although Glaxo opted to pull Lotronex from the market, having already made $56 million off the drug. 1 6 8 In response to a public outcry and patients' willingness to accept the risks associated with Lotronex, Glaxo applied to re-market the drug in December of 2OO1. Although safety reviewers emphasized, "potentially everyone who takes Lotronex is at risk," the FDA advisory committee reapproved the drug in 2OO2, under the condition that the dosage would be halved and restricted to patients who had exhausted traditional forms of treatment. 1 6 9 As a result of his experience, Dr. Paul Stolley, who joined the FDA in 2OOO as a senior consultant assigned to examine the post marketing safety of Lotronex, went on to become a contributing staff member at Public Citizen, a consumer advocacy group. He spoke out against the FDA, which he called "a servant of industry," after the re- approval of Lotronex: "I think it's a shame how it has fallen down on the job, and Lotronex is a perfect example. The FDA 1 6 7 Kathleen Uhl , Zili Li, A n n Corken M a c k e y , and Paul Stolley. "Lotronex Safety & Risk M a n a g e m e n t S u m m a r y . " FDA. Center for Drug Evaluat ion and Research . Apri l 2 3 , 2OO2. 1 6 8 U.S. F o o d and D r u g A d m i n i s t r a t i o n , "Glaxo W e l l c o m e Decides to W i t h d r a w Lotronex from the Market ," Talk p a p e r : TOO-65; N o v e m b e r 28, 2OOO. 1 6 9 D e p a r t m e n t of H e a l t h and H u m a n Services , F o o d and D r u g A d m i n i s t r a t i o n , Center for Drug Evaluat ion and Research . Gastrointest inal D r u g s A d v i s o r y C o m m i t t e e and D r u g Safety and Risk M a n a g e m e n t S u b c o m m i t t e e of the A d v i s o r y C o m m i t t e e for P h a r m a c e u t i c a l S c i e n c e , 23 Apri l 2OO2. < w w w . f d a . g o v / o h r m s / d o c k e t s / a c / O 2 / t r a n s c r i p t s / 3 8 4 8 T 1 . p d f > was in partnership with industry. It should have been negotiating, not in partnership. Why was it in partnership? Because it's financially supported by industry." 1 7 O CONCLUSIONS The era of globalization has facilitated the emergence of a new set of global health problems that challenge the traditionally unilateral and domestic approaches of state efforts. Regulatory agencies like the FDA are no longer able to fully address the public health threats that endanger their populations or the jurisdictional limitations that hinder their regulatory authority. The globalization of clinical research necessitates an expansion of ethical oversight. International codes of conduct contribute important substantive standards, but lack legal enforcement mechanisms, and fail to be widely implemented due to the absence of competent regulatory agencies in many parts of the developing world. The FDA has enormous potential to protect research subjects and enforce ethical standards due to its position as the gatekeeper to the most profitable market for prescription drugs in the world. In 2OO5, the U.S. spent more on prescription drugs than Australia, Canada, Germany, Netherlands, New Zealand, and the United Kingdom combined. 1 7 1 With this level of influence, any improvement in the FDA's regulatory efficacy would be valuable in 1 7 0 R a y M o y n i h a n . "Alosetron: a case study in regulatory c a p t u r e , or a v ictory for p a t i e n t s ' r ights?" British Medical Journal 325 (2OO2): 592¬ 5 9 5 . < h t t p : / / w w w . n c b i . n l m . n i h . g o v / p m c / a r t i c l e s / P M C 1 1 2 4 1 O 8 / p d f / 5 9 2 . p d f > 1 7 1 S. M o r g a n and J. K e n n e d y , Prescript ion D r u g Accessibi l i ty and Affordabi l i ty in the United States and A b r o a d , T h e C o m m o n w e a l t h F u n d , June 2O1O. 46 ensuring ethical and technical clinical compliance internationally. But as much as agency capacity is limited by resources, international collaboration, and jurisdictional limitations, it is even more profoundly debilitated by industry interests. As I have demonstrated, FDA control has been gutted by a complex process of industry capture. In a political climate brimming with anti-regulatory opinion, conflicts of interest are becoming more and more embedded into agency structure: the revolving door between industry and agency, and the Prescription Drug User Fee Act increasingly put regulators at odds with their duties. In order to pursue the expansion of regulatory oversight both domestically and abroad, industry influence must be limited. To prevent the occurrence of the revolving door paradigm, stringent conflict of interest laws must be implemented to restrict former high-ranking FDA officials from becoming pharmaceutical company board members. 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"An Assessment of the Quality of Randomized Clinical Trials Conducted in China," Trials. 53 Taste and Odor Problems in Clinton Lake Reservoir's Drinking Water Diana L. Restrepo-Osorio (McNair Scholar) Department of Ecology and Evolutionary Biology, INTRODUCTION Water is a requirement for human health and welfare; however, an exceedingly large number of people around the world lack reliable sources of drinking water 1 . According to the World Health Organization, approximately 3.5 million people die every year, generally in developing countries, from diseases linked to poor water supplies2. The United States of America has one of the best drinking water supply systems in the world. According to the United States Geological Service (USGS), an average person in the U.S. uses 80-100 gallons per day 3 . Americans often take for granted the availability of water, and seldom do they question its quality. However, humans' keen senses are able to detect minute levels of chemicals causing taste and odor in water, and when this happens, institutions treating drinking water are often the first to be blamed. Great efforts are being made, however, to build public awareness that every person plays a major role in reducing pollution that leads to taste and odor problems, and that water treatment facilities alone may be inadequate to provide high quality drinking water to our communities. BACKGROUND More than 100,000 people in northeast Kansas get their drinking water from Clinton Lake reservoir. The Army Corp of Engineers built Clinton Lake reservoir in 1977 for flood control; however, it serves multiple purposes, such as swimming, boating, fishing, municipal water supplies, etc. 4 , 5 . The reservoir covers an area of 30.81 km 2 with an average depth of 5.1m. Clinton reservoir is located in the Wakarusa River watershed 6 , 7 , which encompasses 95,320 ha, including Deer Creek and Rock Creek which are major tributaries 4 , 5 , 8 . According to KDHE, the watershed is primarily used for agriculture (Table 1) 9 . Most of the runoff that drains into the tributaries, therefore, comes from agricultural land, which generally contains elevated amounts of fertilizers, pesticides, manure, etc. Yearly weighted input of non-point fertilizer ranges from 1,604 to 2,312 metric tons for nitrogen (N) and from 269 to 325 metric tons for phosphorous (P) 8 . Local water-treatment plants have difficulty adequately treating this non- point pollutant runoff, and currently it is not adequately regulated by the Kansas Department of Health and Environment or the U.S. Environmental Protection Agency. In the US, non-point pollutants are the most challenging to control and the most significant cause of water pollution in the Kansas River 7 . In contrast, point source pollutants are those that drain into a river via an identifiable location such as a pipe or a conduit and are carefully regulated by EPA and KDHE. The types of pollutants and their amounts are regulated by the National Pollutant Discharge Elimination 54 System (NPDES) with the Clean Water Act permit program 7 . Although point source pollutants are regulated, immense amounts are discharged into the Wakarusa watershed; two wastewater treatment plants release up to 1.12 million liters per day into tributaries of the Wakarusa River, and there is an NPDES permitted hog feed yard situated in the Deer Creek arm 8 , which is one of the main tributaries of Clinton Lake reservoir. These point source pollutants, together with non- point pollutants greatly affect the water quality of the reservoir. Nutrients such as nitrogen and phosphorous are found naturally in water bodies and are needed by all aquatic organisms in low levels. When these nutrients rise to abnormally high quantities, however, the balance of the water ecosystem is disturbed 7 . Clinton reservoir is eutrophic (Table 2), which results from excess nutrients increasing the unwanted growth of blue-green algae (cyanobacteria) 4 . When conditions are optimal, these cyanobacteria are able to create large biomasses or algal blooms. When this large amount of organic material decays, it uses dissolved oxygen (DO), and if the DO level falls below a certain threshold, fish kills can happen readily7. Cyanobacteria biomasses are said to be responsible for taste and odor problems in drinking water and in addition, it also decreases recreational value 7 . Cyanobacteria produce an organic chemical called geosmin that dissolves in water. This is responsible for the earthy/musty taste and odor residents perceive during certain times of the year 8 , especially during the fall and winter months 5 . Unfortunately, the water treatment method used today has not been able to completely remove geosmin from drinking water. In December of 1995, the level of geosmin rose to such high levels that the City of Lawrence Clinton Lake Water Treatment Plant was shut down due to the high number of customer complaints8. There are three dominant taxa of cyanobacteria residing in Clinton reservoir: Microcystis sp., Aphanizomenon sp., and Anabaena sp. Aphanizomenon sp. was found to be most common during late spring (May-June) and Anabaena sp. accounted for over 90% of biomass during the summer and early fall (June-October) 5 , 1 0 . Cyanobacteria and algal blooms affect the aesthetics and, therefore, the recreational value of the reservoir. Clinton reservoir has a large economic impact on the City of Lawrence 1 1 . In 2007, this reservoir was the most visited out of 17 reservoirs around the area with 2,008,108 visits in a year. According to Smith et al. visitor spending generated $30.4 million and 423 jobs in the region 1 1 . It is in the residents' and authorities' best interest to successfully manage the state of cyanobacteria at this reservoir due to the multipurpose nature of the reservoir and the many impacts caused by the presence of blue-green algae. The Army Corp of Engineers controls the public land surrounding Clinton Lake reservoir, which includes the lacustrine and transitional zones of the reservoir; however, riverine zones are mostly privately owned, and the local authorities are unable to monitor the pollutant input resulting from this land (Fig 1). Deer Creek, the Wakarusa River, and Rock Creek are 55 the main tributaries of Clinton reservoir. The smaller streams feeding these tributaries are commonly located in private land and much of the pollutants coming from these are thought to directly affect the reservoir. METHODS The study was carried out during the summer of 2010. Sites were chosen in places that seemed to account for input from all small streams that drained into Rock Creek (1,2,3,5); one (4) site was chosen to be in a larger stream that drains into the creek of interest (Fig 1). Sample site 1 was designated as the reservoir site, sample sites 2 and 3 were midstream sites, and sample sites 4 and 5 were headwaters sites. Field Measurements of WATER QUALITY Turbidity A turbidity tube, which consists of a clear Plexiglass tube with a small Secchi disk at one end, was used. The tube was filled with water from the stream, the water level was slowly lowered through a release valve and when the disk became visible, the depth of the water was measured in centimeters. This provides a measure of suspended solids (such as sediment or algae) in the water column 1 2 . Phosphorous Phosphorous (P) is one of the limiting factors for aquatic plant growth. This element enters a stream in several ways including: industrial waste, treatment plant wastewater, stormwater runoff, runoff from agricultural land, livestock waste, and others. According to the Citizen Science Fact Sheet W-5, a major phosphorous input comes from soil runoff from erosion of areas that have been recently treated with fertilizer1 3. Phosphorous was measured by taking sample water from the sampling sites and was processed using a CHEMets orthophosphate test kit. Phosphorous is rarely detected in surface water unless it was recently added; therefore, any P detected with this kit was added shortly before testing took place. According to the Kansas Department of Health and Environment, 0.1ppm of phosphorous can have detrimental effects on aquatic life. The kit test used for this experiment tests for phosphorous in its PO4 form which presents a chronic criteria level of 0.3ppm which is three times greater than the equivalent phosphorous value of 0.1ppm 1 3 . Nitrogen Decomposing plants become organic debris and release ammonia (NH3), followed by bacteria which converts it to nitrite (NO2). Next, bacteria carry out the conversion of NO2 to nitrate (NO3), which is then used by plants such as algae for growth. Consuming excessive nitrate in drinking water (>10ppm) is not only dangerous to wildlife but to pregnant women who can develop serious health concerns such as blue baby syndrome 1 2 . Hach test strips were used for this experiment; nitrate is tested on a 1-50ppm range, nitrite on a 0.15- 3.0ppm range on the same strip and ammonia on a 0.25-6.0ppm. According to the Citizen Science Fact Sheet W-4, there are no quantitative national or state standards established for nitrate/nitrite. 56 Velocity Streams have characteristic higher velocities when compared to lakes, a factor that is important to this study given that the sampling sites vary in velocities depending on their location from the headwaters to the reservoir. In this study, velocity was measured along a 100 ft stretch at the sampling site using an ice cold orange, which used as a float, and a timer 1 4 . Chlorophyll a Concentrations Samples were processed at the Kansas Biological Survey the same day they were collected using a five- sample vacuum by filtering approximately 200ml of sample with Gelman A/E filters, Daigger Catalog Number EF8583K, these filters were folded in half and placed inside a labeled Fisher Qualitative P8 filters, Fisher Scientific 09-795C. The corners were stapled and the samples placed in silica desiccant inside a black box and frozen to prevent disruption of the cells. USGS (Lawrence, Kansas) helped with the Chlorophyll a sample analysis by providing a fluorometer. The USGS summer 2007 protocol was used to analyze the samples. Chlorophyll a levels are thought to be one of the best indicators of eutrophication and recreational interest since it is strongly related to algal biomass concentrations4 , M 8 . The Trophic State Index (TSI) used by the KDHE to classify trophic states for reservoirs and lakes served as a reference point for this study 8 . Data Analysis and Quality Control of Historic Data Sets Unanalyzed data sets containing information on geosmin, Chlorophyll a and nutrient input to Rock Creek and Clinton Lake reservoir were obtained for the months of June, July and August of 2010. The Army Corp of Engineers (ACOE) provided data on nutrient levels in Rock Creek, Kansas Department of Health and Environment (KDHE) provided data on Chlorophyll a and nutrient levels in Clinton Lake reservoir, and the City of Lawrence Department of Utilities provided data on geosmin levels. We subjected these complex data sets to quality control procedures and analyzed the data. This helped to put our results from our 2010 field season in context, and provided insights into possible relationships between the parameters. Historical weather data were obtained using the Weather Underground web site at http://www.wunderground.com to carry out quality control based on rain/storm events during the dates chosen for analysis. Data providers were also contacted to obtain detailed information regarding methodology used in sampling, including whether samples were collected during rain/storm events. Dates and years with adequate and comparable data were chosen to investigate important phenomena over a long period of time i.e., Chlorophyll a and geosmin levels. Spatial Visualization Google Earth Pro was used as a Geographic Information System (GIS) to display and analyze possible patterns in complex data sets related to a physical location that may otherwise not be detected through other analytical methods 1 M . Google 57 Earth Pro was used to record a tour as an interactive and easily retrievable spatial visualization. The tour illustrated the global and regional location of the Upper Wakarusa watershed and emphasizes the importance of Clinton Lake reservoir as the water source for important establishments. Rock Creek's watershed location and land usage was included as well as bar graphs and scatter plots of analyzed data sets. Colored polygons, pathways and photographs were placed in strategic geographical locations for better understanding of the material 1 6 . RESULTS Field Measurements of WATER QUALITY Velocity decreased at sites closer to the reservoir, allowing the sediment and other matter that is suspended on the water column to settle to the bottom. When this occurs, more sunlight is able to penetrate the water body and is available to plants and algae on the bottom and in the water column. Nutrients that runoff into Clinton Lake reservoir, in addition to extra sunlight, serves as the catalyst for overgrowth of plants, green algae, and cyanobacteria. Cyanobacteria is one of the organisms that forms blooms due to the excess nutrient supply in water bodies, creating multiple problems for the city of Lawrence. The excessive growth of cyanobacteria was observed in this study with the use of Chlorophyll a. A clear pattern of increasing Chlorophyll a while approaching the reservoir was seen, confirming the fact that upstream events greatly affect downstream water quality (Fig 2). Visit https://sites.google.com/site/shawne ecountynria/rock-creek- comprehensive to see photographs of sampling sites during the three sampling dates. Major factors influencing sampling sites and a detailed upstream series of photos can also be found on that web site. Data Analysis and Quality Control Acquiring data and its analysis was challenging since the relevant data have not been made accessible to the public online. Additionally, data sets were challenging to analyze due to the fact that the methodologies used by the various government agencies are not standardized. By creating scatter plots and bar graphs, we identified specific areas for improvement in sampling methods, effects of nutrient input, and confirmed previous findings regarding the movement of contaminants entering the water body. During the month of July during the years 1997 to 2010, nitrogen input to Rock Creek was higher during rainy weather and lower on days without rainfall. No indication of these weather conditions, however, was included in the data sets released by the state and federal agencies. Phosphorous displayed similar characteristics, however, the effect of weather was not as extreme (Fig 3). During the months of June through August of the years 1979 to 2009, levels of nitrogen input to Clinton Lake Reservoir seemed to have increased. During the same time period, levels of phosphorous input to 58 the reservoir did not show a specific pattern (Fig 4). During the 9onths (0 June through August of the years 1979 to 2009, 9ore than half of the Chlorophyll a sa9ples in Clinton Lake reservoir exceed the fully eutrophic levels, and sa9ples for 1998 and 2003 exceed the hypereutrophic levels. Geos9in levels in tap water fro9 the reservoir fro9 2006 to 2010 went over the hu9an detection levels of 10 ng/L in 9ore than half of the sa9ples (2006, 2007 and 2009). The highest sa9ple was that of August 2007 where geos9in levels was four ti9es that of the hu9an detection level (Fig 5). Spatial Visualization The Google Earth visualization allowed us to co99unicate the definition of the concept of a watershed, highlighting i9portant geographical land9arks including Rock Creek as the site of interest (Fig 6). Although Clinton Lake reservoir is the draining point of the Upper Wakarusa watershed, the visualization highlighted the i9portance of this reservoir to institutions and businesses outside the watershed. Patterns were found through color-coded layers representing data set analysis, which were placed on appropriate geographic locations along Rock Creek coupled to bar charts/scattered plots (Fig 7,8). Photographic evidence of factors affecting the quality and quantity of Rock Creek's water supported previous findings of inco9ing pollutants to the water body, their trajectory to the public reservoir and the contribution 9 a d e by anthropogenic activities along the creek to the degradation of the reservoir (Fig 9). DISCUSSION Nutrient inputs fro9 the Upper Wakarusa watershed have shown to be proble9atic for the past decade in spite efforts to alleviate this issue. The effects of nutrient input at Rock Creek have been reflected in Clinton Lake reservoir with elevated levels of Chlorophyll a and geos9in concentrations surpassing the hu9an detection levels of 10ng/L 9ultiple t i9es during the past four years 4 , 5 8 1 0 , According the Kansas Biological Survey (KBS), Clinton Lake reservoir surpassed hu9an detection levels 86% of the t i9e , second to Cheney reservoir with 89% during the length of the study in 2007, long after i9prove9ent atte9pts had been put in place 8 , 1 7 . Their findings included a correlation between cyanobacteria and turbidity as a 9ethod to predict the appearance of geos9in, which is the sa9e 9odel used in this paper where, as turbidity decreases cyanobacteria increases leading to the e9ergence of geos9in and therefore taste and odor proble9s during the winter season for Clinton Lake reservoir4 , 5 1 0 , 1 7 . There are several 9onetary and health related consequences of non-point pollution to consider, such as; the decrease of inco9ing revenue with algae-filled unusable recreational areas, toxic effects to hu9ans and pets fro9 a variety of blue-green algae species bloo9ing in the reservoir, lethality to water dwelling organis9s such as fish due because of decreased dissolved oxygen, higher water treat9ent costs to di9inish the effects 59 of geosmin and the costs of dredging the reservoir as it fills with sediment from erosion 8 4 1 1 4 1 4 . The actual situation is often undetected due to inadequate methodologies used at the time of sampling. Weather conditions are often disregarded, resulting in a data set with a mixture of rain and non- rain event samples; sampling during dry periods minimizes the amount of nutrients in the sample and does not adequately detect nutrients in runoff. The effects of nutrient input during rain events can be seen in nitrogen levels in Clinton Lake reservoir from 1979 to 2009. Methodologies need to be revised to measure nutrients during runoff events, carry out quality control on data sets, and make them available to the public. Further expansion and development of Rock Creek's subwatershed Natural Resource Inventory Assessment will serve as a basis for pilot projects related to city planning and development. Future work includes Natural Resource Inventory Assessments for Shawnee County and perhaps the remainder of the Upper Wakarusa in Douglas County (Fig 3). ACKNOWLEDGEMENTS Funding was generously provided by the McNair Scholars Program at the University of Kansas. With help from: the Army Corps of Engineers, KDHE, KBS, and USGS. This research was conducted under the supervision of Dr. Raymond Pierotti, University of Kansas and Dr. Cynthia Annett, Kansas State University and with the collaboration of Heidi Mehl, Kansas State University and Tom Huntzinger, Upper Wakarusa WRAPS Coordinator. 60 FIGURES 61 Land Cover Acres Percentage Water 10,391 4.48 Urban/Developed 1,762 0.76 Barren/Transitional 164 0.07 Forest/Woodland 29,593 12.75 Shrub land 832 0.36 Grassland/Herbaceous 65,628 28.27 Pasture/Hay 60,364 26.00 Cropland 59,075 25.44 Urban/Recreational Grasses 1,118 0.48 Wetlands 3,259 1.40 Total 232,286 100.00 Table 1. Land Cover Statistics for Entire Watershed (9) 62 Velocity 63 64 Chlorophyll a 6 i Figure 2. Velocity, Water Clarity and Chlorophyll a (2010 Study Results) 65 Rock Creek July Total Nitrogen Samples 1.4 12 1 Ob ( • } Rain event o n e day before / ~ \ w \y Rain event o n e day b e f o r e 0 run o f f s a m p l e a n d rain event o n e day b e f o r e 0 Large rain event d u r i n g 4 days before s a m p l e flushed o f f n u t r i e n t s 0 8 2010 21 1997-2010,.im Depth, ACOE Rock Creek Jury Total Phosphorous Storm Samples 025 0 1996 1998 2000 2002 2004 2006 2008 2010 2012 Figure 3. Rock Creek Data Analysis-Run off (N,P)- Clinton Reservoir June-August Samples * Total Phosphorous 200 180 LfiO 110 120 5 100 3 HO 60 •to 197S 1980 1985 1990 1995 2000 2005 2010 2015 10/70-2000. KDHt Figure 4. Clinton Reservoir Data Analysis- N, P- 66 Clinton Reservoir Geosmin in Tap Water so 4 5 • Aug-07 40 35 3 0 • Geosmin (ng/L) 1" 20 IS 10 a • Nov 06 —Human detection levels (ng/L) 1979-2009, K D H E 2006-2010, City o f L a w r e n c e D e p t . o f utilities. Figure 5. Clinton Reservoir Data Analysis Chlorophyll a and Geosmin Figure 6. Upper Wakarusa Watershed and Major Tributaries 67 Figure 8. Water Clarity in Rock Creek- Summer 2010 68 Figure 9. Factors Affecting Water Quality and Quantity of Rock Creek 69 ENDNOTES U N Web Services Section, D. o. P. I., United Nations. (2006). "International Decade For Action." Retrieved May 17, 2010, from http://www.un.org/waterforlifede cade/background.html. W H O . (2010). "Quantifying Environmental Health Impacts." Retrieved May 17, 2010, from http://www.who.int/quantifying_ ehimpacts/publications/saferwate r/en/index.html. U S G S . (2010, March 31, 2010). "The Water Cycle." Retrieved May 17, 2010, from http://ga.water.usgs.gov/edu/w ate rcyclehi.html. Wang, S. H., D. G. Huggins, et al. (1999). "An analysis of the trophic state of Clinton Lake." Lake and Reservoir Management 15(3): 239-250. Shih-Hsien, W., A. R. Dzialowski, et al. (2005). "Relationships between cyanobacterial production and the physical and chemical properties of a Midwestern Reservoir, USA." Hydrobiologia 541(1): 29-43. The watershed is an area of land that receives snow or rain and drains or seeps into a collective spot Kaw, F. o. t. "The Kansas River Watershed." Retrieved May 17, 2010, from http://sites.google.com/site/friend softhekaw/river-atlas/ks-river- watershed. Wang, S. H., Kansas Biological Survey., et al. (2000). Assessment of Clinton Lake and its watershed : water quality and plankton communities in Clinton Lake, Kansas, May 1997 through November 1998. Lawrence, Kan., Kansas Biological Survey, University of Kansas. 9 Environment, K. D. o. H. a. (2005). Clinton Lake and Upper Wakarusa Watershed. 1 0 Meyer, J . (1998). Phytoplankton Production and Drinking Water Quality in Clinton Reservoir. Ecology and Evolutionary Biology. Lawrence, University of Kansas. Master of Arts: 88. 1 1 Smith, C. L., John; Boyer, Will. (2008). Economic Contributions of Recreation at Clinton Lake. Manhattan, Kansas State University. 1 2 Janke, R. (2002). "The River Friendly Farm." Retrieved July 12, 2010, from http://www.ksre.ksu.edu/rff/Clea nStreamWeb2_files/frame.htm. 1 3 Janke, R. M. , Rebecca; Powell, Morgan (2006). Citizen Science Water Quality Fact Sheet, PK-13 W-5 Phosphorous. Kansas State University Agricultural Experiment Station and Cooperative Extension Service. K. S. University. Manhattan, Kansas. 1 4 Janke, R. M. , Rebecca; Powell, Morgan (2006). Citizen Science Water Quality Fact Sheet, PK-13 W-9 Stream Site Assessment. Kansas State University Agricultural Experiment Station and Cooperative Extension Service. K. S. University. Manhattan, Kansas. 1 5 Cohen, P. (2011). The New York Times. "Digital Maps Are Giving Scholars the Historical Lay of the Land". Retrieved July 26, 2011, 70 from http://www.nytimes.com/2011/07 /27/arts/geographic-information- systems-help-scholars-see- history.html To view tour visit ww.dianarestrepo.info Dzialowski, A. R., D. G. Huggins, et al. (2007). Predicting Taste and Odor Events in Kansas Reservoirs-Phase 1. Kansas Biological Survey Report No. 143. Lawrence, Central Plains Center for Bioassessment. Kansas Biological Survey University of Kansas. 143. 71 Evaluating the use of DNA Sequences for Species Identification in Medusozoans (Phylum Cnidaria) Rhea Richardson (FacultyAdvisor: Paulyn Cartwright) Ecology and Evolutionary Biology INTRODUCTION The Phylum Cnidaria is comprised of two subphyla: Anthozoa and Medusozoa. Anthozoa are sessile polyps lacking a medusa stage in their life cycle. Medusozoa, which comprise almost 4000 species (Daly et al., 2007) can have a free- swimming medusa stage and a benthic polyp stage as part of their life-cycle. However there are many modifications of this life cycle in different species of medusozoans (Brusca and Brusca, 2003). The medusozoans are also unique in that they have a linear mitochondrial genome (Ortman et al., 2010). Medusozoa is divided into four separated classes: Hydrozoa, Cubozoa, Scyphozoa, and Staurozoa. Hydrozoans are the most diverse class of medusozoans (approximately 3,500 species) and comprise the groups: Filifera, Capitata, Aplanulata, and Leptothecata, Siphonophora, and Trachylina (Daly et al., 2007). Due to the variety of morphologies, life-cycles, and sheer number of species, understanding medusozoan diversity can be enigmatic and therefore interesting to study. Identifying species based on DNA sequences, often referred to as DNA barcoding has a variety of practical and theoretical applications. This technique can be used to identify endangered species targeted for poaching or illegal importing and exporting (Dalton and Kotze, 2010) as well as disease tracking (Alcaide et al., 2009), discovery of new species (Meyer and Paulay, 2005), and to reveal cryptic species (C.J. Moura et al., 2011). More generally, DNA barcoding can be used to quickly identify species by comparing a sequence from an unknown species to an existing database of DNA sequences from species that have been properly identified from a taxonomic expert and vouchered through a museum specimen. Once this database has been developed, further taxonomic expertise would not be required to identify a species through a DNA sequence. In other words, these DNA barcodes are auxiliary characters that allow identification of an unknown specimen in terms of a known classification (Bucklin et al., 2010). DNA barcoding also elucidates the possibility to test taxonomic hypotheses and provide new insights into evolution (C.J. Moura et al., 2011). This is especially relevant in organisms such as jellyfish, that can be easily damaged during collection; making species identification by subtle morphological traits impossible (Ortman et al., 2010). Although DNA barcoding has many applications, more investigations are needed to evaluate the ability of a relatively short DNA sequence to distinguish between species. Identifying a DNA barcoding molecule that efficiently and correctly categorizes species would allow for a relatively low cost way to identify species, where taxonomic expertise is lacking or the specimen is not preserved in a way to identify based on morphology alone. 72 Currently there are efforts to use molecular barcoding as the standard of identification of biological species. This initiative, called Barcode of Life, intends to identify all possible multicellular species into an online database (http://www.barcodeoflife.org). The standard molecular barcoding molecule used for this project is C O l (Hebert et al., 2003). An ideal barcoding marker should have low intra-specific and a relatively higher inter-specific sequence variation (Meyer and Paulay, 2005). It is also necessary that variation within species is less than - and does not overlap with - variation between species (Ortman et al., 2010). This gap between genetic distances of intra-specific variation and inter-specific variation is termed the "barcoding gap". The larger the barcoding gap, the better the molecule at delimiting species. It has been suggested that C O l is not the best barcoding molecule for all organisms (Hollingsworth et al., 2009; Vences et al., 2005; Shearer et al., 2008) and due to the variable rate of mutation between different groups of organisms, more research is needed before concluding that C O l can be used as the standard molecular barcoding molecule for all multicellular life. In plants, C O l has a lower substitution rate of mitochondrial DNA and it has been seen that plastid genes are more efficient (Hollingsworth et al., 2009). C O l is also inappropriate to use in the sister group of medusozoans, anthozoans, due to the slow evolutionary rate in the C O l gene (Shearer et al., 2008). The overlap between intraspecific variation and interspecific divergence results in the inability to establish an appropriate threshold value for anthozoaons (Shearer et al., 2008). In amphibians, C O l exhibits a high rate of variation both at the level of groups and similar species (Vences et al., 2005). Not only is C O l unsuitable for use in amphibians, it is suggested that the l6S rDNA gene is better at delimiting between species. For medusozoans, a study done by Ortman et al. suggests C O l is sufficient and indicative of species delimitation for Scyphozoa and Hydrozoa. Due to a faster rate of evolution in the mitochondria, C O l exhibits favorable levels of divergence within and between species. This allows C O l to be seen as an indicator of speciation. The other barcoding molecule that is useful among medusozoans is the mitochondrial large ribosomal subunit (l6S) rDNA gene. l6S has been found to be much easier to amplify than COl , particularly in the hydrozoan clades Anthoathecata and Leptothecata groups (C.J. Moura et al., 2 0 l l ) . In addition, l 6 S genetic information of hydrozoans has been found to be consistent with nuclear genetic markers and morphology (C.J. Moura et al., 2 0 l l ) . This is extended evidence for the potential of l 6 S as a barcoding molecule. It has allowed for recognition and discrimination of nominal and cryptic hydrozoan species (C.J. Moura et al., 2 0 l l ) . In medusozoans, it has been sequenced extensively and is readily available in public databases. We generated C O l and l6S DNA sequences from medusozoan species and assembled large datasets of both C O l and l6S sequences from newly generated and publicly available sequences. We used these large datasets to compare multiple groups of medusozoans including Cubozoa, Staurozoa, Scyphozoa, and the hydrozoan groups, Filifera, Aplanulata, Siphonophora, Leptothecata, Trachylina, and Capitata. We analyzed both C O l and 73 16S to determine their utility to delimit species and thus to be used as a DNA barcoding molecule. MATERIALS AND METHODS DNA used for this study was from an existing collection provided by Paulyn Cartwright. PCR amplification was performed using the primers 16S: F2 ('TCGACTGTTTACCAAAAACATAGC'} and R2 ('ACGGAATGAACTCAAATCATGTAAG'} (Cunningham and Buss, 1993}; 16S: SHB ('GACTGTTTACCAAAAACATA'} and BR ('CATAATTCAACATCGAGG'} (Cunningham and Buss, 1993; Schroth et al., 2002}; C01: F1 ('GGTCAACAAATCATAAAGATATTGG'} and R1('TAAACTTCAGGGTGACCAAAAAATCA' } (Folmer et al., 1994}; and C01: HCOcato ('CCTCCAGCAGGATCAAAGAAAG'} and LCOjf ('GGTCAACAAATCATAAAGATATTGGAAC' } (Dawson, 2005} . PCR conditions for primers C01: HCOcato and LCOjf used a ramp-up program. The steps for this program are as follows: 1} 94 Q F for 8 minutes 2} 49 Q F for 2 minutes 3} 72 Q F for 2 minutes 4} 94 Q F for 4 minutes 5} 50 QF for 2 minutes 6} 72 Q F for 2 minutes 7} 94°F for 45 seconds 8} 51 Q F for 45 seconds 9} 72 Q F for 1 minute 10} go to step 7, 32 times 11} 72 Q F for 10 minutes. For all other primers we used a different ramp-up program. The steps for this program are as follows: 1} 94 Q F for 5 minutes 2} 94 Q F for 50 seconds 3} 45 Q F for 50 seconds 4} 72 Q F for 1 minute 5} go to step 2, 4 times 6} 94 Q F for 50 seconds 7} 50 Q F 1 minute 8} 72 Q F 1 minute 9} go to step 7, 29 times 10} 72 Q F for 5 minutes. PCR fragments were evaluated by size using gel electrophoresis. Unpurified PCR products were plated and sent to the University of Washington DNA sequencing center for sequencing. Sequences were edited and assembled in the software program Geneious (Drummond et al., 2011}. DNA sequences were aligned using the algorithm Muscle (Edgar, 2004} in the program SeaView (Gouy et al., 2010}. Pairwise distances were calculated using the Kimura 2-Parameter (K2P} and genetic distances were plotted using the R (R Development Core Team, 2012} package SPIDER (Brown et al., 2012}. Graphs plot the genetic distances on the x-axis and the density on the y-axis. The density plot represents the amount of sequences, at a particular genetic distance, as a percentage of all the available sequences. Pairwise genetic distances were calculated between all C01 and 16S sequences within a species to determine intraspecific variation. To determine interspecific variation, pairwise genetic distances were calculated between species for all groups except C01 sequences in Cubozoa, where data was only available for a single species. RESULTS We generated DNA sequences for 16S and C01 and combined them with publicly available sequences. Our combined database consisted of 864 16S sequences and 765 CO1 sequences from a variety of medusozoan species. There were 60 Capitata, 52 Filifera, 156 Scyphozoa, 219 Aplanulata, 69 Siphonophora, 21 Cubozoa, 153 Leptothecata, 26 Trachylina, and 4 Staurozoa DNA samples that were barcoded using CO1. There were 97 Capitata, 204 Filifera, 63 Scyphozoa, 47 Aplanulata, 49 Siphonophora, 57 Cubozoa, 257 Leptothecata, 63 74 Trachylina, and 21 Staurozoa DNA samples that were S? 6 list of all species sampled, GenS and C01 sequences (Figure 1 and Figure 2)? Fi=ure 1 depicts intra- and inter¬ specific genetic variation in the medusozoan classes Staurozoa, CuS sequences of Staurozoa in that there was suS sequences in CuS, overlapping with the inter-specfic variation? In the hydrozoan suS data shows two distinct peaks with suS also has an additional peak of intra-specific variation that surpasses that of inter-specific? In Filifera, C01 and 1>S have significant intra-specific variation whose range exceeds that of inter-specific variation, although the peak of intraspecific variation is less than the peak of interspecific variation? While S comparisons, we see that the inter¬ specific variation spreads across the entire graph, overlaying with intra- specific variation? In Capitata, C01 reveals two distinct peaks distinguishing intra- and interspecific variation with additional small peaks of highly variaS comparisons in Capitata display distinct peaks, there is considera v v > are an old nation, with a rich heritage. February I960, the cabinet decided to to .. , , , , , Inspired by a historical past ... NWe are] name the new capital Islamabad - the r J V v. J eager to build a new city which, in city of Islam . With such advancements, to J addition to being an adequate and ideal the situation in Pakistan became such that , . .. seat of government, should also reflect there became an irrevocable connection u . .1 . i c - i .1 our cultural identity and national between the idea of purity and the , ... „_. e j , a j A U , aspirations" fMumtaz 1985: 184-185]. glorification of Islam. As Imran Ahmed f v j puts it, "Islamabad attempts to naturalize Designing the Dynapolis t h e n e w n a t i o n - s t a t e o f p a k i s t a n ; t h r o u g h The master plan for Islamabad was t h e r h e t o r i c a t t a c h e d t o t h e c h o i c e o f s i t e , designed by Doxiadis Associates, the firm t h r o u g h t h e c h o i c e o f ^ t ^ t h r o u g h t h e established by Constantinos Apostolou r e f e r e n c e t o a s u p p o s e d I s l a m i c g e o m e t r y Doxiadis, a notable Greek town planner i n i t s g r i d l a y o u t ; t h r o u g h t h e I s l a m i c and father of Ekistics. The approval of the r e f e r e n c e s o f i t s a r c h i t e c t u r a l s t y l e s , a n d master plan took place in May 1960. The t h r o u g h t h e n e t w o r k o f S e c t o r m o s q u e s " goal of the master plan was to allow [ V a l e 2 0 ° 8 : 1 4 7 ] . M u c h l i k e t h e p a k i s t a n i Rawalpindi and Islamabad to grow at the n a t i o n a l s t r u g g l e i t s e l f w a s t h e s t r u g g l e t o same time through the siting of Islamabad c o n c e i v e a n d e x e c u t e t h e c r e a t i o n o f on a fan-shaped area rammed between a I s l a m a b a d . A h m e d r e f l e c t s t h a t " I n wall of steep hills and the existing city of I s l a m a b a d , t h e i d e o l o g i c a l a g e n d a a n d i t s Rawalpindi. This was a tacit criticism of v i t a l i z i n g n a r r a t i v e i n a r c h i t e c t u r e a n d nearly all of the designed capitals that u r b a n i s m h a s t w o r o o t s : t h e u r g e t o came before Islamabad, such as W e s t e r n i z a t i o n , w h e r e n a t i o n h o o d w i t h Washington, Canberra, New Delhi, i t s o s t e n s i b l y c o l o n i a l o r i g i n s i s t a k e n a s a Chandigarh, and Brasilia, and were s i g n o f m o d e r n i t y a n d p r o g r e s s ; a n d a wm designed as bounded areas and presented t o f u n d a m e n t a l i s m , w h e r e t h e r e l i g i o u s as static entities which would eventually c o m m u n i t y o f I s l a m i s t h e o r i g i n a l a n d be filled out. Doxiadis, on the other hand, o m n i s c i e n t s o u r c e o f t h e p a k i s t a n i promoted Islamabad as a 'dynapolis' - a i d e n t i t y " [ V a l e 2 0 0 8 : 1 4 7 ] . W i t h city endlessly expanding in a linear fan I s l a m a b a d , t h e G o v e r n m e n t o f p a k i s t a n shape from an initial fixed point. Thus, p r o m i s e d t h e p e o p l e a m o d e r n a n d p u r e Islamabad would begin with one node in w h i t e c i t y t o t h e n o r t h . the top corner of the fan and, with time, T , n .. , ^ , . A .. rrr^A^ spread to the southwest in one direction. The Capital Development Authority (CDA) ^ was constituted in September 1960. Because it was being created near an 162 existing city, it would be a two-nucleus dynopolis and because growth would be guided and unidirectional, the two nuclei would spread in space and form a dynamic metropolis (Doxiadis 1965). Figure 6 Towards a dynamic metropolis (Source: Islamabad: The Creation of a New Capital) Doxiadis felt that a linear form could not be envisaged in dealing with a two- nucleus metropolis. He found the need to work with forms whose dimensions in two directions crossing each other at a right angle would not differ much. This led to the basic form of a concentric city with a pattern of radial and circular streets - very similar to a naturally growing settlement - or to a pattern of a grid of streets crossing each other at right angles The circular was excluded because Doxiadis thought that suited a static city and not a growing one (Doxiadis 1965). The grid was then chosen but the question arose as to what kind of grid - the elongated city blocks of the past, square blocks, straight or curved streets. According to Doxiadis, various considerations showed that the traditional elongated city block was a rational product of the fact that the block consists of plots which are in two rows of the same orientation. He added that unless the form of the landscape compels one to, there was no need for the main roads to be curved. Thereafter, not only the basic form of a grid was chosen, but also the basic form of squares which by conception (of a grid of squares) are all equal; these were the cells of the city (Doxiadis 1965). In choosing the grid, Doxiadis used historical precursors as well: Mohenjo Daro, one of the first cities in history was based on a typical rectangular grid; Lahore, a prime example of Moghul planning, was based on a two-axial system. Thus, both present day requirements and the cities of the past led to the same conclusion: full respect for a geometric grid. This gridiron layout divided Islamabad into sectors according to urban functions (Doxiadis 1965). 163 Figure 7 The forms of the past (Source: Islamabad: The Creation of a New Capital] Islamabad's capital complex acted as the culmination point of a long axial way named Capitol Avenue by Doxiadis "now known as Jinnah Avenue). The Capitol Avenue was intended to act as a ceremonial route ending at the capitol complex where the President and the Parliament were neighbors in Islamabad's elevated zone of government buildings, depicting Pakistan's Parliamentary republic form of government where both the Parliament and the President are elected by the people (Vale 2008). Figure 8 View of model along Capitol Avenue with the administrative center in the background and the civic center to the left of the avenue (Source: Islamabad: The Creation of a New Capital) Doxiadis started to rethink the sequence of building priorities and criticized the planners of previously designed capitals for beginning design with "government buildings, the monumental areas and the high income dwellings" (Vale 2008: 149). "This process," Doxiadis continued, "cannot lead to success for it is imperative that the lower income groups - those which can build a city are settled first. If this is overlooked, the result is a composite settlement consisting of a central monumental part and several other non-coordinated areas, including several with slums" (Vale 2008: 149). Instead, he claimed, "we must start by covering needs, and not by building monuments" (Vale 2008: 149). He thus, initiated a certain rethinking of the sequencing of building priorities, but his design did nothing to challenge previous attitudes toward the privileged position and the isolation of the capitol complex. 164 The process was adjusted but this part of the product remained routinely similar to the past ones (Vale 2008). Figure 9 The metropolitan area of Islamabad (Source: Islamabad: The Creation of a New Capital) Islamabad initially became a city only dominated by the institutions of government administration because other functions, such as housing, were directed towards Rawalpindi. As of 1968, the new capital could be described as "a little administrative island, neatly separated from the crowds of the big cities" (Vale 2008: 149) and affording "the feeling of complete isolation from life in the rest of the country" (Vale 2008: 149). A system of eight housing types correlated with civil service ranks was designed to include, at the least, a narrow range of income groups in each of the city's residential sectors. Provision was also made for exclusively high end residential sectors in the areas closest to the capitol complex. Planner Richard Meier, in looking back at the first twenty-five years of the development of Islamabad, saw the convergence of a need to elevate the status of the government with the systems of rank in the military and the bureaucracy in the birth of most of Islamabad's structure. In his view, the rectilinearity of the plan was reinforced by the capital city wanting a processional way that leads to the seat of power and a classification based upon squares imposed by the long view lines (Vale 2008). Meier then adds, "The rank of a person could determine the section of the city in which he would live. In the military hierarchy, ordinary soldiers were assigned places in the barracks on the periphery, but each level above merited increasing levels of privileges. Non-commissioned officers deserved a bit more space, according to the rank, and junior officers needed an extra room for a servant, but those at the top of the pyramid were allotted quarters for four servants. Civil ranking could exactly parallel the military, except that the unskilled workers were granted 1 U room flat roofed raw brick hutments instead of barracks! Islamabad's socio­ economic segregation was not carried out in quite such rigid terms, but its inhabitation was initiated on the expectation that all comers to the city would be assigned a residence according to their salary and that, with the exception of the high government officials and diplomats already provided with special housing, all other would be 165 expected upon promotion to change house and settle into a higher class of community" (Vale 2008: 151). "Public order in a capital city," Meier continues, "was easier to understand if like lived next to like" (Vale 2008: 151). This privileged treatment for residential districts became even more obvious when it came to the capitol complex. A new administration's desire to advance public order was established through the medium of urban design, exactly like designed capitals built before and after Islamabad (Vale 2008). The Architectural Conflict The most prominent public buildings of Islamabad are a great illustration of the conflicting and changing ideals that have defined a great deal of contemporary architecture in Pakistan: professional architects like to push the envelope towards what they consider to be modern whereas the people of Pakistan have an affinity for architecture that reminds them of their Islamic heritage. Unlike Chandigarh and Dhaka where Le Corbusier and Louis Kahn prepared the master plans and also designed the major buildings, Doxiadis, not in any case known as an architect, did not design any major buildings in Islamabad. Unlike the other two capitals, a panel of international 'signature' architects of the time was assigned the task of designing the major buildings of Islamabad. Robert Mathew Johnson-Marshall from Britain prepared the overall plan of the administrative sector and also designed the National Museum and the National Arts Gallery. The Government Hostel and the Secretariat Complex were designed by Italian architects Ponti, Fornarolli and Rosselli. Kenzo Tenge from Japan designed the Supreme Court, and following an international competition, Turkish architect Vedat Dalokay built the King Faisal Mosque. A team of architects working under the Colombo Plan was responsible for the municipal offices, schools, housing, and markets in various sectors. Derek Lovejoy and Partners from Britain were responsible for the city's extensive landscaping. Other famous international architects involved were Arne Jacobsen from Denmark and Louis Kahn and Edward Durrell Stone from the US. All of them prepared a number of proposals for the Parliament Building and the President's House, with Stone's design being eventually built (Malik 2003). When the Parliament building was first proposed in 1962, for instance, it was suggested that, "if the Parliament House is then to be built ... the building will be of a substantial size and in order to be architecturally impressive, it will have to be carefully designed to reflect our past culture, at the same time utilizing modern methods of construction" (Mumtaz 1985: 187). Arne Jacobsen's uncompromising 'modern' design for the Parliament building was criticized for not being 'national' and the Capital Development Authority suggested that some "Islamic features be incorporated in the form of some arches in the cylinder, a dome 166 above the cylinder, or some additions to the fore-courtyard" (Mumtaz 1985: 187). Louis Kahn replaced Arne Jacobsen but even his final designs were not accepted because of their failure to reflect the demand of Pakistan to introduce Islamic architecture in Islamabad's public buildings. Edward Durrell Stone was then contacted because of his love for Mughal architecture and the spirit of grandness Mughal buildings casted. There was a strong sentiment, thus, connecting the desire for Islamic architecture to the subcontinent's Mughal past. This feeling was verified by the chairman of the CDA, NAFaruqi who said that "since we have lost the best specimens of our architecture in Delhi and Agra, we are anxious to have some semblance of our architectural treasure. It is the form that matters and not the details such as the use of precious stones, etc., which are no longer available" (Mumtaz 1985: 187). Mr.Faruqi's eagerness to have the Islamic heritage of architecture reflected in the public buildings of Islamabad led him to consider Stone for the design of all four buildings in the most prominent square of Islamabad: the Supreme Court, the Parliament building, the Foreign Office, and the President's Secretariat (Stone's designs for the Parliament building and President's Secretariat were chosen). Mr.Faruqi reminded that "there is a grave dissatisfaction in the Government and among our people regarding the architecture of the public buildings put up so far in Islamabad" (Mumtaz 1985: 187). He insisted on a modern internal arrangement of the buildings, yet, wanted aesthetics that looked "native to the soil" (Mumtaz 1985: 187). He stated that the buildings of Islamabad should be a reflection of the pride that the people of Pakistan take in their long and beautiful architectural heritage - he wanted the buildings not to look like they were cheap copies of buildings build somewhere else but like buildings that were inherently Pakistan's own. In consistency with his understanding of Mughal concepts, Stone designed a layout for the capitol complex with a formal symmetry. At this complex, the President's Secretariat is flanked by the Parliament building and the Foreign Office. The pyramidal design of the President's Secretariat consists of receding tiers with white walls and louvered windows. The Parliament building takes a similar tiered form. Both the Parliament and the Foreign Office are given austere facades (Mumtaz 1985). Although the exterior of all three buildings was stripped of any ornamentation, they are all connected by means of very extensive landscaping. The interior of the Parliament building, however, is very reminiscent of Mughal ornamentation. The ceilings and walls are decorated by means of geometric patterns and calligraphy. 167 Figure 10 Stone's Parliament Building (right) and President's Secretariat (left) (Source: Architecture in Pakistan) Figure 11 Interior of Parliament building (Source: www.urbanpk.com) The Secretariat Complex designed by Italian architects Ponti, Fornarolli, and Roselli is a grouping of buildings into a well-integrated unity. The use of water and terraces at many levels is reminiscent of Mughal landscaping. The spaces are self-defined in a series of quiet enclosures which flow into each other through the building masses (Mumtaz 1985). Figure 12 The Secretariat Complex (Source: Architecture in Pakistan) The Government Officers' Hostel designed by the same team of Italian architects attains its architectural integrity from an organic unity of form, structure, function, and materials. The building also makes use of barrel vaults as lightweight sun protection in the form of a ventilated double roof, though barrel vaults are not a common form of traditional construction in the region. Also present is the traditional courtyard. The bricks used have the traditional slim proportions but are without the accompanying thick bed of lime mortar. The so-called Mughal Garden in one of the courts is only loosely derived from the traditional form (Mumtaz 1985). Figure 13 Government Officers' Hostel (Source: Architecture in Pakistan) The Supreme Court building is flanked by the Secretariat Complex to the south and 168 President's House and the Parliament building to the north. Designed by Japanese ar9hite9t : e n ; o . Karachi in the 1950s. 2007. Photograph. Pakistani Defense Forum. Web. 14 Mar 2012. . 171 King FaisalMosque. 2007. Photograph. Wikipedia. Web. 14 Mar 2012. . Map showing East and West Pakistan. 2008. Map. Suburban Emergency Management Program. Web. 14 Mar 2012. . Map showing Rawalpindi. 2009. Photograph. Wikimedia Commons. Web. 14 Mar 2012. Mumtaz, Tamil Khan. Government Officers' Hostel. 1985. Photograph. Architecture in Pakistan. Print. Mumtaz, Tamil Khan. Stone's Parliament building and President's Secretariat. 1985. Photograph. Architecture in Pakistan. Print. Mumtaz, Tamil Khan. The Secretariat Complex. 1985. Photograph. Architecture in Pakistan. Print. Supreme Court. 2007. Photograph. UrbanPKWeb. 14 Mar 2012. . Trend of Population Growth (in millions) in Karachi. 2012. Photograph. Wikipedia. Web. 20 Apr 2012. . 172 Social Factors that Encourage Post-High School Education: What 8or9s across racial and socioecono:ic di;ides Beth O'Neill In order to understand the social factors that encourage education post-high ABSTRACT education than those from more privileged socioeconomic categories. INTRODUCTION school I conducted intervie6s among a strategic sample of University of Kansas students4 selected to create diversity in Students of racial minority groups and lo6er socioeconomic status are race and economic status of the student d i s p r o p o r t i o n a t e l y u n l i k e l y to .attend body in their graduating high schooL as c o l l e g e i n c o m p a r i s o n t o t h e i r C a u c a s i a n determined by Department of Education p e e r s o r t h o s e o f h i g h e r s o c i o e c o n o m i c data. Previous research explored factors s t a t u s . C o n c m a b o u t t h i s h a s l e d including peer groups4 availability of p o l i c y m a k e r s a n d e d u c a t o r s t o l o o k t o advanced placement courses and faculty f i n d 6 a y s t o c o m b a t t h i s . H h i l e t h e r e a r e attitudes about the perceived future i n i t i a t i v e s a c r o s s t h e c o u n t r y t o a t t r a c t success of students. None of this research m i n o r i t y s t u d e n t s t o c o l l e g e s a n d took into account the 6ays these factors u n i v e r s i t i e s a n d s t u d i e s e x a m i n i n g t h e i r interact and for 6hich groups these e f f e c t i v e n e s s i n m o t i v a t i n g s t u d e n t s to factors make the biggest difference. The a t t e n d c o l l e g e 4 1 c h o s e t o t a k e a d i f f e r e n t intervie6s in this research explore a p p r o a c h . R a t h e r t h a n s t u d y i n g t h e influential factors including t e a c h e r e f f e c t s o f s p e c i f i c f o r m a l p r o g r a m s a n d curricula4 and peers. The information p r a c t i c e s 4 1 c h o s e t o f o c u s on t h e q u e s t i o n gathered from these intervie6s 6 a s then f r o m t h e p e r s p e c t i v e o f t h o s e 6 h o h a v e analyzed for patterns4 including paying m a d e i t t o c o l l e g e . K e t t e r u n d e r s t a n d i n g attention to factors that crossed racial t h e i r e x p e r i e n c e a n d t h e i r r e f l e c t i o n s o n and socioeconomic divides. I find that t h e s e e x p e r i e n c e s c a n p r o v i d e one important influence is that of i n f o r m a t i o n on s t r a t e g i e s t o e n c o u r a g e teachers 6 h o also served students in an u n d e r r e p r e s e n t e d p o p u l a t i o n s t o p u r s u e advising capacity in extracurricular c o l l e g e e d u c a t i o n . 1 s o u g h t t h e i r activities. I also find that significant r e f l e c t i o n s on t h e f a c t o r s t h e y foimd factors 6ere more likely to cross racial i n f l u e n t i a l i n g e t t i n g t h e m t o c o l l e g e a n d than socioeconomic divides. F i n a l ^ it h e l p i n g t h e m p e r s i s t . seems that students in lo6er H i s t o r i c a l l y 4 c o u n s e l o r s socioeconomic categories express more e n c o u r a g e d s t u d e n t s o f l o 6 e r positive attitudes about school and gratefulness for their chance at higher socioeconomic status to pursue employment after college4 but evolved into the rhetoric of "college for everyone" 173 (Schneider 2003). Race and class differences still shape students' educational experiences and attainment. Students of lower socioeconomic status are more likely to delay college and less likely to obtain a bachelor's degree. Those who do attend college are less likely to experience the increased wealth accumulation and opportunities that more students from privileged backgrounds enjoy as a result of educational attainment (Goldrick-Rab and Han 2011; Walpole 2003). Although educational aspirations beyond high school are rising nationally, (Roderick et al. 2009) there are still gaps in desired educational attainment across race and income boundaries with fewer racial minorities and students of lower socioeconomic status looking to pursue the same level of educational attainment as students of more privileged backgrounds. However, none of the studies used examining racial minorities incorporate those of higher socioeconomic status when studying their aspirations. Structural disparities among high schools can also impact the level of difficulty students encounter when applying to college. For example, researchers examining the impact of the culture in urban high schools find that they tend to lack structural and organizational arrangements that facilitate better access to grants, scholarships and other assistance programs in the college application process (Holland and Farmer-Hinton 2009). The research examined for this study does not examine the elements that counteract the structural shortcomings in disadvantaged high schools. While certain skill sets are valuable to future college education, increasing access to advanced placement and college preparatory courses is not enough. Increasing opportunities for students to enroll in advanced placement courses tends to allow the same students to take multiple courses rather than encouraging a broader diversity of students to take at least one (Hallett and Venegas 2011). High schools deemed "at-risk" because they have lower graduation rates and test scores are more likely to leave students ill-prepared for college or employment regardless of course offerings (Williams 2012). These studies neglect to find the impact from the perspective of affected students- the differences they felt these initiatives did or did not make and the factors they found most important. Another large body of research focuses specifically on the role of peers and their effect on students' aspirations. These studies find that more encouragement from parents and friends during adolescence is positively associated with increasing high school grade point average as well as educational aspirations (Witkow and Fuligni 2011, Holland 2011). The motivation levels of students and "passion, dedication, and commitment of staff" also play a vital role in pursuing a college education (Contreras 2011, Barile et al. 2012). I can find no research, however, examining whether these factors have equal impact across racial or socioeconomic status divides. A great deal of research looks at the ways high school environments affect attitudes about college. Much of this focuses on the degree to which necessary skills are learned in the classroom including content knowledge and basic skills, core academic skills, non-cognitive or behavioral skills and "college knowledge"- that is, knowing how to effectively search and apply for college (Roderick et al. 2009). A 2012 report 174 found thatwhen these "college knowledge" programs are implemented effectively, students attend college in greater numbers, are more likely to remain in college after the first year, more likely to earn a degree, become employed and earn higher wages (Johnson 2012). The idea of a college culture is becoming more prominent in high schools across the country, but we still do not know the impact of teacher support, individualized attention, and the broader support system in the school in helping students move forward. A broadly defined college culture results in greater numbers attending college, but researchers do not know which components are the most influential and how that might vary by students' race and class. While research literature examines the disparities between advantaged and disadvantaged students in educational aspirations, college preparatory course enrollment and structural programs in college preparation, I could find none that explored the perspective and motivation of disadvantaged students who pursued education beyond high school. The research addresses the positive relationship between peer support and encouragement and teacher commitment, but I want to further examine the relationship between students in historically low-achieving areas wanting to separate themselves from their peers through higher education. I focus specifically on the role of informal factors in increasing students' confidence from their perspective, inspiring them to pursue further education and creating an interest in them to learn more. METHODS Qualitative interviews were used to collect data about participants' high school experience and college preparation. The advantages of this approach included greater possibility for discovering influential factors than numerical data can provide. It went in depth through anecdotal evidence, a feature quantitative research could not provide. Asking open-ended questions allowed participants to elaborate and take the interview in a direction the researcher may not have anticipated and would have therefore been left out of survey questions. By allowing the interviews to evolve naturally and using a less structured format, the participant- driven method could be analyzed through the ways in which participants gave importance to issues and where they elaborated most. I conducted these interviews with a sample of 12 University of Kansas students (see Table 1). The participants were selected using snowball sampling techniques in which initial participants were referred through an advisor working with programs for first- generation college students and students of color. This selection method was chosen because the students referred were involved with programs to promote academic success, thus these students had a greater likelihood of persisting and succeeding in college. These participants then referred future participants. The interviewees were from different years in their college careers, with an equal number of male and female participants. Of the participants, four were selected from each of three racial categories (Caucasian, Hispanic, African- American) strategically selecting students in each category that graduated from both economically advantaged and economically disadvantaged high schools. Race was self-identified by the interviewee. The socioeconomic status of the participant's high school was determined using State Department of 175 Education data on free and reduced lunch rates. If the high school had more than 50% of students on free or reduced lunch, the school was classified as economically disadvantaged. If the school had less than 50% on free or reduced lunch, it was classified as economically advantaged. Using what I knew from the information found in the research literature as well as topics I had not seen explored, I developed an interview guide to structure the interview and address key points (see Appendix A). In addition to general questions pertaining to their high school experience, interviewees were asked about the aspirations and support of their peers, as well as how closely connected they felt to their peers and pursuing education possibly at the expense of leaving peers behind. Interviewees were also asked to relate how close they remain to high school peers who chose separate paths. The level of detail in the college planning experience with advice and resources, the investment and commitment of the teacher or counselor, and what specific factors encouraged them to apply for college was important in analyzing the greater picture. As themes emerged early in interviews, the following interviews varied slightly in response in order to explore these themes in more detail. Each of the interviews was audio recorded. The interviews lasted between twenty and forty-five minutes with the average lasting approximately thirty minutes. After each interview, I wrote a memo taking note of things that could not be captured on audio- participants' comfort level, their willingness to open up and other non-verbal gestures. I transcribed and began to code the transcriptions early in the interview process. Initially I began to code for mentions of key words including influence/influential, relationship, and mentor. On the basis of those early interviews, I also began coding for references to meaningful, lessons and help/prepare. Then I looked for factors that recurred across interviews as well as when new ones emerged. The emerging themes that were not addressed in the literature added complexity to the research in determining why these factors had strong influence. Themes that were found when unsolicited with prompts were given special attention because they were of such importance to the participants they were mentioned without question. In comparing across interviews, a few themes emerged consistently: teachers serving as advisors (often through extra-curricular activities), students surrounding themselves with like-minded peers and disassociating from those not sharing the same goals, and the degree to which the student was grateful for the access to a college education. RESULTS Finding a Mentor is Critical The most prominent theme was something I never found discussed thoroughly in the research literature- the importance of informal advising. Teachers serving students in extra¬ curricular advising roles in addition to classroom teaching had the opportunity to develop relationships that eventually helped with the college planning process. However, these relationships looked different for students depending on their socioeconomic background. Take the experiences of two students who graduated from economically advantaged high schools. Alicia, a white senior, talks about having a mentor in college preparation this way: 176 There were teachers [who helped prepare for college], but they weren't my own teachers. They were like friends of friends that I grew up with that just happened to be teachers. They were good mentors. They helped me establish a role to lean towards. Penny, a white freshman, describes teachers' and mentors' role in helping with college preparation this way: I don't know if [the relationships were] more helpful, as though they were more supportive. I mean, they weren't saying 'you should do this.' It was more like you can do whatever you set your mind to. One of the stories that best encompasses the advising role described by many students from economically disadvantaged backgrounds was told by Clinton, an African-American student from an economically disadvantaged high school. Here he tells the story of his forensics teacher: I spent a lot of time with my forensics teacher, so I guess I would say I was pretty close to her. Just because you gotta spend hours outside of school working on your craft in forensics, you start to share stories and get close with them that way...Well, you just, I don't know [laughs], you just start sharing stories about life pretty much. I mean, she kinda connected with me because she grew up the same way I grew up and those things translated to other stories and just connecting that way, and we had a lot of commonalities in that we were into forensics, we both did debate and involved in high school. It just made our relationship grow stronger... I would say I connected with [her] the most. I remember I didn't get accepted to KU because it was like some, like, conflict with my, like, transcript and I knew it was wrong, because how could I not get accepted to KU? And then like she was the one calling admissions for me and actually, like, resolved the issue for me and ultimately, got me into KU. Like Clinton's story of the relationship that developed with his teacher because of the time they spent together outside of the classroom, many students echoed similar relationships that began this way and resulted in advising for college. Like Gabby, a Hispanic junior from an economically disadvantaged high school: So like my English teacher who was also my forensics coach, was also my Scholar's Bowl coach, so we spent a lot of time together inside of the classroom, outside of the classroom... It's something that we talked about and that, you know, even if it was just a casual conversation about what I wanted to do with my life he was very helpful with advice and with little helpful hints, stuff like that. We see a similar experience from Ben, a Hispanic student from an economically disadvantaged high school: My forensics and debate teachers I was pretty close to, because we used to go to tournaments that was like out of school like sessions or whatever for debate and forensics. They just offered me knowledge and asked me. They were kind of like mentors, just asking me how school was going, asking me how 177 my days went, what they could do help me and further my education. From the relationships that formed from commonalities shared over extra-curricular activities, they also found common interests in the classroom that helped students flourish and would eventually lead to a course of study in college. This is the case with Max, a white student from an economically disadvantaged high school: I felt like at [my high school] it was essential to find a mentor.. to kind of move on and to kind of have guidance throughout [high school]... I found some of my English teachers were probably some of the greatest mentors I had in high school just because I'm an English major now. I've always loved to read and like it was something that we found in common and they were kind of able to foster. Other close relationships with invested teachers were important to students when planning for college. Hugh, a Hispanic freshman from an economically disadvantaged high school explained his relationship with a math teacher this way: [I was closer to] my math teacher whose son goes to the University of Kansas... It was awesome. She was like my second mother whenever my mom was away. He goes on to describe her help when preparing for college: In the end of it, it was really up to my decision, but my teacher really helped me out in choosing what I really wanted by asking me questions and kind of thinking through it myself... The application process was one of the most grueling things because my mom didn't attend college so it was a struggle for me and I asked them [for help]. The mentor relationship described by several interviewees is summed up by Zach, a Hispanic junior from an economically advantaged high school as he describes his choir teacher: So there's all these components, but you still have to balance that between also being a mentor, a friend, it's a really unique relationship, but that's what made it so great. You had that balance, but you could be more than just a teacher, because I think you see that in class. He was more than that and that was pretty influential. The extra time spent outside of school makes a difference for many students. It provides an opportunity for teachers and students to form deeper connections and sets them up to help with college planning and preparation. Sharing a common interest in an extra¬ curricular activity creates an initial bond that opens up new lines of communication that can eventually lead to discussions about goals and college aspirations. In these relationships, teachers act as role models where they were one of few, if not the only, driving force behind students pursuing post-high school education. Gabby, Ben and Max (all from economically disadvantaged high schools) all valued teachers who offered them advice and knowledge and fostered their talents while these were less critical for other participants in high schools of higher socioeconomic status. Alicia, Penny and Zach (all from economically advantaged high schools) all appreciated having a mentor but framed them as 178 playing a supportive and encouraging role in college planning while those from economically disadvantaged high schools were more likely to place a mentor as a driving and integral force behind their college planning process. The economically advantaged participants relied less upon teacher support when thinking about college as opposed to economically disadvantaged students who were in greater need of teacher support when applying for college and dealing with obstacles. Clinton's story of his forensics teacher contains a critical element. Because the forensics teacher "grew up the same way [he] grew up" making them more connected, he could identify with his teacher. Seeing as his teacher would ultimately attend college after high school, it gave him someone with a similar background who pursued education post-high school. Having a person in authority take an interest in him and giving him the extra help to get to college motivated him. Identifying with someone like himself who attended college when he may not have had a significant number of people in his life who did so gave him encouragement to do the same. The relationships that developed from the outside interaction between teachers and students led teachers to offer advice to students in the college planning process, write letters of recommendation, suggest programs of interest, and ensure they have everything in order for applications. Teachers could also fill roles that more privileged parents may be better able to play if they were familiar with the college planning process (as in the case of Hugh) or clearing up issues with admissions requirements (as in the case of Clinton). This theme is significant in answering what factors make a difference across boundaries because it was mentioned by students regardless of race and class background. However, how these relationships were framed differed by class. Students of more privileged backgrounds were less likely to need a teacher to play an integral role in helping them get to college. It's the CompanyYou Keep Across all participants, we see a common theme of the importance placed upon peer groups. This includes surrounding oneself with friends in college (whether at the University of Kansas or elsewhere) and disassociating oneself from peers who did not attend college. From there, the theme takes different shapes in regards to class differences that inform participants' actions. For example, the expectations of friends' aspirations after high school are different among students of differing economic backgrounds. Take this example of two students who were asked about what their friends were doing now. Tia, an African-American freshman from an economically advantaged high school describes her peer this way: I'm actually kind of disappointed because, one of my friends, she dropped out of college after the first semester. I guess it was too hard for her. While Suzie, an African-American senior from an economically disadvantaged high school has a different attitude about a friend in a similar situation: My friend, she always talked about [going to college], but she never went... She hated school. So I never really expected her to keep going... Now I don't really 179 know why, I'm not really friends with [her] anymore. There were a variety of responses when participants were asked about their friends in high school, their aspirations and their discussions about college. While many participants shared feelings of wanting to separate themselves from those who were unsure of what direction they wanted to take in life, Penny, a white freshman from an economically advantaged high school, was surrounded by peers who had a different way of dealing with the situation: Out of my group of friends a good chunk of us, like, knew what we loved, what we wanted to do. And then, you know, the one's that didn't, they tried everything until they found it out. When asked about her relationships with high school friends who made different choices, Claire, a white junior from an economically disadvantaged high school said: Until last year, we had done really, really well about staying in contact, but it's kind of that thing where life goes in a completely different direction and the things that you have in common to talk about, you don't have any more and it's- it becomes a little more like your relationship is focused on the past than anything current in your lives. Ben, a Hispanic junior from an economically disadvantaged high school expresses shares a similar loss of communication with friends who made different choices: I do have like a group of friends that are kind of just like homebodies that are in [my hometown] and have either not gone to school or dropped out of school since then. And then kind of.. I have lost touch with them. Then the other ones, I can still keep in touch with that are at a university. Ben's choice to only maintain relationships with friends who attended college is shared by other participants. Clinton notes that he purposefully surrounds himself with like-minded people: So, I mean, most of the people, the friends that I kept close to me, like came here with me or went to a different school and still have very strong values and like I don't associate with people that's not really doing anything with their life. Lance, an African-American student from an economically disadvantaged high school shared this attitude as well: I've always set myself, like, taught myself that you're kind of looked upon with who you hang out and who you surround yourself with. So I've always thought of myself as being a driven person who wants to graduate from college and get a degree and get a nice job. I believe that's a lot of people's goal in college. So like you kind of are who you surround yourself with. I think I've surrounded myself with a lot of good individuals. As they persist through college, students from economically disadvantaged backgrounds look to advance themselves through education and no longer share this commonality with their former peers. The differences that emerge between students who choose to pursue college education and those who do not become dividing factors 180 in relationships, making them more difficult to maintain, as mentioned by Claire. 9 a : also e:presses tliat lie lost touch with the people who chose not to pursue college after high school. Separating oneself from high school peers was common among students from economically disadvantaged backgrounds, but not all of these separations were as amicable as "losing touch? in the cases of Claire and 9 a : . Clinton and Lance were more purposeful in disassociating themselves with people who did not share what were considered "very strong values? or were "good individuals.? Their separation had a deeper meaning than casually losing touch over the loss of commonalities. We learn a lot from Tia's remark about being "disappointed? in a friend who dropped out of college after a semester, especially when comparing her to other participants. While we see differences between Claire and 9 a : and Clinton and Lance, we see even greater differences between these four and Tia. No matter the reasons for which they separated from former peers, they all seemed to detach themselves in an unemotional way. Whether it slowly faded away or they believed friends no longer shared their values, they gave very little insight to how they felt about this. However, Tia, most of whose friends are still persisting in college, e:presses feelings of disappointment over a friend no longer in college. This feeling implies she had initial e:pectations for that friend to obtain a college degree as she e:pects all of her other friends will. None of the economically disadvantaged students e:pressed a similar feeling of disappointment. Suzie shares that she never e:pected her friend to go to college and e:presses a feeling of detachment from the situation. We often see lesser e:pectations of post-high school education placed on friends from participants of economically disadvantaged high due to different college cultures in their schools. Clinton and Lance's reasoning of separating themselves due to a mismatch of values or not considering one a good individual because they chose not to attend college gives insight to the values systems both of these participants put in place upon attending college. They value their education and value peers who chose to further theirs as well. For peers who chose alternative lifestyles after college, they no longer consider these people to hold similar values or measure up to their standard of good. Penny's description of friends who "didn't know what they wanted to do? also brings a perspective to the way class background influences what is considered uncertainty about the future. While she takes for granted that her friends would attend college even if they were unsure of what they wanted to do, participants from economically disadvantaged backgrounds never made the assumption their friends would attend college to e:plore their options. Thus they adopted the strategy of surrounding themselves with people who knew what they wanted to do with their lives. This transition of separating themselves from peers who chose alternative options after high school changed significantly with students in their sophomore, junior or senior years as opposed to those who were freshmen at the time of interviews. Freshmen were less likely to have severed contact with peers who were not attending college. Those who had lost contact with high school peers did not connect that with whether or not they were attending college. Freshmen have not been out of 181 high school long so they have had less time to diverge from these peers or have not fully developed an identity as a college student giving them less motivation to separate from non-college attending peers. The distance that came 8et9een students and high school friends g r e 9 stronger as the years in college increased. While these students 9ere in college and had moved a9ay from their hometo9n and 8egan living independently 9hile attending school, they report that their high school classmates often remained in their hometo9ns. Because they had less in common, they related them more 9ith 8eing a part of the past than the future. Appreciation for High School Experience At the end of the intervie9s, I asked intervie9ees to reflect on their high school experience. At this time, only one of the students from a privileged 8ackground expressed gratitude a8out her high school experience. On the other hand, a majority of the students from disadvantaged 8ackgrounds expressed gratitude. Instead, many of students from economically advantaged 8ackgrounds referred to superficial factors including friends, easy classes, or extra-curricular memories. For example, Zach, a Hispanic junior from an economically advantaged high school: I 9ouldn't say it's a positive or negative experience. It 9as , I think, it's kind of contextual in terms of, there 9ere parts of it I really enjoyed, there 9ere social parts, there 9ere also parts that I 9asn't so keen on in terms of social aspects. Tia, an African-American freshman from an economically advantaged high school focuses on the "fun" aspect of her high school experience: My high school experience I guess, it 9 a s fun. I had—I 9 a s 9ith a lot of friends I 9 a s 9ith since elementary school so I mean I kind of liked that, 8ut some people didn't ...And it 9 a s a really good environment, my school 9 a s really judged against for 8eing the rich kid schools 9hich that kind of sucked 9hen you met other people or 9hatever, 8ut it 9 a s still fun. Ho9ever, several participants from economically disadvantaged high schools took the opportunity to share 8roader reflections on their high school and stressed a similar point- although they came from high schools that 9ere not as privileged as the high schools of many of their college classmates, their high school experience shaped them into the students they are today. Claire, a 9hite junior from an economically disadvantaged high school, mentions her experience in this 9ay: I just really 9ant to emphasize... h o 9 much I appreciated it. Like it 9 a s such an amazing time, 8ecause I had all of these people that I cared a8out and cared a8out me and everyone. The 9hole community 9 a s very supportive and I think the fact that everyone there had so many opportunities to try so many different things 9 a s a really, really great thing a8out gro9ing up in such a small to9n that I really appreciated. Lance, an African-American junior from an economically disadvantaged high school talks a8out the 9ays his high school experience prepared him for college in relation to his peers: 182 Just one thing is that I really did have a good high school career. I believe the high school that I went to definitely prepared me for college and I think that's a strong kind of emphasis that that high school that I went to.. . is that they placed is that we're kind of prepared for college not only just to get accepted to college, but also to prepare you for what college is gonna bring to your doorstep. Like just the work, I was kind of used to it more, because some of the other freshman entries in my class and I was able to adjust more to the workload and like how college was set up because that was kind of how high school was set up as well. Max remembers high school as a positive experience while also acknowledging its shortcomings: [My high school] is a special place. I think that it's interesting, because it really has this AP program that really caters to the highest achieving students and then it.. it's probably one of the best at special ed departments, in [the state] and in [the county]. Which isn't really saying much, but then what the problem is with [my high school] is that it doesn't cater to that middle like eighty percent and that's where I found the dropout factory to really happen. And like those were the kids that I expected I would never see again and that's where they're trying to come up with programming for that and like I kind of experienced that because a lot of my friends were in that kind of gap. And like I wasn't in the gifted program and they got like priority advising and I was going in the counseling office. We see this same attitude from Penny, a white freshman who graduated from an economically advantaged high school, only after transferring from an economically disadvantaged school: Because I was new to that school and the education I had before I moved [there], I'm one of the few I think, after looking at what people say, that I really appreciate my education. While most of the students from economically disadvantaged high schools noted their high schools did not provide the same things economically advantaged high schools could provide, they were quick to add that this did not detract from the influence their high school career had on them. This acknowledgement led to an appreciation of where they came from and the ways it equipped them with skills they may not have gained in a high school of higher socioeconomic status. A comparable appreciation of their high school experience was not mentioned by any of the participants from economically advantaged backgrounds suggesting the level of influence does not cross socioeconomic divides. The responses given by students from economically disadvantaged backgrounds can also be attributed to the fact that students from underprivileged backgrounds are among the minority in college. Because they are frequently surrounded by those who came from dissimilar backgrounds, they are more aware of their experiences and the way these shaped them. Conversely, we do not see this from students of economically advantaged backgrounds as they are among the majority of college students which makes it more difficult to see this background as a point of reflection. 183 Privileged students were probably more likely to have had someone in their family attend college and knew how to do apply and enroll and were expecting them to follow the same path. Students from disadvantaged backgrounds may be encouraged to go to college, but their parents may not be able to give them much guidance as to how to get there. Their background contributed to the development of their identity as a college student and allowed them to better understand and appreciate the work it took them to get there and the influences that helped them achieve this status. While high schools of lower socioeconomic status are often looked upon as not being able to prepare students as well for college, Lance feels his high school experience prepared him well. Using this information, we can also understand this theme as a set of responses to societal stereotypes of economically disadvantaged high schools. As more pressure is placed upon students to attend high schools that are often regarded as best preparing them for college, we see students who made it to college more greatly acknowledge adequate preparation after attending high schools that are often less regarded in society because of the resources they are able to offer students. DISCUSSION/CONCLUSION From this research we find two critical factors and another important theme. Having a teacher in a mentoring role through extra-curricular advising can form a relationship that sets a student's aspirations for college in motion. College students coming from backgrounds that lack resources, both culturally and materially, found it important to separate themselves from friends who were not in college and surround themselves with other achieving students to help them persist. As students persist through college, there is a growing recognition of the pride students from disadvantaged backgrounds have about where they came from. Each of these is important to better understanding how to narrow the gap between the amount of privileged and underprivileged students attending college. One of the most critical themes found in this research is that race does not seem to make the difference that class does. While there are no significant differences among members of different racial categories, there are greater differences between participants of different socioeconomic status. Participants from advantaged backgrounds relied on mentors in determining majors and finding the top programs while those from disadvantaged backgrounds needed more help encouraging the idea of college and navigating the application process. Those from advantaged backgrounds were less likely to have peers who were not also in college and had expectations of their peers while participants from disadvantaged backgrounds separated themselves from a greater number of peers who were not in college. In their reflections on high school, privileged participants focused on more tangible factors unlike disadvantaged participants who reflected on how their high school experience shaped them. While a majority of the participants shared similar experiences in some respects, they were framed differently depending on the socioeconomic background of the participant and the value they placed on that. In addition to this finding, we see another issue presented when reading participant transcripts. While participants never acknowledge their race, they acknowledge their 184 socioeconomic status. This is often indirect, but still important to understanding the question because it is not only prevalent to the researcher but also a distinguishing mark for the participant. My interviews showed how these factors to work together and complement each other, rather than a single factor influencing all participants over others. The combination of an encouraging mentor and surrounding oneself with like-minded peers led them to develop a skill set that helped them transition and persist through college. Having a mentor made the participants appreciate their high school experience because that person encouraged their development and helped them achieve their goals. We also see a trend of high school appreciation strengthening as participants began to surround themselves with like-minded peers who frequently have different backgrounds and thus gain a better awareness of what they overcame to get to college. The interweaving of these factors creates a structure in which each of these elements is critical in creating an environment for students to aspire to attend college and then thrive in the college environment. The research also shows a pattern of themes being much more consistent among upperclassmen. They were more likely to elaborate on stories and include more insight in their answers which provided more room for analysis. I believe that this is due to the greater separation between their current status in college and their high school experience as opposed to freshmen who were interviewed and after only being in college for approximately a semester. It also teaches how the college experience helps students develop an identity and that while in school their student status often becomes their master status. College students from economically disadvantaged backgrounds form a distinct identity. They are disassociating themselves from those with shared backgrounds as those peers infrequently attend college. However, they are the minority among college students because of this same background. These divides result in this demographic of students forming an identity through the combination of these two components. This exploratory research creates a better understanding of the experiences of college students from diverse backgrounds which leads to hypotheses about what could make significant impact in high schools and colleges. This research lays a foundation for future studies that could further examine how to promote these environments. It reiterates the theories of past literature on the importance of peers in achieving aspirations and can inform future studies of the changing nature of these relationships. It may also lead to future studies on the way these students utilize their background in their personal identity development and as motivation to further themselves. While this research brings about new questions to be studied further, it helps answer some of the basic questions and provides a solid foundation and gives direction to future work. In addition to further studies on the impact of social factors, it can be used to develop smart experiments within high schools and colleges. These include explorations into how to prepare teachers to best serve in a mentoring capacity and successfully encourage college among underrepresented populations. High schools can provide training for teachers on mentoring students and helping them 185 with college preparatory issues while also encouraging opportunities for both teachers and students to become involved with extra-curricular activities and form relationships. 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Print. Table 1- Participant Data P s u e d o n y m 7 a c e High S c h o o l SES Status Y e a r Alicia W h i t e E c o n o m i c a l l y A d v a n t a g e d Senior Claire W h i t e E c o n o m i c a l l y D i s a d v a n t a g e d Junior M a x W h i t e E c o n o m i c a l l y D i s a d v a n t a g e d S o p h o m o r e P e n n y W h i t e E c o n o m i c a l l y A d v a n t a g e d F r e s h m a n Zach Hispanic E c o n o m i c a l l y A d v a n t a g e d Senior H u g h Hispanic E c o n o m i c a l l y D i s a d v a n t a g e d F r e s h m a n G a b b y Hispanic E c o n o m i c a l l y D i s a d v a n t a g e d Junior Ben Hispanic E c o n o m i c a l l y D i s a d v a n t a g e d Junior Tia A f r i c a n - A m e r i c a n E c o n o m i c a l l y A d v a n t a g e d F r e s h m a n Suzie A f r i c a n - A m e r i c a n E c o n o m i c a l l y D i s a d v a n t a g e d Senior Lance A f r i c a n - A m e r i c a n E c o n o m i c a l l y D i s a d v a n t a g e d Junior Cl inton A f r i c a n - A m e r i c a n E c o n o m i c a l l y D i s a d v a n t a g e d Senior Appendix A- Interview Guide Tell m e about y o u r high school experience Classes W h a t classes did y o u enjoy most?[l i fe skills, specific k n o w l e d g e ] W h a t extra-curricular activities w e r e y o u involved in?[academical ly enriching, leadership , o p p o r t u n i t y to excel] T e a c h e r s W e r e there particular t e a c h e r s y o u w e r e close to? [dedicated, invested in future, c o n c e r n e d with welfare] W e r e there certain t e a c h e r s w h o w e r e m o r e helpful? [assist in college appl icat ions , provide r e s o u r c e s for college planning] P e e r s Tell m e about the k ind of p e o p l e y o u h u n g out with in h igh school . [ involvement , aspirat ions , att itudes a b o u t school] W h a t are t h e y doing n o w ? [separation due to different choices] Is that w h a t y o u expected w h e n y o u w e r e in high school? C o n c l u s i o n Is there anything else y o u w o u l d like to tell m e a b o u t y o u r h igh school experience? 187 Scapegoat Theory and the Discursive Representations of Immigration Kenneth Stowe (Faculty Advisor: Donn Parson) Communication Studies ABSTRACT 9ca:;>icult ; c o n o ? i c and :olitical @o;s caus; majority :o:ulations to las= out a