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Background: While natural disasters like hurricanes are increasingly common, their long-term effects on people who inject drugs are not well understood. Although brief in duration, natural disasters can radically transform risk environments, increasing substance use and drug-related harms. Methods: Based on a study of people who inject drugs (PWID) and injection risk behaviors in rural Puerto Rico, the present study uses data from two different phases of the parent study. Data for 110 participants were collected from December 2015 to January 2017, soon before Hurricane Maria landed in September 2017; the 2019 phase, in the aftermath of the hurricane, included a total of 103 participants. The present study’s main analyses used data from 66 PWID who participated in both the pre-Maria and post-Maria interviews (66 individuals measured at two time points, for a total of 132 observations), using mixed-effects binomial logistic regression to examine recent overdose experiences pre- and post-Maria. A separate descriptive analysis included all 103 participants from the 2019 interview. Results: After Hurricane Maria, some declines in injection frequency were observed (the percentage of people reporting injecting monthly or less increased from 3.0% before Hurricane Maria to 22.7% after Hurricane Maria). However, fewer PWID reported using a new needle for most or all injections. In the pre-Maria interview, 10.6% of participants indicated they had experienced an overdose during the year of the interview and/or the calendar year prior, and this figure increased to 24.2% in the post-Maria interview. In the regression analysis, the odds of reporting an overdose during the interview year and/or calendar year prior were three times as high post-Maria, relative to pre- Maria (odds ratio 3.25, 95% confidence interval 1.06–9.97). Conclusion: Substance use patterns, injection risk behaviors, and overdose episodes and deaths differed after Hurricane Maria, relative to before the hurrican

Background: While natural disasters like hurricanes are increasingly common, their long-term effects on people who inject drugs are not well understood. Although brief in duration, natural disasters can radically transform risk environments, increasing substance use and drug-related harms. Methods: Based on a study of people who inject drugs (PWID) and injection risk behaviors in rural Puerto Rico, the present study uses data from two different phases of the parent study. Data for 110 participants were collected from December 2015 to January 2017, soon before Hurricane Maria landed in September 2017; the 2019 phase, in the aftermath of the hurricane, included a total of 103 participants. The present study’s main analyses used data from 66 PWID who participated in both the pre-Maria and post-Maria interviews (66 individuals measured at two time points, for a total of 132 observations), using mixed-effects binomial logistic regression to examine recent overdose experiences pre- and post-Maria. A separate descriptive analysis included all 103 participants from the 2019 interview. Results: After Hurricane Maria, some declines in injection frequency were observed (the percentage of people reporting injecting monthly or less increased from 3.0% before Hurricane Maria to 22.7% after Hurricane Maria). However, fewer PWID reported using a new needle for most or all injections. In the pre-Maria interview, 10.6% of participants indicated they had experienced an overdose during the year of the interview and/or the calendar year prior, and this figure increased to 24.2% in the post-Maria interview. In the regression analysis, the odds of reporting an overdose during the interview year and/or calendar year prior were three times as high post-Maria, relative to pre- Maria (odds ratio 3.25, 95% confidence interval 1.06–9.97). Conclusion: Substance use patterns, injection risk behaviors, and overdose episodes and deaths differed after Hurricane Maria, relative to before the hurrican

We analyze a network of needle-sharing ties among 117 people who inject drugs (PWID) in rural Puerto Rico, using exponential random graph modeling to examine whether network members engage in partner restriction to lower their risk of contracting HIV or hepatitis C (HCV), or in informed altruism to prevent others from contracting these infections. Although sharing of used syringes is a significant risk factor for transmission of these diseases among PWID, we find limited evidence for partner restriction or informed altruism in the network of reported needle-sharing ties. We find however that sharing of needles is strongly reciprocal, and individuals with higher injection frequency are more likely to have injected with a used needle. Drawing on our ethnographic work, we discuss how the network structures we observe may relate to a decision-making rationale focused on avoiding withdrawal sickness, which leads to risk-taking behaviors in this poor, rural context where economic consider- ations often lead PWID to cooperate in the acquisition and use of drugs.

Background: Sharing drug injection equipment has been associated with the transmission of HCV among PWID through blood contained in the cooker and cotton used to prepare and divide up the drug solution. While epidemiologists often subsume this practice under the sharing of “ancillary equipment,” more attention should be paid to the fact that indirect sharing takes place within the process of joint drug acquisition and preparation. Methods: We employed an ethnographic approach observing active PWID (N = 33) in four rural towns in Puerto Rico in order to document drug sharing arrangements involved in “caballo”, as this practice is locally known. We explored partners’ motivation to engage in drug sharing, as well as its social organization, social roles and existing norms. Findings: Findings suggest that drug sharing, is one of the main drivers of the HCV epidemic in this population. Lack of financial resources, drug packaging, drug of choice and the desire to avoid the painful effects of heroin withdrawal motivates participants’ decision to partner with somebody else, sharing injection equipment—and risk—in the process. Roles are not fixed, changing not only according to caballo partners, but also, power dynamics. Conclusion: In order to curb the HCV epidemic, harm reduction policies should recognize the particular sociocultural contexts in which people inject drugs and make decisions about risk. Avoiding sharing of injection equipment within an arrangement between PWID to acquire and use drugs is more complex than assumed by harm reduction interventions. Moving beyond individual risk behaviors, a risk environment approach suggest that poverty, and a strict drug policy that encourage users to carry small amounts of illicit substances, and a lack of HCV treatment among other factors, contribute to HCV transmission.

We analyze a network of needle-sharing ties among 117 people who inject drugs (PWID) in rural Puerto Rico, using exponential random graph modeling to examine whether network members engage in partner restriction to lower their risk of contracting HIV or hepatitis C (HCV), or in informed altruism to prevent others from contracting these infections. Although sharing of used syringes is a significant risk factor for transmission of these diseases among PWID, we find limited evidence for partner restriction or informed altruism in the network of reported needle-sharing ties. We find however that sharing of needles is strongly reciprocal, and individuals with higher injection frequency are more likely to have injected with a used needle. Drawing on our ethnographic work, we discuss how the network structures we observe may relate to a decision-making rationale focused on avoiding withdrawal sickness, which leads to risk-taking behaviors in this poor, rural context where economic considerations often lead PWID to cooperate in the acquisition and use of drugs.

Background: Sharing drug injection equipment has been associated with the transmission of HCV among PWID through blood contained in the cooker and cotton used to prepare and divide up the drug solution. While epidemiologists often subsume this practice under the sharing of “ancillary equipment,” more attention should be paid to the fact that indirect sharing takes place within the process of joint drug acquisition and preparation. Methods: We employed an ethnographic approach observing active PWID (N = 33) in four rural towns in Puerto Rico in order to document drug sharing arrangements involved in “caballo”, as this practice is locally known. We explored partners’ motivation to engage in drug sharing, as well as its social organization, social roles and existing norms. Findings: Findings suggest that drug sharing, is one of the main drivers of the HCV epidemic in this population. Lack of financial resources, drug packaging, drug of choice and the desire to avoid the painful effects of heroin withdrawal motivates participants’ decision to partner with somebody else, sharing injection equipment—and risk—in the process. Roles are not fixed, changing not only according to caballo partners, but also, power dynamics. Conclusion: In order to curb the HCV epidemic, harm reduction policies should recognize the particular sociocultural contexts in which people inject drugs and make decisions about risk. Avoiding sharing of injection equipment within an arrangement between PWID to acquire and use drugs is more complex than assumed by harm reduction interventions. Moving beyond individual risk behaviors, a risk environment approach suggest that poverty, and a strict drug policy that encourage users to carry small amounts of illicit substances, and a lack of HCV treatment among other factors, contribute to HCV transmission.

We analyze a network of needle-sharing ties among 117 people who inject drugs (PWID) in rural Puerto Rico, using exponential random graph modeling to examine whether network members engage in partner restriction to lower their risk of contracting HIV or hepatitis C (HCV), or in informed altruism to prevent others from contracting these infections. Although sharing of used syringes is a significant risk factor for transmission of these diseases among PWID, we find limited evidence for partner restriction or informed altruism in the network of reported needle-sharing ties. We find however that sharing of needles is strongly reciprocal, and individuals with higher injection frequency are more likely to have injected with a used needle. Drawing on our ethnographic work, we discuss how the network structures we observe may relate to a decision-making rationale focused on avoiding withdrawal sickness, which leads to risk-taking behaviors in this poor, rural context where economic considerations often lead PWID to cooperate in the acquisition and use of drugs.

We analyze a network of needle-sharing ties among 117 people who inject drugs (PWID) in rural Puerto Rico, using exponential random graph modeling to examine whether network members engage in partner restriction to lower their risk of contracting HIV or hepatitis C (HCV), or in informed altruism to prevent others from contracting these infections. Although sharing of used syringes is a significant risk factor for transmission of these diseases among PWID, we find limited evidence for partner restriction or informed altruism in the network of reported needle-sharing ties. We find however that sharing of needles is strongly reciprocal, and individuals with higher injection frequency are more likely to have injected with a used needle. Drawing on our ethnographic work, we discuss how the network structures we observe may relate to a decision-making rationale focused on avoiding withdrawal sickness, which leads to risk-taking behaviors in this poor, rural context where economic consider- ations often lead PWID to cooperate in the acquisition and use of drugs.

Background: While PWID of Puerto Rican origin have been migrating to the US for decades, the range of factors influencing their migration to the US and the resources they draw on to do so are not well understood. This is particularly true for rural Puerto Rican PWID, and the present study is the first empirical research to document migration patterns among this population. The specificities of their migration raise important challenges that need to be documented in order to implement more effective harm reduction policies at home (Puerto Rico) and abroad (US). Methods: This paper draws from data obtained employing a modified NHBS survey which was administered to (N =296) PWID in four rural municipalities of Puerto Rico with participants 18 years or older. The primary dependent variables for this paper are the number of times a person has lived in the continental US, and if they are planning on moving to the continental US in the future. Results: Findings suggest that 65% of the sample reported ever lived in the US and that 49% are planning on moving in the future. The number of times living in the US is associated with higher education and older age, but not with self-reported positive HIV or HCV statuses. Planning to move to the US is associated with knowing PWID who have moved or plan to move, negatively associated with age, and is not associated with HIV or HCV status. Around one-third of those that lived in the US reported having some sort of support, with the majority receiving support from family sources. No participant received help to enter HIV/HCV treatment. Conclusions: A multi-region approach to prevention is required to make a dent in curbing HIV/HCV transmission in this population. Understanding PWID migration patterns, risk behaviors, and health care needs in the US is now more important than ever as natural disasters prompted by human-made climate change will only increase in the future, raising demands not only for service providers but also harm red

This study documents how people who inject drugs (PWID) in rural Puerto Rico perceive payments for participating in HIV epidemiological studies. In-depth interviews were conducted among a subset (n = 40) of active PWID older than 18 years of age who had been previously enrolled in a much larger study (N = 360). Findings suggest that financial compensation was the main motivation for initially enrolling in the parent study. Then, as trust in the researchers developed, participants came to perceive compensation as part of a reciprocal exchange in which they assisted researchers by providing a trustful account of their experiences and researchers reciprocated with financial support.

Background: While PWID of Puerto Rican origin have been migrating to the US for decades, the range of factors influencing their migration to the US and the resources they draw on to do so are not well understood. This is particularly true for rural Puerto Rican PWID, and the present study is the first empirical research to document migration patterns among this population. The specificities of their migration raise important challenges that need to be documented in order to implement more effective harm reduction policies at home (Puerto Rico) and abroad (US). Methods: This paper draws from data obtained employing a modified NHBS survey which was administered to (N =296) PWID in four rural municipalities of Puerto Rico with participants 18 years or older. The primary dependent variables for this paper are the number of times a person has lived in the continental US, and if they are planning on moving to the continental US in the future. Results: Findings suggest that 65% of the sample reported ever lived in the US and that 49% are planning on moving in the future. The number of times living in the US is associated with higher education and older age, but not with self-reported positive HIV or HCV statuses. Planning to move to the US is associated with knowing PWID who have moved or plan to move, negatively associated with age, and is not associated with HIV or HCV status. Around one-third of those that lived in the US reported having some sort of support, with the majority receiving support from family sources. No participant received help to enter HIV/HCV treatment. Conclusions: A multi-region approach to prevention is required to make a dent in curbing HIV/HCV transmission in this population. Understanding PWID migration patterns, risk behaviors, and health care needs in the US is now more important than ever as natural disasters prompted by human-made climate change will only increase in the future, raising demands not only for service providers but also harm red

This study documents how people who inject drugs (PWID) in rural Puerto Rico perceive payments for participating in HIV epidemiological studies. In-depth interviews were conducted among a subset (n = 40) of active PWID older than 18 years of age who had been previously enrolled in a much larger study (N = 360). Findings suggest that financial compensation was the main motivation for initially enrolling in the parent study. Then, as trust in the researchers developed, participants came to perceive compensation as part of a reciprocal exchange in which they assisted researchers by providing a trustful account of their experiences and researchers reciprocated with financial support.

Understanding the short- and long-term transmission dynamics of blood-borne illnesses in network contexts represents an important public health priority for people who inject drugs and the general population that surrounds them. The purpose of this article is to compare the risk networks of urban and rural people who inject drugs in Puerto Rico. In the current study, network characteristics are drawn from the sampling “trees” used to recruit participants to the study. We found that injection frequency is the only factor significantly related to clustering behavior among both urban and rural people who inject drugs.

Background—The War on Drugs has raised the incarceration rates of racial minorities for non-violent drug-related crimes, profoundly stigmatized drug users, and redirected resources from drug prevention and treatment to militarizing federal and local law enforcement. Yet, while some states consider shifting their punitive approach to drug use, to one based on drug treatment and rehabilitation, nothing suggests that these policy shifts are being replicated in Puerto Rico. Methods—This paper utilizes data from 360 PWID residing in four rural towns in the mountainous area of central Puerto Rico. We initially recruited 315 PWID using respondent-driven sampling (RDS) and collected data about risk practices and conducted HIV and HCV testing. During a second phase, we conducted 34 micro-ethnographic assays, in which we randomly recruited 34 participants from the first phase and included their ego networks in this phase. Our ethnographic inquiry produced significant data regarding the effects of the war on drugs on the local drug trade, drug availability, and injectors’ social networks. Results—Findings suggest that repressive policing has been ineffective in preventing drug distribution and use among those in our study. This type of law enforcement approach has resulted in the disproportionate incarceration of poor drug users in rural Puerto Rico, and mainly for nonviolent drug-related crimes. In addition, incarceration exposes PWID to a form of a cruel and unusual punishment: having to quit heroin “cold turkey” while the prison environment also represents a HIV/HCV risk. In turn, the war on drugs not only diverts resources from treatment but also shapes treatment ideologies, punishing non-compliant patients. Conclusion—Shifting the emphasis from repression to treatment and rehabilitation is likely to have a positive impact on the health and overall quality of life of PWID and their communities.

Background—People who inject drugs (PWID) in Puerto Rico engage in high levels of injection and sexual risk behavior, and they are at high risk for HIV and hepatitis C (HCV) infection, relative to their US counterparts. Less is known, however, about the clustering of risk behavior conducive to HIV and HCV infection among rural Puerto Rican communities. Objectives—The purpose of this study was to examine concurrent injection and sexual risk subtypes among a rural sample of PWID in Puerto Rico. Methods—Data were drawn from a respondent-driven sample collected in 2015 of 315 PWID in 4 rural communities approximately 30–40 miles from San Juan. Latent class analysis (LCA) was used to examine risk subtypes using 3 injection and 3 sexual risk indicators. In addition, demographic and other PWID characteristics were examined as possible predictors of latent class membership. Results—Four LCA subtypes were identified: low risk (36%), high injection/low sexual risk (22%), low injection/high sexual risk (20%), and high risk (22%). Younger age and past year homelessness predicted high risk latent class membership, relative to the other classes. In addition, daily speedball use predicted membership in the high injection/low sexual risk class, relative to the low risk and low injection/high sexual risk classes. Conclusion/Importance—The findings suggest ways in which PWID risk clusters can be identified for targeted interventions.

Background—The prevalence of hepatitis C (HCV) and HIV among persons who inject drugs (PWID) and the ability of these diseases to spread through injection networks are well documented in urban areas. However, less is known about injection behaviors in rural areas. Objectives—This study focuses on the association between the number of self-reported injection partners with the PWID’s self-reported HCV and HIV status. Injection networks provide paths for infection and information to flow, and are important to consider when developing prevention and intervention strategies. Methods—Respondent driven sampling was used to conduct 315 interviews with PWID in rural Puerto Rico during 2015. Negative binomial regression was used to test for associations between the number of self-reported injection partners and self-reported HCV and HIV statuses. Multinomial logistic regression was used to test for associations with the participant’s self-reported HCV and HIV statuses. Results—Self-reported HCV status is significantly associated with injection risk network size. Injection partner networks of self-reported HCV− respondents are half what is reported by those with a positive or unknown status. Self-reported HIV statuses are not associated with different numbers of injection partners. Conclusions—Smaller injection networks among those who self-reporta HCV− status suggests that those who believe their status to be negative may take protective action by reducing their injection network compared to those have a self-reported HCV+ or an unknown status. Although the cross-sectional design of the study makes it difficult verify, such behavior has implications for prevention programs attempting to prevent HCV transmission.

Background — The establishment of trust between researchers and participants is critical to advance HIV and HCV prevention particularly among people who inject drugs (PWID) and other marginalized populations, yet empirical research on how to establish and maintain trust in the course of community health research is lacking. This paper documents ideas about trust between research participants and researchers amongst a sub-sample of PWID who were enrolled in a large, multi-year community health study of social networks and HIV/HCV risk that was recently conducted in rural Puerto Rico. Methods — Qualitative research was nested within a multi-year Social Network and HIV/HCV Risk study involving N = 360 PWID > 18 years of age living in four small, rural Puerto Rican communities. Semi-structured interviews were conducted between March 2017 and April 2017 with a subset of 40 active PWID who had been enrolled in the parent study. Interview questions invited participants to draw upon their recent experience as research participants to better understand how PWID perceive and understand participant-researcher trust within the context of HIV/HCV-related epidemiological research. Results — Fear of police, stigma and concerns regarding confidentiality and anonymity were identified as structural factors that could compromise participation in HIV/HCV-related research for PWID. While monetary compensation was an important motivation, participants also valued the opportunity to learn about their HIV/HCV status. During their participation in the study, gaining knowledge of safe injection practices was perceived as a valuable benefit. Participant narratives suggested that PWID may adopt an incremental and ongoing approach in their assessment of the trustworthiness of researchers, continuously assessing the extent to which they trust the research staff throughout the course of the research. Trust was initially generated through peer Respondent Driven Sampling recruitment. Research staff

Understanding the short- and long-term transmission dynamics of blood-borne illnesses in network contexts represents an important public health priority for people who inject drugs and the general population that surrounds them. The purpose of this article is to compare the risk networks of urban and rural people who inject drugs in Puerto Rico. In the current study, network characteristics are drawn from the sampling “trees” used to recruit participants to the study. We found that injection frequency is the only factor significantly related to clustering behavior among both urban and rural people who inject drugs.

Background—The War on Drugs has raised the incarceration rates of racial minorities for non-violent drug-related crimes, profoundly stigmatized drug users, and redirected resources from drug prevention and treatment to militarizing federal and local law enforcement. Yet, while some states consider shifting their punitive approach to drug use, to one based on drug treatment and rehabilitation, nothing suggests that these policy shifts are being replicated in Puerto Rico. Methods—This paper utilizes data from 360 PWID residing in four rural towns in the mountainous area of central Puerto Rico. We initially recruited 315 PWID using respondent-driven sampling (RDS) and collected data about risk practices and conducted HIV and HCV testing. During a second phase, we conducted 34 micro-ethnographic assays, in which we randomly recruited 34 participants from the first phase and included their ego networks in this phase. Our ethnographic inquiry produced significant data regarding the effects of the war on drugs on the local drug trade, drug availability, and injectors’ social networks. Results—Findings suggest that repressive policing has been ineffective in preventing drug distribution and use among those in our study. This type of law enforcement approach has resulted in the disproportionate incarceration of poor drug users in rural Puerto Rico, and mainly for nonviolent drug-related crimes. In addition, incarceration exposes PWID to a form of a cruel and unusual punishment: having to quit heroin “cold turkey” while the prison environment also represents a HIV/HCV risk. In turn, the war on drugs not only diverts resources from treatment but also shapes treatment ideologies, punishing non-compliant patients. Conclusion—Shifting the emphasis from repression to treatment and rehabilitation is likely to have a positive impact on the health and overall quality of life of PWID and their communities.

Background—People who inject drugs (PWID) in Puerto Rico engage in high levels of injection and sexual risk behavior, and they are at high risk for HIV and hepatitis C (HCV) infection, relative to their US counterparts. Less is known, however, about the clustering of risk behavior conducive to HIV and HCV infection among rural Puerto Rican communities. Objectives—The purpose of this study was to examine concurrent injection and sexual risk subtypes among a rural sample of PWID in Puerto Rico. Methods—Data were drawn from a respondent-driven sample collected in 2015 of 315 PWID in 4 rural communities approximately 30–40 miles from San Juan. Latent class analysis (LCA) was used to examine risk subtypes using 3 injection and 3 sexual risk indicators. In addition, demographic and other PWID characteristics were examined as possible predictors of latent class membership. Results—Four LCA subtypes were identified: low risk (36%), high injection/low sexual risk (22%), low injection/high sexual risk (20%), and high risk (22%). Younger age and past year homelessness predicted high risk latent class membership, relative to the other classes. In addition, daily speedball use predicted membership in the high injection/low sexual risk class, relative to the low risk and low injection/high sexual risk classes. Conclusion/Importance—The findings suggest ways in which PWID risk clusters can be identified for targeted interventions.

Background — The establishment of trust between researchers and participants is critical to advance HIV and HCV prevention particularly among people who inject drugs (PWID) and other marginalized populations, yet empirical research on how to establish and maintain trust in the course of community health research is lacking. This paper documents ideas about trust between research participants and researchers amongst a sub-sample of PWID who were enrolled in a large, multi-year community health study of social networks and HIV/HCV risk that was recently conducted in rural Puerto Rico. Methods — Qualitative research was nested within a multi-year Social Network and HIV/HCV Risk study involving N = 360 PWID > 18 years of age living in four small, rural Puerto Rican communities. Semi-structured interviews were conducted between March 2017 and April 2017 with a subset of 40 active PWID who had been enrolled in the parent study. Interview questions invited participants to draw upon their recent experience as research participants to better understand how PWID perceive and understand participant-researcher trust within the context of HIV/HCV-related epidemiological research. Results — Fear of police, stigma and concerns regarding confidentiality and anonymity were identified as structural factors that could compromise participation in HIV/HCV-related research for PWID. While monetary compensation was an important motivation, participants also valued the opportunity to learn about their HIV/HCV status. During their participation in the study, gaining knowledge of safe injection practices was perceived as a valuable benefit. Participant narratives suggested that PWID may adopt an incremental and ongoing approach in their assessment of the trustworthiness of researchers, continuously assessing the extent to which they trust the research staff throughout the course of the research. Trust was initially generated through peer Respondent Driven Sampling recruitment. Research staff

Background—The prevalence of hepatitis C (HCV) and HIV among persons who inject drugs (PWID) and the ability of these diseases to spread through injection networks are well documented in urban areas. However, less is known about injection behaviors in rural areas. Objectives—This study focuses on the association between the number of self-reported injection partners with the PWID’s self-reported HCV and HIV status. Injection networks provide paths for infection and information to flow, and are important to consider when developing prevention and intervention strategies. Methods—Respondent driven sampling was used to conduct 315 interviews with PWID in rural Puerto Rico during 2015. Negative binomial regression was used to test for associations between the number of self-reported injection partners and self-reported HCV and HIV statuses. Multinomial logistic regression was used to test for associations with the participant’s self-reported HCV and HIV statuses. Results—Self-reported HCV status is significantly associated with injection risk network size. Injection partner networks of self-reported HCV− respondents are half what is reported by those with a positive or unknown status. Self-reported HIV statuses are not associated with different numbers of injection partners. Conclusions—Smaller injection networks among those who self-reporta HCV− status suggests that those who believe their status to be negative may take protective action by reducing their injection network compared to those have a self-reported HCV+ or an unknown status. Although the cross-sectional design of the study makes it difficult verify, such behavior has implications for prevention programs attempting to prevent HCV transmission.

Introduction—In contrast to urban populations, little is known about polysubstance use among rural people who inject drugs (PWID), particularly in Puerto Rico where injection drug use and related health consequences are prevalent. The aim of the study is to compare injection and non-injection substance use profiles among separate urban and rural samples of Puerto Rican PWID. Material and Methods—Data for the urban sample come from 455 PWID who participated in the CDC's National HIV Behavioral Surveillance survey of injection drug use in San Juan. The data for the rural sample come from 315 PWID residing in four rural cities approximately 40-miles from San Juan. Latent class analysis was used to derive separate urban and rural profiles of weekly injection and non-injection substance use. Injection behaviors were examined as possible correlates of latent class membership. Results—Five latent classes were identified in the urban sample, and three latent classes were identified in the rural sample. Classes were similar across samples; however, key differences emerged. Both samples had classes of primary heroin injectors, primary speedball injectors, and cocaine-heroin injectors. The urban sample had one high polysubstance class. Polysubstance use profiles that shared similar characteristics between samples also shared similar injection patterns, with some variation. Discussion—Variations in substance patterns and associated health risks are likely shaped by social and geographic boundaries. Conclusions—Understanding variations in substance use patterns across rural and urban locales may improve surveillance efforts and tailor desistance and harm reduction efforts at the state and local levels.

Hundreds of thousands of clinical trials are conducted annually around the world, working to further scientific knowledge and expand medical treatment. At the same time, clinical trials also present novel challenges to researchers who have access to large pools of research participants and are routinely approached by pharmaceutical companies seeking to recruit subjects for clinical trials. This case study discusses the ethical dilemmas faced by a community health investigator who received an invitation to enroll people who inject drugs (PWID) into a clinical trial of a drug that promised a new treatment option for Hepatitis C. The author elaborates on the ethical tensions that he confronted between “doing good” and “avoiding harm. The paper suggests that issues of distributive justice should also be considered, particularly when the drugs being tested might eventually command prices that place them out of reach of the population enrolled in the trial. This case does not attempt to provide an ethical road map to assist researchers in similar circumstances, but rather to illustrate some of the considerations involved in making a decision about whether or not to participate in clinical trials research.

Due to the high cost of treatment, preventative measures to limit Hepatitis C (HCV) transmission among people who inject drugs (PWID) are encouraged by many public health officials. A key one of these is serosorting, where PWID select risk partners based on concordant HCV status. Research on the general U.S. population bySmith et al. (2013) found that knowledge of one's own HCV status facilitated serosorting behaviors among PWID, such that respondents with knowledge of their own status were more likely to ask potential partners about their status prior to sharing risk. Our objective was to see if this held true in rural Puerto Rico. We replicate this study using a sample of PWID in rural Puerto Rico to drawcomparisons.Weused respondent driven sampling to survey 315 participants, and have a final analytic sample of 154. The survey was heavily modeled after the National HIV Behavioral Survey, which was the dataset used by the previous researchers. We found that among PWID in rural Puerto Rico, unlike in the general population, knowledge of one's own HCV status had no significant effect on the selection of one's most recent injection partner, based on his/her HCV status. We conclude that PWID in rural Puerto Rico differ fromthe general U.S. population when it comes to serosorting behaviors, and that these differences should be taken into account in future outreaches and intervention strategies.

Background: People who inject drugs (PWID) take on significant risks of contracting blood-borne infection, including injecting with a large number of partners and acquiring needles from unsafe sources. When combined, risk of infection can be magnified. Methods: Using a sample of PWID in rural Puerto Rico, we model the relationship between a subject’s number of injection partners and the likelihood of having used an unsafe source of injection syringes. Data collection with 315 current injectors identified six sources of needles. Results: Of the six possible sources, only acquisition from a seller (paid or free), or using syringes found on the street, was significantly related to number of partners. Conclusions: These results suggest that sources of syringes do serve to multiply risk of infection caused by multipartner injection concurrency. They also suggest that prior research on distinct forms of social capital among PWID may need to be rethought.

One of the most recent innovations in social epidemiology is the combination of epidemiological data collection with ethnographic fieldwork in order to produce algorithmic models that estimate rates of disease prevalence over time. This paper uses a case study about a multi-year study of social networks and risk among people who inject drugs (PWID) in a rural community in the US to document the challenges raised by this form of knowledge production. As the anthropologist in charge of overseeing data collection, I had a privileged position to reflect on the tensions inherent in mixed-methods collaboration in health research. The research design relied on a combination of respondent-driven sampling (N=315) of active injectors with the elaboration of “micro-ethnographic network essays” to map social networks and risk practices. One burden of such mixedmethods collaboration is that highly specialized disciplinary knowledge makes it extremely difficult for all parties to have more than a superficial understanding of each field, which can increase the potential for conflicts and misunderstandings. In addition, mixed-methods projects often have to address the inter-team tensions resulting from the higher prestige and rewards awarded to quantitative modes of reasoning. Based on this case study and following the literature on actor network theory, I argue that successful collaboration in such a multimethods research depends on whether a team member can assume the role of a cultural broker, someone who is knowledgeable in the intricacies of both qualitative and quantitative methods, and thus able to act as a translator. (1-page summary)

Worldwide there are an estimated 130 million people infected with hepatitis C (HCV), 40 million living with HIV, and between 4 and 5 million co-infected with HIV and HCV (Alter, 2006; Perz, Farrington, Pecoraro, Hutin, & Armstrong, 2004; WHO. AIDS epidemic update, 2004). In Western Europe and the United States, co-infection tends to concentrate among people who inject drugs (PWID) mainly driven by blood contained in shared syringes and contaminated injection equipment (Hahn, Page-Schafer, Lum, et al., 2002; Doerrbecker, Behrendt, Matheu-Gelabert et al., 2013). Epidemiological data shows wide discrepancies in HIV/HCV prevalence among PWID across the world (Bao & Li, 2009; Rahimi-Movaghar, Razaghi, Sahim-Izadian, & Amin-Esmaeili, 2010). In Western Europe some studies involving HIV positive individuals with a history of injection drug use documented a HIV/HCV co-infection rate of around 66%,while similar studies conducted on positive HIV patientswho inject drugs enrolled in a large HIV clinical trial showed that between 72%–95% were co-infected with HCV (Denis et al., 1997; Roca et al., 2003; Sherman, Rouster, Chung, & Rajicic, 2002; Sulkowski & Thomas, 2003).

Introduction—In contrast to urban populations, little is known about polysubstance use among rural people who inject drugs (PWID), particularly in Puerto Rico where injection drug use and related health consequences are prevalent. The aim of the study is to compare injection and non-injection substance use profiles among separate urban and rural samples of Puerto Rican PWID. Material and Methods—Data for the urban sample come from 455 PWID who participated in the CDC's National HIV Behavioral Surveillance survey of injection drug use in San Juan. The data for the rural sample come from 315 PWID residing in four rural cities approximately 40-miles from San Juan. Latent class analysis was used to derive separate urban and rural profiles of weekly injection and non-injection substance use. Injection behaviors were examined as possible correlates of latent class membership. Results—Five latent classes were identified in the urban sample, and three latent classes were identified in the rural sample. Classes were similar across samples; however, key differences emerged. Both samples had classes of primary heroin injectors, primary speedball injectors, and cocaine-heroin injectors. The urban sample had one high polysubstance class. Polysubstance use profiles that shared similar characteristics between samples also shared similar injection patterns, with some variation. Discussion—Variations in substance patterns and associated health risks are likely shaped by social and geographic boundaries. Conclusions—Understanding variations in substance use patterns across rural and urban locales may improve surveillance efforts and tailor desistance and harm reduction efforts at the state and local levels.

Worldwide there are an estimated 130 million people infected with hepatitis C (HCV), 40 million living with HIV, and between 4 and 5 million co-infected with HIV and HCV (Alter, 2006; Perz, Farrington, Pecoraro, Hutin, & Armstrong, 2004; WHO. AIDS epidemic update, 2004). In Western Europe and the United States, co-infection tends to concentrate among people who inject drugs (PWID) mainly driven by blood contained in shared syringes and contaminated injection equipment (Hahn, Page-Schafer, Lum, et al., 2002; Doerrbecker, Behrendt, Matheu-Gelabert et al., 2013). Epidemiological data shows wide discrepancies in HIV/HCV prevalence among PWID across the world (Bao & Li, 2009; Rahimi-Movaghar, Razaghi, Sahim-Izadian, & Amin-Esmaeili, 2010). In Western Europe some studies involving HIV positive individuals with a history of injection drug use documented a HIV/HCV co-infection rate of around 66%,while similar studies conducted on positive HIV patientswho inject drugs enrolled in a large HIV clinical trial showed that between 72%–95% were co-infected with HCV (Denis et al., 1997; Roca et al., 2003; Sherman, Rouster, Chung, & Rajicic, 2002; Sulkowski & Thomas, 2003).

Due to the high cost of treatment, preventative measures to limit Hepatitis C (HCV) transmission among people who inject drugs (PWID) are encouraged by many public health officials. A key one of these is serosorting, where PWID select risk partners based on concordant HCV status. Research on the general U.S. population bySmith et al. (2013) found that knowledge of one's own HCV status facilitated serosorting behaviors among PWID, such that respondents with knowledge of their own status were more likely to ask potential partners about their status prior to sharing risk. Our objective was to see if this held true in rural Puerto Rico. We replicate this study using a sample of PWID in rural Puerto Rico to drawcomparisons.Weused respondent driven sampling to survey 315 participants, and have a final analytic sample of 154. The survey was heavily modeled after the National HIV Behavioral Survey, which was the dataset used by the previous researchers. We found that among PWID in rural Puerto Rico, unlike in the general population, knowledge of one's own HCV status had no significant effect on the selection of one's most recent injection partner, based on his/her HCV status. We conclude that PWID in rural Puerto Rico differ fromthe general U.S. population when it comes to serosorting behaviors, and that these differences should be taken into account in future outreaches and intervention strategies.

One of the most recent innovations in social epidemiology is the combination of epidemiological data collection with ethnographic fieldwork in order to produce algorithmic models that estimate rates of disease prevalence over time. This paper uses a case study about a multi-year study of social networks and risk among people who inject drugs (PWID) in a rural community in the US to document the challenges raised by this form of knowledge production. As the anthropologist in charge of overseeing data collection, I had a privileged position to reflect on the tensions inherent in mixed-methods collaboration in health research. The research design relied on a combination of respondent-driven sampling (N=315) of active injectors with the elaboration of “micro-ethnographic network essays” to map social networks and risk practices. One burden of such mixedmethods collaboration is that highly specialized disciplinary knowledge makes it extremely difficult for all parties to have more than a superficial understanding of each field, which can increase the potential for conflicts and misunderstandings. In addition, mixed-methods projects often have to address the inter-team tensions resulting from the higher prestige and rewards awarded to quantitative modes of reasoning. Based on this case study and following the literature on actor network theory, I argue that successful collaboration in such a multimethods research depends on whether a team member can assume the role of a cultural broker, someone who is knowledgeable in the intricacies of both qualitative and quantitative methods, and thus able to act as a translator. (1-page summary)

Hundreds of thousands of clinical trials are conducted annually around the world, working to further scientific knowledge and expand medical treatment. At the same time, clinical trials also present novel challenges to researchers who have access to large pools of research participants and are routinely approached by pharmaceutical companies seeking to recruit subjects for clinical trials. This case study discusses the ethical dilemmas faced by a community health investigator who received an invitation to enroll people who inject drugs (PWID) into a clinical trial of a drug that promised a new treatment option for Hepatitis C. The author elaborates on the ethical tensions that he confronted between “doing good” and “avoiding harm. The paper suggests that issues of distributive justice should also be considered, particularly when the drugs being tested might eventually command prices that place them out of reach of the population enrolled in the trial. This case does not attempt to provide an ethical road map to assist researchers in similar circumstances, but rather to illustrate some of the considerations involved in making a decision about whether or not to participate in clinical trials research.

Background: People who inject drugs (PWID) take on significant risks of contracting blood-borne infection, including injecting with a large number of partners and acquiring needles from unsafe sources. When combined, risk of infection can be magnified. Methods: Using a sample of PWID in rural Puerto Rico, we model the relationship between a subject’s number of injection partners and the likelihood of having used an unsafe source of injection syringes. Data collection with 315 current injectors identified six sources of needles. Results: Of the six possible sources, only acquisition from a seller (paid or free), or using syringes found on the street, was significantly related to number of partners. Conclusions: These results suggest that sources of syringes do serve to multiply risk of infection caused by multipartner injection concurrency. They also suggest that prior research on distinct forms of social capital among PWID may need to be rethought.

Background: Blood contained in needles and injection equipment has been identified as a vector for HIV and HCV transmission among people who inject drugs (PWID). Yet, there is often a wide discrepancy in prevalence for both viruses. While microbiological differences between viruses influence prevalence, other variables associated with the way drugs are acquired and used, also play a role. Methods: Respondent-driven sampling (RDS) methods recruited a sample of 315 current intravenous drug users in rural Puerto Rico. Information about type and frequency of use, HIV and HVC risk behaviors (sharing needles, cookers, cotton, and water), sexual behaviors, and alcohol use was collected. HIV and HCV statuses were assessed via rapid antibody tests. T tests compare means of participants who tested positive (reactive) to those who tested negative. Logistic regression analyses were used to validate the association of the risk factors involved. Results: Tests showed a significant difference in HIV (6 %) and HCV (78.4 %) prevalence among a population of current PWID. The main risk behaviors in HCV transmission are the sharing of injection “works”, (e.g., cookers, cotton, and water). Sharing works occurred more than twice as often as the sharing of needles, and HCV+ and HCV− individuals reported the same needle sharing habits. Conclusions: Washing and rinsing injection works with water seems to prevent HIV transmission, but it is unable to prevent HCV infection. While education about the need to clean injection equipment with bleach might be beneficial, equipment sharing—and the subsequent risk of HVC—might be unavoidable in a context where participants are forced to pool resources to acquire and use intravenous drugs.

Background: Blood contained in needles and injection equipment has been identified as a vector for HIV and HCV transmission among people who inject drugs (PWID). Yet, there is often a wide discrepancy in prevalence for both viruses. While microbiological differences between viruses influence prevalence, other variables associated with the way drugs are acquired and used, also play a role. Methods: Respondent-driven sampling (RDS) methods recruited a sample of 315 current intravenous drug users in rural Puerto Rico. Information about type and frequency of use, HIV and HVC risk behaviors (sharing needles, cookers, cotton, and water), sexual behaviors, and alcohol use was collected. HIV and HCV statuses were assessed via rapid antibody tests. T tests compare means of participants who tested positive (reactive) to those who tested negative. Logistic regression analyses were used to validate the association of the risk factors involved. Results: Tests showed a significant difference in HIV (6 %) and HCV (78.4 %) prevalence among a population of current PWID. The main risk behaviors in HCV transmission are the sharing of injection “works”, (e.g., cookers, cotton, and water). Sharing works occurred more than twice as often as the sharing of needles, and HCV+ and HCV− individuals reported the same needle sharing habits. Conclusions: Washing and rinsing injection works with water seems to prevent HIV transmission, but it is unable to prevent HCV infection. While education about the need to clean injection equipment with bleach might be beneficial, equipment sharing—and the subsequent risk of HVC—might be unavoidable in a context where participants are forced to pool resources to acquire and use intravenous drugs.

This paper explores Native American perceptions on DNA biobanking. A qualitative study was conducted among self-declared Native Americans living off reservation in two Midwest cities. Findings demonstrate a paradox: Informants maintain strong hopes for the transformative power of gene-based research while voicing very particular social anxieties. Emerging genomic technologies elicit concerns over the potential for genetic stigmatization or discrimination based on race, preventing access to health insurance or employment. Frequently, social anxieties adopt the narrative form of conspiracy theories which portray powerful agents exploiting or abusing a disenfranchised population. We argue that while Native Americans do not have a monopoly on the production of conspiracy narratives, their anxieties originate in a unique set of historical and social circumstances that position genetics research as part of a much larger political narrative. We conclude by suggesting that tribal approaches to biomedical research and in particular the use of biobanks that use concepts such as ‘‘DNA on loan’’ and emphasize trust building, collaboration and benefit sharing present a good model to deal with some of the anxieties elicited in this research but could also be taken as a model for biobank governance in general.

The pharmaceutical industry is—along with the financial and weapons industries—one of the most globalized and profitable business domains. But they wouldn’t make any profits if they weren’t able to recruit research subjects to test an increasing number of drugs. This global trial economy creates its own assemblages of clinical trials, often run by hired contract research organizations (CROs), who fight among each other in a rat-race competition, promising quick and effective trials; at the same time, enterprising countries, hospitals, and doctors jump on the drug trial economy bandwagon by promising quick, endless access to a large pool of research subjects, with little or no ethical oversight. This is the world that Edison Bicudo has examined in Pharmaceutical Research, Democracy and Conspiracy. Based on dozens of interviews with pharmaceutical company representatives, CRO managers, clinical trial recruiters, physicians conducting trials, as well as staff and administrators for drug trial sites, the book aims to explore “the new relationships between global and local actors” (p. 6). Fieldwork was conducted in five countries: the UK, Spain, France, Brazil, and South Africa. The first three are home to the largest number of pharmaceutical companies, or “sponsors,” and their CROs, while the last two accommodate the largest number of hired physicians and patients/subjects. The focus of the study is on the “initial stages, in which studies are yet not running, investigators not yet dealing with clinical matters and research with subjects not yet undergoing the study procedures” (p. 7). Bicudo justifies this choice with the reasoning that it allows him “to surprise the trials industry forging the social chains with which clinical trials are made not only scientifically and legally feasible but also socially and culturally possible” (p. 7). One potential pitfall of this choice is that we never learn about subjects’ experiences as research subjects. Bicudo draws attention

We commend the important work of Deren et al. that underscores the high rates of HIV among Puerto Rican people who inject drugs (PRPWID) and highlights the health, social, and service disparities between Puerto Rico and the Northeast US region. As articulated in their article, HIV/AIDS risk and substance use are not individual problems with individual consequences—the epidemic impacts community and culture, across borders and boundaries. In addition to service disparities, various socioeconomic contextual factors are associated with and may exacerbate the spread of HIV/AIDS in PRPWID, including limited educational and employment opportunities, poverty, and political disenfranchisement. Efforts to reduce the incidence of HIV/AIDS and associated health risks and complications, including other infections, drug overdose, and social stigma, necessitate structural policy intervention in addition to programmatic improvements. Moreover, policy implementation that attends to contextual factors such as incarceration and impediments to culturally appropriate services is needed. We identify two contexts that represent opportunities for improvements in policy implementation that may curb the HIV/AIDS epidemic among PRPWID.

We commend the important work of Deren et al. that underscores the high rates of HIV among Puerto Rican people who inject drugs (PRPWID) and highlights the health, social, and service disparities between Puerto Rico and the Northeast US region. As articulated in their article, HIV/AIDS risk and substance use are not individual problems with individual consequences—the epidemic impacts community and culture, across borders and boundaries. In addition to service disparities, various socioeconomic contextual factors are associated with and may exacerbate the spread of HIV/AIDS in PRPWID, including limited educational and employment opportunities, poverty, and political disenfranchisement. Efforts to reduce the incidence of HIV/AIDS and associated health risks and complications, including other infections, drug overdose, and social stigma, necessitate structural policy intervention in addition to programmatic improvements. Moreover, policy implementation that attends to contextual factors such as incarceration and impediments to culturally appropriate services is needed. We identify two contexts that represent opportunities for improvements in policy implementation that may curb the HIV/AIDS epidemic among PRPWID.

The pharmaceutical industry is—along with the financial and weapons industries—one of the most globalized and profitable business domains. But they wouldn’t make any profits if they weren’t able to recruit research subjects to test an increasing number of drugs. This global trial economy creates its own assemblages of clinical trials, often run by hired contract research organizations (CROs), who fight among each other in a rat-race competition, promising quick and effective trials; at the same time, enterprising countries, hospitals, and doctors jump on the drug trial economy bandwagon by promising quick, endless access to a large pool of research subjects, with little or no ethical oversight. This is the world that Edison Bicudo has examined in Pharmaceutical Research, Democracy and Conspiracy. Based on dozens of interviews with pharmaceutical company representatives, CRO managers, clinical trial recruiters, physicians conducting trials, as well as staff and administrators for drug trial sites, the book aims to explore “the new relationships between global and local actors” (p. 6). Fieldwork was conducted in five countries: the UK, Spain, France, Brazil, and South Africa. The first three are home to the largest number of pharmaceutical companies, or “sponsors,” and their CROs, while the last two accommodate the largest number of hired physicians and patients/subjects. The focus of the study is on the “initial stages, in which studies are yet not running, investigators not yet dealing with clinical matters and research with subjects not yet undergoing the study procedures” (p. 7). Bicudo justifies this choice with the reasoning that it allows him “to surprise the trials industry forging the social chains with which clinical trials are made not only scientifically and legally feasible but also socially and culturally possible” (p. 7). One potential pitfall of this choice is that we never learn about subjects’ experiences as research subjects. Bicudo draws attention

This paper explores Native American perceptions on DNA biobanking. A qualitative study was conducted among self-declared Native Americans living off reservation in two Midwest cities. Findings demonstrate a paradox: Informants maintain strong hopes for the transformative power of gene-based research while voicing very particular social anxieties. Emerging genomic technologies elicit concerns over the potential for genetic stigmatization or discrimination based on race, preventing access to health insurance or employment. Frequently, social anxieties adopt the narrative form of conspiracy theories which portray powerful agents exploiting or abusing a disenfranchised population. We argue that while Native Americans do not have a monopoly on the production of conspiracy narratives, their anxieties originate in a unique set of historical and social circumstances that position genetics research as part of a much larger political narrative. We conclude by suggesting that tribal approaches to biomedical research and in particular the use of biobanks that use concepts such as ‘‘DNA on loan’’ and emphasize trust building, collaboration and benefit sharing present a good model to deal with some of the anxieties elicited in this research but could also be taken as a model for biobank governance in general.

A growing number of clinical trials incorporate invasive procedures like nondiagnostic tumor biopsies for biomarker or pharmacodynamic analysis.1 Such invasive research procedures are ethically contentious. Tumor biopsies involve pain and complication risk,2 and at least one procedure-related death has been reported.3 However, nondiagnostic tumor biopsies obtained in the research context generally have no value for managing the participant’s medical condition. Some commentators therefore argue that research biopsies “take” from participants without “giving in return.”4 Because such procedures are conducted contrary to research participants’ medical interests, an ethical framework for enrolling patients in studies that include a research biopsy rides heavily on informed consent. In particular, study participants should understand that research biopsies are nontherapeutic and burdensome and that participation is discretionary in studies involving them. Yet little is known about whether decisions to enroll in a study that involves a research biopsy, including those that permit participants to opt out of the procedure, meet thresholds of consent validity, in other words, whether individuals sufficiently understand and appreciate the consequences of their decision and whether they are not unduly influenced.5 Some studies about research biopsies suggest that individuals often misconstrue nondiagnostic biopsies as therapeutic; 6 others suggest the contrary.7 Interpreting these findings is further complicated by the fact that because participants were often enrolled in clinical drug trials, they might have legitimately imputed therapeutic value to research biopsies when receiving access to investigational drugs was conditioned on providing a biopsy for research.8 There are at least three reasons that clinical trials that include research biopsies might present challenges for consent validity. First, because procedures are burdensome, individuals who enroll in these trials m

A growing number of clinical trials incorporate invasive procedures like nondiagnostic tumor biopsies for biomarker or pharmacodynamic analysis.1 Such invasive research procedures are ethically contentious. Tumor biopsies involve pain and complication risk,2 and at least one procedure-related death has been reported.3 However, nondiagnostic tumor biopsies obtained in the research context generally have no value for managing the participant’s medical condition. Some commentators therefore argue that research biopsies “take” from participants without “giving in return.”4 Because such procedures are conducted contrary to research participants’ medical interests, an ethical framework for enrolling patients in studies that include a research biopsy rides heavily on informed consent. In particular, study participants should understand that research biopsies are nontherapeutic and burdensome and that participation is discretionary in studies involving them. Yet little is known about whether decisions to enroll in a study that involves a research biopsy, including those that permit participants to opt out of the procedure, meet thresholds of consent validity, in other words, whether individuals sufficiently understand and appreciate the consequences of their decision and whether they are not unduly influenced.5 Some studies about research biopsies suggest that individuals often misconstrue nondiagnostic biopsies as therapeutic; 6 others suggest the contrary.7 Interpreting these findings is further complicated by the fact that because participants were often enrolled in clinical drug trials, they might have legitimately imputed therapeutic value to research biopsies when receiving access to investigational drugs was conditioned on providing a biopsy for research.8 There are at least three reasons that clinical trials that include research biopsies might present challenges for consent validity. First, because procedures are burdensome, individuals who enroll in these trials m

On June 16, 2001, the national press first reported the death of Ellen Roche, a healthy 24-year-old who volunteered for an asthma study at Johns Hopkins University. The story revealed that a few days into the trial she felt very sick, was discharged, and sent home. Within some hours she checked into the emergency room at a local hospital and fell into a coma. Ellen remained in this state until her death a month later. She had received $375 for participating in seven to nine sessions as an outpatient in the clinical drug study that resulted in her death. This tragedy exposed real gaps in our understanding of human subjects in medical research. Although bioethicists have focused on the ethics of paying subjects to test drug safety, less attention has been paid to who the healthy paid subjects are, what motivates them, how they make decisions about joining a trial, or the effects money has in the way they perceive and deal with risk. The pharmaceutical industry is one of the most globalized and profitable businesses in the United States. Anthropologists have been exploring—particularly in this last decade—different aspects of the industry, from the influence of drug reps on medical prescription practices, to the globalization of clinical trials. Yet the participation of healthy paid subjects selling their bodies in the first phase of drug development has remained all but invisible. The lack of control and oversight of Phase I Trials and in subsequent phases of drug development might not only endanger professional research subjects and trial participants, but might also compromise the public health and well-being of us all.

Recent technological advances in biomedicine have introduced new therapeutic possibilities but have also contributed to the emergence of a global market for human bodies and body parts. For example, artificial modes of human reproduction created a market for eggs, semen, and surrogate wombs. In addition, organ transfer generated a demand for kidneys and half livers. The whole body has become a valuable commodity as professional research subjects venture into the economy of Phase I Clinical Trials, testing drug safety for pharmaceutical companies. In the process, the trade has become a deeply unequal one in which poor, vulnerable, and easily exploited women and men, in the United States and, increasingly, in the global south, exchange their bodies for cash. Yet, these economic transactions are often obscured by buyers—either individuals or corporations— frequently using the language of donation, voluntarism, and “gift” giving. This unjust and exploitative trade is one that anthropologists have documented and denounced since its inception in the 1990s. Few were more forceful in understanding the forces behind body commodification and in opposing the most abusive aspects of this trade than anthropologist Nancy Scheper-Hughes. As an author, Scheper-Hughes has documented the ideologies, institutions, and social networks behind organ trafficking, one of the most egregious examples of bodily commerce. More than a decade of dedicated ethnographic research has allowed Scheper-Hughes to follow these transactions, leading her to Israel, Turkey, Brazil, South Africa, Western Europe, and the United States, among other sites. In Malinowskian fashion, she has uncovered the circulation of organs and other body parts: “In general, the flow of organs, tissues, and body parts follows the modern routes of capital: from South to North, from third to first world, from poor to rich, from black and brown to white, and from female to male bodies,” she writes (Scheper-Hughes 2001). According

On June 16, 2001, the national press first reported the death of Ellen Roche, a healthy 24-year-old who volunteered for an asthma study at Johns Hopkins University. The story revealed that a few days into the trial she felt very sick, was discharged, and sent home. Within some hours she checked into the emergency room at a local hospital and fell into a coma. Ellen remained in this state until her death a month later. She had received $375 for participating in seven to nine sessions as an outpatient in the clinical drug study that resulted in her death. This tragedy exposed real gaps in our understanding of human subjects in medical research. Although bioethicists have focused on the ethics of paying subjects to test drug safety, less attention has been paid to who the healthy paid subjects are, what motivates them, how they make decisions about joining a trial, or the effects money has in the way they perceive and deal with risk. The pharmaceutical industry is one of the most globalized and profitable businesses in the United States. Anthropologists have been exploring—particularly in this last decade—different aspects of the industry, from the influence of drug reps on medical prescription practices, to the globalization of clinical trials. Yet the participation of healthy paid subjects selling their bodies in the first phase of drug development has remained all but invisible. The lack of control and oversight of Phase I Trials and in subsequent phases of drug development might not only endanger professional research subjects and trial participants, but might also compromise the public health and well-being of us all.

Recent technological advances in biomedicine have introduced new therapeutic possibilities but have also contributed to the emergence of a global market for human bodies and body parts. For example, artificial modes of human reproduction created a market for eggs, semen, and surrogate wombs. In addition, organ transfer generated a demand for kidneys and half livers. The whole body has become a valuable commodity as professional research subjects venture into the economy of Phase I Clinical Trials, testing drug safety for pharmaceutical companies. In the process, the trade has become a deeply unequal one in which poor, vulnerable, and easily exploited women and men, in the United States and, increasingly, in the global south, exchange their bodies for cash. Yet, these economic transactions are often obscured by buyers—either individuals or corporations— frequently using the language of donation, voluntarism, and “gift” giving. This unjust and exploitative trade is one that anthropologists have documented and denounced since its inception in the 1990s. Few were more forceful in understanding the forces behind body commodification and in opposing the most abusive aspects of this trade than anthropologist Nancy Scheper-Hughes. As an author, Scheper-Hughes has documented the ideologies, institutions, and social networks behind organ trafficking, one of the most egregious examples of bodily commerce. More than a decade of dedicated ethnographic research has allowed Scheper-Hughes to follow these transactions, leading her to Israel, Turkey, Brazil, South Africa, Western Europe, and the United States, among other sites. In Malinowskian fashion, she has uncovered the circulation of organs and other body parts: “In general, the flow of organs, tissues, and body parts follows the modern routes of capital: from South to North, from third to first world, from poor to rich, from black and brown to white, and from female to male bodies,” she writes (Scheper-Hughes 2001). According