Negotiating Pharmaceutical Uncertainty
135 pages
English

Vous pourrez modifier la taille du texte de cet ouvrage

Découvre YouScribe en t'inscrivant gratuitement

Je m'inscris

Negotiating Pharmaceutical Uncertainty , livre ebook

Découvre YouScribe en t'inscrivant gratuitement

Je m'inscris
Obtenez un accès à la bibliothèque pour le consulter en ligne
En savoir plus
135 pages
English

Vous pourrez modifier la taille du texte de cet ouvrage

Obtenez un accès à la bibliothèque pour le consulter en ligne
En savoir plus

Description

Telling the story of a clinical trial testing an innovative gel designed to prevent women from contracting HIV, Negotiating Pharmaceutical Uncertainty provides new insight into the complex and contradictory relationship between medical researchers and their subjects. Although clinical trials attempt to control and monitor participants' bodies, Saethre and Stadler argue that the inherent uncertainty of medical testing can create unanticipated opportunities for women to exercise control over their health, sexuality, and social relationships. Combining a critical analysis of the social production of biomedical knowledge and technologies with a detailed ethnography of the lives of female South African trial participants, this book brings to light issues of economic exclusion, racial disparity, and spiritual insecurity in Johannesburg's townships. Built on a series of tales ranging from strategy sessions at the National Institutes of Health to witchcraft accusations against the trial, Negotiating Pharmaceutical Uncertainty illuminates the everyday social lives of clinical trials.

As embedded anthropologists, Saethre and Stadler provide a unique and nuanced perspective of the reality of a clinical trial that is often hidden from view.

Sujets

Informations

Publié par
Date de parution 25 avril 2017
Nombre de lectures 0
EAN13 9780826521415
Langue English
Poids de l'ouvrage 1 Mo

Informations légales : prix de location à la page 0,1000€. Cette information est donnée uniquement à titre indicatif conformément à la législation en vigueur.

Extrait

NEGOTIATING PHARMACEUTICAL UNCERTAINTY

NEGOTIATING PHARMACEUTICAL UNCERTAINTY
Women’s Agency in a South African HIV Prevention Trial
Eirik Saethre and Jonathan Stadler
Vanderbilt University Press
Nashville
© 2017 by Vanderbilt University Press
Nashville, Tennessee 37235
All rights reserved
First printing 2017
This book is printed on acid-free paper.
Manufactured in the United States of America
Library of Congress Cataloging-in-Publication Data on file
LC control number 2016015311
LC classification number HQ29 S25 2017
Dewey class number 306.70820968—dc23
LC record available at lccn.loc.gov/2016015311
ISBN 978-0-8265-2139-2 (hardcover)
ISBN 978-0-8265-2140-8 (paperback)
ISBN 978-0-8265-2141-5 (ebook)
Contents
Acknowledgments
Introduction
Part 1
1: Infested Natives and Empowering Biotechnologies
2: Testing Hope
Part 2
3: Recruiting Meaning
4: Libidinous Sociality
5: Experiencing Efficacy
6: The Biotechnical Salvation of a Failed Pharmaceutical
Conclusion
Appendix
Notes
References
Index
Acknowledgments
Foremost, we would like to thank the participants in the MDP301 trial, as well as the men and women of Soweto and Orange Farm. These people graciously and openly shared their outlooks, experiences, and aspirations with us. Without them, this book would not have been possible.
We must also acknowledge the contributions of the hundreds of people—clinicians, administrators, managers, nurses, and assistants—who worked tirelessly on the MDP301. We are especially grateful to our colleagues in Johannesburg at the Wits Reproductive Health and HIV Institute (WRHI), including Helen Rees, Sinead Delany-Moretlwe, Sibongile Walaza, Jocelyn Moyes, and Thesla Palanee-Phillips. At the MDP301 in London, Sheena McCormack, Charles Lacey, Robert Pool, and Catherine Montgomery supported our work, as did our social science colleagues from other MDP301 trial sites: Oliver Mweemba, Agnes Ssali, Mitzy Gafos, Shelley Lees, Andrew Vallely, Gita Ramjee, and Neetha Morar. We would also like to recognize the assistance of Johannesburg site staff and thank those with whom we worked closely on the social science research component: Mdu Mntambo, Sello Seoka, Florence Mathebula, Edmond Mudau, Thembakazi Mantshule, Elisa Shikwane, Neo Mohajane, and Zelda Masango.
Throughout the conceptualization and writing of this book, we have benefited enormously from the insights of and feedback from Isak Niehaus, John Sharp, Fraser McNeill, Jimmy Pieterse, Mary Crew, Robert Thornton, David Copland, and Catherine Burns.
Through the MDP301, our work has received significant financial support from the United Kingdom’s Department for International Development (DFID) and the Medical Research Council. Additional funding was supplied by the International Partnership for Microbicides, the European and Developing Countries Clinical Trials Partnership, and the Wellcome Trust. Eirik Saethre’s research activities were additionally funded through a postdoctoral fellowship at the University of Pretoria. His travel to South Africa was financed through the generous support of the WRHI. Jonathan Stadler’s work was additionally sponsored by UK Aid from the DFID through the STRIVE Research Programme Consortium.
Introduction
As pharmaceuticals have come to revolutionize the treatment of diseases such as HIV, cancer, hypertension, and depression, drugs are being developed, tested, licensed, marketed, and consumed at an ever-increasing rate. Each year, scientists and doctors celebrate as new medicines emerge from clinical testing. However, for every pharmaceutical that is proven to work, many more are found to be ineffective. This is the story of an unsuccessful HIV prevention drug, the international clinical trial that tested it, and the thousands of African women who participated in the trial. Much more than a series of physical exams and statistical calculations, medical research powerfully reconfigures the lives of those involved, changing attitudes, expectations, and aspirations. While ostensibly a tale of pharmaceutical failure, this is also a tale of hope, biomedical ambiguity, and female agency.
From 2005 to 2009, the Microbicides Development Programme 301 (MDP301) was a large international clinical trial designed to test the efficacy of a new microbicide, PRO 2000/5. An innovative biotechnology, microbicides function by disabling viruses or preventing their entry into host cells. It is hoped that microbicides—suspended in gels, films, creams, or rings that are used vaginally—will one day provide a way of arresting HIV transmission without the use of condoms. Optimistic that PRO 2000/5 would be the first efficacious microbicide, the MDP301 enrolled 9,389 women at 6 sites: Zambia, Uganda, Tanzania, and 3 locations in South Africa. Although the trial was conducted solely within Africa, PRO 2000/5 was manufactured by a pharmaceutical company in the United States, while trial funding came from the British Medical Research Council. In 2009, after four years of testing, the trial reported that PRO 2000/5 was not harmful, but neither did it prevent HIV infection (McCormack et al. 2010). In short, PRO 2000/5 didn’t work.
While the results might appear to be simple, the reactions to them and the trial itself were decidedly complex. Microbicide advocates and researchers were careful to note that the trial was not a failure, because it had objectively proved that the gel was harmless but also ineffective against HIV. As some trialists focused on the science of the MDP301, others evaluated its financial and social outcomes, saying that it had increased infrastructural and research resources in Africa as well as positively impacting trial participants. Although PRO 2000/5 did not prevent the spread of HIV, advocates stressed that the MDP301 had demonstrated that microbicides could improve the lives of African women. Sheena McCormack, the chair of the MDP301, declared that microbicide researchers had the “method right,” recommending a redoubling of efforts to find an effective product (Citizen News Service 2009). Rather than being categorized as a total failure, the MDP301 was often portrayed as a qualified success.
Meanwhile, southern African government officials, journalists, and citizens had long questioned the ethics and outcomes of the clinical trials conducted on their continent. A few years prior to the MDP301, microbicide trials testing nonoxynol-9 and cellulose sulphate had put participants at higher risk for contracting HIV. Although PRO 2000/5 was found to be harmless, 123 participants on the placebo and 130 participants on the 0.5 percent arm did contract HIV while enrolled in the trial. Edwin Mapara, a London-based Zimbabwean medical doctor, responded to the results with strong words:
This is simply sanctioned murder (Grievous Bodily Harm) FROM THE WEST, in the name of scientific research, by the Medical Research Council and DFID [Department for International Development] at a cost of £40 million to infect ONLY one hundred and twenty-three (123) simple, cheap, black, AFRICAN women’s lives in Uganda, Tanzania, South Africa and Zambia. The lead researcher says, “IT IS DISHEARTENING!” No it is MURDER! (quoted in Tatoud 2012; emphasis in original)
For Mapara and others who shared his view, the MDP301 was not merely a failure, but an orchestrated exercise in infecting Africans with HIV. Equated with colonial exploitation, clinical trials like the MDP301 are increasingly seen as sinister, anti-African enterprises controlled by foreigners.
Although Mapara and McCormack differ on the outcome of the MDP301, they do agree that its participants were impoverished, vulnerable African women, whom they portray as the victims of more powerful agents. Whether the MDP301 is viewed as a foreign exploitative enterprise or one designed to empower African women, its participants are cast as passive and unable to resist either the coercion of the trial or the agency of men. While critics of clinical trials underscore the helplessness of women, the voices of participants are conspicuously absent in these accounts, as they are in the trials themselves. Because trials strive to eliminate social bias through randomization, double-blinding, and careful physiological assessments, trial researchers consider the perceptions of participants largely irrelevant. But as anthropologists who have spent many years working in and around clinical trials, we believe that the experiences and beliefs of trial participants are critical. Examining relationships that are often overlooked, we seek to reframe scientific endeavors as social endeavors. By foregrounding the perspectives of women who enrolled in the MDP301 and shifting the focus from idealized models and homogenizing statistics to the complexities of participants’ lives, we illustrate the profound impact that international medical research can have on the communities in which it is conducted.
Boikanyo was one of the many women whose lives were impacted by the MDP301. She was 22 years old at the time of her enrollment and lived in an informal settlement next to Soweto’s Chris Hani Baragwanath Hospital. Although they are only a short drive from the wealthy malls of northern Johannesburg, townships like Soweto are characterized by high rates of poverty, unemployment, and crime. Like the overwhelming majority of MDP301 participants, Boikanyo was often unemployed and unable to support herself. She lived in a two-room shack with her mother and brother. Boikanyo had been in a relationship for about a year and commented that her boyfriend was “sweet” and never yelled at her or beat her, as boyfriends often did. Nevertheless, she felt vulnerable. Having already contracted genital herpes, Boikanyo worried that she would soon become infected with HIV. Although a few of her neighbors told her that the MDP301 would give her AIDS, Boikanyo discounted these rumors and joined the trial in part to gain access to reg

  • Univers Univers
  • Ebooks Ebooks
  • Livres audio Livres audio
  • Presse Presse
  • Podcasts Podcasts
  • BD BD
  • Documents Documents