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Global Pharmacovigilance for Antiretroviral Drugs: Overcoming Contrasting Priorities

  • Nyasha Bakare,

    Affiliation: Forum for Collaborative HIV Research and Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America

    Current address: J&J Pharmaceuticals Research and Development, Titusville, New Jersey, United States of America

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  • Ivor Ralph Edwards,

    Affiliation: WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden

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  • Andy Stergachis,

    Affiliation: School of Public Health, University of Washington, Seattle, Washington, United States of America

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  • Shanthi Pal,

    Affiliation: Quality Assurance and Safety: Medicines, Department of Essential Medicines and Pharmaceutical Policies, World Health Organization, Geneva, Switzerland

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  • Charles B. Holmes,

    Affiliation: Office of the US Global AIDS Coordinator, US Department of State, Washington, D.C., United States of America

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  • Marie Lindquist,

    Affiliation: WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden

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  • Chris Duncombe,

    Affiliation: Department of HIV/AIDS, World Health Organization, Geneva, Switzerland

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  • Alex Dodoo,

    Affiliation: WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, University of Ghana Medical School, Accra, Ghana

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  • Joel Novendstern,

    Affiliation: Ranbaxy Inc., Princeton, New Jersey, United States of America

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  • Jude Nwokike,

    Affiliation: Management Sciences for Health, Strengthening Pharmaceutical Systems (SPS) Programs, Arlington, Virginia, United States of America

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  • Ricardo Kuchenbecker,

    Affiliation: Graduate Studies Program in Epidemiology, Federal University of Rio Grande do Sul, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil, and Brazilian National Institute of Science and Technology for Health Technology Assessment (IATS CNPq), Porto Alegre, Brazil

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  • Judith A. Aberg,

    Affiliation: New York University School of Medicine, New York, New York, United States of America

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  • Veronica Miller,

    Affiliation: Forum for Collaborative HIV Research, Washington, D.C., United States of America

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  • Jur Strobos mail

    jur@berkeley.edu

    Affiliation: Forum for Collaborative HIV Research, Washington, D.C., United States of America

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  • Published: July 05, 2011
  • DOI: 10.1371/journal.pmed.1001054

About the Authors

Nyasha Bakare
Forum for Collaborative HIV Research and Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
Ivor Ralph Edwards, Marie Lindquist
WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Andy Stergachis
School of Public Health, University of Washington, Seattle, Washington, United States of America
Shanthi Pal
Quality Assurance and Safety: Medicines, Department of Essential Medicines and Pharmaceutical Policies, World Health Organization, Geneva, Switzerland
Charles B. Holmes
Office of the US Global AIDS Coordinator, US Department of State, Washington, D.C., United States of America
Chris Duncombe
Department of HIV/AIDS, World Health Organization, Geneva, Switzerland
Alex Dodoo
WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, University of Ghana Medical School, Accra, Ghana
Joel Novendstern
Ranbaxy Inc., Princeton, New Jersey, United States of America
Jude Nwokike
Management Sciences for Health, Strengthening Pharmaceutical Systems (SPS) Programs, Arlington, Virginia, United States of America
Ricardo Kuchenbecker
Graduate Studies Program in Epidemiology, Federal University of Rio Grande do Sul, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil, and Brazilian National Institute of Science and Technology for Health Technology Assessment (IATS CNPq), Porto Alegre, Brazil
Judith A. Aberg
New York University School of Medicine, New York, New York, United States of America
Veronica Miller, Jur Strobos
Forum for Collaborative HIV Research, Washington, D.C., United States of America

Corresponding Author

Email: jur@berkeley.edu

Competing Interests

The Forum for Collaborative HIV Research is part of the University of California Berkeley, where VM and JS are employees. This project was supported by the Bill & Melinda Gates Foundation. The Forum also receives unrestricted grants from the Glazer Pediatric AIDS Foundation, the National Institutes of Health, the Centers for Disease Control, amFAR, Kaiser Permanente, the HAART Oversight Committee, Merck, Johnson & Johnson, Gilead, Viiv, Pharmasset, Abbott, Vertex, Bristol Myers Squibb, Boehringer Ingelheim, Idenix, Incyte, Monogram, Tobira, and BD. Over the last year, the Forum for Collaborative HIV Research has also received grants from Becton-Dickinson, Intermune, Roche, and Virco. NB has accepted a position with Johnson & Johnson. IRE and ML are employed by the Uppsala Monitoring Center of WHO, which has received grants for two projects from the European Union FP7:Monitoring Medicines and PROTECT. AS is an employee of the University of Washington and is supported in part by the Bill & Melinda Gates Foundation and indirect grants from USAID. CBH is an employee of the US Government. AD has received funding for undertaking pharmacovigilance, including a grant in 2009 from the Global Fund to Fight AIDS, Tuberculosis and Malaria to develop a pharmacovigilance toolkit and a sub-grant (main grantee Swiss Tropical and Public Health Institute) in 2010 to develop a malaria pharmacovigilance toolkit. J. Novendstern is employed by Ranbaxy, a pharmaceutical company that makes antiretroviral medications. J. Nwokike works for the USAID-funded Strengthening Pharmaceutical Systems program. RK is an employee of the University of Rio Grande do Sul and advisor to the National STD/AIDS Program of the Brazilian Ministry of Health. JAA is an employee of New York University Medical Center, and serves or has served in past 2 years as a scientific advisor for BMS, Gilead, Merck, Theratech, Tibotec, and Viiv. Her university also receives research support for her participation as an investigator on multicenter clinical trials from Gilead, GSK, Merck, Pfizer and Tibotec. She is funded by the NIH supported AIDS Clinical Trials Group Grant # AI069532. All other authors have declared that no competing interests exist. The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the US Department of State.

Author Contributions

Wrote the first draft: NB JS. Contributed to the writing of the manuscript: NB IRE JAA AD CD CBH RK ML JN JN VM SP AS JS. ICMJE criteria for authorship read and met: NB IRE JAA AD CD CBH RK ML JN JN VM SP AS JS. Agree with the manuscript's results and conclusions: NB IRE JAA AD CD CBH RK ML JN JN VM SP AS JS.