News Release

Global safety monitoring of HIV drugs is essential, says International Forum

Peer-Reviewed Publication


With increasing numbers of people worldwide—5 million in 2010—on antiretroviral drugs for the treatment of HIV, the International Forum for Collaborative HIV Research recommends that improved and sustained global drug safety monitoring, including monitoring for substandard products, drug diversion, inappropriate use, and toxicity, is critical.

Writing in this week's PLoS Medicine, the Forum reports on a meeting in which key stakeholders from the UN and government agencies, donors, industry, academia, multilateral organizations, and implementers discussed the creation of a sustainable global pharmacovigilance system for antiretroviral drugs.

While all participants claimed that they were dedicated to establishing global pharmacovigilance, important contrasting priorities and values among stakeholders, such as national sovereignty versus regional and international collaboration, confidentiality of safety data versus need for transparency and public access, and generic versus innovator antiretroviral manufacturers remain barriers to progress.

The Forum authors state: "Many stakeholders with substantial interests are still not routinely at the table. Most prominently, the pharmaceutical industry, both innovator and generic, are not included, although both sets of institutions have substantial investment in global infrastructure, personnel, data management, databases, and other resources that could be purposed, at least in part, to sustaining global pharmacovigilance systems in [resource-limited settings]."

The Forum concludes: "Recognition, understanding, and respect for these contrasts is a pathway for increased collaboration and cooperation that will then lead to a sustainable system involving all stakeholders including industry and experienced regulatory agencies."


Funding: The Bill & Melinda Gates Foundation were the funders. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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.

Citation: Bakare N, Edwards IR, Stergachis A, Pal S, Holmes CB, et al. (2011) Global Pharmacovigilance for Antiretroviral Drugs: Overcoming Contrasting Priorities. PLoS Med 8(7): e1001054. doi:10.1371/journal.pmed.1001054



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