GlaxoSmithKline To Remain Involved in AIDS Drug Clinical Trial Amid Political Pressure
GlaxoSmithKline on Wednesday said it would continue its participation in a NIH-sponsored study comparing the effectiveness of different antiretroviral drug regimens in developing countries, the Newark Star-Ledger reports (Silverman, Newark Star-Ledger, 7/1). The study originally was designed to compare three regimens -- all of which involved GSK's Combivir -- among 1,000 patients in some African countries, Brazil, India and other countries (Whalen, Wall Street Journal, 7/1). However, after researchers substituted Gilead Sciences' Emtriva for Combivir in one of the regimens being studied, GSK said it would no longer participate, according to Reuters. GSK spokesperson Nancy Pekarek said the company dropped out of the study because the design no longer met World Health Organization guidelines (Fox, Reuters, 6/30). Thomas Campbell, University of Colorado professor of medicine , and a researcher for the study, said its design, which originally had been approved in 2002, was changed to reflect new research. As a result of the changes, Emtriva was substituted for Combivir in one part of the study (Newark Star-Ledger, 7/1). Rep. Henry Waxman (D-Calif.) on Wednesday sent a letter to GSK CEO J.P. Garnier saying that the company's decision was delaying the study's progress, according to the Journal. "According to a senior investigator involved with the study, your company attempted to pressure researchers to drop [the] comparison [of Combivir and Emtriva] 'as a quid pro quo for providing the drug,'" Waxman wrote (Wall Street Journal, 7/1). Garnier after reading the letter agreed to provide the drug for about 65 cents per day (Newark Star-Ledger, 7/1). "We will continue to work with Congressman Waxman and the NIH to ensure the study meets the needs of the developing world," Pekarek said (Wall Street Journal, 7/1).
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