Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Wall Street Journal - July 1, 2004
Jeanne Whalen, jeanne.whalen@wsj.com
Earlier, Glaxo, the world's second-biggest drug maker, had told researchers it was withdrawing, delaying the trial's start and throwing its future into doubt. That decision drew heat from U.S. Rep. Henry Waxman, who blasted the company in a letter dated yesterday, addressed to Glaxo Chief Executive J.P. Garnier.
The trial, sponsored by the U.S. National Institutes of Health, will compare three treatment regimes among more than 1,000 patients in Africa, Brazil, India and other regions. Glaxo, unhappy with the trial's design, decided last year not to provide its top HIV drug, Combivir, the letter said.
Mr. Waxman, a California Democrat, said his office learned after contacting people in charge of the study that Glaxo withdrew after the study was revised to compare the effectiveness of drug combinations containing Combivir against combinations without Combivir.
"According to a senior investigator involved with the study, your company attempted to pressure researchers to drop this comparison 'as a quid pro quo for providing the drug,' " wrote Mr. Waxman, the ranking Democrat on the House of Representatives' health and environment subcommittee and a frequent advocate of aggressive AIDS research.
Yesterday, Glaxo changed its stance, and said Mr. Garnier decided to honor Rep. Waxman's request and make the drug available "at preferential prices."
"We will continue to work with Congressman Waxman and the NIH to ensure the study meets the needs of the developing world," said Nancy Pekarek, a Glaxo spokeswoman.
Glaxo also noted that it is currently supporting 20 different HIV drug trials in Africa, supplying the company's drugs either free or at cost.
HIV treatments often have been compared for efficacy in developed nations like the U.S., but little work has been done to test the best drug combinations for patients in poorer countries, said Robert Schooley, a University of Colorado physician who helped design the study. Patients in different regions of the world differ genetically and by their standards of nutrition, variables that can alter a drug's effectiveness and toxicity, he said.
Other companies involved in the study include Bristol-Myers Squibb Co. and Merck & Co. of the U.S. and Germany's Boehringer-Ingelheim GmbH.
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