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October 07, 2008  
MEDTECH NEWS: Latest Headlines

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  • Activists Demand Drug Maker Halt AIDS Test


    July 14, 2004

    A biotech company that is using prostitutes in its AIDS drug experiments is being accused of exploiting the women and giving them poor education to further its research.

    Researchers in Africa and Cambodia are experimenting with Gilead Sciences Inc.'s popular drug Viread to see if it can be used as a sort of AIDS "prevention pill." At least some of the prostitutes involved will take pills with no medicinal value to see if they contract HIV, the virus that causes AIDS, more readily than prostitutes who take the drug.

    Some activists and prostitutes, demanding that the San Francisco Bay Area company halt the testing, disrupted a Gilead-sponsored seminar at an international AIDS conference in Bangkok on Tuesday.

    The protesters, led by the AIDS activist group Act Up, accused the researchers of purposely providing insufficient prevention education to the volunteers because it needs infection data to analyze Viread's potential to protect against the virus. The protesters also demanded that the company take care of the lifetime medical needs of any volunteers who contract AIDS during the experiment.

    Gilead's research chief Norbert Bischofberger said all the overseas experiments were approved by the U.S. Food and Drug Administration, even though U.S. approval wasn't needed, and that all participants receive "extensive counseling."

    Bischofberger also said the company isn't compelled to provide lifetime health coverage to the studies' participants because researchers are giving them education on condom use and other areas that will make them less likely to contract HIV.

    "Many more of these women would have become positive without the study," Bischofberger said.

    Viread is already approved in the United States for use by people already infected with HIV. Earlier studies in monkeys suggested the drug was effective in protecting monkeys from getting the simian version of AIDS when injected with the virus. Now Foster City-based Gilead and outside researchers hope those results will translate to humans.

    Armed with a combined $12 million in grants given by two U.S. government agencies and the Bill and Melinda Gates Foundation, researchers have launched ethically complex human experiments among HIV-negative prostitutes at high risk of contracting the disease in Cameroon, Ghana, Nigeria and Cambodia. Gilead is providing the drugs for free.

    In Cambodia, for instance, some 960 women ultimately will be enrolled in an experiment bankrolled by a $2.1 million grant from the National Institutes of Health.

    Half those volunteers in the Cambodia experiment will be given Viread, known generically as tenofovir, and the others will take a dummy pill with no medicinal value. A year later, researchers will compare the two groups to determine if significantly fewer volunteers taking Viread were infected with HIV than those receiving the dummy pill.

    Viread accounted for $193 million in sales for the first three months of the year, helping make Gilead one of the few profitable biotechnology companies in the world.


    Last updated: 14-Jul-04

       
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