sábado, fevereiro 05, 2005

Estudo PREP com tenofovir parado nos Camerões

Convém mencionar que a comunidade está muito divida acerca dos princípios éticos aplicados nestes estudos em África e na Ásia.

Cameroon Suspends AIDS Study

The Ministry of Health in Cameroon yesterday suspended a study of HIV transmission to uninfected sex workers. The suspension was in response to a campaign by the AIDS activist group ACT UP Paris, which has branded the studies "unethical" and accuses the researchers of using participants as "guinea pigs." But Mark Harrington, a co-founder of the New York-based Treatment Action Group and a former leader of the original ACT UP, has shot back, calling the campaign "misleading" and claiming it could endanger future AIDS research.

Belly Aching? Activists led by ACT UP Paris, holding signs that say "Tenofovir makes me vomit," staged demonstrations last summer in Bangkok at the 15th International AIDS Conference. CREDIT: Zainal Abd Halim/Reuters

The 1-year study, which is funded by the Bill and Melinda Gates Foundation and run by Family Health International (FHI), began in June and completed enrollment in December. The trial involves 400 participants (mostly sex workers) who are at high risk of becoming infected with HIV and who are randomized to either take daily doses of the drug tenofovir or a placebo. All volunteers receive counseling about how condoms help prevent HIV infection. The study received approval from the Ministry of Health, as well as institutional review boards in Cameroon and the United States.

ACT UP Paris, which has been joined by the Cameroonian AIDS activist group Reds, has complained about several aspects of the study. They would like all volunteers who become infected during the study to be guaranteed HIV treatment. And they have assailed the manufacturer of tenofovir--Gilead from Foster City, California--for relying on sex workers, a socially vulnerable group.

In response, Cameroon's Ministry of Health appointed an independent commission to evaluate the trial. The commission came up with a list of concerns, including properly accrediting the clinic running the study and better defining the administrative hierarchy. It also requested that Gilead and FHI make access of tenofovir available to African countries, even though Gilead already offers the drug to poor countries at a no-profit cost of 85 cents a pill (as compared to $12 a pill in the United States). The commission's concerns led Cameroonian Health Minister Urbain Olanguena Awono to close the doors of the clinic running the study.

The suspension stunned researchers. "I'm surprised by the decision," says Anderson Doh, an obstetrician/gynecologist who coordinates the research for the study in Cameroon. Doh worries that if the ministry does not quickly lift the suspension, it could undermine the study as trial participants might not receive their monthly supply of pills, as well as counseling and condoms. Adds Harrington, "It's a disgraceful day for AIDS activism."

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