Wall Street Journal - May 18, 2005
Marilyn Chase, marilyn.chase@wsj.com

The meeting, convened by the International AIDS Society, is a forum for finding common ground between protesters and the study's sponsors, the Bill and Melinda Gates Foundation, the National Institutes of Health and the Centers for Disease Control and Prevention. Across the table will be representatives of the French group Act Up Paris and other HIV patient advocates, who question the ethics of the studies.

Sponsors fear the dispute is delaying studies of Gilead Sciences Inc.'s Viread, or tenofovir, for HIV prevention -- a potential stopgap since a vaccine may be a decade away and the virus infects five million people a year. But the gulf between funders and activists may be too wide for any quick fix. Separately, UNAIDS, the joint United Nations program on HIV/AIDS, is holding global talks on ethics of prevention studies.

Behind the conflict is the expansion of AIDS drug trials into poor countries in Africa and Asia, where the disease is spreading rapidly. The trials throw a spotlight on the gap in care between rich and poor countries.

Activists seek to close this gap by asking researchers to ensure volunteers will essentially get developed-world standards of prevention and the same level of care if they get sick. Researchers say they try to improve local clinics and training, but argue that imposing such high hurdles could stunt studies.

Scientists need to do prevention studies in the developing world, where HIV rates are high and the disease's spread is swift, because studies in such areas assess efficacy more quickly. Tests there need fewer volunteers and less time than in the U.S., where lower HIV rates and slower spread require more volunteers and many more years to prove statistically whether preventive measures like Viread work.

Protests aided by activists had led studies to be canceled in Cambodia in August, and suspended in Cameroon in February. The main issue: a demand that volunteers who became infected during the study not simply be referred to local agencies for care, but be provided lifelong AIDS drugs. Researchers say such offers could breach the ban on undue inducement to participate in a study. (A third study was canceled in Nigeria due to unrelated clinic problems.)

At a study site in Thailand, activists are demanding that intravenous drug users be offered free needles -- in addition to the counseling, condoms and bleach to clean the kits they already are offered. The CDC says offering needle exchange in the study would clash with a congressional ban.

Originally, some researchers hoped they could determine if tenofovir protected people from catching AIDS as early as 2006. Now it appears results may not be in before 2007.

Act Up Paris and other European activists have also flexed their muscles by helping shut down trials in France, Germany and Spain of another drug, Pfizer Inc.'s experimental AIDS treatment, maraviroc, over separate issues of volunteer-recruitment criteria and safety.

Gilead, of Foster City, Calif., tenofovir's maker, isn't running the drug's prevention trials, but it does supply the drug for them. At an AIDS conference in July, Act Up Paris threw fake blood at and demolished Gilead's display and charged, "Gilead's greed kills."

"We attacked Gilead because it was a good opportunity" to publicize the trial volunteers' plight, says Fabrice Pilorge, an Act Up Paris member. The group charges researchers need people to become infected to obtain study results.

Ward Cates, leader of the Cameroon trial for the nonprofit research group Family Health International, has said study volunteers in these AIDS-ravaged countries -- even when on placebo -- generally have lower-than-normal infection rates as a result of the counseling they receive.

Helene Gayle, an HIV expert at the Gates Foundation, says the activists are raising valid questions. But in a March interview she worried, "Are we making this so complicated that nobody will do research trials?" She added, "If we stop tenofovir, we may stop something that could prevent millions of infections."

050518
WJ050504

Copyright © 2005 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.

Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2005. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .