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Thai Activists Monitor Trial of Anti-HIV Gel

Friday, December 29, 2006

HIV activists in Thailand are monitoring plans for trial of an anti-HIV gel, set for 2007. If the product comes to market they say it must be affordable in Thailand, where married women are one of the fastest-growing HIV-infected populations.

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HIV activists in Thailand are monitoring plans for trial of an anti-HIV gel, set for 2007. If the product comes to market they say it must be affordable in Thailand, where married women are one of the fastest-growing HIV-infected populations.
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A woman who contracted AIDS from her husband.

BANGKOK, Thailand (WOMENSENEWS)--As Thailand serves as a popular testing ground for anti-HIV microbicides, a well-organized grassroots advocacy community here is becoming increasingly vigilant about its watchdog role.

"This is something concerning the rights of the women," said Pat Laphimon, a spokesperson for the Thai Women HIV-AIDS Taskforce, based in Chiang Mai. "The relationship between the researcher and the women participants should be a partnership. It shouldn't be one having power over the other."

Thailand is a prime potential market for anti-HIV vaginal gels, or microbicides. In contrast to condoms, which men control, microbicides are designed to give women in stable relationships more control over the conditions of intercourse.

Married women, or others in stable relationships, have become one of the fastest growing HIV-infected populations in Thailand, where the United Nations estimates 580,000 people are infected with the virus.

Half of all new infections in Thailand are transmitted by a spouse, while 10 years ago that rate was as low as 5 percent, said Dr. Sara Whitehead, a researcher with the Atlanta-based U.S. Centers for Disease Control.

In 2006, 17.7 million women in the world were living with HIV.

"Having a technology that women can initiate and women can have control over is critically important," said Whitehead, who heads a research station in northern Thailand that conducted the original trials of Carraguard, the most well known of microbicides still being analyzed today.

Thailand Provides Testing Ground

Thailand has hosted several microbicide trials, including those that test the safety of a product on several dozen human subjects over a few weeks or months and then later a bigger group over a longer period of time.

During these trials--designated as Phase I and II by the U.S. Food and Drug Administration--researchers look for evidence of vaginal irritation or other ill effects on the vaginal wall or the rectal area. Later, in Phase III, the actual effectiveness of the product is tested.

Clinical trials of preventive medicine are often politically sensitive since they are testing a procedure on a healthy population, not attempting to cure a sick one.

Microbicide trials are particularly sensitive since they often test low-income women in developing countries. Advocates not only want to safeguard trial participants' health, they also want to ensure that the low-income people who make products possible can afford to buy them if they are approved for marketing.

Currently 16 types of microbicide have passed animal safety tests and are being tested on humans, according to the Washington-based Global Campaign for Microbicides. The campaign estimates that by the end of this decade at least one of these microbicides could be ready for mass marketing in countries that suffer from a high HIV rate.

AIDS Drugs Often out of Reach

Until four years ago, Thailand was unable to treat the majority of its HIV-infected population because pharmaceutical patent laws put the price of anti-retrovirals, or ARVs, well beyond the coverage abilities of its universal health care system.

"Before we start the trial the community needs to negotiate what the benefit to the community is if we join the trial," said Nimit Pienudom, director of AIDS Access Foundation, a Thai nongovernmental organization based in Bangkok that aims to ensure access to HIV drugs for adults and children infected with the disease. "The community must have information."

Pienudom's group has secured a seat in a newly formed community advisory board to the Thai Red Cross, which is overseeing the latest trial being planned for the country along with the Australian pharmaceutical maker Starpharma, based in Melbourne.

Slated to begin in 2007 the trial is supposed to involve HIV-negative women and, at an unspecified later date, HIV-positive women. Objections from the community advisory board have stalled that process, according to the Thai Red Cross.

The Thai Women HIV/AIDS Taskforce, another member of the advisory board, is demanding that Starpharma guarantee future, affordable access to the microbicide, called Vivagel, to the Thai marketplace in addition to extra safety measures for women participating in the research.

Price Not Set in Advance

Starpharma has said it can only guarantee low prices, and cannot specify what those prices will be. But if approved and brought to market, the company says it is sure to be affordable in Thailand, since money for the trials is coming from the United States' National Institutes of Health.

"The agreement we have with the NIH and the collaborating partners in Thailand is we have to make every effort to make sure that the product is readily available in Thailand" and affordable, said Jeremy Paull, Starpharma's vice president of regulatory and clinical affairs.

He also said the company was keen to heed the advice coming from Thai Women's HIV/AIDS Taskforce and other grassroots groups who are cautious about the treatment that participants in the upcoming trials will receive.

"This is a very sensitive issue and I think that's why we're still in the planning stage," said Dr. Nittaya Pungpapong, a researcher with Thai Red Cross.

Laphimon said her group was alarmed when they came across a marketing plan on Starpharma's Web site that only listed Europe and North America as potential markets for the approved product.

The Taskforce is demanding that Starpharma and the Thai Red Cross set aside extra money for a media campaign to begin now, years before any microbicide is set to hit the market, that will begin educating the country about vaginal gels and HIV.

"Otherwise we would do anything to stop this trial," Laphimon said. "If they are not cooperating we're going to stop this trial. We're going to put pressure through media. We're going to do the protests we plan on doing, a lot of things."

Laphimon said that the trial "has a lot to say whether women from developing countries from the southern part of the world will be able to have access to microbicides . . . We're not sure whether it will be successful. If it is successful we have a right to be able to access it at an affordable price."

The Thai Red Cross says negotiations will continue between the two sides.

Megan Cossey is a journalist based in Bangkok, Thailand.

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For more information:

Global Campaign for Microbicides:
http://www.global-campaign.org

Starpharma:
http://www.starpharma.com/vivagel.asp

"African Women Test Anti-HIV Gel":
http://www.womensenews.org/article.cfm/dyn/aid/2630/