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IT’S ALL BACK TO FRONT

Why no microbicides for gay men?

The barebacking debate continues to rage. But while microbicide research intensifies for women with HIV, Anna Forbes asks why no one is talking loudly about rectal microbicides for gay men

A microbicide is a substance which, when applied topically (ie to the part of the body that needs protecting), stops viruses and other germs entering. It does this by killing the germs, placing a physical barrier between them and the body, or both.

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artwork: raffaele reo

A sexual microbicide that could be incorporated into neutral lubricants like KY could lead to huge reductions in HIV transmission, especially between people from vulnerable communities. But while microbicides for vaginal use are developing apace, the more technical and contentious task of developing a microbicide for use in anal sex has not received the support of the community most likely to benefit from it: gay men.

Why are rectal microbicides being ignored? After all, they are a medically-proven way of reducing risk without condoms.

Four gay men, two British and two American, explored this question with me in recent interviews. All recalled the excitement when they first heard about the possibility of rectal microbicides.

“Amazing!” was Kirk’s first reaction, a 30-year-old, HIV negative San Franciscan. He was delighted by the thought of a gel or lube that men could apply before sex for added protection with a condom or to reduce risk in the absence of a condom.

For Jack, a Londoner in his late 30s who has HIV, it seemed a very simple and obvious solution. “Why aren’t they here yet?” he demanded. Another Londoner, Will, who has HIV and also works as a health promoter, was just as enthusiastic.

Jim, a 37-year-old Chicago resident living with HIV, is sure there would be widespread enthusiasm for rectal microbicides among gay men “once they know how to pronounce the word”. But, he says, “The problem is, when you go looking for information about microbicides, it’s always presented from a very heterosexual point of view, as something that will be great for women. The link is never made for its relevance to gay men.”

So why aren’t the gay community, and specifically the gay press, generating noise on this issue? Perhaps part of the answer may lie in the fact that rectal microbicides, still in the early stages of development, are seldom discussed in scientific circles, and news of them is scanty.

So what are the major breakthroughs for microbicides?

imageIn July, 2003, researchers at the University of Washington in Seattle, found that an anti-viral protein, Cyanovirin-N (CV-N), derived from a blue-green algae, was capable of preventing rectal transmission of lab-created simian/human (SHIV) in monkeys. The data indicated that none of the macaque monkeys treated with one to two per cent CV-N gel showed evidence of SHIV infection after rectal exposure to the virus. The other good news was that neither CV-N nor the placebo gel caused irritation when applied rectally.

To date, most of the gay press coverage of microbicides has revolved around Nonoxynol-9 (N-9), a spermicide commonly used in over-the-counter birth control products. Manufacturers started adding N-9 to condoms and sexual lubricants in the 1980s when it was shown to kill HIV in a test tube.

In 2000 it was made public that N-9 products, especially when used rectally, could actually increase an individual’s risk of HIV rather than offer extra protection. The World Health Organization now advises against the use of lubricants and condoms containing N-9. That message has circulated throughout gay communities in the US and UK.

The highly publicised failure of N-9 gave many people the inaccurate impression that the whole idea of microbicides is unrealistic, but in fact over 60 other potential microbicides - new products that don’t include N-9 - are now on the drawing boards. Most researchers are focused on developing products for vaginal use. Rectal studies, nevertheless, are moving slowly forward. Two ‘Phase 0’ trials are underway in the US to measure whether observed rectal irritation or damage is being caused by the test product or is damage that could have occurred anyway, even without the product. These trials are a vital first step toward designing accurate safety trials for the first rectal microbicides.

If such progress is newsworthy, why hasn’t it been widely reported in the gay press?

Kirk, with his 1980s San Francisco gay experience, says that all men of his generation want to know about microbicides: “How does it feel up the butt? Does it give you a rash? Does it cause diarrhoea?” Excellent and pressing questions, but not ones that can be answered until a proven, safe microbicide can be identified.

It seems a common belief, however, that microbicides are decades away. Perhaps the public health and charity sector is just afraid and they don’t want to do anything that appears to approve of men having sex without condoms. Or is it just that gay men’s health promoters find it “hard to promote something that doesn’t continue to fetishise condoms,” as one of them suggests.

Does unprotected sex have a value?

Since microbicides are unlikely to be as effective as condoms, they must necessarily be presented as part of a harm reduction message; one emphasising condoms as the most effective prevention option, but adding that a safe, effective microbicide (once one is available) is substantially more effective that unprotected sex. In the UK there is a shift toward using a harm reduction model for HIV prevention and this trend bodes well for the effective incorporation of microbicides into the larger discussion. In the US, by contrast, HIV prevention messages are still centered almost exclusively on risk elimination via condom use or abstinence.

Both American interviewees I spoke to firmly believed that most men do want to protect themselves, but prefer to do or use something that, as Kirk comments, “won’t get in the way of the raw sex they want to have. People need other methods that allow for more sensation and fluid exchange, friction and spontaneity”. These experiences are “really meaningful for a lot of gay men. If they weren’t, we wouldn’t have all these seroconversions.”

“Unprotected sex has a value,” says Jack. “People don’t do it to spite anyone or because they are crazy but because it has a value.”

Among younger men in San Francisco, Kirk says, “the condom is over. People are just over them.” Despite this, he does not anticipate the kind of highly visible, concerted demand for microbicides among gay men that we saw generated in the 1980s and 90s by treatment activists demanding more and faster research to develop effective Aids drugs. “In the late 80s, we were in such a state of crisis around Aids. We’re just not experiencing that state of crisis now. Seroconversions are a very quiet phenomenon and death is a very loud one, so the crisis sounds different.”

Sigma’s gay men’s study and the future for microbicides

Sigma Research, the London-based social research group investigating HIV-related behaviour and policy, is attempting to find out about gay men’s interest in microbicides. This year, its annual Gay Men’s Health Survey, one of the largest such surveys in the world, included the questions: “Have you ever heard of microbicides?” and “If a partially effective anti-HIV microbicide became available offering some protection against getting or passing on HIV when fucking, would you consider using it?”

The responses, collected from over 10,000 gay men in the UK and Ireland, will be published in 2004 and should illuminate the level of men’s interest in microbicides considerably.

The Global Campaign for Microbicides, an international coalition working to build support for microbicide and other user-controlled prevention options, projects that the first vaginal microbicides are likely to reach the market around 2007-10 and that rectal microbicides won’t become available until after that. The Campaign cites lack of interest for the products as a major reason why rectal microbicide research proceeds at such a slow pace. Because no major pharmaceutical company has yet invested in microbicide research and development (R&D), a number of universities, small biotech companies and some NGOs have taken the lead. But in order to fund their research, these entities require public grants and, to the extent they can raise it, venture capital. The result: chronic underfunding and a clogged research pipeline.

It was estimated in 2002 that if a single pharmaceutical company were managing all microbicide research leads, it would have to invest $775 million over five years to ensure the production of at least one safe, effective product. This report also showed that if current funding levels continue, the amount spent on microbicide R&D worldwide between 2001 and 2005 will total about US $230 million. Currently at least US $545 million shortfall is occurring between funding levels and the expected cost of getting one successful microbicide on the market.

This shortfall means that, for every product like CV-N that is being developed as a potential rectal microbicide, many others are sitting on lab shelves because the funding to explore their possible efficacy isn’t available.

What will it take to get you interested?

How can we generate a loud, compelling demand for rectal microbicides among gay men? It looks like the gay and HIV community badly needs a leader to campaign for microbicides; someone who is dynamic and sexy. And it needs a well co-ordinated microbicide campaign to go with it. Whether one develops in the UK may depend, in part, on the findings of the Sigma survey. It is inescapably true, however, that campaigning on this issue would make a difference to how the need for microbicides is perceived by developers and funders.

With condoms, public health educators and marketers have been struggling for over two decades to make the consumer audience adjust its behavior to fit the available product; this is normally the other way round in any product marketing strategy. Perhaps that’s why it’s a difficult conundrum. But gay men could have non-condom HIV and STD prevention tools. And gay men could choose to use their power and collective voice to make rectal microbicides available sooner rather than later. Whether they do so remains to be seen.

Anna Forbes is Director of the Global Campaign for Microbicides.For more information, please contact the UK/Ireland Campaign for Microbicides, an affiliate of the Global Campaign for Microbicides, at policyandcampaigns@nat.org.uk or 020 7814 6759. Or visit the Global Campaign’s website at www.global-campaign.org

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