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"We Need a Microbicide Now!"

By Theo Smart

April 2006

We Need a Microbicide Now!
The Microbicides 2006 Conference held April 23-26, 2006, in Cape Town, South Africa, maintained a consistent focus on the vulnerability to HIV infection of women in Africa (and elsewhere) and the need to find better ways for women to protect themselves.

"Asking women to simply abstain, be faithful, or use condoms is not practical. Nor is it enough, especially when ... 75% of new infections are acquired from a spouse or regular partner," said Graça Machel, (Foundation for Community Development), who gave one of the conference's opening addresses (see "Microbicides 2006 Conference Opening Address," below).

Machel's long list of distinctions include Founder and President of the Foundation for Community Development, former Minister of Education and Culture, former First Lady of Mozambique, and current wife of former South African President Nelson Mandela. She is also a renowned advocate for women's health and, more recently, for microbicide research.

Microbicides are products that could reduce the transmission of HIV and other sexually transmitted infections when used in the vagina or rectum. Microbicides can can have a variety of formulations, such as gel, foam, cream, sponge, or intravaginal ring. Since microbicides can be applied by a woman before and, in some cases, even after sex, they are being touted as a female-controlled prevention method.

"Too many women, married or not, lack the social power to negotiate condom use with their partners or husbands," said Machel. "The development of vaginal microbicides is key to [preventing] more women [from] becoming infected with HIV. Whether it be a gel, or a cream, or an intravaginal ring ... regardless of the type, we need a microbicide now!"

Nowhere is this more true than in southern Africa, where more than 60% of HIV-infected adults are women. One in four South African women aged 15 to 24 is infected with HIV, compared to one in 14 of young men of that age. But in some communities, the prevalence is much higher, with up to two thirds of pregnant women aged 25 to 29 now HIV-infected. For Machel, this means the existing methods to prevent HIV infection in women are failing. "Despite the huge investment we have made [in] HIV prevention, little has changed," Machel said.

However, according to projections presented at Microbicides 2002 by Charlotte Church (London School of Hygiene and Tropical Medicine), if a microbicide that is 60% effective reaches the market, and is used consistently by 30% of women at risk, it could prevent 3.7 million HIV infections. Even a weakly effective microbicide could have similar effects if it reaches a higher percentage of women; and if it is affordable, would translate into substantial savings for Africa's overstretched public health systems.

As a result of such modeling (and the apparently poor prospects for an HIV vaccine) over the last several years, interest and funding for microbicide research has grown substantially. Currently, over six products are in advanced clinical studies in Africa, involving over 25,000 participants (five are being studied in South Africa in at least 12,000 women). If found to be at least partly effective, one of these products could move toward licensing as soon as 2010.

Editor's Note: Reprinted with permission from www.aidsmap.com (first e-published April 26, 2006). Look to next month's issue of the IAPAC Monthly for clinical coverage of the Microbicides 2006 Conference.


Microbicides 2006 Conference Opening Address Delivered by Graça Machel

Good afternoon and welcome to Cape Town. I am delighted to be here with all of you today. I am especially pleased that [the] Microbicides 2006 [Conference] is, for the first time, taking place in Africa. We have the unenviable position of being the continent most affected by HIV/AIDS. And southern Africa is the epicenter of the pandemic. HIV/AIDS is having a devastating impact on society. The developmental gains we have made in Africa are being reversed, our economies are suffering, and communities are being shredded and destroyed. For me, what is most painful is to see what the pandemic is doing to women.

Globally, almost half of all people living with HIV are females. But nowhere is the "feminization" of the epidemic more acute than in Africa. Here, where women and girls make up almost two thirds of all people infected with HIV, and where 76% of those who are HIV-positive in the age group of 15- to 24-year-olds are young women, we are facing life-or-death situations. To some it may sound extreme to put it in such terms, but believe me ... it is not strong enough!

The vulnerability of women stems from their pervasive disempowerment. Many women have little capacity to say no to sex; they are unable to negotiate condom use in their relationships; they lack legal protections against abuse and sexual violence; and it is most often girls who are pulled out of school to take care of sick parents.

Poverty and food insecurity forces women to engage in "transactional" or "survival" sex, further exposing them to the virus. The vulnerability of women is further exacerbated by legal systems that deny them equal status. For too long, we have paid lip service to gender equality and have shown modest results. Our efforts have been insufficient and inefficient, and we have shown a lack of urgency in creating a more equal society, and this is coming back to haunt us now.

We have to drastically change a situation where women in Africa continue to bear the brunt of the HIV epidemic. Every statistic, every new report documenting the havoc wreaked by the pandemic, is a terrible reminder that we are failing to protect our mothers, sisters, and daughters. Two decades have elapsed since HIV/AIDS first came to light in the early 1980s. It is completely unacceptable that for over 20 years we have failed to provide women with the means to protect themselves against HIV infection. I see no pursuit more worthwhile than the search for an effective microbicide, and that is why we are here.

Despite the huge investment we have made [in] HIV prevention, little has changed. The existing methods to prevent HIV infection are failing many women. Asking women to simply abstain, be faithful, or use condoms is not practical. Nor is it enough -- especially when UNAIDS reports that 75% of new infections are acquired from a spouse or regular partner. Closer to home, in studies among young women in Harare, Durban, and Soweto, 66% of women said they have one lifetime partner, and 79% said they had abstained from sex at least until the age of 17. Yet, 40% of these young women were HIV-positive. Marriage, or being in what a woman thinks is a monogamous, faithful relationship, is sadly, one of the biggest HIV risk factors for many young African women.

Condoms are important, but not enough. Too many women, married or not, lack the social power to negotiate condom use with their partners or husbands. But let me add that it is important that female condoms be readily available -- and affordable -- for women in Africa and worldwide.

Existing prevention methods are not working. They must be broadened and expanded -- women must have access to education and information, sexual and reproductive health services, female-controlled prevention methods, and prevention of mother-to-child transmission (PMTCT) methods.

The development of vaginal microbicides is key to preventing more women becoming infected with HIV. Whether it be a gel, or a cream, or an intra-vaginal ring, whether it prevents HIV infection but allows for conception -- an incredible scientific feat, I must say -- regardless of the type, we need a microbicide now!

We must have and [we must] empower women with a range of approaches. Microbicide science is advancing rapidly, and current clinical trials provide hope that a microbicide could be available in five to seven years. We have microbicide candidates in large-scale efficacy trials and a new generation of microbicides already in safety studies. Five first-generation microbicide candidates have now entered large-scale efficacy trials around the developing world. I do understand the limitations of science, but we simply have to find ways to do this faster.

I am told that even if a microbicide were only 60% effective, it could prevent 3.7 million infections within three years if used by all women who are unable to use condoms. I am sure you all share my sense of urgency and are prepared to accept the challenge that we have to make such a product available now and not in a few years' time.

Clinical trials, a crucial component in the development of an effective product, are complex. There are issues of science, ethics, and advocacy that must be pondered and debated. Successful clinical trials require networking and institutional collaborations between research organizations, government and civil society, and knowledge transfer between institutions in the North and South. They require funds that are not readily available. They require facilities and staff development and training which can take several months. But most important of all, clinical trials require acceptance by the community and participation of women. To gain women's trust and collaboration, we have to be sensitive and ethical in our approach and have impeccable research methods.

We are attempting to do this in Mozambique. The government of Mozambique; Manhiça Research Centre; the Foundation for Community Development (FDC), my foundation; and our UK and South African partners are currently in the process of setting up microbicide feasibility studies in the country. In a short six months, we have come a long way -- in fact, I have no doubt that we are on our way to establishing a clinical site. Why? Because we have worked together to build on the strengths of each partner. Synergies are needed since none of us, be it the national or international partners, could have taken on this challenge alone.

If we are to have a microbicide that will be accessible and affordable for poor women in rural and urban areas, we need to embark on a truly global effort -- with political leadership, financial resources, and community mobilization. We know all too well in this part of the world what happens when profits take precedence over lives. We do NOT want to repeat the struggles in the efforts to get affordable access to antiretroviral treatment to people living with AIDS.

From the pharmaceutical industry, we need their active participation in the discovery of effective microbicides. We also need increased investment from the business and corporate sector for the development and distribution of new preventive technologies. My primary concern is to save the lives of women, but I am convinced it makes good business sense to invest in microbicides.

Some companies might be unable to see the business case to develop an effective microbicide since it poses scientific challenges, can take up a significant amount of time, and requires a series of large investments to research and develop a product. But what about those pharmaceutical companies that believe themselves to be industry leaders, innovators, and visionaries? Can you not see that the investment, risks, and costs you incur will be recouped through microbicide sales in developed and developing countries once the product is on the market? Can you not see that demand will also be constant? Can you not see that demand will be massive? We are talking of many millions of women in developing and developed countries that would buy microbicides to protect themselves from HIV infection and choose to buy your product rather than die of AIDS.

From developed countries, we need political leadership, continued support in research and development, and sustained financial support. We need to increase the efforts and commitments of scientific institutions and agencies. In 2004, US$140 million was committed to microbicide research, development, and advocacy worldwide. However, if we are to ensure timely development of a safe and effective microbicide, annual investment will have to double to US$280 million per year for the next five years ... and thereafter, it will have to remain at approximately US$260 million per year until satisfactory microbicides are licensed.

At the G8 Summit last year, the leaders of the most powerful countries in the world reaffirmed their commitment to meet the development target of [donating] 0.7% of their [gross national product as] overseas development aid -- a goal that was introduced a few decades ago, that has been affirmed over and over again. Now, a number of countries have set a deadline of 2015 to reach 0.7%. We must not let this become another empty promise.

G8 leaders also promised global AIDS treatment for all by 2010. I would like to have a similar commitment to protect women from HIV infection by 2010. Delivering on this will require generating increased resources, [investing in] scientific research, making drugs and microbicides accessible and affordable, and strengthening health systems. But in 2010 we have to be able to say, "We are protecting a significant number of women against HIV, and we are providing universal treatment to all." I expect our friends in donor countries to hold their governments accountable, so that the resources that are so desperately needed -- for new preventive technologies and the response to HIV/AIDS -- transpire.

From developing countries, we need to support efforts on the ground. That means building networks and engaging with communities; it means working with partners in clinical trials, and ensuring that women -- and men -- know about microbicides and the incredible potential they hold. We also need our leaders to prioritize the response to HIV/AIDS -- with special focus on women and AIDS -- in the work of government. Our weakened health care systems must be strengthened and improved, so that when a microbicide is [developed], it can get to the women who need it most.

And how are we going to reach these women? We need a strong women's movement to achieve this. My hope is that we use every opportunity we can -- international meetings, in gatherings like this one, or simply in our daily interactions -- to build a continent-wide women's movement. HIV/AIDS has the potential to wipe out an entire gender ... have we ever had a greater cause to mobilize and demand change?

In my lifetime, I have seen how a strong women's social movement can transform society. On this continent, we have fought and defeated colonialism, and apartheid. Now we must turn our efforts to the plight of women. We need women in all sectors -- from business, to science, to government, parliament -- to take up the issues that affect women with commitment and passion. But more than that, we need to challenge traditional practices that are harmful to women.

We can no longer remain silent when our sisters face sexual violence, rape, and female genital mutilation. We can no longer stand for discriminatory laws that deem women as minors. We must hold our governments and institutions accountable for the decisions they make -- or fail to make -- when it comes to women. When our governments sign and ratify international frameworks guaranteeing women equal status and a host of rights, we must insist that our national laws reflect the letter and spirit of these treaties. Signing a convention, enacting a law that looks good on paper and makes headlines is not enough!

We must move from rhetoric to action. We must demand the enforcement of laws that protect women. We must say, individually and collectively, enough is enough. ... Our sisters and daughters are dying ... and we will not stand for this any longer! Women must be at the forefront of every decision that is taken about their lives -- whether it is in the halls of parliament, or in their own homes. I must say I am impatient for change.

Last year, during a session on microbicides in Maputo, after the formal proceedings, the discussion was opened up for questions. The first question came from an activist from Swaziland. She asked, "Where do women living with AIDS fit into this plan? What about those of us who are already positive?" Nobody could give a satisfactory response to her question. Our slowness to act, our inadequate response to the pandemic, has resulted in the loss of millions of lives. Let me repeat that ... it has resulted in the loss of MILLIONS of lives. We cannot allow another generation of women to live in a world that does not offer them options to protect their health, their future, and save their lives!

I would like to praise women living with HIV who acknowledge their HIV-positive status openly and in public forums. Given the stigma and discrimination they know they will face from their family, community, peers, and society, it takes huge amounts of courage and determination to disclose their HIV status. I praise these women because they have become advocacy agents. I praise these women because they are educating other women and all of society. I also praise them because they are changing our mindset and demanding results. ... But most of all I praise them because despite the personal price they pay they are indeed our conscience.

Every single one of us in southern Africa is personally affected by the AIDS pandemic. I often wonder how we shall turn things around. Will we one day find ourselves in a world where AIDS is curable, or will it continue to spread and ravage our societies, our communities, and our families? Some people say that we will always be running to "catch up"; that the virus is too strong, too fast, and too clever ... others say that only with the discovery of a vaccine will we see the end of the pandemic.

I cannot predict the future. But I believe that it will not be one thing that changes the trajectory of AIDS -- we will need a host of methods, responses, and tools to make the change. We cannot set up false dichotomies -- it is not about choosing one thing over another. It is not that we need investment in preventive technologies, or in treatment. Or that we should focus on one group over another. No! We need resources for microbicides and vaccines and new medicines for second- and third-line regimens. We need a holistic approach, and our action must lead by a sense of urgency.

The work that each and every one of you is doing, whether in research, in advocacy, or in the community -- what you are engaged with ... that is finding a tool that will allow women to prevent HIV infection and empower them ... well, I cannot think of a more worthy cause. Your work is invaluable and urgently needed. A future of a generation of African women depends on it.




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