Keynote lecture by Stephen Lewis, UN Special Envoy for HIV/AIDS in Africa

11th Conference on Retroviruses and Opportunistic Infections 8 February 2004, San Francisco, United States

In the situation of intimate partners, condom use is very low. Nor can it be demanded. In representative surveys of women in 14 African countries, it was found that only 7% reported condom use in the last sex act with their regular partner. The prevailing assumption is that commercial or casual sex is the primary way in which women are infected. The assumption is wrong. There is a growing body of evidence to show that a significant number of infected women in Africa have been infected by their husbands or intimate partners. There is virtually no defence against that reality: the power imbalance in marriage is too great to permit or to request the regular use of condoms.

Thus it is that the classic “ABC” intervention doesn’t work in the one place where the risk for the woman may be greatest. Marriage without sex is not realistic, nor is it desirable. Abstinence in marriage is not possible; Being faithful is assumed; Condom use is irregular at best.

A way must be found to allow the woman to protect herself, independent of male hegemony. Female condoms are one possibility, but they are very expensive, and they require partner consent. And of course they act as barriers to conception. The most exciting prospect that we have on the scientific and social horizon is a microbicide.

I recognize that this is an audience of vast and copious knowledge, but let me simply say, for exposition’s sake, that a microbicide can be formulated as a topical gel, film, sponge, lubricant, time-released suppository, or intra-vaginal ring that could be used for months at a time. It would restore to the woman the power to protect herself from HIV in the absence of a condom. It would reduce, geometrically, the incidence of infection.

Alas, we’re still at least five years away from a first-generation microbicide. But with government support and financing, there are enough products in the testing pipeline now to achieve the breakthrough in that timespan. The Rockefeller Foundation, deeply committed to the development of a microbicide, estimates that the cost required is in the vicinity of $775 million. At the end of 2002, research and development funding totaled $343 million. Thus the shortfall is in the vicinity of $400 million. It may be higher. In May of 2003, the Global HIV Prevention Working Group recommended an additional $1 billion of public sector spending. But whether it’s three-quarters of a billion, or a billion, it’s peanuts in the vast panorama of international financial architecture.

Using mathematical models, researchers at the London School of Hygiene and Tropical Medicine found that a microbicide, of even 60% effectiveness, used by only 20% of women in contact with local health services, could reduce the numbers of infections by millions. Millions. It’s breathtaking.

Some of the products under development are likely to be contraceptive as well as microbicidal; others will be non-contraceptive for disease prevention. As we meet, eleven potential microbicides have advanced into human safety trials, and some may well enter large-scale Phase II/III trials in 2004. Obviously, there’s a long way to go, but it’s not without hope.

But we must have the money. The amount is so relatively modest --- all the amounts related to HIV and tuberculosis and malaria are relatively modest in the grand scheme of things --- that you have to ask yourself what kind of warped dementia has crept into the political process of assessing human priorities. Were we to pull out all the stops, and get microbicides of various types, and various levels of protection, to the market, we could give a significant measure of sexual autonomy to the women of Africa and prevent millions of HIV infections, and the millions of premature deaths that follow, and the millions of orphans left behind.

Can anyone in this illustrious gathering explain to me why that shouldn’t be one of the greatest of political priorities?

Which brings me logically to the fourth item: is not the same true for a vaccine? It’s interesting to me how the search for an AIDS vaccine is also struggling around issues of funding, and is often eclipsed, in public debate, by the preoccupations of care and prevention and treatment. Perhaps this is inevitable. It’s tough for the world to fix on a vaccine, when millions of people are understandably clamouring for treatment. But just because a vaccine is a long-term proposition, and obviously very tough science, it cannot, it must not be depreciated.

These various aspects of the pandemic are not mutually exclusive. There will be limitations to vaccines as there will be limitations to microbicides, but a vaccine, as the ultimate answer to the catastrophe, must be pursued with an almost supernatural fervour. There should not be the slightest equivocation around funding. The rule of thumb suggests that roughly ten per cent of the resources allocated in the battle against AIDS should go to vaccines and microbicides. That’s not happening. Yet, the greater the number of vaccine trials, assuming plausible candidates, the greater the prospect of discovery. If ever a Nobel Prize lay in waiting, it’s for an AIDS vaccine.

Vaccines, of course, are part of a continuum of work, stretching from the basic science and research done by so many in this room, through to product development and moving the products forward. And it must focus on the needs of the developing world, embracing developing world scientists and sites, and planning determinedly, in advance, how access for all will be secured when a vaccine is finally found. It’s important to note that there are more potential vaccines in the pipeline than ever before, and that trials are underway on six continents. Much of this is driven by IAVI, the International AIDS Vaccine Initiative, artfully using public-private partnerships. But we need more, much more, from NIH, from big pharma --- only Merck is appreciably involved --- from biotech companies and from IAVI.

I recall chatting with Seth Berkeley, the CEO of IAVI, not long ago. He was making the point --- and, incidentally, regretting that is was not widely understood --- that a vaccine is also a women’s issue. A fully effective vaccine, indeed, to some extent, even a partially effective vaccine, would give to women the ultimate protection from HIV infection without the male partner, intimate or casual, having any involvement whatsoever. The best prospect of course for women, is to have access to both a microbicide and vaccine, the one complementing the other.

We’re losing three million people a year. Treatment will slow, but not eliminate the carnage. There are 14,000 new infections daily. If we’re five to ten years away from microbicides or vaccines, there’s a desperate human toll to be faced between now and then. At least let the world rally to the prospect of bringing this cataclysm to an end sooner than later. And that means working on every front, on emergency footing simultaneously: care, prevention, treatment, microbicides, vaccines. It was Colin Powell, the American Secretary of State who said that HIV/AIDS poses the single greatest threat to the world community. He’s right. So where, I ask you, is the world community?