Call for Poor Country Focus on Treatment, Care Programs Elicits Voice of Concern from Vaccine Outfit
"Elusive and Intangible Hope"
Two days after Kofi Annan gave his speech in Abuja, Nigeria, proposing the creation of the Global Fund, an article appeared on the Associated Press news wire. "Experts Worry Vaccine Research Overlooked in AIDS Pandemic." Which experts? Why, pass the envelope, it's Seth Berkley, "president of the New York-based International AIDS Vaccine Initiative" who "said Friday from the sidelines of the African AIDS summit" that, in the AP's words, "efforts to develop an AIDS vaccine are at risk of being overlooked in the push to raise money to fight the epidemic." The article goes on to note that "the IAVI . . . . has raised more than $300 million to assist vaccine research and create systems for distributing them to developing countries. Berkley estimated that the project would require at least double that figure to give research bodies a chance of developing vaccines by 2007."
Certainly nothing in the past few years of explosive growth for IAVI indicates that its funding is in any way jeopardized by the new efforts to provide desperately needed HIV prevention, treatment and care programs to places which need them now -- not in the ten or twenty years it will take to develop, test, approve, and distribute a safe and effective HIV vaccine. And certainly no one who is fighting to build a global system to provide HIV prevention, care, and treatment for poor countries now fails to recognize the critical need for a safe, effective vaccine -- or fails to support expanded AIDS research efforts which may lead to one.
But it is breathtaking that Dr. Berkley misses no opportunity to beat the drums for IAVI, even appearing to complain about Secretary General Annan's enlightened call for a massive mobilization to do something now. "Billions of dollars have gone into the development of effective AIDS treatments, but vaccine research has received relatively little funding," according to the AP reporter, no doubt thinking independently.
In the past few years, actually, NIH funding for clinical trials has remained flat, while funding for vaccine research has increased by 25-30% per year. In fact, the article itself goes on to point out that "about $250 million [went] towards vaccine research [last year]." In other words, if the NIH vaccine effort continues at $250 million for the next five years, NIH alone will have spent $1.5 billion on an HIV vaccine -- plus IAVI's $300 million -- and both figures are likely to grow significantly. Moreover, any global fund for HIV must, and most likely will, help to subsidize the distribution of a safe and effective HIV vaccine when and if it comes.
In the meantime, Dr. Berkley should support efforts to prevent HIV infections and to treat people infected with HIV. The only alternative is to let 35 million, or 100 million, or however many are infected before NIH, IAVI, and others develop and distribute a vaccine, simply die. Dr. Berkley should also consider what vaccine researchers are providing, other than elusive and intangible "hope" and the opportunity to enroll in twenty or 100 slots in a phase one vaccine study, to the devastated communities around the world where IAVI and other vaccine research programs such as the NIH-funded HIV Vaccine Trials Network operate.
For example, a phase one study is being carried out in Hlabisa, KwaZulu-Natal, South Africa, in a district where one third of adults are infected with HIV. Let us presume that the study will enroll 20 HIV-negative people, and that many more will be screened for potential eligibility. Let us assume that 100 people will be screened, and that 33 will turn out to be HIV-positive. Being HIV-positive, none of them will be eligible for the study. What is the vaccine research center going to do for them? I have asked this of Anthony Fauci from NIAID, and of Seth Berkley from IAVI, and they haven't been able to answer the question.
Another thing which could be done now: Let us suppose that some people become infected during the phase one trial of the candidate vaccine, which is unlikely to be completely protective -- even if it's protective at all. Suppose that these seroconversions are detected within three to six months. There is a huge, on-going ethical debate about whether it's ethical not to offer antiretroviral therapy to people who become infected in the course of a vaccine study. This debate usually presumes that it's a question of either lifelong expensive treatment starting immediately versus no treatment at all, ever. This creates a false dichotomy.
Newer interventions, such as those pioneered by Bruce Walker and Eric Rosenberg at Harvard, suggest that it might be possible to treat a newly-infected person with one or two brief (weeks to months) cycles of HAART and turn them into long-term non-progressors. This would be a hypothesis well worth studying in a resource-poor setting, because for the cost of a few weeks or months of treatment (plus monitoring), recent seroconverters might be converted into long-term non-progressors, and might thus not require therapy for twenty years or more.
Even if they were average progressors, under current guidelines and with an average progression rate, half would not need treatment for ten years. But they could be followed and studied in natural history cohorts which promised them ongoing monitoring and effective treatment when they needed it. And by that time, drug prices will have come down, drug regimens and strategies will have improved, and some poor countries may have developed HIV/AIDS care and treatment programs.
It is simply narcissistic for advocates of vaccine research to attack the people and programs that are trying to provide prevention, care and treatment in the interim. And it's
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