"There are hundreds of physicians whose concern for and commitment to the sanctity of human life will prompt them to step forward and volunteer for this landmark study," said Farthing, who is medical director of the AIDS Healthcare Foundation in Los Angeles. "Physicians need to respond to the moral imperative of doing everything possible to bring low-cost, effective vaccines to market."
Farthing expects to have several hundred registered volunteers for the live-attenuated HIV vaccine study by Nov. 11, 1997, when he will present IAPAC's proposal to have a Phase I (human safety) trial in place by the year 2000. His presentation will be among several innovative proposals presented at IAPAC's First International Conference on Healthcare Resource Allocation for HIV/AIDS and Other Life-Threatening Diseases taking place November 10-11 at the J.W. Marriott Hotel in Washington, D.C. Other proposals include guaranteeing all U.S. children access to AIDS drugs regardless of financial circumstances, prioritizing HIV/AIDS and cancer drugs to parents, and improving access to healthcare for communities of color.
"It is time to follow in the tradition of Louis Pasteur, Walter Reed, and hundreds of our colleagues who made the commitment to be the first human subjects in critical clinical trials," Farthing explained. ""Each day we delay in moving aggressively ahead in the development of such a vaccine results in the unnecessary deaths and suffering of thousands of people, many of whom are in resource-poor countries and lack access to the promising drugs that many of us can now give our patients."
The live-attenuated HIV vaccine is one of several candidate vaccines that have been seriously delayed by a variety of problems detailed in the August Journal's cover story, "Obstacles and Progress Toward the Development of a Preventive HIV Vaccine," by Drs. William L. Hayward, Kathleen M. MacQueen, and Harold W. Jaffe of the Centers for Disease Control and Prevention (CDC). According to the authors, a principal obstacle to human subject trials of live vaccines is the assumption by trial sponsors that volunteers might be reluctant to enroll in such trials because of a perceived risk of contracting HIV.
Farthing argues that IAPAC's ability to organize a registry of potential volunteers for such a trial could play a pivotal role in convincing the National Institutes of Health (NIH), the World Health Organization (WHO), and private vaccine trial sponsors to bypass what he describes as "unnecessary, expensive and time consuming primate trials" and go directly to human trials. Farthing estimates that such a step could cut down the time line for an effective vaccine by at least 5 years and save millions of lives.
While other types of non-live virus vaccines also hold promise, Farthing cited an International AIDS Vaccine Initiative report indicating that some people with a weaker strain of HIV have remained healthy for more than 12 years, and at least one person with a weakened HIV strain may have successfully warded off multiple exposures to other HIV strains. Some primate studies also support this finding.
In his Journal editorial this month, IAPAC's Gordon Nary announces that he and José Zuniga, IAPAC's new deputy director, have joined Farthing and several of his colleagues as the first volunteers for the clinical trial. He urges other leaders in the AIDS community to join physicians and researchers as volunteers for this human study.
"José and I have registered because as political advocates for children, women and men living with and at risk for HIV, we can only justify our advocacy if we take the same risks as physicians and researchers," Nary writes. "Otherwise, how can we ask the White House, Congress, local and state legislators, foundations, and those who share similar responsibilities in other countries to provide the necessary funding and leadership to properly care for those affected and end this epidemic? We must lead by example."
IAPAC is devoted to developing and implementing global strategies to maximize the quality of life of all people with HIV/AIDS and other life-threatening diseases. The association has 5,500 members in 42 countries. In the United States, IAPAC's member physicians care for the majority of people with HIV disease.
[To arrange an interview with a physician or an activist in the United States or internationally who has registered as a potential volunteer for the pilot human safety trial of a live-attenuated HIV vaccine, please call IAPAC's José Zuniga at (312) 419-7512. IAPAC conference information and media credential forms are also available upon request, with updates issued periodically. For more information, call IAPAC.]