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AIDS Group Calls for End of Federal Funds for Vaccine
  March 26, 2008
By Donna Young
Washington Editor
from Jules Levin: how do you justify underfunding effective and underresourced programs in the USA such as prevention, testing, access to care and treatment, services for HCV/HIV coinfected and continue to put millions into an AIDS vaccine program that has yielded nothing with no hint of a promise to yield positive results.
As AIDS experts gathered in Bethesda, Md., Tuesday to examine a path forward for what so far has been an unsuccessful attempt to produce a vaccine to prevent the infection, one of the largest advocacy organizations called for an end in federal spending in the effort.
The AIDS Healthcare Foundation asserted that it is highly unlikely that there will be a vaccine to prevent HIV infection and therefore federal dollars should be used for HIV/AIDS therapies, testing and education programs.
"After 25 years and tens of billions of dollars, we have made no progress on an AIDS vaccine," Michael Weinstein, president of the Los Angeles-based foundation told reporters Tuesday during a conference call.
"The only thing you can say that this effort has yielded to this point is a guide for how not to have a vaccine," Weinstein contended, noting the failure in September of a study of Merck & Co.'s vaccine candidate MRKAd5 trivalent, which aimed to stimulate production of immune system T cells that can kill HIV-infected cells.
The Phase IIb clinical trial, which began enrolling volunteers in December 2004, was co-sponsored by Merck and the National Institute of Allergy and Infectious Diseases (NIAID).
The multinational, multisite 3,000-patient trial, known as STEP, was halted after the study's data safety monitoring board determined that the vaccine could not be shown to prevent HIV infection or affect the course of the disease in those who had become infected with HIV.
While many dedicated people have committed years of their lives to the quest of discovering a vaccine to prevent HIV infection, Weinstein said, "the best scientific minds" in the field "have come to the conclusion that is it not feasible."
He noted that last month Nobel Prize winner David Baltimore, president of the American Association for the Advancement of Science, portrayed a pessimistic picture of the future of a vaccine to prevent HIV infection. (See BioWorld Today, Feb. 15, 2008.)
"Nevertheless, over the last 27 years, we have made enormous progress in the development in prevention testing and treatment methods that are capable of bringing about AIDS control in the world," Weinstein said. "Unfortunately, many of these programs are being grossly underfunded," he added.
The "runaway train" of HIV vaccine research, Weinstein demanded, "needs to be stopped."
"We need to redirect the almost $1 billion per year that the United States government is spending into areas that we believe can bring about better results," he insisted.
About 25 percent of the 1 million Americans who are HIV-positive, Weinstein maintained, "don't know they are positive, who are contributing to the majority of infections."
In addition, he said, nearly half of those infected with HIV "are not receiving treatment."
"It is important that we prioritize in a period of limited resources," Weinstein said.
Clinical trials of HIV vaccine candidates, said Homayoon Khanlou, the foundation's U.S. chief of medicine, "have yielded no results. In fact, not only are there no results, but also it has left us with no clue in terms of which way to go."
Khanlou urged the AIDS advocacy community to join his group in its plea to the government to redirect vaccine research and development funding to clinical care and prevention activities.
But Richard Jefferys of the AIDS research and policy think tank, the Treatment Action Group, during the conference call asserted that the AIDS Healthcare Foundation's argument was based on "ignorance."
"Is this a model you would recommend for malaria and TB?" Jefferys asked.
Weinstein responded that the challenges or possibilities for vaccines for retroviruses like HIV "are something different" than those of malaria or tuberculosis.
Weinstein noted that his group does not oppose private donors "placing money where they want to" in vaccine research "as long as they don't harm patients."
At Tuesday's AIDS summit, NIAID Director Anthony Fauci said his agency plans to make adjustments to its vaccine research efforts, including shifting more of its funding to laboratory rather than clinical research activities.
Fauci noted that NIAID's "extramural" spending on HIV vaccine activities totaled $476 million in fiscal year 2007. Of that, $182 million, or 38 percent, was dedicated to clinical research activities.
Many at the conference argued in favor of focusing more efforts for tackling a vaccine for HIV prevention on primate studies.
The nature of transmitted viruses and the target of vaccines "is still quite hazy and something that we clearly need to understand in detail," said Eric Hunter, professor of pathology and laboratory medicine at the Emory University Vaccine Research Center. But he added that human clinical trials are "critical" to the progression of a vaccine.
"Clearly, there's a lot to be learned in human trials," Hunter said. "It's an integral part of the vaccine discovery effort."
Seth F. Berkley, CEO of the International AIDS Vaccine Initiative, insisted that while "we can do a lot more Phase IIb" trials, going forward, the vaccine candidates tested should not "look exactly the same" or be slightly different than those that already have been tested and failed.
"They would have to be quantitatively or qualitatively better," Berkley declared.
John P. Moore, professor of microbiology and immunology at the Joan and Sanford I. Weill Medical College of Cornell University, argued that any clinical trials moving forward should involve a small number of human volunteers.
"We will learn more from a trial in 10 to 15 individuals that's very, very carefully analyzed than we are going to learn from a trial of a vaccine in thousands of individuals that is not carefully analyzed because it's too large of a trial," he maintained.
Some of the unknowns scientists still need to answer involve the genetics of human responses to vaccines, Moore said.
"We know quite a lot about the genetics of human responses to HIV infections, but what do we know about HIV vaccine antigens" in a human population?
"There's more in the literature on the genetics of human responses to MMR, which is probably not highly funded, than there is on the genetics of human responses to HIV antigens," Moore insisted. "That needs to be fixed," he said.
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