Kaisernetwork.org (Washington, DC)
18 July 2008
Politics and Policy
House Will Approve Senate's Version of PEPFAR Reauthorization Legislation Next Week, Leaders Say
[Jul 18, 2008]
The House next week will approve the Senate's version of a bill to reauthorize the President's Emergency Plan for AIDS Relief, sending the measure to President Bush to sign into law, leaders said on Thursday, CQ Today reports. The Senate on Wednesday voted 80-16 to approve the bill (HR 5501) after substituting language from its version (S 2731). The House Foreign Affairs Committee said that it will accept the Senate version, and Bush is expected to sign the bill (Graham-Silverman, CQ Today, 7/17).
The Senate version of the legislation allocates a total of $50 billion -- $48 billion of which would go to PEPFAR and $2 billion of which would go to American Indian issues. The chamber also adopted an amendment intended to increase oversight of the Global Fund To Fight AIDS, Tuberculosis and Malaria and encourage cost-sharing and transition strategies as part of agreements with countries that receive PEPFAR aid. The Senate version also includes a provision that would ease U.S. HIV/AIDS travel restrictions.
The House version of the legislation, which would allocate $50 billion for PEPFAR, passed in April. One primary difference between the House and Senate versions is that the House version would allow groups to use PEPFAR funding for HIV testing and education in family planning clinics but not for contraception or abortion services (Kaiser Daily HIV/AIDS Report, 7/17). The Senate bill does not mention family planning programs, according to CQ Today (CQ Today, 7/17).
In addition, the House version includes some spending mandates that are not in the Senate bill, including a requirement that 20% of PEPFAR funding be allocated to prevention. The Senate version includes a provision that more than half of the program's aid go toward HIV/AIDS treatment and care. Both versions would overturn an existing law that requires one-third of prevention funds be spent on abstinence and fidelity programs, instead requiring a report to Congress if countries do not spend half of prevention money on such programs (Kaiser Daily HIV/AIDS Report, 7/17). Both measures also would direct 10% of funding to programs for orphans and vulnerable children, as well as allocate $2 billion for the Global Fund in fiscal year 2009. Both bills contain an existing requirement that organizations receiving PEPFAR aid have a policy that opposes commercial sex work. The Senate version would create links between HIV/AIDS and nutrition programs and set a target of recruiting 140,000 health care workers. In addition, both measures would allocate $5 billion for malaria programs and $4 billion for tuberculosis initiatives (CQ Today, 7/17).
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Senate Appropriations Committee Approves Foreign Operations Bill That Includes HIV/AIDS, Millennium Challenge Funding
[Jul 18, 2008]
The Senate Appropriations Committee on Thursday voted 28-1 to approve a $36.6 billion foreign operations bill (HR 2764) that would provide "substantial funding boosts" for HIV/AIDS-related programs, CongressDaily reports (Kivlan, CongressDaily, 7/18).
The Senate bill was approved one day after the House State, Foreign Operations and Related Programs Subcommittee cleared its version. The Senate bill would provide $5.1 billion for global HIV/AIDS activities, a "step below" the House's $5.5 billion but $117 million above the 2008 fiscal year level, according to CQ Today. In addition, the Senate measure would provide $254 million for the Millennium Challenge Corporation, a decrease from the $1.5 billion provided in FY 2008, which the House bill would maintain. President Bush requested $2.2 billion for MCC. John Danilovich, MCC's chief executive officer, said the Senate's level is "absurdly low." Danilovich added, "I am concerned that news of this proposed funding level will have a chilling, disturbing and destabilizing effect on our partners who are investing their own hard work and significant resources into our program" (Graham-Silverman, CQ Today, 7/17).
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Science & Medicine
NIAID Director Fauci Cancels Planned HIV Vaccine Trial
[Jul 18, 2008]
Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, on Thursday canceled a planned trial of NIH's Vaccine Research Center's HIV vaccine candidate, saying that additional research is needed before the candidate is tested in humans, the New York Times reports.
According to the Times, Fauci's decision to cancel the trial came after several meetings with scientists to discuss a failed Merck vaccine candidate (Altman, New York Times, 7/18). Merck in September 2007 announced it had halted a large-scale clinical trial of its experimental HIV vaccine after the drug failed to prevent HIV infection in participants or prove effective in delaying the progression of the virus to AIDS. The vaccine candidate also might have put some trial participants at an increased risk of HIV.
The VRC candidate, called PAVE-100, is similar to the Merck vaccine in that both stimulate CD4+ T cells against HIV and both contain the cold virus adenovirus-5 (Kaiser Daily HIV/AIDS Report, 3/25). The VRC candidate also contained pieces of HIV strains from around the world to spark immunity (Chase, Wall Street Journal, 7/18).
The PAVE trial aimed to determine whether the vaccine could decrease HIV viral loads in people who received the vaccine but later contracted HIV, according to Fauci. However, Fauci said a smaller trial is needed to determine the vaccine's effect on viral loads before a larger trial is conducted. Announcing the cancellation Thursday, Fauci said researchers have realized they do not know enough about how HIV vaccines and the human immune system interact. He added that smaller studies are needed until scientists understand which immune reactions are most likely to prevent HIV (New York Times, 7/18).
VRC initially planned to enroll 8,500 people in the U.S. and Africa in the trial. In March, the agency scaled back the trial to 2,000 volunteers after the failure of the Merck HIV vaccine candidate in 2007 (Kaiser Daily HIV/AIDS Report, 3/25). Fauci on Thursday called for a "leaner, meaner" study of the vaccine candidate that aims to lower viral loads (Wall Street Journal, 7/18). According to the San Francisco Chronicle, Fauci said he wants to conduct a study that would address "one fundamental question: whether the vaccine works." The study needs to determine as soon as possible whether people who are vaccinated and subsequently contract HIV can control their viral loads better than those who contract the virus but had been given a placebo. According to the Chronicle, Fauci's "scaled-down test proposal will still do that."
At least 30 trial participants over five years will need to contract HIV after receiving the vaccine for a scaled-down trial to be effective, according to James Kublin, director of the HIV Vaccine Trials Network, which would have run the trial. It is unclear how many trial participants will need to enroll for 30 participants to contract HIV, according to the Chronicle (Russell, San Francisco Chronicle, 7/18).
Comments, Reaction
Despite the trial's cancelation, NIAID in a statement said it "believes the vaccine ... is scientifically intriguing and sufficiently different from previously tested HIV vaccines to consider testing it in a smaller, more focused clinical study." Seth Berkley, president of the International AIDS Vaccine Initiative, said researchers "can still learn something from testing the PAVE candidate in humans" but that it is "not necessary to do so in a trial involving thousands, as called for in the PAVE 100 design" (Fox, Reuters, 7/17).
Fauci emphasized that the agency is "not willing to entirely shelve the concept" of the vaccine but that a "less expensive trial, with less people, that's focused on the question of whether the vaccine can lower viral load" is necessary (Lauerman, Bloomberg/Philadelphia Inquirer, 7/18). "Show me that the vaccine works by lowering the amount of HIV in the blood. Then we will move to a larger trial that will document the link with a particular immune response," Fauci said, adding that until then, a "large trial is not justified" (New York Times, 7/18).
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