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Washington Post, March 31, 2007

World AIDS Program Garners Praise; Experts, However, Criticize Hill's Mandate for Abstinence-Only Efforts

By David Brown

An independent panel of experts said yesterday that the Bush administration's massive global AIDS program "has made a strong head start" and is "well positioned" to help AIDS-devastated countries control their epidemics.

But, as have other groups, the panel said a congressional requirement for abstinence-only messages "has greatly limited" the ability of countries to design their own AIDS-prevention campaigns. That provision, as well as less controversial ones, should be repealed in favor of less prescriptive budgeting, the report said.

The panel also said it might be more efficient to scrap a requirement that all AIDS drugs bought through the program be approved by the Food and Drug Administration -- a rule that, at least initially, drove up costs and limited choice.

The scientists and public health experts noted that "continued commitment" by the United States will be necessary before the 15 AIDS-ravaged nations targeted by the President's Emergency Program for AIDS Relief (PEPFAR) can manage the epidemic on their own. This amounted to an indirect suggestion that Congress should renew the five-year, $15 billion program next year.

"PEPFAR is doing quite well, but it needs an enduring component to transition from the emergency mode to the sustainable mode," said Jaime Sepulveda, the former head of Mexico's National Institutes of Health, who chaired the panel.

The 314-page report by the Institute of Medicine, a branch of the National Academies that reviews health policy issues, appeared to please almost everyone.

Mark Dybul, the AIDS physician and ambassador who runs the program at the State Department, noted that the document contains much praise and said that its few criticisms are being addressed. Activist groups that have fought against its promotion of "abstinence-until-marriage" from the start also felt vindicated.

Bush announced the plan, the largest foreign-aid effort directed at a single disease in U.S. history, in his 2003 State of the Union address.

Through last September, PEPFAR was paying for anti-retroviral treatment for 822,000 people in the "target countries" -- 12 in Africa, and Guyana, Haiti and Vietnam. Of those under treatment, 61 percent were women and 9 percent were children. The program also pays for drugs for 165,000 people elsewhere in the developing world.

PEPFAR money has also gone to give more than 500,000 pregnant women short courses of medicines that reduce their chances of infecting their newborns. The strategy has prevented about 100,000 infections, program officials say. PEPFAR is also helping support 4.7 million people from AIDS-affected families, including 2 million orphans.

Much of the Bush AIDS program is built on the unusual model of contracting with U.S. charities and universities, including Harvard and Columbia, to arrange for health-care delivery for tens of thousands of poor people. Much of the actual work is performed by hundreds of small organizations, many of them faith-based groups and many delivering health care for the first time.

The Institute of Medicine panel, which interviewed hundreds of people and sent delegations to 13 of the 15 countries, did not address how this model of foreign aid compared with more traditional ones. Because the review was done soon after most of its programs opened for business, it also did not address long-term results, such as infection rates and social stability. Instead, it focused on implementation.

The law requires that 55 percent of PEPFAR's budget go for anti-retroviral treatment for HIV-infected people, with three-quarters of that going to buy drugs. Twenty percent must be spent on AIDS prevention, with one-third of that sum used for "abstinence-until-marriage" programs. Palliative care gets 15 percent and orphan assistance 10 percent.

The abstinence message is one-third of a strategy called ABC, the other letters standing for "be faithful" and "condom use."

The report's authors wrote that while nobody in the field argued for dropping the abstinence component, "the committee has been unable to find evidence . . . that 33 percent is the appropriate allocation for such activities." They added that endless debate over ABC has distracted from efforts to pay attention to other behaviors, such as alcohol abuse and violence against women, that increase the risk of HIV transmission.

"This earmark has caused confusion at the country level. We have been saying that for years," said Paul Zeitz, executive director of the Global AIDS Alliance, a local advocacy group.

Dybul, however, said the percentages apply only to PEPFAR's overall budget allocations. He said countries do not have to spend money on abstinence messages if they have little sexual transmission of HIV, as is the case with Vietnam, where the injection of illicit drugs is the main route of infection.

But Dybul said evidence shows that in countries with high rates of heterosexual transmission of the virus, ABC is the best strategy. The guidelines are necessary because "we are not quite where everyone has come along with the evidence," he said.

The requirement that AIDS drugs be approved by the FDA initially prevented countries from buying foreign-made generics with PEPFAR money. The FDA then agreed to review and certify those drugs even if they cannot be sold in the United States because of patent protections. Dybul said that practice effectively gives PEPFAR countries access to the cheapest AIDS drugs on the world market.

That view was corroborated by the scientific director of the Elizabeth Glaser Pediatric AIDS Foundation, which gets $80 million a year from PEPFAR and helps pay for the medical care of 98,000 people in Africa. Several years ago, the foundation paid $700 a year for a patient's anti-retrovirals. Now it pays $100.

"I think most of the problem of access to first-line drugs, be they branded or generic, has been resolved," said Richard G. Marlink of the foundation.

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