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At a Congressional briefing today, AIDS experts expressed grave concern about a shift in the focus of the US President’s Emergency Plan for AIDS Relief, from providing HIV treatment to patients to providing technical assistance to developing country governments. The policy shift comes hand-in-hand with a pull-back from funding targets authorized in the Lantos-Hyde Act, which reauthorized PEPFAR.

These policies are leading to disturbing trends on the ground, including HIV-infected patients being denied access to lifesaving drugs in Uganda and elsewhere, emergency stock-outs of antiretroviral drugs, rising concerns about the emergence of HIV resistance,  and patients being “dumped” into the hands of ill-equipped government health facilities.

Much of the focus of the briefing, attended by key House staff members and a dozen or so HIV advocates, was on Uganda, which was featured prominently in a front-page New York Times story today about the devastating implications of stagnant funding for global AIDS programs.

“Uganda is the tip of the iceberg,” said Sharonann Lynch, of Doctors Without Borders. “You absolutely cannot ration care at this point… It’s throwing the last ten years of clinical practice out the window. What we’re seeing on the ground now is worse than six months ago. So what’s it going to be like six months for now?”

She said members of Congress need to ask the Obama Administration, including top officials at the Office of the Global AIDS Coordinator, pointed questions about their commitment to HIV treatment.

“How many new treatment slots will there be in 2010? How many new treatment slots will there be in 2011?” she asked.

Lynch noted that in several countries, such as the Democratic Republic of Congo, there are reports of PEPFAR redirecting money from treatment, i.e. purchasing ARVs, to providing training and technical assistance. That is devastating to developing country health systems, which are not equipped to take on the burden of AIDS treatment programs.

“It’s a radical shift in policy,” Lynch said. “PEPFAR had been filling the empty medicine cabinet, and technical assistance can only go so far. You can’t keep someone alive” if there are no drugs to treat their disease. She said there needs to be pressure on OGAC to get back to the business of saving lives and pursuing bold treatment targets.

Asia Russell, of Health GAP, said that OGAC officials initially told concerned activists that they could expand treatment, despite the limited funding, to more than 4 million people by finding cost savings in its current programs. But she learned on a recent trip to Uganda that implementers are being told that they cannot use any money saved through program efficiencies to add new treatment slots. She noted that creates a perverse disincentive to run efficient programs.

She said this policy seemed to be driven by the Office of Management and Budget, not OGAC. “They’re in the caboose,” she said of OGAC.

Russell said another problematic development in Uganda is that providers had once worked very closely with the public sector, sharing information and resources. But that’s not happening anymore, as treatment is being capped and patients are being steered toward ill-equipped government-run clinics.

Pearl-Alice Marsh, with the House Committee on Foreign Affairs, said she feared that the policy shift was intended to transfer programs to developing countries in a “very short period of time” and this new policy means less of a focus on bending the curve of the epidemic. But “we’re not out of the emergency phase” when it comes to AIDS.

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Five key House lawmakers—including the chair of the Congressional Black Caucus—have called on the Obama Administration to step up its commitment to combating global AIDS.

In a letter to the president, Rep. Barbara Lee, D-Calif., and other House members expressed concerned that “continued rapid roll out of AIDS treatment is endangered in Africa” and said the White House needed to dramatically ramp up funding in the Fiscal Year 2011 budget. A similar letter, from a bipartisan group of U.S. senators, is expected to go to the White House later this week.

Despite broad support in Congress for expanding the President’s Emergency Plan for AIDS Relief (PEPFAR), demonstrated in last year’s reauthorization of that program as the Lantos-Hyde Act, “we will fail to meet its promise if the current funding trends continue,” the lawmakers wrote. In addition to Lee, the House letter was signed by Reps. Henry Waxman, Donald Payne, John Conyers, and Eliot Engel.

“Without expanded funding beyond these 2-3 percent rate increases, it will be incredibly difficult to substantially expand access to treatment, roll out promising prevention programs, train new health workers, or care for the millions of orphans,” as the Lantos-Hyde Act mandates, the letter states. “In order to get back on track with the authorization levels in Lantos-Hyde, we urge you to commit $7.5 billion for bilateral AIDS programs and $1.75 billion for the Global Fund in your fiscal year 2011 budget request.” The letter also calls on Obama to provide $650 million for bilateral tuberculosis programs and $924 million for malaria. (more…)

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Lawmakers have finalized the fiscal year 2010 budget for foreign assistance, setting funding for key programs to fight global HIV and TB and reaching a landmark deal to revise the needle-exchange ban.

The agreement—expected to pass the House before the end of this week and the Senate before the end of next week—includes some modest increases for bilateral HIV and TB, as well as for the Global Fund to Fight AIDS, Tuberculosis and Malaria. But the funding levels still fall far short of what’s needed to combat these twin epidemics and of what was authorized in the Lantos-Hyde Act passed by Congress last summer.

The deal, for example, would allocate $5.359 billion for global AIDS, $1.05 billion for the Global Fund, and $225 million for TB. It also includes a slight boost for NIH. The gloal AIDS figure does not include bilateral HIV/AIDS funds for USAID or the CDC’s Global AIDS Program; with those pots of money tallied, the total US bilateral AIDS funding for 2010 stands at $5.828 billion. (See chart below for more details on how this comparies to last year, etc.)

The real headline, though, is this: Key congressional negotiators agreed to ease the ban on federal funding for needle exchange programs. This is a long-overdue move that will remove an unnecessary and harmful barrier to effective HIV prevention efforts. It’s also a big surprise.

Earlier this year, the House approved lifting the ban, but included so many restrictions as to make federal funding for such programs essentially unfeasible (i.e., not near any schools, parks, arcades, etc.). The Senate voted to keep the ban in place.

The new agreement revises the ban so it would only prohibit the use of federal funds for needle exchange programs in a location “that local public health or law enforcement agencies determine to be inappropriate.”

Here’s the chart, which lays out the approved spending levels for FY2009, the funding levels authorized in the PEPFAR II, the President’s request for FY2010, and last night’s Congressional agreement.

Dollars in millions

  FY09 PEPFAR II Obama FY 10 Final
Global AIDS $5.159bil $6.5bil $5.259bil $5.359bil
Global Fund $600 $2bil $600 $1.05 bil
Tuberculosis $163 $650 $173 $225
NIH $30.566 N/A $30.758 $31.008

 

Notes:  The reauthorization bill did not contain specified year by year funding levels with the exception of the Global Fund which was authorized at $2 billion.   The amounts listed under PEPFAR II for bilateral Global AIDS and TB are extrapolated from the overall five-year funding levels authorized in the bill. In addition, as noted above, the global AIDS figure does not include money directed to USAID or CDC for their bilateral HIV programs.

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The search for new TB drugs and diagnostics is a long and windy road, paved with regulatory bumps and expensive R & D hurdles.

But the path could get a little smoother under an amendment recently added to the Senate’s fiscal year 2010 funding bill for the Food and Drug Administration and other related programs. The provision, offered by Sen. Sam Brownback, R-Kansas, would require the FDA commissioner to create two review groups to recommend new solutions for “the prevention, diagnosis and treatment of rare diseases and neglected diseases in the developing world.”

Brownback’s provision aims to streamline the regulatory process for new drugs and other tools to combat rare and neglected diseases that can take a huge toll on poor people in the developing world, where the potential to make big bucks off a new drug are slim to none. Click here for the amendment text and status of the bill.

In his floor speech urging support for the provision, Brownback specifically mentioned tuberculosis as a neglected disease that is “rampant” in the developing world but that has not gotten adequate R & D attention.

“You can have millions, even more than that, who are affected by a disease, but there is not a large marketplace to support the research that is necessary to develop a cure,” Brownback said. “It is my hope that what this will lead to is us developing systems and ways where we can reduce the cost and the time for drug delivery and development.”

Brownback’s provision passed the Senate but is not included in the House version of the bill. So a House-Senate conference committee will decide its fate. The Center for Global Health Policy, along with a coalition of other groups, is strongly supporting final passage.

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First, a quick update on needle exchange: The Senate Appropriations subcommittee on labor, health and education programs approved a spending bill this week that leaves in place the funding ban on needle exchange programs. This means a fight in conference over the fate of that provision, since the House approved language lifting the ban, albeit with lots of restrictions on where needle exchange programs can be located. As we’ve written here before, the ban technically only applies to domestic programs, but PEPFAR officials have extended it to international programs, so this has major implications for global HIV prevention efforts.

Now, for those who didn’t get enough HIV/AIDS science or policy news at the IAS conference in Cape Town (or those who didn’t get to go in the first place), Aidsmap.com has launched an online discussion forum to further delve into questions raised at the conference. Among the topics up for debate: the implications of calls for earlier initiation of antiretroviral treatment. Click here to check out the Aidsmap forums–and make sure to cross-post comments here, so the discussion can be wide-ranging.

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This is an update to our post earlier this morning on two key HIV policy votes in the House today.

So much for a new era of evidence-based AIDS policy in a Congress controlled by Democrats. In today’s vote on HIV/AIDS research, lawmakers agreed (by voice vote) to strip out funding for three HIV research grants, apparently because they involved examining the role of substance abuse and sexual behavior in HIV transmission. Never mind that physician-scientists say understanding the risk factors posed by prostitution and illicit drug use are vital to controlling the HIV/AIDS epidemic.

In a second pivotal House vote today, HIV/AIDS advocates won, sort of, when an amendment to reinstate the ban on federal funding for needle exchange programs was narrowly defeated.

It was only “sort of” a win because the language that was preserved by today’s vote is pretty muddy to begin with. Instead of a clear repeal of the ban, as Rep. David Obey, D-Wis., originally proposed, the langauge was significantly watered down to say that no needle exchange programs could be funded within 1,000 feet of certain locations, such as schools, arcades, etc.

Obey inserted that weaker language, even as he reportedly acknowledged that it is probably unworkable. He has said he would work toward an alternative as this bill moves forward.

Both these provisions were included in a massive spending bill to fund domestic health, labor, and education programs. The fight will likely now move to the Senate and then a conference committee, where the two chambers will work out any differences in their competing versions of the spending bill.

Advocates will be working to restore the HIV research money and  press for a full repeal of the needle-exchange ban.

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The House of Representatives will take up two pivotal HIV/AIDS-related amendments today as it debates a massive spending bill for domestic labor, health and education programs. Although the policy decisions at stake today are part of a domestic funding bill, they have implications for global AIDS. 

The first is a proposal by Rep. Darrell Issa, R-CA, to rescind funding for three peer-reviewed grants that focus on HIV/AIDS  prevention. Issa says they are an example of wasteful spending. The three grants ar focus on : substance abuse and HIV risk among Thai women;  HIV prevention for hospitalized Russian alcoholics; and venue-based HIV and alcohol use risk reduction among female sex workers in China. More information is included below in an action alert being circulated by health advocates.

The second amendment, from Rep. Mark Souder, R-Ind., would reinstate the ban on federal funding for needle exchange programs. As we’ve written in earlier posts on this subject, Rep. David Obey, D-Wis., moved to overturn the ban in subcommittee. He inserted a watered-down version in full committee but has pledged to work toward full repeal. Souder’s proposal would cut those efforts short and put back in place a ban that physicians and other AIDS advocates have long criticized as an unnecessary hurdle to effective HIV prevention efforts.

(more…)

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