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Former US President Bill Clinton speaks to the International AIDS Conference

Filed by Meredith Mazzotta from Vienna

“This is only the end of the beginning,” former President Bill Clinton said at the Monday morning plenary session of the International AIDS Conference in Vienna. “We have to transition now from what has essentially been a ‘make-it-up-as-you-go’ initial response to a calculated, long-term response.“

Part of that response, he said, is recruiting more well-trained health care workers. “Specifically, we need people who can do good work at a lower cost over a wider geographic range than doctors can do alone in poor countries, or that doctors and nurses can do alone.” Clinton also spoke about fighting the idea that there is a dichotomy between investing in HIV/AIDS treatment and prevention and investing in health care systems. Part of that involves showing that we are spending the money we do have effectively and wisely.

A few other recommendations he mentioned: challenging African nations to spend more on health, educating as well as advocating on the economic benefits of HIV treatment and prevention, cutting the cost of service delivery, and spending a higher percentage of donor aid on in-country services managed by local government or nongovernmental organizations.

At the Sunday evening opening ceremony, protesters marched into the session room and onto the stage with posters, flags and horns, chanting about keeping promises for AIDS funding. This was in response to recent budget proposals for FY2011 that indicate a retreat from the Obama administration’s promise to fund global AIDS at $50 billion over the next five years.

In response to the protesters, Clinton offered this advice, “You have two options here. You can demonstrate and call the president names, or we can go get some more votes in Congress to get some more money. My experience is that the second choice is the far better one and more likely to pay off,” Clinton said, adding, “There is no way the White House will veto an increase in spending for AIDS.”

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Ezekiel J. Emanuel, center, White House global health advisor

Ezekiel J. Emanuel, head of the Department of Bioethics at The Clinical Center of the National Institutes of Health and a breast oncologist, is on extended detail as a special advisor for health policy to the director of the White House Office of Management and Budget.

But that doesn’t speak to his impact. He is one of the architects of the Obama administration’s Global Health Initiative, and he has been a lightning rod of criticism for activists who want a much more vigorous global AIDS response from the administration.

Emanuel spoke to John Donnelly on Saturday about how the Obama administration now needs better ideas for making global health programs more efficient, and how he won’t shy away from taking on AIDS activists. “I have two brothers and all we do is disagree,’’ he said.

Q: You haven’t been shy in pushing back on criticism from AIDS activists about the Obama administration’s smaller increases in the global AIDS budgets than under the Bush administration. What really upsets you?

A: We can have disagreements about the right policy, which way we are going forward, but we can’t have a disagreement about the facts – the facts of the budget. A number of advocates are saying we are cutting the PEPFAR budget. The fact is funding for HIV and our work on PEPFAR is going up – in 2009 2010 and 2011. That is matter of fact. You may not like the allocation we have made, or not like the pot we are putting it in, but (saying we are) cutting the budget is wrong.

The second thing is [the notion] that somehow I am `anti-HIV,’ or `anti-work-we-are-doing-on-HIV,’ is absolutely wrong. This development of the [Global Health Initiative (GHI)] is building on everything we have done, using what our work in HIV and malaria has shown us. One of the things that we have shown is that you can take complicated medical interventions, get them working in rural areas — including sophisticated techniques like measuring T cell and viral loads — and monitor people. A lot of what we have put into the GHI is built on the foundation of PEPFAR. We want to broaden it.

And (another thing) is that we have a moral obligation to the people we are trying to help that if we are spending money on things that are not efficient, we have to be more efficient. There is a moral obligation from the community (working in AIDS issues) not to just ask for more money, but to say, `We have this pot of money, how are we going to do the most with it?’

We’re not doing this because we are green-eyeshade, no-morals people. It’s because we want to save lives and spend money most efficiently.

Q: Still, Ambassador Eric Goosby told Science Speaks this week that even with efficiencies, there will be a `mismatch’ between funds and the need.

(more…)

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Dr. Eric Goosby, US Global AIDS Coordinator

Global AIDS: `An inevitable mismatch of resources and need’

Ambassador Eric Goosby, MD, the US global AIDS coordinator who assumed his position a little more than a year ago, will be a significant presence at the International AIDS Conference in Vienna, which kicks off Sunday night. John Donnelly interviewed him Wednesday about his expectations for the conference, what was behind the Uganda problem with shortages of AIDS medicine, and whether The New York Times was right when it reported in May that the Ugandan drug shortfall was “the first example … of how the war on AIDS is falling apart.’’


Q: You just wrote an article on the State Department blog on how you traveled to Uganda in June to address drug shortages, detailing how the Global Fund suspension of funding had a spillover effect on all AIDS treatment there. Why did you feel the need to go to Uganda to sort it out?

A: The reason was that I wasn’t getting a clear picture of what the problem was and why we were finding ourselves in a situation where seven of our clinics were saturating (reaching the limit of number of patients). Attempts to work through the PEPFAR team in country resulted in explanations … patients came, we saw them, that’s what happened. It wasn’t that they were withholding their explanation of the domino-effect of the Global Fund sites. The truth was, they weren’t aware of it. So when we went we interviewed every provider, and looked at all the records, and saw an abrupt increase in enrollment that had not been budgeted for in PEPFAR. I asked the question, `Why did that occur?’ I found out that 11 Global Fund supported public clinics in the course of 18 months or so had gone from stuttering to stopping. Their Global Fund grant stopped. There was no formal closing of these clinics. They quietly closed. Patients who went to those clinics just showed up at our door.

Q: So is this an isolated problem based in one country with one large grant? Was The New York Times wrong in reporting from Uganda in May that “Uganda is the first and most obvious example of how the war on global AIDS is falling apart,’’ or was there some truth to it?

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Mark Harrington is the Executive Director of the Treatement Action Group.

The International AIDS Conference starts this coming weekend. ScienceSpeaks sat down with Mark Harrington (right), executive director of the Treatment Action Group (TAG), to get his thoughts on the meeting.

TAG is an independent AIDS research and policy think tank fighting for better treatment, a vaccine, and a cure for AIDS. TAG’s programs focus on antiretroviral treatments, HIV basic science and immunology, vaccines and prevention technologies, hepatitis and tuberculosis.

Tell me about the IAS pre-meeting you are attending in Vienna, on potential functional and sterilizing cures to HIV/AIDS?

This 2-day meeting is a collaboration between IAS and TAG which will bring together both scientists as well as some community activists who are interested in the science of HIV.  The pre-meeting will look at both functional and sterilizing cures. A functional cure doesn’t mean you’ve gotten rid of all of the virus in the body, but it does mean long-term absence of detectable virus without therapy, so you wouldn’t have to take medication every day.   We’ll also look at sterilizing cures, which would therapeutically eradicate the virus. The discussion and research are preliminary, and not ready for standardized trials. But there is a need for targeted studies and we will be addressing that.

Why is it a priority for you to attend that meeting?

Part of TAG’s mission is to ensure that research is done to end the epidemic, and that will be through a cure and a vaccine. So it’s natural that we would be a part of this.

Some research recently presented at CROI in February showed that adding the integrase inhibitor raltegravir to an already suppressive triple Highly Active ART (HAART) regimen did not further reduce viral burden. This is because current HAART suppresses all full cellular replication of HIV, so the only HIV expressed during effective HAART is coming out of latently infected CD4 T cells which are reawakening from latency. HAART is fully effective in preventing these new viruses from infecting new cells. This led researchers to reopen the search for therapies which could awake the virus out of latency so they could be killed by HAART, which would be one approach to a cure.

HAART or combination antiretroviral therapy, on the other hand, has set the stage for revival of eradication research. We’ve reached the limits of what we can do with HAART in terms of what it’s able to do about virus population, so new research is needed because HAART does not affect HIV DNA resting in latently infected CD4 T cells. (more…)

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Daniel R. Kuritzkes, MD, Professor of Medicine at Harvard Medical School

The International AIDS Conference starts up in less than a week in Vienna, Austria.  ScienceSpeaks is gathering thoughts from leaders in the field HIV/AIDS treatment, research and advocacy in the question and answer series “Looking toward Vienna.”

Daniel R. Kuritzkes, MD, is a Professor of Medicine at Harvard Medical School. He is also the Head Director of the AIDS Research section of Retroviral Therapeutics at Brigham & Women’s Hospital in Boston.  Dr. Kuritzkes also serves as Vice Chair of the Executive Committee of the Adult AIDS Clinical Trials Group (ACTG) and is the Director and Principal Investigator of the Harvard Adult AIDS Clinical Trials Unit.

What are your expectations for the conference?

I hope that the conference will be another opportunity for networking and for inter-disciplinary discussion, particularly for people that have been developing therapeutics and those charged with rolling out ART in developing countries where there is high demand for these medicines.

I’m looking forward to dialogue about the intersection of therapeutics and prevention. The results of the first PrEP trials will be fostering much discussion, with the presentation of the CAPRISA trial results.

Any sessions you are particularly looking forward to?

President Clinton is going to be speaking again on Monday and that’s always interesting and exciting. Also, the sessions on therapeutics and drug resistance are a particular interest of mine. The discussions on the intersection of therapeutics and prevention, and discussions of the ongoing roll-out of HIV treatment in developing countries, are what this meeting especially helps to foster.

I do expect to hear news about novel antiretroviral regimens, HIV drug resistance, the role of immune activation in disease pathogenesis, HIV prevention, and of course HIV and TB.

The pivotal trial for rilpivirine (TMC278) will also be presented.  This drug potentially provides an alternative to efavirenz (EFV), lacking the CNS toxicity and the teratogenicity of EFV.  In addition, the AIDS Clinical Trials Group will be presenting data on bone effects of NNRTI- and PI-based regimens.  Lastly, before the actual conference gets underway there is an IAS-sponsored workshop dealing with viral persistence and eradication (Friday-Saturday) that I will be attending.

Are you aware of any new research in Vienna being released on HIV drugs?

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The strongest scientific-journal rebuttal yet to the Obama Administration’s proposal to shift resources to maternal and child health at the expense of HIV/AIDS treatment scale up comes from two medical students, who in a commentary just published in AIDS make a clear and convincing case that such a move would actually undermine the health of women and children around the globe, not improve it.

“While we welcome the Mother and Child Campaign in a diverse portfolio of global health strategies funded by the United States, we are troubled by the ‘either/or’ mentality that places HIV/AIDS funding in direct opposition to initiatives to improve MCH,” write Sarah Leeper and Anand Reddi, who are studying medicine at Brown University and the University of Colorado respectively.

Referring to a JAMA article by Colleen Denny and Ezekiel Emmanuel that first outlined this proposal, they write: “We do not accept the premise by Denny and Emmanuel that the proportion of child deaths due to AIDS is ‘small,’ nor do we support the characterization of highly active antiretroviral therapy (HAART) as ‘new, complex, and expensive.’ We would argue that policies based on misrepresentations such as these threaten to undermine rather than support MCH worldwide.”

Leeper and Reddi take apart the Denny-Emmanuel argument piece by piece. For starters, they note that in the five countries with the highest HIV adult prevalence, HIV is the No. 1 cause of mortality for children under 5 years old. “One-thousand children were born with HIV everyday in 2007, due in part to the fact that <25% of all HIV-positive women worldwide have access to prevention of mother-to-child transmission,” they write.

The article also notes that all children born to HIV-positive mothers, whether they have HIV themselves or not, are at a much higher risk of death if maternal HIV is not treated. Leeper and Reddi point to a study of 3,468 children of HIV-positive mothers in Africa found that uninfected children with HIV positive mothers who gave birth “at an advanced disease stage” were at significantly higher risk of death. “This may be attributable in part to the fact that children with HIV-positive caregivers reside in food-insecure households more often than their unaffected peers, putting them at higher risk for malnutrition and death from diarrhea and acute respiratory infection,” they write.

Leeper and Reddi detail how HIV therapy is a cost-effective intervention and highlight the opportunities to build on PEPFAR and other global AIDS initiatives to improve maternal and child health, rather than doing the latter at the expense of the former. They note that clinical studies in Rwanda and Haiti have shown how PEPFAR has led to better maternal and child health outcomes.

“Confronting illness in isolation–whether by funding PEPFAR at the expense of programs that target MCH or vice versa–cannot be our way forward. Integrated health service delivery models that address the well-being of both HIV-positive and HIV-negative families, without prioritizing one at the expense of the other must be developed, funded, and implemented,” they conclude. “The complex and interrelated challenges of MCH against the devastating global backdrop of HIV require comprehensive models of care that combine HIV/AIDS and MCH initiatives.”

You can find their article here. It has been published online ahead of print.

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A crucial milestone was passed this week in the effort to get increased funding levels approved for global health programs, including PEPFAR, USAID and the Global Fund. The State and Foreign Operations Subcommittee of the House Appropriations Committee, led by Rep. Nita Lowey (D-NY), approved some increases for these programs relative to FY 2010, despite having less money overall to work with.

The Subcommittee divides up an overall amount of money that is only about 1.4% of the total US budget.   But, this total was $4 billion less than what President Obama requested, due to a cut imposed by the Chair of the Appropriations Committee, Rep. David Obey.  In fact, it was the international affairs account that bore the brunt of the cuts to the President’s budget proposal.

All of the global health programs in this bill were increased over FY 10 enacted levels.  Tuberculosis, family planning, and the Global Fund received increases above the President’s request.  Advocates had requested specific, higher levels and have sent a letter to both the House and Senate raising concern about HIV/AIDS funding.

These are the amounts approved for a few areas of interest, drawing on info from the Global Health Council:

The Global Fund — the Subcommittee rejected the Obama proposal to cut the US contribution below the FY 2010 level.  Instead, the Subcommittee approved $825 m,  a boost of  $75 million for the Fund above FY 2010. (President’s Request: $700 m; FY10: $750 m).  However, it remains to be seen whether the portion of the US contribution that comes through the Labor Health and Human Services budget will be provided in full.

Bilateral HIV/AIDS — the Subcommittee provided a boost of $91 million over the FY 2010 level, approving $5.050 b (President’s Request: $5.150 b; FY 10: $4.959b).  This is about half of what President Obama had requested.  Obama had proposed using half of his requested increase for PEPFAR to help finance technical and management assistance for the GHI Plus Countries, and we hear that the report language accompanying allows this.  That means  that about $50 m of the boost for PEPFAR will go to this purpose and only $41 m will be available to expand access to direct services, such as prevention, care and treatment.

USAID’s TB program —  The Subcommittee gave this program a boost of $15 m over the FY 2010 level, approving a total of $240 m (President’s request was $230 m; FY 10: $225 m)

In other decisions, the Subcommittee provided the full amount requested for the Peace Corps, giving it a boost of $46 m over 2010.  And it approved a $71 m increase for Embassy Security, Construction and Maintenance, $114m above the Obama request.

The panel considered an amendment offered by Rep. Rehberg that would have reduced most of the bill’s spending levels by 7.27 percent and reduced multilateral assistance by 31.85 percent.  But, this was voted down along party lines.

There are still many hurdles yet before the funding levels are finalized.  The Senate’s State and Foreign Operations Subcommittee is expected to consider the International Affairs budget sometime in July.  Then a conference committee would have to iron out any differences. Finally, the bill would have to be approved by the full Congress, which could be significantly delayed by the fall elections.

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