PEPFAR Reauthorization in Danger

Just when it looked like PEPFAR would be reauthorized and that Congress would appropriate even more money than the president asked for, seven Senators, led by Tom Coburn of Oklahoma (along with Jim DeMint, Jeff Sessions, Saxby Chambliss, David Vitter, Jim Bunning, Richard Burr), have placed a hold on the bill, dramatically reducing the chances that it will pass this Congress. A hold is an obscure procedure in the U.S. Senate that enables any Senator to stop a bill that they do not like by preventing it from coming to the floor.

Michael Gerson, Bush’s former speechwriter, flagged this egregious action to set up an internal Republican dispute. As Gerson notes, Coburn objects that more of PEPFAR money is being spent on things other than treatment.

The seven, led by Coburn, complain that the reauthorization is too costly. They object to “mission creep” — the funding of “food, water, treatment of other infectious diseases, gender empowerment programs, poverty alleviation programs” — as though people surviving on AIDS treatment do not need to eat, work or get their TB treated.

They want 55% by law to be spent on treatment (which was how the first PEPFAR authorization worked) but this is stupid, as we’re not succeeding on prevention, meaning that more and more people are getting HIV and ultimately needing treatment. As Gerson writes:

Given that there are about 2.5 new HIV infections for every person starting on AIDS drugs, there is no way to control the pandemic through treatment alone. And because treatment is less expensive than it used to be, PEPFAR is meeting its treatment goal for less money. The 55 percent treatment floor would force the program to waste money in pursuit of an arbitrary, nonsensical spending target — the worst kind of congressional earmark.

You may want to give Coburn and company an earful about this nonsense. The ONE campaign has a letter to sign here. Direct contact info is available here.

UPDATE: Here is part of Coburn’s response where he rails against Gerson, touts his own credentials as a physician who has cared for AIDS patients and a consistent champion of HIV/AIDS programs. What he seems to be worried about is that the absence of a directive that 55% of PEPFAR money be spent on treatment will result in the program spending more money on consultants rather than services. I’m not sure if those funding directives are the best or only way to ensure that problem doesn’t occur.

Part of Gerson’s moral outrage is focused on my controversial stance that AIDS treatment dollars be spent on treatment. I want to preserve PEPFAR’s original formula that sends at least 55 percent of all dollars to AIDS treatment so widows and orphans and actual patients, not program officers and consultants, will be the primary beneficiaries of the program. This formula is made all the more important because the new authorization calls for a three-fold increase in funding from $15 billion over five years to $50 billion over five years. Moreover, this smart and well-designed policy, which Gerson once supported but now scorns, is a major reason why PEPFAR has been a Marshall Plan-like response, rather than a Katrina-like response, to the AIDS crisis in Africa.

Gerson’s determination to critique not just our policy concerns but our morality suggests that he is viewing this debate as proxy battle in the broader struggle in the Republican Party between what he views as “seedy” or “anti-government” conservatism and the “compassionate” conservatism he helped shape in the White House. That’s a broader debate that I welcome.

I don’t see a coherent answer to Gerson’s concern about prevention. I suppose that with an increased budget there would be enough money for treatment and prevention, even with the 55% limit, but 55% seems like an arbitrary Congressional mandate.

The AIDS Entitlement Crisis?

Mead Over of the Center of Global Development has a new paper, identifying a problem I wrote about before (see here). Unless the U.S. government gets a handle on AIDS prevention, the extension of ARV therapy will consume a larger and larger share of U.S. foreign assistance. In effect, we have created an external entitlement for foreigners. In the worst case scenario, a disruption in our funding would consign those people to death. Right now, the political support for sustained and increased spending is strong. However, as the pricetag rises for an ever larger population of people sick enough to need ARVs, the U.S. government needs a new commitment to prevention strategies. Over emphasizes the importance of male circumcision, as I have recently in a CSIS op-ed. Here is the abstract of Over’s paper:

U.S. global AIDS spending is helping to prolong the lives of more than a million people and is widely seen as a foreign policy and humanitarian success. Yet this success contains the seeds of a future crisis. Life-long treatment costs are increasing as those on treatment live longer, and the number of new HIV infections continues to outpace the number of people receiving treatment. Escalating treatment costs coupled with neglected prevention measures threaten to squeeze out U.S. spending on other global health needs, even to the point of consuming half of the entire U.S. foreign assistance budget by 2016.

This paper describes the dimensions of these problems and argues that the United States has unwittingly created a new global “entitlement” to U.S.-funded AIDS treatment that currently costs about $2 billion per year and could grow to as much as $12 billion a year by 2016— more than half of what the United States spent on total overseas development assistance in 2006. And the AIDS treatment entitlement would continue to grow, squeezing out spending on HIV prevention measures or on other critical development needs, all of which would be considered “discretionary” by comparison.

Over suggests ways to substantially restructure the President’s Emergency Plan for AIDS Relief (PEPFAR) in order to avert a crisis in which Americans would have to choose among indefinitely increasing foreign assistance spending on an entitlement, eliminating half of other foreign aid programs, or withdrawing the medicine that millions of people depend upon to stay alive. His suggestions include consolidating treatment success and leveraging treatment for prevention by making the extension of further AIDS treatment financing conditional on success in both treatment adherence and prevention outreach; shifting to a focus on prevention by underwriting male circumcision efforts and expanding HIV testing and counseling for couples more so than for individuals; and intensifying the effects of
prevention interventions by mapping high risk locations and targeting them with tailor-made prevention programs.

New Op-ed on male circumcision and HIV Prevention

Over at the CSIS Africa Policy Forum, I have a new op-ed on male circumcision and HIV prevention. Here are some excerpts:

In the past few years, clinical trials in Kenya, Uganda, and South Africa confirmed that male circumcision (MC) reduces the risk of transmission of HIV infection by approximately 60%.

In its Fourth Annual Report, the program [PEPFAR] announced that it had allocated $16 million in fiscal year 2007 for MC activities, up from $600,000 the year before. In FY 2008, funding may rise to $30 million.

The average cost to circumcise an individual has been estimated to be about $50. Thus, the $16 million for FY 2007 could be providing services to large numbers of people. Even assuming high start-up costs for training and administration, if only a quarter of these resources were dedicated to actual service delivery, that would still mean that more than 80,000 men could have received MC services by now. Unfortunately, while PEPFAR does a good job counting the number of individuals on anti-retroviral treatment, analogous data for circumcision services are not available. However, there is concern among experts and observers in the field that the number of people who have received MC services to date through PEPFAR is very, very low – probably fewer than 2,000.

A large part of the problem is that there are simply not a sufficient number of trained professionals nor properly equipped facilities to safely carry out the circumcision surgery for the large numbers of people who might request it. More worrisome still is the concern that MC funds are not being dedicated to organizations with the most experience and/or capacity to train people to carry out the procedure. In some cases, funds may be targeted to social marketing of the procedure and to encouraging local populations to support MC, without sufficient investment in the actual capacity and infrastructure necessary to meet that demand.

Male circumcision offers the same sort of compounded benefit that most effective vaccines offer to populations – herd immunity. As more men are circumcised, not only is their own risk of acquiring HIV reduced, but their current and future partners and their partners’ partners also are at lower risk.

While concerns about cultural acceptance should inform where and when MC services are provided, the main problem holding back the wider availability of such services appears to be supply, not demand. If training and infrastructure are the primary barriers to more expansive rollout of MC services, then it is incumbent on PEPFAR, now undergoing reauthorization before Congress, as well as on other donors, to respond. They need to do a better job channeling funding to those purposes and to implementing organizations that can translate support into effective service provision. To miss the potential of MC through squandered resources, oversensitivity to cultural concerns , and ineffective programming will only prolong the tragedy of HIV/AIDS in Africa.

Compromise on PEPFAR Reauthorization

It looks like a bipartisan compromise on PEPFAR reauthorization has been reached which will do several things:

(1) provide even more money than President Bush asked for (which already represented a doubling over the previous five year program)

(2) ease the rules and restrictions that directed a portion of prevention money to abstinence, and

(3) invest in the training of more than a 140,000 health care workers.

These are all good things. Here is an excerpt from the Times editorial:

The House Foreign Affairs Committee this week approved a bipartisan compromise, crafted in negotiations between House leaders and the White House, that would authorize a hefty $50 billion over the next five years to support campaigns against AIDS, tuberculosis and malaria. This represents a huge increase over the $19 billion appropriated in the first five years of the program and a significant increase over the new funding requested by President Bush. The president had originally proposed $30 billion over five years, primarily to fight AIDS, whereas the new bill would authorize perhaps $37 billion to $41 billion to the AIDS struggle.

In one farsighted move, money will be used to train some 144,000 new health care workers over the next five years to care for people infected with H.I.V., the virus that causes AIDS. That is at best a start on easing the severe shortage of health care workers in the developing world, which some estimates peg in the millions.

The most troublesome ideological constraint on the program — a requirement that one-third of the funds used for prevention services be spent on abstinence education — has been greatly eased…. It requires countries to report if abstinence and fidelity funding falls below a certain percentage, but it sets no firm percentage that has to be met.

Uganda begins production of $9 per month ARVs

From the KaiserNetwork.org

A pharmaceutical plant in Uganda this week will begin production of generic antiretroviral drugs following an order from the Ugandan
government for drugs worth 17 billion Ugandan shillings, or about $10 million, the East African Business Week reports (Etyang, East African Business Week, 1/28).

Ugandan President Yoweri Museveni in October 2007 commissioned the 15-acre pharmaceutical plant, which will produce triple-therapy combination antiretroviral and first-line malaria treatments. Ugandan pharmaceutical importer Quality Chemical Industries and Indian
pharmaceutical company Cipla will produce the drugs. The factory will manufacture the antiretroviral combination therapy Triomune, which contains lamivudine, stavudine and nevirapine. In addition, the factory will produce the first-line antimalarial combination treatment Lumartem, which contains artemisinin and lumefantrin (Kaiser Daily HIV/AIDS Report, 11/26/07)…

…According to the Business Week, about 100,000 Ugandans currently have access to no-cost antiretroviral treatment, but about
238,000 people in the country are expected to need the drugs by 2012. In 2005, about 42% of people in need of antiretrovirals had access to them, according to statistics (East African Business Week, 1/28).

Life insurance for HIV+ in South Africa

I belatedly discovered podcasts in my final weeks in Mbarara (Uganda) last December.  Two series, PRI radio programs on Health and Technology, have short stories that may interest readers.  The Health coverage includes a subset of HIV-specific podcasts.

One story from March 2007 reported on the new life insurance market for HIV+ residents in South Africa signaling a dramatic shift in access to HIV treatment. Interestingly, life insurance can be one requirement for securing a home mortgage.  According to the report, until recently without a life insurance policy, even well-off HIV+ individuals would have had a more difficult time trying to buy a home.

My comment on CSIS Online Africa Policy forum

Amy Patterson has a post on a new CSIS online Africa Policy forum.

Here is my comment on her piece.

Amy Patterson makes a number of important points. I generally agree that greater civil society mobilization would likely foster country ownership of HIV/AIDS programs, but what would that look like? How would that alter what donors are already doing? And, given the opportunity costs of focusing on civil society mobilization compared to other possible priorities, is a greater focus on participation by community organizations the most pressing need in the fight against HIV/AIDS?

Patterson notes that HIV/AIDS is not seen as a top priority in Afrobarometer polling. Does that not suggest that there may be difficulties in mobilizing civil society in Africa for this cause? The basic supposition in this piece is that the failures to date have been in part failures of insufficient engagement at the local level.

That may be true, but it also could be difficult for well-meaning outsiders to engender this kind of mobilization in the absence of top-level support by African leaders. We have witnessed the difference in the aggressive approach by President Museveni of Uganda in contrast to South Africa’s Thabo Mbeki whose support for AIDS denialists is well-known. Can or should external donors empower local groups in the face of state opposition? In the case of South Africa where the Treatment Action Campaign was already active, external support has been important. But, what if civil society is not especially active, the country’s executive is hostile, and the health system is decrepit? Where are resources best spent?

I am sympathetic to Patterson’s argument, but those of us who worry about public health and HIV/AIDS in sub-Saharan Africa need to flesh out what our specific policy recommendations would look like. The closest we gets in terms of specifics come in terms of the need for more simplified and harmonized reporting requirements by donors and finanicial support for civil society groups to hire and train bookkeepers, community organizers, and grant writers. All of that sounds reasonable, but I do not know how transformative efforts like that would be, if they were implemented.

It appears that bilateral programs like PEPFAR have focused on getting anti-retroviral drugs to needy populations in short order, which may have come at the cost of building local capacity in the health sector. Other donors like the Global Fund may have had more success in coordinating with local groups, yet they too have imperatives of getting money out the door and people on treatment. Alex de Waal’s 2006 book presciently warned of this potential outcome of focusing on short-term exigencies over long-term capacity.

In recent months, the debate about whether or not HIV/AIDS funding is coming at the cost of other health care priorities taps into this anxiety that people are getting treated for AIDS, but two problems are not being addressed as they should 1) other health care needs (and implicitly local health care capacity) and 2) prevention programs.

As I understand it, donors are increasingly seeking funds not just for HIV but for broader health systems capacity. Moreover, the ABC agenda seems to have run aground; changing sexual behavior is hard and political disagreements in the West have made it difficult to implement a coherent strategy.

As a consequence, the prevention discussion has turned towards male circumcision as a powerful strategy to reduce new infections. If this is where the discussion at the policy level is headed, how would or could civil society mobilization enhance the success of those programmatic efforts?

In the 1980s and 1990s, donors chose to go around the state because of fears about corruption and lack of capacity, but the argument has turned. Donors now know that long-run success depends on capable governance by recipient countries (as well as efficient markets). The political imperative of getting HIV/AIDS funds spent quickly and effectively has cut against this broader recognition of the importance of state and market capacity in health systems.

I worry that focusing so much effort on civil society mobilization could come at the cost of state capacity and development of markets for health care. There certainly is an important role for community groups in this process, particularly in terms of holding governments and service providers accountable. To the extent Patterson and other scholars can draw out the implications of this line of critique, I think the discussion will be richer for it.

The most persuasive article on male circumcision

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A January 2008 article in a new journal Future HIV Therapy makes the most persuasive case for male circumcision being rolled out on a much, much wider scale in sub-Saharan Africa. We have blogged about the importance of male circumcision before (see here, here, and here).

This new piece is by Jeffrey D Klausner, Richard G Wamai, Kasonde Bowa, Kawango Agot, Jesse Kagimba & Daniel T Halperin. They start their paper by asking “What would the reaction of the international public health community have been if a year ago scientists had announced the discovery of a vaccine or chemical gel that, in three separate clinical trials, had reduced the risk of heterosexual HIV infection in men by at least 60%?”

They answer that question by noting that male circumcision (MC) provides that kind of risk reduction potential and also one which potentially provides an “‘African solution to African problems.”

Here are some choice quotes:

Currently, MC is the only modality for preventing sexual HIV transmission that has been proven to work by the highest standards of scientific evidence; specifically, findings from multiple randomized controlled trials. In fact, it appears that the actual protective effect of MC is probably somewhat higher than the official 60% estimate cited by WHO and UNAIDS, especially among higher-risk men.

In fact, it appears that the actual protective effect of MC is probably somewhat higher than the official 60% estimate cited by WHO and UNAIDS, especially among higher-risk men. In part, this is because some men who were randomly assigned to the circumcision arm in each trial did not show up for their appointment and, more importantly, a larger number of men who were randomly assigned to noncircumcision decided to get circumcised on their own during the trial period. Hence, the ‘as-treated’ protective effect, taking into account the actual MC status of participants, was a 76% HIV reduction in the trial in South Africa (where HIV prevalence was highest) [19]; and averaging across the three trials it was 65% [12].

The ultimate population-level impact of MC would be further amplified by a ‘herd immunity’ phenomenon if a sufficiently large proportion of men were to become circumcised in the population.

Modeling suggests that widespread circumcision in the rest of sub-Saharan Africa could avert up to 2 million new HIV cases and 300,000 deaths over the next 10 years, and 3.7 million infections and 2.7 million deaths in the following 10 years, many of those among women [27].

What about the cultural acceptability of male circumcision? Is this not cultural imperialism? This article largely puts that notion to bed.

A dozen acceptability studies conducted in different parts of Africa where MC is no longer traditionally practiced have found that the majority of uncircumcised men want the procedure performed, and generally an even higher proportion of women in those regions would prefer to have an circumcised partner.

Male circumcision was historically practiced in nearly all of Africa, but 19th century European missionaries condemned the widespread traditional initiation ceremonies, which included circumcision, as pagan practices.

In a 2006 household survey of Swazi men in both urban and rural areas, 87% said they would want the procedure if it helped reduce the risk of HIV infection. In January of that year, the media reported on a ‘circumcision riot’ when over a hundred men in the capital city were turned away because not enough physicians were available at a ‘free circumcision Saturday’ event.

The authors are incredulous that there has been a delay in rolling out male circumcision on a broader scale.

So the question must be asked: why the continuing delays in the implementation of MC? Why do some prominent officials, nongovernmental organizations, Ministries of Health and international organizations vacillate as thousands become infected every day, preferring to debate over cultural imperialism, the ‘rights’ of the foreskin, the ‘real world’ validity of randomized trials and so on?

We understand the very real operational challenges, implementation logistics, safety concerns and the enormous task of scaling-up a surgical procedure so that it is readily available for millions of impoverished people.

They make their own personal case:

Two of the authors (Wamai and Agot) are from Kenya and have witnessed first-hand the devastation in the part of the country (Nyanza Province) where the virus has flourished due in large part, we now realize, because that is the one province where MC is not a cultural norm. Another (Bowa) is a Zambian urologist who has struggled to make safe MC available at the University Teaching Hospital in Lusaka; due to funding limitations, the demand for services has far outstripped supply and the waiting list has grown up to 8 months long. Another (Kagimba) was one of the original architects of the now famous ‘Zero Grazing’ behavior change (partner reduction) strategy in Uganda, and seeks to add MC to the ‘ABC’ prevention approach.

They conclude with a call for action:

Now, 25 years after the pandemic was first identified, we have an important additional tool, the knowledge to help bring life back, to give people some hope. We need the rallying cry; above all, we need accountability. We need you – the reader, the media, the viewer, the voter, the caring man or woman on the street – to say not whether but when. When will there be widespread, safe and affordable MC services available in Africa? Every day we are counting and watching.

Immediately, the front page of every major newspaper and other broadcast media around the world – certainly those in southern Africa – should report on the great impact that implementation of MC could bring.

New infections outpace treatment

This from the Kaiser Family Foundation reports:

HIV/AIDS Treatment Programs Will Not Keep Pace Unless Number of New Cases Decreases, Experts Say at PEPFAR Reauthorization Hearing
[Dec 12, 2007]
HIV/AIDS treatment programs in Africa will not be able to keep pace unless the number of new cases significantly decreases, experts said Tuesday at a Senate Health, Education, Labor and Pensions Committee hearing to reauthorize the President’s Emergency Plan for AIDS Relief, the Boston Globe reports (Donnelly, Boston Globe, 12/12).

I agree with the critics that Congress’ mandated spending requirements on prevention money are insane, but I disagree with those who think that if we just dump all our prevention money into condoms that will solve things. If you are married woman in the developing world, what chance do you have of forcing your husband to always use a condom? He may have a long-term girlfriend on the side which increases the risk to him and you, but asking your husband to use a condom potentially puts woman at great personal risk of abuse.

Here, one expert suggests that condoms are not the main answer and that abstinence and faithfulness policies have a role to play as part of prevention.

Experts at the hearing testified that the “most important battle” in curbing HIV/AIDS is stopping HIV transmission but disagreed on how to stop the spread of the virus, the Globe reports. Some witnesses at the hearing debated the effectiveness of a PEPFAR requirement that one-third of HIV prevention funds focus countries receive through the program be used for abstinence-until-marriage and fidelity programs (Boston Globe, 12/12).

Norman Hearst, a professor at the University of California-San Francisco School of Medicine, said that encouraging married men to be faithful to their wives and delaying the onset of sexual intercourse are the two main ways to stop the spread of HIV in Africa (Walker, CQ HealthBeat, 12/11).

According to Hearst, programs that focus on promoting condom use have “never worked” in areas where HIV is generalized (Boston Globe, 12/12). “It’s easier to change sexual behavior than getting the people to use an imported sexual device all of the time,” Hearst said (CQ HealthBeat, 12/11).

At the end of the day, it still seems that people are grasping for answers on prevention. Hence, the interest in male circumcision.

AIDS numbers inflated

I am sure this will become a big item of discussion, but Craig Timberg, who has written critical news articles about AIDS estimates before has written another article in the Washington Post detailing forthcoming new estimates, using improved sampling methodologies.

The latest estimates, due to be released publicly Tuesday, put the number of annual new HIV infections at 2.5 million, a cut of more than 40 percent from last year’s estimate, documents show. The worldwide total of people infected with HIV — estimated a year ago at nearly 40 million and rising — now will be reported as 33 million.

For example, the United Nations has cut its estimate of HIV cases in India by more than half because of a study completed this year.

There is some suggestion that the epidemic has crested, that fears of a potential global epidemic in places like China and India are overblown. I thought the line in the story about India was interesting in that India has been thought to have the largest number of AIDS cases, even if a small proportion of the total populace. This suggests the disease is much less of a problem in India than initially feared.

What does this mean for policy? The study quotes some other experts who think 33mn is still too high. I think in time this might mean more emphasis on health systems (broadening the health emphasis beyond HIV) and perhaps more targeted efforts to southern Africa and vulnerable populations in other countries.