15 years later, PEPFAR is still at war with a global epidemic

WASHINGTON — Funeral processions clogged the streets of Harare, gravediggers in South Africa could not keep pace with deaths, and in Uganda everyone knew someone who had died from AIDS. Once the disease was identified, a diagnosis was almost always a death sentence, and many who received it were ostracized from their communities and cast out by their families. Doctors, with no treatments to provide, watched their patients grow sicker and more fearful. The United States government’s assistance helped parents create memory boxes for their children, and little else.

In the 1990s, the number of people infected with HIV/AIDS in sub-Saharan Africa more than doubled, and by 2000 it was clear just how devastating the epidemic had become. That year, Dr. Melinda Wilson moved to South Africa with the U.S. Agency for International Development. Thinking back on that time, her voice trembled.

“We were burying people six deep at certain points in time in the epidemic,” said Wilson, a senior care and treatment advisor at USAID. “We were helpless; all we could do was help people die with dignity.”

Descriptions of what the President's Emergency Plan For AIDS Relief has achieved in the last 15 years often include words “miracle,” and “unprecedented.” The initiative has provided antiretroviral medications to more than 14 million people, saved millions of lives, and helped stave off an epidemic that threatened to consume entire countries and cripple their economies. As PEPFAR celebrates its 15th anniversary this month, perhaps even more striking is the widespread agreement among the initiative’s biggest backers that if PEPFAR does not go even further — or if political support falters — the basic mathematics of disease will bring about a new emergency, wiping out a victory that was never fully achieved.

Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, knew what it was like to be one of those health professionals, dedicated to saving lives, but with no way to prevent patients from dying. Sub-Saharan Africa in the early 2000s felt eerily similar to the U.S. in the early-1980s.

“People can’t appreciate what it was like when you were trained to be a healer and to make people better, and yet everybody that you took care of ultimately died a terrible death with very few exceptions,” he said.

In the 1980s and early 1990s, medical researchers made slow, painful progress, developing individual drugs, and then realizing they needed combination therapies. But 1996 saw a breakthrough. Researchers developed a drug combination that turned HIV from a death sentence with a median survival rate of one year from the time patients presented to a treatable, chronic disease.

“It was what you called the ‘Lazarus effect,’ because people were essentially on their way to dying, and they were turning around and going back to work, going back to school, going back to productive relationships and families … We were saying, ‘my god, this is nothing short of breathtaking,'” Fauci said.

“It was at that point that many of us — at least a few of us — became very cognizant of the fact that the epicenter of the epidemic was in the developing world, particularly in sub-Saharan Africa,” Fauci said.

In March 2002 President George W. Bush sent a delegation of policymakers, medical professionals, and faith leaders on a fact-finding mission to Africa.

“There were six of us who were outside of government who went on that trip,” said Shepherd Smith, president and founder of the Institute for Youth Development, and an influential Christian evangelical.

Their mission — coordinated by a handful of the U.S. government’s global health leaders, including Anthony Fauci; Mark Dybul, who would later become the U.S. global AIDS coordinator; and Bill Steiger, now chief of staff to the USAID administrator — was to assess the health assets that existed in the sub-Saharan countries they visited, Smith said.

“My only clue that it was being done essentially for PEPFAR was that several times a friend on the trip was saying, ‘we really want to know what sort of programs could be supported here.’ PEPFAR was kept under wraps very well by a very small number of people,” Smith said.

For Fauci, the trip to Africa was a terrible déjà vu. He likened what he saw there to the U.S. epidemic, when doctors were reduced to putting “bandaids on hemorrhages, because we didn’t have any drugs for HIV — because we didn’t even know it was HIV.”

“And here I am now in Africa in 2001, 2002 … and I’m seeing physicians in Africa in the same frustrating position that I was in [20 years earlier]. And that is — being able to take care of people, but not having any tools to give them,” Fauci said.

The initial scope of the scouting effort was small. Fauci, Dybul, and other officials wanted to find out what it would take — and what health systems were already in place — to support a U.S. effort to stop mother-to-child transmission of HIV.

“We came back with a plan for $500 million for mother-to-child transmission, which, at the time, I thought was an enormous amount of money,” Fauci said.

Bush, in a move that has made even his biggest political critics into admirers of his commitment to HIV/AIDS, told them he wanted something bigger. He asked for a program to treat, prevent, and care for people with HIV that would be completely transformative for the continent.

“This is impossible, because it’s going to cost billions and billions of dollars,” Fauci recalled telling the president.

“Let me worry about the money. Just see if we can put the plan together,” Bush told him.

The plan

Many people at the time doubted a major HIV treatment program in sub-Saharan Africa was possible. In 2001, then USAID Administrator Andrew Natsios said that money for the Global Fund to Fight AIDS, Tuberculosis and Malaria, which had just been launched, should be used for prevention and not for antiretroviral drugs.

“Africans don’t know what Western time is,” don’t have watches, and would not adhere to ARV regimens, Natsios argued at the time. He pointed to poor infrastructure and bad roads that would make it difficult to deliver drugs to people infected with HIV.

There were small pockets of successful HIV treatment happening in some places, where foundations and other funders were supporting clinics to purchase and administer drugs. When treatment centers had drugs, they were able to get them to people who needed them; and the people who needed them actually took them, Fauci said.

“So contrary to the somewhat racist attitude that some people had that, ‘well you can’t really do this in Africa because they’re incapable of taking the drugs and things like that.’ That was wrong. If you gave them the opportunity to save their lives, they did it,” he said.

Building on what they had seen during the trip, Fauci enlisted Dybul to put together a plan. It called for $15 billion over five years, the prevention of 7 million HIV infections, treatment of 2 million people, and care for 10 million people including babies.

In his State of the Union Address, on Jan. 28, 2003, President Bush announced a massively ambitious effort to tackle HIV — an initiative he called, “a work of mercy beyond all current international efforts to help the people of Africa.”

Then came the task of marshaling support in U.S. Congress, and creating legislation that could turn Bush’s surprising announcement into a funded initiative with a legal mandate.

There are fewer and fewer members remaining in Congress who were there when Bush announced PEPFAR. Barbara Lee, representative for California, is one of them. Even before the State of the Union she was working with the Congressional Black Caucus and pushing Bush to “launch a major new U.S. initiative to fight AIDS,” in a late 2002 letter.

There were tense moments and difficult negotiations, Lee said. Some members of Congress didn’t want any funding to support care for women who were commercial sex workers, which led to a big fight in committee.

“At the committee level the amendments were just horrible,” she said.

For the faith community to be involved, they needed assurances they would not face government grant requirements to conduct activities that went against their beliefs, said Smith, who worked to build support among Christian groups and conservative Republicans. Many of them objected to the third “C” in PEPFAR’s “A, B, C” prevention strategy — distributing condoms. Chris Smith, a Republican representative for New Jersey, barely succeeded in attaching an amendment to PEPFAR’s authorizing bill, which provided a “conscience clause,” allowing organizations to opt out of providing services that conflicted with their beliefs.

Despite the ideological battles, PEPFAR remained a bipartisan effort, and on May 27, only four months after Bush’s announcement, Congress passed the authorizing legislation. The first signs of PEPFAR’s impact soon followed.

On April 1, 2004, PEPFAR’s antiretrovirals shipments arrived in South Africa. Waiting rooms were packed with HIV positive patients seeking help, said Wilson, who was still working with USAID. The ARVs worked quickly, and the same people who had once faced a dire prognosis began to make rapid progress.

“The shift from treatment readiness to a treatment program was probably the joy of my life,” Wilson said. “It was so much nicer when that mom — when people didn’t die. And that’s the difference it made. We were used to people dying, and when that money came along we didn’t have to be used to that anymore.”

Transformation

From the start PEPFAR was a unique initiative, combining a treatment agenda few thought possible with a focus on results and accountability — and massive sums of money.

“The money really mattered. You couldn’t have done anything without the money. But it was more than that. It was a results-based approach, and it was a transformational view on the centrality of treatment,” Dybul said.

Three years earlier, the Millennium Development Goals had failed to include a target on treatment for HIV, “because the majority, if not the vast majority of the public health field, said treatment wasn’t possible in Africa,” Dybul said.

The Millennium Development Goals also didn’t come with any money.

“It was quite a different thing to have money attached to very specific goals and objectives,” Dybul said. He likes to quote something Rwanda’s President Paul Kagame told him about PEPFAR’s results-based model: “This is the first time someone has respected us enough to hold us accountable.”

PEPFAR was also built to draw in multiple different sectors, including — controversially at the time — the private sector.

“Everyone runs around talking about the engagement of the private sector now. Back then, everyone was saying, ‘over my dead body,’” Dybul said.

Just as the initiative sought to break down silos between development and business, so did it take aim at the walls between federal agencies, with a whole-of-government approach that hadn’t been seen before. Despite hand-wringing from USAID, the U.S. Department of State housed the initiative and coordinated the seven agencies involved.

That meant ambassadors led the efforts and made funding decisions — including Jimmy Kolker, who was the U.S. ambassador to Uganda when PEPFAR launched.

“Looking back, it was not a foregone conclusion. There were institutional rivalries, doubts, and systems to scale up,” he said.

In Uganda, once the PEPFAR money came through, Kolker said he was able to deploy it quickly, in part because there were already strong partners, particularly the Joint Clinical Research Centre and TASO, The AIDS Support Organization, in place. 

PEPFAR’s funding system was revolutionary, Kolker said, adding that instead of implementers or embassies having to apply for money, they were given funds based on a proportion of people who needed treatment, short circuiting the USAID procurement system.

The procedural innovations “saved literally years of staff time and permitted the country teams to move immediately to consider specific in-country programs,” Kolker wrote.

“When PEPFAR was created, it was created out of a failure of the existing aid infrastructure to deal with this growing pandemic,” said Matthew Kavanagh, director of the Global Health Policy and Governance Initiative at the Georgetown University O'Neill Institute. “The core ideas behind PEPFAR were really transformative: It was sufficiently large deal to deal with the pandemic, it leveraged all parts of the U.S. government, had high-level leadership.”

In the early days PEPFAR was “truly an emergency program,” an “all hands on deck” effort to get services to people and deliver medications as quickly as possible, said Sara Allinder, deputy director and senior fellow of the CSIS' Global Health Policy Center, who spent 10 years at PEPFAR. That meant a lot of the early years were spent building capacity — from health facilities to training health workers, and building labs.

Some of the global health community’s biggest emerging priorities — treating noncommunicable diseases such as cancer and diabetes in developing countries, for example — fundamentally rely on the treatment and delivery systems that PEPFAR helped to create.

“An infrastructure and a mindset around chronic delivery is now in place that is opening up opportunities around noncommunicable diseases that would not exist — would absolutely not exist — were it not for the response to the HIV epidemic,” Dybul said.

“It’s hard to imagine success in most of global health without PEPFAR as a backbone,” said Catherine Connor, senior director of public policy and advocacy at the Elizabeth Glaser Pediatric AIDS Foundation.

The new emergency

PEPFAR’s long-term goal of ending the AIDS epidemic in Africa faces a fundamental challenge: Demographics. The population of sub-Saharan Africa is projected to double between now and 2050, and young people — who will comprise the majority in many countries — are the highest risk for HIV infection.

“It’s just math. If you double the size of the population of the people most at risk ... [and] if you maintain where you are today, you will double the number of infections,” Dybul said.

Part of PEPFAR’s current challenge is a product of its own success.

Around 2.2 million children have been born HIV free to HIV positive mothers because of PEPFAR’s work on preventing mother-to-child transmission. But some of those children, particularly those saved in the early efforts, are now in their teens, and as they grow up continue to be exposed to HIV. Across sub-Saharan Africa, teenage girls have among the highest rates of new infections, accounting for 74 percent of new HIV cases among adolescents, according to PEPFAR’s data.

In South Africa, where Babalwa Mbono lives and works for mothers2mothers, it is partly due to sexual relationships between teenage girls and older men, which girls are often pressured into in exchange for money to support their families. South Africa has the largest HIV epidemic in the world, with about 19 percent of all people living with HIV, 15 percent of new infections and 11 percent of AIDS-related deaths, according to UNAIDS.

Mbono — who is HIV positive and a recipient of PEPFAR support — has a 15-year-old daughter, Anathi, who was born HIV-free. She looks at her daughter and others like her who were saved by PEPFAR and worries.

“We managed to save them, now they’re growing up and are exposed to HIV,” she said. “What it means to us, is we need to make sure we maintain processes to support them to survive, live a healthy lifestyle and stay negative.”

That means encouraging testing, education, making safe sex important, and addressing socioeconomic issues that leave young girls vulnerable to exploitation and abuse. Peer relationships and peer counseling, a model that mothers2mothers has used to help support women with HIV, is critical to reaching the girls, Mbono said.

If programs don’t support those children, the early investments that allowed them to be born HIV free will have been a waste, she added.

PEPFAR, in part due to its focus on data, launched a program about three years ago called DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe), aimed at reducing HIV infections among adolescent girls and young women in select African countries. The program addresses social issues that increase their HIV risk, including sexual violence, poverty, gender inequality, and lack of education.[a] PEPFAR reported that in nearly two-thirds of the highest-HIV burden communities where the program was running, there was a 25 to 40 percent decline in new diagnoses.

Answering the question of how to reach adolescent girls will be critical in addressing the future of the epidemic, and DREAMS could offer valuable models to replicate. However, that may be unlikely due to funding constraints. Countries are struggling to add DREAMS in even one or two communities this year as they plan, Kavanagh said.

The administration of President Donald Trump, in both its fiscal year 2018 and 2019 budget requests, proposed significant cuts to PEPFAR’s funding, calling for an $800 million reduction in the latest blueprint. Congress, which ultimately determines the U.S. federal budget, has flatly rejected those efforts, and lawmakers have been outspoken in their support for continuing a U.S. legacy that has spanned three presidential administrations.

The most recent White House request, in March, caused particular concern, though, stating that: “At the funding level requested in the Budget, the United States would provide sufficient resources to maintain all current patient levels on HIV/AIDS treatment.”

That sentence caused more consternation in the advocacy community than Elizabeth Glaser Pediatric AIDS Foundation’s Connor had seen in a long time, she said. It raised the question of whether PEPFAR — if the Trump administration ever got its way — would only continue to maintain patients currently on ARVs or whether it would continue to provide treatment to newly identified HIV-positive individuals.

Lives — and the difference between ending an epidemic or seeing its deadly resurgence — hang in the balance.

PEPFAR’s future

With budget pressure coming from the White House, PEPFAR launched a new strategy in September. It calls for focusing on 13 countries that have shown an ability to achieve epidemic control by 2020.

While the strategy says that PEPFAR will continue to invest in 50 countries to maintain lifesaving treatment, make testing linked to treatment more accessible, and provide more services to orphans and vulnerable children, it also begs a question: What will happen to non-focus countries?

South Africa, Nigeria, and Mozambique, which all have high HIV burdens, were left off the list of 13. While they are unlikely to achieve epidemic control by 2020, there is little doubt they need continued investment to make progress and forestall a resurgence of the epidemic.

“Where the broader goal is globally controlling the epidemic, you can’t do that and claim epidemic control on the continent of Africa without Nigeria,” said Chip Lyons, president and chief executive officer at the Elizabeth Glaser Pediatric AIDS Foundation.

“It would be a mistake … to have leaders — political, policy, and funding leaders — think that a limited number of country epidemic control strategies is the same as a global epidemic control strategy,” he said.

While declining drug prices — and new, affordable regimens coming online — will reduce some treatment costs, PEPFAR implementers push back on the argument that they can keep squeezing more efficiency out of their programs to make up for potential funding cuts or budget shifts.

While they defend PEPFAR’s budget, U.S. lawmakers will also consider whether to reauthorize the initiative this year — a legislative act that could help PEPFAR achieve some funding security, but which could also open the initiative up to renewed political battles, such as the ones that surrounded its creation.

While advocates say there is still bipartisan support for the program in Congress, many of the legislators who helped to pass PEPFAR 15 years ago are no longer in office. Only about 20 percent of Congress today was serving when PEPFAR was authorized and they don’t know the history, Lee said.

“It’s a defining moment and I don’t want to risk losing what we have,” she said. “I have to be convinced it would move us forward not backward.”

PEPFAR would continue to operate without the reauthorization, and advocates worry that legislation would be a potential vehicle for additional measures or constraints, or a way to try to codify the Mexico City policy prohibiting funding to organizations that provide information about abortion.

“No one wants to see PEPFAR dragged through the political mud, so that’s the other concern, that if it [is] raised in this climate it could tarnish its reputation for bipartisan support,” said Jenny Ottenhoff, global health policy director at the ONE Campaign.

“Complacency is a risk,” Kolker said. “It is not headline grabbing, it is not an emergency crisis, but still tackling a disease of this magnitude is just an all-out effort. Political leadership and recognition have to be in it for long term.”