Two events make up the pillars of the narrative people who have worked with Dr. Deborah Birx tell, when they talk about the the physician researcher who has been nominated to lead the President’s Emergency Plan for AIDS Relief. One event concerns the only clinical trial for an HIV vaccine candidate to yield proof of the concept that a vaccine could protect against HIV acquisition. The other concerns a drive to unite opposite ends of HIV-fighting efforts, by bringing the promise of HIV treatment to research sites. In both cases, they say, the woman named to lead PEPFAR into its next phase diverged from conventional wisdom to set precedents that made all the difference.
The day after President George Bush announced the formation of the global HIV fighting strategy that would become the President’s Emergency Plan for AIDS Relief, Dr. Deborah Birx, then director of the United States Military Research HIV Program, called her staff together, to discuss how to become part of the plan.
It was an interesting, but also surprising idea. At least one staffer asked her to explain, adding: that’s not what we do. It seemed an important point. The MHRP, established in the late 1980s in response to the threat the HIV epidemic posed to U.S. and allied military forces, was set up to develop preventive measures with a primary focus on finding an anti-HIV vaccine. With clinical trial sites in Uganda, Kenya, Tanzania and Thailand, that was a substantial mission alone.
Colleagues who worked with Dr. Birx at the time recall her answer: Because, she said, marrying prevention to care was the ethical way to do research. By bringing treatment to trial sites they would add value from their presence, whatever the outcomes of trials. Providing access to treatment addressed challenges to researchers as well.
“One of the things we had to overcome was a reluctance [potential trial subjects had] to get tested,” Dr. Merlin Robb, MHRP’s director of clinical research, who has worked with Birx since 1990, “Because testing was associated with death. That was one of the obstacles we now have overcome.”
Dr. Fred Sawe, a physician working in Kenya’s west highlands Kericho county, points out another issue. When only participants in trials could access any hope at all, “informed consent had no meaning, because people wanted to live.” With the MHRP bringing treatment through PEPFAR, access to treatment no longer hinged on trial participation.
“Debbie has vision,” Col. Nelson Michael, M.D., who succeeded Birx as director of MHRP in 2005 and worked under her from 1988 until then. “She sees things others don’t.”
That meant that outside of the program, no one thought the Department of Defense should be involved, Robb recalled. In addition, as with many sites as PEPFAR began, logistics, including supply chain management were a challenge. But Robb adds, “She wouldn’t take no for an answer. It was the wrong answer.”
Sawe, whose specialty in gynecology had made prevention of mother to child transmission one of the focal points of his work, said he watched the transformation of his community.
“In 2000, people were dying left right and center,” he said. “In coded language, doctors could only tell people to go home and die. We had nothing for them.” Even the hope offered by mother to child HIV transmission prevention was tainted by tragedy, he said. ” A society that can’t look after its children is doomed. We wondered who would look after these children when their mums were dead.”
He too, however didn’t understand the role of the military in HIV prevention and care. “A lot of us associated the army with going to war. I saw the soft side of the army; these are people who truly care.”
He had wondered, when he first met Birx in Kericho, why she chose it as a trial site. “It was one of those run-down hospitals,” he said. She told him about a laboratory worker she had seen there, maneuvering a broken slide for a malaria test, keeping it together with his fingers. “It touched her,” he said. “She told me these were the kind of people she wanted to work with.”
By then, Birx, who completed her internship and residency at Walter Reed Army Medical Center with training in immunology, and had focused since on HIV and global health, had reason to know she needed to work with people ready to overcome obstacles.
The probability in HIV vaccine trials of success has been slim; no trial had turned up a candidate with even a suggestion of effectiveness. But the RV 144 HIV vaccine trial in Thailand that Birx was then championing at the MHRP had faced exceptional doubts. Combining elements that had failed on their own, the RV 144 was the subject of a letter sent to Science Magazine in 2004, signed by leading scientists calling its scientific rationale weak, and calling for it to be abandoned.
“It’s one thing to fly in the face of convention,” recalled Mitchell Warren, executive director of AVAC, Global Advocacy for HIV Prevention, of which Birx serves on the board. “She was launching a trial that leading scientists in the field said ‘that’s crazy.'”
Had the trial yielded the results the letter’s writers predicted, “she would have been vilified,” Warren added. “The Thai trial took amazing courage.”
“There was definitely a sentiment in some scientific circles that this was destined to fail,” Robb concurs. Instead, in December 2009, the results of the Thai trial were released in the New England Journal of Medicine showing a modest benefit from the vaccine candidate, the first vaccine trial results to support proof of concept that a vaccine can protect against HIV acquisition. It also yielded data that continues to be explored.
“I think it paid of quite handsomely,” Robb says, “It has given insights, hope.”
By that time Birx had left the MHRP to head the U.S. Centers for Disease Control and Preventions Global AIDS Program. “Essentially she had built a resilient organization so the trial continued,” Michael said. “She protected that study during the period of its greatest vulnerability.”
Through their nearly three decades of work together, Michael believes he has seen all of the qualities the next leader of PEPFAR will need.
“I think she’s going to elevate the position,” he said. “I think it was just magical that she was selected. The burden of AIDS falls disproportionately on women. Women are underempowered. Girls are getting infected. I think having the face of the largest treatment program be the face of a woman, the field is going to see something remarkable happen to an already remarkable program.”
With the position of U.S. Global AIDS Coordinator having stood empty since the first of November, Warren hopes that happens soon.
“We are at one of the most delicate moments in the fight,” he said recently. “The last thing we need is gaps in leadership, gaps in funding. Those gaps will cause further harm.”
He worries already that with some countries reaching the “tipping point” at which the number of people starting antiretroviral treatment for HIV exceeds the number of people becoming newly infected with the virus, complacency could slow continued efforts.
“Those countries could tip right back, and we’ll be further behind,” he said.
It is a concern Birx herself noted at a Morroco conference in October.
“Uganda was a success story,” she said then. “We all clapped for ourselves and said, together we’re stemming the epidemic in Uganda, because you can see the blue line originally went down, but the blue line quickly went back up. Yet Kenya next door, both the new infections and deaths continue to decline.”
In the western highlands of Kenya, Sawe says the research center in Kericho has become “a mutually beneficial synergy.” Sawe said. “We have a spillover from research to larger public health benefits. It has helped build local capacity.”
The rundown facility that Birx visited, where a lab worker maneuvered a broken slide by hand, now is part of a facility that has been rated the second best hospital in the country, he said.
He credits Birx, and the potential she saw there.
“She gave me a very rare opportunity to be of service to my community,” he said. Almost 30,000 people needed treatment when the MHRP began to work with PEPFAR, Sawe said. “The majority of those thirty thousand would be dead by now if it wasn’t for the treatment program, and if it wasn’t for Debbie to bring it. Someone would have come by now, but not as soon. It enabled us to think outside the box and instead of barriers, see opportunities. Kericho owes Debbie a lot.”
For Robb and Michael, the road between Entebbe and Kampala tells the story of what has happened since the day Birx instructed her staff to find a way to work with PEPFAR.
An hour-and-a-half journey, it was a byway lined with vendors selling produce, hardware, clothing, furniture, the stuff of everyday life, except, among the bed frames at every furniture vendor, for the coffins.
“Now,” Michael said, “you can take that drive and not see a single coffin.”
“It’s one of those visually imprinting memories that will stay with me for the rest of my life,”Robb said. “You saw that industry go away. The road was a hallmark of success.”