Trying To Treat Africa

The Bush White House’s December 2003 call for grant proposals to the $15 billion President’s Emergency Plan for Aids Relief (PEPFAR) could not have come at a better time for teams of Harvard researchers working to provide treatment to AIDS patients in Africa.

Led by Harvard School of Public Health (SPH) Professor of Immunology and Infectious Diseases Phyllis Kanki, an AIDS expert with over 20 years of experience fighing AIDS in developing countries, the Harvard teams were building clinics, training health workers and treating thousands of patients with anti-retroviral drugs.

The researchers saw PEPFAR as an opportunity to broaden the scope and scale of their work. In just four weeks the Harvard team, with Kanki as principal investigator, put together a winning bid.

When then-U.S. Secretary of State Colin Powell announced that a $107 million, five-year grant would be awarded to Harvard in February 2004 for conducting studies and treatment in Botswana, Nigeria, and Tanzania, researchers were ecstatic.

There was just one problem: no one told top Harvard administrators—including University President Lawrence H. Summers—that this grant would legally bind Harvard to treating thousands of patients per year and overseeing drug supply and delivery in the region. With grant money and drugs frequently landing on the black markets of the countries in which Harvard would be operating, such a task could be very difficult­­—and not something large research universities like Harvard usually do.

Harvard’s Joint Committee on Inspections (JCI), a monitoring board made up of members of the Corporation and the Board of Overseers and led by Corporation Senior Fellow James R. Houghton ’58, subsequently demanded that Mass. Hall oversee the grant. The resulting five-month delay held up millions of dollars in funding even as 1,000 AIDS-infected patients were awaiting treatment. Up to 400 Nigerians on a waiting list for anti-retroviral drugs died before funding was released in July.

In the most recent of the highs and lows that followed the February 2004 announcement, researchers worried that the University would not accept funding for the grant’s second year, which began April 1.

While experts assert that Harvard’s on-the-ground progress in these African countries continues to set new global standards for AIDS treatment delivery, administrative difficulties have dogged this grant throughout much of its 15-month history.

EXECUTIVE ORDER

The initial elation inspired by the windfall for SPH quickly dissipated into anxiety once Summers’ and University Provost Steven E. Hyman’s concerns about the grant became known.

Mass. Hall refused to accept the grant’s initial $17 million until it created a position of an executive director for the PEPFAR program, reporting directly to Summers and Hyman. Richard L. Skolnik, a former World Bank official, was appointed to the post in January.

But the fact that an outside executive director presided over the principal investigator, Kanki, and three country directors was a source of irritation to many academics in SPH, who saw the administrative intrusion as a heavy-handed power grab.

At the center of the controversy was a letter sent to Kanki in August 2004 by SPH Dean Barry R. Bloom setting forth the terms of the new working relationship Kanki would have with the executive director. The letter was rescinded on May 18 after extensive back-and-forth between Kanki and the Provost’s Office over those terms.

Bloom’s letter, obtained by The Crimson in the spring, stated that Kanki’s research group’s “failure to observe the terms of this letter may have serious consequences not only for your individual roles within the program but also for the program itself.”

New operating principles were negotiated between Kanki and Hyman in May.

“These have the goal of ensuring that Harvard is in the best position to meet the expectations of the U.S. government and to serve Africans suffering with AIDS,” Hyman wrote in an e-mail last Friday. “These new arrangements also recognize Professor Kanki’s role as the programmatic leader of this effort.”

FUNDING DELAY

The five months it took to restructure the administrative aspects of the grant—from March until the first infusion of cash at the end of July 2004—had serious consequences for the African clinics and their patients, according to researchers.

Professor John Idoko, chair of infectious diseases at Jos University Teaching Hospital in Jos, Nigeria and head of one of SPH’s Nigerian clinics, criticized the University for the delay in 2004.

He said it came while at least 1,000 AIDS-infected patients were on a waiting list for anti-retroviral drugs that were supposed to be purchased by Harvard with PEPFAR funds.

But the funding for those drugs was not released by the University until the end of last July, Idoko told The Crimson in April, and up to 400 patients died while waiting for them.

John Longbrake, a spokesman for Summers, said at the time that the University believed the delays were necessary in order to lay the groundwork for optimal treatment.

“We believe strongly that our early attention to this program will allow us to maximize these funds in order to treat more people and save more lives,” his statement read.

The delay also meant that in-country partners in Nigeria—including doctors, nurses, counselors, and community health workers—went without pay from Harvard for five months, according to Idoko.

Max Essex, chair of the department of immunology and infectious diseases and of the Harvard AIDS Institute, said that some of the initial delays were likely not necessary.

“Obviously it hasn’t been well coordinated, and I do believe that until recently there was a lack of understanding of the extent of expertise available in the SPH for such work in developing countries,” Essex said last Friday.

TAKE TWO

Funding for the second year of the program, which officially began April 1, was also delayed until last week. The University is supposed to “draw down,” or accept a portion of the PEPFAR money, at least once every quarter—or risk defaulting and losing the grant, according to Program Director for Nigeria and SPH Adjunct Professor of Infectious Disease Robert Murphy.

Reached in Nigeria last Friday, Murphy said that there was a danger that Harvard would lose the grant if it did not draw down soon. Murphy said Friday that the University had yet to accept the funding.

But Hyman said last Sunday that the funds for the second year had been accepted “sometime in the past week,” although Murphy was unaware of this.

“It is quite normal for a school or department to advance funds between grant periods with the full knowledge that this will be reimbursed by the government when funding starts,” Hyman wrote in an e-mail. Murphy could not be reached after Friday.

ON TARGET

Although the official second-year funding was delayed, it has not interrupted treatment of patients, Murphy said.

And despite the funding and administrative delays experienced during the first year of the program, the PEPFAR teams were able to reach the first-year targets for the number of patients treated set by the grant.

“Because the treatment has gone on as long as it has, there is already clear evidence that anti-retroviral drugs for very sick patients works and is cost effective,” Essex said. “Despite the advanced stage of their sickness, they’ve done just as well one to two years later as people who get treatment in a Boston hospital. Therapy can work very well.”

“I think that’s a great tribute to Phyllis. She’s really the one who’s held this together over a course of confusion in the initiation of the program,” he added.

—Staff writer May Habib can be reached at habib@fas.harvard.edu.