AIDS Deaths Tied to Delays

A specialist working with Harvard School of Public Health (SPH) researchers on AIDS treatment in Nigeria said yesterday that up to 400 people may have died while waiting for treatment that was to be paid for by funds that were delayed for five months by Mass. Hall.

Professor John Idoko, chair of infectious diseases at Jos University Teaching Hospital in Jos, Nigeria and head of one of SPH’s Nigerian clinics, said that at least 1000 AIDS-infected patients were on a waiting list for anti-retroviral drugs that were supposed to be purchased by Harvard in March 2004. The funding for those drugs was not released by the University until the end of last July and some of those patients died while waiting for them.

Harvard University President Lawrence H. Summers and University Provost Steven E. Hyman held up the funding until July 2004 because of concerns about the legal and liability issues associated with the African AIDS programs, funded by a $107 million federal grant.

The grant commits Harvard to treating thousands of patients a year with anti-retroviral drugs and implementing clinical drug delivery mechanisms in three African countries—Botswana, Nigeria, and Tanzania.

Mass. Hall delayed the funding until it imposed a structure that placed more administrative control over the grant in the hands of University officials, angering some faculty members involved with the projects. Those faculty members said that the appointment of an executive director infringed upon the role of SPH Professor Phyllis J. Kanki, who applied for the grant.

World Bank development expert Richard L. Skolnik was appointed executive director of the grant.

Idoko criticized the University for delaying funds to the programs in Nigeria.

“They were people with very bad disease and therefore needed urgently to get the drugs,” Idoko said yesterday in a phone interview from his clinic in Jos. “The demand for drugs in this country is so high.”

The grant, funded through the White House’s $15 billion fund for African AIDS relief, aims to treat 40,000 people in Nigeria in five years. The program is currently treating 7,300, and is well on its way to the first-year target of 8,000 patients, Skolnik said yesterday.

Idoko and Nigerian program director Robert Murphy, adjunct professor of infectious disease at SPH, said lives might have been saved had the University released the funding in March as originally planned.

“They basically held us hostage,” Murphy said last week. “They didn’t draw down on the funds, they delayed until the very end and we were just kind of limping along. We were delayed significantly.”

Hyman has said that the University was concerned that anti-retroviral drugs purchased through the grant—which he called a “highly unusual” grant for an academic institution—would end up on the black market and that patients who began treatment would have to stop because of shortages or supply chain problems.

John Longbrake, a spokesman for Summers, said in a statement yesterday that the University believes that the delays were necessary in order to lay the groundwork for further 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,” the statement read.

Skolnik said that all reports of patients who die while on anti-retroviral drugs go to the Human Subjects Committee at Harvard for review.

“When people die who are on drugs, it is assessed if it has anything to do with the fact that they were on drugs,” he said yesterday. “People are going to die, but hopefully they won’t die because of problems with the quality of care.”

Another of the grant’s three program directors, SPH Associate Professor Wafaie Fawzi, head of the efforts in Tanzania, said that many patients who died while awaiting treatment were probably in the critical last stages of the disease.

“If there’s any reason to believe that it is related to the program, it is noted,” Fawzi said. “But in many cases, it’s not the quality of care, but rather that a great many of the people who had initiated treatment were very advanced in the disease.”

Skolnik said that so far, no deaths have been attributed to the quality of care.

But Murphy said yesterday that although the patients on the waiting list were “the sickest patients,” many could have lived longer had they received treatment in March.

“I don’t think [University officials] understood the consequences of delaying this grant,” Murphy said. “I don’t think there was any maliciousness....It’s very unfortunate. That’s how it goes with this disease.”

Murphy said 2,000 to 3,000 additional patients could have been on treatment had it not been for the funding delay.

‘HEART AND SOUL’

Because funding for the program was delayed in March, in-country partners in Nigeria—including doctors, nurses, counselors and community health workers—went without pay for five months, Idako said.

“They were getting stipends from the hospital,” Idoko said. “But Harvard gives them stipends for Harvard-related work, and they weren’t getting that.”

The employees at his clinic began receiving their stipends at the end of July, Idako said, but employees at other Nigerian sites did not begin receiving their pay until last September.

“The only reason they were even willing to start was because of the existing relationship they had with Professor Kanki and myself,” Murphy said. “We’ve been working there for years. It’s amazing that they worked for nothing.”

An oversight committee for the grant, chaired by Harvard Medical School Professor Martin Hirsch, will be meeting next week to begin planning the grant’s first annual audit report, Skolnik said. The audit will be done by independent, outside experts, he added.

The audit report is scheduled to be released next November.

Skolnik stressed the program’s successes in meeting treatment targets in Nigeria and elsewhere.

He also indicated that the AIDS treatment programs would soon save roughly 40 percent of the cost of anti-retroviral drugs, thanks to the recent Food and Drug Administration fast-tracked approval of a generic AIDS drug.

“Harvard should be proud of the work that people have done here,” Skolnik said. “This is a really challenging, difficult, life and death issue. People are giving their heart and soul to this project.”

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