Newsday - June 17, 2001
Laurie Garrett, Staff Writer

The toll in the countries of Africa has at last brought a halt to business as usual. Much of the world's political and scientific leadership are in seeming unison, calling for a level of funding sufficient, at least theoretically, to bring the pandemic to its knees.

A turning point in attitudes can be found in last summer's World AIDS Conference in Durban, South Africa -- the first time the biannual meeting was held in a developing country, one hard-hit by the disease. Though a call for globalization of HIV treatment had been made four years earlier, it was in Durban that momentum began to build.

"I found that after the Durban meeting I could not live with the intrinsic contradiction that every European and American deserves the best possible treatment to save their lives, but every African has to wait for a vaccine and change their behavior," said one researcher, Stanford University's Dr. David Katzenstein. He left with the realization that "the equity health issue in

AIDS is the paramount moral, technological and logistics challenge of the 21st century." Several weeks ago UN Secretary-General Kofi Annan called for a global AIDS fund of $7 billion to $10 billion. On June 25, the UN General Assembly will convene a three-day special session on AIDS -- the first session ever called for discussion of a health issue. And four weeks later, when the G-8 summit of the world's most powerful political figures gathers in Genoa, Italy, AIDS will top the agenda.

Annan's war chest would be unprecedented in the world of global public health. Dollars are being raised now at a level that could top $3 billion by summer's end. And though some experts say even more is needed to be effective -- some estimate as high as $20 billion annually -- the promise of realizing at least a portion of those fund-raising goals has pushed unlikely partners to a shared debating table.

But the tasks at hand -- setting targets and mobilizing forces, and doing so through shared decision making -- are expected to challenge the ability of the players -- scientists and activists, poor countries and international lenders, pharmaceutical companies and UN development agencies -- to reach consensus. In fact, acrimony already has surfaced.

Never before have all these players tried to do so much as find a common language for debate. And though the global fund is yet to be formed, disputes are already arising over nearly every aspect of its application -- down to who should constitute the panel of experts that would dole out the money and set priorities.

The overall cause, of allocating resources to wage an all-out war on HIV, has found new supporters among traditionally conservative political leaders whose support had been previously focused on HIV prevention through sexual abstinence.

"The world is on the verge of a modern-day plague that not only threatens the developing world, but the stability and health of the entire globe," Rep. Henry Hyde (R-Ill.) said on June 6. "Let us be clear: The HIV scourge that is spreading through sub-Saharan Africa and elsewhere is reason enough for the generous American people to act."

Hyde's comments came as he introduced a bill that would authorize $519 million next year for the pandemic, most of it earmarked for U.S. Agency for International Development prevention efforts in sub-Saharan Africa. It would also permit contributions to the global AIDS fund, with a stipulation that each $1 must be matched by $3 from all other wealthy nations combined. So far only France and the United Kingdom have committed funds, totalling $234 million.

"Simply stated, the AIDS virus is one of the great moral challenges of our era," Hyde said.

The White House already had budgeted $200 million to the global fund. This week a Senate bill called for $200 million for 2002, and another $500 million for 2003.

Total global spending on AIDS fell well short of $3 billionin 2000. Past U.S. contributions to global HIV control have gone to the UN AIDS Programme, created five years ago and which has a $70 million budget this year, according to the U.S. General Accounting Office.

One of the controversies surrounding the new global fund is the agency's role. Though the fund will be held by the World Bank, the Bank's leaders say they want it administered by a board with an as-yet undefined membership that probably would include UNAIDS Executive Director Dr. Peter Piot. Global funding efforts are expected to get a boost this summer from the European Commission, which, according to U.S. State Department sources, may contribute as much as $2 billion. And Italy, which will sponsor the July 20-22 G-8 summit, has called upon the 1,000 largest corporations in the world to each donate half a million dollars.

But there are strings attached to all this apparent generosity. And controversies, as well.

The EC's commissioner for development, Poul Nielson, said in a May 16 speech in Brussels that the Europeans want assurances that the fund will reflect the EC's action plan on not just AIDS, but also malaria, tuberculosis and a list of other communicable diseases. Moreover, Nielson said, the fund should be used to "strengthen national health systems that we see as the bedrock of efforts to improve the health of the poor." The EC will oppose any "single-issue funds," directed solely at AIDS, Nielson continued.

The poor countries must be aggressive partners in any such effort, Nielson insisted, "keeping prevention efforts to the fore. This is crucial."

Finally, he vowed, "a global fund cannot succeed and will not get our support" unless the pharmaceutical industry worldwide agrees to cut its prices for poor countries.

Those provisos rub against other demands. Barely had the fund's existence been announced when other agendas began to surface.

World Health Organization Director-General Gro Harlem-Brundtland told the World Health Assembly, WHO's governing body, in Geneva on May 15 that the fund should be used to address a broad range of health issues.

"We have an opportunity to leverage a significant increase in resources," she said. Because details of the fund's constitution will be announced at the UN session, "the timetable is necessarily a tight one," she continued. "You might say that we are going to sail in the boat while we are building it."

And they will sail in rough seas.

"Quite clearly at the moment ... [the fund] means all things to all people, and I think leaving it in that way for a long time means it will fail," said Dr. Desmond Johns, South African representative to the WHA.

The prospect of funds for long-neglected or impoverished programs made many WHA delegates act like well-seasoned shoppers at a Barney's warehouse sale.

If we wanted to use funds for malaria bed nets, would these funds be available, asked Mali. Could AIDS-devastated countries that aren't desperately poor receive funds, asked diamond-rich Botswana. Will the IMF and World Bank let us take this money without repayment strings attached, queried Lesotho. Can the nongovernmental organizations on the front lines get money, too, asked Holland's Medicaments Internationals.

Clearly concerned that an unseemly melee was unfolding, Brundtland said in an interview in Geneva, "My primary point is I don't want any turbulence about the co-sponsorships of the fund setting up friction between WHO and UNAIDS. But it's clear to me that the larger health sector response is fundamental to the AIDS fight."

In other words, the war on AIDS needs to be part of a united front against a vast spectrum of diseases, which, Brundtland insisted, can be won only by strengthening basic health infrastructures.

If the various contenders get funds for non-AIDS projects, they will have AIDS activists and UNAIDS to thank.

"Our strategy was to politicize AIDS," UNAIDS executive director Piot said during the drive from Geneva to his home in southern France. "Now we've got what we want. I'll continue to push the whole UN system to take on AIDS as a core issue."

Now that real money may be on the table, Piot turns to the next concern. "I'm really worried that we don't do harm. Physician: Do no harm," he said, citing the classic motto of medicine.

What worries him is the potential misuse of the global fund by forces interested in waging political battles over such issues as:

Debate within international economic development circles over the wisdom of making one-time charitable donations to poor countries' health systems vs. the need for long-term commitments to bolstering the basic infrastructures of health. Those infrastructures include clinics, networks of trained personnel, public health disease surveillance, vaccination programs and basic and sterile supplies.

Arguments about the World Trade Organization that are part of larger battles over globalization. In particular, the global fund has been a lightning rod for debate over the Trade-Related Aspects of Intellectual Property Rights agreement, or TRIPs, which protects pharmaceutical patents and prices.

Squabbles over the relative importance of spending dollars for treatment vs. prevention of disease.

Fears the funds will feed corruption instead of moving rapidly to desperate areas.

The call for globalization of HIV treatment was first made in 1996 by the French government. Others subsequently issued similar suggestions. But it wasn't until last year's World AIDS Conference in Durban that the movement gathered momentum.

Stanford University's Katzenstein was one person who became obsessed with finding a solution.

Since 1984, he had been doing HIV research and AIDS treatment in Harare, Zimbabwe. He reached a point where he could no longer stomach treating his California patients with $18,000-a-year cocktails of anti-HIV drugs, then telling his Zimbabwean clients they couldn't have the same medicines because they were too poor.

Last fall, Katzenstein was nearly overwhelmed by the scale of the moral dilemma. And then, he recalls, he had an epiphany.

"If there were a disease killing 3 percent of young adults in America every year, there would be an organized effort to act on scientific information to provide treatment and dignified death for those people. Africa has been told, "We cannot afford it.' Africa has chosen denial as the way to face it. It's not unlike ignoring the Holocaust.

"And the epiphany," he said, "is that we know how to do this. "We' is ... all the incredible organizations that have grown up around meeting this challenge in the United States."

Here, activists, scientists and physicians created ways to fast-track innovations and get them to most HIV-positive individuals, regardless of their financial or insurance status, Katzenstein says. And if such a change could happen here, why not there?

"The first principle is, one acts to extend human life if you have the means," he concluded.

About the same time, Dr. Bruce Walker at Harvard Medical School reached roughly the same conclusion, having compared the situations of his Ugandan, South African and Boston patients. Dr. Tom Quinn of Johns Hopkins University similarly took note of how healthy his Baltimore patients seemed, while his Ugandan patients died in droves.

"To simply turn our backs on 25 million persons who are infected is not the appropriate response," Walker said.

For the AIDS physicians the paramount issue became a moral imperative to treat.

As such thinking percolated through the HIV clinical research community in the U.S. and Europe, activists connected to such groups as ACT UP and New York's Treatment Action Group embraced the question of treatment access with opposition to what they call corporate greed.

"The African AIDS holocaust, perpetuated in great part by corporate greed and racist development policies, resonates deeply with our membership," said Paul Davis of ACT UP Philadelphia, the group that has spearheaded attacks on drug prices. The Philadelphia group, largely composed of African Americans who are infected with HIV, "has lived the experience of medical apartheid, of shoddy services to poor people," Davis said.

ACT UP found allies among those that had been complaining about what they considered pharmaceutical industry price-gouging: the Nobel Peace Prize-winning humanitarian group Doctors Without Borders, the governments of Brazil and South Africa, the Washington D.C.-based Consumer Project on Technology and London-based relief group Oxfam. A transatlantic coalition formed, pressuring the drug industry, WHO and UNAIDS.

They shared a key goal -- forcing the UN agencies to set up bulk purchasing mechanisms for anti-HIV drugs so that WHO, for example, could buy millions of doses of antiretrovirals and distribute them to hard-hit countries.

Doctors Without Borders' Dr. Bernard P coul and the group's Geneva office brokered a deal before Christmas with Cipla, a drug manufacturer in India. The company agreed to make a generic version of three popular HIV drugs and sell the treatments to Africans for about $350 a year. If Cipla could make a profit selling the drugs for about $10,000 less than they cost in the U.S., observers said, then the patent companies' markup was a factor to consider.

WHO, UNAIDS and eventually Annan called for greater pricing flexibility from the drug industry.

The industry's umbrella lobbying organization, the International Federation of Pharmaceutical Manufacturers Associations, backed lawsuits against the governments of South Africa and Brazil in hopes of blocking their use of cheap, generic versions of patented products.

The suit against South Africa was withdrawn in April, and the industry began cutting its prices, even offering free drugs in some cases.

And the pharmaceutical manufacturers associations changed its posture. The issue, spokesman Harvey Bale explained, "is not patents. Some 1.95 billion people have malaria, tuberculosis, onchocerchiasis, schistosomiasis, dysentery... and there are very effective drugs for all of these diseases. And very few of these drugs have patents."

But the drugs are still out of reach of people in the Third World.

Bale called for focus to shift to drug delivery, infrastructure, access to care and individual purchasing power.

Now the global fund is caught in a crossfire between consumer price advocates and the pharmaceutical associations. The advocates want some of the fund used, P coul explained, to purchase drugs. Sources close to the White House say the administration would oppose using the fund for bulk drug purchasing, particularly if such an approach undercut profits for American drug manufacturers. Looming in the background of this debate is the Trade-Related Aspects of Intellectual Property Rights, or TRIPs, accord. Most of the nations of the world have signed the World Trade Organization treaty, hoping to benefit from its economic provisions. But the intellectual property components of the World Trade Organization, which kick into play in 2005, are controversial.

"We always say that we respect TRIPs," P coul says, insisting that Doctors Without Borders does not seek to bring down the international patenting system. "But the system needs some flexibility," so poor countries have leverage in forcing down drug prices.

The pharmaceutical industry insists that any weakening of the Trade-Related Aspects of Intellectual Property Rights accord will erode patent protections, decreasing their ability to invest in drug research and development.

It's likely that access to drugs will be item No. 1 in the global fund debate. Item No. 2 will be infrastructure and its corollary: which should get more money, prevention or treatment.

As drug prices fell this spring, Harvard University economist Jeffrey Sachs, UNAIDS economists and World Bank analysts calculated drug costs, the sizes of affected populations in poor countries and rock bottom clinical costs, reaching estimates ranging from $3 billion to $5 billion annually to treat Africa's millions of infected people. With each fresh analysis since the Durban meeting, the cost estimates have risen, the most extreme being that arrived at by the Bill and Melinda Gates Foundation. Gates favors weighting the expenditures on the prevention side, and thinks control of the three diseases in Africa alone would cost upwards of $20 billion a year.

There's a fair amount of guesswork in all of these figures, experts admit. And, in reality, no one expects the global AIDS fund to meet even the low-ball estimates. UNAIDS economist Robert Hecht said the first move will involve the core issues of development in poor countries: infrastructure, equity, corruption and sustainability -- or how to prevent such an ambitious effort from being waylaid by such pitfalls as poor roads, no electricity, underskilled staff, lack of safe water supplies, corruption and theft.

"You must have systems that should enable you to use the drugs," South African Minister of Health Dr. Manto Tshabalala-Msimang said in an interview. "So if you have not started with infrastructure you will only make more problems."

Tshabalala-Msimang pointed to her country's mining company, Anglo-American, which recently agreed to provide antiretrovirals to thousands of infected employees and their spouses.

But, Tshabalala-Msimang noted, wives of many employees were in inaccessible villages, and many "do not understand the importance of completing a course of drug therapy. People don't have watches."

In the end, explained South Africa's ambassador to the United States, Sheila Sisulu, "even if you are able to put a tablet in a person's hand, they are unable to take that tablet if they do not have clean water. It's basic. It's not just throwing tablets at the problem. It's about general health care infrastructure."

South Africa has been offered highly discounted, even free drugs, but balks at their distribution because the government doesn't have mechanisms to make the medicines available, and properly used, by everybody from gay men in Capetown to poor rural women in the villages of KwaZulu Natal.

"I find this very painful," South African Justice Edwin Cameron said last week in a talk at Gay Men's Health Crisis in Manhattan. "In my own country, the government that has led the way for the whole world in human rights is still dithering at the most elementary steps of providing drugs for people with HIV."

Cameron, who sits on South Africa's highest court of appeals, last year revealed that he is HIV positive. While he is the highest ranking South African to openly declare his HIV status, Cameron says that "at least 70, perhaps 100 members" of his country's Parliament are infected.

In a recent speech at the National Institutes of Health in Bethesda, Md., Dr. M.W. Makgoba, president of the Medical Research Council of South Africa, angrily denounced as murder his government's apparent paralysis in the face of infrastructural failures. Each day, it is estimated, 200 babies are born HIV positive in South Africa -- each of those infections could be prevented by giving the pregnant mothers Nevirapine -- a drug the German manufacturer has donated free to African countries. Because South Africa cannot figure out how to guarantee all the nation's millions of pregnant women HIV tests and access to Nevirapine, it gives the drug to no one.

Government officials throughout Africa are worried about instability, and therein may lie the final rub of the global fund. Getting antiretrovirals to poor countries affordably is only the first stage of the global equity battle. The second, as Tshabalala-Msimang points out, is equitable distribution within nations, guaranteeing that the drugs don't spark instability.

"I'm concerned that antiretrovirals will become a form of currency," says Breda Gahan of Concern Worldwide. For years Gahan has worked for the humanitarian relief organization in Tanzania, Uganda and Rwanda, focusing on AIDS. "We already see this currency business with broad spectrum antibiotics."

Most parties to the debate acknowledge that treatments will, at least for the first two to three years, reach only the urban elite in most poor countries, and they worry that word of miraculous recoveries will prompt uprisings among the poor.

"Who will get these drugs? Not the poor farmer," Piot says. "It's a fundamental discussion about equity and the role of the state... I think that's why governments are reluctant to get involved."

Ultimately, Cameron says, "the HIV/AIDS fight and access to care has the potential to change civil society, discourse and action in southern Africa. It could be tremendously empowering."

Behind-the-scenes battles are being waged now over who will administer the fund. When the list of names is announced, all of the stakeholders in the battle will inspect it with great concern.
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