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Outrage, Indifference Greet Plans for Worldwide Treatment Agenda — As Millions More Die

“No Drugs in Time for Her”

In April, Kofi Annan, the UN Secretary General, said it would take just $7-10 billion a year to mobilize the resources necessary to reverse the ravages not only of HIV, but of tuberculosis and malaria. Also in April, a group of economists, doctors and others from Harvard said that it would take $1.1 billion to treat one million HIV-infected people in Africa. Mark Harrington took it upon himself to find out what these figures were based on — and to see how realistic they might be. The result was a captivating narrative of the rapid-pace developments over the past nine months, which finds its genesis in last July’s protests and picnics in South Africa.

It’s been an astonishing year for AIDS treatment activism, full of amazing highs and lows. One year ago, with great fanfare, five big drug companies, along with the World Health Organization and UNAIDS, announced that they would provide steep reductions in the cost of HIV/AIDS drugs in developing countries. In July 2000, ten thousand AIDS researchers and activists went to Durban, South Africa, for the 13th International AIDS Conference. On the opening evening of the conference, some of us marched with 5,000 South Africans from the Treatment Action Campaign (TAC), many of them chanting and singing in Zulu, and were demanding global access to AIDS drugs. Then those of us who were conference delegates filed into Kingsmead soccer stadium to hear South African President Thabo Mbeki refuse to make the connection between HIV and AIDS, or between pharmaceutical company prices and the plight of 35 million people with HIV around the world who could not afford treatment. Instead, he treated us to a lecture on poverty, reading from a World Bank report published in the early 1990s.

Over the course of the year, a global groundswell arose. No one was getting the drug discounts announced in May. Drug companies negotiated slowly, company by company, drug by drug, country by country. Meanwhile they held steadfast in their determination to litigate South Africa’s 1997 medicines act, and successfully pressured the Clinton administration to haul Brazil before the World Trade Organization for its 1996 intellectual property law.

Then I went back to South Africa with my three colleagues from TAG and two from Project Inform. We spent two more weeks there with TAC, training 300 activists, health care workers, nurses, counselors, labor union officials, youth workers and PWAs about AIDS treatment. We met intensely political activists from Johannesburg who seemed to know more about the ballot controversies in Florida than we did, despite our being sated with CNN. We heard people tell us their doctors wouldn’t give them Bactrim or ketoconazole because “You’ve got AIDS and you’re going to die.” And we heard Soweto pediatrician Glenda Gray tell us, and TAC, about the “memory boxes” her patients would make, filled with photos and memorabilia and tapes telling their children that they loved them, that they wished they could still be around, but that AIDS had taken them away, and blessing their children and wishing them good lives. We met women from rural KwaZulu-Natal who came out with HIV in front of 50 other participants at the workshop in Durban and begged for solidarity. We heard about AIDS orphans getting raped because some people thought that having sex with a virgin would take the HIV away.

Every day at the Cape Town workshop, the 150 participants filed in singing and chanting ANC freedom songs with the words changed so that they were about AIDS. A woman took me out during a break and told me about her depression. She had been positive for years. I said, maybe activism can help. She shook her head. It was the despair of knowing that there was no way the government was going to provide any treatment in time for her. At the end of each workshop, the TAC people stood and sang the beautiful anthem of the new South Africa, “Nkosi Sikelel’ iAfrica,” and we would cry.

On our last day in Cape Town we had dinner at Zackie Achmat and Jack Lewis’ house in a beach community on the bay just south of Table Mountain. We were all set for a fish feast, a braai, with beer and wine and food and friends. When we got to their house everyone looked ashen. Yet another TAC member had died that day — just one of five that died in the two weeks we were in South Africa. We were having dinner with our friends and fellow activists, but nothing could bridge the gap between the privilege of our world and the struggle of theirs.

On February 6, 2001, the Indian drug company Cipla dropped a bomb by announcing that it would provide a good HAART regimen — d4T, 3TC, and nevirapine — for $1,200 to the private sector, for $600 to governments, and for $350 to NGOs such as Médécins sans Frontières (MSF). Cipla had already offered the brand-name companies a 5% royalty if they would let Cipla have voluntary licenses for their antiretrovirals in developing countries, but it had received no response.

Suddenly industry had to scramble. Their secret, vague, privately-negotiated, country-by-country discounts were suddenly exposed as the sham they were. In Washington, D.C., the Pharmaceutical Research & Manufacturers Association (PhRMA), along with several of its members, held a meeting called at very short notice with several HIV community groups which had not been working on global access issues and floated a trial balloon under which they would provide bigger discounts to Africa as long as the African countries abandoned their rights to use, make, or import generic drugs for AIDS. This initiative was quickly squelched when word got out to the broader community.

All of a sudden the drug companies began making much broader public offers. On February 21, at a press conference announcing a 13% rise in profit for the newly merged company, the new GSK CEO, Jean-Pierre Garnier announced that they would reduce the price of Combivir by 90% — to $2/day — to NGOs and non-profits in poor countries — but no further — while rejecting Cipla’s request for a voluntary license. This would bring the price of Combivir to about $730/year.

On March 15, Bristol-Myers Squibb (BMS) announced that it would sell its two nucleoside analogues, ddI and d4T, for just $1.00 a day together in Africa. That was half the price of GSK’s offer for Combivir. BMS also stated that it wouldn’t defend its patents in Africa or block African countries from importing generic equivalents. (Upon examination, BMS admitted that it didn’t have any patents on ddI in Africa, and the only country where it had a d4T patent was South Africa.)

Abbott Laboratories, which hadn’t even been part of the big five announcement in May 2000, was last to join the parade, announcing on March 28 that it would sell its protease inhibitors Norvir (ritonavir) and Kaletra (lopinavir/ritonavir) for less than $1,000 each “at no profit” in Africa, and also heavily discount its rapid HIV-1/HIV-2 test, selling it for just $1.20 a kit.

Roche, which had been part of the May 2000 announcement, failed to announce a single discount for a single drug in a single country.

By April, talk was growing of a more systematic, global approach to the problem of providing HIV/AIDS treatment in poor countries. A group of doctors and economists from Harvard issued an ambitious yet well-crafted treatment plan, complete with detailed budget figures, on April 4. Later that month — a week after the Norway meeting — the Rockefeller Foundation cosponsored a meeting on AIDS care in Africa. On April 24, in Abuja, Nigeria, UN Secretary General Kofi Annan issued a call for a $7-10 billion global fund to fight AIDS, tuberculosis, and malaria.

The response was less than encouraging. Many pundits expressed doubt that treatment should be a priority. Public health experts, imbued with a century of prevention-first ideology, were skeptical. Some people who ran prevention programs were worried that they would now compete for dollars against treatment programs. The head of the International AIDS Vaccine Initiative (IAVI) worried that people were forgetting about the need for an HIV vaccine (see accompanying article) — never mind that we didn’t have any, nor would we for a decade at least, during which time 100 million people will die if nothing is done.

No one stepped up to the plate. Everyone waited for someone else to take the first step. The silence from the European Union was deafening. Then the new US President announced, with Kofi Annan and Nigerian President Olusegun Obasanjo at his side, that the US — the richest country in the world — was going to provide $200 million dollars, or 2% of the $10 billion needed. No other country offered so much as a penny.

It’s shocking how many people have expressed fear or outrage that HIV treatment has finally been put on the global agenda, as if trying to save the lives of 35 million people — a number certain to pass 100 million long before we have an effective vaccine or otherwise stem the pandemic — is somehow an affront. Maybe to some of them it is an affront, while to others it goes against the grain of the entire 20th century public health ideology which helped to make the global health system into the catastrophe that it is. Just a sampling of some of the more outrageous recent quotes from people who purport to care about global public health:

“If we are just talking about a global AIDS fund, we will not participate. It is too narrow.”

— Poul Nielson, EU Development Commissioner, AP, 16 May 2001

“No one wants to be hardhearted, but treatment cannot be the overriding priority in Africa.”

— Jim Hoagland, “An AIDS Emergency,” Washington Post, 17 May 2001

These kinds of remarks confuse the issue. They are an excuse to keep on doing nothing. What the UN Secretary General actually said in Abuja was:

“I propose the creation of a Global Fund, dedicated to the battle against HIV/AIDS and other infectious diseases. This Fund must be structured in such a way as to ensure that it responds to the needs of the affected countries and people . . . This battle can be won only if we mobilize and focus the efforts of a wide range of stakeholders: national leaders like yourselves, donor governments, the United Nations system, pharmaceutical and other companies, foundations, and voluntary groups — especially those that represent people living with HIV. In other words, we need a complete mobilization of society at large.”

Kofi Annan has suggested a $7-10 billion (per year) Global Health Fund to provide a system to prevent, treat, and care for people with HIV/AIDS, tuberculosis, and malaria. This is a credible figure for the first few years. The only detailed math I’m aware of has been done by Harvard (Jeffrey Sachs, Bruce Walker, et al.) in their brilliant “Consensus Statement on ART for AIDS in Poor Countries.”

Don’t get me wrong — I’m anything but a mindless Harvard booster, having known all too well its smug, often lazy intellectual superiority, its often fake liberal tolerance, its (then) barely disguised horror of homosexuality, and its incestuous old boy networks. However, this time at least, they’ve done something which no one else has begun to do, which is to quantify the amount that is going to be needed to develop a comprehensive program to prevent, treat, and care for HIV/AIDS in poor countries. (Where was UNAIDS when we needed it?)

AIDS

Harvard’s plan is to treat one million people by year 3 and three million by year 5. According to the Harvard economists, $3.3 billion is “a sum that is small in proportion (0.01% of an aggregate GNP of nearly $23 trillion) to the wealth of the donor countries called on to fund this effort.” But that’s just for Africa. How about the rest of the world? Actually, since Africa accounts for 70% of the world’s HIV infected people, it’s not that hard to just add 30% to get $4.4 billion.

The biggest hole in the Harvard plan is that it doesn’t include funding for viral load and CD4 testing. Nor are the costs of health care worker training and salaries, treatment education and counseling, or the treatment of opportunistic infections addressed. OI prophylaxis, six annual clinic visits and basic blood tests are covered (under the section they label “clinical care,”) but that’s about it.

Admittedly, the Harvard plan does not purport to consider many of these ancillary costs — its focus is antiretroviral treatment — but if anti-HIV drug therapy is to be responsibly administered, these costs will need to be covered by someone, somewhere.

Tuberculosis

One third of the world’s population is infected with Mycobacterium tuberculosis (MTB). However, only a small fraction of that number develops clinical tuberculosis (TB) each year. Nonetheless, despite the fact that it is preventable and curable, TB kills over 1.5 million people per year. About 50% of untreated cases die from TB. In 1994, the World Health Organization developed a global strategy for tuberculosis control, dubbed DOTS — Directly-Observed Therapy, Short-course.

From 1995 to 1999, DOTS coverage expanded from 22% of the world’s population to 45%, and is now used in 127 of the world’s 211 countries. Originally the goal was to have 70% case detection and an 85% treatment success rate by 2005. Unfortunately, despite rapidly expanding global implementation of DOTS for TB, and increasing treatment success, TB incidence is rising. The AIDS epidemic got in the way.

According to the latest figures from the WHO Global Tuberculosis Report for 2001, there were an estimated 8.47 million cases of TB around the world in 1999. Of these, an estimated 3.7 million were smear-positive (they tested positive for acid-fast bacilli (AFB) in their sputum twice, or once in sputum with one confirmatory X ray) and therefore infectious.

TB cases rose by half a million from 1997 to 1999 (from 7.96 million to 8.47 million), mainly because of increasing HIV/AIDS rates in Africa and because of the collapsing public health system in Russia. They rose by 20% in Africa alone.

It’s pretty obvious that the HIV pandemic is driving the TB epidemic. WHO estimates that African TB cases will double over the next ten years due to HIV. Cambodia, Myanmar, Thailand and Vietnam accounted for 365 million cases and also have high HIV rates. Other countries on the list, such as India, the Russian Federation, and — most likely — China, now have escalating if not exploding HIV rates. So unless HIV is brought under control in the 22 countries that make up the TB80, all the progress made against TB since the initiation of the DOTS program is likely to be reversed. Thus, it’s obvious that providing antiretroviral treatment should be a priority in the TB80. TB care can be integrated into HIV care — and vice versa.

One would think that expanding DOTS coverage to 100% rates in the TB80 would be a very expensive undertaking. But since most of the countries are already implementing DOTS, the WHO estimates that for just $400 million per year (for the next five years) quality medicines and treatment services could be made available to at least 70% of the world’s 8 million new TB cases.

Malaria

Almost 300 million clinical cases of malaria occur worldwide each year and over one million people die. Ninety percent of these deaths occur in sub-Saharan Africa, where young children are the most affected. In highly endemic areas adults acquire a degree of immunity through continued exposure, but in areas of less intense transmission and particularly in epidemic areas, most of the population is at risk.

If malaria is diagnosed and treated promptly, the infection may quickly subside. But without effective treatment, severe complications — such as cerebral malaria, severe anemia or multiple organ failure — can rapidly develop, leading to case fatality rates of 10 – 30%. The progression from mild symptoms to death can be rapid.

The rapid spread of resistance to antimalarial drugs presents a potentially devastating threat to effective treatment. Safe, effective and affordable options are quickly running out, and the discovery of new antimalarials is not keeping pace. Replacement drugs generally last only a few years before they too experience significant resistance. In some areas, such as Brazil and Thailand, only multi-drug therapies are now effective.

WHO estimates that the annual global cost of halving malaria deaths would be between $375 million and $1.25 billion.

I wrote this piece to find out for myself how much it would cost to save the lives of the 35 million people who are living with AIDS in poor countries around the world. What I found was that they were credible and surprisingly well-founded. What I found — was encouraging.

 

Treat 5 Million HIV-Infected People by 2006?

The (revised) Harvard Plan at Years 3 and 5 — Africa

Year 3
(original)
Year 3†
(TAG revision of original)
Year 5
(original)
Year 5†
(TAG revision of original)
Number of people tested 3.3 million 5.0 million 10.0 million 15.0 million
Number of people treated 1.0 million 1.5 million 3.0 million 5.0 million
Annual cost $1.1 billion $1.1 billion $3.3 billion $3.3 billion
† Harvard assumes an annual drug cost of $500/person, but Cipla has offered triple therapy for $350 — and others have given figures as low as $295. If first-line therapy is based on an NNRTI and second-line therapy on a PI, the probability-weighted drug cost could likely be reduced to $400/person. Similarly, Harvard uses a figure of $10/person for initial HIV antibody screening. This price can be brought down. Abbott’s low-tech Determine HIV-1 (which includes Group O)/HIV-2 rapid test kit can be purchased for $1.00-1.20 per kit. The Harvard-Haiti project reports a cost of $7/episode of counseling and testing.

 

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