Wall Street Journal - November 19, 2003
Mark Schoofs, Staff Reporter of The Wall Street Journal

The decision ends years of divisive debate that delayed treatment for AIDS patients and mired South African President Thabo Mbeki in controversy. South Africa has more HIV-infected people than any other country in the world -- 5.3 million, according to the latest Health Department estimate, out of a total population of around 45 million. The cabinet decision commits the country to one of the most ambitious public-health programs ever attempted in sub-Saharan Africa, and the endeavor will challenge the country's struggling health system. But if it succeeds, South Africa could become a model for AIDS treatment in Africa.

The move follows -- and will likely take advantage of -- a deal announced last month by the Clinton Foundation HIV/AIDS Initiative and four generic-drugs companies, including one in South Africa. That deal slashed the price of AIDS medicine by more than a third from already discounted prices, and is available to South Africa and several other African and Caribbean nations that former President Bill Clinton is assisting. In addition, almost 25 advisers from the Clinton Foundation helped the South African government develop the plan approved Tuesday.

"I strongly welcome today's announcement by the South African government," said Peter Piot, director of the Joint United Nations Programme on HIV/AIDS, or UNAIDS, in an e-mail. Noting that the South African program "has the potential to be the world's foremost treatment initiative in the world," Mr. Piot said, "I particularly want to acknowledge President Mbeki's personal commitment to this program. This has been a long journey for him, but today he can rightly be proud."

More than four years ago, Mr. Mbeki began questioning mainstream science about the causes and treatment of the disease. All along, the president's aides insisted he was acting responsibly by raising critical questions and focusing on social factors such as poverty, but many doctors and activists reacted with outrage at what they saw as dithering and denying while hundreds of thousands died.

Ambitious Drug Plan

The more than 600-page AIDS treatment plan that the cabinet approved calls for antiretroviral AIDS drugs to be available within the first year of the program in all 53 health districts in the country, even those in the most remote and impoverished rural areas. As of the end of June, only about 76,000 patients in the whole of sub-Saharan Africa were taking antiretroviral treatment, according to Axios International, a consulting firm that collates sales data from six large pharmaceuticals companies. Under the program adopted Tuesday, within five years more than a million South Africans are expected to embark on the life-long regimens. For the estimated 25% of patients who can't afford proper meals, the government will give out nutrition packs containing vitamin and mineral supplements, as well as a daily meal.

To make such a program feasible -- and to make sure it doesn't drain resources from other health-care efforts -- the government has committed to large investments in recruiting and training doctors and nurses, and in improving laboratory services and drug distribution. Indeed, the drugs themselves add up to only about a third of the program's total budget, according to people involved in the program.

The cost of the program, which starts at 296 million rand, or $45 million, for the rest of this fiscal year, is estimated to rise to approximately 4.5 billion rand per year by fiscal year 2007-08. That's about 11.5% of South Africa's current public-sector health spending, according to Finance Minister Trevor Manuel.

The plan recommends that South Africa pay for the biggest slice of the program out of its own treasury rather than with donor funding. The South Africans don't want to depend on other nations partly because they want to make sure funding is in place for patients to take antiretroviral drugs uninterrupted for life. And like many developing nations, South Africa is skeptical of aid promises. Donor money for AIDS treatment might fall off because of "a war or postwar reconstruction efforts required here or there," Finance Minister Manuel notes. "If you're sitting with an unaffordable program, I don't know how you look people in the eye and say, 'Sorry, we can no longer afford to give you these drugs.' "

The treatment program poses huge challenges. The biggest is the brutal fact that although the government has built 700 new clinics since the fall of apartheid almost a decade ago, the country's health system is still overburdened -- in part because AIDS patients are flooding the wards. Even major urban hospitals report frequent shortages of medicines and other essentials. The public health system is short about 30,000 nurses. The AIDS program won't eliminate that shortfall but plans to bring in more than 5,000 new nursing staff.

Meanwhile, huge numbers of South Africans go to traditional healers for herbal remedies. Could those preparations, some of which have strong effects on the body, interfere with AIDS drugs? Or will gastrointestinal diseases, which are rampant in poor areas, prevent the drugs from being absorbed properly? Also, a large proportion of South African AIDS patients come down with active tuberculosis. Should doctors treat TB first and then HIV, or both simultaneously?

To answer such questions, the plan calls for a major research effort. Mr. Mbeki himself, according to people who worked on the plan, requested careful monitoring for toxicities and the development of drug resistance.

Help From Clinton Foundation

Noting that the plan calls for a database of patients enrolled in AIDS care, Harvard immunologist Bruce Walker said, "This is a gold mine in terms of being able to create knowledge for future use of these drugs for whole world." Dr. Walker worked on the plan as part of the Clinton Foundation HIV/AIDS Initiative.

While expensive, the treatment program is budgeted at much less than what the South African government estimated it would cost in August. A major reason for the lower cost is the new Clinton Foundation drug deal.

However, South Africa has the continent's strictest patent laws, so it is unclear how quickly the government can take advantage of the Clinton deal, which so far involves only generic-drug manufacturers. Some of those companies, such as Indian firms Ranbaxy Laboratories Ltd. and Cipla Ltd., don't have licenses from the patent-holders to produce the medicines. Therefore, say some legal experts, South Africa might have to issue compulsory licenses or negotiate with patent holders to persuade them to issue such licenses voluntarily. Either process could take months. In the meantime, South Africa might have to purchase the drugs from the patent-holders at substantially higher costs, which could bring negative publicity upon the big pharmaceuticals companies.

The South African generics firm involved in the Clinton deal, Aspen Pharmacare Holdings Ltd, does have licenses to produce almost all the AIDS drugs South Africa plans to use. But the hitch for Aspen is that only one of its AIDS drug has been medically registered for use in humans by the South African equivalent of the Food and Drug Administration, the Medicines Control Council.

Write to Mark Schoofs at mark.schoofs@wsj.com.

031119
WJ031104

Copyright © 2003 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.

Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .