San Francisco Chronicle - Tuesday, December 2, 2003
Sabin Russell, Chronicle Medical Writer

The endorsement Monday by Dr. Lee Jong-wook, director general of the WHO, in ceremonies here marking World AIDS Day is controversial because the low- cost, three-in-one pill violates patents held by Western drug companies.

Lee's announcement was part of a formal roll-out of the WHO's "3 by 5" initiative, which has set the audacious goal of bringing AIDS drugs to 3 million people in low-income nations by 2005. The WHO estimates that the goal can be met by raising $5.5 billion for the 2-year period ending in 2005.

"Now that we know what is needed, our task is to make it happen," Lee told an audience of citizens and dignitaries in Livingstone, a tourist town at the edge of Victoria Falls. Lee is here as part of an 80-member delegation to Africa led by Health and Human Services Secretary Tommy Thompson.

The AIDS drug, manufactured by maverick Indian drug maker Cipla, combines in a pill's three layers generic versions of the patented anti-viral medications 3tc, D4t and nevirapine. In the United States and Europe, the three drugs are produced by three different pharmaceutical giants, and would cost about $12,000 a year.

Cipla is ignoring the patents held by GlaxoSmithKline, producer of 3tc; Bristol-Myers Squibb, which makes D4t, and Boehringer Ingleheim, maker of nevirapine.

The major drug companies have offered to supply their brand-name products at a fraction of their cost in the developed world, but the generic Cipla product is between a half to a third of even that discounted price. The Cipla drug could bring the price of AIDS treatment in poor countries to less than 50 cents a day.

In addition to its low cost, the Cipla combination pill needs to be taken just once in the morning and once in the afternoon; some other multi-drug regimens require that dozens of pills be taken throughout the day.

Since he was named head of the WHO in July, Lee has taken his organization toward a much more aggressive stance in favor of AIDS treatment for the poor.

He said he joined the Thompson delegation in part to acknowledge the positive contribution that President George Bush made in calling for $15 billion in overseas spending against the epidemic.

Lee had originally intended to mark World AIDS Day in Nairobi, Kenya, but changed plans after Thompson announced his four-nation Africa tour.

Thompson has brought with him nearly the entire Bush administration senior health leadership.

Included are Ambassador Randall Tobias, the coordinator for all the Bush administration AIDS programs; National Institute of Allergy and Infectious Diseases chief Dr. Anthony Fauci; Centers for Disease Control and Prevention Director Dr. Julie Gerberding; and National Institutes of Health Director Elias Zerhouni.

In an interview aboard the jet carrying the Thompson entourage as it flew toward Zambia Sunday, Lee said that Bush's startling decision to spend billions on the international AIDS problem represented a "quantum leap" that has yet to be duplicated by the rest of the world. The WHO's "3 by 5" program is Lee's attempt to up the ante, he said.

Lee orchestrated a declaration on Sept. 22 saying it was "a global health emergency" that more than 6 million AIDS patients around the world have no access to the treatments that have slowed the virus in richer countries.

Africa is home to 29 million of the world's estimated 40 million people with HIV infections, but only about 50,000 of those infected on this continent receive anti-viral drugs.

The WHO chief said prior responses to the epidemic have not addressed the gravity of the problem. "This is like Armageddon. This is like an asteroid that has hit the Earth. We have to mobilize the planet," he said.

The energetic, Korean-born WHO leader does not always see eye-to-eye with United States policy makers. He scoffed at the notion, popular in the Bush administration, that there is inadequate infrastructure in the developing world to handle the rapid scale-up of cheap anti-viral drug delivery.

"If we wait for the infrastructure to grow, it will never grow," he said.

"In an African village, if they know a drug will help their sister or their sons live, then the will create an infrastructure in no time."

Nevertheless, Lee lauded the presence of nearly all the Bush administration's top AIDS leaders in the tiny Zambian city to observe World AIDS Day. The tourist community is the hardest hit by the epidemic in Zambia. An estimated 31 percent of Livingstone adults are HIV-positive, compared to 16 percent in the country as a whole.

Thompson declared to the gathering that "this is the right place and the right time to be with you." He noted that the Joint United Nations Program of HIV/AIDS recently estimated that AIDS was killing 3 million people around the globe each year and infecting an additional 5 million.

He is characteristically a sunny politician and a perpetual optimist, but Thompson on Monday warned that "We are losing the battle. We are losing this war. ... What we need is help from everybody, from God on down."

Dr. Brian Chituwo, the Zambian health minister, noted that strong leadership from the top has been critical to the success stories against AIDS in Africa.

Although praising Zambia's current leadership, the health minister candidly admitted that "alas, we were slow. We were suffering from inertia."

Noting that Zambia is one of 14 nations designated to receive part of the Bush administration's pledge of $15 billion in overseas AIDS help during the next five years, he thanked the American delegation. "Now, there is hope," he said. "This meeting gives us resolve that we are not alone in the fight against HIV."

E-mail Sabin Russell at srussell@sfchronicle.com.
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