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No Good Deed Goes Unpunished By: James K. Glassman
TechCentralStation | Tuesday, July 13, 2004

Two years ago in Barcelona, a small group of noisy activists shouted, whistled and booed their way through a speech by U.S. Secretary of Health and Human Resources Tommy Thompson at the 14th International AIDS Conference.

Thompson persevered, finishing his speech after a 20-minute hiatus despite screams of "Murderer!"

On Sunday in Bangkok, Thailand, the 15th International AIDS Conference gets underway, and the top U.S. official this time, Randall Tobias, while ready for dissent, is forcefully calling for cooperation.

"The big message," Tobias said in an exclusive interview in his office in Washington before he left for Vietnam and Thailand, "is that the real enemy is denial, stigma and complacency. It is not each other. We must use all the energy toward fighting the pandemic of AIDS . . . I want people to come together."

The anger against the U.S. carries a certain irony. America's taxpayers are by far the biggest contributors to battling AIDS globally, America's drug companies and research institutions like NIH are the leaders in developing therapies, and no world leader has made a greater commitment to ending the scourge than America's president.

AIDS has infected an estimated 40 million people and annually kills 3 million, about three-quarters of them in Africa. "Think of crashing 20 loaded Boeing 747s a day," says Tobias. "Every day, two and half times as many people die as in the 9/11 attacks."

Tobias, who was formerly CEO of Eli Lilly & Co., the pharmaceutical company, and vice chairman of AT&T, is President Bush's Global AIDS Coordinator. He heads PEPFAR (the President's Emergency Plan for AIDS Relief), the organization that oversees a commitment over the next five years of $15 billion in U.S. taxpayer money to fight AIDS in 15 countries--12 in Africa, plus Haiti and Guyana in the Caribbean Basin and Vietnam in Southeast Asia.

Congress appropriated $2.4 billion for the first year, and, Tobias said, $865 million has already been dispersed for programs of prevention, treatment and care.

But AIDS activists often ignore such facts. In the past, they have emotionalized and obscured the important issues surrounding the disease.

Lately, they have been charging, unfairly and inaccurately, that the U.S. has refused to buy certain kinds of drugs in order to protect makers of U.S. patented pharmaceuticals against competition from companies, especially in India, that specialize in copycat medicines. That question will certainly be a focus of contention in Bangkok.

But some of the heat may have come off the United States. Recently, the World Health Organization announced that two HIV drugs, made by the Indian firm Cipla, did not meet quality standards and were removed from the WHO list of qualified medicines. That action, which the WHO took quietly, confirms what some have long suspected--that some copycat drugs may not be bioequivalent to drugs that have undergone extensive testing.

The U.S. has said that it will not buy AIDS drugs that are not approved by the U.S. Food & Drug Administration. As Tobias told me, "I can't understand why the activists are screaming. Why should there be one standard in the U.S. and another in Africa?"

Responding to the urgency, Tobias and Thompson have agreed to streamline the process of gaining FDA approval for companies making fixed-dose combinations (FDCs) of anti-retrovirals, the class of drug that stops the progression of HIV into AIDS. The FDA is pledged to complete its review of these FDCs--"from any drug company anywhere in the world," as Tobias says--in just three to six weeks.

Two groups of innovator companies--that is, firms that make patented drugs--immediately announced they would start developing such FDCs. But the copy-drug companies have not submitted their FDCs--some of which, like Cipla's Triomune, are already in use in Africa--for FDA review.

"We sent people from our office to Cipla and Ranbaxy in India and Aspen in South Africa. We asked, 'Are you going to apply?'" So far, no applications.

Why? That's a question that will certainly be explored in Bangkok.

But Tobias makes the American position clear: "We're going to buy the least expensive drugs that we can find without regard to country of origin, patented or generic--as long as we are satisfied that they are safe and effective. And the only way to tell is FDA approval."

Meanwhile, the U.S. continues to distribute funding. Some $500 million was released in late June and received with gratitude by countries like South Africa, which will use $70 million in U.S. funds to support a comprehensive plan to treat 53,000 people with anti-retrovirals, as well as to provide palliative care, support for orphans and vulnerable children and programs for prevention.

The U.S. last year spent more money fighting AIDS globally all other governments combined, said Tobias. "In 2004, we have approved twice the spending of all other governments combined."

For example, said Tobias, the U.S. foots 35 percent of the bill for the Global Fund to Fight AIDS, Tuberculosis and Malaria, whose current chairman is Secretary Thompson. The Global Fund, Tobias said, "is a fledgling, start-up organization without resources on the ground. The Global Fund has deposited $2.6 billion" in its bank account, but "only $400 million has gone out the door in two years."

The U.S. backs the Global Fund, but Tobias says bilateral efforts on AIDS are moving more swiftly. Still, there are serious constraints of what Tobias calls "physical and human infrastructure," which I saw firsthand last December on a trip with Tobias to Africa in a delegation headed by Thompson. The continent lacks education, clinics, beds, roads, and health-care workers. It's not just the medicines.

"Take Mozambique," says Tobias. "It has a population of 18 million," he says, "but there are only 500 to 600 doctors in the country. There's a brain drain in Africa. There are more Ethiopian doctors in Chicago than in all of Ethiopia."

A new report by the United Nations Program on HIV/AIDS, released on Tuesday, estimates that 1.3 million people in Mozambique and 1.5 million in Ethiopia are living with HIV, the AIDS virus. Last year, in those two countries alone, 230,000 people died of AIDS. By contrast, AIDS deaths in the U.S. in 2003 totaled 14,000.

Tobias is ready for Bangkok. "Instead of trying to find fault, I would like to see the energy focused on fighting stigma and complacency."

He gives an example of fighting stigma. On a recent trip to Ethiopia, he said that he wanted to be tested for AIDS. "I want you to see what this is all about," Tobias said he told the media. "The next day, I was dedicating a major testing center we had funded. The mayor of Addis Ababa was there. I said I would like to challenge you to go get tested and tell people. The mayor said he would get tested today."

Tobias continued, "I was told a week ago that something like 100 Ethiopian officials have gotten tested since the mayor. That's what we need to put our energy into."

James K. Glassman is a resident fellow at the American Enterprise Institute, and host of TechCentralStation.com. He is also chairman of Investors Action, a new advocacy organization for America's small investors.

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