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Haste makes waste

News | Despite his record $15 billion initiative to fight the global spread of HIV, President Bush is pilloried at the International AIDS Conference in Bangkok. Activists insist the only answer is more condoms and more drugs immediately -- though reality often fails to back up their rhetoric

Issue: "UN's abuse of power," July 24, 2004

When President Bush in 2003 announced a five-year, $15 billion plan to fight AIDS in developing countries, supporters saw it as a giant step in putting the "compassionate" back in "compassionate conservatism."

Apparently, the 1,000 or so protesters gathered outside the July 12 opening session of the International AIDS Conference missed the memo. "Access Denied to All," read their pink T-shirts, an ironic twist to the official title of the conference, "Access for All." Many carried anti-American banners and posters, including an oversized photo of George W. Bush, spattered with red ink and stamped with the caption "Wanted: AIDS Accomplice."

"We're sick of bilateral donors such as the U.S. who give money with strings attached," said protest organizer Asia Russell of Health GAP, a patients'-rights organization based in San Francisco. Though U.S. taxpayers contribute more money to the international AIDS fight than all other governments in the rest of the world combined, Health GAP and similar groups fault the Bush administration for wanting to have a say in how those funds are spent.

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Two policies, in particular, are drawing the ire of activists gathered in Bangkok. First, the White House wants to see American dollars used to promote abstinence, not simply provide free condoms. That's anathema to many AIDS groups, which view abstinence education as a plot hatched by American Christians.

"It appears that this is naked pandering to an extremist constituency," charged Steven Sinding, director general of the International Planned Parenthood Federation. "Millions of people around the world have been persuaded by the arguments of the U.S. government and religious right. Their actions represent a setback in bringing HIV/AIDS under control."

Rather than a setback, however, Ugandan President Yoweri Museveni told the Bangkok conferees that emphasizing abstinence has been key to his country's success in fighting AIDS. "I look at condoms as an improvisation, not a solution," said President Museveni, who saw the infection rate plummet from 30 percent to 6 percent following the nationwide rollout of an ABC program (Abstinence -- Being faithful -- Condoms only as a last resort).

Besides the condom controversy, AIDS activists criticize the administration's go-slow policy on using generic drugs to fight the disease in poor countries. Though the World Health Organization (WHO) has a list of approved "combination" drugs -- generic knock-offs that combine multiple, patented medications in a single pill -- the White House wants the Food and Drug Administration to assess the drugs for quality before shipping them to target countries. In May, the FDA said it would review applications for approval within six weeks -- quite a feat for an agency that usually takes at least six months.

AIDS activists charge the president is dragging his feet to protect the R&D investment of American drug companies, but the administration insists it's concerned about efficacy, not economics.

"If we make a mistake in our little practice of 100 people, 100 people will be hurt," said Joseph O'Neill, Mr. Bush's deputy global AIDS coordinator, speaking at the annual meeting of the Presidential Advisory Council on HIV and AIDS. "If we make a mistake in our little practice of 2 million people, large swaths of the world will be hurt."

Two million is the number of HIV sufferers throughout the developing world that Mr. Bush has vowed to provide with life-saving prescriptions. Generic combination drugs could help make that goal attainable because a single daily pill is a more realistic regimen for impoverished, illiterate patients who rarely stick to the complex drug "cocktails" that require popping up to 20 pills a day.

Despite the advantages, however, the Bush administration insists generic combinations are not the panacea some would claim. For one thing, federal health officials aren't sure the drugs certified by the WHO are true generics -- drugs that are chemically identical to the original brands. The FDA wants to conduct its own tests before the U.S. government starts shelling out billions of dollars for potentially defective pills.

While the WHO carries out some regulatory functions, such as inspecting drug manufacturers on site, it is not primarily a regulatory body like the FDA, and its processes are not as transparent, according to Mary Pendergast, a former FDA official. The U.S. agency, for instance, posts on its website inspection results and extensive analyses of why a drug was approved. The WHO does not, so it's not clear whether the group is applying the same standards across the board.

And even with the best intentions, Ms. Pendergast sees a tension between recommending a drug and regulating it. "Structurally, I don't think WHO is the proper place to do quality assessment," she said. "For one thing, it's a member organization, so they have to please members" -- many of whom are clamoring for the very drug under evaluation.

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