Subject: [HEALTHGAP] WashPost: AIDS Activists Misfiring

Subject: [HEALTHGAP] WashPost: AIDS Activists Misfiring AIDS Activists Misfiring By Sebastian Mallaby Monday, July 19, 2004; Page A17 In the past few years, global AIDS activists have worked miracles. They have shaken rich governments awake, causing international AIDS funding to rise 15-fold. They have beaten back big pharma's jihad against cheap, non-brand medicines, creating an opportunity to treat millions of people in poor countries. But the activists, or at least some of them, are in danger of tipping from heroism into shrill anti-Americanism. The sound bites from last week's AIDS conference in Bangkok were straight out of a Michael Moore movie. Inconveniently for those who enjoy stereotypes, the Bush administration is far and away the leader in the global AIDS fight. This year the United States will spend $2.4 billion on the pandemic, nearly twice as much as all other donor governments combined; attacking the Bush team for indifference to AIDS is like attacking it for inadequate defense spending. But when Randall Tobias, the U.S. global AIDS coordinator, addressed the Bangkok gathering last week, he had to endure 10 minutes of furious heckling before he could get a word in edgewise. What triggers this hostility? The activists' first complaint is that U.S. AIDS spending will finance programs to promote sexual abstinence and fidelity. Never mind that only 7 percent of the money will be spent this way; the abstinence agenda is derided as some kind of kooky anti-scientific plot cooked up by President Bush's evangelical supporters. Yet the plotters actually include very un-evangelical people such as Edward Green, a Harvard medical anthropologist (and liberal Democrat) who's written a book on AIDS prevention. Green has shown how Uganda's success in cutting HIV infection rates from 21 percent to 6 percent depended crucially on teaching abstinence. In the first half of the 1990s, the number of young Ugandans engaging in premarital sex plummeted; by 1995, fully 95 percent of Ugandans reported that they were either abstaining or monogamous. Elsewhere in Africa, experience also supports the Bush administration's desire to make abstinence and fidelity part of its prevention strategy. The evidence from Botswana, South Africa, Kenya and Zimbabwe suggests that there's no clear link between the availability of condoms and reduced HIV rates: All four countries have plenty of condoms yet plenty of infection. Meanwhile in South Africa, the single most promising development is that reported rates of teenage sexual activity have fallen for three years straight, disproving the notion that there's no point in telling youths to change their behavior. In sum, it is not the Bush administration that is ignoring the evidence. It is Bush's critics. The activists' second complaint about the U.S. AIDS program is that it is hostile to generic medicines. Until recently, this was true: Perhaps because of its ties to the big pharmaceutical companies that sell patented drugs, the administration has been scandalously slow to allow cheaper generic copies to be used in its programs. But in May the Bush team finally announced that generics were okay, subject only to a six-week review by the Food and Drug Administration to determine safety and efficacy. The activists do not believe the FDA's change is for real, and their suspicions are reinforced by Cipla, a leading Indian producer of generic AIDS drugs. Cipla's charming joint managing director, Amar Lulla, explains to anyone who calls that he would love to get his drugs approved for distribution in U.S.-financed programs in the poor world but that the Bush administration's fine print is cluttered with obstacles. On close inspection, however, these obstacles aren't serious. For example, Cipla's best known AIDS medicine is called Triomune; it combines three separate antiviral drugs in one pill, simplifying treatment. Lulla says the FDA has not explained whether he needs to demonstrate the safety of combining the drugs this way, in which case Cipla would have to conduct prohibitively expensive clinical trials. But if you go to www.fda.gov/oc/initiatives/hiv/hivguidance.html, you'll find the explanation that Lulla says he's waiting for. Attachment B lists three-drug cocktails that the FDA already accepts as safe, among them one combining stavudine, lamivudine and nevirapine, the three constituents of Cipla's Triomune. Cipla also says it worries that if it files an FDA application, it may be sued by U.S. patent holders. But the FDA's rules allow Cipla to file a statement certifying that its pills are intended for sale outside the United States, a maneuver that would almost certainly eliminate the risk of being sued for U.S. patent infringement. None of this is to deny that the Bush administration panders to the religious right on some issues, or that it's cozy with pharmaceutical lobbyists. After misrepresentations on issues from tax policy to Iraq intelligence, the suspicion with which Team Bush is greeted is partly of its own making. And of course some criticisms of the administration's AIDS program remain fair, notably that it shortchanges multilateral efforts against the killer. And yet the bottom line on the Bush administration's AIDS initiative is that it is huge and serious. The AIDS activists at last week's conference, whose motives are doubtless honorable as well, would do better to redirect their heckling to countries such as Japan and South Korea, which give shockingly little to their cause. When you're fighting an enemy that takes 8,000 lives a day, it pays to pick your targets wisely. mallabys@washpost.com