Diary Prequel Package — page 104

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