Microbicides

“The number of adverse events in the N-9 [nonoxynol-9 vaginal microbicide] gel group was higher than in the placebo group (40% versus 13%). Reported number of any genital symptoms was significantly higher in the N-9 group (38% N-9, 13% placebo). The number of total epithelial disruptions was higher in the N-9 group (20% versus 3%); however, the number of genital ulcers and abrasions in the N-9 group was low (2% and 3%, respectively) and not different from that in the placebo group (1% and 2%, respectively)…Although these findings alone were not sufficient to cancel the planned phase III study, when considered together with the negative results from the COL-1492 effectiveness trial of 52.5 mg N-9 gel, the decision was made to cancel the planned phase III trial of 100 mg N-9 gel.”

“In the remotest part of Thailand you can buy a bottle of Coke. We want [vaginal] microbicides to be available like that”

“We aimed to determine the effectiveness of the vaginally administered spermicide nonoxynol-9 (N-9) among women for the prevention of HIV and other sexually transmitted infections (STIs). We did a systematic review of randomised controlled trials. Nine such trials including 5096 women, predominantly sex workers, comparing N-9 with placebo or no treatment, were included…[We found that the] relative risks of HIV infection [was 1.12 times greater], gonorrhoea [was 0.91 as (less) likely], chlamydia (0.88), cervical infection (1.01), trichomoniasis (0.84), bacterial vaginosis (0.88) and candidiasis (0.97) were not significantly different in the N-9 and placebo or no treatment groups. Genital lesions were more common in the N-9 group (1.18). Our review has found no statistically significant reduction in risk of HIV and STIs, and the confidence intervals indicate that any protection that may exist is likely to be very small. There is some evidence of harm through genital lesions. N-9 cannot be recommended for HIV and STI prevention.”

“239 (32%) women [sex workers] reported use of a mean of more than 3·5 applicators per working day, and in these women, risk of HIV-1 infection in nonoxynol-9 users was almost twice that in placebo users…This study did not show a protective effect of COL-1492 [a gel containing Nonoxynol-9] on HIV-1 transmission in high-risk women. Multiple use of nonoxynol-9 could cause toxic effects enhancing HIV-1 infection. This drug can no longer be deemed a potential HIV-1-prevention method.”

“The story of nonoxynol-9, known as N-9, an active ingredient used in chemical barriers to HIV and STD transmission, raises disturbing questions about research ethics, drug company profits and the role in Africa of international development agencies…the results of the UNAIDS trial were reported at the 2000 Durban International AIDS Conference, as follows: 'At the end of the trial, researchers found that the women who used N-9 gel had become infected with HIV at about a 50% higher rate than women who used the placebo gel. Further, the more frequently women used only N-9 gel (without a condom) to protect themselves, the higher their risk of becoming infected. Simply stated, N-9 did not protect against HIV infection and may have caused more transmission. Women who used N-9 also had more vaginal lesions, which might have facilitated HIV transmission.' As we now know, these precise results of N-9, announced in 2000, were already publicly known by 1993. And yet UNAIDS began its trial in 1996, knowing that N-9 increased the risk of HIV infection, especially among those who might use the microbicide with high frequency, such as prostitutes. Despite this knowledge, after the results were announced at the Durban AIDS Conference, Dr Joseph Perriens of UNAIDS could still say: 'We were dismayed to find out that the group using N-9 gel had a higher rate of HIV infection than the group using a placebo.'…The Business Day edition of 13 July 2000 reported Dr Rees as 'caution(ing) that the (negative) results were not conclusive and more work needed to be done on the issue. She pointed out, for instance, that it was possible that the group using the placebo (or substitute with N-9) may have been exposed to a more active microbicide.' Presumably by saying that 'more work needed to be done', she meant that more women needed to be exposed to the highly toxic N-9.”

“27 (45%) of 60 women in the nonoxynol 9 sponge group and 20 (35%) of 56 women in the placebo group developed HIV antibodies. The hazard ratio for the association between nonoxynol 9 sponge use and HIV seroconversion was 1.7 [i.e. use of the nonoxynol-9 spermicide makes becoming HIV-positive more likely]”