Excerpt from FOI / U.S. Food and Drugs Administration transcripts by Knut M. Wittkowski

Joint Meeting of the Nonprescription Drugs, Reproductive Health Drugs, Anti-Infective Drugs, and Antiviral Drugs Advisory Committees,
Wednesday, November 20, 1996, Gaithersburg, MD

Craig, William (Chairman)

United States of America, Food and Drugs Administration

Keywords: condom, spermicide, N9, N-9, HIV, heterosexual, transmission, prevention, efficacy

Questions

Is the type of evidence presented adequately to evaluate whether the use of topical vaginal nonoxynol-9 provides safe and effective prophylaxis from infection with Neisseria gonorrhoeae or Chlamydia trachomatis in women? What additional type of information would be helpful?
Existing studies have used nonoxynol-9 with barrier methods. If it was determined that the probability of infection with Neisseria gonorrhoeae or Chlamydia trachomatis in high risk women was reduced by use of nonoxynol-9 with barrier methods, how could such information be made available to the con-sumer without undermining the use of more effective barrier methods? Discuss the role of providing information to the professional versus providing information directly to the consumer.

Introduction (David Feigal, Acting Director for the Office of Drug Evaluation for Anti-Infective Drug Products):

The purpose of this meeting […] is to provide

[A] evidence needed to show the effectiveness of vaginal products and

[B] the evidence needed to assess the safety, and

[C] the types of evidence to translate the effectiveness from the clinical trial setting to safe an effective consumer use.

[We] will focus specifically on the nonoxynol-9 (N-9) containing products, [although] we can’t do that in the absence of examining the broader issue of HIV prevention in general and whether or not it is possible to accomplish this with vaginal or rectal products.

Conclusions (Chairman Craig):

[Re Question 1], the vote [is] 18 for and one against in terms of effective prophylaxis. [… In terms of safety] the vote is 11 for and 8 against. Not quite a 50/50 split. [Among those who] feel that the answer is "no", […] the primary concerns were actual use studies, looking more also at substitution [of condoms by N-9]. [Re Question 2], what we heard is that at least in terms of labeling, on would want this to be relatively spe-cific so that we listed those diseases for which [N-9] does not have any efficacy and also to comment on the fact that clearly there are potentially other methods such as condoms that would provide better protection than what is seen here. And that we need clearly the kind of studies that would look at label comprehension to be sure that the message that was labeled was getting across to the potential consumers.

Requests for the complete transcript to: Food and Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857, U.S.A.

Related publications:

[1] WITTKOWSKI, K.M. (1989) Die Abschätzung der Effektivität von Barriere-Methoden zur HIV-Prophylaxe. [Assessing the effectivity of barrier methods for HIV prevention.] AIDS-Forschung 4: 3-8

[2] WITTKOWSKI, K.M. (1989) Preventing the heterosexual spread of AIDS: What is the best advice if compliance is taken into account? AIDS 3:143-145

[3] WITTKOWSKI, K.M. (1997) The efficacy of nonoxynol-9 from an in vivo point of view. AIDS 11:392-394

[4] WITTKOWSKI, K.M., SUSSER, E., DIETZ, K. (1998) The Protective Effect of Condoms and Nonoxynol-9 against HIV Infection. Am J Public Health 88: 590-596