From: MPetrelis@aol.com
Date: Fri, 5 Apr 1996 04:10:20 -0500
Subject: Advocate REALITY column


Our Little Secret 
By Gabriel Rotello, The Advocate, April 16, 1996

    How would you feel if you found out that years ago researchers 
created a product with the potential to slash the HIV 
infection rate among gay men-but were told by the federal 
government to forget about it? Well, get ready for this: It 
turns out that a new kind of condom was developed and tested 
in the early '90s that seemed to solve a lot of the problems 
gay men have with traditional condoms. However, Food and Drug 
Administration officials told the manufacturer the device 
could never be approved. Why? Because, the officials said, 
sodomy is against the law in almost half the states, and the 
government could never license a product that encouraged 
people to break the law. 
    AIDS workers spend lots of time fighting for condom awareness 
and availability, but there's not much they can do about the 
simple fact that many gay men hate condoms. Among our chief 
complaints: Condoms greatly reduce sensation; you can't put 
them on until you're turned-on, which is a big turnoff; and 
they do sometimes break under the rigors of anal sex. They 
also create a personal power imbalance: The bottom is the 
person at greatest risk of infection, but the top is the one 
who has to use the condom.
    Similar problems affect the much larger heterosexual market, 
so condom manufacturers spent years trying to develop a 
"female condom" that could be worn in the vagina. A successful 
device was finally produced by the Female Health Co. and 
approved by the FDA in 1993. AIDS prevention workers who 
distribute this vaginal condom to female sex workers report 
that it helps solve many of the problems associated with 
traditional condoms: Women can put it on before foreplay 
begins. It stays in place, so it doesn't blunt sensation for 
the male. It's made of polyurethane instead of latex, so it's 
much thinner and more sensitive and doesn't break if you use 
an oil-based lubricant. And, perhaps best of all, it gives 
control to the woman, who can now protect herself instead of 
having to rely on the man to protect her. 
    That's the good news. The bad news is that the same device has 
never been marketed to gay men, even though the Female Health 
Co. also tested it as an anal condom and found that it worked 
just as well. In a 1991 study of gay male couples at Chicago's 
Howard Brown Health Center, not a single one of the condoms 
ripped, tore, or broke during anal sex, and not a single one 
fell out or dislodged-a significant improvement over regular 
condoms. That's not to say that gay men declared the device an 
unqualified success. About half of the receptive partners 
reported some discomfort with the anal condom, and several men 
suggested design improvements. But the independent researcher 
conducting the study believed these problems were easily 
fixable, and in any event many of the men thought the device 
was excellent as it was. The study concluded that the anal 
condom "would be well accepted by gay males." 
    That, at the very least, should have prompted further study. 
But when company officials reported these initial findings to 
the FDA in 1992, they say they were told that sodomy laws 
prevent the government from ever approving a condom marketed 
for anal sex. "The FDA was adamant about that," says Female 
Health Co. president Mary Ann Leeper. As a result, her firm 
abandoned further testing and never applied to market the 
device for anal sex. Instead, they sell it as the Reality 
Female Condom-a name guaranteed to discourage gay men from 
trying it. Over the years, however, some gay men have 
discovered it on their own, and when AIDS activist Michael 
Petrelis strolled into a San Francisco shop in search of a 
better condom, a salesperson suggested he try the "female" 
device. Petrelis tried it, liked it, and began calling the 
company to find out why they didn't market it to gay men. 
That's when the story came tumbling out. 
    It's a story so outrageous that even the government sounds 
embarrassed. Victor Zonana, a spokesman for Health and Human 
Services secretary Donna Shalala, points out that Bush was in 
office when these conversations allegedly occurred and says 
that the FDA is now "actively interested in getting data" 
about such devices. "Clearly," he told me, "because of the 
risk of HIV transmission, if such a device were determined to 
be safe and effective, it would be approved." That's great, 
but it's news to the Female Health Co. And Zonana knows of 
nobody currently testing such a device-which is hardly 
surprising. Tests cost big bucks. If FDA officials have been 
quietly telling manufacturers that anal condoms will never get 
approval, manufacturers would have to be crazy to spend money 
testing them. 
    It's tempting to simply blame this outrage on government 
bureaucrats, but that would be too easy. After all, the 
company could have blown the whistle years ago and chose not 
to. And then there's us gay men and AIDS activists. We spend a 
lot of effort agitating for drug research and development but 
rarely demand research to keep people from getting infected in 
the first place. If there's a moral to this story, it's that 
prevention activists need to be just as vigilant as treatment 
activists in monitoring government and industry, which clearly 
still care little about whether we live or die. If we want 
better AIDS prevention, we'll have to get it the old-fashioned 
way: We'll have to scream bloody murder. 
  --30--