Kissing for Anal Rights

Michael Petrelis, pictured above holding aloft a "Reality" female condom, organized a Kiss-in zap in front of the Female Health Company's booth.


Vancouver, Canada - President Bill Clinton's hand-picked Presidential Advisory Council on HIV/AIDS has issued a call for studies on anal condom use by gay men as a barrier against contracting AIDS while engaging in sodomy. The Clinton AIDS task force states in its report that "[s]tudies should be funded to assess potential safety and efficacy of anal usage of insertive condoms."

Gay AIDS activists staged a kiss-in at the Female Health Company's, the manufacturer of the Reality Female Condom, booth in the exhibit hall of the BC Place complex to call attention to the company being denied Food and Drug Administration (FDA) permission to market the device to gay men

Though a polyurethane pouch was approved as an AIDS barrier by the FDA in 1992, it was only as a vaginal device. Due to sodomy laws, the FDA denied approval of Reality for anal use.

Because of their fear of the religious right and anti-sodomy laws, currently on the books in about half of the United States, FHC isn't submitting the "reality" condom for FDA consideration for anal intercourse.

AIDS activists are angry that social prejudice is getting in the way of a vital AIDS prevention possibility.

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Michael Petrelis
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More Information on the Reality Condom and related issues
Gays using anal condoms

There is a Better Condom - So Why Can't Gays Have It?

Federal Study of lubricant Agency to wiegh effect on gay men

Gays using anal condoms

Source: Associated Press June 25, 1996

NEW YORK -- The Reality condom, a lubricated plastic pouch for women, is quietly gaining favor among gay men as the newest way to avoid AIDS during sex.

However, the condom remains scientifically unproven for men and the manufacturer has no plans for tests, saying it doesn't have the money and doesn't want to touch off a furor over the morality of anal sex, which is still outlawed in nearly half the states.

Although gay men who have used the condom say it works well, government regulators won't allow it to be promoted for such use without extensive clinical trials that usually involve thousands of people and cost millions of dollars.

This means that many gay couples and heterosexuals who engage in anal sex might never find out about a potentially lifesaving product.

"I wish I had had this device sooner because then I wouldn't have contracted HIV," said Michael Petrelis, who waged a one-man campaign in San Francisco this spring that persuaded the city to give away the Reality condom to gay men at public health clinics. "I am most comfortable using the Reality condom with my boyfriend, who also likes it."

"It gives the receptive partner -- the person at greatest risk -- an opportunity to provide protection for themselves and not have to depend on their partner," said Dr. Robert Jobst, a Chicago physician whose small 1991 study showed the condom may be effective for gays.

But Mike Russell, a spokesman for the Christian Coalition, the conservative religious group, said: "It would be our view that the government would have a very tough time approving such a product. They are promoting an activity that is clearly illegal in many states."

Reality was approved two years ago by the Food and Drug Administration as the first condom that women can use to protect themselves against pregnancy and disease.

It's a thin, polyurethane sheath that a woman can insert into her vaginal canal hours before sex, a feature that the manufacturer, Chicago-based Female Health Co., promotes as a big advance over male condoms.

A four-week test done by Jobst with 11 gay male couples showed none of the condoms broke or tore. However, some of the couples were turned off by the condom's ungainly look -- it's 7-by-3 inches -- while others had trouble inserting it and experienced discomfort during sex.

In the early 1990s, Female Health had hoped to market a version of the product to gay men. It even came up with a name, Aegis, for the shield worn by the Greek god Zeus.

Mary Ann Leeper, president of the Female Health Co., said she was later told by the FDA it would never approve the product for gay sex, so the idea was dropped.<P>

Nonetheless, small numbers of men began buying and using it anyway. This spring, a variety of gay publications began talking up the condom and protesting what they perceive as its suppression.

Carol Rogers of the Philadelphia Department of Public Health has been distributing Reality condoms to women and gay men for a year. "We've had a lot of response from men who have sex with men and they like it very much," she said.

FDA spokesman Don McLearn acknowledged the agency had concerns about the idea in 1991 but said there is no reason now to block its approval for men -- as long as someone submits tests proving it works.

It won't be the Female Health Co.

The tiny manufacturer has been losing money and spent the last year in a reorganization that delayed advertising the condom even for women.

Gaining approval for men would be "a political basketball that's going to be batted around," Leeper said. &quot;We're too small. We couldn't survive that."

While independent groups or universities could take on the project, none has stepped forward.

"It would probably save lives," said Gabriel Rotello, a columnist for The Advocate, a national gay magazine. "But unless there's some sustained political pressure, the government, the company and the researchers will just pass the buck."

There Is a Better Condom - So Why Can't Gays Have It?
SF Activist Sues for 'Female Condoms' for Anal Sex

by Mike Salinas, Bay Area Reporter, February 27, 1996
Even with the recent advances in virology, immunology, and vaccine research, it's clear that condoms are still the best line of defense against AIDS.

Unfortunately, advances in condom manufacture have not kept pace with the burgeoning market. The packaging may change, but virtually all the products themselves are still latex balloons, with all the limitations of rubber-based products.

Among other problems, latex condoms melt within seconds if rubbed with Vaseline or other oil-based lubricants. Friction causes them to tear fairly easily. They can bind, make erections difficult, and cause performance anxiety in many men. They can fall off. Putting them on interrupts foreplay. They reduce sensation. Latex allegies are becoming increasingly common. Latex smells and tastes bad. And yet, they are still utterly indispensable.

Perhaps if someone invented odorless, tasteless, plastic condoms that wouldn't bind the penis or interrupt foreplay - and if they were made available for free through the state's network of health clinics - they could cut the HIV transmission rate.

The surprising thing is they do exist. And they are free.

And if you're a gay man, you can't get them.

With This Ring x

The device, which was called the Aegis when it was tested in a 1990 trial by Chicago-area gay men, is a wide plastic tube, about three times as big as a conventional condom, with a firm plastic ring around the opening and a smaller ring around the closed end. According to the manufacturer's instructions, it is designed to be worn internally (inside the anal canal of the "receptive partner") instead of externally (on the penis of "the insertive partner").

It is a relatively simple matter to insert the Aegis, its users and manufacturer say, after which the sphincter holds the smaller ring in place to keep it from dislodging; the larger ring on the outside of the body is, of course, the opening for the penis. It can be worn for some time before sex, and because it is a polyurethane plastic, there is no unpleasant taste or odor and no restriction on the kind of lubricant partners can use.

Although the Chicago men expressed a high degree of satisfaction with the Aegis, the Food and Drug Administration refused to grant approval for its use in preventing HIV transmission during anal sex. That might be because the application was handled by the FDA's obstetrics/gynecology device department - which did approve it for vaginal sex, as the Reality brand "female condom." There is no difference between what was called the Aegis and the Reality, which is sold at Walgreen's and other drug stores; only the instruction booklet was changed. But at three dollars each, and with virtually no awareness that the Reality can be used for anal sex, gay men in California haven't been snapping up the potential lifesavers.

A pilot study by the State's AIDS Office is now providing Reality condoms to public health clinic clients who undergo family planning education. With one exception: recipients must be female.

At least one San Francisco activist thinks that is outrageous. Michael Petrelis has filed a sex discrimination complaint with the city's Human Rights Commission after he was told at a San Francisco health clinic he was ineligible for the giveaway. Next, he told the Bay Area Reporter, he may file a class action lawsuit to force the state to make the internal condoms available.

"According to the most recent annual report put out by the San Francisco AIDS Office - which was in 1991-92, by the way; why is that? - people with AIDS in this city are 98 percent male," he said in a recent interview, "and 86 percent of them got it through male-male sex.

"So why are we being intentionally excluded from this pilot study?"

'Johns Never Even Know'

Petrelis, whose AIDS activism goes back to the early days of the epidemic and the first meeting of the original ACT UP - he helped create the name, in fact - is an enthusiastic user of the Reality condom, as he is happy to tell anyone.

"They look a little weird," he said, "but they're great once you stop thinking about that. They're very freeing to both partners, and the ring that keeps them in place actually feels good!"

Because of its unique design, Petrelis told the B.A.R., sex is possible from any angle: standing, lying, or sitting. And because it can be inserted long before the sex begins, the Reality makes more spontaneous penetration possible. "It's like having sex in the 70s again," Petrelis gushed. "No more wasting time trying to put on an inside-out condom, or a condom that's too small. And no more trying to stay hard."

Hassan J. Gibbs, who distributes Reality condoms in Philadelphia as part of the Gay and Latino AIDS Education initiative's Midnight Cowboy program, also says the advance insertion is a plus. He told the Philadelphia Inquirer in January that says sex workers "really like female condoms because they can be inserted prior to the sexual act.

"And if it's dark enough, the johns never even know."

Better than Trojans

Of course, the most important question is whether internal condoms work. According to the Chicago study, carried out by the Howard Brown Memorial Clinic, they do. Specifically, since that study only determined whether people would use them and whether they tore or dislodged, the results were very promising. Although some people requested design changes - mostly having to do with the internal ring - none reported rips, tears, or dislodgment. When the Reality's disease prevention properties were tested in 1990 by San Francisco Dr. Marcus Conant and two colleagues, the researchers reported its plastic was impermeable to both cytomegalovirus and HIV. An overview of another study found that women's vaginal exposure to seminal fluid because of dislodgment dropped from 8.1 percent of the time when a Trojan was used, to 2.7 when a Reality was used. Breakage was also less common with Reality than with Trojan Enz.

"No sperm in vagina with proper use," is how the overview summarized the study findings.

Despite the findings, San Francisco public health administrators were all but unaware that Reality condoms can be used for anal sex until Petrelis started asking for them. None contacted by the B.A.R. had seen the Aegis study. Petrelis finds that shocking. "This is all a by-product of 'de-gaying' AIDS in America," he said. "And see where it's gotten us. There's this wonderful thing out there that can save lives, and we as gay men can't get them, and our public health officials don't even know what they are or that they've already been studied.

"Officials gave away 80,000 of those condoms in Philadelphia in five months," he added. "Since when does San Francisco lag behind Philadelphia in AIDS prevention efforts?"

Federal study of lubricant blasted, Agency to weigh effect on gay men

by Joyce Price, July 25, 1996, The Washington Times
To the dismay of social conservatives, a $280,000 federally funded study, which will soon be getting underway in Seattle, seeks to determine if a chemical widely used in sexual lubricants makes anal sex safer for homosexuals.

Dr. Connie Celum, lead investigator in the research, said 35 homosexual couples--all males--will participate in the study that's designed to find out if the rectal application of the chemical, nonoxynol-9, or N9, is safe or whether it causes any tissue irritation that might increase the risk of transmission of the human immunodeficiency virus (HIV), which causes AIDS, and other sexually transmitted diseases (STDS).

AIDS activists say such research is important, since anal sex remain the No. 1 method of HIV infection. "There are little critters out there we need to protect ourselves from, and gay men want to protect themselves," said Wayne Turner, a homosexual and spokesman for ACT UP/Washington, DC.

But leaders of conservative groups advocating family values are appalled that the National Institutes of Allergy and Infectious Diseases is spending nearly $300,000 on a study that's restricted to homosexual men engaged in a sexual practice that's illegal in many states.

"We are facilitating, at taxpayer expense, an illegal and immoral activity that's abhorrent to most Americans . . . If we make homosexual sex safer, all we're going to do is promote promiscuity, which will lead to more STDs," said Bob Maginnis, senior policy analyst for the Family Research Council.

The Rev. Lou Sheldon, chairman of the Traditional Values Coalition, had this reaction to the "Phase 1 Rectal Microbicide Study": "Perversion is perversion any way you try to rewrite it. The funding of this kind of study is inappropriate and really goes against the beliefs and values of a significant majority of Americans."

A mircobicide is a product that kills microorganisms such as bacteria and viruses. N9 is a spermicide that's been shown effective in preventing HIV transmission in laboratory studies.

"But we don't know if it works in people," said Zeda Rosenberg, a senior scientist in the AIDS Division of the institute.

She cited a study in Kenya in the 1980's that tested high-dose N9 in women and found it caused vaginal ulceration. Such modifications increase the risk for HIV transmission, she said, adding:

"Rectal tissue is much thinner," so problems could be worse for passive participants in anal sex, she said.

Dr. Celum, assistant professor of medicine at the University of Washington and also medical director of the Harborview STD Clinic in Seattle, said the study, to start in about a month, hopes to recruit 25 HIV-negative and monogamous couples and 10 HIV-positive and nonmonogamous couples.

Michael Petrelis, and AIDS-homosexual rights activist who is HIV-positive, said it's a "good development that this study is underway" but wanted a bigger effort.

"The protocol is not being disseminated, and gay men are not aware of this research," Mr. Petrelis said in a telephone interview from his home in San Francisco.

"I want it discussed openly by Clinton administration officials, and I want the study expanded beyond Seattle. I want it conducted here in San Francisco and in New York and Washington, DC."

Dr. Celum said she's "sympathetic to the concerns" raised by conservative critics of the study but feels the research is vital.

"Ultimately, we need to equip people at risk to prevent them from being infected with HIV or other STDS."

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