Bay Area Reporter, 395 Ninth Street, SF, CA 94103 415/861-5019 415/861-7230 - 29 Feb 1996
Mike Salinas, Bay Area Reporter

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 allergies are becoming increasingly common. Latex smells and tastes bad.

Perhaps the invention of an odorless and tasteless device that wouldn't bind the penis, interrupt foreplay, or fall apart in oil-based lubricants could cut the HIV transmission rate.

The surprising thing is it already exists.

And the FDA doesn't want you to know about it.

The invention, which was tested on Chicago gay male couples in a 1990 trial, is a wide tube of extremely thin plastic, about three times as big as a conventional condom, with a flexible plastic ring around the closed end. According to the instructions provided to study participants, it is worn internally (inside the anal canal or the "receptive partner." Or bottom) instead of the way condoms are usually worn., externally (on the penis or "the insertive partner," or top).

Although the Chicago men expressed a high degree of satisfaction with what was then called the "Aegis," and evidence showed it was probably save and effective, the Food and Drug Administration refused in 1992 even to consider it for possible use in preventing HIV transmission during anal sex.

The FDA agency panel that quashed the Aegis approved a Pre-Marketing Approval application for the vaginal use of the device, and two years later cleared it for over-the-counter sales - the identical product, with a different instruction book - as the Reality brand "female condom."

The company cannot legally promote the device for anal sex, even indirectly, so gay men have remained mostly uninformed about it. And allegedly the FDA's decision to prevent that potentially lifesaving information from getting out was deliberate, and based upon squeamishness about the mechanics of how the virus is spread, on archaic laws, and on homophobia.

A spokeswoman at Female Health company, which manufactures Reality/Aegis, told the Gay Area Reporter that FHC President Mary Ann Lieper was explicitly told at an FDA obstetrics/gynecology department Device and Diagnostics panel meeting, "Because sodomy is illegal in many states, we cannot support a male condom."

"NOT VERY REASONABLE"

Ben Schatz, executive director of the San Francisco-based Gay and Lesbian Medical Association said the admission of analphobia at the FDA "doesn't surprise me, but it does appall me.

"If that's true, it's an outrageous abuse of federal power."

Dr. Lillian Yin, who still heads the department at the FDA, told the B.A.R. data on the Aegis study at the Howard Brown Memorial Clinic were "never brought in for approval," and that "we would have no problem" with studying the concept of Reality as an anal HIV barrier.

"But I was told," she added, "that the inner ring was not very...reasonable for anal tissue.

"That's the extent I heard."

FHC spokeswoman Holly Sherman says the information was never brought in for Yin's approval because the fate of the Aegis had already been made known at the panel meeting. Two years earlier "they approved the guidelines and protocol" for the Howard Brown study, she told the B.A.R., then refused to carry it over into the next phase after the study was done.

Despite what Yin hay have heard, some users of the "female condom" for male-male sex report it is very . reasonable, with many advantages over latex condoms. As a polyurethane plastic, it carries no restriction on the kind of lubricant partners can use - although health experts agree water- based is still healthier - and has no unpleasant taste or odor. Although its plastic is nearly indestructible, it feels thinner than Saran Wrap and many times thinner than latex condoms, so it transmits heat faster and sensation better.

Reality doesn't make sex perfect again, of course, but as Steve Gibson at the Stop AIDS Project told the B.A.R., "It's another option.

It's a question of what works for you."

Those who have tried and like the internal condom say it is a relatively simple matter to put the Aegis into place, after which the smaller ring and internal muscles automatically keep it from dislodging; the larger ring on the outside of the body is the opening for the penis - or can be opened wider for oral-anal contact, providing protection against cryptosporidiosis.

Users also say it adds spontaneity since it doesn't require fumbling between erection and penetration.

Timothy J. Rodrigues of the San Francisco AIDS Foundation lauded another advantage, saying that "anything that puts choice into the hands of the bottom - and frees him from having to argue with a top about putting on a condom - we could support."

Moreover, according to a volunteer who distributes Reality condoms in Philadelphia as part of the Gay and Latino AIDS Education's Midnight Cowboy program, the option of advance insertion has many advantages. Hassan J. Gibbs told the Philadelphia Inquirer in January that 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.

BY 'SCRIP OR CLINIC

Chicago and Seattle have also initiated Reality condom distribution programs. Now the California state AIDS Office has begin providing Reality condoms to clients at some health clinic, including some in San Francisco. Originally the city clinics provided them only to female clients, but the program had been broadened this week to include men as well. Dr. Mitch Katz, M.D. directory of the San Francisco AIDS Office, confirmed to B.A.R. a memo to that effect is being drafted for distribution throughout the city's clinics.

Now a foreseeable problem, expressed by Supervisor Tom Ammiano's aide Lauri Irving, is that the condom giveaway could prove so popular among male San Franciscans that "the few scant resources allotted for women and AIDS issues will be spent on gay men.

"I'm all for the passing them out if they save lives," Irving said, "but I worry about diverting funds from women and not replacing them. We should focus on expanding resources."

Fortunately, health clinics are no the only place to fine Reality. They are available at retail drug stores and around three dollars each, and there is the additional option of MediCal reimbursement for those who are eligible and who can find a doctor willing to write the prescription for the device (MediCal billing code X6; product code 9914P; manufacturer's code 11423X6) for a non FDA-approved use.

Dr Margaret Posher, a San Francisco physical, told the B.A.R. "As a physical I would want to do anything possible to protect my patients from HIV infection." And as for it being used for anal, rather than vaginal, sex, she said, "We prescribe all sorts of substances that are `off-label' [for non-approved uses] because we know they work. If I had evidence that this condom worked, I would be happy to prescribe it.

"That data should be made available."

SEMINAL FLUID EXPOSURE

The data made available to the B.A.R. taken from the study carried out by the Howard Brown Memorial Clinic in Chicago, yielded very promising results. None of the men reported dislodgment, and close examination of the anal condoms found no rips or tears after sex.

When the Realty's disease prevention properties were tested in 1990 by San Francisco AIDS researcher Dr. Marcus Conant and two colleagues, its plastic was found to be impermeable to both cytomegalovirus and HIV. 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 Reality was used. Breakage was also less common with Reality than with Trojan Enz.

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

Despite the data, most public health administrators and supervisors seem unaware that Reality condoms can be used for anal sex. With the exception of Stop AIDS's Gibson, non of the officials and educators contacted by the B.A.R. knew o the six-year-old Aegis study. Victor Zonona, spokesperson for Health and Human Services Secretary Donna Shalala in Washington, said he had literally no concept of Reality, for vaginal or anal sex.

Zonona, a former reporter for the Los Angeles Times, pointed out the George Bush was still in the White House when the FDA panel shut off further research for Aegis. "It's a shame," he said. "This administration believes every new infection is a wasted infection. I've heard the secretary say it' I've heard the president say it."

AIDS czar Patsy Fleming and White House Gay Liaison Marsha Scott did not answer the B.A.R.'s calls by press time.

San Francisco AIDS activists Michael Petrelis became the first male to ask for the internal condoms at the city health clinics, which lead to a brief inquiry by the city's Human Rights Commission into whether the refusal to his request constituted sex discrimination, before the policy was changed.

Petrelis said he is outraged that the federal government stopped progress on the Aegis because of homophobia, and also derided health officials for not fully investigating the Reality, which he blamed on "the de-gaying of AIDS" and homophobia.

"According to the most recent annual report put out by the San Francisco AIDS Office (in 1991-92) people with AIDS in this city are 98 percent male," he said in a recent interview. "Eighty-six percent of them got it through male-male sex - and there's this wonderful thing out there that can save lives, but because they're called `female condoms' even out gay public health officials don't know what they are, or that they've already been studied for anal sex."

Next, he said, he may file a class action lawsuit to make the internal condoms available to men statewide.

"How many gay people must contract HIV/AIDS through anal sex," he asked, "before the authorities think we can handle Reality?"

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