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Success For Redesigned Female Condom Seems Inconceivable

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By DONALD G. McNEIL Jr., New York Times

Published: November 17, 2007

The female condom has never caught on in the United States, but in the developing world, where it was introduced in the late 1990s, public health workers hoped it would overthrow the politics of the bedroom, empower women and stop the AIDS epidemic in its tracks.

It did not. Female condoms never really caught on there, either.

Only about 12 million female condoms are delivered each year in developing countries, compared with about 6 billion male condoms. Couples complained that the female version was awkward, unsightly, noisy and slippery - or, as Mitchell Warren, who was one of its earliest champions, now says, "the yuck factor was a problem." Many women tried it, but in the end, it was adopted mainly by prostitutes.

Now scientists are trying again. A new design - much the same at one end, different at the other - has been developed, and its makers hope it will succeed where its predecessor failed.

"Over 15 years, there's been no real competition, no second-generation product," said Michael J. Free, head of technology at PATH, a nonprofit group based in Seattle that did the redesign. "There's no lack of interest, but we've been stalled."

'Almost Undiscussable'

However, the new design does not overcome the glaring drawback that doomed the first to be a niche product: It cannot be used secretly. For that reason, married women, now one of the highest risk groups for AIDS in developing countries, rarely use it.

"I don't want my husband to know that I am wearing a condom," said Lois B. Chingandu, the director of SAfaids, an anti-AIDS organization in Zimbabwe.

"Condoms are almost undiscussable within a marriage" in Africa, she added. "It is something associated with casual sex. If a wife uses a condom, the message is that you have been unfaithful. If she even initiates the discussion, it tips the power scale. Men resist quite a lot, and it can result in violence."

For couples who have agreed on condoms, and for sex workers whose clients cooperate, the new design has several advantages.

The redesigned female condom is made of softer, thinner polyurethane to better transmit warmth. It is easier to insert; one end is bunched up as small as a tampon, an improvement on the old design, which resembled the stiff rubber ring of a diaphragm and had to be folded into a figure 8 for insertion.

Couples in Seattle, Thailand, Mexico and South Africa tested a series of prototypes, said Joanie Robertson, project manager for the condom at PATH.

According to PATH, more than 90 percent of the couples were satisfied with the ease of use and comfort of the new condom, and 98 percent found the sensation of sex to be "OK to very satisfactory."

Seeking FDA Approval

Nonetheless, progress is stalled.

PATH is seeking approval from the Food and Drug Administration so the condom can be sold in the United States. With the drug agency's approval, it would be much easier to license the condom in developing countries or get a World Health Organization endorsement.

Although the FDA designates male condoms as Class 2 medical devices - meaning that a new maker has to pass tests only for leakage and bursting - it puts female condoms in Class 3, the same category as pacemakers, heart valves and silicone breast implants.

That decision was made in 1999, after much debate, and well after the condom was in use overseas, because there was no clinical data on the effectiveness of female condoms, and failure could be life-threatening if the woman's partner had AIDS. An advisory panel suggested not even calling it a "condom" and instead labeled it an "intravaginal pouch," but the agency rejected that advice.

Cost A 'Huge Impediment'

Names notwithstanding, the Class 3 listing means that any new design must pass clinical trials, which would cost $3 million to $6 million.

"That's a huge, huge impediment, close to a 100 percent block, because no one's willing to put up that sort of money," Free said.

The U.S. Agency for International Development, the Bill & Melinda Gates Foundation, the Lemelson Foundation and others paid for design costs and prototypes, but they are not willing to pay for clinical trials and the cost of building a factory. Private investors also have balked because the American and European markets for the original design proved smaller than had been predicted.

The failure of the original design - made by the Female Health Co. of Chicago and marketed worldwide under names like FC1, Reality, Dominique, Femy and Protectiv - is still galling to AIDS experts.

"Their use has remained frustratingly and tragically low," said Peter Piot, executive director of UNAids, the U.N. AIDS agency.

In the 1990s, Warren, former director of international affairs for the Female Health Co., visited 24 countries trying to get the female condom accepted. Brazil, South Africa and Zimbabwe were the most receptive, said Warren, who now works on AIDS vaccines.

"It had some elements of success," he said, "but hasn't had the blockbuster numbers the company had hoped for."

Design, Not Marketing, Is Better

However, as Chingandu noted, even in Zimbabwe, after an initial flurry of excitement from women, the condom settled into a niche: a tool of the sex trade.

Whether the condom did well or poorly in a particular country, Warren said, was determined mostly by how it was introduced. Brazil's rollout order was for 1 million. Bangladesh, by contrast, tried to start with only 20,000. Uganda bought 1 million but then did little marketing and no training in how to use it.

"People said, 'Oh, it failed,'" he said. "Well, it didn't fail. It just wasn't available, or its introduction was a bad program. People need to practice with it before it catches on."

He called the new design "a better mousetrap" but said it still faced another problem it shares with the original: It is expensive compared with male condoms.

Athough those are made by simply dipping molds in latex, the female one uses complex thin-film polyurethane. The most closely related technology is that used for blood bags, so PATH is visiting companies that make them.

However, as Robertson noted, companies that make blood bags have little expertise in marketing sexual products.

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