By Jesse Marx
By Chris Parker
By Jake Rossen
By Jesse Marx
By Michelle LeBow
By Alleen Brown
By Maggie LaMaack
By CP Staff
Female Health needed cash, which meant unloading its backlog of unsold condoms. In 1996, the Joint United Nations Programme on HIV/AIDS signed a three-year agreement with Female Health to distribute the female condom in developing countries in exchange for a discount on the product. (The company is selling the condoms to health agencies in both the Third World and industrialized nations for less than $1 each.)
Which is where Arden Hills' DSS came into the picture. DSS was already shipping orders for Female Health. Last spring, Female Health asked it to begin shipping unsold condoms to public health agencies for use in such impoverished countries as Uganda, Paraguay, Ghana, Haiti, and Indonesia. First, however, the expiration dates needed changing.
Which isn't as shady as it sounds. In what Dan Schultz of the FDA calls a "common strategy," companies seeking approval from the agency often propose a shorter life span than is actually the case. Because the testing process products must go through to gain FDA approval is costly, companies can ask for the life span that they have hard data to support. Then once the product is on the market they have the time and the capital coming in to do the long-term testing needed to earn an extended and more realistic shelf life.
Reality was initially given a three-year shelf life, Schultz explains. Later testing done by Female Health determined that the condoms could last for at least five years, so last March, the FDA approved Female Health's request for a new expiration date and DSS began repackaging the long-stored excess inventory.
There's little question the relabeled condoms are safe to use, according to members of the medical community. "The expiration date is much less important for the female polyurethane condom than the latex condom," explains Dr. Robert Hatcher, author of the textbook Contraceptive Technology. "Latex condoms are much more fragile. Polyurethane is also not as heat or moisture sensitive as latex and doesn't require special storage. The female condom could last much longer than five years."
The FDA's decision, coupled with contracts to sell Reality to public health agencies throughout the United States and elsewhere, meant Female Health could sell off its backlog. During the first quarter of 1998, the sales boost increased revenue for Female Health by 116 percent.
Leeper says Reality stands a good chance of gaining popularity in other countries. "In some countries women recognize they are more at risk for STDs and HIV," Leeper says. Studies show that women who perceive themselves at high risk for infection with HIV or STDs are more likely to use Reality, and more than 90 percent of all adults with HIV or AIDS live in developing countries. Women in the United States perceive these infections as less of a threat, says Leeper. "There's a lot of denial and a sense of invulnerability in the United States."
Researchers at the World Health Organization say that while studies in developing nations turn up the same "yuck factor," women there, as Leeper predicted, are actually trying and using the female condom.
The other group in which Reality seems to be gaining ground is gay men. Two weeks ago, Jeffrey Gould received his second shipment of condoms from DSS. A health educator with Washington state's nonprofit Thurston County Public Health Co., Gould manages a program that distributes the condoms to gay men for free.
After hearing that gay men in London used Reality, several months ago Gould bought a box of the devices and handed them out in a couple of support groups for gay men to rave reviews. "What I've heard from women is that they're a bit noisy and that they looked big and bulky. Many women just looked at it and said, 'Ooh that looks scary,'" he says. But "men are loving them. They love the increased freedom. I've had lots of positive feedback."
Since then, Gould has heard that public health programs in other states have had similar success distributing the female condom to gay men. Tom Lindsay, manager of the Minnesota AIDS Project's community outreach program, worked on a study conducted by San Francisco public health agencies that examined Reality's potential for use by gay men. He says MAP has not begun distributing the female condoms for free because they're very expensive.
Leeper says that while Female Health doesn't market the condom directly to gay men, she knows there are pockets of men who are using them. "Information travels among gay men about it," she says. "We know that clusters of men are using it." Female Health did do one study which it says shows that the female condom is potentially strong enough for use during anal sex. The company developed instructions for its use, which Leeper says are under consideration by the FDA. If the agency eventually decides that anal sex is an approved use for the condoms, Female Health will begin marketing to gay men.
The bottom line, says Leeper, is that it takes enormous amounts of both time and money to launch a new form of birth control. Once on the market, the education process is long and expensive, and until something better can be developed, the Reality Female Condom is what we've got. "I think if a nonhormonal method could be found that killed both bacteria and viruses and that was invisible, it would be extremely successful," Leeper says. "But the trouble is it's difficult to find. Many have been working on it for years and still haven't come up with it yet."
Which means that for now the workers at DSS will continue repacking the "more than thousands" of Reality Female Condoms that Leeper says are entitled to an extended expiration date.