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The Female Health Company would like to address the article which appeard in the New York Times Health section on Tuesday November, 13th 2007, “Redesigning a Condom So Women Will Use It,” by Donald McNeil Jr. (text and link are below).

FHC was surprised to read this article as we were never contacted by Mr. McNeil. Further, we regret that he has not used correct information relative to the FC female condom.

For your information we have listed some points to keep you fully informed. We have also copied below our letter to the editor. If you have any comments or concerns regarding this article or the Female Health Company's response please contact us at info@femalecondom.org

___________________________________________________________________________________________

Letter to the Editor of the New York Times from Female Health Company's Chairman and CEO - O.B. Parrish

___________________________________________________________________________________________

Re: “Redesigning a Condom So Women Will Use It” (Health, November 13), we were surprised that The Times published a detailed review of future prospects for the female condom without contacting the company that produces the only female condom that has been cleared by WHO for purchase by UN agencies and approved by the FDA. Had we been contacted, we would have noted that a second-generation female condom (FC2) already exists, and that it is produced with the same cost-efficient dipping process that allows male condoms to be produced cheaply. We would have also noted that peer-reviewed research on the second-generation female condom has demonstrated that 80 percent of users like the product, an acceptance rate comparable to the male condom.

As experts cited in your article noted, the primary challenge for the female condom has never been user reaction to the product itself. (Acceptance rates for the first-generation female condom were comparable to the male condom as well.) Rather, it has been a failure to implement broad education campaigns and public awareness programs that target women and men who want and need safe, proven, and effective prevention options. When the male condom and the tampon were first introduced, they were not embraced as essential health products until they were actively promoted to consumers. We face a similar challenge with the female condom. To address that challenge and expand access, our company has invested millions from its own limited resources to develop a second-generation female condom that is already 30 percent less expensive than its predecessor and can be made much cheaper if it is purchased and distributed in large quantities. We have also partnered with UNFPA to scale up education programs and distribution of the female condom in more than 20 countries, including nationwide distribution programs in Zambia, Zimbabwe, and Malawi. As a result of these comprehensive efforts, distribution of the female condom has grown rapidly over the past three years, and it is now more than double the figure cited in the article. Such efforts are a strong first step toward the large-scale programming that is essential to drive down the product’s cost and make it directly accessible to women and men in resource-poor nations.

We have worked closely with PATH on the development of their new female condom prototype, and we support all efforts to develop additional woman-initiated methods that can help women prevent HIV infection. Research demonstrates that when people have access to a diverse array of prevention options, they are more likely to have safer sex. Both PATH and our company are focused on achieving the same goal: providing women and men with access to multiple products that they can use to prevent HIV infection.

_______________________________________________________________________________________

Redesigning a Condom So Women Will Use It - New York Times - November 13, 2007

The female condom has never caught on in the United States. But in the third 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 poor 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.”

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 poor 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.”

But 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.

During sex, the new female condom also moves more like a vagina than the old design did, according to couples in Seattle, Thailand, Mexico and South Africa who tested a series of prototypes, said Joanie Robertson, project manager for the condom at PATH. The old design hung passively from the rubber ring, which could shift around and sometimes hurt; the new design has dots of adhesive foam that adhere to the vaginal walls, expanding with them during arousal.

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 “O.K. to very satisfactory.”

Nonetheless, progress is now stalled.

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

While the F.D.A. 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.

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,” Dr. Free said.

The United States 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 have also 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 Company 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 Dr. Peter Piot, executive director of UNAids, the United Nations AIDS agency.

In the 1990s, Mr. Warren, former director of international affairs for the Female Health Company, visited 24 countries trying to get the female condom accepted. Brazil, South Africa and Zimbabwe were the most receptive, said Mr. 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.”

But, as Ms. 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, Mr. Warren said, was determined mostly by how it was introduced. Brazil’s rollout order was for one million. Bangladesh, by contrast, tried to start with only 20,000. And Uganda bought one 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.

While 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.

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

FC & FC2 Female Condom

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Corporate Information ______________________ -----Recent Female Condom--Media Coverage ______________________ Foundation Information		CORPORATE INFORMATION The Female Health Company (FHC) is the maker of FC Female Condom® — the first and only female-initiated barrier method of contraception and disease prevention. FHC was created as a worldwide company in February 1996 with the purchase of Chartex Resources Ltd., the holder of exclusive worldwide rights to FC. FHC is the sole manufacturer and marketer of FC in the world. FHC manufacturers all FCs in a state-of-the-art facility in London, England. FHC holds exclusive product and technology patents in the United States, Australia, Brazil, Canada, the European Patent Convention, France, Germany, Italy, Spain, the United Kingdom, the People’s Republic of China, South Korea and Japan. The company now has the registered trademark FC Female Condom in the United States. FC is available through public sector agencies in more than 90 countries and throughout the United States. It is also sold commercially in 17 countries - including the United States, the United Kingdom, Australia, Brazil, Canada, Denmark, France, Germany, Holland, Italy, Japan, Mexico, Spain, Suriname, Switzerland, Turkey and Venezuela. Back to the top _________________________________________________________________________ RECENT FEMALE CONDOM MEDIA COVERAGE The Female Health Company would like to address the article which appeard in the New York Times Health section on Tuesday November, 13th 2007, “Redesigning a Condom So Women Will Use It,” by Donald McNeil Jr. (text and link are below). FHC was surprised to read this article as we were never contacted by Mr. McNeil. Further, we regret that he has not used correct information relative to the FC female condom. For your information we have listed some points to keep you fully informed. We have also copied below our letter to the editor. If you have any comments or concerns regarding this article or the Female Health Company's response please contact us at info@femalecondom.org Points for reference about the FC female condom: There is rapidly increasing demand globally for the FC Female Condom. FC unit growth has averaged greater than 30% each year for the last 3 years. Research has consistently demonstrated that acceptability for both the FC1 and FC2 female condom is comparable to acceptability rates for the male condom. The issue has never been consumer rejection of the “product.” Rather, it has been a failure to implement broad education outreach campaigns and public awareness programs to engage consumers. The reason for increased growth is increased implementation of education outreach programs. UNFPA and FHC have partnered on many of these programs. FC unit distribution in 2007 went to 75 countries, reflecting broad-based global acceptance; most were reorders. FC2 was developed to specifically address the cost and access issues raised by Mr. McNeil. FHC wanted to find a way to make the exact same product design more cheaply. Our objective was to ensure the same level of efficacy and safety, the same methods of insertion, etc., but to make FC less expensive to the major donors with the ultimate goal of increasing accessibility to the women who want and need it. FC2 is available to ex-US countries. To date, approximately 7 FC2 million units have been distributed. FC2 is 30% cheaper than FC1, and its cost will decrease as the volume of procurement increases. (Remember there are 6-9 billion male condoms distributed through the global public sector annually vs our >25 million units this year). FC1 is the only female condom approved by FDA and on WHO’s essential product list. FC2 is also recommended by WHO for purchase by UN agencies. FC2 documentation for FDA approval is in final stages of preparation and will be filed to FDA by year end. Female and male condoms used correctly are effective in preventing HIV/AIDS. While research on new products is essential, it is also essential to recognize the need to provide women and men with access to the safe and effective prevention options that are available now because products currently in development may not be available for years to come. The immediate focus must be on programming and education outreach on the use of currently available prevention products, including FC. Providing women and men with access to currently available tools - as well as education on safer sex, HIV prevention, and partner communication – will only strengthen and accelerate the uptake and programming of new methods when they become available. ___________________________________________________________________________________________ Letter to the Editor of the New York Times from Female Health Company's Chairman and CEO - O.B. Parrish ___________________________________________________________________________________________ To the Editor: Re: “Redesigning a Condom So Women Will Use It” (Health, November 13), we were surprised that The Times published a detailed review of future prospects for the female condom without contacting the company that produces the only female condom that has been cleared by WHO for purchase by UN agencies and approved by the FDA. Had we been contacted, we would have noted that a second-generation female condom (FC2) already exists, and that it is produced with the same cost-efficient dipping process that allows male condoms to be produced cheaply. We would have also noted that peer-reviewed research on the second-generation female condom has demonstrated that 80 percent of users like the product, an acceptance rate comparable to the male condom. As experts cited in your article noted, the primary challenge for the female condom has never been user reaction to the product itself. (Acceptance rates for the first-generation female condom were comparable to the male condom as well.) Rather, it has been a failure to implement broad education campaigns and public awareness programs that target women and men who want and need safe, proven, and effective prevention options. When the male condom and the tampon were first introduced, they were not embraced as essential health products until they were actively promoted to consumers. We face a similar challenge with the female condom. To address that challenge and expand access, our company has invested millions from its own limited resources to develop a second-generation female condom that is already 30 percent less expensive than its predecessor and can be made much cheaper if it is purchased and distributed in large quantities. We have also partnered with UNFPA to scale up education programs and distribution of the female condom in more than 20 countries, including nationwide distribution programs in Zambia, Zimbabwe, and Malawi. As a result of these comprehensive efforts, distribution of the female condom has grown rapidly over the past three years, and it is now more than double the figure cited in the article. Such efforts are a strong first step toward the large-scale programming that is essential to drive down the product’s cost and make it directly accessible to women and men in resource-poor nations. We have worked closely with PATH on the development of their new female condom prototype, and we support all efforts to develop additional woman-initiated methods that can help women prevent HIV infection. Research demonstrates that when people have access to a diverse array of prevention options, they are more likely to have safer sex. Both PATH and our company are focused on achieving the same goal: providing women and men with access to multiple products that they can use to prevent HIV infection. O.B. Parrish CEO and Chairman Female Health Company _______________________________________________________________________________________ Link to New York Times Website- http://www.nytimes.com/2007/11/13/health/13cond.html?_r=1&ref=science&oref=slogin Redesigning a Condom So Women Will Use It - New York Times - November 13, 2007 By DONALD G. McNEIL Jr. The female condom has never caught on in the United States. But in the third 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 poor 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.” 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 poor 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.” But 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. During sex, the new female condom also moves more like a vagina than the old design did, according to couples in Seattle, Thailand, Mexico and South Africa who tested a series of prototypes, said Joanie Robertson, project manager for the condom at PATH. The old design hung passively from the rubber ring, which could shift around and sometimes hurt; the new design has dots of adhesive foam that adhere to the vaginal walls, expanding with them during arousal. 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 “O.K. to very satisfactory.” Nonetheless, progress is now stalled. PATH is seeking approval from the Food and Drug Administration so the condom can be sold in the United States. And with the drug agency’s approval, it would be much easier to license the condom in poor countries or get a World Health Organization endorsement. While the F.D.A. 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. 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,” Dr. Free said. The United States 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 have also 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 Company 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 Dr. Peter Piot, executive director of UNAids, the United Nations AIDS agency. In the 1990s, Mr. Warren, former director of international affairs for the Female Health Company, visited 24 countries trying to get the female condom accepted. Brazil, South Africa and Zimbabwe were the most receptive, said Mr. 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.” But, as Ms. 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, Mr. Warren said, was determined mostly by how it was introduced. Brazil’s rollout order was for one million. Bangladesh, by contrast, tried to start with only 20,000. And Uganda bought one 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. While 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. But as Ms. Robertson noted, companies that make blood bags have little expertise in marketing sexual products. Back to the top. __________________________________________________________ FOUNDATION INFORMATION Established in 1996 by The Female Health Company, (the developer of the FC female condom), the Female Health Foundation (FHF) is a US registered 501 (C) 3, international not-for-profit organization dedicated to improving women’s health by elevating awareness about their vulnerability and developing innovative, gender-sensitive programs in addressing their needs in family planning and STD/HIV/AIDS prevention. Registered in the US and UK and with partners and friends throughout the world, FHF engages in limited global advocacy and works to develop communication, education and outreach programs at the community level for women (and men) in Africa, Asia, Europe, Latin America and North America. Our Mission The Female Health Foundation is dedicated to promoting women’s health and protecting women’s reproductive rights through sexuality education, empowerment, and skills-building programs. Our global efforts help policy makers, program planners, communities and individuals better prepare for, understand, demand and access a range of prevention technologies and skills-building programs. In this way we hope to contribute to a broad, sustainable response to the critical issues facing women and their families, most notably HIV/AIDS and sexually transmitted infections (STIs). FHF believes that promoting women’s health involves protecting women’s reproductive rights. Policy makers, program planners, community organizations, service providers and women themselves must be fully prepared to advocate for and have access to preventive reproductive health technologies. As the global leader in the field of female-initiated prevention technologies, the Female Health Foundation plays an important role in defining and articulating women’s protection strategies. In so doing, we recognize that gender power inequities shape women’s ability to make and implement reproductive health choices, and that their economic vulnerability fuels their sexual vulnerability. Moreover, we believe that the unequal status of girls and women in many societies is central to any discussion of protection strategies, and that the underlying task of changing the power balance between men and women is essential for real and sustained change. To this end, FHF looks to serve as a forum for the exchange of ideas and debate on key subjects related to women’s protection - both the technology options as well as the social, economic, and behavioral approaches women need to protect themselves from disease and unintended pregnancy. We see ourselves as a catalyst between the latest research and innovative program initiatives. Our Work The Foundation’s current primary focus is to support information, education, communication, and outreach programs that empower women. In the long-term, the Foundation will seek to contribute to self-sustaining program models and initiatives that improve the health and well-being of women around the world. FHF is an evolving organization and effort. The areas of focus listed below have as a base to move forward, many years of information gathering and experience in fine-tuning an effective approach to bring new women-initiated technologies to the grass-roots of need and demand. Working with the FC female condom, FHF has a wealth of experience in developing programs to teach about women’s anatomy, sexuality, and basic reproductive health in diverse cultural and country contexts. Our ability to critically evaluate programming efforts through the use of policy and program data as well as through feedback from users allows us to distill the essential elements of what works and what doesn’t. Our knowledge base can be adapted and applied to newly-emerging women’s prevention technologies in the future. With this as background, FHF’s work aims to: Introduce female health products and accompanying empowerment programs into diverse health care settings worldwide. Stimulate the innovation and exchange of information needed to develop programs and technologies aimed at enhancing women’s protection strategies. Foster dialogue and debate among global business leaders and public health experts on critical issues of sustainability and public-private sector partnerships. Strengthen the links made on both research and policy levels between women’s economic empowerment, education, and reproductive health. How We Work The Female Health Foundation builds upon its unique strategic partnership with the Female Health Company and its propriety product - the FC female condom - the only FDA- approved safe and effective female-initiated prevention technology on the market today. The Foundation forges strategic linkages and collaborates with both public and private sector organizations involved in related product development efforts. FHF’s primary focus is not to fund research but to develop information, education, communication and outreach programs that focus on empowering women to make sound reproductive health choices. More specifically FHF works with United Nation agencies, other non-governmental organizations (NGOs) and community based organizations (CBOs) and governments and other groups to develop outreach programs that address specific cultural, economic and social needs within a country and community primarily addressing HIV/AIDS prevention. The majority of this work is funded by The Female Health Company and is carried out by regional staff based in Senegal, South Africa, Thailand, the UK and the US. Our Current Activities Developing, collecting, and disseminating information, education and communication on sexuality, female anatomy, and essential elements of reproductive health and disease protection. Conducting education and skills-building programs aimed at increasing women’s self-awareness and self-confidence in matters related to sexual health. Increasing public and private sector attention to, and resources for, the creation and delivery of effective STI and HIV prevention technologies and related programs. Introducing female-initiated prevention technologies in tandem with skills-building programs by collaborating with partners in developing countries and the private sector. Forward-Looking Activities • Identify and convene women leaders in industry, academia, government and NGOs to discuss and debate central issues concerning sustainability and public-private sector partnerships. • Sponsor “Day of Dialogue” series on critical issues at the intersection of women’s economic empowerment and reproductive health. • Seek strategic partnerships with product development entities involved in expanding women’s health care products. How We Are Governed The work of the Foundation is overseen and directed by its Board of Advisors, a group of public health advocates. These members participate as individuals and do not officially represent their respective organizations. FHF is initiating efforts to identify additional persons to participate on the Board, particularly with international public health advocacy experience and interests. BOARD OF ADVISORS Mary Ann Leeper, PhD, Chair President, The Female Health Company Martha Brady, M S Gender, Family and Development Program Population Council Patrick Friel, RH, HIV/AIDS Consultant Pamela P. French, MD, MPH Public Health Consultant specializing in Anti-Infectives/Biologicals, United States Erica L. Gollub, DrPH Consultant Mary Latka, PhD Center for Urban Epidemiologic Studies, New York Academy of Medicine Mitchell Warren, Executive Director, AVAC – AIDS Vaccine Advocacy Coalition In addition the following persons are special advisors on an as needed basis: Virginia Gonzales, MSW, MPH, EdD Marilyn John Sharon Marshall, MD Carol Rogers, PA Pramilla Senanayake, MD, PhD Denese Shervington, MD. MPH More Information info@femalehealth.com leeperma@femalehealthfoundation.org REGIONAL CONTACT: Sub-Saharan Africa: katypepper@femalehealthfoundation.org Asia: pweisenfeld@femalehealthfoundation.org Europe & Francophone Africa: tnakari@femalehealthfoundation.org Latin America: simonemartins@femalehealthfoundation.org Back to the top.

FC & FC2 Female Condom

Redesigning a Condom So Women Will Use It - New York Times - November 13, 2007