FDA Committee Says No to the Testosterone Patch

By Amy Allina

In December 2004, the Food and Drug Administration’s (FDA) Reproductive Health Drugs Advisory Committee voted unanimously against approval of a testosterone patch to treat low sex desire in women. Advisory Committee members explained their opposition, citing concerns about the safety of long-term use of the patch and its use by groups of women who have not yet been adequately studied. Procter & Gamble, which asked the FDA to consider the new product—whose proposed name was Intrinsa—had conducted research in women who had had their ovaries removed, were taking estrogen, and were experiencing a problematic lack of desire for sex. A few weeks after the Committee met, Procter & Gamble withdrew its application for Intrinsa’s approval. A company spokeswoman told reporters that the Proctor & Gamble plans to work with the FDA on a revised approach and to file a new application for the product in the future.

NWHN Opposed Intitnsa
At the Advisory Committee meeting, the National Women’s Health Network (NWHN) and several other organizations urged the Committee not to approve the drug. While recognizing that women who are troubled by their lack of desire for sex have a real problem that needs attention, the NWHN opposed approving Intrinsa because numerous questions and concerns remain about the safety of women’s testosterone use. Many of the concerns raised by the NWHN were cited in the Committee’s discussion.

Research indicates that Intrinsa could benefit the narrow group of women in whom it has been studied: women whose ovaries have been removed and/or who take estrogen. The need in this group is real, and the chance to provide help is hard to pass up. As women’s health advocates, however, the NWHN cannot consider the product in a vacuum, and neither should FDA.

Intrinsa is intended for long-term use; women who might benefit from the testosterone patch need to know about its long-term effects on their health. In the wake of the Women’s Health Initiative trial showing health risks associated with long-term use of hormone therapy, it is both appropriate and necessary to exercise special caution about the safety of long-term hormone use. The limited knowledge available about the effects of testosterone on women raises concerns about its effect on both breast cancer and heart disease and highlights the need for long-term safety data.

It would be naive and irresponsible to expect that Intrinsa will only be promoted and prescribed to women exactly like those studied in the trials. Viagra use quickly spread beyond an initial, conservatively drawn target group. It is extremely likely that advertising and other promotional efforts are likely to blur descriptions of appropriate users in order to expand the market for Intrinsa. Even a cursory scan of health websites and publications addressing sexual health issues shows that broader groups of women are already being advised to use testosterone for the problems they face in their sex lives.

Yet, the drug’s effects have only been studied among women whose ovaries have been removed and/or who take estrogen. Testosterone use by women in their reproductive years raises a whole new set of questions about the drug’s safety and we have yet to generate reliable answers to these questions. For example, testosterone use is contraindicated during pregnancy; how might the drug affect the future fertility of women who use Inrinsa when they are pregnant?

Supporting Research That Looks Beyond Medical Solutions
Despite opposing Intrinsa, the NWHN is committed to increasing awareness of women's options for addressing sexual problems and improving sexual health. The NWHN recognizes that, for many women who experience problems with sexual activity and/or sexual dissatisfaction, there is no physiological cause and drugs are unlikely to help. Sexual problems may be caused by relationship issues, work fatigue, economic anxieties, or past experiences of sexual violence, just to name a few possibilities. To help women who have the courage to confront their sexual dissatisfaction, the NWHN believes it will be necessary to look beyond medical solutions.

Just as Viagra galvanized a new public conversation about men’s sexuality, Intrinsa and similar products aimed at women may generate opportunities for both genders to discuss women’s sexual lives and the need to support sexual health research. Sexuality holds a central place in individuals’ lives—it affects physical and mental health, relationships, and families. For this reason, it is critically important that the government fund sexual health research that explores social, relational, economic and other issues involved in problems with sexual activity and satisfaction.

Public funding is essential because the research conducted by drug companies focuses on developing profitable drug products. Such research is unlikely to explore the broader sexual health questions that must be examined in order to truly understand these issues. In recent years, unfortunately, conservative members of Congress have attacked funding for sexual health research, which has had a chilling effect on the field (see “The Politicization of Science,” Women’s Health Activist, Jan/Feb, 2004). The NWHN hopes that the Reproductive Health Drugs Advisory Committee’s unanimous vote is a positive sign of impending change in this attitude.

NWHN was joined in opposing Intrinsa by a number of other women’s health advocacy organizations. The NWHN and other organizational statements and additional background materials on “Female Sexual Dysfunction” are available at http://www.fsd-alert.org/intrinsa.html.

Amy Allina is NWHN’s Director of Programs.