1. Home
  2. News & Issues
  3. US Politics

FDA Panel Rejects Intrinsa

Page 2

by Kathy Gill
for About.com



Why Testosterone
Intrinsa, which P&G licensed from Watson Pharmaceuticals Inc. in 1997, releases testosterone through the skin in an amount a women would have produced before menopause. This is a much smaller dose than transdermal patches for men, which is Watson's target.

The focus in news analylsis is on "lifestyle" - however, testosterone has many functions beyond sexual desire. These include maintenance of muscle mass and strength, maintenance of bone density and strength, and mental and physical energy.

Australian researcher Susan Davis, director of research at the Jean Hailes Foundation in Melbourne, said "All the talk of enhancing sexual performance and the 'Pink Viagra' tag is highly misleading . . . I dislike the term for Intrinsa because it is more of a wellbeing drug, not purely a sexual function treatment."

She also said that the "good thing about taking testosterone" is if you develop a side effect, it stops the minute you stop wearing the patch or implant."

In the US, testosterone is available at compounding pharmacies for women whose doctors will prescribe it; usually the formulation is a cream. Most insurance plans will not pay for this formulation. That is one reason FDA approval is important -- it legitimizes the drug. Moreover, it sets recommended dosages.

Testosterone is also available in the US - off-label use - in a non-bio-identical form that is paired with the same non-bio-identical estrogen implicated in WHI.

Politics
In USA Today, Laura Berman writes:
    The flawed idea that what's true for men is also true for women is leaving women on the fringes of one of medicine's most promising new frontiers: sexual health.

    Since the FDA approved Pfizer's Viagra for men in 1998, we have witnessed a revolution in the treatment of male sexual dysfunction. Six years later, the 43% of American women who suffer from sexual dysfunction still lack an FDA-approved medication.
She also points out that one of the problems in getting approval for women is that the FDA has set a "male-defined outcome" for determining effectiveness by focusing on number of orgasms. She says that this model works for men but does not for women where "intimacy" is a necessary part of the equation.

She contends that research which screens women who have psychological impediments from those who have physical impediments shows that drugs like Viagra do have a positive impacton arousal and satisfaction.

She closes by writing: "Though women may be more complicated, our sexual health deserves as much attention as men's. At the very least, it merits the same debate that race is currently stirring up within the medical community."


Sources:

Explore US Politics

About.com Special Features

What is a Recession?

Sure, we're all talking about it, but what, exactly, defines a recession? More >

Weird Breaking News

A daily look at some of the oddest (and dumbest) crimes around. More >

  1. Home
  2. News & Issues
  3. US Politics
  4. Political Issues
  5. Health Care
  6. Politics: FDA Panel Rejects Intrinsa - Page 2>

©2009 About.com, a part of The New York Times Company.

All rights reserved.