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It’s only been ten years since estrogen replacement was huckstered as a sexual fountain of youth. Women don’t lose their hormones because they get old, they get old because they lose their hormones was the lucrative sales pitch. Hormone replacement therapy was practically a right of passage for US women–promised as the way to keep their looks and husbands, making billions for Wyeth which is now Pfizer.
But ten years ago a federal study found hormone replacement drugs in women greatly increased the risk of breast cancer, ovarian cancer, heart attacks, stroke, blood clots and dementia, The one-size-fits-all hormone replacement was not just worthless–it was causing many of the things it was supposed to prevent.
Public health agencies and medical groups had major egg on their face when millions of women quit hormones in 2003. The incidence of breast cancer in the US fell actually fell seven percent and 15 percent for tumors fed by estrogen. Heart attacks in women also fell. The “cause” of cancer was in clear site and it wasn’t lifestyle, genetics or environmental factors–it was Big Pharma!
It was even more embarrassing to public health officials because the whole sequence had occurred before. The same drops in cancer had been seen thirty years earlier when estrogen-only therapy was used. At that time, women quit hormone therapy then because of its links to endometrial cancer…whereupon progesterone was added to prevent endometrial cancer. Who can say short memory?
It’s no secret that testosterone is the new estrogen for both men and women. Marketed to men, it is a way to stay young and virile and maintain “performance” as the radio ads say. Marketed to women, testosterone is a way to recapture waning sexual desire and boost the libido. Two new pills to boost women’s libidos are under consideration by the FDA. One contains testosterone and adds sildenafil, the active ingredient in Viagra. The other contains testosterone with the antidepressant buspirone. The drugs have a peppermint-flavored testosterone coating said to “melt in the mouth” allowing the second ingredient to kick in. They are advancing in the FDA approval process and expected to be cleared for larger clinical trials soon. If all goes well, they could be on the market in two years.
Yet marketing male hormones to women is not new and not without controversy. A testosterone patch made by Procter & Gamble to increase women’s sexual desire has already been rejected by the FDA. Some say Intrinsa, denied approval by the FDA in 2004, failed to fly because it came too soon after the Vioxx debacle which many attributed to the FDA’s hasty, industry-friendly approval. Marketed as a super aspirin for everyday arthritis or menstrual discomfort, Vioxx resulted in 88,000 heart attacks and 38,000 deaths before it was withdrawn from the market, according to published reports.
Intrinsa produced only “small improvements in sexual parameters and large placebo responses,” said a review in Drug and Therapeutics Bulletin that proved a nail in the drug’s coffin. “Unwanted side effects are common and not always reversible.” Who can guess what those side effects are? Nor did it help that three women testified during FDA hearings for Intrinsa that they had developed breast cancer while using it.
Have public health officials, doctors and women learned anything from the first two hormone marketing scourges? Or will testosterone be number three?
Martha Rosenberg is an investigative health reporter. She is the author of Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).