Bette, 72, who asked that her last name be withheld, testosterone therapy has restored a sex drive that virtually vanished after she underwent a hormonal treatment for breast cancer. She was terribly distressed, she says, when the "terrific sex life" she and her husband had enjoyed for 52 years crashed. So she traveled from her Kansas City home to see whether Irwin Goldstein, director of sexual medicine at San Diego's Alvarado Hospital, could help. He could, it turned out. He treated her with a low dose of a testosterone gel that has been approved for men with certain medical conditions. The medicine isn't FDA approved for use in women, but doctors like Goldstein can legally prescribe it "off label" if they think it might help
While Bette may be happy with her treatment, experts advise that breast cancer survivors must be especially cautious about taking hormone-based treatments for low libido. The body converts some testosterone into estrogen, which could raise a woman's risk of recurrence, says Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute. Aromatase inhibitors, which Bette and many other breast cancer survivors take, can prevent this conversion from happening, Goldstein says.Some doctors don't recommend off-label treatments at all. "Whenever you're using a drug [to treat] an indication for which it has not been tested, you're playing russian roulette," says Steven Nissen, who oversees cardiovascular medicine at the Cleveland Clinic. "It's risky business."
His message won't sway everyone, though. Says Bette: "I'd rather have something worth living for right now, rather than living in the old folks' home. I'm not going to miss any fun."
Saturday, 29 March 2008
Women Lacking Libido Aren't Sick
After 10 years of buzz about a Viagra-like drug for women, nothing has been approved to date. Two companies are racing to change that. Both have active, advanced research programs working on prospective female libido drugs, one of which is available now to women who qualify to join a clinical trial.
Illinois-based BioSante Pharmaceuticals has launched several late-stage studies of a testosterone gel intended to remedy libido loss after menopause. About 100 U.S. medical institutions are now on board to test the drug's safety and effectiveness among thousands of women; volunteers, some of whom will unknowingly receive a placebo, are still being recruited. Earlier trials found the gel useful in women bothered by low desire following medically needed surgery to remove their ovaries. (Those sex organs produce roughly half a woman's natural testosterone. Though often thought of as a "male hormone," testosterone is tied to libido in both sexes.) A dollop a day of the gel on their arm boosted the frequency of satisfying sexual events compared with a placebo.
An approved medication for low female libido may be in higher demand than Viagra ever was for men, says Stephen Simes, president and CEO of the company. His rationale: 1.4 million off-label testosterone prescriptions were written for women in 2006 alone. He forecasts the drug will be available by 2011, as long as no snags arise. (Women interested in enrolling in the trial can E-mail the company's investigators to see if they're eligible.)A nonhormonal treatment is also on the horizon, with late-stage testing well underway. Boehringer Ingelheim's once-daily pill acts on serotonin receptors in the brain, which, after all, is the organ most heavily involved with sexual desire. Studies involve pre-menopausal women bothered by a low sex drive.Too soon to tell. Still, excitement might be premature at this point, experts say. In 2004, a testosterone patch poised to be the first-ever treatment was denied approval by an FDA advisory committee. Long-term safety was a major worry. Procter & Gamble had demonstrated the patch's effectiveness with minimal side effects, but that couldn't shake concern that it might carry health risks down the line. After all, painkiller Vioxx had just been yanked off the market and the unforeseen ills of female hormone replacement therapy had recently surfaced.
"Before we approve a therapy that could be used by millions of women, I'd like to know that we're not going to hurt them, particularly when the benefit is modest," says Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, who was involved in deciding the patch's fate. "This is not a lack of sympathy for those who are unable to have a satisfying sexual relationship, but about balancing risks and benefits." The patch is approved in Europe.
One reason for the delay is that the FDA has set its approval standards high: A drug for women must not only elicit desire but also yield an increased number of sexually satisfying events. That's a requirement that Viagra never had to meet, says Anita Clayton, professor of psychiatry at the University of Virginia, and coauthor of Satisfaction: Women, Sex, and the Quest for Intimacy.
"I think the holdup is really our lack of understanding of female sexuality and applying this greater complexity to how we're studying potential treatments," says Clayton. "For women, a lot of our sexuality is above the neck, not below the waist," she says, which could explain why Viagra failed to produce results when tested in females. Viagra helps men with their most typical sexual problem—the inability to achieve and maintain an erection during sex—by causing blood to pool where it's needed. But female sex problems are more complicated and can be caused by a combination of hormonal, psychological, and interpersonal factors.
Illinois-based BioSante Pharmaceuticals has launched several late-stage studies of a testosterone gel intended to remedy libido loss after menopause. About 100 U.S. medical institutions are now on board to test the drug's safety and effectiveness among thousands of women; volunteers, some of whom will unknowingly receive a placebo, are still being recruited. Earlier trials found the gel useful in women bothered by low desire following medically needed surgery to remove their ovaries. (Those sex organs produce roughly half a woman's natural testosterone. Though often thought of as a "male hormone," testosterone is tied to libido in both sexes.) A dollop a day of the gel on their arm boosted the frequency of satisfying sexual events compared with a placebo.
An approved medication for low female libido may be in higher demand than Viagra ever was for men, says Stephen Simes, president and CEO of the company. His rationale: 1.4 million off-label testosterone prescriptions were written for women in 2006 alone. He forecasts the drug will be available by 2011, as long as no snags arise. (Women interested in enrolling in the trial can E-mail the company's investigators to see if they're eligible.)A nonhormonal treatment is also on the horizon, with late-stage testing well underway. Boehringer Ingelheim's once-daily pill acts on serotonin receptors in the brain, which, after all, is the organ most heavily involved with sexual desire. Studies involve pre-menopausal women bothered by a low sex drive.Too soon to tell. Still, excitement might be premature at this point, experts say. In 2004, a testosterone patch poised to be the first-ever treatment was denied approval by an FDA advisory committee. Long-term safety was a major worry. Procter & Gamble had demonstrated the patch's effectiveness with minimal side effects, but that couldn't shake concern that it might carry health risks down the line. After all, painkiller Vioxx had just been yanked off the market and the unforeseen ills of female hormone replacement therapy had recently surfaced.
"Before we approve a therapy that could be used by millions of women, I'd like to know that we're not going to hurt them, particularly when the benefit is modest," says Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, who was involved in deciding the patch's fate. "This is not a lack of sympathy for those who are unable to have a satisfying sexual relationship, but about balancing risks and benefits." The patch is approved in Europe.
One reason for the delay is that the FDA has set its approval standards high: A drug for women must not only elicit desire but also yield an increased number of sexually satisfying events. That's a requirement that Viagra never had to meet, says Anita Clayton, professor of psychiatry at the University of Virginia, and coauthor of Satisfaction: Women, Sex, and the Quest for Intimacy.
"I think the holdup is really our lack of understanding of female sexuality and applying this greater complexity to how we're studying potential treatments," says Clayton. "For women, a lot of our sexuality is above the neck, not below the waist," she says, which could explain why Viagra failed to produce results when tested in females. Viagra helps men with their most typical sexual problem—the inability to achieve and maintain an erection during sex—by causing blood to pool where it's needed. But female sex problems are more complicated and can be caused by a combination of hormonal, psychological, and interpersonal factors.
Dinner date, which could be purchased for $150, to a 24-hour date that cost customers $1,500. Other services offered include bondage
Two local women were arrested Tuesday night on misdemeanor sex charges after the pair reportedly offered to "put on a show" for a bachelor party that turned out to be a police sting operation.Prattville Police Chief Alfred Wadsworth confirmed Thursday that Dawn Renee Williams and Ashley Lynn Whitesell, both 33-year-old Prattville residents, are each charged with one count of promotion of prostitution in the third degree. The charge is a misdemeanor, and the women, both of whom are married, were each released on a $500 appearance bond.
Williams, known as "Dixie" on the pair's Web site, and Whitesell, who goes by the name "Darlin'," maintained a site that included racy pictures of themselves, along with a list of services and prices.
The services ranged from a dinner date, which could be purchased for $150, to a 24-hour date that cost customers $1,500. Other services offered include bondage, couples action and "nude housekeeping." According to the Web site, Williams even offered to travel anywhere in the U.S. or overseas, for a fee of $5,500.
The price list included a chart for converting the U.S. dollar amounts to the Euro, British pounds, Canadian and Australian dollars and Japanese yen.
Posted on the site were statements such as, "I love what I do and would like to show you that I do," and, "I am a lady and expect to be treated that way."
The duo also advertised that they were available for bachelor parties, birthday parties or private parties. That's what ultimately led to their arrests.
According to Wadsworth, his department began an investigation into the pair's activities after several citizens notified the mayor's office of the online solicitations. Police set up a fake bachelor party, then arrested the women when they showed up to fulfill the promises they made on their Web site.
"Some citizens called the mayor's office to complain about the Web site, and he notified us," the police chief said. "Our officers selected the bachelor party (which came with a cost of $300, plus tips) and booked a room in a local motel. The women were arrested after they arrived at the motel."
Police and local prosecutors then searched the Williams residence and seized several pieces of evidence, including a home computer and a client list that included the names and phone numbers of several men in the River Region, including "a few" from Prattville, Wadsworth said.
"We're not releasing the names of the clients, because there isn't any crime we can charge them with," he said. "At this point, the only name I can tell you that is not on there, is former New York Gov. Eliot Spitzer."
He said police are continuing their investigation into the online operation, and speculated that other charges could evolve from that investigation.
"Our Computer Forensics Unit will evaluate her computer and see if there were any other violations of the law," he said.
The police chief said realization that such an enterprise was being conducted in the Fountain City caught him a little unaware. He added that police acted promptly to bust the operation in order to show that such criminal activity would not be tolerated within the city limits of Prattville.
"In the past, we've had some women from Montgomery who rented motel rooms here and did this type of thing," he said. "But it was really surprising to be notified that this business was operating so much in the open, in our city. We hope these arrests will deter other people from doing this type of thing here, and will cause the people who utilize these services to go somewhere else."
Williams, known as "Dixie" on the pair's Web site, and Whitesell, who goes by the name "Darlin'," maintained a site that included racy pictures of themselves, along with a list of services and prices.
The services ranged from a dinner date, which could be purchased for $150, to a 24-hour date that cost customers $1,500. Other services offered include bondage, couples action and "nude housekeeping." According to the Web site, Williams even offered to travel anywhere in the U.S. or overseas, for a fee of $5,500.
The price list included a chart for converting the U.S. dollar amounts to the Euro, British pounds, Canadian and Australian dollars and Japanese yen.
Posted on the site were statements such as, "I love what I do and would like to show you that I do," and, "I am a lady and expect to be treated that way."
The duo also advertised that they were available for bachelor parties, birthday parties or private parties. That's what ultimately led to their arrests.
According to Wadsworth, his department began an investigation into the pair's activities after several citizens notified the mayor's office of the online solicitations. Police set up a fake bachelor party, then arrested the women when they showed up to fulfill the promises they made on their Web site.
"Some citizens called the mayor's office to complain about the Web site, and he notified us," the police chief said. "Our officers selected the bachelor party (which came with a cost of $300, plus tips) and booked a room in a local motel. The women were arrested after they arrived at the motel."
Police and local prosecutors then searched the Williams residence and seized several pieces of evidence, including a home computer and a client list that included the names and phone numbers of several men in the River Region, including "a few" from Prattville, Wadsworth said.
"We're not releasing the names of the clients, because there isn't any crime we can charge them with," he said. "At this point, the only name I can tell you that is not on there, is former New York Gov. Eliot Spitzer."
He said police are continuing their investigation into the online operation, and speculated that other charges could evolve from that investigation.
"Our Computer Forensics Unit will evaluate her computer and see if there were any other violations of the law," he said.
The police chief said realization that such an enterprise was being conducted in the Fountain City caught him a little unaware. He added that police acted promptly to bust the operation in order to show that such criminal activity would not be tolerated within the city limits of Prattville.
"In the past, we've had some women from Montgomery who rented motel rooms here and did this type of thing," he said. "But it was really surprising to be notified that this business was operating so much in the open, in our city. We hope these arrests will deter other people from doing this type of thing here, and will cause the people who utilize these services to go somewhere else."
Don't believe the hype! We're misled that "good" sex is lots of penetration with g-spot stimulation and huge orgasms.
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