The quest for "pink Viagra" presses onward. Can testosterone gel revive a woman's libido?
Viagra, more than just info,Today marks a decade since Pfizer's lovechild was borne through the straits of regulatory approval. The little pill has helped millions of men reclaim their pride and their sex lives. It has also spawned progeny, in a sense, in the form of the erectile dysfunction drugs Levitra and Cialis. Men these days have little reason to let ED ruin a romp in the bedroom. Women, on the other hand, might not be as eager to celebrate. 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.
Nonetheless, treating patients will remain a difficult process until a product for women is approved, says Irwin Goldstein, director of sexual medicine at San Diego's Alvarado Hospital. Patients trek to his clinic from all corners of the country to seek a solution for their sexual woes. When medically appropriate, Goldstein and other specialists prescribe testosterone products approved for men off-label in significant numbers of women like Bette (who asked that her last name not be used), whose levels of the hormone are deemed low by blood tests. Doses, of course, are scaled way back because men have much higher levels of the hormone to begin with (too much testosterone can cause acne, excess hair growth, and voice lowering in women). "There are people who would like to go to their nearby doctor to get this care," says Goldstein. "Having a drug that's FDA approved would [make that possible]."
Some don't agree. A group of self-appointed feminists are doing everything they can to ensure that female libido drugs don't reach pharmacy shelves. "This is not what women want, and this is not what's in their best interest," says Leonore Tiefer, clinical associate professor of psychiatry at the New York University School of Medicine, who's at the helm of this countermovement. Her view: It's normal for some healthy women to experience a decline in sexual interest, and it doesn't warrant medical treatment.
So much controversy, and pink Viagra hasn't even entered the world yet.
By:Lindsay Lyon
VIAGRA, VIAGRA & VIAGRA
Health Buzz: Viagra's Anniversary and Other Health News
Happy Birthday Viagra
Ten years ago yesterday, Viagra received the Food and Drug Administration's stamp of approval, and since then roughly 1 billion Viagra tablets have been doled out to men suffering from erectile dysfunction. Women, on the other hand, might not be as eager to celebrate. After 10 years of buzz about a Viagra-like drug for women, nothing has yet been approved.
Lindsay Lyon explores prospective female libido drugs now in research programs.
FDA Investigating the Link Between Singulair and Suicide
The Federal Drug Administration said yesterday it is investigating the possibility of increased suicidal behavior and mood changes in users of the popular asthma drug Singulair.
Viagra celebrates its 10th birthday
By Willemien Groot*
28-03-2008
The potency enhancing drug Viagra has been on the market for 10 years. In 1998, pharmaceutical company Pfizer introduced the erection drug that was to change millions of lives at a stroke. A solution to erectile dysfunction had been found, and the taboo surrounding impotence was largely a thing of the past.
The little blue pill that enabled millions of couples to reawaken their sex lives was discovered by accident, says sexologist Vera Steenhart of the Dutch Sexology Association.
Effect
The forerunner to Viagra was developed to make blood vessels relax. The test subjects were given the drug to improve blood circulation to the heart to reduce the chance of heart failure. Viagra has the same effect on the penis. When the man is sexually stimulated, the blood supply is improved and it becomes easier for him to maintain an erection.
It's a myth that the pill can produce an unwanted erection. The user does actually have to be in the mood, so Viagra has little or no effect if he is unwilling to have sex or feels anxious about it. In that case it would be more appropriate for him to have a good talk with his partner or pay a visit to a psychologist or sexologist.
Revolution
After Viagra's chance discovery, the manufacturer immediately recognised its potential market. The drug's official introduction represented a genuine revolution for men with erectile dysfunction. All that had previously been available to them were decidedly unerotic aids such as vacuum pumps, which were of little use at all to older men. With the advent of Viagra, a simple solution had been provided. According to Pfizer, the drug has been taken by at least 30 million men around the world since its introduction in 1998 .
The only remaining barrier is a visit to the doctor to get a prescription. "For some men this is still difficult," says Ms Steenhart. Nevertheless, the sexologist advises against buying the drug over the internet.
"If men accidentally buy fake pills, the consequences can be dire."
In the Netherlands, twelve people are assumed to have died after using illegal Viagra. According to the Health Ministry, the victims were men with heart conditions, who shouldn't have been taking the drug.
The side effects associated with Viagra also make it inadvisable to take the drug without supervision by a doctor. Users sometimes suffer from headaches or blurred vision. Side effects generally decrease with long-term use. The drug also becomes more effective after the first few times. "Men should keep on taking Viagra, even if they think it doesn't work the first time," Ms Steenhart advises.
Taboo
According to the sexologist, most men now feel able to discuss their problems with their wives. And this has a number of advantages. Not only does it help break down the taboo, but it also contributes to a better sex life.
"Men only talk about their problems if they know they can be solved."
A decade and rising: happy 10th birthday for Viagra
VIAGRA has turned 10 — and many happy returns. At least that's what thousands of Australian men are thinking.
Or, as Impotence Australia's president, Brett McCann, says: "We can keep going on with researchers saying men shouldn't be so focused on their penis, but we just are — that's the bottom line."
Scientists have warned that the impotence drug could harm sperm and may prevent some men from fathering families.
But it has been welcomed in Australia by some unlikely people, including some of the nation's traditional Chinese medicine practitioners. James Flowers, president of the Australian Acupuncture and Chinese Medicine Association, said the blue pill had given impotent men with obvious health problems, such as weight or heavy drinking, a quick fix.
"We haven't got a miracle cure," he said, although men with other health problems would often seek a miracle cure. "That happens a lot less now," he said. While Chinese practitioners have for years advised men to get fit, eat healthily and form a loving relationship to help overcome erectile dysfunction, Viagra has already played an important role, according to Associate Professor Doug Lording, one of Australia's leading authorities on erectile dysfunction.
"I've seen many men where it's really changed their outlook on life," he said.
But many have complained that the drug takes the spontaneity out of their love lives.
In fact, say some critics, the drug can have unexpected side effects on long and stable relationships. When Viagra kicks in, it's not all happy endings.
London's The Observer newspaper recently quoted from a letter published by a syndicated problem column in US newspapers, which read: "I am 62 years old and the mother of six grown children, and I was thrilled when my 64-year-old husband began to slow down about two years ago.
"So now what happens? A pill called Viagra is invented and the old goat is back in the saddle. I do love my husband, but I believe I have earned a rest. Besides, these pills cost $10 apiece. Last week he had four."
The makers, Pfizer, could not give The Sunday Age figures on the number of tablets sold in Australia, but it claims 1.8 billion have been dispensed worldwide.
This story was found at: http://www.theage.com.au/articles/2008/03/29/1206207499079.html
Reid Sexton
Happy Birthday Viagra
Ten years ago yesterday, Viagra received the Food and Drug Administration's stamp of approval, and since then roughly 1 billion Viagra tablets have been doled out to men suffering from erectile dysfunction. Women, on the other hand, might not be as eager to celebrate. After 10 years of buzz about a Viagra-like drug for women, nothing has yet been approved.
Lindsay Lyon explores prospective female libido drugs now in research programs.
FDA Investigating the Link Between Singulair and Suicide
The Federal Drug Administration said yesterday it is investigating the possibility of increased suicidal behavior and mood changes in users of the popular asthma drug Singulair.
Viagra celebrates its 10th birthday
By Willemien Groot*
28-03-2008
The potency enhancing drug Viagra has been on the market for 10 years. In 1998, pharmaceutical company Pfizer introduced the erection drug that was to change millions of lives at a stroke. A solution to erectile dysfunction had been found, and the taboo surrounding impotence was largely a thing of the past.
The little blue pill that enabled millions of couples to reawaken their sex lives was discovered by accident, says sexologist Vera Steenhart of the Dutch Sexology Association.
Effect
The forerunner to Viagra was developed to make blood vessels relax. The test subjects were given the drug to improve blood circulation to the heart to reduce the chance of heart failure. Viagra has the same effect on the penis. When the man is sexually stimulated, the blood supply is improved and it becomes easier for him to maintain an erection.
It's a myth that the pill can produce an unwanted erection. The user does actually have to be in the mood, so Viagra has little or no effect if he is unwilling to have sex or feels anxious about it. In that case it would be more appropriate for him to have a good talk with his partner or pay a visit to a psychologist or sexologist.
Revolution
After Viagra's chance discovery, the manufacturer immediately recognised its potential market. The drug's official introduction represented a genuine revolution for men with erectile dysfunction. All that had previously been available to them were decidedly unerotic aids such as vacuum pumps, which were of little use at all to older men. With the advent of Viagra, a simple solution had been provided. According to Pfizer, the drug has been taken by at least 30 million men around the world since its introduction in 1998 .
The only remaining barrier is a visit to the doctor to get a prescription. "For some men this is still difficult," says Ms Steenhart. Nevertheless, the sexologist advises against buying the drug over the internet.
"If men accidentally buy fake pills, the consequences can be dire."
In the Netherlands, twelve people are assumed to have died after using illegal Viagra. According to the Health Ministry, the victims were men with heart conditions, who shouldn't have been taking the drug.
The side effects associated with Viagra also make it inadvisable to take the drug without supervision by a doctor. Users sometimes suffer from headaches or blurred vision. Side effects generally decrease with long-term use. The drug also becomes more effective after the first few times. "Men should keep on taking Viagra, even if they think it doesn't work the first time," Ms Steenhart advises.
Taboo
According to the sexologist, most men now feel able to discuss their problems with their wives. And this has a number of advantages. Not only does it help break down the taboo, but it also contributes to a better sex life.
"Men only talk about their problems if they know they can be solved."
A decade and rising: happy 10th birthday for Viagra
VIAGRA has turned 10 — and many happy returns. At least that's what thousands of Australian men are thinking.
Or, as Impotence Australia's president, Brett McCann, says: "We can keep going on with researchers saying men shouldn't be so focused on their penis, but we just are — that's the bottom line."
Scientists have warned that the impotence drug could harm sperm and may prevent some men from fathering families.
But it has been welcomed in Australia by some unlikely people, including some of the nation's traditional Chinese medicine practitioners. James Flowers, president of the Australian Acupuncture and Chinese Medicine Association, said the blue pill had given impotent men with obvious health problems, such as weight or heavy drinking, a quick fix.
"We haven't got a miracle cure," he said, although men with other health problems would often seek a miracle cure. "That happens a lot less now," he said. While Chinese practitioners have for years advised men to get fit, eat healthily and form a loving relationship to help overcome erectile dysfunction, Viagra has already played an important role, according to Associate Professor Doug Lording, one of Australia's leading authorities on erectile dysfunction.
"I've seen many men where it's really changed their outlook on life," he said.
But many have complained that the drug takes the spontaneity out of their love lives.
In fact, say some critics, the drug can have unexpected side effects on long and stable relationships. When Viagra kicks in, it's not all happy endings.
London's The Observer newspaper recently quoted from a letter published by a syndicated problem column in US newspapers, which read: "I am 62 years old and the mother of six grown children, and I was thrilled when my 64-year-old husband began to slow down about two years ago.
"So now what happens? A pill called Viagra is invented and the old goat is back in the saddle. I do love my husband, but I believe I have earned a rest. Besides, these pills cost $10 apiece. Last week he had four."
The makers, Pfizer, could not give The Sunday Age figures on the number of tablets sold in Australia, but it claims 1.8 billion have been dispensed worldwide.
This story was found at: http://www.theage.com.au/articles/2008/03/29/1206207499079.html
Reid Sexton
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