SnakebyteXX
12-05-2004, 11:42 AM
Women are losing this drug war
Dec 5, 2004
The guys have Viagra.
And if they don't like Viagra, they can now swallow a pill called Levitra instead. And if neither one of those does the trick, there's another prescription drug on the market.
36-Hour Cialis, it's called.
"If a relaxing moment turns into the right moment, you can be ready," the TV commercial for Cialis says with a wink.
And that isn't even the most memorable marketing line from this new fresh generation of male-performance drugs. It's the medical warning - or is it a promise? - tacked at the end of one of these so-called erectile-dysfunction ads: "Men who experience an erection for more than four hours should seek immediate medical attention."
What did he just say?
Yikes!
We'll definitely keep that in mind!
Obviously, something important is happening here with these so-called "lifestyle drugs" and the bedroom behavior of American men.
Is it better living through pharmacology? Or is it just the latest route to soaring profits at Pfizer, Lilly and GlaxoSmithKline?
Millions of men don't seem to care one way or the other. They're more than happy to cough up $10 a pop for the special magic these pills can do. The guys are voting day and night with their credit cards and drugstore charge accounts.
Voting YES! YES! YES!
It's like a friend of mine, a man pushing 60, told me at the gym the other day: "Best money I've ever spent. A whole lot cheaper than proving how manly I am by buying another round of drinks."
And lower-calorie too, I guess.
All of which might be good news for the aging men of America.
But who's been looking out for the women in all this? Don't they have their own needs too?
Of course they do. And Procter & Gamble is among the forward-looking companies paying eager attention to them.
For the past two years, P&G has been testing a new medication designed to increase female libido. The drug is called Intrinsa. It's a clear circular patch that is placed on a woman's abdomen twice a week, releasing a small dose of testosterone.
As a first step, the company proposed prescribing Intrinsa only for woman who've had their ovaries removed, certainly a sympathetic group of patients. But hopes are high that Intrinsa - or some similar medication - could also help millions and millions of other women whose sex drives aren't what they could be.
The early test results have been promising. The studies showed "clinically meaningful" results, a federal panel concluded the other day. And P&G scientists said they'd found no big safety concerns.
"We didn't see any reason for concern," said Procter & Gamble spokeswoman Mary Johnson.
But the drug won't be on the market any time soon.
On Thursday, the 17-member FDA Advisory Committee for Reproductive Health Drugs dashed the women's hopes. Not to mention the company's research investment so far.
Forget Intrinsa for now, the panel members said. For a good long while to come, the men of America will be having all the fun.
By a unanimous vote, the panelists told the Food and Drug Administration that more tests are needed before Intrinsa should be allowed on pharmacy shelves.
Panel member Steven Nissen, a Cleveland cardiologist, openly acknowledged the drug's potential. "The number of men who take Viagra is enormous," he said. "Why would women be any different? I think there's a huge demand for this agent."
But Nissen and his colleagues drew up a long road map of new demands. They said the company should study at least 5,000 women for several years to tell if the testosterone patch raises cardiovascular risk.
Who knows how long that might take?
Which isn't to say Intrinsa is perfect.
Some experts warned the drug could be over-prescribed.
"This is not a glass of Chardonnay, but it's going to be marketed like Viagra," Leonore Tiefer, a sexuality expert at New York University's School of Medicine, told the panel in Washington.
And Intrinsa, like all drugs, has certain possible side effects. For Intrinsa, they include hair growth, acne, oily skin and a rare deepening of the voice.
Which does raise one frustrating possibility: A nation of voracious women - not one of whom is able to get a date.
But Intrinsa has been called safe and effective by some serious experts, including the American Society for Reproductive Medicine, the American Association of Clinical Endocrinologists, the American Association of Pastoral Counselors and the American Association of Sex Educators, Counselors and Therapists.
But here we are, pretty much where we began.
The men are choosing from a whole jelly bean jar of different medications. The women are waiting for the FDA.
Link (http://www.newsday.com/news/columnists/ny-nyhen054066902dec05,0,2396116.column?coll=ny-news-columnists)
Dec 5, 2004
The guys have Viagra.
And if they don't like Viagra, they can now swallow a pill called Levitra instead. And if neither one of those does the trick, there's another prescription drug on the market.
36-Hour Cialis, it's called.
"If a relaxing moment turns into the right moment, you can be ready," the TV commercial for Cialis says with a wink.
And that isn't even the most memorable marketing line from this new fresh generation of male-performance drugs. It's the medical warning - or is it a promise? - tacked at the end of one of these so-called erectile-dysfunction ads: "Men who experience an erection for more than four hours should seek immediate medical attention."
What did he just say?
Yikes!
We'll definitely keep that in mind!
Obviously, something important is happening here with these so-called "lifestyle drugs" and the bedroom behavior of American men.
Is it better living through pharmacology? Or is it just the latest route to soaring profits at Pfizer, Lilly and GlaxoSmithKline?
Millions of men don't seem to care one way or the other. They're more than happy to cough up $10 a pop for the special magic these pills can do. The guys are voting day and night with their credit cards and drugstore charge accounts.
Voting YES! YES! YES!
It's like a friend of mine, a man pushing 60, told me at the gym the other day: "Best money I've ever spent. A whole lot cheaper than proving how manly I am by buying another round of drinks."
And lower-calorie too, I guess.
All of which might be good news for the aging men of America.
But who's been looking out for the women in all this? Don't they have their own needs too?
Of course they do. And Procter & Gamble is among the forward-looking companies paying eager attention to them.
For the past two years, P&G has been testing a new medication designed to increase female libido. The drug is called Intrinsa. It's a clear circular patch that is placed on a woman's abdomen twice a week, releasing a small dose of testosterone.
As a first step, the company proposed prescribing Intrinsa only for woman who've had their ovaries removed, certainly a sympathetic group of patients. But hopes are high that Intrinsa - or some similar medication - could also help millions and millions of other women whose sex drives aren't what they could be.
The early test results have been promising. The studies showed "clinically meaningful" results, a federal panel concluded the other day. And P&G scientists said they'd found no big safety concerns.
"We didn't see any reason for concern," said Procter & Gamble spokeswoman Mary Johnson.
But the drug won't be on the market any time soon.
On Thursday, the 17-member FDA Advisory Committee for Reproductive Health Drugs dashed the women's hopes. Not to mention the company's research investment so far.
Forget Intrinsa for now, the panel members said. For a good long while to come, the men of America will be having all the fun.
By a unanimous vote, the panelists told the Food and Drug Administration that more tests are needed before Intrinsa should be allowed on pharmacy shelves.
Panel member Steven Nissen, a Cleveland cardiologist, openly acknowledged the drug's potential. "The number of men who take Viagra is enormous," he said. "Why would women be any different? I think there's a huge demand for this agent."
But Nissen and his colleagues drew up a long road map of new demands. They said the company should study at least 5,000 women for several years to tell if the testosterone patch raises cardiovascular risk.
Who knows how long that might take?
Which isn't to say Intrinsa is perfect.
Some experts warned the drug could be over-prescribed.
"This is not a glass of Chardonnay, but it's going to be marketed like Viagra," Leonore Tiefer, a sexuality expert at New York University's School of Medicine, told the panel in Washington.
And Intrinsa, like all drugs, has certain possible side effects. For Intrinsa, they include hair growth, acne, oily skin and a rare deepening of the voice.
Which does raise one frustrating possibility: A nation of voracious women - not one of whom is able to get a date.
But Intrinsa has been called safe and effective by some serious experts, including the American Society for Reproductive Medicine, the American Association of Clinical Endocrinologists, the American Association of Pastoral Counselors and the American Association of Sex Educators, Counselors and Therapists.
But here we are, pretty much where we began.
The men are choosing from a whole jelly bean jar of different medications. The women are waiting for the FDA.
Link (http://www.newsday.com/news/columnists/ny-nyhen054066902dec05,0,2396116.column?coll=ny-news-columnists)