SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

   Biotech / MedicalPFE (Pfizer) How high will it go?


Previous 10 Next 10 
To: BigKNY3 who wrote (7227)3/17/1999 8:31:00 AM
From: BigKNY3
   of 9519
 
Drug Firms Turn to Women's Sexual Dysfunction
By Cecilia M. Kang

03/17/99
The Wall Street Journal

PALO ALTO, Calif. -- After the success of treatments for male-sexual dysfunctions, pharmaceutical companies are turning their attention to women.

According to a recent study in the Journal of the American Medical Association, 43% of 1,749 women sampled said they suffered sexual problems, compared with 31% of 1,410 men surveyed.

For the same reasons men's sexual dysfunctions have only recently been addressed -- social taboos, limited government funding and closeted demand for treatment -- research and drugs for women have moved slowly. Advances in female treatments have also lagged because women's dysfunctions are largely more complex than men's troubles, medical experts and drug companies said.

Women's problems range from lack of sexual desire, trouble attaining orgasm, vaginal dryness and pain associated with intercourse, according to a soon-to-be-published report by Irwin Goldstein, professor of urology at Boston University School of Medicine. Together with 18 other urologists, he has prepared what might be the first consensus classification on women's dysfunctions.

Working on the premise that women and men get aroused in basically the same way and are sexually hindered by the same things -- aging, fatty foods, smoking and alcohol -- drug companies are coming up with products based on existing treatments for men, but dressed to suit female needs. Hoping its much-ballyhooed Viagra will work the same physical and financial wonders, Pfizer Inc. is in the second phase of testing the impotence treatment on women and expects results from those tests later this year.

Viagra overwhelmingly dominates what some estimate as a $1 billion male market. The drug, which increases blood flow to the genitals, posted $788 million in sales during its first nine months despite reports of potential side effects.

And the company that created Prozac is also hoping to get in the business of sexual healing. Eli Lilly & Co. and Icos Corp. are in Phase II trials of an oral treatment using phophodiesterase type-5 inhibitors. Eli Lilly said it will enter its next phase of trials this year.

Several smaller drug companies also are forging ahead with remedies. Vivus Inc., a Mountain View, Calif., start-up, temporarily revived its depressed stock earlier this month with a patent for topical treatments using alprostadil, the same agent in its male-erectile drug Muse. Vivus said its female product will likely be a cream applied to the genitals to enhance blood flow as it does in Muse.

Pentech Pharmaceuticals Inc. also holds a patent for a blood-flow enhancement pill for females using apomorphinethe agent in its male treatment licensed to TAP, a joint venture of Abbott Laboratories and Takeda Chemical Industries Ltd. of Japan. The patent for the female version hasn't be licensed yet, the company said. The female version of apomorphine, which begins Phase II human trials in the second quarter, works through the central nervous system, and the Buffalo Grove, Ill., company says it works faster than Viagra to accelerate blood movement to the genitals.

Zonagen Inc., The Woodlands, Texas, is in Phase I human testing of a female version of its male impotence drug Vasomax, which also enhances the flow of blood to genitals. The company is testing a vaginal suppository version of the treatment and expects to remain in Phase I trials for the remainder of the year.

Hormone treatments are also in the works to perk up women's sexual desire and pleasure. Solvay Pharmaceuticals Inc., a unit of Belgium's Solvay SA, is making an oral hormone pill, and TheraTech Inc. is in Phase II clinical trials for a testosterone patch. Both hormone treatments are intended to strengthen sexual desire in menopausal women.

Then there are herbal remedies that aim to increase libido. Erogen Inc. of Marina Del Ray, Calif., said it is directly selling tablets that free existing testosterone in women, meant to increase female sexual desire. A spokeswoman said demand for the herbal medication has been overwhelming, forcing the company to hire answering services to handle what she said is a boom in orders. She declined to disclose specific order figures.

But until a definition and guidelines for symptoms and outcomes of sexual dysfunctions in women are widely accepted, the Food and Drug Administration will hold drugs from the public, said Vivus Chief Executive Officer Leland Wilson.

That notion is echoed by Dr. Goldstein, an expert on impotence and one of 19 medical experts working to create a consensus classification system for symptoms and outcomes of female-sexual dysfunctions. "The FDA isn't going to accept that drug company X's drugs cure female sexual disorders until the FDA knows the parameters of sexual dysfunction," he said.

Share RecommendKeepReplyMark as Last Read


To: BigKNY3 who wrote (7227)3/17/1999 8:40:00 AM
From: BigKNY3
   of 9519
 
Viagra opens up opportunities for patients and industry alike
ELIZABETH NEUS

03/15/99
Gannett News Service
FINAL

Greg McGreer already knew a lot about treatments for impotence -- not only is he a psychotherapist specializing in sexual dysfunction, but his multiple sclerosis made him a candidate for medical remedies himself.

But when Viagra came along, he thought for three months before giving it a try. He compared the cost to that of his current treatment, the injectable Caverject, and considered some of the medical factors as well. Pure curiosity also played a part.

The payoff was not what he expected. ''The first time,'' said McGreer, 52, who practices in the Philadelphia area, ''(Viagra) didn't give me the effects I wanted. The Caverject erection is better than Viagra. It's more reliable.''

Patients and doctors alike are learning as they go when it comes to Viagra. That little blue pill, a revolutionary treatment for erectile dysfunction, the preferred term for impotence, is the only treatment that does not involve injecting, inserting or implanting something into the penis.

In theory, if a man takes Viagra an hour or so before intercourse and is in a situation where he could become sexually aroused, he will get an erection. Without the sexual stimulation -- which has to come from someplace other than Viagra, which is not a libido-booster -- the pill will do nothing.

To the dismay of about 30 percent of men who try it, it does nothing anyway. Among the other 70 percent, results may vary from man to man, even from dose to dose. But there is no way yet to find out without trying it.

''Many people didn't quite understand what the promise of Viagra was. The promise was that it would help between 65 percent and 70 percent of people, and to that extent it has,'' said Dr. Geoffrey Sklar, a urologist at the University of Maryland Medical Center who was among the original Viagra researchers. ''People thought it would be something that would make sex better, and it's not.''

Standard procedure for men who want to try Viagra begins with a visit to the doctor -- unless he buys it off the Internet, a practice which infuriates both urologists and Pfizer, the drug's maker. Viagra has enough potentially dangerous side effects, and a long enough list of people who should not take it, that a physical is recommended before a prescription is written.

Impotence can be a sign something else is physically wrong with a man.

''I diagnose a dozen cases of diabetes a year and hypertension that's gone untreated,'' said Dr. Andre Guay, an endocrinologist and director of the Center for Sexual Function at the Lahey Clinic near Boston.

''Anyone I've got any concern about, I call in a cardiologist and make them take an exercise stress test. We send about 10 people a year to get cardiac rehabilitation before (beginning) therapy,'' said Dr. John Mulhall, director of the Center for Male Sexual Health at Loyola University Medical Center in Maywood, Ill.

The standard prescription is between 6 and 8 pills a month, although some men complain that is not enough, while others can make it last a while. ''Older couples aren't looking to be porn stars. Maybe once or twice a week, Saturday night. These guys just want to be normal guys,'' said Dr. J. Francois Eid, director of the Erectile Dysfunction Unit at the New York Hospital-Cornell Medical Center.

For the majority of men, the most common side effects -- headache, blue vision, stuffy nose -- are not an issue. Some take aspirin with Viagra to stave off the headache.

''The biggest side effect is the pinch in the wallet, especially if (the pill) doesn't work,'' said Karen Brash McGreer, a sex therapist and Greg McGreer's wife.

What surprises many patients is the fact they don't get a guaranteed erection with Viagra and that getting an erection may take some time. ''If I'm tired, it will not have the same effect. It just won't work,'' Greg McGreer said.

Unplanned sex disappears with Viagra, since its effects only last so long and are not instantaneous. But doctors and patients disagree how much that matters. The McGreers say they turn to Caverject, a pen-like device containing a tiny needle that injects medication into the penis and which provides an almost-instant erection, if they don't feel like planning ahead for sex.

"Spontaneity is kind of a myth, anyhow. That goes out the window in your mid-30s. People have pretty tight schedules,'' said Dr. Andrew McCullough, director of male sexual health and fertility at the New York University Medical Center.

The biggest surprise may be complete failure. Sometimes the problem is as simple as stage fright.

''There were people in the clinical trial who had to try the pill three or four times before they overcame the hump of performance anxiety and are getting better erections now,'' said Eid.

Doctors have a few advance clues on who might become a Viagra failure. Smokers do not do as well, nor men with severe, uncontrolled diabetes. Men who had prostate surgery that damaged the nerve that controls blood supply to the penis may not have luck with Viagra, nor older men on multiple medications with multiple health problems.

Then there are the men who should never try Viagra: those with heart conditions or taking drugs containing nitrates (combining Viagra with nitrates can send the blood pressure plummeting dangerously).

For all those men, ''the honeymoon with Viagra is over,'' said Nina Ferrari, a spokeswoman for Vivus , the company that makes MUSE, a urethral suppository that was the market leader before Viagra came along. ''We know people are coming in and asking, 'What else is there?'''

Viagra decimated the market share of its competitors, but the competition is grateful for one thing.

''There was a market that was fairly untapped -- there are three times as many prescriptions (for Caverject) being written today than a year ago. There is a very big expansion in the entire market,'' said Kristen Elliott, spokeswoman for Pharmacia & Upjohn, maker of Caverject. ''Viagra can take credit for that.''

Doctors are pleased to have so many options to offer men with erectile dysfunction, compared to what they had a few years ago. What a patient chooses may depend on what his doctor is comfortable with. Guay likes MUSE; Eid promotes Caverject.

The choice may also depend on how the doctor makes the pitch or the patient's past experience with erectile dysfunction treatments.

''If you take a patient on penile injection therapy and change him to Viagra, he tries it, and says he likes the penile injection better. It gives him an erection regardless of the situation,'' said Eid.

''Take a patient who has never taken anything and has failed on Viagra and offer him the injection, he's horrified.''

Share RecommendKeepReplyMark as Last Read


To: BigKNY3 who wrote (7227)3/17/1999 8:43:00 AM
From: BigKNY3
   of 9519
 
Viagra displacing Prozac in pop culture
ELIZABETH NEUS

03/15/99
Gannett News Service
FINAL

Without President Clinton and Viagra , comedians would have been bereft of material last year.

London theater critics -- without explanation -- can call Nicole Kidman's onstage performance ''pure theatrical Viagra ,'' and everyone understands.

TV shows from ''NYPD Blue'' to ''ER'' to a notorious episode of ''Mad About You'' -- just about every major show on television short of ''Rugrats,'' basically -- has made Viagra key to the plot or at least given it a mention.

This used to be a Prozac nation; now it's a big blue Viagra world.

''It's as true about Viagra as it is about Monica -- anything in the headlines is going to be fodder. That's America,'' said Dr. John Mulhall, director of the Center for Male Sexual Health at Loyola University Medical Center in Maywood, Ill.

Pfizer, Inc., makers of Viagra , claims the company had no idea it was creating a cultural icon as well as a treatment for impotence. Officials there had hoped only that men would become more willing to discuss the topic of erectile dysfunction -- the term doctors use -- and seek treatment.

''We wondered if it would become a discussion topic on talk shows,'' said company spokeswoman Mariann Caprino -- and in fact, it was on CNN's ''Larry King Live'' that Bob Dole announced to the world that he had used the new drug and loved it.

''Overnight, there was dialogue on this condition, and that's good,'' Caprino said.

That depends, of course, on the definition of ''dialogue.'' For example, when three American scientists won the Nobel Prize for medicine in October for discoveries that led to the development of Viagra , Jay Leno cracked, ''Hope they don't get swelled heads.''

The ''Mad About You'' episode, which reportedly annoyed Pfizer, featured the lead male character wandering around New York painfully tumescent and searching for his wife after taking a Viagra -like pill.

Celebrities of advanced age were irresistible targets: David Letterman said that if Bob Dole were president, Viagra would be served at all state dinners. When Tony Randall, 78, became a father, Letterman's comment was: '' Viagra , shmiagra, everything's in working order, Pepe.''

Some of the joking may stem from simple discomfort.

''The 25- to 45-year-old age group never wanted to deal with the fact that their parents were having sex. Now our attitude about the life span of a sex life has dramatically increased -- suddenly, sex didn't go away,'' said Greg McGreer, a Philadelphia-area psychotherapist who specializes in sexual dysfunction.

He does not care for the tenor of much of the Viagra discussion. ''We kind of snicker and laugh at this, like we're all a bunch of 10- or 12-year-olds. We are the most sexually immature culture you can find.''

Viagra also was introduced during a scorching presidential sex scandal: By the time the drug came on the market, Americans had been immersed in two months' worth of round-the-clock talk about oral sex and stained dresses.

''I think it's unfortunate that ( Viagra ) happened at a time when the president was having problems with his own sexuality. You got tired of it. You didn't want to hear about sex anymore,'' said Dr. Andrew McCullough, director of male sexual health and fertility at the New York University Medical Center.

Karen Brash McGreer, McGreer's wife and a sex counselor, believes much of the wink-nudge-heh-heh quality to the national discussion comes from lack of knowledge about sex. ''People do not know how to talk about sex in a respectful way,'' she said.

''It hits at so many aspects of our culture,'' Greg McGreer said. ''What's taken place in the last year has taken something that's not very well lit and shined a brighter light on it. Kids are asking their parents (sex-related) questions right out of the news, and that got embarrassing for people.''

Pfizer -- publicly, at least -- doesn't care what people say about Viagra as long as they get their facts straight.

''I haven't watched TV in a year,'' Caprino said. ''We have been working with ( Viagra ) for years. Talking about erections is so routine for us that we've become desensitized to that kind of thing.''

Share RecommendKeepReplyMark as Last Read


To: BigKNY3 who wrote (7227)3/17/1999 8:45:00 AM
From: BigKNY3
   of 9519
 
Viagra receives worldwide support
ELIZABETH NEUS

03/15/99
Gannett News Service

The splash that Viagra made in the United States created a worldwide ripple effect that turned into a tidal wave of sales.

More than 70 countries -- including even Iraq -- have approved use of Viagra since the drug became available in the United States last March, and Pfizer Inc. expects worldwide approval by the end of 2000.

The sole exception will be India, the second-largest country with a population of 960 million. Pfizer does not plan to introduce Viagra there, because the company believes Indian patent protection laws aren't tough enough.

''We won't compete with a low-price generic,'' said Pfizer spokeswoman Mariann Caprino.

International sales account for 13 percent of Viagra 's total 1998 sales -- $105 million out of $788 million. As they did in the United States, men lined up almost immediately in the countries when the drug was put on the market. Great Britain even limited the number of pills it would pay for through its National Health Service, citing high costs.

But even in countries where Viagra wasn't approved, the drug rolled over existing local remedies, thrived in black markets and lured thousands to the United States to buy it legally.

Countless Japanese men flew to Hawaii to procure a prescription, and some even came on special package tours that included prearranged appointments with doctors. A Japanese man was among the earliest of the Viagra -related deaths.

Before the drug was approved in Taiwan, black-market sales outpaced those of traditional, ancient impotence remedies such as Big Hero Pill and Essence of Tyrant.

Traditional practitioners claimed their secret formulas still were better than Viagra , ''but if they're so powerful and convenient, then why all the interest in Viagra ?'' Taiwanese urologist Chen Kuang-kuo said last summer.

Pharmacies along the U.S.-Canadian border reported the bulk of their Viagra sales were to Canadians, who had no access at home to the drug until it was approved March 9. In some stores, Canadians account for 75 percent to 80 percent of Viagra sales, and they drive hundreds of miles for their medicine. They pay for it themselves.

''I can't recall a prescription for a local person in quite some time, but the other day I filled three in a row for people from Canada,'' said Dexter Spaulding, a pharmacist at Swanton Rexall Drugs in Swanton, Vt., six miles from the Canadian border.

Although the family-owned pharmacy and other border stores could lose sales now that Canada has approved Viagra , ''I'm kind of hoping they will,'' Spaulding said. ''It's a long drive for people. We aren't greedy.''

Approval of the drug doesn't necessarily end any furor. In Japan, where Viagra was approved in January, women are livid over the fact that it sailed through the Health Ministry in six months, while the pill had languished in the approval process for nine years. The birth control pill may make it onto the Japanese market this summer.

In Hong Kong, where Viagra was approved in early February, police are arresting people for selling it without a prescription and for inflated prices.

Men in Singapore may be hit with a double financial whammy. Not only do insurance companies there not cover Viagra itself, but some also are arguing they may not even cover treatment for any adverse effects drug. If they die after using Viagra , however, their life insurance still will pay up.

Jordanian doctors and pharmacists in December called for a boycott of U.S. drugs to protest American airstrikes against Iraq but said that the newly approved Viagra would be exempt because it is unique.

Speaking of Iraq, men there may have to wait for their shot at Viagra until international sanctions placed during the gulf war are lifted.

Private companies may import the drug, but the government will not help pay for it because it does not fit into the definition of ''badly needed humanitarian items'' -- the only kind Iraq is permitted to buy under terms of the sanctions.

Share RecommendKeepReplyMark as Last ReadRead Replies (2)


To: BigKNY3 who wrote (7236)3/17/1999 8:48:00 AM
From: BigKNY3
   of 9519
 
Details on erectile dysfunction treatments

03/15/99
Gannett News Service
FINAL

------

Various erectile dysfunction treatments

------

Viagra

Cost: $9 to $10 per pill (not all insurance plans cover it)

Prescription: One 50 mg pill, taken about an hour before intercourse; no more than one a day

How it works: Prevents an enzyme that hinders erection from doing its job. Does not affect libido.

Side effects: Headache, flushed face, heartburn, stuffy nose, blue haze over vision, lowered blood pressure.

Who can't use it: Men with heart disease, who have recently had a heart attack or stroke, who take nitrites, who have abnormally-formed penises, or who are prone to priapism (prolonged erection) -- that includes men with sickle cell anemia, leukemia or bone marrow tumors.

------

MUSE

Cost: $12 to $18 per dose (often covered by insurance)

Prescription: One pellet of alprostadil, a naturally occurring substance, dose calibrated to meet your needs. A man can dose himself with MUSE twice a day. Drug keeps longer when refrigerated.

How it works: Medicated pellet inserted into the urethra before sex helps increase blood flow to the penis and triggers erection.

Side effects: Aching groin, burning in the urethra, minor urethral bleeding due to improper insertion of the medication. Less commonly: Swelling of leg veins, dizziness, fainting, rapid pulse, prolonged erection.

Who can't use it: Men who have been told not to have sex, who are sensitive to the medication, with abnormally formed penises, or who are prone to priapism (prolonged erection) -- that includes men with sickle cell anemia, leukemia or bone marrow tumors.

------

Caverject

Cost: $5 to $15 per dose (sometimes covered by insurance)

Prescription: One injection of alprostadil, a naturally occurring substance, dose calibrated to meet your needs, right before intercourse. Maximum dosage is three times a week, with 24 hours between each dose.

How it works: Medication injected with a tiny, fin-gauge needle into the side of the penis before intercourse opens blood vessels and triggers erection.

Side effects: Mild to moderate pain after injection, a small amount of blood at injection site. Less commonly: prolonged erection, possible scarring of the penis.

Who can't use it: Men who have been told not to have sex, who have penile implants, who have abnormally formed penises, or who are prone to priapism (prolonged erection) -- that includes men with sickle cell anemia, leukemia or bone marrow tumors.

------

Penile implants

Cost: Medicare pays about $1,000 for procedure

Prescription: Surgery.

How it works: Semi-rigid or inflatable cylinders implanted into the penis, attached to a pump in the scrotum with a reservoir in the scrotum or abdomen. Patient pumps up implant before intercourse to create erection.

Side effects: Permanent, last-ditch method of treatment. May destroy any remaining natural ability to have erection. Semi-rigid rods may be hard to hide; poorly-sized rods may protrude through the tip of the penis. Mechanical failure or infection possible; surgical repair may be needed.

Who can't use it: Men with abnormally formed penises or those with severe medical problems.

------

Vacuum therapy

Cost: $400 to $500 (cheapest therapy)

Prescription: External mechanical device used to pump up penis. Erection can be maintained safely for 30 minutes.

How it works: Penis placed into a cylindrical vacuum-like device; negative air pressure pulls blood into the penis and creates erection. A tension ring is placed on the end of the penis to keep the blood in; erection subsides after ring is removed.

Side effects: Penis could be damaged if tension ring left in place too long; ejaculation could be hampered; sometimes uncomfortable to use.

Who can't use it: Patients who lack manual dexterity, men who take blood thinners

Share RecommendKeepReplyMark as Last Read


To: BigKNY3 who wrote (7236)3/17/1999 8:53:00 AM
From: BigKNY3
   of 9519
 
A year in the Viagra nation
ELIZABETH NEUS

03/15/99
Gannett News Service
FINAL

The little blue sex pill with the name that conjures a gushing waterfall was an instant sensation when unveiled a year ago.

Viagra even knocked President Clinton's blossoming sex scandal off the front pages and became the punch-line for the pros like Letterman and Leno and the amateurs at your office coffee machine.

The blazing attention given to a drug that helps men overcome impotence should have been no surprise. An estimated 30 million men suffer from what doctors prefer to call ''erectile dysfunction,'' and the omnipresent baby boomers are reaching an age where sexual difficulty is more likely.

But Viagra was the first simple treatment for the problem, one that did not involve injecting or inserting or implanting something into the penis. One pill, combined with a few suggestive thoughts and a willing partner, could bring on an erection in many men who had gone years without one.

''It was the typical American cultural solution -- here's a pill, take a pill, everything will be better,'' said Greg McGreer, a Philadelphia-area psychotherapist who specializes in sexual dysfunction and who takes Viagra himself.

And that pill struck a nerve.

The hype surrounding its launch -- little of it orchestrated by its maker, Pfizer Inc., which did not start a formal advertising campaign until recently -- was bright enough to blind.

''I think we were a little surprised by how quickly it happened,'' said Pfizer spokeswoman Mariann Caprino.

Issues of physical dysfunction became entangled in issues of libido and desire. This would be the start of the sexual revolution for men, as important as The Pill had been for women. Relationships would change in ways we couldn't even imagine.

Actual events triggered by the drug just kept the hysteria rolling. Sales soared to $788 million in just eight months. Bob Dole announced he used Viagra -- and liked the results. People from other countries made special trips to the United States to pick up Viagra . Angry patients sued insurance companies that refused to pay for the budget-busting drug. Fears grew as tales were told of men who had died having sex after taking Viagra .

In some quarters, what happened with Viagra -- insurance problems, dangerous side effects, patients clamoring for prescriptions, media attention -- was seen as something that could have been possible with any major drug launch. Only this was on a far higher plane, and tinted by the link with sex.

''The talk is all about Viagra , but it could be any drug,'' Caprino said. ''It's been held to a different standard. The more people who know about a product, the higher on everyone's radar screens it is, and you're more likely to hear about problems.''

A year later, we've caught our breath.

Now that the novelty of hearing Tom Brokaw say the word ''erection'' on the nightly news has subsided, now that the land-rush mentality has disappeared from urologists' waiting rooms, it is clear Viagra 's impact has been world-wide.

And the major effect is the one that doctors who treat impotence had hoped.

''Now everyone talks about it. People are less embarrassed about having erectile dysfunction. It's wonderful to have a lot of different options to treat these men,'' said Dr. J. Francois Eid, director of the Erectile Dysfunction Unit at the New York Hospital-Cornell Medical Center.

Viagra gives men a conversational gambit to broach the delicate subject with busy doctors.

''It's one way to bring it up,'' said Edward Laumann, a Pfizer consultant and University of Chicago sociology professor who recently wrote a major study on the prevalence of sexual dysfunction. ''I think physicians are very poorly trained to take a sexual history. They're very uncomfortable with it. And if you're only going to see somebody for 10 minutes, you don't want to start something like that.''

Doctors wrote more than 7.6 million prescriptions for Viagra in the eight months it was on the market in 1998. Refills began to outpace new prescriptions by September, and the overall number of prescriptions has fallen off, according to IMS Health Inc. which collects prescription data.

While it overwhelmed the market for erectile dysfunction treatments -- a competitor fell from a 95 percent market share to just 2 percent after Viagra -- the pill never sold as well as the hype would have you believe.

The top-selling drug in the last quarter of 1998 actually was Premarin, an estrogen replacement for post-menopausal women. Premarin prescriptions totaled 11.8 million; Viagra accounted for 2.2 million.

Urologists find that more and more of their new cases actually are Viagra failures, and makers of competing treatments report their prescription numbers are rising again as a result. Primary care physicians, who do not have the special training necessary to explain the more complex impotence treatments that work where Viagra doesn't, still can write a prescription.

The deaths put a damper on some of that. Between late March and mid-November 1998, 130 Americans died after being prescribed the drug. Most had risk factors that should have eliminated them as candidates for Viagra use, and they died soon after taking the drug.

Pfizer made the guidelines more clear, and cardiologists' associations also issued strong warnings about who should receive the drugs. Some doctors even suggested that men undergo cardiac stress tests before getting a prescription.

A few doctors tried to eliminate patients based solely on age, but an 80-year-old man capable of playing three sets of tennis a week isn't physically the same as one whose major daily activity is punching the buttons on the TV remote. Many had forgotten that sexual intercourse was exercise.

''When the most stressful thing you do all day is to get out of bed and go to the kitchen table -- it was the sex that killed them, not the Viagra ,'' said Dr. Geoffrey Sklar, a urologist at the University of Maryland Medical Center who was among the original Viagra researchers.

The Food and Drug Administration, which still considers the drug safe enough to stay on the market, no longer reports Viagra -related deaths on its Web site, although the curious can write a letter and ask for updated details. ''It served its purpose,'' said spokeswoman Susan Cruzan.

A handful of those who died had no apparent risk factors, or had coronary artery disease that was discovered only at autopsy. Erectile dysfunction with a physical cause does not come out of nowhere, urologists say, and doctors should check for cardiac problems in men who have trouble maintaining erections.

''We had patients whose only significant problem was impotence,'' said Dr. John Mulhall, director of the Center for Male Sexual Health at Loyola University Medical Center in Maywood, Ill.

''They took a cardiac stress test, and they had abnormal stress tests two times as often as the average population of the same age. Anyone who's graduated medical school in the last 10 years has to have an indication that impotence is a vascular disorder.''

What they also hope people understand is that the restoration of sexual function may not be a quick fix for a broken relationship. Counseling is a major part of treatment for erectile dysfunction; doctors are happiest when both members of a couple show up for an appointment.

''The women are, I hate to say it, much more realistic about this. They can put sex into perspective,'' said Dr. Andre Guay, an endocrinologist and director of the Center for Sexual Function at the Lahey Clinic near Boston.

Although nearly every urologist in the country can moan at will about the wannabe Lotharios that show up in their offices -- the 70-year-old man who left his 61-year-old common-law wife of 10 years so he could play the field is a particularly famous tale -- they also say that most patients act like adults.

''You don't hear about the 55-year-old couple who can't have sex and the pill has done amazing things for them,'' Mulhall said. ''That is the overwhelming majority of my couples.''

''It's not changing relationships, it's not changing people, it's not changing habits, it's just allowing men who couldn't be sexually active to be sexually active,'' said Dr. Andrew McCullough, director of male sexual health and fertility at the New York University Medical Center.

True, the introduction of Viagra may change an individual relationship. A couple may have deluded themselves into thinking their troubles stem from the fact that they cannot have intercourse. They can then be surprised to find -- when intercourse is back in the equation -- to find that the problem is more deep-rooted than just sex.

''We've had some divorces,'' said Guay. For those couples, he said, Viagra ''brought the issue to a head.''

Many myths still need to be overcome. Facts and pseudo-facts about Viagra long have been confused in the American mind.

Doctors regularly try to cool off elderly men who think Viagra will help them rock 'n' roll like a 17-year-old (well, maybe a 37-year-old); men and some women who believe the drug will boost their will to have sex as well as their physical ability -- it doesn't; men with normal sexual function who still believe that Viagra will make them sexual gods (get real).

''You get the weirdos and the macho men and the guys with three girlfriends,'' sighed Guay. ''A lot of (my patients) are very nice, but you've got the minority who want 30 pills a month.''

Some doctors report that the underground market for Viagra does exist, ''like in high school when people were trying dope -- 'Oh, man, it was so good!' ''Eid said, imitating a teen-ager. ''Men are still so immature.''

Despite the general willingness to talk about Viagra and the condition it treats -- Bob Dole's smiling face appears in Pfizer's newspaper and TV ads promoting awareness of sexual dysfunction -- more than a few men still find it mortifying to discuss, and not everyone wants to hear about it.

A recent editorial cartoon, for example, featured Dole brandishing a picture of his wife Elizabeth, who is considering a run for the Republican presidential nomination in 2000, as two hapless people and threatening, ''Vote for my wife or I'll tell you more about erectile dysfunction!''

Doctors think that craving for privacy on the issue is the reason for the burst of online sales of the drug, a practice currently under investigation by the National Association of Boards of Pharmacy and loudly protested by Pfizer.

''Is it getting easier to talk about? I was walking in Long Island past a T-shirt shop, and (one shirt) said, 'Real men don't need Viagra .' I think there's still a taboo there,'' said McCullough.

------

Share RecommendKeepReplyMark as Last Read


To: BigKNY3 who wrote (7227)3/17/1999 8:56:00 AM
From: BigKNY3
   of 9519
 
A year in the Viagra nation
ELIZABETH NEUS

03/15/99
Gannett News Service
FINAL

The little blue sex pill with the name that conjures a gushing waterfall was an instant sensation when unveiled a year ago.

Viagra even knocked President Clinton's blossoming sex scandal off the front pages and became the punch-line for the pros like Letterman and Leno and the amateurs at your office coffee machine.

The blazing attention given to a drug that helps men overcome impotence should have been no surprise. An estimated 30 million men suffer from what doctors prefer to call ''erectile dysfunction,'' and the omnipresent baby boomers are reaching an age where sexual difficulty is more likely.

But Viagra was the first simple treatment for the problem, one that did not involve injecting or inserting or implanting something into the penis. One pill, combined with a few suggestive thoughts and a willing partner, could bring on an erection in many men who had gone years without one.

''It was the typical American cultural solution -- here's a pill, take a pill, everything will be better,'' said Greg McGreer, a Philadelphia-area psychotherapist who specializes in sexual dysfunction and who takes Viagra himself.

And that pill struck a nerve.

The hype surrounding its launch -- little of it orchestrated by its maker, Pfizer Inc., which did not start a formal advertising campaign until recently -- was bright enough to blind.

''I think we were a little surprised by how quickly it happened,'' said Pfizer spokeswoman Mariann Caprino.

Issues of physical dysfunction became entangled in issues of libido and desire. This would be the start of the sexual revolution for men, as important as The Pill had been for women. Relationships would change in ways we couldn't even imagine.

Actual events triggered by the drug just kept the hysteria rolling. Sales soared to $788 million in just eight months. Bob Dole announced he used Viagra -- and liked the results. People from other countries made special trips to the United States to pick up Viagra . Angry patients sued insurance companies that refused to pay for the budget-busting drug. Fears grew as tales were told of men who had died having sex after taking Viagra .

In some quarters, what happened with Viagra -- insurance problems, dangerous side effects, patients clamoring for prescriptions, media attention -- was seen as something that could have been possible with any major drug launch. Only this was on a far higher plane, and tinted by the link with sex.

''The talk is all about Viagra , but it could be any drug,'' Caprino said. ''It's been held to a different standard. The more people who know about a product, the higher on everyone's radar screens it is, and you're more likely to hear about problems.''

A year later, we've caught our breath.

Now that the novelty of hearing Tom Brokaw say the word ''erection'' on the nightly news has subsided, now that the land-rush mentality has disappeared from urologists' waiting rooms, it is clear Viagra 's impact has been world-wide.

And the major effect is the one that doctors who treat impotence had hoped.

''Now everyone talks about it. People are less embarrassed about having erectile dysfunction. It's wonderful to have a lot of different options to treat these men,'' said Dr. J. Francois Eid, director of the Erectile Dysfunction Unit at the New York Hospital-Cornell Medical Center.

Viagra gives men a conversational gambit to broach the delicate subject with busy doctors.

''It's one way to bring it up,'' said Edward Laumann, a Pfizer consultant and University of Chicago sociology professor who recently wrote a major study on the prevalence of sexual dysfunction. ''I think physicians are very poorly trained to take a sexual history. They're very uncomfortable with it. And if you're only going to see somebody for 10 minutes, you don't want to start something like that.''

Doctors wrote more than 7.6 million prescriptions for Viagra in the eight months it was on the market in 1998. Refills began to outpace new prescriptions by September, and the overall number of prescriptions has fallen off, according to IMS Health Inc. which collects prescription data.

While it overwhelmed the market for erectile dysfunction treatments -- a competitor fell from a 95 percent market share to just 2 percent after Viagra -- the pill never sold as well as the hype would have you believe.

The top-selling drug in the last quarter of 1998 actually was Premarin, an estrogen replacement for post-menopausal women. Premarin prescriptions totaled 11.8 million; Viagra accounted for 2.2 million.

Urologists find that more and more of their new cases actually are Viagra failures, and makers of competing treatments report their prescription numbers are rising again as a result. Primary care physicians, who do not have the special training necessary to explain the more complex impotence treatments that work where Viagra doesn't, still can write a prescription.

The deaths put a damper on some of that. Between late March and mid-November 1998, 130 Americans died after being prescribed the drug. Most had risk factors that should have eliminated them as candidates for Viagra use, and they died soon after taking the drug.

Pfizer made the guidelines more clear, and cardiologists' associations also issued strong warnings about who should receive the drugs. Some doctors even suggested that men undergo cardiac stress tests before getting a prescription.

A few doctors tried to eliminate patients based solely on age, but an 80-year-old man capable of playing three sets of tennis a week isn't physically the same as one whose major daily activity is punching the buttons on the TV remote. Many had forgotten that sexual intercourse was exercise.

''When the most stressful thing you do all day is to get out of bed and go to the kitchen table -- it was the sex that killed them, not the Viagra ,'' said Dr. Geoffrey Sklar, a urologist at the University of Maryland Medical Center who was among the original Viagra researchers.

The Food and Drug Administration, which still considers the drug safe enough to stay on the market, no longer reports Viagra -related deaths on its Web site, although the curious can write a letter and ask for updated details. ''It served its purpose,'' said spokeswoman Susan Cruzan.

A handful of those who died had no apparent risk factors, or had coronary artery disease that was discovered only at autopsy. Erectile dysfunction with a physical cause does not come out of nowhere, urologists say, and doctors should check for cardiac problems in men who have trouble maintaining erections.

''We had patients whose only significant problem was impotence,'' said Dr. John Mulhall, director of the Center for Male Sexual Health at Loyola University Medical Center in Maywood, Ill.

''They took a cardiac stress test, and they had abnormal stress tests two times as often as the average population of the same age. Anyone who's graduated medical school in the last 10 years has to have an indication that impotence is a vascular disorder.''

What they also hope people understand is that the restoration of sexual function may not be a quick fix for a broken relationship. Counseling is a major part of treatment for erectile dysfunction; doctors are happiest when both members of a couple show up for an appointment.

''The women are, I hate to say it, much more realistic about this. They can put sex into perspective,'' said Dr. Andre Guay, an endocrinologist and director of the Center for Sexual Function at the Lahey Clinic near Boston.

Although nearly every urologist in the country can moan at will about the wannabe Lotharios that show up in their offices -- the 70-year-old man who left his 61-year-old common-law wife of 10 years so he could play the field is a particularly famous tale -- they also say that most patients act like adults.

''You don't hear about the 55-year-old couple who can't have sex and the pill has done amazing things for them,'' Mulhall said. ''That is the overwhelming majority of my couples.''

''It's not changing relationships, it's not changing people, it's not changing habits, it's just allowing men who couldn't be sexually active to be sexually active,'' said Dr. Andrew McCullough, director of male sexual health and fertility at the New York University Medical Center.

True, the introduction of Viagra may change an individual relationship. A couple may have deluded themselves into thinking their troubles stem from the fact that they cannot have intercourse. They can then be surprised to find -- when intercourse is back in the equation -- to find that the problem is more deep-rooted than just sex.

''We've had some divorces,'' said Guay. For those couples, he said, Viagra ''brought the issue to a head.''

Many myths still need to be overcome. Facts and pseudo-facts about Viagra long have been confused in the American mind.

Doctors regularly try to cool off elderly men who think Viagra will help them rock 'n' roll like a 17-year-old (well, maybe a 37-year-old); men and some women who believe the drug will boost their will to have sex as well as their physical ability -- it doesn't; men with normal sexual function who still believe that Viagra will make them sexual gods (get real).

''You get the weirdos and the macho men and the guys with three girlfriends,'' sighed Guay. ''A lot of (my patients) are very nice, but you've got the minority who want 30 pills a month.''

Some doctors report that the underground market for Viagra does exist, ''like in high school when people were trying dope -- 'Oh, man, it was so good!' ''Eid said, imitating a teen-ager. ''Men are still so immature.''

Despite the general willingness to talk about Viagra and the condition it treats -- Bob Dole's smiling face appears in Pfizer's newspaper and TV ads promoting awareness of sexual dysfunction -- more than a few men still find it mortifying to discuss, and not everyone wants to hear about it.

A recent editorial cartoon, for example, featured Dole brandishing a picture of his wife Elizabeth, who is considering a run for the Republican presidential nomination in 2000, as two hapless people and threatening, ''Vote for my wife or I'll tell you more about erectile dysfunction!''

Doctors think that craving for privacy on the issue is the reason for the burst of online sales of the drug, a practice currently under investigation by the National Association of Boards of Pharmacy and loudly protested by Pfizer.

''Is it getting easier to talk about? I was walking in Long Island past a T-shirt shop, and (one shirt) said, 'Real men don't need Viagra .' I think there's still a taboo there,'' said McCullough.

------

Share RecommendKeepReplyMark as Last ReadRead Replies (2)


To: BigKNY3 who wrote (7239)3/17/1999 11:40:00 AM
From: Anthony Wong
   of 9519
 
Viagra Trials End, Lift-Off In China's Bedrooms Awaits
Inside China Today

SHANGHAI, Mar. 17, 1999 -- (Agence France Presse)
China has completed clinical tests on the popular
anti-impotence pill Viagra and it could be approved for
use in the world's most populous nation "within a few
months," the Shanghai Star said Tuesday.

The newspaper quoted Jiang Yu, a urology professor
at Shanghai's Renji Hospital as saying simultaneous
trials involving around 600 volunteer patients were
held over four weeks in Beijing, Shanghai and Wuhan.

The results have been sent to the national co-ordinator
at Beijing Medical University, who will in turn pass
them on to a test center in Britain for complete
statistical analysis, he said.

While the report did not say how long the overseas
analysis would take, it said the State Drug
Administration (SDA) would use it to pass final
judgment on the drug.

Jiang described the trials as "a double-blind study in
which both the doctor and the patient have no idea
whether the real drug or a placebo is being
administered."

Each volunteer who participated will be entitled to "a
certain amount" of Viagra free of charge from the U.S.
manufacturer, Pfizer, if the SDA approves it.

The professor cautioned that the drug is effective only
on patients suffering from erectile dysfunction ED.

"Some people mistakenly identify the drug as an
aphrodisiac. As a matter of fact, it is useless to men
with normal erectile competency," he said.

The newspaper cited a large-sample study conducted
in northeastern Shenyang city as showing about 10
percent of Chinese males suffer from ED to a varying
degree.

Viagra, which set pharmaceutical sales records after its
release in the West, is expected to have a giant
potential market in China, where herbal medicine has for centuries sought cures for
impotence.

The drug has been selling for up to $50 a pill on the black market across the
country.

Pfizer has already set aside space at its factory in northern Dalian city for a
manufacturing line in anticipation of approval.

But SDA officials have warned they are "cautious" about Viagra imports.

"We will set certain limits of Viagra sales and applications even if we do allow the
drug to enter China," a spokesman for the administration said in January.

"Second-generation" anti-impotence drugs touted as even more effective than
Viagra will soon be available from Pfizer and other Western pharmaceutical makers.
( (c) 1999 Agence France Presse)

insidechina.com

Share RecommendKeepReplyMark as Last Read


To: BigKNY3 who wrote (7239)3/17/1999 3:47:00 PM
From: Little Gorilla
   of 9519
 
03/17/99- Updated 07:21 AM ET

Viagra celebrates first anniversary
By Rita Rubin, USA TODAY

A year ago, most Americans had never heard of "erectile dysfunction."

Now Bob Dole is a television pitchman for it.

A year ago, men of a certain age - and their partners - assumed that impotence was an inescapable side effect of getting older.

Now, rumor has it, nonagenarians are patronizing bordellos.

A year ago, impotent men seeking treatment could choose from shots, implants, urethral suppositories and a vacuum pump.

Now, thanks to the approval of Viagra last March 27, they simply can pop a pill.

Viagra, the little blue tablet that has triggered a sexual revolution, is about to turn 1. And life in the USA, and in more than 50 other countries in which it's marketed, will never be the same.

"I think it's been an extraordinary social phenomenon," says John Bancroft, director of the Kinsey Institute for Research in Sex, Gender and Reproduction in Bloomington, Ind.

"It has opened up discussion about ordinary sexual function," Bancroft says. "It's raised this whole question about the relevance of sex to middle years and later years and its priority in relation to health care and insurance coverage. Just in terms of how we think about male sexuality, it's had an impact that's still resounding."

Aside from the escapades of President Clinton and Monica Lewinsky, who can remember another topic that captivated commentators on Face the Nation as well as comedians on Saturday Night Live?

No other brand-name drug has become so ingrained in the vernacular. "It's been worked into the plots of The Love Boat, NYPD Blue," says Pfizer's Mariann Caprino, who adds that her company gave up trying to track every Viagra mention in the popular media.

Viagra, also dubbed the Pfizer Riser, has had the most successful first year of any drug. Pfizer expects to meet a projected $1 billion in Viagra sales by the drug's first birthday. By the end of 1998, the company had sold $788 million worth globally, including $656 million in the USA. At a wholesale price of $7 a pill, that's nearly 100 million pills sold just in this nation.

Dole, former Senate majority leader and 1996 Republican presidential nominee, will be playing a central role in Pfizer's campaign to spread the word about erectile dysfunction, Caprino says. Dole, already open about his prostate cancer, announced on Larry King Live last year that he was a satisfied Viagra customer.

More than 80% of users are men over age 50, Caprino says. "That's exactly what you would expect, based on the demographics of the condition."

About 2% of users have been women, she says, although the drug has been approved only for men. Pfizer is studying Viagra's effectiveness in treating female sexual dysfunction and expects to analyze data later this year, Caprino says.

"It's opened up the whole topic of women's sexuality and sexual dysfunction," Bancroft says. "It's exposed the fact we understand very little about what is important about the quality of sexual life in women."

Before Viagra, he says, female patients "presented themselves typically in terms of their sexual relationships with their partners, rather than their sexual physiology. With men, it tended to be the other way around."

Theoretically, Viagra should help women. It works by increasing the effects of nitric oxide, a common chemical in the body. In men, nitric oxide relaxes the smooth muscle in the penis, increasing blood flow to that organ. When women are aroused, the vagina becomes engorged with blood, just as the penis does when men are sexually excited.

The first published research of Viagra in women wasn't encouraging. A study of 33 volunteers in the journal Urology this month found that the drug is probably no better than a placebo.

Even in men, it's not a perfect drug. In clinical trials, Viagra improved erections - but, Bancroft notes, not necessarily sex lives - in about 70% of subjects who took it. And it's not without side effects.

When taken with nitrate drugs such as nitroglycerin, Viagra can cause dangerously low blood pressure. That was the main warning on the impotence pill's original labeling.

In light of reports of 80 men dying of strokes, heart attacks or other cardiovascular events after taking Viagra, Pfizer added more warnings to the label in late November. The label now cautions doctors against prescribing the drug to heart disease patients who might not be able to tolerate the exertion of sexual intercourse. In addition, the label now warns, doctors should think twice about prescribing Viagra to any man who's had a heart attack, stroke or irregular heartbeat in the previous six months.

Unquestionably, the availability of an impotence pill has spurred many men to see a doctor for the first time in decades.

"My whole practice has changed, and I've been in this business for 20 years," says Irwin Goldstein, a Boston University urology professor who specializes in treating erectile dysfunction.

Before Viagra, Goldstein says, patients used to complain, "Gee, Doc, I'm impotent, and nobody will take care of me, nobody will examine me." Now, patients complain, plenty of doctors are writing Viagra prescriptions with just a cursory examination and no mention of alternative treatments, Goldstein says. He says much of his practice consists of the 30% of Viagra users who saw no improvement with the pill.

These days, patients don't ever have to talk to a doctor to get Viagra. Dozens of Web sites offer "on-line consultations," brief questionnaires that supposedly are reviewed by physicians.

With a few clicks of a mouse, anyone in the world can get a Viagra prescription and have it filled on line, a practice that has drawn the ire of the American Medical Association, medical licensing boards and four Democratic congressmen, who have asked the General Accounting Office to investigate.

These critics of so-called Internet prescription mills point out that impotence is often a symptom of a serious medical problem, such as diabetes or heart disease, that needs to be monitored by a doctor.

Diabetes drove Dan Stokes, 52, to try Viagra. About seven years ago, not long after he married his current wife, Stokes began experiencing erectile dysfunction.

"It kind of gradually over time became more significant," he says. "I couldn't count on everything working."

Stokes, an Environmental Protection Agency technician in Ann Arbor, Mich., says he tried everything from an herbal remedy to penile injections before Viagra came along.

"We were doing a lot of fiddling around with the vacuum gizmo," Stokes says. "My wife was saying it sure would be nice to have plain old ordinary sex like everybody else did."

Thanks to Viagra, Stokes says, they now do. "I didn't expect to be 19 again, and I'm not," he says. His insurance covers what it considers a five-week supply: six pills. The drug has failed only once or twice, Stokes says, and the only side effect has been a faster heart rate, "but I suspect it has more to do with amore."

Bruce Feldman, 39, a psychiatrist in Springfield, Ill., began experiencing erectile dysfunction seven years ago, 11 years after he was diagnosed with multiple sclerosis. Feldman didn't think much of most treatments. The vacuum pump? "Not too romantic." Injections? "I refuse to use them." Urethral suppositories? "Didn't do anything."

Through Pfizer connections, Feldman says, he was able to get Viagra before it hit drugstore shelves last April. Both he and his wife are pleased with the drug. "We have a terrific marriage, but it enhances things," Feldman says.

A terrific marriage enhances Viagra because the drug fosters erections only in men who are aroused by their partner. "Viagra is neither an aphrodisiac nor a love potion for relationships in distress," Robert Butler, former director of the National Institute on Aging, wrote in October in the journal Geriatrics, where he serves as medical editor.

"If sex is only seen as something mechanistic or biological that has nothing to do with mutuality and sentiment and warmth and closeness, then it is not a good idea," says Butler, president of the International Longevity Center at Mount Sinai NYU Medical Center in New York.

Bancroft says the Kinsey Institute and four other research centers have launched a study of Viagra's impact on relationships. They're examining the characteristics of couples who find it most useful. "Maybe a year from now we'll have some answers," he says.

Meanwhile, a number of companies are rushing to develop the next Viagra. Goldstein says he is involved in a half-dozen companies' clinical trials of sexual-dysfunction treatments for men and women. By 2010, he predicts, there will be more than a dozen new companies marketing drugs or devices to treat impotence.

That makes good business sense, Goldstein says. According to conservative estimates, he says, nearly 10% of the world's population will be over 65 by the year 2025. And the older you are, the more likely you are to be dealing with sexual dysfunction.

--------------------------------------------------------------------------------



Share RecommendKeepReplyMark as Last ReadRead Replies (1)


To: Little Gorilla who wrote (7241)3/17/1999 8:52:00 PM
From: Anthony Wong
   of 9519
 
Man Fined for Selling Peppermints as Viagra
Fox News
12.10 p.m. ET (1710 GMT) March 17, 1999

HANOVER — A German man has been fined for selling peppermint sweets
claiming they were Viagra sexual potency pills, police said Wednesday.

The man persuaded 34 men to part with a total of 6,000 marks ($3,370) by
offering the Viagra tablets through an advertisement placed on the Internet. He
instead sent them blue "Fisherman's Friend" pastilles which looked similar to the
sex drug.

"The plaintiffs filed legal complaints against him when they realized the pills were
not having the desired effect," a Hanover police spokeswoman said.

The man was fined 2,000 marks and had his computer confiscated.

foxnews.com

Share RecommendKeepReplyMark as Last ReadRead Replies (2)
Previous 10 Next 10