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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: Anthony Wong who wrote (7299)3/25/1999 6:50:00 PM
From: Little Gorilla  Respond to of 9523
 
The Dark Side Includes
Abuse and Health Risks

By MARTY ROSEN
Daily News Staff Writer

t was approved and marketed as the prescription impotence cure for men, but Viagra also has a popular following on the club scene, with women, in some gyms and over the Internet.

To the dismay of doctors and the federal Food and Drug Administration, which fears unregulated use of the drug could be disastrous, consumers are finding unapproved uses of the little blue pill.


The 'little blue pill'

Viagra is making the club scene as a hot — and potentially lethal — party drug combined with cocaine or Xstacy, the herbal drug ephedra, which raises blood pressure and heart rate. Users say the drug cocktail boosts sexual performance.

The same goes for those who work out and bulk up with steroids, which can affect sexual activity.

"Often, as they use cocaine more and more they lose the ability to have sex when they're high," said Dr. James Peloquen, a psychiatrist at Long Island College Hospital, in Brooklyn, who has seen a spike in younger Viagra abusers. Combined with club drug Xstacy, people report "having sex for six to eight hours with four orgasms."

At the same time, with 132 Viagra deaths reported to the FDA among men who took nitrates or had heart conditions, the warning list accompanying prescriptions has expanded beyond the danger of a potentially fatal interaction with nitroglycerin to tell men about prolonged or painful erections.

The American Heart Association also warns against its use by people with angina or those who take multiple medications for high blood pressure.

Several states — including New York — are looking to limit the booming Internet market for the drug, fearing people with undiagnosed medical conditions may take it and be harmed.

Women have clamored for the drug, and there are a few reports of its effectiveness among those who have had hysterectomies. But other studies suggest it may be minimally effective for females.

Dr. Steven Kaplan, a Columbia-Presbyterian Medical Center urologist, found that Viagra had limited success in 33 postmenopausal women he studied.

Pfizer Inc. is conducting a wide-scale clinical trial of the drug on European women, with plans for a final phase of testing on their American counterparts. But ultimate approval for women could be years away, said company spokesman Andy McCormick.

"The only clinical data that exists is for men," said McCormick. "As with any medicine, physicians can prescribe it legally, but we don't recommend that they do, and neither does the FDA."

Original Publication Date: 03/25/1999

nydailynews.com



To: Anthony Wong who wrote (7299)3/25/1999 6:51:00 PM
From: Little Gorilla  Respond to of 9523
 
It Doesn't Always
Get Job Done

By MARTY ROSEN
Daily News Staff Writer

The sexperts say Viagra sometimes isn't enough. When New Jersey sex therapists Greg and Karen McGreer plan to have intercourse at least an hour ahead, Viagra works best. But in a pinch they rely on the Caverjet, an injectable dose of prostaglandin that dilates the blood vessels and increases blood flow to the penis in less than two minutes.

"It doesn't hurt," said Greg McGreer, who finds the results consistently surpass Viagra's.

As they tell clients at their joint practice in Cherry Hill, a little blue pill isn't always the magic fix for erectile dysfunction, which can be triggered by emotional or physical problems. In Greg's case, it's multiple sclerosis, but they see patients rendered impotent by heavy drinking, smoking, diabetes, high blood pressure and age.

The drug doesn't work every time, which is why many men don't get refills and come to the McGreers depressed at their failure with the "perfect" sex drug.

And while doctors increasingly recognize the underlying physical causes of erectile dysfunction, some therapists worry that men who use Viagra might not address relationship problems that also may contribute to their dysfunction.

Psychiatrists report not all men — or their wives — want a more active sex life. Dr. James Peloquen said one male patient who hadn't slept with his wife during their brief marriage refused to take Viagra.

"It quite increased the strain on their marriage because she couldn't understand why he wouldn't give her sexual pleasure," said Peloquen, a psychiatrist at Long Island College Hospital, in Brooklyn.

The McGreers are working with several patients who won't tell their partners they need Viagra, a sign that those men see sex strictly as a performance.

"Sex isn't just about making physical connections," said Greg McGreer. "If the ability to make an emotional relationship is poor, the ability to perform sexually also will be poor."

Original Publication Date: 03/25/1999

nydailynews.com



To: Anthony Wong who wrote (7299)3/26/1999 8:10:00 AM
From: BigKNY3  Read Replies (1) | Respond to of 9523
 
Impotence treatment rules 'fail the poor'
Aisling Irwin Medical Correspondent

03/25/99
The Daily Telegraph

IMPOTENCE-sufferers launched a last attempt yesterday to persuade the Government to relax restrictions on the availability of Viagra and other impotence treatments - an issue which has split the medical profession.

The Government's temporary guidelines, which permit GPs to prescribe the treatments only for certain causes of impotence, were attacked as arbitrary and discriminating against the poor, in a meeting hosted by the Impotence Association.

GPs said that the Government's restrictions represented an attempt to undermine their clinical skill.

"The doctor's right - or privilege - of professional judgment has been taken away," Dr Ian Banks, spokesman on men's health for the British Medical Association, told the meeting at the House of Commons.

The group was attacking temporary guidelines produced by the Department of Health in response to fears that Viagra prescriptions would eat a huge hole in the limited NHS budget. The consultation period over these guidelines ends today.

Under the guidelines, a man with problems after surgery for prostate cancer would qualify for Viagra on prescription. But a man who had opted for radiotherapy for the same disease would not qualify.

Impotence caused by depression or heart disease would also not qualify for immediate NHS prescriptions.

Sufferers in these categories would have to be referred to a specialist first.



To: Anthony Wong who wrote (7299)3/27/1999 1:05:00 AM
From: Anthony Wong  Read Replies (1) | Respond to of 9523
 
Potent Medicine: A Year Ago, Viagra Hit the Shelves and the Earth Moved. Well, Sort Of.

By Peter Carlson
Washington Post Staff Writer
Friday, March 26, 1999; Page C01

Abraham was a hundred years old, when his son Isaac was born unto him.

And Sarah said, God hath made me to laugh, so that all that hear will laugh
with me.

-- Genesis 21:5-6

"It's just sex!" says David Brinkley, 41, the head of Pfizer Inc.'s Team
Viagra. "What's the big deal? It's just sex and sex is wonderful!" He smiles.
Then he laughs. "I'm joking a little bit. But sex is a natural, normal thing. It's
how you were born. Your parents had it. You're probably having it."

Brinkley is getting a little bit giddy, but that's understandable. It's been a
very weird year. On March 27, 1998, the Food and Drug Administration
approved the sale of Viagra, a drug that can help many impotent men
achieve erection. Shortly thereafter, Pfizer released Viagra into the world.

And the world went a little bit wacky.

In Taiwan, a politician distributed free Viagra as part of his campaign.

In the Philippines, nightclubs mixed crushed Viagra pills with gin or
whiskey to create cocktails they advertised on the Internet.

In France, a chef was arrested for serving his customers "beef piccata in
Viagra sauce with fig vinegar and fine herbs."

Brinkley says the folks at Pfizer knew the drug would be successful. They
expected it would garner some publicity. They suspected it might inspire
some jokes. But they had no idea that their little diamond-shaped blue pill
would cause a worldwide plague of bizarre behavior.

In Brazil, the mayor of a small town promised to distribute Viagra in an
effort to boost population and thereby increase federal aid.

In New York, a 63-year-old woman filed a palimony suit against her
70-year-old common-law husband, claiming that after using Viagra, he'd
left her for another woman, telling her, "It's time for me to be a stud again."

In Israel, when the Knesset's five-member science committee held a
hearing on the drug, a witness passed around a sample box of eight Viagra
pills. When the box came back, four pills were missing.

For a year, Brinkley has watched all this and marveled. In countless
interviews, he has tried to stay on message, stressing the Pfizer line that
Viagra is a serious drug for a serious medical condition that affects millions
of men and their partners. But it's no use. All over the world, people
continue to behave with appalling immaturity and stupidity.

In London, the Independent reported that black-market Viagra was selling
briskly in the city's nightclubs: "Fast becoming the drug of choice on the
gay and fetish scenes, Viagra is now being taken by large numbers of
women."

In Nevada, prostitutes at a brothel called the Moonlight Bunny Ranch
reported that Viagra was rejuvenating geriatric customers: "They're paying
more and staying longer."

In Taiwan, a prostitute was arrested for killing a Viagra-fueled 74-year-old
customer who demanded a second round of sex. "After we made love, he
wanted to do it again," explained Hseih Hui-ling, 31. "When I refused, he
choked me and knocked out my false tooth. So I took out the knife and
stabbed him."

All of this has made David Brinkley philosophical. He is a veteran of 15
years at Pfizer, first launching drugs for animals, then moving into drugs for
humans. Now, after selling $1 billion worth of Viagra to over 5 million
men, Brinkley sits in his unimpressive office in Pfizer's Manhattan
headquarters, surrounded by Viagra boxes and framed Viagra ads, and he
reflects on what he has learned during Year One of the Viagra era. He has
witnessed what happens when you create a drug that affects the male's
most beloved body part and it has made him a wiser man. He keeps
talking about "human nature."

"Human nature," he says, "is a very, very funny thing."

ALMOST ALOND

It all started back in 1992 with a drug designed to improve blood flow to
the hearts of angina patients.

It worked, too -- but not as well as drugs that already existed, like
nitroglycerin. However, some men using the drug in clinical tests reported
an interesting side effect -- they were able to achieve erections, in some
cases for the first time in years. So Pfizer's scientists started investigating
the drug's ability to combat what was then known as impotence, but would
soon be repackaged, thanks to Pfizer's ad agency and Bob Dole, as
"erectile dysfunction" or "ED."

ED is, as the Pfizer people never tire of repeating, a "serious problem that
affects up to 30 million American men," frequently as a side effect of such
diseases as diabetes, high blood pressure or prostate cancer. Before the
advent of Viagra, treatments for ED involved the use of penile pumps or
penile injections or suppositories inserted into the urethra. Pfizer figured
that a simple, effective pill would be infinitely preferable. They began
testing their drug on ED sufferers and found that it was effective for about
70 percent of them.

Originally, the drug now known as Viagra was called "UK 92-480"
because it was invented at Pfizer's United Kingdom laboratories in 1992.
Later, the active ingredient was given the official chemical name of
"sildenafil citrate." In 1997, as Pfizer prepared to market the drug, the
company began searching for a trade name. Like other drug companies,
Pfizer maintains a "name bank" composed of freshly coined words that
have been tested by professional linguists to ensure that they have no
meaning in any language -- or, as Brinkley puts it, "to see if it means
something horrible like 'Your mother has a mustache.' "

The word "Viagra" passed the test. A few years ago, it was nearly
assigned to a new drug used to shrink swollen prostate glands. "But they
didn't like it for that product," Brinkley says, "and it went back into the
name bank."

It was still there a year later, when Brinkley and his team were looking for
a name for their drug. "We liked it because it sounded strong," he says.
"Another name that was in the name bank was Alond, which seemed kind
of -- I don't know." He shrugs. "It sounds like elong. And it just doesn't
roll off the tongue as well."

So it was Viagra, not Alond, that became a household word around the
world. And Viagra, not Alond, was the name given to a cheese, a pizza
and an ice cream in Italy. And "Viagra blue," not "Alond blue," was the
name bestowed on the color used in a line of dresses by French fashion
designer Daniel Tribouillard.

Viagra immediately became wildly popular all over the world. And its
appeal was not diminished by an FDA report that 130 men, most of them
heart patients, had died after using it -- 27 of them "during or immediately
after sexual intercourse." Last November, the FDA required the drug to
carry a label that warned doctors to be careful in prescribing Viagra for
men with heart conditions. Pfizer agreed.

Like war, famine and pestilence, Viagra caused massive movements of
people across international borders. All over the world, men flocked from
countries that had not yet approved the drug to countries that had. Italians
smuggled Viagra home from Hungary. Scots smuggled it from Spain and
Tenerife. Vietnamese and Malaysians smuggled it from Thailand. In Japan,
a travel agency booked special Viagra tours to Hawaii and Guam. And
Canadians swarmed into Vermont, inspiring one Yankee urologist to dub
the drug "Vermont's number one export."

POWER OF SUGGESTION

Hugh Hefner loves Viagra.

The founder of Playboy magazine is 72 years old. He is separated from his
wife. He is dating three women, none of whom is even half his age, two of
whom are twins. He attributes his sexual renaissance to Viagra.

"It would be very difficult without Viagra," he told Rolling Stone magazine.
"I think they're actually underselling Viagra because it's more than an
impotence drug: It's a recreational drug. It eliminates the boundaries
between expectation and reality."

Hefner is hardly Viagra's only unpaid cheerleader. All over the world,
newspapermen tried the drug -- purely in the interests of science, of
course, they didn't actually need it -- and reported that it turned them into
sexual supermen.

"I was a monster of desire," wrote Sean Thomas in the Times of London.
"We had sex in the bed, beside the bed. . . ."

"My activity was incessant, pleasureable and above all made me proud of
the sensory euphoria I was provoking in my partner," wrote Brazilian
columnist Paulo Sant'Ana, 58. "Just when I thought my night was over, the
pill showed up for round two," wrote Gersh Kuntzman in the New York
Post, "answering the bell like a vascular version of Muhammad Ali."

All these guys are full of baloney, Brinkley says. Viagra has absolutely no
effect on men who do not suffer from erectile dysfunction. None. Zero.
Zip.

"Physiologically -- and we understand the drug very well -- there is no
basis for that," he says.

If you don't have a headache and you take aspirin, nothing happens. It's
the same with Viagra, Brinkley says. If you don't have ED, the drug has no
physical effect.

It may have a psychological impact, of course. That's the placebo effect:
People think it's going to work, so it works.

"A really interesting feature of products for sexual functioning in men is a
high placebo rate," Brinkley says. The normal placebo rate for most drugs
is less than 5 percent. "In our studies, 20 percent of the men who were
taking the placebo -- who were taking sugar pills -- said they were getting
these rip-snorting erections."

Indeed, other treatments for ED show similarly high placebo rates. One of
Viagra's competitors is a drug injected directly into the penis. That drug,
too, was tested in a placebo-controlled experiment.

"A certain amount of the men would inject distilled water into their penis
and get big erections -- because they thought they were going to," Brinkley
says.

He smiles. "Human nature," he says, "is very interesting."

THE SOFT SELL

"The whole idea was for us to take control of the image from Leno and
Letterman," says Carol DiSanto. She's explaining why Pfizer bothered to
advertise a product that was so popular that it was rumored to sell for
$100 a pill on the black market. "It was our job as advertisers to establish
the image. It's not the sex drug."

DiSanto is a vice president of Cline, Davis & Mann, a New York
advertising agency that specializes in medical ads. She's sitting in a corner
office 31 stories above Lexington Avenue. Outside the plate glass
windows, Manhattan's skyscrapers rise toward the heavens. Around the
table are five other agency vice presidents. This is the team that created the
ad campaign for Viagra.

It wasn't easy. They started by gathering focus groups of ED patients.
They interviewed them, got them talking, gave them magazines and scissors
and glue sticks and asked them to create collages that expressed their
feelings about erectile dysfunction.

After that, the agency team came up with 17 possible ads. One idea was
built around the slogan "Viagra: Man's New Best Friend." Another idea
was to show guys walking up to a drugstore whistling the old Glenn Miller
tune "In the Mood." A third went something like this: "If your hand didn't
work, you'd go to a doctor. If your leg didn't work, you'd go to a doctor.
If something else doesn't work, why not go to a doctor for that?"

Ultimately, all those ideas were rejected and the agency went with a
concept called "The Dance," which was inspired by scenes of couples
spontaneously dancing in such movies as "Picnic" and "The Big Chill." The
idea was to show how Viagra could put the romance back into a
relationship deadened by ED. The ad people gathered actors and
actresses, most of them middle-aged or older, and brought them to
different sets -- a kitchen, a ranch, a railroad station, a lakeside dock.
There, the couples danced, gazing lovingly into each other's eyes.

DiSanto's team used still photos of the dancers in print ads that began
appearing in magazines last summer, accompanied by the slogan "Let the
Dance Begin." Then they created 15-second TV commercials of the
sweetly dancing couples followed by one simple sentence: "Ask your
doctor about Viagra." Those ads premiered a couple of weeks ago.

By then, the agency had already rolled out its other ad -- the one that
features former senator Bob Dole.

This commercial never mentions Viagra. It was designed to raise public
awareness about erectile dysfunction. In fact, the ad introduced the
formerly obscure medical term as the alternative to "impotence," a word
the men in focus groups hated so much they were loath to even utter it.

The ad agency toyed with various concepts for the ED campaign. One
idea was to hire actor Dennis Franz to do the ads because the detective
Franz plays on "NYPD Blue" started taking Viagra after prostate surgery.
But then Dole appeared on "Larry King Live" and revealed that he'd taken
Viagra after prostate surgery and he loved it. For months, the Pfizer people
were too nervous to ask Dole to do the ads, Brinkley said. When they
finally worked up the courage, they found him eager and enthusiastic.

"He was very sincere," says Ed Wise, the agency vice president who
worked with Dole. "He wanted to make sure it wasn't funny, it wasn't
laughable."

And it isn't funny. But then somebody at the table hauls out a thick
scrapbook full of stuff about Viagra. It's got magazine covers and
newspaper stories, and also some of the less lofty flotsam of Viagramania.
There's a picture of an Italian street vendor selling "Viagra pillboxes,"
which are decorated with a reproduction of Botticelli's "Birth of Venus."
There's a photo of a sign outside a Midwestern pharmacy: "Beanie Babies
and Viagra." And there's a political cartoon that shows Dole standing in the
snows of New Hampshire, holding a sign that reads, "Vote for My Wife or
I'll Tell You More About Erectile Dysfunction."

Seeing that, the ad execs are no longer able to maintain their air of somber
solemnity. They burst out laughing.

THE LAST LAUGH

Which brings up the topic of Viagra jokes.

By now there must be millions of them. Leno tells them. Letterman tells
them. Imus and Howard Stern tell them. Whoopi Goldberg told one at the
Oscars. And the Internet churns them out by the thousands.

Did you hear about the first Viagra overdose? A guy took 12 pills and his
wife died.

Did you hear about the new Viagra coffee? One cup and you're up all
night.

Did you hear about the new Viagra for computers? Turns your floppy disk
into a hard drive.

. . . hear about the minister who took Viagra? . . .

. . . hear what happened when Dan Quayle took Viagra? . . .

In the beginning, David Brinkley kind of liked the jokes. He figured they
would help destigmatize ED, get people talking about it, encourage men to
go see their doctors. But now he's not so sure.

"If you suffer from erectile dysfunction, what do you think is the effect of
these jokes?" he says. "We think part of the effect is that it turns guys off.
We had a period of enlightenment where people understood that it was a
medical condition and now we've gone back to where it's something to be
ashamed of because it's the butt of every joke. Who's going to stand up
and admit they have this condition that everybody's laughing at?"

Brinkley isn't too thrilled with the jokes, but he is amused that a lot of
people think that Pfizer is somehow responsible for them.

"I cannot tell you how many people come up to me and say, 'How do you
get Jay Leno to put you in the monologue every night? You guys must have
a really good PR agency.' " He rolls his eyes theatrically. "Oh, yeah, we're
behind it," he says sarcastically. "This is what we consider to be really
good drug marketing."

It's been that kind of year for Brinkley. One weird thing after another.
Every time he thinks he's seen every strange manifestation of Viagra's
effect on his fellow man, the next day's headlines prove him wrong.

Now, a year later, he is philosophical about all this. He maintains an air of
comic bemusement. He has learned an important truth about human nature.

"People are strange when it comes to sex," he says.

© Copyright 1999 The Washington Post Company

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