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


To: BigKNY3 who wrote (7184)3/10/1999 7:47:00 AM
From: Anthony Wong  Respond to of 9523
 
Viagra is approved and will be available in about three weeks
'Major medical advance': 300,000 Canadian men are expected to seek treatment

Wednesday, March 10, 1999
Tom Arnold
National Post

Viagra, the much-heralded pill to
treat impotence, has received its final
approval from Health Canada.

Growing anticipation for Viagra among
Canadian men is expected to make it
one of the hottest selling drugs in
Canada when it ecomes available in
about three weeks. The tiny blue pill, the
first oral medication for erectile
dysfunction, has become the best
selling pharmaceutical in the United States following its introduction last March.

More than 300,000 Canadian men are expected to seek treatment
-- about 10% of the estimated three million who suffer from erectile
dysfunction which is associated with a range of medical conditions,
including diabetes, multiple sclerosis, cardiovascular disease, and
depression.

More than 50 countries have approved Viagra. About seven million
prescriptions for Viagra have been filled out for more than three
million American men.

Sold here by prescription in packs of four or eight, Viagra will cost
about $12 to $13 a pill, plus a dispensing fee.

"It's a major medical advance," said Dr. Pierre Roland, medical
director of Pfizer Canada Inc., the pharmaceutical company which
manufactures Viagra. "There are two to three million men with
erectile dysfunction and we feel that a much larger percentage will
probably come forward now that there is an oral treatment.

"And the verdict of all the agencies is that Viagra is safe and
effective, if used appropriately."

According to the clinical trials, which involved about 500
Canadians, Viagra was effective in seven out of 10 men. Taken up
to one hour before sex, it restores normal erectile function, though
men still need stimulation to achieve an erection. It is considered a
novel alternative to pumps, suppositories, injection needles, and
other invasive procedures used to stimulate the flow of blood to the
penis, needed to gain and maintain an erection.

Viagra's approval in Canada had been delayed because of adverse
reactions reported in other countries. More than 170 deaths
worldwide have been linked to Viagra, although there is no
conclusive evidence that the pill is to blame. The deaths most
commonly involved patients using nitrates for heart disease.

"For the first time in Canada there is an effective pill," said Dr.
Gerald Brock, a London urologist who is also head of the Canadian
Male Sexual Health Council. "It's been really a taboo subject over
the past decades. But now men are asking for treatment."

The financial impact on the health system isn't clear. Viagra is not
expected to be covered by most provincial health plans.

"We have people worried that all these guys with erection problems
are going to cost the health system millions of dollars," said Dr.
Brock. "But I think it is wonderful because the overall health of men
will dramatically improve."

According to an Angus Reid poll last year, Canadian doctors said
they expect to be pressured to prescribe Viagra.

"It's resurrected my sex life, which is what it's supposed to do," said
Allard Gee, a retired railway equipment supervisor from Gilmour,
Ont. "It's certainly given my wife and I better quality of life."

Married for 29 years, Mr. Gee, 58, has had erection problems for
more than seven years. As a participant in Viagra trials for more
than two years, he has not paid for the medication, but he added "It
wouldn't deter me one bit."

Related Sites

www.viagra.ca
A.k.a. The Erectile Dysfunction Institute, this site is run by Pfizer,
the maker of Viagra.

Health Canada
The governmental body that has given full approval to Viagra.

U.S. Food and Drug Administration
A balanced discussion of the merits and drawbacks of Viagra.

Viagra Falls: The Canadian Battle to Promote Viagra
healthwatcher.net
Part of the Healthwatcher site, this page traces the regulatory battles
that have taken place in Canada since the drug achieved
prominence in the States. It has a wealth of Canada-based news
stories and hotlinks.

nationalpost.com



To: BigKNY3 who wrote (7184)3/10/1999 8:01:00 AM
From: Anthony Wong  Respond to of 9523
 
Eager Canadians get their Viagra at last
Ottawa approves anti-impotence drug after two-year review

Wednesday, March 10, 1999
CAROLYN ABRAHAM
Medical Reporter
The Blobe & Mail

The little blue pill that has caused a very big fuss
is to penetrate the Canadian market in three
weeks and the bedrooms of an estimated three
million Canadian men soon after.

Health Canada has approved Pfizer's
anti-impotence drug Viagra after a two-year
safety review and pleading phone calls from
sex-hungry Canadians. It's expected in
pharmacies by the end of March.

Since the United States approved the drug a year
ago, Canadians have had countless prescriptions
filled across the border at what some doctors
dubbed "Viagra Falls."

Originally developed to treat heart conditions,
Viagra proved to have the unexpected side effect
of sparking strong and long-lasting erections in
men who otherwise suffered penile dysfunction.

Ironically, the manufacturer's main public
relations battle has since been countering reports
that the drug actually causes heart problems.

Viagra has nevertheless become a cultural icon
for a different kind of sexual revolution, a hot
commodity in more than 70 countries and one of
the fastest-selling drugs in medical history.
Gerald Brock, a urologist at St. Joseph's Health
Centre in London, Ont., and an associate
professor of urology at the University of Western
Ontario, said "We are very happy that Health
Canada has finally decided, as many other
countries have, that Viagra is a safe and effective
treatment for erectile dysfunction."

The drug is reported to help seven in 10 men
with erectile problems and Pfizer is now testing
its sexual effects in women.

Urologists who appeared on behalf of Pfizer at a
news conference yesterday, said reports that
Viagra might be harmful have been misleading.
They said deaths linked to the drug in the United
States included a homicide and a drowning of
men who just happened to have prescriptions for
Viagra.

They also denied that Viagra increases the risk of
cardiac problems, which the U.S. Food and Drug
Administration concluded after reviewing the data
in November, 1998. To date, about seven million
American men have taken 60 million Viagra pills
and about 130 men have died.

"What's confusing is that guys with erectile
dysfunction are at a higher risk of . . . cardiac
problems," Dr. Brock said. He explained that
such men should perhaps no more be having sex
than they should be shovelling snow or running
up the stairs.

"Sex is exercise," he said. "We are just hearing
about this now because we are seeing a landslide
of men coming forward for [Viagra]."

Diseases of aging, like diabetes and heart disease,
also tend to put men at higher risk of erectile
problems.

But both the drug company and doctors are
adamant that Viagra must not be taken by
patients who are also taking any form of
nitroglycerin, which is usually prescribed for
cardiac patients. The two drugs together could
result in a nitroglycerin overdose.

Side effects reported during international clinical
trials -- which involved 498 Canadians -- included
headaches, flushing and indigestion. A blue tinge
in vision has also been reported. But all men are
advised to see their doctor with their partners and
have a medical exam before taking the drug.

"I don't know how many of you would like to
stick a needle in your penis," said Jack Barkin,
chief of urology at the Humber River Regional
Hospital, referring to the injections, vacuums and
implants currently used in treatment.

Viagra -- sildenafil citrate -- helps the flow of
blood into the penis necessary to obtain and
maintain an erection. But, Dr. Barkin warned,
"You can't just pop the pill and watch Oprah and
expect something to happen to you." Men still
require natural sexual stimulation after taking
Viagra, he said, which is to be taken 30 minutes
to an hour before the patient expects to have sex.

The urologists also emphasized that Viagra is not
an aphrodisiac, nor is there evidence that it
enhances the erections of normal, healthy men.

In Canada, Viagra is to sell for $12 to $13 per
pill, excluding the dispensing fee. This would
make it comparable to the U.S. price, although
for Canadian sales the drug company has
significantly changed the packaging to blister
packs of four or eight tablets. Theresa Firestone,
Pfizer Canada's vice-president of government
and public affairs, said this was partly done to
prevent counterfeit production of the drug --
which has been a problem in other countries.

THE LITTLE BLUE PILL

How it works: Viagra aids blood flow into the
penis, enabling men to obtain and maintain an
erection.

Success rate: Pfizer Inc. reports that the drug is
effective in seven out of 10 men with erectile
problems.

Dosage: Men with erectile problems are
supposed to take a single tablet 30 minutes to an
hour before they expect to have sex.

How do you get it? By prescription only from
pharmacies.

Side effects: Headaches, indigestion and feeling
flushed. Viagra is not recommended for people
taking nitrate-based heart medication and all
cardiac patients should fully discuss its use with
their doctors. Use of the drug by men who don't
need it could cause permanent erectile problems.

Cost: Just under $100 for a pack of eight pills,
excluding dispensing fee.

THE DRUG: HOW IT WORKS

Erectile dysfunction may be caused by
insufficient amounts of chemical messages being
received by the penis or by the smooth muscle's
inability to relax. How Viagra can help
1. In the penis's flaccid state, the smooth muscle
cells in the erectile tissue are contracted,
constricting the arteries and limiting blood flow to
the penis.

2. Sexual stimulus causes chemical messages to
be produced that should have the effect of
relaxing the smooth muscle, allowing blood to fill
the erectile tissue. These messages are gradually
broken down by enzymes.

3. Viagra works by blocking the specific enzymes
that would break down the chemical messages.
This allows for the production and reception of
sufficient quantities of chemical messages,
allowing and erection to form.

4. As the Viagra wears off, enzymes are no
longer blocked and break down the chemical
messages. The erectile tissue contracts, reducing
blood flow into the penis and opening veins,
which carry blood away.

...
Erectile dysfunction is associated with many
underlying conditions and risk factors.
Age-related illnesses rather than aging itself, are
usually the cause. Here are a few:

Diabetes

High cholesterol

High blood pressure

Spinal-cord injury

Alcohol use

Depression

Smoking

Pelvic surgery

Multiple sclerosis

Copyright © 1999 The Globe and Mail

theglobeandmail.com