Viagra Information (in the news)
The
following represent a comprehensive list of articles that address
the use of Viagra for treatment Erectile Dysfunction (impotence):
Viagra,
Rationed
Kamran Abbasi
British Medical Journal
Jan 30, 1999
Viagra
is Licensed in Europe but Rationed in Britain
British Medical Journal
Alex Brooks
Sept 19, 1998
UK
issues guidance on prescribing Viagra.
British Medical Journal
Jan 30, 1999
Viagra
Prescriptions UK: Nightclub Cocktail
BBB News
Study
Shows Viagra Safe for Men with Hypertension
Worldwide Biotech
April, 2001
Study
of Viagra(R) in General Medical Practice Confirms No Increased
Risk of Heart Attack.
PR Newswire
March 19, 2001
Erectile
Dysfunction Patients Remain Satisfied With Viagra After Two Years,
New Study Shows
PR Newswire
May 4, 1999
Using
Viagra
American Family Physician
Sept 15, 1999
Viagra
Tale: How One Man Sought an Impotence Cure - and Found One
U.S. News & World Report
May 4, 1998
Save
Money On Prescription Medications
Consumer Reports May 2001
VCU
Discovery Shows That Viagra Protects the Heart.
PR Newswire
August 19, 2002
Viagra
Exclusion Allowed. (insurance coverage for medicine Viagra)
Business and Health
Sept, 2001
Viagra
Wins Medical Innovation Award
PR Newswire
Issue: Nov 22, 2000
All
Hail the Viagra Generation
USA Today (magazine)
Sept, 2000
Erectile
Dysfunction Patients Remain Satisfied With Viagra After Two Years,
New Study Shows
PR Newswire
May 4, 1999
New
Study of Viagra in General Medical Practice Confirms Safety Profile
Established by Clinical Trials.
PR Newswire
Oct 9, 2000
Viagra
Makes Flowers Stand up Straight
British Medical Journal
July 31, 1999
A
MAN AGAIN ': Experts Praise a Pill that Treats Impotence (the
use of the Viagra, an impotence drug)
Maclean's v111, n18
Viagra, Rationed
Kamran Abbasi
British Medical Journal
Jan 30, 1999
On 21 January,
the health secretary Frank Dobson's announcement on prescribing
Viagra (see p 273 and p 279) was denounced by the BMA as "cruel
and unethical." But doctors found few allies in the press.
As Jennifer Trueland wrote in the Scotsman (22 January), the Viagra
debate "shows that the NHS has finite resources and that
it cannot meet every demand" The Evening Standard, however,
was first into the fray (21 January): "Doctors do not run
the National Health Service: taxpayers do. But try telling that
to the British Medical Association. It was in the interests of
the taxpayers, and of common sense, that the Health Secretary,
Frank Dobson, announced his new, binding guidelines.... The BMA
needs to be slapped down hard on this."
The Independent
(23 January) argued that "rationing by queueing" was
as old as the NHS, and that, while the 1990s was "the Happy
Decade" (thank you Prozac and Viagra), it would "also
be remembered as the decade in which the rationing of healthcare
started in Britain." The BMA, it claimed, was more concerned
about doctors' priorities than those of the NHS--"as selfish
and irresponsible a vested interest as the worst of the flying
pickets in the 1970s." Doctors had become rebels, and their
leaders rabble rousing trade unionists: "For the BMA to instruct
its members to defy the Government by prescribing as much Viagra
as they think is justified by `clinical need' until the guidelines
take effect is the kind of gesture politics which got Arthur Scargill
where he is today."
" Dobson's
choice" as the media dubbed it, centred around the health
minister's belief that impotence isn't life threatening and doesn't
cause physical pain. "We have to find a sensible balance
between treating men with a distressing condition and protecting
the resources of the NHS to deal with other conditions, for example,"
chose Mr Dobson, "cancer, heart disease, and mental health
problems." Apparently not the mental anguish of impotent
men, though.
General practitioner
David Devlin told the Daily Telegraph (22 January): "I think
this is quite unfair. I have more than 100 patients on Viagra
and all are suffering from impotence caused by psychological or
physical disorders. A lot of people consider Viagra users to be
promiscuous men. This is not true."
Andrew Marr
of the Observer offered an explanation (24 January): "We
had reason to think that his [Dobson's] contribution to the drugs
debate would be to manufacture the filthiest Viagra joke on the
planet. Instead he has changed the National Health Service forever.
This is about values: and unlike his jokes, Dobson's are decent
to the core. A nation which spends taxpayers' money on better
erections, while leaving old ladies to soil themselves and starve
in under-staffed wards, is sick indeed." Marr is convinced
that Dobson's choice is the "clearest act of national drugs
rationing yet." Who could disagree?
Mr Dobson
was firm, doctors were defiant, and Pfizer--manufacturer of Viagra--was
furious but exploring "all its options." For three days
the controversy raged: "Impotence is not a joke, say doctors"
(Independent 22 January), while "Impotence is not really
such a serious problem, claims Dobson" (Express 22 January).
The Express applauded as "Dobson strikes right balance on
Viagra" (22 January), but added a new twist: "And today
The Express reveals that because the drug is registered in Britain,
this country's exchequer makes money from every pill sold across
the world--in theory, more than enough to offset the costs of
prescribing Viagra."
Confused?
The Sun seemed to be as well. The "Sun Man's Sex File"
confessed: "Dear Mr Dobson, I am a Sun journalist and I am
on Viagra--when I can afford it" (22 January). Page 3 not
doing the trick then? "How dare you suddenly change the rules
of the NHS now, after I have spent the better part of my working
life paying into it? Viagra has been a Godsend." Another
Sun journalist, Richard Littlejohn, was unhappy that the NHS should
"legalise and supply a proven killer like Viagra." Instead,
he offered his own rationing test: "If you're strong enough
to get the cap off the bottle, you can buy it yourself."
Inevitably,
the prime minister made one of his regular forays into the tabloid
press. "We have to be hard on Viagra," he exclusively
told the Mirror on 23 January. "I personally believe that
the public understands very well that there are certain severe
medical conditions in relation to impotence that should be treated
on the NHS." Do they? "You have got to make a choice
as to priorities."
Rationing
is the word the government dare not mention--prioritisation is
more acceptable in "Third Way" terminology--but everyone
else is dispensing it freely. The first rationing skirmishes have
been won in the press by the government, with doctors portrayed
as power crazed idealists rather than patients' advocates. Rationing
is now dearly with us, though the method of making it work remains
elusive. Where will the National Institute of Clinical Excellence
fit in? How might doctors' and patients' views be better considered?
Viagra has
crystallized the rationing debate as only a matter of male sexual
prowess could. Where now Viagra? Where now rationing? The future
is foggy, not least for impotent men.
back
to the top of the page
Viagra is Licensed
in Europe but Rationed in Britain.
British Medical Journal
Alex Brooks
Sept 19, 1998
The long awaited
licence for sildenafil citrate (Viagra) was granted this week
by the European Medicines Evaluation Agency, but British patients
will not be able to get the drug on the NHS, at least for the
time being.
Following
the advice of the Standing Medical Advisory Committee, the Department
of Health has advised doctors not to prescribe sildenafil until
definitive guidance is drawn up in the next few weeks. This is
the first time that the NHS has refused to fund a licensed drug
with proved benefits to a large number of people. The efficacy
and safety of sildenafil has already been demonstrated in trials
and use in the United States.
Admitting
that the decision was primarily because of cost, the health secretary,
Frank Dobson, said: "Media coverage of this drug to date
has created expectations that could prove a serious drain on the
funds of the NHS. If this were to happen, other patients could
be denied the treatment they need. I cannot allow this to happen.
"
He added:
"The potential availability of this drug raises issues about
the priority which should be given to the treatment of impotence
on the NHS." He told Channel 4 News that he expected eventual
"limited availability" of sildenafil.
Philip Hammond,
the Conservative shadow health spokesman, said that Mr Dobson
has acknowledged "what the Government has always denied--that
there is rationing on the NHS." The Conservative party has
called for the public to be able to have a "full and open
debate about what the priorities should be."
Stephen Thornton,
chief executive of the NHS Confederation, praised the government
for realising that availability of sildenafil on the NHS "would
have led to huge financial problems and organisational chaos for
the health service." He also said that Mr Dobson was right
to "issue guidance to clinicians and health service managers
about how the drug should be rationed."
The Department
of Health has advised health authorities "not to support
the provision of sildenafil at NHS expense to patients requiring
treatment for erectile dysfunction, other than in exceptional
circumstances which they should require be cleared in advance
for them." It is not yet clear what these exceptional circumstances
would be. However, it was also emphasised that "ministers
have not made any decisions relating to the nature and extent
of any future availability of this drug as part of NHS services."
Because sildenafil
is not a lifesaving drug, it is an easy target for rationing.
The government eventually agreed to the price suggested by Pfizer
of 4.84 [pounds sterling] ($7.8) for a 50 mg tablet, the normal
dose. The drug costs $7.5 for an equivalent dose in the United
States. The price of other impotence treatments is much higher
than for sildenafil--for example, alprostadil (Caverject) costs
6.74 [pounds sterling] for a single 5 [micro]g injection. Dr Douglas
Savage, a GP in Doncaster who has an interest in impotence, described
it as "crazy" that a drug without serious side effects
that was substantially cheaper than other treatments was banned
on the NHS.
The NHS spends
about 12m [pounds sterling] annually on impotence treatments,
but with the introduction of oral treatment, demand is expected
to be much higher than at present. The BMA has calculated that
the annual drug bill for sildenafil would exceed 1bn [pounds sterling]
($1.6bn) a year, if all of the men who might benefit were prescribed
the drug. Pfizer insists that the cost of treatment is closer
to 50m [pounds sterling] after five years.
Another problem
is the potential misuse of sildenafil, with healthy individuals
taking it to "pep up" their sex lives. Mr Dobson said:
"I don't really think that the NHS should be financing people
waving their potency at a disco." There is also some concern
at the reported use of sildenafil with amyl nitrate ("poppers")
in the homosexual community. Pfizer insists that only a very small
number of tablets have reached the black market. It emphasises
that sildenafil is not an aphrodisiac or performance enhancer
in a normal healthy individual.
Roger Kirby,
a consultant urologist at St George's Hospital in London and honorary
secretary of the British Association of Urological Surgeons, was
surprised that a "breakthrough" treatment was rationed,
while the NHS continued to prescribe for constipation and warts.
He has privately prescribed sildenafil for nearly 200 patients
and found it "safe and effective." To avoid massive
waiting lists, GPs, if properly educated, should be able to prescribe
the drug for patients with a genuine clinical need, he said.
One of the
few absolute contraindications for sildenafil is concomitant administration
with organic nitrates, which can cause a severe drop in blood
pressure. There have been 69 deaths associated with sildenafil
reported by the Food and Drug Administration in the United States
since its launch there in April (p 759, 824).
back
to the top of the page
UK
issues guidance on prescribing Viagra.
British Medical Journal
Linda Beecham
Jan 30, 1999
The UK government
last week issued draft guidance to doctors on when they could
prescribe sildenafil citrate (Viagra) to patients on the NHS.
Doctors' representatives immediately rejected the government's
proposals as "cruel and unethical."
Frank Dobson,
secretary of state for health, said that GPs could prescribe Viagra
and other drug treatments for impotence only to patients who have
undergone prostatectomy or radical pelvic surgery, or have a spinal
cord injury, diabetes, multiple sclerosis, or single gene neurological
disease.
The minister
says that NHS treatment may also be available "in a hospital
setting subject to specialist assessment in those exceptional
circumstances where impotence is causing severe distress."
Doctors will be advised to restrict their prescribing of treatment
for impotence to one treatment a week. Patients not suffering
from one of the named conditions would be able to get a private
prescription. The pills cost about 6 [pounds sterling] each.
Mr Dobson
pointed out that if Viagra were freely available the cost of treating
impotence could increase 10-fold or more. He said that he wanted
to keep spending to its current level--estimated to be between
10m [pounds sterling] ($16m) and 12m [pounds sterling] a year.
Mr Dobson said, "We have to find a sensible balance between
treating men with a distressing condition and protecting the resources
of the NHS to deal with other patients-for example, with cancer,
heart disease, and mental health problems."
During the
six week consultation period on the government's proposals the
BMA will countermand the recommendations of the secretary of state
and advise GPs to prescribe the drug on the NHS where it is clinically
indicated.
When the drug
was licensed last summer, the Standing Medical Advisory Committee
(SMAC) advised that doctors should not prescribe the drug other
than "in exceptional circumstances" (19 September 1998,
p 836). The committee set up a working party to prepare more detailed
guidance, and reported to the government in November. It predicted
that as an oral treatment Viagra was likely to be more acceptable
than injections or mechanical devices and was cheaper.
It concluded
that there was no medical reason why the drug should not be available
on the NHS, nor why it should not be prescribed by GPs with referral
to hospital specialists where appropriate. It also suggested that
ministers should consider the priority given to all the methods
of managing erectile dysfunction in the NHS relative to treatments
for other conditions, but that any decision should take into account
equity of access as well as availability of resources.
The BMA's
General Practitioners Committee took great exception to the proposals
at its meeting last week. It saw them as unworkable and said they
made a cruel and unethical distinction between acceptable and
unacceptable forms of impotence. The committee believes that it
is wrong to distinguish between patients according to the cause
of their erectile dysfunction.
Members criticised
the minister's statement that "impotence is in itself neither
life threatening, nor does it cause physical pain." The chairman
of the BMA council, Dr Ian Bogle, said that if those were the
criteria for treatment "they exclude most of my life's work."
Many patients would have to be referred to hospital when they
could be treated by their GPs and this would increase consultants'
workload.
Dr John Canning,
a GP in Middlesbrough, supported the government's stance. He told
the GPC that the profession had continually asked the government
to make rationing decisions and Mr Dobson had now made an attempt
to do so. There was a risk that GPs might raise expectations if
they prescribed Viagra under the NHS and then had to stop if new
regulations were introduced at the end of the consultation period.
The president
of the Royal College of Physicians, Professor George Alberti,
also said that the government's decision was a dear indication
of overt rationing, which the college supported. "What we
have got here is a drug that could cost a lot of money,"
he said, and he challenged critics to name the diseases which
should be dropped from NHS treatment in order to pay for Viagra.
The chief
executive of the NHS Confederation, Stephen Thornton, said, "These
are landmark proposals from government, representing the first
time that it has set dear eligibility criteria for a new drug
on a national basis. This will ensure that we have a uniform approach
around the country, avoiding the danger of postcode prescribing.
We would support similar action from the government in respect
of new drugs in the future, as resources must be managed in the
NHS to protect other more pressing priorities."
The King's
Fund also welcomed the consultation period. Angela Coulter, the
fund's director of policy and development, said, "This is
the first time a government of any party has involved the public
in a rationing debate."
Pfizer, which
makes Viagra, has accused the government of breaching one of the
NHS's principles, that medical treatment should be available to
patients on the basis of clinical need. The company says that
the conditions specified by Mr Dobson represent about 15% of those
who could benefit clinically from Viagra and that the minister
has discriminated against patients with heart and psychological
problems (see pp273, 284, 338).
back
to the top of the page
Viagra
Prescriptions UK: Nightclub Cocktail
BBB News
The first
research into the use of Viagra in nightclubs has found that the
anti-impotence drug is being used by clubbers in combination with
drugs like Ecstasy, poppers and cocaine.
Fifteen people
- 3% of those questioned - at a club in the North West admitted
to taking the drug. Ten were men and five were women.
The research
was done a month after Viagra was licensed for use in the UK.
It was available
on a private basis, but the clubbers all obtained it illegally,
mostly through dealers and friends.
One obtained
it through the Internet.
Because they
did not get the drug legally, none were aware that the manufacturers,
Pfizer, warn against mixing it with nitrate-based drugs, such
as poppers.
Positive
effects
However, all
experienced positive experiences with Viagra and said they would
use it again.
Effects included
increased sexual desire, enjoying sex more, having longer-lasting,
better orgasms and feeling generally "loved-up".
Dr Fiona Measham
from Manchester University, who was involved in the research,
said the effect could have been due to the cumulative effect of
Viagra and the other drugs the clubbers had taken.
It could also
be psychological because of the hype surrounding the anti-impotence
drug.
However, Dr
Measham said the medical view was that Viagra did not work on
people with no sex problems and none of the clubbers said they
had sex problems.
Some researchers
have warned that Viagra could destroy penile tissue in healthy
men, actually causing impotence.
Negative
effects
The only negative
side effects reported were headaches, feeling intoxicated and
genital soreness.
Dr Measham
said the genital soreness could be related to the people having
more sex.
The feeling
of intoxication and lack of inhibitions on the dance floor could
be due to the mixture of different drugs the clubbers were taking.
This included
mainly cocaine, cannabis, ecstasy, alcohol and GHB, which has
been compared to date rape drug Rohypnol.
Dr Measham
said it was known that Viagra and nitrate-based drugs could lower
blood pressure to dangerous levels.
But it was
not known what the affect of illegal drugs were on Viagra.
" Viagra
dilates the blood vessels and stimulants like amphetamines, cocaine
and ecstasy put pressure on the circulatory system so there could
be long-term physical consequences of using them in combination,"
said Dr Measham.
" Many
are very knowledgeable about some drugs, for instance, they know
to take a lot of water with ecstasy, but they don't know what
the effect of mixing drugs is. We are all in the dark on this
to some extent," she added.
The Viagra
research is part of a big two-year study, funded by the Economic
and Social Research Council, on the health of clubbers. It will
be published next year.
Dr Measham
said one of the early findings, reflected in the Viagra research,
was how willing young people were to experiment with new drugs.
back to the top of the
page
Study
Shows Viagra Safe for Men with Hypertension
Worldwide Biotech
Issue: April, 2001
An important
study recently published in the American Journal of Hypertension
shows that VIAGRA (sildenafil citrate), the breakthrough oral
treatment for erectile dysfunction (ED), has comparable efficacy
for ED for men taking antihypertensive (high blood pressure) medications
concurrent with VIAGRA, as for men treated with VIAGRA alone.
As the largest analysis of clinical trial data to date, the study
assessed the efficacy and safety of VIAGRA in men with ED who
were already taking one or more antihypertensive medications.
Erectile dysfunction
-- the inability to achieve or maintain an erection sufficient
for satisfactory sexual activity -- is a common problem in men
with high blood pressure. In fact, some studies report that one-in-five
men with high blood pressure suffer from ED. According to the
published study results, taking one or more antihypertensive medications
(diuretics, beta blockers, alpha blockers, ACE inhibitors or calcium
channel blockers) had no effect on the effectiveness or side effect
profile of VIAGRA.
"Along
with the effect of hypertension itself, some of the medicines
used to treat high blood pressure are felt to have a negative
impact on erectile function," said Dr. John Parker, Cardiologist,
Mount Sinai Hospital and University Health Network Hospitals,
Toronto, Ontario. "The results of this study of hypertensive
men confirm that VIAGRA is safe and effective in a wide variety
of men who suffer from ED, including those with high blood pressure,"
said Dr. Parker.
Developed
and discovered by Pfizer, VIAGRA is the first effective oral treatment
for erectile dysfunction, commonly known as "impotence."
Available in Canada now for two years, VIAGRA was approved by
Health Canada on March 8, 1999. To date, more than one million
prescriptions have been written for VIAGRA in Canada.
In the journal-published
study, the efficacy of VIAGRA was assessed in 3,414 men, of whom
1,218 were taking antihypertensive medication. In ten double-blind
placebo-controlled studies, participants received VIAGRA (5 to
200 mg) or placebo over periods of six weeks to six months. Significant
improvements in erectile function demonstrated by VIAGRA-treated
men were comparable in patients taking high blood pressure medication
and those not taking hypertensive medication. For men taking VIAGRA
and high blood pressure medication, the incidence of treatment-related
adverse events was similar to that for the VIAGRA-treated men
not taking any antihypertensive agents.
"The
recent study demonstrates that men with high blood pressure can
enjoy the benefits of VIAGRA, even if they are on antihypertensive
medicines," concluded Dr. Parker.
VIAGRA is
a prescription medication available only from doctors and should
always be used in accordance with its approved labeling. In clinical
trials, there was no difference in the rate of serious cardiovascular
events between patients treated with VIAGRA or placebo. While
it is well tolerated and effective when used as prescribed, VIAGRA
should not be taken by patients who use nitrates. The most common
side effects of VIAGRA are headaches, facial flushing and indigestion.
back
to the top of the page
Study of Viagra(R)
in General Medical Practice Confirms No Increased Risk of Heart
Attack.
PR Newswire
Issue: March 19, 2001
Study Confirms
Safety Profile Established by Clinical Trials, Orlando Fl. Pfizer
Inc said today that men with erectile dysfunction (ED) who have
been prescribed Viagra (sildenafil citrate) do not have an increased
risk of heart attack or death from ischemic heart disease, according
to results from the first phase of a large-scale, observational
study of Viagra presented at the annual meeting of the American
College of Cardiology (ACC).
The study
of 5,601 men in the United Kingdom found that the risk of these
cardiovascular events for Viagra users were comparable to U.K.
national health data in the general population of men of the same
age. Men in the study were prescribed Viagra in the general practice
setting and their doctors provided responses on all adverse events
an average of five months after the first prescription. Viagra
was effective in 85 percent of patients, according to reports
from physicians who provided an opinion for the study.
"More
than 10 million men have taken Viagra since its approval and this
study provides additional confirmation that Viagra has an excellent
safety profile and is well tolerated in the wide variety of men
who suffer from ED," said Joe Feczko, M.D., Senior Vice President
for Medical and Regulatory Operations for the Pfizer Pharmaceuticals
Group (PPG).
The average
age of men in the study was 57 years (range 18-90); 64 percent
of men studied were between the ages of 50 and 69. In addition,
the study also found there were no cases of heart attack, stroke
or death reported during the first month after treatment was prescribed.
Dr. Saad Shakir,
FACP, FFPM, MRCGP, Director of the Drug Safety Research Unit (DSRU)
at Southampton University, UK, presented the results of the study
at the ACC annual meeting. These results were also published in
the March 16 issue of the British Medical Journal.
Pfizer said
that these findings are consistent with data used to support the
approval of Viagra worldwide. The database of clinical trials
currently includes 36 double-blind placebo-controlled trials,
including 4,500 men taking Viagra and over 3,000 men taking placebo.
These trials involved men of different ages, backgrounds and health
status, including men with pre-existing cardiovascular disease.
Discovered
and developed by Pfizer, Viagra is the breakthrough treatment
for erectile dysfunction that was approved by the U.S. Food and
Drug Administration in March 1998 and by the European Commission
in September 1998. The medicine has since been approved by regulatory
authorities in over 100 countries around the world. Viagra is
a widely prescribed medication, with over 25 million prescriptions
written for over 10 million men. More than 300 million tablets
have been dispensed worldwide.
Viagra is
a prescription medication and should always be used in accordance
with its approved labeling. Viagra is contraindicated in patients
who use nitrates in any form at any time. Viagra should be prescribed
with caution in patients with recent serious cardiovascular events,
strokes, or uncontrolled hypotension or hypertension. As with
all ED treatments, a patient's cardiovascular status should be
evaluated before beginning treatment. The most common side effects
of Viagra are headaches, facial flushing and indigestion.
The DSRU is
an independent academic unit at Southampton University that conducts
observational cohort studies (called Prescription Event Monitoring
studies) on many new drugs when they first become available by
prescription in the United Kingdom. The DRSU receives charitable
funds from many pharmaceutical companies including Pfizer to fund
its independent research efforts.
Pfizer Inc
discovers, develops, manufactures and markets leading prescription
medicines, for humans and animals, and many of the world's best
known consumer products. Pfizer had global revenues of $29.6 billion
in 2000. Pfizer plans to make a research and development investment
of about $5 billion in 2001.
back
to the top of the page
Erectile Dysfunction
Patients Remain Satisfied With Viagra After Two Years, New Study
Shows
PR Newswire
May 4, 1999
Long-term
Analysis Demonstrates Consistency With Safety Experience in Clinical
Trials
'DALLAS, May
4 /PRNewswire/ -- An overwhelming majority of patients taking
Pfizer Inc's (NYSE: PFE) Viagra (sildenafil citrate) said they
remained satisfied with the erectile dysfunction medication after
two years, according to data presented here today at the annual
meeting of the American Urological Association.
In a two-year
study involving 401 patients, participants were asked every three
months whether they were satisfied with the effect Viagra had
on their erections. After two years of treatment, 93 percent of
patients taking Viagra reported they remained satisfied with the
medicine.
The average
age of the men who participated in the study was 55, and each
had suffered from ED for an average of 4.5 years. Further, 16
percent of patients in the study also suffered from hypertension,
8 percent suffered from depression, 5 percent were diagnosed with
ischemic heart disease and 4 percent had diabetes.
Patients took
either 25 mg, 50 mg or 100 mg of Viagra about an hour before sexual
activity. The most common treatment-related side effects were
flushing, headache and nasal congestion.
Separately,
data from the longest-term safety analysis of Viagra showed that
Viagra remained a safe and well-tolerated treatment option for
men with ED. The incidence of all myocardial infarctions -- or
heart attacks -- was tracked in more than 6,500 patients who participated
in 43 placebo-controlled clinical trials.
The incidence
of myocardial infarction was O.84 per 100 patient years for men
receiving Viagra and 1.05 per 100 patient years among those receiving
placebo. There is no statistically significant difference between
these figures.
"These
data reaffirm the safety profile of Viagra and demonstrate how
well it is accepted by men who suffer from this common and distressing
condition," said Dr. Mike Sweeney, Medical Director for Viagra.
"These new data are consistent with the data Pfizer presented
to regulatory authorities in both the United States and Europe
to secure Viagra's approval last year."
Viagra is
contraindicated in patients who use nitrates in any form, at any
time, and should always be used in accord with the FDA-approved
labeling. Viagra has been shown to result in small, transient
decreases in blood pressure.
ED is a serious
medical condition that affects an estimated 30 million American
men and their partners. It is frequently linked to serious underlying
conditions such as depression, hypertension, diabetes and other
cardiovascular diseases.
Since its
approval by the U.S. Food and Drug Administration on March 27,
1998, more than nine million Viagra prescriptions have been written
in the United States alone, and the medicine has been taken by
more than 4.5 million American patients. Viagra currently is available
in more than 60 countries.
The Pfizer-sponsored
study was headed by Dr. Geoff Hackett of St. Chads Health Centre
in Lichfield, Staffordshire, and Dr. Clive Gingell of Southmead
Hospital in Westbury on Trym, Bristol, both in the United Kingdom.
Pfizer Inc
is a research-based global pharmaceutical company that discovers,
develops, manufactures and markets innovative medicines for humans
and animals. The company reported revenues of more than $13.5
billion in 1998 and expects to spend about $2.8 billion on research
and development this year. In 1999, Pfizer celebrates its 150th
anniversary.
back to the top of the
page
Using Viagra
American Family Physician
Sept 15, 1999
What is Viagra?
Viagra is
the brand name for sildenafil. It's a medicine that helps men
with erectile dysfunction have sex again.
What is erectile
dysfunction?
Erectile dysfunction
is the inability of the penis to become rigid, or to stay rigid
long enough to complete the sex act.
How should
I take Viagra?
Take one tablet
one hour before you plan to have sex. Don't take more than one
tablet in 24 hours. The medicine comes in tablets of 25 mg, 50
mg and 100 mg. Most patients start with 50 mg.
Even if you
take Viagra, you still need physical and mental stimulation and
desire to have an erection. If your first dose of Viagra doesn't
help, call your doctor. Your doctor may want to change your tablet
size.
What are the
side effects of Viagra?
Viagra has
some common side effects:
- Headache
- Flushing
(face and upper body turning red and warm)
- Stomach
upset
- Runny nose
(sniffles)
- Vision
changes (things look blue)
Headache is
the most common side effect. Vision changes are the least common.
Talk to your doctor if you have any side effect that bothers you.
Can everyone
use Viagra?
You shouldn't
use Viagra if you take any of these forms of nitroglycerin or
any other nitrates:
- Isosorbide
mononitrate (brand names: Ismo, Monoket, Imdur)
- Isosorbide
dinitrate (brand names: Isordil, Sorbitrate)
- Sublingual
nitroglycerin tablets or spray (brand names: Nitrostat, Nitrolingual
Spray)
- Transdermal
nitroglycerin patches or paste (brand names: Minitran, Nitro-Dur,
Transderm-Nitro TTS)
If you use
Viagra and get chest pains, be sure to tell the paramedics, nurses
or doctors at the hospital how long ago it was that you last took
Viagra.
back
to the top of the page
Viagra
Tale: How One Man Sought an Impotence Cure - and Found One
U.S. News & World Report
Comarow, Avery
May 4, 1998
How one man
sought an impotence cure--and found one
This is a
report from Viagra's front lines. It is from a married man in
his early 50s--a friend of this writer who has tried out Pfizer's
new impotence drug. Call him X; he does not want his name used.
And call him grateful; Viagra worked for him. Is it a wonder drug?
The 75,000 prescriptions written for Viagra in the first two weeks
after it came to market in late March suggest that many hope it
could be--and the potential market numbers as many as 30 million
American men, a significant share in their 40s or even younger.
Mechanically,
an erection must accomplish two goals. Blood must flow vigorously
into three parts of the penis stuffed with erectile tissue that
absorbs the blood like a sponge. And the muscles in the penis
and the valves in the veins leading away must keep the blood from
leaking out. When a patient complains about impotence, a physician
first looks for a history of diabetes or cardiovascular problems,
because the circulation disorders that often accompany these conditions
can interfere with an erection.
Candor difficulties.
X, who has been married about 30 years, began experiencing erectile
dysfunction--now the preferred medical term for impotence--about
four years ago. He could achieve an erection but could sustain
it less and less often. Seeking medical advice didn't help. During
a physical exam, the internist posed his usual inquiry about personal
problems. "I said something like, 'Well, I've been having
some sexual difficulties,' " says X. "He looked at me
and made a note but didn't ask anything else, and I just dropped
it. I got the impression that he really didn't want to discuss
it, and I was self-conscious enough as it was. "This conversation
echoed an assertion by the National Institutes of Health, in a
1992 report on impotence, that "embarrassment of patients
and the reluctance of both patients and health care providers
to discuss sexual matters candidly contribute to underdiagnosis."
The physician
and patient had similar nonconversations over the next couple
of years. Meanwhile, X's ability to perform slipped from occasional
to rare and, then, inexorably, never. X's relationship with his
wife slowly chilled. "I felt as if we were work colleagues,"
says X. "We'd go places, we'd get done what we had to do
around the house, but there was this huge, dark subject we wouldn't
discuss."
Last February,
X mustered the nerve to push his doctor. That won a referral to
a urologist. Once the specialist learned of X's history of heart
disease, he didn't bother with a physical examination. Nor did
he think X needed specialized tests. "I am 99 percent certain
that you've got a circulation problem," he informed X.
The doctor
said X could try mechanical contrivances like a vacuum cuff or
pump. Or he could have bendable rods surgically implanted. Or,
using a small, fine needle, he could inject alprostadil, a drug
that mimics a natural substance produced during sexual arousal,
into the penis, to encourage blood flow. X did not care for any
of these options.
Priapism warnings.
His reaction was slightly less negative to the urologist's final
proposal: a tiny alprostadil suppository placed about an inch
into the opening of the penis with the aid of a special insertion
device. Made by Vivus and called the MUSE system, it produces
an erection 60 to 70 percent of the time, and X thought it seemed
somewhat less onerous than the other methods.
Yet many men
who try MUSE abandon it because of insertion discomfort; nearly
one third did so in one large study. The urologist also warned
of a small but real danger of priapism--a painful, ongoing erection
that threatens permanent damage and must be treated at an emergency
room. Too, the timing discourages spontaneity. The drug works
five to 10 minutes after it is administered, during which time
sitting, standing, or walking around is recommended to stimulate
blood flow. And languid dallying is out; the effect wears off
after 30 to 60 minutes.
"There's
a pill coming out in six months, maybe less," the urologist
told X. "Take the MUSE brochure. Look it over. See what you
think. Maybe the thing to do is to wait for the pill. It's called
Viagra."
The $209 visit
did warm up the atmosphere at home. Armed with the MUSE brochure,
X was inspired to reveal to his wife that he had been seeking
help. "She was touched," he says. "She thought
I had stopped caring at all." While put off by the fussy
MUSE procedure, she was willing to go along. But X was due for
a follow-up talk with his internist. The couple put off the MUSE
decision until then.
The internist,
his interest now piqued, disagreed with the urologist. X's circulation
was fine, he said. As X lay on the examining table, the internist
pressed X's fingers to the femoral arteries in his groin. "A
strong pulse, right?" The blood vessels to the penis branch
off the femoral arteries, and good femoral circulation argues
against poor blood flow to the penis.
The internist ordered up a testosterone blood test, and the results
made him smile with satisfaction; the number was extremely low.
A depressed level of the male sex hormone, pumped out by the testes
under the control of the pituitary gland in the brain, does not
automatically produce erectile dysfunction--men with low testosterone
can have normal sexual function--but it might explain X's problem.
X met with
an endocrinologist in early April, and left, for the first time,
with hope. The hormone specialist took a detailed history, including
a list of all of the medications X was taking. He examined X thoroughly,
including a rectal check of the prostate gland. He was nonjudgmental,
empathetic, and eager to answer X's questions.
Moreover,
he was flexible. X's testosterone, he said, could be boosted either
by injecting the hormone once every week or two or with a testosterone
skin patch. But the shots would require frequent visits, or X
or his wife would have to learn to give them.
X was aware
that Viagra had come on the market the week before. Would it make
sense to try the new drug before turning to supplementary testosterone?
Sure, replied the endocrinologist, writing a prescription for
10 pills and asking X to report back. The most excruciating moment
of his four-year ordeal, says X, was when he approached the pharmacy
counter to pick up his prescription. The clerks at the pharmacy
have a habit of repeating the name of the medication aloud to
prevent mistakes. This time it didn't happen. X was grateful.
The night
X and his wife put Viagra to the test taught them that the drug
is not an aphrodisiac. It aids an erection but does not cause
one. As is true in the absence of Viagra, stress or nerves play
havoc with sexual response, the couple found. A more relaxed attitude
allowed Viagra to do its work. The phone call to the endocrinologist
would be effusive.
Viagra facts.
U.S. News health writer Mary Brophy Marcus looked into these common
questions about Viagra:
How does Viagra
work?
It enhances
the effect of nitric oxide. This chemical is released into the
penis during sexual arousal and relaxes the organ's smooth muscle
tissue so that blood flows in, producing an erection.
Will Viagra
help me?
The success
rate is about 70 percent. Problem candidates usually have conditions
like poorly managed diabetes, blocked arteries, or long-standing
high blood pressure.
Do I have
to see a doctor?
Don't trust
any doctor willing to prescribe Viagra by phone who isn't very
familiar with your health and sexual history, and don't get a
prescription off the Internet. Erectile dysfunction can signal
illnesses such as diabetes, heart disease, and certain prostate
conditions. Your regular physician or a urologist will get a full
medical and sexual history, do a physical exam, and test your
blood and urine.
How quickly
does Viagra take effect?
It can take
as long as an hour, but some men see results in 20 minutes. Most
doctors start their patients on 50 milligrams of Viagra but may
later alter the dose up to 100 milligrams or down to 25 milligrams.
It may take four or five experiences using Viagra before you learn
the dosage and timing that are best.
How long does
the effect last?
Four to six
hours, or until orgasm.
How often
can I take it?
The approved
dosage is no more than one pill a day. "I know some of my
patients, couples who are high-powered Washington types, who when
they finally get away for a weekend together and want to have
some fun are probably going to take one in the morning and one
at night. That most likely will not cause a problem," says
a Washington urologist. It might increase the possibility of side
effects, which occur in up to 10 percent of men.
What kinds
of side effects?
Mild, temporary
reactions such as flushed skin, headaches, upset stomach, and
blue-tinted vision. (Or a pregnancy.
Viagra shouldn't
be taken along with nitroglycerin because of blood pressure concerns.
Is Viagra
good for women, too?
Jennifer Berman,
a urologist at the University of Maryland Medical Center in Baltimore,
believes there may be as many "impotent women" as men--women
who do not enjoy sex because of poor lubrication and other physiological
factors--and thinks Viagra could help. This summer Berman will
help conduct a study in Boston. Preliminary results should be
out within a year. Currently, Viagra is not recommended for women.
back
to the top of the page
Save
Money On Prescription Medications
Consumer Reports May 2001
How much can
you save? Consumer Reports on Health, a sister publication, recently
sampled retail prices at six independent, chain, and mass-merchandiser
pharmacies in the Washington, D.C., area for two top-selling medications:
atorvastatin (Lipitor) and quinapril (Accupril), used to reduce
cholesterol and blood pressure, respectively. The potential saving
for quinapril was $105 per year; for atorvastatin, $120.
Not all companies
will match the best price you find. CVS stores wouldn't even match
cheaper drug prices we found on the company's own web site.
When you shop
for renewable prescriptions and non-rush orders, get prices from
a variety of retailers, including independent pharmacies and pharmacies
at supermarkets and mass-merchandise stores such as Costco Wholesale.
When you call, be prepared with the name of the medication, the
pill count, and the strength in milligrams (mg.).
But that's
not the only way to save.
Once a year,
bring all your drugs and nutritional supplements to your pharmacist
and physician so they can suggest any less expensive alternatives.
Sometimes inexpensive versions--including generics or older, well-established
drugs--work as well as newer, higher-priced drugs. The doctor's
review should focus first on whether you still need all your medications.
It's not unusual for a person to start taking a drug such as a
tranquilizer for a specific symptom and to keep taking it even
when it's no longer necessary.
Ask your doctor
for free samples, especially if you need a one-time supply of
a drug for, say, a bacterial infection. But avoid samples for
chronic conditions if it means continuing on a costly new drug
when cheaper, effective alternatives are available.
You can sometimes
cut costs by asking your doctor to prescribe a drug at double
dose so you can divide the tablets at home with a pill splitter.
For instance, both the 10-mg. and 20-mg. pills of lisinopril (Prinivil)
for high blood pressure cost about $27 for a 30-day supply. If
you need only 10 mg., you can buy the 20-mg. version and cut the
pills in half, saving $15 per month. But not all pills can be
split without compromising their effectiveness.
Some consumers
may be eligible for discounted drugs through state or drug-company
programs. Patients can apply through their doctor.
back
to the top of the page
VCU Discovery
Shows that Viagra Protects the Heart.
PR Newswire
August 19, 2002
RICHMOND,
Va. -- A researcher at Virginia Commonwealth University has invented
a new and potentially important use for the male impotence drug,
Viagra -- heart protection.
The discovery
by Dr. Rakesh C. Kukreja, professor of internal medicine and Eric
Lipman Chair in cardiology at VCU's School of Medicine, is reported
in the September issue of the American Journal of Physiology -
Heart and Circulatory Physiology. The journal, published by the
American Physiology Society, is available online at http://ajpheart.physiology.org/
Target Link
"Some
people who are using Viagra may get an unintentional benefit of
protecting the heart," said Dr. Kukreja. "If they develop
a heart problem later, it might not be as bad. These results are
very exciting because of the possibility that one day we may be
able to use Viagra for other cardiovascular diseases, in addition
to erectile dysfunction in men."
Kukreja's
discovery is particularly noteworthy because Viagra generally
is not recommended or prescribed now to men with many types of
heart problems.
Pfizer Inc.
won Federal Drug Administration approval in March 1998 to manufacture
and sell the drug, sildenafil, as an oral treatment for impotence,
which affects millions of men. In the past four years, Pfizer
Inc. has sold enough of the drug, trade named Viagra, to fill
100 million prescriptions for 20 million patients worldwide, making
Viagra one of the world's largest- selling medicines.
Other than
for treating impotence, however, little has been known about additional
beneficial effects of Viagra, although researchers and clinicians
worldwide have been seeking more uses for the medicine. Shortly
after it was released, reports linked Viagra to sudden heart attacks
and hypotension during sex in men who were taking nitroglycerin
for cardiovascular disease, prompting the FDA and Pfizer to amend
prescription labels to warn doctors against prescribing the drug
for impotence in patients with known heart conditions. Kukreja
began looking at Viagra early this year as part of his on-going
research into "preconditioning," which is a way to protect
the heart muscle from serious damage in the future by subjecting
it to very brief periods of deprivation of blood flow and, therefore,
oxygen. Kukreja and his colleagues at VCU's School of Medicine
have been studying preconditioning for 14 years.
Some preconditioning
occurs naturally. For example, research has shown that people
who suffer angina (chest pain) before a heart attack tend to have
fewer complications and deaths resulting from the heart attack
than those who never suffered angina before the heart attack.
At times preconditioning is planned by doctors for its therapeutic
effects. For example, drugs with preconditioning effects can be
given to people with heart disease at risk of having a heart attack.
Donor hearts removed for transplants and hearts undergoing surgery
and placed on cardiopulmonary bypass also can benefit from preconditioning
to protect the heart muscle from injury. (For more information,
see www.americanheart.org
)
"My hypothesis
was that because Viagra causes dilatation of blood vessels and
reduces blood pressure, that such a hypotensive effect might lead
to the release of certain agents, including bradykinin and nitric
oxide, that could trigger signaling in the heart cells, leading
to cardio protection -- similar to what is observed after preconditioning,"
Kukreja said.
Kukreja gave
both oral and intravenous doses of Viagra to adult male New Zealand
white rabbits. In both cases, Viagra reduced the severity of heart
damage in the rabbits. The impact was observed in 30 minutes and
lasted almost 24 hours after administration of the drug.
Kukreja says
more research and extensive clinical trials are needed to understand
the molecular reasons that Viagra appears to protect a healthy
heart against future damage -- research that could take another
2-3 years. But the implications already are exciting to the medical
profession.
"There
could be great clinical significance from these findings,"
said Dr. George Vetrovec, chair of cardiology at VCU's School
of Medicine and world renowned for his research on coronary artery
disease. "Everything you do to protect the heart muscle reduces
the risk of death and improves the outcome for patients with heart
attacks."
Dr. Vetrovec
suggested that Viagra one day might be given before surgery to
patients who are scheduled for angioplasty or coronary bypass.
In addition, he said, it might be given to patients at high, short-term
risk of acute myocardial infarction (heart attack), including
those patients with such risk factors as high cholesterol, low
HDL, hypertension, diabetes or history of smoking.
Kukreja suggested Viagra eventually could be used to protect the
brain, liver and other organs against ischemic injury -- those
injuries that are caused by lack of oxygen.
VCU has applied
for a patent on the use of sildenafil for cardio protection.
About VCU:
Virginia Commonwealth University is ranked by the Carnegie Foundation
as one of the nation's top research universities. Located on two
campuses in Richmond, Va., VCU enrolls 25,000 students in more
than 160 undergraduate, graduate, professional, doctoral and post-graduate
certificate degree programs at 11 schools and one college. Sixteen
graduate and professional programs have been ranked by U.S. News
& World Report as among the best of their kind in the nation.
The VCU School of Medicine, founded in 1838, is one of 125 fully
accredited U.S. medical schools and houses the nation's oldest
transplant program. The VCU Health System is one of the leading
academic medical centers in the country. VCU recently launched
VCU Life Sciences, a comprehensive undergraduate and graduate
program involving academic and medical faculty. In addition, the
university is developing the Virginia Biotechnology Research Park
in collaboration with business, civic and government leaders.
VCU's Office of Technology Transfer received 93 invention disclosures,
filed 61 patents and received licensing revenue of more than $1
million in the fiscal year ended June 30, 2002. For more, see
http://www.vcu.edu
back
to the top of the page
Viagra Exclusion
Allowed. (insurance coverage for medicine Viagra)
Business and Health
Janet Gemignani
Sept, 2001
California's
Department of Corporations lacks authority to reject Kaiser Foundation
Health Plan's request to exclude Viagra from its formulary. In
Kaiser Foundation Health Plan Inc. v. Director, Department of
Managed Care, Judge Lloyd Connelly of the Sacramento Superior
Court held that state law does not require the plan's drug benefit
to cover drugs to treat all medical conditions. The Knox-Keene
Health Care Service Plan Act spells out four classes of drugs
plans must cover by law, but Viagra is not among them.
Beverly Hayon,
Kaiser's director of national media relations, told B&H the
plan still abides by a previous ruling requiring it to cover Viagra
but is completing the "bureaucratic process" to exclude
it. It was unclear, at the time of this writing, whether the state
would appeal.
Kaiser's 1998 request to exclude Viagra was based on a cost-benefit
analysis complaining of the difficulty in distinguishing patients
using Viagra as a medical necessity from those who want it for
sexual enhancement. The plan estimated that its coverage of 10
Viagra pills per month would cost at least $100 million per year,
eclipsing the $59 million Kaiser Permanente spent in 1997 for
all antiviral drugs, including protease inhibitors for treatment
of HIV.
Hayon says
Kaiser's Viagra costs actually "ended up being lower"
but wouldn't give specifics. When asked whether the California
Kaiser, which by state law must cover contraceptives, considered
gender equity when considering Viagra coverage, Hayon responded,
"When we went through the exclude process, we didn't consider
a male having an erection in the same category as a woman trying
to avoid a pregnancy.
back
to the top of the page
Viagra Wins
Medical Innovation Award
PR Newswire
Nov 22, 2000
Viagra (sildenafil
citrate), developed and marketed by Pfizer, for the treatment
of male erectile dysfunction (ED), was named last night as joint
winner of the Prix Galien 2000 medical award for scientific excellence
and innovation. The award was presented in London by Professor
Sir Michael Rawlins, Chair of the National Institute For Clinical
Excellence.
Dr Donna McVey,
Medical Director for Pfizer Limited said: ``Viagra has revolutionised
the treatment of erectile dysfunction and brought the subject
into the open, making it easier for patients to seek help. As
the first licensed oral treatment for ED, Viagra has increased
understanding amongst doctors as well as the public that ED has
a significant health impact both for the sufferer and for the
partner. It is very often associated with chronic underlying illnesses,
such as cardiovascular disease, diabetes and depression. Erection
problems affect an estimated 10 per cent of the male population
- that's over 2 million men in the UK. In many cases, the couple
finds it difficult to discuss sexual problems and many men report
that their erection problems contributed to the break up of their
relationship.''
Presenting
the award, Professor Rawlins said: ``This drug has become a household
name. The fact that it has launched a thousand jokes should not
distract us from its significant benefits; quite apart from being
an effective treatment, it has brought men's health in general,
and impotence in particular, out of the closet. It is innovative,
well tolerated, and provides treatment where existing therapies
have been shown to be suboptimal.''
Prior to the
availability of Viagra, erectile dysfunction was treated mainly
by hospital doctors because of the invasive nature of treatments
available at that time, such as injections, and the limited experience
of GPs in this area of medicine. The introduction of Viagra and
better training for healthcare professionals during the past two
years means that GPs are now more confident and able to treat
ED.
``We are delighted
that this award recognizes Pfizer's pioneering discovery of the
role of PDE5 inhibitors in the treatment of ED,'' commented Dr
Gill Samuels, Senior Director of Science Policy and Scientific
Affairs at Pfizer in Sandwich. ``The research programme that produced
Viagra dates back to 1985,'' continued Dr Samuels, ``and is a
remarkable story of innovation, teamwork and commitment. Each
compound that reaches the market represents an investment of approximately
#300 million in research and development, and takes between ten
and fifteen years from the start of a project to regulatory approval
for use. In addition, in the case of Viagra very few people outside
the company even thought it possible to develop an oral treatment
for ED.''
``The onset
of ED can be an early indicator of other diseases, such as high
blood pressure, heart disease or diabetes,'' commented Dr McVey.
``Men with ED should be encouraged to go to their GP for help,
not only to discuss possible treatment for their ED, but for a
full men's health check-up. More effective management of ED can
help us meet goals for improving other areas of health, such as
preventing cardiovascular disease or managing the complications
of diabetes.''
The Prix Galien
was launched in France in 1970 by the French pharmacist Roland
Mehl. The aim of the award was, and remains, to promote and encourage
research into therapies which will make a lasting contribution
to patient care. The Prix Galien is recognised within the pharmaceutical
industry as the gold standard award for Innovation in the development
of new medicines.
Notes to Editors
1. The discovery
of Viagra resulted from a research programme led by the Pfizer
team from the European Research Centre, Sandwich, Kent. An extensive
clinical trials programme investigated the role of selectively
inhibiting the enzyme phosphodiesterase type 5 (PDE5) on which
Viagra acts, to enhance the natural mechanism of penile erection.
During sexual stimulation, Viagra relaxes the blood vessels in
the penis, allowing blood to flow into the penis to make it expand
and harden - thereby producing an erection.
2. Viagra
has been evaluated for its efficacy in the treatment of ED of
mixed causes, in more than 4400 men worldwide, aged 19-87 years.
These trials demonstrated that Viagra improved erections for up
to 84% of patients compared with 10-30% of patients receiving
placebo. The most commonly reported adverse events were headache,
flushing, dyspepsia and nasal congestion, although these were
generally mild and transient in nature.
3. Viagra
was first approved for use in the United States in March 1998,
and in the European Union in September 1998. The medicine has
since been approved by regulatory authorities in over 100 countries
around the world. Since Viagra has been available, over 25 million
prescriptions have been written for over 10 million men worldwide,
and more than 300 million tablets have been dispensed.
4. Wyeth were
the joint winners, with Pfizer, of the Prix Galien 2000 award
for their vaccine, Meningitec. For further details, please contact
Don Barrett, Corporate Affairs Director, on 01628 604377.
back
to the top of the page
All Hail the
Viagra Generation
USA Today (magazine)
Sept, 2000
There is a
new generation of children who probably would not exist without
pharmaceuticals like Viagra, maintains Ken Gronbach, CEO and president
of KGA Advertising, Middletown, Conn. "We call these children
`The Viagra Generation,' and we project that their impact will
be significant. Not since the return of GIs after World War II
has this country seen such an important artificially created trend."
He defines
the Viagra Generation as "a group of babies who would not
have been anticipated were it not for an artificially created
increase in procreative activity from the use of pharmaceuticals.
Without drugs like Viagra, I think it's safe to say that these
children simply would not have been fathered. So, instead of seeing
the naturally occurring end of Generation Y, which peaked in 1990,
we are seeing it continue. We've done the math and we expect Viagra-type
drugs to make a significant contribution to our population."
Gronbach bases
his conclusions on an assortment of figures: One-third of the
male population is in its procreative years. In the U.S., that
amounts to 46,000,000 males. A conservative estimate is that there
are 5,000,000 prescriptions per month written for Viagra alone.
At six pills per month (the amount allowed by insurance companies),
that equals 30,000,000 procreative acts. The average chance for
a normally fertile couple having unprotected intercourse to conceive
is around 25% during each menstrual cycle, according to the Worldwide
Fertility Network. "Let's take a conservative view and say
that only 10% of those acts result in a child," Gronbach
indicates. That means, potentially, an additional 3,000,000 conceptions.
By way of comparison, at the height of Generation Y, just over
4,000,000 babies were born. "There's no way [such] a population
increase could not have an impact on everyone from city planners
to mini-van manufacturers."
What does
this mean for businesses? "Right now, we're seeing the tail
of the comet. It's going to take awhile for this trend to become
visible to marketers. But we can expect Gen Y to be the largest
generation in the history of the U.S. Bigger than the baby boomers.
These kids will have enormous spending power, because those using
Viagra tend to be in the upper 10% of the socioeconomic segment
of our population. It will effect everything from ailing hospitals
... to stroller manufacturers. Look for an uptick in sales of
baby products and clothes, mini-vans, infant furniture, and toys.
If I were [the toy company] Mattel, I'd be buying stock in the
pharmaceutical company that makes Viagra."
back
to the top of the page
Erectile Dysfunction
Patients Remain Satisfied With Viagra After Two Years, New Study
Shows
PR Newswire
May 4, 1999
Long-term
Analysis Demonstrates Consistency With Safety Experience in Clinical
Trials
DALLAS, May
4 /PRNewswire/ -- An overwhelming majority of patients taking
Pfizer Inc's (NYSE: PFE) Viagra (sildenafil citrate) said they
remained satisfied with the erectile dysfunction medication after
two years, according to data presented here today at the annual
meeting of the American Urological Association.
In a two-year
study involving 401 patients, participants were asked every three
months whether they were satisfied with the effect Viagra had
on their erections. After two years of treatment, 93 percent of
patients taking Viagra reported they remained satisfied with the
medicine.
The average
age of the men who participated in the study was 55, and each
had suffered from ED for an average of 4.5 years. Further, 16
percent of patients in the study also suffered from hypertension,
8 percent suffered from depression, 5 percent were diagnosed with
ischemic heart disease and 4 percent had diabetes.
Patients took
either 25 mg, 50 mg or 100 mg of Viagra about an hour before sexual
activity. The most common treatment-related side effects were
flushing, headache and nasal congestion.
Separately,
data from the longest-term safety analysis of Viagra showed that
Viagra remained a safe and well-tolerated treatment option for
men with ED. The incidence of all myocardial infarctions -- or
heart attacks -- was tracked in more than 6,500 patients who participated
in 43 placebo-controlled clinical trials.
The incidence
of myocardial infarction was O.84 per 100 patient years for men
receiving Viagra and 1.05 per 100 patient years among those receiving
placebo. There is no statistically significant difference between
these figures.
"These
data reaffirm the safety profile of Viagra and demonstrate how
well it is accepted by men who suffer from this common and distressing
condition," said Dr. Mike Sweeney, Medical Director for Viagra.
"These
new data are consistent with the data Pfizer presented to regulatory
authorities in both the United States and Europe to secure Viagra's
approval last year."
Viagra is
contraindicated in patients who use nitrates in any form, at any
time, and should always be used in accord with the FDA-approved
labeling. Viagra has been shown to result in small, transient
decreases in blood pressure.
ED is a serious
medical condition that affects an estimated 30 million American
men and their partners. It is frequently linked to serious underlying
conditions such as depression, hypertension, diabetes and other
cardiovascular diseases.
Since its
approval by the U.S. Food and Drug Administration on March 27,
1998, more than nine million Viagra prescriptions have been written
in the United States alone, and the medicine has been taken by
more than 4.5 million American patients. Viagra currently is available
in more than 60 countries.
The Pfizer-sponsored
study was headed by Dr. Geoff Hackett of St. Chads Health Centre
in Lichfield, Staffordshire, and Dr. Clive Gingell of Southmead
Hospital in Westbury on Trym, Bristol, both in the United Kingdom.
Pfizer Inc
is a research-based global pharmaceutical company that discovers,
develops, manufactures and markets innovative medicines for humans
and animals. The company reported revenues of more than $13.5
billion in 1998 and expects to spend about $2.8 billion on research
and development this year. In 1999, Pfizer celebrates its 150th
anniversary.
back
to the top of the page
New Study of
Viagra in General Medical Practice Confirms Safety Profile Established
by Clinical Trials.
PR Newswire
Oct 9, 2000
Pfizer Inc
said today results from the first stage of a large-scale, post-marketing
study of Viagra (sildenafil citrate) in men with erectile dysfunction
(ED) confirm the safety profile established by the extensive clinical
trials program.
The independently-conducted
observational study of 5,391 men in the UK found no evidence of
increased risk of heart attack or death from ischemic heart disease.
The data were comparable to UK national health data of the general
population of men of the same age. Men in the study had been prescribed
Viagra in the general practice setting and had been taking the
medicine for an average of five months. Among physicians who provided
an opinion on effectiveness, Viagra was reported to be effective
in 85 percent of patients. The study did not identify any safety
issues.
"With
availability of Viagra now having passed the two-year mark, this
study provides important confirmation that Viagra has an excellent
safety profile and is well tolerated in the wide variety of men
who suffer from ED," said Joe Feczko, M.D., Senior Vice President
for Medical and Regulatory Operations for the Pfizer Pharmaceuticals
Group (PPG).
Among the
men taking Viagra in the study, the combined incidence of fatal
and non-fatal heart attacks was 7.2 per 1000 person-years and
incidence of mortality due to ischemic heart disease was 3.2 per
1000 person-years. The mean age of men in the study was 57 years
(range 18-89); sixty four percent of men studied were between
the ages of 50 and 69. The study found that when compared to UK
national health data, the incidence of these findings were similar
to that occurring in the general population of men of the same
age. In addition, the study also found there were no cases of
heart attack, stroke or death reported during the first month
after treatment was prescribed.
"Our
interim results are reassuring and did not produce any surprises,"
said Saad Shakir, FACP, FFPM, MRCGP, Director of the Drug Safety
Research Unit (DSRU) at Southampton University, UK, who recently
presented the interim results of the study at the annual meeting
of the European Society of Pharmacovigilance, in Verona, Italy.
Pfizer said
that these findings are consistent with data used to support the
approval of Viagra worldwide. The database of clinical trials
currently includes 36 double-blind placebo-controlled trials,
including 4,500 men taking Viagra and over 3,000 men taking placebo.
These trials involved men of different ages, backgrounds and health
status, including men with pre-existing cardiovascular disease.
Discovered
and developed by Pfizer, Viagra is the breakthrough treatment
for erectile dysfunction that was approved by the U.S. Food and
Drug Administration in March 1998 and by the European Commission
in September 1998. The medicine has since been approved by regulatory
authorities in over 100 countries around the world. Viagra is
among the most widely prescribed medications, with over 25 million
prescriptions written for over 10 million men. More than 300 million
tablets have been dispensed worldwide.
Viagra is
a prescription medication available only from doctors and should
always be used in accordance with its approved labeling. Viagra
is contraindicated in patients who use nitrates. The most common
side effects of Viagra are headaches, facial flushing and indigestion.
The DSRU is
an independent organization that conducts safety studies (called
prescription event monitoring studies) on many new drugs when
they first become available by prescription in the United Kingdom.
The DRSU receives charitable funds from many pharmaceutical companies
including Pfizer to fund its independent research efforts.
Pfizer Inc,
discovers, develops, manufactures and markets leading prescription
medicines, for humans and animals, as well as many of the world's
best known over-the-counter brands. This year, Pfizer expects
global sales of more than $30 billion and has a research and development
budget of $4.7 billion.
back
to the top of the page
Viagra Makes
Flowers Stand up Straight
British Medical Journal
Judy Siegel-Itzkovich
July 31, 1999
Viagra (sildenafil
citrate) is good not only for treating male impotence. Israeli
and Australian researchers have discovered that small concentrations
of the drug dissolved in a vase of water can also double the shelf
life of cut flowers, making them stand up straight for as long
as a week beyond their natural life span.
They have
already tested Viagra on strawberries, legumes, roses, carnations,
broccoli, and other perishables. In this latest research they
found that 1 mg of the drug (compared with 50 mg in one pill taken
by impotent men) in a solution was enough to prevent two vases
of cut flowers from wilting for as much as a week longer than
might be expected.
Professor
Yaacov Leshem, a plant researcher at Bar-Ilan University in Ramat
Gan, Israel, and Professor Ron Wills of the food technology department
of the University of Newcastle, Australia, also patented a safe,
cheap process for increasing the shelf life of fruit, vegetables,
and cut flowers using nitric oxide. The produce and cut flowers
were fumigated with the colourless, odourless gas, an environmental
pollutant that in minute quantifies acts as the body's most important
signalling molecule.
The results
of the applied research on nitric oxide were first fully reported
in late 1998 in Plant Physiology and Biochemistry (1998;36:825-33)
and have since been the topic of discussion at international conferences
of the food storage and packaging industry. Professor Leshem will
present his discovery at the opening plenary session of the September
1999 international conference on flesh cut produce in England.
An unexpected
finding of Professor Leshem's group is that Viagra has a similar
effect on plant ripening as it does on men's sexual organs. Viagra
increases the vase life of flowers by retarding the breakdown
of cyclic guanosine monophosphate (cGMP) (the production of which
is mediated by nitric oxide).
Both chemicals
could provide the food industry with entirely new, dramatically
improved processes for preserving agricultural produce, Professor
Leshem said.
"Nitric
oxide is practically free and plentiful, with no identifiable
side effects at the very low concentrations we used," he
added. "Right now, Viagra costs much more but does have certain
advantages over nitric oxide-for example, it's easier to use in
cut flowers.
"It is
now up to industry to develop the engineering methods for large
scale, pretreatment of produce based on our discoveries."
back
to the top of the page
A MAN AGAIN
': Experts Praise a Pill that Treats Impotence (the use of the
Viagra, an impotence drug)
Maclean Hunter (Canada)
In December,
1994, Lorne had just turned 40 and life was good. Married, he
had two young children, a house near Vancouver and a job he enjoyed.
Then disaster struck: as he changed a tire on his car beside a
roadway, another automobile hit him. Though Lorne can walk and
is about to go back to work, the accident damaged spinal nerves
and left him with enduring problems, including numbness in some
parts of his body and distressing limits on his sex life due to
difficulties having and maintaining erections. "It was depressing,"
he recalls, "when my wife was in the mood for sex and I just
wasn't interested." Doctors suggested remedies involving
pumps and injections, but Lorne was not interested in them. Then,
he had the opportunity to take part in clinical trials for a new
drug called Viagra that is designed to deal with problems like
his. In December, 1996, Lorne began popping a sky-blue tablet
whenever sex was in the offing. Once again, his life was transformed.
"Sex is as good as it used to be-maybe even a little better,"
he says. "This medication is just fantastic."
Thousands
of American men appear to agree. Since Viagra was approved for
sale in the United States early in April, demand has soared to
the point that physicians are scribbling an estimated 40,000 prescriptions
a day. Manufactured by New York City-based Pfizer Inc., Viagra-which
