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


To: BigKNY3 who wrote (5574)9/16/1998 5:47:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 9523
 
Viagra on sale in Ulster for œ15 a pill - Black market grows for wonder drug
Wednesday September 16

By Nigel Gould.

VIAGRA is set to become one of the most popular drugs ever in Northern Ireland, a top consultant claimed today.

And already the new love wonder pill is spicing up the lives of many couples across the province - despite an NHS ban because it's too expensive.

It is understood men are buying the drug through the internet or on the black market - at up to œ15 a pill.

The Department of Health has also confirmed that the anti-impotence drug can be obtained privately from local GPs who cross refer patients not on their NHS lists.

Dr Wallace Dinsmore, principal consultant of the impotence department at the Royal Victoria Hospital in Belfast, branded Viagra as "one of the most important drug developments since the discovery of antibiotics." Dr Dinsmore, who has a number of patients on Viagra, said: "Any registered medical practitioner can supply it to patients on a named basis but they must be familiar with side affects.

"Very few doctors, however, are prepared to." But Dr Dinsmore, one of the first medical experts in the world to test the drug, said there were dangers if not properly controlled.

"It can be extremely dangerous if it falls into the wrong hands - if mixed with nitrates - poppers - for example," he said.

And he revealed that hospital accident and emergency units were now obliged to ask patients, particularly those brought in with chest pains, if they were using Viagra.

Viagra is the first oral pill for male impotency which effects more than one in 10 Ulster men.

Estimates on how much the drug will cost the NHS range from œ50m to œ1 billion a year.

The Government's total drugs bill is about œ5.5 billion a year.

Viagra might end up costing the Government even more than drugs for life threatening diseases such as heart conditions and cancer.

It has also emerged that under a loophole, GPs can cross-refer sufferers on their NHS list to other GPs in the same practice privately if they are willing to pay for the pill.

But this was condemned by the chiarman of the Men's Health Forum, Dr Ian Banks.

"I don't think it is in the best interests of the patients to be cross-referred to a doctor not familiar with their case history.

"It's discourteous but I suspect it's something which will not happen for long." Plans to make Viagra available for free next week to medical card holders south of the border are also currently being considered by Irish Health Minister Brian Cowen.

A working party report has claimed the drug, which was licensed for prescription in the Republic yesterday, could end up costing the Irish Government between IRœ7m and IRœ20m if it is offered for free.

The first supplies of the drug are expected to be available in some parts of the Republic by the middle of next week.

c Copyright Belfast Telegraph Newspapers Ltd. .

yahoo.co.uk



To: BigKNY3 who wrote (5574)9/17/1998 11:33:00 AM
From: Anthony Wong  Read Replies (1) | Respond to of 9523
 
EU Health Systems Plan to Limit Viagra Coverage

By Anne Swardson
Washington Post Foreign Service
Thursday, September 17, 1998; Page A27

PARIS, Sept. 16-The governments of Europe, where the impotence
drug Viagra was approved by the European Union on Tuesday, are
worried their taxpayer-financed national health systems will be drained by
a flood of new patients eager for the pills.

The arrival of Viagra in the European market of 380 million people has
been eagerly awaited. Le Monde newspaper in France devoted a
front-page article and another full page to it two weeks ago. In
Switzerland, the only European country where the prescription pill is
already available, $1.4 million in Viagra has been sold since it went on the
market in July. That's 20 cents worth for every Swiss citizen, though it is
considered likely that some of the Swiss customers actually are
border-crossing French, Germans and Italians.

Because nearly all EU countries pay for at least some health care with
government money, the expected success of Viagra means more
government spending. In an attempt to curb what is predicted to be
rampant demand, several European governments have said their national
health programs will not reimburse patients for the cost of the drug. But
they cannot stop people from going to the doctor to be treated for
impotence. Those appointments are taxpayer-financed in many countries.

Britain's National Health Service said Monday it will not pay for Viagra
prescriptions for a few weeks while officials sort through the cost and
equity issues. "Media coverage of this drug to date has created
expectations that could prove a serious drain on the funds of the NHS,"
said Frank Dobson, the secretary of state for health.

In France and Italy, where prices are expected to run $8 to $10 per pill,
consumers will not be reimbursed for Viagra purchases, although visits to
the urologist are. In Germany, public and private health plans generally will
not reimburse for Viagra unless a patient is suffering from depression or
another impotence-related illness. "The door is open to the imagination of
the doctors" in finding ways to categorize Viagra treatments, a German
official said.

In Britain as well, officials will look for ways to make Viagra available to
people who have a medical need as opposed to "pleasure and recreational
purposes," said Health Department spokesman Philip Ayledt.


Approval of new drugs in Europe is under the control of the institutions of
the 15-nation EU. So under Tuesday's ruling, countries cannot ban Viagra
from pharmacy shelves. "But who pays for it is up to the member states,"
said European Commission spokesman Jochen Kubosch.

Pfizer Inc., the manufacturer of Viagra, has been careful not to heighten
European expectations. The company's Web site on Viagra says, "The
information provided on this site is intended only for residents of the United
States." But preparations have been made. All of Europe, plus some
countries in Africa, will be supplied by one Pfizer factory in Amboise, a
town in the French Loire Valley. That factory has been producing just for
Switzerland -- which is not a member of the EU and thus can approve new
drugs on its own schedule -- but is ready to gear up for some 30 additional
countries.

"In principle we should be able to satisfy all demand," Pfizer France
spokeswoman Sylvie Cukier said.

c Copyright 1998 The Washington Post Company

washingtonpost.com



To: BigKNY3 who wrote (5574)9/18/1998 5:32:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 9523
 
Verdict out: Viagra is good for Asians too
By Stella O. Gonzales
Philippine Daily Inquirer
September 19, 1998

SINGAPORE-The results are out and the verdict is much the
same as earlier clinical trials conducted on American men:
Viagra is an effective, well-tolerated drug treatment for impotent
Asian men.

Now it's up to Asian governments to decide whether they will
allow the sale of the much-ballyhooed drug in their countries.

A report made yesterday during the 4th Asian Congress on
Urology at the Raffles City Convention Center here said 86
percent of 127 erectile dysfunction patients from the
Philippines, Singapore and Malaysia who participated in the
trial reported improvement in erection after 12 weeks.

A similar test, this time on 130 patients from Hong Kong,
Indonesia and Thailand, reported 81 percent improved
erections.

Viagra, manufactured by Pfizer, has been approved for sale in
Thailand and Australia. Among other countries awaiting
approval from local regulation agencies are Japan and those
who conducted the Asian clinical trials.

It has been estimated that 3.5 million Filipino men are suffering
from erectile dysfunction. In Asia, one in two men over 40 years
old suffer from it and nearly half of the sufferers have a specific
underlying physical cause. The average age of the impotent
Asian man is 46 years.

The worldwide estimate is 100 million impotent men.

The Asian Sildenafil Efficacy and Safety Study (ASSESS) by
Viagra (generic name: Sildenafil) manufacturer Pfizer used 690
patients from the six countries mentioned above plus Taiwan,
where testing is ongoing.

ASSESS

Participants were all Asians, aged 18 years or older, were
clinically diagnosed to have erectile dysfunction, are not
receiving any other treatment for ED, and have a stable
relationship with a female partner.

They were grouped into two--one taking Viagra (not more than
once daily) one hour before sexual intercourse, the other a
placebo. It was a randomized, double-blind test where even the
doctors who gave the medicine did not know who received
Viagra and who got the placebo. The results from the Asian
countries were turned over to Pfizer's central research group in
New York.

ASSESS-1 included the Philippines, Singapore and Malaysia
while ASSESS-2 covered Hong Kong, Indonesia and Thailand.

In the Philippines, 67 patients took placebo and 66 Viagra.
Individual results of the Philippine clinical trial conducted by
Doctors Benjamin Mendoza, Reynaldo de la Cruz, Telesforo
Gana and German Jose Albano are not known. They have been
incorporated into the results of ASSESS-1.

Of the 127 patients in ASSESS-1 who took Viagra, 86 percent
reported improved erections while 33 percent who took placebo
also reported an improvement. Of the 130 patients in ASSESS-2
who took Viagra, 81 percent reported improved erections while
28 percent in the placebo group reported an improvement.

In ASSESS-1, there was a 74-percent success at attempted
sexual intercourse among Viagra users; in ASSESS-2, 68
percent.

Common side effects

There was no reported incident of a heart attack or stroke
among those who took Viagra. One patient receiving Viagra
experienced severe angina pectoris which was not considered
to be related to the treatment. One placebo patient suffered an
accidental injury to the hand. (Clinical trial protocol requires the
reporting of all ailments even if these are not related to the
drug-taking).

In ASSESS-1, the most common side effect among those who
took Viagra was headache (11 percent of active group),
vasodilation (7.9 percent), rhinitis (4.7 percent), mylagia (3.1
percent), visual disturbances (3.1 percent), paresthesia (1.6
percent), and dyspepsia (1.6 percent). Incidentally, even those
in the placebo group reported similar side effects with 7.9
percent reporting headaches, 4.7 percent vasodilation, 1.6
percent rhinitis, and 0.8 percent dyspepsia.

In ASSESS-2, reported side effects are flushing (15 percent),
headache (10 percent), dizziness (7 percent), rhinitis (5 percent)
abnormal vision (5 percent).

Dr. Akmal Taher of the urology division of University of
Indonesia's Faculty of Medicine told the conference that the
results ''are not surprising, considering the extensive clinical
trials already conducted in the US and from experience in other
countries.''

Dato Dr. Tan Hui Meng, consultant urologist at the Subang
Jaya Medical Center in Malaysia, said specialists like him
''welcome any new treatments which will help the many millions
of men who suffer from it.''

The Asian clinical trial was a rare occasion when a multinational
drug company conducted extensive local tests on a drug even if
the US Food and Drug Administration had already approved its
sale.

inquirer.net