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


To: Tunica Albuginea who wrote (3804)6/30/1998 3:30:00 PM
From: VLAD  Read Replies (2) | Respond to of 9523
 
Tuna,

How high do you think the total body count will have to get before Pfizer or the FDA decides to throw in the towel? I am now trying to obtain information on law firms which plan on getting involved in a class action suit against Pfizer for wrongful death. Pfizer's defense will probably sound something like "the FDA said it was OK so why blame us". Last week a pain killing drug was pulled by the FDA because of 2 or 3 suspicious deaths relating to the drugs effect on the liver. I can go on and on regarding drugs which were pulled with much much fewer suspect deaths. In our male dominated society it will take I'd say a total death count of about 100+ before the safety issue takes precedent over getting a better hard on.



To: Tunica Albuginea who wrote (3804)6/30/1998 3:32:00 PM
From: utee  Read Replies (2) | Respond to of 9523
 
Most people on this board wish you would take a PERMANENT VACATION!!!



To: Tunica Albuginea who wrote (3804)7/4/1998 2:38:00 PM
From: Tunica Albuginea  Read Replies (2) | Respond to of 9523
 
The retinal side effects of Viagra according to the Barons article are now up to 10% from the previously published 2% ( I think ) in Phase III Viagra trials.
This is due to people's increasing use of the higher approved dose of 100 mg. At this higher dose, even though Viagra is a selective PDE5 inhibitor,it now becomes non-selective, like every other known phosphodiesterase inhibitor, and starts inhibiting PDE6 in the retina thus causing the blue vision .
In the long term this continued stimulation of the retina can cause premature retinal degeneration and blindness. This may cause a restriction in it's wide spread use even more than the deaths reported so far, although those too are worrisome.

=========================================================

interactive.wsj.com

By Andrew Barry, Barons, July 6, 1998, page MW5

IS VIAGRA STARTING TO FADE?

Following a steady decline in new prescriptions during the past month, there's some concern on Wall Street that Pfizer's widely hyped impotence drug may not prove to be a multibillion-dollar blockbuster. The worries have depressed Pfizer's stock, which has become prisoner to developments surrounding Viagra in recent months.
Pfizer fell 4 7/16 to 107 1/2 last week, and is down from a record 121 3/4 at the time of the drug's launch in late April.
New prescriptions for Viagra peaked at over 278,000 in the week ended May 18 but fell to 151,000 in the week ended June 19, the most recent reporting period, according to IMS America, the Nielsen of the drug business. The weekly "script" data are still extraordinarily high for a new pharmaceutical, and refill prescriptions for Viagra continue to increase.
But given the enormous expectations for the drug and the runup in Pfizer's stock this year, any indication of slowing momentum for Viagra causes some nervousness among investors. Pfizer is up 44% in 1998, 78% in the past year and commands the highest multiple in the drug group, trading at over 50 times projected 1998 profits.
"A lot of people are saying Viagra will do $1 billion in sales this year and eventually hit $5-$10 billion annually. I don't think that will happen," says James Flynn, drug analyst at Furman Selz. Flynn, who recently downgraded Pfizer to Hold from Buy, sees Viagra ringing up $2 billion in annual sales in five years, an impressive level but below the most optimistic projections. Flynn says the recent prescription data show Viagra's U.S. sales running at an annual rate of $700 million.
"If you look at lifestyle drugs, they typically peak about three months after they're launched," he says. The big question regarding Viagra is whether it's just another "lifestyle" drug like diet pills or baldness remedies and thus lacks staying power. Or is Viagra, which already has had the strongest debut of any drug in history, on its way to becoming the biggest-selling prescription drug in history?
Flynn argues that most men who really wanted the product already have it. "Pfizer has probably seen 100% penetration of the easy-to-reach market," he adds. The challenge now for the company will be enticing the millions who might benefit from Viagra but haven't shown an interest in trying it yet. "You've got men who are embarrassed, don't care, or would care more if the drug weren't so expensive." Viagra costs about $10 a dose and isn't covered by many insurance plans.
So far, Pfizer has done a good job addressing safety concerns about the drug, including the deaths of men taking Viagra. But there hasn't been any long-term testing of Viagra. One concern is whether the drug begins to lose its effectiveness over time. Pfizer says there's no evidence of this.
However, Flynn points out that Viagra users are increasingly favoring higher-dose pills. "This suggests people aren't getting the desired effect from the lower dosage," he reasons. Viagra is available in dosages of 25, 50 and 100 milligrams. The 100-milligram pills have risen to 22% of prescriptions from 8% initially. One problem with the stronger pills is that they cause a higher incidence of visual color disturbances, or bluish vision, according to Neil Sweig, an analyst at Southeast Research Partners.
Pfizer downplays the blue-vision side effect, which occurs in about 10% of men taking the 100-milligram pills, saying it's "confident" there are no long-term effects on the vision of those taking the proper dosage. But Sweig, citing the views of many eye doctors, wrote recently that the blue-vision issue could be "serious." He said blue vision appears to be a "unique" side effect of Viagra that isn't present with any disease or other drug and that "some event" is occurring in the retina to trigger the problem. It's too early, he wrote, to determine whether Viagra has no long-term adverse effect on the eyes.

In downgrading Pfizer, Flynn also cited the company's surprise setback recently involving Zeldox, a schizophrenia drug, which got a "non-approval" letter from the Food and Drug Administration. The Street was hoping that Zeldox could become a $500 million product, but now it's unclear whether it will ever come to market.
Flynn also points out that Pfizer has reaped enormous benefits from co-marketing Warner-Lambert's blockbuster cholesterol drug, Lipitor, which could generate $2 billion in sales this year. But the downside for Pfizer is that it must reciprocate and give Warner-Lambert co-marketing rights to one of its new drugs. Flynn says Pfizer might have to give Warner the co-marketing rights to two drugs to make up for its Lipitor windfall, diminishing the value of its own admittedly strong pipeline. Neither Pfizer nor Warner have revealed much about the Lipitor agreement.
While Pfizer fell last week, Warner-Lambert hit a new record, rising 6 1/8 to 73 1/8 . Warner benefited from a recommendation by an analyst at Donaldson Lufkin & Jenrette, solid sales of its diabetes drug Rezulin, and optimism about its marketing agreement with Pfizer. Warner, which has doubled since the Rezulin safety scare last December, now sports a multiple that's nearly as high as Pfizer's. Warner trades at almost 50 times projected 1998 profits and at 40 times estimated 1999 earnings of $1.82.
Christina Heuer, Smith Barney's drug analyst, says investors are overreacting to the Viagra prescription data. "People are missing the big picture. Pfizer has a brilliant outlook and phenomenal earnings momentum." A Viagra bull, Heuer estimates that sales of the drug will hit $2 billion next year and $5 billion worldwide in 2002. Pfizer, she says, will be powered by Viagra, Lipitor and Celebra, the first of a new class of drugs being developed to treat arthritis pain.
Heuer, a long-time Pfizer fan, sees the company earning $2.15 a share this year, $2.70 in 1999. Her price target for the stock is $150 by the end of 1999.

=================================

TA



To: Tunica Albuginea who wrote (3804)7/5/1998 12:55:00 AM
From: Tunica Albuginea  Respond to of 9523
 
VIAGRA RETINAL ( and other ) SIDE EFFECTS :this is everything ( or, almost everything ) published so far on it; it's a good starting point. As all side effects in medicine, time will tell:

=========================================================
[ 1 ]

Message 4327441

SAN FRANCISCO, May 4, 1998 /PRNewswire/ -- Today, doctors at the American Academy of Ophthalmology, the world's largest organization of eye physicians and surgeons, warned users of the newly-approved anti-impotence drug, Viagra, about the potential side effects that may affect vision.
Michael F. Marmor, MD, Professor of Ophthalmology at Stanford University and spokesperson for the Academy, said that a moderate percentage of people taking Viagra have experienced problems with their vision. "FDA clinical trials show that taking the medication, especially at higher doses, can cause some retinal dysfunction and affect the way we see for a number of hours." Patients reported visual disturbances described as bluish color tinge and light sensitivity. Dr. Marmor said a clinical study showed that electrical measures of retinal function dropped by 30 to 50 percent and lasted for at least five hours after taking a high dose of Viagra.
"On the surface, seeing the world with a bluish tinge may just be annoying," Dr. Marmor said. It is not known, however, whether or not the drug causes any permanent changes in vision. "We need to do some studies about the long-term effects of taking Viagra." In the meantime, Dr. Marmor urged those with retinal eye conditions such as macular degeneration or retinitis pigmentosa to use the drug with caution. "Stay at the lowest dose level possible," he said. According to the FDA, the recommended dose level for most patients is 50 mg.
The American Academy of Ophthalmology is the world's largest organization of eye physicians and surgeons (Eye M.D.s), with more than 23,000 members. The mission of the Academy is to achieve accessible, appropriate and affordable eye care for the public by serving the educational and professional needs of ophthalmologists. Visit the Academy's website at www.eyenet.org.
SOURCE American Academy of Ophthalmology
CO: American Academy of Ophthalmology
ST: California
==========================================================
[ 2 ]

quote.bloomberg.com
Scientists Using Gene-Altered Mice to Study Diseases, Post Says

Scientists Using Gene-Altered Mice to Study Diseases, Post Says
Washington, June 7, 1998 (Bloomberg) -- Scientists at the National Institutes of Health in the U.S. are using mice genetically engineered with human diseases to better understand disease processes and find cures faster, The Washington Post reported in its final Sunday edition. Scientists can then analyze as many times as needed the mice, which are injected at embryonic stages with the same biological defects that cause diabetes, cancer or cystic fibrosis in humans, the paper said, citing NIH immunologist Ronald Schwartz. Critics, however, say the practice is cruel and contradicts recent, more compassionate trends in high-technology animal research, the newspaper said.
Trial tests for Pfizer Inc.'s impotence-fighting Viagra found that some pregnant mice treated with the drug produced blind offspring. (WP, 6/7, A1, www.washingtonpost.com)

=========================================================
[ 3 ]
case-against.com

Technology and Culture Commentary
The Case Against
Dealing with the Devil
Viagra can be a Killer
by Jim Nourse and Jennifer Montgomery May 22, 1998
Web posted at: 6::30 p.m. EST

Reported minor side effects included slight vision impairment caused by decreases in electrical measurements of retinal function. Such decreases lasted for at least five hours and occurred only after test subjects had taken prescribed high dosages. Naturally, long-term studies have not yet been compiled on the side effects of the pill. As a result the medical world cannot report with certainty whether or not such slight impairments could evolve into permanent changes in vision or whether they will simply remain annoying, yet manageable, side effects.
========================================================

[ 4 ]
Message 4799228
June 10, 1998
Deaths of Men Taking Viagra
Point to Limits of Drug Testing
By NANCY ANN JEFFREY and ROBERT LANGRETH
Staff Reporters of THE WALL STREET JOURNAL

Debora Farber, associate director of the Jules Stein Eye Institute at the University of California at Los Angeles, is currently testing Viagra on animals to see if it can harm their eyesight. "We are very, very concerned that something could happen in patients taking Viagra for long periods of time," she says. Pfizer says it has done extensive studies on Viagra's potential for eye-related side effects in humans and has found nothing, other than the occasional and temporary blue-green tinge to vision.

[NOTE: The above DrFarber is the same DrFarber that published this article on retinal degeneration when PDE is desrtoyed:
===========================================================

[ 5 ]
Message 3203236

SCIENCE - VOL. 272 - 17 MAY 1996
Retinal Degeneration in Mice Lacking the,gamma
Subunit of the Rod CGMP Phosphodiesterase

By Stephen H. Tsang, Peter Gouras, Clyde K. Yamashita,
Hild Kjeldbye, John Fisher,* Debora B. Farber, Stephen P. Goff-,
The retinal cyclic guanosine 3',5'-monophosphate (CGMP) phosphodiesterase (PDE) is a key regulator of phototransduction in the vertebrate visual system. PDE consists of a catalytic core of a and b subunits associated with two inhibitory g ( gamma ) subunits. A gene-targeting approach was used to disrupt the mouse PDE-g gene. This mutation resulted in a rapid retinal degeneration resembling human retinitis pigmentosa. In homozygous mutant mice, reduced rather than increased PDE activity was apparent; the PDEap dimer was formed but lacked hydrolytic activity. Thus, the inhibitory -g subunit appears to be necessary for integrity of the photoreceptors and expression of PDE activity in vivo

Our results indicate that an interaction between the gamma subunit and PDE ab is essential for the proper activation of PDE and that all three subunits may be essential for assembly of a stable, active holo enzyme. The genetic loss of PDEGamma is manifested as an increase in cGMP content in the developing mutant retinas.
The hi cGMP concentrations may keep cGMP-gated cationic channels open
continuously and lead to an excessive energy load on the rod
photoreceptors resulting in degeneration.
..........................................

The above Authors are currently at :

C.K. Yamash la and C. S. Farber, Jules Stein Eye Institute. Molecular Biology Institute and Department of Ophthalmology UCLA School of Medicine, Los Angeles, CA 90095, USA.

S.H. Tsang, J Fisher, S. P. Goff, Howard Hughes Med co nstitute, Department of Biochemistry and Molecular Biophysics, Columbia University, College of Physicians and Surgeons, New York, NY 10032, USA.

P Gouras and H. Kjeldtye, Edward Harkness Eye Institute, Department of Ophthalmology, Columbia University, College of Physicians and Surgeons, New York, NY 10O32, USA.


'Present address: Regeneron Pharmaceutcas, Tarry lesson, NY 10591. USA,
========================================================
[ 6 ]

And finally Barons article of July 6 1998

interactive.wsj.com.

By Andrew Barry, Barons, July 6, 1998, page MW5
IS VIAGRA STARTING TO FADE?

So far, Pfizer has done a good job addressing safety concerns about the drug, including the deaths of men taking Viagra. But there hasn't been any long-term testing of Viagra. One concern is whether the drug begins to lose its effectiveness over time. Pfizer says there's no evidence of this.
However, Flynn points out that Viagra users are increasingly favoring higher-dose pills. "This suggests people aren't getting the desired effect from the lower dosage," he reasons. Viagra is available in dosages of 25, 50 and 100 milligrams. The 100-milligram pills have risen to 22% of prescriptions from 8% initially. One problem with the stronger pills is that they cause a higher incidence of visual color disturbances, or bluish vision, according to Neil Sweig, an analyst at Southeast Research Partners.
Pfizer downplays the blue-vision side effect, which occurs in about 10% of men taking the 100-milligram pills, saying it's "confident" there are no long-term effects on the vision of those taking the proper dosage. But Sweig, citing the views of many eye doctors, wrote recently that the blue-vision issue could be "serious." He said blue vision appears to be a "unique" side effect of Viagra that isn't present with any disease or other drug and that "some event" is occurring in the retina to trigger the problem. It's too early, he wrote, to determine whether Viagra has no long-term adverse effect on the eyes.

===============================================================

TA

PS For previously published other Viagra side effect reports please go to the following posts:

Good Morning Vietnam, ( the radio station where it all started:
Message 4716042

Report No 1: Message 4716059
Report No 2: Message 4716080
Report No 3: there is none .
Report No 4: techstocks.com
Report No 5: fresnobee.com
Message 4739522
Report No 6 : Message 5064065