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


To: Lazlo Pierce who wrote (2752)5/22/1998 3:02:00 PM
From: Anthony Wong  Respond to of 9523
 
Scouring the black market for potency drug
Friday May 22 11:10 AM EDT

CAIRO (Reuters) - Egyptian men are clamoring to get their hands on the sex potency drug Viagra, now available only on the black market for 40 pounds ($11.75) a pill.

The new drug, produced by U.S. pharmaceuticals firm Pfizer, has set off a media frenzy in Egypt and turned local unit Pfizer-Egypt into one of the hottest stocks on the Cairo exchange, but still
awaits government approval.

Newspapers have splashed reports and cartoons of men combing pharmacies for the drug, which Pfizer began marketing with phenomenal success in the United States last month.

The state-owned Al-Ahram newspaper said one man offered a pharmacy 60,000 pounds for 50 boxes of Viagra, each holding 30 pills, but the offer was refused to give other buyers a chance.

Pfizer-Egypt's stock price hit a year-high of 31.98 pounds on Wednesday, up from its year-low of 13.41 on February 9.

Brokers said they believed the stock price was inflated by the Viagra media hype and profit-taking could soon set in.

The U.S. Food and Drug Administration (FDA) approved Viagra in March, but the Egyptian Health Ministry has yet to complete tests and is trying to confiscate black market supplies.

"We can't talk about it until we see its side-effects," said Gamila Moussa, under secretary at the ministry. "Not all that is approved by the FDA has to be used here."

Viagra works by improving the flow of blood to a man's penis, enabling him to get and maintain a reliable erection.

An executive at Pfizer-Egypt said the company would market the drug in Egypt only after the ministry had approved it.

Viagra is being tested on some 120 patients being treated by 11 Egyptian specialists in a research project begun this month.

Doctors said they expected results to be ready by August, when they would be published and sent to the Health Ministry.

Many Egyptian andrologists and neurologists voiced strong support for Viagra, citing the worldwide testing of 3,700 patients, but some said it could have harmful side-effects.

"Of course there's no question that we need this drug in Egypt," said Khaled Lotfy, secretary general of the African Society for Impotence Research and regional representative of the International Society for Impotence Research.

"I consider it more important than cancer medication," he said, adding that victims of impotence often suffered from social problems that affect their work

Bahgat Mottawea, vice president of Egypt's Andrology Society said Viagra was the first effective oral anti-impotence drug. "It's an attractive scientific idea," he said.

Mottawea said other remedies such as surgical implants and injections were more painful, costly and not always effective.

He said Viagra's reported side-effects, including headaches, flushing, dizziness and abnormal vision, were not serious enough to warrant its being kept off the local market.

dailynews.yahoo.com



To: Lazlo Pierce who wrote (2752)5/22/1998 3:06:00 PM
From: Anthony Wong  Respond to of 9523
 
FDA: Some men on Viagra die, cause not clear
Friday May 22 1:18 PM EDT

By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - Six men have died after taking the blockbuster impotence pill Viagra, but it is not clear whether any of the deaths were caused by the drug, the Food and Drug Administration said Friday.

The FDA said it and Pfizer, the makers of the drug, were investigating the causes of the deaths. But Pfizer pointed out that more than a million men, most of them middle-aged, have taken the drug.

FDA spokeswoman Laurie McHugh said the FDA called Pfizer on Thursday to ask how many men had died after taking Viagra. "They reported to us that they had learned of six deaths of people taking Viagra," she said.

"We are going to look into these reports as we do all adverse reports," she said. "We continue to believe that the drug is safe and effective for its indications and the patient population."

The drug's label clearly states that it should not be taken by men who are also taking nitroglycerin or other nitrate drugs prescribed for heart disease, and Pfizer has made this clear in its advertising. On
Thursday Pfizer reiterated those warnings, saying it was appropriate to do so given the huge amounts of attention the drug has received.

The FDA and Pfizer both said they did not yet know whether the deaths were a result of a drug interaction, or were unrelated to the use of Viagra. The drug is the first pill to be cleared for use in treating impotence.

"There are over a million men who have taken the drug," Pfizer spokeswoman Mariann Caprino said in a telephone interview.

In the clinical trials, which involved only a few thousand men, eight deaths were reported. None was attributed to use of Viagra.

"Pfizer maintains that this is an effective and safe medicine when used appropriately in men who have diagnosed erectile dysfunction," Caprino added. "Men with erectile dysfunction tend to be older and
frequently suffer from serious underlying medical conditions ranging from diabetes to hypertension to cardiovascular disease."

And she noted the drug did require a prescription and that men had been urged to go to specialists who would take a careful health history before prescribing the drug. "It is not something that can be
prescribed over the Internet," she said.

Pfizer said it estimated that about 85 percent of the men who had been prescribed Viagra were between the ages of 50 and 70. "Obviously we are vigilantly monitoring all severe adverse events including deaths," Caprino said.

The tests required for a drug to win FDA approval and go to market usually involved a few thousand people. Drug companies, and the FDA, always expect more side-effects and adverse reactions to be reported once a drug is used by a wider population -- and Viagra registered record sales since it went on the market last month.

"The bottom line is that we are not seeing anything beyond the experience of our clinical trials," Caprino said. "Everything is in line with what we experienced in the clinical trials."

Side-effects include headaches, flushing, nausea and an odd effect on the eyes that renders some men temporarily unable to distinguish between green and blue.

"We are also asking the company to provide additional information to consumers regarding the appropriate use of Viagra," the FDA's McHugh said.

The company denied a television news report Thursday that it had issued a nationwide alert regarding combinations of Viagra and nitroglycerin.

Caprino said Pfizer has consistently cautioned doctors and the public about the serious danger of taking Viagra in combination with organic nitrates such as nitroglycerin.

She said Viagra's package insert clearly states that such a combination could lead to a dangerous fall in blood pressure. It also says Viagra is not approved for use by women.

dailynews.yahoo.com