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

To: BigKNY3 who wrote (7471)	4/21/1999 9:07:00 AM
From: BigKNY3	Read Replies (1) \| Respond to of 9523

FDA unworried by deaths linked to "super-aspirin" By Lisa Richwine WASHINGTON, April 20 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Tuesday there is no need to worry about a new ''super-aspirin'' despite reports of 10 deaths among people who took the drug. The Wall Street Journal reported that Celebrex has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhage. More than 2.5 million prescriptions have been written for the drug in the three months it has been on the market. But an FDA adviser said such numbers were meaningless. ''Ten cases is absolutely uninterpretable,'' Dr. Steven Abramson, chairman of rheumatology and medicine at the Hospital for Joint Diseases in New York, who chairs the FDA's arthritis advisory committee, said in an interview. Celebrex, made by Monsanto subsidiary G.D. Searle & Co. (MTC - news), is one of a new class of painkillers called COX-2 inhibitors. They were designed to battle pain and inflammation without the side-effects of aspirin and related drugs such as ibuprofen, which can cause internal bleeding. The FDA keeps tabs on as many adverse reactions as it can. Just because a death has been reported in a person taking a drug does not necessarily mean the drug caused that death. An FDA spokeswoman said she could not confirm the Wall Street Journal's figures, but said she was not worried. ''We don't believe this represents a signal at this point, because you have to take into account the 2 million prescriptions,'' she said. ''We would continue to monitor this and look at the gastrointestinal effects.'' Monsanto spokeswoman Scarlett Foster said the Wall Street Journal story ''erroneously links the data'' that were reported to use of Celebrex. ''It's wrong to make that link,'' she said. ''At this time, there isn't any evidence that points to a causal relationship between a patient's death or hospitalization to the use of Celebrex,'' Foster added. ''You really have to consider other medical conditions as you analyze these cases.'' Abramson agreed, saying more information was needed before any link could be made between Celebrex and the deaths. ''Were they taking an aspirin a day? Low doses of aspirin can cause acute hemorrhaging,'' he said. ''We don't know what over-the-counter medications these people were taking.'' Steve Geis, Searle's vice president for arthritis clinical studies, said that of the 10 deaths reported, eight had prior histories of heart, liver or gastrointestinal problems. Abramson, whose committee recommended approval of Celebrex, said information from trials showed Celebrex is safe and effective when used as prescribed. Celebrex, known generically as celecoxib, went through the approval process on a fast-track basis, winning the marketing go-ahead six months after it submitted the application. The FDA was eager to approve one of the COX-2 inhibitors because side-effects are so serious from aspirin and related drugs, known as non-steroidal anti-inflammatory drugs (NSAIDS). NSAIDS can cause potentially fatal stomach bleeding. Last year Dr. Gurkirpal Singh of Stanford University in California estimated that 16,500 people died from gastric bleeding every year in the United States. Several companies are also developing COX-2 inhibitors which have the potential to take a huge chunk out of the $5 billion to $12 billion worldwide analgesic market. Abramson's panel recommended approval of Merck's (MRK - news) COX-2 inhibitor Vioxx on Tuesday.

To: BigKNY3 who wrote (7471)	4/21/1999 9:11:00 AM
From: BigKNY3	Respond to of 9523

Extra clinics to cope with Viagra rush today Chin Soo Fang and Wendy Tan 04/20/1999 The Straits Times (Singapore) Page 31 SGH will need about 5,200 pills this month but Pfizer said the first shipment can fulfil all orders THE anti-impotency drug Viagra is finally here and the rush is on. The Singapore General Hospital, the biggest urology service here, will be opening up 10 special clinics to handle an extra 300 patients this week, on top of the daily patient load of 100 to 150 patients. Dr Michael Wong, a consultant surgeon at the hospital's Department of Urology said: "We're bursting at our seams. But for those whom we've been following up all these years, we know that they need it and we are more than happy to provide for them. "We owe it to them." The extra clinics, to be held from today until Saturday, will see 30 patients each. The hospital's pharmacy has estimated that it would need about 5,200 pills this month. Each of the little blue pills, which is 50 mg in strength, comes in packs of four with two accompanying leaflets of information on the drug. More than 10,000 packs of the much-hyped drug arrived in Singapore yesterday. Each pill will be sold for between $16 and $17 here. Dr Tan Peng Kok, a urologist at the Mount Alvernia Medical Centre, said that most of the patients awaiting Viagra are between 45 and 60 years of age, with some coming from other countries, such as Indonesia and Vietnam. Although there was no rush, many of them will be meeting him today, he said. Mr Michael Khor, marketing director of Pfizer, the drug company which manufactured Viagra , said the first shipment is "enough to fulfil all orders here". The US-made drug will also be available in 25 mg and 100 mg dosages later. Mr Khor said: "The recommended starting dose is 50 mg. It is to the physicians to change the dosage of their patients where necessary." According to Health Ministry guidelines, doctors cannot prescribe more than 12 pills or three packs for a patient within a month. And the drug should not be taken by men below 18 years old, or by women. Pfizer's product licence will be valid for six months before the ministry re-evaluates the situation. Said Mr Khor: "In US, those on Viagra are primarily men above 40. I think it would be the same in Singapore." Men who are potent "should save their money as Viagra does nothing for them," he added. With the availability of the drug here, he believes that impotency may not be as much as a taboo as before. People will also stop turning to the black market, he said. VITAL FACTS ABOUT VIAGRA * It is to be taken an hour before sex. * It is not for patients taking nitrates in any form, such as for treatment of chest pain. * It is only available on prescription of a registered medical practitioner. * The prescribing guideline by the Singapore Urological Association is 12 doses per patient per month. * It is for men aged 18 and above here, and not for women. * Do not take it if the packaging is torn or if it is past its expiry date. To find out more about impotency, the public can call Pfizer's Info-Line at 1800-734-9377 The toll-free automated service is available 24 hours a day from this month and is in English and Chinese.