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

To: BigKNY3 who wrote (7107)	2/27/1999 9:01:00 PM
From: Anthony Wong	Respond to of 9523

Viagra wins Canadian OK Calgary Herald Saturday 27 February 1999 Mark Lowey and Robert Walker, Calgary Herald Things are looking up for Canadian men who need a boost below. The anti-impotence pill Viagra has received medical approval and could get a drug-information number in March, a Health Canada official said on Friday. "For all men, it's great news," said Dr. Curtis Bell, a Calgary family physician. "The major hurdle is passed" to the drug being OK'd for sale in Canada. Viagra, the first pill for erectile dysfunction, became the biggest-selling drug in the U.S. after being introduced a year ago. Made by Pfizer, it is available in more than 50 countries. About three million Canadian men have sexual problems, studies show. But while the little blue pill soon may give Alberta men a lift, it probably will lighten their wallets. It looks unlikely the drug will be paid for by Alberta Blue Cross government-funded programs for seniors and others. Health Minister Halvar Jonson said there are many drugs for which Alberta Health does not pay, because government does not consider them medically necessary. If Viagra is not deemed medically necessary by the expert committee which examines all new drugs being considered for payment, it is unlikely it will be approved, Jonson said. The costs of government-funded drug plans have escalated during the past 10 years. The bill is now $216 million for non-hospital drugs. Dr. Neil Graham, chairman of the expert committee, said his first impression of Viagra "is that it's going to be a relatively low priority." But there are diabetics and those who have had prostate surgery who may have disabilities for which the drug could be authorized, he said A recommendation likely would be made at one of the committee's meetings in May or July and a decision announced Oct. 1. "That one's going to be a bit of a hot potato," Bell predicted. Alberta Health spokesman Garth Norris said that while he won't pre-judge the expert committee's advice, "of course, we don't fund drugs that are not medically necessary." Cost versus the benefit received would be another factor, Norris added. Alberta Blue Cross is developing a policy on how Viagra might be covered by private insurance plans. Group plans are available to some employers that can be customized for a range of benefits, including drugs, said Susan Bramm of Blue Cross. "Many of our plans, for example, do cover oral contraceptives." Before Viagra can be sold, it still has to be scrutinized by the bureau of pharmaceutical assessment and pass labelling requirements, said Dr. Hans Heich, a Health Canada medical evaluator. Viagra must have a drug identification number before Pfizer can import it from its manufacturing site in France, put a Canadian price on it (it costs $14 US a pill south of the border), and lobby the provinces and insurance companies for coverage. The pill is a novel alternative to the pumps, needles, suppositories and other invasive techniques used to stimulate blood flow in the penis needed to achieve and maintain an erection. Calgarians are asking for Viagra and some have travelled to the U.S. to get it, Bell said. "I think it'll become a popular drug," he added. "It's so much easier to use than other methods or treatments for erection." The initial target for Viagra's approval in Canada was the end of December. That was delayed because of adverse reactions. As well, more than 170 deaths worldwide have been linked to Viagra, although there's no conclusive evidence that the pill was to blame. The deaths most commonly involved patients using medications called nitrates, such as nitroglycerine, for heart disease. Bell said he expects that when Viagra is approved for sale, doctors will be cautioned not to prescribe it to anyone taking nitrates. calgaryherald.com

To: BigKNY3 who wrote (7107)	2/27/1999 9:28:00 PM
From: Anthony Wong	Respond to of 9523

Medicaid Viagra Bill Passes - (INDIANAPOLIS) -- An Indiana Senate committee has passed a bill that would restore Medicaid funding for the anti- impotence drug, Viagra. Committee members say the state stands to lose 55-Million dollars in federal funds without the funding. Last summer, Governor O'Bannon banned the state Medicaid program from paying for Viagra... but the federal government ordered states to pay for the drug... threatening the loss of federal funds if states refuse. Aides to the governor say while O'Bannon still opposes Medicaid funding for the drug... he might sign legislation overturning his ban. States News Service February 25, 1999 dailynews.yahoo.com

To: BigKNY3 who wrote (7107)	2/28/1999 12:39:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

South Africa: Viagra gets go-ahead, Stampede expected as miracle sex pill is launched in SA this week Sunday Times [South Africa] 28 February 1999 LAURICE TAITZ THE wonder sex drug Viagra will be launched in South Africa this week after the Medicines Control Council finally approved the marketing of the pill on Thursday night. Since April, the council has refused to give the miracle anti-impotence pill the green light because of concerns about 130 deaths linked to the drug in the US dating from March last year. Pharmacists canvassed yesterday expect a huge demand for the drug when it hits the shelves, but the council has insisted on stringent safety measures for its use in South Africa. Council chairperson Dr Helen Rees confirmed that the controversial drug had been given the go-ahead. "The matter was discussed, and the launch will happen soon," she said yesterday. Viagra manufacturer Pfizer was told on Friday of the council's decision. Company spokesman Dr Koanji Sebati said: "We are very pleased that we have reached agreement with the council." The drug has been stored in warehouses in South Africa since October, when approval for its registration was given and then suddenly withdrawn. Pfizer is now preparing to supply the drug to pharmacies, where it could go on sale as early as this week. Sebati said its availability was dependent on how quickly the company could place new package inserts and get the drug to wholesalers and retailers. Pfizer has complied with requests from the council to ensure the safe use of the drug and has begun undertaking safety measures including: Countrywide educational meetings on erectile dysfunction; Letters to doctors and pharmacists informing them on when to prescribe the drug; Labelling which complies with international standards, including a requirement that a thorough cardiovascular assessment be carried out on potential patients before the drug is prescribed; A patient information leaflet warning about possible negative drug interactions and advising against use if the patient has a heart condition; and A letter informing doctors and pharmacists of changes to the package insert and their safety responsibilities. The package insert has been rewritten twice to comply with the council's recommendations. The company has also recently launched an education programme for pharmacists and emergency room workers around the country. Once Viagra is on the market Pfizer will begin monitoring the drug's use. The high number of deaths linked to Viagra raised questions of whether the US Food and Drug Administration approved the drug too quickly - it took just six months. Critics of the FDA said that by July the administration had received 77 reports of deaths and yet it took the company and the FDA more than four months to agree on a new, more stringent warning label, which was issued in November. The drug comes with a warning that Viagra should not be prescribed for men taking nitrates to treat angina or chest pain, as the combination can cause a sudden lowering of blood pressure, possibly triggering a heart attack. However, the sex act itself could be responsible for many of the deaths as men suffering from impotence may have had an undiagnosed heart condition and may not have been used to the exertion of intercourse. In an article in the SA Medical Journal this month, product manager Sam Nkulashe described the last few months as a "traumatic time". He said the company had lost about R20-million in expected sales revenue since May. Sandton pharmacist Trevor Charters said he expected the demand for the drug to be "enormous". "When the hype first started we had calls every day asking when we were getting Viagra. It has died down, but we still get at least a call a day," he said. A Viagra tablet will sell for between R70 and R110 for three strengths: 25mg, 50mg and 100mg. suntimes.co.za