An excellent Viagra review article published in today's Newsday.
library.newsday.com
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Viagra's Vibrance / One year later, impotence pill's popularity shows no sign of fading
By Kathleen Kerr. STAFF WRITER
JUST ONE YEAR after the anti-impotence drug Viagra burst onto pharmacy shelves with all the wallop of a tsunami, the baby blue pill that roared is being sold in 50 countries worldwide, ranging from Thailand to Chile to South Africa. How popular has it been? Before gaining government approval in Thailand, Viagra sold on the black market for about $30 per pill - about triple the U.S. retail price. And before the Canadian government approved the drug, men there flocked across the border in order to fill prescriptions - leading some to dub the honeymoon capital of the world "Viagra Falls." More than 4 million men worldwide had used Viagra since its approval for sale in the United States on March 27, 1998, according to Andy McCormick, a spokesman for the Pfizer Corp., which makes Viagra. And while sales have leveled off some - dropping from a high of 275,000 prescriptions per week early last May to about 180,000 weekly - the drug remains highly successful. "I think Viagra had the strongest start ever," said Kelly Ringen of IMS Health in Pennsylvania, a supplier of pharmaceutical data. "I've never seen a product start as big . . ." The hype surrounding Viagra has, in fact, left many thinking that, dollarwise at least, it's the most successful drug ever. But that honor, said Ringen, belongs to Prilosec, an anti-ulcer medication that pulled in $2.9 billion last year for 26.7 million prescriptions. Nonetheless, Viagra's momentum as it left the gate contributed (along with two other successful drugs - Norvasec for high blood pressure, and Zoloft for depression) to a dramatic increase in Pfizer stock. It began the year at $75 a share; recently, the stock hit an all-time high of $140 per share. Indeed, the little, diamond-shaped tablet has quickly established itself as both a financial and a social phenomenon. From show biz to the restaurant business, Viagra made its mark quickly, and everybody, it seemed, wanted a piece of the action. At times, Viagra even vied with Monica Lewinsky as the main grist for tabloid headline writers and late-night comedians. A Nevada brothel owner reported increased business from patrons who used it. And a French chef spiked a fig vinegar and herb sauce with the blockbuster impotence fighter - all the better to help customers experience la vie en rose. Then there are the Internet sites - places in cyberspace where embarrassed men can order up prescriptions for Viagra with nary a doctor in sight. In fact, experts have said that Viagra, along with the fen-phen diet drugs and alleged baldness cures, helped prompt an explosion of new Web sites selling presciption drugs, even though taking Viagra without medical monitoring can be dangerous. Then, of course, there was Bob Dole, former U.S. senator and presidential candidate and the husband of Elizabeth, herself exploring a presidential run. Dole, a prostate cancer survivor, took Viagra to overcome erectile dysfunction and extolled its virtues on CNN's "Larry King Live" show - later becoming a spokesman for Pfizer. Elizabeth Dole just giggled. Like Bob Dole, about 30 million American men suffer from erectile dysfunction, and Viagra, clearly, offers them hope. Still, all hasn't been rosy for the wonder drug, which, in addition to its charms, turns out to have some disturbing side effects. For one thing, Viagra causes some users to see things through a blue haze, which in some instances can be dangerous. For example, the Federal Aviation Administration recommends that pilots not take Viagra within six hours of flight because they might not be able to distinguish between flight instruments of different colors. Additionally, some men experience headaches, flushing and nasal congestion. The largest concern, however, has been the 132 men in the United States who died after taking the drug, as of November, according to the FDA. For the most part, the deaths seem to have occurred in men with low blood pressure or heart problems, or in those who used Viagra along with nitrate medications or with "poppers," illegal nitrates sometimes used to enhance sex. As a result, the FDA ordered a labeling change for the drug noting that people with a history of heart attack, severely low blood pressure or other heart disease should be examined by a physician before usingthe pill. Still, the FDA has refused Newsday's requests for more up-to-date figures on deaths and other adverse side effects associated with Viagra. It is the agency's policy, an FDA spokesman said, not to release those figures without a Freedom of Information request. But despite the problems associated with Viagra, America - and the rest of the world - remains largely enchanted with the drug, with the company estimating that about 225,000 U.S. physicians have prescribed the impotence drug. Pfizer scientists in Britain developed sildenafil citrate - the chemical name for Viagra - as a heart medication, but that use wasn't successful. They soon realized Viagra's other potential, however, and the FDA approved Viagra after tests were conducted on 4,500 men with erectile dysfunction. Viagra works by helping smooth muscles in the penis to relax. That, in turn, assists blood flow, which helps lead to an erection. And the drug blocks the action of an enzyme that tends to prevent erections. In recent interviews, urologists in New York City and on Long Island said Viagra, in the majority of men who use it, does exactly what it promises and that serious side effects appear to be limited to those who use it incorrectly or those who shouldn't be using it at all. Currently, about 60 percent of all Viagra prescriptions are covered, at least in part, by employer, government or private insurance plans. And last July the federal government asked all state Medicaid programs, which cover medical costs for the indigent, to pay for Viagra. But some states balked, and New York was one of them. Frances Tarlton, a spokeswoman for the New York State health department, said New York doesn't want to provide Medicaid coverage for Viagra because of the drug's side effects and the possibility that people might buy it with Medicaid money and then sell it on the street. Tarlton insists the state was not concerned about the costs of Medicaid coverage for Viagra - an expensive little $10 pill - and said the federal government has taken no steps to force New York to cover it. "We've provided our concerns to the federal government and they have not, so far, required us to cover it," Tarlton said. With or without insurance coverage, though, plenty of patients are flocking to doctors who can prescribe Viagra. One 51-year-old Nassau County man in the nursing home supply business is so happy with the results he's had with Viagra that he's made foreign-language promotional films for Pfizer. The man, who prefers not to be identified, turned to Viagra in April, 1998, after a 1996 prostate cancer operation left him with impotence problems. He had the nerve-sparing operation that Yankees manager Joe Torre recently underwent. "With the advent of Viagra, it was a renaissance, a rebirth," said the happy Nassau man. "It works on average 90 percent of the time. The Viagra brings sexual satisfaction to my wife and myself and it makes us feel whole." Dr. Robert Waldbaum, chief of urology at North Shore University Hospital in Manhasset, said he writes about 15 prescriptions a week. Waldbaum has had a few patients who, after taking Viagra, experienced minor side effects such as flushing or headaches but nothing serious. And he's also had patients who refuse to use Viagra because of what he calls the "hype about cardiovascular problems." "I would say more than 50 percent who continue to use it are quite satisfied," said Waldbaum. Dr. Ridwan Shabsigh of the Columbia-Presbyterian Center at New York Presbyterian Hospital in Manhattan said the actions of Viagra have been largely successful for his patients. Shabsigh, director of Columbia-Presbyterian's New York Center for Human Sexuality, said he's written more than 1,000 Viagra prescriptions in the last year. He notes, though, that men should consider other treatments for impotency, such as penile implants and injection therapy, as well as other drugs in development. Still, he's delighted with Viagra's success. "I think this medication, if used properly and according to instructions and the practice of good medicine, is a very safe medication," said Shabsigh. "Altogether, it has been a very highly demanded medication." Shabsigh has prescribed Viagra for patients whose ages ranged from 20 to 85, with an average age of about 58, and said Viagra worked well in 60 to 70 percent of them. And, said Shabsigh, a not-yet published Columbia-Presbyterian study of 164 men who used Viagra has found no lasting, serious side effects in any of them. But, Shabsigh said, patients should beware of getting Viagra prescriptions through unorthodox means. He warns that men should not go to unethical clinics where they can get "hallway" prescriptions for Viagra from a nurse, without ever seeing a doctor. And Shabsigh said men need to see doctors for thorough checkups before using Viagra and that buying the drugs through Web sites - with no medical oversight - is dangerous. In fact, Rep. John D. Dingell (D-Mich.) has asked the Congress' General Accounting Office to investigate companies that market drugs on the Internet. The Web sites often charge a shipping fee and a "consultation fee" for the doctors who allegedly read customers' applications for prescriptions - which can total between $35 to $85 in addition to the drug's cost. Shabsigh and Waldbaum both note that Viagra is not an aphrodisiac: It will not increase desire in men; it simply improves physical function. Like McDonald's, which was sued for serving coffee that was too hot,Pfizer has had its share of odd lawsuits stemming from Viagra usage. For example, a 63-year-old Garden City woman sued, charging that her live-in boyfriend took Viagra and with his new-found potency left her for a younger woman. The couple later reconciled and, at last report, were planning to marry. Other more serious lawsuits have charged that Viagra led to death during sexual exertion. What next for the wonder drug? A preliminary study by Columbia Presbyterian urologist Dr. Steven Kaplan found that Viagra did little to help sexual function in women, although there are anecdotal stories to the contrary. But Pfizer maintains high hopes and is conducting its own study on the effects of Viagra in women; results are due around midyear. Clearly, Viagra is here to stay. |