03/17/99- Updated 07:21 AM ET
Viagra celebrates first anniversary
By Rita Rubin, USA TODAY
A year ago, most Americans had never heard of "erectile dysfunction."
Now Bob Dole is a television pitchman for it.
A year ago, men of a certain age - and their partners - assumed that impotence was an inescapable side effect of getting older.
Now, rumor has it, nonagenarians are patronizing bordellos.
A year ago, impotent men seeking treatment could choose from shots, implants, urethral suppositories and a vacuum pump.
Now, thanks to the approval of Viagra last March 27, they simply can pop a pill.
Viagra, the little blue tablet that has triggered a sexual revolution, is about to turn 1. And life in the USA, and in more than 50 other countries in which it's marketed, will never be the same.
"I think it's been an extraordinary social phenomenon," says John Bancroft, director of the Kinsey Institute for Research in Sex, Gender and Reproduction in Bloomington, Ind.
"It has opened up discussion about ordinary sexual function," Bancroft says. "It's raised this whole question about the relevance of sex to middle years and later years and its priority in relation to health care and insurance coverage. Just in terms of how we think about male sexuality, it's had an impact that's still resounding."
Aside from the escapades of President Clinton and Monica Lewinsky, who can remember another topic that captivated commentators on Face the Nation as well as comedians on Saturday Night Live?
No other brand-name drug has become so ingrained in the vernacular. "It's been worked into the plots of The Love Boat, NYPD Blue," says Pfizer's Mariann Caprino, who adds that her company gave up trying to track every Viagra mention in the popular media.
Viagra, also dubbed the Pfizer Riser, has had the most successful first year of any drug. Pfizer expects to meet a projected $1 billion in Viagra sales by the drug's first birthday. By the end of 1998, the company had sold $788 million worth globally, including $656 million in the USA. At a wholesale price of $7 a pill, that's nearly 100 million pills sold just in this nation.
Dole, former Senate majority leader and 1996 Republican presidential nominee, will be playing a central role in Pfizer's campaign to spread the word about erectile dysfunction, Caprino says. Dole, already open about his prostate cancer, announced on Larry King Live last year that he was a satisfied Viagra customer.
More than 80% of users are men over age 50, Caprino says. "That's exactly what you would expect, based on the demographics of the condition."
About 2% of users have been women, she says, although the drug has been approved only for men. Pfizer is studying Viagra's effectiveness in treating female sexual dysfunction and expects to analyze data later this year, Caprino says.
"It's opened up the whole topic of women's sexuality and sexual dysfunction," Bancroft says. "It's exposed the fact we understand very little about what is important about the quality of sexual life in women."
Before Viagra, he says, female patients "presented themselves typically in terms of their sexual relationships with their partners, rather than their sexual physiology. With men, it tended to be the other way around."
Theoretically, Viagra should help women. It works by increasing the effects of nitric oxide, a common chemical in the body. In men, nitric oxide relaxes the smooth muscle in the penis, increasing blood flow to that organ. When women are aroused, the vagina becomes engorged with blood, just as the penis does when men are sexually excited.
The first published research of Viagra in women wasn't encouraging. A study of 33 volunteers in the journal Urology this month found that the drug is probably no better than a placebo.
Even in men, it's not a perfect drug. In clinical trials, Viagra improved erections - but, Bancroft notes, not necessarily sex lives - in about 70% of subjects who took it. And it's not without side effects.
When taken with nitrate drugs such as nitroglycerin, Viagra can cause dangerously low blood pressure. That was the main warning on the impotence pill's original labeling.
In light of reports of 80 men dying of strokes, heart attacks or other cardiovascular events after taking Viagra, Pfizer added more warnings to the label in late November. The label now cautions doctors against prescribing the drug to heart disease patients who might not be able to tolerate the exertion of sexual intercourse. In addition, the label now warns, doctors should think twice about prescribing Viagra to any man who's had a heart attack, stroke or irregular heartbeat in the previous six months.
Unquestionably, the availability of an impotence pill has spurred many men to see a doctor for the first time in decades.
"My whole practice has changed, and I've been in this business for 20 years," says Irwin Goldstein, a Boston University urology professor who specializes in treating erectile dysfunction.
Before Viagra, Goldstein says, patients used to complain, "Gee, Doc, I'm impotent, and nobody will take care of me, nobody will examine me." Now, patients complain, plenty of doctors are writing Viagra prescriptions with just a cursory examination and no mention of alternative treatments, Goldstein says. He says much of his practice consists of the 30% of Viagra users who saw no improvement with the pill.
These days, patients don't ever have to talk to a doctor to get Viagra. Dozens of Web sites offer "on-line consultations," brief questionnaires that supposedly are reviewed by physicians.
With a few clicks of a mouse, anyone in the world can get a Viagra prescription and have it filled on line, a practice that has drawn the ire of the American Medical Association, medical licensing boards and four Democratic congressmen, who have asked the General Accounting Office to investigate.
These critics of so-called Internet prescription mills point out that impotence is often a symptom of a serious medical problem, such as diabetes or heart disease, that needs to be monitored by a doctor.
Diabetes drove Dan Stokes, 52, to try Viagra. About seven years ago, not long after he married his current wife, Stokes began experiencing erectile dysfunction.
"It kind of gradually over time became more significant," he says. "I couldn't count on everything working."
Stokes, an Environmental Protection Agency technician in Ann Arbor, Mich., says he tried everything from an herbal remedy to penile injections before Viagra came along.
"We were doing a lot of fiddling around with the vacuum gizmo," Stokes says. "My wife was saying it sure would be nice to have plain old ordinary sex like everybody else did."
Thanks to Viagra, Stokes says, they now do. "I didn't expect to be 19 again, and I'm not," he says. His insurance covers what it considers a five-week supply: six pills. The drug has failed only once or twice, Stokes says, and the only side effect has been a faster heart rate, "but I suspect it has more to do with amore."
Bruce Feldman, 39, a psychiatrist in Springfield, Ill., began experiencing erectile dysfunction seven years ago, 11 years after he was diagnosed with multiple sclerosis. Feldman didn't think much of most treatments. The vacuum pump? "Not too romantic." Injections? "I refuse to use them." Urethral suppositories? "Didn't do anything."
Through Pfizer connections, Feldman says, he was able to get Viagra before it hit drugstore shelves last April. Both he and his wife are pleased with the drug. "We have a terrific marriage, but it enhances things," Feldman says.
A terrific marriage enhances Viagra because the drug fosters erections only in men who are aroused by their partner. "Viagra is neither an aphrodisiac nor a love potion for relationships in distress," Robert Butler, former director of the National Institute on Aging, wrote in October in the journal Geriatrics, where he serves as medical editor.
"If sex is only seen as something mechanistic or biological that has nothing to do with mutuality and sentiment and warmth and closeness, then it is not a good idea," says Butler, president of the International Longevity Center at Mount Sinai NYU Medical Center in New York.
Bancroft says the Kinsey Institute and four other research centers have launched a study of Viagra's impact on relationships. They're examining the characteristics of couples who find it most useful. "Maybe a year from now we'll have some answers," he says.
Meanwhile, a number of companies are rushing to develop the next Viagra. Goldstein says he is involved in a half-dozen companies' clinical trials of sexual-dysfunction treatments for men and women. By 2010, he predicts, there will be more than a dozen new companies marketing drugs or devices to treat impotence.
That makes good business sense, Goldstein says. According to conservative estimates, he says, nearly 10% of the world's population will be over 65 by the year 2025. And the older you are, the more likely you are to be dealing with sexual dysfunction.
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