|Sacramento Bee - Little Pill, Big Impact
Sacramento Bee METRO FINAL EDITION
Scene; Pg. E1
March 26, 2003, Wednesday
Little pill, Big impact The hype around viagra has quieted, but some questions remain
by Alison apRoberts Bee Staff Writer
Thursday is Viagra's fifth birthday. It's time to light a billion candles to celebrate - one for each pill that has been sold.
Perhaps the pill's most remarkable accomplishment: how quickly it's gone from a very big deal to an everyday fact of life. It's there in the dictionary, in bathroom cabinets (well, maybe tucked behind some other items) and in advertisements everywhere.
Remember how controversial those early ads were, the ones with former Sen. Bob Dole that had kids asking questions and parents stuttering and blushing? Remember the "Help, Viagra turned my husband into a sex maniac" letters to Dear Abby?
The headlines have died down. The letters have quieted. There are still lots of ads, but there's little in them to make you turn red. They're full of soft-focus, feel-good images instead of any embarrassing clinical language. (Now that everyone knows what Viagra does, there's no need to spell it out.)
Yet there remain plenty of questions and controversies over Viagra and its effect on our lives, from public health to private romance.
Body of knowledge
A dose of serendipity brought Viagra to the market. In the early '90s, researchers with the pharmaceutical company Pfizer were conducting trials of a drug called sildenafil citrate as a treatment for angina (chest pain caused by a decrease of blood supply to the heart) when they noted an odd side effect: The drug increased circulation in a way that facilitated erection.
In 1998, the FDA approved Viagra, Pfizer's brand name for the drug.
The Viagra rush was on.
"Before Viagra, there weren't many treatments that were acceptable to our patients; they were usually invasive," says Dr. Jay Young, a urologist in private practice in Southern California.
As one of the doctors who helped administer Viagra's clinical trials, he has been prescribing it for about 10 years.
"I think it significantly increased the quality of life in many of our patients," he says.
According to Pfizer, about 10 percent of men are affected by ongoing erectile dysfunction (what used to be called impotence). As men age, the chance of dysfunction increases, with about 20 percent of men in their early 50s reporting difficulty.
You could argue that the little blue pill didn't need any marketing with the media coverage that followed its approval.
But after Dole spoke of it - positively and without pay on CNN's "Larry King Live" - he was hired to promote it, becoming the first celebrity spokesman for the world's first impotence pill.
Some heralded Dole as a hero who ushered in a new era of openness. But not everyone agreed.
To Michael Montagne, a professor of pharmacy at Massachusetts College of Pharmacy and Health Sciences in Boston, Viagra presents a disturbing example of the triumph of marketing over medical caution.
"Proponents (of direct marketing) claim that patients want information, but research shows that when you're a patient, you don't engage in good consumer behavior, you'll just grab for anything," he says.
Benefits and risks
Under the influence of hype and hope, people may ignore risks. Ordering Viagra over the Internet, without a full physical, is particularly dangerous.
For instance, Viagra should not be taken by those using medicines with nitrates, such as nitroglycerin (typically taken to treat angina). The combination can cause blood pressure to plummet dangerously.
There is another, emerging health hazard as Viagra's popularity grows as a party drug to boost sexual stamina, often taken in combination with other drugs. For example, taking it with amyl nitrite, a recreational drug called "poppers," poses a similar blood-pressure hazard as taking it with nitrates.
Besides that danger, there is also the risk of Viagra contributing to the spread of sexually transmitted diseases. Health officials have been increasingly concerned about reports of people taking the pill as a party drug, often to offset impotence induced by other drugs, such as Ecstasy and methamphetamine. The result of relaxed inhibitions combined with enhanced sexual capability can lead to riskier sex with more partners and higher rates of STDs.
Used as directed, Viagra is pretty safe. There have been some heart-related side effects reported, including heart attack.
According to researchers, it is not clear whether the adverse effects were caused by the medication or simply exertion. Men should talk to their doctors about their particular risks.
"Viagra is a very safe drug," Young says. "The big question is not whether it is safe to take Viagra; the main question is, is the patient in good enough cardiac health to engage in sexual activity?"
Young says few men find Viagra's usual side effects troublesome. Side effects include headache, flushing, upset stomach and slight changes in vision.
These side effects don't appear to be slowing down the market, which is likely to grow as new drugs come out.
Two competitors that may arrive in the United States this year are Levitra, a brand name for vardenafil, a joint development of Bayer and GlaxoSmithKline; and Cialis, a brand name for tadalafil, a joint venture of Eli Lilly and Co. and ICOS Corp.
Levitra is reportedly faster-acting than Viagra, and Cialis is longer-acting.
"The field is exploding, and will continue to explode once the new products are on the market," Young says.
The heart of the matter
While Viagra works physically, as a cure for relationships, its value - despite those feel-good ads - is not proved.
(The New York Times reported that half of all Viagra prescriptions are never refilled, suggesting that for many men the romance with Viagra is short-term.)
"It's a miracle pill, but it doesn't help any psychological problems," says Ava Cadell, a clinical sexologist with a private practice on the Sunset Strip. She is frequently cited in popular magazines from Cosmopolitan to Men's Health, and she will be part of an expert panel for "Love U," a relationship reality series coming to the TLC cable channel on April 11.
"Viagra is about sex, but it isn't about intimacy," Cadell says. "I have a couple that didn't have much sex. He had ED (erectile dysfunction) and then he took Viagra, and he started straying. He's having sex, but not with his wife."
Cadell says the very notion of medication for sex can put too much focus on physiology.
"When people talk about sex, I'd like them to promote it more as a humanistic, even spiritual, experience, not an animalistic act," she says.
In her practice, Cadell recommends other approaches before taking Viagra - including exercises, mechanical devices and prostaglandin injections. The list of options is impressive.
"Men are so lucky because there are so many answers for them," Cadell says. "Women are still lagging behind."
Young acknowledges the lack of equal medical opportunity: "Women are more complex; men are simple animals."
In 2000, the FDA approved the first medical mechanism to help women achieve orgasm, a vacuum device called EROS.
There are also many herbal remedies available for women, but none is backed by large double-blind clinical trials the way Viagra is.
After earlier discouraging studies, Pfizer is again looking at whether Viagra might work for some women, based on a recent, more encouraging study conducted by Dr. Jennifer Berman, a urologist who runs the Center for Sexual Medicine at the University of California, Los Angeles.
Of wrinkles and acceptance
While women are getting older waiting for their own pill, they might find some consolation in the way that Viagra is extending our ideas of sexuality - from the exclusive province of the young to a pleasure of midlife.
Pfizer is doing what it can to make us more accepting of middle-age sexuality, with those warm ads showing satisfied couples over 35, and mature spokesmen, such as baseball player Rafael Palmeiro, who is 38, and NASCAR driver Mark Martin, who is 44.
(Now that the NFL has lifted its ban on pharmaceutical advertising, we might soon see football players join the promotions team.)
But we may not quite be in the midst of a new sexual revolution for the middle-aged.
"I'm not convinced that there's been a great script change of seeing sexuality as a big life force from 18 to 85," says Rebecca F. Plante, a sociology professor at Wittenberg University in Springfield, Ohio, and co-editor of "Sexuality: Behavior, Identity and Society," an anthology to be published in early 2004 by Oxford University Press.
Plante says her college students - at ages associated with free-thinking and spontaneity - hold narrow views of what sex should be and who should be having it.
"We talk about this in class," she says. "The students say people should have sex from like 17 to their late 30s. I say, 'What about grandpa, is he allowed to have sex?' They say, 'I guess if he has Viagra he can, but not with grandma.' "
Men of all ages are pretty narrow-minded, too, especially when it comes to talking about any sexual worries, according to Mark R. Leary, who studies social anxiety and embarrassment as a professor of psychology at Wake Forest University in Winston-Salem, N.C.
"For the normal Joe on the street, sexuality is a big part of who you are, and taking Viagra could make you worry that you look incompetent," Leary says.
"I don't think real people are talking about it. If I were taking it, I wouldn't admit it."
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The Bee's Alison apRoberts can be reached at (916) 321-1113 or email@example.com.
March: The U.S. Food and Drug Administration approves Viagra, the Pfizer Inc. brand name for sildenafil citrate. It is the first oral medication for impotence.
July: A 53-year-old used-car salesman from New Jersey sues Pfizer, claiming that Viagra caused him to see blue light flash from his fingers before he blacked out and crashed his car into two parked cars. Pfizer refuses to comment.
October: The Federal Aviation Administration recommends pilots not take Viagra within six hours of flying because visual side effects could make it tough to distinguish between the blues and greens of lights on cockpit instruments and runways.
November: After 6 million prescriptions have been written, the FDA and Pfizer Inc. issue new warnings for Viagra in response to reports of some adverse effects, including sudden cardiac failure.
February: Countless American kids learn to spell and say "erectile dysfunction," thanks to a TV ad campaign starring Viagra's first celebrity spokesman, Bob Dole.
March: Viagra is approved by Canadian health authorities. Pharmacies in places near the Canadian border (including Niagara Falls, nicknamed Viagra Falls) had been filling hundreds of prescriptions for Canadian men crossing the border.
June: Viagra gets its own entry in the newly published Oxford Concise Dictionary.
May: A large-scale study of Viagra use by women finds it doesn't work any better than a placebo.
February: Viagra gets into the driver's seat, sponsoring Winston Cup driver Mark Martin.
April: Viagra teams up with major league baseball player Rafael Palmeiro of the Texas Rangers, who promotes the drug in Spanish and English ads.
July: Number of Viagra users hits 20 million mark.
October: Pfizer files suit in the United States to block the launch of drugs that work similarly to Viagra, claiming patent infringement. It failed to win a similar fight in European court.
February: Cialis, a Viagra competitor, is made available in much of Europe, Australia and New Zealand.
March: Levitra, a drug similar to Viagra, is approved for sale in the European Union nations.
Thursday: Viagra celebrates its fifth birthday. One billion of the blue tablets have been sold, and annual sales top $1.5 billion.
Sources: Pfizer Inc. and Bee news services.