Youth appeal

Hawkers in popular bars now sell anti-impotence drugs, whispering that they have “blues� available for 5 bucks a pop, less than the pharmacy price.

Friends pass their pills along to others, often drug users who use them to counter the effects of drugs such as methamphetamines or Ecstasy, which can leave them unable to get an erection.

Websites sell the drugs -- or counterfeits -- to nearly anyone who requests them.

And many healthy young men with normal sexual functioning are asking their general physicians for Viagra, Levitra or Cialis to help them conquer anxiety or offset the effects of smoking and partying.

Meanwhile, the makers of the erectile-dysfunction drugs are running racier-than-ever campaigns targeting younger men and straying from the depictions of the drugs as medicine. “Get back to mischief,� woos the latest Viagra slogan, with devil’s horns seeming to emerge from behind a middle-aged man’s ears.

These are all part of the new and rapidly changing face of erectile dysfunction drugs. Since the first impotence drug, Viagra, debuted in 1998 to address a physical problem for some men, it and newer sister drugs Levitra and Cialis have been used increasingly by healthy younger men for perceived performance-enhancement purposes or as psychological life-preservers to alleviate performance anxiety.

“When Viagra first came out, the whole emphasis was on older men, with Bob Dole doing the marketing and the age group being around 70,� says Dr. Abraham Morgentaler, a urologist and associate professor at Harvard University. “Now we’re seeing the bar lowered, not just for men wanting it but for physicians giving it out to those who are younger and less severely affected.�

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Breathing easier

And while physicians say the drugs have been a godsend to many men who need them, the expanding usage is raising questions about whether insurers should continue to pay for the drugs, whether the drugs may be a factor in the increase in sexually transmitted diseases and whether the newest ads promote the drugs more as lifestyle-accouterment than medical necessity.

Other countries have already taken action to address some of these concerns. Most private and government insurance plans in Europe do not cover the drugs, and amid vigorous debate, the United Kingdom’s national health insurance has severely limited its coverage of the pills.

Another concern is that the drugs may be psychologically addictive, says Morgentaler, author of “The Viagra Myth,� a book about the common misperceptions surrounding the drug. Healthy men may begin to feel inadequate without the pill, he says.

“For younger men to feel the need to take a pill to be deemed adequate is a lost opportunity to find out that who they are is enough and that they can be loved for who they are.�

Many seem to have gotten the wrong idea about what the drugs can and can’t do. One cardiologist tells of a healthy man in his 20s with no apparent functional problems who asked for a prescription to help him celebrate his anniversary in Las Vegas. And a sex therapist says that men as young as 16 have sought her help, thinking they need Viagra to have sex or that it might compensate for having a smaller penis.

In fact, the pills enable some men who have hypertension, diabetes or prostate problems to get an erection by increasing blood flow to the penis, provided the brain kicks in with some sexual stimulation. They don’t make people better lovers, instantly mend broken relationships or enlarge penises.

Still, many doctors and drug companies don’t believe the drugs are being overused and, in any case, see little danger in them. About 75% of the erectile drugs are now prescribed by general practitioners rather than urologists or cardiologists.

Dr. Louis Kuritzky, a clinical assistant professor at the University of Florida’s department of community health and family medicine, says he generally gives a prescription when asked. “There’s no way to prove they have it any more than a woman having menstrual cramps or headaches. We trust them unless there’s reason to believe otherwise.�

Even if the cause is psychologically rooted, Kuritzky says, many people can’t afford the money or the time that therapy would require. The pills, he adds, can offer a temporary quick fix to restore confidence, which may be all that’s needed.

“When you have garbage that is rotting, the best thing to do is to take it out,� he says. “But if you can’t, sometimes it’s best to spray perfume on it. Sex therapy is a luxury for only the economically elite.�

Pfizer, which sold $1.9 billion worth of Viagra last year and says 23 million men worldwide have tried it, maintains that it is not promoting the drug for enhancement purposes. Spokesman Daniel Watts says the company believes that if a man is troubled enough by erection problems, then he should consult a doctor about a possible underlying condition.

Carole Copeland, a spokeswoman for Eli Lilly, which makes Cialis, says the company “strongly discourages� use by those seeking enhancement only. “It’s just not safe. People who don’t have a condition that necessitates it shouldn’t use any drugs,� noting that erectile dysfunction drugs can be deadly if taken with nitrates. (Those drugs, which are used by 6 million to 8 million Americans to treat angina and high blood pressure, are also taken recreationally and are known as “nitrate poppers.�)

Moreover, drug makers and several physicians interviewed for this story contend that the increasing awareness about erectile dysfunction has pushed many men to see their physicians, subsequently discovering that they have diabetes or heart disease that might otherwise have gone undetected. (Because an erection requires 20 times the normal blood flow to the penis, even the early stages of the diseases can affect the organ’s tiny veins and arteries.)

Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai, however, dismisses the claims of early disease detection as mostly hype. “Come on, people don’t find heart problems by finding out they have erectile dysfunction -- the other way around is true.�

He also questions whether some of the purported need for the drugs has been drummed up by the drug makers’ advertising and reports that 30 million men in the U.S. may suffer from erectile dysfunction. Some men might never have thought they had anything to worry about before hearing there was an instant-fix drug available that might improve things. “It seems the disease was created overnight with Viagra.�

Moreover, there is disagreement about how the drugs affect men who don’t have erectile dysfunction. No studies have been done to assess this.

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Younger demographic

There’s little doubt that the age of erectile drug users is getting younger. Express Scripts, which, with 50 million members, is one of the nation’s largest managers of employee prescription drug benefit plans, said the fastest-growing segment of users who applied for reimbursement of Viagra prescriptions was men ages 18 to 55 during 1998 to 2002.

The number of men younger than 45 using the drug tripled during that time, although it is still small compared with the majority of users who are older than 50. Pfizer says the average age of men taking the drug is now about 53, lower than it was previously, although exact comparisons aren’t available. As of earlier this year, about 8% of Viagra users were age 34 to 40, about 26% were in their 40s, 36% in their 50s and 22% in their 60s, Pfizer’s data shows.

Express Scripts concluded that fewer men are using the drug because they need it for medical purposes -- which the company determined by reviewing whether the prescription user had filled prescriptions for conditions that might contribute to erectile dysfunction. “We saw over time that less and less men were having those diseases present,� said Tom Delate, Express Script’s research director.

(Lilly counters that men who might need the erectile dysfunction drug might not require other prescriptions if their case is in the early stages; it also says Express Scripts didn’t include all prescriptions that might be used for other conditions.)

Some healthy men who have used the medications say the drugs enable longer and firmer erections and reduce what is known in urological parlance as “refractory time,� the amount of time between erections.

The anti-impotence medications also can be used to offset the effects of alcohol and drugs -- including antidepressants -- as well as smoking (which constricts the blood vessels and can cause erectile problems), or lack of sleep or anxiety.

Dr. Ira Sharlip, a urologist and clinical professor at UC San Francisco who serves as spokesman for the American Urological Assn., maintains that the drugs “can’t make a superman out of a normal man.� Although middle-aged men who have seen firmness decline may note an improvement with the drugs, he says, an already firm erection won’t become any firmer.

But Kuritzky, the Florida physician, says that since the brain is such a critical element in sexual functioning, the so-called “placebo effect� can play a big role for some men.

If a man with a healthy cardiovascular system thinks his erections are or will be better with the drug, that’s often what counts the most (at least in the man’s own assessment). The same might be true if a guy with normal sexual functioning believes that an amulet in his hand will make him into the Hercules of sexuality, Kuritzky says.

Meanwhile, Delate says, some employers are now reconsidering whether the drugs should be subsidized.

“These are expensive medications,� Delate said in a phone interview. “We’re probably increasing the quality of life but not increasing the length of life, and one could make the same statements for Botox or hair loss.�

Express Scripts says about 70% to 80% of corporate pharmaceutical insurance plans pay for erectile dysfunction drugs, although many limit the number of pills they’ll pay for each month. Pfizer says about half of Viagra pills are paid for by insurance companies.

Mark A.R. Kleiman, a public policy professor at UCLA and director of its drug analysis program, goes so far as to contend that the drugs meet the criteria for distribution as “controlled substances� in the U.S., handled in the way drugs such Oxycontin are.

“Using a prescription drug for a purpose not prescribed is in essence drug abuse,� Kleiman says. “Clearly there is a lot of demand for the drug among people who don’t have the condition,� he says. “It’s not that men have it [erectile dysfunction] or don’t have it, it’s that men vary in sexual performance,� he says. “A lot of people want to be higher on the curve. Being a 50-year-old who no longer performs like a 20-year-old is not a disease.�

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Use among gays, bisexuals

Meanwhile, public health directors across the country have asked the drug makers and the regulatory agencies to mandate more warnings in advertising about the possibility of contracting a sexually transmitted disease when using Viagra, Cialis or Levitra.

The erectile dysfunction drugs are particularly popular with gay and bisexual men. A study in San Francisco a few years ago showed that while the predominant use of the drugs was in heterosexuals, 7% of the heterosexual men in the city had reported using Viagra versus 31% of gay and bisexual men.

In San Francisco, men who use the erectile dysfunction drugs have two to three times the risk of getting a new STD or HIV compared with non-Viagra users, says Dr. Jeffrey D. Klausner, the city’s STD Prevention and Control Services director.

New STD cases in the city have skyrocketed among men having sex with men. Syphilis, for example, has surged from 10 reported cases in 1998 to 450 in 2003 -- increases mirrored in gay communities in other major U.S. cities. Meanwhile, the cases of HIV among men having sex with men shot up 17% nationwide in 2003 over the previous year.

Klausner believes that the erectile dysfunction drugs may foster STD transmission because they enable longer-lasting erections. The longer the penetration, the more likelihood of disease transmission, perhaps by increasing the odds of ruptured skin or a broken condom.

There has not been a documented increase in STDs among heterosexuals nationwide.

At the federal Centers for Disease Control and Prevention, Ronald Valdisseri, deputy of the division responsible for STDs, HIV and tuberculosis prevention, says the agency is concerned about use of impotence drugs. But health officials there blame other drugs for the rise in disease. “Obviously, Viagra enables sexual functioning,� he says, “but it’s the crystal meth use that is clouding their judgment,� regarding safe sex.

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Drug-death connection?

The U.S. Food and Drug Administration and physicians say the drugs are safe for most men if used as directed, with the exception of those taking nitrates or those with poor cardiovascular health.

They acknowledge that some men experience headaches or flushing and in rare cases extended and painful erections that won’t subside, a condition called priapism.

Cedars-Sinai cardiologist Kaul isn’t convinced that the drugs are safe and says he probably wouldn’t take the drugs himself if he were to need them.

In 2000, he and colleagues at Cedars-Sinai analyzed 1,473 major adverse reports associated with Viagra use filed with the FDA. Of those, 522 people died, most due to heart attacks. Most had taken the standard 50 milligram dose of Viagra within the previous few hours and most were younger than 65 with no known cardiac risk factors.

Some of the deaths occurred in patients who had taken the drug with nitrates, but 88% of the deaths had occurred in those who did not.

Kaul notes that one can never be sure that the medication caused the attacks, just that there was an association with taking the drug. It also could be that some of the victims had previously been sedentary and the drug enabled them to engage in sexual activity, which in itself caused the heart attack.

The drug makers and FDA say the deaths could be caused by exertion during sex.

The FDA does not have tallies of how many heart attacks have been reported to the agency regarding the erectile dysfunction drugs in the past few years.

Sex-therapist and UCLA psychology professor Gail Wyatt, who co-wrote the book “No More Clueless Sex,� worries that all the hype surrounding erections enabled by the erectile dysfunction drugs -- how many, how long, how quick the recovery -- is distracting men as well as their physicians from the more vital issue: the quality of the entire sexual experience.

America has become a nation addicted to “fast food sex� rather than “gourmet sex,� she says.

“Men just think if they last longer, they’ll be better and that their cheerleader partners will be satisfied,� Wyatt says. But “without the skill, it doesn’t necessarily mean that it will be a more satisfying experience ... some men really don’t get it.�