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A Reason for Hope

The word's in on sildenafil, and it's good. The first oral drug for impotence may give sufferers a chance to be whole again.

March 16, 1998|SHARI ROAN | TIMES HEALTH WRITER

Every so often, a medication comes along that has the power to change the way a disorder is managed--and to dramatically increase the number of people treated.

By most accounts, that is the scenario expected when sildenafil--for the treatment of impotence--is approved by the Food and Drug Administration and reaches the marketplace, probably within months.

Sildenafil, sold by Pfizer Inc. under the brand name Viagra, will become the first oral medication for impotence--or erectile dysfunction, the preferred term among urologists. Studies show Viagra helps about 60% to 70% of men with physical impotence and more than 80% of those with psychological impotence.

An estimated 18 million American men suffer from erectile dysfunction, most of whom could be successfully treated. Yet only about 5% seek help. Embarrassment may be only part of the reason for their reluctance. Until Viagra, the treatment options for impotence ranged from implants to vacuum pumps to injections into the penis to suppositories into the urethra--options that most men find none too appealing.

The ability to simply swallow a pill and, within 20 to 40 minutes, have a normal erection after sexual stimulation may send impotent men to their doctors in droves. And it may even lower the threshold for what is considered impotence.

"Viagra is without question an amazing therapy that will have a huge potential benefit to men," says Dr. Harin Padma-Nathan, director of the Male Clinic in Santa Monica and well-known researcher in the field. "Oral medications have dramatic appeal. They are pills that you can take when you want to take them. But the most critical aspect for a drug for erectile dysfunction is that it's safe."

Several other companies are nearing completion of research on oral medications for erectile dysfunction as well. And Padma-Nathan, who is also a clinical associate professor of urology at USC, is about to launch a study to see whether the medications can even prevent impotence.

But Padma-Nathan cautions that Viagra and the other pills that will follow it are not fuel for a "sexual revolution."

"It is not going to change men's behavior. It is not an aphrodisiac," he says. "It will not alter libido. The medications improve erections in men who have erectile dysfunction. They don't change erections in men who are normal. [The medications] have no potential for abuse."

Yet, studies of Viagra and the other oral medications show they do have the ability to transform lives.

*

Even though he underwent a radical prostatectomy for cancer with a good attitude "since I'd never had a problem in that area," Tolman Geffs was dismayed to find the 1995 surgery did cause erectile dysfunction. He and wife Jill, who are 64 and 58, respectively, had married in 1990 and had just seen the last of their children and stepchildren grow up and leave their Orange County home.

"We were newlyweds," Tolman says. "We were empty-nesters with freedom. But, as the male, even though I knew Jill loved me, I had this horrible fear of, 'Am I going to lose my mate?' "

"We had just discovered each other," adds Jill. "We have this wonderful love, and I wondered, 'Am I going to lose this man to cancer?' "

Tolman turned to Padma-Nathan for treatment at the end of 1995 and decided to try Caverject, the first injectable medication for erectile dysfunction. The drug worked but caused side effects.

"It was far, far from a desirable solution," Tolman says. "The hormone left a severe aching sensation--talk about aching for love! Then, pretty quickly, I ran into a problem with scar tissue [from the injection]."

While injections are a significant advance in treatment, they can also cause prolonged erections.

At that point, Padma-Nathan had begun using Viagra in clinical trials and offered Tolman a chance to join the study. It's been bliss ever since.

"You take this drug, and you have the spontaneity of a normal, married life," Tolman says. "We think the drug is wonderful."

According to Padma-Nathan, the research participants were so enthused about Viagra that, after the study was completed, they petitioned Pfizer to request continued use of the drug under a "compassionate extension" protocol.

"It's astounding how effective it is with men in organic dysfunction," says Padma-Nathan, who will present new data on Viagra at the American Urological Assn. meeting in San Diego in May. These organic conditions include men with post-radical prostatectomy impotence, diabetes, severe vascular disease and spinal cord injuries.

*

Daniel, 52, was diagnosed with diabetes about seven years ago. When he began to experience erectile dysfunction a few years later, he didn't make the connection that the diabetes was probably causing the problem. But his wife, a nurse, did.

"My wife and I are good friends and we could talk about it," Daniel says. "She said, 'I think I know what the problem is.' "

He sought treatment and used the injected medications until he enrolled in the Viagra study Padma-Nathan was directing.

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