Departments
|
Week of 24 April 1998 |
Vol. I, No. 29 |
Feature
Article
MED research vital in demonstrating effectiveness of new impotence treatment
by Eric McHenry
Ever since word that the FDA had approved a new treatment for impotence made its way into the national media earlier this month, Irwin Goldstein has been fielding lots of phone calls.
And that's fine with him. A professor of urology at the BU School of Medicine, Goldstein says he's eager to spread the word -- both to news outlets and to prospective patients -- about ways to counteract what he characterizes as a "closet condition."
"If you have hepatitis, you have no qualms about going to the doctor and discussing it," says Goldstein. "If you have angina, you have no problem going to your cardiologist. You cannot imagine how difficult it is when you have impotence to pick up the phone and make an appointment. One of the ultimate goals of our work here is to make this a little more public, so that people can get help rather than remaining in silence and suffering."
Goldstein was one of several consultants to the pharmaceutical company Pfizer Inc., as it pushed the development, testing, and approval of sildenafil citrate, which is being marketed under the name Viagra. The pill inhibits an enzyme that would otherwise prevent the dilation of blood vessels. This makes it a potentially effective treatment for impotence in both men and women, Goldstein says.
He and his BU research contingent were responsible for providing proof that the drug performed as expected when introduced to human tissue. Their findings were published earlier this month in the journal Life Sciences, although they had been known within the scientific and medical communities for some time. "That was the first and most scientifically significant evidence that Pfizer used in its FDA submission," Goldstein says.
|
|
|
Irwin Goldstein |
According to Goldstein, MED has for many years been at the vanguard of sexual disorder research. Robert Krane, currently professor and chairman of the department of urology, established the New England Male Reproductive Center -- the first national clinic of its kind -- at BU in 1978.
"There's been a real dearth of research in this area," Goldstein says. "Much of what's been accomplished has happened here at BU. We have about 160 publications on impotence to our credit. We have multiple grants. It's an ongoing process."
"One of the most exciting collaborations I have at BU is with the department of mechanical and aerospace engineering," says Goldstein. "We've analytically characterized the penis as a rigid structure. We've also done work in biochemistry, and in pharmacology. The largest epidemiological study in impotence, the Massachusetts Male Aging Study data, comes out of BU. We've done the largest number of penile bypass surgeries here for people with blocked arteries. And on and on. It's been one of BU's real accomplishments."
In keeping with its history of leadership in this area, MED will open a women's sexual health center on July 1. It too will be unique in the United States, Goldstein says -- at least for the moment. The American Foundation of Urologic Disease recently awarded BU a two-year fellowship that will enable Jennifer Berman (MED'92), a urologist currently completing her residency at the University of Maryland, to investigate blood flow as it relates to female sexual processes.
Like the study of male impotence, research into female sexual dysfunction has for years faced a paucity of interest and support. It has been further obstructed, Berman says, by an unmet need for criteria.
"We've never had a means for evaluating it objectively," she says. "For years, no one has really known how to measure vaginal blood flow or clitoral sensation or changes in temperature. The subject has always met with snickers from the academic community."
Berman will also serve on the new center's clinical staff, which will include a female psychologist and a female nurse. The early successes of sildenafil citrate, Goldstein explains, laid the groundwork for this development.
"We now have ammunition," he says. "Human sexuality is an interesting field. Unless and until you have a therapy, then no patients come and seek you out. In 1973, the urologic community made available safe and effective penile prosthetic devices. Then, out of the woodwork people started coming to urologists claiming they had impotence, and doctors had no testing and no understanding of the physiology. So a field developed.
"The same pattern applies to females. As long as there's no effective therapy, women aren't going to come complaining about a sexual problem. Why would they discuss such a personal topic only to be prescribed an aspirin? With the advent of an effective therapy, the field can explode. We can start developing objective diagnostic studies, which are sorely needed, expand the therapeutic armamentarium beyond just sildenafil, and get funding from governmental and industrial sources."
"The objective is to remain state-of-the-art in sexual health issues," Goldstein says. "The emphasis on male problems is fine; clearly there are a lot of men who confront the problem of impotence and need help. But it does seem a little odd that we're becoming so focused on sexual health, and we all intuitively understand that it's a couples issue, and yet the assumption persists that women are entirely normal and men occasionally abnormal."