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Title: UROLOGISTS SHOULD BE VOICE OF REASON FOR SILDENAFIL ,  By: Bankhead, Charles, Urology Times, 00939722, May98, Vol. 26, Issue 5

CHARLOTTESVILLE, VA –The headlines proclaim it the “sexual liberation pill of older adults,” but urologists who have conducted clinical trials of sildenafil citrate (Viagra) caution against letting expectations run too high.

“The good news is that it’s approved,” said William Steers, MD, chairman of urology at the University of Virginia here. “The dark side is that it might be so widely prescribed and so overrated that everyone will think it’s a cure.”

Since the FDA approved sildenafil on March 27, the phones have been “ringing off the hook” in Dr. Steers’ office. Physicians are receiving e-mail messages from patients seeking information and prescriptions for the drug.

“Every attending physician, every nurse, every secretary wants to know what we’re going to do with all these calls,” said Dr. Steers.

Sildenafil, the first oral drug for erectile dysfunction, is a phosphodiesterase type 5 inhibtor that works by improving blood flow to the penis. Taken an hour before anticipated sexual activity, it works naturally with sexual stimulation. In clinical trials, the drug restored sexual function in approximately 70% of men overall with minimal side effects It is available in 25-, 50-, and 100-mg strengths.

At New York University, the urology department’s voice mail system has a dedicated compartment to handle sildenafil inquiries.

“This is going to bring in a lot of patients who in the past would have been reluctant to see a physician about erectile dysfunction,” said Andrew McCullough, MD, assistant professor of urology and director of male sexual health and fertility at New York University. “Conservatively, we’re talking about 30 million men with erectile dysfunction, fewer than 10% of whom are currently coming in for evaluation.”

Dr. Steers and Dr. McCullough, who both were involved in the U.S. controlled efficacy trials of sildenafil, agree that the urology community should maintain a voice of reason to help patients and perhaps many physicians from getting carried away with enthusiasm.

“Patients still have to be evaluated in a face-to-face office visit,” said Dr. McCullough. “This isn’t a medication that should be prescribed over the phone or over the Internet, as at least one New York physician is doing.”

The availability of a drug for erectile dysfunction has the potential to shift more physician-patient interaction into the primary care setting. Urologists should work with generalists to ensure that patients get a proper evaluation for erectile dysfunction and that sildenafil is prescribed appropriately, said Dr. McCullough.

“There are enough patients so that urologists don’t need to feel that they have to see every patient with erectile dysfunction,” he said. “The number of men coming in for evaluation will probably quadruple, and that’s a number that is much too large for every urologist to see.”

The ready availability of a pill for erectile dysfunction may tempt busy physicians to breeze past the workup and go for the script pad. Shortchanging the workup for erectile dysfunction could prove risky for some patients.

“Erectile dysfunction can be a symptom of a serious medical disorder, such as pituitary tumors, uncontrolled diabetes, or neurologic disease,” said Dr. Steers. “Every year, I diagnose several diabetics who haven’t been diagnosed previously. Every couple of years, I pick up a pituitary tumor. Some patients have erectile dysfunction secondary to claudication.

“In the vast majority of cases, there won’t be a problem. But occasionally, erectile dysfunction is related to a serious medical problem, which could be missed if the workup is cut short.”

Another factor potentially overlooked in the media blitz is the success rate of sildenafil and how to proceed in men who do not respond. Overall, about 70% of men who have used the drug have had successful intercourse.

“Urologists need to work with our generalist colleagues to make sure they refer on to a urologist the 30% who fail sildenafil therapy,” said Dr. McCullough. “This is not about a turf battle.”

Much remains to be learned about the ultimate role of sildenafil in the treatment of erectile dysfunction, Dr. Steers said. The side effects, if any, associated with long-term use have yet to be elucidated, he said. Worldwide, 4,000 to 5,000 men have been treated with sildenafil, often for no more than a few months at a time, he pointed out.

“We need experience in [many more] men before we know the true side effect profile,” said Dr. Steers.

The effects of “recreational” use are largely unknown, said Dr. McCullough. In early studies, sildenafil was evaluated for side effects in healthy volunteers but not efficacy. Discussions about the possible benefits of sildenafil in women who have sexual dysfunction are premature, he added.

“At this point, it is ill-advised for the urologist to be prescribing this drug for what might be perceived as female sexual dysfunction,” said Dr. McCullough. “Women are involved in phase I trials in England, but no data are available.”

Sildenafil clearly is “not the last word” in treatment of erectile dysfunction, said Dr. Steers, who points out that the drug doesn’t work in some patients and has only a partial effect in others. At the AUA meeting later this month, Virginia investigators will report results of laboratory investigations into combination drug therapy.

“If you combine sildenafil, which basically amplifies the signal in the penis, with a drug that might work in the brain, such as apomorphine, you get a better response,” he said.

PHOTO (COLOR): Dr. Steers

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By Charles Bankhead, Contributing Editor

Title: BRAVE NEW WORLD ,  By: McGovern, Celeste, Report / Newsmagazine (BC Edition), 14888106, 08/28/2000, Vol. 27, Issue 8

• A Y2K consultant hired last year to improve security for the White House computer network found massive pornographic video files jamming the system, according to WorldNetDaily. Real-time video files downloaded from hard-core sex sites to high-ranking officials in the West Wing featured homosexual, animal and teen-sex material (www.worldnetdaily.com/bluesky%5fsperry%5fnews/20000809%26#95;xnspy%26#95;webporn%5fsc.shtml).

• A group of 26 British McDonald’s customers is suing the fast food giant, alleging they were scalded by drinks served too hot. “Hot coffee, hot tea and hot water are at the centre of this case,” Malcolm Johnson, a solicitor at the London law firm Steel & Shamash, told Reuters. The UK case follows that of a U.S. woman who in 1994 was awarded punitive damages of US$2.7 million, later reduced to $480,000, for burns she received after spilling a cup of McDonald’s coffee on her lap (http://news.excite.com/news/r/000802/11/odd-mcdonalds-dc).
• Vivien Heath of Orpington Town, UK, is suing the Bromley Health Authority on behalf of her eight-year-old triplets, Kristian, Ellis and Matthew Heath, claiming she should have had the option to abort two of them, the Scotsman.com reported August 9. The three Heath children are variously afflicted with conditions including cerebral palsy, learning disabilities and physical developmental problems after they were born three months premature. A fourth child, Nathan, died shortly after birth. Mrs. Heath had taken powerful fertility drugs to stimulate her ovaries The case is scheduled to be heard in October 2001, and fertility experts fear if it is won it will set a precedent for thousands of couples disappointed by fertility treatments.
• Canada’s healthcare system is straining under an “epidemic” of twins, triplets and multiple births caused by fertility treatment, the Society of Obstetricians and Gynecologists warned in June. The rate of triplets soared more than 340% between 1974 and 1997. Children of multiple pregnancies account for 20% of the $100 million annually spent on premature babies (Vancouver Sun, June 28).
• Half of all babies who survive premature birth are mentally or physically disabled later in life, researchers at the University of Nottingham reported in the August 8 issue of the New England Journal of Medicine. Of the 308 babies born before the 26th week of pregnancy who survived, 155 had no problems, but the remaining 153 infants were labelled as suffering disabilities ranging from hyperactivity and learning difficulties to speech problems (news.bbc.co.uk/hi/english/health/nesid_873000/873976.stm).

• Camel racing Sheikh Mohammed bin Rashid Al Maktoum is using new reproductive technology to improve his camel stock. Camel embryos are being frozen and stored and implanted into surrogate camels to produce superior racers, Julian (Lulu) Skidmore told experts gathered at the Fertility 2000 meeting in Edinburgh in August. Breeders at the Camel Reproduction Centre in Dubai City are also attempting to collect semen from top bull camels and to sort sperm before in vitro fertilization so that only highly prized female embryos can be produced. “A good racing camel is worth a lot of money,” explained Ms. Skidmore (National Post, August 8).
• Nancy Hart used her dead husband’s previously frozen sperm to conceive a child through artificial reproduction. She then sued the Texas Social Security Administration for death benefits for her resulting daughter. Mrs. Hart won her case and is using part of the $700 per month each that she and her daughter were awarded to finance studies at South Texas College of Law, where she is specializing in reproductive technology law (Canadian Speeches, January/February).
• On August 12, Canada’s first conference on the rights of children born by donor insemination, is to be held in Toronto. Shelly Kreutz, 19, conceived by sperm donor insemination, is scheduled to speak. The National Post reported July 31 that she intends to demand that the government implement legislation, to allow “DI” children to have access to their donor father’s biological records. Tens of thousands of such children would like to know, for example, whether their fathers had diseases such as diabetes, and whether their future partners are not half-siblings. Some sperm donors are believed to have fathered more than 100 children through in vitro fertilization.

• Pfizer Inc., the maker of Viagra, is working on a faster-working, inhalable version of the anti-impotency drug. In its current form a little blue pill costing $10 to $15 apiece Viagra takes up to an hour after ingestion to stimulate sexual response. Trials of an inhalable version on dogs, scientists reported to the New Scientist in April, showed even more rapid “onset of action.” (http://www.salon.com/health/sex/urge/world/2000/04/12/viagra/index.html).

• British scientists believe they have found the part of the brain linked to true feelings of love, the BBC News Online reported July 5. Dr. Andreas Bartel and colleagues of University College London took two brain scans of 17 male and female volunteers while they viewed pictures of a platonic friend and of someone with whom they claimed to be “head over heels in love.” Scans revealed activity in parts of the brain associated with “gut feelings” and euphoria while the subjects viewed their loved ones, but no activity in those brain parts when they looked at a picture of a friend of the same sex. “I’m convinced we can use it as a test for love however, it’s rather an expensive one,” said Dr. Bartel (news.bbc.co.uk/ hi/english/health/newsid_82000/820857.stm).
• British and German scientists claim to have identified the part of the brain responsible for human intelligence, the BBC News Online reported July 21. Blood flow to an area called the frontal lateral cortex increases when research subjects performed tasks such as solving puzzles (news.bbc.co.uk/hi/english/sci/tech/newsid_844000/844217.stm) .

• A radical social change is afoot. Every week small evidences of it emerge and the overall picture is brought into sharper focus: humans are a product of their nature, not their nurture, we are told.

For 50 years, scientists, psychologists and educators have said that we are products of our environment. It is the right parenting, the right schools, the right extracurricular activities that produce good people, they said. Biology can be conquered by hot lunches and Head Start. Now, the message is reversed. Human conditions, from fidgetiness and overeating to criminality and homelessness, are a result of our genetic inheritance. “We are our genes.”

The announcement in June of the virtual completion of the Human Genome Project is the clearest sign of the change. All of humanity, scientists declared, has been “decoded” into a series of four amino acids represented by the four letters A, C, T and G, repeated and varied 3.2 billion times. Human destiny has been mapped.

On August 8 the BBC News Online reported that researchers have already discovered the part of the human genome responsible for intelligence (http://news.bbc.co.uk/hi/english/sci/tech/newsid%5f850000/850358.stm). Scientists at the U.S. National Institutes of Health analysed the DNA of 200 of the smartest kids in America and compared them with the genetic material of average children. They have homed in on a small grouping of genes that plays a large role in the difference.

“I think we need to recognize that we will find genes for intelligence,” Professor Robert Plomin, who led the research, told the BBC. “Each may account for a small piece of the action, but together they give us a significant source of prediction for intelligence.”

The findings mean scientists may soon prophesy the intelligence potential of newborns. Or of fetuses who could be “terminated” if their scores don’t match the expectations of their parents. Or of embryos who, if they are not up to IQ snuff, can be discarded.

In his book The Biotech Century, Jeremy Rifkin warned that the shift towards nature over nurture is accompanied by a resurgence in eugenics. Already women are pressured to abort babies with genetic handicaps, and they succumb to the pressure in high percentages. But we are all about to be put on genetic trial, warned Mr. Rifkin, and our society is in danger of being cut on new class lines between the genetically rich and the genetically poor.

One of Australia’s largest insurers admitted this month that it would offer discount premiums to people who underwent DNA testing and were proven free of genetic disease. People will not be forced to take a test, but they will pay more if they don’t, said the company’s national risk manager (www.theaustralian.com, August 10).

Jerome Lejeune warned about this sort of ghettoizing of the genetically poor. The physician who discovered the chromosomal aberration beneath Down’s syndrome, Dr. Lejeune was humble enough to recognize that he had not answered all the questions. Why do some Down’s syndrome children learn and grow to function nearly independently while others’ IQ scores cannot be forced an inch beyond 20, he wondered? How could some people live so well despite radical sex-linked genetic mutations?

Dr. Lejeune cautioned other geneticists not to read too much into genes. He died in 1994, but more of his sort of humility and compassion would be welcome in the coming age of genetic feudalism. “It happens that nature does condemn,” he once said. “Our duty has always been not to inflict the sentence but to try to commute the pain.”

PHOTO (COLOR): Celeste McGovern

PHOTO (COLOR): Camels: Embryos are frozen to produce a superior breed of racers.

PHOTO (COLOR): Human brain: Intelligence is in our genes.

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By Celeste McGovern

Title: Consultants try the HARD SELL ,  By: Rosenfeld, Jill, Fast Company, 10859241, Mar2001, Issue 44

IS CORPORATE viagra THE NEXT BIG IDEA OR JUST ANOTHER LIMP NOTION?

DO YOU WORK FOR A COMPANY THAT SUFFERS FROM performance dysfunction? Then this may be the time to get a fresh surge of energy with a breakthrough treatment from the consulting world: corporate viagra . It’s a new remedy that’s getting a hard sell from some overstimulated consultants who provide a “dose of viagra ” for businesses that have gone soft.

Take, for example, Thomas A. FitzGerald, author of an article on corporate viagra for the consulting newsletter the CEO Refresher: “FLACCID!” the article begins, as a fictional female board member loudly interrupts a presentation by the board’s chairman.

“IMPOTENT!” she bellows. What the company really needs, the screaming board member suggests, is “a strong dose of viagra !”

“Corporate Impotence, especially the early stage, is the first indicator of deeprooted problems,” FitzGerald explains.

To help limp companies, FitzGerald offers a Corporate Vitality Profile (CVP) and a dose of corporate viagra . But FitzGerald isn’t the only consultant who’s been flogging this metaphor. The Houston, Texas—based consulting firm Extreme Achievers claims to offer better results than viagra does: “Unlike with the male anti-impotence drug viagra , the Extreme Achievers Quotient Survey is the amazing pill that lets both men and women achieve amazing feats of performance—with no adverse side effects!” asserts the company Web site.

The Consultant Debunking Unit (CDU) decided to go after some hard facts and find out whether this metaphor is capable of sustaining itself.

First stop: Giles Brindley, professor emeritus of physiology at the University of London. Brindley, a true pioneer in the world of urology, is one of the best-known researchers in the area of impotence, due to a prominent demonstration he made at a urology conference in 1983.

At that convention, Brindley injected himself with a drug that he’d been testing and offered a full monty to an audience of colleagues. It was the first time that urologists had witnessed an “erection by injection.” Boston University Medical Center urologist Irwin Goldstein recalled the experience in a New York Times Magazine article last year: “He walked down the aisle and let us touch it. People couldn’t believe it wasn’t an implant.”

What about corporate viagra ? “The problem is that viagra is a temporary treatment,” Brindley points out. “ viagra doesn’t treat the problem itself—just the symptom. And I wouldn’t recommend taking viagra every day. It’s a new drug, and you just can’t know what the side effects might be.”

Does Brindley have a better suggestion? “If I were a consultant, I might consider saying that I’m like an injection of prostaglandin E-1, which men are more likely to respond to than they are to viagra ,” he says. “Prostaglandin E-1 gives you an erection no matter what, provided your blood system is intact. Of course, the drug still produces only a temporary solution.”

Next stop for the CDU: the vacuum erection system, arguably the oldest and most American of impotence remedies. In the mid-1970s, Geddings Osbon, who had founded a successful tire-retreading business, invented the vacuum pump by hooking a bicycle pump to a truck-tire valve, reversing the cylinder to create negative pressure, and applying it to his nether parts. His tire rose, and an invention was born.

Osbon has since passed away, but his son and grandson carry on the family tradition of manufacturing vacuum systems. “The pump allows you to achieve the fullest erection physically possible,” says grandson Michael Osbon. “It gives you the firmest results.”

What about viagra for companies? Does it hold up? “I’d think that if you were in business, you’d want a solution that was surer than viagra ,” young Osbon says. “A lot of men contact us after they’ve had an unsuccessful experience with viagra .”

For the final word, the CDU turned to David M. Friedman, author of A Mind of Its Own: A Cultural History of the Penis, due out in November from the Free Press. Friedman first formally contemplated the subject in 1996, when he injected himself with an anti-impotence drug and chronicled the ensuing four-hour erection for Esquire.

“For the record, those shots really do work,” Friedman says. “The pump makes you cold, purple, and kind of dead. As for viagra , it doesn’t take into account the fact that there are two people in a sexual relationship. It treats the penis as the patient. There’s a word for having sex with the penis alone: ‘masturbation.’”

Which may be what consultants know how to do best.

“I’D THINK THAT IF YOU WERE IN BUSINESS, YOU’D WANT A SOLUTION THAT WAS SURER THAN viagra .”

PHOTO (COLOR):

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By Jill Rosenfeld

Title: RATIONALE EXISTS FOR USING VASOACTIVE AGENTS IN WOMEN ,  By: Snider, Tim, Urology Times, 00939722, Dec2000, Vol. 28, Issue 12

Section: Special Populations

Clevelandthe sexes are wildly dissimilar. That’s why it is incorrect to assume that what works for sexual dysfunction in men will also work in women, said Harin Padma-Nathan, MD, at the Society for the Study of Impotence annual meeting.

“[Men and women] are wired very differently. These are two different fields, and we can’t make generalizations in women just because we made these observations in men” Dr. Padma-Nathan said.

Although the field of oral therapies for female sexual dysfunction is in its infancy, there does appear to be a rationale for using vasoactive drags in this setting. However, the efficacy of these agents awaits the outcome of additional trials.

Dr. Padman-Nathan, clinical professor of urology, University of Southern California (Beverly Hills) School of Medicine, presented a state-of-the-art review of drug therapies to treat female sexual dysfunction, focusing on two studies looking specifically at female sexual arousal disorder (FSAD).

“There are critical questions we need to ask ourselves about the entire concept of drug therapy in female sexual dysfunctions,” he said. “Is there a rationale for vasoactive drugs for female sexual arousal disorder? Who should we study? Andwhat is the evidence-based data to date?”

Dr. Padma-Nathan said several clinical trialsare evaluating the efficacy and safety of a number of oral vasoactive drags in the treatment of female sexual arousal disorder, including PDE5 inhibitors, the dopaminergic agent apomorphine, and the combination of alpha-2 agonists L-arginine and yohimbine.

“Almost all of the drags have been examined in men, and some perspective is being gained in female sexual dysfunction,” he said, citing studies of three oral PDE5 inhibitors–sildenafil citrate (Viagra), IC351 (Cialis), and vardenafil, the latter two of which are still investigational.

“A great deal of studies to date are anecdotal reports as well as poorly designed studies lacking placebo control or randomization. Those studies employing nonvalidated instruments have dominated reports of efficacy in FSAD to date,” he cautions.

Dr. Padma-Nathan discussed two studies that, he said, present the most significant data on the efficacy and safety of pharmacologic therapies in women with FSAD.

The first was a large-scale, double-blind, placebo-controlled, randomized clinical trial of sildenafil in 583 estrogenized women with FSAD as the primary presenting symptom (Ob Gyn 2000; 95:54).

“The women in the study were 18 to 55 years of age who were pre-menopausal or post-menopausal and receiving hormone-replacement therapy,” Dr. Padma-Nathan said.

Patients were randomized to receive placebo or 10, 25, or 50 mg of sildenafil taken on an as-needed basis over a 12-week study interval. Efficacy was measured by a sexual function questionnaire, the Life-style Satisfaction Checklist, and an event log of sexual activity.

“There was no clear dose response seen between 10, 50, and 100 mg, and this was not statistically, clinically, or otherwise different from the placebo response” Dr. Padma-Nathan said.

He added that there was also no difference between sildenafil or placebo with regard to improvement in the ability to have sex.

“Enjoyment of sex seemed to be slightly greater with the 100-mg dose, but this was not statistically different from the other doses or placebo,” he said.

The adverse events in the studywere about the same as those found in men, including headaches, flushing, rhinitis, nausea, altered vision, and dyspepsia. One woman presented with menorrhagia.

Despite the results of this study, Dr. Padma-Nathan said that vasoactive drags may still play a role in the management of FSAD, but perhaps only in carefully selected patients or in specific subpopulations.

“There probably is value from the early evidence at looking at special populations, including FSAD related to post-hysterectomy and post-menopause that persists in the face of adequate estrogen and testosterone replacement” he said. “Another scenario is in SSRI [selective serotonin reuptake inhibitor]-related FSAD.

“The important point to remember is that this was a well-constructed study with good utilization and good instruments. But it was a broad range of patients, and maybe the parallels don’t exist in the unisexual response cycles”

Dr. Padma-Nathan also discussed another study that examined the sexual and cardiovascular effects of sildenafil in a group of women with arousal disorder secondary to spinal cord injury (Urology 2000; 55: 812-5). The placebo-controlled study of 19 women compared placebo with 50 mg of sildenafil using a cross-over design.

“Sildenafil demonstrated increases in vaginal pulse amplitude. Objective measures as well as subjective arousal responses tended to be better than those with placebo” Dr. Padma-Nathan said.

Although there is no broad body of evidence that vasoactive drugs work similarly in women and men, there is enough ongoing clinical research that may reveal that different drugs with different mechanisms and actions may produce better responses in certain populations of women.

“There is data that is already focusing in on some populations” Dr. Padma-Nathan said. “This is clearly the direction we should head in.”

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By Tim Snider, Managing Editor

To examine how drug therapies may work in women, Dr. Padma-Nathan said the first step is to use a working definition of female sexual dysfunction. He cited the International Consensus Conference on Female Sexual Dysfunction definition published in the Journal of Urology (2000; 163:888-93).

“The definition is `a persistent or recurring inability to attain and/or maintain sufficient sexual excitement,’” he said.

Another development is that, in contrast to the Master and Johnson linear model of the female sexual response cyclea new model has been proposed by Rosemary Basson, MD, suggesting that, unlike male, the female cycle may be more `circular’ (J Sex Marital Ther 2000: 26:61-65). In this model, women are neutral in desire but make a deliberate choice to experience stimulation for the `extras’: emotional closeness. this receptivity facilities arousal, which then increases desire. This alternative model was proposed to improve the behavioral, psychological treatment of female sexual dysfunction.

The treatment of FSD has been recently helped by advancements measuring the condition’s facets, including the Female Sexual Function Index questionnaire and new measuring devices.

“Perhaps the best one objectively documented in the literature and most widely used in clinical research is vaginal photoplethysmography, which measures vaginal blood volume change or pulse amplitude changes in the flow to the vagina,” he said.

Title: ALPROSTADIL FOR THE TREATMENT OF ERECTILE DYSFUNCTION ,  By: Andolsek, Kathryn M., American Family Physician, 0002838X, 4/1/97, Vol. 55, Issue 5

Section: Tips from Other Journals

Erectile dysfunction affects 10 to 20 million men in the United States. It is usually due to organic factors and affects not only sexual performance but self-esteem and relationships. In a multicenter, double-blind, placebo-controlled study, Padma-Nathan and associates evaluated the effectiveness of transurethral alprostadil, a synthetic compound identical to prostaglandin E,, in the treatment of erectile dysfunction.

A total of 1,511 men who ranged from 27 to 88 years of age and had chronic erectile dysfunction resulting from various etiologies were included in the study. The men were tested for erectile response with one of four doses of alprostadil. Those who had a sufficient response were randomly assigned to three months of treatment with either the dose of alprostadil that had been effective for them or placebo.

Erections sufficient for intercourse were achieved without adverse effects in 996 (65.9 percent) of the men during clinic testing. The dose of alprostadil required to achieve this effect varied. Twelve percent of patients achieved maximal erections with the 125-Mu g dose; 17 percent required the 250-Mu g dose; 30 percent required the 500-Mu g dose, and 41 percent required the 1,000-Mu g dose.

The results of at least one home treatment were reported by 961 men. Two hundred ninety-nine (64.9 percent) of the 461 men treated with alprostadil reported successful intercourse on at least one occasion, compared with 93 (18.6 percent) of the 500 men in the placebo group. Orgasm occurred at least once in 63.6 percent of the alprostadil group, compared with 23.6 percent of the placebo group.

The mean age of patients was 61 years and causes of the erectile dysfunction were the same in both study groups. Vascular disease was present in 28.7 percent of the study subjects, 20.6 percent had diabetes mellitus, 29.6 percent had surgery or other causes, and 21.0 percent had other causes of dysfunction. Alprostadil was equally efficacious regardless of the age of the patient or the cause of the erectile dysfunction.

Mild penile pain was the most frequently reported complication, occurring in 10.8 percent of the men receiving alprostadil. Rarely, the pain was sufficient to lead to early termination of the trial. Most of the men rated the transurethral application as “neutral,” “comfortable” or “very comfortable,” and 88 percent completed the entire three-month trial. Hypotension occurred in the clinic during the test dose in 3.3 percent of the study subjects and was more likely with increasing dose. Symptoms of hypotension during home treatment were uncommon. None of the study subjects experienced urethral stricture, penile fibrosis or priapism.

The authors conclude that transurethral alprostadil was a well tolerated and efficacious treatment for erectile dysfunction in men with mixed etiologies of erectile dysfunction.

Padma-Nathan H, et al. Treatment of men with erectile dysfunction with transurethral alprostadil. N Engl J Med 1997;336:1-7.

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By KATHRYN M. ANDOLSEK, M.D., M.P.H.

“Tips from Other Journals” are written by the associate editors of American Family Physician.

Title: SILDENAFIL MAY HELP SSRI-RELATED FEMALE DYSFUNCTION ,  By: Hannapel, Coriene E., Urology Times, 00939722, Feb2001, Vol. 29, Issue 2

Boston–Sildenafil citrate ( viagra ) has been shown to be effective for treating selective antidepressant-induced sexual dysfunction in a carefully defined group of women.

“Sildenafil should be considered a first-line treatment for this troublesome side effect,” said H. George Numberg, MD, professor of psychiatry and director of clinical trials at the University of New Mexico, Albuquerque. “What is also going to emerge from this new focus on sexual dysfunction is what really is a viagra problem and what is not. For instance, a woman who loses libido may need testosterone therapy instead of viagra .”

The most common complaints among women with antidepressant-induced sexual dysfunction include decreased libido, arousal disorder, dyspareunia, and delayed orgasm or anorgasmia.

Dr. Nurnberg presented results from an open-label pilot study at the recent Boston University Female Sexual Function Forum. In designing a protocol to ascertain that antidepressant sexual dysfunction was being targeted, a number of criteria for entry in the study were established:

• Patients must have been sexually functional before the antidepressant therapy began.
• Patients must have reached a point where their antidepressant therapy was having a positive effect so that the depression itself could not be a contributing factor in the sexual dysfunction.
• And they must have been on a stable dose of continuation antidepressant treatment.

In the open-label study, sildenafil was prescribed for 10 female outpatients who reported sexual dysfunction induced by antidepressant medication, primarily selective serotonin reuptake inhibitors (SSRI). They were given a 50-mg dose of sildenafil and were instructed to take it approximately 1 hour before sexual activity. Those patients who experienced a partial response or lack of response were told to increase the dose to 100 mg on the next occasion.

Significant reversal of sexual dysfunction was reported in nine of the 10 patients, based on patient self-reports, clinical assessment, and clinician reports. The tenth patient declined the trial.

“Improvement was seen pretty rapidly. Generally, if it was going to work, it would work by the second week,” Dr. Nurnberg said.

In most cases (75% of patients), this happened with the first dose of 50 mg of sildenafil (Psychiatr Serv. 1999; 50:1076-8).

Dr. Nurnberg has now begun an eight-center, SSRI sexual dysfunction study comparing sildenafil and placebo in 150 women.

“All patients get put into the double-blind, placebo-controlled phase for 8 weeks and, when that’s finished, we’ll put them in another 8 weeks of open-label,” Dr. Nurnberg said.

Dr. Nurnberg told Urology Times that noncompliance with SSRI resulting from their sexual side effects is usually high.

“When we look at the data, we see that only 25% to 30% [of patients] complete antidepressant treatment. So while you have a treatment that is potentially 90% effective, only about a quarter of the patients actually finish a full course,” he said, adding that an added benefit of sildenafil treatment is that it encourages patients on SSRI-induced therapy to remain on their medication.

Looking at the demographics of who is going to be on antidepressants in a psychiatric population, twice as many women as men will have SSRI-induced sexual dysfunction. However, three times as many women as men are on antidepressants, explained Dr. Nurnberg.

“The men’s studies with viagra were very straightforward, and it seemed that if you had men with erectile dysfunction viagra would help,” said Dr. Nurnberg. “The initial studies to come in on viagra in women were much more equivocal.”

The studies on sildenafil in women were confusing, said Dr. Nurnberg, until “two things became obvious–assessment of hormonal status and pre-existing sexual dysfunction.”

“The issues in women’s sexual health are probably in lots of ways much more complex than in men, and some of the studies coming out had problems in terms of design–more than [problems with] the drug,” he said.

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By Coriene E. Hannapel, UT Correspondent

Title: LOVE’S LITTLE BLUE HELPER ,  Newsweek, 00289604, 02/15/99, Vol. 133, Issue 7

Section: PERISCOPE

VITAL STATS

NEED A VALENTINE’S GIFT FOR THAT SPECIAL GUY? ONE IN 10 American men wants to try viagra –seniors, and also boomers weaned on pharmacology and free love.

MAP: U.S. (Indicating: viagra envy, Curiosity, Hard sell, Not interested)

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By MICHAEL J. WEISS

Title: ACC AND AHA STATEMENT ON Sildenafil AND NITRATES ,  By: ROSE, VERNA L., American Family Physician, 0002838X, 10/15/98, Vol. 58, Issue 6

Section: Clinical Briefs

The American College of Cardiology (ACC) and the American Heart Association (AHA) have issued a joint statement recommending that Sildenafil (Viagra) not be prescribed to patients taking nitrates. According to the ACC/AHA statement, the combination of Sildenafil and nitrate-containing medicines may be lethal. The statement provides recommendations for the use of Sildenafil in cardiac patients with various medical profiles as well as treatment procedures for patients receiving Sildenafil who have a cardiac event. The statement recommends nonnitrate therapies for the treatment of myocardial infarction and angina in patients who have used Sildenafil .

The ACC/AHA statement also notes that the combination of Sildenafil and inhaled nitrates, such as amyl nitrates, could be fatal. In addition, caution should be used in prescribing Sildenafil to patients with certain other cardiovascular profiles even if they are not taking nitrates. Patients who are taking certain drugs, such as erythromycin or cimetidine, and patients with severe liver or renal disease may be at risk if they take Sildenafil .

The ACC/AHA summary statement is available on the ACC Web site at http://www.acc.org or by calling 800-253-463, ext. 694. It is based on a draft of an expert consensus document titled “The Use of Sildenafil (Viagra) in Patients at Clinical Risk from Cardiovascular Effects” that the ACC and the AHA are developing. The consensus document is expected to be released in December 1998.

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By VERNA L. ROSE

Title: NATION’S LARGEST HMO SAYS NO TO COVERING viagra PAYMENTS ,  By: Glanton, Eileen, Hudson Valley Business Journal, 10501096, 07/06/98, Vol. 9, Issue 5

NEW YORK (AP) — The nation’s largest HMO, Kaiser Permanente, has become the latest insurer to deny coverage for viagra , saying the wildly popular impotence pill is too expensive and not a medical necessity.

Already last week, Aetna US. Healthcare said it wouldn’t pay for viagra . Aetna, a health insurer, covers nearly 14 million people. Kaiser, which 9.1 million members, announced its decision last Friday.

Since its debut in early April, viagra has become the fastest-selling drug in history, with 2 million prescriptions written at $8 to $10 a pill.

Many insurance companies are still determining their policies on viagra , and those that do pay for it have imposed limits on the number of pills they will cover - in many cases, six or eight plus a month.

“We recognized the drug’s potential for abuse and the financial impact that misuse of this drug would have on our community’s health care costs,” said Richard Dent, chief medical officer of Blue Cross and Blue Shield of Rochester., which will cover six pills a month for patients who have suffered impotence for at least six months.

IMS America, a consulting group that tracks the drug industry, has estimated that half of the men taking viagra are reimbursed at least partially.

Kaiser said it decided not to cover viagra because of the cost and because a panel of doctors, pharmacists and ethicists drew a distinction between “quality-of-life” treatments and drugs deemed medically necessary.

Kaiser, recovering from a $270 million deficit last year, estimated that national coverage of 10 viagra pills per month would cost it at least $100 million per year. That would dwarf the $59 million Kaiser spent last year on all antiviral drugs,, including protease inhibitors for the AIDS virus.

“We could, of course, build the cost of viagra into everyone’s premium, but is that the right thing to do?” asked Dr. Francis Crosson, executive director of the Permanente Federation, the HMO’s corporate parent.

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By EILEEN GLANTON, AP Business Writer

Title: viagra ‘S EFFECT ON NERVE ACTIVITY ,  USA Today Magazine, 01617389, Oct2001, Vol. 130, Issue 2677

CARDIOVASCULAR SYSTEM

The drug sildenafil citratecauses a dramatic increase in the nerve activity associated with cardiovascular function, especially during physical and mental stress, bolstering recommendations that men with severe cardiovascular disease use caution when taking the drug. This finding comes from researchers at the University of Iowa Cardiovascular Research Center, Iowa City.

“Little is known about viagra ’s effect on the cardiovascular system. particularly during situations when the cardiovascular system is under stress, as it is during sexual activity,” notes Bradley G. Phillips, assistant professor in the university’s College of Pharmacy. “Recent concern and reports of heart attacks, arrhythmias, and even deaths temporally related to viagra use in patients with heart failure initially raised questions about the drug’s effect on the cardiovascular system.”

Researchers studied 14 healthy men, ages 25 to 39, who were given a 100mm dose of viagra or a placebo on two separate days. Men who received viagra on the first visit were given the placebo on their second visit and vice-versa. Neither the participants nor the researchers knew which drugs were being administered on either of the study days.

The researchers took baseline measurements of subjects’ blood pressure and heart rates, noradrenaline levels, and sympathetic nerve activity (nerve activity that causes blood vessels to constrict). The investigators took similar measurements 30 and 60 minutes after administering viagra and the placebo while subjects rested. Immediately following the 60-minute “rest” period, each participant’s cardiovascular response was evaluated during stressful conditions, including exercise, mental stress, and cold exposure.

Compared to the placebo, the researchers found that viagra resulted in more than a doubling of sympathetic nerve activity and a 30% increase in blood levels of noradrenaline. Moreover, sympathetic nerve activity after taking viagra increased even more dramatically during stressful conditions.

“It is well-recognized that sympathetic nerve activity is already increased in patients with cardiovascular diseases like heart failure and that this high sympathetic activity is detrimental over the long term,” Phillips indicates. “Our study showed that viagra increases this type of nerve activity at rest and even further during stressful situations. For people with unstable cardiovascular disease, this could be a problem.”