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Title: SADDLE SORE ,  By: Beech, Mark, Mravic, Mark, Sports Illustrated, 0038822X, 05/15/2000, Vol. 92, Issue 20

Section: Scorecard

Gear

Who Would have guessed that riding a bike could jeopardize your plans for a family? It’s no laughing matter for male and female cyclists, who sometimes struggle with sexual dysfunction, along with numbness or soreness in their backsides, after taking long rides. It turns out that tiny seats, and not tight pants, were making the term numb nuts more than just a put-down at the Tour de France.

Conventional saddles, which are often padded with gel or foam, lose their form when you sit on them, bulging upward and pressing against the nerves and arteries that run along the “sit bones.” Body Geometry Saddles, which are made by Specialized Bicycles, of Morgan Hill, Calif., are designed to correct that problem. The rear portion of the saddle is split in the middle to avoid contact with a rider’s most sensitive areas, and its surface is flatter so that padding doesn’t bunch up in the middle. Saddles, which come in men’s and women’s models, cost from $40 to $130, depending on the style.

For riders who experience numbness and soreness in their hands from handlebars putting pressure on the ulnar and median nerves, the company has designed gloves that are strategically padded. Gloves cost from $20 to $40. For more information visit Specialized Bicycles on the Web at www.specialized.com.

PHOTO (COLOR)

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By Mark Beech

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Copyright of Sports Illustrated is the property of Time Inc. and its content may not be copied or e-mailed to multiple sites or posted to a listserv without the copyright holder`s express written permission. However, users may print, download, or e-mail articles for individual use.
Source: Sports Illustrated, 05/15/2000, Vol. 92 Issue 20, p37, 1p

Title: viagra FOR THE THIGHS? ,  By: Lemonick, Michael D., Park, Alice, Time, 0040781X, 05/10/99, Vol. 153, Issue 18

Section: Science

A diet drug called orlistat could take off like last year’s big seller–but oh, those funky side effects

No matter what she did, Cindy Smith just couldn’t shed the 60 lbs. she’d gained during her pregnancy nine years ago. She went through over-the-counter weight-loss pills, liquid diets, starvation diets–always with the same result. “I would try it for about a week,” says Smith, 38, a customer-service manager at a Houston bank. “I’d lose maybe 5 to 10 lbs., then get discouraged and end up dropping it.”

A friend told her about an experimental diet drug being tested at nearby Baylor University, and Smith signed up. For two years, she and thousands of other overweight patients maintained a low-fat diet, exercised–and swallowed a medication called orlistat three times a day. “My clothes started fitting a lot looser after a month,” she says. Today Smith is down to 150 lbs., her prepregnancy weight. Not only that, but she’s maintaining the loss and hopes to drop even more.

Now millions of Americans will be getting the chance to see if orlistat works for them as well. The FDA ruled last week that the drug, made by Hoffman-LaRoche, can go on sale in the U.S. The dark blue capsules, under the trade name Xenical, could be available by prescription as early as this week.

Officially, orlistat is supposed to be taken only by the obese–those whose weight is at least 30% higher than it should be (27% for those with high blood pressure, high cholesterol or diabetes). But this is just a guideline: once a drug has been approved, doctors can prescribe it any way they want. And given Americans’ obsession with getting slim, the demand could be enormous. “The reality,” says Dr. Steven Heymsfield, deputy director of the Obesity Research Center at St. Luke’s Roosevelt Hospital in New York City, “is that millions of people who have tried everything else and are frustrated with their weight will walk into their physician’s office and say, ‘I want Xenical.’”

In short, the FDA has unofficially launched a gigantic, uncontrolled experiment on the U.S. population, much as it did with the diet drug Redux in 1996 and the impotence pill viagra in 1998. The Redux fad ended abruptly a year later when some users developed serious heart-valve defects–and major side effects are always a possibility with Xenical as well. With Redux, though, hints of danger had shown up in clinical testing. That’s not true of orlistat, either in animals or in human studies conducted in some of the 17 countries where the medication is already available. (An initial suspicion that users had a higher incidence of breast cancer proved unfounded.)

One reason may be that hardly any of the drug is absorbed into the body. Unlike all previous diet drugs, orlistat doesn’t reduce appetite. Instead, it interferes with an intestinal enzyme that breaks down dietary fat into an absorbable form. In essence, orlistat turns normal fat into something akin to Olestra, the fat-free fat Procter & Gamble has been using in snack foods since 1996.

As a result, about a third of the fat that would ordinarily be taken into the body is flushed right through the digestive system. Unfortunately, so are vitamins A, D, E and K, which bind to fat molecules. To make sure that patients don’t develop vitamin deficiencies, the FDA requires that the Xenical label recommend that users take a multivitamin two hours before or after taking the drug.

The good news is that orlistat is flushed out of the body too: less than 1% of the drug remains in the system. Perhaps as a consequence, the only documented side effectsare flatulence, greasy stools and, in a few cases, oily anal leakage.

That’s one reason orlistat users are supposed to change their eating habits. If someone takes it without also switching to a low-fat diet, says Dr. Michael Hamilton, director of Duke University’s Diet and Fitness Center, “that person is going to have a rude awakening.”

Beyond that, orlistat isn’t dramatically effective by itself. All the patients in the double-blind study went on strict eating regimens and exercise programs. Half of them were given orlistat, and half got an inert placebo. While those in the orlistat group lost an average of 10% of their initial weight after six months, the folks on the sugar pills lost nearly as much–a not inconsiderable 5%.

That’s not enough of a difference to justify putting orlistat on the market, says Dr. Jules Hirsch, an obesity expert at Rockefeller University and a member of the FDA advisory panel that evaluated the drug. Hirsch voted against approval. “We’re talking about something that will take a little bit of weight offfor a few years,” he says, “but that will not make obesity vanish. The question is, How valuable is that?”

By itself, not all that valuable. Ideally, says St. Luke’s Heymsfield, doctors should first urge obese patients to change their diet and start exercising regularly. If they still can’t lose weight, he would add orlistat to the mix. Another possibility, suggests Duke’s Hamilton, is to use orlistat with an appetite suppressant. The value of this new drug, says Heymsfield, is that it adds to the available anti-obesity therapies and lets doctors tailor the treatment to a patient’s needs. “I don’t see Xenical as something to displace one or another of the currently available drugs,” he says. “It’s not a magic bullet. But having one more bullet, so to speak, is very helpful.”

HOW IT WORKS Orlistat blocks an enzyme that breaks down fat in the intestines, preventing about 1/3 of it from being absorbed

ORLISTAT (XENICAL) Q & A

Who should take it?

Anyone whose weight is 30% or more above normal (27% for those suffering from high blood pressure, high cholesterol or diabetes). It’s not recommended for those who want to lose 5 lbs.

How well does it work?

Without changes in diet and a commitment to regular exercise, not all that well. Orlistat is best suited for kick-starting a new life-style.

What are the side effects?

Users can experience flatulence, diarrhea, oily stools and a condition delicately known as “anal leakage.” They may also suffer deficiencies in vitamins A, D, E and K.

How much does it cost?

One capsule costs $1.10; the standard regimen of three a day adds up to about $1,200 per year.

DIAGRAM: How Xenical works

ILLUSTRATIONS

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By Michael D. Lemonick

Reported by Alice Park/New York

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Copyright of Time is the property of Time Inc. and its content may not be copied or e-mailed to multiple sites or posted to a listserv without the copyright holder`s express written permission. However, users may print, download, or e-mail articles for individual use.
Source: Time, 05/10/99, Vol. 153 Issue 18, p72, 2p

Title: CONFLICTS ABOUND WHEN TREATING HIV PATIENTS WITH ED ,  By: McCann, Brian, Urology Times, 00939722, Dec2000, Vol. 28, Issue 12

Section: Special Populations

Cleveland– As the U.S. population ages, more patients will complain of erectile dysfunction and seek oral pharmacotherapy. When the patient is HIV-positive, difficult ethical and legal problems can arise.

Moral and ethical conflicts surface when a physician suspects that a patient may spread the HIV virus if erectile dys-function is restored, Hossein Sadeghi-Nejad, MD, said here at the Society for the Study of Impotence; meeting.

“What is the physician’s responsibility to society in general and to the third party; ie, the partner who may be infected with HIV as a result of our intervention?” said Dr. Sadeghi-Nejad, assistant professor of surgery/urology, UMD-New Jersey Medical School, and director of Center for Male Reproductive Medicine, Hackensack (NJ) University Medical Center.

The reasons why HIV-positive men wish to regain sexual potency vary, he said. Some may have had erection difficulties caused by the disease or treatments prescribed for HIV. Or perhaps they’re with another partner.

“Obviously, the advent of oral pharmacotherapy may have caused some of these HIV-positive men to rethink their celibacy” said Dr. Sadeghi-Nejad. “But how can we be sure that an HIV patient with restored erectile function will act responsibly?

“Right now, the bottom line is that you should not refuse treatment to an HIV patient unless you have objective evidence that patient will go out and harm somebody,” he said.

Clinical dilemma

Dr. Sadeghi-Nejad said this was an emerging clinical dilemma that needed more thought and, hopefully, the development of universal guidelines. He said that there are many legal documents pertaining to the rights of HIV-positive patients and the physicians who treat them. However, there is nearly nothing on the rights of a third party at risk for contracting the vires.

From a legal, practical perspective, physicians need to be aware of the Americans with Disabilities Act (ADA), particularly the case of Bragdon vs. Abbott, the first AIDS-related case to be considered by the U.S. Supreme Court.

In this landmark case, a person diagnosed as being HIV-positive is entitled to the protection of the ADA act–whether or not they are symptomatic, Dr. Sadeghi-Nejad explained.

“The evidence presented in Bragdon vs. Abbott was sufficient to show that asymptomatic HIV infection is a physical impairment with immediate, constant, and detrimental physical effects that substantially limits the major life activity or production;’ he said. “The legal fallout has been that the ADA probably applies to all people with an HIV infection.”

However, there are provisions under the ADA in which a physician can refuse to treat a patient if that patient poses a direct threat to others, Dr. Sadeghi-Nejad said.

“It is very important to emphasize that the medical provider who is refusing to treat (an HIV-positive patient with ED) must prove direct threat and this must be by individual assessment concerning mode of transmission, severity of harm, probability of transmission, and duration of infection,” he said.

Refusal to treat rarely justifiable

Dr. Sadeghi-Nejad also emphasized that a majority of Americans live in legal jurisdictions where asymptomatic HIV infection will be considered a disability and fall under the Bragdon vs. Abbott findings.

“This means that only in rare instances will the physician’s refusal of treatment for erectile dysfunction of an HIV-positive patient be legally justifiable,” he said.

Dr. Sadeghi-Nejad said it was important for physicians to keep in mind that different parts of the United States have their own legal issues and approaches specific to that area. The physician must carefully document patient treatment and history, and that the patient was counseled on the risk of transmission and other safety issues.

Consistent meteculous, and thorough documentation combined with informedconsent with hopefully prevent third party liability and lawsuits.

PHOTO (COLOR): Americans with Disabilities Act (ADA) 42 USC section 1218 (a): No individual shall be discriminated against on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation by any person who owns, leases (or leases to), or operates a place of public accommodation.

PHOTO (COLOR): Dr. Sadeghi-Nejad

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By Brian McCann, UT Correspondent

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Source: Urology Times, Dec2000, Vol. 28 Issue 12, p1, 2p

Title: TO OUR HEALTH–AND YOURS ,  Newsweek, 00289604, 04/06/98, Vol. 131, Issue 14

Section: LETTERS

BYLINES

HOLLYWOOD HAS THE Oscars; the magazine business has the National Magazine Awards. Last week the American Society of Magazine Editors nominated NEWSWEEK as a finalist in the Personal Service category for three 1997 cover stories: “The Scary Spread of Asthma,'’ “The Hidden Causes of Heart Attacks'’ and “The New Science of impotence .'’ It’s always gratifying to be recognized, especially for work deemed by the judges to “help readers take action to improve the quality of their lives.'’ But it was particularly rewarding to be nominated for three stories on health-related issues. In the last few years NEWSWEEK has made a special commitment to report on stories that affect the well-being of every American, both in our weekly coverage and in our monthly FOCUS ON YOUR HEALTH section. All three of the nominated stories were edited by Senior Editor John Capouya. The team of writers was led by Geoffrey Cowley and included John Leland, Sharon Begley, Anne Underwood and Adam Rogers. The ASME committee also nominated two NEWSWEEK writers for work in other publications. General Editor Alan Zarembo was cited in the Reporting category for “Judgment Day'’ in Harper’s Magazine. Contributing Editor Fareed Zakaria’s “The Rise of Illiberal Democracy,'’ published in Foreign Affairs, was nominated in Essays and Criticism. The winners will be announced on April 29.

PHOTO (COLOR): NEWSWEEK’S August 11, 1997 Issue - The Cover: “The Hidden Causes of Heart Attacks”

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Copyright of Newsweek is the property of Newsweek and its content may not be copied or e-mailed to multiple sites or posted to a listserv without the copyright holder`s express written permission. However, users may print, download, or e-mail articles for individual use.
Source: Newsweek, 04/06/98, Vol. 131 Issue 14, p14, 1p

Title: ORAL MEDICATIONS FOR ERECTILE DYSFUNCTION: MODE OF ACTION AND TREATMENT ISSUES ,  By: Casey, Richard, Canadian Journal of Human Sexuality, 11884517, Fall98, Vol. 7, Issue 3

ABSTRACT: This paper describes the physiological processes involved in penile erection and uses this information to explain the mode of action of oral medications used in the treatment of erectile dysfunction (ED). New biomedical treatments for ED, such as sildenafil, present both a challenge and an opportunity for health care professionals to address ED with their patients and clients. An algorithm for the treatment of ED by primary care physicians is proposed and discussed in relation to diagnosis, outcome measurement, referral, and use of sildenafil and other treatment options.

Key words: Erectile dysfunction, Physiology of erection, Oral medications, Treatment Sildenafil

INTRODUCTION

The high prevalence of erectile dysfunction (ED) in North America has been well documented (Feldman et al., 1994), as have the various biomedical treatments used in treatment (Coleman, 1998). The emergence of sildenafil (Viagra[TM]), an effective, easy-to-use, and relatively low risk oral medication (Goldstein et al., 1998; Morales et al., 1998), has given this issue wide publicity and, in the process, altered the landscape for public and professional education about ED and its treatment. Until recently, clinicians estimated that they were seeing only about 10% of men who had symptoms that would fit the standard definition of ED, that is, men who had persistent difficulty in getting or maintaining an erection sufficient for satisfactory sexual performance and who perceived this as a problem. Since ED can cause considerable distress, it was assumed that many men were not seeking treatment due to embarrassment, resignation, acceptance or discomfort with the available treatment methods.

Those of us who treat ED have long sought treatment options that have high efficacy, low adverse effects, and high acceptance by men and their partners. The approval of sildenafil (Viagra[TM]) in the U.S. (pending in Canada) can be expected to have a significant impact on both the number of men and couples seeking treatment, and the delivery of sexual health care in general. A reported 2 million prescriptions for sildenafil were written in the first four months following its approval. Given expanded public access to information (and misinformation) about ED and related sexual problems, it seems likely that physicians and other health professionals will face increasing requests for clear and understandable explanations about new oral medications and other “traditional” treatment options.

While most men with ED do not want or need a detailed lecture on the physiology of erection, they and their partners may nevertheless want to know how pharmacological agents and other biomedical treatments work. This paper therefore describes the process of penile erection, identifies the sites of action of pharmacological agents used in the treatment of ED, and comments on emerging issues in this field.

HOW DOES THE PENIS WORK?

Our improved understanding of penile physiology has led to better diagnosis and treatment of men with ED. We now recognize that two sets of processes are involved in penile function: one set maintains the flaccid condition, the other facilitates erection.

FACTORS THAT MEDIATE NATURALLY OCCURRING ERECTION Erection occurs when nerve impulses from the brain (psychogenic erection) and from genital stimulation (reflexogenic erection) combine to cause blood to flow faster into than out of the penis. From this limited perspective, the penis can be viewed as a hydraulic organ. It is composed of three sponge-like cylindrical bodies that run the length of the penis (the two corpora cavernosa and the corpus spongiosum) and are supplied with blood by small branches of the penile artery (see Figure 1). These helicine arteries empty into blood spaces (sinusoids) in this spongy tissue. The spaces are lined with vascular epithelial cells and are separated from each other by trabeculae, partitions made of smooth muscle. Blood is carried to the helicine arteries by branches of the pelvic artery, and carded away from the sinusoidal spaces by surface veins that run adjacent to the sheath (tunica albuginea) that surrounds each corporal body.

The nervous input that induces erection is delivered to the penis via the pelvic nerve, which exits the spinal cord at the lower sacral level (S2-S4) and branches into the cavernous nerve that supplies the corporal bodies. Both parasympathetic fibres that release acetylcholine (cholinergic fibres), and other nerves that release nitric oxide (NO), are involved in this process (Figure 2). It is damage to this nerve supply during some rectal and prostate surgeries that can cause post-treatment ED. Nervous input during sexual arousal causes dilation of the cavernosal arteries and results in a 30- to 40-fold increase in the rate of flow of blood through these arteries into the sinusoidal spaces. How does this nervous input cause the increased blood flow that initiates erection?

NITRIC OXIDE AND ERECTION When the penis is flaccid, the smooth muscle fibres that surround the sinusoids are contracted, thus restricting the rate of blood flow into the spaces of the corporal bodies. Erection occurs as a result of the action of nitric oxide (NO) on these smooth muscle fibres. NO activates the enzyme guanylate cyclase that converts guanosine triphosphate (GTP) to cyclic guanosine monophosphate (cGMP). cGMP causes smooth muscle relaxation (probably by decreasing cellular calcium which is needed for contraction) with a resulting increase in blood flow into the sinusoidal spaces (Figure 3). cGMP is inactivated naturally by an enzyme, phosphodiesterase type 5 (PDE-5), which is present in the smooth muscle cells. Sildenafil (Viagra[TM]) inhibits PDE-5, and thus prolongs the effect of cGMP. This is particularly relevant in the case of ED where the natural NO-stimulated production of cGMP is insufficient to cause or maintain an erection.

NO is released from the both the non-adrenergic non-cholinergic (NANC) nerves that supply the penis, and also from the endothelial cells that line the sinusoids. The endothelial cells are triggered to release NO by acetylcholine from parasympathetic nerve fibres that are active during sexual stimulation. This explains why conditions that damage endothelial cells (such as high cholesterol, diabetes, or smoking) may also compromise erection. The mechanisms that mediate NO release and cGMP production and action are thus key features in the process of erection (see Figure 3).

Although it is thought to play a lesser role than NO in facilitating erection, prostaglandin E₁ (PGE₁) is also released during sexual arousal. Like NO, it activates production of a compound in smooth muscle cells that causes muscle relaxation. In this case, the compound is cyclic adenosine monophosphate (cAMP). PGE₁ activates the enzyme adenyl cyclase that converts adenosine triphosphate (ATP) to cAMP. These observations explain why PGE₁ injected intercavernosally (Caverject[TM]) or inserted as a pellet intraurethrally (MUSE) can induce erection in men with ED. Other naturally occurring neuropeptides, such as vasoactive intestinal peptide (VIP), may also be involved in the smooth muscle relaxation that leads to erection (see Figure 3).

RESTRICTION ON VENOUS OUTFLOW DURING ERECTION Continued filling of the sinusoids as a result of the above processes eventually compresses the veins that carry blood away from the penis against the tunica that surrounds the corporal bodies. This compression further facilitates erection by blocking blood outflow.

FACTORS THAT MAINTAIN THE NORMAL FLACCID CONDITIONS OF THE PENIS In the flaccid penis, sympathetic nerve fibres release norepinephrine (such nerves are called noradrenergic) which binds to alpha 1 adrenergic receptors on penile smooth muscle to cause intracellular changes that result in contraction. In some men, damage to the endothelial cells may cause release of endothelin, an action which can also cause smooth muscle contraction (see Figure 4). A variety of other factors (not shown) can also regulate the contraction that maintains penile flaccidity.

Our increasing knowledge of the physiological processes involved in erection makes it possible to understand the sites of action of the various medications currently being used or proposed to restore or enhance erectile function in men with ED.

HOW DO ORAL, INTRAURETHRAL AND TOPICAL MEDICATIONS FACILITATE ERECTION?

Pharmacological agents can facilitate erection by enhancing the natural processes that induce erection (see Figs 1-3) or by inhibiting the processes that maintain flaccidity (see Fig. 4). The scheme used by Morales (1997) to classify non-invasive pharmacotherapy agents for ED is expanded here in Table 1 to include other compounds currently being considered for either oral or topical use.

ORAL MEDICATIONS

Peripheral Agents

Sildenafil (Viagra[TM]) inhibits PDE-5 and thus blocks degradation of cGMP in the corpus cavernosal smooth muscle when sexual stimulation is present. cGMP causes smooth muscle relaxation and increased blood flow into the sinusoids. This blood flow raises oxygen tension in the endothelial cells and facilitates their production of NO in response to the acetylcholine that is released from parasympathetic fibres in response to sexual stimulation. Sildenafil’s action thus requires that some NO production and release be present.

L-arginine is a precursor in NO synthesis and has therefore been tested as an oral medication for ED because of is possible role in elevating, NO levels (Zorgniotti & Lezzi, 1994). To date, the efficacy of L-arginine remains unproven.

Adrenergic Receptor Agonists

Yohimbine, is a selective inhibitor of alpha adrenergic receptors and produces elevation of blood pressure and heart rate. Despite its use in ED treatment, the efficacy of this compound remains in doubt (see above and Coleman, 1998).

Phentolamine has long been used in combination with other agents in intracavernosal injection (ICI). It blocks both alpha 1- and alpha 2-adrenergic receptors, and thus inhibits the normal contractile effect of noradrenaline on cavernosal smooth muscle. It has also been tested as an oral agent with some success (Goldstein and The Vasomax Group, 1998; Gwinup, 1988; Wagner et al., 1996).

Dopamine Receptor Agonists

Apomorphine This centrally acting drug is thought to excite dopaminergic pathways in the CNS and is proposed for use in treatment of ED that does not have a major organic component. Preliminary testing showed some enhancement of erectile function, with higher doses increasing the severity of such side effects as hypotension and nausea (Heaton, Morales, Adams, Johnston & el-Rashidy, 1995). A more recent placebo-controlled double blind study found that sublingual apomorphine SL administered to men with ED (no major organic component) led to erections firm enough for intercourse in 45.8%, 52.0%, and 59.6% at doses of 2, 4 and 6mg respectively; placebo resulted in similar responses in 32.0%-35.0% (Padma-Nathan et al., 1998). The main side effect of nausea (mainly mild to moderate) was also dose-dependent (2.1%, 19.5% and 39.0% vs. a maximum or 4.9% for controls).

Serotonergic Receptor Agonists

Trazodone, a tricyclic antidepressant, has been associated with the development of prolonged penile erection and priapism. Two recent double blind placebo-controlled studies found that men on trazodone did not differ from the placebo groups in terms of erectile or sexual function (Costabile & Spevak, 1998; Meinhardt et al., 1997). The exact mechanism of action has not been described, and there is little clinical evidence to support its routine use.

INTRAURETHRAL AGENTS

Alprostadil, a synthetic prostaglandin, is inserted into the urethra in pellet form (MUSE, Medicated Urethral System for Erection) from whence it is absorbed into the cavernosal tissue. It is presumed to bind to PGE₁ receptors on cavernosal smooth muscle, and probably exerts its muscle relaxant effect, and hence its impact on ED, by causing cAMP elevation (Padma-Nathan et al., 1997).

THE CHANGING FACE OF ED TREATMENT

The preceding overview provides a basis for understanding the rationale for current biomedical treatments for ED, and particularly for oral medications which are the primary focus of this paper.

BACKGROUND Prior to 1980, there were few biomedical treatments for men with ED. The introduction of intracavernosal injection therapy (e.g., papaverine, phentolamine, prostaglandin) in the early 1980s allowed physicians to study erectile activity and to offer patients an effective alternative to penile implantation. This period also lead to an explosion of penile vascular procedures geared to improving blood flow to the penis (arterial surgery) or decreasing venous outflow (dorsal vein ligation). In exceptional cases (traumatic injury to the pudendal artery) these procedures are successful, but most urologists have all but abandoned revascularization/venous ligation procedures due to the limited success in most patients and the difficulty in selecting who may benefit from surgery.

CLINICAL GUIDELINES FOR TRADITIONAL “GOAL-DIRECTED” THERAPY FOR ED In an attempt to standardize patient care, the American Urologic Association (AUA) established a Clinical Guidelines Panel in 1996 to analyze all available literature regarding current methods for treating ED. This resulted in practical recommendations published in December, 1996 (American Urologic Association, 1996). The panel analyzed outcome evidence for five treatment alternatives:

1. Oral drug therapy (yohimbine)
2. Vacuum Constriction Devices;
3. Intracavernosal vasoactive drug injection therapy;
4. Penile prosthetic implantation;
5. Arterial and venous surgery.

The panel recommended that before treatment is considered, all options should be explained to the patient and, if possible, his partner. Based on a review of the data available at the time, the panel concluded that yohimbine did not appear to be an effective treatment for organic ED, and that the chances of success for arterial and venous surgery did not appear to be high enough to justify the routine use of such therapies. The three recommended options from which patients might choose were thus: Vacuum Constriction Device (VCD) therapy, intercavernosal drug injection therapy (ICI), and penile prosthesis surgery. These methods had been shown to result in sufficiently increased patient and partner satisfaction (and return to intercourse) to warrant continued use (for reviews of these methods and their effects and side effects, see Basson, 1998 and Coleman, 1998).

The panel’s recommendations are consistent with the concept of “goal-directed therapy” first suggested by Lue (1990) and now used by most physicians who treat erectile dysfunction. While this therapeutic approach is often successful, it tends to ignore the individual etiologies for ED because patient choice determines what treatment is used. This approach does not necessarily require that the treating physician make an accurate etiologic diagnosis before deciding on treatment. Furthermore, the treatment options chosen by patients may downplay or ignore other significant psychogenic factors that may be associated with the ED (e.g., the choice of ICI for ED that had its onset secondary to premature ejaculation). Recent developments in treatment of ED have highlighted the need for a rethinking of diagnosis and treatment.

AN EMERGING APPROACH TO CLASSIFICATION AND TREATMENT OF ED

The introduction of the intraurethral medication alprostadil (MUSE, medicated urethral system for erection) and the oral medication sildenafil (Viagra[TM]) has expanded the range of treatment options and, in so doing, made it more difficult to continue the “goal-directed approach” described above. As other therapeutic options appear (e.g., oral phentolamine, apomorphine, topical agents), physicians will need a better functional classification for the medical treatment of ED. There is presently no “gold standard” and no urologically established therapeutic classification for ED. A newly developed classification scheme (Heaton, 1998; Heaton, Adams & Morales, 1997) may allow clinicians to evaluate new treatments as they are introduced and to better link etiology and treatment method. The scheme identifies four primary modes of action for medications used in the treatment of ED: central initiator, peripheral initiator, central conditioner, peripheral conditioner (local or systemic). The scheme also suggests two subcategories that list routes of delivery and mechanisms of differential sensitivity. The modes of action are briefly summarized below.

Central initiators are medications that have their site of action within the CNS. For example, the neurotransmitter dopamine in the brain plays a role in activating the neural events that lead to erection, and central initiator-type medications would exert their effects at such sites (e.g., apomorphine). Central conditioners improve the internal milieu of the CNS to enable erection, but do not initiate the process (e.g., serotonin plays this role naturally, as does testosterone). Peripheral initiators act outside the CNS and would influence sites directly involved in the initiation of erection (e.g., cholinergic nerves, NO-releasing nerves in the penis play this role naturally; prostaglandin therapy would be expected to work at this level). Peripheral conditioners improve functions in penile tissue or associated systems (nerves, blood vessels) that enhance, but do not cause, erection (e.g., sildenafil acts at this level).

While the Heaton et al. (1997) scheme was developed to indicate where and how medications might be targeted to enhance erectile function, Gajewski (1998) has also used it to explain why ED may be associated with a variety of medical conditions (diabetes mellitus, cardiovascular disease) or a side effect of medications used to treat health problems. Heaton et al. (1997) suggest that the scheme will facilitate a diagnostic classification based on the man’s capacity to respond to particular therapies. In this way, treatment options can be better linked to clinical diagnostic findings. This link between diagnosis and treatment will become increasingly important as compounds with greater specificity make it possible to be more precise and selective in choice of therapy.

CRITICAL ISSUES IN THE ASSESSMENT AND TREATMENT OF ED IN PRIMARY CARE

INCREASING DEMAND FOR TREATMENT Until now, the absence of a single therapy for ED has meant that the majority of patients are seen in specialized centres that have the resources to offer all, or at least most, forms of biomedical treatment. The average patient probably waited about three years before seeing someone about their ED and then another six months for an appointment with a specialist who could offer this range of treatment.

The present infrastructure of ED treatment in Canada and the U.S. cannot easily meet the high demand for treatment that sildenafil and other emerging treatments are expected to produce. Family physicians will be increasingly involved in diagnosis and prescription, and sex counsellors and therapists who are not physicians will be required to make referrals as they integrate biomedical treatments into other therapeutic approaches.

ROLE OF THE PRIMARY CARE PHYSICIAN

A number of authors have emphasized the role of primary care physicians in sexual health care in general, and in the treatment of ED in particular (Holzapfel, 1998; Basson, 1998). As demand increases, we can expect, in the absence of contraindications, that sildenafil and other oral medications will be widely used in the treatment of ED. The treatment algorithm in Figure 5 outlines how a primary care physician who is not a specialist in sexual medicine might routinely address the needs of men with ED. The first step would involve a medical and sexual history and a physical examination to determine: treatable risk factors for ED (obesity, smoking, etc.); biomedical conditions and medications that might cause or exacerbate ED; level of sexual desire as a contributing factor; and relationship issues that are a cause or consequence of ED.

While a number of methods have been developed to test erectile function (nocturnal penile tumescence testing, duplex Doppler blood flow recordings of the penile arteries, dynamic infusion cavernosometry for assessment of venous outflow, office-based trial with an injectable intracavernosal agent), these are unlikely to be used routinely by primary care physicians. Each method has limitations, even in the hands of a sexual medicine specialist or urologist, and the history and physical can often reveal the information needed for subsequent action (see Fig. 5). Some physicians may use questionnaires, or selected questions from them, to assess ED or sexual functioning. Examples include the International Index of Erectile Function (Rosen et al., 1997), The Brief Male Sexual Function Inventory (BMSFI) and the self-administered Derogatis Inventory for Sexual Functioning (DISF-SF). This information can provide a baseline for assessing treatment efficacy and outcomes.

However, before undertaking a trial with sildenafil, physicians and their patients should consider a number of factors. The patient should be aware of treatment options and their possible side effects. Where possible, the partner’s knowledge of and interest and involvement in the treatment should be assessed. The primary goal of safe prescription means that medical contraindications for sildenafil should be ruled out (see Goldstein, 1998; Morales et al., 1998). This would prelude its use by men taking nitrates or those with recent heart attack or chronic heart disease. It would warrant caution for men with angina, recent coronary artery surgery or problems with exercise tolerance. Patients who are reviving sexual activity after a prolonged period of inactivity should be treated as the physician would a patient who requests an assessment before starting an exercise program. A good role of thumb is to exclude patients who cannot easily climb three flights of stairs or who would be referred to a cardiologist prior to such a program.

The predominance of psychological factors in the apparent etiology would warrant referral to a sexual therapist. Attention to these psychological/situational issues should also be part of primary care, since situational ED is often accompanied by anxiety and the concomitant sympathetic nervous system activation that causes peripheral vasoconstriction.

This may explain why patients with a high level of anxiety often experience a suboptimal response to peripheral agents. This would be of particular importance in the case of sildenafil, the action of which requires sufficient sexual response to induce some NO release in the penile tissues. In such high anxiety cases, ICI might therefore be more effective than sildenafil, particularly if psychological counselling to reduce anxiety-provoking expectations is not provided (see Basson, 1998, for discussion of the use of sildenafil in the context of such counselling).

Men who wish to improve “normal” erectile function are probably not candidates for sildenafil. While there are anecdotal reports of patients’ experiencing harder erections and shorter post-ejaculation refractory periods, the exact response of men with uncompromised erectile function is unclear. One would expect that normal erectile function is unlikely to be sufficiently enhanced by sildenafil to warrant prescription.

Having addressed these issues, and in the absence of medical contraindications (see Goldstein et al., 1998; Morales et al., 1998) or other impediments, the patient may opt for a trial of sildenafil (see Fig. 5). As with any such treatment, a key issue will be the choice of a realistic outcome measure. The lIEF is particularly helpful in this regard, because its parameters provide a basis for assessing changes in both erectile function (in sexual situations including intercourse) and psychological well-being (enjoyment, confidence, sexual satisfaction, relationship satisfaction) (Rosen et al., 1998). However, studies that have used this instrument to measure outcome have captured little information on time to onset of erection, duration of erection, or partner reaction and satisfaction. We can anticipate such information in the future but, even then, what constitutes a successful treatment outcome for any method may remain an important and debateable question.

Men who do not have a satisfactory outcome on sildenafil might then be tested with intracavernosal injection or a vacuum erection device (VED). Referral to a sexual medicine specialist might be done before such a trial if the physician is not prepared for this next step or after if it unsuccessful.

The preceding observations indicate that sexual arousal in men involves a complex interaction of physiological and subjective processes. We now have a variety of methods for assessing erectile function (and dysfunction) and the promise of sildenafil and other emerging pharmacological methods for treating the latter. This promise highlights the need for physician training and cross-disciplinary collaboration to meet the sexual health care needs of men and couples seeking treatment for ED.

Correspondence concerning this paper should be addressed to Richard Casey, MD, The Male Health Centres, 1235 Trafalgar Road North Suite 407, Oakville, Ontario, L6H 3P1. Tel: 905-338-1078; Fax: 905-338-3150.

Table 1 Medications for treatment of erectile dysfunction

ORAL MEDICATIONS

Peripheral agents

• Sildenafil
• L-arginine

Adrenergic receptor antagonists

• Yohimbine
• Phentolamine (Vasomax[TM])

Dopamine receptor agonists

• Apomorphine

Serotonergic receptor agonists

• Trazodone

INTRAURETHRAL AGENTS

• Alprostadil (synthetic PGE₁)

TOPICAL AGENTS

• Minoxidil
• Prostaglandin E₁ (Topiglans)
• Nitroglycerin

UNKNOWN MECHANISMS

• Testosterone

Adapted from Morales (1997)

DIAGRAM: Figure 1. Penile Anatomy and Circulation

DIAGRAM: Figure 2. Key Nerves of the Penis

DIAGRAM: Figure 3. Chemical Messengers and Neurotransmitters Involved in Erection

DIAGRAM: Figure 4. Chemical Messengers Involved in Muscle Cell Contraction

DIAGRAM: Figure 5. Suggested assessment/treatment diagram for PCP

References

American Urologic Association. (1996). Report on the treatment of organic erectile dysfunction. Clinical practice guidelines. Baltimore: author.

Basson, R. (1998). Integrating new biomedical treatments into the assessment and treatment of erectile dysfunction. Canadian Journal of Human Sexuality, 7, 213-229.

Coleman, E. (1998). Erectile dysfunction: A review of current medical treatments. Canadian Journal of Human Sexuality, 7, 231-244.

Costabile, R.A., & Spevak, M. (1998). Trazodone is not effective therapy for erectile dysfunction: The results of a placebo controlled, double blind study (abstract). Journal of Urology (Suppl.), 159, 240.

Feldman, H.A., Goldstein, I., Hatzichristou, D.G., et al. (1994). impotence and its medical and psychosocial correlates: Results of the Massachusetts Male Aging Study. Journal of Urology, 151, 54-61.

Goldstein, I., Lue, T.F., Padma-Nathan, H., Rosen, R.C., Steers, R.C., & Wickes, P.A. (1998). Oral sildenafil in the treatment of erectile dysfunction. New England Journal of Medicine, 338, 1397-1404.

Goldstein, I., & The Vasomax Study Group. (1998). Efficacy and safety of oral phentolamine (Vasomax[TM]) for the treatment of minimal erectile dysfunction (abstract). Journal of Urology (Suppl.), 159, 240.

Gwinup, G. (1998). Oral phentolamine in nonspecific erectile insufficiency. Annals of Internal Medicine, 109, 162-163.

Heaton, J.P.W. (1998). New classification system for dysfunction therapies. Journal of Andrology, 19, 399404.

Heaton, J.P.W., Adams, M.A., & Morales, A. (1997). A therapeutic taxonomy of treatments for erectile dysfunction: An evolutionary imperative. International Journal of impotence Research, 9, 115-121.

Holzapfel, S. (1998). The physician’s role in dealing with men’s sexual health concerns. Canadian Journal of Human Sexuality, 7, 273-286.

Lue, T.F. (1990). impotence — A patient’s goal-directed approach to treatment. World Journal of Urology, 8, 6774.

Meinhardt, W., Schmitz, P.I., Kropman, R.F., de la Fuente, R.B., Lychlama A Nijeholt, A.A., & Zwartendijk, J. (1997). Trazodone: A double blind trial fro treatment of erectile dysfunction. International Journal of impotence Research, 9, 163-165.

Morales, A. (1997). Noninvasive pharmacotherapy for erectile dysfunction. In J.P.W. Heaton, A. Morales and S.G. Holzapfel (Eds.), Erectile Dysfunction: Diagnosis and Management in Primary Care (pp. 31-34). Toronto: Pegasus Healthcare International.

Morales, A., Gingell, C., Collings, M., Wickes, P.S., & Osterloh, I.H. (1998). Clinical safety of oral sildenafil citrate (Viagra[TM]) in the treatment of erectile dysfunction. International Journal of impotence Research, 10, 6974.

Padma-Nathan, H., Fromm-Freek, S., Ruff, D., McMurray, J.G., & Rosen, R.C. (1998). Efficacy and safety of apomorphine vs. placebo for male erectile dysfunction (MED) (abstract). Journal of Urology (Suppl.), 159, 241.

Padma-Nathan, H., Hellstrom, W., Kaiser, F.E., Labasky, R., Lue, T.F., Nolten, W., Norwood, P.C., Peterson, C.A., Shabsigh, R., Tam, P.Y., Place, V.A., & Gesundheit, N.(1997). Treatment of men with erectile dysfunction with transurethral alprostadil. New England Journal of Medicine, 336, 1-7.

Rosen, R.C., Riley, A., Wagner, G., Osterloh, I.H., Kirkpatrick, J., & Mishra, A. (1997). The International Index for Erectile Function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology, 49, 822-830.

Wagner, G., Lacy, S., Lewis, R., & Zorgniotti, A. (1996). Buccal phentolamine: A pilot trial for male erectile dysfunction at three separate clinics. Journal of Urology, 155, 49.

Zorgniotti, A.W., & Lizza, E.F. (1994). Effect of large doses of the nitric oxide precursor, L-arginine, on erectile dysfunction. International Journal of impotence Research, 6, 33-35.

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By Richard Casey, The Male Health Centres, Oakville, Ontario

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Source: Canadian Journal of Human Sexuality, Fall98, Vol. 7 Issue 3, p203, 10p

Title: Keeping it up ,  By: Adams, Bob, Advocate, 00018996, 11/11/2003, Issue 902

Section: health update

Changes in erection function are normal with age — but for gay men these changes are often anything but acceptable

When Jeremy Morse sneaked a little blue Viagra pill from his partner’s prescription bottle in 1999, it was curiosity — not medical necessity — that fueled his desire to try the erectile dysfunction drug. “I was thinking it might give me the erection of stone; that’s what I was really looking for,” says the 33-year-old Phoenix resident.

Morse’s experimentation with and expectations of erectile dysfunction medications aren’t uncommon, health care providers say. Although Viagra use is widespread among heterosexual men, there’s a general sense among medical professionals that gay men are more apt to try or use the drug on a regular basis.

Data from more than 5,000 HIV-negative gay men participating in an HIV vaccine trial seem to bear out this suspicion, says Ken Mayer, medical research director for Boston’s Fenway Community Health. When participants were asked in 2002 about drug use during the past six months, 15% to 20% of the men reported taking Viagra.

The reasons gay men turn to erectile dysfunction treatments more readily than their straight peers are numerous and complex, but much of the explanation may be rooted in gay male culture’s idolization of youth and sexual prowess, says Tony Mills, an openly gay Los Angeles physician and the 1998 International Mr. Leather titleholder. “There’s definitely a heightened importance on sex and casual sexual relationships in gay culture,” he says. “And it’s very common for part of a gay man’s self-esteem to be wrapped up in his sexual performance. When we notice even a slight change in that, it ends up being a very big thing in our minds.”

Change does occur. Varying degrees of sexual dysfunction are relatively common as men grow older. Some studies have shown that about 5% of men in their 40s experience symptoms of erectile dysfunction, such as erections that aren’t quite as hard or the occasional difficulty in getting aroused, with the percentage climbing significantly as men age. The Viagra Web site claims that half of all men between the ages of 40 and 70 experience at least occasional erectile dysfunction symptoms.

But Stephen E. Goldstone, medical director of the Web site GayHealth.com, says that while erectile dysfunction among older men is not unusual, gay men already are more likely to be concerned by even rare signs of it — and are more likely to seek treatment. “We go for Botox; we go for plastic surgery,” he says. “We don’t want to see our erections drop as we grow old either.”

However, it’s not just middle-aged gay men seeking treatment. Physicians say there also is a sizable demand for the drugs among young gay men, some even in their early 20s or younger. Experimentation drives much of that, as does the desire of recreational drug users to counter the erection-hindering effects of ecstasy, ketamine, and crystal metharnphetainine. Yet many young gay men still coming to terms with their sexuality may experience real, if temporary, impotence problems because of their anxiety or nervousness about having sex with another man, Goldstone says: “For these guys, Viagra can certainly lower the anxiety level tremendously by taking away the worry about being able to get an erection, and help them over the proverbial hump, so to speak.”

Viagra and Levitra, an erectile dysfunction drug approved by the Food and Drug Administration in August, work by increasing blood flow to the penis. (A third medication, called Cialis, is currently under FDA review.) They’re widely prescribed to treat erectile dysfunction caused by smoking, high blood pressure, high cholesterol, diabetes, and other physical ailments — as well as mental health conditions such as depression, stress, and anxiety. The drugs also are commonly used by HIV-positive men experiencing a condition called hypogonadism, which reduces the amount of testosterone in the body, making it difficult to achieve erections.

“For these men, they can be amazingly effective drugs,” Mills says.

But men who merely experiment with erectile dysfunction medications are often disappointed with the results, with the spontaneity-killing wait of 30 minutes or more for the medications to kick in, or with such side effects as flushing, headaches, and even blue-tinted vision. “A lot of people also think it’s going to improve libido and the sex drive, but it doesn’t,” says Mills, 42, who himself occasionally uses Viagra and Levitra. “It really only works on function.”

That’s precisely what Morse discovered. “As far as enhancing the sex, it didn’t do much of anything,” he says.

While erectile dysfunction treatments can restore the self-confidence and rejuvenate the sex lives of many gay men, unexpected emotional issues can arise, says Michael Alvear, a gay sex advice columnist and author of the book Men Are Pigs but We Love Bacon. These problems are not uncommon — even among the partners of the men who are taking the medications.

“One of the most interesting letters I’ve ever gotten was from a gay man whose boyfriend was impotent, got a prescription for Viagra, and schwing, things started happening,” Alvear says. “But the boyfriend said he felt like he was getting ‘pill-fucked.’ He wanted the experience of turning his partner on, and Viagra actually led to a building resentment because he wasn’t getting that experience.”

Morse also struggled with those feelings when he discovered that his partner of 11 years was secretly taking Viagra. “I started wondering if I wasn’t good enough or sexy enough,” he says. “These stupid little pills became the bane of my existence.”

Despite glowing media reports and upbeat advertising campaigns, erectile dysfunction drugs also don’t work for everyone. Viagra’s Web site acknowledges that the medication is ineffective in about 20% of the men who take it. “Because we’ve made Viagra seem like the be-all, end-all for sexual dysfunction,” Goldstone says, “if it doesn’t work for people, they end up being devastated.”

Another worry for health providers is that gay men who combine Viagra or Levitra with party drugs may ultimately engage in unprotected sex, possibly even multiple sexual encounters, putting themselves or others at risk for HIV and other sexually transmitted diseases. “You may be so high that you have no real sense of judgment,” Goldstone says. “But now you’re able to get an erection and just jump in.”

This is particularly true for injectible medications like Caverject and Trimix, drugs that are administered as a shot directly into the penis. Although more difficult to obtain without a prescription than pills like Viagra or Levitra, injectible treatments are often sought by recreational drug users who may already be accustomed to injecting themselves or desire the quick-acting and virtually guaranteed effects of the shots, Mills says.

While a boon for men with legitimate ED symptoms who don’t respond to Viagra or Levitra, injectible treatments are significantly more likely to cause a dangerous condition called priapism, in which an erection doesn’t go away, resulting in damage to penile tissue. Doctors counsel patients taking Caverject and Trimix on how to treat erections lasting longer than four hours — for example, a double dose of the over-the-counter decongestant Sudafed may help, Mills says — and when to seek emergency room treatment.

But men high on party drugs may not realize a long-lasting erection poses a medical danger until they reach a point where surgery may be the only successful treatment. “And with that comes the risk that there will be long-term problems getting an erection naturally,” Mills warns.

Mills, however, believes that in the absence of party-drug usage, ED treatments actually can improve the likelihood of safer sex for many gay men, especially those who lose their erections when they use condoms. “When that does happen, you’re stuck — do you risk losing an erection when you try to use a condom, or do you just have sex without it? Viagra can be helpful in making sure you stay hard so you can use condoms,” he notes.

Despite the possibility for the medications to be misused, Mills, Goldstone, and Mayer agree that Goldstone says treatments are needed and useful in treating what was once a condition rarely discussed by doctors or patients. All three also are typically willing to give their gay patients samples or limited prescriptions to try the medications if they’re experiencing even occasional symptoms of sexual dysfunction.

The key, Mayer says, is to seek the drugs from your health care provider and not get them from friends, in a club, or through the Internet. Talking with your doctor allows physicians to screen patients for possibly dangerous conditions, like diabetes, that may be causing the erectile dysfunction; educate them about the risks and benefits of the drugs; and encourage them to practice safer sex.

“Then people will have the context to make informed decisions and to use the drugs in an optimal way for their health,” he says.

Find other stories on gay and lesbian health, as well as news briefs updated daily, at www.advocate.com

RISKS AHEAD

Proceed with caution

Combining erectile dysfunction drugs with other medications — and even with the recreational substances amyl nitrite or nitrate, commonly called poppers — can result in dangerously low blood pressure and possibly even death, says Ken Mayer, medical research director for Boston’s Fenway Community Health. The interaction between erectile dysfunction drugs such as Viagra and Levitra and other medications also can affect the levels of the medications absorbed by your body.

Do not take erectile dysfunction medications if you:

• have a history of low blood pressure;
• have a history of cardiovascular problems;
• are taking nitrate-based drugs, including those to treat certain cardiac conditions; or
• use poppers.

Talk with your doctor before taking ED medications if you:

• are taking protease inhibitors for HIV;
• take alpha blockers to treat high blood pressure or prostate problems;
• are being treated for the eye disease retinitis pigmentosa; or
• are taking certain antibiotics, including erythromycin.

Erectile dysfunction drugs also can cause a rare condition called priapism, in which an erection does not go away, which can cause permanent damage to penis tissue. Seek immediate medical attention if you experience an erection lasting longer than four hours.

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By Bob Adams

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Source: Advocate, 11/11/2003 Issue 902, p38, 3p

Title: MEASURE FREE TESTOSTERONE BEFORE YOU PRESCRIBE HORMONE REPLACEMENT THERAPY ,  Modern Medicine, 00268070, Dec96, Vol. 64, Issue 12

Section: abstracts: DRUG THERAPY

A flagging libido and testicular atrophy do not necessarily correlate with low testosterone levels, say the authors of this prospective study from Seattle. They recommend that you measure the free fraction of testosterone before prescribing hormone replacement.

The authors examined the records of 268 men who presented with sexual dysfunction over a period of 22 months.

• A total of 48 men (18%) had low (<300 ng/dl) testosterone levels (range: 85 to 294; mean: 236).
• After being tested again, 42 (16%) still measured low.
• Of the 42 who tested low at least twice, 24 (57%) did not have a waning libido or testicular atrophy.
• Of 34 men for whom data were available, 17 (50%) who had low total testosterone. had normal free testosterone.
• Only 3 of the 170 men whose serum prolactin levels were known had low levels (2 of them had a low free fraction of testosterone and 1 had a normal free fraction).

The authors recommend that physicians measure serum prolactin levels only in men who have a low free fraction of testosterone and/or a history of a diminished sex drive or testicular atrophy.

Govier FE, McClure RD, Kramer-Levien D. Endocrine screening for sexual dysfunction using free testosterone determinations. J Urol (Aug.) 1996;156:405-8

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Source: Modern Medicine, Dec96, Vol. 64 Issue 12, p54, 1p

Title: VIAGRA FOR DEPRESSION ,  Harvard Mental Health Letter, 10575022, Feb2002, Vol. 18, Issue 8

IN BRIEF

Sildenafil (Viagra), the popular remedy for inability to maintain an erection, may also be good for lifting a man’s mood.

About 150 men who requested treatment for erectile dysfunction were rated on a symptom checklist for depression and satisfaction with life, then divided into two groups and given either Sildenafil or a placebo for 12 weeks. Sildenafil improved erections in 90% of users and the placebo in 11%. Depressive symptoms were reduced and life satisfaction higher in the men whose erections improved, whether they were taking the active drug or not.

It was unlikely that the erection problems of these men were symptoms of depression. They were not seriously depressed and were not requesting treatment for a mood disorder. In fact, men with major depression had to be excluded from the study because it would have been unethical to deprive them of a standard treatment (psychotherapy or an antidepressant drug). Furthermore, the placebo response of 11% was far lower than the average placebo response in studies of depression (35%).

Sometimes depression and erectile dysfunction have a common cause, usually alcoholism or a physical illness such as diabetes or a heart condition. The test would be to give antidepressants to men who don’t respond to Sildenafil . If undiagnosed physical illness is the source of the sexual problem, their mood should improve but not their erections.

After considering these possibilities, the authors conclude that the obvious explanation is the right one. The men were unhappy about their sexual problem, and when it improved, so did their mood. How long the improvement lasts and whether it also occurs in men with more severe depression are questions for further study.

Seidman, S.N. et al. “Treatment of Erectile Dysfunction in Men With Depressive Symptoms: Results of a Placebo-Controlled Trial With Sildenafil Citrate,” American Journal of Psychiatry (October 2001): Vol. 158, No. 10, pp. 1623-30.

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Source: Harvard Mental Health Letter, Feb2002, Vol. 18 Issue 8, p7, 1p

Title: Grassroots effort for Lilly’s Cialis ,  By: Young, Lesley, Marketing Magazine, 00253642, 1/19/2004, Vol. 109, Issue 2

Section: NATIONAL news

The erectile dysfunction drug market is starting to swell with the arrival of a pugnacious first competitor to Viagra in Canada: Lilly ICOS’s Cialis, dubbed “le weekender” in Europe.

Lilly ICOS received approval for Cialis, a prescription drug that treats ED, in Canada and the United States late last year. Cialis is now offered in more than 50 countries worldwide and boasts a duration of 36 hours, compared to Viagra’s five.

ICOS is using a grassroots personalized direct-to-consumer (DTC) campaign, an effective strategy to differentiate itself from Pfizer, according to Lea Katsanis, associate professor of marketing at the John Molson School of Business at Concordia University in Montreal.

“There is a large untapped market for ED drugs,” she notes, adding ICOS is likely going after brand new prescriptions. “Viagra did not experience the exponential growth it forecast.”

Called “Music for 2,” the unbranded Lilly ICOS promotion is designed to help men improve their sexual health and revitalize relationships with their partners. It features an annual live concert series in romantic settings — promoted through contests — a music and ED health-themed informational Web site (the Canadian site is music36.ca) and CD giveaways. The inaugural concert is slated for February in Monte Carlo and features tenor José Carreras and Blondie singer Debbie Harry.

David Ricks, marketing director of Eli Lilly Canada in Toronto, says that unlike other makers of ED drugs, Lilly ICOS chose music over sports as a platform to engage men in conversation with their partners and doctors about a condition that impacts them at the deepest emotional and physical levels.

“We did a lot of consumer research on middle-aged men and their musical tastes,” says Ricks. “And we found that one-third of men in their 50s enjoy music.”

In Canada, a buzz campaign is launching that will place free CDs in strategic locations across the country, starting with airports. The discs feature romantic music and encourage men to register for the contest that will eventually send 36 Canadian winners and their partners to Monte Carlo. Unbranded radio ads will also promote “Music for 2″ and ED on eight radio stations in Canada. (”Music for 2″ will first be open to men in Canada, Mexico, the United Kingdom, Germany, Portugal and Sweden before expanding to other countries.) Katsanis says the approach also reaches out to men’s partners, an important target because women tend to be more open about sexual health issues and will encourage men to seek ED help.

The “Music for 2″ campaign was developed by Manning Selvage and Lee in the United Kingdom and executional support in Canada was provided by National Public Relations in Toronto. Eli Lilly Canada’s consumer ad agency is Grey Worldwide in Toronto.

A third competitor to Viagra, Levitra (marketed by Bayer and GlaxoSmithKline) is waiting for approval in the Canadian market.

Katsanis says the increase of DTC advertising for lifestyle drugs in North America will make it increasingly difficult for Health Canada to sustain its strict regulations on drug ads. “There’s no question the market is going to get a lot more competitive and the ads will become a lot more aggressive,” she adds.

PHOTO (COLOR): Research showed men 50-plus appreciate music

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By Lesley Young

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Source: Marketing Magazine, 1/19/2004, Vol. 109 Issue 2, p3, 1p

Title: VIAGRA FALLS ,  By: Hitchens, Christopher, Nation, 00278378, 05/25/98, Vol. 266, Issue 19

MINORITY REPORT

Then I tried to rape her again.

In terms of pure technique, of rape knowhow, my second bid was a definite improvement on my first. Different class, really. This time I came at her from behind in a writhing, wriggling rush. The element of surprise took a more central role here, because Selina was fast asleep at the time. You don’t get much more surprisable than that. Having learnt the night’s lessons, I did the rape-smart thing: I flattened her body and prised her legs apart with my own in a reverse-tweezer action. It worked, too. Fabulous, I said to myself She’s utterly at my mercy. Brilliant. All I need now is a hard-on…

Relax. Mr. Amis is only describing, in rather noir terms, a farcical moment in a bad night that involves two consenting adults. You can look it up. It fell easily on the consensual side of the line, even in the days before Clintonoid feminists lowered the bar. (”Are we talking,” says a bewildered guy to a sternlooking gal in a New Yorker cartoon from the Jurassic eighties, “about women the sex or women the movement?” Good question.)

Direct your attention, rather, to the last seven words of Amis’s internal monologue. He is speaking of those very private moments when, what with one thing or another, boys cannot quite manage to be boys. The whole unspoken tragedy was caught by the Hollywood reporter Vernon Scott, who once interviewed a tearful Norma Jean in the Beverly Hills Hotel:

Once in a while I meet a nice guy, a really nice guy, and I know it’s going to work…. And we have a few drinks, and we go to bed. Then I see his eyes glaze over and I can see it going through his mind: “Oh my God, I’m going to fuck Marilyn Monroe,” and he can’t get it up.

From Niagara to Viagra. I can think of three reasons why this most delicate of subjects has only now been broached on Page One. The first is that impotence was men’s greatest secret. The second is that it was one of womanhood’s greatest secrets. And the thirdis that it now seems to yield to a pharmaceutical magic bullet. Well, in that case… If it can be cured, it’s out in the open.

Among the innumerable reasons to scorn the creationists’ pathetic “argument from design” is that no intelligent, let alone loving, Creator could possibly have “designed” the male reproductive system in its current form. The lord of creation, the paragon of animals, the Mister Monster, was always acutely,aware that his own boss, his tiny megalomaniacal tyrant, might fail to mm up. And without this authority, which was both a heroic giver of orders and a distant receiver of them, how was stability to be insured? Erections could be like cops: often there when you emphatically didn’t require them and sometimes absent when you did. Or so I have been told by friends who thought they could trust me.

Richard Pryor is the only performer I know who ever made a public joke about this calamity occurring, not to someone else but to himself. His riff on “whose dick is this?” was a barn-burner. But the mirth was edgy. The same with the porter’s scene in Macbeth, in which the greatest plumber of human nature wrote some lines for the crowd about the sorry effects of drink (”It provokes the desire, but it takes away the performance…. Makes [a man] stand to and not stand to”). One of Shakespeare’s permanent themes is the fragility of kingship; here he stepped aside to satirize the very hydraulics of patriarchy. As they say in the theater, there are no small parts–only small players.

Ten years ago there was an essay by Hugh Drummond, Hippocratic correspondent for Mother Jones, on the medically generated sure-fire erection. The technology then at the prototype stage involved various wrinkly prosthetic implants, but Dr. Drummond wrote a highly “sensitive” piece on what he saw as a looming danger. Ponce de Le6n’s search for the fountain of youth, the savagery of the spice trade and therefore slavery, the exploitation of the New World for the aphrodisiac properties of chocolate–he read off the whole history of imperial expansion as a metaphor for the quest for a sturdier member. (”They’re very difficult,” as Amis puts it elsewhere in Money. “They’re not at all easy. That’s why they’re called hard-ons.”) But this admonition against phallocracy was, I thought, one-sided. Men may seem insufferable when they are confident, but they do not behave better when they are sexually insecure. The grotesque element in pornography, and the subtext of a lot of fascistic imagery of ruthless maledom, is deeply connected to the fear of exposure in this regard. It’s well caught in the film of The Executioner’s Song, and in the evidence of many rape victims who have been defiled in every way but one. (The Central Park jogger was spared nothing, but one of her assailants admitted in court that he had had to feign his manly role.)

I once knew a woman who recounted a sexual episode with one of the totally famous studs of our time. And how was it? I inquired diffidently. “Oh,” she replied with an air, “a bit like trying to get an oyster into a parking meter.” A passage or two in Scott Thompson’s memoirs, concerning the “present danger” war-lover Paul Nitze, and some of the latent imagery in the empty, wretched lives of Nixon and Kissinger, convince me that moments of rage and frustration of precisely this kind may have exacted a Dr. Strangelove price that dared not speak its name.

Writing in a mocking vein about Viagra in The New York Times, Maureen Dowd yearned for a pill that men might take that would change their chemistry an hour after sex. I think she mentioned flowers, phone calls, tenderness. (”Coming, dear.”) But she may have confused the necessary and the sufficient condition, as did Drummond when he wrote: “Maybe the capacity for impotence was all that was left of a certain critical vulnerability for the male ego. And maybe the capacity to accept that vulnerability was the last hope for a certain kind of humanity.” This is too soft and fuzzy a prose in which to analyze something so near the core. Why assume that men will be less humane because of a capsule that gives them not just the time butthe inclination?

ILLUSTRATION

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By CHRISTOPHER HITCHENS

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Source: Nation, 05/25/98, Vol. 266 Issue 19, p8, 1p