Diabetic Sexual Dysfunction | National Federation of the Blind Male and Female Sexual Dysfunction by Ed Bryant This article originally appeared in Voice of the Diabetic, Volume 19, Number 1, Winter 2004 Edition, published by the Diabetes Action Network of the National Federation of the Blind. The principal symptom of diabetes, type 1 or type 2, is high blood sugar. In time, excess glucose in the blood can cause damage to the eyes, kidneys, nerves, and circulatory system. As human sexual response involves so many systems at the same time, it is not unusual to find a person with long-term diabetes experiencing sexual difficulties: ranging from diminished interest, slow response, discomfort, pain, and, for men, outright impotence. Though these problems express differently in men and women, and sexuality is the sum of many different factors, having diabetes is a major predictor of sexual difficulties, for both men and women. Female Sexual Dysfunction Having diabetes can interfere with a woman's participation in and enjoyment of the sex act. Diabetic complications can make sex painful and unpleasant -- and reluctance to participate can be understandable.

But the culture throws negative labels around, and, traditionally, women's sexual issues have not been addressed to the same depth as men's issues--so many medical professionals are less than fully "up to speed" on this subject, so less likely to ask their female patients, and only recently has the medical profession acknowledged any "female sexual dysfunction" at all--so there is a shortage of professional expertise here. Some doctors have real difficulty separating diabetogenic (caused by diabetes) difficulties from unrelated issues. More studies, especially of women with diabetes, are urgently needed. Too many assumptions are derived from the study of diabetic men, and need to be tested. Diabetic women, many of retirement age, were, many of them, raised in a time when "nice girls didn't talk about such things." There can be real reluctance to bring up the subject of sexual difficulties, diabetogenic or otherwise. Anna Sarkadi, MD, and Urban Rosenqvist, MD, PhD, in their paper: "Intimacy and Women with Type 2 Diabetes," published in The Diabetes Educator (2003), stress that both the patient and the clinician need to push for more openness and discussion.

In their book, For Women Only: A Revolutionary Guide to Overcoming Sexual Dysfunction and Reclaiming Your Sex Life (2001 Edition), sisters Jennifer Berman, MD, and Laura Berman, PhD, quote a survey published in the Journal of the American Medical Association, stating that "43% of American women, young and old suffer from some sexual dysfunction (JAMA,1999)" They continue: " And yet for most of this century doctors have dismissed women's sexual complaints as either psychological or emotional." The Bermans go on to state: "Many of the same health problems that cause erectile dysfunction in men, such as diabetes, high blood pressure, and high cholesterol, as well as many medications used to treat these conditions, can cause sexual dysfunction in women." Female sexual disorders (according to the Bermans) are classified into four categories: 1) Hypoactive sexual desire disorder, 2) Female sexual arousal disorder, 3) Orgasmic disorder, and 4) Sexual pain disorders. Each disorder has different treatments (Brassil, D.F. and Lewis, J.H., 2003).

Sarkadi and Rosenqvist (2003) point out that although "female orgasmic disorder" does not correlate with diabetes, #4, sexual pain often does, and it is vital for both patients and providers to overcome old reluctance, and raise the subject with each other. Just as with men, female sexual dysfunction can result from physiological, hormonal, neurogenic or psychological causes, or a mix of the above -- and physical discomfort can engender psychological issues. Some physical causes include: pelvic surgery or trauma, blood flow problems such as coronary heart disease, high blood pressure, high cholesterol, smoking, spinal cord injury, and even (for both men and women) excessive bicycle riding. Hormonal causes can include menopause, endocrine disorders, postpartum hormone deficiencies, and diabetes. In their article: "Sex, Intimacy, and the Kidney Patient" (in Kidney Beginnings magazine), Donna Brassil, RN, MA, CURN, and Jean Lewis, BSN, RN, CNP, caution that although kidney failure (diabetic or otherwise) itself imposes no limitation on sexual activity, sexual function is impaired in many individuals with chronic kidney disease.

"A kidney transplant may cause improvement," they report, "although sexual function rarely returns to the pre-illness state." This applies to both men and women. Certain medications have also been shown to adversely affect female sexual response. Some of them might have been prescribed for diabetes complications. The culprits are the same as for the men: anti-hypertensive agents, anti-depressants, sedatives, neuroleptics, anti-convulsants, anti-ulcer drugs, anti-cancer drugs, and many illegal "recreationals." Be sure to discuss medication options with a physician or nurse. Psychological issues must also be evaluated for their possible relationship to sexual disorders. Many disorders, not just diabetes, have been shown to impact sexual response. These will need to be "ruled out." Sarkadi and Rosenqvist caution that too many have been "taught to accept" bad "folk explanations" (that are not in fact explanations at all, but value judgements) for their difficulties, like "because you're too old, or too fat, or too lazy ..." and their resulting guilt and self-blame exacerbate the problems.

As when you think you have the answer (however incorrect you may be!), you're not likely to bring up the question, self-blame's consequences range from unpleasant, to dangerous, to outright lethal. How does diabetes cause female sexual difficulties? Neuropathy, nerve damage, can interfere with the ability to feel, to detect touch, and can cause both pain and numbness. Diabetic small vessel circulatory damage can cause dryness, cracking, and impaired lubrication of skin and mucous membranes. Sarkadi and Rosenqvist (2003) state: "women with diabetes had double the rate of disturbed (inadequate) lubrication as their non-diabetic peers." These ramifications can seriously interfere with satisfaction, and with the willingness to participate in sexual activity. Diabetic high blood sugars greatly increase the odds of a woman having a vaginal infection, most commonly a yeast infection. Diana Guthrie, past Professor at University of Kansas School of Medicine--Wichita, warns such infections can dry and irritate the skin, cause terrible itching, and produce severe pain during intercourse. Good diabetes control cuts the odds of such infections, and effective topical treatments for yeast infection are available.

"For diabetics, such infections are generally not sexually transmitted," warns Professor Guthrie, "but safe sex must be practiced if you or your partner have such an infection." In one study, where participants' average age was over 60, 18% of the women with type 1 diabetes reported sexual difficulties, but the figure was 42%, for those women with type 2. It was a small study, but the point is valid--type 2 diabetes produces a lot of sexual difficulties! Berman and Berman advise there is no single "cure-all" for female sexual dysfunction, and options for treatment vary as much as the symptoms. They further advise that, although medications may play a role in treatment, sexual dysfunction disorders may persist if accompanying emotional issues remain unaddressed. As a result, they recommend treatment on both a physiological and psychological level. They stated, "Diagnosis and treatment should ideally combine the mind and body in order to attend to all the components of a woman's sexual life." Their suggestions are just as valid for men facing sexual difficulties. Medicinal treatments for women increasingly include prescriptions for Viagra (sildenafil).

Similar to its effects for men, Viagra increases blood flow to the vagina, clitoris, and labia, causing engorgement of these tissues, enhanced sensation, and increased vaginal lubrication. It is recommended that sildenafil be taken on an empty stomach, about an hour before intercourse, without alcohol. In addition, a woman must have the desire to engage in sexual relations, and be sexually stimulated enough for it to have an effect. Discuss with your doctor or nurse whether such use is appropriate for you. Note, as other new therapies for men come on to the market, some of them may prove effective for women as well. Talk to your health care team about new therapies. Hormone replacement therapy (HRT) is currently the only drug treatment that has been approved by the FDA for women with complaints of sexual problems associated with the drop in hormone levels brought on by menopause. Talk to your doctor about whether or not such therapy is appropriate for you. The Eros-CDT (clitoral therapy device), by Urometrics, Inc., of Anoka, Minnesota, became the first treatment for female sexual dysfunction approved by the FDA in May, 2000.

The CDT is in essence a small pump with a tiny plastic cup attachment that fits over the clitoris and surrounding tissue. It provides gentle suction and stimulating blood flow to the area. The CTD can cause orgasm in women, and it may help to prevent the fibrosis (collagen deposits) in women that can build up in the arteries leading to the clitoris. Consult your physician for more information on this device. Because no drugs are administered, diabetes contraindications are less likely. Sexual dysfunction's symptoms should be taken seriously. Talk to your doctor. It is not a "moral issue." Get it checked out--as something undetected (like kidney disease) can cause sexual difficulties--then you can start dealing with it, and getting on with your life. A recent Mayo Clinic heart disease study stated people with sexual difficulties had a greatly increased likelihood of undiagnosed heart problems. So Just don't ignore it. Act! The best prevention is the same as for diabetic men: Tight control. Diabetes per se does not cause these ramifications -- they follow long periods of elevated blood glucose, and your best insurance is to keep those numbers down. The better you do, the less the risk.

Smoking increases the odds and severity of diabetic complications; it should be stopped. Alcohol use needs to be limited. Male Sexual Dysfunction Of all the complications of diabetes, this one, male impotence (the inability to achieve and sustain an erection sufficient for sexual intercourse), may be most feared, but it is also one of the most treatable. More than 50% of diabetic men may experience erectile dysfunction, but over 95% of cases can be successfully treated. With proven treatment available, and new treatments appearing, a diabetic man experiencing this problem does have options. It isn't something he--or any man--or his partner--should have to live with. Many men do not feel difficulties with their sexual performance are a fit subject to discuss with their partners--or anyone else; they fear they will be ridiculed or condemned for having such. They couldn't be more wrong--for they make things worse by "suffering in silence." Men, all of them, need to move beyond the old idea that the sex act is something the male provides. He is part of a relationship, and what interferes with one affects both. A man's partner is equally involved.

Achieving and sustaining an erection requires interaction between the neurological, arterial, hormonal, and psychological functions of the body. Simply, a lot of different parts have to work right. Proper hormonal balance, normal sex drive and emotional make-up, functioning nerves and blood vessels, and healthy penile tissue are all required. Both Libido, the interest in sexual activity, and potency, the ability to perform, must be present. Several different sets of nerves are involved, and neuropathy, nerve damage, to any of them can impair the sex act. Erection is a function of the parasympathetic nervous system, but orgasm and ejaculation are controlled by a different set of nerves: the sympathetic system. "Erection is a hydraulic phenomenon, that occurs involuntarily," says Arturo Rolla, MD, of Harvard University School of Medicine. "Nobody can will an erection!" Anything that limits or impairs blood flow can interfere with the ability to achieve an erection, no matter how hard a man tries, or how much he wants to achieve one. Although sexual vigor generally declines with age, a man who is healthy, physically and emotionally, is able to produce erections, and enjoy sexual relations, regardless of his age.

Impotence is not an inevitable part of the aging process. On occasion any man may experience the inability to achieve or sustain an erection. Such transient episodes are common and may be attributed to illness, fatigue, stress, relationship problems, depression, etc. The occasional inability to perform, however traumatic to both partners, is normal. Repeated inability to achieve and sustain an adequate erection can be caused by anything that affects a man, psychologically or physically. Psychological, or "psychogenic," impotence can follow major life changes, unrelated medical treatments or conditions, stressful events, relationship difficulties, or even the fear of becoming impotent. The physiological changes associated with fear can themselves cause erectile dysfunction! When a diabetic discovers the source of his difficulties is not physical--that it is due simply to his fear of the ramifications--sexual function is usually restored. But to tell the difference between physical and psychogenic impotence, and to make any progress against it, requires that you TALK about this sensitive issue--with your partner, your physician, and, ideally, with a urologist specializing in male sexual difficulties. Sexual dysfunction can contribute to psychological problems such as feelings of inadequacy, frustration, loss of self-esteem, and despair.

Strained relationships with partners may well result. It is important for people to discuss the problem with their partners, and to promptly seek medical attention. Many men may find counseling helpful. Diabetic impotence is not a sign of diminishing sexual interest! It is generally a result of the blockage of or damage to blood vessels responsible for erection, damage to the nerves that dilate those blood vessels, or a mixture of the two. In some cases, re-establishing good glycemic control may decrease the problem, though permanent damage to nerves and small blood vessels may not be reversible. Such blockage may be an indicator of previously undiagnosed heart disease. A diabetic man can decrease his risk of impotence (and many other complications) by carefully controlling his diabetes. Poorly controlled diabetes, and high cholesterol, increase the chances of vascular complications, which may lead to erectile dysfunction or other circulatory problems. End Stage Renal Disease (ESRD), a common diabetes complication, imposes its own stresses on the body, and can lead to impairment of sexual function. Short of a kidney transplant, the best treatment is to do whatever possible to keep your kidneys healthy. Exercise regularly, and avoid nicotine and alcohol.

Smoking causes constriction of the blood vessels, and greatly increases the odds of diabetic circulatory damage. Good health practices, and tight blood glucose control, help men prevent impotence, just as they ward off the other major complications of neuropathy, nephropathy, and retinopathy. Impotence, the chronic inability to have and sustain an erection adequate for sexual intercourse, may well be a symptom of more serious disorder, such as previously undiagnosed heart complications. Seek prompt medical help for sexual dysfunction--as it can lead to early diagnosis of other problems--for which prompt intervention might save your life. Identification of the source of impotence can point the way to the prevention of strokes, heart attacks, and other life-threatening illnesses. Whatever the cause, if a man does not have or cannot sustain erections adequate for vaginal penetration, and the problem continues over a period of four to five weeks, he should recognize a problem exists, and seek medical help. Don't delay--erectile dysfunction doesn't "just go away!" In treatment of impotence, the choice of doctors is most important--all are not equally qualified to diagnose or treat such a condition.

Among the best choices are those practicing at centers specializing in erectile dysfunction, urologists who subspecialize in the treatment of impotence, and other physicians specifically trained in this field. Most people's first contact is with their family doctor. Ask that primary care physician for a referral to a medical professional who is particularly familiar with this disorder. Local hospital referral services may keep lists of such experts in practice nearby. With an interview and physical exam, the doctor should be able to determine whether the erectile dysfunction is psychological or physical in nature. Where diabetes is present, a vast majority of instances of erectile dysfunction have a partly or completely physical cause. But based on examination and interview, the doctor may determine the cause to be psychological, and if so, refer the man to a qualified health professional specializing in psychologically-induced erectile dysfunction. This may be a psychiatrist, psychologist, sex therapist, or marital counselor. Please, do not see such a diagnosis as an insult, or as a defeat--to do nothing, to choose inaction, would be the real defeat. Troy A.

Burns, MD, of PropartnersMD in Overland Park, Kansas (who was formerly Medical Director of the Diagnostic Center for Men), reports that an old at-home test for erectile activity during sleep (the lack of which would suggest physically-caused impotence) was the postage-stamp test. The patient was instructed to wrap several stamps snugly around his penis at bedtime. If the stamps had perforated by the time he awakened, some penile tumescence probably occurred! Of course more sophisticated tests are used today. Impotence is sometimes a side effect of medications prescribed for other disorders. Such medications can include: some antihypertensives (diuretics and beta blockers), some ulcer medications, the heart medication Digoxin, antihistamines used for allergy control, antipsychotics, commonly used tranquilizers such as Diazepam, certain antianxiety drugs, certain narcotics, anticholinergics, tricyclic antidepressants, and many illegal drugs. Elavil and other tricyclic antidepressants, sometimes used to treat the pain of neuropathy, can cause, trigger, or aggravate impotence.

Be careful of interactions between your medications and any "alternative" herbal supplements too - tell your doctor what you're taking. Non-prescription treatments for a person's unrelated disorders may contribute to the problem, as over-the-counter medications, including certain eye drops and nose drops, have been associated with erectile dysfunction. If you experience erectile dysfunction, and you are using other medication(s), discuss it with your doctor. By adjusting the dosage of current medication(s) or by switching to valid alternates, erectile dysfunction may be alleviated. Ask your doctor or pharmacist for information about side effects, and be sure to read the package insert in the container. Consult a physician before discontinuing any medications. Much is now known about the causes and treatments of erectile dysfunction, and impotent men should be aware of their various treatment options. Although surgery is one choice, 95% of cases are resolved by nonsurgical means, and the National Institutes of Health recommends trying nonsurgical treatments before more invasive methods. All options should be considered, but the man's personal preferences--and those of his partner--are vital in the choice of treatment. For purpose of discussion I've divided treatments into three categories: medications, external mechanical devices, and surgery.

Medications Topical "Vasodilators" May Improve Blood Flow: When diagnosis indicates a problem in the vascular system, particularly arterial insufficiency, externally-applied vasodilators (example: nitroglycerine ointment) can be used to dilate arteries, improving blood flow into the penis. Commonly used in treatment of high blood pressure and associated heart disease, such ointment is applied to the penis to increase penile arterial flow and improve erections. The most notable side effect of nitroglycerine ointment is that it may give the female partner headaches, as it is absorbed into her bloodstream through the vagina. To prevent this, the man should use a condom. Note: some men are "intolerant" of nitroglycerine as well, and cannot use such a product. Talk to your health care team. Another topically applied vasodilator, Minoxidil, was found to have fewer side effects and be more effective than nitroglycerine cream. Although some cases of erectile dysfunction respond well to this kind of therapy, the effectiveness of topical vasodilator products for this purpose has not yet been determined by the scientific community. Research continues.

Yohimbine Therapy Shows Promise: Yohimbine medication comes from the bark of a tree that grows in Africa and India. The extract, long used as an aphrodisiac and folk remedy for impotence, has proved effective in some impotence cases, and has an FDA approval for use as an aphrodisiac. It is not known exactly how the medication works. Note that desire is not ability--and an aphrodisiac, "folk" or FDA-approved, does not address the circulatory difficulties central to diabetogenic impotence. Some "alternative" medications, sold on the Internet as "sex-life enhancers," contain yohimbine as one component. The few side effects of yohimbine tablets can be easily alleviated. Many doctors prescribe this therapy for cases of very mild, physically caused dysfunction or for psychological impotence. This therapy does have merit and should be considered. Alprox-TD, a topical cream containing alprostadil, has completed several Phase III clinicals.

Manufactured by NexMed (from Robbinsville, New Jersey), it appears to produce a statistically significant improvement in impotence symptoms, and "demonstrated significant efficacy in double-blind, placebo-controlled, take-home studies in a broad patient population." Many of the test population also had cardiac complications, and the medication appeared safe for them as well. "The use of Alprox-TD is not contraindicated in patients using nitrate medication for cardiovascular disease or any other type of medication," says NexMed. This medication (already available in Asia) is not yet FDA approved, but the company expects U.S. marketing clearance shortly. This is NOT "alternative," but carefully-researched medication, and the manufacturer is making sure the product is safe and effective. Oral Medications: Viagra, Pfizer, Inc.'s oral medication for the treatment of male erectile dysfunction (impotence) was approved by the U.S. Food and Drug administration in March of 1998. Viagra is a simple pill, priced about $7 per dose, and appears to successfully treat a wide percentages of cases. Although sometimes contraindicated where circulatory disease is present (talk to your doctor first!), for some, it may be the most convenient treatment of all.

Levitra, from Bayer and GlaxoSmithKline, won approval late in 2003, and is now available. Its pattern of action is similar to that of Viagra. Another Viagra competitor, Cialis, sold on many overseas websites as "Super Viagra," won FDA approval in November of 2003. Uprima, manufactured by TAP Pharmaceuticals, is said to work in a similar manner, but where Viagra acts directly on the circulatory system, Uprima "stimulates the appropriate neurotransmitters in the human brain." It is sold on the Internet, billed as an "orgasm enhancer." It might work for some, as might its foreign competitors and generic equivalents: Vig-Rx and Asotas--but these are not "mainstream," and caution is advised. Be extremely cautious with all such overseas "gray-market" medications; your health care team may be unfamiliar with their consequences and contraindications, and familiar labels may be dishonest. Vasomax, by Zonagen Pharmaceuticals, was another anti-impotence oral medication.

An oral form of the proven anti-impotence injectable medication phentolamine, approved in Mexico, it failed its final clinical tests in the U.S., and was withdrawn from the market before it could incur the stigma of "banned by the FDA." Penile Injection Therapy: Many sources report that penile injection therapy has an estimated 80% rate of success. Injected directly into the penis, the medication alprostadil produces erection by relaxing certain muscles, increasing blood flow into the penis and restricting outflow. The therapy has disadvantages, such as risks of infection, pain, and scarring--fibrosis--in the penis, and it may create "priapism," a prolonged, painful erection lasting six hours or more (although reversible with prompt medical attention). A popular version of this medication is Upjohn Corporation's Caverject, the first to be approved for such use by the FDA. Note: The MUSE system, described below, administers the same medication, without needles, and (if and when FDA approved), NexMed's Alprox-TD will offer it in a cream.

Drug Combination Injection Therapy: Therapies using combinations of drugs have been developed and are proving to be a good "fallback" for individuals who experience difficulties with Caverject alone. "About 15% of all individuals who try therapy with Caverject experience significant pain at the injection site," says Troy A. Burns, MD. "For these 15%, a combination of Caverject, Papaverine, and Phentolamine produces less or no pain." Alternatives The MUSE System, by VIVUS, is a noninvasive alternative to penile injection. The user dispenses his medication (a pellet of alprostadil/Caverject) with an eye-dropper-like applicator, directly into the urethra. No needles are required. Both the drug and the delivery system have been approved by the Food and Drug Administration for this use. For many impotent men, the MUSE may be the therapy of choice. "Rejoyn" is an inexpensive, nonprescription alternative to the many vacuum-actuated devices described below.

Described by its manufacturer as a "support sleeve," it does not "cause" an erection, but rather supports the flaccid penis as if it were erect (one wears it under a condom). External Mechanical Devices This category of treatments for erectile dysfunction includes external vacuum therapies; noninvasive external mechanical devices that produce painless erections by causing blood to flow into the penis while constricting outflow of blood. Such devices imitate a natural erection, and do not interfere with orgasmic experience. External vacuum therapy mechanisms are approximately 95% successful in causing and sustaining an adequate erection. All are portable, and costs range between $200 - $500, covered under most insurance plans, and Medicare Part B. The vacuum constriction device consists of a vacuum cylinder, various sizes of tension rings, and a vacuum pump, either hand-operated or electric. The penis is placed in a cylinder to which a tension ring is attached. Air is evacuated from the cylinder by means of the pump, creating a vacuum, which produces the erection. The cylinder is removed, leaving the tension ring at the base of the penis to maintain the erection. Vacuum therapy devices have a few minor disadvantages. One must interrupt foreplay to use them.

THE TENSION RING MUST BE REMOVED AFTER SUSTAINING THE ERECTION FOR 30 MINUTES, TO PREVENT PENILE BRUISING. You must use the correct-size tension ring. Although considered to be basically pain free, initial use may produce some soreness. Such devices may be unsuitable for men with certain disorders related to blood clotting. In general, vacuum constriction devices are successful in management of long-term impotence, and they enjoy wide physician acceptance. They are relatively inexpensive, and they work on simple principles, so they are easy for patients to understand. Widely available, they are now offered in mass-market catalogs like "Dr. Leonards," and, as long as the user follows the instructions, and is in otherwise good physical condition, they usually work well. As no medication needs to be consumed or injected, these devices are good for many men. Surgical Treatments There are many less-invasive and less-expensive options, and surgery should be considered only after all others have proved unsatisfactory. Of the two kinds of surgery performed, one involves implantation of a penile prosthesis; the other attempts vascular reconstruction. Less than 5% of impotent men may benefit from vascular surgery.

Expert opinion about surgical implants has changed during recent years; today, surgery is no longer so widely recommended. Even though it is 90% effective (on an appropriate subject), surgery is expensive in both monetary and human terms, but it is one available option for impotent men. The decision to have or not have surgery is one that should be made by the man and his sexual partner, after medical consultation. Companies that market surgically-implanted prosthetic devices sell only to hospitals and physicians and will not provide the selling price to consumers. Some years ago, I checked prices, and found that the malleable prostheses cost about $1,400, and inflatable devices cost about $4,000--just for parts. If the man elected to undergo the surgery, and fees were totaled (surgical, operating room, and the markup on the prosthesis), the cost would be thousands more. The main risk associated with penile surgery is infection. Although every attempt is made during the procedure itself to prevent infection, it can develop, and may force removal of the prosthesis. As with all invasive procedures, there may be some pain, bleeding, and scarring.

If for some reason the prosthesis or parts become damaged or dislocated, surgical removal may be necessary. With a general success rate of about 90%, any of the devices will restore erections, but they will not affect sexual desire, ejaculation, or orgasm. Prostheses: Many different types of penile prostheses are available, in three categories: rods, inflatable prostheses, and self-contained prostheses. Semi-rigid or malleable rods are the simplest and least expensive of all. Their main disadvantage is that the penis remains constantly erect, which may cause problems with concealment. Inflatable prostheses are complex mechanical devices that imitate the natural process of erection. Parts are inserted surgically into the penis and scrotum, and activated by squeezing. When erection is no longer desired, a valve on the pump is pressed, and the penis becomes flaccid. Disadvantages include risk of mechanical breakdown or leakage. Fully inflatable devices are the most expensive of the three categories, because of the complicated surgery necessary to implant the parts. Self-contained single-unit prostheses are similar to the inflatable types, but more compact. The entire device is implanted into the penis.

When erection is desired, the unit is activated by either squeezing or bending, depending on which of the two types of self-contained prostheses is used. Some of the mechanical types have been known to fail during intercourse; the inflatable device can sometimes be difficult to operate. All penile implants will produce erections suitable for intercourse. When decisions are being made regarding the kind of surgery, other factors should be considered. According to Bruce A. MacKenzie in Impotence Worldwide (Volume 7, No.2), purpose is only one of several elements considered when selecting an implant. MacKenzie said, "To those who wish to simulate nature to the furthest extent--then a fully inflatable would be their choice; for those who wanted something relatively simple, ready to use, lower cost, one day less in the hospital--their choice would be the hinged or malleable; to those who wanted a compromise between the two--a hybrid--they would choose a self-contained; and for those who wanted the least expensive (low end of the line)--the semi-rigid would fit the bill." Vascular Reconstructive Surgery for Impotence uses highly sophisticated techniques and equipment to physically correct the underlying causes of impotence in the penis.

The surgeon may attempt reconstruction of the arterial blood supply, or remove veins when the cause is due to leakage. Less than 5% of men with erectile dysfunction have such surgically treatable impotence! Conclusion When your quality of life is affected by sexual dysfunction, diabetogenic or otherwise, you should seek a physician's help, preferably that of a carefully chosen specialist. Don't wait for your doctor to ask you about sexual function - talk about it! Nothing is cured by silence. Talk about it with your partner/spouse, too, as he/she is equally affected by this condition. Remember, you're both involved, so your partner is integral to the relationship and deserves complete honesty. Relationships are solid only when couples consider each other's feelings, so COMMUNICATE WITH YOUR PARTNER. Remember, man or woman, you are not alone; others have faced these difficulties. You do have options! COMPANIES THAT MARKET IMPOTENCE THERAPY SYSTEMS American Medical Systems, 10700 Bren Road West, Minnetonka, MN 55343; telephone: 1-800-328-3881; Web site: They offer prosthetic devices.

Encore, Inc., 7696 15th Street East, Sarasota FL 34243; telephone: 1-800-221-6603. They offer vacuum constriction devices. Mentor Corp., 501 Mentor Drive, Santa Barbara, CA 93111; telephone: 1-800-235-5731; Web site: They offer prosthetic devices. Mission Pharmacal Co., 10999 IH-10 West Suite 1000, San Antonio, TX 78230; telephone: 1-800-531-3333; Web site: They offer the VED line of vacuum constriction devices. Soma Blue Corp., PO Box 10026, Augusta, GA 30903; telephone: 1-800-827-8382; Web site: They offer vacuum constriction devices.

Pfizer, Inc., 235 East 42nd Street, New York, NY 10017; Web site: They offer the oral impotence medication Viagra. Pos-T-Vac, 1701 N. 14th Street, PO Box 1436, Dodge City, KS 67801; telephone: 1-800-627-7434or 1-800-279-7434; Web site: . They offer vacuum constriction devices and the "Rejoyn" support sleeve. See also TIMM Medical, PO Box 5679, Hopkins, MN 55343; telephone: 1-800-438-8592; Web site: Successor to Osbon Medical Systems, they offer both vacuum constriction and prosthetic devices.

UROMETRICS, Inc., 2022 Ferry Road, Suite 3125, Anoka, MN 55303; telephone: (763)323-1968; fax: (763) 323-1988; Web site: They offer the EROS-CTD device. VIVUS, Inc., 605 E, Fairchild Drive, Mountain View, CA 94043; telephone: (650) 934-5200; Web site: . They offer their noninvasive MUSE delivery system for the drug alprostadil (Caverject). RESOURCE LIST OF INFORMATION AND SERVICES Diabetes Action Network of the National Federation of the Blind, 1412 I-70 Drive SW, Suite C, Columbia, MO 65203; telephone: (573) 875-8911; Web site: They offer other information pertinent to diabetes and its ramifications.

The Erectile Dysfunction Institute, 10949 Bren Road East, Minnetonka, MN 55343; telephone: 952-852-5559 and 1-866-563-2432; Web site: ( ). They offer information, advice, and the location of trained specialists. Much useful information on their Web site. National Federation of the Blind, Materials Center, 1800 Johnson Street, Baltimore, MD 21230; telephone: (410) 659-9314; Web site: Hours: 8:00 a.m. to 5:00 p.m. They offer advice about blindness, and a free book-length publication of this and other articles about ramifications of diabetes, in large print, or on 4-track audiocassette, titled: Diabetes Action Network Articles. National Kidney and Urological Diseases Information Clearinghouse, #3 Information Way, Bethesda, MD 20892-3580; telephone: (301) 654-4415; Web site: .

Part of the National Institutes of Health, they publish an "Impotence Fact Sheet," free upon request. Bibliography Berman, Jennifer B. and Laura Berman. For Women Only: A Revolutionary Guide to Overcoming Sexual Dysfunction and Reclaiming Your Sex Life. New York: Henry Holt and Company, 2001. Brassil, Donna F. and Jean H. Lewis. "Sex, Intimacy and the Kidney Patient." Kidney Beginnings June/July (2003): 6-8 and 26. Diabetes UK: "Let's Talk About Sex." Balance Magazine ( ) #196, November/December 2003. Laumann, E.O., A. Paik, and R.C. Rosen. "Sexual Dysfunction in the United States: Prevalence and Predictors." Journal of the American Medical Association 281 (1999): 537-44. Sarkadi, Anna, and Urban Rosenqvist. "Intimacy and Women With Type 2 Diabetes: An Exploratory Study Using Focus Group Interviews." The Diabetes Educator, Vol. 29, No.

4, July/August (2003): 641-652. ©2017 All Rights Reserved - Copyright 2017 NFB JMIR-Internet-based Prescription of Sildenafil: A 2104-Patient Series | Jones | Journal of Medical Internet Research Journal of Medical Internet Research Published on 31.01.01 in Vol 3, No 1 (2001) This paper is in the following e-collection/theme issue: Consultative & Diagnostic Pathology, Inc, Lee's Summit MO, USA Corresponding Author Miles J Jones, MD (FACP) 1704 SE 11th St Phone: +1 800 217 7330 Fax:+1 618 937 1525 Email: ABSTRACT Background: The Internet is becoming increasingly important as a way for patients to acquire medical information and as a means for patient-physician communication. Questions about appropriate use of this new technology have been brought to the fore by the many patients using the Internet to seek sildenafil prescriptions.

Objective: To present the first description of a physician designed and directed Internet-based prescribing system of sildenafil, together with data covering more than 2,100 patient encounters. Methods: Retrospective analysis of a large case series from a medical practice that prescribes sildenafil based on medical and sexual histories obtained through a physician designed and directed World Wide Web (WWW) site, compared against patients from clinics at a Midwestern inner city medical center. We compared all 2,104 Internet patients seeking sildenafil prescriptions online between June 14, 1998, and March 1, 1999, with all 36 medical center patients obtaining sildenafil prescriptions during the same period. The outcome measures compared were: completeness of medical record; patient safety as noted by the follow up responses of all patients requesting refills, any comments received by the internet site (webmaster), and patient or physician comments noted in the clinic medical record; satisfaction as noted by the follow up responses of all patients requesting refills, any comments received by the internet site (webmaster), and patient or physician comments noted in the clinic medical record; examinations and laboratory tests.

Results: Fifty-six percent of Internet requests came from 46 states, and 44% from eight foreign countries. Of 2,104 requests, 2,100 were granted. Three hundred ten patients have requested medication refills: all reported erections sufficient for intercourse and 69% said their satisfaction exceeded all expectations; none were at all dissatisfied. Side effect rates were comparable to those in the literature. Comparison of the medical history obtained from Internet patients with that recorded in clinic patients' charts revealed that the former was far more complete. No clinic patient received any examination or laboratory test specific for erectile dysfunction or its causes. There were no reported deaths or serious complications in either group. Conclusions: Internet-based prescription of sildenafil provides the physician with a complete and very detailed medical and sexual history for 100% of patients without denying any information routinely obtained in a direct patient contact setting. Internet-based practice, which may be expected to require far fewer healthcare resources than traditional settings, rates very high in patient satisfaction among patients requesting a refill; no negative comments were received from all other patients. Overall, these data support the safety and effectiveness of Internet prescribing of selected medications.

J Med Internet Res 2001;3(1):e2 doi:10.2196/jmir.3.1.e2 Physician-Patient Relations Introduction Erectile dysfunction is an extremely common condition: according to the Massachusetts Male Aging Study, 52% of surveyed men aged 40 to 70 had some degree of erectile dysfunction, with dysfunction being moderate to complete in approximately half of the 70-year-old men [ 1 ]. Similarly, the National Health and Social Life Survey found erectile dysfunction reported by 18% of men aged 50 to 59 (the oldest group surveyed) [ 2 ]. Until recently, the condition was often ignored. This reflected both the mistaken perception that nothing practical could be done, and the understandable discomfort of many patients and healthcare providers in openly and frankly discussing sexual matters. This changed dramatically with the March 1998 approval of sildenafil (Viagra, Pfizer), the first effective oral medication for treatment of erectile dysfunction. Within two weeks, newspapers reported physicians were writing 15,000 to 20,000 prescriptions a day for the medication [ 3 ]. Erectile dysfunction had graduated from secret shame to headline news.

Even with erectile dysfunction on the front pages, many men continue to feel uncomfortable discussing their own conditions face-to-face with a health-care provider [ 4 ]. At the same time, many patients are turning to the Internet for medical information and advice on a wide variety of conditions, often because they find the relative anonymity of the Internet less intimidating than a traditional office-based consultation [ 5 ]. Their Internet usage may take the form of formal physician consultation [ 6 , 7 ]; informal physician-originated information and advice [ 8 , 9 ]; or information, advice, and support from others with similar conditions [ 10 ]. This combination of circumstances suggests the Internet as a natural resource for addressing the needs of men with erectile dysfunction who may be reluctant to seek help from their regular physicians. To meet this need, the NET Doctor Group (an association of physicians, pharmacists, and information specialists) established an Internet-based system to provide information on erectile dysfunction and its treatment with sildenafil; to obtain the medical histories of patients with this condition, when appropriate and desired by the patient; and to prescribe sildenafil and, if requested, dispense it through an independent licensed pharmacy.

We report on the first 2,104 patients to request sildenafil prescriptions, together with a comparison group of patients who received sildenafil prescriptions in a traditional medical practice (inner city teaching hospital clinic) setting, during the same 10.5 month period. Methods Setting The NET Doctor Group is a private company that uses a physician-designed World Wide Web (WWW) site ( ) to collect patient information and medical history relevant to prescription of sildenafil. This form is shown in Textbox 1 . Physicians associated with but not employed by the NET Doctor Group review the provided medical history, on a fee-for-service basis (the fee is waived if the requested prescription is refused). All physicians are United States educated and trained, hold active license in multiple states, have current DEA registrations, practice independently of the NET Doctor Group, provide full licensure and identification information to dispensing pharmacies, and maintain individual professional liability insurance. The physicians also attempt to make telephone contact with all patients requesting sildenafil prescriptions; such contact is required when the submitted information appears contradictory or otherwise inadequate to support a decision. Requests are typically approved or refused within 24 hours of submission. U.S.

patients who are approved for sildenafil prescription have a choice of receiving the medication directly from the NET Doctor Group's independent pharmacy (not owned or operated by the NET Doctor Group), or of having the prescription faxed to their usual pharmacy. Non-U.S. patients receive the medication directly from the NET Doctor Group. All prescriptions are written for 100-mg tablets of sildenafil as follows: Use 1/2 tab po at least 30 min. before anticipated intercourse (may need to take up to 2 hours before intercourse for maximal effect). If effect inadequate try 1 tab po as above. Warning: Do not take more than 1 tab/day. If unusual pain or symptoms occur consult physician. If chest pain occurs report immediately to nearest ER. For unusual pain or symptoms, patients are advised to consult a physician. Patients are free to contact any physician, including the NET Doctor Group associated physicians, at any time. The patient insert (see Textbox 2 ) advises the patient to consult his or her personal physician. For the most severe and life threatening reactions associated with vigorous or infrequent sexual activity, patients are unequivocally advised to report immediately to the nearest ER.

The patient informational insert developed specifically for the NET Doctor Group's patients and included with directly dispensed medication is shown in Textbox 2 . The patient information sheet used by the private pharmacy for its non-NET Doctor Group clients is shown in Textbox 3 . The typical prescription written for non-NET Doctor Group patients is for 25 mg sildenafil and reads as follows: Take as directed. ‎ View this box Patients This study includes all patients of the NET Doctor Group who requested prescriptions for sildenafil during the period from the opening of the Web site on June 14, 1998, to March 1, 1999. All patients acknowledged a waiver of liability and agreed to specific terms of comprehension and truthfulness before submitting their request for physician consultation. The wavier applies to the NET Doctor Group, and not the independent physicians associated with the NET Doctor Group, as they are not employees of the NET Doctor Group. Each physician may rely on the patient's understanding of sildenafil and its potential complications, and the veracity of the patient's answers to the data collection device, as implied by the wavier. We informally compare these Internet patients to patients receiving sildenafil prescriptions at clinics of an inner city teaching hospital during the same period.

We reviewed charts of these patients, most of whom had been seen on several occasions prior to prescription of sildenafil, for a period of up to one year prior to the prescribing visit and for all subsequent visits. This report covers information obtained from the medical records of all patients who received sildenafil prescriptions as a result of in-person clinic consultations. It should be noted that the clinics are part of an inner city teaching hospital that is a publicly owned and operated facility. Thus, most clinic patients are members of a lower socioeconomic group. Most patients of the hospital do not have the financial means to afford treatment for erectile dysfunction. The small number of patients (36) in the office-based comparison group is a reflection of the group's socioeconomic status. Results Characteristics of patients receiving sildenafil prescriptions are reported in Table 1 . During the period covered by this report, 2,104 patients requested sildenafil prescriptions at the NET-Doctor Web site. These patients were somewhat younger than typical for men with erectile dysfunction (mean age 49.4 + 5.3 years, median age 45.9 years), possibly reflecting a lower rate of computer usage among the elderly.

Diagnoses of hypertension were reported by 18%, of diabetes by 13%, and of atherosclerosis by 7%. Ten patients had been treated for prostate cancer and one had experienced a spinal cord injury. Approximately 33% of the patients said they smoked; very few reported more than social drinking, while an unusually high 86% reported exercising regularly. About 95% of the patients said that their impotence had occurred gradually, and 97% that it involved an inability to maintain, rather than to achieve, an erection. Most said their penises were slightly firm but not self-supporting, although a significant minority reported hardness sufficient for sex despite decreased firmness. Eighty seven percent indicated that there were times they were not impotent. Significantly, almost 66% of the patients reported previously seeking treatment from other physicians for their erectile dysfunction. At least 75% of these men received only psychological counseling or reassurance, and almost none were satisfied with their previous treatment. Of the 2,104 requests for sildenafil, 2,100 were granted. The small number of refused requests may appear unusual.

It must be remembered that patients requested sildenafil only after reading information on the drug and its contraindications and completing an extensive medical history form. Individuals with contraindications to sildenafil presumably did not complete and submit the form, and therefore do not appear in the database of patients requesting sildenafil. Three of the requests that were refused came from the same address, provided the same demographic information, and requested the maximum number of tablets (30) for a single prescription. Attempts to reach the requester or requesters by telephone were unavailing. The other patient whose request was refused reported having been diagnosed with stroke, hypertension, and angina, yet denied chest pain. Attempts to reach him by telephone were likewise unavailing. Attempts were made to contact all patients by telephone. Less than 10% of all patients had conversations with the consulting physician. Less than one dozen questions required a physician's response; all questions were answered by email within 24 hours. The questioning patients submitted no follow-up questions.

Category Being treated for other medical conditions 46 Both mother and father alive 884 Time since last sexual activity 37 +/-9.4 days Penis not at all firm 63 Penis slightly firm, not self supporting 1267 Firmness decreased but sufficient for sex 770 Previous treatment for erectile dysfunction: Medical Chest pain (past or present) 0 View this table There were 2,101 male patients and 3 female patients in the group. One of the female patients reported a complete absence of libido, which had been relieved by taking sildenafil. The second had experienced sexual dysfunction since her complete hysterectomy three years previously. The physician managing her case had recommended that she try sildenafil in addition to the estrogen-testosterone combination with which she was currently being treated. The third reported problems of sexual performance. She was prescribed 10 sildenafil tablets. Category Being treated for other medical conditions 36 Improvement sufficient for sexual activity 310 Improvement sufficient for penetration /intercourse 310 View this table Three hundred ten (14.76%) of the 2,100 patients requested refills during the study period and have filled out forms reporting their experiences with the drug (see Table 3 ).

The number of patients granted refills at their pharmacies is unrecorded. All 310 reported improvement sufficient for them to resume sexual activity and to achieve penetration. Two hundred eighty seven reported that they almost always enjoyed successful sexual performance, with 16 claiming that their sexual performance was always successful and 7 stating that successful performance occurred occasionally. Two hundred fifteen said that their overall satisfaction exceeded all expectations, 76 that it met most expectations, and 19 that they were satisfied; none said that they were dissatisfied or somewhat dissatisfied. Reports of side effects listed in Table 3 were comparable to those from sildenafil clinical trials [ 11 ]. Since data could be obtained only from patients requesting refills, however, the sample may not be fully representative. No patient has complained directly to the NET Doctor Group via its web site. All prescriptions list the name, address, and telephone number of the dispensing pharmacy. The name of the prescribing physician is included on each prescription and the dispensing pharmacy has the physician's DEA number, state license, office address, and telephone numbers. No pharmacy has contacted the NET Doctor Group or its associated physicians concerning patient complaints. During this same period, 36 patients obtained sildenafil prescriptions from the hospital clinics.

The type of medical information contained in the office-based group's charts is summarized in Table 2 . These patients' medical records generally showed that blood pressure and pulse rate had been recorded at least once during the previous six months (including the index visit). Twenty of the 36 patients had received a general physical examination during that period, but only 6 had had their height and weight recorded and there was no record that any had received a rectal examination. Eight clinic patients were recorded as stating that their sex lives were poor and 4 as saying that there were times they were not impotent; these items were not recorded on any of the other reviewed charts. No chart contained any statement as to the quality of the patient's erection or whether the onset of erectile dysfunction was gradual or sudden. Likewise, no chart recorded either a blood lipid profile or any laboratory test relevant to diabetes. The only medical conditions of note recorded in these patients' charts were 4 instances of hypertension and 1 cerebrovascular accident. Just 16 of the 36 charts included a complete list of medications being taken by the patient. Since the primary contraindications to sildenafil use are certain concurrent medications, this is a significant omission.

No deaths or serious complications among patients using sildenafil have been reported to the NET Doctor Group, its associated private physicians or independent pharmacies by any patient; patient family member; attorneys representing the patient or their estate; or any local, state, or federal governmental agency. The medical records of the clinic patients had no indication of any adverse effects or death related to sildenafil usage. Lastly, FDA and Pfizer surveillance systems have not reported any deaths directly attributed to sildenafil. The possibility of unreported deaths or complications cannot be completely ruled out. Discussion The explosive popularity of sildenafil, and the demonstrated desire of many patients to obtain this medication without a face-to-face discussion of what they regard as intimate personal matters, has brought to the fore the simmering question of Internet-based medical advice and consultation [ 12 ]. Concern has been expressed by the Food and Drug Administration, members of the American Medical Association's Council on Ethical and Judicial Affairs, and the vice president of the Federation of State Medical Boards [ 13 ]. Yet sildenafil is only a small part of the changes currently in progress.

At least two groups are offering fee-for-service Internet-based medical consultations on a wide variety of conditions [ 6 , 7 ] and many other physicians find themselves responding to on-line requests for medical information and advice even when that is not their officially stated policy [ 9 ]. Indeed, medical information on the Internet is proliferating so rapidly that it has been the subject of an official report from a panel convened by the U.S. Department of Health and Human Services [ 14 ]. While this panel did not specifically address one-to-one communication between physicians and patients, it did note many of the benefits, such as greater willingness to engage in frank discussions about health status, behavioral risks, and fears and uncertainties. Advantages and problems Advantages of Internet-based patient-physician communication when real-time contact is not required include convenience for the patient and savings in both time and office resources for the physician. Perhaps most importantly, the computer interface greatly facilitates both obtaining and recording a complete medical history. This conclusion is supported by our comparison of medical history data from the Internet consultation form with that from the charts of clinic patients.

Due to the limited number of patients and the limited clinical setting, our findings indicate the need for funding further study and comparisons of physician directed Internet prescribing versus traditional prescribing practice. One objection that has been raised to Internet-based consultation and prescribing is that, as with the NET Doctor Group, there is generally no mechanism for providing a consultation report to the patient's primary care physician. Several points need to be made. One is that, even in the U.S., it cannot be assumed that all patients have a primary care physician. A second is that many patients - almost half of those seeking sildenafil prescriptions - are from outside the U.S.; they and their physicians may have very different expectations regarding consultation reports. Third and most significantly, a considerable fraction of the patients may have sought Internet-based consultation because they did not want their usual physician to know of their condition or of a specific sildenafil order. For example, they may not wish their wife to know of the order and may not fully trust the discretion of a physician who treats both family members. Although this is regrettable, respect for patient autonomy requires that there should be no attempt to contact the patient's primary care physician without the patient's explicit permission.

This latter point is also relevant to the frequently expressed opinion that it is easier to assess a patient's truthfulness in a face-to-face encounter [ 15 , 16 ]. We are dealing here with patients who have specifically chosen to seek a prescription from someone other than their usual physician. In the absence of an established relationship, mere physical propinquity would do little to assure a complete and truthful medical and sexual history. Indeed, the relative anonymity of the Internet may, in our opinion, well increase patient truthfulness and openness. Another objection sometimes raised is that Internet-based practices, including the one described here, may not specifically list the credentials of the associated physicians [ 15 , 17 ]. However, while physicians reviewing the site might find such information reassuring, its usefulness to patients appears remote. With rare exceptions, very few patients either understand or utilize the data on physician credentials that are available to them. Rather, they typically base their initial choice of physician on friends' recommendations and on convenience. Those factors remain valid in the context of Internet-based prescribing. Can erectile dysfunction be managed online? Clearly, not every medical condition is appropriately managed by Internet encounters alone. Erectile dysfunction may be particularly prominent among the appropriate conditions.

Although objective means exist for establishing the existence of erectile dysfunction and for distinguishing between organic and psychogenic causes [ 18 ], these tests are cumbersome and often omitted even from specialists' most comprehensive recommendations. Indeed, there appears to be little in the way of consensus as to what, if anything, beyond the medical history might be appropriate in the diagnostic work-up of erectile dysfunction [ 19 ]. Recommendations that the physical examination focus on signs of vascular [ 20 ] and neurologic [ 21 ] disease, together with palpation of the penis for Peyronie's disease [ 22 ] and tests for atrophy are common [ 23 ]. Except for detection of Peyronie's disease, which can usually be elicited by a thorough medical history, these observations are directed primarily toward determining a cause for the dysfunction. Prior to advent of sildenafil, the etiology of erectile dysfunction rarely affected the choice of treatment [ 24 ]. Consequently, Hakim and Goldstein limit their recommended physical examination to abnormal penile curvature and palpable corporal fibrosis [ 25 ].

Vinik has noted that erectile dysfunction is often the presenting symptom of diabetes and is also a marker for development of generalized vascular disease and for myocardial infarction [ 26 ]. Godschalk et al [ 23 ] recommend inclusion of a hemoglobin A1c and a lipid profile in all work-ups for erectile dysfunction. Similarly, Mobley and Baum recommend assessment of sacral root function by means of a rectal examination that includes evaluation of the bulbocavernosus reflex and of sphincter tone [ 27 ]. All three tests are absent from the recommended diagnostic work-ups of other experts. Significantly, we found no mention of them in the charts of any of the teaching hospital clinic patients who received a sildenafil prescription. One can conclude that there is an almost total absence of expert consensus as to the essential components of an erectile dysfunction work-up. The only area of agreement is the importance of a complete medical and sexual history. Our observations of practice in a Midwestern inner city teaching hospital clinic suggest that physicians in this setting rely primarily on the history in deciding whether a sildenafil prescription is appropriate. Yet we also find that the medical and sexual history they obtain is less complete than that obtained by the NET Doctor Group.

Once the physician has concluded that a sildenafil prescription is appropriate, the next step is to instruct the patient in the medication's proper and safe use. Although it is extremely difficult to assess how well different physicians communicate such instructions to their patients, many observations suggest that physician-patient communication is often less than optimal [ 28 ]. It would presumably follow that many patients do not understand the instructions they receive. When oral information is poorly expressed or poorly understood, the patient information sheet becomes critical. As a comparison of Textbox 2 and Textbox 3 shows, the information sheet provided by the NET Doctor Group to its Internet patients is far more thorough and complete, and perhaps more comprehensible as well. Further, it is not the standard for pharmacists to provide a specific patient instruction sheet when dispensing sildenafil. Greater thoroughness may be particularly important given the intuitively plausible assumption that Internet users as a group are likely to grasp information more easily when it is presented in written rather than oral form. Are current ethical codes and legislation too restrictive? The American Medical Association has noted that: Telecommunications advisory services, by way of phone, fax, or computer, can be a helpful source of medical information for the public.

Often people are not sure where to turn for information of a general medical nature or do not have easy access to other sources of information. Individuals may also be embarrassed about directly bringing up certain questions with their physicians [ 29 ]. The statement goes on to say: "Under no circumstances should medications be prescribed." This dictum, which is currently being revised [ 13 ], appears unduly restrictive. It may derive from the belief that, without physical examination and laboratory tests, the etiologic basis of a patient's complaint cannot be identified. The point overlooked by this assumption is that sildenafil is only one of many medications intended, not to cure an etiology, but to relieve a symptom; symptoms are normally diagnosed solely on the basis of patient histories. The ease with which the appropriateness of certain medications may be assessed underlies the prescriptive authority sometimes granted pharmacists, who are highly expert in medications and their uses but have little or no diagnostic training. As of 1996, 16 states plus the Indian Health Service and the Department of Veterans Affairs allowed pharmacists to initiate or modify drug therapy under certain conditions; similar legislation was pending in 15 additional states [ 30 ].

In almost all instances, this authority was gained with the acquiescence of organized physician groups [ 31 ]. Support for pharmacists initiating drug therapy is greatest when the condition being treated is diagnostically obvious. A 1993 survey of New York State internists and family practitioners found that 64% of the physicians questioned supported pharmacists providing a butoconazole vaginal cream for candidiasis and 61% supported pharmacists providing a steroid-containing rectal suppository for hemorrhoid sufferers [ 32 ]. Washington State allows certain pharmacists to directly dispense emergency contraceptives [ 33 ]. And although Florida pharmacists are authorized to prescribe approximately 30 types of medication, 82% of their prescriptions fall into just three categories: topical pediculicides (lindane shampoos), oral analgesics, and otic analgesics [ 34 ]. Neither physicians nor the Food and Drug Administration, which in recent years has approved the transfer of large numbers of formerly prescription-only drugs to nonprescription status [ 35 ], believe that every prescription drug calls for elaborate physician physical examination and history.

The clinic records from the inner city teaching hospital we examined indicate that some believe sildenafil may belong in this category. It might well be argued that the only reason sildenafil requires a prescription is the need for monitoring of contradictions and potential drug interactions, plus the mistaken ideas many patients hold about its indications and proper usage. This study provides evidence that both monitoring and the provision of patient information can be performed via the Internet at least as well as, and perhaps better than, through a traditional face-to-face physician-patient interview. Cross-border issues Concerns have been expressed about the potential availability to patients of drugs not yet approved in their countries of residence [ 12 ]. That this is a very real possibility is shown by the experience of the NET Doctor Group: 44.4% of the sildenafil prescriptions were issued to patients in 8 different non-U.S. countries. The concern is not truly limited to Internet-based prescribing: many Canadians crossed the border to obtain sildenafil from U.S. pharmacies prior to the medication's availability in their own country [ 36 ]. A large number of countries allow patients to import small amounts of nationally unapproved medications for their personal use.

The question is whether individuals' increased ability to obtain nationally unapproved drugs without physically traveling outside their country of residence calls for changes in the law. Conclusions Our results support Internet-based prescription (IBP) of sildenafil utilizing a physician designed and controlled information and decision system. The Internet-based prescribing physician consistently has more, not less, clinically relevant and useful information than was typically obtained and utilized in a specific hospital clinic setting. The data suggest that contrary too conventional thought, there is no evidence of compromise to patient safety. This statement is made with the important limitation that our study utilized only passive means to document patient adverse reactions or complaints. Our web site is available for comments 24 hours a day every day of the year. No negative feedback from patients using sildenafil was noted. Established monitoring systems operated by the FDA, Pfizer, local and state governments are actively gathering data. As of the current date we have served over 5100 patients and have received only one complaint from a patient (the patient had a history of asthma and was distressed that he was granted a prescription, he had been advised by a physician "acquaintance" it was unsafe for him to use sildenafil).

While our patients represent a minute proportion of all patients using sildenafil, we expect the aforementioned external event tracking systems would detect any significant variation in the expected outcomes of our patients. Based on the significant lack of spontaneous and voluntarily recorded complaints and the overwhelmingly positive comments of patients seeking refills, patients appear to be satisfied with our approach. IBP is associated with extremely low demands on health care resources and maximum responsiveness to patient needs. Health care standards and governmental regulatory efforts to date have not been based on objective or experimental evidence. They have significantly lagged behind the capabilities and implementation of Internet prescribing systems. We hope that data from this first large, objective scientific study can serve as a starting point for development of fact based, meaningful standards and regulations. We encourage further and broader evaluation of physician-designed and controlled Internet prescribing systems. Acknowledgments

Question: The first oral medicine to treat erectile dysfunction, Viagra was approved for sale by the FDA on March 27, 1988. Which company produces it?
Answer: Pfizer