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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: James Baker who wrote (3969)	12/20/1997 9:46:00 PM
From: BigKNY3	Read Replies (2) \| Respond to of 23519

James <<But if Barron's quotes a doc who is supposed to know something about ED but in fact has been a paid consultant or investigator for every other company in ED except Vivus and this is not acknowledged, then this is WRONG and can not go unanswered.>> James, you make an excellent point and I agree that Barron's should have clarified this point. However, if in fact Dr. Goldstein has never evaluated MUSE in a clinical study (still hard to believe), it points to a major weakness in the MUSE marketing and medical plan. Like him or not, Dr. Goldstein is one of the most influential physicians in the field of erectile dysfunction. BigKNY3

To: James Baker who wrote (3969)	12/20/1997 10:53:00 PM
From: BigKNY3	Read Replies (2) \| Respond to of 23519

James: I always like a research challenge! Dr. Irwin Goldstein has investigated MUSE. In a 1997 issue of Medical Tribune (38 (3):1997) an article "Understanding As Important As Treatment for Erectile Dysfunction" featured an interview with Dr. Irwin Goldstein. It is noted that "Dr. Goldberg, who participated in clinical trials of the device, said many men prefer the MUSE to penile injections." BigKNY3 ________________________________________ Understanding As Important As Treatment for Erectile Dysfunction By Charles Bankhead [Medical Tribune: Family Physician Edition 38(3): 1997. c 1997 Jobson Healthcare Group] ------------------------------------------------------------------------ The growing array of treatment options for erectile dysfunction has focused more attention on the importance of recognition and clinical evaluation, two urologists said. "In the 1990s, physicians can help almost every man achieve an erection, and in 95% of the cases, the help does not involve surgery," said Kenneth Goldberg, M.D., a urologist and medical director of the Male Health Center in Dallas. However, today as in the past, the first step often proves to be both the most important and the most difficult. "Erectile dysfunction is still a very uncomfortable topic for many physicians and patients," said Irwin Goldstein, M.D., a professor of urology at Boston University. "I've often wondered how many men have gone to physicians and complained about hemorrhoids when the real problem was impotence, but the men were afraid to ask about it. "For a man to admit to a physician that he has the problem is a big issue. If a patient takes the risk and mentions the problem and a physician doesn't listen or doesn't pay attention, that's like double jeopardy. Perhaps the most important thing a physician can do is to be empathetic." Half of men aged 50 and older have some degree of erectile dysfunction. By age 70, seven in 10 men have the problem. The numbers reflect a point that physicians need to convey to patients: erectile dysfunction is not uncommon. Patients also need to know early on that erectile dysfunction is probably not all in their heads. "The pendulum has really swung back and forth on this issue," Dr. Goldberg said. "In the '60s, Masters and Johnson said 90% of impotence was psychological. Now experts say that up to 90% of impotence has a physiologic basis." The initial workup for erectile dysfunction should be neither complicated nor expensive, Dr. Goldstein said. A thorough medical history and physical exam are the primary components. Obvious areas to explore in the history are diabetes, hypertension, drug and alcohol abuse, hypothyroidism and vascular disorders. "I think it's important for medical personnel to recognize that impotence may represent the beginnings of systemic vascular disease," Dr. Goldstein said. "It would not be unreasonable to pursue that issue." The history should include a careful review of medications, and physicians should keep an eye out for any drugs known to affect libido or erectile activity. Antihypertensives are common suspects, as are various psychotropic agents. Laboratory work should be kept to a minimum, usually routine urine or blood tests. Depending upon the patient's clinical characteristics, Dr. Goldberg said he may request a hormone analysis, prostate-specific antigen or an SMA-20. His initial workup (which runs $250 to $300) also includes a book on male sexuality. A variety of physiologic tests has evolved for evaluation of erectile dysfunction, but most are used selectively. The tests include nocturnalpenile tumescence studies, neurologic evaluations and vascular tests (such as duplex ultrasound studies and dynamic pharmacocavernosometry).The tests often are conducted by specialists, but Dr. Goldstein said primary-care physicians who have a special interest in erectile dysfunction also may perform the tests. Last November, the American Urological Association adopted clinical guidelines that recommend three types of treatment for erectile dysfunction: vacuum constriction devices; penile injection of vasoactive drugs; and penile prostheses. The guidelines appeared in The Journal of Urology (1996;156:2007-2011). Of the recommended treatment options, vacuum devices and penile injections are used most often. Drs. Goldstein and Goldberg agreed that all treatment options should be reviewed with a patient in an unbiased manner. The patient should then decide which option might work best for him. "We keep about 50 to 75 vacuum devices around all the time to loan to patients," Dr. Goldberg said. "It's unreasonable to accept the treatment without trying it out. We also let patients have a trial with injection therapy." According to the AUA guidelines, medical therapy, primarily in the form of yohimbine, has not proven effective. Dr. Goldberg has seen responses in 35% to 40% of patients who have tried the oral agent, but he acknowledged that the responses could represent a placebo effect. Patients also may want to consider a treatment option not cited in the AUA guidelines. The Medicated Urethral System for Erection (MUSE, Vivus), recently approved by the Food and Drug Administration, is used to deposit a dose of the vasodilator alprostadil in the urethra. Dr. Goldberg, who participated in clinical trials of the device, said many men prefer the MUSE to penile injections. The AUA guidelines characterized the surgical approaches to erectile dysfunction as investigational. Ultimately, successful treatment has its roots in a good relationship between physician and patient. An impotent man should never leave a physician's office with nothing other than a pat on the back and some words of consolement, Dr. Goldstein said.