TA: Thanks for the opportunity to show off my research skills!!
<<The following points need to be made, for Viagra:
1) need for continued stimulation.I draw your attention to this paragraph from the original article:"They received a single dose of sildenafil (10, 25 or 50mg) or placebo. Each dose was followed by visual sexual stimulation (VSS)starting 30min post-dose and lasting for two hours." >>
TA: You are quoting from the methodology section of this study. Visual stimulation up to 2 hours was the protocol. No coitus was attempted in the study. But, why listen to me. Here is additional input on the study by Dr. Boolell... that was published in the April,1997 issue of British Journal of Urology. Dr. Boolell described his study and the use of RigiScan:
1997 British Journal of Urology 79, 661-664
"The RigiScan data are expressed as a geometric mean with 95% confidence interval because of the lack or normal distribution in the raw data. The apparent moderate increase in the mean duration of penile erection on sildenafil compared with placebo is influenced by the large variability between subjects and the process of data transformation to produce a geometric mean. For example, the duration of rigidity >80% at the base of the penis ranged from 9 to 93 min in those taking 50 mg sildenafil, compared with 0-18 min with placebo. This degree of rigidity lasted for >20 min in six of 12 patients on sildenafil but in none of the patients when they received placebo.
Our study was designed to test the hypothesis that a novel cyclic GMP-specific PDE5 inhibitor has the potential to enhance penile erectile activity during sexual stimulation. The patients selected had penile erectile dysfunction for a duration of 1.5-10 years and had been referred to the Urology Clinic by the primary care physician. The etiology of the erectile dysfunction in the study population was not established, although patients with a known organic cause (e.g. diabetes) were excluded. In a more recent study, we have shown that sildenafil is effective in diabetic patients with penile erectile dysfunction . Several larger clinical studies are currently underway to evaluate the efficacy of sildenafil in patients with penile erectile dysfunction of different etiologies."
M. Boolell
<<2)Furhtermore I am worried about side effects.
Remember that at higher doses ALL the phosphodiesterase inhibitors become NON Selective, which means they can affect the retina and the heart. here is a quote from the recent article Newsweek Magazine article on Erectile Dysfunction:
NOVEMBER 17, 1997 NEWSWEEK 67
The third pill, Pfizer's Viagra: marketing studies have includ-
ed men with varying degrees of impotence,The drug's most common side effects include indigestion and headaches, and some users report visual disturbances, such as a loss of color perception or a halo effect. But those effects are transitory. Experts are hopeful that low-dose
co mbinations of the new pills will boost benefits and reduce
side effects". Well you can't have it both ways : you either jack up Viagra dose to get a better erection but then you ran the risk of side effects in the eye ( Nature article 1996 on retinal degeneration, plus possible cardiac effects ) or , you keep the dose low to minimize sideeffects i which case you get a ten minute erection.>>
TA: You are being selective in your exerpts from this article.Even though Newsweek is not the best source for accurate medical information, let's start with the cover:
"The New Science of IMPOTENCE Can It Be Cured with a PILL?
Now, the opening sentence of the article:
"Newsweek 11/17/97 Lifestyle/Impotence: A Pill for Impotence?
New drugs awaiting approval by the FDA could be a boon to millions of men with erectile dysfunction. They're painless and discreet (no needles), a potential bonanza for pharmaceutical companies and the booming industry of male medicine. And if they make enough boomer guys feel like virile teenagers again, they could trigger another sexual revolution."
Now. the body of the article, before the low-dose/side-effect statement... that was actually not specific to Viagra but referred to three oral drugs:
"The ideal remedy would be easier to take, and would make erections possible instead of compulsory. That's where the pills come in. Three are now in the final stages of development. They have different mechanisms of action, but none requires any fancy equipment, and each can improve sexual function without interfering with dish washing. TAP Holdings' Spontane (apomorphine) is a non-narcotic morphine relative that stimulates the brain centers involved in erection. In premarketing studies, 70 percent of mildly impotent users have found it useful. Zonagen's Vasomax (phentolamine) gently dilates penile blood vessels by blocking the effects of adrenaline. Urologists have long included phentolamine in injectable cocktails, but this will be its first time out in pill form. Like Spontane, it's intended for men with mild problems, but studies suggest only 40 percent benefit. The third pill, Pfizer's Viagra, looks like the star of its class. When it hits the market, says Dr. John Mulcahy of Indiana University, "most physicians will just say, 'You have impotence? Try it'."
Finally, what was the consumer response to this cover story? Let's check out Newsweek's Interactive article :
NEWSWEEK Interactive November 24, 1997
By the readers of NEWSWEEK Interactive with Todd Oppenheimer
Is there no longer such a thing as a problem without a pill? Maybe. After men have suffered decades, if not centuries, of frustration with impotence -- meanwhile resorting to such drastic measures as stuffing their organs with implants and pumps -- enter, at last, the impotence pill. They're not officially approved for mass market yet; that's expected next spring. But the men in early trials are reporting good results -- far better than men have with previous remedies.
Some specialists, however, are expressing fears about the wisdom of long regimens on whole body drugs for a localized problem. There's more worry about abuse of this drug for a problem whose roots are often psychological or inter-personal, and perhaps better handled with counseling. And there's some concern about side-effects, vaguely called "minimal" so far.
What, we wondered, did readers? We specifically asked men what risks they would you go to in seeking a cure for impotence -- and to share any experiences they've had. Many were surprisingly forthright with their struggles, and their confusion about how to deal with the ultimate sexual dilemma.
"It is not just impotence as we generally think of it," HerbK13139 wrote, "but the reduced capacity for erections in a long-time marriage. A medication to help the body be more "cooperative" may give most marriages a wonderful "boost." Now if my wife's "headaches" only had a cure..."
"I have had this problem for quite awhile," QSWalt added. "Erecto-aid helps, but it is a little clumsy when you have to say, 'Let's pump it up first.' When my wife was alive, it was O.K.. Now I find it would be a little embarrassing if you are on a date."
Troubles of this sort were mere inspiration to LeDauphin: "The thought of an erection pill is great. Sex is a gift, a blessing, a great way to spend time being social. I like the idea of harder, bigger, longer. And the thought of lots of stock in the pharmaceutical company producing the stuff -- what's wrong with a good stiffy or being filthy rich? Nothing. It's all in how you use it..."
A few writers, however, were specifically concerned about impotence's link to prostate cancer treatments. "I was a four-times-a-week, happily married man," wrote E7SADOM1 (Sal S. Domina). "Now after seven weeks of daily radiation, I am lucky once a month. Will the pills help me? Send me a few. I will try them. Thank you for a very informative subject. We need frank conversations."
To which HerbRak replied with some good news. "I am 63 and now four years past cryosurgery for prostate cancer. So far no cancer, but the price is impotence. After two years I got on a clinical trial of sildenafil [one of the impotence pills featured in NEWSWEEK's story last week]. It really does work. Take a pill (on empty stomach) and 30 minutes later with appropriate stimulation, you can have a good sex life again. No side effects, and I have had multiple blood tests, etc. as part of the trial. It is not like I was 18 again, but nothing else is either."
Tkennea921 argued for the pill by describing, in some detail, further problems with current remedies. "I have used the injection method, the 'insertion' method (tiny tablets forced into the [penis] by a plastic device, and now I am considering the pill. Of the above, the needle method is not only painful, however effective, but it is not conducive to maintaining a good self-image and must be used in private. Few men find this method satisfactory or realistic in real life. Using the 'insertion' method is far less painful but lacks reliable, consistent results. Not aware of any serious side-effects, I am all in favor of the pill. No pain, no embarrassment."
In a final note of positive context, JMCBAINE said, "I, for one, am glad to be living in a time where solutions can be found for conditions like this. I have friends who have had prostrate surgery which carries a very high risk of impotence -- nerve damage due to the surgery. So, to fight prostrate cancer (and possible loss of life), the risk of impotence seems like a reasonable one. However, what man would prefer the result of impotence if he had an option? We have drug therapy and surgical techniques for all sorts of conditions today. What makes a face lift or liposuction any more 'acceptable' than a solution for impotence? Ask a man -- any man -- which procedure they consider more important. I think it's great. I just wish they would hurry up with the pill to cure male pattern baldness!
<<3) A third point: Look at article No7 in th ebibliography and who do we see?"7 Kim N, Azadzoi KM, Goldstein Irwin, De Teiada IS. A nitric
oxide-like factor mediates non-adrenergi@, non-cholinergic
relaxation of penile corpus cavernosum smooch muscle.
neurogenic JClin Invest 1991; 88: 112-118".One of the Authors is our good friend Irwin-pad my bicycle seat- Goldstein of Barrons fame speaking poorly ov Vivus.
TA: You may not like Dr Goldstein and Vivus may choose not to do MUSE studies with him, but here is what your reference Newsweek article said about him:
" At Dr. Irwin Goldstein's urology clinic in the Boston University Medical Center, the new chemicals are already reshaping the way we think of impotence. Goldstein, 47, is one of the pioneers of the erection business; his clinic sees 700 new patients a year. "
TA: The ball is in your court. Thanks for the slow pitch right down the middle!!
Best regards and good investing!
BigKNY3 |
