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

To: Cacaito who wrote (4179)	1/2/1998 2:32:00 PM
From: Tunica Albuginea	Respond to of 23519

Cacaito, "Self-reporting is a very common technique of evaluating many clinical situations and sometimes the only way of getting information in an ethical way, What are they going to do? Video patients and partners?" Video patients and partners is what Master's and Johnson did in ~ 1967 in their landmark study, " Human Sexuality ".They also put pressure probes in female genitalia, if I remember correctly, to document relaxation/dilatation phase pre-orgasm, with penis" free floating' barely touching vaginal vaul texcept at the entrance, just pre - orgasm. They were the first to describe the physiological changes duiring sex and their work was pioneering. TA

To: Cacaito who wrote (4179)	1/4/1998 10:06:00 PM
From: MissLil	Read Replies (1) \| Respond to of 23519

I am going to respond to these comments because I believe that the comments here reflect several common mis-perceptions about what constitutes an adequate clinical study. Others who may know more than I do about clinical study may correct any deficiencies. reference: Cacaito on Jan 1 1998 10:24PM EST >MissLil, the study is not for the FDA, Muse is already approved. My comments did not address this. However, the FDA has a wide range of experience in evaluating studies. Admittedly, some studies do not meet their criteria that might otherwise have useful information. In my sole opinion, this study does not. >Double blind is not strictly necessary, it is more difficult and more expensive to do, the researchers probably were in a hurry and short of money. It is not exponsure by Vivus, maybe not even from other pharma. Double blind is not strictly necessary. However, in the case of this study, it is warranted in my opinion. >It is a post marketing study looking at a population that is not the initial aim group for Muse , this is the severe ED patient that needs injection therapy. How do you know that? Are you one of the researchers? Or are you assuming this? The patient characteristics were not described. One might treat patients clinically who do would not have met all the characteristics for study entry. I don't know what criteria the physicians used to decide to treat these patients. This certainly could have been described and would have improved the utility of the study. >It is a small view of what this researchers (independent?) are seeing in the real clinical world. >Double blind not necessary because the patients were all known to be responders to the injection treatment, and Muse efficacy in ED is known. On what basis are they known to be responders? I could have accepted this study better if the patients were allowed to bring MUSE home and then report the efficacy based on whatever efficacy they reported with injection therapy. >Or are you going to subject the patients to an intraurethral placebo? To stick something in your penis that does not work, when ther is something known that it works? Not ethically appropriate, and one of the reasons the FDA is very tough before approval, one something is out that works it is very difficult not to give it to the patient and use placebo. It could be done, but most more difficult. In this case, the appropriate control was an active control. My main objection with the study is that the criteria for efficacy was not the same for both the injection therapy and MUSE. One can argue about whether a placebo would be appropriate in this study. In my opinion it would not be appropriate until when and if the investigators design an adequate study. If that is done, one could argue that many thousands of patients may use one medication over the other based on the results of a study. If the study is done under careful monitoring with physicians who are adequately trained to handle complications, this may actually improve the safety for the many others. These drugs will probably be prescribed by primary care physicians who are not as knowledgeable about the complications. Adequate documentation of the relative risks/benefits will guide recommendations for which drugs are more safe to be prescribed by these physicians. The discussion of the ethics of placebo controls is hotly debated and not for here. I personally would question the ethics of subjecting any patients to a study that does not provide usable information. Self-reporting is a very common technique of evaluating many clinical situations and sometimes the only way of getting information in an ethical way, What are they going to do? Video patients and partners? contract patients and surrogated partners? >f they use highly "objective" test like: buckling test, blood flow measurements , penile gauges, How will they correlate the results with the real sex life of patients? Self-reporting could be probably closer to real life than many of the objective tests. Besides there are ways of decreasing the chances of lies and inconsistencies from the subjects (usually most subjects are honest). Most people are honest. However, there is a "placebo" effect with some people responding to any treatment. The magnitude of this effect varies with the circumstance. With impotence, one can imagine that this might be quite significant. The same test should be used to measure both treatments. Otherwise, there is no way to compare efficacy. >The study is good in what it was looking for: responders to Muse in a gorup of ED patients on injection therapy. Note that these were responders under very different conditions than responders to injection therapy. >The Muse/prazosin combination studies most be highly rigorous studies, and this are in plans. or ongoing? Don't understand question.