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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Linda Kaplan who wrote (6487)	5/7/1999 6:29:00 PM
From: BDR	Read Replies (1) \| Respond to of 7041

<<I still don't think that nausea, vomiting and diarrhea are conducive to a pleasant sexual experience. Silly me.>> Hey, don't knock till you've tried it, I always say.(g) <<I don't know why there would be better efficacy in an uncontrolled study than in a study that was controlled by placebo. Do you?>> Patient selection could make the difference (were nitrate taking patients, i.e. sicker patients, excluded in both studies or just the one reporting better results) or the means of measuring success could be different. I thought most people studying impotence agreed to try to report results using a standardized measurement of outcomes so that one could make meaningful comparisons between studies. Can't tell since I don't have access to the details of the studies. <<Certainly if initial dosage of Vasomax must be provided by a physician in office, that would be a deterrent to sales.>> Vivus's MUSE is supposed to be administered the first time in the physician's office for the same reason. But that isn't the main deterent to sales of MUSE.

To: Linda Kaplan who wrote (6487)	5/7/1999 6:44:00 PM
From: Brander	Read Replies (1) \| Respond to of 7041

Linda, I don't know the details of the uncontrolled study, but the different result does not surprise me. Many times, even different controlled placebo studies of the same medication and problem yield statistically different results. That is why a single scientific study is given much more credence when it is replicated by different labs.

To: Linda Kaplan who wrote (6487)	5/7/1999 11:14:00 PM
From: Cacaito	Read Replies (1) \| Respond to of 7041

Placebo controlled and double "blindness" and multicenter studies are precisely the ones that the FDA respects. Investigators and patients biases are eliminated a lot in a WELL designed study. There are statisticians that could design studies to break even the blindness, tricky people indeed. Many centers eliminate "center noise", the places that "unexplicably" get good results no matter what, tricky places? no, again tricky people. The Mexican studies of Vasomax showed impressive results showing the center noise very clearly, again tricky places. But the open label study of Vasomax patients are the ones who chose to stay from the subjects in the previous studies, they decided to keep using the medication now in a non blinded matter or OPEN. The company uses the open study to generate longer term data mainly for safety and side effects issues and to track satisfaction. If the 69% represents the patients who stay in the open, is a fair number but not strong, they should keep at least 80% to show strong satisfaction. It is not the effectiveness (or lack of it)of the pill what is look at in the OPEN study, that was already shown in the blind studies. The open label patients should show close to 100% effectiveness because almost only the patients that feels they are helped by the pill will continue on it. But if the researchers switched the placebo patients to Vasomax, at the time that the study became open, then whoever responded in the placebo group will be add to it... .... and another chunk that did not respond to placebo, but now they are told : Hey, before it was not the real thing, NOW you WILL get the real thing, and another strong placebo effect is created.... ...The none responders will drop themselves out... ..... The final number then could reach the 69% effectiveness (if that is what the analyst is talking about). One could see how the numbers can go from 37% to 69%, impressive doubling, plus they just decided to use the sexy 69%, instead of the boring rounded 70%.... ...Very smart, symbols also work in the mind of everybody, even the FDA. This is an intentional placebo result, sugar pills for the analysts and the street. They do not mentioned that the problem with Nitrates and Viagra is a simple combination of two powerful drugs that could cause hypotension. Phentolamine will not escape this, it already showed hypotension by itself (not a surprise). Nausea and vomiting are common, the rare side effect is gastric bleeding known to phentolamine that the analyst did not mentioned.