To: Dauntless who wrote (2134 ) 1/29/1998 5:17:00 PM From: Dr. Voodoo Respond to of 7041
I read the pertinent parts of the text of the workshop. Many people have continued to state that the workshop was not a VALID study of phentolamine levels in blood. If so, then you could make a case that all of the unpublished work at Zonagen is INVALID. Point I would like to make, just because someone doesn't publish something in a peer reviewed journal, doesn't mean that their data isn't scrutinized and validated. I know alot of people who haven't published alot of stuff, some of which they did years ago. When asked they scratch their head and say,"You know, I should really get around to writing that up in a paper someday!" Regarding the method used to measure the phentolamine levels in blood. Although in the body of the text of the Imhof presentation, it mentions that gas chromatography was used and levels were given, no mention of the methodolgy was given. Of interest then, becomes what work was done to make sure that the assay was indeed accurate and that the numbers provided were not estimates. The cool thing about workshop and conference proceedings is the the question and answer portion of the text that most of these books have. This isn't exactly peer review, but often a number of details show up in these questions that can be important in interpreting what comes out. In fact, Dr. Imhof states that his GC analysis was accurate to 10 ng/mL. With this information I can understand why someone would doubt Zonagen's claims--JMO. The 1978 paper is next on my get list. I think it will shed some light on why he developed it. I haven't seen it but my guess is that the GC analysis is a pain in the butt to run, and he wanted a quickie way to estimate concentrations--purely speculation on my part, need to get the paper. Does this mean anything? My opinion is NO. Do not overinterpret this unless your planning on suing Asensio, in which case as I said before, go get an expert(I personally, wouldn't go further with this.--JMO..). As has been pointed out, the patent on the use of rapidly absorbable therapy for impotence is irrespective of their formulation. Suffice it to say I would argue that they have discovered nothing new regarding their rapidly dissolving tablet, and the data that they presented is more illustrative than useful toward their patent claims. To boil it down, Zonagen could argue that Imhof's data is inaccurate. I could argue that Imhof discovered a rapidly absorbable formulation of phentolamine. Can someone patent the use of a generic drug for another(new) indication and not have to compete with other generic drugs? What does this mean for marketability? Anybody like to comment on this one? Rob P.S. Sorry for the clock building excercise sometimes I get a little carried away.