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Non-Tech : Bill Wexler's Dog Pound -- Ignore unavailable to you. Want to Upgrade?

To: Druss who wrote (2800)	8/4/1999 1:33:00 AM
From: out_of_the_loop	Respond to of 10293

Druss: Do not be confused. There are two studies. I tried to explain this in my posts, but here are longer explanations that should clear up things. The first study was done a long time ago and was sent to the NEJM where now it awaits final word. I am well-aware of the NEJM, having sat on the committee that oversees its business affairs (7/1989- 6/1990). The first study tested volunteers with cold symptoms and (double-blind) treated half with Zicam and half with placebo. It was found that the people who received Zicam had their cold symptoms relieved in an average of 1.5 days compared to average of 10-14 days in the placebo group. The p was <0.001, which means that the chance that Zicam DID NOT account for the difference was one in one thousand. Since most studies require only a five in one hundred significance (P<0.05), this is very compelling and is easily conceivable as material submittable to any major medical journal, especially on the heels of the other recent studies of common cold medications in JAMA, etc. The second study is described below as taken verbatim cut and paste from a recent GUMM press release: (http://biz.yahoo.com/prnews/990715/az_gum_tec_1.html) . Initial clinical research has indicated that use of ZICAM(TM) can reduce the duration of the common cold from 12 -- 14 days to 1 -- 3 days. According to R. Steven Davidson, CEO of Gel Tech, ''Scientists at two major universities have begun work on the next phase of clinical research concerning the efficacy of ZICAM(TM). The research will have three objectives: confirming ZICAM(TM)'s ability to significantly reduce the duration of the common cold; exploring ZICAM(TM)'s ability to act as a preventive measure against the common cold and its symptoms; and testing ZICAM(TM)'s ability to relieve symptoms caused by allergic reactions to common airborne allergens.'' Davidson continued, ''The independent studies will be conducted at multiple sites according to rigorous scientific protocols. The research on ZICAM(TM)'s therapeutic and preventive benefits will be conducted by inoculating patients with a common strain of rhinovirus.'' Davidson concluded, ''Baring unforeseen delays, we anticipate that the research will be completed by the end of October, 1999.'' I hope this clears up any misunderstanding about the studies. Regards, Howard

To: Druss who wrote (2800)	8/4/1999 1:50:00 AM
From: DanZ	Respond to of 10293

Druss, <If further results are pending I would not give that particular article even a minute chance of publication in The New England Journal of Medicine.> This is an interesting point and I will investigate it. To clear up the confusion from tonight. A double-blind placebo-controlled clinical study to determine the effectiveness of Zicam against common cold symptoms has already been completed. The results of that study had a very high statistical significance and were submitted to the NEJM a few months ago. A second round of studies is currently underway. One of these studies will investigate the ability of Zicam to prevent the common cold. The second study will investigate the effect of Zicam on allergy symptoms. The third study is similar to the study that has already been completed. I was told that they are doing this because the FDA requires two studies to be completed before certain claims can be made on the packaging and advertising. The studies for prevention and allergy symptoms are clearly different than the study that has already been completed. In your opinion, do you think the NEJM would wait for the results of these studies before publication of the first, or would they consider them completely different issues? Speculation exists that the NEJM will wait for the results of the second round of studies before making a decision to publish the first study. GumTech will not confirm this rumor, understandably, because they probably don't know if the NEJM will wait. This is probably what prompted Bo's comments tonight. Thanks for your input, Dan