[20228025]
(b)(6) investigators began using the bahr mgmt hot flash monitor for their initial (b)(6)-funded project on postmenopausal women. They found that a number of women reported itching and irritation from the electrodes. They relayed their concern to the company, but were told that no one else had raised this concern. Subsequently they prepared a report to simplex stating that 9 of 67 women experienced some skin irritation, but were told that the company did not have an explanation. Investigators informed women to stop wearing the monitor if it became too bothersome. When they began their next (b)(6)-funded study, the revised bahr monitor was available and they purchased the newer ones for use in their study. They again received complaints from the women about reactions to the adhesive patch. In (b)(6) 2011, they were told that the only complaints that simplex had received came from this particular group at (b)(6) for both studies. They have had 4 women in their second study refuse to wear the monitor any longer due to their reactions to the electrode. Among 108 women recruited to date, 43 reported some sort of irritation due to the adhesive. Some of the participants' comments include: "tape caused welts and was extremely uncomfortable. " "adhesive itched very badly to the point i scratched around it the entire time, small bumps have appeared upon removing it. " "the adhesive patch was very uncomfortable and irritated my skin. Still irritated. It was the worst! " "extremely uncomfortable. " investigators have had to tell women to stop wearing the monitor if the itching and rash are too bothersome. Because (b)(6) has ongoing studies using the bahr monitor, results reported in the article by (b)(6), noting that the bahr monitor caused itching among women in the (b)(4) study - laboratory and ambulatory eval of vasomotor symptom monitors from the menopause strategies finding lasting answers for symptoms and health network. Menopause 19 -6-, 2012; epub ahead of print-. The second issue has been the program to analyze the data. Investigators repeatedly inquired about the availability of the program for well over a yr before (b)(6) informed them in (b)(6) 2010, that the program should be ready in jan of 2011. They finally received the program (b)(6) 2011, almost a yr after they were originally told it would be available. They can use the program to download data, but it is not clear to them how a hot flash is determined by the program. The program reports when a hot flash has been detected by the monitor or reported by the participant and the exact time of the hot flash. However, if the times differ by one second, the program does not consider the hot flash detected by the monitor as the same as that reported by the participant. (b)(6) suggested that a hot flash detected by the program and reported by the participant within an interval of 15 minutes should be considered the same. They will explore this window, as well as others, and compare the results, but this is not an acceptable response. Finally, simplex informed investigators that there is now a newer version that could affect the results. In conclusion, the company has not been responsive to or provided any sensible recourse for the (b)(6) investigators. I would be most appreciative if the fda would contact me for f/u: (b)(6).
Patient Sequence No: 1, Text Type: D, B5