To: (no name provided) who wrote (75 ) 3/4/1998 6:28:00 AM From: FCC Respond to of 246
I am more informed that you would know. I have called the company many times and hope that there info is correct. A couple of your points are wrong. Your pt. The product is not reimbursed because it was decided by HCFA back in the mid-1980s that breast thermography was worthless and it withdrew reimbursement at that time. A. This not the mid 1980's, there have been advancements since then. Travellers insurance did not have a stake back then, Why now? I was told last night that they are going to eval again. By the way, This technology was owned by Fabrege' in the early 80's and after a hostile takeover the company and product was dismantled. Your 2nd pt.- This is simply untrue. The BreastAlert device has undergone several clinical trials according to HMSC prospectus. It is less sensitive than mammography of the early 1980s. In addition, it has higher false positive rate. A. You read the press releases it states that, HMSC is conducting clinical trials at this moment, to be released in 2Q. HMSC was not in existence in the 80's. The latest info from company 3/3/98, states that the BA is more sensitive that mammos or palpation. CHECK THE NUMBERS!!! Your 3rd pt.- There is absolutely no data to support that BreastAlert can detect malignancy at an earlier stage than palpation or mammography. A.That is why they are doing the clinical trials now. The modifications that were made are now being tested. Your 4th pt.-The patient does have something to lose (other than money). Due to the high false positive rate, there will uncertainty in a large number of users. A.- I have heard that women are accepting and agreeing to take this test without hesitation. I'm sure they rather have a false positive than a missed malignancy. Just another tool for the doc to possibly find malignancy before it has doubled in size. mammos don't work well in young women 20-40 y.o. due fibrous tissue. " Your 5th pt.-.Clinical trials have been done. Read the prospectus. A. I REPEAT, YOU CHECK THE PRESS RELEASES WRITTEN AFTER THE PROSPECTUS WAS FILED. Clincal trials are in progress in Virginia right now based on the redesigned product. With all this said, the time is not now to short there will be much exitement in coming days. Then your time may come. VIVUS 17-84 back to 12 in about 9 months. GO LONGS!!!!