To: FCC who wrote (70 ) 3/4/1998 4:51:00 AM From: (no name provided) Read Replies (2) | Respond to of 246
Dear FCC, A couple of your points are wrong. "1. The reason that the product is not reimbursed at this time is because it had come to the market first. A OB-GYN friend of mine told me this fact. By the way Traveller's insurance comp. owns a stake in HMSC." 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. "2.This product was never meant to replace mammograms, but to supplement them. This technology is more sensitive than mammos, and palpation of the breast by the doctor. This product is meant to be the earliest detection device for breast cancer, is they find a developing tumor the pt has a greater chance for survival." 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. "3. The product cost only $40. Very inexpensive as compared to other tests. The doctors are charged $25 and make a small profit." I'll give you this one. "4. Any doctor who doesnt offer this test,even if it doesn't work for all patients will one day get a letter from the lawyers office wondering why their client was not given the opportunity to possibly catch the malignancy at an earlier reversible stage." There is absolutely no data to support that BreastAlert can detect malignancy at an earlier stage than palpation or mammography. "5. Patient has nothing to lose, to try a painless, radiation less, inexpensive, speedy test. The time that the women must wait to here results from mammos seems like an eternity." 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. "6. No one knows how well this product works, that's why they are doing the clinical trials. They have made changes in the product before shipping. The reason for the delay was that the product gave a false reading if it was shipped to very warm climate. That has all been rectified." Clinical trials have been done. Read the prospectus.