RE: RE: placebo u say........... HT, most people reject the use of chemo not because it might kill them but the horrible side effects and how sick it makes them feel. In truth, if there is an alternative medicine that would not wipe out your good cells indiscriminately, wouldn't you take it. I think that's wht patients in P3b does not want to take the chance of being assigned the MitomycinC. In addition, MitomycinC has not even been proven effective. Why would you want to take the chance of getting incredibly sick, wipe out your good cells with a useless drug. If the P3B were using a proven alternative drug like Valstar, there might be a chance of patients accepting the comparative choices.
Arch, the placebo is usually a "non-drug". If one were to test a new drug in the absence of an existing effective drug available, you do need to compare your drug to the effect of "no drug" to establish the benefits of your drug. The fraudulent practice in manipulating the data does not negate the fundamental need of comparing a new drug to no treatment at all. Mayo is right. If there is an existing drug that is working, it more appropriate and important to compare the new drug to that already working to determine whether it is really justifiable to use the new drug. That's what BNC was trying to do in its original P3B design, comparing BCG to Urocidin.
In the present attempt for the NOC/c via HC, they don't have the data comparing to an existing drug, the BCG. TRhat's why it will be a rather difficult sell in my opinion. They will have to based solely on Urocidin's safety factors and the shortage of BCG to move HC. I hope HC will heed our case because it's a Canadian pharma and will bring jobs and prestige to Canada Biopharma. industry. Let's see if that's good enough of a motivation for HC.
GLTA