I just saw Dr Scott Gottlieb, former FDA official, on Fox News talking about the need for the FDA to change its policy for approving cancer drugs. He believes that the efficacy standards are too high in the case of cancer drugs. He talked about Proveng and Junovan and how they should have been approved. He and Dr Thorton apparently feel the same way about these drugs. Patients should be given the right to take more risk if they so choose. He didn't like the use of placebos for cancer patients because patients in early stages of cancer don't want to take the chance of getting a placebo and those in the late stages are harder to help.
It looks like there may be a public outcry building that may put some pressure on the FDA.
No matter how you look at the data Provenge is going the same direction, it works. The p-value threshold is completely arbitrary, there is nothing scientific about, it is just due to the fact that the sample size is low
The new FDA guidelines are very clear: "as long as a drug is reasonably likely to be effective" for "serious and life threatening diseases" it will be approved.
With or without chemo, Provenge shows significant survival rate increases, common guys, 47% against 11% survival rate, don't you think a second patients will be willing to pass on? this is almost 5 times.
We are passed that point, the congress is going to have an investigation on this one. There are 200,000 patients diagnosed every year and 30,000 people that die every year. 47% is almost 15,000 people saved. Don't you think that congress will not start an inquiry for 15,000 deaths?
Wooptie-dam-do, the approval of Provenge has nothing to do with public out cry or people suffering with prostate cancer. Grow up, it's all about the money. Provenge will see approval when Wall St is properly positioned.