The company had taken a peek at the data before, so this patient may have been revealed to the company then, but in the CFO's email all he really did was confirm that the patient was in the trial. He didn't say with certainty that he was in the two thirds of the patients receiving the drug.
The mother of a poster also had been in the trial and died, when she was autopsied her tumors were also found to be neucrotic. TNFerade's criticism at ASCO because it didn't adequately explain tumors not shrinking much. It appears that dead tumor doesn't shrink, nor do the body's normal cleansing mechanisms clear it away in a timely way. I believe over time that they'll need to address how to dispose of neucrotic material and the results if they can do that will be cures in time.
I certainly agree that the absents of any cancer doesn't say cure by inself. Cures are generally considered being cancer free for five years, and even after that time they're known to reoccur. Reporters over time have called cancer free patients cured rather than saying they had a Complete Response.
Cure just sounds like a better word, just as the FDA would rather say the next peak at the trial data will be after 92 events. The FDA likes to make people think about events, rather than deaths, that way the delays they create don't seem to mean that much to most of the people.
On the DNDN board someone does a daily count of how many have died of Prostate Cancer since Provenge wasn't approved. IMHO many of these people would eventually probably die anyway, but nearly all would live somewhat longer, perhaps some would live additional years, but the FDA has taken that away, at least for now.
I'm very much a believer in conditional approvals from the FDA, the problem is their failure to approve, but instead call drugs approvable, and ask for more. When they get what they ask for some times they once again say approvable, and ask for something else they didn't ask for in the first place. This needs to end, especially for terminal diseases. If America want to stay a leader in drug development, we need to make the process faster and cheaper. Conditional approvals permit any post approval questions to be answered, and if the answers show there's a problem the use of the drug may be limited, or the approval cancelled, but something must be done to stop the delays the FDA is creating in the approval of most drugs they review.
Gary |
