I have been trying to post a question to Cow but for whatever reason Yahoo won't let me post it. I think it is because I was quoting AF in his Nov 13 report . I would like to hear any reactions to what he said in that article which accuses AZN of opening a closed data and adding the one patient to make their data meet the minimum significace.
I have a post in your CATALYST thread that appears and disappears at random. Yahoo (jerks) have really f*d up the message boards. As if they care.
hijacked pointed to a thread on an IV board that discusses this. The poster stated that access to the data base is tightly controlled and produces an audit trail. Selectively adding previously censored patients after unblinding is a no-no and would be captured in the audit trail. A guess as to what happened is that after the record was added prior to unblinding, it was subsequently discovered that the efficacy endpoint would not have been met without that one patient data. As long as no unblinding occurred until after the record was added, there shouldn't be a problem and I wouldn't consider it an important issue.
There are two things I am more concerned about. First is the inconsistency between the two study results. The 12.5 mg dose in KODIAC-4 had greater efficacy than the 25 mg dose in KODIAC-5. Does that make sense in parallel 630 patient studies? Were there differences in controls between the two studies? Were there study sites that produced uniformly efficacious or failed results? It just seems odd. The second is the cancer pain study data, which has yet to be released. If that fails, use for palliative care probably goes away. Terminal cancer patients make up a large number of individuals under palliative care.
"There are two things I am more concerned about. First is the inconsistency between the two study results. The 12.5 mg dose in KODIAC-4 had greater efficacy than the 25 mg dose in KODIAC-5. Does that make sense in parallel 630 patient studies? Were there differences in controls between the two studies? Were there study sites that produced uniformly efficacious or failed results?"
If it is the US versus the EU, as cavoni has suggested, then it is a problem because the EMA is often far more perceptive in their stidies than the FDA. Actos is a case in point, it is a top ten seller in the US but is banned in the EU. And the real problem may be the more common side effects of abdominal pain, nausea and vomiting, the first of which occurs in almost all patients. So you are left with a situation wherein an opiod is administered to relieve pain and the treatment for the resultant OIC causes even more pain and discomfort.