I have been struggling with some doubt lately regarding the DCVAX L trial. I’ll try to keep this as brief as possible. I’m hoping others that have had the same thoughts at times can help assuage my fears. I like the science behind the vaccine, I love the phase I/II results, but I have a list of concerns regarding the phase III trial:
• Pace of enrollment and trial delays. I understand the delay caused by the market collapse, but that was many years ago. Why haven’t clinics completed enrollment by now? If I was a doctor or investigator in this trial, and 2/3 of my group had exceeded the OS or PFS by a substantial amount, it would be pretty obvious to me that this treatment might be working. Based on that information, I would encourage as many patients as possible to give it a try. This doesn’t seem to be happening.
• Lack of anecdotal evidence of trial participation. We live in an age where people share what they ate for dinner with the world, but there isn’t much discussion anywhere about patients actually enrolled in the trial. I’m not talking about details on how they are fairing, but more like ‘hey I have a friend or relative in that trial.’ There are a couple of long term survivors from the early days, a couple of others that we know may have either received the placebo or did not respond to the vaccine, and a few others mentioned on blogs, etc. (I hope I don’t sound apathetic to the human element in my comments. I realize these patients and their families/friends have endured a tremendous amount of pain and suffering). My point is that it is way too quiet for a trial that has hopefully enrolled well over a hundred people by now.
• Where’s the buzz about this trial in the medical community? If this is the next big thing in science, why haven’t more medical doctors or scientists chimed in?
• Lack of institutional interest and performance of the stock. I would bet all of my money that large investment firms, hedge funds, and big pharma have contacts in the participating clinics. There is a lot of evidence to support my opinion. I understand that it is a double blind trial, however, the participating physicians would know firsthand if there might be a chance of success. Based on the limited institutional investment and rampant selling by hedge funds, I really have to wonder how this treatment could be performing at the exceptional level believed by many on this board. Such significant news would be bound to leak.
Anyway, those are some of my concerns. Feel free to rip them apart.
