flipper44,
I get what you are saying, I really do and I am angry just as you are but, and this is a big BUT, if patients do receive some benefit from wearing it all the time and it is synergistic with DCVax-L then why not use it right after surgery in unmethylated patients if benefit is evenly distributed between meth+ and meth- ie based only on amount of time worn? I'm for whatever has a chance to help patients more than I am against a doctor, who helped patients with Temodar and wanted to try something else to help patients but saw it failing and tried hard to bail it out for the sake of some he might be convinced are benefitting. Our indignation at how this was all done to get approval for Optune ignores what I believe was good intentions that turned into some strong built in bias in trial results so that Dr. Stupp would not be tied into a failure because patients were not complying with requisite use. Doctors like Dr. Stupp spend much of their time seeking ways to help others and when failure is not an option the fudge factor usually is employed. We have all seen this. Is ut goid to call this out? Yes but I believe he believes he is helping those who wear the device when they wear it often enough.
When someone of influence and authority believes strongly others will often go along with it. I remember an experiment that I saw done in a video in psych class where someone in authority, a presumed Dr., told volunteers in the experiment to give patients increasing levels of shock treatment and they did it even though it led to levels that would have killed someone. It was a set up with actors but almost every single person did what they were told, even though they had reservations, because of the presumed undetstanding and authority of those giving the orders. The idea of the experiment was to determine why the Holocaust was able to occur. That experiment went a long way towards explaining in it. I don't think Dr. Stupp believes what happened was wrong because the altruistic goal being believed is that everything was done for the greater good of those who would comply. Do we have the right, dare I say the RESPONSIBILITY to see it differently? Yes but let's find out the truth for the sake of all patients and those paying for it so that it's use is properly administered. If patients aren't going to wear it then return it and don't reimburse for it. A tamper proof usage meter or other usage validation method should not be difficult to come up with. There is probably an app for that already somewhere. With the evidence gathered to date I believe that at a minimum a post approval data set should be immediately required for all patients using the device and that reimbursement by the company to those paying for it's use should be made if the company is billing for usage when inadequate followup for compliance is happening. This way insurance companies and Optune makers will be motivated to check for compliance and the burden won't be placed all on the patient. As a matter of fact, the patients might actually be motivated by those checking in on them so that perhaps L or other will eventually get them out of the helmet. Best wishes.
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