there have been studies where patients have done better when told that a drug was more expensive. now that the study has been unblinded i would assume the treatment patients are not going to improve because the improvement they showed was all placebo, i.e., they improved because they wanted to improve, they got a shot of adrenalin every time they went in for testing, who knows? the control patients didn't suffer any brain damage, the burr hole did not penetrate the brain. i hate to say it but the one thing that has proven to make a pd'er reduce their symptoms besides drugs is exercise, and i'd like to know if patients exercised more after the treatment because they were more motivated, that alone could give them maybe 5-10 point improvement in their movement scores.
to be able to charge $100,000 they had to hit a home run, they didn't.
- i'm not stupid, I can read about their wanting to analyze the data more, find patients that responded better, see if the placebo affect tapers off and the treatment affect lasts and/or improves. Previous studies that had poor phase2 results did the same thing and came to the same conclusion, it didn't work or the benefit was so small there was no point in setting up another trial. Just how in the world are they going to attract pd'ers without the hope of a major reduction in pd symptoms? And with no biomarker it is very difficult to show any treatment stops progression, TEVA tried to do that with a maob inhibiter called azilect and failed, FDA wouldn't approve the drug for that use and TEVA has huge resources. Just try to recruit pd'ers with such an iffy benefit and ask who to pay for the experimental operation, LCT doesn't work in a vacuum, there are other clinical trials trying to do what they are doing, there is DBS, drugs.
- As far as the healing of damaged tissue possibly causing the placebo affect, they didn't pierce the skull with the control patients.
- Basically seen this story too many times in other trials.
- Finally, the fact that the NTCELL400 treatment with 2 sides of the brain implanted seemed to have worse results in 4 patients in the phase2b trial than in the phase1 patients that had only 1 side implanted to me makes me wonder what went on in the phase1 study, maybe nothing.
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