XOV,
I understand that placebo's in some cases do result in improvements in those receiving them, but I don't believe that would ever be the case if the person receiving it is unconscious, which would be the case with people on a ventilator.
I frankly disagree with the regulators worldwide in evaluating drugs by insisting that they must achieve an improvement over the SOC. If they equal the SOC they'd be giving the Dr. an additional tool to work with. In some cases drugs that aren't as good as the SOC provide a substantially better quality of life, that too should be considered. Perhaps the biggest reason for more tools in the toolbox is that fact that diseases become refractory to the SOC, when they are, another drug may become effective, and even it it's for a brief period of time, the SOC may again be effective after the treatment with other drugs. My point is that no one has enough money to do trials that produce such results. If they looked at "First, do no harm" as the basis of accepting drug, I believe that many drugs that aren't approved would be, and people in general would live longer and have higher quality of life with a variety of drugs.
In the case of PSTI, I believe trials to date show few if any quality of life issues. If anything, our placenta based cells may be improving conditions in the body they weren't even targeted at, that really hasn't been studied to my knowledge. I really wonder if they've given thought to whether it would have benefits in our most important muscle, the heart. I suspect it could.
As someone who received stem cells I'm very thankful of whoever donated them, while drugs may have maintained a remission, statistically the chance was small it would last over 3 years. The one change I've noted has been an allergy to something common to suntan lotions. I get red and irritated from the lotions, whether I go in the sun or not, I never had that problem before the stem cells, so I'm reasonably certain my donor must have had that allergy. The beauty of our placenta cells is no DNA matching is required at all, whereas I had a 12 point match for my stem cells, which is excellent. Perhaps the day will come when placenta cells can be used in leukemia treatment with no matching required, but I question whether they'd have the time to adopt to a patient and mature to the point where they can restart an immune system that's been eliminated by chemo prior to their introduction. It was rather fascinating each day after the stem cells to see the blood counts, at first their was nothing, but after the first few days they were detected, and each day they grew. Those few stem cells were completely rebuilding my ability to make blood. I would not be surprised if in the future PSTI's drugs may be used in conjunction with donor stem cells to accelerate the process and lessen the hospital time required. I was lucky to go home 19 days after the transplant as my Dr. was out, and an associate permitted me to go earlier than my Dr, who was head of the Dept. would have. I saw him four days later and he indicated that I'd probably have been kept even longer had I not been released earlier. It's not that I was sick, it's out of concern that if something went wrong, they can jump on it if I'm in the hospital. I did have complications later on that did bring me back into the hospital.
Gary
AI
