After seeing Dr Rader videos and some more videos of other clinics during the years,
I must admit that I believe these days some countries are becoming very skilled in Stem Cell therapies because they don't get stopped by agencies like FDA and the EMEA.
I am aware of some of the risks stem cell treatment poses, our doctor in Israel who is a part of the CINERG group told me all about it, the cancer risks, yes I know.. but, sometimes it seems that regulatory agencies like the FDA or the EMEA take too much power over decisions we have the birthright to make. If stem cell are dangerous than we can decide if we want our child to be exposed to it or not based on current knowledge the company supplies us, anyhow some of our DMD children don't have much time left, do they? but this is only our business not the FDA, right?
Why countries like China, India, east Europe Etc, can be much much more advanced in stem cell practice than we are? Isn't it ridiculous that some political groups like the FDA and EMEA prohibit us, in our own countries, from taking decisions for our dying children? Who are they to think better than us for our children, let the companies put all the risks and benefits and let us decide and choose if we want to risk our children or not and it has to super fast!
From time to time we hear about top researcher that are calling those clinic to get info, uncover the trick or the deception, but get no answer, well maybe just maybe we need to stop approaching these clinics with arrogance or with the approach that "we know the best and can't be they are ahead of us". Maybe there is something there even though it is not in Phase III or any Phase at all? Maybe we just need to see if it is true, not by attacking their scientific methods with our superpower ingrained in intellectual and scientifical knowledge and perfect enough regulations?
you bring up many excellent concerns and I share your frustration regarding regulatory agencies (FDA & EMEA). My son is 11.5 years old and we can't wait much longer for a break thru. Sometimes I ask Pat and others when should we go medieval on DC. I keep joking about having a sharpened pitch fork in my garage at the ready. All this endless waiting can drive a family crazy. Still, I can't help but wonder about things such as the recent AVI- PPMO Exon Skipping tests which showed that compound to be toxic to our beautiful boys. My son already has enough physical challenges just with DMD and side effects of steriods. I am no scientist, and wouldn't feel good about making a decision that could jepordize him further without strong valid scientific data to back it up. Even if I hired scientists/doctors to help me decide on going to China/India/Costa Rica for stem cells or any other chemestry not approved, they most likely would not agree on what is best. The disease is very complicated, it has many layers, it has baffled experts for decades. All treatment options we are seeing, except stem cells, have been in the works already for 10+ years and are coming to fruition.
I agree with you when you say maybe there is something there even though it is not Phase III. I congratulate & admire those brave enough to seek treatments outside the box. But then, again, I must wait & watch even them to see how things unfold because nobody knows what can or will happen. Not sure if China is really more advanced with stem cells... perhaps they are simply able to take more risks?
Tulika is right. Regulators will change after the random attempts provide valid results. I don't really live in fear the FDA or EMEA. The EMEA has actually been much faster to respond than the FDA and the FDA (even tho I don't much care for them) must work for the people of America, even those with DMD. We can and will change them, I believe Pat has been working at this for sometime. FDA can't control progress being made worldwide and should be pubically humiliated when dying american children leave the country in mass to find valid treatments in other places.