Dr Rader STEM CELL practice and FDA\EMEA domination - some thoughts


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?

 

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I would like to bring out a brave new world some of the parents are attemping. I must say these are the bravehearts...they are challenging the issue with all they can, personal risk, time, money anything at their disposal is going into fighting the disease. This is medical research turned upside down, regulators will come into play after these random attempts give any frutful results.

Yesterday I got a mail from a group of Indian Parents (Thanks to Raktim). Sharing with you the mail contents but not the details of the person who gave this comment.

Conents of the message
Hi.

I am not too convinced about this particular treatment – the reason being – patients own autologous use of stem cells. I had done this treatment on my son in 2007 at AIIMS New Delhi and we have not seen any benefit.

However we have tried a new treatment on my son in Bangalore in first week of March. Transplant of Stem Cells Derived from Donor Umbilical Cord without HLA Matching. There are 5 such transplants to be done with each injection in the right leg, followed after a month in the left leg, then respectively in the upper limbs and then lastly in the Hips portion. These are 5 such injections in a span of 5 months. Many parents from Mumbai have already come to Bangalore for 2-3 times to take this treatment and I have taken 1 treatment for my son earlier this month and subsequent treatments will be done in Mumbai.
Great Tulika this is the way to do things in our case !

NOT BEING AFRAID OF these regulators!!! We need to try new things as well,
Otherwise it will take about some good 12 years until we see a market
product either from AVI or Prosensa or Summit or PTC they are too slow for us
I think we need to convince Pat to invest some money into these practices as well, and sure I know the regular speach about being responsible etc...
In our case maybe being more RESPONS-ABLE is giving more power to these non FDA practices?

Who care if we get a good not approved FDA EMEA treatment, who cares? Only the company! cause they need to get the $ and the FDA approval guarantee market domination for 15 years - that's a lot of money so they have time' right!
We don't and we need to give our money to non FDA EMEA researchers as well - only my humble opinion,

I am glad there are parts of the world that are not controlled by patronizing attitudes like the FDA and EMEA poses on us
Thank you anyway
Dori
Dori,
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.
Cheryl,

I agree with you - while the FDA often seems more an impediment than anything, there is something to be said for real and careful science.

It seems to me that the middle ground would be orphan status for DMD - It's clear, in the case of exxon skipping, that without that designation, many of us will never see a benefit from that technology.

Like everyone else, I am desperate for an effective treatment - and would do whatever it takes to get one. At the same time, I'm scared as hell to try a treatment that may do more damage than good.
cheryl cliff said:
Dori,
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.
Steve you bring out the exact dilemma I have. The biggest problem I was facing is how to make a informed decision. Found something interesting which is worth sharing with everyone.

WHO has come up with a very clear mechanism on how medical proof needs to be collated from any clinical trial. If someone is interested in 'how' to effectively engage with the clinics offering stem cell treatments this give a lead on what information should be available from the attempts being made.

I am in no way suggesting that this is sufficient for me to start poking my kid with uncontrolled stuff, but it at least gives me a tool. I can use the WHO guidelines to evaluate the claims made by the doctors/clinics.

WHO Guidelines on Clinical Trails

http://www.who.int/ictrp/network/criteria_summary/en/index.html

Primary Registries in the WHO Registry Network as well as Partner Registries need to meet certain criteria so WHO can be sure that the data collected meets the standards of the ICTRP. These criteria can be categorized into 6 main areas:

:: Content
:: Quality and Validity
:: Accessibility
:: Unambiguous Identification
:: Technical Capacity
:: Administration and Governance

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