ASCTA had the first of what I hope will be several webinars today to inform patients of why ASCTA was formed, what the goals are and what we can do to help. In the future, I will post all webinar notices in the ASCTA subforum so that anyone that wants to participate can.
There is great urgency in getting this grassroots effort off the ground. Volunteers are needed to be in charge of blog control, discussion boards, political letter writing campaigns, and more. Please e-mail info@safestemcells.org if you can volunteer your time or expertise to this great cause.
Dr. Centeno made some great points in the webinar pointing out that the FDA is not allowed to regulate the practice of medicine. Congress regulates this and yet the FDA is threatening to shut down his practice. He compared it to the Ottoman Empire, trying to get into Constantinople. If that had happened, there would be no Europe as we know it today. The FDA is doing the same thing going after a small company like Regenexx. The FDA will go after whoever is standing in the way of its regulatory goal.
Regenexx has the world's largest mesenchymal stem cell tracking base of over 400 patients and yet the FDA does not care. They want to declare our own stem cells drugs.
This means that Regenexx or any clinic or doctor that uses our own stem cells will be held to GMP guidelines as the FDA will consider that they are producing a drug if there is the slightest manipulation of any kind performed.
The problem with not culturing or expanding our cells for treatment is that without it, there usually is not a relevant amount of stem cells extracted to do us any good. Simple cell culture will bring the numbers up to where they can be beneficial.
The irony of it all is that fertility clinics are not held to these same standards and yet they are manipulating cells on a daily basis. They are allowed to do this using guidelines that physicians have written. ASCTA wants the same for stem cell clinics and doctors using our own stem cells. It makes sense. The GMP guidelines do not even pertain or make sense for the most part for stem cell therapy. The FDA wants Regenexx to file an IND for a new drug request which virtually means the end of Regenexx as this process is so lengthy and costly that they could not survive.
Big pharmaceutical companies have billions of dollars involved. If we cannot move forward on this very quickly, then we will lose and we will wait years for legalized treatment to be available in the U.S. with our own stem cells if any manipulation is involved.
ASCTA is a group of doctors and patients coming together to fight this. Safe stem cell guidelines have already been written for labs and doctors. There will be a transplant registry that member physicians will use for each therapy they are involved in. Each physician will be able to practice safe stem cell therapy in his or her own field of expertise. Patients will benefit because they will not have to travel out of the country. Many on this forum are simply too sick to do this anyway. The FDA simply does not care if we die.
We cannot allow the FDA to create this double standard at our expense. We lost a valued member last week for lack of her being able to get treatment. Every single day, fertility clinics are able to continue their work, unregulated by the FDA. There are over 8500 published articles Dr. Centeno says on mesenchymal stem cells alone with another 2500 being published this year. Treatments have been given for a wide variety of diseases with no complications.
If the FDA gets away with declaring our stem cells to be drugs, it will take 5-10 years to process each disease as clinical trials are conducted. If your particular disease doesn't have a good disease model (and I can think of many Pioneer members that this would include), then no clinical trial would be forthcoming simply because your disease was not that "popular". This would leave you no options here in the U.S. No insurance would cover you either for a stem cell treatment.
What can possibly be motivating the FDA to do this? In one word, MONEY. Big pharma has billions of dollars invested. They aren't real excited about a healthy population that doesn't need a lot of drugs. The FDA seems to be intertwined with big pharma in a way that no regulatory agency should be.
It is interesting to be finding out that many in Congress are not even slightly aware that the FDA is declaring our cells drugs. It is imperative to reach our legislators and let them know what is going on. Mailing a letter with a real stamp is probably the best bet. If you want, cut and paste from this post or any others you find, but get it sent off to your reps today. Call their office and e-mail them too and voice your concerns over what is happening.
If any of you have found blogs, websites, news articles, etc. please post them in the ASCTA subforum so that others can go to them and post comments easily. It's going to take all of us working very hard now before it's too late. Thank you.
There is great urgency in getting this grassroots effort off the ground. Volunteers are needed to be in charge of blog control, discussion boards, political letter writing campaigns, and more. Please e-mail info@safestemcells.org if you can volunteer your time or expertise to this great cause.
Dr. Centeno made some great points in the webinar pointing out that the FDA is not allowed to regulate the practice of medicine. Congress regulates this and yet the FDA is threatening to shut down his practice. He compared it to the Ottoman Empire, trying to get into Constantinople. If that had happened, there would be no Europe as we know it today. The FDA is doing the same thing going after a small company like Regenexx. The FDA will go after whoever is standing in the way of its regulatory goal.
Regenexx has the world's largest mesenchymal stem cell tracking base of over 400 patients and yet the FDA does not care. They want to declare our own stem cells drugs.
This means that Regenexx or any clinic or doctor that uses our own stem cells will be held to GMP guidelines as the FDA will consider that they are producing a drug if there is the slightest manipulation of any kind performed.
The problem with not culturing or expanding our cells for treatment is that without it, there usually is not a relevant amount of stem cells extracted to do us any good. Simple cell culture will bring the numbers up to where they can be beneficial.
The irony of it all is that fertility clinics are not held to these same standards and yet they are manipulating cells on a daily basis. They are allowed to do this using guidelines that physicians have written. ASCTA wants the same for stem cell clinics and doctors using our own stem cells. It makes sense. The GMP guidelines do not even pertain or make sense for the most part for stem cell therapy. The FDA wants Regenexx to file an IND for a new drug request which virtually means the end of Regenexx as this process is so lengthy and costly that they could not survive.
Big pharmaceutical companies have billions of dollars involved. If we cannot move forward on this very quickly, then we will lose and we will wait years for legalized treatment to be available in the U.S. with our own stem cells if any manipulation is involved.
ASCTA is a group of doctors and patients coming together to fight this. Safe stem cell guidelines have already been written for labs and doctors. There will be a transplant registry that member physicians will use for each therapy they are involved in. Each physician will be able to practice safe stem cell therapy in his or her own field of expertise. Patients will benefit because they will not have to travel out of the country. Many on this forum are simply too sick to do this anyway. The FDA simply does not care if we die.
We cannot allow the FDA to create this double standard at our expense. We lost a valued member last week for lack of her being able to get treatment. Every single day, fertility clinics are able to continue their work, unregulated by the FDA. There are over 8500 published articles Dr. Centeno says on mesenchymal stem cells alone with another 2500 being published this year. Treatments have been given for a wide variety of diseases with no complications.
If the FDA gets away with declaring our stem cells to be drugs, it will take 5-10 years to process each disease as clinical trials are conducted. If your particular disease doesn't have a good disease model (and I can think of many Pioneer members that this would include), then no clinical trial would be forthcoming simply because your disease was not that "popular". This would leave you no options here in the U.S. No insurance would cover you either for a stem cell treatment.
What can possibly be motivating the FDA to do this? In one word, MONEY. Big pharma has billions of dollars invested. They aren't real excited about a healthy population that doesn't need a lot of drugs. The FDA seems to be intertwined with big pharma in a way that no regulatory agency should be.
It is interesting to be finding out that many in Congress are not even slightly aware that the FDA is declaring our cells drugs. It is imperative to reach our legislators and let them know what is going on. Mailing a letter with a real stamp is probably the best bet. If you want, cut and paste from this post or any others you find, but get it sent off to your reps today. Call their office and e-mail them too and voice your concerns over what is happening.
If any of you have found blogs, websites, news articles, etc. please post them in the ASCTA subforum so that others can go to them and post comments easily. It's going to take all of us working very hard now before it's too late. Thank you.