I am certainly not surprised that the FDA or it's attorneys would want to hide the FDA's wrongdoings. This is just one of their "wrongdoings"-----
The FDA wants to declare our own stem cells as drugs!!! This means that any clinic or doctor that uses our own stem cells will be held to GMP (Good Marketing Practice) 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. And, they are allowed to use GTP (Good Traceability Practice) and GLP (Good Laboratory Practice). ASCTA (American Stem Cell Therapy Association) 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.
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 (5-10) 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 patients are simply too sick to do this anyway. The FDA simply does not care if we die.
Every single day, fertility clinics are able to continue their work, unregulated by the FDA. There are over 8500 published articles Dr. Centeno of the ASCTA 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.
Our Congress states that "the FDA is not allowed to regulate the practice of medicine". That is up to the doctor.
What can possibly be motivating the FDA to do this? In one word, MONEY. After all, if we can be helped or healed by our "own" stem cells, we won't be needing to take all those drugs that they sell! 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.
The FDA has failed us in many ways. Just google this phrase: “FDA admits”, and see what you come up with. The FDA must return to a culture that places public health concerns ahead of industry profits.
I ask you to please not allow the FDA to declare that our own stem cells are drugs. After all, is our own blood taken from us prior to a scheduled surgery for re-injection into our bodies at the time of surgery, classified as a drug? Will they next be regulating our choice of who gets our other body parts when we die?

The patient site to join ASCTA is More ... There is also a physician site at More ... This grassroots organization needs the public to join and contact the FDA, media,legislators and President Obama. The FDA is already on the move to force stem cell doctors and clinics to close or comply. This will set the U.S. back tremendously and will mean that many people will die because of this latest round of insanity and greed from the FDA. Dr. Centeno has the world's largest mesenchymal stem cell tracking of over 400 patients. Safe stem cell treatment should be available for everyone using their own stem cells with treatment given by U.S. doctors who will be well trained and will keep a registry of transplants performed. I am frightened of a regulatory agency that has made a decision as to whether I can get life saving treatment here in the U.S. or not using my own stem cells. I should be making this decision, not the FDA.