Linda Powers of Toucan Capital has blasted the FDA's "lack of balance" between science and the needs of the patients. She says the FDA "is guardian of safety and effectiveness" of new medications and therapies but it is "supposed to do it in a balanced way that reflects the needs of the public and the country's health care system". She further rightly points out that the FDA bureaucrats are not "open minded" and should not make the same requirements over and over again at each different level of regulatory hurtle."
Our poorly educated and timid friends at the FDA find it so much safer for their own personal jobs to require the very same tests be done over and over again in clinical trial after clinical trial. What's proven in Phase I trials must be demonstrated again in Phase II trials and again in Phase III trials. This unnecessary repetition in not only enormously expensive, it is time consuming and much, much worse pointlessly time wasting while Americans are suffering and dying. While my son, Paul, sits in pain in a wheel chair.
In her podcast at the Genetic Engineering website she says that there are over 200 clinical trials of stem cells going on right now. These trials are showing remarkable success. Yet are being relentlessly delayed by FDA red tape.
If American patients understood the revolution of cures that is here right now waiting to be used, they would sweep the FDA bureaucrats out of the way.
Once patients are allowed access to these REGENERATIVE THERAPIES the demand for the therapies will drive a multi-trillion dollar industry. That industry and those high paying jobs are going to happen one way or the other. Those jobs can be here in the United States or they can be in China, India, Dominican Republic or other countries.
Most of these tens of thousands of jobs would be require only a high school diploma and pay between $40,000 and $70,000. There would also be a plethora of better paying jobs into the high six figure range if that industry is allowed to start here. These jobs could drive economic recovery in America. But only if the FDA bureaucrats get out of the way.
Here her podcast at: http://www.genengnews.com/blog/item.aspx?id=487
She refers to Prochymal by Osiris in the podcast when she takes about mesenchymal stem cells that stop Graft versus Host Disease. She says that GvHD kills 50% of patients who develop it in the first hundred days after symptoms start. GvHD happens ONLY to bone marrow transplant recipients. The new bone marrow contains a new immune system as bone marrow is maker of all immune and blood cells and components.
The new transplanted immune system sometimes attacks the new host (transplantee--patient who got the transplant). As the new immune system attacks the transplantee it dissolves away the tissues of the poor patient. It is kind of like having every possible autoimmune disease at once. Prochymal stops this process virtually 100% of the time. There is nothing else like it on the market, not even close.
As you know if a drug or procedure can stop GvHD, it can stop autoimmune disease. Prochymal offers the real possibility of a life time cessation of all autoimmune symptoms. In addition because it is made of precursors of bone marrow cells it also has the potential of ending any blood disease that is caused by missing blood components like aplastic anemia or hemophilia.