I posted this on Dr. Amy's blog and wanted to let you all see her response. We are not alone in this struggle!
http://spinalinjuryfoundation.blogspot.com/2009/04/parkinsons-adult-stem-cell-breakthrough.html
Barbara Hanson said...
I will take your advice and refuse to allow others to define boundaries for me. I have my own mission and that is to create awareness for ASCTA (www.safestemcells.org, a grassroots organization started by doctors because the FDA declared our own stem cells to be drugs. There is a very troubling double standard being applied as fertility clinics are not being directed by the FDA to adhere to the same regulatory standards that the FDA is now imposing on doctors and clinics that treat patients with their own stem cells. The FDA has decided on its own, that any culturing of the cells (which is needed to make them clinically relevant in most cases)indicates that these cells are drugs. Clinics and doctors who want to treat patients with their own stem cells will be held to GMP guidelines even though half of these very guidelines make little sense when applied to stem cells. They will also need to file an IND for a new drug request. Fertility clinics which manipulate cells in their daily work are not being held to these same regulations. This makes one sniff the air and the odor is one of big pharma.
As the co-founder of www.stemcellpioneers.com, the largest patient moderated forum for stem cell discussion and support for those who have had therapy and those thinking of having it, the reality of this nonsensical ruling is that many people will die because of it. They are too ill or do not have the money to travel outside the U.S. where such treatment has been available for several years now. ASCTA is promoting safe treatment and they have already written guidelines for physicians and labs that would have to be followed just like the fertility clinics do now. Last week on the Pioneer forum, we lost another member, for lack of available stem cell therapy. It was a senseless death of a wonderful lady and it wasn't the first since the forum began. I urge anyone reading this to join ASCTA and make your voice heard. Most legislators have no clue that the FDA is doing this. It must be stopped. The intertwining of a regulatory agency like the FDA and big pharmaceutical companies is disturbing to say the least. This grassroots effort by ASCTA could mean the difference between life and death for someone you know and care about. Barbara Hanson
April 19, 2009 5:06 PM
Barbara,
Thanks for being there for patients and creating a voice. As adult stem cells are accepted as the real form of treatment that they are costs will go down, the technology will be at a local level and affordable for those in need.
People are pioneering this technology at extensive cost to them selves and spending funds on FDA type mazes that could go for research and improved treatment protocols
Dr Amy
http://spinalinjuryfoundation.blogspot.com/2009/04/parkinsons-adult-stem-cell-breakthrough.html
Barbara Hanson said...
I will take your advice and refuse to allow others to define boundaries for me. I have my own mission and that is to create awareness for ASCTA (www.safestemcells.org, a grassroots organization started by doctors because the FDA declared our own stem cells to be drugs. There is a very troubling double standard being applied as fertility clinics are not being directed by the FDA to adhere to the same regulatory standards that the FDA is now imposing on doctors and clinics that treat patients with their own stem cells. The FDA has decided on its own, that any culturing of the cells (which is needed to make them clinically relevant in most cases)indicates that these cells are drugs. Clinics and doctors who want to treat patients with their own stem cells will be held to GMP guidelines even though half of these very guidelines make little sense when applied to stem cells. They will also need to file an IND for a new drug request. Fertility clinics which manipulate cells in their daily work are not being held to these same regulations. This makes one sniff the air and the odor is one of big pharma.
As the co-founder of www.stemcellpioneers.com, the largest patient moderated forum for stem cell discussion and support for those who have had therapy and those thinking of having it, the reality of this nonsensical ruling is that many people will die because of it. They are too ill or do not have the money to travel outside the U.S. where such treatment has been available for several years now. ASCTA is promoting safe treatment and they have already written guidelines for physicians and labs that would have to be followed just like the fertility clinics do now. Last week on the Pioneer forum, we lost another member, for lack of available stem cell therapy. It was a senseless death of a wonderful lady and it wasn't the first since the forum began. I urge anyone reading this to join ASCTA and make your voice heard. Most legislators have no clue that the FDA is doing this. It must be stopped. The intertwining of a regulatory agency like the FDA and big pharmaceutical companies is disturbing to say the least. This grassroots effort by ASCTA could mean the difference between life and death for someone you know and care about. Barbara Hanson
April 19, 2009 5:06 PM
Barbara,
Thanks for being there for patients and creating a voice. As adult stem cells are accepted as the real form of treatment that they are costs will go down, the technology will be at a local level and affordable for those in need.
People are pioneering this technology at extensive cost to them selves and spending funds on FDA type mazes that could go for research and improved treatment protocols
Dr Amy