Thursday, March 26, 2009

Doctors Challenge FDA Over Adult Stem-Cell Restrictions

We've all heard how under an Obama administration the government would no longer stand in the way of scientific research. Well, maybe President Obama could have a little talk with his own FDA. Here's a press release from group of Doctors who wishes he would (emphases added):

Physician Group Opposes FDA’s Position on Adult Stem Cells

BROOMFIELD, COLO. (March 26, 2009)-The American Stem Cell Therapy Association (ASCTA) announced today the on-line publication of its mission statements and charter. The organization was formed in response to the Food and Drug Administration's (FDA) recent position that the adult stem cells found in everyone’s body are drugs, a position the ASCTA opposes. This physician organization is establishing laboratory guidelines that will allow doctors to bring adult stem cell therapy to their patients more quickly. These guidelines will be similar to those used by fertility specialists in In-Vitro Fertilization (IVF) labs, where many of the same cell culture techniques are used.

"Many patients are dying or suffering day by day with incurable diseases or problems that require major surgery. These patients should have access to basic adult stem cell therapy now.” stated Christopher J. Centeno, M.D. “ASCTA is establishing guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors.” continued Centeno. Another ASCTA physician member, Frank Falco, M.D. stated, “The FDA’s position against someone using their own stem cells is taking it too far. We are talking about a person using their own tissue to treat a degenerative disorder or process safely without the use of medications or surgery. Although we agree that oversight and standards are necessary, this should be provided through a physician organization such as ASCTA rather than by a government agency.”

The rest of the press release is here.

H/t to our friend Don Margolis, who weighed in on the issue:

"FDA’s Stance On Your Own Stem Cells

The FDA’s stance on Adult Stem Cells taken from a patient is that it should be treated as a new drug- ie, subject to 7-10 years of clinical trials and testing for each use of it. This means 7-10 years of clinical trials for adult stem cells for heart disease. 7-10 years of clinical trials and tests for diabetes, 7-10 for spinal cord injury…you get the picture. Think about how much money and how much time it will take to get through the hurdles for each particular disease/condition. How many people will die and suffer during that time because they can’t be treated with their own cells- which are safe and have no side effects.

Adult Stem Cells- the same as Lipitor or Viagra?

Cells taken from your own body are being treated by the FDA exactly the same as Lipitor or Viagra were treated. Lipitor and Viagra have side effects (ex. Lipitor- muscle weakness, Viagra- risk of heart attack) because you are introducing a new foreign chemical into your body. Adult Stem Cells are not some mysterious concoction of chemicals brewed up after 10 years of research and development. The Adult Stem Cells are your own cells- removed from a patient so they have no side effects. They are safer than taking an aspirin.

Stem Cells- Your Own Repair System In Place

In essence, your own stem cells are already there to repair damage to the body, let the body heal itself. When you fall and scrape your knee, your body will send stem cells to heal the damage. However, sometimes for certain conditions and diseases, there aren’t enough of these stem cells to do that. Therefore, these doctors/researchers are multiplying the amount of adult stem cells and then putting them into the area that needs repair- and then they let the body’s own repair mechanisms (the adult stem cells) do what they are “born to do”- no controversy, no ethical concerns, a 3rd grader can understand this— so why shouldn’t it be available in the United States?

These American doctors are finally speaking up and I (and thousands of patients who can benefit from using their own stem cells) applaud them."

Let's pray the FDA gets out of the way!

Posted by Gibbons J. Cooney

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