Friday, April 10, 2009

Now we know exactly who to blame for blocking stem cell progress

I had expressed bewilderment before that patients were having to leave the United States and go to other countries to get treatments with adult stem cells. I've learned who the culprit is: It's the Food and Drug Administration:

The FDA’s stance is that a person’s own stem cells must be tested as a new drug- ie. subject to 7-10 years of clinical trials and testing for each disease/condition it is used for.

If I'm understanding this correctly, any time a new use is discovered for using a patient's own stem cells, doctors elsewhere in the world can just treat it like a medical procedure and start treatment, but US doctors have to wait for clinical trials and FDA approval.

On the one hand, I'm all for not jumping the gun and unleashing new and potentially dangerous processes. But adult stem cells have a strong record of success without the risks and side effects of embryonic stem cells.

Paul Harvey blamed prolifers for the fact that Don Ho had to go to Thailand to get stem cell treatment for his heart. Now we know who to blame.

I've signed up at Safe Stem Cells -- I want my nephew to walk again. I want my fellow citizens to be able to get the kind of care right here at home that patients are getting overseas.


Anonymous said...


It’s not correct to claim that the FDA is to blame for blocking stem cell research. The FDA is a regulatory agency, and does not “block” research per se. Rather, the FDA requires that any object marketed as a drug, device, or biologic be scrutinized for its safety and efficacy.

When a treatment is approved by the FDA, clinicians can use it as appropriate. There is the phenomenon of “off-label usage” where, for example, clinicians can prescribe a medication that is outside of its regulatory approval, if the clinician has good reason to believe that the treatment will be beneficial.

You state: “But adult stem cells have a strong record of success without the risks and side effects of embryonic stem cells.” This is a bizarre assertion. It’s like saying since penicillin has had a strong record of success we should not use gene therapy to fight disease. Adult and embryonic stem cells are apples and oranges.

Adult stem cells are most efficacious when they are used autologously – that is a patient’s own stem cells are removed and then re-introduced to treat a disease. This gives adult stem cells a different regulatory status, since they are the patient’s own tissues. Embryonic stem cells are biologically different, thus require a different regulatory oversight.

Anonymous said...

I've added a link to your post from Discerning Science - Human Life - Adult Stem Cells

David said...

God bless you this Easter day and always. Jesus Christ is risen