Is the FDA Protecting You?



In 2008, the United State Food and Drug Administration (FDA) accused the Regenerative Science (Regenexx) of Colorado of practicing medicine without a license required for the introduction of a new drug. The organization was using people's own stem cells (known as autologous) for orthopedic purposes, and the FDA was in effect claiming that our own stem cells are a drug.
In 2010 the FDA sued to stop Regenerative Sciences from performing these procedures and in a district court ruling in Washington D.C. last year the FDA's ruling was upheld. The case is now being appealed.
Last year the FDA closed the labs of Celltex Therapeutics in Texas for treating patients the same way. Celltex is the company that famously treated governor Rick Perry of Texas for his back problems.
In both cases the FDA cited that the stem cells (SCs), once removed from the person's body, were "more than minimally manipulated". There are so many issues here that a simple article will not cover them, but let me focus on several of the main ones:
  1. Does a person have the right to have their own SCs re-injected back into their own body without the FDA getting involved?
  2. Does the FDA have the right to classify SCs as drugs?
  3. Can the FDA continue to "move the goalposts" in determining what constitutes what "more than minimally manipulated" means and how it is defined?
  4. And perhaps most importantly, when there is no other alternative other than degeneration and degradation of a quality of life, doesn't a person get to choose what they do with their own body?
People who have had Stem Cell Treatments
There are at least several tens of thousands of people who have had this type of treatment around the world, including in the US, and many of them have had significant symptomatic relief. A woman by the name of SammyJo Wilkinson is a perfect example of someone here in the US who was treated by Celltex.
There are also many stories, admittedly anecdotal, that come out of other countries where regulations have been different than those in the US. One country where some tens of thousands of patients have been treated is China, the target of much criticism by the stem cell establishment. Whereas some of this criticism is justified, there are also many stories of people who have had their quality of life improved in varying degrees. You can see and hear for yourself patients who tell their stories of spinal cord injuries with umbilical derived adult SCs (allogeneic) and other stories at the Stemcell China website, as well as on many YouTube videos that are available on the internet.
What is missing here is the ability for the powers that be here in the US to be objective and open-minded, and to other possibilities of treatment protocols; to be open to going to see these patients and hospitals and getting first hand information before passing judgments. I have been in China several times and it was a huge eye-opener.
It's the Proof that Matters
If there is no proof that these treatments, autologous and umbilical derived allogeneic stem cells are dangerous, shouldn't we have the right to treat our bodies in the way we want to?
Steve Marshank has been working as an entrepreneur in health care with a focus on the burgeoning stem cell industry for more than six years. A member of the Stem Cell Research Group, Advances in Stem Cell Discoveries Society, Regenerative Medicine Foundation and the Cell Therapy Industry Group, he has developed a wide-reaching network of relationships with companies, medical professionals, scientists and business leaders in the industry. You can read more about stem cells and this 21st century industry at http://www.stemcellsconsulting.com/

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