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Tuesday, January 14, 2014

What's the "skinny" on when and why the FDA decided to regulate the cells in your body a drug?!

Published by : Jennifer Ziegler

In the 1990's The FDA encroached into the practice of medicine, making adult stem cell therapy subject to the same regulatory over site as mass produced pharmaceutical drugs. They did this without compliance to the, "administrators procedures act," which involves an extensive public comment period. This unprecedented power grab buy the FDA stated,  if your cells were expanded in any way they were considered drugs, even though they were still your cells. The FDA without proper notice to the public made a one word "midnight language change," in the federal registry.  It changed a single word from "another" to "A." It's regulatory authority was initially put in place to control communicable diseases during organ transplants. Because of this language change, the FDA's regulatory authority was expanded from simple control over someones cells used as a transplant from, "another," person,  to all cells from "A," person. This one word change gave the FDA sweeping new authority over the cells in your body.  Here's the link to a short 4 minute, informative video going over all the things I mentioned above. It's called "How the FDA expanded it's authority over your body." 

Why would the FDA want such authority? A couple of theories come to mind. Many patients think the main reason has to do with PROFIT. If the cells in our bodies can treat our own diseases or conditions, then the need for pharmaceutical drugs has the potential to become nonexistent. Who will get to profit from adult stem cell treatments? Patients believe this to be a medical procedure between one consenting patient, and their fully capable physician. Risk vs. benefit is very low as your doctor is only treating you with your own cells. Side effects are known to be few, and safety and efficacy are also known to be strong. Here's another article that explains all the things that can be treated with adult stem cells and that those treatments are shown to be safe and effective.



Another theory is the FDA would like to slow down the testing and use of adult stem cells so that a lab created equivalent or a bio-similar product could be used as competition. Everyone has probably taken a generic form of an FDA approved drug, and that's exactly what I'm talking about here. Scientist would like to create a generic equivalent of your adult stem cells so that they could be sold to you at a marked up price. Just like many expensive pharmaceutical drugs today.


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"Stu's Views & MS News" / 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly
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