By Susan Brinkmann, OCDS
One of the nation’s leading adult stem cell therapy organizations is warning the public that the Food and Drug Administration (FDA) is teaming up with the nation’s pharmaceutical industry to declare a person’s own stem cells to be a “drug” which can be regulated, thus slowing down the use of these therapies by requiring years of clinical trials before they can be used.
In a May 1 interview with h+ Magazine, Dr. Christopher Centeno, says the FDA is teaming up with “Big Pharma” to control the use of a person’s own stem cells.
“We’re trying to develop physician guidelines in the U.S. for the safe use of stem cells, similar to the way fertility clinics operate,” said Dr. Centeno, who established an organization to define guidelines and standards called The American Stem Cell Therapy Association (ASCTA).
“We’ve got an organization to formulate guidelines, and we’ve got clinicians working to form a stem-cell registry. But the FDA doesn’t appreciate that. We only do adult cells from the same person. But the FDA contends that if one cultures stem cells at all, regardless of the use of those cells, then it’s a prescription drug.”
According to the ASCTA website, adult stem cells do indeed require an incubation period in culture before use.
Unfortunately, “the FDA’s current regulatory framework makes this type of cell culture the manufacture of a new drug, essentially removing cell therapy from your doctor’s black bag until the FDA approves your stem cells as drugs for each and every medical condition,” the site explains.
“So while your doctor could do all of this safely in a physician run lab and begin treating a host of diseases, you have to wait 5-20 years for access to your own stem cells (as a drug).”
Dr. Centeno says it is inconceivable that a person’s own cells could be classified as a drug — but that’s exactly what the FDA wants to do. “The FDA is working to protect the interests of Big Pharma,” he says.
To be sure, the stakes for the pharmaceutical industry are very high. “You’re talking about replacing $60 billion in drug- and device-care with $6 billion in stem-cell care,” Dr. Centeno observes. The end result will either be individual physicians owning and controlling labs, or, says Dr. Centeno, “It will all be controlled by Big Pharma, and innovation will move at a snail’s pace.”
According to the ASCTA, the FDA has been maneuvering their position on adult stem cells into the classification of biological drugs for quite some time by slowly changing their definition of stem cells.
“That definition has undergone a very significant change over the past five years,” the site explains. “Originally, human cell tissue or tissue based products (HCT/P) was defined as ‘any human tissue derived from a human body and intended for transplantation into another human…’ Now, however, HCT/P is defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient . . .”
Why make this change?
Because “by changing one simple phrase, the agency has given itself new sweeping powers to regulate stem cells as biological drugs,” the ASCTA explains. “In fact, the very existence of CBER (the cell based therapy group at FDA) depends on this little change of phrase. Without it, the FDA has no authority to regulate the patient’s own stem cells as a drug. But with it, FDA gives itself unheard of authority and a whole new section of the federal government has a reason to exist.”
Even more suspicious is how the FDA made these changes to the law without public comment.
“Federal law provides that the FDA cannot make new regulations without notifying the public and offering the public the opportunity to comment,” the site explains. “In this case, had the FDA notified the public of a proposed change, it would have infuriated doctors and others involved in medical procedures because the new regulation purports to give the FDA authority to regulate the practice of medicine.”
If adult stem cell therapies become the exclusive domain of the pharmaceutical industry, as regulated by the FDA, this could push back the availability of this therapy 15 to 20 years in to the future.
The ASCTA is encouraging everyone to write to the FDA to protest these changes. Visit the following website for a prepared letter that can be sent to the FDA ombudsmen http://www.safestemcells.org/The_FDA_s_Position.html
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