Associate Investigator Ting Xie, Ph.D., does research on adult stem cells at the Stowers Institute for Medical Research in Kansas City, Mo., on Feb. 14, 2005. (Charlie Riedel/Associated Press)
Unauthorized Change Undermines Most Promising Stem Cell Research
By Susan Brinkmann, For The Bulletin
Published:
Tuesday, May 26, 2009
A leading adult stem cell therapy organization is warning the public that the Food and Drug Administration (FDA) has teamed up with the pharmaceutical industry to declare a person’s own stem cells to be a “drug” which can be regulated, thus slowing down the progress of these promising therapies by requiring years of clinical trials before use.
Dr. Christopher Centeno, of Regenerative Science, Inc. of Broomfield, Colo., realized what was happening when he was contacted by the FDA last summer about his work using a patient’s own stem cells to regenerate bone and cartilage.
“The FDA contends that if one cultures stem cells at all, regardless of the use of those cells, then it’s a prescription drug,” said Dr. Centeno.
By declaring adult stem cells to be a drug means subjecting each application to 7-10 years of clinical trials before approved use.
“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 said.
Why would the FDA want to slow the progress of such promising research? To protect the interests of the pharmaceutical industry, Dr. Centeno says.
“You’re talking about replacing $60 billion in drug- and device-care with $6 billion in stem-cell care,” he said.
In his final book, published just before his death six months ago, acclaimed author Michael Crichton foresaw this invasion of privacy. Next is the story of one family’s fight against a biotech firm which claims legal rights to their “cell line.” In Mr. Crichton’s story this claim is ultimately rejected as a violation of the 13th Amendment’s prohibition of slavery — any person’s owning another human being.
Adult stem cell therapy also competes with the struggling field of embryonic stem cell research, which has been beset by clinical problems.
“If we can treat your heart failure with your stem cells, send them to the lab down the street where they’ll process them, and we’ll put the cells back into you — that would dramatically and negatively compete with the big pharma embryonic stem cell business model,” he said.
Dr. Centeno, who established an organization to define guidelines and standards for adult stem cell research called The American Stem Cell Therapy Association (ASCTA), hired a team of lawyers last summer to challenge the FDA’s assertion.
It was during this process that they discovered a critical change had been made in 2005 to the agency’s definition of human cell tissue or tissue based products, known as HCT/P’s. This change is what now allows adult stem cells to fall into the category of a biological drug.
“Prior to 2005, the regulation clearly stated that if a physician took tissue from patient A and put it into patient B, the Public Health Service Act determined that this would be an FDA regulated event because the FDA is authorized to prevent the transmission of disease,” Dr. Centeno explained.
The FDA does not have authority over tissue taken out of a person and put back into the same person because this is the purview of doctors in the practice of medicine.
“For instance, if you go in for bypass surgery and a doctor takes a vein from your leg and puts it in your heart, there’s no disease transmission risk there, which is what the FDA is charged with preventing,” Dr. Centeno explains. “Congress considers anything taken out of a person and put back into the same person to be the practice of medicine.”
However, the FDA changed its definition of the use of human tissue based products in a way that could only be called a “game changer.”
As the ASCTA Web site explains: “Originally, human cell tissue or tissue based products (HCT/P) were defined as ‘any human tissue derived from a human body and intended or 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 ...”
By changing one simple phrase, the agency has given itself sweeping new powers to regulate stem cells as biological drugs. But this change is problematic for the FDA because it amounts to a new regulation, something they are not authorized to make without notifying the public and offering the public the opportunity to comment.
“In this case, had the FDA notified the public of this 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,” the ASCTA Web site explains.
FDA spokesperson Peper Long says she has no knowledge of any change in the definition of human tissue products and said regulation of this type of tissue depends on its use.
“If it is used in the mitigation, treatment, cure or diagnosis for a disease, it needs a biologic license application,” she said. “If it is not intended for those uses, it would be regulated under the Public Health Services Act and still be regulated under the FDA’s Center for Biologics Evaluation and Research.”
When asked how taking cells from a person and putting them back into the same person presents a threat of spreading disease, Ms. Long said “there could still be contamination in the process.”
Dr. Centeno found this response to be curious.
“First, the FDA has itself acknowledged that there exists a low risk of the spread of communicable disease when adult stem cells are taken from the patient and re-implanted into that same patient. Moreover, if the FDA asserted its jurisdiction over any product or procedure which involved the slightest possibility of contamination, the FDA would thereby regulate every hospital and doctor’s office in the country. The sorts of contamination to which Ms. Peper refers are commonly called ‘infections.’ An infection is a medical complication, not a federal public health issue.”
To Dr. Centeno, and the more than 70 other doctors who have joined him in challenging the FDA, it is inconceivable that a person’s own cells could be classified as a drug.
However, if left unchallenged, adult stem cell therapies will become the exclusive domain of the FDA regulated pharmaceutical industry, thus pushing back the availability of these treatments 15 to 20 years into the future.
The ASCTA is encouraging everyone to write to the FDA to protest these changes. Visit the following Web site for a prepared letter that can be sent to the FDA ombudsmen: http://www.safestemcells.org/The_FDA_s_Position.html.
