FDA Scoffs at ‘Third Way’ Forward in Stem Cell Therapy
/By A. Rahman Ford, PNN Columnist
In a commentary recently published in the journal Stem Cells and Development, Jeffrey Gimble, MD, and his co-authors make a measured critique of the FDA’s cautious regulation of autologous stem cells, including cells derived from adipose tissue, a person’s own body fat.
Gimble, who is the co-founder of Obatala Sciences, a Louisiana stem cell company, shares the FDA’s concerns about the rapidly evolving field of regenerative medicine and proposes a “third way” forward that protects patients, while loosening federal regulation of the industry.
Gimble and his co-authors take aim at “rogue” predatory clinics offering stem cells in a “wild west” medical landscape. In their view, a “combustible mix of unmet needs, an ambiguous regulatory pathway, untested therapies, and clinics rapidly rushing in to fill a void” is at the root of several cases of patients being injured by stem cell procedures.
Sadly, the authors are parroting fictionalized, unsubstantiated stem cell propaganda to support their position.
Gimble and his colleagues contend that autologous cell therapies should be exempt from the FDA’s conventional clinical trial process, which was intended for pharmaceuticals, not a person’s own stem cells.
In their view, primary authority for policing stem cell practitioners should be at the state level, with accreditation agencies, state medical boards and specialty societies. In essence, they want the FDA to relinquish oversight of stem cell therapy.
Gimble and his co-authors recommend the FDA re-evaluate how it categorizes tissues as “structural” or “cellular” to recognize the different safety profiles of stem cells products. They also think the FDA should work with accreditation agencies like AABB and FACT to develop meaningful accreditation standards, along with a national registry for stem cell therapies.
An Imperfect Way Forward?
This measured “third way” seeks to carve a compromise between the FDA’s regulationist faction and “wild west” stem cell providers -- a new ideological center that synthesizes the aspirations of two opposing parties in an effort to achieve a compromise.
It must be stated that there are serious questions as to whether the authors’ proposed polarity is in fact an artifice created for the specific purpose of legitimizing their “third way.” Upon serious inspection, the authors’ stated “dangers” of stem cell clinics may actually be a disingenuous straw man created for their own business interests.
To promote their own agenda and to gain favor with the FDA, Gimble and his co-authors seem to have thrown stem cell clinicians like Dr. Mark Berman under the proverbial bus. Berman, who is a defendant in a FDA lawsuit over his use of autologous cells, recently won a victory in federal court. The judge found that the FDA may not have regulatory authority over Berman’s procedures and that a trial needs to be held to resolve the issue.
FDA Scoffs at Compromise
Nevertheless, the impetus behind the authors’ recommendations is to move forward with bringing stem cells to patients faster and in a safer manner. Regrettably, the FDA does anything but take the authors seriously. In a lengthy response to the Gimble article, Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, merely reiterates the agency’s firmly-established regulationist position.
After commending the authors for their “desire to accelerate the scientific investigation and development of stem cell therapies,” Marks demonstrates the FDA’s backward-looking posture by stating the agency’s regulation of stem cells “is distinct from the practice of medicine” and should be left alone.
“This is an existing paradigm that has been in place for decades,” Marks wrote. “Autologous cellular therapies do hold tremendous promise, but they will only find their way into routine clinical practice to bring benefit to all patients if they are held to the same standards to demonstrate safety and efficacy as other unproven medical products.”
Marks attempts to bolster his argument by citing patient safety, the dearth of research on adipose-derived stem cells and the unethical “bad actor” clinics that exploit desperate patients. However, the spirit of his position reveals a resistance to any sort of change whatsoever.
Marks and the FDA are living in the past. They consider your cells to be unproven medical products. Apparently, they have yet to realize that the stem cell poles have already shifted.
A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.
