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. 

The FDA v. Your Stem Cells: An Insider’s View

By A. Rahman Ford, PNN Columnist

Mark Berman, MD, is a key player in the escalating conflict between stem cell therapy providers and the Food and Drug Administration.

Berman is co-founder of the California Stem Cell Treatment Center, a California-based clinic that specializes in stromal vascular fraction (SVF) stem cells, which are autologous cells derived from adipose tissue --- a patient’s own body fat.

Berman and his partner are defendants in a federal lawsuit filed by the FDA. The lawsuit claims that SVF products are considered “drugs” and “biological products” under the  Food, Drug and Cosmetic Act, and thus subject to federal regulation.

In June of this year, a federal judge in Florida upheld the agency’s position in a similar lawsuit against another stem cell company.

Berman maintains that FDA regulations for autologous cells are illegal and wants to set the record straight on the motives behind the agency’s crackdown on stem cells generally and against him and his partner, specifically.

DR. MARK BERMAN

In Berman’s view, the FDA’s assault against autologous stem cells has far less to do with the health, safety and welfare of patients, and much more to do with three other factors:

1. The pharmaceutical industry’s influence over FDA regulations.

2. The unfairness of the FDA’s clinical trial process, which preserves the position of large companies at the expense of smaller ones.

3. The medical establishment’s fear of the paradigm-shifting, market-disrupting effect of healing with one’s own stem cells.

Basic Training in Stem Cell Therapy

Berman was in many respects an accidental recruit to stem cell therapy. A cosmetic surgeon with a private practice in Beverly Hills since 1983, Berman is well known as one of the pioneers of facial rejuvenation using fat grafting.

In 2008, Berman was introduced to equipment developed by Dr. Hee Young Lee of Medikan that harvests fat in specialized syringes. Berman was intrigued and decided to purchase the equipment, which Dr. Lee said could also be used to isolate stem cells.

“Who knew? Plastic surgeons actually pioneered and advanced adipose stem cells,” says Berman.

Over the next couple of years, Berman learned more about adipose-derived SVF and how to isolate it. He also started discussing stem cell trials on orthopedic cases with Dr. Tom Grogan, a colleague in orthopedic surgery.

After a fact-finding mission to Japan in 2010, Berman and Grogan agreed to see patients. One of those patients was Berman’s wife, Saralee, who had significant hip pain after years of running marathons. Saralee was treated with adipose-derived SVF and “has remained pain free to this day,” according to Berman.

Another patient came to Berman for a face lift and said she wanted to get it done because she was scheduled to have both knees replaced in the 2-3 months. Instead, Berman and Grogan treated her knees with SVF cells for free. She demonstrated marked improvement and long-term freedom from pain.

“After seven years, we did a touch-up procedure on her and she continues to be pain free and functional,” says Berman.

In 2010, Berman and urologist Elliot Lander, MD, founded the California Stem Cell Treatment Center. Although successful, Berman and Lander never thought their SVF business would last.

“We figured we’d be good for two or three years of service and then ‘cells in a bottle’ would come along and replace adipose-derived SVF,” Berman told PNN. “It turns out that personal cell therapy may be a massively transformative technology for a variety of reasons and we’re here to stay unless the FDA can illegally have their way with us to protect Pharma and Academia.”

Early on, Berman and Lander treated orthopedic conditions associated with chronic pain – arthritis, back pain and inflammatory conditions. Not only did their patients experience pain relief, they began reporting improvement in other ancillary ailments as well.

“We quickly realized that by filtering the SVF, we could provide the cells via an IV for any variety of conditions,” Berman recalls. “Acute concussion heals overnight. Chronic traumatic brain injury may improve in many cases. Parkinson’s frequently responds well. We’ve had some good response with multiple sclerosis, Alzheimer’s and muscular dystrophy. ALS has not had good results. We’ve seen improvements with chronic heart conditions, COPD, and radiation necrosis following cancer treatments.”

Combating the ‘Unproven’ Disinformation Campaign

Their discoveries led Berman and Lander to publish a SVF safety study involving over 1,500 patients with various degenerative, inflammatory, and autoimmune conditions. They also formed the Cell Surgical Network, a network of physicians who use the same equipment and protocols taught by Berman and Lander. To date, the network has treated over 12,000 patients.

Berman maintains with conviction that “there’s no drug as safe as your own cells.” In fact, he and his family have all had successful personal stem cell treatments, as have most of the affiliate physicians in his network.

Yet news stories about “unproven stem cell procedures” persist. And Google recently went so far as to ban advertising for “unproven or experimental medical techniques,” including most stem cell therapies.

“It is sad and ridiculous that we can safely and effectively treat many people right now, but we’ve been fighting this false press that stem cells are dangerous and unproven when there’s virtually no danger and plenty of proof,” Berman says. 

“Saying it’s unproven denies how science advances. Most science does not rely upon placebo trials, something Pharma routinely takes advantage of to get a new version of an old drug on the market to exploit the public.”

The FDA As Proxy for Big Pharma

Berman has a theory why he and his partner have become targets of the FDA. It has to do with the power and influence of the pharmaceutical industry.

“When corporations get so big, and in this case actually finance government agencies, they end up controlling them in a variety of ways. They have many inside people that can facilitate their needs, but they also have pushed the FDA to write draconian regulations to keep smaller players out of the club as much as possible,” Berman explained.

“Physicians have the obligation to try to help their patients when they can – not to sit around while some sanctimonious academics or Big Pharma or FDA regulatory people decide we can try,” he adds.

Berman poses an intriguing question.

“Isn’t it interesting that no major pharmaceutical company has applied for an IND (new drug application) for personal cell therapy?” he asks.

“The answer is obvious: because they can’t own it.”

Berman believes FDA regulations are designed to protect Big Pharma from competition.

“The FDA has ignored clinicians’ and patients’ requests to be able to use their own cells for their own purposes. It’s absurd and it’s illegal.”

— Dr. Mark Berman

“Surgeons used to perform a lot more coronary bypass surgery, but Pharma developed stents and drugs to compete for the same patients,” he says. “Pharma and academia are the only two voices that matter to the FDA. The FDA has ignored clinicians’ and patients’ requests to be able to use their own cells for their own purposes. It’s absurd and it’s illegal.”

Berman and Lander intend to fight the FDA in court to the very end. A hearing date was scheduled for this month, but has been postponed until early next year.

“They’re trying hard to ruin us through the press and through these extensively long and unfair court proceedings that have been dragging out for over a year. If it’s not clear, we’re fighting for the basic civil and constitutional rights of our patients,” Berman says.

“We should be achieving new heights in healthcare and freedom yet there are so many people more interested in controlling us than letting us naturally rise to thrive.”

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. 

The information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.