BEVERLY HILLS, Calif. — In a corner of Mark Berman’s cosmetic-surgery suite is a box labeled the “Time Machine” that is the heart of his stem-cell operation.
In mini-liposuction procedures, Berman extracts fat tissue from patients and puts it into the Time Machine box, where a centrifuge separates stem cells from fat. The cells are then injected back into the patients to supposedly treat a variety of health problems, such as arthritic knees, heart disease, amyotrophic lateral sclerosis and even autism.
Berman, 63, is the co-founder of the biggest network of commercial stem-cell clinics in the United States. His therapies don’t have the Food and Drug Administration’s stamp of approval, but he said he doesn’t need it.
“If stem cells didn’t work, we would go back to our day jobs,” Berman said. “It’s a disruptive technology. We are the black swan.”
But the disruptive technology might itself face disruption. The FDA, which has taken a mostly hands-off approach toward the rapidly proliferating stem-cell clinics, is signaling that some of the treatments should be regulated as drugs are, which would require advance approval. That would entail a lengthy process, with extensive safety and effectiveness data, at a potential cost of millions of dollars.
The issue has ignited a fierce debate among physicians, patients, scientists and politicians about whether the agency should crack down on therapies that critics deride as snake oil but that some patients swear by. And it is fueling a broader, longer-term debate over how cellular therapies should be regulated.
On Monday, the FDA opened two days of hearings on draft guidelines intended to clarify the agency’s views on stem-cell treatments. The guidelines, which deal with decade-old regulations, have set off an uproar in parts of the stem-cell world because they could jeopardize many of the clinics’ operations.
That’s fine with some leading scientists who say the clinics are peddling potentially dangerous procedures that take advantage of desperate patients.
“Hucksters are hijacking the public’s enthusiasm” for stem cells, said Luis Garza, a dermatologist at the Johns Hopkins School of Medicine whose lab is investigating how skin stem cells might improve care for amputees. “Ninety-nine-point-nine percent of the stuff you hear about is bogus.”
Paul Knoepfler, a stem-cell researcher at the University of California at Davis, said regulators for too long have remained on the sidelines while patients are charged thousands of dollars for unapproved treatments and exposed to potential risks. “I’m worried that these are essentially experiments,” he said.
But patients who say they have benefited from clinic treatments are urging the government not to clamp down. “People have the right to decide what happens in terms of the tissues and cells from their own bodies,” said Doug Oliver, 54, a Nashville resident who has a rare form of macular degeneration that left him legally blind. After treatments at a Florida stem-cell clinic, he said, his vision improved significantly and now he can drive.
Stem-cell therapies, like other treatments, generally must be tested in clinical trials and approved by the FDA before being marketed to patients. But such clearance is not required if the stem cells are not altered much, are used in a function similar to their original role in the body, aren’t combined with another “article,” and don’t have a systemic effect on the body. But the FDA’s attempts to clarify the details have been fraught with disagreement.
Knoepfler noted, for example, that many clinics derive stem cells from fat, which the FDA views essentially as a cushioning material. Using those cells for injured knees or shoulders or diseases like Alzheimer’s, he said, means they are not being used for their original “cushioning” function.
Berman said that the versatility of stem cells means one of their basic functions is to repair damage throughout the body. In any case, he and other clinicians say, they aren’t subject to FDA regulation because they are practicing medicine, which the agency doesn’t oversee.
Orthopedic treatments are the most commonly marketed procedures. Mayo Friedlis of the National Spine and Pain Centers, a network of pain clinics, said at the FDA hearing that stem cells derived from bone marrow are as effective as surgery for some musculoskeletal disorders.* But Knoepfler and other critics said there isn’t enough published data to support such claims.
As the debate rages about clinics, some Republican senators, led by Mark Kirk of Illinois, want to revamp parts of the FDA approval process to expedite stem-cell therapies. But the outlook is uncertain, given the compressed congressional calendar and opposition from Democrats and some industry and patient groups.
Scientists say that stem cells’ remarkable ability to develop into many kinds of cells means that someday they might be used to repair diseased or damaged cells or replace entire organs. Promising developments are occurring in several areas. Stanford researchers said this year that they were “stunned” by the way stem cells injected directly into the brains of a small group of stroke patients had restored mobility in some patients.
Nevertheless, research for most therapies remains at an early stage, and the FDA has approved only a few stem-cell therapies, mostly for blood disorders.
Five years ago, only a few dozen stem-cell clinics existed in the United States, and most Americans seeking treatment went abroad. Now, according to a recent study co-written by Knoepfler, there are 570 clinics — many in California, Florida and Texas — marketing directly to consumers. Beverly Hills has 18 clinics, more than any other city. Most of the clinics use adult stem cells, not the embryonic ones that were at the center of controversy years ago because their extraction destroyed the embryos.
Berman, who spent most of his career working as a cosmetic surgeon, started providing treatments in 2010. Two years later, he co-founded the Cell Surgical Network, a stem-cell clinic business with about 80 affiliates.
Typically, Berman said, he charges patients $8,900 for a treatment, although he sometimes offers discounts or free care for patients who cannot afford his fee. He said he doesn’t make claims to his patients that the treatments will work.
John Putnam, a 52-year-old Santa Monica resident, said he went to Berman four years ago, after his doctor said he needed surgery to repair sports-related injuries in both of his shoulders. At first, the stem-cell treatment didn’t seem to make a difference, but after five months, he said, “I had zero issues on either shoulder, and to this day my shoulders are in great shape.”
Critics said that pain is very responsive to the placebo effect and that some ailments improve on their own.
Berman said his network has treated about 5,000 patients, including him and his wife, and that the only side effects have involved occasional soreness at the injection site and bruising around the abdomen because of liposuction. He said that in his experience, “85 percent of the orthopedic patients get better,” and that he has seen improvement in some patients with Parkinson’s disease and autism, but not in the dozen or so patients he has treated for amyotrophic lateral sclerosis (ALS).
Knoepfler brushes off such assertions and focuses on safety. He noted that two patients died after being treated at a Florida clinic. There also have been reports of patients being blinded by treatments for eye problems. And the FDA warns that stem cells can migrate to the wrong site or turn into tumors.
The clinics’ fate depends partly on whether the FDA sticks to the tough stance outlined in the draft guidelines. But even if it does, it is not clear that the agency will have the resources to enforce the rules, some experts said.
In the absence of strong oversight, scientists and others are worried that patients may be swayed by personal testimonials. “I think we have to be careful about anecdotes,” said Timothy Caulfield, a University of Alberta law professor who has followed the issue for years. “We need good, controlled studies.”
Correction: This article originally stated that Mayo Friedlis said stem cell therapies are as effective as surgery for musculoskeletal disorders. He says they are as effective for only some musculoskeletal disorders.