Column: Erectile dysfunction becomes the new frontier for stem-cell clinics hawking unproven ‘treatments’

Ben Greenfield is a self-styled men’s fitness guru who makes a point of his willingness to undergo just about any indignity in search of improved sexual performance.

That quest is what brought him last August to a Florida clinic where he underwent liposuction to produce a solution of his own stem cells. The idea was to inject them subsequently into his male member in the expectation that the result would be male enhancement and a better sexual experience.

Greenfield told me he thinks the $8,000 procedure worked, although he acknowledged that he may be unable to distinguish its results from all the other male enhancement methods he has been experimenting with.

Greenfield’s yarn has been shooting around the internet with great vigor lately. That owes much to his own account, published in January in Men’s Health magazine, and perhaps even more to an article about him last month on Gizmodo and his appearance in late January on a podcast with the testosterone-fueled stand-up comedian Joe Rogan.

His story raises a number of issues that medical and health regulators should examine very closely. That’s because the marketing of “stem-cell” treatments for a panoply of medical ailments already has become infected with “unscrupulous hype,” in the words of Scott Gottlieb, commissioner of the Food and Drug Administration.

Gottlieb made the remark last August, when he announced a new enforcement campaign aimed at “unscrupulous actors who have seized on the clinical promise of regenerative medicine … in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products.”

“A select few,” he said, “often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients. These so-called treatments run afoul of the FDA’s legal and regulatory framework governing this new field.”

Gottlieb understated the case when he referred to “a select few.” Hundreds of clinics hawking unproven treatments have sprung up across the country to offer stem-cell “interventions,” as biologist Paul Knoepfler of UC Davis and bioethicist Leigh Turner of the University of Minnesota documented in 2016.

The targets of this hype are desperate patients suffering from conditions such as Alzheimer’s, Parkinson’s, multiple sclerosis — and erectile dysfunction. As we’ve reported at length, they’re especially vulnerable to practitioners offering scientifically unproven, but hugely expensive, “treatments.”

Sexual performance appears to be a new frontier for the stem-cell promoters. But it wouldn’t be surprising that they see it as a potential gold mine. U.S. Stem Cell, the Florida company that performed Greenfield’s liposuction and prepared the stem-cell cocktail he had injected, estimates the market for erectile enhancement and dysfunction treatment at “more than $4 billion annually.”

That company has issued three news releases about its role in Greenfield’s “treatment for erectile enhancement,” which began in August last year.

The money-losing firm identifies itself as a “research and development company,” but in the nine months ended Sept. 30, the latest period for which figures are available, it spent $12,242 on R&D and $3.6 million on marketing, general and administrative expenses.

The company has conducted its activities largely in Florida thus far, but it has ambitions to expand. Last month, American Stem Cell Centers of Excellence, a firm associated with U.S. Stem Cell’s CEO, Michael Tomas, and its chief science officer, Kristin Comella, opened a facility in Glendale that will use U.S. Stem Cell’s “products and services.”

The Sunrise, Fla., clinic was the target of a blistering warning letter in August from the Food and Drug Administration, which accused it of marketing stem cell products without FDA approval and doing so in a way that could be “putting patients at risk.” The FDA letter said its inspectors had found 14 “significant objectionable conditions” at the clinic, ranging from flawed record-keeping to failure to perform adequate testing to ensure that the substances it was injecting into patients were free from contamination.

Comella, who also serves as the clinic’s chief science officer, replied with a truculent letter asserting that it wasn’t subject to FDA regulations on “good manufacturing practices” because it is not manufacturing a drug — an interpretation with which the FDA disagrees. She said the facility met sterility standards for clinics. That’s where matters apparently stand at the moment.

Last year, the New England Journal of Medicine alleged that the injection of stem-cell material into the eyes of three patients at the clinic in Sunrise had resulted in the patients’ blindness or seriously degraded vision.

The clinic is a “partly-owned subsidiary” of U.S. Stem Cell Inc., a public company also located in Sunrise, which said in a public disclosure that as of last November it was the clinic’s 33% owner. The company said in public disclosures that two lawsuits involving eye treatments had been settled and it had been served with a third, though it wasn’t entirely clear that the lawsuits involved the same cases mentioned in the NEJM.

U.S. Stem Cell said in December that it “discontinued” the use of its stem-cell procedure for macular degeneration, the eye malady affecting the three patients in the NEJM article, “after adverse events were reported.”

Like many other clinics in the burgeoning stem-cell field, U.S. Stem Cell offers treatments that haven’t been shown to be scientifically valid and often aren’t covered by health insurance.

Comella told me by email that the firm’s clinics have “shown positive results in treating orthopedic conditions (tendon/ligament injuries, osteoarthritis); degenerative conditions (chronic obstructive pulmonary disease, diabetes); neurological conditions (multiple sclerosis, Parkinson’s disease, spinal cord injuries, traumatic brain injury); autoimmune (rheumatoid arthritis, Crohn’s disease, colitis, lupus) conditions and more.” She said treatment also is “available to any male patients interested in increased libido.”

When I asked if the company could cite scientific studies or trials validating the treatments, the company replied that “the medical procedures performed by physicians do not go through double blind studies” of the sort required by the FDA for drugs. “For medical procedures using stem cells and tissues from the patients own body, there is nothing to bottle and sell therefore no pharmaceutical company would ever pay for that trial.”

I’ll take that as a “No.”

As for Greenfield, his “I’ll try anything” taste for self-experimentation is reminiscent of the masochism that made Johnny Knoxville and his fellows big TV and movie stars back around the turn of the century. (The show and movies, it may be recalled, were entitled “Jackass.”)

Indeed, Greenfield, a triathlete and adventure junkie, told me that “having spent the last couple of decades of my life doing some of the most masochistic endurance events on the face of the planet, I think my filter is a little more porous when it comes to what I might risk doing to my body.”

He said he first met Comella at Paleo f(x), an Austin marketing fair for health-and-wellness marketers. “When I decided to do stem cells for this Men’s Health article I was doing, she was one of the people I thought of.” He underwent liposuction at the Sunrise clinic, but had the extract mailed to him months later and underwent the injections at an independent clinic near his home in Spokane.

Is it likely that a conventional clinic would be eager to participate in a self-experiment by a patient who couldn’t cite a medical condition needing treatment? Certainly the FDA would be hard-pressed to accept this sort of procedure as a legitimate clinical trial.

But does the FDA have to stand by as the stem-cell “treatment” industry expands? Plainly the answer is no. Commissioner Gottlieb has said he’s intent on bringing “bad actors” to heel. He should act fast, before they multiply any further.

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