Florida: A paradise for dubious stem cell clinics

As frequently as I write about quackery and the “integration” of pseudoscience into medicine that’s become so commonplace these days, for instance the way far too many oncologists have embraced naturopaths, even including them as part of their tumor boards, sometimes the worst quacks are the ones who co-opt seemingly science-based treatments. Among the worst of these quacks are those running dubious stem cell clinics. Stem cells, of course, are a real medical breakthrough, with the potential to provide a means of repairing tissue that couldn’t be repaired before, restoring organ function, and even potentially regrowing organs. Unfortunately, that promise has not yet been realized, although more modest uses of stem cells are accepted, such as the isolation of hematopoietic stem cells from the bone marrow and their use in bone marrow transplants to restore the bone marrow after high dose chemotherapy has wiped it out. That’s not what we’re talking about, though.

What we’re talking about are stem cell clinics like the one that treated Gordie Howe for his stroke and produced a flurry of credulous reporting about a “miraculous cure” that wasn’t, including from Keith Olbermann. I’m talking about stem cell clinics that treated Jim Gass for his stroke and left him with an undifferentiated tumor mass in his spinal cord. I’m talking about the hundreds of “stem cell” clinics in the US that promise near-miraculous cures while charging tens of thousands of dollars for them, even though the clinics have no evidence for their efficacy, and using despicable hard sell tactics to sell them. Some have even taken a page from the Stanislaw Burzynski playbook and registered scientifically dubious clinical trials as a means of selling their stem cells. (Even naturopaths are getting in on the action.) Even though recently the FDA has issued regulatory guidelines on the use of stem cells by these clinics, I’m skeptical at how effective the FDA will be in stemming the tide of dangerous quackery offered by these clinics.

If you want to see what I mean, check out this report by Diane Lade of the South Florida Sun Sentinel, Florida a destination for desperate patients buying unproven stem cell treatments. The paper’s investigation has found that, of the 570 for-profit stem cell clinics in the US, 113 were located in California, with Florida coming in second, with 104 stem cell clinics, noting:

• Some of these clinics’ medical procedures are questionable, experts say, such as injecting patients with experimental stem cell solutions in both eyes at the same time, risking blindness.
• Florida clinics use online seminars, high-tech websites and listings in the federal database ClinicalTrials.gov to market their treatments to patients. They tout Florida sunshine and tourist attractions such as fine hotels, beaches and unique shopping districts.
• Some stem cell clinics use hard-sell tactics and lead patients to rake together thousands of dollars, as insurance doesn’t cover stem cell treatments.
• State and federal regulators rarely have stepped in to stop these advertising and medical practices.

Florida has become a hotspot for stem cell clinics, as it was for the cosmetic surgery industry before that. Once an industry is successfully established, other similar industries tend to follow, experts say.

None of the findings above should be any surprise to anyone who’s been following this blog for the last three years or so, which is when I started to get interested in stem cell quackery. When it comes to stem cells, basically it’s the Wild West out there. The FDA rarely intervenes, so much so that I wonder why quacks even bother to set up clinics in Mexico. The lack of regulatory enforcement in the US is almost as bad. Naturally, owners of these clinics make the same excuses that quacks like Stanislaw Burzynski make:

“I don’t do this for money but to give hope to these people and try to help them, to give them treatments that are scientifically good,” said Dr. Burton Feinerman, owner of the for-profit Stem Cell Genetic Med Clinic based in Wellington.

Clinic operators say patients receive documents outlining the risks, that patients know the treatments are experimental and come with no guarantees.

But do patients really know?

Does reason ever win out over hope when seriously ill people are desperate for solutions?

“I don’t do this for money”? I call bullshit. Interestingly, Dr. Feinerman’s website is nothing more than a blank right now; so I went to the almighty Wayback Machine at Archive.org and found the usual snake oil claims, such as “We challenge the incurable,” and a list of the usual medical conditions that Dr. Feinerman claims to treat:

• Advanced Cancer
• ALS
• Alzheimer’s Disease
• Anti-Aging
• Atherosclerosis
• Autism
• Brain Damage
• Building an Athlete
• Cerebellar Ataxia
• Cerebral Palsy
• Diabetes
• Erectile Dysfunction
• Glaucoma
• Heart Diseases
• Huntington’s Disease
• Kidney Disease
• Lupus
• Macular Degeneration
• Multiple Sclerosis
• Muscular Dystrophy
• Parkinsonism
• Retinitis Pigmentosa
• Rheumatoid Arthritis
• Sarcoidosis
• Scleroderma
• Spinal Cord Injury
• Stroke
• Tay-Sachs Disease
• Transverse Myelitis
• and more

There is, of course, no convincing evidence that a stem cell treatment is able to cure or treat any of these things. I further noted some major quackery on his website regarding autism treatment. For instance, Dr. Feinerman opines that most people “now feel that some types of chemicals, toxins and vaccines are the causative agents,” which could be from “aluminum ingestion or absorption, lead exposure, chemicals in foods such as MSG and aspartane, mercury preservative in vaccines, reaction to measles, or pertussis in vaccines.” The treatment? Oh, how quacky the treatment was:

Stem Cell Genetic Med approaches the treatment as a chronic inflammatory condition of the brain with immunological dysfunction. The protocol consists of:

• Chelation intravenous or oral.
• Stimulation of endogenous stem cells in the brain with oral and injectable agents.
• Delivery of neuron stem cells with nerve cell factor, brain neuropeptide, neurotrophin, glial derived neurotrophins, transformation growth factor, vascular growth factor either intravenously with an agent to penetrate the blood brain barrier or intrathecal spinal canal administration under local anesthesia.
• Intravenous infusion of glutathione and neurological supplements.
• Laboratory studies to check T and B lymphocytes, helper and suppressor cells, immunoglobulins IgA, IgG, IgM, IgG1,IgG2, IgG3, IgG4, cytokines.

Patients will be given intravenous infusions to counterattack inflammatory cytokines and modulate antibodies attacking the neuroglia brain cells.

I bet if I were to look into a number of these clinics, I’d find the same sort of quackery.

One of the stories told in this report is that of Tammy Rivero, a 60-year-old woman “riddled with lung disease,” who two years ago “pinned her hopes for a better life on a stem-cell treatment that has never been clinically proven to work.” Rivero had what sounded like severe chronic obstructive pulmonary disease (COPD), possibly end stage. She was offered an unproven stem cell treatment, with the promise of being able to reduce her use of supplemental oxygen by 94%.

The clinic sucked money out of poor Ms. Rivero with a ruthlessness that I haven’t even seen from Stanislaw Burzynski:

Rivero needed $7,500 for the procedures. With little savings and just $740 in monthly disability payments, traveling to Florida from North Carolina seemed impossible. She said the clinic’s patient coordinators walked her through a list of ways to raise the money, such as launching an online GoFundMe campaign that solicits strangers to chip in.

“Get creative … You could offer to send a hand drawn portrait to anyone that donates $20 dollars to your campaign” is one of the tips on the Lung Institute’s blog.

At the clinic’s suggestion, Rivero said she used the only thing of real value she owned: She took out a home equity loan on her 112-year-old small, wooden house, where her mother was born, at the end of a dirt road in rural Hildebran, N.C.

“I was going to get healthy and have a life, start working again,” said Rivero, who feels like she’s suffocating if she spends more than 10 minutes without supplemental oxygen.

Rivero said she was surprised to learn after the procedures that she would need to spend even more for best results.

Yes, grifters like this always want more, more, more. After Ms. Rivero’s stem cell transplant, the Lung Institute tried to get her to pay another $70 a month to “reboost” her stem cells and buy supplements ranging from $16.95 to $45 each, plus a $120 PowerLung AireStream breathing training device. Not surprisingly, she’s no better. Her tale is, indeed, very sad:

She couldn’t afford the extra fees, and today her condition is worse. Rivero said doctors have given her less than a year to live.

“I risked everything I had in the world,” she said, in tears.

She’s also not alone in having paid a lot of money for no improvement. For instance, Howard Bennett, an 86-year-old disabled Korean War veteran with severe lung disease, also heard the siren call of the Lung Institute. He was given a veteran’s discount and paid $6,000 for a treatment. It didn’t work. When Bennett told the Lung Institute that his symptoms had not improved, it suggested that he buy more treatments.

Unfortunately, in Florida, patients who spend large sums of money for unproven stem cell treatments are basically out of luck when it comes to getting their money back. They get little help from law enforcement or state regulators, which is not surprising given that Florida appears to be a quack paradise with lax regulations and an even laxer medical board. For example, here is one story:

Val Dienhart, of Lafayette, Ind., has given up her fight to get back part of the $57,000 total she and her husband paid two years ago to Regenocyte stem cell clinic in Bonita Springs, on Florida’s southwest coast.

Her family had raised most of the cash payment with help from their town so that Jeff Dienhart could have treatment for cystic fibrosis. But he died a week before the procedure, at age 44.

Dienhart hired a lawyer, but she never could collect her $57,000.

“We were working on refunding her money when she filed a court case against us,” said Dr. Zannos Grekos, the clinic’s owner. “So we stopped.”

Court records show her attorney tried between September 2015 and March 2016 to serve legal papers to Regenocyte, without success.

“I hate the fact that I had to give up,” Dienhart said. “But I’m frustrated and running out of money.

This is what quack clinics count on, that patients have fewer resources and less money to undertake a protracted legal battle to recover their funds. Also, there is the cynical calculation that a not insignificant number of these patients, many of whom have serious and potentially fatal diseases, will die before they can prevail in court.

Then there are the patients with retinal diseases, such as macular degeneration. Imagine that you are slowly going blind. How far would you go to arrest the decline in your vision? I can imagine the desperation. After all, I’m a surgeon. If my vision were to decline beyond a certain point, I’d be out of a career. Ahmad Farouki, who’s a decade younger than I am, was facing the loss of his vision. He trusted Dr. Jeffrey Weiss of MD Stem Cells in Connecticut, who runs the Stem Cell Ophthalmology Treatment Study. The result was not good:

Weiss injected both of his eyes with stem cells drawn from Farouki’s bone marrow in October 2015. Not only did his vision not improve, Farouki said, but he was devastated to discover he could see nothing out of his left eye, which had been his better one.

I wrote about this sort of dubious treatment before, as well as the sorts of scientifically bankrupt clinical trials run by these stem cell clinics. Curious, I looked up the Stem Cell Ophthalmology Treatment Study on ClinicalTrials.gov. Perusing its entry, I found a notice that I’ve never seen for a clinical trial, ever, before: “This study is enrolling participants by invitation only.” What? I mean, what? Seriously, I did a major double take when I read that. There is no way that I can envision that patient accrual “by invitation only” can produce a scientifically valid clinical trial. Of course, this study is not randomized and not blinded. Basically, as clinical trials go, this is crap.

Quacks, however, always have excuses, and, when called out, always blame the victims, because they think their motives are so very, very pure:

Weiss said Farouki and Gibson are spreading inaccurate information about their treatment results.

He joins other stem cell clinic operators who say their main motive is to help those whom traditional medicine has failed. He said any criticisms are due to “tremendous envy and jealousy” from the medical establishment because of what he’s been able to accomplish.

Weiss considers himself to be a research pioneer in this field. He co-signed a letter to the Sun Sentinel stating he is “actually doing clinical research and publishing in medical journals to advance stem cell treatment options for patients with otherwise blinding and untreatable eye disease.”

That’s right. These quacks just want to help people. What’s wrong with you nasty skeptics, accusing them of pseudoscience? As for Dr. Weiss’ “publications,” I perused PubMed for his publication record. Let’s just say that I was not impressed. I’m with Paul Knoepfler, only more militant. Just like the case with Stanislaw Burzynski’s dubious clinical trials, it is highly unethical to charge patients for an unproven treatment in a clinical trial. Given the—shall we say?—less than rigorous design of these clinical trials, which are not randomized, not blinded, lacking in rigorous inclusion and exclusion criteria, inclusive of a number of unrelated conditions, and reliant on mostly subjective outcomes, and which, even if “positive,” would not constitute sufficient evidence for an FDA approval of the treatments under study, it’s doubly unethical. These clinical trials are of, at best, questionable scientific value. At worst, they are, like Burzynski’s clinical trials, only a means to allow the use of unproven therapies and to give the stem cell clinic operators an excuse to say that they are “doing research” when the research they’re doing is scientifically worthless.

In the three years or so that I’ve been paying closer attention to the sale of unproven stem cell therapies than I had in the past, I have been consistently appalled by the lack of evidence and ethics demonstrated by doctors running these stem cell clinic. This story does nothing to change that assessment and a lot to reinforce it. I still can’t fathom how these quack clinics continue to be allowed to operate so brazenly.