Let me just say right up front that I’ve come to a conclusion regarding private, for-profit stem cell clinics, and that that conclusion is that they are all selling outright snake oil. I’ve been covering the topic of stem cell therapies for years now, and in particular I’ve been covering the topic of the proliferation of for-profit stem cell clinics over the last few years, some of the harms that they’ve been causing, both financial and physical, to patients, and the unethical hard-sell techniques and misinformation used on vulnerable, sick people to sell their wares. It’s taken me a long time to come to his conclusion, and it’s not as though I haven’t been looking for disconfirming evidence. I have. The main reason is that, personally, I believe that stem cells, both adult and embryonic, have great potential in medicine. I just haven’t been able to find a single example of a private, for-profit stem cell clinic not affiliated with a university that isn’t selling what I consider to be outright snake oil at high prices to often desperate patients with claims that these cells magically treat stroke, autism, chronic lung disease, diabetes, macular degeneration, cancer, heart disease, and, well, just about any chronic disease. That’s why I was glad when the FDA finally issued draft guidance on the regulation of stem cell products, although I questioned how effective the FDA would be. I was even happier when the FDA brought the hammer down on two particularly egregious stem cell quack clinics, although, again, I feared that the FDA is stretched too thin to stop the proliferation of several hundreds of these clinics in the US thus far. At NECSS, I gave a talk about these clinics and the sad state of their regulation. So I had been looking for an opportunity to post an update on this topic. Quite unexpectedly, that opportunity came from Richard Jaffe.
For those of you who don’t remember Richard Jaffe, he was the lawyer for cancer quack Dr. Stanislaw Burzynski for nearly two decades; that is, until he stopped representing Burzynski three years ago, apparently in a dispute over payment for services rendered, a bill of a quarter million dollars. Burzynski has been discussed extensively on this blog, of course, particularly how he has managed to continue to use his “antineoplastons” to treat cancer patients for four decades, even though he has never been able to convincingly demonstrate their efficacy against any cancer. Richard Jaffe was a “pioneer,” if you will, in the field of legal representation for quacks, all of which he did under the name of “health freedom.” Indeed, he was the one who, if his book about his experience defending quacks is to be believed, came up with cynical idea of having Burzynski flood the FDA with clinical trials of antineoplastons against over 70 cancers as a strategy to allow Burzynski to treat any cancer patient who came through his door. More recently, Jaffe has been lamenting how the organization that certifies most continuing medical education (CME) is trying to make its standards more rigorous, thus endangering courses in “complementary and alternative medicine” (CAM), and speaking out against SB 277, the law that eliminated personal belief exemptions to school vaccine mandates in California. He’s also been advocating for more freedom for stem cell clinics.
That’s what makes his latest post on his blog less than a week ago so shocking. The post, entitled Some things in the private stem cell clinic debate are complicated, but some aren’t, left me gobsmacked in the way that, say, a post by P.Z. Myers professing that he had become an evangelical Christian or a post by Skeptical Raptor saying that he’d reconsidered and now thinks that vaccines cause autism would—or, a post by stem cell scientist Paul Knoepfler publishing “turn-by-turn directions to a specific unproven stem cell clinic that I recommend patients go to right now.” Richard Jaffe’s statements in this post are just that discordant.
Here’s what I mean:
I am a believer and advocate that patients should have the freedom to use their own processed and expanded stem cells. That should mean that I support US Stem Cell Clinic’s fight against the FDA’s injunction action.
But I don’t.
I just can’t get past the fact that this Florida stem cell operation allowed a nurse practitioner to inject stem cells into several patients’ eyeballs which resulted in total or partial blindness. A nurse practitioner! Legal though it may have been under Florida law, it is an inexcusable lapse of judgement. Plus, the clinic had already settled several malpractice lawsuits and is facing at least one more lawsuit involving a patient.
I am an advocate for a patient’s right to use his/her own stem cells, but that doesn’t mean that a clinic which continues to cause serious harm to patients has the right to keep injuring them.
In my opinion, US Stem Cells has done serious and irreparable harm to patients, and it needs to be stopped now, not in next few years, which seems like the FDA’s current time table. I don’t often agree with the big dog (aka Paul Knoepfler) but on this issue, I do. See his post at https://twitter.com/pknoepfler.
I’m just going to say one thing before I address the rest. The fact that this stem cell clinic allowed a nurse practitioner to inject its “stem cell” product (whatever it was) into patients’ eyes is hardly the offense that should get this clinic shut down. What should result in this clinic being shut down and its owners fined to bankruptcy is the fact that it was injecting unproven stem cell products into patients’ eyeballs in the first place. I don’t care who did it. I don’t care if it was a nurse practitioner or an ophthalmologist doing the actual injections. The injections themselves were quackery. Even worse, clinic personnel injected both eyes at the same session for the same patient, when the prudent thing to do is always to do one eye at a time, so that if there is a complication it doesn’t affect both eyes and potentially render the patient blind. That’s how responsible ophthalmologists roll. Add to that that this particular clinic claimed that its stem cell products could be used to treat Parkinson’s disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, heart disease, pulmonary fibrosis, Crohn’s disease, lupus, and diabetes, and we’re talking 100% grade-S snake oil here. None of that quackery bothers Jaffe. Only the fact that a couple of patients with macular degeneration lost sight does. Still, it’s a good first step. Maybe he’ll eventually come to appreciate why what these clinics sell should be considered quackery as a result of the shock he suffered seeing what U.S. Stem Cell Clinic, LLC did.
Jaffe notes that malpractice suits are unlikely to shut the clinic down:
Malpractice claims are typically covered by malpractice insurance, and I have to believe given the clinic’s past experience, the first bill it pays after rent is its malpractice policy premium. It’s surely tough being sued, but when you’re not paying to defend and not paying the settlement amount, it’s not quite as tough, and is not a business ending event. So I don’t think any single or even a small number of malpractice lawsuits will do the job.
Jaffe is correct, but what insurance company would write a policy for this clinic after the FDA has brought action for such a serious patient injury and some big malpractice suits. Blinding a patient through what was in my opinion gross incompetence coupled with quackery is pretty bad, and this is one rare case where the litigation-friendly nature of Florida might actually be a good thing. Also, if the malpractice settlement (and U.S. Stem Cell had really better pray that this case doesn’t go to trial) is above what the clinic’s malpractice insurance, the clinic could still be forced to pay the difference. Of course, Richard Jaffe is likely correct that the clinic has lots of money, given how it’s been selling and marketing its product for huge sums of money. That’s why he notes:
More effective would be fraud or deceptive practices lawsuits. These most likely won’t be insurance covered, at least not by malpractice insurance. I think there has been at least one such case filed against the clinic by a Miami law firm. I’m rooting for the plaintiff in that case. But these cases take time, and often times, the cases are settled. And insurance or not, I assume these Florida clinic folks have made a ton of money from their stem cell patient business, and they also have a training and franchise operation of sorts, so I wouldn’t expect even a fraud lawsuit or two to put them out of business, not in the short term at least.
So if malpractice and/or fraud lawsuits are unlikely to shut U.S. Stem Cell down any time soon, and the FDA’s standard actions against clinics like this move too slowly, then what can be done? Jaffe has some ideas. First, he thinks the FDA’s OCI (Office of Criminal Investigations) should be involved. He thinks the Form 483 (the FDA site inspection form which reports on the findings of the inspection and the violations observed) would be enough to “establish sufficient knowledge and intent to support a probable cause finding that the crimes are felonies,” and thus provide enough justification for a federal judge to sign-off on a search warrant. Then, Jaffe suggests that the OCI:
- Execute the search warrant and take all the clinic’s patient records.
- Have the warrant search for non-FDA cleared medical devices or any other devices used in connection with the alleged criminal activity.
- Invite the Florida medical board to participate in the raid.
- Start interviewing the clinic’s patients. Jaffe notes that many “will be supportive of the clinic, including some who have received no benefit, but some won’t be.”
- Interview all the clinic’s employees and vendors/suppliers. Jaffe notes that the “OCI has some interesting interviewing techniques which in effect threaten criminal prosecution to people doing business with the target without technically threatening them, but the vendors get the message.”
Jaffe further notes that “some or all of this might seem like legal thuggery, but me and my clients have been on the receiving end of all of them.” Funny how he laments this “legal thuggery” when directed against his clients, yet proposes it as a solution to a stem cell clinic he’s decided he doesn’t like. (Also funny how a lawyer apparently can’t write proper English. I know that I usually frown on spelling and grammar flames, but this was so egregious that I couldn’t resist. Also, I tend to frown on them most when they are the only thing said.)
He also proposes using the fact that U.S. Stem Cells is a publicly traded company against it by trying to get the SEC interested in investigating the company’s reporting documents (10K’s and 10Q’s) to see if the company’s disclosures were adequate. (He’s betting they were not.) With this, a class action firm could potentially file a shareholders’ suit.
Whatever Jaffe’s motivations, I wholeheartedly agree with this:
The FDA and the US Attorney’s Office should do what they should have done in the beginning, file a preliminary injunction motion, and request a hearing as soon as practical.
That’s going to present some interesting conundrums for the clinic’s principals. Do they testify? If they do, they can’t lie, or they’ll be charged with perjury. Can they say they didn’t know what they were doing is illegal? They can say it, but the judge doesn’t have to believe it. I doubt they’ve been told by an FDA attorney that what they’re doing is legal, so there won’t be an “advice of counsel” defense. Ultimately, they will either be forced to testify and most likely further incriminate themselves, or they’ll fold their tent and go away. (I’d bet on the former.)
If they don’t close down, then the final step is a criminal indictment, and that will put a whole new complexion on things. There’s a saying in criminal law. “You can beat the rap, but you can’t beat the ride.”
But in this case, once the blinded patients and the other injured patients testify, a preliminary injunction case, the permanent injunction case and a criminal trial are effectively over. No reasonable judge or jury is going to let these people continue.
Yes, I would be in favor of criminal prosecutions of these clinics, if the FDA and US attorneys can put together the evidence. As I’ve said, I’ve yet to find a good example of one of these stem cell clinics that is not a quack clinic and not selling pure stem cell-infused snake oil. I’d also be willing to bet that U.S. Stem Cell is just the tip of the iceberg. No, I know it is.
More evidence of how numerous these stem cell clinics have become showed up in the form of an article last week by Erin Allday in the San Francisco Chronicle entitled Merchants of Hope. (I complained about the headline for this report, which really should have been Merchants of False Hope, but what are you going to do? Maybe the lawyers prevented the SF Chronicle from using that title.) Although this article doesn’t really deal with U.S. Stem Cell Clinic, other than to mention that it had blinded patients with its stem cell injections and was the target of the FDA. Rather, it dealt more with another prominent stem cell clinic and chain of clinics, California Stem Cell Treatment Center and Cell Surgical Network, run by a plastic surgeon turned stem cell guru Dr. Mark Berman and business partner, Dr. Elliot Lander, a urologist. (There’s a joke about a plastic surgeon and a urologist in there somewhere.) It turns out that Berman’s clinics represent the largest chain of for-profit stem cell clinics in the US, with over 100 affiliates in 33 states and 38 locations in California alone. Its claims and products are very similar to those of U.S. Stem Cell, with implied claims of efficacy for stem cell treatment of asthma, myocardial infarction, Parkinson’s disease, muscular dystrophy, spinal cord injury, amyotrophic lateral sclerosis, and many more conditions.
Also, the owners of so many of these quack stem cell clinics, Berman included, he seems to be following the example of Stanislaw Burzynski by having patients pay to be part of their (crappy) research protocols, which they describe as “patient funded and not approved by the FDA.” Whenever I’ve looked at the “clinical trials” that clinics like U.S. Stem Cell and Berman’s clinics advertise, I’ve never found a single example of a rigorous, well-designed clinical trials. They’re always unblinded, single arm studies in which everyone gets stem cells (paid for by the patients, which is unethical) and rarely using anything resembling a “hard” outcome measure as endpoints. It’s basically the model that Jaffe “pioneered” for Burzynski adopted by quacks running stem cell clinics as a means of advertising and justifying administering stem cells for unproven indications, all while having patients pay for it.
The SF Chronicle article is well worth reading in its entirety, but I can’t help but quote one passage of it:
Scientists performing the most rigorous research say that what Berman and other for-profit providers suggest is not possible. Adult stem cells taken from fat — the technique Berman uses — cannot replace cells in the eye. They won’t target an injured area of the brain. They won’t float around the body healing the immune system.
To critics, Berman said, “We’re a bunch of quacks and scallywags … we’re charlatans and taking advantage of people.
“That’s ridiculous,” he said. “Why would I be doing this unless it was incredibly successful?”
Critics point to one answer: money.
Procedures at Berman’s clinics cost $8,900, though he said he’ll reduce or waive costs for patients in need. He and Lander also charge doctors who join their network about $30,000 for training and equipment, including a device they call the “time machine” — a reference to stem cells’ fabled ability to reverse the effects of aging — to make the product they use in treatments.
Berman said he understands the value of rigourous, long-term research to test the safety and efficacy of new therapies. But he’s convinced that what he’s selling is already helping people. And if he’s able to offer a treatment now, even if it’s imperfect, “that’s our moral duty,” he said.
This is very similar to Berman’s previous excuses for his quackery. Now as then, Dr. Berman is, of course, spouting 100% grade-A bullshit. If “moral duty” had anything to do with Dr. Berman’s motivation, then I submit that he should immediately reconstitute his business as a nonprofit corporation and plow any money over expenses his company makes into real research. If “moral duty” had anything to do with Berman’s motivation, he’d insist on doing rigorous randomized, controlled clinical trials with well-designed correlative studies to look at mechanisms by which stem cells might repair damaged tissue. Does he do any of that? Of course not! Instead, he charges $9,000 a pop for unproven stem cell treatments, with most patients being told they need repeated treatments, while franchising out his model to other unscrupulous doctors and selling them expensive and unproven equipment. Worse, he does this all while nauseatingly pontificating about “moral duty,” all the while using motivated reasoning to convince himself that he’s doing something good. I know a quack when I see one.
This brings me back to Rick Jaffe. Jaffe has been defending quacks for decades, all in the name of “health freedom.” He worked closely with Stanislaw Burzynski for nearly two decades to defend him from all legal threats and allow him to continue to prey on desperate terminally ill patients and their families, something he is, unfortunately, still doing, albeit without Jaffe. If Burzynski hadn’t stiffed him on a quarter million dollar legal bill, Jaffe would likely still be representing him. So, when I see a passage like this, I am not kind:
And that’s why this is such a horrible case for stem cell advocates like myself. The idea that these people are the poster children for patients’ unfettered access to their own stem cells is disconcerting. That this case might set precedent for all same-day surgical procedure clinics should be distressing to all such clinic operators.
Unlike Paul Knoepfler—whom, I’m afraid, I must disagree with here—I can’t see Jaffe’s statement as a “gutsy move.” It’s a cynical move. Finally, after all these years, very public reporting of serious injuries due to a quack stem cell clinic have reached the public consciousness, and Jaffe’s worried because patients with macular degeneration blinded by U.S. Stem Cell’s quack treatments are now, increasingly, what people think of when they think of stem cell clinics. Jaffe is thus willing to throw U.S. Stem Cell under the bus in order to protect the 700+ other quack stem cell clinics now operating, clinics that he hopes will not be quite so obviously quacky and a bit more careful not do do things as risky as injecting unproven concoctions that might or might not be real “stem cells” into the eyes of patients facing vision-endangering diseases. To that end, he’s hoping to see the FDA do to U.S. Stem Cell what it did to some of his clients, all so that the rest of the quacks can continue to profit selling snake oil.