Will the Medical Board of California crack down on the stem cell hard sell?

A frequent topic here at the ol’ blog has been the proliferation of for-profit stem cell clinics that offer dubious “stem cell therapies” with little or no evidence to support them. The reason is obvious. The claims made by owners of these clinics have far outpaced the actual science to the point where owners of stem cell clinics claim that they can use stem cells to treat conditions ranging from stroke, to autism, to chronic lung disease, to cancer, to just about any disease or chronic health condition you can imagine. If that’s not enough, many (if not most) of these for-profit stem cell clinics promote “anti-aging” treatments, selling stem cells as a mystical magical fountain of youth to repair and regenerate pretty much any organ or body part that might be slowly failing due to the combination of degeneration and injury that we all experience as we age. Indeed, these stem cell clinics frequently bill themselves as “regenerative medicine”. In the meantime, alternative medicine practitioners, including naturopaths and chiropractors, have jumped on the stem cell bandwagon, offering what might or might not be actual stem cells as therapy and treating them as magic cells that can do basically anything if you just inject them into the bloodstream. Of course, this leads to the question: Why haven’t state medical boards done anything? In California, at least, there has been a very positive development suggesting that the situation might be changing, as you will see. But first, how have these clinics proliferated?

The proliferation of these dubious stem cell clinics has, unsurprisingly, been aided and abetted by testimonials. For instance, just this year, Suzanne Somers’ old claim that she “grew a new breast” with stem cells after having undergone a partial mastectomy and radiation therapy for breast cancer that left her treated breast markedly smaller than her unaffected breast popped up in the news again during—when else?—Breast Cancer Awareness Month. The Australian version of the television news magazine 60 MINUTES recently ran a long segment about a girl with cerebral palsy whose parents took her to one of these stem cell clinics. Even though it’s unclear whether the girl benefited at all from the very expensive treatments, reporter Liam Bartlett presented the parents’ struggle as heroic and benefiting the little girl even though objectively it was not at all clear that it did. A few years ago, the story of hockey legend Gordie Howe’s stroke and his family taking him to a dubious stem cell clinic in Mexico made the news, and plenty of credulous reporting followed, including by my local news stations and nationally by Keith Olbermann who reacted…poorly…to criticism. I could go on and on with examples, but I also can’t help but mention how crowdfunding on social media by patients and families have also allowed them to afford these very expensive treatments, which frequently run into tens of thousands of dollars per treatment and require multiple treatments.

Of course, besides the profit motive, much of what’s allowed the proliferation of these stem cell clinics in the US is a failure of regulation. For years, it seems, the FDA and FTC didn’t know what to do about these clinics, which tried to frame their treatments as procedures akin to surgical procedures that move cells or tissue from one part of the body to another (like liposuction or plastic surgery muscle flaps) or to blood transfusions, both of which were not viewed as drugs by the FDA. Some clinics set up scientifically questionable clinical trials, taking a page from the Stanislaw Burzynski handbook to sign all their patients up for profit. That began to change in response to news reports of patients blinded by stem cell treatments for macular degeneration and of a man who developed a mass on his lower spine after stem cell treatments for his stroke. Other news reports of the unethical, time share-like hard sell methods used by stem cell clinics and manufacturers to sell their product shed a not-so-flattering light on this new and apparently highly profitable industry.

In response to these concerns, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) started to investigate for-profit stem cell clinics. As a result, the FTC recently settled deceptive advertising claims against clinics offering “amniotic stem cell” treatments. Interestingly, there turned out to be—surprise! surprise!—no actual stem cells in the treatments being used. Unfortunately, that seemed to be the main reason the FTC proceeded. Instead of examining the science, it was easier simply to go after these clinics on the basis of there being no actual stem cells in their stem cell treatments. Meanwhile, the FDA did announce a crackdown on dubious stem cell clinics.

But what about state medical boards?

The Medical Board of California acts

As important as the FDA and FTC are in regulating drug and device safety and advertising claims, respectively, they play a relatively minor role in regulating the day-to-day practice of medicine. A doctor who is using drugs or devices that are not FDA-approved can run afoul of the FDA, but if he’s using FDA-approved drugs and treatments in a manner that is not supported by science or clinical evidence he’s far less likely to draw the attention of the FDA because the FDA doesn’t regulate the practice of medicine. That’s how “Lyme-literate” doctors, for instance, get away with their unproven treatments for “chronic Lyme disease” without FDA intervention, for instance. They’re using FDA-approved antibiotics, just not in a manner supported by science, and the FDA allows wide latitude (arguably too wide) for so-called “off-label” use of drugs; i.e., the use of a drug for a purpose other than that for which the FDA originally approved it. Similarly, the FTC can only really intervene if a company or doctor is making false advertising claims, and even then it’s hard to make sanctions stick. That leaves the state medical boards.

The reality in the US is that doctors are not regulated by one central authority, but rather by fifty. Each state has a state medical board, and each state sets its own licensing requirements for physicians. Similarly, each state sets its own laws regulating the practice of medicine and the procedures for sanctioning physicians who pose a danger to the public. Unfortunately, state medical boards have been notoriously reluctant to crack down on the doctors running quack stem cell clinics. However, that might be about to change, if the Medical Board of California has anything to say about it:

Ironically, this story ran while I was actually in San Diego. Funny that I missed it. I must have been out doing other things.

The report is actually quite good in that it shows how a local stem cell clinic was doing all the things that these dubious stem cell clinics do in their advertising and promotion, such as claiming they could treat everything from chronic low back pain and pain due to degenerative joint disease to dementia to a variety of other ailments and dodging questions about whether their treatments are “FDA-approved” by saying that they have “FDA clearance,” whatever that means. Particularly hilarious is the reporter asking the organizer of a stem cell clinic seminar what “FDA clearance means” and her responding that “you have all the information you need.” When the reporter says, “No, we don’t,” she responds, “Yes, you do.” It really is comical, as is the reporter chasing the Carlsbad chiropractor into his car asking him if his stem cell treatments are FDA-approved. I’m guessing that investigative reporters live for moments like that.

And this:

Dr. Sarah Apollo, the Medical Director and CEO of the San Marcos West2North Medical Solutions clinic told NBC 7 Investigates over the phone that she was “surprised” that Van Derschelden had not told the seminar audience the procedure was not FDA-approved. Apollo was also surprised when we told her the clinic’s advertisements never mention the procedure is not FDA-approved.

In an email to NBC7 Investigates, Apollo thanked NBC 7 Investigates for “bringing these potential issues to us.” She says the clinic is “dedicated to meeting our duties and responsibilities with respect to compliance.” She added that she believes the clinic is in compliance with state and federal laws.

“Moving forward, we will mention that this procedure is not FDA-approved,” she said. Apollo added that there is a posting in the clinic stating the procedure is not FDA-approved, something that is required by state law, as of January 1, 2018.

So it only took the San Marcos West2North Medical Solutions clinic almost until the end of 2018 to start to follow a law that went into effect on January 1, 2018 and then only when a local news station started investigating.

In any event, it appears that the Medical Board of California, at least, is preparing to act:

Recently, the California Medical Board announced they are setting up a task force to investigate the claims made by these stem cell clinics, among other things.

Its impetus was a letter from U.S. Senator Lamar Alexander (R-TN) to the Federation of State Medical Boards, in which he voiced concerns that “recent reports indicate some patients have been harmed by unproven or investigational treatments received at stem cell clinics.”

The Federation was asked to create a “best practices” list for state medical boards to review when dealing with these types of clinics. The result is 11 recommendations that range from reviewing a clinic’s marketing materials to physicians being required to support health claims made with documented evidence.

A spokesperson for the California Medical Board said they are now reviewing the Federation’s recommendations but there is no date set for when the task force will get to work.

NBC7 Investigates has learned the California Attorney General and San Diego County District Attorney’s offices have both received information on various stem cell clinics and their practices. Neither office would confirm or deny that any active investigation is taking place.

This is good news indeed, particularly if more state medical boards besides the Medical Board of California start to take action. However, my optimism is tempered by the vagueness of what I’m reading here about the recommendations issued by the Federation of State Medical Boards. So I looked up just what the FSMB recommended.

The Federation of State Medical Boards and “best practices”

The FSMB issued a press release about its report and recommendations regarding the “best practices” in regulating physicians who use stem cell treatments in May. The FSMB task force notes in the introduction to the report:

Stem cell and regenerative therapies offer opportunities for advancement in the practice of medicine and the possibility of an array of new treatment options for patients experiencing a variety of symptoms and conditions. Despite significant momentum in research and development, and the potential for such medical advancements, there is reasonable concern about a growing number of providers and clinics in the United States that are undermining the field. Such providers and clinics have been known to apply, prescribe or recommend therapies inappropriately, over-promise without sufficient data to support claims, and exploit patients who are often in desperate circumstances and willing to try any proposed therapy as a last resort, even if there is excessive cost or scant evidence of efficacy.

The FSMB also notes many of the advertising techniques used by doctors running dubious stem cell clinics to give the appearance of scientific legitimacy, including testimonials and endorsements by celebrities or “experts”; the use of technical language full of “scientific-sounding words that imply academic rigor”; forming organizations to self-regulate in ways that support premature commercialization; publishing research and commentary in journals with limited or nonexistent peer review; registering clinical trials whose sole reason for existence is not science but rather to attract patients; and other techniques, the vast majority I or other SBM bloggers have written about at one time or another.

The report also notes when cellular or tissue-based products (HCT/Ps) do not require FDA approval. This has been discussed before, but I’ll briefly recap. About a year ago, the FDA issued draft guidance on this very topic, “Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use“, as well as another guidance entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception“. The intent is to clarify regulations with respect to “human cells, tissues, and cellular and tissue-based products” (HCT/P).

There are two issues relevant to stem cell “medicine” in these guidelines. The first is: How much are the cells manipulated? In other words, what constitutes “minimal manipulation”? Basically, the FDA has in the past ruled that autologous products, like blood transfusions, are not drugs, at least not in the same sense that other drugs are. The same is true of autologous tissue removed from the body and reimplanted elsewhere, as plastic surgeons do when they do liposuction and use the fat to sculpt the body elsewhere or, in fact, when surgeons remove a flap of muscle and reimplant it elsewhere or resect a section of bowel and sew it to somewhere else in the digestive tract (something general surgeons do all the time). Considering such autologous products to be drugs that need to be regulated would interfere with surgery and a lot of other well-accepted medical procedures. However, it’s different if the products are manipulated or changed somehow. Traditionally, the FDA has said that “minimal manipulation” of such products is acceptable; more than that and you’re looking at a drug or a product that needs to be regulated. The problem is that what constitutes “minimal manipulation” has never really been well-defined.

Second, is the use homologous or not? Homologous use basically involves using a like product only to treat a like tissue or organ (i.e., fat to treat fat; skin to treat skin; blood for blood or immune cells; etc.). Non-homologous use involves using HCT/P to treat organs not related to their origin or to carry out biological functions that they don’t normally do.

If the definition of “minimally manipulated” is a bit…unclear, then the definition of “homologous” is arguably even less so. However, even though the line might be gray regarding what is and isn’t homologous, we can still tell some uses that clearly are not homologous. To aid us in that determination, perhaps the money quote from the draft guidelines is here:

If an HCT/P is intended for use as an unproven treatment for a myriad of diseases or conditions, the HCT/P is likely not intended for homologous use only.” (Page 15 of “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use”, here is the link again: https://pactgroup.net/system/files/GD_HCTs_20171116_UCM585403.pdf)

Basically, this covers pretty much every one of these for-profit stem cell clinics, given the wide range of treatment claims they all make.

So the FSMB came up with eleven recommendations for “best practices”. Most of them are pretty straightforward, such as:

• “Physicians should employ a “shared decision making” process when discussing treatment options with patients. Physicians must avoid any claims that may be deceptive or are intentionally or knowingly false or misleading, especially in terms of making promises about uncertain or unrealistic outcomes.”
• “Physicians should refrain from charging excessive fees for treatments provided. Further, physicians should not recommend, provide, or charge for unnecessary medical services, nor should they make intentional misrepresentations to increase the level of payment they receive.”
• “Physicians should be prepared to support any claims made about benefits of treatments or devices with documented evidence, for example with studies published in peer-reviewed publications.”
• “Physicians must only offer treatments to patients for which they have a bona fide physician- patient relationship. Physicians must have received adequate and appropriate training, and be able to perform any proposed intervention safely and competently.”

Of course, you know and I know that pretty much every dubious stem cell clinic claims to be doing these things. Of more interest is what the FSMB thinks that state medical boards should be doing. For instance, I particularly like these two recommendations:

• “State medical boards should review professional marketing materials and claims, including any office/clinic and/or doctor websites, and information publicly available about an office/clinic or licensee on online blogs or social media, as information sources in the investigation of complaints made against physicians.”
• “State medical boards should pro-actively monitor warning letters sent to licensees that are made publicly available on the FDA website in order to ascertain information, and consider opening an investigation, about licensees who may be engaged in other unscrupulous or unprofessional practices related to the provision of regenerative and stem cell therapy. State medical boards should investigate such practices, when appropriate, in conjunction with applicable state laws, policies, and procedures.”

My concern, of course, is how state medical boards will be able to do these things. Such active monitoring requires resources, and state medical boards tend to be resource-strapped to the point where they often have trouble taking rapid action on the most obvious of threats to patient safety, such as doctors with substance abuse problems or doctors who diddle their patients. Similarly, I can’t argue with this:

Where evidence is unavailable for a particular treatment in the form of clinical trials or case studies, physicians must only proceed with an appropriate rationale for the proposed treatment, and justification of its use, in relation to the patient’s symptoms or condition. Novel, experimental, and unproven interventions should only be proposed when traditional or accepted proven treatment modalities have been exhausted. In such instances, there must still be a basis in theory or peer-acknowledged practice.

On the other hand, medical boards are notoriously unwilling to evaluate the science behind medical claims and crack down on utter quackery. For instance, Stanislaw Burzynski has continued to practice his cancer quackery in Texas for 40 years. True, from time to time the Texas Medical Board has tried to shut him down, but every time Burzynski has eluded the most serious sanctions and managed to continue to practice. There are “integrative medicine” doctors in nearly every state offering outright quackery like acupuncture and even “energy medicine”, and state medical boards do little or nothing. Does the FSMB really expect that state medical boards will be willing to go toe-to-toe with doctors running highly profitable clinics over whether the science justifying their claims is adequate for them to be treating people? I mean, look at Dr. Christopher Duntsch, a Texas neurosurgeon who had multiple complaints to the Texas Medical Board against him for poor surgical technique leading to horrific and avoidable complications that resulted in paralysis and even death. It took a couple of years to finally shut him down.

Will stem cell clinics ever be regulated properly?

Currently, the Medical Board of California is in the process of deciding how to implement the FSMB’s recommendations. According to Paul Knoepfler, a stem cell scientist, the board is going to be holding meetings beginning in early 2019 to “review the FSMB policy and determine if any changes need to be made in California based upon the policy.” Paul also notes that “stem cell clinics now face a broad range of overseers from the FDA, the FTC, state medical boards, and law enforcement officials (both nationally and locally),” as well as “potentially serious problems for clinics too such as from patient lawsuits.”

I hope he’s right, but if there’s one thing I’ve observed about these unproven stem cell clinics is that they are resilient. The FDA has only so much resources to devote to this one area, and state medical boards are even more constrained in their resources. Moreover, many of the owners and operators of these clinics are wealthy and well-connected. While I’m happy that federal, state, and local authorities are paying more attention to quack stem cell clinics, I’m not as optimistic as Paul is that this increased attention is going to put much of a dent into the business of the likely over 1,000 for-profit quack stem cell clinics that operate in the US alone any time soon.

Indeed, I just got a flyer in the mail advertising an informational session for a stem cell clinic scheduled to take place in a venue a mere 3 miles from my house less than two weeks from now. The usual unsupported claims are all there. I’m seriously tempted to sign up, go, and report back on what I find. If more skeptics did that, perhaps there would be more for authorities to work with in trying to shut down these quack clinics.