Stem cells are magical. Stem cells are all-powerful. Stem cells cure everything. Stroke? No problem! Paralysis? Stem cells’ll fix it. Autism? Yes, even autism.
That’s the narrative one frequently hears about stem cells in the press and courtesy of offshore stem cell clinics and direct-to-consumer marketing of stem cells in the US. Of course, stem cells aren’t mystical and magical, although they are very promising as a treatment for some degenerative conditions. As promising as they are, though, they don’t cure everything. In fact, we don’t even know for sure that they cure anything because for the vast majority of conditions for which stem cells are used in these clinics, they are still at best experimental and at worst completely unproven. In fact, at their worst, they can do great harm.
I learned about the unrelentingly positive spin the media tend to place on stem cell treatments when I first started blogging about Gordie Howe’s stroke and Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies reached out to the Howe family to see if it could help him with its products. When Howe and McGuigan discovered that Howe was not eligible for any of their US clinical trials, they facilitated Howe’s receiving an unproven stem cell therapy through one of its partners in Mexico, Novastem, which uses Stemedica stem cell products to treat patients in its clinic, Clínica Santa Clarita. In the ultimate bit of privilege for a sports hero (or, as I saw it at the time and as it ultimately turned out, an excellent investment for marketing and advertising of Stemedica products) Gordie Howe even received the treatment for free, even though Clínica Santa Clarita charges everyone else around $30,000. Let’s just say that I didn’t find the explanations for waiving this rather massive fee in Gordie Howe’s case to be persuasive, and I was rather disturbed at the entitlement expressed by Howe’s son over it, who didn’t see the ethical problem at all. Nor did I find the excuses given by Stemedica and Novastem for why their clinical trial protocol in Mexico was so substandard.
It turns out that this new, poorly regulated industry operates a lot like the many quack cancer clinics that I’ve blogged about over the years and like a lot of other dubious businesses, such as multilevel marketing scams. This comes in the form of a recent paper in Stem Cells Translational Research by Paul Knoepfler, who describes attending a marketing seminar.
The scope of the stem cell industry
Back in July, I took note of a paper published by a real stem cell scientist, Paul Knoepfler (who, by the way, wrote a guest post for this blog on the problem of unregulated stem cell clinics, describing many of them accurately as “unapproved, for-profit human experimentation“) in which he identified at least 570 stem cell clinics operating in the US and discussed some of the dubious claims found on their websites. Right here in the good ol’ USA, there are clinics claiming that stem cells can cure arthritis, dementia, Alzheimer’s disease, Parkinson’s disease, diabetes, and host of other chronic diseases and conditions. Particularly outrageous was the Regenerative Medicine Group, which claimed to offer a stem cell “therapy for autism that WORKS.” Before I discuss Dr. Knoepfler’s paper, even though it was only a couple of months ago that I last referenced this, I think it’s worth reminding you of the sort of highly dubious claims being made by sellers of equally dubious stem cell therapies, in this case by Bryn J. Henderson, DO, JD, FACPE, CIME, the executive director of RMG:
As I pointed out at the time, this video is beyond pathetic, at least as far as evidence goes. Dr. Henderson claims that RMG has helped “dozens” of children with autism using his stem cell therapy, further claiming that most of the time the change noted in the patient is major. Yet, he provides not one iota of objective evidence and doesn’t reference a single clinical trial to support his claims. Instead, he brags about the thank you cards he’s received from parents. I can’t resist repeating again how pathetic this is and how even antivaccine quacks like Mark and David Geier, Brian Hooker, or Andrew Wakefield can do a better job at providing evidence. Given how far into pseudoscience antivaccine quacks are, that should tell you just how bad RMG and Dr. Henderson are.
Unfortunately, judging by Dr. Knoepfler’s description of the stem cell seminar he attended, other forms of marketing by the stem cell industry appear no better than that of RMG as far as science and accuracy go.
A stem cell scientist attends a stem cell infomercial seminar
In his blog post and recent paper, Dr. Knoepfler describes the stem cell patient recruitment seminar that he attended recently as the “stem cell hard sell” and the type of seminar he attended as a “stem cell infomercial seminar.” It’s an accurate description, given his account. Not surprisingly, Dr. Knoepfler was a bit nervous attending the seminar, fearing he would be recognized. To me, this rather implies that one or more of the organizers or one or more of the speakers must have been people who either knew him or knew of him:
Noting an advertisement for what I perceived to be a stem cell clinic infomercial seminar, I traveled to the location to attend. To enable a higher degree of frankness in this report, I am omitting the identity of the stem cell business, the location of the seminar, and the names of the speakers. Because I am known in the stem cell clinic world, I was uncertain as to the reception I might receive. I strove to be unobtrusive when I arrived, but soon after sitting down in the audience at the hotel meeting room where the seminar was about to begin shortly, one of the organizers came up to me and indicated that he knew who I was.
My purpose was to gather information about this clinic and experience first-hand what a stem cell clinic infomercial seminar was like. My sense was that they knew I was not there as a potential customer. Those running the seminar frequently sat or stood immediately behind me during the meeting, perhaps as an attempt at intimidation or to see the notes I was taking. Because I was identified by the people running the seminar prior to its beginning, a caveat in this piece is that they could have changed aspects of the seminar because they knew I was in the audience. However, I saw no clear evidence of that.
I note here that my only criticism of the paper is that I really wish Dr. Knoepfler and the editors of Stem Cells Translational Research had not decided to omit the names of the companies, stem cell clinics, and speakers at the seminar. Of course, given that Dr. Knoepfler is on the faculty of the University of California Davis, it would not be unreasonable to guess that the seminar was probably within a reasonable drive of Sacramento. (I’d be willing to bet that the seminar was held in San Francisco or elsewhere in the Bay area, given that Dr. Knoepfler stated that he “traveled” to the area and I tend to doubt he flew there, but I could be wrong.) I also rather suspect that the editors of Stem Cells Translational Research were concerned about Dr. Knoepfler and their journal being sued for libel, which I can understand. However, I still don’t like it. I really wanted to yell as I read the paper: Name names! Who is making the sorts of bogus, pseudoscientific claims documented by Dr. Knoepfler? Call them out! But that’s just me.
Dr. Knoepfler then noticed something that is not uncommon at such sales pitches, namely how the promoters do everything to emphasize the medical authority of the speakers. The seminar team nearly all dressed in medical scrubs, rather than what I normally would choose to wear giving a talk, either a suit and tie or sport jacket with or without a tie, depending on the level of formality. You know why I used to make fun of Dr. Oz for so often doing his TV show in his scrubs, as though he had just left the OR to come and do his show? It’s because the wearing of scrubs outside of the hospital is nothing more than shouting at the audience, “Listen to me. I am a real doctor. I have authority. I know what I’m talking about!” And it works, which is why Dr. Oz and doctors selling dubious treatments keep doing it. I wonder if any of them wore their white coats too.
Dr. Knoepfler also noted that there were about 30 attendees, many with obvious serious medical conditions. (One wonders how many oxygen canisters and walkers he saw.) This led him to express the concern that the attendees could be vulnerable to a sales pitch, which, of course, was the entire point of the seminar. Indeed, if you don’t believe that, read what Dr. Knoepfler reports next, in which every attendee was asked to fill out a credit application:
The seminar team (mostly dressed in medical scrubs) handed out a clipboard to each attendee with three pieces of paper very much like those that one might be given on arriving at a new doctor’s office. We were told to fill in our information and then to return the sheets back to them before we left. Notably, the top sheet was a credit application. On another page, the clinic asked for extensive personal information, including name, age, birthdate, address, e-mail, and phone number. Additional questions asked about medical conditions, as well as medical tests that had already been conducted.
Then, in another classic hard sell technique, the seminar team didn’t allow questions during the seminar itself, but rather asked the attendees to save their questions for the end of the seminar, so that…well, here is the explanation:
As the seminar began, the audience was told to hold all questions until after the speakers were done, and then they would talk one-on-one with attendees. I had hoped to ask a few questions from my place in the audience, which others present could hear, as a means to catalyze a meaningful discussion of key issues, but this “rule” seemed to negate that chance, and I had no interest in being disruptive of the meeting.
The obvious purpose of this ploy was to prevent anyone from publicly asking questions that might be too…skeptical. Such questions might poison the enthusiasm for the therapies the organizers were trying to stoke and thus potentially decrease the number of sales they could generate from this event. Also, as any skilled con man knows, the hard sell works better one on one, where the con man, who is almost always very charismatic and convincing, can more effectively break down a mark’s objections to what is being sold and gradually win him over. So far, Dr. Knoepfler’s description of the event he attended sounded a lot like a description of an event I made the mistake of attending in which the organizers tried to sell the audience time shares.
But what about the medical and scientific claims?
Dubious marketing, dubious claims
The meeting began with the owner of a successful stem cell business, whom Dr. Knoepfler dubbed “Ted,” and who portrayed himself as a successful entrepreneur and stem cell expert. Instead of starting out with evidence, not surprisingly Ted started out with anecdotes, describing how he had had a family member with a serious medical condition and could thus empathize with those whose family members suffered from chronic medical conditions. This is, of course, a method of persuasion used by everyone from politicians to salespeople to con men, convincing the audience that you are like them and that you understand their problems. Then there’s the promise:
Ted next asked the audience to close their eyes and ask themselves, “What could you do in the past that you can’t do now?” With my eyes open, I estimated that nearly every member of the audience had closed his or her eyes. I wondered about the impact of this approach by the seminar organizers on the audience’s state of mind.
The answer, of course, is obvious. Ted was clearly implicitly telling the attendees that his product could help them recapture the ability to do things that their illnesses had robbed them of the ability to do. The wag in me can’t help but note that if I were asked such a question, I would probably note that I can no longer eat as much as I desire and not gain any weight, as I could do when I was in my teens and 20s. However, I don’t have a serious chronic debilitating disease. To such people, a question like this focuses the mind on the disability caused by their disease. In the case of this audience, it was arthritis and chronic pain that were the most common conditions, and arthritis can definitely greatly limit one’s ability to do routine tasks of daily life.
Of course, Ted was selling amniotic stem cells; so it didn’t take long for his pitch to bring them up. He made the analogy that his stem cells were like an uncle or other relative we all have who is a “Mr. Fixit,” who can “fix anything.” This is the core of the promise of embryonic stem cells, of course, the problem being that we as yet do not know how to direct these cells where they need to go and trigger them to differentiate into the tissues they need to become. Over the course of his talk, Ted made a number of medical claims besides the claim that embryonic stem cells can “fix everything”:
- A range of conditions successfully treated
- No side effects
- Safer than the current standard of care
- No immune rejection
- FDA approved
- Specific efficacy for arthritis/pain
Dr. Knoepfler pointedly notes that at no time did he hear or see any disclaimers or waivers of any kind regarding the claims being made at the seminar. My reaction upon reading this passage was: What? No quack Miranda warning? Apparently not, I guess, if the claim was made that the therapy was FDA-approved. In any case, in another post, Dr. Knoepfler lists ten things to look out for when considering stem cell treatments; this seminar appeared to have clicked ten out of ten of these.
Not surprisingly, Ted presented a lot of anecdotes and made quite a few dubious claims. In order to make his product look better, he reported that it is illegal to use or even study embryonic stem cells. It’s not, of course. The real picture is much more complicated, in which for a time the NIH wasn’t allowed to fund research projects involving embryonic stem cell research and still, even now after President Obama’s 2009 executive order removing some restrictions on embryonic stem cell research, the Dickey-Wicker Amendment still bans (1) the creation of a human embryo for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero. There are also a few state statutes prohibiting human therapeutic and reproductive cloning. Still, if “any” embryonic stem cell research is “illegal,” then Ted’s embryonic stem cells are all that’s left, which is good for the sales pitch. One notes that, while there are stem cells in amniotic fluid, claims that they can treat many different conditions are not based in science.
After claiming that his amniotic stem cells are like a “new car” with no potential for rejection, Ted further touted their use for knee osteoarthritis:
The treatment was then described in further detail, leading to additional medical claims. For instance, Ted indicated that the treatment would be a same-day, painless injection, so patients would just walk out with a bandage. “There is no surgery and this is the new gold standard,” he said. Furthermore, he reported that they have observed “no side effects,” another unambiguous medical claim. In contrast, traditional procedures such as knee replacements have “many risks,” we were told, including heart attacks. Ted claimed to the seminar audience that 5,000 people die each year from a heart attack after knee surgery. I factchecked this claim and found a recent study indicating no major long-term increase in the rate of heart attacks following knee surgery . Thus, the clinic statement, rather than being based on data to accurately inform the seminar audience, was rather a claim most likely intended to make the treatment being sold at the seminar appear dramatically safer and more effective than the standard of care, such as joint replacement surgery.
He made another definite, quantitative medical claim: “90% of patients had a 50% or better improvement” with this treatment. Ted went on to try to bolster the claim of efficacy with before-and-after photos from patient x-rays and MRIs. He even showed data from a competing clinic in another state. He flashed a slide with a table of numbers of their own data purporting to show great improvements in patients’ perception of pain after receiving the stem cell “treatment.” He invoked some specific patient testimonials, including a video, and he also made a claim that the clinic had treated a particular professional sports celebrity with stem cells.
If you can’t dazzle them with data and clinical trials, baffle them with testimonials, right? Then add a stealth celebrity endorsement, crappy data with no control group and no attempt to account for placebo effects, and a bunch of technobabble, and the money prints itself.
Quite frankly, there is almost no difference here between the techniques of persuasion used by Ted to market his stem cells at this seminar and the techniques used by cancer quack Stanislaw Burzynski to sell antineoplastons or Robert O. Young to sell his “pH Miracle Living” cancer cure or Brian Clement selling his wheatgrass enemas. The only difference is that stem cells have some plausibility as a treatment for some conditions. That’s not enough, though. There has to be good, solid evidence, and that as yet is in short supply.
It’s not just this clinic
Dr. Knoepfler’s account is strikingly similar to an account published on Dr. Knoepfler’s blog last year by David Brafman, who is an Assistant Professor in the Department of Bioengineering at Arizona State University who has been performing stem cell-related research for better part of a decade. Dr. Brafman attended a similar seminar by the Lung Institute, which operates clinics in Arizona, Texas, Tennessee, Florida, and Pennsylvania and whose website looks very much like a lot of other stem cell clinic websites, full of testimonials and flashy, science-y-looking graphics but really short on valid evidence. Dr. Burton Feinerman, founder of the Lung Institute, also makes a boatload of dubious claims to be able to treat all manner of chronic lung diseases. I encourage you to read it. From Dr. Brafman’s description, the people attending the Lung Institute’s seminars were even more ill than the ones who attended the seminar described by Dr. Knoepfler. Indeed, Dr. Brafman noted that “there were over 40 people in attendance and most, if not all, the people in attendance were elderly, many of them had supplemental oxygen, and by my guess suffering from some sort of lung disease.” The clinic claims to be able to use stem cells derived from blood, adipose tissue, and/or bone marrow to treat bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung disease, emphysema, chronic bronchitis, and other forms of chronic obstructive pulmonary disease (COPD).
Dr. Brafman lists just a few of the “outrageous” claims that Dr. Feinerman made at the seminar he attended:
I will not go into all of the claims that Dr. Feinerman made but some of the more outrageous statements he made were as follows:
- In a typical ‘treatment’, 200-500 million stem cells are isolated from the patient. These cells are injected intravenously back into the patient, in which they home with 100% frequency back to the lung. Once these cells arrive at the lung, they differentiate into mature, functional pulmonary tissue.
- These therapies can be used to treat non-pulmonary disease such as ALS, PD, diabetes, etc. Throughout the presentation Dr. Feinerman was careful not to use the word “cure” but instead used words such as “treat” and “help”.
- The “majority” of patients see some beneficial effects from treatment. When later asked by an audience member what percentage of patients see improvement, Dr. Feinerman stated that the percentage of patients that see improvement is around “70%”.
As any reader of this blog with some basic knowledge about stem cell biology would know that these claims are quite dubious. For example, making the claim that stem cells injected to the blood would somehow find their way back to damaged lung tissue and then repair damaged tissue would be similar to me claiming that I could fix your broken iPhone by just injecting some metal into it. It’s just that simple!
Similar to the seminar that Dr. Knoepfler attended, a lot of testimonials and a seeming celebrity endorsement were used. Unlike the seminar Dr. Knoepfler attended, questions were allowed, as I will discuss in the next section.
The stem cell hard sell
In Dr. Knoepfler’s account, the “closing the deal” hard sell phase of the seminar began after all the anecdotes and sales pitch with this:
Ted then indicated that all the audience members should close their eyes again. He told the attendees to visualize and project themselves 6–12 months in the future. “Put yourself in the future where now you can do those things that you couldn’t before.” I saw a few audience members nodding in agreement. Then Ted said, “It is your choice to be in pain or not.” My sense was that this had a powerful impact on the audience.
Very slick. No quack could have done this better. Ted even out and out lied about FDA approval, claiming “While this treatment is FDA-approved, it is not covered by insurance.” Of course, if the treatment were actually FDA-approved for the given indication for which Ted was marketing it, chances are very good that insurance companies would cover it.
Next came the real hard sell:
The price of the treatment was quoted as $5,999, but we were told that there was a “seminar special” under way during which attendees could get $1,000 off the price. However, this deal was only good “if you sign up today at the seminar.” This felt to me like a hard sell, and I turned back to the credit application on my clipboard, wondering about patients going into debt. A number of people had been filling out some of the forms during the seminar. Finally, Ted added that monthly payment plans below $100 were possible as well, and he said rather generally that many people were signing up, as reflected by the fact that the clinic was already booked 1–2 months out.
I’ve experienced these sorts of pitches before. For instance, when we needed a new roof for our house, we once made the mistake of calling a certain roofing company, whose salesperson came out to give us an estimate. After one of the longest, most intense hard sells I’ve ever seen, he told us he’d give us a very “discounted” estimate—but only if we signed on the dotted line that very evening to have his company replace our roof. The same thing happened at the seminar selling time shares I made the mistake of attending. I’ve had car salesmen try that tactic on me as well. I’ll even admit that, back in the late 1980s when I was a new resident, living in a new city with no friends, and very lonely I briefly considered signing up for a dating service. There were no online services back then, and the services that existed cost up to thousands of dollars to join. I attended an informational seminar about one such service (whose name escapes me, given that this was over 25 years ago), and when we got to the end the very same thing happened. Sign up for the service now, and you get a large “discount.” If you leave and later change your mind, we’ll charge you a lot more. (Oh, and we have your name, address, and telephone number; so don’t try coming back as a “new” customer.) I left. Within a year I met the woman who would later become my wife; so things worked out just fine.
Now consider that the same sales pitch was used at the stem cell seminar Dr. Brafman described:
At the end of her presentation, she stated that the next round of treatments were going to begin in May. Unfortunately, they were almost fully booked. However, if patients signed up that day they would receive a $2000 discount (as an aside the treatments offered by the Lung Institute have been reported to be in excess of $10,000). Act now to take advantage of this special opportunity!
My momma always taught me that if you have to sign right now to get a certain price for goods or services, walk away. Don’t let the salesman pressure you. It was good advice then, and it’s good advice now. Certainly, it’s good advice for patients looking at stem cell therapies.
Here’s where we learn why the stem cell clinic whose seminar Dr. Knoepfler attended didn’t allow public questions, at least not at the seminar he attended. We learn this from Dr. Brafman’s account:
At this point I found myself compelled to speak. My original intention of attending this seminar was to just simply observe one of these sessions in person. I had no intention of speaking up or asking questions. However, after observing the questionable claims in person I felt the need to voice my opinion. So, I stated that I was an Assistant Professor in the Department of Bioengineering at Arizona State University who has been performing stem cell-related research for better part of a decade. I commented that from my standpoint the claims that Dr. Feinerman was making about his therapies were dubious and appeared to have no scientific basis. I shared my concern that Dr. Feinerman was selling these patients false hope. Additionally, I encouraged all the patients to research on the internet what other reporters and scientists had to say about the treatments offered by Dr. Feinerman and his clinic. Finally, I encouraged the audience members to perform a simple Google search for ‘Stem Cell Clinics’ to see what other patient experiences have been with clinics similar to the Lung Institute as well as the warnings that the FDA has provided with regards to such clinics.
As I was talking, Ms. Myers’ rushed over and grabbed the microphone from Dr. Feinerman. She told me that “I didn’t know what it was like not to be able to breath”. In addition, unlike FDA-approved clinical trials in which certain patients receive a placebo, that all of their patients receive the “real thing”. I replied that I was not trying to cause a scene or debate them directly but I was simply encouraging all patients in attendance to do their research. Ms. Myer’s replied that the patients have done their research and that many were working with their doctors in coordination with the Lung Institute (that’s a concerning thought—doctors are referring patients to these clinics!). Finally, as I was being escorted out of the presentation, she said “Don’t act like you are the first person to question what we are doing”. Thank goodness!
Don’t ever let the marks hear a discouraging word! Of course, although Dr. Knoepfler doubts that the organizers of the seminar he attended changed anything, I’d be willing to bet that they made an immediate decision to dispense with their usual public question-and-answer segment when one of them recognized that a real stem cell scientist was attending their seminar and taking notes. In any case, Dr. Brafman, clearly a newbie at this, was surprised and disappointed at the hostility directed at him by the attendees, who booed him and applauded as he was escorted out, noting that the audience response “left me quite disheartened and feeling somewhat hopeless.”
In actuality, that is exactly the response that I would have predicted. Patients go to these seminars for hope, and they don’t want to hear anything that takes the hope away. Seminar organizers know this and actively work to keep the audience on their side. Don’t get me wrong. I greatly admire Dr. Knoepfler’s and Dr. Brafman’s efforts; I’ve never “gone into the lions’ den” like that, so to speak, although I almost did attend a screening of the antivaccine film VAXXED recently. Such undercover efforts to show what quacks are actually saying at their promotional events are very valuable and to be encouraged. It’s just that any skeptics who do go to these events should not be surprised or disappointed if the marks turn on them. That’s why I almost always advise not making one’s presence known and simply being a good observer, the better to report back later. Dr. Brafman is correct to recommend that scientists become active, communicate with patient advocacy groups, contact their representatives and the FDA, and share their knowledge, but I’m not sure that direct confrontation at these seminars accomplishes much other than to potentially put the scientist-observer’s safety at risk.
The scope of the problem
Dr. Knoepfler ends by trying to estimate the scope of the problem:
Approximately 30 people attended the one clinic seminar at which I was present, and, on the basis of an informal observation of advertisements, I have noted that the sponsors have held many of these seminars. Thus, it is possible that approximately 200 people have seen just this one type of seminar alone in one city in the U.S. from a single clinic. Given the growing realization that there are hundreds of stem cell clinics in the U.S. today in 2016 and the observation that many hold recruitment seminars, it is possible that thousands of members of the public each year are attending infomercial seminars that provide misleading or even outright factually incorrect information about stem cells and questionable medical claims. This could not only lead many patients to receive unnecessary, unsafe, or ineffectual treatments, but it may also contribute to public confusion about stem cells and the field of stem cell clinical research. These seminars represent only one type of an assortment of recruitment methods, including Internet, radio, newspaper, and television ads for various clinics, which may also contain dubious statements. I believe that such stem cell clinic marketing poses a significant threat to public perception and understanding of the legitimate stem cell translational medicine field.
Indeed it does. That’s why I agree with Dr. Knoepfler’s and Dr. Brafman’s exhortation for scientists and physicians to become more involved in educating the public, pressuring the FDA and our legislators, and exposing the claims of what are, in my opinion, nothing less than quack clinics selling an as yet unproven but promising new treatment to desperate people for large sums of money.