60 MINUTES Australia broadcasts an infomercial for Bioss Stem Cells, a quack clinic in Mexico

What is it about Monterrey and quackery? When last I discussed a clinic and hospital in Monterrey, Mexico, I was discussing Clínica 0-19, where Drs. Alberto Siller and Alberto Garcia have been subjecting children with the diffuse intrinsic pontine glioma (DIPG), a deadly brain tumor, to repeated cerebral angiography to administer an unknown cocktail of toxic chemotherapy agents into the brainstem combined with an unproven “immunotherapy.” They have never published their results other than as an abstract at a Mexican conference, and there is no way to judge their outcomes. Worse, children have suffered harm. The family of one Australian girl was stranded in Mexico for two months, after she ended up in the intensive care unit at Hospital Angeles, where the family racked up $2,500 a day in medical charges but couldn’t afford to come home because a medical flight back to Australia would have cost a quarter million dollars. This time around, I came across one of the most egregious examples of a story that crosses the line between journalism and advertising, courtesy of 60 MINUTES Australia. It’s a girl being treated at Bioss Stem Cells, a clinic in Monterrey that looks to me to be no different than all the other quack stem cell clinics I’ve written about over the years that charge huge sums for unproven treatments.

One of the problems with quack clinics like Clínica 0-19 is the way the media is so interested in treating stories of desperate families paying huge sums to go to these clinics as human interest stories that they fail to demonstrate even a modicum of skepticism. I don’t know that Australian media is any worse than any other country’s media, the US included, but I documented some pretty egregious stories about Australian families who took their children with DIPG to Clínica 0-19. Sadly, this report on 60 MINUTES Australia that aired Sunday night was at least as bad as the worst of these, possibly even worse still. I had heard about it then, but for some reason couldn’t find the video to evaluate until stem cell scientist Paul Knoepfler found the two ten-minute segments on YouTube:

Watch the segments for yourself, if you have time. This story is one of the worst examples of the credulous treatment of an unproven treatment sold by quacks I’ve ever seen and a blight on the 60 MINUTES brand. While it’s true that 60 MINUTES in the US has stumbled occasionally over its five decades of existence, at the very least it’s done at least one excellent takedown of stem cell quackery and the unjustified (and expensive) promises made by the unethical doctors who run them. Heck, the 60 MINUTES Australia even nailed Belle Gibson, the woman who claimed to have kept her brain cancer at bay with a vegan diet and used her story to build a wellness empire in Australia. Spoiler: It turned out that she had never had cancer at all. This story by the Australian version of the show is exactly the opposite; basically, other than the inclusion of token skepticism, it’s in essence an infomercial for Bioss Stem Cells.

Meet the cute, lovable girl and her dedicated, loving parents

The first segment of the story starts out with reporter Liam Bartlett introducing six-year-old Isabella Lombardo, who, we are told, is one of the one in 500 children born in Australia every year with cerebral palsy. Bartlett lays down effusive praise of the girl, who is undeniably cute, intelligent, and impossible not to like unless you’re a heartless bastard. Similarly, her parents are clearly loving and willing to go to incredible lengths to try to help their daughter. It’s impossible not to like them as well and feel empathy for them as they are shown agonizing over their decisions, comforting their daughter as she cries getting blood drawn, and in general being super-dedicated parents. As is always the case with families who are desperate enough to take their children to quacks, as I watched, I wished only the best for this girl and her family, even as I feared what I was about to see.

The story is then framed right from the beginning this way:

When it was diagnosed, her mum and dad vowed to do anything and everything they could to help their precious daughter. For years, Libby and Joseph Lombardo have searched the world and spent all their savings, but eventually found a radical new stem cell treatment in Mexico. The prize it offered was the hope that she might walk for the first time, but then they faced the most difficult decision of all: Should they put their faith—and their daughter’s life—in the hands of unknown doctors and untested science?

See what I mean? The first segment is basically framed as the parents’ quest to heal their daughter, using any means necessary, spending whatever it takes, going wherever they have to go. After being treated to a scene of Bartlett interviewing Isabella, who talks about how she’d just like to be able to walk like the other kids, we see the family at the clinic, their daughter being prepared for the stem cell therapy. I must admit that, seeing this scene, I wondered if the family were at Hospital Angeles, the same hospital where the DIPG quacks Drs. Siller and Gonzalez inject chemotherapy directly into the arteries leading to the brainstem of DIPG patients. It looked as though it could be, but I haven’t seen enough shots of the inside of the hospital to be sure, and hospitals do tend to look a like. In any case, the family is shown in what looks like a hospital and, later, in an operating room. Wherever she received her treatment, she clearly underwent general anesthesia, and Bartlett had been allowed to observe, as he was shown in the same room. Throughout the story, stem cell therapy is described in superlatives, such as “groundbreaking,” thus causing me to grate my teeth.

Part of what irritated me about this segment is the “us against the world” narrative about the parents. Bartlett intones how in Australia, the only treatment offered is Botox to relieve spasticity. We’re then shown how the parents took Isabella to the US to undergo a spinal procedure that Australian doctors didn’t recommend to the point of saying that it wouldn’t work. It’s claimed that she improved, but no objective evidence is presented for that. I was able, however, to find out that the operation was selective dorzal rhizotomy at St. Louis Children’s Hospital. This surgery is somewhat controversial and involves cutting some of the sensory nerve fibers that come from the muscles and enter the spinal cord, although there is some evidence that it can reduce spasticity if applied using strict clinical criteria. One big disadvantage of the surgery is that it is permanent and irreversible. Also, long-term outcomes are not yet clear. I also can’t help but note that the operation, contrary to the 60 MINUTES Australia report, is offered at some large children’s hospitals in Australia, which makes me wonder if Isabella was ever evaluated and deemed not a good candidate for the operation.

Yep:

Isabella did not qualify for the surgery in Australia because her doctors said she was too young, her condition was not serious enough, and the irreversible procedure might have made her worse.

Funny how 60 MINUTES fails to mention this.

Bartlett does “challenge” the parents, pointing out to them that not one doctor in Australia that they had consulted thought that what they were doing, either the surgery or the stem cell treatment, was a good idea. The parents’ decision to ignore medical recommendations and seek out these treatments is not portrayed as a bad thing. Quite the contrary, it’s portrayed as incredibly admirable. Joseph replies to this “challenge” that “you have to put your faith in yourself and not in anyone else,” thus appealing to everyone’s desire to view himself as smarter than those pointy-headed experts. Worse, the questionable success of the surgery is also portrayed as justification for the parents to seek out “even more radical solutions,” meaning, of course, the Bioss Stem Cells treatment.

Of course, the Lombardos’ online research is what led them to Bioss Stem Cells clinic, which is described in the story as a clinic where doctors “seemed to be making progress in cutting edge treatment in stem cell therapy.” Again, it’s pointed out how Australian doctors were very much against this—good for the Australian doctors!—but the parents decided to go anyway. Again, this is portrayed as a good thing.

The dilemma of the token skeptic

At this point, we meet the token skeptic, Professor Ernst Wolvetang, an Australian stem cell expert based at the University of Queensland. It turns out that Prof. Wolvetang was the stem cell expert who took the phone call from Libby Lombardo and advised her not to go to Mexico for stem cell therapy because “more trials are needed to prove that it works.” I also have to hand it to Prof. Wolvetang for having the guts to be the only naysayer featured on the segment, although it’s possible that he didn’t know that he’d be the only skeptic.

Of course, stories like this present a dilemma for scientists, science-based physicians, and skeptics: Do you go on the show even though you know that you’re the token skeptic being used to provide false balance to the story in the hopes that you can get your message through enough to make a difference and that too much of your interview isn’t left on the cutting room floor? Or do you say no? There is no right answer, at least not as far as I’m concerned. Prof. Wolvetang’s segment shows another peril for skeptics in participating in stories like this. For one thing, like any scientist, he said that we don’t know if it works and that it “could work” for some neurologic conditions. Of course, as I’ve said before, stem cells are all too often described in terms better suited to magic than to science-based medical treatments. What, for instance, is the mechanism by which stem cells might affect the disability from cerebral palsy? How are they targeted? So many times, it seems to be assumed that if you just inject these cells into the bloodstream they will “know” where to go and what to do.

In any event, Bartlett, after hearing Prof. Wolvetang’s statement that stem cell treatments like the one Isabella Lombardo underwent are unproven, challenged him by saying, “And yet you have medical clinics in foreign countries offering at great cost stem cell treatment for cerebral palsy sufferers.” Prof. Wolvetang responded about as well as any stem cell scientist could respond, noting that this is “of great concern” to clinicians and governing bodies and that such treatments are potentially dangerous. Unfortunately, he didn’t mention some of the worst potential dangers, such as stem cell tumors like the one Jim Gass suffered from when he sought out stem cell treatments for his stroke.

Unfortunately, Prof. Wolvetang’s words of caution only serve as part of the narrative, leading Bartlett to say, “But nothing deters a desperate parent,” as if that were always good thing. (Sometimes it is. Sometimes it isn’t.) Their decision is presented as a false dichotomy, with Joseph Lombardo stating that it’s a decision between doing what he and his wife were doing versus waiting for these treatments to be validated in Australia, which can be ten or twenty years, “by which time it’s too late.” Note that this line of reasoning assumes that the stem cell treatment works and is not potentially dangerous; it reads more like a justification than a good rationale. The first segment wraps up with the question, “Will Isabella take her first steps?” with a tease that she will.

Off to Bioss Stem Cells in Monterrey!

The second segment opens with shots of Monterrey, with Bartlett voicing how beautiful the city is and lobbing Libby a softball question: “Is it frustrating, though, to have to come all this way.” Gee, did Bartlett think she’d say no? Equally irritating is how Bartlett builds on his prior framing about Australia and notes with wonder that Monterrey is a place where stem cell treatments not allowed in Australia are available. Never, it seems, did it occur to him to ask why these stem cell treatments aren’t allowed in Australia, although he did have enough awareness to note that there’s a fine line between doing what’s best for Isabella and “using her as a guinea pig.” Personally, I’d say the line isn’t that fine at all and that, unfortunately, the parents crossed it.

In many ways, the second segment is even more infuriating, scientifically, than the first. The reason is Bartlett’s interview with Dr. Ana Carolina, the doctor who runs the Bioss Clinic. Bartlett notes that she claims that, over the last seven years, she and her team have achieved amazing results using her stem cell treatments not just for cerebral palsy, but for autism, diabetes, and stroke. In her interview, she claims to have produced amazing improvements in patients with cerebral palsy. I’m guessing that Bartlett thought it was the height of skepticism to challenge her by saying that this “sounds almost too good to be true,” but she got away with agreeing but saying that it is true.

Looking at this entry on the Lombardos’ Facebook page, I’d agree:

I note that the Duke study cited by the Lombardos (assuming I got the right studyu) was disappointing and basically a negative study.

Before I get back to the story, I had to take a look at the Bioss Stem Cells website. I took a look at the conditions treated:

• Autism
• Cerebral palsy
• Stroke
• Intervertebral discs
• Muscular dystrophy
• Diabetic foot
• Osteoarthrosis
• Amyotrophic Lateral Sclerosis (ALS)
• Joints
• Avascular necrosis
• Quadriplegia
• Dorsal Spine
• Anti-aging
• Erectile Dysfunction

Erectile dysfunction? Stem cells for erectile dysfunction? Really?

So what is the evidence? As you might imagine, there is none. Dr. Carolina has not published any of her results that I can find, and all she can provide are anecdotes—just take her word for it. In this, she and her clinic are basically indistinguishable from the numerous quack stem cell clinics that I’ve written about over the years. I even searched PubMed and was unable to find any publications by this woman related to stem cell treatments. Heck, I wasn’t able to find much of anything about her anywhere on the web, other than on the Bioss Stem Cells website. I did find a bit about her on the Bioss Facebook page:

So her full name is Dr. Ana Carolina Ramírez Cazares, and she’s a pediatrician specializing in clinical hematology, certified by the Mexican Council of hematology and the pediatrics council, an active member of the Mexican group for the study of hematology. Knowing her full name, I was able to find her website, which shows a fairly standard pediatric hematology practice, plus Bioss Stem Cells. The Bioss Facebook page also features posts like this:

Without evidence, Dr. Carolina claims:

That’s right. With no evidence at all, Bioss is offering stem cell therapy for autism. Of course, my experience looking at stem cell quackery for autism leads me to think of Kent Heckenlively and how he borrowed $15,000 from his daughter’s grandparents to travel to Costa Rica to have “stem cells” injected into his daughter’s cerebrospinal fluid by lumbar puncture (i.e., intrathecal injection). Basically, it’s gross quackery.

Then there’s cerebral palsy:

And, of course, there’s anti-aging:

There are even promotions, like this Stem Cell Summer Camp that happened last week:

Yes, what we have here is what appears to me to be a typical quack stem cell clinic. Dr. Carolina harvested Isabella’s bone marrow, after which, according to Bartlett, the cells are “engineered in the laboratory,” whatever that means. It’s not explained, even in lay terms. Then they’re reinfused.

Did the stem cells fix Isabella’s problem?

So, did the stem cell treatment work? Who knows? Dr. Carolina was interviewed after Isabella’s treatment and chirped about how she was “optimistic” that the treatment would work and that in the future Isabella would be able to walk someday. Particularly telling is this:

Dr Carolina can’t fathom why a simple, and in her eyes proven treatment, is currently prohibited in Australia.

“Proven”? Based on what? There are no published clinical trials showing that Dr. Carolina’s treatment works. In her hubris or greed, she thinks it does. I don’t know if she’s deluded or lying, but she actually makes the claim that in Mexico that a treatment has to be shown to work before it can be used. I’ve already shown that this is not at all true and that Mexican law in fact lets doctors do pretty much anything they want to with stem cells when I discussed the Gordie Howe’s trip to Mexico to receive stem cells to treat his stroke. In reality, Mexico’s regulation of stem cell treatments is quite lax, which is the reason there is so much stem cell quackery there.

Particularly deceiving, whether intentionally or unintentionally, is the followup. Isabella is described as showing remarkable improvement, but it’s also revealed that her parents had taken her to Houston to be treated by “world renowned cerebral palsy therapist Mike Poole.” This is portrayed as a necessary followup to the stem cell treatment, but it strikes me as equally likely that it is the intense physiotherapy that accounts for any improvements that Isabella might have experienced. Sure, Prof. Wolvetang pops up again and points out that there are no clinical trials and we don’t know if stem cell treatments are beneficial for cerebral palsy and makes my point that Mexico skipped the clinical trials and just went straight for treatment, but it’s too little, too late. It’s the very epitome of token skepticism thrown in after this emotional story of loving parents trying to overcome all options to give their daughter the best chance of being able to walk someday, no matter how much it costs or what it takes.

I will give Prof. Wolvetang great credit on one answer he gave. When Bartlett asks him if he would go to Monterrey if he had a child with cerebral palsy, he said quite simply that he’d be tempted but that he wouldn’t do it. He would wait. We can all understand why parents like the Lombardos might not be willing to wait, and that’s exactly what quacks like Dr. Carolina count on to make big bucks selling stem cell snake oil.

Cost versus benefit and things left unsaid

There is another huge hole in this report, besides its basically serving as an infomercial for Bioss Stem Cells, and it’s an inexcusable one. There is no reference to how much it cost the Lombardos, other than vague references to a high cost. How much do these therapies cost? I know from previous examinations of quack stem cell clinics that these sorts of treatments tend to cost around $10,000 or more a pop, plus travel, lodging, and hospital expenses, and that multiple treatments are almost always the norm. I know from news reports that the selective dorsal rhizotomy cost the Lombardos $100,000. Who knows how much the stem cell treatment cost? I haven’t been able to find out. At various points, Libby asks if it’s worth it. That’s a very good question, and the answer is almost certainly no. However, the way the story is told, the viewer is left with the impression that the answer is yes.

I can understand why a story like that of the Lombardos is an appealing one to a TV producer. Indeed, the story basically writes itself. You have a cute, articulate six year old with a condition that renders her unable to walk. Her parents are appealing, loving, and highly dedicated to helping her. They’re intelligent, but, as I’ve seen happen with so many quacks, like Stanislaw Burzynski or the doctors at Clínica 0-19, have let their hope and desperation overcome their skepticism (although the story certainly can’t be told that way, as understandable as their reaction might be). Frame the narrative as these fantastic people fighting against all odds (including the objections of the local medical authorities, who must be portrayed as unimaginative and dogmatic) to make their daughter whole. All you have to do is to shoot some scenes with the reporter interviewing the girl and her parents, do a softball interview with stem cell clinic CEO, some shots of the girl undergoing her treatments, and include for “balance” the token skeptic. There’s just one problem. This story downplays the risks of what the parents are doing and very much overplays the potential benefit of the therapy they’ve administered to their children and in doing so plays as a commercial for an unproven therapy that many (myself included) view—and quite rightly so, in my not-so-humble opinion—as quackery. Sure, the uncertainty over the treatment is emphasized over and over again, but always in a hopeful, positive, encouraging way, never in a way that might suggest to other parents of children like Isabella that traveling to Monterrey to go to the Bioss Stem Cells clinic is a bad idea with little chance of helping their children.

This story will be selling quack stem cell therapies a decade from now to sell snake oil to the next generation of parents of children like Isabella Lombardo.