And now for something completely different... (Yes, there's been enough vaccine blogging for the moment.)

The date of the Kinsman Sports Celebrity Dinner in Saskatoon is fast approaching on February 6. It reminded me of my discussion of how Gordie Howe was flown to Tijuana to undertake a dubious stem cell therapy for his serious stroke that involved the intravenous and intrathecal (into the cerebrospinal fluid) injection of "stem cells," a treatment that was followed by glowing reports from the family and credulous reporters in the press describing Howe's "miraculous" recovery from his stroke. Sadly, with only one exception, there has been precious little skepticism about the claims of Howe's family of an astounding recovery. Even more sadly, no one other than I appears to have dug particularly deeply into the dubious clinical trial being run by Novastem in Tijuana, in which patients are charged $20,000 to $30,000 per treatment and Gordie Howe was not because he's famous. Indeed, in retrospect the whole thing comes across as a publicity stunt by Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies, the company that supplies stem cell products to Novastem and its Clínica Santa Clarita. After all, they were the ones who contacted the Howes first with an offer to facilitate Gordie's receiving stem cell therapy, not the other way around.

Before I go on, let me just mention that I wish Gordie Howe nothing but good. He is a genuine sports hero and Detroit sports icon. I'm not really a hockey fan, but I live in a hockey-crazed area. Just to get an idea of how much Detroiters love their Red Wings, consider this. My next door neighbors sons all play hockey. They even named their dog "Gordie" (yes, after Gordie Howe). One of them makes a mockup of the Stanley Cup every year out of garbage cans and shines a red light on it at night. They are not atypical of high school-aged boys in southeast Michigan. So, imagining Gordie Howe felled by a serious stroke and dying of it is a sad thing to contemplate here in Detroit and among hockey fans everywhere. I mean, I grew up watching Gordie Howe, and even though I never developed that much of an interest in hockey (sacrilege in southeast Michigan!) I still admired his skill and gentlemanly manner.

To be honest, I can't remember a time when I've seen a medical story presented so many times in a manner so devoid of basic fact checking. Part of it, I think, has to do with the fact that most stories about Howe's stem cell treatment were done by sports reporters and home town local news teams, rather than reporters who might have the background to tackle the case properly. As I explained (and so did Paul Knoepfler, who also described Stemedica's unconvincing response), it's incredibly unlikely that that injecting mesenchymal stem cells into Gordie Howe's blood and cerebrospinal fluid would result in such a rapid and significant recovery. Certainly the rapidity of the reported improvement does not fit with a plausible mechanism by which stem cells, even if they were doing what advocates claim they were doing, were rebuilding neurological pathways shattered by the death of large swaths of neural tissue. From what we know, it would take longer. Indeed, the only reports showing a modicum of proper scientific skepticism came from Bradley Fikes in late December and Jesse Singal at NYMAG.com:

“This seems to be a lot about hype for the company, and it’s an anecdotal sample size of one story, which is really hard to interpret,” said Dr. Jack Parent, a professor of neurology at the University of Michigan Medical Center and staff physician at the VA Ann Arbor Healthcare System. Parent, who has a decade’s worth of experience researching the role of adult stem cells in epilepsy and stroke, said that neither of the two days of treatment consisted of anything that has been shown to be effective in stroke patients. On the first day, neural stem cells were injected into Howe’s spinal canal, the idea being that those cells would then be delivered to the site of the injury to Howe’s brain. Injecting the cells directly into the spinal fluid would allow them to bypass the blood-brain barrier, which would otherwise prevent them from getting into the brain, but Parent doubted that would be enough for them to actually perform the regenerative work Novastem is claiming. “I am skeptical that enough of the cells make it to the brain from the bottom of the spinal column, penetrate into the substance of the brain itself. and survive for any significant length of time,” he said.

And:

There’s a lurking possibility here that isn’t fun to think about. Maybe the improvement Murray and his family are seeing doesn’t have anything to do with the stem cells but is rather the result of a combination of the natural recovery some people experience after a stroke and the by all accounts very good, very comprehensive care Howe’s family is providing for him (as Murray explained, Gordie has regular appointments with a speech therapist, a physical therapist, and an occupational therapist). To Parent, the University of Michigan neurologist, this theory makes sense. “There are other reasons for people to get better,” he said. “There are placebo effects, there is concurrent medical care where when you’re treating someone you’re making sure they’re hydrated and they’re taking their other medicines appropriately and things like that. So you really need a control to be able to tell whether the effect you see is really from the treatment or not.”

Exactly. Almost certainly this is what's going on. Yet none of this has stopped stories like this from appearing in the media:

The whole interview is embarrassing. Keith Olbermann, indeed, should hang his head in shame for this. It's pathetic, a PR video for Stemedica. Olbermann shows no glimmer of that famous skepticism that he used to direct against conservative opponents. Of course, as I noted before, Olbermann has been taken in before by quacks. Specifically, he was played for a fool by the antivaccine movement back in 2009 when he attacked Brian Deer based on misinformation fed to his staff about him. This is just as bad, if not worse, as Maynard Howe (no relation to the Howe family) is allowed to spout off talking points without even the mildest followup question. For instance, early in the interview, Howe says that Stemedica has an FDA-approved trial that's going on at "several major universities" in the US. That's a bit of—shall we say?—an exaggeration, unless two sites, one university and one community equals "several" in Howe's mind, as there are only currently two sites carrying out the Stemedica trial of stem cells for stroke. I suppose Howe (geez, it's hard not to get all the Howes in this story mixed up) could be referring to other Stemedical trials and lumping them in the mix, but the stroke trial is only happening at UCSD and a hospital in Arizona.

It gets even more embarrassing for Olbermann, who basically slobbers all over Maynard Howe, gushing about how supposedly Gordie Howe has gone from death's door to doing "everything but the Macarena." This gushing gives Maynard Howe an opening to gush himself, making claims without evidence about how his stem cells have cured people with "locked in" syndrome, major traumatic brain injury, and serious vegetative state, which he characterized as a "number of very miraculous treatments." Olbermann then basically feeds Howe questions, like the interviewer on an infomercial, leading him to be able to rattle off all the conditions he is planning on testing Stemedica's stem cell treatments on. There's even the obligatory question of, "How do interested people see if they can get your product?" (OK, how can interested people see if they're eligible for your clinical trials?) and "Are there scammers out there that I should look out for?"

This question allowed Howe to mention his "four red flags" of what to look out for in dubious stem cell clinics. One "red flag" in particular amused me, and that was the one where Howe said that you should be able to ask the clinic for documentation of the minister of health or other government body's approval of the clinical trial. My thought upon seeing that was this: How disingenuous can you get? I'm sure Howe knows quite well that in Mexico the government approves clinics to administer stem cells and the clinics can then administer them however they wished based on the physicians' clinical judgment. Indeed, I documented this in my last post, having learned how Mexico regulates clinical trials of stem cells in an e-mail from Novastem's director. The short answer is: Basically, the Mexican government doesn't regulate stem cell clinical trials. Things just don't work there the way they work here in the US, with the FDA approving clinical trials of new biologics, such as various stem cell treatments. Once a clinic in Mexico is approved to administer stem cells it can do so however it wants, carry out trials if it wants, or not.

Oh, and it can charge for the privilege. In the case of Novastem, it's $20,000 to $30,000 a pop. What Howe should have mentioned as a red flag is that patients interested in participating in a trial of stem cells should not have to pay for them, but then he couldn't well do that, could he? After all, his company sent Gordie Howe to Novastem, which makes me suspect that Stemedica probably routinely shunts patients not eligible for its FDA-approved clinical trials to Tijuana, to Novastem, to receive stem cells as part of its dubious trial.

Of course, Olbermann, his nose stuck so far up Howe's rectum that he could use Howe's uvula as a handkerchief, saw none of this. Truly, Olbermann has fallen far.

Then, just last night, there appeared this story on my local NBC affiliate WDIV this story by sportscaster Hank Winchester:

As you can see, Dr. Murray Howe, Gordie Howe's son, is still, unfortunately, touting the Novastem treatment as a "miracle":

I wrote his eulogy. We were making his funeral arrangements and didn't have a whole lot of hope for him," said Gordie's son, Dr. Murray Howe. Murray thought his father's life was over. A stroke late last year caused a big setback. "It was to the point where even if you pounded on his chest there would be no response from him," said Murray. The one-time hockey great appeared lifeless. He was unable to communicate. "His eyes were open but there was just kind of nothing there," said Murray. As family members scrambled to make funeral arrangements, one phone call changed everything. "He just said that they had a stem cell company," said Murray.

Then came the Lazarus-like transformation after the stem cells:

It required flying an almost lifeless Gordie Howe from his daughter's house in Texas to San Diego. Then he had to travel to Mexico, where the clinical trial already was underway. Just hours after the stem cells were injected, Gordie showed a new sign of life. "I said, 'Dad, you can't walk,' and he said, 'The hell I can't,'" said Murray. Gordie, who was nearly paralyzed just hours earlier, began to walk. "It was really funny. He was like, 'Let's go,' you know, 'I'm outta here.' He didn't even want the wheelchair when he left. I said, 'Dad, you gotta be in the wheelchair, we don't want you to fall on the way out,'" said Murray. He started walking and hasn't stopped. Video recently shot by the Howe family shows Gordie playing floor hockey with his grandson.

"Nearly paralyzed"? What does that mean? Clearly, Howe had motor function before the stem cell treatment and wasn't completely paralyzed. I understand how Dr. Howe thinks that stem cells caused Gordie's apparent recovery. I really do. Unfortunately, being a physician, Dr. Howe seems unaware of his own weaknesses with respect to his ability to assess the cause of his father's recovery. Nothing against Dr. Howe, but, as I pointed out before, doctors tend to be very prone to the same sorts of wishful thinking that anyone else is while at the same time tend to overvalue their powers of observation outside of their specialty because, well, they are doctors. Remember, Dr. Howe is a radiologist. He's not a neurologist. He doesn't take care of stroke patients; in fact, he probably doesn't really take care of patients more than doing invasive imaging procedures on some of them (judging from his appearance in surgical scrubs). When it comes to what should be expected from a stroke patient at various times in their recovery, he is no expert. In any case, if a single anecdote, like that of Gordie Howe, could tell us whether a treatment worked or not, we wouldn't need clinical trials.

Also, as I mentioned above, there is no plausible biological mechanism whereby infusing stem cells could result in such an immediate and dramatic (and, apparently, permanent) effect. Rebuilding neural pathways would be expected to take days, weeks, or even months, even assuming the stem cells were doing what was claimed for them. As Steve Novella has described to me, doing clinical trials on stroke patients is difficult because measuring function is prone to all sorts of confounders, including how much their caregivers push them to do. It's not hard to imagine that perhaps Gordie Howe had become depressed after his recent hospitalization for dehydration in early December that had scared the family into thinking he was at death's door. He then recovered from that and, no doubt, was hydrated well with intravenous fluids before the stem cells were administered, and he perked right up. Certainly that is a far more likely explanation, given what we know about mesenchymal stem cells, than a miraculous recovery within hours. Is it possible that the stem cells are responsible for Howe's improvement? Sure. Is it likely? Not very.

The only new thing in this video is a very brief shot of Howe shown playing floor hockey with his grandson. It's rather odd. Mr. Hockey's face is not shown. He stands in the same place and doesn't walk. All he does is to shoot the ball a couple of times at the net. One would think that if Gordie Howe had made such a miraculous recovery the family would have had video of him walking, talking, and strutting his stuff, showing just how well he is doing. To me, the 20 seconds or so of video looks highly odd in context. Again, if Howe is so improved, why not show his face, show him walking, or have him converse with the reporter on camera? It's hard from the brief snippet of video shown not to conclude that perhaps Gordie Howe is not as improved as is being claimed. I suppose we'll see eventually. In the meantime, that video raises more questions than it answers.

Nobody wishes ill upon Gordie Howe or his family. Nobody. Least of all, me. Nor do I think Howe's family is being deceptive. It's very clear that Murray Howe very much believes that stem cells are responsible for his father's improvement, even though he has demonstrated clearly some major blind spots about how dubious Novastem's "clinical trial" is. However, the continued credulous and irresponsible reporting on his "miracle" recovery from stroke due to Stemedica stem cells, administered at the Clínica Santa Clarita via Novastem, continues. The most recent story from local media is utterly devoid of anything that might be described as critical thinking, science, or medicine. With precious few exceptions, in general thus far the reporting on Gordie Howe's stem cell treatment has been completely without even the minimal level of reasonable scientific skepticism. Indeed, it's been bordering on advertising for Stemedica, Novastem, and their stem cell treatments. Strike that. Some of it has been advertising; certainly it's not reporting. For example, neither Keith Olbermann nor Hank Winchester even bothered to interview an actual neurologist or stem cell expert for their stories. For WDIV and Hank Winchester, there's no excuse, given that there's just such an expert, someone doing stem cell research for neurologic disorders, readily available less than 50 miles away at the University of Michigan.

There still remains Gordie Howe's impending appearance at the Celebrity Sports Dinner on Friday. If he doesn't show up, it'll be a strong indication that his condition is not as improved as advertised. If he does, hopefully there will be video. Either way, as Jesse Singal notes, it won't be enough to make a scientific assessment of whether or not Novastem's stem cell treatment is responsible for Gordie Howe's condition. Let no one doubt that I hope Howe's condition is improved. I just doubt that it was the stem cells that were responsible for his improvement and have a lot of questions and concerns about Novastem's treatments and clinical trials, concerns I deem well-justified.