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The stem cell hard sell, Stemedica edition

The stem cell hard sell returns.

The stem cell hard sell returns.

I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was Clínica Santa Clarita, the Tijuana-based clinic where Howe received his stem cell infusion. As far as I was able to glean, it’s a clinic to which Novastem supplies Stemedica stem cells. Basically, what happened is that Stemedica CEO Dr. Maynard Howe (no relation to Gordie Howe’s family) and VP Dave McGuigan contacted the Howe family late 2014, after having seen news stories about how poorly Gordie Howe was doing, to offer Howe its stem cell therapy.

Unfortunately, Gordie Howe was not eligible for Stemedica’s US-based clinical trial of its stem cell product for stroke because it had not yet been over six months since his last neurologic event and he was not yet neurologically stable. So Maynard Howe and McGuigan steered the Howe family to Novastem, one of Stemedica’s international partners. As a result, under the auspices of a highly dubious “clinical trial” conducted by physicians utterly unqualified to run a decent clinical trial under Mexican regulations that basically allowed “approved” clinics to do anything they want with stem cells, (whose details I discussed at the time), Gordie Howe received Stemedica stem cell infusions at Clínica Santa Clarita.

Because of Gordie Howe’s celebrity and the admiration Howe and McGuigan had for him, Novastem even waived the normal $30,000 per infusion charged to typical patients. From my viewpoint, they used Gordie Howe as a marketing tool, with the waived $30,000 an investment in publicity. Unfortunately Gordie Howe’s son Murray Howe, who happens to be a radiologist, was all too happy to go along, expressing an extreme sense of obliviousness and entitlement in response to questions about whether Clinica Santa Maria treated his father Gordie for free, responding, “You betcha. They were thrilled and honored to treat a legend. Would you charge Gordie Howe for treating him? None of his doctors ever do. I certainly am not going to criticize them for being generous.” Let’s just put it this way. I doubt that Gordie Howe’s other physicians refrained from charging Medicare and whatever insurance Howe had at the time for their services or collecting their copays.
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Posted in: Clinical Trials, Politics and Regulation, Science and the Media

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Carotid Artery Stenosis: Surgery, Stent, or Nonsurgical Stroke Prevention?

One treatment for carotid artery stenosis: stent placement

One treatment for carotid artery stenosis: stent placement

The carotid artery in the neck is a common site of atherosclerosis. As plaque builds up, it leaves less room for blood flow and can cause strokes through clotting or embolization. Carotid stenosis is defined as a greater than 70% narrowing of the lumen (the space through which the blood flows in an artery). It can cause symptoms, including transient ischemic attacks (TIAs) and minor strokes; but it is frequently asymptomatic. It can be treated with carotid endarterectomy (CEA) or carotid angioplasty and stenting (CAAS). There has been much discussion about which procedure is better and when it is better not to do either. (more…)

Posted in: Diagnostic tests & procedures, Surgical Procedures

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Did chiropractic neck manipulation kill Katie May?

Katie-May

Well, we’re back.

Yes, after having our WordPress database somehow borked to the point where no new posts could be added and no existing posts could be edited since Friday, Science-Based Medicine is back in business—finally! As a result, some of you might have seen this post elsewhere, as it was considered to be somewhat time-sensitive, and I didn’t want to delay, particularly given that I didn’t know how long SBM would be down. Fortunately, we’re back a bit sooner than I thought; so let’s look at something that was in the news over the weekend.

Katie May was a model, and by all accounts a very successful one, having appeared in Playboy, Sports Illustrated, and other magazines and websites. Self-proclaimed the “Queen of Snapchat,” she also had nearly two million Instagram followers and was a major social media force, having recently parlayed her modeling and social media career into entrepreneurship. She also died unexpectedly on Thursday night at the too-young age of 34, leaving behind a seven-year-old daughter. What makes May’s tragic death an appropriate topic for SBM is not so much her young age but rather the circumstances surrounding her death, particularly the cause. Basically, May died of complications due to stroke, as her family confirmed in a statement issued on Friday:

“It is with heavy hearts that we confirm the passing today of Katie May – mother, daughter, sister, friend, businesswoman, model and social media star – after suffering a catastrophic stroke caused by a blocked carotid artery on Monday,” the statement reads.

“Known as MsKatieMay on the Internet and the “Queen of Snapchat,” she leaves behind millions of fans and followers, and a heartbroken family. We respectfully ask for privacy in this this difficult time. Those wishing to contribute to the living trust being set up for the care of her young daughter may do so at her GoFundMe page.”

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Posted in: Chiropractic, Science and the Media

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Stem cells versus Gordie Howe’s stroke, part 3

Gordie Howe in his Red Wings days.

Gordie Howe in his Red Wings days.

Here I am in Philadelphia attending the 2015 American Association for Cancer Research (AACR) meeting to imbibe the latest basic and translational science about oncology. So what am I doing in my non-conference time? I’m holed up in my hotel room near Rittenhouse Square writing a DoD Grant and this post. Fortunately, I am nearly done with the grant, with nothing I can do until I receive one last letter of support from a person who, as much as he’s my bud, is incredibly annoying and always makes me sit on pins and needles waiting for his letter of support. (Those of you who’ve applied for a lot of grants know what I mean.) Then tomorrow I will have to assemble the PDF package to get to my grants office two days before the deadline, which is pushing it to make sure they get it uploaded to Grants.gov in time. Fun times.

With the Stanley Cup playoffs just getting underway (complete with the ugly faux “Stanley Cup” made out of garbage cans our next door neighbor’s son puts on his lawn every year, bathed in red light for the Red Wings), it’s also the perfect time to revisit a story I’ve written about a couple of times before right here on this very blog. I’m referring (this time) to the story of hockey legend Gordie Howe and news stories of his “miraculous” recovery from a serious stroke suffered back in October due to treatment at a stem cell clinic in Tijuana back in December. Of course, when I looked into it, there were a lot of holes in the story and clearly a lot of hype on the part of several parties: Howe’s son Murray Howe, whose love for his father apparently blinded him to some rather obvious issues with the care that his father was receiving and whether it was responsible for his recovery; Stemedica, the American stem cell company based in San Diego that sells its stem cells to a dubious Mexican stem cell company, Novastem, for use outside its U.S. clinical trials; and, of course, the credulous sports media, led by that most credulous of the credulous (with respect to Gordie Howe), Keith Olbermann, who was none too pleased with a certain not-so-pseudonymous “friend” of SBM and completely embarrassed himself in the process of attacking anyone who questioned whether stem cells caused Howe’s recovery. The whole story did have one salutary effect, though. It introduced me to a real stem cell scientist, Paul Knoepfler, who did a guest post for us.

It’s been a couple of months since I last paid attention to what was going on with Gordie Howe’s recovery. Fortunately, our very own Scott Gavura tweaked me by sending me a story by Avis Favaro and Elizabeth St. Philip that appeared over the weekend in the Toronto Star, entitled “A closer look at the startling recovery of Gordie Howe.” Accompanying the story is a broadcast on CTV’s W5 entitled “Gordie’s Comeback”. (See part 1, part 2, part 3.) Also accompanying all of this is a press release discussing how a Canadian stem cell researcher visited Novastem and left unimpressed.
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Posted in: Clinical Trials, Neuroscience/Mental Health, Science and the Media

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An aboriginal girl dies of leukemia: Parental “rights” versus the right of a child to medical care

makayla-sault-v2

One topic that keeps recurring and obligating me to write about it consists of critically analyzing stories of children with cancer whose parents, either on their own or at the behest of their child, stop or refuse chemotherapy or other treatment. It is, sadly, a topic that I’ve been discussing for nearly a decade now, starting first on my not-so-super-secret other blog and continuing both there and here. Indeed, the first post I wrote about this problem was in November 2005, a fact that depressed me when I went back through the archives to find it because so little has changed since that time.

I was painfully reminded of this last week when stories started circulating in the media about the death of Makayla Sault, an Ojibwe girl and member of the New Credit First Nation in Ontario:

The entire community of New Credit is in mourning today, following the news of the passing of 11 year old Makayla Sault.

The child suffered a stroke on Sunday morning and was unable to recover. Friends and family from across the province travelled to New Credit First Nation today to offer condolences, share tears and pay their respects.

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Posted in: Cancer, Public Health, Religion, Science and the Media

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Stem cells versus Gordie Howe’s stroke, part 2

Gordie-Howe

Another Christmas has come and gone, surprisingly fast, as always. I had thought that it might make a good “last of 2014” post—well, last of 2014 for me, anyway; Harriet and Steve, at least, will be posting before 2014 ends—to do an end of year list of the best and worst of the year. Unfortunately, there remains a pressing issue that doesn’t permit that, some unfinished business, if you will. I’m referring to a story I commented on last week, specifically the credulously-reported story of how 86-year-old hockey legend Gordie Howe is doing a lot better after having undergone an experimental stem cell therapy for his recent stroke. As you might recall at the time, I saw a lot of holes in the story. It turns out that over the last week there have been developments that allow me to fill in some of those holes. Unfortunately, other holes still remain.

First, a brief recap is in order (You can click here for a more detailed timeline). Gordie Howe suffered a massive stroke on October 26, leaving him hemiplegic and with serious speech impairment. Since then, judging from various media reports, he has been slowly improving, although not without significant setbacks. We also know that Howe suffers from significant dementia. Out of the blue, a press release issued on December 19 by the Howe family announced that on December 8 and 9, Gordie Howe “underwent a two-day, non-surgical treatment at Novastem’s medical facility. The treatment included neural stem cells injected into the spinal canal on Day 1 and mesenchymal stem cells by intravenous infusion on Day 2.” His response was described as “truly miraculous,” although, as I pointed out in my post, it’s not clear exactly what “miraculous” meant, given conflicting contemporaneous news accounts before the Howe family press release, particularly his hospitalization from December 1 to 3 for a suspected stroke that turned out to be dehydration.

I noted a number of problems with the story, the first of which is that Howe was clearly not eligible for the clinical trial offered by Stemedica, a company in San Diego that manufactured the stem cells used. Another glaring issue was my inability to locate any description of an actual clinical trial for stroke offered by Novastem. I could find no such trial listed in ClinicalTrials.gov, and you, our intrepid readers, searched the registry maintained by the Mexican Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) and were not able to find any registered clinical trials for stroke being carried out by Clínica Santa Clarita, the clinic Novastem operates. What you, our intrepid readers, did find were trials of stem cells for:

I did the search again over the weekend, and there were no further trials that I could find.
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Posted in: Clinical Trials, Medical Ethics, Science and the Media

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Stem cells versus Gordie Howe’s stroke

GordieHowe1

Note: There is now a major update to this story published here, which explains a lot of the questions remaining in this blog post.

Seven years ago I returned to Michigan, where I was born and spent the first quarter century of my life, after an absence of more than 20 years. In the interim, I had done my surgical residency and earned my PhD in Cleveland, a surgical oncology fellowship in Chicago, and worked in New Jersey at my first academic job for eight and a half years. Then I was lured back with a job in Detroit. One of the odd things about this return after such a long absence was the culture shock, how much I had forgotten about the Detroit area. One of those things that I had forgotten is just how crazy about hockey Michigan, in particular Detroit (meaning the Detroit metropolitan area), is. Detroiters love their Red Wings—love them. Hockey is ingrained in the suburban culture from a very young age, so much so that many Canadians would feel right at home here. Memories of trying and failing to be halfway decent at street hockey and of not being anywhere good enough a skater even to try real hockey as a teen came flooding back to me. (It didn’t help that back then I was approaching six feet tall and weighed only 135 lbs.; “beanpole” didn’t even begin to describe me back then.) In fact, the “cultural center” of the town where I live consists of—I kid you not—a hockey rink and some classrooms that are used for various community functions. No, really, it’s named the city’s Cultural Center.

So it should be no surprise, given how much Detroiters love hockey in general and their Red Wings in particular that it was big news here in late October when Red Wing legend Gordie Howe at age 86 suffered a debilitating stroke that paralyzed the right side of his body, a condition known as hemiplegia. Understandably, there was an outpouring of good wishes for recovery, coupled with retrospectives of Howe’s stellar hockey career. Indeed, I remember that Howe’s condition sounded bad enough from the tenor of the news reports at the time that it seemed likely that he would not survive. But survive he did, and is apparently recovering slowly, with occasional setbacks, such as a recent hospitalization in early December for a suspected “mini-stroke” that turned out to be dehydration and several much smaller strokes before that. The most recent press report I saw before the announcements I’m going to discuss described Howe as on the upswing again.

Then, on Friday, I saw headlines all over the place that were basically similar to this Detroit Free Press headline, “Gordie Howe underwent stem cell clinical trial in Mexico.” The story consisted largely of a press release from Howe’s family that read:
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Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Science and the Media

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Low Dose Aspirin for Primary Prevention

600px-Aspirine_macro_shot

From the Wikimedia Commons.

A new study published in JAMA sheds further light on a controversial question – whether or not to prescribe low-dose aspirin (81-100mg) for the primary prevention of vascular disease (strokes and heart attacks).

Primary prevention means preventing a negative medical outcome prior to the onset of disease, in this case preventing the first heart attack or stroke. Secondary prevention refers to treatments given to patients who have already had their first heart attack or stroke in order to reduce the risk of subsequent events.

The evidence strongly supports the efficacy of aspirin for the secondary prevention of both heart attacks and strokes. Aspirin has two effects which likely contribute to this protective effect. First, aspirin is an anti-platelet agent – it reduces the stickiness of platelets, which are cell fragments in the blood that clump together to stop bleeding. They can also clump together around an ulcerated cholesterol plaque on an artery, forming a thrombus, resulting in blockage or embolus (the clot traveling downstream) and causing either a heart attack or stroke.

Other anti-platelet agents, such as clopidogrel, are also effective in preventing stroke and heart attack.

Of course, platelets exist for a reason, and blocking their action increases the risk of bleeding or can make bleeding worse when it occurs. Therefore determining the optimal dose and target population are important to maximize the benefit of aspirin or other anti-platelet agent while minimizing the bleeding risk. (more…)

Posted in: Neuroscience/Mental Health, Public Health

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Stroke Death from Chiropractic Neck Manipulation

vertebral dissectionCase reports are perhaps the weakest form of medical evidence. They are essentially well-documented anecdotes. They do serve a useful purpose, however: they can illuminate possible correlations, the natural course of illness and treatment, and serve as cautionary tales regarding possible mistakes, risks and complications. I say “possible” because they are useful mainly for generating hypotheses and not testing or confirming hypotheses.

Dramatic case reports, however, with objective outcomes, like death, can be very useful by themselves in pointing out a potential risk that should be avoided. For example, case reports of objective and severe adverse outcomes are often used as sufficient evidence for pulling approved drugs off the market, or at least adding black box warnings.

The chiropractic community, it seems, does not respond in a similar way to dramatic adverse events that suggest possible risk from chiropractic manipulation. A recent and unfortunate case raises once again the specter of stroke following chiropractic neck manipulation. Jeremy Youngblood was 30 years old, completely healthy, and saw his chiropractic for some neck pain. According to news reports, Jeremy suffered a stroke in his chiropractor’s office while being treated with neck manipulation for the neck pain. According to reports the chiropractor did not call 911, but instead called Jeremy’s father who had to come and pick him up and then bring him to the ER. Jeremy suffered from a major stroke and later died.

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Posted in: Chiropractic, Neuroscience/Mental Health

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Neuro-Acupuncture and Stroke

On the home page of Zhu’s Neuro-Acupuncture Center there is a video relaying a testimonial of how scalp acupuncture helped a patient recover from acute stroke. The use of testimonials is very common in the promotion of dubious health treatments. A personal story and endorsement is psychologically more compelling than dry data. Testimonials are completely unreliable, however, and in fact I would argue that they are ethically questionable. I would even go as far as saying that the presence of testimonials is almost a sure sign that the treatment being promoted is not legitimate.

Webpage screenshot (click picture to embiggen)

Webpage screenshot (click picture to embiggen)

What I could not find on Zhu’s website were links to published scientific researcher establishing the safety and efficacy of his treatments. You would think if they existed, he would display them prominently.

Acupuncture for stroke is a common claim, contradicting the notion that acupuncture is primarily used for the symptomatic treatment of subjective symptoms. That, in my experience, is part of the promotional strategy for many CAM treatments. They are presented as benign treatments for symptomatic treatment only, so what’s the possible harm. In reality, proponents will claim they can actually treat diseases whenever given the chance.

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Posted in: Acupuncture

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