What’s the harm? Stem cell tourism edition

What's the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There's the harm.

What’s the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There’s the harm.

It’s been over two weeks now since hockey legend Gordie Howe died at the age of 88. Detroit, as I’ve pointed out elsewhere, is a serious hockey town, as hockey-crazy as any town in Canada (just look at the fancy new hockey arena named after crappy pizza being built downtown only a mile from where I work), and it worshiped Gordie Howe for as long as I can remember growing up here.

The reason I mentioned this is because in late 2014, Howe suffered a series of debilitating strokes that brought him close to death. He survived, but with major neurologic deficits. As a result of Gordie Howe’s fame, representatives of a company known as Stemedica who were also fans of Gordie Howe and whose company is developing stem cell treatments for a variety of illnesses, approached the family and persuaded them to take Gordie Howe to the Novastem Clinic in Tijuana, a clinic that to me appeared to exist mainly as a means for patients not eligible for Stemedica’s clinical trials in the US to receive Stemedica’s stem cells outside of a clinical trial, cash on the barrelhead, no questions asked. In a rather ethically dubious move that could only be viewed as paying for publicity (which it got in abundance), Stemedica administered its stem cells to Gordie Howe for free. If you’re not Gordie Howe, however, it’ll cost you about $32,000.

As is the case for most anecdotes like this, Gordie Howe did improve. That is not surprising, because, as Steve Novella, who is a neurologist and thus takes care of stroke patients as part of his practice, told me at the time, the natural history of stroke is neurologic recovery that eventually plateaus several months after the stroke. This occurs as the inflammation from the initial stroke abates and as much regeneration as the body can muster occurs. Also, as I noted before, Howe had a hemorrhagic stroke, which is more dangerous and likely to kill early but, if the victim survives, he is more likely to experience better functional recovery than in the case of the much more common ischemic stroke, in which a blood clot clogs a blood vessel, resulting in the death of brain tissue supplied by that vessel. In any case, as I described in a three part series of posts (part one, part two, part three), it’s impossible to know whether the stem cell infusion that Howe underwent had anything whatsoever with his partial recovery that allowed him to make a few public appearances in 2015 and 2016.

Unfortunately, the offer by Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies to treat Gordie Howe at Novastem worked brilliantly. Gordie Howe quickly became the poster child for dubious stem cell therapies. Local and national news aired credulous, feel-good human interest stories about his seemingly miraculous recovery, while Keith Olbermann practically served as a pitch man for Stemedica and didn’t take kindly at all to any criticism of his—shall we say?—enthusiastic coverage. The predominant angle taken in stories about Gordie Howe was he had undergone Stemedica’s stem cell therapy and, as result, enjoyed a “miraculous recovery” from his stroke. The vast majority of news coverage also tended to present the magic of stem cell therapies credulously, as all benefit and no risk, as a qualitative analysis published last year clearly showed, finding that the “efficacy of stem cell treatments is often assumed in news coverage and readers’ comments” and that media coverage “that presents uncritical perspectives on unproven stem cell therapies may create patient expectations, may have an affect [sic] on policy discussions, and help to feed the marketing of unproven therapies.”

No kidding.

Why, you might ask, am I reminding you of Gordie Howe’s use of stem cells to treat his strokes? Simple, it became part of a marketing blitz, credulously swallowed whole by Keith Olbermann and many reporters, for unproven stem cell therapies, which have been portrayed as very promising (which is likely true, although that promise hasn’t yet been proven or realized) and harmless, which is definitely not true, as evidenced by the story of Jim Gass, as published last week in The New England Journal of Medicine, The New York Times, The Boston Globe, and a variety of other media. Before I discuss Mr. Gass in more detail, however, let’s recap a bit about stem cells. (more…)

Posted in: Clinical Trials, Ethics, Health Fraud, Science and the Media

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Book Review Lagniappe

Lagniappe, a word often heard in New Orleans, refers to a bonus or extra gift, like the thirteenth donut in a baker’s dozen. You may have noticed that I write a lot of book reviews. I read far more books than I review, and I have always loved to read about the experiences of doctors and the interesting patients and intriguing illnesses they have encountered. I thought I would write an extra post this week to share some titles that SBM readers might also enjoy.

I value these books for several reasons. They are entertaining. They prove that doctors are not all evil Big Pharma shills just in it for the money. They let readers vicariously experience what it is like to be a doctor in a particular specialty or setting. They highlight the joys of helping patients, as well as the many frustrations doctors struggle with. They put a human face on the practice of medicine. (more…)

Posted in: Book & movie reviews

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Why Science-Based Medicine Matters

A child with smallpox; the cost of unscientific medicine. This is why science-based medicine matters.

A child with smallpox; the cost of unscientific medicine. This is why science-based medicine matters.

The regular contributors at Science-Based Medicine (SBM) work diligently every week to explore the world of science-based medicine and the gauzy, nebulous netherworld of fantasy-based medicine. They shine light on the leading edge of medical science, dissect the nuances of mainstream care, expose the misconceptions and sometimes the frank deceptions of so-called alternative medicine. Launching SBM on January 1, 2008, sbmadmin (Steven Novella?) described the mission of the blog as: “scientifically examin[ing] medical and health topics of interest to the public [including] reviewing newly published studies, examining dubious products and claims, providing much needed scientific balance to the often credulous health reporting, and exploring issues related to the regulation of scientific quality in medicine.” He went on to propound an elegant yet simple core philosophy that “safe and effective health care is critical to everyone’s quality of life; so much so that it is generally considered a basic human right.”

This last deserves, I think, especially careful consideration. Enshrined in the aspirational manifesto of the United States, the Declaration of Independence, is the claim for all people to inherent and inalienable rights to “Life, Liberty and the pursuit of Happiness.” And while Jefferson used the phrase in the context of personal political freedoms, health is central to the exercise of those rights. It is the role of medicine to secure health, to provide a structure and a system by which all can live life as long and as free from disease and disability as our individual circumstances allow. (more…)

Posted in: History, Science and Medicine

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About Herbs: an app to avoid

Pictured: A better source of health information than "About Herbs".

Pictured: A better source of health information than “About Herbs”.

Medicine has an intellectual hierarchy. Supposedly the best and the brightest are in the academic medical centers and are the thought leaders in their field.

Those of us lower in the hierarchy are well aware of some of the warts present on our betters, but I would expect those at the top would adhere to the highest intellectual and ethical standards. People being, well, people, expecting exceptional standards is admittedly an unrealistic expectation.

It would appear that many academic centers are doing their best to avoid meeting my expectations, attempting to abandon all standards.

I mentioned over at SfSBM that Dana-Farber is spending 2 million dollars on a renovation to, in part, offer the unmitigated steer manure that is reiki and reflexology to their cancer patients. Yes. Reiki. Reflexology.

Those are not fracking earthquakes in Kentucky, those tremors are the result of the tremendous kinetic energy of Flexner spinning in his grave as his life’s work becomes a farce.

Dana-Farber is just one of many academic medical centers who are putting their imprimatur on nonsense.

Memorial Sloan Kettering Cancer Integrative has released “About Herbs”, an iPad/iPhone guide to Botanicals, Supplements, Complementary Therapies and More. Spoiler alert: the ‘More’ does not include critical thinking. This guide is not anywhere as ludicrous as offering reeky, sorry, reiki, but at times it comes close. (more…)

Posted in: Acupuncture, Commentary, Critical Thinking, Herbs & Supplements, Homeopathy, Traditional Chinese Medicine

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The rise and inevitable fall of Vitamin D

Is Vitamin D a panacea? The evidence says otherwise.

Is vitamin D a panacea? The evidence says otherwise.

It’s been difficult to avoid the buzz about vitamin D over the past few years. While it has a  long history of use in the medical treatment of osteoporosis, a large number of observational studies have linked low vitamin D levels to a range of illnesses. The hypothesis that there is widespread deficiency in the population has led to interest in measuring vitamin D blood levels. Demand for testing has jumped as many physicians have incorporated testing into routine care. This is not just due to alternative medicine purveyors that promote vitamin D as a panacea. Much of this demand and interest has been driven by health professionals like physicians and pharmacists who have looked at what is often weak, preliminary and sometimes inconclusive data, and concluded that the benefits of vitamin D outweigh the risks. After all, it’s a vitamin, right? How much harm can vitamin D cause? (more…)

Posted in: Herbs & Supplements, Nutrition

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MEND Protocol For Alzheimer’s Disease

Post-mortem cross sections of a healthy brain (left) and a brain with advanced Alzheimer disease (right), showing characteristic shrinkage.

Post-mortem cross sections of a healthy brain (left) and a brain with advanced Alzheimer disease (right), showing characteristic shrinkage.

The medical profession is currently engaged in a simmering debate about what is the best overall approach to take toward the relationship between science and health care. I would say that the current dominant model is Evidence-Based Medicine (EBM). We, of course, advocate for a number of tweaks to EBM we call Science-Based Medicine (SBM).

SBM essentially advocates for an ironic-sounding holistic approach to scientific evidence. All evidence should be considered in its proper context with an eye toward the strengths and weaknesses of each kind of evidence, and in the context of the institutions of science and medicine. SBM represents a higher standard of overall evidence, which we feel is justified given the degree to which medical interventions are adopted prematurely (as evidenced by later reversals).

At the same time there are those, in the minority but with an established presence, who are essentially arguing for lowering the standard of science in health care. They exist on a spectrum, at one end including those who would abandon science entirely in favor of spirituality and philosophy-based medicine. At the other end are those who claim to endorse science but want to change the rules of scientific medicine to include a much lower standard of evidence. This is more pseudoscience than antiscience. Chief among them, in my opinion, are proponents of what they call “functional medicine.” Functional medicine essentially uses science incorrectly, but still cloaks itself with the imprimatur of science. (more…)

Posted in: Neuroscience/Mental Health

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The ROCA Screening Test for Ovarian Cancer: Not Ready for Prime Time

Ovarian cancer

Ovarian cancer

Ovarian cancer is relatively rare but deadly. The lifetime risk of ovarian cancer is 1.5% compared to 12% for breast cancer, but it is the 5th most common cause of cancer death for women. Since the ovaries are hidden deep in the pelvis and the symptoms of ovarian cancer are non-specific, the cancer is often advanced by the time it is diagnosed and survival rates are low. Early detection by screening would be expected to improve outcomes. Two screening methods have been proposed: the cancer antigen CA-125 blood test, and pelvic ultrasound. The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) found that screening with CA-125 and ultrasound did not reduce ovarian cancer mortality. The USPSTF recommends against screening for ovarian cancer because it does not reduce mortality and carries important potential harms from false positives and unnecessary surgeries.

Ovarian cancer screening is being re-considered in the light of a recent study, the UKCTOCS trial, published in The Lancet in December 2015. On the basis of that study, a test called ROCA is being offered directly to the public for $295. It’s important to understand what the study actually found, and why experts have questioned the wisdom of offering this test to the public at this time. (more…)

Posted in: Cancer, Diagnostic tests & procedures

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Whither the randomized controlled clinical trial?

Whither the randomized controlled clinical trial?

One of the most frequent complaints about evidence-based medicine (EBM), in contrast to science-based medicine (SBM), is its elevation of the randomized clinical trial as the be-all and end-all for clinical evidence for an intervention for a particular disease or condition. Unknown but enormous quantities of “digital ink” have been spilled explaining this distinction right here on this blog, beginning with our founder’s very first post, continuing with Kimball Atwood’s series of posts explaining the shortcomings of EBM’s reliance on clinical trials über alles using homeopathy as his example, to my referring to this aspect of EBM as “methodolatry,” defined as profane worship of the randomized controlled clinical trial (RCT) as the only valid method of clinical investigation. The problem, of course, with methodolatry, is that it completely ignores prior plausibility, and when that prior plausibility is as close to zero as you can imagine (e.g., for clinical trials of homeopathy), then the only positive results that you see in such trials can reasonably be concluded to be due to noise, shortcomings in trial design, and bias. Unfortunately, a failure to realize this has led to many pointless clinical trials and contributed to the rise of a whole new “specialty” known as integrative medicine, dedicated to “integrating” quackery and pseudoscience into science-based medicine.

So we know that practitioners of “complementary and alternative medicine” (CAM), now referred to more frequently as integrative medicine, don’t like RCTs. They love pragmatic trials, because such trials are usually unblinded, often not randomized, and generally face a lower bar of evidence. That pragmatic trials are intended to test the “real world” use of medical and surgical interventions that have already been shown to be safe and effective in RCTs and that the vast majority of CAM nostrums have not met that standard appears not to concern them in the least. However, CAM practitioners are not the only ones critical of RCTs, as I learned when, via Steve Novella, I came across an article in The New England Journal of Medicine entitled “Assessing the Gold Standard — Lessons from the History of RCTs” by Bothwell et al. Given that the article is two weeks old, I wonder how I missed it. Be that as it may, although Bothwell et al make some good points, I tend to agree with Steve that the overall gist of the article is overly critical, to the point of, as Steve put it, portraying the RCT as broken rather than flawed and advocating revolution rather than reform.

Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Use of Dental Appliances in the Management of Tourette Syndrome

Editor’s note: This Science Based Medicine blog post is another collaborative effort between Grant Ritchey and Clay Jones. Not only have they previously co-authored an SBM post on fluoride, their partnership has recently expanded into other areas of science journalism. Since the departure of Dr. Jason Luchtefeld as co-host of The Prism Podcast, Clay has joined Grant as the new co-host. To this end, Clay and Grant have added a Science Based Medicine segment to each podcast episode, in which recent SBM blog posts are reviewed and discussed with the authors themselves. Check them out on iTunes or your favorite podcatcher.

"We'll remove that headgear when your tics improve."

“We’ll remove that headgear when your tics improve.”

One of our primary goals is to promote the concept of scientific skepticism and the importance of prior plausibility when interpreting new research. On the pages of this website, and in extracurricular activities like our various podcasts and personal blogs, we often call upon these two load-bearing pillars of science-based medicine when investigating implausible and unproven claims championed by well-meaning true believers and outright charlatans. What our collective experience has revealed time and time again is that both will often hope that a gullible public will put their trust in a warped version of science, while relying on emotional responses to anecdotes and testimonials.

In our post today, we will walk readers through our investigation of thus far unproven claims involving the treatment of a complex neurological disorder, Tourette syndrome (TS), with a fitted dental appliance aimed at improving the alignment of a patient’s jaw. From the perspective of a dentist (Grant) and a pediatrician (Clay), there aren’t any obvious connections between the jaw and this childhood-onset neuropsychiatric disorder, but proponents believe that there is one and that these appliances can significantly reduce the severity of symptoms. Although impossible to enter into an investigation such as this completely free of emotion or bias, we truly attempted to keep an open mind throughout the process.

First up, a disclaimer:

Clay was diagnosed with Tourette syndrome when he was 7 years old. As both a pediatrician who has now cared for a number of patients with TS and someone who has personally experienced many of the negative physical and social sequelae associated with the condition, this is a topic that Clay takes rather personally. Although his symptoms are now on the milder end of the severity spectrum, and are far from debilitating, they do often serve as a source of frustration in his day-to-day life. The thought of children with Tourette syndrome being taken advantage makes him angrier than that time somebody switched out his regular coffee for Colombian decaffeinated crystals.

Without hesitation, we would love for there to be another effective treatment option for Tourette syndrome in our armamentarium, especially one that would be essentially risk free and relatively inexpensive. Again, as scientific skeptics we are open to new evidence as it emerges. But before we get to the claim and the research being used to back it up, we will give a primer on the scientific consensus on TS so that readers can better assess for themselves the prior plausibility of this proposed treatment.

Posted in: Critical Thinking, Dentistry, Medical devices

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Bye Bye Bravewell

Bravewell Collaborative

Exactly one year ago tomorrow, The Bravewell Collaborative shut down, an event so momentous that few seem to have noticed. It’s been a while since we at SBM devoted much attention to Bravewell, although, at one time, its doings were a regular feature of SBM posts.

For those of you not familiar with Bravewell, a brief history. The main mover and shaker behind The Bravewell Collaborative was Christy Mack, wife of former Morgan Stanley head John Mack and a financier of sorts in her own right. She and the widow of another Morgan Stanley bigwig, Susan Karches, neither of whom had any particular expertise in finance, managed to get about $220 million in bailout funds from the Federal Reserve, a boondoggle recounted in Matt Taibbi’s 2011 hilarious Rolling Stone article, “The Real Housewives of Wall St.” Ms. Mack had established the Bravewell Collaborative a few years earlier, with her own contributions and that of other philanthropists, as a private operating foundation, a further opportunity to benefit from government largesse in the form of tax deductions.

Here’s Bravewell’s definition of “integrative medicine”:

Integrative medicine is an approach to care that puts the patient at the center and addresses the full range of physical, emotional, mental, social, spiritual and environmental influences that affect a person’s health. Employing a personalized strategy that considers the patient’s unique conditions, needs and circumstances, integrative medicine uses the most appropriate interventions from an array of scientific disciplines to heal illness and disease and help people regain and maintain optimal health.


Posted in: Acupuncture, Chiropractic, Energy Medicine, Homeopathy, Medical Academia, Naturopathy

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