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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.
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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.
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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.

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

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AMA Decides Gun Violence is a Public Health Issue

ama_gun_vote

AMA members voting on the issue of gun violence research.

On June 14th the American Medical Association’s (AMA) House of Delegates in Chicago, IL voted almost unanimously to adopt a resolution supporting the idea that gun violence is a public health issue. The resolution also called for lobbying Congress to eliminate the ban on research into the causes of gun violence. The AMA reports:

“With approximately 30,000 men, women and children dying each year at the barrel of a gun in elementary schools, movie theaters, workplaces, houses of worship and on live television, the United States faces a public health crisis of gun violence,” said AMA President Steven J. Stack, M.D. “Even as America faces a crisis unrivaled in any other developed country, the Congress prohibits the CDC from conducting the very research that would help us understand the problems associated with gun violence and determine how to reduce the high rate of firearm-related deaths and injuries. An epidemiological analysis of gun violence is vital so physicians and other health providers, law enforcement, and society at large may be able to prevent injury, death and other harms to society resulting from firearms.”

The resolution is aimed primarily at a congressional ban on research into gun violence by the Centers for Disease Control (CDC). I will discuss this ban further, but first let’s address the underlying issue. (more…)

Posted in: Public Health

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The Blood Cleaner: Invented by Ray Jardine

Imaginary germs awaiting imaginary electrocution by Ray Jardine's Blood Cleaner device.

Imaginary germs awaiting imaginary electrocution by Ray Jardine’s Blood Cleaner device.

I recently heard about a man who was planning a hike in a tick-infested area and thought he could avoid Lyme disease by using Ray Jardine’s Blood Cleaner. Ray Jardine is a well-known mountaineer, rock climber, long-distance hiker, and outdoor adventurer. A lightweight hiking enthusiast, he has branched out into selling lightweight equipment like backpack kits, tarps, and insulated hats. Most of his products are reasonable, but one is not: the Blood Cleaner. It is a micro electronic device that allegedly kills or disables pathogens in a person’s bloodstream. It is worn on the wrist in a pocket on a wristband that has another pocket holding a 9-volt battery. He and his wife make the devices themselves at home and sell them for $78.95. It could not possibly work as claimed. It is as useless as Hulda Clark’s infamous zappers.

How Ray’s Blood Cleaner supposedly works

It sends pulsed micro-currents through the skin and into the blood vessels. The micro-currents are claimed to electrocute the germs in the bloodstream, killing bacteria, protozoa, and fungi, and disabling viruses, without harming the white blood cells. It is supposed to clean germs out of the blood just as taking a shower cleans germs off of the skin. It comes with two probes, one for cleaning the bloodstream and another for making nano-silver in a glass of water to kill pathogens in the upper GI tract. Nano-silver (a form of colloidal silver) may kill germs in vitro, but it is useless and potentially harmful when ingested by humans. Colloidal silver has been known to turn people as blue as a Smurf. (more…)

Posted in: Lyme, Medical devices

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How low antivaccine “warriors” will go: Of Facebook harassment reporting algorithm abuse and publicly attacking a 12 year old boy

NOTE: Anyone who has seen several derogatory articles about me on the web and is curious about what the real story is, please read this and this.
Marco Arturo

I was going to write about something else this week, but events over the last several days led me to change my mind. The first was the reaction of a pseudonymous antivaccine “warrior” going by the ‘nym Levi Quackenboss to a viral video posted by a 12-year-old boy named Marco Arturo. The second was my learning that other antivaccine “warriors” had resumed abusing the Facebook reporting algorithm to get pro-science advocates supporting vaccines banned from Facebook for periods up to 30 days and thereby silence them. I wrote about this latter tactic a couple of years ago, when the Australian antivaccine group the Australian Vaccination Network (AVN), or AVN (which was forced to rename itself the Australian Vaccination Skeptics Network in 2014), started abusing Facebook’s algorithm for reporting harassment and abuse in order to get members of the skeptic group Stop the Australian Vaccination Network (SAVN) temporary Facebook bans. It’s a tactic that has continued, with a fresh batch of temporary bans issued by Facebook in response to bogus complaints over the last few days.

I’ve frequently written about how often the preferred tactic of antivaccinationists and others pushing medical pseudoscience is not to answer criticism with evidence, science, and rational argument, but rather to respond with attacks and attempts to intimidate and silence. The reason, of course, is that they do not have any of that to support their beliefs. At some level, I suspect that many of them know it. Be that as it may, those of us who lament how few physicians and scientists, even those sympathetic to scientific skepticism, are willing to publicly speak out and call the quacks to task know that the consequences of doing so are often quite unpleasant: Online attacks, poisoning of one’s Google reputation, attempts to get one banned from Facebook, and, of course, the antivaccinationists’ favorite: Harassment through one’s job by complaining to one’s bosses. To illustrate these hazards, I’ll start with the story of Marco Arturo, before moving on to a more organized effort. (If you read my not-so-super-secret other blog, you’ll have heard of Marco’s story before, but I’ll summarize here as well.) Then I’ll update you on how Facebook continues to allow its reporting algorithms to be abused to silence pro-vaccine voices there. I’ll finish up with examples of what we at SBM have experienced and some thoughts on what can be done. (more…)

Posted in: Computers & Internet, Health Fraud, Vaccines

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The Harm of Integrative Medicine: A Patient’s Perspective

The Integrative Medicine Wheel: False hope and lies

The Integrative Medicine Wheel: False hope and lies

Being an avid reader of SBM and a cancer patient, I have come to deeply appreciate the writing and respect the various contributors for their expertise and attention to detail on a topic as important as cancer treatment. I have unfortunately found SBM lacking when it comes to a patient’ or lay-person’s’ perspective. This is understandable, as the average person is typically not well versed in science, medicine, or logical fallacies, all important when examining medical claims and practices. Nonetheless, this is a general problem because lack of patient and public involvement in healthcare is partly responsible for the spectacular growth of the integrative medicine industry. Under the integrative and CAM umbrella there is an almost-endless list of topics (as readers are well aware) to write on but there is only so much space in one article. To address this gap, I would like to focus on the general harm caused to patients by the presence of integrative medicine in healthcare (hence the creative title). (more…)

Posted in: Cancer, Commentary

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Chiropractic Moves into Transportation

Pictured: Not a justification for chiropractic care
I debated which of two topics to blog about this week that appeared in my feeds.

The first was “Graduate slams CQU for offering ‘pseudoscience degree’,” where an Australian is upset that her University is offering an undergraduate Bachelor of Science in Chiropractic and a postgraduate Master of Clinical Chiropractic degree because chiropractic is “complete pseudoscience”.

And the second was:
Foundation for Chiropractic Progress Publishes Landmark White Paper : Non-Pharmaceutical Pain Management is a Safer Strategy than Opioids.”

Why choose? Just keep in mind that chiropractic is “complete pseudoscience” as we look at the landmark white paper. (more…)

Posted in: Chiropractic, Humor

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Health and Wellness Coaching: cautious optimism and some concerns

NCCHWC logo

The National Consortium for Credentialing of Health & Wellness Coaches (NCCHWC) and the National Board of Medical Examiners (NBME) signed an agreement last month for the launch of a national certification for individual health and wellness coaches in the U.S. According to a joint press release, the agreement is a landmark in the efforts of a dedicated group of individuals who have been working for years to establish professional practice and educational standards for health and wellness coaching.

What is “health and wellness coaching?” According to NCCHWC’s website:

Health and Wellness Coaches partner with clients seeking self-directed, lasting changes, aligned with their values, which promote health and wellness and, thereby, enhance well-being. In the course of their work health and wellness coaches display unconditional positive regard for their clients and a belief in their capacity for change, and honoring that each client is an expert on his or her life, while ensuring that all interactions are respectful and non-judgmental.

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Posted in: Nutrition, Public Health

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Pulsed Electromagnetic Field Snake Oil

noel edmonds
Noel Edmonds is a game show host, famous for Britain’s version of Deal or No Deal. As far as I can tell, he has no medical or scientific qualifications at all. This unfortunately has not stopped him from using his celebrity status to offer dubious medical advice via his Twitter feed. Such is the world in which we live.

Edmonds tweeted, referring to the EMP Pad:

A simple box that slows ageing, reduces pain, lifts depression and stress and tackles cancer. Yep tackles cancer!

This Twitter-brief statement packs in many red flags for quackery and snake oil: such as a simple device that can tack a wide range of medical conditions that do not appear to share a common cause or mechanism. The word “tackle” is vague, but implies either a cure or at least a significant treatment. Anyone claiming to treat or cure cancer deserves close scrutiny.

In response, cancer patient Vaun Earl tweeted:

I think Noel Edmonds should stick to what he’s good at. Presenting quiz shows and beard trimming, rather than curing cancer.

To which Edmonds responded:

Scientific fact-disease is caused by negative energy. Is it possible your ill health is caused by your negative attitude? #explore.

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Posted in: Cancer, Medical devices, Science and Medicine

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