Articles

Archive for Medical devices

The Gene: An Intimate History

A superb writer, Siddhartha Mukherjee's books are easier to read than his name is to spell

A superb writer, Siddhartha Mukherjee’s books are easier to read than his name is to spell

Six years ago I reviewed Siddhartha Mukherjee’s book The Emperor of All Maladies: A Biography of Cancer. It was hands-down one of the best books I have ever read on a medical topic. Now he’s done it again. His new book is titled The Gene: An Intimate History.

Mukherjee is a superb writer. Much of what I said about his first book applies equally to his second, so I will quote myself:

It is a unique combination of insightful history, cutting edge science reporting, and vivid stories about the individuals involved: the scientists, the activists, the doctors, and the patients. It is also the story of science itself: how the scientific method works…

Beautifully written and informative

Reads like a detective story with an exciting plot.

He links this second book to his first by pointing out that cancer is an ultimate perversion of genetics, and that studying cancer means also studying its obverse: normalcy. He gives the subject a human face by interspersing anecdotes from his own family’s struggles with mental illness and its connection to inherited genes. He sets out to tell the story of the birth, growth, and future of one of the most powerful and dangerous ideas in the history of science: the gene. He says it is one of three destabilizing ideas that have transformed science: the concept that irreducible units underlie matter (the atom), digitized information (the byte or bit), and biological information (the gene). He explains how the consequences of these ideas have transformed our thinking, our language, our culture, politics, and society. (more…)

Posted in: Basic Science, Book & movie reviews, History, Medical devices

Leave a Comment (0) →

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.
(more…)

Posted in: Critical Thinking, Dentistry, Medical devices

Leave a Comment (0) →

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

Leave a Comment (0) →

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.

(more…)

Posted in: Cancer, Medical devices, Science and Medicine

Leave a Comment (0) →

April Fool Cannot Surpass SCAM

Stick some coffee up the tailpipe and you've got yourself some complementary and alternative auto care!

Stick some coffee up the tailpipe and you’ve got yourself some complementary and alternative auto care!

It’s April Fools’ day in the US of A. One of the internet traditions is to come up with a story that is weird or unlikely, but not so weird or unlikely that it is not believable, in order to fool people that the story is real.

I gave it the old SBM try, I really did, but I couldn’t do it. I wanted to come up with a SCAM therapy so weird, so unlikely, that I could not find an example of it actually being practiced.

It can’t be done. Like a Trump utterance*, you can’t invent a SCAM (Supplements, Complementary and Alternative Medicine) that someone, somewhere, has already pulled out of, er, well, thin air and are using it on patients.

Of course, what would you expect given that many SCAMs were in fact, pulled out of, er, well thin air. Think chiropractic and DD Palmer, iridology by August von Peczely, and reiki by Mikao Usui. Making up fantastical stuff is what they do.

But even within the spectrum of pseudo-medicine there are those are practices and papers that are so bizarro they should be an April Fools’ joke. But are not. It may be a matter of taste, what one person considers wack-a-loon another would find imminently reasonable. There are certainly assigned delegates that prove that assertion. But even within the wack-a-loon world of SCAM, there are those practices and papers that are more wack-a-loon than others and should be April Fools’ jokes. Maybe it is like more unique. Unique is one of a kind, so something can’t be more one of a kind. More wack-a-loon? Such is the world of SCAM. (more…)

Posted in: Acupuncture, Energy Medicine, Homeopathy, Medical devices, Naturopathy, Politics and Regulation, Science and Medicine

Leave a Comment (0) →

Willow Curve Device for Pain: Strong Claims, Weak Evidence

willow curveWillow Curve is advertised as the “world’s first digital anti-inflammatory device”, “a laser smart device” designed to relieve joint pain with thermal and photonic energy. It contains over 150 bio-sensory and bio-therapeutic components that continuously monitor the body’s thermal and electrical response to the device, and computer chips use that information to tailor a digital prescription on the fly. That prescription consists of “multiple energies” that change thousands of times a second.

It’s not clear exactly what the sensors sense, or how they work. It’s not clear how the device responds to information from the sensors to alter the output of heat and light, and it’s not clear how it chooses the appropriate dose for that patient. They don’t divulge information like intensity and wavelength for the various treatment protocols. They claim that the treatment “stimulates 15 bio-physiological processes for treating the joint and surrounding tissues.” Which 15 are those, exactly? They say that the Willow Curve dilates blood vessels, slows nerve response time (is that a good thing?), releases endorphins, blocks specific pain receptors, and detoxifies by removing toxic debris from the joints.

They offer no evidence in support of these claims. I tried to get clarification from the company, but they didn’t answer my inquiries.

(more…)

Posted in: Medical devices

Leave a Comment (0) →

Galvanic Skin Response Pseudoscience

How_Zyto_works

Selling snake oil is all about marketing, which means that a good snake oil product needs to have a great angle or a hook. Popular snake oil hooks include being “natural,” the product of ancient wisdom, or “holistic.”

Perhaps my favorite snake oil marketing ploy, however, is claiming the product represents the latest cutting-edge technology. This invariably leads to humorous sciencey technobabble. There are also recurrent themes to this technobabble, which often involve “energy,” vibrations and frequencies, or scientific concepts poorly understood by the public, such as magnetism and (of course) quantum effects. Historically, even radioactivity was marketed as a cure-all.

One category of technical pseudoscientific snake oil measures some physiological property of the body and then claims that this measurement can be used for diagnosis and determining optimal treatment. For example, machines might measure brain waves, heart rate variability, thermal energy or (the subject of today’s article) the galvanic skin response.

(more…)

Posted in: Medical devices

Leave a Comment (0) →

Cryotherapy: A Layman’s Attempt to Understand the Science

Whole Body Cryotherapy
NOTE: I get a lot of emails asking me whether treatment X is evidence-based or a scam. This one was different. Zachary Hoffman had done his homework and had already answered the question for himself (at least, as well as it could be answered with the existing published evidence). I asked him to write up his findings as a guest post for SBM. This is a great example of how a layman can figure things out for himself using little more than google-fu and critical thinking skills. I hope it will be an inspiration to others who may not have thought they were qualified to do what we do on SBM.


Recently a friend alerted me to something called “Whole-Body Cryotherapy” which has been making the rounds on Facebook and is being promoted by many athletes and celebrities. I had only heard of cryotherapy in the context of freezing off a wart, but I was about to find out there was so much more. She explained that subjecting your entire body to extreme cold (-200˚F!) for a few minutes a day was a virtual panacea, with weight-loss, tissue repair, and beauty treatments as the target market. My limited background in biology hadn’t quite prepared me for understanding why subjecting oneself to cold air could possibly help treat any illness.

For instance, up here in Boston, I ride my bike all winter long, and on a particularly cold day, after a 5 degree ride, no one has commented that I seem particularly trim, or that my face is looking unusually beautiful. Unfortunately, a few days ago while riding my bike, I took a spill and mushed my hand pretty good. However, the cold winter air hasn’t done much to alleviate that pain or stop my right hand from being twice the size of the left. In any case, it seemed to me that I’d have to give this a closer look before I made any comments.

A quick search on Google led me to a website, Cryohealthcare, Inc. The website is aesthetically pleasing and has plenty of information about how this treatment can transform your life. To top it off, there are lots of endorsements from professional teams and athletes. It appears that for about $65 a pop you can subject yourself to unfathomably low temperatures and enjoy a whole-body tingle when you step out (when I was younger I used to jump in the snow and then get into a hot tub, so I get the appeal). A quick scroll down and we see indications for injury recovery, pain mitigation, and athletic performance, among others, followed nicely by the FDA quack Miranda warning. (more…)

Posted in: Health Fraud, Medical devices

Leave a Comment (0) →

New FDA regulatory role threatens bogus diagnostic tests

lab test
The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it focused on commercial tests kits, which are broadly marketed to laboratories or the public. These tests had to undergo the same pre-market approval process as other medical devices regulated by the FDA, including, in some cases, clinical studies demonstrating that the device is safe and effective for its intended use.

Historically, LDTs were developed by hospitals, researchers and academic medical centers for their own use. That is no longer true. In the past 15 years or so, there has been an explosion in the use of LDTs by commercial labs and biotechnology companies. The FDA now estimates that there are about 11,000 LDTs offered by 2,000 laboratories. One estimate is that the results of clinical lab tests (although not exclusively LDTs) influence 70% of health care decisions. (See the Congressional Research Service Report’s exhaustive analysis of FDA regulation of IVDs and inclusion of LDTs for more on the history and current use of LDTs.)

Do you have any idea whether the IVDs that have poked around in your blood or tissues are FDA-approved or unapproved LDTs? (Does your physician?) Do you know what evidence (if any) there is standing behind these tests? No? Me either. That’s because there is no requirement that anyone give you this information. (more…)

Posted in: Diagnostic tests & procedures, Legal, Medical devices, Naturopathy, Politics and Regulation

Leave a Comment (81) →

Do doctors pay attention to negative randomized clinical trials?

vertebroplasty

We at the Science-Based Medicine blog believe that all medicine, regardless of where it comes from, should be held to a single science-based standard with regards to efficacy, effectiveness, and safety. We tend to focus primarily on “complementary and alternative medicine” (CAM), now more commonly known as “integrative medicine,” because (1) we believe it to be undermining the scientific basis of medicine and allowing outright quackery (or, as I like to refer to it, quackademic medicine) to infiltrate medical academia, which is fast becoming medical quackademia and (2) because when it comes to the other threats to the scientific basis of medicine as it is practiced today, such as pharma influence and various medical dogmatism, there are a whole host of active critics better equipped and more energetic than we are who can do the job (usually) better. That is why, whenever I hear advocates of CAM/”integrative medicine” attack us for not spending enough time on various corruptions of clinical trial processes or the perfidy of big pharma, I tend to gently tell them in my characteristically diplomatic manner that that’s what I like to call the “Why don’t you blog about what I think is important and interesting instead of what you think is important and interesting?” criticism, then I refer them to our posts on John Ioannidis, overdiagnosis and overtreatment, the shortcomings of mammography, or any number of other posts we at SBM have done through the years pointing out where current medical practice falls short. Indeed, it never fails to amuse me to point out how angry an eminent radiologist became at me for my posts criticizing him for his misleading attacks on certain studies that question the value of screening mammography.

In particular, though, I like to point out a post I did on vertebroplasty as a treatment for vertebral compression fractures (VCFs) due to osteoporosis. Basically, I discussed then recent evidence showing how vertebroplasty for such fractures is, basically, placebo medicine, no better than acupuncture. Indeed, I likened the state of evidence regarding vertebroplasty to that of acupuncture, in which small, pilot studies appear to be positive, but then the follow-up rigorous randomized clinical trials fail to find a benefit greater than that of placebo. It turns out that a rather telling study regarding vertebroplasty was published earlier this year that I somehow missed that addresses a problem we have in “conventional” medicine.
(more…)

Posted in: Clinical Trials, Medical devices

Leave a Comment (146) →
Page 1 of 2 12