Archive for Medical devices

Galvanic Skin Response Pseudoscience


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.


Posted in: Medical devices

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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

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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

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Do doctors pay attention to negative randomized clinical trials?


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.

Posted in: Clinical Trials, Medical devices

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Point-of-Care Ultrasound: The Best Thing Since Stethoscopes?

A bit of good news for a change: a “Perspective” article in the New England Journal of Medicine describes how point-of-care ultrasound devices are being integrated into medical education. The wonders of modern medical technology are akin to science fiction. We don’t yet have a tricorder like “Bones” McCoy uses on Star Trek, but we are heading in that direction, and the new handheld ultrasound devices are a promising development.

The stethoscope has become iconic, a symbol of medical expertise draped proudly around the neck by doctors and other medical personnel. Before it was invented, doctors could only try to listen to a patient’s heart by direct application of ear to chest. In 1816, Laennec interposed a tube of rolled paper between ear and chest, and the stethoscope was born. It quickly became an essential tool, allowing us to hear the distinctive murmurs produced by different heart valve abnormalities, to take blood pressures, to detect the wheezing of asthma or the collapse of a lung , to hear the bruits caused by atherosclerotic narrowing of blood vessels, to detect intestinal obstructions by listening for borborygmi (I love that onomatopoeic word!).

The stethoscope allows us to hear sounds produced by the body, but sound also allows us to see inside the body. Diagnostic ultrasound has a multitude of uses. With prenatal sonograms, we can determine the sex of a fetus, watch it suck its thumb, and even take its picture for the family album. With echocardiography we can evaluate heart valves, see fluid accumulation in the pericardium, observe the thickness and motion of the heart wall, and even quantify the efficiency of the pumping process. Ultrasound lets us see clots in blood vessels and stones in the gallbladder, evaluate abdominal organs, detect cysts, screen for carotid artery narrowing and abdominal aortic aneurysms, and guide needles into the body for therapeutic and diagnostic purposes. (more…)

Posted in: Diagnostic tests & procedures, Medical Academia, Medical devices

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E-cigarettes: The growing popularity of an unregulated drug delivery device

This post is not about vaccines (for a change).

However, I deem it appropriate to mention that one of the topics that I blog most frequently about is vaccines and how the antivaccine movement pushes pseudoscience and quackery based on its apparently implacable hatred of vaccines. (You’ll see why very shortly.) It seems almost as long as my interest in the topic since I first noticed that the antivaccine movement acquired its very own celebrity spokesperson in Jenny McCarthy, who at least since 2007 has been promoting outrageous quackery and pseudoscience associated with her antivaccine views. To her, vaccines are chock full of “toxins” and all sorts of evil humors that will turn your child autistic in a heartbeat and in general “steal” your “real” child away from you the way she thinks vaccines “stole” her son Evan away from her. Indeed, among other “achievements,” she’s written multiple books about autism in which vaccines feature prominently as a cause, led a march on Washington to “green our vaccines” and has been the president of the antivaccine group Generation Rescue for the last few years. None of this stopped ABC from foolishly hiring her to join the regular cast on The View beginning in a few short weeks.

Because I occasionally check on what Jenny McCarthy is up to, I noticed a couple of weeks ago that she had been hired to be a celebrity spokesperson for blu™ e-cigarettes. Here she is, hawking the blu™ Starter Pack:


Posted in: Cancer, Medical devices, Politics and Regulation, Public Health

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Will Your Smartphone Become a Tricorder?

The Star Trek universe is a fairly optimistic vision of the future. It’s what we would like it to be – an adventure fueled by advanced technology. In the world of Star Trek technology makes life better and causes few problems.

One of the most iconic examples of Star Trek technology is the medical tricorder. What doctor has not fantasized about walking up to a sick patient, waving a handheld device over them, and then having access to all the medical information you could possibly want. No needle sticks for blood tests, no invasive tests, scary MRI machines, and no wait. The information is available instantly.

It’s clear that we are heading in that direction as technology progresses, but how close are we?

The Smartphone in Medicine
Many people in developed nations today are walking around with supercomputers in their pocket – their smartphone. Technological advances are often strange – the ones we anticipate seem to never come, but then life-changing technology creeps up on us.


Posted in: Diagnostic tests & procedures, Medical devices, Science and Medicine

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Bogus Electrodermal Testing Devices and the Failure of Regulators to Act

Electrodermal testing is a bogus procedure where measurements of skin conductance with a biofeedback device are entered into a computer to diagnose nonexistent health problems and “energy imbalances” and to recommend treatments for them, often involving the sale of homeopathic remedies and other useless products. It falls under the general category of EAV (Electro Acupuncture of Voll). The history and variants of EAV are explained in an article on Quackwatch.

I’ve written about electrodermal testing before. I’ve explained how it amounts to fooling patients with a computerized Magic 8 Ball and I’ve discussed the legal and regulatory issues.

Now Stephen Barrett (founder of Quackwatch and Vice-President of the Institute for Science in Medicine) has written an article in FACT (Focus on Alternative and Complementary Therapies) entitled “Bogus electrodermal testing devices: where are the regulators?” He points out that existing regulations are sufficient to ban these devices, but that regulators have failed to take appropriate action.


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

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Molecular breast imaging (MBI): A promising technology oversold in a TED Talk?

Occasionally, there are topics that our readers want — nay, demand — that I cover. This next topic, it turns out, is one of them. It’s a link to a TED Talk. I’m guessing that most of our readers have either viewed (or at least heard of) TED talks. Typically, they are 20-minute talks, with few or no slides, by various experts and thought leaders. Many of them are quite good, although as the TED phenomenon has grown I’ve noticed that, not unexpectedly, the quality of TED Talks has become much more uneven than it once was. Be that as it may, beginning shortly after it was posted, readers of both this blog and my other super-not-so-secret other blog started peppering me with links to a recent TED Talk by Dr. Deborah Rhodes at the Mayo Clinic entitled A tool that finds 3x more breast tumors, and why it’s not available to you.

At first, I resisted.

After all, I’ve written about the issues of screening mammography, the USPSTF guideline changes (here, too), the early detection of cancer (including lead time and length time bias, as well as the Will Rogers effect), and a variety of other topics related to the early detection of breast cancer, such as overdiagnosis and overtreatment. Moreover, to put it bluntly, there really isn’t anything radically new in Dr. Rhodes’ talk, at least not to anyone who’s been in the field of breast cancer for a while. Certainly, there’s no new conceptual breakthrough in breast imaging and screening described. As I will discuss in more depth later in this post, there’s an interesting application of newer, smaller, and more sensitive detectors with a much better spatial resolution. It’s cool technology applied to an old problem in breast cancer, but something radical, new, or ground-breaking? Not so much. What Dr. Rhodes describes in her talk is the sort of device that, when I read about it in a medical journal, produces a reaction along the lines of, “Nice technology. Not ready for prime time. I hope it works out for them, though. Could be good.” So it was with molecular breast imaging (MBI), which is the topic of Dr. Rhodes’ talk. So I continued to resist for about two or three weeks.

Then our very own Harriet Hall sent me the link. I cannot resist Harriet. When she suggests that perhaps I should blog about a topic, it’s rare that my response would be anything other than, “Yes, ma’am. How soon would you like that post and how many words?” I keed, of course, but only just. The best I could come up with was a wishy-washy “But this isn’t really anything all that new,” which is true enough, but the way Dr. Rhodes tried to sell the audience on the idea of her technology brings up a lot of issues important to our audience. I also thought it was important to put this technology in perspective. So here I go. First, I’ll start by describing what really set my teeth on edge about Dr. Rhodes’ talk. Then I’ll go to the primary literature (namely her brand, spankin’ new article in Radiology describing the technology) and discuss the technique itself.

Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Medical devices, Science and the Media

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The FDA for the Average SBM Consumer

How the Food and Drug Administration came to be is a story that is filled with death, intrigue and dubious characters. It also, like most stories, has its share of heroes and vindications. The list of those who have died to bring us the agency we know today is long, but even today, the death-toll continues. Now this is not the horrible thing it may at first seem. People are all born with a terminal disease known as life, and they will die. The goal of Medicine is to forestall that death as long as possible and to give people good, long, healthy and safe lives. This is where the Food and Drug Administration comes into play. They help guide the pharmaceutical world in the safest manner possible.

The legal quagmire that is the Food and Drug Administration (FDA) is a result of a series of laws which it behooves the Science-Based Medical community, to understand. Many of these laws were a result of deaths, which were themselves the result of either poor safeguards, or, as we will see in one case, lack of information on the part of a company. It began with the Division of Chemistry inside the U.S. Department of Agriculture. The original concern of this group was the misbranding and adulteration of both food and drugs. The first of the laws which came into effect, to give the Bureau of Chemistry as it became known, was the Biologics Control Act of 1902. As is so often the case with FDA regulations, this was a result of deaths in the populous.

Posted in: History, Medical devices, Politics and Regulation

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