Articles

Archive for Medical devices

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) →

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

Leave a Comment (31) →

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:

(more…)

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

Leave a Comment (166) →

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.

(more…)

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

Leave a Comment (10) →

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.

(more…)

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

Leave a Comment (13) →

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.
(more…)

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

Leave a Comment (8) →

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.
(more…)

Posted in: History, Medical devices, Politics and Regulation

Leave a Comment (43) →

Biofeedback and Laser for Allergies

AllergiCare Relief Centers are a chain of franchises started by a man called David Tucker who is not listed as having an MD or any other title. They offer diagnosis of allergies by biofeedback and treatment of allergies by laser acupuncture. They admit that the method is not backed by any science, and they claim that what they are doing is not medical treatment.

Responsible journalism might have investigated this as quackery or practicing medicine without a license. Instead, irresponsible journalism has helped promote these centers and has given them invaluable free advertising.

From one news story:

Tucker said the device works based on biofeedback. The allergy sufferer wears a sensing clip on his finger for testing, and the computer simulates the bio-frequency for 10,000 known allergens. As the body responds to those stimuli, the computer lists which substances are irritants. “This digitized allergen actually matches the harmonic frequency of the actual allergen, making the body believe it is in contact with the real substance,” Tucker said. “The body will react if it is allergic to the particular substance.” ….Once the allergens are identified, a laser stimulates biomeridian points on the body — the same points used in acupuncture and acupressure. Tucker said the idea is to strengthen organs to act properly the next time they encounter the allergen — that is, to treat them as harmless…So far, there is no science to prove the devices work, but Tucker claims a 70 percent positive response rate. (more…)

Posted in: Energy Medicine, Health Fraud, Medical devices, Science and the Media

Leave a Comment (27) →

FDA approval of drugs and transparency in clinical trial results

ResearchBlogging.orgNote: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.

One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.

Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at ClinicalTrials.gov at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.
(more…)

Posted in: Clinical Trials, Medical devices, Politics and Regulation, Science and Medicine

Leave a Comment (5) →

Recognizing Dubious Health Devices

The public is often left to fend for themselves in the marketplace of medical devices and health aids. Current regulations in most countries are inadequate to prevent grossly misleading claims in advertising and to provide adequate evidence for safety and effectiveness for products on the market. So it is helpful for consumers to be aware of the red flags for dubious devices to watch out for.

I came across this ad for The Rebuilder, which purports to be a treatment for painful neuropathy.  About 2.4% of the population has some kind of peripheral nerve damage (neuropathy), which means there are about 7.2 million Americans with neuropathy. In most cases there is no cure (although there is effective treatment for some of the symptoms of neuropathy) so it is not surprising that neuropathy is a common target for questionable treatments and devices.

The ad is full of misleading or unsupported claims and blatant misinformation and provides an excellent example of the many features of quackery marketing to look out for.

(more…)

Posted in: Medical devices, Science and Medicine

Leave a Comment (26) →
Page 1 of 2 12