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Archive for Diagnostic tests & procedures

Woo-omics

Every so often, I come across studies that leave me scratching my head. Sometimes, these studies are legitimate scientific studies that have huge flaws or come from an assumption that is very off-base. Other times, they involve what Harriet Hall has termed “tooth fairy science,” wherein the tools of science are used to study a phenomenon that is fantastical, whose very existence hasn’t been demonstrated. Many such studies, not surprisingly, are studies of “complementary and alternative medicine” (CAM) or “integrative medicine” (IM). Modalities like reiki (which is faith healing that substitutes Eastern mysticism for Christian beliefs) and homeopathy (which is, when you boil it down to its essence, sympathetic magic) fall into the category of therapeutic modalities that are based on fantasy but are studied as with the latest tools of science, producing no end to confusing noise. This “tooth fairy science” has, over the last few years, reached its epitome in the application of the latest genomics technology to, in essence, magic, and I’ve recently come across an incredible example of just such a thing. But, first, let’s take a step back to what is going on in medical science now before I introduce a concept that I’ve dubbed “woo-omics.”

A prelude to woo-omics: Genomics, proteomics, everywhere an “omics”

One of the most difficult problems in science-based medicine is how to do a better job identifying which patients will respond to which treatments. Clinical trials, by their very design, have to look at average responses in populations. In essence, a treatment is compared to either placebo or standard-of-care, a choice mainly driven by ethics and whether effective treatments exist for the condition being studied. It is then determined using statistics whether a significant difference exists between the two groups. The difficulty, as any clinician knows, is applying the results of clinical trials to individual patients. In any population, there is, after all, a range of responses to any drug or treatment, and it would be desirable to be able to predict which patients will fall at the end of the bell-shaped curve where the treatment is most effective and which will fall at the end of the curve where the treatment works poorly or not at all.
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Posted in: Basic Science, Diagnostic tests & procedures, Medical Academia, Science and Medicine

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Are Prenatal Ultrasounds Dangerous?

Several questionable sources are spreading alarms about the possible dangers of prenatal ultrasound exams (sonograms). An example is Christine Anderson’s article on the ExpertClick website. In the heading, it says she “Never Liked Ultrasound Technology.”

[She] has never been sold on the safety using Ultrasounds for checking on the fetuses of pregnant women, and for the last decade her fears have been confirmed with a series of studies pointing to possible brain damage to the babies from this technology.

Should We Believe Her?

Should we avoid ultrasounds because Anderson never liked them? Should we trust her judgment that her fears have been confirmed by studies? Who is she?

“Dr.” Christine Anderson is a pediatric chiropractor in Hollywood who believes a lot of things that are not supported by science or reason. Her website mission statement includes

We acknowledge the devastating effects of the vertebral subluxation on human health and therefore recognize that the spines of all children need to be checked soon after birth, so they may grow up healthy.

It also states that “drugs interfere… and weaken the mind, body, and spirit.” Anderson is a homeopath, a craniosacral practitioner, a vegan, and a yoga teacher. She advises her pregnant patients to avoid toxins by only drinking filtered water and only eating organic foods. She sells her own yoga DVD. (more…)

Posted in: Diagnostic tests & procedures, Obstetrics & gynecology

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Electrodermal Testing Part II: Legal and Regulatory Aspects

Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things.

Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require new approval — for biofeedback. It is illegal to use the devices for anything other than biofeedback. The FDA has prohibited their sale or importation for unapproved purposes like electrodermal testing; it has sent warnings to companies, raided clinics, and confiscated machines. States have prosecuted users for practicing medicine without a license. Medical boards have chastised licensed providers. The Quackwatch website lists these regulatory actions but points out that there has been no systematic effort to drive these devices from the marketplace.

Excuses, Excuses

One electrodermal testing website admits that what it is doing is illegal and tries to fight back with this specious disclaimer:

It is important to understand that the laws in the USA forbid me from being able to treat, diagnose, cure or prevent disease. The AMA has a patent on those words and only a licensed medical doctor can do that.  And although it is legal for a licensed medical doctor to violate the Hippocratic oath and prescribe toxic drugs that cause harm and sometimes even kill patients, it is illegal for me to claim you can be cured using natural, nontoxic remedies, even though thousands of people can testify how they have been healed using natural remedies.

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Posted in: Diagnostic tests & procedures, Energy Medicine, Legal

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Virtual Colonoscopy Can Be Hazardous to Your Health

The US Preventive Services Task Force (USPSTF) recommends that everyone aged 50-75 be screened for colon cancer with any one of three options: colonoscopy every 10 years, flexible sigmoidoscopy every 5 years, or fecal occult blood testing (FOBT) every year. Conventional colonoscopy is considered the “gold standard” since it allows for direct detection and biopsy of early cancers and removal of precancerous polyps. It involves passing a long colonoscope via the rectum through the full length of the colon and is also known as optical or visual colonoscopy. A newer and less invasive alternative, virtual colonoscopy or CT colonography, is being promoted by some as the test of choice. Others disagree. One area of controversy is that CTs frequently find “incidentalomas” that require further investigation. An article in the journal Radiology highlights this problem, describing “the clinical drama that follows screening or diagnostic tests.” (more…)

Posted in: Cancer, Diagnostic tests & procedures

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Et tu, Biomarkers?

Everything you know may be wrong. Well, not really, but reading the research of John Ioannidis does make you wonder. His work, concentrated on research about research, is a popular topic here at SBM.  And that’s because he’s focused on improving the way evidence is brought to bear on decision-making. His most famous papers get to the core of questioning how we know what we know (or what we assume) to be evidence. (more…)

Posted in: Basic Science, Clinical Trials, Diagnostic tests & procedures, Epidemiology, Science and Medicine

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Hope and hype in genomics and “personalized medicine”

“Personalized medicine.” You’ve probably heard the term. It’s a bit of a buzzword these days and refers to a vision of future medicine in which therapies are much more tightly tailored to individual patients than they currently are. That’s not to say that as physicians we haven’t practiced personalized medicine before; certainly we have. However it has only been in the last decade or so that our understanding of genomics, systems biology, and cell signaling have evolved to the point where the vision of personalized medicine based on each patient’s genome and biology might be achievable within my lifetime.

I was thinking about personalized medicine recently because of the confluence of several events. First, I remembered a post I wrote late last year about integrating patient values and experience into the decision process regarding treatment plans. Second, a couple of months ago, Skeptical Inquirer published an execrably nihilistic article by Dr. Reynold Spector in Skeptical Inquirer in which he declared personalized medicine to be one of his “seven deadly medical hypotheses,” even though he never actually demonstrated why it is deadly or that it’s even really a hypothesis. Come to think of it, with maybe–and I’m being very generous here–one exception, that pretty much describes all of Dr. Spector’s “seven deadly medical hypotheses”: Each is either not a hypothesis, not deadly, or is neither of the two. Third, this time last week I was attending the American Association for Cancer Research (AACR) meeting in Orlando. I don’t really like Orlando much (if you’re not into Disney and tourist traps, it’s not the greatest town to hang out in for four days), but I do love me some good cancer science. One thing that was immediately apparent to me from the first sessions on Sunday and perusing the educational sessions on Saturday was that currently the primary wave in cancer research is all about harnessing the advances in genomics, proteomics, metabolomics, and systems and computational biology, as well as the technologies such as next generation sequencing (NGS) techniques to understand the biology of each cancer and thereby target therapies more closely to what biological abnormalities drive each cancer. You can get an idea of this from the promotional video the AACR played between its plenary sessions:

Which is actually a fairly good short, optimistic version of my post Why haven’t we cured cancer yet? As I mentioned before, with this year being the 40th anniversary of the National Cancer Act, as December approaches expect a lot of articles and press stories asking that very question, and I’m sure this won’t be the last time I write about this this year.
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Posted in: Basic Science, Cancer, Clinical Trials, Diagnostic tests & procedures, Politics and Regulation

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Overdiagnosis

Dr. H. Gilbert Welch has written a new book Over-diagnosed: Making People Sick in the Pursuit of Health, with co-authors Lisa Schwartz and Steven Woloshin.  It identifies a serious problem, debunks medical misconceptions and contains words of wisdom.

We are healthier, but we are increasingly being told we are sick. We are labeled with diagnoses that may not mean anything to our health. People used to go to the doctor when they were sick, and diagnoses were based on symptoms. Today diagnoses are increasingly made on the basis of detected abnormalities in people who have no symptoms and might never have developed them. Overdiagnosis constitutes one of the biggest problems in modern medicine. Welch explains why and calls for a new paradigm to correct the problem. (more…)

Posted in: Book & movie reviews, Cancer, Diagnostic tests & procedures

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

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Oprah’s buddy Dr. Christiane Northrup and breast thermography: The opportunistic promotion of quackery

Fibrocystic breasts

As many readers know, October is Breast Cancer Awareness Month. What that generally means at our cancer center and in the rest of the “real world” is that, during the month of October, extra effort is made to try to raise awareness of breast cancer, to raise money for research, and promote screening for cancer. Unfortunately, what Breast Cancer Awareness Month means around the Science-Based Medicine blog is that a lot of breast cancer-related pseudoscience and outright quackery will be coming at us fast and furious. There’s no way, of course, that I can deal with it all, but there’s one area of medical pseudoscience related to breast cancer that I just realized that none of us has written about on SBM yet. Actually, it’s not really pseudoscience. At least, the specific technology isn’t. What is pseudoscience is the way it’s applied to breast cancer and in particular the way so many “alternative” medicine and “complementary and alternative medicine” (CAM) practitioners market this technology to women. The technology is breast thermography, and the claim is that it’s far better than mammography for the early detection of breast cancer, that it detects cancer far earlier.

I’ve actually been meaning to write about thermography, the dubious claims made for it with regard to breast cancer, and the even more dubious ways that it’s marketed to women. In retrospect, I can’t believe that I haven’t done so yet. The impetus that finally prodded me to get off my posterior and take this on came from what at the time was an unexpected place but in retrospect shouldn’t have been. You’ve met her before quite recently when SBM partner in crime Peter Lipson took her apart for parroting anti-vaccine views and even citing as one of her sources anti-vaccine activist Sherri Tenpenny. I’m referring, unfortunately, to one of Oprah Winfrey’s stable of dubious doctors, Dr. Christiane Northrup. Sadly, Peter’s example of her promotion of vaccine pseudoscience is not the first time we at SBM have caught Dr. Northrup espousing anti-vaccine views. We’ve also harshly criticized her for her promotion of “bioidentical hormones” and various dubious thyroid treatments. However, Dr. Northrup is perhaps most (in)famous for her advocating on Oprah’s show the use of Qi Gong to direct qi to the vagina, there apparently to cure all manner of female ills and promote fantastic orgasms in the process. This little incident ought to tell you nearly all that you need to know about her. Even Oprah looked rather embarrassed in the video in which Dr. Northrup led her audience in directing all that qi goodness “down below.”

What brought Dr. Northrup to my attention again was my having joined her e-mail list. As you might imagine, I’m on a lot of e-mail lists, ranging from that of Mike Adams, to Generation Rescue, to Joe Mercola and beyond. I do it all for you, in order to have the blogging material come to me rather than my having to seek it out. True, the price is that my e-mail in box is frequently clogged with quackery, but it’s a small price to pay. This time around, Dr. Northrup’s e-mail brought my attention to a post of hers, Best Breast Test: The Promise of Thermography. It was truly painful to read, and I consider it inexcusable that someone who claims to be an advocate of “women’s health” could write something that reveals such ignorance. But, then, I suppose I shouldn’t be surprised after her recent flirtation with anti-vaccine views. If it isn’t already complete, Dr. Northrup’s journey to the Dark Side is damned close to complete. You’ll see what I mean right from her very introduction:
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Posted in: Cancer, Diagnostic tests & procedures, Public Health

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The mammography wars heat up again

PRELUDE: THE PROBLEM WITH SCREENING

If there’s one aspect of science-based medicine (SBM) that makes it hard, particularly for practitioners, it’s SBM’s continual requirement that we adjust what we do based on new information from science and clinical trials. It’s not easy for patients, either. To lay people, SBM’s greatest strength, its continual improvement and evolution as new evidence becomes available, can appear to be inconsistency, and that seeming inconsistency is all too often an opening for quackery. Even when there isn’t an opening for quackery, it can cause a lot of confusion; some physicians are often resistant to changing their practice. It’s not for nothing that there’s an old joke in medical circles that no outdated medical practice completely dies until a new generation of physicians comes up through the ranks and the older physicians who believe in the practice either retire or die. There’s some truth in that. As I’ve said before, SBM is messy. In particular, the process of applying new science as the data become available to a problem that’s already as complicated as screening asymptomatic people for a disease in order to intervene earlier and, hopefully, save lives can be fraught with confusion and difficulties.

Certainly one of the most contentious issues in medicine over the last few years has been the issue of screening for various cancers. The main cancers that we most commonly subject populations to routine mass screening for include prostate, colon, cervical, and breast cancer. Because I’m a breast cancer surgeon, I most frequently have to deal with breast cancer screening, which means, in essence, screening with mammography. The reason is that mammography is inexpensive, well-tested, and, in general, very effective.

Or so we thought. Last week, yet another piece of evidence to muddle the picture was published in the New England Journal of Medicine (NEJM) and hit the news media in outlets such as the New York Times (Mammograms’ Value in Cancer Fight at Issue).
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Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Politics and Regulation

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