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Archive for May, 2012

The regulation of nonsense

 The most meticulous regulation of nonsense must still result in nonsense.

– Edzard Ernst, M.D., PhD., professor, Complementary Medicine, Peninsula Medical School, University of Exeter, UK

One necessity of licensing so-called “complementary and alternative,” or “CAM,” practitioners is to spell out exactly what is encompassed in the CAM scope of practice. This is unfortunate for the practitioners because it forces an exposé of the nonsensical precepts underlying their claims. For example,

‘Acupuncture’ refers to a form of health care, based on a theory of energetic physiology that describes and explains the interrelationship of the body organs or functions with an associated acupuncture point or combination of points located on ‘channels’ or ‘meridians’. . . Acupuncture points are stimulated in order to restore the normal function of the aforementioned organs or sets of functions.

(Delaware acupuncture practice act.)

[Chiropractic is] the science of adjusting the cause of the disease by realigning the spine, releasing pressure on nerves radiating from the spine to all parts of the body, and allowing the nerves to carry their full quota of health current (nerve energy) from the brain to all parts of the body.

(North Carolina chiropractic practice act.)

The practice of naturopathic medicine includes, but is not limited to, the following services:. . . ordering, administering, prescribing, or dispensing for preventive and therapeutic purposes: food, extracts of food, nutraceuticals, vitamins, minerals, amino acids, enzymes, botanicals and their extracts, botanical medicines, herbal remedies, homeopathic medicines, dietary supplements and nonprescription drugs as defined by the federal Food, Drug, and Cosmetic Act, glandulars, protomorphogens, lifestyle counseling, hypnotherapy, biofeedback, dietary therapy, electrotherapy, galvanic therapy, oxygen, therapeutic devices, barrier devices for contraception, and minor office procedures, including otaining specimens to assess and treat disease. . .

(Minnesota naturopathic practic act.)

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Posted in: Energy Medicine, Legal, Politics and Regulation, Science and Medicine

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Prince Charles Alternative Medicine Charity Closes

The Princes Foundation for Integrated Health closed shop in 2010. Now the company that ran the foundation has officially closed. The foundation was a vanity project by Prince Charles, who had a soft spot for so-called alternative medicine and natural therapies. The foundation was established in 1993 and in the last 19 years has misinformed the public about CAM therapies, promoted nonsense like homeopathy, and has been an official royal seal of approval on the anti-science in medicine movement in the UK.

In short the foundation was an excellent example of why political ideology should not interfere with the normal process of science. The website for the charity no longer exists, but this is what it said about it’s mission:

“The Prince’s Foundation for Integrated Health is a UK charity championing an integrated approach to health.

“The Foundation works towards a culture of health and wellbeing with people and communities taking more responsibility for their own health, and where health professionals collaborate and share learning in the best interests of their patients.

“Integrated health means an approach to health which:

  • “emphasises prevention and self-care
  • “looks at the person in the round, taking into account the effects on health of lifestyle, environment and emotional wellbeing
  • “brings together the safest and most effective aspects of mainstream medical science and complementary healthcare.”

This is typical CAM bait and switch. Preventive medicine, healthy lifestyles, and taking a complete approach to health is not alternative or complementary – it is part of mainstream science-based medicine. All of that is actually a misdirection from the real goal of the CAM or “integrative” movement – to promote health products and services that fail to meet minimal standards of evidence and plausibility, or which have already been shown to be ineffective. The Prince’s Foundation was not exception, promoting over the years every form of quackery from homeopathy to Reiki.

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Posted in: Public Health

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RISUG: Birth Control for Men

According to an enthusiastic article on the Internet, “The Best Birth Control In the World Is For Men.”

It’s called RISUG: Reversible Inhibition of Sperm Under Guidance. It involves a minor surgical procedure in which the vas deferens is exposed and pulled outside the scrotum by the same techniques used for a vasectomy. A copolymer, powdered styrene maleic anhydride (SMA, for which the method was previously named) combined with dimethyl sulfoxide (DMSO) is then injected into the vas deferens. The polymer coats the walls of the vas and kills the sperm as they swim by. The mechanism is not understood, but the developer thinks the polymer’s mosaic of positive and negative charges causes the membranes of the sperm to burst, rendering them immotile.

RISUG is rapidly effective: in a phase II clinical trial in India, viable sperm were absent as soon as 5 days after the procedure. They say there have been no pregnancies in the first months “other than a handful of cases in which the RISUG was not injected properly.” (One wonders how they determined that it was not injected properly: by the fact that pregnancy occurred? Could this be just a rationale to explain away failures? Or to spare patients the embarrassment of discovering the wife had another sperm donor?) The contraceptive effect is said to last for a decade or more; it might require repeat injections every 10 years.
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Posted in: Surgical Procedures

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Another cancer tragedy in the making

I despise cancer quacks.

I know, I know. My saying that is probably akin to saying that the sun rises in the east, water is wet, and Donald Trump’s hair resembles nothing in nature. You know, brain-meltingly obvious statements. It’s true, though. I despise cancer quacks. It doesn’t much matter to me whether the quack is a true believer or a calculating con artist, the end result is the same: People with cancer throwing their one best chance to survive away chasing pixie dust and promises of “natural” cures without the toxicity that is the unfortunate byproduct of the surgery, radiation, and chemotherapy that are the mainstays of our current armamentarium against cancer. I’m a cancer surgeon. This I cannot abide, which is part of the reason I became active promoting science-based medicine, started my other blog, and then was so eager to join up when the opportunity to join this blog presented itself four years ago.

It’s hard to blame patients, too. After all, as I’ve described so many times before, curing cancer is hard. Very hard. Cancer is complicated. Incredibly complicated. Quacks make it sound easy and simple. They postulate One True Cause of Cancer, and, as a result, often what they represent as the One True Cure for All Cancer. Faced with a life-threatening disease and the possibility of chemotherapy, surgery, and/or radiation therapy, patients are understandably frightened and, if they don’t have a scientific background, susceptible to the blandishments of quacks. That’s what happened to a patient I wrote about long ago, and that’s what happened to Kim Tinkham.

It’s also what is happening right now to a woman named Danielle, and, worse, she’s falling victim to the same cancer quack. Worse still, from my point of view, she’s blogging it.
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Posted in: Cancer, Health Fraud, Science and Medicine

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Dental X-rays and Brain Tumors — Oh My!

Fear sells, and the media loves it. If it’s scary, no matter how tenuous the link or inconclusive the study, you are going to see it on the news. How many times over the years have you heard that your cell phone might give you brain cancer, even though it never turns out to be true? Once such a claim is made, however, it becomes lodged into the public’s psyche and is accepted as true, even after refutations and retractions are published (see Wakefield, Andrew).

And so it is with x-rays. The latest scare du jour, a recent study out of Yale that claims to show a correlation between dental x-rays and intracranial meningioma — the most common brain tumor and usually benign — has been enjoying widespread attention in newspapers and on the evening news. We don’t know if it will be on Dr. Oz, because we can’t bring ourselves to watch that show, but we feel the chances are good. Other alt-medders will no doubt have collective woogasms over the story and will further incite fear and mistrust into the doctor-patient relationship. In fact, the Mercola website wasted no time in weighing in:

While this study does not necessarily establish causation between dental X-rays and tumors, previous research has also implicated dental X-rays in the development of thyroid cancer, and research clearly shows this type of radiation is not harmless…

Typical alarmist fear-mongering. When has any health care professional claimed that radiation is harmless? This is not cutting edge research; Wilhelm Röntgen, the discoverer of x-rays in 1895 and winner of the Nobel Prize in 1901 for his research in the field, advocated the use of lead aprons for protection from the ionizing radiation way back when. Further, trying to lump one study linking dental x-rays to meningioma to another study linking them to thyroid cancer is taking quite the kitchen sink approach. But if there are multiple alleged possible potential theoretical adverse effects from our dental death rays, it must be true, right?

Well, not so fast. We’re dentists, and unlike many knee-jerkers, we’ve actually read the study and would like to offer a little bit of insight into this before everyone panics. In fact, with respect to Letterman, we’d like to offer our Top Three Reasons Not To Panic:
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Posted in: Cancer, Dentistry, Epidemiology, Medical Academia, Science and the Media

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Announcement: New Edition of Consumer Health

For decades Consumer Health: A Guide to Intelligent Decisions was the only textbook available for college classes on the subject, and it is still the best: the most comprehensive and the most reliable. It was first published in 1976, and it has clearly had staying power. An updated 9th edition has just been released. The authors have changed over the years: this edition’s authors are Stephen Barrett, William London, Manfred Kroger, Harriet Hall, and Robert Baratz. It’s an invaluable compendium of information that would be useful to any consumer, and it’s unfortunate that McGraw-Hill is marketing it as an expensive textbook ($163).

What exactly is “consumer health”? The book’s preface and the table of contents are available here. They will provide the long answer to that question. The short answer is:

The book’s fundamental purpose is to provide trustworthy information and guidelines to enable people to select health products and services intelligently. (more…)

Posted in: Announcements, Book & movie reviews

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The drug expiry date: A necessary safety measure, or yet another Big Pharma conspiracy?

Consider this scenario: You’re in good health and take no prescription drugs. You use the following remedies occasionally:

  • Excedrin for the rare migraine
  • Arnica 30CH for bumps and bruises
  • Echinacea capsules, when you feel a cold coming on

Today you look in your cupboard, and notice all three products expired last year. Would you still consider taking any of them? Why or why not?

Your answer is probably influenced by a number of factors, including perceptions of risk and benefit. I’ve encountered patients who believe that drugs are less active as they near the expiration date, and others who see expiry dates solely as marketing ploy from Big Pharma. Few understand how they’re calculated.

Over the past few months I’ve written several posts on different aspects of drug development and testing, including drug interactions, fillers and excipients in drug products, the equivalence testing of generic drugs, and the management of drug allergies. I’ve done this for two reasons. The first is to develop a SBM-oriented resource for common questions and misconceptions about the mechanics of modern medicines. The second, less obvious reason for these posts has been to illustrate the serious credibility gaps with CAM therapies. Largely because of a lax regulatory framework, the CAM industry has ballooned into a multi-billion dollar market without answering basic questions that should be asked of any supplement or drug, “alternative” or otherwise. What’s not well known to consumers, but is glaringly obvious to SBM advocates, is that CAM largely ignores issues of  pharmacology: understanding how a chemical substance, once consumed, behaves in the body. It’s critical to scientific medicine, but an unnecessary step for CAM, where there’s no need to determine if a product has a beneficial biological effect before selling it. Fundamental tests in medicine, like the identification and isolation of an active ingredient, or understanding dose-effect relationships, are simply ignored. As David Gorski and Mark Crislip have pointed out over the past week, we have a reality bias at SBM.  And this bias is equally jarring when it comes to considering expiry dates for products: real drugs, and also CAM.

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Posted in: Basic Science, Herbs & Supplements, Pharmaceuticals

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Pseudoscience is not Cost Effective

Industrialized nations are in the middle of a health care crisis (some more than others), or at least a dilemma. As our medical technology advances, people are living longer, they are living with chronic diseases, and they are consuming more health care. The cost of this health care is rising faster than economic growth, so it is becoming a greater and greater burden on society. Many countries ration health care in one way or another in order to contain costs. Otherwise there is no easy or obvious solution and it’s likely that difficult choices will have to be made.

An interesting side effect of this dilemma is a renewed focus on the cost effectiveness of medicine. Effectiveness alone is not enough. We simply cannot afford, for example, to introduce a very expensive treatment for marginal improvement in outcome in a common disease. Different options can also be compared not only for their safety and efficacy, but for their cost effectiveness. In other words, we need to use cheaper alternatives when available rather than always reaching for the latest and greatest (and most expensive) treatment.

This situation provides an opportunity for science-based medicine. Treatments that are promoted as complementary and alternative (CAM) are often sold as cost effective because they are less expensive up front than standard medical care. We cannot, however, cede this argument to proponents of dubious therapies. Cheap does not mean cost effective. You have to be effective in order to be cost effective, and most of the dubious treatments that are marketed under the CAM umbrella are ineffective.

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Posted in: Politics and Regulation, Science and Medicine

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Homeopathy and Nanoparticles

I had never heard of Dr. Shantaram Kane, a chemical engineer in Mumbai, India. I don’t know how he heard of me, but he apparently knows I am critical of homeopathy. He e-mailed me out of the blue to tell me about a study he had published in 2010 in the journal Homeopathy: “Extreme homeopathic dilutions retain starting materials: A nanoparticulate perspective.” The full text is available online here.  It was lauded in an accompanying editorial.  Incredibly, it is an uncontrolled study.

Kane recognizes that a major objection to homeopathy is that, at high potencies, not a single molecule of the starting material is present. He says his study found nanoparticles of the parent metal in 200C dilutions of metal-based remedies. He says his findings represent a paradigm shift. In other words, there really is something there when we assumed there wasn’t. (more…)

Posted in: Homeopathy

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Plausibility bias? You say that as though that were a bad thing!

On Friday, you might have noticed that Mark Crislip hinted at a foreshadowing of a blog post to come. This is that blog post. He knew it was coming because when I saw the article that inspired it, I sent an e-mail to my fellow bloggers marking out my territory like a dog peeing on every tree or protecting my newfound topic like a mother bear protecting her cubs. In other words, I was telling them all to back off. This article is mine.

Mine! Mine! Mine! I tell you!

My extreme territorial tendencies (even towards my friends and colleagues) notwithstanding on this issue aside, if you read Mark’s post (and if you didn’t go back and read it now—seriously, go now), you might also remember that he was discussing a “reality bias” in science-based medicine (SBM), a bias that we like to call prior plausibility. In brief, positive randomized clinical trials (RCTs) testing highly implausible treatments are far more likely to be false positives than RCTs testing more plausible treatments. That is the lesson that John Ioannidis has taught us and that I’ve written about multiple times before, as have other SBM bloggers, most prominently Kimball Atwood, although nearly all of us have chimed in at one time or another about this issue.

Apparently a homeopath disagrees and expressed his disagreement in an article published last week online in Medicine, Health Care, and Philosophy entitled Plausibility and evidence: the case of homeopathy. You’ll get an idea of what it is that affected us at SBM like the proverbial matador waving his cape in front of a bull by reading this brief passage from the abstract:

Prior disbelief in homeopathy is rooted in the perceived implausibility of any conceivable mechanism of action. Using the ‘crossword analogy’, we demonstrate that plausibility bias impedes assessment of the clinical evidence. Sweeping statements about the scientific impossibility of homeopathy are themselves unscientific: scientific statements must be precise and testable.

Scientific. You keep using that word. I do not think it means what you think it means. Of course, his being a homeopath is about as close to a guarantee as I can think of that a person doesn’t have the first clue what is and is not scientific. If he did, he wouldn’t be a homeopath. Still, this particular line of attack is often effective, whether yielded by a homeopath or other CAM apologist. After all, why not test these therapies in human beings and see if they work? What’s wrong with that? Isn’t it “close-minded” to claim that scientific considerations of prior plausibility consign homeopathy to the eternal dustbin of pseudoscience?

Not at all. There’s a difference between being open-minded and being so “open-minded” that your brains threaten to fall out. Guess which category homeopaths like Rutten fall into. But to hear them tell it, homeopathy is rejected because because we scientists have a “negative plausibility bias” towards it. At least, that’s what Rutten and some other homeopaths have been trying to convince us. This article seems to be an attempt to put some meat on the bones of their initial trial balloon of this argument published last summer, which Steve Novella duly deconstructed.

Before I dig in, however, I think it’s necessary for me to “confess” my bias and why I think it should be your bias too.
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Posted in: Basic Science, Clinical Trials, Homeopathy, Science and Medicine

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