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NCCAM Criticism from a Not-Quite-Opponent

The demographic of SBM readers are likely to remember the early Miller Lite beer television commercials where sports personalities debated as to whether the beverage “tastes great” or was “less filling.” In one classic version, New York Mets’ Marv Throneberry breaks the shouting match to level his decision: “I feel strongly both ways.”

My colleagues at Science-Based Medicine have generally been opposed completely to the existence of the NIH’s National Center for Complementary and Alternative Medicine (NCCAM). The primary objection is that the Center awards roughly $125 million per year in taxpayer dollars to studies that are generally not based on a strong scientific foundation or, in some cases, absolutely no scientific basis. On the other hand, the best NCCAM-supported studies have provided fruitful results, if not negative with regard to clinical outcomes.

The recent series of articles by Trine Tsouderos at the Chicago Tribune (1, 2, 3, 4) has reignited a national debate as to whether NCCAM is needed at all. After all, NCCAM was not because of science but because of politics, particularly the efforts of Senator Tom Harkin and Representative Dan Burton. And other NIH institutes, such as the National Cancer Institute, seem to do a much more rigorous and science-based job of funding studies of alternative cancer therapies through their unfortunately-named Office of Cancer Complementary and Alternative Medicine, or OCCAM.

In fact, I have long argued that if alternative therapies are to be investigated rigorously, they should be done so under each of the specific NIH institutes and centers (ICs) that have been established to focus on organ systems (National Institute of Diabetes and Digestive and Kidney Diseases; NIDDK) or a class of related disorders (National Institute on Drug Abuse; NIDA).

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Hypothyroidism: The facts, the controversies, and the pseudoscience

As glands go, we don’t give the butterfly-shaped thyroid that straddles our trachea too much  thought — until it stops working properly. The thyroid is a bit like your home’s thermostat: turn it high, and you’re hyperthyroid: heat intolerant, a high heart rate, and maybe some diarrhea. Turn it down, and you’re hypothyroid: cold, tired, constipated, and possibly even depressed. Both conditions are associated with a long list of more serious health consequences. Between the two however, hypothyroidism is far more prevalent. The mainstay drug that treats it, levothyroxine (Synthroid), is one of the most prescribed in the world.

One of my more memorable pharmacy experiences involved levothyroxine. The store had recently changed its prescription labelling standards: It switched from listing the brand name, to only including the generic name (with the manufacturer in parentheses). Few patients noticed. But one elderly patient, taking Synthroid, was furious, and accused me of making a dispensing error. I assured her that levothyroxine was the active ingredient in Synthroid, and she was getting the exact same product as her last visit — but she would have none of it. Her symptoms had worsened, she said, because the medication wasn’t the same. “I want Synthroid — this levothyroxine stuff does not work,” she screamed at me across the counter. No amount of reassurance would satisfy her — I think we eventually resorted to custom, typewritten labels.

I mention this anecdote not to dismiss the symptoms of hypothyroidism as sensitive to placebo effects — hypothyroidism is a real condition with objective monitoring criteria. But this episode was one of my earliest lessons in understanding how perceptions  can shape expectations of effectiveness — something that I’ll come back to, when we look at the controversies of this common condition. Any the treatment of hypothyroidism is not without its controversies – most of which occur outside the realm of medicine, and can more accurately be labelled pseudoscience. (more…)

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Iridology

There are many medical pseudosciences that persist despite a utter lack of either plausibility or evidence for efficacy. Some practices emerged out of their culture of origin, or out of the prevailing ideas of a pre-scientific age, while others were manufactured out of the imagination of perhaps well-meaning but highly misguided individual practitioners. They were just made up – homeopathy, for example, or subluxation theory.

Iridology belongs to this latter category – a system of diagnosis that was invented entirely by Ignatz Peczely, a Hungarian physician who first published his ideas in 1893. The story goes that Peczely as a boy found an owl with a broken leg. At the time he noticed a prominent black stripe in the iris of one eye of the owl. He nursed the bird back to health and then noticed that the black line was gone, replaced by ragged white lines. From this single observation Peczely developed the notion of iridology.

Peczely’s idea was that the iris maps to the rest of the body in some way, and therefore the flecks of color in the iris reflect the state of health of the various body parts. This basic approach to diagnosis or treatment is called the homunculus approach – the idea that one part of the body maps to the rest of the body, including the organ systems. Reflexology, auricular acupuncture, and even straight chiropractic follow this approach.

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A Christmas Card from the SkepDoc

The holiday season is upon us. As a bit of a holiday from science-based writing, I thought I would offer some thoughts inspired by the season and not supported by any scientific evidence.

One of my friends refers to Christmas as “The Feast of St. Dyspepsia.” Holidays are indeed an occasion for over-indulging. People change their routine: they have time off work, they travel, spend too much money, go to parties, skip exercising, eat and drink things they ordinarily avoid, gain weight, and then suffer from post-holiday guilt.

Science and Mom both tell us we will be healthier if we eat our fruits and vegetables, exercise, avoid large quantities of alcohol, get enough rest, avoid stress, and control our weight. I would argue that if we follow that guidance most of the time, an occasional lapse is not likely to matter very much. And the pleasure we experience might even be good for our health.

Now for some heretical words.

Science isn’t everything. Health isn’t everything. Even truth isn’t everything. Humans find value in other things like music and mythology, things that bring great pleasure and help make life worth living.

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The compassion gambit

I’ve spent the last three weeks writing about a “brave maverick doctor” by the name of Stanislaw Burzynski who claims that he can cure cancers that regular oncologists cannot. He uses a combination of what he calls “antineoplastons” (which, it turns out, are more or less than the active metabolites of an orphan drug known as sodium phenylbutyrate) plus a very expensive cocktail of chemotherapy and targeted agents chosen in a haphazard fashion and thrown together with little rhyme or reason. This week, I had planned to move on. However, I felt that I had to mention the Burzynski saga because it provides me with the most appropriate segue to a topic I’ve been meaning to write about for a long time, possibly since this blog began. In fact, it’s about as perfect a framework as I can think of upon which to drape the points I want to make in this post.

What I will discuss is perhaps the most effective, devastating attack that proponents of quackery, woo, and nonsense aim at supporters of science-based medicine (SBM). As far as that is the case, it is not effective because it’s fact-based, evidence-based, or science-based. Far from it. Rather, it’s effective because it appeals to the emotions and very effectively demonizes SBM proponents to the point where they often have a hard time standing their ground when it is used. Sometimes, it preemptively prevents them from even speaking up in the first place. It’s a little tactic that I like to call the “compassion gambit,” which means trying to discredit critics of “alternative” medicine by painting them as cold, unfeeling, uncaring, arrogant monsters who want to hurt or kill children (and probably get a big smile on their faces when they torture puppies, to boot).
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Alas poor Craniosacral. A SCAM of infinite jest, of most excellent fancy.

It is hard to Sokalize alternative medicine. The closest has been buttock reflexology/acupuncture, but that is a tame example.  Given the propensity for projections of the human body to appear on the iris, hand, foot, tongue, and ear, postulating a similar pattern on the buttocks are simple variations on a common SCAM (Supplements, Complementary and Alternative Medicine) theme. The buttocks?  Not really different from any of the other focal acupunctures.  Most of SCAM does not concern itself with application of reality  and physiology, anatomy, biochemistry, etc can all be expected to be ignored with virtually all SCAM modalities.

Every time I think the heights (or depths) of absurdity has been reached, I discover a Braco the Starer or Himalayan Salt Inhalers. This blog is not affiliated with the British Medical Journal in any way, and although this is being published near Christmas, I want no one think that what follows is a hoax.  I am not, I repeat not,  making up what follows. It is not fiction. Well, it is fiction, but not written by me and believed and practiced by some who really should know better.

Craniosacral Therapy
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Vaccination mandate exemptions: gimme that ol’ time philosophy

Each of the 50 states and the District of Columbia require vaccination against certain diseases as a prerequisite to public and private school attendance, most commonly polio, mumps, measles, diphtheria, rubella, chicken pox, Heamophilus influenza type b, pertussis, tetanus, pneumococcal disease and hepatitis B. Unfortunately, mandatory vaccination for home-schooled children is rare. (1)

All states provide medical exemptions to vaccination mandates for those for whom vaccination poses a health threat. Indeed, it is doubtful that a state could constitutionally deny such medical exemptions.

Forty-eight states also allow exemptions based on religious beliefs. While it might be assumed that religious exemptions are required by the protection afforded religion under the First Amendment to the U.S. Constitution that is not the case. The opposite is true. Religious exemptions themselves are constitutionally suspect. In fact, to pass First Amendment muster, a state’s religious exemption statute may have to be so broad as to become, in essence, a “philosophical” exemption.

Vaccination mandates survive early challenges

Compulsory vaccination laws have enjoyed strong support in the state and federal courts for over a century. Early in the 20th century, the U.S. Supreme Court considered the constitutionality of a statute authorizing a municipal board of health to require and enforce vaccination, in this case during a smallpox epidemic. The Court found the legislation represented a valid exercise of the state’s police power. In a statement that proved prescient about the failed constitutional challenges to vaccination mandates which followed, the Court said that “we do not perceive that this legislation has invaded any right secured by the Federal Constitution.” Jacobson v. Massachusetts, 197 U.S. 11, 38 (1905).

In 1922, the Court specifically addressed the subject of school vaccination, holding that it is a valid exercise of the state’s police power to make vaccination a condition of attending public or private school. Zucht v. King, 260 U.S. 174 (1922).
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Defending CAM with Bad Logic and Bad Data

At SBM our mission is to promote the highest standards of science in medicine, and to explore exactly what that means, both in the specific and the general. We do spend a lot of space criticizing so-called CAM (complementary and alternative medicine) because it represents a semi-organized attempt to reduce or even eliminate the science-based standard of care, and to sow confusion rather than clarity as to how science works and what the findings of medical science are.

CAM proponents tend to use the same bad arguments over and over again. They have no choice (other than deciding not to be CAM proponents) – if a treatment were backed by solid logic and evidence it would not be CAM, it would just be medicine.  As SBM’s fourth year comes to a close I thought I would round up the most common bad arguments that CAM proponents put forward to defend their position. Like creationists, pointing out the errors in their facts and logic will not stop them from continuing to use these arguments. But this lack of imagination on their part makes it somewhat easy to counter their arguments, since the same ones will come up again and again.

The argument from antiquity

Our SBM colleagues in Australia have been critical of the incorporation of unscientific methods into academia. In defense of this practice:

Professor Iain Graham from Southern Cross University’s School of Health yesterday defended his university, saying the use of alternative therapies, such as homeopathy, can be traced as far back as ancient Greece.

This is a common claim – that some CAM modalities have been around for centuries, or even thousands of years, and so they must work. I am not sure if professor Graham intended to state that homeopathy can be traced back to ancient Greece, perhaps he just meant that some CAM therapies can, and chose homeopathy as a bad example. For the record, homeopathy was invented by Samuel Hahnemann about 200 years ago.

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Phthalates and BPA: Of Mice and Men

Is your soup poisoning you? In a recent study  subjects who ate canned vegetable soup had markedly increased levels of BPA in their urine compared to those who ate freshly prepared soup. We are constantly bombarded with alarmist warnings about the dangerous chemicals in the products we use. Especially BPA (Bisphenol A) and phthalates. Beware plastic bottles! Beware rubber ducks! And now, beware canned soup!   BPA and phthalates are classified as endocrine disruptors. They have been discussed before on SBM here and here.  BPA has been accused of causing everything from obesity to prostate cancer. Phthalates have been accused of causing everything from breast cancer to reduced anogenital distance in baby boys (the significance of this is unknown: there is not even any standard for what the normal distance is).

In the book Slow Death by Rubber Duck

Using a variety of test methods, the authors determined individual “body burdens,” or the toxic chemical load we carry. The innocuous rubber duck, for example, offers a poison soup of phthalates that “permeate the environment and humans.” From other products and food we also have a collection of chemicals shorthanded as PFCs, PFOAs, PSOSs, and PCBs. None of them are good, and they are everywhere…

Is this science or irresponsible fear-mongering? What does the best evidence tell us? Should we be afraid of our canned soup and rubber ducks? (more…)

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Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure

Over the last couple of weeks, I’ve been spending a lot of time (and, characteristically, verbiage) analyzing the phenomenon known as Dr. Stanislaw Burzynski and his “cancer cure” known as antineoplastons. In part I of this series, Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R., I used the legal threats against bloggers criticizing the credulous promotion by the British press of fundraising campaigns to send children with terminal cancer to the Burzynski Clinic and the promotion of the medical propaganda movie Burzynski The Movie: Cancer Is Serious Business to review the movie’s claims and look into Burzynski’s claims for antineoplastons. Not surprisingly, I found the evidence for extravagant claims for their anticancer effects unconvincing. In part II, Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?, I looked into Dr. Burzynski’s recent efforts to “diversify his portfolio, in which he has apparently decided to ride the new wave of genomic medicine to claim he can do “personalized, gene-targeted cancer therapy.” I concluded that he does appear to do that, only very badly, in essence “making it up as he goes along.”

In this third and final part, I want to come back to antineoplastons, because it has been pointed out to me that there is an aspect of this story that has received little attention. One reader in particular has helped enormously in my education about this aspect of the Burzynski saga. I wish I could credit this person by name, but, for reasons I fully understand, I can’t. However, this person’s input was essential, and I’ve even appropriated (with permission, of course) a little bit of text here and there from our e-mail exchanges to “integrate” into this post. Putting this together with information in my previous posts, I think we can come to some conclusions about what it is that Dr. Burzynski is really doing.

Burzynski and an orphan drug

In the first part of this series, I pointed out that back in the 1970s Dr. Burzynski claimed to have discovered cancer-fighting substances in human urine, which he dubbed “antineoplastons,” claiming that patients with cancer had lower levels of these substances in their blood and urine. However, I was pretty vague about just what these substances were, other than to point out that they were modified amino acids and that since 1980 Dr. Burzynski has been synthesizing them in a chemistry lab rather than isolating them from urine as he had done up until then. This vagueness came simply from my interest in moving straight to looking at Burzynski’s claims rather than what these substances were. In retrospect, that might have been a mistake. The reason is that understanding what two of Burzynski’s antineoplastons are is critical to understanding what he is doing with them and why he might occasionally appear to be observing an antitumor response.
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