The ill-advised, NIH-sponsored Trial to Assess Chelation Therapy (TACT) is finally over. 839 human subjects were randomized to receive Na2EDTA infusions; 869 were randomized to receive placebo infusions. The results were announced at this weekend’s American Heart Association meeting in Los Angeles. In summary, the TACT authors report a slight advantage for chelation over placebo in the “primary composite endpoint,” a combination of five separate outcomes: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina:
Although that result may seem intriguing, it becomes less so when the data are examined more carefully. First, it barely achieved the pre-ordained level of statistical significance, which was P=.036. Second, none of the individual components of the composite endpoint achieved statistical significance, and most of the absolute difference was in coronary revascularization–which is puzzling:
[Editor's note:It's a holiday here in the U.S.; consequently, here is a "rerun" from my other super not-so-secret other blog. It's not a complete rerun. I've tweaked it a bit. If you don't read my other blog, it's new to you. If you do, it's partially new to you. See you all next week with brand spankin' new material. It also (Ih hope) complement's Scott's excellent post from Thursday discussing the same issue and the same paper, but from a different perspective.]
As a cancer surgeon specializing in breast cancer, I have a particularly intense dislike reserved for cancer quacks, which I have a hard time containing at times when I see instances of such quackery applied to women with breast cancer. I make no apologies. These women are, after all, the type of patients I spend all my clinical time taking care of and to whose disease my research has been directed for the last 13 years or so. That’s why I keep revisiting the topic time and time again. Unfortunately, over the years, when it comes to this topic there’s been a depressing amount of blogging material. Indeed, Scott Gavura took a bite out of this particularly rotten apple just a few days ago. Even though he handled the discussion quite well, I thought it would be worthwhile for a breast cancer clinician to take a look. Our perspectives are, after all, different, and this is an issue that, from my perpective, almost can’t be discussed too often.
One question that comes up again and again is, “What’s the harm?” Basically, this question boils down to asking what, specifically, is the downside of choosing quackery over science-based medicine. In the case of breast cancer, the answer is: plenty. The price of foregoing effective therapy can be death; that almost goes without saying. In fact, it can be a horrific and painful death. It is, after all, cancer that we’re talking about. Aside from that, however, the question frequently comes up just how much a woman decreases her odds of survival by avoiding conventional therapy and choosing quackery. It’s actually a pretty hard question to answer. The reason is simple. It’s a very difficult topic to study because we as physicians have ethics. We can’t do a randomized trial assigning women to treatment or no treatment, treatment or quacke treatment, and then see which group lives longer and by how much. If a person can’t see how unethical that would be without my having to explain it, that person is probably beyond explanations. (As an aside, I can’t help but point out that a randomized trial of not vaccinating versus vaccinating is unethical for exactly the same reason; physicians can’t knowingly assign subjects to a group where he knows they will suffer harm. There has to be clinical equipoise.) There’s no doubt that foregoing effective treatment causes great harm. (more…)
I do not want to get all angsty and omphaloskeptic, but I have been thinking more of late about the purpose of the blog and my role in it. Blogs,and the people who write them, are ephemeral. It takes a unique personality and commitment to churn out these essays and commit them to the ether. Especially since Michelson and Morley.
I have never given much thought as to who our readers are, at least as a composite. I read most of the comments on every entry and have certainly developed a mental picture of some of our regular commenters, although I suspect I probably do not have even the gender correct most of the time. The commenters represent a tiny fraction of the regular readers and an even smaller fraction of occasional readers. It occurs to me I haven’t a clue who the real audience of this blog is.
I write first for my own education and entertainment, then for the slightly bored and overwhelmed medicine resident, since that is who I spend most of my time educating at work. Someone educated with an understanding of basic medicine but has more important things on their mind than a need for a detailed understanding of why homeopathy is complete nonsense. I doubt the majority of my readers are health care workers and I suspect continuing medical education is not a major part of the blog.
I never considered SBM to be a consumer protection group, but this week my wife showed me a half page advertisement in the local paper, and I realized that not only was the advertisement a good topic for blogging, but consumer protection is a fundamental result of this blog. There really is no site on the interweb that looks at both SCAM and real medicine with quite the same skeptical eye. Here is the headline:
A Special Wellness Report
New Medicine Based On An 88- Year Old Theory By Albert Einstein Can Help Almost Everyone Who Is Sick Or Injured! (more…)
Editor’s Note:Dr. Gorski was on a rare vacation last week, recharging his batteries. As a result, there is no new material by him this week. Fortunately, Ben Kavoussi was ready with another in his series of posts on traditional Chinese medicine. Dr. Gorski will return next week; that is, if he doesn’t return even sooner because he can’t stand to be away from SBM for two whole weeks.
The established laws of nature do not support Oriental Medicine’s claim of Yin and Yang and Five-Phases Theory. Oriental Medicine’s main theory was constructed when our civilization had limited methods to understand our surroundings, and as such, it is only an ancient illusion.1
— Yong-Sang Yoo, MD, PhD, Chairman of the Committee for Medical Unification, Korean Medical Association, 2010
Yong-Sang Yoo is one of the strong and growing voices in Korea that is calling for an end to the national insurance coverage for Oriental Medicine.
Similarly, Professor Zhang Gongyao of the Central South China University petitioned the central government of China in 2006 to abolish support for Oriental Medicine because it has “no clear understanding of the human body, of the functions of medicines and their links to disease. It is more like a boat without a compass: it may reach the shore finally but it’s all up to luck.”2 Zhang Gongyao and fellow critics have consequently blasted China’s traditional medicine as an often ineffective, even dangerous derivative of witchcraft that relies on untested concoctions and obscure ingredients to trick patients, and employs a host of excuses if the treatments do not work.3
Bloodletting is used in Oriental Medicine to relieve excess “heat,” meaning fever, sore throat, joint pain, muscle sprain, as well as inflammation. It is often practiced in unsanitary conditions.
A Product of Archaic Thinking
The arguments of Yong-Sang Yoo and Zhang Gongyao are reminiscent of those of William R. Morse, Dean of Medical School at West China Union University, who wrote in 1934 that China’s traditional medicine was a “weird medley of philosophy, religion, superstition, magic, alchemy, astrology, feng shui, divination, sorcery, demonology and quackery.” Morse added that Chinese diagnostic methods “border on the ridiculous and possibly cross the line into absurdity.” Harvey J. Howard — a Dean at the Peking Union Medical College — also wrote in 1934 that “the great majority of these Chinese medicines reminds one of the list of remedies suggested by the third witch in Shakespeare’s Hamlet.”4
I contribute biweekly to Science-Based Medicine and could easily devote every post to writing about weight loss supplements, and never run out of topics. As soon as one quick fix falls out of favour, another inevitably replaces it. Some wax and wane in popularity. And pharmacies don’t help the situation. I cringe every time I walk down the aisle where weight loss products and kits are located. Detox? Hoodia? The “fat blaster”? Here are pharmacists, well educated and perfectly positioned to provide good advice to consumers, but standing behind a wall of boxes with ridiculous weight loss promises. Yet pharmacists tell me that these products are not only sought out by customers, but they actually sell well. It’s a lost opportunity to provide good advice, and consumers pay the price.
Perhaps because consumers associate these products with pharmacies, I get regular questions about weight loss programs. I end up developing some degree of familiarity with many of them, if only to be able to credibly redirect away from some of the more harmful plans and approaches. It’s that philosophy that I used recently when I was asked about how to best to manage a “plateau” on the HCG diet. I’d never dispensed human chorionic gonadotropin (HCG) before, but knew of its use for the treatment of infertility, where it promotes egg release. But weight loss? I couldn’t think of a mechanism for how HCG could promote weight loss. So I did some digging, and found a long, rich vein of pseudoscience that dates back decades. (more…)
Many of the specific issues that the Governor and the Legislature asked the Commission to review have festered because the [California] Acupuncture Board has often acted as a venue for promoting the profession rather than regulating the profession.
– Little Hoover Commission, Regulation of Acupuncture: A Complementary Therapy Framework: September 2004, page 63.
On March 12, 2012, during a brief Sunset Review hearing, the California Senate Committee on Business, Professions and Economic Development asked the California Acupuncture Board (the Board) to respond to a set of harsh criticisms.
It is not the first time that the dysfunctional Board — which falls under the Department of Consumer Affairs — is being scrutinized by the legislator. The Board has a long history of operating in an inefficient manner, misreading its governing statutes, and potentially endangering the public by refusing to promulgate regulations concerning the sterilization of acupuncture needles or the wear of medical gloves by practitioners.
In the past, members and affiliates have even been investigated for taking bribes and selling licensing exam answers. The Board was replaced several times in order to clean up the quasi-anarchic and corrupt practice of acupuncture and Oriental medicine in California.
This time, the Senate Committee listed 10 major issues in a Background Paper, which is a worthwhile read for those interested in the regulation of acupuncture. The Senate expressed serious concerns about many administrative, educational, licensing, enforcement, consumer protection and budgetary matters. In response, the Board Chair and Executive Director offered little explanation. The Board now must respond to the Background Paper in specifics. (more…)
A couple of months ago, a reader sent me an article that really disturbed me. In fact, I had originally been planning to write about it not long after I received it. It is, as you might imagine given my specialty and what disturbs me the most wehen I encounter quackery, a story of a cancer patient. Worse, it’s the story of a cancer patient in my neck of the woods. True, it’s not in the same country, but my cancer center is only around two or three miles from the Detroit River and the Canadian border; so it’s plenty close enough. Too close, in fact. Reading the story, in fact, I realized that it features a form of cancer quackery that, as far as my searches have been able to tell me, we haven’t covered before here at SBM, which alone makes it worth taking on, even though the story is two months old. The “cure” is called Cantron, and it is deeply rooted right here in my metropolitan area. Not only that, its siren song and false promises are attracting patients from across the boarder in Canada. Bernie Mulligan is one such patient: (more…)
Voodoo science is a sort of background noise, annoying but rarely rising to a level that seriously interferes with genuine scientific discourse… The more serious threat is to the public, which is not often in a position to judge which claims are real and which are voodoo. Those who are fortunate enough to have chosen science as a career have an obligation to inform the public about voodoo science.
Imagine you are an ordinary person with limited knowledge of science and medicine, and you see this 2010 video on tai chi and qi gong by the National Center for Complementary and Alternative Medicine (NCCAM) — one of the agencies that make up the National Institutes of Health (NIH). I am certain that the solemn voice of the Director of NCCAM, Dr. Josephine Briggs, talking about “rigorous scientific research” and “accurate, authoritative information on complementary and alternative medicine,” will leave you with a strong sense of confidence in her message.
In addition, despite the fine-print and the disclaimer, the appearance of Dr. Briggs in the video could be broadly viewed as a sign of tacit endorsement. Often, the very fact that a treatment is associated with the government is already a de facto stamp of approval and a warranty of efficacy. For instance, the publication below by the California Department of Consumer Affairs states that the NIH formally “endorses” acupuncture, simply because in 1997, a panel of scientists assessed its use and effectiveness for a variety of conditions. Since 1997 the scientific review of acupuncture by NIH has become synonymous with its endorsement, despite the fact that as a federal research agency, the NIH does not endorse any product, service, or treatment.
In October 26, 2011, a few weeks after Steve Jobs’ death, Josephine Briggs decided to do something she has never done before: she put an explicit disclaimer on her blog:
When making treatment decisions, unproven “alternative medicine” approaches should not replace conventional medical care approaches known to be useful or helpful. Simply put, the evidence is not there (emphasis added).2
Three paragraphs down the page, she goes on — with a candor rarely seen from her — that given the recent news about Steve Jobs’ choices for cancer treatment, all health decisions “should be guided by the best available evidence.” (more…)
“The forces of graft and unrighteousness are peculiar to no country or clime, and they have their champions in the high places and the low. Until the people themselves are better educated concerning the danger and iniquity of quackery, they must be protected from the forces that prey. The popular understanding of these matters is becoming better every day, and, aided by proper laws, the time will come, perhaps, when quackery will be unprofitable.”
The above quote is from a recently published JAMA (Journal of the American Medical Association) article. I should say that it is republished, because it first appeared on June 8, 1912. The brief article outlines the issues surrounding the regulation of medical practice so as to protect the public from “quackery.” It is interesting to see that the issues faced 100 years ago are virtually identical (in broad brush strokes) to those we face today. Despite the fact that so much has changed in medicine over the last century, in this regard very little has changed.
To put this article into historical context, it was published just two years after the Flexner Report, generally recognized as the turning point in American and Canadian medical education when it truly embraced scientific and evidence-based practices. Mainstream medicine in 1912 was barely making the transition from being based upon tradition and authority to having scientific backing and genuine standards. Life expectancy in the US had just passed 50, up from a low of around 40 thirty years earlier. Phrenology was still practiced by mainstream psychiatrists and neurologists – although it was on the way out (having recently been refuted by scientific studies) and was increasingly being pushed to the fringe. The last purely homeopathic medical school in the US would not close until 1920. Patent medicines were still the norm, and the 1906 Pure Food and Drugs Act had only recently been enacted to establish some standards of safety in the medicine marketplace (this would essentially transform into the FDA in 1930).
I’ve been at this blogging thing for over seven years, over four of which I’ve been honored to be a part of this particular group blog dedicated to promoting science as a basis for rational medical therapies. For three or four years before that seven year period began, I had honed my chops on Usenet in a group known as misc.health.alternative (m.h.a.). So, although I haven’t been at this as long as Steve Novella, I’ve been at it plenty long, which led me to think I had seen just about everything when it comes to pseudoscience and quackery.
As usual whenever I think I’ve seen it all, I was wrong.
I’m referring to something that has been mentioned once before on this blog, namely something called “Miracle Mineral Solution” (MMS). I must admit that after a brief reaction of “WTF?” I basically forgot about it. I shouldn’t have; I should have looked into it in more detail at the time. Fortunately, being a blogger means never having to say you’re sorry (at least about not having caught a form of quackery the first time it made big news), and fortunately MMS was brought to my attention in the context of an area of quackery that I frequently blog about. You’ll see what I mean in a minute.
What happened is that MMS was brought to my attention again by a couple of readers and, not remembering it other than vaguely, I did what I always do when confronted with these situations. I Googled, and I found what I needed to know. Basically, MMS is 28% sodium chlorite in distilled water. In essence, MMS is equivalent to industrial strength bleach. Proponents recommend diluting MMS in either water or a food acid, such as lemon juice, which results in the formation of chlorine dioxide. (more…)