On the pages of SBM we frequently discuss homeopathy, and rightfully so considering its position as one of the most pervasive yet dumbest forms of alternative medicine. Just yesterday our own Scott Gavura, who is neither pervasive nor dumb, wrote an excellent review of some recent improvements in the regulation of these ridiculous remedies in Canada, and I encourage readers to check that out. Sadly, despite numerous high profile setbacks for the practice, including a thorough trouncing by the Australian National Health and Medical Research Council in March, proponents of what is essentially the belief in sympathetic magic continue to clutter the pubmeds and interwebs with worthless studies. (more…)
Do you believe in magic? It might surprise you to learn that some people believe sugar pills have healing properties. This belief system, called homeopathy, is a multi-billion dollar industry worldwide, and it’s growing. While there is no convincing evidence to demonstrate that homeopathic treatments are more effective than a placebo, many consumers and even some health professionals accept homeopathy as a legitimate health treatment, and its providers as legitimate health professionals. Responding to the perceived consumer demand for these products, government regulators have had a difficult decision to make: They could ignore homeopathy as a health practice, treating it like we might think of astrology: firmly outside of medicine. Or they could choose some form of regulation, targeting the providers (homeopaths) or the product (homeopathy), possibly with the goal of managing its use, or perhaps limiting harms to consumers. The risk of regulating nonsense, as has been described before, is the perceived legitimacy that recognition and regulation implies. Regrettably, regulation in many countries has had that exact effect. What’s worse, regulation often seems to have prioritized the commercial interests of homeopaths over the public interest, leaving consumers with little understanding that homeopathy lacks scientific credibility as a health practice. Consequently, homeopathy has attracted regular criticism from SBM’s bloggers, science and health journalists, and other science advocates over the years. It appears this advocacy is finally having an effect. Regular readers will recall several posts over the past few weeks, describing the possibility of new regulation of homeopathy by the US Food and Drug Administration (FDA). And just recently, Health Canada announced two important changes to its homeopathy regulation, which may signal a new direction. Are we witnessing the beginning of more sensible regulation of this prescientific practice? (more…)
In a recent editorial for the New York Times, Aaron E. Carroll argues, “Labels Like ‘Alternative Medicine’ Don’t Matter. The Science Does.” I agree with this headline thesis, but the details of his argument ironically show the harm that the so-called CAM (complementary and alternative medicine) movement has done.
Carroll starts out well, essentially pointing out that the division between “conventional” and “alternative” medicine, and the division between “Western” and “Eastern” medicine are false dichotomies. Despite this strong start, he muddles his way through the rest of his editorial.
The primary error he commits is to swing from a false dichotomy to a false equivalency, essentially saying that there is no difference between conventional and alternative practice or practitioners. In order to support this contention, however, he has to distort the facts beyond recognition.
In other words, Carroll commits the less-well-known false continuum logical fallacy. Let me explain.
The real differences between SBM and CAM
“Dr. Joe” (from the title of his radio show) has done it again. He keeps putting out books faster than I can take them in; this one is titled Monkeys, Myths, and Molecules. It is packed with pithy analyses of health-related subjects that should be of particular interest to SBM readers.
Dr. Joe is Joseph Schwarcz, a chemistry professor and science popularizer based at McGill University. I’ve reviewed two of his many previous books before, Is that a Fact? here on SBM and The Right Chemistry over at Skeptic.com, as well as his free online chemistry lectures, “Food for Thought“, over at edX.org. As usual, this new book is a compendium of short (four-page) articles on a variety of subjects, written in a humorous, accessible style, and larded with intriguing trivia like where to see the largest illuminated advertising sign in the world.
If you read this book, you will:
- Learn that Mozart only had seven teeth when he died.
- Learn what was the first synthetic drug ever given to a human, and who administered it.
- Learn that Popeye really ate spinach for the vitamin A, not for the iron, and how myths about myths about spinach (no, that’s not a typo) led to ever-increasing misinformation.
- Hear the story of American military experts in WWII who had the bright idea of turning bats into weapons by attaching small incendiary devices to them. In an experiment hilariously gone wrong, the flaming bats set fire to a general’s car. (Remember that saying about military intelligence?)
- Learn the role of coprolites (fossilized animal poop) in the development of modern agriculture.
- Learn why Greek yogurt is not friendly to the environment.
Dr. Joe is a packrat for tidbits like these. I wonder where he finds them all. He seems to have a bottomless supply. (more…)
The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients suffering from deadly diseases demand faster approval of drugs that might give them the hope of surviving their disease, or at least of surviving considerably longer. This is a powerful force for reform, as evidenced by HIV/AIDS activism in the 1980s and 1990s that led to the development of fast-track approval mechanisms for drugs for life-threatening conditions, a change whose effects have been mixed. It’s also a powerful force potentially for ill, as I’ve documented in my posts about the understandable but misguided “right-to-try” movement. After all, what politician can say no to a constituency representing desperately ill people who only want a shot at survival? It’s not all desperate patients, however. Also wanting more rapid drug approval are powerful business interests in the form of the pharmaceutical and medical device industries, for whom the time and expense of prolonged clinical trials eat into profits and make some drugs not worth developing from a business standpoint.
In 1962, after Frances O. Kelsey, MD, PhD (who died on Friday at the age of 101) successfully prevented the approval of the drug thalidomide in the US, a drug found to cause serious birth defects, Congress passed the Kefauver-Harris Drug Amendments to the Federal Food, Drug, and Cosmetic Act. These amendments required that drug companies not just show safety before their drugs could be FDA-approved, as had been the case prior to the amendments, but also to provide substantial evidence of effectiveness for the product’s intended use. That evidence had to be in the form of adequate and well-controlled clinical trials, which at the time was considered a revolutionary requirement. (Believe it or not, no requirement for high quality clinical trials existed before 1962.) This led to the current system of phase I, II, III, and IV clinical trials in force in the United States today. The amendments also included a requirement for informed consent of study subjects and codified good manufacturing processes, as well as the requirement that adverse events be reported. This has been, with some tweaking over the years, the law of the land regarding how the FDA approves drugs for specific indications
Medicine is a lot more complex now than it was in the 1960s however, and there has been a growing sentiment that the system is, if not broken, at least functioning in a way that is behind the times, a manner that was acceptable and appropriate 40 years ago but is no longer so in this era of genomics, precision medicine (formerly known as “personalized medicine”), and targeted therapies. The new drug approval process, which can take up to a decade and cost a billion dollars, it is argued, is too rigid, cumbersome, and slow for the 21st century. (Why it wasn’t too rigid, cumbersome, and slow in the 20th century, no one seems to say. I guess that “21st century” sounds way cooler.)
Into this ongoing controversy have marched Rep. Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.), who have sponsored a bill passed by the House of Representatives in a rare display of bipartisanship in July. The bill, H.R.6, is entitled the “21st Century Cures Act“. Given how it passed the House by a vote of 344-77, one would think that it should glide through the Senate easily. Certainly, its sponsors and supporters have mounted a mighty PR effort. That might not be the case, given that in the Senate a single senator can hold up or even kill a bill through a filibuster, and to shut down a filibuster or prevent a threatened filibuster requires 60 votes. Be that as it may, I’m not so much interested in the politics of this bill, which, if it survives the Senate, will almost certainly be significantly amended, but rather what the bill does.
Do You Believe in Magic?
Do you believe in magic for a back pains fix
How the needles can free her, where ever it pricks
And it’s magic, if the chi is groovy
It makes you feel happy like an old-time movie
I’ll tell you about the magic, and it’ll free your soul
But it’s like trying to tell a CAM ’bout randomized control
If you believe in magic don’t bother to choose
Although subluxation is simply a ruse
Just go and get adjusted on the table
It won’t wipe off the pain no matter how hard you try
Your wallet is empty and you can’t seem to find
How you got there, so just blow your mind
If you believe in magic, come along with me
We’ll CAM until morning paid for by the OHP
And maybe, if the CAM is right
I’ll meet you tomorrow, sort of late at night
And we’ll go dancing, baby, then you’ll see
How the magic’s in the CAM and the CAM’s in me
Yeah, do you believe in magic
Yeah, believe in the magic of a back pains fix
Believe in the magic of CAM
Believe in the magic that can set you free
Oh, talking ’bout magic
Do you believe like I believe… Do you believe in magic
Do you believe like I believe… Do you believe, believer
Do you believe like I believe… Do you believe in magic
The Lovin’ Spoonful. Sort-of.
Maybe not my best lyrics.
More Oregon magic
Oregon has a problem with prescription pain pills. Oregon leads the nation in the abuse of such drugs, federal statistics show, with Oregon’s rate of prescription drug abuse 39 percent higher than the national average. Go us.
Why that is, I do not know. As an Infectious Disease doctor I prescribe a narcotic about once a year. There are real problems with the treatment of chronic pain and while I am aware of the issues and the changes over the last 25 years, it does not impact my practice, so my knowledge of the issues is basic.
I am also well aware of the Oregon Health Plan (OHP). The OHP was intended to make health care more available to the working poor, while rationing benefits. They were fairly transparent that resources were fixed and not everything would be covered.
Given limited resources, part of the plan has always included a prioritization of treatments and diagnostics, paying for care that give the most bang for the buck. Not a perfect way to ration care and as is always the case, no good deed goes unpunished. (more…)
Author’s note: The FDA has asked for public comments on the regulation of homeopathic products. The Society for Science-Based Medicine’s Comment follows, modified for this format. The Comment is based in part on two previous posts, “How should the FDA regulate homeopathic remedies?” and “Homeopathic industry and its acolytes make poor showing before the FDA.” The comment period closes August 21, 2015.
Society for Science-Based Medicine
Comment: Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century
All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription, fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. In accordance with its consumer protection mandate, the FDA should take immediate action to remedy this by requiring that all homeopathic drugs comply with the same statutes and regulations as all other OTC and prescription drugs. (more…)
Recently there was another round of scaremongering headlines and articles claiming that cell phones can cause brain cancer. The Daily News wrote: “The scientists were right — your cell phone can give you cancer.” Many online news sites declared: “SHOCK STUDY: CELLPHONES CAN CAUSE CANCER,” in all caps to make sure you understand that you should be alarmed. None of the mainstream reporting I saw looked past the press release.
Let’s take a look at the actual study: “Oxidative mechanisms of biological activity of low-intensity radiofrequency radiation” published in Electromagnetic Biology and Medicine.
The first thing to note as that this is a review article. It does not present any new data. It is not an experiment or observational study. It’s not even a meta-analysis. It is just a group of researchers looking at the literature and proclaiming that it confirms what they already believed.
“A gentle ethical defence of homeopathy” by Levy et al. was recently published in an ethics journal. A full-text preprint is available online. They say:
Utilitarian critiques of homeopathy that are founded on unsophisticated notions of evidence, that adopt narrow perspectives on healthcare assessment, and that overstate the personal, social and ontological harms of homeopathy, add little to our understanding of the epistemology of medicine. But when they are used to denounce the ethics of homeopathy – they are not only ill-considered and counterproductive, but philosophically and socially perverse.
I found their arguments unconvincing. (more…)
When I first started writing about the claims made for medical marijuana and the cannabis oil derived from it, it didn’t take long for me to characterize medical claims for cannabis as the “new herbalism,” as opposed to pharmacognosy, the branch of pharmacology devoted to the study of natural products. The reason is simple. Although I support legalization of marijuana for recreational use, when I look at how medical marijuana has been promoted as a “foot-in-the-door” prelude to legalization, I see testimonials and flimsy evidence ruling over all. I see all the hallmarks of alternative medicine herbalism and none of the hallmarks of pharmacology. Here’s what I mean. Pharmacognosy examines an herb, plant, or other natural product and seeks to identify the chemicals within it that have pharmacological activity against a condition or a disease, the better to purify and isolate those chemicals and turn them into drugs. Herbalism, on the other hand, emphasizes the use of whole plants or extracts from plants, rather than the isolation of the most active compounds. Thus, herbal remedies often contain hundreds, or even thousands, of different compounds, of which only one or a few are active. Even extracts, such as cannabis oil, contain many compounds.
In contrast to pharmacognosy, herbalists make the claim that whole herbs and plant components possess a synergy that is missing from the purified active constituents and/or that the mixture is safer than the pure components because one compound can reduce the side effects of another without reducing therapeutic efficacy. When looked at closely neither claim stands up to scrutiny. Synergism between plant constituents is rare and very difficult to demonstrate, for example. In essence, herbalism turns back the clock 200 years to a time before scientists had developed the techniques and abilities to isolate active ingredients with pharmaceutical activity. Moreover, herbalism, in contrast to pharmacognosy, emphasizes anecdotes over scientific evidence.
Indeed, in my previous posts in this series on medical marijuana, one theme has emerged, which is that cannabis—specifically, a class of active chemicals in marijuana known as cannabinoids—has potential for some diseases but is not the panacea claimed by its proponents. It does not cure cancer, for instance, contrary to glowing testimonials promoted by people like Rick Simpson. For other conditions, the evidence is either not particularly compelling or only mildly promising.
So I reacted with considerable dismay on Friday night when I saw this news report on the 11 o’clock news, “Michigan panel recommends allowing marijuana for autism“: