We frequently write about placebo effects here on Science-Based Medicine. The reason is simple. They are an important topic in medicine and, at least as importantly, understanding placebo effects is critical to understanding the exaggerated claims of advocates of “complementary and alternative medicine” (CAM), now more frequently called “integrative medicine” (i.e., integrating pseudoscience with science). Over the years, I (and, of course, others) have documented how CAM advocates have consistently moved the goalposts with respect to the efficacy of their pseudoscientific interventions. As larger and better-designed clinical trials have been done demonstrating that various CAM therapies without a basis in science—I’m distinguishing these from science-based modalities that have been co-opted and “rebranded” as CAM, such as exercise and nutrition—have no specific effects detectable above placebo effects, CAM advocates move the goalposts and claim that CAM works through the “power of placebo” and do their best to claim that “harnessing” that “power of placebo” is a justification to use their treatments. It turns out, however, that when placebo effects are examined rigorously there’s just not a lot of there there, so to speak. Results are underwhelming, and trying to “harness the power of placebo” without an intervention that actually impacts the pathophysiology of disease can even be dangerous. That’s not to say that learning to maximize placebo responses (whatever they are) while administering effective medical treatments isn’t important; rather, it’s to point out that, by themselves, placebo effects are not of much value.
Unfortunately, none of this has stopped what Steve Novella refers to as the “placebo narrative” from insinuating itself into lay discussions of medicine. That narrative proclaims in breathless terms (as Steve put it) the “surprising power of the placebo effect” without putting it into reasonable perspective or even really defining what is meant by “placebo effect.” First, as we have tried to explain time and time again here, there is no single “placebo effect.” There are placebo effects. Second, the only really correct reference to “the placebo response” or “placebo effect” is the outcome measured in the placebo arm of a clinical trial. The problem is that, all too often, discussions of placebo responses conflate the placebo effect measured in a clinical trial with all the other various placebo effects that add up to the response that is measured in that trial. Those effects include reporting biases, researcher biases, regression to the mean, conditioning, and many other components that contribute to what is measured in the outcome of a clinical trial. Another common misconception about placebo effects is that they are somehow “mind over matter,” that we can heal ourselves (or at least reduce our symptoms) through the power of will and mind. This is not true. Placebo effects are not the power of positive thinking.
The battle to rid modern scientific societies from the blatant and harmful pseudoscience of homeopathy continues. This past year has been overall a good one – in the US both the FDA and FTC decided to review their regulation of homeopathy. They have gathered their testimony and are now apparently reviewing everything. Their decisions on this topic are eagerly anticipated and could decide the fate of homeopathy for the next one or more generations.
In the UK the situation is also very positive. Their national health service is considering blacklisting homeopathy so that general practitioners cannot prescribe homeopathic products.
Success in the UK is largely due to The Good Thinking Society, founded by Simon Singh. They have been tirelessly campaigning against NHS coverage of homeopathy and are making steady progress. They are demonstrating that skeptical activism can be effective.
Likewise, SBM and the Society for SBM are having an impact in the US, mainly through persistent persuasive writing and being available as a resource to politicians, the press, and regulators. Members have personally consulted with the FDA, FTC, and staff of senators interested in the issue.
Pictured: Stem cells. Surprisingly, the best youth is in the chump.
Injecting animal cells into humans for therapeutic reasons has a long history. The most infamous was John Brinkley who injected goat testicles into 16,000 men in the 1920s and 30s to treat impotence. Harriet wrote a review of Charlatan: America’s Most Dangerous Huckster, the Man Who Pursued Him, and the Age of Flimflam, which covers the topic. I wonder who would get the title today. Chopra…Gesundheit.
I had thought this therapy was consigned to the sharps container of history. Of course not. No SCAM ever fades away.
As part of my ID reading I came across the headline “Q Fever Outbreak Among Travelers to Germany Who Received Live Cell Therapy — United States and Canada, 2014.”
It surpasses the classic “Notes from the Field: Campylobacter jejuni Infections Associated with Sheep Castration — Wyoming, 2011” for foolishness, where:
…men reported having used their teeth to castrate some of the lambs.
Really. A most curious way to acquire Campylobacter. But at least the castrators were doing practical, albeit eeewwwwwwww, work. And there is an alternative to teeth, including the Burdizzo Emasculatone, which is:
an elegant little tool especially suited to crushing the spermatic cords of a variety of male mammals. It really helps to make a neat job of what would otherwise be an unpleasantly messy endeavor, and the Burdizzo achieves the goal of bloodless castration admirably.
But I digress and leave to the commenters to make completely inappropriate remarks. Only the SCAM universe can be odder than infectious diseases. (more…)
Health care systems around the world are being pressured to “do more and spend less”, to make healthcare more cost effective. Owing to aging populations and the growing cost of providing health services, there’s more scrutiny than ever on the value of different health treatments, with the goal of reducing the use of treatments that don’t help. The Choosing Wisely initiative was establishing expressly for this purpose. Regrettably, while well-intentioned, Choosing Wisely hasn’t had as much of an effect as you might expect. Medicine can be slow to change, as David Gorski discussed earlier this week. Unless we ruthlessly scrutinize what we do for effectiveness, and are willing to act on what we learn, self-driven change is unlikely. One way that governments (and insurers) can dramatically reduce the use of a health service or treatment is to simply stop offering it, or paying for it. Yet stopping funding is something that is relatively uncommon in health care. It seems to be much more difficult to stop a practice, possibly owing to inertia, a reluctance to change, and the sometimes-vociferous protests that can emerge from patients or physicians that may feel that their preferred therapy is effective. The formidable challenge of stopping health care funding, once it has started, is one reason why this blog has been very critical of the expanding scope of practice being granted to alternative medicine purveyors – the legislative alchemy that is the first step towards insurance coverage. Because once that’s in place, it will be far more difficult to stop it. So it’s essential to understand the evidence. (more…)
The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice
It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.
Now the US Department of Justice (DOJ) is getting in on the fun:
USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.
This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.
FTC vs. homeopathy: Cage match?
Well, I’m back.
OK, returning from London isn’t nearly as epic as Sam Gamgee’s final words in The Lord of the Rings returning to his wife and daughter after having accompanied Frodo, Gandalf, Bilbo, and key elves of Middle-Earth to the Grey Havens, there to say goodbye to them as they boarded a ship to the undying lands. I just love the quote. It says something to me returning home after a long journey, even if it was just a vacation to J.R.R. Tolkien’s native land. It also suggests a bit of the exhaustion after a long day of traveling, complete with a long-delayed flight, a late arrival, and a state of utter exhaustion that accompanied it, plus an unfortunate lower gastrointestinal issue.
All of this is a way of saying that this post might actually be relatively brief for a post by me…no epics this week. [Addendum: Nope. Even lower GI annoyances and exhaustion couldn’t keep me from going over 2,000 words. At least I didn’t hit 3,000.] In its nearly eight year history, I’ve never missed more than one week at SBM, and I don’t intend to start now. Specifically, with the FTC workshop on homeopathy rapidly approaching, one week from today, I couldn’t resist adding my 2 pence to the mix, now that the agenda and list of participants have been announced.
Two institutions duke it out: FTC versus FDA.
Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under the Food, Drug and Cosmetic Act (FD&C Act). Lax regulation has resulted in consumer confusion: consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, and the lack of scientific evidence underlying claims made by homeopathic drug companies.
As it turns out, we were in excellent company. The Federal Trade Commission (FTC), the agency charged with preventing fraudulent and deceptive business practices, submitted its own comment to the FDA, making these same points. (The FTC is holding its own workshop on advertising homeopathic drugs later this month. We’ll get to that shortly.)
The FTC’s advertising substantiation policy requires that health-related efficacy claims be supported by competent and reliable scientific evidence. The FDA, despite federal law, does not require evidence of efficacy for homeopathic drugs prior to their being marketed. This creates a potential conflict between the two regulatory schemes, resulting in homeopathic over-the-counter (OTC) “drugs” on the market that both comply with FDA’s policy and violate FTC’s policy. This, says the FTC, can be harmful to consumers and create confusion for advertisers. The FTC “recommends that the FDA reconsider its regulatory framework for homeopathic medicines” and tells the FDA what it can do to remedy the situation. (more…)
Just say no to homeopathic cough syrup! Actually, avoid all cough syrups.
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…)
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…)