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.
One of the main, but perhaps underappreciated, reasons quackery thrives in the United States is that the states legalize it by licensing practitioners of pseudoscience as health care providers. These practitioners are placed under the regulatory jurisdiction of, well, themselves. I call the whole deplorable process Legislative Alchemy, and you can see all posts on the topic here. It gives practitioners an underserved imprimatur of state authority and leaves public protection from harmful practices to the oversight of those who are themselves engaging in the very same conduct. Each year, dozens of bills are brought before the state legislatures to establish initial licensure or, once that goal is achieved, scope of practice expansion.
Most attempts fail, but CAM practitioners are a dogged bunch, and they will come back each year until they get what they want. It took chiropractors about 60 years to become licensed in all 50 states. Acupuncturists are almost there. Naturopaths lag far behind, but are slowly gaining ground each year, even if it is only via practice expansion in states where they are already licensed. 2015 was a losing season for all, but not without advancement toward larger goals.
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…)
A rare double-face palm, so you can’t see the tears
I run across a lot of information in my feeds that I need to save for further evaluation. The study “Does additional antimicrobial treatment have a better effect on URTI cough resolution than homeopathic symptomatic therapy alone? A real-life preliminary observational study in a pediatric population“, I saved with the file name, ‘jaw droppingly stupid’.
The worst homeopathy clinical trial ever doesn’t spring full formed like Athena from the head of Zeus. No. The worst homeopathy clinical trial ever started with a seed. The seed is “Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: A randomized, double-blind, placebo-controlled trial, which is a standard lousy homeopathic study. (more…)
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…)
The Integrative Addiction Conference 2015 (“A New Era in Natural Treatment”) starts tomorrow in Myrtle Beach, SC. Medical doctors, doctors of osteopathy, naturopaths and other health care providers will hear lectures on such subjects as “IV Therapies and Addiction Solutions,” given by Kenneth Proefrock, a naturopath whose Arizona Stem Cell Center specializes in autologous stem cell transplants derived from adipose tissue. Proefrock, who was disciplined for using prolotherapy in the cervical spine without proper credentialing in 2008, claims that stem cells treatments are an “incredibly versatile therapy” and uses them for variety of conditions, such as MS and viral diseases. At the same time, he admits that they are not FDA approved and he is not claiming they are effective for anything (and he’s right), which leads one to wonder why he employs them.
Proefrock also offers a typical naturopathic mish-mash of services, from oncology to urology to “naturopathic endocrinology,” and claims he specializes in treating influenza, high blood pressure and kidney stones, as well as addiction. In other words, he doesn’t seem to be the sort of expert you’d find speaking at a science-based conference on addiction medicine.
You’ll find similarly troubling bios of some of the other speakers, as well as dubious treatments for addiction, on the conference website. Here, for example, are speaker Giordano’s and Eidelman’s websites.
Dalal Akoury, MD, is the “Title Sponsor” of the conference and appears to be running the show. Although she is listed by the S.C. Board of Medicine as board certified in pediatrics, she is the founder of the “Integrative Addiction Institute” and runs the “AwareMed Health and Wellness Resource Center” in Myrtle Beach. Like the Arizona Stem Cell Center, it offers a range of treatments that defy categorization as any particular specialty: addiction recovery, “adrenal fatigue” treatment, stem cells, “anti-aging,” weight loss, “functional medicine” and “integrative cancer care“. Yet, only Akoury and one licensed practical nurse are on the staff of the Center. Again, it is questionable whether she is has sufficient qualifications in addiction medicine to run a conference on the subject. (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…)