Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of “natural” medicine. They are calling the regulation a “ban” on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.
The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage – even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.
The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.
UPDATE 4/27/2011: Here’s the online video of Dr. Novella’s appearance on The Dr. Oz Show:
- Controversial Medicine: Alternative Health, Part 1
- Controversial Medicine: Alternative Health, Part 2
- Controversial Medicine: Alternative Health, Part 3
I must say I was a bit shocked two weeks ago when I was contacted by a producer for The Dr. Oz Show inviting me on to discuss alternative medicine. We have been quite critical of Dr. Mehmet Oz over his promotion of dubious medical treatments and practitioners, and I wondered if they were aware of the extent of our criticism (they were, it turns out).
Despite the many cautions I received from friends and colleagues (along with support as well) – I am always willing to engage those with whom I disagree. I knew it was a risk going into a forum completely controlled by someone who does not appear to look kindly upon my point of view, but a risk worth taking. I could only hope I was given the opportunity to make my case (and that it would survive the editing process).
Of course, everyone was extremely friendly throughout the entire process, including Dr. Oz himself (of that I never had any doubt). The taping itself went reasonably well. I was given what seemed a good opportunity to make my points. However, Dr. Oz did reserve for himself the privilege of getting in the last word—including a rather long finale, to which I had no opportunity to respond. Fine—it’s his show, and I knew what I was getting into. It would have been classy for him to give an adversarial guest the last word, or at least an opportunity to respond, but I can’t say I expected it.
I have been following the story of Dr. Zamboni, an Italian vascular surgeon who claims that multiple sclerosis (MS) is primarily caused by blockages in the veins that drain blood from the brain. This results in backup of blood in the brain, leading to inflammation around the blood vessels and MS. He sought to find the cause and cure for MS because his wife suffers from this disease – and he claims to have found one in his own specialty.
New ideas are presented in science and medicine all the time. This is healthy and necessary – we have to keep churning the pot so that new ideas can emerge and our thinking does not become calcified. But science is both a creative and destructive process, and most new ideas fall victim to the meatgrinder of research and peer-review. Ideally this process will take place mostly within the halls of science, and then those ideas that survive at least initial examination will start to penetrate the broader culture.
This is not what often happens today, however. With the internet and mass media, preliminary speculative studies are often presented to the public as if they are a stunning breakthrough. When the scientific community responds with their typical and completely appropriate skepticism, this may lead some to think that they are being stodgy or dogmatic, or even that a cover-up is in the works. The originator of the speculative claim is usually portrayed as a brave maverick, although sometimes the story can be framed as, “Brilliant scientist or dangerous crank? You decide.” When the topic is a new medical treatment, the stakes can be quite high. In this case many patients with progressive MS are seeking treatment with the so-called liberation procedure to treat the highly speculative CCSVI as an alleged cause for their MS.
This story has all the makings of the kind of scientific and medical drama the mass media loves. While the controversy rages, the science is quietly being done in the background, and the results are not heading in a favorable direction for Zamboni. A recent study, the largest to date, drives a further stake into the heart of CCSVI as a cause of MS.
A recent US News and World Report article on the incorporation of complementary and alternative medicine (CAM) into US medical schools credulously repeats the pro-CAM marketing hype. There is no evidence that the author, Meryl Davids Landau, spoke to a single critic of CAM, or is even aware that such criticism exists. The result looks more like marketing copy than serious journalism.
Now that nearly 40 percent of American adults swear by some form of complementary and alternative medicine, or CAM—from nutrition and mental relaxation to acupuncture, magnet therapy, and foreign healing systems like traditional Chinese medicine and Indian ayurveda—a growing number of medical schools, too, are supplementing medication with meditation.
There is much to deconstruct just in this first paragraph. The entire article in an argument from popularity. This is a game the pro-CAM community has been playing for years. People are using CAM because it’s popular; medical schools should teach it because people are using it; the government should research it because of all the interest in it; and CAM should be popular because it’s being researched and taught in medical schools. CAM is like Paris Hilton – famous for being famous.
Science is a philosophy, a technology, and an institution. It is a human endeavor- our collective attempt to understand the world around us, not something that exists solely in the abstract. All of these aspects of science have be progressing over the past decades and centuries, as we refine our concepts of what science is and how it works, as we develop better techniques, and organize and police scientific activities more effectively. The practice of science is not relentlessly progressive, however, and there are many regressive forces causing pockets of backsliding, and even aggressive campaigns against scientific progress.
So-called complementary and alternative medicine (CAM) is one such regressive force. It seeks to undermine the concepts, execution, and institutions of medical science in order to promote sectarian practices and ideological beliefs. Examples of this are legion, exposed within the pages of this blog alone. I would like to add another example to the pile – the recent defense of homeopathy by Dana Ullman in the Huffington Post (names which are already infamous among supporters of SBM).
In a piece titled: Homeopathy for Radiation Poisoning, Ullman demonstrates yet again the pseudoscientific aspects of homeopathy and its proponents. The primary principle that is abused by Ullman this time is the need for scientists to carefully define their terms and concepts. Scientific concepts should be defined as carefully, precisely, and consistently as possible. Squishy concepts are very difficult to deal with in science – but are the bread and butter of pseudoscience.
The scientific approach to understanding the world includes the process of carefully separating out variables and effects. Experiments, in fact, are designed specifically to control for variables. This can be especially challenging in medicine, since the body is a complex and variable system and there are always numerous factors at play. We often characterize the many variables that can influence the outcome in a clinical study as “placebo effects” or “non-specific effect” – things other than a specific response to the treatment in question.
A common error to make when interpreting clinical studies is to confuse non-specific effects – those that result from the therapeutic interaction or the process of observation – with a specific effect from the treatment being studied. While this is broadly understood within the scientific medical community, it seems that within certain fields proponents are going out of their way to sell non-specific effects as if they were specific effects of the favored treatment.
This is perhaps most true for acupuncture. As has been discussed numerous times on SBM, the consensus of the best clinical studies on acupuncture show that there is no specific effect of sticking needles into acupuncture points. Choosing random points works just as well, as does poking the skin with toothpicks rather than penetrating the skin with a needle to elicit the alleged “de qi”.
Mark Tonelli, MD has problems with evidence-based medicine (EBM). He has published a few articles detailing his issues, and he makes some legitimate points. We at science-based medicine (SBM) have a few issues with the execution of EBM as well, so I am sympathetic to constructive criticism.
In an article titled: Integrating evidence into clinical practice: an alternative to evidence-based approaches. The abstract states:
Evidence-based medicine (EBM) has thus far failed to adequately account for the appropriate incorporation of other potential warrants for medical decision making into clinical practice. In particular, EBM has struggled with the value and integration of other kinds of medical knowledge, such as those derived from clinical experience or based on pathophysiologic rationale. The general priority given to empirical evidence derived from clinical research in all EBM approaches is not epistemically tenable. A casuistic alternative to EBM approaches recognizes that five distinct topics, 1) empirical evidence, 2) experiential evidence, 3) pathophysiologic rationale, 4) patient goals and values, and 5) system features are potentially relevant to any clinical decision. No single topic has a general priority over any other and the relative importance of a topic will depend upon the circumstances of the particular case. The skilled clinician must weigh these potentially conflicting evidentiary and non-evidentiary warrants for action, employing both practical and theoretical reasoning, in order to arrive at the best choice for an individual patient.
I often receive e-mail from SBM readers (or SGU listeners) who have had the experience of their doctor, nurse, dentist, physical therapist, or other health care provider recommending to them a treatment option that seems dubious, if not outright pseudoscientific. They want advice on what to do. There are common themes to the e-mails – the writer often feels very uncomfortable in the situation. They do not feel comfortable confronting their provider directly, yet they do not want to acquiesce to the advice either. They are also often asking my opinion about the advice – is it really as wacky as it seems. This uncertainty saps them of their resolve, leaving them feeling a bit helpless.
Here is one such e-mail:
Ten days ago, my wife and I welcomed our first child into the world. She was born a couple weeks early, which left her mouth a bit too small and week to breastfeed effectively. To prevent her from losing too much weight, we were referred to a lactation consultant (who works out of the pediatrics department at the hospital where our daughter was born). This consultant (who is also an RN) suggested a regimen of supplementing nursing with pumped breast milk.
This was working great until my wife’s milk production dropped the day before our follow-up appointment. When we asked what to do about this, the nurse recommended that my wife take fenugreek, an herbal supplement. I was a bit skeptical of this advice, so I asked what it was about fenugreek that helped with milk production. The lactation nurse’s answer was vague — she said things like, Herbs can be helpful for lots of health issues, and, a lot of women I see seem to think it helps (oh, the logical fallacies). When we pushed her on this a little more, she handed us a flyer, printed by the hospital about fenugreek. The flyer seemed to support the use of the supplement, but mentioned that there was no scientific research demonstrating that fenugreek increases milk supply. When we asked why it hadn’t been researched, the nurse responded that there wasn’t a lot of money in lactation and that scientists generally aren’t interested in the kind of things she does (basically, that she was doing the good work that cold-hearted scientists refused to do).
“You are not going to change what we do, you’re not going to change our determination to make these patients better. I see these patients, I know these patients, I value these patients, I’ve looked after them for years. I’ve seen them after the procedure, the vast majority are improved.”
The above quote could be a reference to just about any fringe medical treatment. It is partly an expression of faith in anecdotal experience over scientific evidence. It is partly the fallacy of justifying a treatment because it is needed – whereas the real question is whether or not the treatment works. It is an attempt to justify specific claims with compassion, as if the person quoted cares more for the health of their patients than those who might be skeptical of their claims. And it is an expression of stubbornness – I know the truth, so don’t confuse me with evidence and logic.
Is this person talking about acupuncture? Perhaps they run a stem cell clinic in China, India or somewhere outside the reach of regulation. Or maybe they are defending hyperbaric oxygen therapy for unproven indications, like autism. It could be anything, because this sentiment is the standard mantra of the dubious practitioner, practicing outside the bounds of science-based medicine.
It has long been recognized that there are substantial multifactorial placebo effects that create real and illusory improvements in response to even an inactive treatment. There is a tendency, however (especially in popular discussion), to oversimplify placebo effects – to treat them as one mind-over-matter effect for all outcomes. Meanwhile researchers are elucidating the many mechanisms that go into measured placebo effects, and the differing magnitude of placebo effects for different outcomes.
For example, placebo effects for pain appear to be maximal, while placebo effects for outcomes like cancer survival appear to be minimal.
A recent study sheds additional light on the expectation placebo effect for pain. The effect is, not surprisingly, substantial. However it does not extrapolate to placebo effects for outcomes other than pain, and the results of this very study give some indication why. From the abstract:
The effect of a fixed concentration of the μ-opioid agonist remifentanil on constant heat pain was assessed under three experimental conditions using a within-subject design: with no expectation of analgesia, with expectancy of a positive analgesic effect, and with negative expectancy of analgesia (that is, expectation of hyperalgesia or exacerbation of pain).
What they found was that the positive expectation group reported twice the analgesic effect as the no expectation group, and the negative expectation group reported no analgesic effect. This is a dramatic effect, but not surprising.