It has been very instructive, from a science-based medicine perspective, to watch the story of alleged chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS) unfold over the last three years. In 2009 Dr. Paolo Zamboni, an Italian vascular surgeon, published a paper in which he claimed that 100% of MS patients he investigated showed signs of blockage in the veins that drain blood from the brain, a condition he named CCSVI. This paper sparked immediate controversy. This controversy has been in the news again recently with the making public of the results of an observational study of the liberation procedure to treat CCSVI.
Existing research over the last half century strongly indicate that MS is primarily a disease of immune dysfunction (an autoimmune disease), resulting in inflammation in the brain that causes damage, specifically to the myelin, the insulation around nerve fibers that allows them to conduct signals efficiently. Zamboni is suggesting that MS is primarily a vascular disease causing back pressure on the veins in the brain and iron deposition which secondarily results in inflammation. This would be a significant paradigm shift in MS. It would also not be the first time such a dramatic shift in MS science has been proposed but failed in replication.
The MS community did not give much credence to the notion of CCSVI, but despite this there has been an incredible amount of research on the idea over the last three years (a PubMed search on “CCSVI” gives 103 results). Most of the research has simply attempted to replicate Zamboni’s findings, with mixed but generally unimpressive results. No one has found the 100% results that Zamboni originally reported. The studies have found a range of venous insufficiency in MS patients, down to 0%, but many finding results in the range of 20-40%. However, patients with other neurological disease and healthy controls have also been found to have similar rates of venous insufficiency. Some studies have found a positive correlation with MS, others have not.
“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).
While scanning through recent science press releases I came across an interesting study looking at the use of a pharmaceutical grade antioxidant, N-Acetylcysteine (NAC), in the treatment of certain symptoms of autism. This is a small pilot study, but it did have a double-blind placebo controlled design. The press release reports:
During the 12-week trial, NAC treatment decreased irritability scores from 13.1 to 7.2 on the Aberrant Behavior Checklist, a widely used clinical scale for assessing irritability. The change is not as large as that seen in children taking antipsychotics. “But this is still a potentially valuable tool to have before jumping on these big guns,” Hardan said.
“This was a pilot study,” Hardan said. “Final conclusions cannot be made before we do a larger trial.”
I also noticed that two of the authors list significant conflicts of interest – patents on the use of NAC, and one has equity in the company that makes it. It occurred to me that a larger question than the efficacy of NAC for these autism symptoms is this – if this is a pilot study only and we should not base any firm conclusions on the results, then why the press release?
Among the myriad of supplements being offered to the public are various bee products, including bee pollen. The claims made for bee pollen supplements are typically over-hyped and evidence-free, as is typical of this poorly regulated industry. The claims from bee-pollen-supplements.com are representative:
The benefits are enormous and the substance has been proven by many health experts. This particular substance is known as an effective immune booster and one of the best ways to achieve a sound nutritional regime.
The pollen from the bee has been proven to increase sexual functions in both men and women. It stimulates our organs, as well as our glands and is known to improve the natural increase on a person’s lifespan.
What you never find on such websites are references to published peer-reviewed studies that substantiate the specific claims being made. There are also concerns about safety which have not been adequately studied.
A recent case report highlights one safety concern regarding bee pollen products – allergic and even anaphylactic reactions. The Canadian Medical Association Journal reports:
A 30-year-old woman with seasonal allergies but no history of allergies to food, drugs, insects or latex had an anaphylactic reaction after taking bee pollen. She had swelling of the eyelids, lips and throat, difficulty swallowing, hives and other life-threatening symptoms. After emergency treatment and discontinuation of the bee pollen supplements, there were no further reactions.
The Princes Foundation for Integrated Health closed shop in 2010. Now the company that ran the foundation has officially closed. The foundation was a vanity project by Prince Charles, who had a soft spot for so-called alternative medicine and natural therapies. The foundation was established in 1993 and in the last 19 years has misinformed the public about CAM therapies, promoted nonsense like homeopathy, and has been an official royal seal of approval on the anti-science in medicine movement in the UK.
In short the foundation was an excellent example of why political ideology should not interfere with the normal process of science. The website for the charity no longer exists, but this is what it said about it’s mission:
“The Prince’s Foundation for Integrated Health is a UK charity championing an integrated approach to health.
“The Foundation works towards a culture of health and wellbeing with people and communities taking more responsibility for their own health, and where health professionals collaborate and share learning in the best interests of their patients.
“Integrated health means an approach to health which:
- “emphasises prevention and self-care
- “looks at the person in the round, taking into account the effects on health of lifestyle, environment and emotional wellbeing
- “brings together the safest and most effective aspects of mainstream medical science and complementary healthcare.”
This is typical CAM bait and switch. Preventive medicine, healthy lifestyles, and taking a complete approach to health is not alternative or complementary – it is part of mainstream science-based medicine. All of that is actually a misdirection from the real goal of the CAM or “integrative” movement – to promote health products and services that fail to meet minimal standards of evidence and plausibility, or which have already been shown to be ineffective. The Prince’s Foundation was not exception, promoting over the years every form of quackery from homeopathy to Reiki.
Industrialized nations are in the middle of a health care crisis (some more than others), or at least a dilemma. As our medical technology advances, people are living longer, they are living with chronic diseases, and they are consuming more health care. The cost of this health care is rising faster than economic growth, so it is becoming a greater and greater burden on society. Many countries ration health care in one way or another in order to contain costs. Otherwise there is no easy or obvious solution and it’s likely that difficult choices will have to be made.
An interesting side effect of this dilemma is a renewed focus on the cost effectiveness of medicine. Effectiveness alone is not enough. We simply cannot afford, for example, to introduce a very expensive treatment for marginal improvement in outcome in a common disease. Different options can also be compared not only for their safety and efficacy, but for their cost effectiveness. In other words, we need to use cheaper alternatives when available rather than always reaching for the latest and greatest (and most expensive) treatment.
This situation provides an opportunity for science-based medicine. Treatments that are promoted as complementary and alternative (CAM) are often sold as cost effective because they are less expensive up front than standard medical care. We cannot, however, cede this argument to proponents of dubious therapies. Cheap does not mean cost effective. You have to be effective in order to be cost effective, and most of the dubious treatments that are marketed under the CAM umbrella are ineffective.
Paul Offit has published a thoughtful essay in the most recent Journal of the American Medical Association (JAMA) in which he argues against funding research into complementary and alternative therapies (CAM). Offit is a leading critic of the anti-vaccine movement and has written popular books discrediting many of their claims, such as disproved claim for a connection between some vaccines or ingredients and risk of developing autism. In his article he mirrors points we have made here at SBM many times in the past.
Offit makes several salient points – the first being that the track record of research into CAM, mostly funded by the NCCAM, is pretty dismal.
“NCCAM officials have spent $375,000 to find that inhaling lemon and lavender scents does not promote wound healing; $750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390,000 to find that ancient Indian remedies do not control type 2 diabetes; $700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406,000 to find that coffee enemas do not cure pancreatic cancer.”
The reason for the poor track record is fairly simple to identify – by definition CAM includes treatments that are scientifically implausible, which means there is a low prior probability that they will work. If the treatments were scientifically plausible then they wouldn’t be alternative.
Hypnotherapy is the use of hypnosis as a medical intervention, usually for the treatment of pain and other subjective symptoms. It remains controversial, primarily because the evidence for its efficacy is not yet compelling, but also because it is poorly understood. This situation is not helped by the fact that it is often characterized as an “alternative” therapy, a label that can “ghettoize” an otherwise legitimate treatment modality.
What Is Hypnosis?
Any meaningful discussion of hypnosis, or any other phenomenon, needs to start with a specific, and hopefully operational, definition. If we cannot define hypnosis then it becomes impossible to meaningfully discuss it. The problem of definition plagues the science dealing with many so-called alternative therapies, such as acupuncture. Good science requires controlling for specific variables, so that we can determine which variables are having what effects. If we don’t know which variables are part of the operational definition of a specific therapy, then we cannot conduct proper studies or interpret their results.
For example, with acupuncture, in my opinion the only meaningful definition of this procedure is the placing of thin needles into specific acupuncture points in order to elicit a specific response. Research has shown, however, that acupuncture points do not exist, that placing needles at specific points is not associated with a specific outcome, and even that sticking needles through the skin (as opposed to just poking the skin superficially) does not correlate with outcome. When these variables are isolated they do not appear to contribute anything to efficacy, therefore one might conclude that acupuncture does not work. Research into acupuncture, however, often does not adequately isolate these variables from the therapeutic ritual that surrounds acupuncture, or even mixes in other modalities, such as electrical stimulation.
All scientists should be skeptics. Serious problems arise when a less-than-skeptical approach is taking to the task of discovery. Typically the result is flawed science, and for those significantly lacking in skepticism this can descend to pseudoscience and crankery. With the applied sciences, such as the clinical sciences of medicine and mental therapy, there are potentially immediate and practical implications as well.
Clinical decision making is not easy, and is subject to a wide range of fallacies and cognitive pitfalls. Clinicians can make the kinds of mental errors that we all make in our everyday lives, but with serious implications to the health of their patients. It is therefore especially important for clinicians to understand these pitfalls and avoid them – in other words, to be skeptics.
It is best to understand the clinical interaction as an investigation, at least in part. When evaluating a new patient, for example, there is a standard format to the “history of present illness,” past medical history, and the exam. But within this format the clinician is engaged in a scientific investigation, of sorts. Right from the beginning, when their patient tells them what problem they are having, they should be generating hypotheses. Most of the history taking will actually be geared toward testing those diagnostic hypotheses.
It has been a stunning triumph of marketing and propaganda that many people believe that treatments that are “natural” are somehow magically safe and effective (an error in logic known as the naturalistic fallacy). There is now widespread belief that herbal remedies are not drugs or chemicals because they are natural. The allies in Congress of those who sell such products have even passed laws that embody this fallacy – taking herbal remedies away from FDA oversight and regulating them more like food than drugs.
The other major fallacy spread by the “natural remedy” industry is that if a product has been used for a long time (hundreds or thousands of years), then it must also be safe and effective because it has stood the test of time (this fallacy is referred to as the argument from antiquity). This fallacy even has a specific regulatory term to invoke it – GRAS or “generally recognized as safe.” With food and food ingredients the FDA does not require evidence of safety if the ingredient is generally recognized as safe. This might make sense when referring to foods that have be eaten by humans for a long time. Although the logic is still dubious, it’s just practical – the FDA could not take upon itself the task of proving that every food eaten by humans has no significant negative health consequences. It is more a recognition of practicality than reality.