Several of the bloggers on Science-Based Medicine have been — shall we say? — rather critical of Oprah Winfrey. The reason, of course, is quite obvious. Oprah is so famous that if you mention her first name nearly everyone will know exactly of whom you speak. For the last quarter century, her daytime TV talk show has been a ratings juggernaut, leading to the building of a media behemoth and making Oprah one of the richest and most famous women in the world. Unfortunately, part of Oprah’s equation for success has involved the promotion of quackery and New Age woo, so much so that last year I lamented about the Oprah-fication of medicine, which scored me a writing gig in the Toronto Star. Whether it be promoting bio-identical hormones, The Secret (complete with a testimonial from someone who used The Secret to persuade herself not to pursue conventional therapy for breast cancer), Suzanne Somers, the highly dubious medicine promoted by Dr. Christiane Northrup, or foisting reiki aficionado Dr. Mehmet Oz or anti-vaccine “mother warrior” Jenny McCarthy onto a breathless public, arguably no one is a more powerful force for the promotion of pseudoscience in America, if not the world. Truly, the ending of Oprah’s TV show in the spring is a very good thing indeed for science and rationality. Or it would be, were it not for the fact that the reason Oprah is wrapping up her show after a quarter of a century is to start up her own cable channel, so that we can have Oprah-branded and -inspired programming 24/7.
The mind boggles.
Still, my dislike for how Oprah promotes New Age mysticism and pseudoscience on a distressingly regular basis aside, I actually did think there were limits to how low she would go. I actually thought there were limits to how egregiously vile a quackery Oprah would endorse. The operative word, of course, is “did,” which now needs to be struck off after last Wednesday, which is when Oprah did an entire show entitled Do You Believe in Miracles? (Guess what answer was implicitly, if not explicitly, endorsed.) Featured prominently in that episode were several segments on the faith healer John of God.
Life and medicine generate facts and experiences that require conceptual frameworks that aid in understanding. It is no good have a pile of facts if they cannot be understood within a broader understanding.
The practice of Infectious Diseases, while certainly aided by understanding anatomy, physiology, microbiology, chemistry and the other sciences that form the core of medicine (referred to in Medical School as the basic sciences), gains a broader appreciation from the concepts of evolution. Infectious Diseases, at its most fundamental level, is applied evolution, and understanding evolution often adds greater insight into infectious diseases. Me find bug, me kill bug, me go home may be my motto, but it is meant in jest.
There have been papers or books that have added conceptual frameworks to my understanding of the natural world and medicine. Besides evolution, there was Observations on Spiraling Empiricism a classic that all health care providers should read, as it outlines the cognitive errors we all make in prescribing medications; I have discussed this article before.
There is The Drunkard’s Walk: How Randomness Rules Our Lives by Leonard Mlodinow. So often the explanation of why something happens is a shrug of the shoulders; feces occurs. The book formalized my understanding that much of what happens is random and without cause. The challenge in medicine is trying find a pattern in the randomness of life upon which to base a diagnosis. It is equally important to recognize when patterns are not there. All too often what is seen as a pattern is our imposing structure on what are random events. Or maybe that really is a bunny in the clouds. Clinical study results often occur by chance and having a significant ‘P’ value may still be due to randomness if the study is measuring nonsense.
The long-simmering internecine wars among various factions of chiropractic recently reached a full boil when the Council on Chiropractic Education (CCE) had the audacity to eliminate the word “subluxation” from its draft 2012 “Standards for Doctor of Chiropractic Programs.” The CCE is the official U.S. Department of Education-approved accreditation agency for chiropractic colleges. It intends to adopt the revised Standards in January 2011and asked for comment from those affected.
“Totally unacceptable,” is the response of James Edwards, DC, in a recent article in Dynamic Chiropractic entitled “What Is the CCE Trying to Pull?”
Perhaps taking up the spirit of this election season, Edwards defines the problem in terms of conservative vs. liberal ideologies: “After beating back and defeating the ridiculous ‘subluxation only, no diagnosis’ position of the extreme right-wing minority of the profession, we are now faced with the equally unacceptable ‘ivory tower’ position of the extreme left-wing minority of the profession.” Later in the article he refers to the proponents as the “left-wing fringe.”
One of the core features of science (and therefore science-based medicine) is to precisely identify and control for variables, so that we know what, exactly, is exerting an effect. The classic example of this principle at work is the Hawthorne effect. The term refers to a series of studies performed between 1924 and 1932 at the Hawthorne Works. The studies examined whether or not workers would be more productive in different lighting conditions. So they increased the light levels, observed the workers, and found that their productivity increased. Then they lowered the light levels, observed the workers, and found that their productivity increased. No matter what they did, the workers improved their productivity relative to baseline. Eventually it was figured out that observing the workers caused them to work harder, no matter what was done to the lighting.
This “observer effect” – an artifact of the process of observation – is now part of standard study design (at least well-designed studies). In medical studies it is one of the many placebo effects that need to be controlled for, in order to properly isolate the variable of interest.
There are many non-specific effects – effects that result from the act of treating or evaluating patients rather than a physiological response to a specific treatment. In addition to observer effects, for example, there is also the “chearleader” effect from encouraging patients to perform better. There are training effects from retesting. And there are long-recognized non-specific therapeutic effects just from getting compassionate attention from a practitioner. It is a standard part of medical scientific reasoning that before we ascribe a specific effect to a particular intervention, that all non-specific effects are controlled for and eliminated.
On October 19, 2010, the FDA approved a long-awaited new drug, dabigatran, expected to replace warfarin (Coumadin) as a better way to prevent blood clots in susceptible patients. This provides an opportunity to re-visit several issues that we have addressed before, including Big Pharma tactics, drug approval by the FDA, deciding what is adequate evidence, applying science to clinical practice, and making individual health care decisions based on evidence that is sometimes incomplete.
Patients with atrial fibrillation, artificial heart valves, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, and people undergoing certain types of surgery are at risk of blood clots, embolism, and stroke. They are currently being treated with rat poison. Warfarin (Coumadin) is an anticoagulant originally intended to kill rats. It inhibits the vitamin K dependent synthesis of several clotting factors. It saves human lives but is a mixed blessing. It takes several days to achieve therapeutic levels. Patients must be monitored with frequent blood tests to ensure that their prothrombin levels stay between an INR (international normalized ratio) of 2 and 3. When starting out, this means blood tests every couple of days. For some patients, dosage fluctuates and requires frequent adjustments; others can eventually drop down to a monthly blood test. Warfarin interacts with a long list of other drugs that raise or lower its blood levels. It interacts with many foods, and patients have to modify their diet. It can cause serious bleeding complications; while preventing thrombotic strokes it can cause hemorrhagic strokes. It is taken once daily. There is an antidote, vitamin K, that can reverse its effects promptly.
Warfarin is the 11th most prescribed drug in the US. Its benefits clearly outweigh its risks, but we wish the risks were fewer. We have yearned for a better option: something safer, something that would not require monitoring with blood tests, something that foods wouldn’t interfere with, something that would not interact with every other drug in the book. And now it seems we have it: a direct thrombin inhibitor called dabigatran.
Over the weekend, my wife and I happened to be in the pharmacy section of our local Target store. We happened to be looking for one of our favorite cold remedies, because both of us have been suffering from rather annoying colds, which have plagued both of us for the last week or two. As we perused the Cold and Flu section of the pharmacy, we were struck at how much shelf space was taken up by Airborne (which was “invented by a schoolteacher“). Nearly three years ago Airborne had to settle a case brought against it alleging false advertising to the tune of $23 million. Despite that, Airborne is still being sold, and there are even a whole bunch of knock-off products copying it. Then, as we continued to look for our favored cold remedy, we noted that, sitting right next to the extensive shelf space devoted to the various flavors and types of Airborne supplements, I saw Boiron’s homeopathic remedy for colds containing oscillococcinum, which is derived from duck liver and heart and diluted to 200C (a 10400-fold dilution).
Yes, I was a bit depressed after that. Now I know what my skeptical friends in the U.K. go through every time they walk into a Boots pharmacy.
During the most recent kerfuffle about whether or not Evidence-Based Medicine can legitimately claim to be science-based medicine, it became clear to me that a whole, new round of discussion and documentation is necessary. This is frustrating because I’ve already done it several times, most recently less than a year ago. Moreover, I’ve provided a table of links to the whole series at the bottom of each post*…Never mind, here goes, and I hope this will be the last time it is necessary because I’ll try to make this the “go to” series of posts for any future such confusions.
The points made in this series, most of which link to posts in which I originally made them, are in response to arguments from statistician Steve Simon, whose essay, Is there something better than Evidence Based Medicine out there?, was the topic of Dr. Gorski’s rebuttal on Monday of this week, and also from several of the comments following that rebuttal. Mr. Simon has since revised his original essay to an extent, which I’ll take into account. I’ll frame this as a series of assertions by those who doubt that EBM is deficient in the ways that we at SBM have argued, followed in each case by my response.
First, a disclaimer: I don’t mean to gang up on Mr. Simon personally; others hold opinions similar to his, but his essay just happens to be a convenient starting point for this discussion. FWIW, prior to this week I perused a bit of his blog, after having read one of his comments here, and found it to be well written and informative.
This post is intended to illustrate a bit about how medicine, including alternative medicine, is defined and limited legally by state licensure. This is, of course, an enormous topic, especially given the variety of laws and regulations among the 50 states and District of Columbia, and the many, often mutually inconsistent, court decisions interpreting them. A comprehensive survey would resemble Gibbon’s history of Rome and would likely be out-of-date the moment it was finished. My more modest goal here is to highlight a few of the ways in which licensure and scope of practice laws intersect the practice of CAM and give a few representative examples.
The Rise of Medical Licensure
In the 19th century, a bewildering variety of different approaches to maintaining health and treating disease competed for the trust, and dollars, of prospective patients (or their owners, in the case of animal patients). Caveat emptor was the rule in an unregulated medical marketplace. Mainstream medicine was a competitor in this marketplace, though it was hardly science-based to any great extent compared to conventional medical practices today. Homeopathy was another pretty big player, along with osteopathy and numerous other more or less organized schools, as well as many individual snake oil salesmen, faith healers, local providers of folk remedies, and so on.1,2
One of the recurrent themes of science-based medicine is that any medical intervention that can plausibly cause physiological benefit can also plausibly cause physiological harm. There is no such thing as “it can’t hurt.” Sometimes the risk may be minuscule – but we should never assume that it is zero. Being “natural” or “holistic” or being blessed with some other alleged marketable virtue does not affect the risk vs benefit calculation of an intervention.
Vitamins are an excellent example. There is widespread sentiment that vitamins are harmless, and that supplementing with vitamins is therefore a no risk-possible benefit scenario. It is certainly reasonable to conclude from the evidence that vitamins (at usual supplemental levels) are low risk, compared to many other types of medical interventions. High doses, or megadoses, of vitamins, however, risk toxicity and this risk increases with the dose.
But even at sub-toxic doses vitamins should not be assumed to be risk free. This is especially true when we take a public health perspective – what is the net effect of large scale supplementation on the population? A new meta-analysis looking at the net effects of Vitamin E supplementation on stroke risk reinforces this caution.
Melanie Thernstrom has written a superb book based on a historical, philosophical, and scientific review of pain: The Pain Chronicles: Cures, Myths, Mysteries, Prayers, Diaries, Brain Scans, Healing, and the Science of Suffering. Herself a victim of chronic pain, she brings a personal perspective to the subject and also includes informative vignettes of doctors and patients she encountered at the many pain clinics she visited in her investigations. She shows that medical treatment of pain is suboptimal because most doctors have not yet incorporated recent scientific discoveries into their thinking, discoveries indicating that chronic pain is a disease in its own right, a state of pathological pain sensitivity.
Chronic pain often outlives its original causes, worsens over time, and takes on a puzzling life of its own… there is increasing evidence that over time, untreated pain eventually rewrites the central nervous system, causing pathological changes to the brain and spinal cord, and that these in turn cause greater pain. Even more disturbingly, recent evidence suggests that prolonged pain actually damages parts of the brain, including those involved in cognition. (more…)