The following commentary is the first contribution to SBM by guest author, Mark Crislip.
The airline industry in the United States is often used as an example of a complex technological system that provides high volume, inexpensive and reliable transportation to millions of people every year, that, despite sending tons of aluminum five miles into the air, has an amazing safety record. Crashes and deaths are rare despite the high intrinsic risk of flight.
It is often suggested that the policies and procedures that have been used in the airline industry be applied to health care to help increase the safely and performance of hospitals and to lower complications and deaths.
Some airline methodologies have been applied to health care with good results.
Airlines have many of the same characteristics of health care and many of the same problems in providing for their customers. The airlines are monolithic industries that often treat their passengers like cattle, all of a kind, rather than unique individuals with unique travel needs.
While attending a lecture by a naturopath at my institution I had the opportunity to ask the following question: given the extreme scientific implausibility of homeopathy, and the overall negative clinical evidence, why do you continue to prescribe homeopathic remedies? The answer, as much as my question, exposed a core difference between scientific and sectarian health care providers. She said, “Because I have seen it work in my practice.”
There it is. She and many other practitioners of dubious modalities are compelled by anecdotal experience while I am not.
An anecdote is a story – in the context of medicine it often relates to an individual’s experience with their disease or symptoms and their efforts to treat it. People generally find anecdotes highly compelling, while scientists are deeply suspicious of anecdotes. We are fond of saying that the plural of anecdote is anecdotes, not data. Why is this?
Glucosamine and chondroitin, used separately or together, are among the more popular diet supplements. They are used widely for osteoarthritis, especially of the knee, and have been better studied than most other diet supplements. But do they really work?
The journal of my medical specialty, American Family Physician, recently published an article about the use of dietary supplements in osteoarthritis. They gave a “B” evidence rating to both glucosamine and chondroitin. This means there is inconsistent or limited-quality patient-oriented evidence. They recommended the use of glucosamine sulfate, saying, “Overall, the evidence supports the use of glucosamine sulfate for modestly reducing osteoarthritis symptoms and possibly slowing disease progression.” They did not exactly recommend chondroitin, although they said it “may provide modest benefit for some patients.”
I remain skeptical. And so does R. Barker Bausell, who devoted several pages of his book Snake Oil Science to an analysis of the research on glucosamine and chondroitin. (more…)
Recently, I’ve had a number of people bring to my attention a news story that has apparently been sweeping the wire services and showing up in all sorts of venues. It is, on its surface, a story of hope, hope for the millions of elderly (and even the not-so-elderly) who are or will be afflicted by that scourge of the mind, memory, and personality, Alzheimer’s disease. This disease is one of the most feared of diseases. A progressive and fatal disease of the brain, it robs a person of his memory and personality, until he no longer recognizes loved ones and becomes too demented to care for himself. The pathophysiology involves the accumulation in the brain of a protein known as β-amyloid, which forms plaques outside of cells, while neurofibrillary tangles believed to be due to the hyperphosphorylation of a protein known as tau develop in dying cells. The exact mechanism by which neuron death occurs is not fully understood, but over time this process leads to a decrease in the amount of gray matter in the cortex. There is no known cure, and the current treatments that we have result in at best a modest delay of the inevitable dementia that accompanies progression of the disease.
Given this grim backdrop and the general aging of the population in developed nations, it is expected that there will be a large increase in the number of people developing Alzheimer’s disease over the next few decades. Naturally, this provides a great deal of incentive to develop more effective treatments. Not surprisingly, sometimes the treatments proposed may sound somewhat outlandish and may even be somewhat outlandish. The treatment about which people were e-mailing me falls into this category, and I haven’t decided yet whether it’s science or pseudoscience. It could be legitimate. What I do know, however, is that I don’t like the way its inventors are promoting it by press conference before any evidence of its clinical efficacy in humans has been accepted by a peer-reviewed publication, leading to a flurry of stories about a new possible “miracle cure” for Alzheimer’s disease grounded in not a lot of science. I’m referring, of course, to the “Alzheimer’s helmet” developed by Dr. Gordon Dougal and his colleagues Dr. Paul Chazot and Abdel Ennaceur at Durham University. Dr. Dougal is a director of Virulite, a medical company based in County Durham in the U.K. Here’s a widely cited article from the Daily Mail that describes the device:
Part IV of the ongoing Homeopathy series will have to wait a day or two, because it is superceded by a recent, comment-worthy publication. Nevertheless, “H series” fans will find here a bit of grist for that mill, too.
An important role for this blog is to discuss problems of interpreting data from clinical studies. Academic medicine has committed itself, on the whole, to scientific rigor—to the extent that this is possible in messy, clinical (especially human) trials. Several tools have been proposed, and to a varying extent used, to enhance the rigor of clinical research and the reporting of clinical research. One of those tools is the registering of clinical trials prior to recruiting subjects. Registration would stipulate a trial’s a priori hypothesis(es), design, planned endpoints, and planned statistical methods, among other things. This would guard against several problems: publication bias—the tendency for some trials, usually “negative” ones, to go unreported; selective reporting of the results of a trial, if some are pleasing but others are not; and post hoc data analysis—finding data after the fact to suggest a novel hypothesis that will falsely be portrayed as an a priori hypothesis. Publication bias is also known as “selective publication” or the “file drawer problem”; post hoc analysis is also known as “data dredging” or “HARKing” (Hypothesizing After the Results are Known).
An article in the Jan. 17 issue of the New England Journal of Medicine demonstrates the usefulness of a trial registry:
Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy
Erick H. Turner, M.D., Annette M. Matthews, M.D., Eftihia Linardatos, B.S., Robert A. Tell, L.C.S.W., and Robert Rosenthal, Ph.D.
The press and government agencies ally to shine a disproportionate amount of publicity on false and improbable medical ideas. (Danger: Congressmen and reporters at work.)
The latest was a press release from either the Centers for Disease Control (and prevention? – I’ll get to the “prevention” part later,) or from Kaiser-Permanente Medical Group. Three Bay Area newspapers carried simultaneous articles. The articles announced a new, $338,000 CDC/Permanente study of something they call “Morgellon’s disease.” I say they call it that because what they are describing is not what was originally described as “Morgellon’s,” but what is most likely a form of somatiform illness – delusional parasitosis, or neurodermatitis.
What is Morgellon’s and why is CDC funding Kaiser/Permanente with $338,000 to study it? I was never taught about anything called Morgellon’s, and althoughI had practiced medicine for forty years, I still had not known of it until several years ago when a group of affected San Francisco patients and R L Stricker MD, were reported as having a number of cases of it.
A recent study published in the Journal of General Internal Medicine and featured in a Time Magazine article, indicated that of 466 academic physicians in the Chicago area, 45% indicated that they have prescribed a placebo for a patient. This has sparked a discussion of the ethics of prescribing placebos in particular and deception in general in medicine.
A placebo is a biologically inactive treatment, such as a sugar pill. Any perceived benefit from taking a placebo is due to a combination of factors, mostly biased observation and non-specific effects, collectively referred to as the placebo effect. I discussed the placebo effect at length last week, and now will delve deeper into the question of deception in medicine more generally.
Prior to about 30 years ago the relationship between a physician and their patient was functionally paternalistic. This means that the physician did what they thought was best for their patients as a parent would for their child. It also meant that “benign deception” was often used, including prescribing treatments that were known to be inactive or ineffective. Sometimes the deception was one of omission – for example, not telling a patient that their disease was terminal and incurable so as not to upset them needlessly.
Over the last few months, I have had a truly surreal experience. It started when I noticed a two-page full color spread in TV Guide magazine advertising a product called Akavar 20/50. It contained the same claims that so many bogus weight loss products do: eat all you want and still lose weight. What attracted my interest was their highlighted statement: “We couldn’t say it in print if it wasn’t true!”
I laughed out loud. Anyone can say anything in print until they get caught. These diet ads all say things that aren’t true, and the FTC can’t begin to catch them all.
The ad describes research results they call “staggering.” They have scientific documentation that 23 out of 24 patients using Akavar’s active ingredient lost weight. They also described a controlled, randomized clinical trial of their actual product in which 23 out of 24 patients lost “a substantial amount of weight.” Two questions immediately came to mind: why were the numbers the same in both studies, and if a single active ingredient worked just as well, why was there any need to develop the Akavar formulation?
There was a toll-free number where I could call for further information. I called and asked for the citations of the two studies they referred to. The man who answered was flummoxed: “No one’s ever asked me that before.” He had to go for help. Finally he came up with the names of two journals and no further information.
I searched PubMed for anything in either of those journals that might even remotely be the studies they described, and I couldn’t find anything. I wrote the company’s customer service representative and asked for more information. And then the real fun began. Here are the actual e-mails for your delectation: (more…)
A few years back, my co-blogger Wally Sampson wrote a now infamous editorial entitled Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded. When I first read it, I must admit, I found it to be a bit harsh and–dare I say?–even close-minded. After all, plausibility aside, I believed at the time that the only way to demonstrate once and for all in a way that everyone would have to accept that many of these “alternative” therapies were no more effective than a placebo would be to do high-quality randomized clinical trials to test whether they worked, and NCCAM seemed to be the perfect funding agency to see that this occurred. Yes, this attitude in retrospect was quite naïve, as I have since learned the hard lesson over several years that no amount of studies will convince advocates of complimentary and alternative medicine (CAM) that their favored therapy doesn’t work, be it chelation therapy for autism or cardiovascular disease, homeopathy, reiki, or various other “energy” therapies that invoke manipulation of qi as a means of “healing,” such as acupuncture, but that is what I believed at the time.
Part II of this blog† introduced the homeopathic understanding of “symptoms” as they pertain both to “provings” in healthy subjects (now called “homeopathic pathogenic trials” or “HPTs”) and to histories elicited from patients. Hahnemann conflated “symptoms” and every random itch, ache, pain, sniffle, feeling, thought, dream, pimple or other sign, and anything else that might occur to a subject or a patient. This was amply demonstrated by Oliver Wendell Holmes, Sr., who seemed to doubt that such a morass would yield useful information. As unlikely as it may seem, today’s homeopaths are every bit as whimsical in their elicitation of “symptoms” as was Hahnemann.