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Alternative Flight

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.

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The Role of Anecdotes in Science-Based Medicine

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?

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Science by press release: A helmet to fight Alzheimer’s disease?

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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:
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Posted in: Basic Science, Medical Ethics, Neuroscience/Mental Health, Science and Medicine, Science and the Media

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Annals of Questionable Evidence: a new study reveals substantial publication bias in trials of anti-depressants

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.

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Posted in: Clinical Trials, Medical Academia, Medical Ethics, Science and Medicine

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Itching and the Imaginary Passenger Brake

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.

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Posted in: General, Neuroscience/Mental Health, Science and Medicine

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The infiltration of complementary and alternative medicine (CAM) and “integrative medicine” into academia

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.
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Posted in: Basic Science, Clinical Trials, Energy Medicine, Medical Academia, Public Health, Science and Medicine, Science and the Media

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Homeopathy and Evidence-Based Medicine: Back to the Future–Part III

“Symptoms,” Continued

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.
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Posted in: Homeopathy, Medical Academia, Science and Medicine, Vaccines

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Collision of Incompatibles

Last week’s post was about a recent (October 2007) meeting held at Harvard University on the subject of fascia. The purposes for commenting were several.

First, the organizers were partial believers in some forms of “Complementary and Alternative Medicine” (“CAM”), now being called “Integrative” but more realistically called sectarian or anomalous, aberrant medicine. The meeting is another in a long series of associating sectarian medicines with science – a bad fit.

Second, it illustrated an increasing infiltration of sectarianism, ideological thinking, and pseudoscience into medical schools and academia.

Third, this infiltrating change is no natural evolution, but is a political and economically driven external force, intent on both selfish and ideological interest. The forces are intent on radically changing society with medicine as the point of their phalanx. They chose medicine because of its admitted openness and self-criticism (no trade secrets, no state secrets, no top secret clearances; its self-criticism is open for all to see.) A vulnerable and often willing victim.

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Posted in: Medical Academia, Politics and Regulation, Science and Medicine

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The Placebo Effect

Recently the Federal Trade Commission went after the makers of the Q-Ray Ionized Bracelet for their claims that their device was a cure for chronic pain. Last week Seventh Circuit judge Frank Easterbrook handed down his opinion on the company’s appeal, writing that the company was guilty of fraud and ordering them to pay 16 million dollars in fines. One of the key points for the company’s defense was that the Q-Ray Ionized Bracelet is legit because it exhibits the placebo effect. Judge Easterbrook was not impressed with this argument, writing:

“Like a sugar pill it alleviates symptoms even though there is no apparent medical reason. Since the placebo effect can be obtained from sugar pills, charging $200 for a device that is represented as a miracle cure but works no better than a dummy pill is a form of fraud.”

This decision creates an interesting precedent, since there are a large number of fanciful treatments that do not have any “apparent medical” mechanism and that are claimed by its proponents to work through a placebo effect. In my experience the placebo effect, briefly defined as a measurable response to an inert treatment, is almost completely misunderstood by the public – a fact that is exploited by purveyors of dubious treatments such as the Q-ray. Already in the comments of this blog there has been discussion over the nature of the placebo effect.

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Posted in: Clinical Trials, Science and Medicine

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Homeopathy and Evidence-Based Medicine: Back to the Future – Part II

Part I of this blog† summarized the origin of homeopathy, invented in 1790 by Samuel Christian Hahnemann. It discussed Hahnemann’s first two “homœopathic laws of nature,” similia similibus curantur (like cures like) and the “law of infinitesimals,” and showed that his rationales for each have long been refuted. Hahnemann proclaimed a third doctrine, the “law of psora” ["itch"], said by him to be “the mother of all true chronic diseases except the syphilitic and sycotic.”[1] Oddly, it seems to have been forgotten.

Part II gives Hahnemann the opportunity to explain his assertions more thoroughly, as is his due. It considers those assertions from the vantage point of modernity, as is ours.

“Leave None of them Uncured”

According to Hahnemann, homeopathy is a panacea:

“Now, however, in all careful trials, pure experience, the sole and infallible oracle of the healing art, teaches us that actually that medicine which, in its action on the healthy human body, has demonstrated its power of producing the greatest number of symptoms similar to those observable in the case of disease under treatment, does also, in doses of suitable potency and attenuation, rapidly, radically and permanently remove the totality of the symptoms of this morbid state, that is to say, the whole disease present, and change it into health; and that all medicines cure, without exception, those diseases whose symptoms most nearly resemble their own, and leave none of them uncured.”[2]

How might this happen?

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Posted in: Basic Science, Homeopathy, Politics and Regulation, Science and Medicine

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