Articles

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Part IV of the ongoing Homeopathy series will have to wait a day or two, because it is superceded by a recent, comment-worthy publication.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.

(more…)

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

Leave a Comment (5) →

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.

(more…)

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

Leave a Comment (39) →

The Ethics of Deception in Medicine

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.

Historical Perspective

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.

(more…)

Posted in: Medical Ethics

Leave a Comment (37) →

Akavar 20/50 and Truth in Advertising

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…)

Posted in: Herbs & Supplements

Leave a Comment (111) →

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.
(more…)

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

Leave a Comment (81) →

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.
(more…)

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

Leave a Comment (14) →

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.

(more…)

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

Leave a Comment (53) →

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.

(more…)

Posted in: Clinical Trials, Science and Medicine

Leave a Comment (25) →

Dr. Judah Folkman (1933-2008): The epitome of what a science-based physician should be

The name of this blog is Science-Based Medicine. The reason it is so called is because we, the bloggers who will be contributing, believe that “the best method for determining which interventions and health products are safe and effective is, without question, good science.” Sadly, one of the people who best represented this very sort of philosophy, Dr. Judah Folkman (1933-2008), has died. Dr. Folkman was the epitome of everything that a science-based surgeon or physician should be, and he was first among my scientific and surgical heroes.
(more…)

Posted in: Basic Science, Medical Academia, Pharmaceuticals, Surgical Procedures

Leave a Comment (4) →

No-Touch Chiropractic

Some time ago, I learned that a Seattle chiropractor, Johanna Hoeller, had been featured on a local TV newsmagazine show. She was so proud of the segment that she had it posted on her web page for all to see. Unfortunately it is no longer there, so I’ll have to tell you what it showed.

She demonstrated her techniques on-camera. She put one wrist on top of the other, held them about an inch away from the patient’s neck and proceeded to produce a cracking sound in her own wrists without touching the patient in any way. The patient claimed to have felt something and to have experienced relief of pain.

The funniest part was when the news crew showed her their video of her performance and pointed out that she had not touched the patient. She appeared to be surprised and responded, “My whole thing is that I’m touching.”

Hoeller practices a form of chiropractic called NUCCA (National Upper Cervical Chiropractic Association). It’s a variant of the hole-in-one idea first proposed by B.J. Palmer, the son of the inventor of chiropractic, D.D. Palmer. Supposedly if you adjust the top cervical vertebra, that will correct any problems in the entire spinal column. Fix one and you fix them all. There is no credible evidence for any of NUCCA’s claims.

So here’s a woman “pretending” to do something that doesn’t work even if you actually “do” it. A little knowledge of psychology easily explains why she has so many satisfied patients. It’s even easy to understand how her experiences may have genuinely convinced her she is doing something effective. What I have trouble imagining is how she first got the idea to try treating without touching in the first place! (more…)

Posted in: Chiropractic, Politics and Regulation

Leave a Comment (32) →
Page 203 of 205 «...180190200201202203204205