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Studying Placebo Effects

ResearchBlogging.orgMeasuring placebo effects (often misleadingly referred to as the placebo effect – singular) is a part of standard clinical trial design, because they need to be distinguished from the physiological effects of the treatment under study. Rarely, however, are placebo effects the actual target being measured, but such is the case with a new study published in the most recent edition of the British Medical Journal (BMJ) – Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. (Here is a summary if you cannot access the article directly.)

Dr. Ted Kaptchuk et.al. studied the response to various placebo treatments in 262 adults with irritable bowel syndrome (IBS). The three groups were designed to address three major categories of placebo effects: 1) response to the process of being assessed and observed, 2) response to being given a placebo treatment, and 3) response to the patient-practitioner relationship. These types of placebo effects were represented by three treatment arms: 1) observation alone, 2) placebo acupuncture, 3) placebo acupuncture plus an “augmented” practitioner-patient relationship – with added “warmth, attention, and confidence.”

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Posted in: Clinical Trials, Science and Medicine

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SPECT Scans at the Amen Clinic – A New Phrenology?

Phrenology was a 19th century pseudoscience that claimed to associate brain areas with specific personality traits. It was based on palpating bumps on the skull and was totally bogus. New brain imaging procedures are giving us real insights into brain function in health and disease. They are still blunt instruments, and it is easy and tempting to over-interpret what we are seeing. In his book The New Phrenology William Uttal warns that “the excitement of these new research tools can lead to a neuroreductionist wild goose chase” and that we must be careful not to succumb to new versions of the old phrenology.

The Amen Clinics, founded by Daniel G. Amen, MD, offer SPECT (single photon emission computed tomography) scans to help diagnose and manage conditions such as attention deficit disorders (ADD), mood disorders, anxiety and panic disorders, autistic spectrum disorders, obsessive compulsive disorder (OCD), substance abuse, toxic exposure, brain trauma, memory problems, temper problems, and relationship and marital struggles.

The scans generate colored pictures of the brain that show “areas of your brain that work well, areas that work too hard, and areas that do not work enough.” They do not actually provide a diagnosis, but “must be placed in the context of a person’s life, including their personal history and mental state.” “The goal of treatment is to balance brain function, such as calm the overactive areas and enhance the underactive ones.” (more…)

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

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Colon “cleanses”: A load of you know what…

Death begins in the colon.

Perhaps you’ve heard this little bit of “alternative medicine” wisdom. Oddly enough, I had never heard it until well after I had become a surgeon (although my first thought upon hearing it was that it would make a killer name for a rock band or a blog). That’s when I began encountering claims that seemed to indicate that constipation was the most evil thing in the world, something that must be avoided at all costs. Naturally, I wondered just what the heck was meant by this bit of “wisdom.” What, I wondered, was it based on? What, I wondered, was the purpose of it? To answer this question, recently I decided to go back and review what people say about colon health:

Have you ever considered this simple question: Are you clean inside?

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Posted in: Science and Medicine, Surgical Procedures

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The Weekly Waluation of the Weasel Words of Woo #3

Last Week’s Entry: Everyone’s a Winner!

The resounding total of 4 “translations” for the second W^5 entry might have been trying to tell me something…nah!

I gotta say that each of the four nailed the central point: the esteemed Institute of Medicine (IOM), a subset of the esteemed National Academy of Sciences, has decided that it’s just fine—no, it is “important” and even “required”—that when it comes to “CAM,” the medical profession dispense with ethics, law, and science. Otherwise we might mistakenly argue, er, against the “integration of CAM therapies with conventional medicine.” That, clearly, would be unacceptable.

Stephen Barrett and others have critiqued some of remainder of the text. Regarding our own group of translators: yeah, you are all winners, but Stu once again rose above the crowd. Whadizzy, some kinda ringer? If he keeps this up I might have to insist that he be tested for performance-enhancing substances.

Hoodathunk that the IOM’s opinions are for sale? They are: the language that you deconstructed was bought and paid for, as we clunky Americans are so fond of saying, by…you and me! Yup, our tax dollars, funneled through the NCCAM and some other government agencies, generated the very Pap that we Smeared.

This Week’s Entry

In order to encourage more participation, I’ll try limiting entries to a single paragraph each, for a while anyway. This week’s entry, which will be the first of several from the same treatise, is found on the website of the American Medical Student Association (AMSA) as part of its “CAM Education Initiative“:

EDCAM – CAM and Medical Education Report

Medicine today is experiencing a paradigm shift that involves the blending of two disparate philosophies of health and disease, the biomedical or scientific reductionist view and the clinical, experiential holistic view. While the biomedical model reduces disease to a disturbance in biochemical processes and relies heavily on the “curative model” of care, holistic medicine derives from a “healing model,” which emphasizes the complex interplay between multiple factors: biochemical, environmental, psychological, and spiritual.

Feel free not only to restate it in the Queen’s English (it’s already in the Prince’s), but to comment upon its assertions. Remember, you gotta week, and I’ll announce the lucky winners in 2 weeks.

Happy waluating!

The Misleading Language and Weekly Waluation of the Weasel Words of Woo series:

  1. Lies, Damned Lies, and ‘Integrative Medicine’
  2. Integrative Medicine: “Patient-Centered Care” is the new Medical Paternalism

Posted in: Humor, Medical Academia, Politics and Regulation

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The Ethics of “CAM” Trials: Gonzo (Part II)

Laetrile and the Politics of NIH-Sponsored trials of “Alternative Cancer Treatments”

Part I of this blog ended by asking how, in light of the implausible and arduous nature of the “Gonzalez regimen” for cancer of the pancreas, and the unconvincing “best case series,” the NIH could ever have decided to fund a trial of it.† This entry will begin to answer that question. In so doing it may seem to veer from the original subject, but hold on to your seats: what you’ll find here is a piece of the treasure map that leads to the Mother Lode of Fool’s Gold that is government-sponsored “CAM” research.

All historical accounts of the encroachment of implausible claims into the research agenda of the NIH must begin with Laetrile. By that is meant all implausible claims, not merely those having to do with cancer. Elsewhere we have traced the history of “chelation therapy” for coronary artery disease, and have shown that its origins as a political movement, eventually leading to an unethical, $30 million, 2000 subject NIH trial, were intimately associated with people and organizations advocating Laetrile—the most lucrative health fraud ever perpetrated in the United States. In that essay we offer evidence that the creation of the NCCAM itself was at least partly attributable to the history of Laetrile and its advocates. Several good histories or partial histories of the Laetrile debacle are available online, including here, here, here, here, here, and here. The best,¹ but one that does not seem to be available online, is by the recently deceased dean of historians of American quackery, James Harvey Young. (more…)

Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Politics and Regulation

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Charlie Woo TV

Some of us received the announcement a week ago of the Bravewell Collaborative’s planned conference on “Integrative Medicine” co-sponsored with the National Academies’ Institute of Medicine, to take place in February, 2009.  (Note: I like to cap slogans and commercial trademarks and such and enclose them in quotation marks. Especially when the terms have no consensus meaning or are intended to obscure and confuse. ) 

Several of us may blog on the announcement. I want to emphasize a few points that struck me as revealing.  

The announcement also listed Friday’s Charlie Rose Pub TV interview program with Harvey Fineberg, MD, President of the “IOM,” Christy Mack, wife of the CEO of Morgan Stanley and the ideologue behind Bravewell and the project, and Ralph Snyderman, ubiquitous former dean of Duke University Medical School now vagabond “CAM” promoter and fund raiser. 

First off was a significant disclosure. Charlie Rose had been married at one time to Christy Mack’s sister, and Christy and he were still dear friends. As if disclosure is enough to help a viewer distinguish between facts and views obscured by a haze of politeness, appreciation, and gooey mutual stroking.

So much for  investigative, penetrating, and revealing journalism.

Snyderman, whose school was recipient also of large Templeton Foundation grants to ivestigate significance of spirituality and religion in “healing” revealed that he at one time was one of those straight arrow physicians who treated disease (instead of a person.) Until he experienced some of “the techniques” – unspecified – himself. In typical testimonial phrasing, he found it wondrous that something as intangible as hope could help heal. (Some of us also find that wondrous – even dubiousl.)  And then the tried and trite criticisms of docs being too involved in details (like what works and how to use it) and losing sight of the “whole person.”  ”Health is a value and one can have impact…” Eyes roll at such platitudinous and vacuous language.

If that were not enough, Fineberg demonstrated his deep knowledge of “Integrative Medicine” by telling the difference between “healing” and “curing,” and his democratic outlook by wanting to test any methods that works – regardless of the origin. David G’s blog the other day and Kim Atwood’s previous words discussed that issue, which still befuddles the NCCAM, which seems to test anything whether it contains molecules or not, and whether the idea generated in a crucible of observation and experimentation, or descended in a 2 AM drug-induced revelation.  He then used artemisinin (for resistant malaria) to illustrate the potential mining of miraculous natural drugs from traditional Chinese Medicine. I assume he assumed that TCM practitioners had  had been using it for malaria for centuries…despite the fact that there was no description of infectious diseases in TCM. Finding artemisinin for malaria was a product of extraction and purification from plants, known as modern pharmacology.

Christy Mack tried to introduce new concepts, explaining that one of her new aims is to empower the patient to heal oneself…That is not only decades old, but a word-linkage that, as with all esoteric ideation , means a lot to her and her co-believers, but little to the uninitiated.  Another concept was for each person to make a personal health plan for one’s life.  Can’t I do that now if I want? Seems I already did, then chance and nature intervened…

When Snyderman let slip the term, “CAM”, Mack jumped in saying, “Integrative Medicine” is not “CAM”.  Here was a clue to the joining of these otherwise poorly fitting edges of “IM” and the “IOM.”   We just won’t talk about those inconvenient absurdities that “IOM” might shrink from. My take is that Mack and ”CAM” advocacates want the blessings of as many System organizations as possible to fill their “CAM” CV as prelude to legitimization, licensing, and insurance reimbursement.  “CAM” practitioners are using the Bravewell as internediary to using “IOM.” Morgan Stanley money being an efficient lubricant. Simple.

So “IOM,” in exchange for more $?millions as it did for the NCCAM committee, sells itself and its merit badge for ”CAM”‘s  CV sash.  Fair exchange in this capitalist system, yes?  Seems that the only factor nissing in this exchange that keeps it from illegality is a sexual act. The Quiet Revolution moves on. 

Personal note: In 1993 when I awoke from 3 weeks of post-op unconsciousness in the ICU, the first things I recalled were on the overhead TV: the NCAA basketball finals, the Waco cult building complex on fire, and Charlie Rose interviewing another talking head with that ominous blacked-out background. The Quiet Revolution moves on as the Nightmare recurs. �

Posted in: Faith Healing & Spirituality, Health Fraud, Medical Academia, Science and Medicine, Science and the Media

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Cell Phones and Brain Tumors

The question of whether or not there is a link between the use of mobile phones (also called cell phones) and the risk of brain tumors has been cropping up more and more frequently in the media – every time a new study or analysis comes out. This is a very important question of public health as cell phone use is becoming more common, and brain tumors are a very serious and often life-threatening category of diseases.

Of course such questions are best answered by a dispassionate, careful, and systematic look at the science – what is the plausibility of a link and what is the evidence that there actually is one. At this point we are somewhere in the middle of studying this problem. We already have substantial data, but it is conflicting and the research community is still debating on how to get more definitive data everyone can agree upon. So at present there is a variety of opinions on the matter. The consensus seems to be that cell phones probably do not cause brain tumors, but we’re not sure, there is meaningful dissent from this opinion, and so more study is needed.

There are two types of scientific studies we can do to answer this question. The first is biological and looks at the effects of radiation, and specifically the type and strength of radiation emitted by cell phones, on cells in a test tube and on animals. This will tell us if a risk from cell phones is plausible, if there is a mechanism, and what, if any, the effects are likely to be. But this kind of data will not tell us if cell phones in fact have caused or are causing brain tumors.

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Posted in: Neuroscience/Mental Health, Public Health

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Hormone Replacement Therapy

For years postmenopausal women were told that estrogen was safe. Now they’re being told that estrogen is dangerous. Women are confused. The media haven’t helped; they’ve only increased the confusion and created some myths. Alternative medicine offers the option of herbal remedies they say are safer than estrogen. Suzanne Somers says all of us (even men!) should be taking bioidentical hormones and adjusting our own doses according to how we feel. What’s a woman to do? What does the science really say?

Before the Women’s Health Initiative (WHI) of 2002, there were two main reasons for prescribing hormone replacement therapy (HRT): it relieved perimenopausal symptoms like hot flashes, and it helped prevent osteoporosis and fractures. There was good reason to believe that estrogen might also reduce the risk of heart attacks, but very few doctors (if any) ever prescribed it for the sole purpose of reducing heart risks. And doctors were always aware that estrogen and progestins were powerful drugs and were not risk-free.

There was a time in the mid-20th century when estrogen was thought to be a fountain of youth and women were encouraged to start taking it at menopause and continue for the rest of their lives. That attitude quickly changed as we realized these hormones were associated with blood clots, strokes, and increased rates of some cancers. We also learned that unopposed estrogen caused uterine cancer, and women who still had their uterus had to take progestins along with their estrogen. (more…)

Posted in: Pharmaceuticals

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On the ethics of clinical trials of homeopathy in Third World countries

ResearchBlogging.orgI’m on the record multiple times as saying that I reject the entire concept and nomenclature of “alternative medicine” as being distinct from “conventional” medicine as a false dichotomy, when in reality there should be just “medicine.” Indeed, if there is one major theme to which this blog is dedicated it’s that medicine should be as much as possible science-based, a concept that takes into account not just clinical trials, which are prone to all sorts of false-positive results in the case of modalities that have no plausibility from a scientific perspective. In essence, I advocate treating “alternative” medicine the same as “conventional” medicine subjecting it to the same scientific process to determine whether it has efficacy or not, after which medicine that is effective is retained and used and medicine that fails the test is discarded. Where it comes from, the “alternative” or the “conventional” medical realm, matters little to me. All that matters is that it is based on sound science and that it has been demonstrated to have efficacy significantly greater than that of a placebo.

Given that, you’d think I’d be all in favor of subjecting alternative medicine, be it woo or more credible, to rigorous scientific testing. In many cases, you’d be right. My sole caveat is that, when testing alt-med, priority should be given to modalities that have at least a modicum of scientific plausibility, even if a bit tenuous. Herbal remedies would thus be at the front of my line to be tested, while obvious woo whose core principle on which it is based is so utterly ridiculous and scientifically implausible (like homeopathy, for instance) would be relegated to the back of line, if it’s ever tested at all. More implausible modalities that might work (albeit by a method that has nothing to do with the “life energy” manipulation that is claimed for it) like acupuncture would be somewhere in the middle. It’s a matter of resource prioritization, in which it makes little sense to test blatant woo before more plausible therapies are examined. Indeed, it’s arguable whether blatant woo like homeopathy should even have resources wasted testing it at all, given its extreme scientific improbability. Finally, regardless of what modality is being tested in scientific and/or clinical trials, it has to be done according to the highest ethical standards, on adults fully cognizant of or able to be taught about the questions being asked, the issues involved, and the potential risks who are thus able to give truly informed consent.
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Posted in: Homeopathy, Medical Ethics, Public Health, Science and Medicine

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How Can Smart People Be So Stupid?

This is a quick posting that begins to respond to the question posted today by Joe:

What I don’t understand is why the majority of doctors at Columbia did not say “This is obvious abuse of patients, and it will not be tolerated here.” Given his richly-deserved malpractice record, why was [Gonzalez] even associated with Columbia?

David Gorski answered it in part: “Grant money.” There are also other factors: widespread naivete about the nature of quackery, ignorance of the methods themselves, widespread lack of scientific sophistication among physicians (!), unwillingness to appear contrary to whatever the current trendy thing may be and more. I’ll mention some of the particulars regarding Columbia and Gonzalez over the next couple of weeks.

But today this advertisement arrived:

FOR IMMEDIATE RELEASE

A discussion about Integrative Health with Christy Mack, President of The Bravewell Collaborative, Ralph Snyderman, Chancellor Emeritus for Health Affairs at Duke University, as well as President and CEO of Duke University Health System and Dr. Harvey Fineberg, President of the Institute of Medicine will air on the Charlie Rose show tonight. Please check your local listings for times and future air dates.

For more information or to view the segment on-line, please click on the following link: http://www.charlierose.com/shows/2008/03/28/2/a-discussion-about-integrative-health

Those of you who’ve been following SBM will recognize the imprints of all 3 of Charlie Rose’s guests in recent posts: Harvey Fineberg, who presided over the IOM’s entry in the most recent W^5/2; Christy Mack of the Bravewell Collaborative, which bankrolls the Consortium of Academic Health Centers for Integrative Medicine; and Ralph Snyderman of Duke. Snyderman and the “Consortium” were the authors of two of the misleading passages quoted in Misleading Language: the Common Currency of “CAM” Characterizations Part II.

I suspect that this show will reveal a lot—to those who are aware of the language distortions—about the insidious creep of pseudomedicine into places where it has no business going. If you can’t watch it tonight, go to the website and see it another time.

Posted in: Health Fraud, Medical Academia, Science and the Media

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