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

Part V of this Blog argued that the NCCAM-sponsored trial of the “Gonzalez regimen” for cancer of the pancreas is unethical by numerous criteria.† To provide an illustration, it quoted a case history of one of the trial’s subjects, who had died in 2002.¹ It had been written by the subject’s friend, mathematician Susan Gurney. A similar story was told on ABC 20/20 in 2000, albeit not about a trial subject. Each of these cases demonstrates the wide breadth of Gonzalez’s quackery, as did his brush with the New York medical board during the 1990s.

This entry addresses some aspects of how those in charge of the trial failed in their duty to protect human subjects. By implication, it suggests what is necessary to prevent similar travesties in the future. It also addresses, to the small extent that the information exists, what appear to be the final ethical violations: first, that the trial will never be completed, thus having “expose[d] subjects to risks or inconvenience to no purpose.” Second, that Columbia University and the responsible investigators have no intention of explaining why.

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

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Integrative Medicine – Sectarians’ Trojan Horse

Integrative Medicine – Sectarians’ Trojan Horse leapfrogs science (Or, I can misuse language with the best of them…)

I stumbled across an article from Archives of Internal Medicine, 2002 (Integrative Medicine: Bringing medicine back to its roots. Arch Intern Med. 2002 Feb 25;162(4):395-7). It is one of the first authored by Andrew Weil on “Integrative Medicine “ – another is BMJ in 2001. This one he co-authored with Ralph Snyderman. Dr. Snyderman was dean of the Duke University med school, and is now upstairs as a chancellor of health affairs. He is one of the highest ranking academicians to express fondness for sectarian systems (they prefer “Integrative Medicine.”) Fondness in his case is an understatement. He appears to have fallen up to his frown into the sectarian vat and emerged transformed as the poster-prof for the Bravewell Collaboration, funding organization for the 36 departments and programs in US medical schools. Andrew Weil, of course is one of the prime movers of the “CAM” phenomenon, and may have invented the neo-term, “Integrative” – with the clever occult purpose of diverting attention away from plausibility and toward acceptance according to our suggested motto, “teach it and use it regardless of efficacy.“ He directs this activity from his spread near Tucson, where he also heads the U. of Arizona “integrative” program.

I experienced several problems on reading the article – mainly a cloud of dysphoria and a sense that of disagreement with it, but through a fog of obscure language, I could not identify why. One has to look closely at the language. The abstract alone yields enough for this entry. It displays language distortion by re-definition, as Kim Atwood recently explored, language obscurantism – use of generalizations and words with obscure or multiple meanings, and invented language. It also mis-states, misrepresents, assumes; these are established propaganda techniques and used to construct false labels on sectarianism’s Trojan Horse. After starting this I found a similar article by Edzard Ernst in Mayo Clinic Proceedings in 1993. Nothing new under the sun…

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

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One Hand Clapping

CUSTOMER: Here’s one — nine pence.
DEAD PERSON: I’m not dead!
MORTICIAN: What?
CUSTOMER: Nothing — here’s your nine pence.
DEAD PERSON: I’m not dead!
MORTICIAN: Here — he says he’s not dead!
CUSTOMER: Yes, he is.
DEAD PERSON: I’m not!
MORTICIAN: He isn’t.
CUSTOMER: Well, he will be soon, he’s very ill.
DEAD PERSON: I’m getting better!
CUSTOMER: No, you’re not — you’ll be stone dead in a moment.

Monty Python and the Holy Grail

For some unexplained reason, people at work like to tell me of the positive interactions they have had with acupuncturists and chiropractors and others of that ilk. I must have a friendly face, but I keep checking my back for a “CAM me” sign.

One of the oncology nurses was telling me how she has chronic neck pain, and that she was skeptical about acupuncture, and would never recommend these therapies for one of her cancer patients, but she went to an acupuncturist, and by gosh and by golly if her pain wasn’t better, what do you think of that Mr. Skeptic?

Call me Dr. Skeptic, I replied. Show some respect for the dead.

It does make for an awkward conversation.

I cannot deny that she isn’t better. How can I argue that she doesn’t have decreased pain? She is the one who hurts and is the one who can best judge the degree of her discomfort.

“Nope. You are not better. Sorry. Wrong. You are still in the same amount of pain you were before.”

It is an untenable position.

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Posted in: Science and Medicine

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The Weekly Waluation of the Weasel Words of Woo #4

That’s What I’m Talkin’ ’bout!

The new single-paragraph paradigm for the W^5/2 seems to have worked: there were 13 Waluations for the paragraph submitted in W^5/2 #3, every one of ‘em good. Several themes emerged; I’ll discuss them in no particular order.

  • When did you stop beating your wife? The passage charges that the “biomedical model,” by which is apparently meant modern medicine, does not consider anything other than “disturbances in biochemical processes.” “Holistic medicine,” on the other hand, recognizes the Complex Interplay Between Multiple Factors. DVMKurmes, pmoran, and wertys each exposed the ahistoricity of this claim.
  • Back to the Future. Speaking of ahistoricity (is that a word?), two readers, wertys and Falx, noticed a paradox: the proposed “paradigm shift” of “medicine today” always involves the resurrection of discredited, pre-scientific notions of yesterday.
  • Dr. Feelgood. Several readers, including DVMKurmes, Michelle B, rjstan, wertys, Stu (m’man!), Calli Arcale, and overshoot, alluded to the preference of at least some Woo-Seekers for feeling good (“a healing model”) over being good (“the curative model”). I admit that my shorthand description of the point is oversimplified, but there is truth in it nonetheless. The “feelgood” phenomenon is not to be confused with the similarly named
  • Feelings…Very Special Feelings. Alotta people just want, well, their feelings to be validated. Not that there’s anything wrong with that, but if it’s at the expense of competent medical care, as rjstan, Stu, and Falx noted, they could be Takin’ Trouble by the Tail. Or at least Losin’ a Lotta Lettuce.
  • It Takes a Worried (wo)Man to Sing a Worried Song. Both rjstan and DBonez called attention to the current societal obsession with “health,” frequently called “wellness,” which is an indispensable part of the “CAM”-scam. As rjstan and pmoran pointed out, many of the obsessed have nothing wrong but a surplus of funds. Why don’t those people just getta life?
  • By Hook and By Crook. Tools honed on Madison Avenue are in the kits of sCAMsters, say DVMKurmes, Michelle B, Stu, and ShawnMilo. That they are.
  • Mastering the Art of Zen Cooking. A lotta “reduction” makes my eyes glaze, so I was pleased that at least one reader, overshoot, cited the passage for its tired misportrayal of the “scientific reductionist view.” One o’these weeks we’ll discuss that at some length.
  • The Well-Hewn Tune of Thomas Kuhn is misrepresented by those we impugn, as asserted by wertys and implied by Joe. Another topic to discuss at more length some time.
  • The Autobiography of Malcolm X…prophecies that…his…brother…Michael X…will…one day…rail…against…so-called…integrated…medicine.

This Week’s Entry:

A shaman is a type of spiritual healer distinguished by the practice of journeying to nonordinary reality to make contact with the world of spirits, to ask their direction in bringing healing back to people and the community. The journey is a controlled trance state that practitioners induce by using repetitive sound (drums, rattles) or movement (dancing) and occasionally by consuming plant substances (e.g., peyote or certain mushrooms). Characteristically experiential and cooperative, shamanic healing is found worldwide. It is fundamental to much traditional European, African, Asian, and Native American Indian folk practice and is rapidly gaining popularity among nonnative urban Americans, in which setting it is sometimes called neo-shamanism.

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, Science and Medicine

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Would you like a liver flush with that colon cleanse?

I have to apologize for last week’s post. I’m not apologizing for the subject matter (the obsession that reigns supreme among some alt-med aficionados over “cleansing” their colons to “purge toxins” and achieve the super-regularity of several bowel movements a day). Rather, I’m sorry I probably didn’t emphasize quite strongly enough just how disgusting one of the links that I included was. Among all the glowing testimonials found there touting how lovers of that “clean feeling” inside felt after having supposedly rid themselves of all that nasty fecal matter caked on the walls of their colons and achieved the Nirvana of many bowel movements a day (or, as one happy customer put it, “awesome adventures in the bathroom” and another put it, “I have not noticed anything really weird come out of me yet, but I am sure that there will be”), there were also links to various pictures people took of their own poop, complete with graphic descriptions. A couple of years ago when I showed an acquaintance of mine the Dr. Natura website shortly after I had discovered it, he declared it the “grossest thing on the web.” Sadly, I had to assure him that it was not–not by a longshot. However, I will try spare you any links to anything significantly grosser, preferring instead to leave finding them as an exercise for interested readers.

After having apologized for perhaps grossing out some of our readers, who come to this site for science- and evidence-based discussions of various so-called “complementary and alternative medicine” therapies, not pictures of the various excretions of the human body proudly lined up by the humans who produced them, I thought about what might be a suitable followup this week to such a topic. There really is only one followup that’s appropriate to this stuff, believe it or not. The problem with which I wrestled is that it really is pretty much as disgusting as last week’s topic, if not more so. (You’ll soon see why.) So there I was, trapped on the horns of a dilemma. Hesitating only momentarily, though, as any good general surgeon would do (remember, before I specialized in breast cancer surgery I was a general surgeon, as prone to dive into big brown on the loose as any other general surgeon), I decided just to dive in to the topic as I would have in the old days dived into a particularly foul belly full of purulence, particularly since this week’s “CAM” modality of choice claims to be able to take away a big chunk of the “bread and butter” practice of general surgery by curing a common surgical disease without all that nasty cutting, even if these days it’s almost always done laparoscopically.

So, are you ready for liver flushes? Of course you are. Don’t you want a way to “remove gallstones without surgery“?

Of course you do.
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Posted in: Cancer, Health Fraud, Science and Medicine

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

A Reminder (Mainly to Myself): this Blog will Eventually get back to Discussing the NIH Trial of the “Gonzalez Regimen” for Treating Cancer of the Pancreas†

Which, if you’ll recall, is an arduous dietary and “detox” regimen that includes 150 pills per day, many of which contain pancreatic enzymes, two “coffee enemas” per day, ”a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest,” and more. In Part II I ventured off on a tangent about Laetrile and government sponsorship of trials of implausible cancer “cures.” That became more involved than I had planned (but also more enlightening, or so I hope), and Part III continues on that tangent.

The Politics of “Alternative Cancer Treatments”: the Lamentable Legacy of Laetrile (cont.)

The whole tide is beginning to turn toward metabolic therapy for degenerative disease and preventive medicine. Laetrile…has been the battering ram that is dragging right along with it…B-15,…acupuncture, kinesiology, …homeopathy and chiropractic…And we’ve done it all by making Laetrile a political issue.”

-Michael Culbert, editor of The Choice, the newsletter of the Committee for Freedom of Choice in Medicine. Quoted in 1979.¹

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Posted in: Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

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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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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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