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

Part IV of this blog ended by observing that the NIH-funded trial of the “Gonzalez regimen” for cancer of the pancreas,† to have begun in March, 1999, was in trouble almost as soon as it started. As originally designed, it was to have been a randomized, controlled trial comparing gemcitabine, the standard chemotherapy, to the “Gonzalez regimen” of pancreatic enzymes, “supplements,” twice-daily coffee enemas, and other purported methods of “detoxification.” By June, 1999, according to Dr. John Chabot, the Columbia University surgeon acting as Principal Investigator (PI) of the trial, only 3 of the first 50 potential subjects had agreed to be randomized, and none of the three met the eligibility criteria. By January, 2000 it had become clear that the trial would not accrue a sufficient number of subjects if it remained randomized, because almost all of the potential subjects were intent on being in the “nutritional,” ie, the Gonzalez arm.

Trouble with Randomizing

The investigators at Columbia therefore decided to change the protocol to a “single-armed, non-randomized case-cohort study where patients will only be enrolled in what was the nutritional arm.” Paradoxically, PI John Chabot had recently explained, at the 1999 Comprehensive Cancer Care Conference of James Gordon’s Center for Mind-Body Medicine, why this would not be a scientifically sound design:

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Posted in: Clinical Trials, Health Fraud, Medical Academia, Medical Ethics

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

A Review; then Back to the Gonzalez Regimen†

Part I of this blog introduced the topic of the “Gonzalez regimen” for treating cancer: “Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support” and “detoxification” with twice daily coffee enemas, daily “skin brushing,” “a complete liver flush and a clean sweep and purge on a rotating basis each month,” and more. The topic was occasioned by the federal Office for Human Research Protections having recently cited Columbia University, for the second time, for violations of human subject protections in its NIH-funded trial of Gonzalez’s method as a treatment for cancer of the pancreas.

Part I discussed the implausible and bizarre regimen and cited Gonzalez’s troubles with malpractice suits and with the New York medical board during the 1990s. It ended by wondering what could have induced the NIH to give a $1.5 million grant to Columbia University to study the method.

Parts II and III began to answer that question, tracing some of the key events and individuals from the Laetrile wars in the 1970s to the NCI-funded trial of Laetrile reported in 1982, to the ”immuno-augmentative therapy” (IAT) battles of the mid-’80s, to the Report on “Unconventional Cancer Treatments” by the Congressional Office of Technology Assessment (OTA) in 1990, which in turn led to the NCI adopting its “Best Case Series Program” in 1991.

The end of Part III hinted that the conspiracy mongering that had greeted every attempt by the government to explain its positions on implausible cancer treatments, from Laetrile to the OTA report, ultimately led to the creation of the Office of Alternative Medicine (OAM) at the NIH, also in 1991. There is plenty of evidence for that, both from the conspiracy mongers themselves and from more level-headed observers. Each time the government acted—to fund a trial of Laetrile, to solicit the OTA report and propose a study of IAT, to establish the NCI “Best Case Series” program, and to establish the OAM—it was not because of scientific or medical considerations, but because of political pressure. More on that from time to time, but now back to Dr. Gonzalez.

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Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Medical Ethics

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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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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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The Weekly Waluation of the Weasel Words of Woo #2

You Can’t Foo’ Stu with Woo!

A Spitzerian (“pointed”) analysis

Last week’s inaugural game elicited several amusing and penetrating analyses, including that of the hands-down Gold Medal Winner, Stu. His was the first entry, introduced in a concise and alliterative imperative, and was both hilarious and timely. It implied most of the points discussed by others. This distinctive combination has moved me to grant Stu a legacy here at the W^5. In the future there may be, undoubtedly no more than once in a very long while, entries that live up to the Soaring Standard of Stu®. If so, they will be Duly Acknowledged. (more…)

Posted in: Chiropractic, Humor, Medical Academia, Medical Ethics

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The ultimate in “integrative medicine”: Integrating the unscientific into the medical school curriculum

For the second week in a row I find myself throwing out the original post that I had planned on doing in favor of a different topic. The reason this week is, quite simply, having read Dr. Atwood’s excellent two part post Misleading Language: The Common Currency of “CAM” Characterizations (Part I; Part II). I don’t at this time intend to expand on what Dr. Atwood said, although I may do so at one future time. What caught my attention in his lengthy deconstruction was his segment on the “woo-ification” of health care, which very much echoed my post a while back in which I lamented the creeping infiltration of non-science-based modalities into academic medical centers, as well as the credulous teaching of such modalities in medical schools. What I wanted to explore was just how far this might go and what the end result might be. It turns out that we are already witnessing an experiment in just such a thing.

About a year and a half ago, I first became aware of just how far this infiltration of unscientific “medicine” has infiltrated academia when I saw this brochure published by the Georgetown University School of Medicine. If you’re scientifically inclined, as I am, it ought to make you shudder. Reading this brochure, I truly have to worry whether woo really is the future of American medicine, as has been suggested in some quarters. Certainly, if other medical schools start following Georgetown’s lead, it will be. Not content to offer so-called complementary and alternative medicine (“CAM”) modalities as part of electives that interested students can take if they are so inclined, Georgetown is taking the next logical step that I feared: It’s dedicating significant educational resources and time to teaching “CAM” in its mandatory general medical curriculum, where every student has to learn it:
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Posted in: Medical Academia, Science and Medicine

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Misleading Language: the Common Currency of “CAM” Characterizations Part II

Background

I promised readers the “Advanced Course” for this week, which undoubtedly has you shaking in your boots. Fear not: you’ve already had a taste of advanced, subtle, misleading “CAM” language, and most of you probably “got” it. That was R. Barker Bausell’s analysis of how homeopathy is “hypothesized to work.” In the interest of civility, let me reiterate that I don’t think of Bausell as a horrible person or an ignorant boor for having written that statement. Rather, I think of him as having been so steeped in the de rigueur “CAM” language distortions of the 1990s that he is largely unaware of their insidious power. I suspect too that he, like most of us who grew up when schools no longer stressed the rigors of English composition, has an underdeveloped sense of the relation between the craft of writing and the integrity of its content. That doesn’t excuse him from writing honest prose, of course.

Last week’s post cited blatant language distortions of “CAM”—euphemisms, slogans, and outright falsehoods—and some that were more subtle: question-begging, misrepresentation, and derogation. It would require a semester’s worth of seminars to delve into the overlapping categories of misleading “CAM” language, but here we can consider a few. Then, perhaps, we’ll engage in an amusing diversion—more about that at the end of this post. (more…)

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

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Misleading Language: the Common Currency of “CAM” Characterizations. Part I

The Best Policy

From time to time I have been reiterating that correct use of the language has much to do with logic; I should add that it entails also honesty. I use the word “honesty” in its broadest sense…

Concision is honesty, honesty concision—that’s one thing you need to know.

—John Simon. Paradigms Lost: Reflections on Literacy and its Decline. New York, NY: Clarkson N. Potter, Inc.;1980. pp. 48, 52

Prologue

In 1983, a naturopath in Alberta inserted balloons into the nostrils of a 20 month-old girl and inflated them. The child died of asphyxiation. Subsequently, a judge described the treatment—dubbed “bilateral nasal specific” by the chiropractor who had invented it—as “outright quackery.” [1] Fast-forward 15 years: a woman presented to the otolaryngology clinic at the University of Washington in Seattle “complaining of severe midface pain and epistaxis” (nosebleed). She had suffered nasal septal fractures caused by a similar treatment, by then renamed “NeuroCranial Restructuring” (NCR). In their case report, the surgeons who had treated the woman at U. Wash discussed the claims of NCR and explained that the relevant anatomy predicts that it is implausible and risky. They also reported that it is expensive: “$2000 to $4800 for a standard course (of 4 treatments).” They concluded:

This case report of a complication after a CAM procedure called NCR highlights the wide range of treatment options available to patients. It is important for otolaryngologists to be aware of the spectrum of CAM therapies that patients may pursue and be aware of potential complications from these procedures.

An accompanying editorial used similar language.

How is it that in 1983 a judge could offer a concise summary of the essence of such a method, whereas scarcely a generation later 5 highly-trained medical doctors, even after presenting the sordid facts, could only obscure it with bland euphemism? (more…)

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