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“CAL”: a Medico-Legal Parable

Preamble

From the fall of 2000 to the winter of 2002, the Commonwealth of Massachusetts convened a Special Commission on Complementary and Alternative Medical Practitioners. There were 12 members: 6 legislators, 3 MDs, a naturopath, a lawyer who represented the New England School of Acupuncture, and the chairman, who was also the Director of the Massachusetts Division of Professional Licensure. At the start of deliberations two things became apparent: first, the Commission would concern itself almost exclusively with the petition of “naturopathic physicians” to become licensed health care practitioners in the Commonwealth*; second, there were only two recognizable, medically-sophisticated skeptics among the members. They were Arnold “Bud” Relman, the emeritus editor of the New England Journal of Medicine (appointed by the Massachusetts Board of Registration in Medicine), and I (appointed by the Mass. Medical Society). We expected a third, an MD soon to be appointed by the Commissioner of Public Health, Dr. Howard Koh.

Within a few weeks it became clear that the third MD would not be a skeptic. Dr. Koh, apparently thinking he had found an expert, appointed as his representative David Eisenberg, Director of the Harvard Medical School (HMS) Division for Research and Education in Complementary and Integrative Medical Therapies. Dr. Koh must not have known that in 1997 Dr. Eisenberg had called for

A national listing of licensed alternative medical providers (e.g., chiropractors, acupuncturists, massage therapists, naturopaths, and homeopaths) in each of the 50 states as well as a uniform credentialing process.

Commissioner Koh also must not have known that Dr. Eisenberg had received or was currently receiving funds from several sources committed to furthering the ambitions of ”CAM” practitioners in general or of “naturopathic physicians” in particular: the NCCAM, the Fetzer Institute, the New York Chiropractic College, Cambridge Muscular Therapy Institute, New England School of Acupuncture, American Specialty Health Plan, and the Southwest College of Naturopathic Medicine.

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Posted in: Politics and Regulation, Science and Medicine

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The Weekly Waluation of the Weasel Words of Woo #5

The Master Speaks

It was a delightful surprise for me, and I hope for you fans of the W^5/2, to log onto SBM on Thursday and find this blog by Dr. Wallace Sampson. As I mentioned in that long-ago posting that introduced the topic that eventually hatched the W^5/2, Dr. Sampson is my Yoda, when it comes to the topic that he named: Language Distortions. More about that below.

When the Goin’ Gets Tough…

OK, I’ll admit I threw you a curveball last time. That shaman thing rilly was a bit over the top, even if it rilly did come from an honest-to-god Sacred ”CAM” Scroll. Reminds me of something by Jonathan Swift…I can’t remember where…Gulliver, maybe?…he copied, verbatim, a ship captain’s log, recognizing it as a good satire by itself (extra credit for any reader who finds that reference). So I rilly can’t blame Stu (m’man!) and homeboy David Gorski for their reluctance to Waluate that Suckah. Stu, true to expectations, even submitted an additional explanation that was pretty frickin’ funny in its own right.

The Tough Get Goin’!

On the other hand, five readers Dug Down Deep to Deconstruct the Dang Deal, and they deserve full credit! The winner was, without question, Michelle B: she submitted the most comprehensive translation, even providing a comparative look at ancient and modern popular culture. Michelle B, for the W^5/2 #4, You Da Woman.

Second place goes to mmarsh, a newcomer to the W^5/2, who looks like a playah. Here’s hoping he/she becomes a regular.

Honorable mentions for DVMKurmes , Michael X (in an elliptical sort of way), and overshoot, each of whom gave it a shot, if, er, a somewhat abbreviated one. I wasn’t sure whether wertys was offering a formal Waluation or just an amusing observation, but either one is always welcome, of course. Same for the observation of reechard. Keep those cards and letters comin’!

This Week’s Entry

In honor of Dr. Sampson’s recent blog, here’s another snippet from the article whose abstract he translated:

The integrative medicine movement is fueled not only by the dissatisfaction of consumers with conventional medicine, but also by the growing discontent of physicians with changes in their profession. Physicians simply do not have the time to be what patients want them to be: open-minded, knowledgeable teachers and caregivers who can hear and understand their needs. Their unhappiness is not just the result of the limitations managed care has placed on their earning capacity. It is also a response to a loss of autonomy, to a loss of fulfilling relationships with patients, and, for some, to a sense that they are not truly helping people lead healthier lives. Significant numbers of physicians are now quitting medical practice, and applications to medical schools are decreasing precipitously.

As I’m sure you’ll already have noticed, the “plot” of that paragraph has a little something that’s different from the usual fare.

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, Science and Medicine

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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.

(more…)

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

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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:

(more…)

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

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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: General, Humor, Science and Medicine

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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 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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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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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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