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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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Deception and Ethics in Sectarian Medicine

In January I had the pleasure of attending TAM 5.5 in Fort Lauderdale. On the last day of the conference the JREF had an open house where anyone interested could come see the inner workings at the JREF facility. Since I had a rental car I decided to go through the lobby to see if anyone needed a ride, and sure enough one Dr. Harriet Hall took me up on my offer.During the 20 minute drive that I had Harriet captive we were able to have a pleasant and illuminating (for me) conversation, during which I told Dr. Hall about an experience I had with a chiropractor in my neck of the woods. This got me thinking about honesty and purposeful deception in alternative medicine, and for this reason I’m going to start this blog entry off with a personal anecdote about an incident that occurred some years back just after I graduated from Nursing and had become a full-fledged registered nurse.

After having some back problems I decided to go to a respected chiropractor in Calgary (a city of about 1 million people). Since it was my first visit I needed to go through a full ‘assessment’ and the chiropractor took my blood pressure, had me step on two scales (one for each foot) so that he could weigh both sides of my body simultaneously, and he also took a single anterior X-Ray of my chest/spine (anterior means an X-Ray taken straight on with my back against the photographic plate – actually I think the technical term for that is an AP or anterior-postero X-Ray).

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Posted in: Chiropractic, Health Fraud, Medical Ethics

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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 Ethics of “CAM” Trials: Gonzo (Part I)

Blogger’s note: This blog, which is rough going in places, will be presented in either 2 or 3 parts (I won’t know which until next week). I’ll post a part each week until it is complete, but due to overwhelming popular demand I promise to maintain the every-other-week posting of the far more amusing Weekly Waluation of the Weasel Words of Woo/2.

Introduction

On Feb. 25, 2008, the federal Office for Human Research Protections (OHRP) cited Columbia University Medical Center (CUMC) for violating Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects (45CFR§46). The violations involved Columbia’s administration of the NIH-sponsored trial of the bizarre “Gonzalez Regimen” for treating cancer of the pancreas.† The OHRP’s determination letter to Steven Shea, MD, the Director of the Division of General Medicine and Senior Vice-Dean at CUMC, cited ethical problems of a serious kind:

We determine that the informed consent for the 40 of 62 subjects referenced by CUMC was not documented prior to the start of research activities, nor was the requirement for documentation waived by the CUMC IRB for subjects in this study.

It was the second time that the OHRP had cited Columbia for its dubious management of the “Gonzalez” trial. The first occurred in Dec. 2002, after investigators had determined that the trial’s consent form “did not list the risk of death from coffee enemas.” The OHRP listed several other violations at that time, but “redacted” them from the letter that it made available to the public. (more…)

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

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Be Wary of Stem Cell Pseudoscience

At the end of the 18th and beginning of the 19th century electricity and magnetism were cutting edge science, full of excitement and unknown potential. Capitalizing on this excitement, Franz Anton Mesmer captured the imagination of the European intelligentsia with his bogus claims of animal magnetism. At the turning of the next century radioactivity was the new and fascinating scientific discovery, and this lead to a market for radioactive tonics good for a multitude of complaints, or just for extra energy. A few decades later radio waves were the latest healing craze.

Cutting edge science is cool and exciting, it evokes the promise of the future and the public has learned to expect that the latest gee whiz science appears like magic. Its newness also virtually guarantees that the public at large will mostly not understand the science or its true implications. This is a situation ripe for exploitation.

Today one medical technology that does possess great promise but is not yet ready for prime time is stem cell therapy. Legitimate scientists involved in stem cell research are almost giddy about the possibilities. Early applications are possibly just around the corner, and only time will tell what the full potential of this technology is. But right now there are no legitimate stem cell therapies outside of research protocols. It is therefore not surprising that the con artists of today are exploiting the tremendous hype of stem cells.

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Posted in: Health Fraud

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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…)

Posted in: Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation

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Ultrasound Screening: Misleading the Public

There is a new industry offering preventive health screening services direct to the public. A few years ago it was common to see ads for whole body CT scan screening at free-standing CT centers. That fad sort of faded away after numerous organizations pointed out that there was considerable radiation involved and the dangers outweighed any potential benefits.

Now what I most commonly see are ads for ultrasound screening. In fact, I am sick and tired of finding them in my mailbox and between the pages of my local newspaper. Ultrasound is certainly safe, with no radiation exposure. It sounds like it might be a good idea, but it isn’t.

Life Line Screening advertises itself as “America’s leading provider of quality health screenings.” They offer “4 tests in less than 1 hour – tests that can save your life.” They travel around the country, setting up their equipment in community centers, churches, and YMCAs. For $129 you get ultrasounds of your carotid arteries, your abdominal aorta, your legs, and your heel bone. They mail you your results 21 days later. (more…)

Posted in: Health Fraud, Medical Ethics, Public Health

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Alternative Medicine, and the Internet

When I think back to my own ‘discovery’ of the skeptical movement, it grew out of my experience watching the James Randi Secrets of the Psychics NOVA special. After being enthralled with the special (and with several Randi books already in my library) I sought Mr. Randi out on the Internet. In chat rooms, blogs, forums and skeptical conferences such as TAM this is a tale I’ve heard repeated many times; folks heard about the JREF of CSICOP (now CSI) and then used the World Wide Web to learn more about these organizations.

Recently I began to wonder about my own personal pet peeve (unscientific medicine) and how it has benefited from the Web’s huge explosion and influence. Certainly there are plenty of great sites out there that help to show much of so-called Alternative Medicine for what it really is – blogs like this, Dr. Stephen Barrett’s Quackwatch.org site, the National Council Against Health Fraud, and many other important sites; still the number of sites extolling the virtues of science and critical thinking pale in comparison to those that forward notions embracing magical thinking and quack-related products and health claims. A quick examination of the web’s most popular search tool (Google) shows us the cold hard facts about who’s winning the war of medical woo:

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Posted in: Health Fraud, Science and the Media

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