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Science, Reason, Ethics, and Modern Medicine, Part 3: Implausible Claims and Formal Ethics Statements

The Ethics of Implausible Medical Claims (IMC)

In Part 2 of this series* we learned from David Katz, MD, a key member of the Yale School of Medicine’s “integrative medicine” program, that he had been “pushed toward integrative medicine by the needs of [his] patients.” We also learned that Dr. Katz’s rationale for this decision justifies a wide range of quackery—both in principle and in fact. I had previously alluded to arguments like those of Dr. Katz in a comment on SBM several months ago:

…we must be true to medical ethics, no matter what else we do. If that means losing a few patients, so be it. Patients are free agents, and we can only do so much to influence them. To the extent that we don’t do that as well as we might (which is obviously true in some cases), we might do better. But our ethical obligation is to science and truth; it is not, as many modern physicians would have it and as much as we may lament sometimes losing patients to woo, to seducing patients to stick with us no matter what, if the “what” includes engaging in a charade about “integration” or “complementary therapies”…

Realizing that some might argue that physicians’ obligations to patients ought to trump their obligations to “science and truth,” I later revised that statement:

Several weeks ago I argued here that a physician’s primary ethical obligation is to science and truth. In retrospect I probably should have put it a slightly different way: a physician’s primary ethical obligation is the same as everyone else’s. It is to honesty and integrity. For physicians, however, that means being true to real medical knowledge, among other things, and real medical knowledge comes from science.

In spite of that revision, two readers whose opinions I respect challenged my assertion. Dr. Peter Moran’s worthy efforts to educate patients about the realities of “alternative” cancer treatments are considerable. Here on SBM he has repeatedly challenged us to explain how, when confronted with testimonials of “alternative” cures, we ought to respond without using “a high-handed, ‘we know best’ stance” and thus “appear to want to distance [ourselves] from the intimate concerns of [our] patients.” I was thinking mainly of him when I wrote the revision above, because on this key topic—how to respond ethically, but with compassion, to patients who want to believe in implausible treatments—I’ve come to think of Dr. Moran as the “conscience” of Science-Based Medicine. Those with cancer, he has reminded us, “are folk very like you and me who are simply grasping at any straw that might save or prolong their lives.” His take on why IMCs are appealing to those with less ominous problems is well-developed and agrees with my own, mostly. We part ways, however, when he concludes (also here and here) that ethical physicians might have good reasons—unlike Dr. Katz’s—to entertain benign, if implausible treatments:

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The TACT is at least as Bad as We Predicted

I had wanted to follow Dr. Sampson’s discussion of “Healing Touch” with one of my own, because I had an interesting experience with one of its proponents years ago, and I’ll do that soon. I had also wanted to begin a series of posts about acupuncture, which I’ll also do eventually. Just yesterday, however, Liz Woeckner, co-author of our recently published critique of the NIH Trial to Assess Chelation Therapy (TACT), made a startling discovery: the TACT “Portal” website, intended for investigators and others associated with the trial and previously password protected, is now available to anyone: http://www.chelationwatch.org/s/tact/index.html It is a goldmine of information and I’ve barely begun to look at it, but so far it verifies much of what we’ve written and more. For example, the latest version of the Consent Form is dated 2006 and includes this statement under “risks”:

EDTA, or ethylenediamine tetraacetate is in the chelation solution. It is approved for use by the FDA as a treatment for lead poisoning but not for coronary artery disease.

Yet three Investigator Brochures, dating back to 2003, contain this language:

Edetate disodium USP should not be confused with its calcium salt (calcium edetate), which is used to treat lead toxicity.

We had called attention, in our article, to TACT literature repeatedly conflating Na2EDTA and the safer CaNaEDTA. Now we have reason to believe that this has been done cynically, with eyes wide open.

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Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Science and Medicine

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“Chelation Therapy”: Another Unethical “CAM” Trial Sponsored by Taxpayers

Please forgive the promotion of our own work and the facile evasion of a full-length blog, but two of your faithful bloggers are co-authors of an article published this week:

Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned

Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; Wallace I. Sampson, MD

Medscape J Med.  2008;10(5):115.  ©2008 Medscape

Posted 05/13/2008

Available here.

You may be asked to “register”; don’t worry, it’s free. The article is very long, but the Introduction, Executive SummaryDiscussion, and Conclusion are reasonably succinct and make the important points. Readers who want to learn more details, who want to see more evidence for our assertions, or who are compelled by an odd fascination with crackpotism (my own weakness) will want to read more. Here is a small sample:

Abstract

The National Institutes of Health (NIH) Trial to Assess Chelation Therapy (TACT) was begun in 2003 and is expected to be completed in 2009. It is a trial of office-based, intravenous disodium ethylene-diamine-tetra-acetic acid (Na2EDTA) as a treatment for coronary artery disease (CAD). A few case series in the 1950s and early 1960s had found Na2EDTA to be ineffective for CAD or peripheral vascular disease (PVD). Nevertheless, a few hundred physicians, almost all of whom advocate other dubious treatments, continued to peddle chelation as an office treatment. They claim that chelation dramatically improves symptoms and prolongs life in 80% to 90% of patients. In response, academics performed 4 controlled trials during the 1990s. None favored chelation, but chelationists repudiated those findings.

We have investigated the method and the trial. We present our findings in 4 parts: history, origin and nature of the TACT, state of the evidence, and risks. We present evidence that chelationists and their organization, the American College for Advancement in Medicine, used political connections to pressure the NIH to fund the TACT. The TACT protocols justified the trial by misrepresenting case series and by ignoring evidence of risks. The trial employs nearly 100 unfit co-investigators. It conflates disodium EDTA and another, somewhat safer drug. It lacks precautions necessary to minimize risks. The consent form reflects those shortcomings and fails to disclose apparent proprietary interests. The trial’s outcome will be unreliable and almost certainly equivocal, thus defeating its stated purpose.

We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned.

Readers of my postings on SBM will find more discussion (and abundant evidence) of familiar material: ethical breaches resulting from political incursions into science; the pitfalls, both scientific and ethical, of ignoring prior probability; a Dirty Secret of the Extraordinary Popular Delusion that is “CAM,” that much of what masquerades as sober research or the practice of “integrative medicine” was spawned by Laetrile; and widespread dishonesty in “academic CAM.”

Medscape Journal of Medicine invites readers to post comments or to send private letters to the editor for potential publication (and replies by yours truly, in this case). If you are so moved, you might consider posting comments in duplicate, both there and here on SBM, for the benefit of our select readership.

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

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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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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 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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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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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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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…)

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