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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 Trojan Horses of Education

Last time I described what I could find about the “Quiet Revolution” plan for medicine through the eyes and minds of the Bravewell Collaborative and Christy Mack, wife of the multi-millionaire or billionaire CEO John Mack. The idea seemed two-pronged; “humanize” physicians and medicine generally, and integrate folkway, sectarian and “alternative” methods into the system. What bothered me more, having become inured to patient philandering with quackery, was the brazen attempt to re-educate physicians and indoctrinate students into the political and social views of wealthy idealists. The entry below, one might conclude, has little to do with medical quackery and pseudoscience, but I beg your indulgence for this series as I attempt to connect dots between the stalls of the seemingly unrelated steeds of political indoctrination in universities and the proposed med school re-education camps of Bravewell. For several years a controversy has roiled at the University of Delaware over a program of educational activities for the dorms called Residence Life. The program structures student time with a number of usual activities – games, talks, discussion groups – but the content of the discussion groups and interpersonal counseling upset some students, who complained to an off-campus conservative organization, and got to the attention of faculty, which pressured the administration to stop the program last fall.

To outsiders such as we, the program looked like a feel-good, beneficent guidance tools. To the complaining students and critics the discussions seemed more like indoctrination groups, with political agendas taking on disguised roles as helpful guidance for student angst. Students complained about invasion of their privacy through group and leader pressures, and the faculty saw indoctrination and invasion of their educational duties (turf) by student counselors bearing ideological messages with little qualification.

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Posted in: General, Medical Academia, Politics and Regulation

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Canada Bill C-51 – Regulating Natural Health Products

In Canada a new bill has been proposed, Bill C-51, that would make changes to the Food and Drug Act – the body of laws by which the Canadian federal government regulates food and health products in Canada. This is the equivalent of the Food and Drug Administration (FDA) in the US. It seems that Canada, like the US, is struggling to deal with a burgeoning industry of “natural health products” that are minimally regulated.

The new bill will increase government oversight of natural health products (NHP) for the purpose of ensuring higher quality standards for products and accuracy in the claims that are made for them. Proponents of the bill claim that it will serve to improve consumer protection. But the NHP industry is not happy with the increased oversight the bill would bring. Their hysterical reaction to the proposed bill is very revealing about the propaganda and deception used by the NHP industry.

This history of NHP regulation in Canada also reveals the two primary strategies by which the promoters of unscientific medicine and health products seek to advance their business. On the one hand they seek licensure, certification, and other formal recognition by the government in order to bolster their legitimacy with the public and also to keep competition at bay. When seeking such things they argue that licensure etc. will give the government the opportunity to regulate the industry and ensure quality control. They therefore take the position of consumer protection.

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Posted in: Herbs & Supplements, Politics and Regulation

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The “Art” of Clinical Decision-Making

Much nonsense has been written about the “art” of medicine. All too often, it amounts to a rationalization for doctors doing what they want to do instead of following the evidence. Medicine is not an art like painting. Neither is it a science like physics. It’s an applied science. Since patients are not all identical, it can be very tricky to decide how to apply the science to the individual.

The New England Journal of Medicine periodically runs a feature called “Clinical Decisions.” They present a case history, then they present 2 or 3 expert opinions on how to manage the case. They stress that none of the options can be considered either correct or incorrect. They allow readers to “vote” as well as to submit comments about why they voted that way. It is understood that the voting is only for interest and to stimulate discussion: it does not result in a consensus.

In April 2008 the topic was the management of carotid artery stenosis. The patient is a 67 year old man who has no symptoms but who is found to have a narrowing of 70-80% in one carotid artery and 20% in the other, putting him at increased risk for stroke. He has other risk factors for cardiovascular disease: hyperlipidemia, hypertension, and overweight. The 3 options are medical management, stent placement, and carotid endarterectomy. (more…)

Posted in: General, Science and Medicine

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The early detection of cancer and improved survival: More complicated than most people think

“Early detection of cancer saves lives.”

How many times have you heard this statement or something resembling it? It’s a common assumption (indeed, a seemingly common sense assumption) that detecting cancer early is always a good thing. Why wouldn’t it always be a good thing, after all? For many cancers, such as breast cancer and colon cancer, there’s little doubt tha early detection at the very least makes the job of treating the cancer easier. Also, the cancer is detected at an earlier stage almost by definition. But does earlier detection save lives? This question, as you might expect, depends upon the tumor, its biology, and the quality and cost of the screening modality used to detect the cancer. Indeed, it turns out that the question of whether early detection saves lives is a much more complicated question to answer than you probably think, a question that even many doctors have trouble with. It’s also a question that can be argued too far in the other direction. In other words, in the same way that boosters of early detection of various cancers may sometimes oversell the benefits of early detection, there is a contingent that takes a somewhat nihilistic view of the value of screening and argues that it doesn’t save lives.

A corrollary of the latter point is that some boosters of so-called “alternative” medicine take the complexity of evaluating the effect of early screening on cancer mortality and the known trend towards diagnosing earlier and earlier stage tumors as saying that our treatments for cancer are mostly worthless and that the only reason we are apparently doing better against cancer is because of early diagnosis of lesions that would never progress. Here is a typical such comment from a frequent commenter whose hyperbolic style will likely be immediately recognizable to regular readers here:

Most cancer goes away, or never progresses, even with NO medical treatment. Most people who get cancer never know it. At least in the past, before early diagnosis they never knew it.

Now many people are diagnosed and treated, and they never get sick or die from cancer. But this would have also been the case if they were never diagnosed or treated.

Maybe early diagnosis and treatment do save the lives of a small percentage of all who are treated. Maybe not. We don’t know.

As is so often the case with such simplistic black and white statements, there is a grain of truth buried under the absolutist statement but it’s buried so deep that it’s well-nigh unrecognizable. Because we see this sort of statement frequently, I thought it would be worthwhile to discuss some of the issues that make the reduction of mortality from cancer so difficult to achieve through screening. I will do this in two parts, although the next part may not necessarily appear next week
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Posted in: Cancer, Public Health, Science and Medicine, Science and the Media

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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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Near Death Experiences and the Medical Literature

MIRACLE MAX: See, there’s a big difference between mostly dead, and all dead. Now, mostly dead: he’s slightly alive. All dead, well, with all dead, there’s usually only one thing that you can do.

INIGO: What’s that?

MIRACLE MAX: Go through his clothes and look for loose change.

The Princess Bride

Can you trust anyone when they purport to tell you what the medical literature says? No. As an example we will use the issue of near death experiences, or NDE’s.

We will avoid the obvious paradox in this entry, sort of the ‘everything I say is a lie paradox’ that will cause computers in the Federation to shut down.

Why am I going to comment on this issue? Well, this months Skeptic has a back and forth between Michael Shermer and Deepak Chopra about life after death.

No. I am not going to comment on whether there is life after death. I am more interested in life during life, thank you very much. I’ll let the afterlife take care of itself.

But in their point counterpoint, they both refer to a Lancet article about NDE’s and it then begs the question:

Does anyone actually read or understand the literature they quote ?

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Posted in: Clinical Trials, Neuroscience/Mental Health, Science and the Media

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Science and Health News Reporting – The Case of the Regenerating Finger

Last week it was widely reported that an Ohio man, Lee Spievak, had regrown the end of his finger that had been chopped off in an accident. Reporters informed us, for example:

A man who sliced off the end of his finger in an accident has re-grown the digit thanks to pioneering regenerative medicine.

But this was not the real story. The true and amazing tale, rather, is of how the mainstream news media utterly failed to properly report this story. This is not an isolated incident, but a commonplace example of a broken system, and one that is getting worse. But first, let’s see how this reporting went wrong.

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Posted in: Science and the Media

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On Being Certain

Neurologist Robert A. Burton, MD has written a gem of a book: On Being Certain: Believing You Are Right Even When You’re Not. His thesis is that “Certainty and similar states of ‘knowing what we know’ arise out of involuntary brain mechanisms that, like love or anger, function independently of reason.” Your certainty that you are right has nothing to do with how right you are.

Within 24 hours of the Challenger explosion, psychologist Ulric Neisser had 106 students write down how they’d heard about the disaster, where they were, what they were doing at the time, etc. Two and a half years later he asked them the same questions. 25% gave strikingly different accounts, more than half were significantly different, and only 10% had all the details correct. Even after re-reading their original accounts, most of them were confident that their false memories were true. One student commented, “That’s my handwriting, but that’s not what happened.”

Just as we may “know” things that clearly aren’t true, we may think we don’t know when we really do. In the phenomenon of blindsight, patients with a damaged visual cortex have no awareness of vision, but can reliably point to where a light flashes when they think they are just guessing. And there are states of “knowing” that don’t correspond to any specific knowledge: mystical or religious experiences. (more…)

Posted in: Book & movie reviews, General, Neuroscience/Mental Health

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Mercury emissions from coal-burning power plants and autism: Is there a correlation?

ResearchBlogging.orgOn April 30, outside the courthouse in Dallas, a press conference/rally was held. This particular rally was in response to a new study published by a group led by Dr. Raymond F. Palmer in the Department of Family and Community Medicine at the University of Texas Health Science Center in San Antonio, whose conclusion was that autism prevalence correlates strongly with proximity to mercury-emitting coal-burning power plants and other industrial sources of airborne mercury, the implication being that such sources of mercury may be causal or contributory to the development of autism. Unfortunately, the rally was reported by the media as though this study were slam dunk evidence that mercury environmental mercury is a definite contributor to the development of autism. For example, there is some video (also here) from local news sources of the rally, in the first of which it is stated as fact that mercury caused autism in the child featured in the story and in the second of which a mother who thinks that mercury causes autism is quoted credulously. This study has had much less play in the national news, but antivaccination activists, such as the ones at the Age of Autism website, a site whose main theme is that either mercury in the thimerosal preservative that used to be in childhood vaccines before 2002 or vaccines themselves cause autism, both promoted the rally and posted a glowing and credulous take on the study, as did “alternative medicine” and antivaccinationist website NaturalNews.com.

My first thought upon reading of this is that it is yet more vindication of the science showing that the claim that mercury in thimerosal-containing vaccines is a failed hypothesis. After all, as I have predicted time and time again, as the scientific and epidemiological evidence continued to mount that thimerosal is just plain not associated with autism or autism spectrum disorders, even the most diehard adherents to this belief are starting to realize that they were backing a losing horse, especially since thimerosal was removed from all childhood vaccines other than the flu vaccine in 2001, leaving only trace amounts from the manufacturing process and there is no sign that autism prevalence is falling. That’s why lately, their effort has shifted from primarily demonizing mercury to blaming other “toxins” in vaccines, even to the point that their efforts to demonize some ingredient–any ingredient–in vaccines often reaches ridiculous levels of blatant silliness, such as touting sucrose as one of those “toxins.” Indeed, I was puzzled. If environmental mercury is the new cause of autism, then the rationale antivaccinationists use to demonize vaccines and portray their children as “vaccine-damaged” is much less potent. Why on earth would they tout this study, which, even if a good study (and it’s not), would weaken their arguments against vaccines immeasurably and take power away from their whole new propaganda slogan “Green Our Vaccines”? The only reason I could think of is that perhaps they somehow think that if mercury in the environment can be linked to autism that maybe–just maybe–they can convince people that they were right about mercury in vaccines all along. Indeed, this seems to be the sort of tack that David Kirby took a year ago when he started arguing that mercury emissions from coal-burning power plants in China (which do reach California), coupled with mercury emission from crematoria in which cadavers with mercury fillings were burned, were contributing to the continued increase in the autism caseload in California despite the elimination of thimerosal in 2001.

But what does the study say itself? Is it good evidence that airborne mercury from coal-fueled power plants is an important contributor to the development of autism? I will argue no, because the study’s flaws are so innumerable that it is well nigh uninterpretable. For simplicity’s sake, to summarize its findings, I’ll quote a Science Daily press release about it:
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Posted in: Neuroscience/Mental Health, Public Health, Science and the Media, Vaccines

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