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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

Leave a Comment (20) ↓

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

  1. rickthetwinkie says:

    The only comment on the article is a rather nasty ad hominem including the best canard “Steven Barret is delicensed”. I responded:

    “What an embarassment for the consistently reliable and trustworthy Medscape to publish such a lengthy pseudo-scientific hatchet-job by Kimball C. Atwood”

    Please tell us how chelation works for anything besides acute poisoning?

    “who writes articles with the de-licensed Steven Barrett”

    He was not de-licensed. He is retired. Try again.

    “and the purveyor of a New England ear-piercing parlor, Bobby Baratz,”

    And I have no idea what you mean by this.

    “men it has been reported who are hired by the pharmaceutical industry to destroy all non-drug medicine”

    What source do you have for this?

    “Atwood’s two minions and their front organizations have in recent years been found untrustwothy by American Courts.”

    Again, provide a source and elaborate on what you mean by “found untrustworthy by American Courts”. Sounds like you’re playing weasel words.

    “Don’t just trust what I say. Since you are using the Internet you know how to look them up on Google and on Tim Bolen’s websites and decide for yourself.”

    Well, of course I’m not going to trust what you say. You’re parroting information for Bolen who is rather infamous for lying.

    Until you can back up any of these assertions with something other than Tim Bolen’s websites, your reply is nothing but a stream of pure ad hominem. It’s interesting that you chose the ad hominem route rather than the address the body of the article.

  2. Harriet Hall says:

    I posted this in answer to the ridiculous first comment on the Medscape website:

    Sure, read Tim Bolen’s websites. But also read Peter Bowditch’s website where he exposes Tim Bolen’s lies. http://www.ratbags.com/rsoles/strange/timoranter.htm

    And read Stephen Barrett’s response to Bolen at http://www.quackwatch.com/11Ind/bolen.html

  3. David Gorski says:

    The whole claim about Dr. Barrett being “delicensed” is a smear that, if I recall correctly, was started in the “alt-med” world by Hulda Clark’s pit bull Timmy Bolen. I’ve seen it many times before, particularly in my old Usenet stomping ground of misc.health.alternative. Basically, Dr. Barrett retired and let his license lapse. This makes perfect sense if one doesn’t plan on treating patients anymore because (1) it’s expensive to renew one’s license every couple of years; (2) it’s difficult and expensive to get enough CMEs to be able to renew one’s license every couple of years, especially if one is no longer at an academic medical center or major hospital where one can go to CME activities for free; and (3) it’s really expensive to maintain malpractice insurance, which some states (and I think Pennsylvania is one of them) require as a condition of licensure. Some states have a “retired” status for medical licensure that costs either nothing or a nominal fee to maintain, but many don’t.

    The other favorite smear of Timmy and his ilk is to say that Dr. Barrett is not Board-certified in his specialty. Of course, Dr. Barrett finished his residency and began practicing back in the 1960s, when Board certification was not the universal requirement that it is now. Lots of physicians of that era don’t have Board certification, and they were for the most part grandfathered in as far as hospital privileges and insurance plans go. Of course, most physicians of that era are now retired or within a few years of retirement as well, meaning that many of them are (or soon will be) just as “delicensed” as Dr. Barrett.

  4. David Gorski says:

    By the way, I tried to get on the comments a little while ago on my lunch hour. The link wasn’t working.

  5. It is interesting that Timmy and his pals continually attack Dr. B. by saying that he is “delicensed” and not board certified. I have to wonder if they do it because: 1) it indicates that they know that the people they are trying to influence are impressed by licensed MDs with board certification in a specialty; 2) they believe that people will not trust a professional they believe has had his license revoked and hope that readers will assume that “delicensed” means revoked; 3) they know how annoyed their statements make quackbusters; or 4) all or some of the above.

  6. overshoot says:

    Meta-Comment:

    As the comments on the original article and here show, it is amazingly easy to divert any discussion related to woo into arguments about the personalities involved.

    It’s easy, it works — no wonder it’s popular.

  7. Skip says:

    I love it! The top google ad on the side bar says :

    “The New Chelation Miracle
    Flushes Out Dangerous Plaque and Toxins From Your Blood, Guaranteed!
    TrueHealth.com”

  8. wertys says:

    In my part of the world a large chelation clinic in the state capital city (Melbourne, Australia) got shut down and the doctor involved lost his registration…not just let it lapse when he retired, like Dr Barratt. Thankfully this ‘therapy’ is very uncommon here since…

  9. brainfan says:

    “The other favorite smear of Timmy and his ilk is to say that Dr. Barrett is not Board-certified in his specialty. Of course, Dr. Barrett finished his residency and began practicing back in the 1960s, when Board certification was not the universal requirement that it is now. ”

    During Barrett’s defamation suit against Dr. Tedd Koren, Barrett was forced to admit under cross examination that he failed his psychiatric boards. The judge found that there was insufficient evidence to prove Barrett’s claim that Koren’s newsletter defamed him by saying that Barrett was “de-licensed” and “in trouble because of a $10 million lawsuit,” and that Barrett was a “Quackpot.” The fact that he’s represented himself at numerous other trials as an expert witness in psychiatry, this is nothing less than fraud.

    He’s lost almost 40 other defamation suits because what people say about him is not false. I don’t know or care about Bolen. The fact that Bolen is or isn’t a charlatan proves nothing about Barrett, who’s also presented himself as a legal expert after having taken some law correspondence courses – not finishing them, mind you. I don’t need to continue with him. Read the court transcipts of any number of his lost cases before you waste your time and reputation on this fraudulent failure.

  10. quackdoctor says:

    “Dr. Barrett finished his residency and began practicing back in the 1960s, when Board certification was not the universal requirement that it is now. ”

    Plenty of people did. And they studied and became boarded. Failing boards is very telling od the qualifications of ohysicians. Like I say plenty of physicans of Barretts era became and are boarded. My father was older than Barrett. He got boarded in 2 specialties when he was in his later years.

  11. Harriet Hall says:

    I really don’t see the point of talking about Dr. Barrett’s credentials.

    His credentials are irrelevant. If you think he’s wrong about something, you don’t need to attack him personally – all you need to do is counter his data and arguments with better ones.

  12. brainfan says:

    “I really don’t see the point of talking about Dr. Barrett’s credentials.”

    This sequence of comments are discussion the credibility of either Bolen or Barrett. I post one comment in response to questions about Barrett’s credentials and NOW you want to talk facts — this also after your own post that argued nothing but post two Barrett-related websites. Like we have reason to trust either of them.

    “If you think he’s wrong about something, you don’t need to attack him personally – all you need to do is counter his data and arguments with better ones.”

    I know he’s wrong about MANY things, but there was no factual information presented in this series of post. I was simply following suit. If you didn’t like the suit that had been played, then you should have changed it while you had the chance.

  13. Joe says:

    brainfan on 06 Aug 2008 at 3:28 pm wrote “I know he’s [Dr. Barrett] wrong about MANY things …”

    So, tell us what you know. I call you- blustering and fantasizing.

  14. brainfan says:

    Ok, I’ll play. I’ll use Barrett’s “Multiple Chemical Sensitivity: A Spurious Diagnosis”. This article is based on a booklet he coauthored with Ronald Gots. Gots, as I’m sure Quackwatch fans will recall, is the same Ronald Gots whose Medical Claims Review Services was found in court to be “a completely bogus operation,” writing up claims denials for insurance companies, in many cases never having a physician review the cases in question. Barrett cites Ronald Gots as having reviewed one hundred records of patients with MCS. Use your own judgment when considering the type of reviews that took place. Or didn’t. Not that Barrett would care; he’s sold his reputation, such as it is, to his clients. That of course, is his perogative.

    I began to do a point by point refutation of his article, but it is so chock full of errors, misrepresentations, and lies of omission, that it would take far too much time to be worth spending for a comment section on a blog. The people reading and writing here are intelligent people, so I’ll leave you with Barrett’s article and a contrary article to consider. No doubt many of you will find things to quibble about in the contrary article, but if you’re honest, you’ll admit at least to yourselves that Barrett’s suffers terribly both from a professionally considered point of view and from the point of view of an opinion piece, which is essentially what it is. His references are largely old and/or clearly biased (Idiopathic Environmental Intolerance indeed). They’re also far too few in number, suggesting immediately that he did not use due diligence to fully consider the illness. He rather used what he could find to support the conclusion he and his paying clients prefer. It’s very interesting also to consider that he doesn’t cover the topic of fibromyalgia, a condition his daughter suffers from and a condition whose etiology is theorized to be strikingly similar to MCS ( http://tinyurl.com/3aldwv ).

    http://www.quackwatch.org/01QuackeryRelatedTopics/mcs.html
    http://mcs-america.org/MCSPositionStatement.htm

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