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NIH halts chelation study after patients die

Yet more proof emerged today that "alternative" medicine is not only useless - it can kill. The U.S. government had funded a study to test chelation therapy on heart attack survivors. At least two patients have died already, and the National Institute of Health has now halted the study and launched an investigation. The patients weren't properly informed of the risks - namely, that the treatment could kill you - and there were other serious problems as well.

Kimball Atwood and colleagues published an article in May 2008 (freely available in PubMed) that looked at this study, called TACT (Trial to Assess Chelation Therapy), and wrote:
"We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned."
Wow. It doesn't get much more blunt than this. Nonetheless, the study had already gone on for years, and it was another 4 months (until now) before NIH pulled the plug.

Chelation therapy involves injections of a powerful drug, disodium EDTA, into patients. Proponents claim - with little or no evidence - that disodium EDTA will bind to arterial plaques and help flush them away. Chelation therapy has also been proposed - and used - on autistic children, despite evidence that it carries great risks and despite no evidence that it works.

The just-halted study involves some 1500 patients. The US government approved the study, according to AP reports, because some heart patients were trying chelation therapy anyway, and the study would provide evidence of whether it worked or not. (Note that this is the same argument that NIH recently used when it announced it would study chelation therapy for autistic children.) The argument is bogus. It is a classic example of a logical fallacy, which could be re-stated in this case as "lots of people believe this, so it must be true."

There are (were) multiple problems with this study. The Atwood article states them very bluntly:
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.
Astonishing. And yet, unbelievably, the group of chelation doctors (who should more accurately be called quacks and scam artists), known by the deceptive name American College for Advancement in Medicine (ACAM), are insisting that the allegations of impropriety are "political" and that the trial should resume as soon as these allegations can be dismissed. On ACAM's own website, their president, Jeanne Drisko, says "We call for a swift end to the moratorium and a resumption of the trial."

These chelation practitioners (I can't call them doctors) are deceiving their patients and making money off them by offering harmful therapies. This is, frankly, despicable.

Finally, I have to shine the spotlight of shame on the study's Principal Investigator, Gervasio Lamas of Mt. Sinai Medical Center in Miami Beach. If you know anyone in Miami who needs a cardiologist, stay away from this doctor! Back in 2001, he said of chelation therapy, "It's pretty different - it's cool." I want a doctor who chooses therapies because they work, not because he thinks they're cool.

And finally, which part of NIH funded this study? NCCAM, of course. See my earlier posts on that. This is yet another example of why NCCAM should be shut down.

19 comments:

  1. I will preface this by saying that I'm not a medical doctor and I never took anatomy and physiology (8 am class, no thanks). I also haven't read the pertinent studies.

    That being said, I seem to be vaguely aware of the necessity of calcium fr the heart to function properly.

    Would it not stand to reason that injecting EDTA into the blood would bind up this calcium and cause problems? Could it even accelerate bone-mass loss if there's some sort equilibrium in place between the bones and the blood and you start yanking the blood calcium out?

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  2. John, you are correct - chelation therapy can cause a severe deficiency of calcium, called hypocalcemia, and that in turn can kill you. The Atwood article documents several deaths caused by hypocalcemia in people undergoing chelation, including one death in a 5-year-old boy who was getting chelation to 'treat' his autism.

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  3. mike

    Your comments here against chelation are really stupid. It only makes logical sense that one should clean out one's arteries. I've had many chelation treatments after my triple bypass operation and angioplasty. The triple bypass caused me to have a heart attack, which made me have to have the angioplasty. Now they know the angioplasty stents can cause heart attacks. So which one of the above treatments do you think is safer. You numb nuts need to do your home work on this subject.

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  4. Mike (anonymous) - it's unfortunate that someone has convinced you that chelation can "clean out" your arteries. That's just not true, although it's exactly what some quack doctors claim. For example, the frauds at www.arteryhealthinstitute.com claim that chelation will "unclog arteries and restore cardiovascular function." Nonsense. They also claim "your heart doctor will never tell you about it" - this is the class conspiracy-theory type of claim that quacks like to make.
    If you go to http://www.americanheart.org/presenter.jhtml?identifier=3000843, you can find the American Heart Association's explanation of chelation therapy. They present a sober discussion of why it doesn't work, and why it is dangerous.

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  5. I am with "anonymous".I've taken 70+ chelation treatments in the past 4 years. After a stent in my heart for 90% blockage. Last ultrsound shows 5-15% blockage 6 mo. ago. Accusations have been made that chelation therapists, who are fellow doctors by the way, are pushing this treatment because they get money for it.Sure Dr.'s get paid for doing it, don"t ALL Dr's get paid whether the treatment works or not? This rabid "Foam at the Mouth" response to the STUDY ( I think that means to see if it works)should tell any thinking person, there's something there... Obviously the medical "community" is alarmed at the results of the study which will NOT show ANY good things to the public if the "professionals" have anything to say about it. Apparently the woldwide use of this treatment is totally inconceivable to the superior minds of the AMA, et al. This lofty air to protect the PUBLIC from trying an UNAPPROVED (by the AMA) treatment smacks of negligence. Are they really protecting patients or their own power (read profits). There is no such thing as a "Cure all". And not everyone reacts the same to ANY medical treatment, people even die from aspirin. Is there a hue and cry to ban aspirin? Well? There is no profit in aspirin therapy, so who cares? But this chelation treatment, which runs around $90 or each treatment, is obviously a major threat to the income of cardiologist and the chain of referrals leading to the operating room. Your doctor may have nothing to do with surgery, but he or she still gets the referral fee. And I don't know of any other doctors that allow you in the office for a mere 90 bucks!I am not knocking the cardiologists and their contribution to the medical profession. Thank God they are here when we need them. But why can't chelation therapists exist in the medical chain? If it doesn't provide any relief to the patient, THEN operate. For the medical community to deny that in MANY cases this most certainly can help is counterproductive. But don't "throw the baby out with the bath water". Ask the thousands of patients that have taken this treatment regardless of the cost from their own pocket with no help from insurance companies. And most heard about it word of mouth. It's been said by certain doctors that testimonial medicine is "crap". Of course, it's not "crap" if it say's good things about THEIR OWN practice.Can the AMA or any medical association actually discount that MILLIONS of treatments have been given worldwide? That's one hell of a effective placebo, EH? Reports suggest that 20 or so patients have died from this treatment. And how many from bypass surgery, or any number of other treatments that are invasive? You think an equal 20 or so? Hmm? Let's try honesty here. Let's admit that YES there is something here. If it interferes with some doctors belief and knowledge that THEY know this doesn't work, THEN GET OVER IT! Stop bad mouthing it UNLESS you have tried it and THEN KNOW it doesn't work. If you doctors follow the protocol, it is obviously safe or THOUSANDS of patients would be DEAD! The entire world of medical professionals would be RABID about not using it. But who rejects it now and forever more- Why America's superior doctors, that's who! And if this treatment is denied to your fellow American's through tunnel vision, I, for one will get it thru the underground and I assure you, I won't be ALONE! DON"T TELL ME! SHOW ME IT DOESN'T WORK!

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  6. How about a (very) basic understanding of chelation? Here's mine- Chelation is administered through the body via an intravenous drip. As the EDTA travels through the body, it attracts metals, not just lead, and some metals more than others. It leaves the body through the kidneys (urination). This is not a guess: THE METALS REMOVED CAN BE MEASURED. So let's ask ourselves; Where do metals accumulate in our bodies? What effects do these metals have on the body when they INTERFERE WITH THE PROPER FUNCTIONING OF their surroundings? How does that affect OTHER parts of our body? all of our systems? (side effects) Do your own research of these two questions. If you believe, as I do, that the body is an interactive, interreacting, selfhealing, complex organism you might have already come to the conclusion that as one part of the body is benefitted and can function more efficiently to fight "dis ease" and imbalance the rest of the body benefits also. (side effects) As for chelation- Research other countries uses and results of chelation. And please- be intelligent. If you passionately care about a subject like this, anytime you read about a study, see how many people were inolved,their ages, prior health history, what were the controls, the time frame, etc. Don't let someone else interpret it for you. Ignore isolated incidents, good or bad, where some one may be at fault or where oher circumstances are at play. As for chelation - include in your reseach a visit to a doctor's office and talk to the patients; they LOVE to tell you what it has done for them. (You might even see me there.)
    By the way, I know two "Chelation doctors", who happen to be respected members of the medical community, and they do not tell their patients to do chelation to "clean out their arteries."

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  7. I'm afraid there are too many misunderstandings embedded in these past two responses for me to clear up with a comment here. Simply claiming "it is obviously safe" doesn't make it so. RationalThinker's intuitions (that's what they are) about how chelation works, and about how the body works, sound just like many of the "holistic" theories that abound in the pseudoscience community. None of these theories are worth anything scientifically, or medically, unless they yield testable hypotheses.

    RationalThinker also urges me to "talk to the patients." There's no harm in that, but anecdotes from patients don't comprise scientific evidence. People can be tricked into thinking all sorts of treatments work - the entire CAM industry depends on this.

    Accusing the AMA of conspiring to hide the truth, as Dan Boyd does, is a common ploy, but there's no evidence to back that. Who are these evil doctors? If anything, the doctors who take patients' money for scam treatments (such as chelation) are the bad ones.

    Chelation is indeed biologically active - it has serious effects when injected. There is no evidence that it "cleans out" the arteries, but there is evidence that it carries an increased risk of death.

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  8. Steven, of course there is a risk of death, in ANY treatment, don't single out chelation, as if it's the only one. You don't think there is a risk in bypass surgery? As for the evidence, there were 22,000+ treatments given in the TACT study and yes, a couple of deaths. How many deaths are reported after Bypass surgery and to be fair-22,000 of these surgeries? Probably 1 or 2? Why is there such an outcry on a study that was within a few weeks of completion, at which point, it would have to stand on the DATA that came out of the study? Never mind the reports of the past, we are talking about NOW, a new report, closely monitored by the government, with FRESH info, hot off the press, that can be perused and picked apart at leisure by interested parties. What's the problem? And don't tell me the doctors attacking this study care one whit about J.Q.Public. They care about their own PAYING patients! Do you hear them screaming for the heads of Bypass surgeons who's patients have died? Not a whisper.There is a lot of disinformation about chelation out there. It would be nice if obviously educated people such as yourself would step back and say "What do we have to lose by waiting the 2 months till this study is complete?" And THEN KNOW for sure if it's all B.S. or by damn "There's something to this." If it's B.S., think of the "We told you so" articles you could write! Or, then again, you may have to eat crow! How about we let the final report stand or fall on it's own merits? What do you say? EH? One last point, there is historical evedence the many doctors have been shut down in their practice of delivering chelation and forced out of town! Do you think it was their patients that did this or those "Evil doctors?" You might read the books "Bypassing Bypass" or "Everything You need to Know about Chelation Therapy" Look up the Authors yourself, I don't want to be accused of pushing a book. These are written by Doctors, by the way. They list many studies and reports by other doctors. Some of it may even be true.

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  9. Dan, the problem is not only the risk of death - it's that there is no evidence of benefit. None. I suggest you read this
    article on chelation.

    However, if you truly believe that doctors are only motivated by "their paying patients," then I fear you are too far gone to really listen to reason.

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  10. Sorry Stephen, sounds like you're just out to bash the pro-chelation, pro-"holistic" folk. Dan seems to have the conviction of experience. And I have to agree with the body as a unit idea; this is a marvelous machine that houses me.
    In my experience in other areas of life, those who try to squash thinking that is not mainstream tend to be afraid of the idea they are trying to squash. If chelation is so "bad" it will die it's own death, without help from you or anyone else.

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  11. FedUpWiththe HEalthCareSystemFebruary 1, 2009 at 9:04 PM

    Personally in my experience, Mainstream health care in this country is full of too much "scientific" and not enough doctor patient interaction. Want backup on that theory- take a college course on Basic Health Care Management and you'll get some idea. Maybe I might check out chelation and see if one of those Quacks actually talk to their patient. How do I find a doctor in my area?

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  12. Dan say's to FedUp. Look up ACAM.com. It's American College of Advancement in Medicine, who advocate Chelation. They have a list of Dr.s in nearly all states that do chelation. Get on the Band Wagon. It's a really big one! And to Steven- The boy that died in 2005 was not in the Tact study, was being treated by a Dr. that did not follow protocol, The IV "push" that he used (to speed up the process- a child unlikely to sit still with an IV in his arm for 3-4 hours) was probably not a normal procedure and likely overwhelmed the boy's system. Since the Dr. was reinstated, the board that investigated him obviously was convinced they had no strong case against him.Your take on this?

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  13. Dan: ACAM is an organization set up to promote chelation, at the expense of patients, regardless of what science says. They launched an immediate press blitz when the chelation trial was halted; read this description here:
    http://www.sciencebasedmedicine.org/?p=217
    which includes links to other frauds that ACAM and its members have perpetrated.

    You can find ACAM listed here:
    http://www.quackwatch.org/12Web/healthfinder.html
    as an untrustworthy organization. In fact, they were under an FTC cease-and-desist order not to misrepresent chelation therapy in advertising yet continued to do so on their Web site.

    You asked for my take on this: these guys are frauds. They are out to take your money, they will not provide effective medicine, and they might do a great deal of harm.

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  14. Anecdotal I know but...
    I had an uncle who was a diabetic and was told it was necessary to amputate his foot. He tried chelation therapy first. Afterward, the original doctor (that wanted to amputate) said the circulation was now sufficient and he did not have to lose his foot. That was 10-15 years ago and he still has both feet today. I don't know if has gone back for additional treatments.

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  15. As a successful recipient of Chelation I predicted the NIH study WOULD NOT support chelation, now they have done it, it is called FOLLOW THE MONEY!! Medicine has done marvelous things for society but they are blind to many natural things that work well.
    In January 1996 I had a heart attack, my left descending artery was drilled out. Fortunately they couldn't put in a stint because of the clot location.
    I have used chelation over the insuing years.I use herbs to control blood pressure and irregular heartbeat I am 83 and use NO PRESCRIPTION MEDICATION. NO COUMADIN AND ZERO VISITS TO MEDICAL DOCTORS.
    MEDICINE IS A HUGE BUSINESS AND NOTHING WILL INTERFERE WITH "MAKING MONEY"

    Al Thomas
    althomasdot@juno.com

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  16. Steven, there is a chelation therapy that works but it does not use EDTA. Heart scans before and after prove it. It uses ZINC GLUCONATE. Another one uses Lecithin.

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  17. I have not used the chelation therapy, but have used the baking soda cure. I have had serious pain in my back and neck, I could hardly get my shoes on. I also had severe headacks, brain fog for years. I have been to doctors and had cat scans and other checks and chiropractors only to be told live with it.after two weeks I can get my shoes on with no problem. most of the pain has left. The brain fog has lifted.I have suffered for 40 years I am now 72 and feel better than I have felt for 30 years harold Matthews 928 485 2723

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  18. In January 1996 I had heart surgery. Fortunately they could not put in a stint because of the location of the blockage. I have not been treated by a tradional Heart Physician in 15 years. It is now Nov.2010 and the only treatment I have had is Chelation and some herbs. I and my wife are 84 and take zero prescription medication. All you have to do is search the internet for "deaths" from properly, and improperly prescribed prescriptions to realize that doctors are still "practicing medicine. If break a bone or need surgery I go to an M.D. But they are far from perfect. I have sat next to hundreds of chelation patients over the years. Many could have no more surgery and were doing chelation to survive. Medical doctors are a necessary part of our society but are far from being perfect.
    Lawson A Thomas
    althomasdot@yahoo.com

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  19. This whole thing is stupid. Its obvious the NIH totally miss the boat and blew millions with no tangible results. These guys should be put in jail for fund squandering. It was their job to get viable results and make sure the study was properly ran. Secondly the question wheathr or not Chelation works can be resolved simply with relative little funding and quickly. I neaver believed in double blind placebo 50 million year 50 million dollar studies, what garbage.
    Here is what you jerks do. Get 100 guys and give them the Heart Check America test for their calcium index. Put these 100 guys on chelation 50/50 both IV and drops or pills. After a predetermined period retest the 100 guys for their calcium index. If the index is lower Chelation works. Statisticly analyze the results and publish same. This is so simple even you idiots can figure out how to do this procedure properly and get results. I have Program Managed programs like this blind folded. Give us some results not crap and execuses. Surely people dieing of Heart Decease deserve proper data.

    Steve MSPE

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