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The results of the unethical and misbegotten Trial to Asess Chelation Therapy (TACT) are finally revealed

Chelation therapy, in my somewhat Insolent opinion, is pure quackery. Unfortunately, it’s also one of the most common quackeries out there, used by a wide variety of practitioners for a wide variety of ailments blamed on “heavy metal toxicity.” Chelation therapy involves using chemicals that can bind to the metal ions and allow them to be excreted by the kidneys is standard therapy for certain types of acute heavy metal poisoning, such as iron overload due to transfusion, aluminum overload due to hemodialysis, copper toxicity due to Wilson’s disease, acute heavy metal toxicity, and a handful of other indications.

My personal interest in chelation therapy developed out of its use by quacks who blamed autism on the mercury-containing thimerosal preservative that used to be in many childhood vaccines until 2001 but has since all but disappeared from such vaccines except for one vaccine (the flu vaccine, for which a thimerosal-free alternative is available) and in trace amounts in some other vaccines. Mercury became a convenient bogeyman to add to the list of “toxins” antivaccinationists hype in vaccines. In fact, I’ve been writing about the pseudoscience behind the claim that mercury in vaccines is a cause of autism since nearly the very beginning of this blog, and I’ve periodically written about such things ever since, in particular the bad science of Mark and David Geier, whose idea that chemical castration of children with Lupron “works” against “mercury-induced” autism is based on a chemically ridiculous idea that somehow testosterone binds mercury and makes it harder to chelate. Unfortunately, this particular autism quackery has real consequences and has been responsible for the death of a child.

Chelation isn’t just for autism, though. It’s the quackery that quacks love for almost anything. Despite many practitioners advertising it for autism, cancer, Alzheimer’s disease (which Hugh Fudenberg has blamed on the flu vaccine, a claim parroted with Bill Maher, of course!), and just about every ailment under the sun, it’s easy to forget that the original use for chelation therapy promoted by “alternative medicine” practitioners was for cardiovascular disease. When it is used for coronary artery disease or autism, on a strictly stoichiometric and pharmacological basis, it is extremely implausible.Moreover, it is not without potential complications, including renal damage and cardiac arrhythmias due to sudden drops in calcium levels. Such arrhythmias can and have led to death in children, and in adults complications such as renal failure and death.

Despite this extreme implausibility, randomized controlled studies showing that chelation is no better than placebo for cardiovascular disease, a veritable cottage industry of chelation therapy for cardiovascular disease has sprung up, fueled by extravagant claims likening chelation to a “Roto-Rooter for your arteries” and an alternative to angioplasty and coronary artery bypass surgery and portraying the hostility of SBM to it as not based on medicine but rather on the “need” to protect the “billion dollar industry of angioplasty and CABG.” With most regimens costing $100 to $150 a treatment and “requiring” 30 to 40 doses, it’s a tidy little profit center for “alternative” physicians.

The belief that chelating toxic metals out of people can treat cardiovascular disease has no basis in physiology, biology, or pharmacology, but it’s a major treatment modality favored by naturopaths and many other “alternative” practitioners. Given the infiltration of quackademic medicine into medical academia, it should not be surprising that its advocates promoted clinical trials of this disproven modality. In the early 2000s, they succeeded in the form of the National Institutes of Health (NIH) Trial to Assess Chelation Therapy (TACT), a five year phase 3 trial begun in 2003 to test office-based, intravenous disodium ethylene-diamine-tetra-acetic acid (Na2EDTA) as a treatment for coronary artery disease (CAD). A while back, I learned that the results of this trial would finally be revealed on Sunday (i.e., yesterday) at the American Heart Association’s annual meeting in a session on late-breaking clinical trials in the form of two abstracts:

  • Results of the Trial to Assess Chelation Therapy
  • Quality of Life Outcomes in the Trial to Assess Chelation Therapy (TACT)

The story was embargoed until last night, but now the embargo is lifted and we can write about it freely, thanks to press releases and reported results of the trial. I expect that the results are—shall we say?—disappointing to chelationists. Certainly if this were a conventional medical therapy it would not be viewed as a particularly favorable trial. However, there are enough equivocal findings that the alt-med websites will soon be touting this study as ironclad evidence that chelation therapy works as well as bypass surgery. I guarantee it. In fact, I wouldn’t be surprised if such articles appear at the same time as this post. Chelationists have access to press information too and tend not to be as fastidious as us in honoring press embargoes.

The story of how this $30 million trial is long and depressing and was documented ably and in extreme detail in 2008 by my good bud Kimball Atwood, along with Wally Sampson, Elizabeth Woeckner and Robert Baratz, in an article for the Medscape Journal of Medicine entitled Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned. In it, Atwood et al documented the long and dubious history of TACT, how it came about through the political influence far more than scientific merit (of which it has virtually none), and how the investigators are utterly unqualified to carry out such a large multicenter trial, concluding that the TACT is “pointless, dangerous, unethical, and wasteful.” It’s worth reading the article in full detail, as well as other posts by Kimball Atwood, not to mention a post or two by yours truly. In addition, you should check out R. W. Donnell’s Magical Mystery Tour of NCCAM Chelation Study Sites, Part I, Part II, Part III, Part IV, Part V, Part VI, and Part VII. Seriously. As Dr. Donnell points out, only 12 of the 110 TACT study sites were academic medical centers. Many of the study sites were highly dubious clinics touting highly dubious therapies, including heavy metal analysis for chronic fatigue, intravenous infusions of vitamins and minerals (I could never figure out how infusing minerals could be reconciled with chelation therapy to remove minerals, but that’s just me), antiaging therapies, assessment of hormone status by saliva testing, and much more. Dr. Donnell also points out that the blinding of the study groups to local investigators was likely to have been faulty. So right off the bat, this study was dubious for so many reasons, not the least of which was that some of its site investigators were felons, a problem blithely dismissed by the NIH as being in essence irrelevant to whether the study could be done safely.

Efficacy? It’s a part of my science-based medicine fantasy.

Let’s take a look at the results of TACT, starting with the main outcome measures first, and then we’ll move on to the presentation describing quality of life (QOL) measures. The first presentation is by Gervasio Lamas, MD, a professor of clinical medicine at the Columbia University Division of Cardiology and now Chairman of Medicine at Mount Sinai Medical Center. and was entitled The Trial To Assess Chelation Therapy (TACT): Chelation-Placebo Comparison. One notes right away that the study was funded by the National Center for Complementary and Alternative Medicine (NCCAM, grant U01AT001156) and the National Heart, Lung and Blood Institute (NHLBI, U01HL092607). What’s interesting here is that the study was originally funded by NCCAM and then taken over by NHLBI later. NCCAM seems to be almost embarrassed by it, however. For example, the director of NCCAM, Dr. Josephine Briggs, has a tendency to be very quick to dismiss TACT as no longer within NCCAM’s purview. She is clearly embarrassed by our question and also dismissed it as having come into existence before she took over as director at NCCAM. The second thing I noticed was that this was funded under the NIH U01 mechanism. This mechanism is designed to fund multi-institution collaborations to “discrete, specified, circumscribed projects to be performed by investigator(s) in an area representing their specific interests and competencies.” In practice, what I gather from more senior investigators is that U01 grants are less like R01 grants and more like contracts (more specifically, they are cooperative agreements) to carry out specific projects. As such, they appear to be a bit more amenable to political pressures to be granted—or at least were.

The trial was a 2 x 2 factorial design that looked at:

  • Chelation plus high oral high dose vitamin and mineral supplement
  • Chelation placebo plus oral high dose vitamin and mineral supplement
  • Chelation plus oral high dose vitamin and mineral supplement placebo
  • Chelation placebo plus oral high dose vitamin and mineral supplement placebo

The regimen was also quite rigorous and is described in detail in a recent publication. One notes that the vitamin supplements included doses ranging from 25% to 6,667% of the RDA for these vitamins. For instance, the dose of vitamin C was 2,000% of the RDA; thiamin, 6,667%; and vitamin A, 500%. There were a total of 40 infusions that took three hours each. Thirty of these were administered weekly, followed by ten “maintenance” infusions administered two to eight weeks apart. Now let’s look at the nitty-gritty, followed by the results. First up, the inclusion criteria were:

  • Age 50 or older
  • MI > 6 months prior
  • Creatinine <2.0 mg/dL
  • No coronary or carotid revascularization within 6 months
  • No active heart failure or heart failure hospitalization within 6 months
  • Able to tolerate 500cc infusions weekly
  • No cigarette smoking within 3 months
  • Informed consent

The exclusion criteria were:

  • Chelation therapy within 5 years
  • Allergy to any study drug
  • Coronary or carotid revascularization within 6 months
  • Planned revascularization
  • Symptomatic or clinically evident heart failure
  • Heart failure hospitalization within 6 months
  • Blood pressure > 160/100
  • No venous access
  • Serum creatinine > 2.0 mg/dL
  • Platelet count <100000/mm3
  • Cigarette smoking within the last 3 months
  • Liver disease or ALT or AST >2.0 times the upper limit of normal
  • Diseases of copper, iron, or calcium metabolism
  • Inability to tolerate 500 mL of fluids weekly
  • Inability to keep to study schedules
  • Medical condition likely to affect patient survival within 4 years
  • Women of child-bearing potential

The placebo infusion consisted of 500 mL normal saline and 1.2% dextrose, while the chelation infusion consisted of:

  • disodium EDTA, 3 grams, adjusted downward based on eGFR,
  • ascorbic acid, 7 grams
  • magnesium chloride, 2 grams
  • potassium chloride, 2 mEq
  • sodium bicarbonate, 840 mg
  • pantothenic acid, thiamine, pyridoxine,
  • procaine, 100 mg
  • unfractionated heparin, 2500 U
  • sterile water to 500 mL

I find it very interesting that the investigators included procaine (a product of evil big pharma) in the chelation mixture. Yes, I know that disodium EDTA is also a product of the evil big pharma, but one can’t very well do chelation therapy without the chelating agent, can one? In any case, procaine is actually Novocaine and is a topical anesthetic. Its inclusion makes me wonder how much the chelation concoction being tested in TACT hurts as it is injected, as we usually don’t add local anesthetics to infusions unless the infusion causes significant pain at the injection site. Could this also contribute to the ability of patients to know if they’re getting the “real” drug (and, yes, disodium EDTA is a drug)? One wonders, one does.

One last piece needs to be put into place, and that’s to let you know the outcomes that were tested in TACT. The primary endpoint is a composite of death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. In other words, investigators took all of these endpoints and added them together. The significance of this design will become clear in a moment, after I reveal the results. Another important point was that the original plan was to randomize 2,372 patients with a one year followup, a design that was estimated to have 85% power to detect a 25% difference. However, in 2009, due to low enrollment (more on that later), it was pointed out that “blinded investigators asked for a reduction of total sample size to 1,700, with a compensatory increase in follow-up to maintain same unconditional power.” I find it rather interesting that the word “blinded” is used, instead of just saying that the investigators asked for a decrease in number and a longer followup time in order to try to compensate for low accrual. The implication to me is that there were some investigators who were not blinded. Whether I’m reading too much into this or not, I don’t know, but it sounds odd. In any case, the request was approved.

So, on to the results. The result being touted by the investigators is described in the press release:

Heart attack patients given weekly infusions of chemicals used for chelation therapy had fewer cardiovascular events than those who received identical appearing placebo infusions, according to late-breaking clinical trial results presented at the American Heart Association’s Scientific Sessions 2012.

In the multicenter, double-blind efficacy trial, Trial to Assess Chelation Therapy (TACT),1,708 heart attack patients were randomized to receive 40 infusions of a 500 mL chelation solution or a placebo infusion, with a second randomization to an oral vitamin and mineral regimen or an oral placebo. The chelation solution contained three grams of the synthetic amino acid ethylene diamine tetra-acetic (EDTA), seven grams of vitamin C, B-vitamins, electrolytes, a local anesthetic and heparin, an anti-clotting drug. The placebo infusion was salt water and a small amount of sugar.

Researchers found that patients receiving the chelation solution had fewer serious cardiovascular events than the control group (26 percent vs. 30 percent). Cardiovascular events were defined as death, heart attack, stroke, coronary revascularization and hospitalization for angina.

Although participants with diabetes appeared to have a particular benefit from the infusions, the study team cautioned that subgroup analyses can be unreliable and need to be reproduced.

There’s the spin. Let’s look at the results. The primary endpoint (i.e., the aggregated serious cardiovascular events) did indeed show a modest difference, namely 30% of placebo subjects versus 26.5% of the EDTA chelation subjects (hazard ratio 0.82 for chelation). However, the result is just barely statistically significant, p = 0.035, with the 99% confidence interval for the hazard ratio ranging from 0.69 to 0.99. Note that the predetermined level for statistical significance for purposes of this study was 0.036. More importantly, if you look at the individual endpoints that make up that aggregate, there was no statistically significant difference in death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. Subgroup analysis (always a questionable analysis that requires replication, even when preplanned, as in TACT) purported to show a much greater benefit for diabetics, with a hazard ratio of 0.61 (p=0.002), while patients without diabetes showed no statistically significant difference in any of the outcome measures, including the aggregated total bad outcomes (I like that term better).

There were some problems, as you might imagine. First off, only 65% of subjects finished all infusions, with only 76% finishing at least 30. That’s a high drop-out rate, and is likely largely due to just how grueling it is to have to undergo weekly three hour infusions for well over six months, followed by several more months of less frequent infusions. Moreover, 17% withdrew consent, resulting in missing data. I’m not sure how the investigators tried to correct for this (there are standard ways to do it), but these issues are serious. They might not be so serious if there had been a much more convincing treatment effect, but when you get equivocal results such as this such issues loom much larger. Indeed, critics have correctly pointed this out, as in this AP report:

Other experts questioned the results, especially because 60 more people in the group getting dummy infusions withdrew from the study than in the group getting chelation. Usually, more people in a treatment group drop out because of side effects, said Dr. Christie Ballantyne, a Baylor College of Medicine heart specialist. To find the opposite is “a red flag” that suggests those who got dummy treatments found that out and decided to drop out.

“There’s something funky going on here,” Ballantyne said. “It raises questions about study conduct,” especially since a difference of one or two people or complications could have nullified the small overall benefit researchers reported.

Dr. Clyde Yancy, a Northwestern University cardiologist and a former Heart Association president, agreed.

“It’s funny business,” he said. “I’ve never seen a study in which one in five people withdrew consent.”

Funny business is an understatement. A complete, unabashed fiasco would be a better description. Or maybe a total and complete waste of taxpayer money. Or perhaps an unethical sham of a trial, perhaps? Whatever you want to call TACT, this concern is quite consistent with worries expressed over six years ago by Dr. R. W. Donnell about the adequacy of the blinding of the trial. In light of such concerns, the differential drop-out rate between the two groups makes a lot more sense. Too bad that Dr. Lamias apparently didn’t see fit to include the relevant information in his press release or in his slide set.

Finally, no study would be complete without a consideration of adverse events. After all, in determining whether a therapy is worth pursuing, it is important to weigh its efficaciousness versus its safety. Overall, 79 adverse events were observed forcing discontinuation of infusions. Reasons included: reaching an endpoint; heart failure; other cardiac issues; GI problems; hematological problems; and a variety of other problems. Unfortunately, the presentation slides did not break down how many of these 79 adverse events occurred for patients in the treatment group versus patients from the placebo groups. In fact, given that there were four groups, these adverse events needed to be broken down into four groups but were not. There were a total of four unexpected severe adverse events possibly or definitely related to study therapy, two in the placebo group with one death and two in the treatment group, with one death. Kimball Atwood discussed some of the serious adverse events before in detail. It’s not entirely clear that these deaths didn’t have a lot to do with the incompetence of some of the investigators at the local sites where these patients were treated.

I will be awaiting the full publication, in which (hopefully) more will be revealed about these two deaths. In the meantime, it is clear to me that, even if these results are valid and there is a small benefit to chelation therapy, it’s a long run for a risky short slide.

Quality of life? We don’t need no steekin’ quality of life?

Still, even though the results are so unconvincing that the study investigators concluded that TACT “does not constitute evidence to recommend the clinical application of chelation therapy” and that (of course!) “additional research will be needed to confirm or refute our results and explore possible mechanisms of therapy” while also saying TACT showed “some evidence of a potentially important treatment signal in post-MI patients already on evidence-based therapy,” maybe the therapy does something for quality of life. It’s possible, albeit highly implausible. So in parallel, QOL outcomes were measured and presented as a second abstract at AHA presented by Daniel B. Mark, MD, MPH.

Several QOL tools were administered to participants in TACT. These included:

  • DASI: A cardiac-related functional status tool that ranges from 0-58 and reflects the ability of patients to do physical activities without difficulty or assistance in 12 domains
  • MHI-5: A tool that measures psychological well-being, including both
  • depression and anxiety. Investigators normalized scores to 50±10, with clinically significant difference being >2.5 points.
  • Other measures: SAQ (frequency, stability, QOL), SF-36, EQ-5D

In brief, 911 (53%) of the 1,708 main TACT subjects were randomly selected for the QOL substudy, with structured interviews at baseline, 6 months, 12 months, and 24 months. Let me tell you, though, that this study will be much easier to discuss than the main TACT trial for one very simple reason. There were no statistically significant differences in QOL outcomes measured for any of the assessment tools used at any of the time points examined.

So what do you do when your study is completely negative? Easy! You do subgroup analysis, and that’s what Mark et al did. Well, actually, these subgroup analyses were prespecified; so it’s basically legitimate. Even so, they couldn’t find much. All they could find is that patients with angina symptoms at baseline showed a modest treatment effect in favor of chelation therapy at one year, but at none of the other time points. A good rule of thumb is that for repeated measures, seeing an effect at only one time point is strongly suggestive that the difference for that time point is spurious and not real; so there isn’t much to say about this other than that this was about as close to a completely negative study as one might imagine, and even the press release had to acknowledge that:

“We didn’t see any effect on the quality of life of chelation therapy patients,” said Daniel B. Mark, M.D., M.P.H., lead author of the sub-study and professor of medicine, director of outcomes research at Duke University Medical Center and Duke Clinical Research Institute in Durham, N.C. “Patients weren’t any worse, but they weren’t any better.

One of the tools used to measure quality of life was the Duke Activity Status Index, DASI, to measure patients’ ability to complete daily tasks. The lowest score of 0 means the patient couldn’t do any chores associated with their own care such as feeding, toileting and dressing themselves. The highest score of 48 would be achieved by a professional athlete, Mark said.

At the beginning of the study, patients taking chelation therapy had a score of 24.6 and after two years it went up to 27.1. Those on placebo, dummy infusions that contained no medicine, had a baseline score of 23.5 that went up to 25.1. The small difference between chelation and placebo wasn’t significant enough to show a notable impact on how patients functioned in their daily lives.

The results were similar when researchers used the SF-36, the Short Form Health Survey, which assesses mental wellbeing or stress. After two years of chelation or placebo, patients reported similar scores.

“We thought it might make people feel better, but we didn’t see that consistently enough,” Mark said.

No, Dr. Mark didn’t see it at all, just as the trial investigators apparently didn’t see Edzard Ernst’s criticisms of their trial design when they cited his review article as a source. As Dr. Ernst put it:

The TACT has been criticized as being “unethical, dangerous, pointless and wasteful.” Yet, Lamas et al inform us that it went ahead with “reduced sample size” and that “TACT has finished enrolment.” From my perspective, the most puzzling part of the article of Lamas et al is the following sentence: “EDTA chelation of divalent and trivalent ions has been postulated to produce a favorable effect on atherosclerotic plaque, questionably leading to improvement in endothelial function, reductions in symptoms, and major vascular events.” To support this statement, Lamas et al cite my review that shows an “almost total lack of convincing evidence” and concludes that “given the potential of chelation therapy to cause severe adverse effects, this treatment should now be considered obsolete.”

Ernst was correct, and the now-revealed results of TACT only serve to confirm that.

The bottom line

When we criticize NCCAM and the infiltration of quackademic medicine into medical academia, we often point to the many pernicious effects that “integrating” pseudoscience with science- and evidence-based medicine has. One of these is the drive to test highly implausible therapies without adequate preclinical evidence, a practice at odds with the Helsinki Declaration’s requirement that clinical trials be based on firm basic science in preclinical models. This is problematic enough from an ethical standpoint when the treatment being tested is water (i.e., homeopathy), but when it’s an active treatment with real risks, it is completely unethical. That’s why I have said on multiple occasions that TACT is completely unethical. Worse, TACT was not funded based on a clinical need, scientific or clinical promise, or scientific merit due to its potential to reveal an important previously unsuspected mechanism of disease or target for treatment. Rather, it came into existence because a pro-quackery legislator, Rep. Dan Burton (R-IN) strong-armed the then-director of NCCAM to green light it. Later, it became such an albatross about NCCAM’s neck that NCCAM ceded control to NHBLI and downgraded its involvement to an advisory capacity. Indeed, Dr. Lamas himself seems to indicate that even he didn’t expect any positive results from TACT, although I suppose it’s possible that he means it was unexpected that this trial was, in essence, a negative trial:

“We have to look carefully at these unexpected results,” said Gervasio A. (Tony) Lamas, M.D., lead author of the study and chief of Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Fla. “Although not approved by the Food and Drug Administration for treating heart disease, chelation therapy has been used for over 50 years and has generally been believed by conventional medical practitioners and cardiologists to be without value. A definitive answer on chelation therapy will take much additional research. The most exciting part of this study is that there may be an unexpected signal of benefit. We need to understand whether the signal is true, or whether it occurred by chance.”

No, the “signal” only comes from having aggregated a bunch of outcomes into one large outcome, and even then this signal, in a study of over 1,700 patients, strained to reach statistical significance. On each and every individual outcome, the “signal” doesn’t exist!

Let’s step back a moment an look at this. In the case of TACT, the result of the “integration” of quackery with scientific medicine has been to spend $30 million on a trial conducted at highly dubious CAM and “integrative” medicine clinics whose practitioners were completely unqualified to carry it out. This expenditure of scarce research dollars has resulted in a primary finding that is at best equivocal and at worst completely negative, and a secondary finding that is completely negative. Even if this study’s results are taken at face value, we can say that chelation therapy for coronary artery disease does not increase survival, obviate the need for angioplasty or CABG surgery (a prime claim frequently made by chelationists), or even decrease the severity of patients’ angina symptoms or increase their tolerance for physical activity. It is worthless. Actually, it’s worse than worthless, because it’s expensive, arduous, and, even if we took TACT’s reported results at face value, promises minimal benefit.

I am not condemning this trial because it was negative. Sometimes—often, in fact—clinical trials fail to find a benefit from the experimental treatment. There’s nothing wrong with that. However, such clinical trials are based on a sound preclinical evidence base of basic science and animal experimentation that indicates scientific plausibility and a reasonable likelihood that the treatment would be efficacious in humans. TACT had none of these things. Indeed, there was an existing preclinical and clinical evidence base that gave every indication that chelation therapy shouldn’t work.

The acceptance of chelation among CAM practitioners is also as good an exapmle of the CAM double standard as I’ve ever seen. Imagine, if you will, if big pharma produced a treatment like chelation therapy that had no good preclinical evidence suggesting its efficacy and several existing clinical trials suggesting that it does no better than placebo for cardiovascular disease. Imagine that big pharma tried to get FDA approval to market its chelation therapy for cardiovascular disease. Imagine how CAM practitioners would react. Now look for how they react to this trial. I can predict it. (Not that it’s hard or anything.) They’ll make excuses. They’ll cherry pick the one seemingly promising result. They’ll claim that there was something wrong with the protocol or that the wrong chelating agent was used. They’ll demand more studies. In other words, they won’t simply admit that their therapy doesn’t work and move on.

In fact, I’m already thinking of things that quacks will say about this trial to try to excuse its failure and justify continuing to use chelation. One of them has already been used. In fact, it’s right there in the AP story:

The study’s leader, Dr. Gervasio Lamas of Mount Sinai Medical Center in Miami, said: “The trial needs to be taken for what it is — a step towards future investigation.”

Yes, it’s the “more study is needed” gambit. In these cases, unfortunately, the problem is that more study is always needed, regardless of how negative the study.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

121 replies on “The results of the unethical and misbegotten Trial to Asess Chelation Therapy (TACT) are finally revealed”

Regardless of who wins tomorrow, I’m going to start writing my Congresswoman to see if NCCAM can be put on the radar for Sequestration…..or better yet, the general budget axe.

Why is there also heparin in the ‘chelation’ product? Wouldn’t that be a huge potential confounder?

That’s another thing I hate about CAM. They just throw ingredients into their potions based on whatever seems like it might be good. What the hell was the justification for EDTA plus ascorbate, plus those salts, plus vitamins, plus procain, plus heparin?! And then a high-dose vitamin and mineral supplement on top of that? WTF?

(I guess I could understand supplementing with Mg, in case too much is removed due to chelation by EDTA. But then why no Ca? Maybe that’s in the supplement, but then it would have gone to only half the subjects in chelation.)

I am not a doctor but a B. Tech. and M. Tech. degree holder from world famous Indian Institute of Technology, Bombay. Seven years ago I suffered fatal heart attack but was successfully resuscitated. Later I was told to undergo triple vessel bypass but instead I underwent chelation therapy.
After finding great benefit from it to me and many others I tried to know more about the therapy. Doctors did not tell me anything. I searched and researched. Learned most of the techniques, taught the therapy in all its details to doctors who later practiced it and found great benefit to treated patients.

The mentality of many anti chelation doctors has been described in my book, “Angioplasty, Bypass Surgery Myths and Chelation Therapy Facts”

The book describes the real nature and peril of the conventional methods.

It also give rebuttal of all the anti chelation arguments made by many conventional medical practitioners.

This book has been recommended by International Board for Clinical Metal Toxicology”

The more money involved, the greater the potential for political pressure. Tens of millions of dollars is enough to get a Congresscritter to take notice, and I haven’t seen any evidence that Congresscritters are better informed about science-based vs. alternative medicine than the general public. It doesn’t have to get to Congress, either: a highly motivated bureaucrat could probably swing it, if everybody else in the paper trail were at best indifferent.

That the head of NCCAM wants to wash her hands of this study says quite a bit: this trial is too absurd for somebody whose job it is to promote alternative medicine.

After my earlier post, I went back and read Orac’s link about felons being involved, to find that Dan Burton (no less) was instrumental in getting funding for this study. So without the political pressure, this study would never have gotten off the ground.

2500 units of heparin? Really? How is this ok? How can you say the control for the chelation, which lacked heparin, is an adequate control? And who approved randomly loading people with heparin once a week? That’s not safe. I’m shocked they didn’t have more adverse outcomes.

Whoever designed this trial should be drummed out of academia. Sorry but in science you should be testing a variable at a time, not 7. And shoving a grab bag of drugs into one mixture, and comparing it to saline is just shoddy, stupid science.

“Although participants with diabetes appeared to have a particular benefit from the infusions, the study team cautioned that subgroup analyses can be unreliable and need to be reproduced.”

I’m not a physiologist so I have a question regarding people with diabetes and this study.

The placebo infusion (500 ml) contained 1.2% glucose, isn’t that going to cause issues with a person’s diabetes?

Since its not in the experimental infusion, would that not make it difficult for proper blinding?

I see one positive outcome, and that is that this specific protocol is not going to kill you. As potentially dangerous as EDTA is, that’s a good thing. Doesn’t do anything for you, but at least you’re not going to die from it. So that might not be true if compared vs. aggressive SBM treatment.

A few notes about chelation:

amongst those I survey, chelation is often recommended for other illnesses and conditions- for ASDs, cancer, hiv/aids, MS, Alzheimer’s, SMI… They find a way to justify the procedure which is arduous, expensive and possibly dangerous: it supposedly removes toxins, plaque and whatever else is detrimental to health ( as well as substances that AREN’T detrimental to health but are necessary- which they don’t talk about too much).

So-called professionals who work in synch with woo-meisters ( see Metropolitan Wellness, for some examples) offer chelation as well as IV vitamins and nutritional counselling.

Our old friend, Gary Null, elaborates upon this theme: not only is standard chelation efficacious but it may be supplemented or entirely replaced by eating/ drinking a particular type of diet and following a high dosage supplement regime.

Green juices are advocated as ‘natural chelators’- a patient should ingest several concoctions daily that each include dark green vegetables, sea vegetables and algae-based products; these drinks are supplemented with added dried green vegetable powders/ and dried red/ purple fruit powders ( available at the website’s store) as well as a long list of supplements in capsule form ( available at the website’s store). These regimes are discussed in detail in video and book form ( also available).

If you don’t relish undergoing a series of infusions, you can buy the products plus a juicer ( available as well) and chelate yourself without having to sit through hours and hours at an altie facility which you have to pay for.

Chelation is also sold as a prevention measure: if you suspect that your life of wanton consumption has already done damage to that temple, your body, you can start cleaning house immediately. Prior to discussing these methods, the woo-in-charge usually instructs his audience about the gradual and subtle changes that occur in the CV system, internal organs and brain that will eventually reach a “tipping point” ( his words, not mine), i.e. a stroke, MI or cancer.

-btw- ‘wanton consumption’ includes eating any type of meat or dairy products, non-organic fruits and vegetables, saturated fat, most cooking oils, food cooked over high heat or grilled, any food additives, any products with sugar, any alcohol whatsoever, wheat, GMO products, fluoridated/ chloridated water, pharmaceuticals etc, etc, etc.

I am not making this up.

Shorter bvg:

“You’re all wrong, but I won’t tell you why…read my book to find out!”

Nice try, but that won’t fly here. If you have a rebuttal to any specific claims made in the post above, feel free to share them.

After finding great benefit from it to me and many others I tried to know more about the therapy. Doctors did not tell me anything. I searched and researched. Learned most of the techniques, taught the therapy in all its details to doctors who later practiced it and found great benefit to treated patients.

So? Anecdotes aren’t evidence; you didn’t conduct a proper study and you aren’t even a qualified toxicologist.

The mentality of many anti chelation doctors has been described in my book, “Angioplasty, Bypass Surgery Myths and Chelation Therapy Facts”

The book describes the real nature and peril of the conventional methods.

I think you’ll find that pimping some shoddy book is going to be met with derision and scorn, particularly in light that this is a post discussing an actual study that failed to demonstrate any benefits for chelation and prevention of heart disease or improvement of survival rates.

It also give rebuttal of all the anti chelation arguments made by many conventional medical practitioners.

This book has been recommended by International Board for Clinical Metal Toxicology”

Whoop-de-freakin-doo; from all appearances, IBCMT isn’t a recognised board certifying organisation and is a scam. They are also in denial about the efficacy of chelation therapy for alternative uses.

@Denice Walter

amongst those I survey, chelation is often recommended for other illnesses and conditions

That chelation equipment is expensive – a capital asset like that has got to be put to work to pay for itself.

@ Militant Agnostic:

Actual equipment for chelation / IVs costs money unlike some of their other recommendations: hand-waving, medical hypnosis, NLP, EFT, flower essences, homeopathy, chakra balancing, meditation- which just involve verbalising and hand motions and take up very little shelf space.

-btw- Can you smell the durian from 25 km away?
I have been within 5-6 feet of them – but they were- fortunately- intact and I couldn’t smell anything. And I am rather good at sniffing out things.

Mr. Gokhale, despite Moneylife Foundation’s website describing you as an ‘expert on chelation therapy’ I can find no articles you’ve authored regarding chelation therapy published in any peer-reviewed journal. The minimal details given regarding your academic training (B Tech and M Tech degrees from IIT Mumbai) doesn’t support such a claim to expertise.

Do you consider yourself an expert on chelation therapy, and if so on what basis? (Hopefully something other than having undergone chelation yourself, and time spent at Google U).

Or is the Moneylife Foundation completely misrepresenting your qualifications?

@ bvg (BV Gokhale)

Your *recommendation* for that book has been duly noted here…

http://www.moneylife.in/article/angioplasty-bypass-surgery-myths-and-chelation-therapy-facts/22142.html

“B V Gokhale 11 months ago

To All,

Please note that I am not a doctor.

I have deeply studied alternative medicine. Since I find alternative medical treatments are very effective, safe and relatively inexpensive I take pleasure in promoting them.
I do not expect any monitory gains through my efforts.”

Yeah, we kinda figured that you are not a doctor.

Here’s another article about chelation and indications for its use for actual metal toxicities…

http://www.poison.org/current/chelation%20therapy.htm

“In 2007, the National Center for Health Statistics reported that 111,000 adults said they used chelation therapy, along with 72,000 children under the age of 18. [7] It is highly unlikely that 183,000 US residents required chelation therapy for the limited number of approved indications. It is much more likely that therapies were received for conditions attributed to heavy metals without scientific validation…..”

“…..Chelation “therapy”: unapproved uses of chelation
As noted above, chelation therapy is approved for a limited number of indications involving documented poisoning by heavy metals; it is carried out under medical supervision with prescription drugs. However, entering “chelation therapy” into an internet search engine yields more than 500,000 hits. Alongside entries relating to lead and iron poisoning are entries referring to “veggie caps”, chelation “without chemicals”, “dissolve artery blockages”, “chelation suppositories”, and “undesirable ionic material”, plus many ads for over-the-counter chelating substances. There is at least one entry offering chelation therapy while traveling overseas; this destination also offers cosmetic surgery.

Chelation “therapy” is offered for a number of conditions: arteriosclerosis, angina, poor circulation to the legs and feet, autism, Parkinson’s disease, Alzheimer’s disease, cancer, diabetes, and many other conditions. Even when it is implausible or impossible for chelation to be effective, it has been made to sound rational to people unfamiliar with the causes of these conditions.

To “diagnose” heavy metal poisoning as a cause of these conditions, and therefore appropriate for chelation therapy, practitioners will often administer a test or challenge dose of a chelator. In a day or two, a urine test is done to measure metals. Since some metals are found in all humans, these tests are always “positive”, though they are not measured against established or medically accepted standards. These results are then used to market chelation therapy to the individuals. The American College of Medical Toxicology warns that basing chelation therapy on these types of tests is without benefit to patients and may prove harmful. [15]”

Mr Gokhale says that chelox therapy is an excellent method of detoxifying the human body. It can provide relief to non-diabetics too. Ailments treated by chelox therapy with at least partial success are: coronary artery disease, valvular disease, cardio-myopathy, migraine, hormonal imbalance, macular degeneration, rheumatoid arthritis, schizophrenia, fibromyalgia, Raynaud’s Disease, Scleroderma, multiple sclerosis, Lou Gehrig’s Disease, Alzheimer’s Disease and Parkinson’s Disease.

Utter fraud. Maybe he defines “partial success” as “patient survived the ‘treatment'”

@DW

Can you smell the durian from 25 km away?

I am upwind (prevailing) with a sour gas plant and a few herds of cattle and bison between me and the business (McKay’s Ice Cream) in question. For obvious reasons, the durian is not sold in cones – it is available only on a take out basis.

Anyone else notice that when Mr Gokhale shows up on certain pages (generally ones with favourable reviews of his fantastical book) so does Sohan Modak? Strangely though, many of the latter’s comments seem to go missing and Mr B seems to be responding to questions that aren’t there. Funny that.

The first three comments are *very positive* about the study results.

Dooley indeed pops up in this 1999 item about the Florida chelation racket. In the context, one might wonder whether the change of direction from emergency medicine had something to do with his own disciplinary case.

My father had chelation therapy for his heart problems, back in the 1990s, I think it was. It cost his wife a lot of money, and in all likelihood it did him no good. I’m sure it was a great placebo. 😛

I didn’t know enough about the issue to recognize it as quackery. The brochure for the procedure sure sounded sciencey, though, and it fooled us enough not to try to talk him out of it. Sad waste of money on an unnecessary invasive procedure.

@ Melissa G:

I sometimes wonder if placebos that cost** a great deal and/ or involve some hardship make the mar… excuse me, *patient* feel more comfodent of their efficacy because he or she has so much time, money and effort invested.
This would predict that time-consuming, expensive diets/supplemental regimes should be valued more.

** I think that there’s some data on cost.

@DW

I sometimes wonder if placebos that cost** a great deal and/ or involve some hardship make the mar… excuse me, *patient* feel more comfodent of their efficacy because he or she has so much time, money and effort invested.

It works for wine (at least the cost aspect).

See if you can locate them

It’s not on-line, but you can write away for it if you’re really interested. This is a good one:

“I’m not going to shut up!” yelled Dr. Bruce R. Dooley, a Naples physician who is president of the pro-chelation Alliance for Medical Freedom. “This is a kangaroo court!”

Dooley left the meeting after board members called for a security guard, but he soon returned carrying a large, stuffed kangaroo.

It works for wine (at least the cost aspect).

And is a pillar of the audiophile market.

question: how does the concoction tested compare to an actual chelation regime prescribed by actual doctors for actual metal toxicity?

This Dooley individual seems like quite the character…his response to your comment, lilady, seems to be ‘the trial is correct because it was very sophisticated and Forbes said so’ as well as ‘orac is biased so I didn’t bother to read the post.’
FAIL.

I sometimes wonder if placebos that cost** a great deal and/ or involve some hardship make the mar… excuse me, *patient* feel more comfodent of their efficacy because he or she has so much time, money and effort invested.

There is actual published evidence that this is the case:

“Commercial Features of Placebo and Therapeutic Efficacy,” Rebecca L. Waber; Baba Shiv; Ziv Carmon; Dan Ariely, Journal of the American Medical Association, March 5, 2008; 299: 1016-1017.

Waber et al. won the 2008 Ig Nobel Prize for Medicine for that study.

This Dooley individual seems like quite the character

What really stood out for me was the line “In my opinion a legal challenge should immediately be lodged to force a retraction of this policy statement on three. (3) grounds at least.” The doubling down on the number is some serious pretend-lawyering.

@ Narad: Dooley posted back at me…I just re-posted back at him with other opinions from other cardiologists about the validity of the study…

http://www.forbes.com/sites/larryhusten/2012/11/04/nih-trial-gives-surprising-boost-to-chelation-therapy/

No way, no how, is a legal challenge EVER going to get insurance companies to pay for chelation for cardiac diseases…no less for “anti-aging” chelation therapy that Dooley offers to his patients.

Weekly 3 hour infusions for such a small and clinically insignificant decrease in risk seems like a pretty poor deal to me, even if it wasn’t artefactual, which seems likely. I suspect walking for 3 hours a week would be much more beneficial, cheaper and more fun, depending on where you live, I suppose.

I find it interesting that the chelation brew included procaine, as procaine was once hailed as a miracle drug in its own right, at a similar dose (100mg). It isn’t, I hasten to add, though it may have a mild antidepressant effect (PMID 12204).

This book has been recommended by International Board for Clinical Metal Toxicology”

A group of quacks — set up to promote chelation therapy for everything and to sell certificates qualifying one to administer chelation therapy* — are recommending a book all about the wonders of chelation therapy? No-one saw that coming.

* The IBCMT is the source of Dr Dooley’s qualification for chelation.

No way, no how, is a legal challenge EVER going to get insurance companies to pay for chelation for cardiac diseases…

Check out the “nanobacteria” guy who chimed in.

Anatman, I wondered the same thing. Here is one short doc I found on treating lead poisoning in kids (was, and may still be, a problem in areas, like NYC, with lots older houses with layer upon layer of lead-based paint):
http://www.nyc.gov/html/doh/downloads/pdf/lead/lead-chelation.pdf

in short – for CaNa2EDTA, 1 gram per day for 5 days

Incidentally, ferric ammonium EDTA is the main component in “bleach” for color photographic processing – dissolves out the metallic silver after the color is developed.

Ah, yes, Gary Steven Mezo (who apparently has a habit of appending numbers and a plus sign to his name) has a Florida DUI record. Everything that rises must converge.

I had totally missed out on “Nanobacterium sanguineum.” This pathogen from outer space apparently lacks DNA but is totes susceptible to tetracycline.

Perhaps it was done in the study, and Orac just hasn’t mentioned it, but it would seem to me that rigorous blood and urine chemical analysis would accompany a study of chelation. If I were trying to “improve” something by removing something, I would want to try to identify what I was removing that made the improvement. If isn’t as if anything actually chelated simply disappears or is transmogrified into water or something undetectable – it’s gotta go somewhere, and it’s gonna go when the patient has gotta go. Of course, this puts an even heavier burden on the test subjects – being bled at intervals for (I’m guessing) a day or two before AND after each infusion of soup. And lots of peeing in a cup.

I remember years ago seeing something on TV about chelation for cardiovascular treatment, with some character holding up a vial of a very small amount of some dry material that had be obtained by evaporating his urine after a chelation treatment, and proclaiming how the treatment got that goop out of him. He seemed to have the notion that “regular” pee is just colored water, devoid of solutes.

Perhaps it was done in the study, and Orac just hasn’t mentioned it, but it would seem to me that rigorous blood and urine chemical analysis would accompany a study of chelation.

That’s a very good point evilDoug and a very valid measurement given the hypothesis. I was just going to chime in to ask if blood-essential mineral levels were monitored as chelation isn’t all that specific about what is scavenged.

Chelation can be dangerous, but people have the freedom TO CHOOSE their own healthcare options. Chelation works to clean artieries out. The problem is sometimes it can cause plaque to break off and go to the heart and cause a heart attack. It does work though. Chelation can clean out artteries for a few hundred dollars or less rather than a more dangerous and more expensive open heart surgery.

Of course Vitamin K2 does the same thing but at a slower pace. A combination of Vitamin D and K2 can over time clean out plaque from the arteries and is not as dangerous as helation or as expensive.

K2 does even better. It removes the calcium buildup from the arteries and organs and moves it back into bone where it is supposed to be. It is also great in prevention of kidney stones by helping prevent calcium buildup in the kidneys.

It is amazing how many people advocate healthcare “choice” of women when it comes to abortion but want swat teams to raid vitamin stores. It is rather silly that we have so many anti vitamin people in the world.

Of course you can overdose on Iron and other vitamins as well as herbs, but overall more people have been harmed by prescription meds far more often than vitamins. If you watch tv all you see is lawyers trying to get money out of drug manufacturers becuase of damages or death cuased by said drugs. You never see lawsuits over damages by vitamins or herbs. That is saying alot right there.

Chelation can be dangerous, but people have the freedom TO CHOOSE their own healthcare options. Chelation works to clean artieries out. The problem is sometimes it can cause plaque to break off and go to the heart and cause a heart attack. It does work though. Chelation can clean out artteries for a few hundred dollars or less rather than a more dangerous and more expensive open heart surgery.

Of course Vitamin K2 does the same thing but at a slower pace. A combination of Vitamin D and K2 can over time clean out plaque from the arteries and is not as dangerous as helation or as expensive.

K2 does even better. It removes the calcium buildup from the arteries and organs and moves it back into bone where it is supposed to be. It is also great in prevention of kidney stones by helping prevent calcium buildup in the kidneys.

It is amazing how many people advocate healthcare “choice” of women when it comes to abortion but want swat teams to raid vitamin stores. It is rather silly that we have so many anti vitamin people in the world.

Of course you can overdose on Iron and other vitamins as well as herbs, but overall more people have been harmed by prescription meds far more often than vitamins. If you watch tv all you see is lawyers trying to get money out of drug manufacturers becuase of damages or death cuased by said drugs. You never see lawsuits over damages by vitamins or herbs. That is saying alot right there.

Did you see the testimonial on the NanobacTX site from Richard F. (minister, attorney & congressman)? I said that they clearly forgot to mention that he also saved nuns and kittens from a burning building while he was in astronaut training. Assholes.

As I think I’ve mentioned here at RI before, the claim that chelation therapy can treat blood clots is one (probably the ONLY one) that makes sense. That’s because certain chelators are known to have the side effect of acting as an anticoagulant. Thus, the one plausible claim the chelationists have enjoys that distinction because of something completely unrelated to the heavy metal toxicity that chelators are supposed to cure. Of course, it seems unlikely that the chelators are particularly GOOD anticoagulants.

David N. Brown
Mesa, Arizona

Kansas Practitioner,

Chelation works to clean artieries out.

No it doesn’t. Did you even read the article above?

Of course Vitamin K2 does the same thing but at a slower pace. A combination of Vitamin D and K2 can over time clean out plaque from the arteries and is not as dangerous as helation or as expensive.

Of course? Do you have any evidence that this is true? Or have you simply swallowed a lot of fantasies promoted by chelation therapists and supplement sellers? There is some evidence that vitamin K supplementation may slow coronary artery calcification but none that it will reverse it.

2500 units of heparin? Really? How is this ok? How can you say the control for the chelation, which lacked heparin, is an adequate control? And who approved randomly loading people with heparin once a week? That’s not safe. I’m shocked they didn’t have more adverse outcomes.

From Kimball Atwood elsewhere:

Here are explanations for the presence of heparin and procaine, quoted from Rozema, TC, “The Protocol for the Safe and Effective Administration of EDTA and Other Chelating Agents for Vascular Disease, Degenerative Disease, and Metal Toxicity.” (Journal of Advancement in Medicine Volume 10, Number 1, Spring 1997)

4. Thrombophlebitis
Local irritation at the infusion site may occasionally lead to superficial phlebitis. This uncommon complication can be minimized by adding from 1,000 to 5,000 units of heparin to each infusion. That small dose will act locally but will not generally cause significant systemic anticoagulation.

e. Local anesthetic. Even with the use of magnesium and bicarbonate buffer, lidocaine or procaine may be needed to prevent pain at the infusion site for an occasional patient. This need occurs more commonly during the first few infusions

Note that Rozema is one of Lamas’s co-authors for the TACT presentation at the AHA meeting. He’s also a convicted felon.

Oy. That dose of heparin won’t cause significant systemic anticoagulation? What idiots. 5,000 U heparin is not a “small dose.” A typical loading dose of heparin these days ranges from 50-100 U/kg. 2,500 U, the amount of heparin in the infusion for the TACT protocol, is well within loading dose range for many women and lighter men. True, it’s given over 3 hours, and most loading doses of heparin are given over a much shorter period of time (say, 1 hour), but geez. These guys truly don’t know what they’re doing, do they?

“These guys truly don’t know what they’re doing, do they?”

Understatement of the year.

Lilady, what is the name of the Gadolinium lady at HuffPo?.She just posted on the Forbes article under the name “profitmedicine” . Guess what she is going on about?………

If you watch tv all you see
If the TV is Kansas Practitioner’s main information source, I think I see the problem.

I sometimes wonder if placebos that cost** a great deal and/ or involve some hardship make the mar… excuse me, *patient* feel more comfodent of their efficacy because he or she has so much time, money and effort invested.

You know, of all things, this reminded me of one of the old Henry Reed books I read back when I was young. One of the the various things Henry comes up with to make money involved, I believe, turtles that had pictures painted on their shells. After planning on just selling them all at the same cost because all the pictures took the same amount of time to do, one of his partners suggests putting different prices on them so people who bought the more expensive ones think they were getting something special while the people who bought the cheaper ones think they were getting a bargain.

Yeah, the trick of differential pricing to sell otherwise similar things was mentioned in a children’s book back in the 1960s.

It is amazing how many people advocate healthcare “choice” of women when it comes to abortion but want swat teams to raid vitamin stores. It is rather silly that we have so many anti vitamin people in the world.

…Wut?

Here’s a few hints:

1. We’re not anti-vitamin. That’s your silly, possibly corporate, indoctrination talking. We’re against people telling lies about vitamins to make a profit while providing no benefit. I’m generally against the idea of selling something when the customer won’t benefit from it. Oh, and you don’t send SWAT teams after false advertisers. I’d be worried you’re projecting your own authoritarian enforcement preferences onto us. Personally, I want fewer SWAT teams in America.

2. Vitamins supplements can be helpful for people with deficiencies in their diets or various physiological quirks that necessitate supplementation. Megadoses have some risk of harm, and that’s why I don’t think they should be marketed for the general public with vague buzz phrases, but instead focused specifically for people who have a real medical need. I wouldn’t go as far as requiring prescriptions, but warnings against overdosing and notes on who needs it on the container would probably be appropriate.

3. A lot of vitamin supplements are manufactured by companies owned by “big pharma.” They’re cheap to produce and last I heard, there’s virtually no incentive for quality oversight thanks to DSHEA and similar corporate deregulation measures. That means they can cut a lot of corners and end up very profitable while the customers take on the risks of such cuts. The altie community is probably one of the best things that ever happened to “big pharma” for this reason, and I’m against anything that’d encourage further corruption and opportunism.

4. We aren’t in favor of restricting choice, we’re in favor of informed choice. People should be able to make informed choices based on good, scientific evidence, not market-driven disinformation. Informed choice is inherently more free than misinformed choice. That’s why the altie community is so vehemently pro-censorship and when they can’t use a ban hammer on dissenters, they resort to SLAPPs and other forms of legal thuggery when some skeptic deigns to criticize them with evidence. They don’t want people to think about their choices, they want them to just trust the tribe’s propaganda. We, on the other hand, are blog people. We counter lies by using our freedom of speech. It’s about the only weapon I have right now.

But, of course, you’re not interested in our real opinions. You just want to closedmindedly rehearse your prejudices, so if you come back, you’ll undoubtedly end up lying to my virtual face about what I believe because you’re obedient to your tribe.

Oh, and you don’t send SWAT teams after false advertisers.

You mean you’re not hip to the FDA’s Gestapo tactics? (One gets the same trip from the raw-milk crowd.)

@ Bryan Feir:

Sure, there is material along these lines in attribution research- that people place value on what they choose themselves, work for or pay more for. I can’t seem to find the specific reference about expensive woo ( not the one which Eric notes).

-btw- do you pronounce your name *fire*, *fear* or *fair*?

Off topic, but in John Stone’s latest Jimmy Saville/Deer/Murdoch/etc. conspiracy rant at AoA, one finds that Tomljenovic thinks that the herd effect “does not rest on solid scientific evidence,” which I suppose isn’t particularly surprising, but I hadn’t seen it before.

I have no problem with raw milk myself. Poor farmers have to fear machine gun toting swat teams raiding their farms for selling real (raw) milk which man has partaken of for thousands of years.

I suppose the DHS thinks that dairy farmers must be a larger threat than Islamic militant who wish death on America. Seems like we have more machine gun weilding masked agents raiding vitamin stores and dairy farms than Islamic terrorist organizations these days.

Then again I can understand just how dangerous vitamin store clerks and dairy farmers can be. They might attack America with milk pails and Vitamin D samples. They must be stopped at all costs! They have become a more dangerous threat than Al Qaeda. I bet GNC and Ahmish farms oare higher on Obama’s terror watch list than Bin Laden was.

Don;t get me started on the illegal raids on private vegetable gardens either. That is an offense worthy of a firefight. Citizens should hold their ground in such issues.

Here we are $16 trillion in debt fighting Al Qaeda in multiple countries, warding off cocaine peddling coming from Mexico by way of illegal aliens entering on foot and yet the government’s highest military priorities are defending the nation against people who sell vitamins, milk, and vegetables. The 1950s look REAL good right now.

Sorry, I do not understand this logic.

“I have no problem with raw milk myself. Poor farmers have to fear machine gun toting swat teams raiding their farms for selling real (raw) milk which man has partaken of for thousands of years.”

Yeah, well I have a problem with raw (unpasteurized) milk and soft cheeses made with raw milk, Kansas Practitioner…

http://www.cdc.gov/foodsafety/rawmilk/raw-milk-index.html

“I bet GNC and Ahmish farms oare higher on Obama’s terror watch list than Bin Laden was.”

Haven’t you heard Kansas Practitioner, that brave US Navy Seals, invaded Bin Laden’s compound in Pakistan and “eliminated” the POS terrorist, responsible for the deaths of 3,000 people?

” The 1950s look REAL good right now.”

Yeah, bring back the 1950s when kids were dying from polio and before smallpox was eradicated from the face of the earth.

“Sorry, I do not understand this logic.”

Of course you don’t. You’re just plain ignorant, Kansas Practitioner. What time of medicine did you say you *practice*, Kansas Practitioner?

Raw milk is safe and individual sovereign men and women have the right to purchase raw milk from private farms if they so choose. Why all the crud about raw milk? Are we the only nation on earth who bans raw milk? Probably not, which is rather pathetic.

Bin laden was killed in 2005. Navy seals raided a compound and killed one of his sons. If you remember correctly those same brave SEALs also conveniently died in a helicopter crash shortl thereafter. No pictures of Bin Laden’s body and no live survivors to come forward later with the truth. Real convenient.

If you have a problem with raw milk my suggestion as a practitioner is to stay away from it. As a concerned sovereign indivudal I must persuade you to not restrict other sovereign individuals from purchasing raw milk from private sovereign farmers. I suppose we have to have a black market to sell milk now? What a disgrace this nation has become.

Kids and grownups will always die of something. Unless Jesus comes today , eventually we will all die from something. The 1950s was a time when government had alot less regulatory power. Yeah, I know you will throw in the same old tired worn out argument about blacks and women and the draft and other such things, but economically, morally, and ethically we were a better nation back then.

@ Narad:

Oh, I’ve seen it: herd immunity is a “myth”. Of course, that’s common knowledge @ PRN and I’ve also encountered that courtesy of Janine Roberts.

Isn’t Kansas Practicioner a sock puppet? He does seem very like Medicien Man and his various alter egos.

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