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Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means.
~ Henry K. Beecher

tact

A couple of weeks ago, Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM), posted a short essay on the NCCAM Research Blog touting the results of the Trial to Assess Chelation Therapy (TACT) (italics added):

The authors found that those receiving the active treatment clearly fared better than those receiving placebo. The accompanying editorial in the AHJ reminds readers about the value of equipoise and the need to “test our beliefs against evidence.”

Most physicians did not expect benefit from chelation treatment for cardiovascular disease. I readily admit, initially, I also did not expect we would find evidence that these treatments reduce heart attack, strokes, or death. So, the evidence of benefit coming from analyses of the TACT trial has been a surprise to many of us. The subgroup analyses are suggesting sizable benefit for diabetic patients—and also, importantly, no benefit for the non-diabetic patient. Clearly subgroup analyses, even if prespecified, do not give us the final answer. But it is also clear that more research is needed to test these important findings.

And TACT findings are indeed a reminder of the importance of retaining equipoise [sic], seeking further research aimed at replicating the findings, and neither accepting nor rejecting findings based on personal biases. The scientific process is designed to weed out our preconceived notions and replace them with evidence.

Dr. Briggs concluded:

So, TACT is a reminder—an open mind is at the center of the scientific method.

Dr. Briggs’s title was “Bayes’ Rule and Being Ready To Change Our Minds”, a reference to a recent editorial that had accompanied one of the TACT papers. That editorial, by Dr. Sanjay Kaul, a physician and statistician from UCLA, begins with this quotation:

Preconceived notions are the locks on the door to wisdom.
~ Merry Browne

Here is the relevant passage from Dr. Kaul’s editorial (italics added):

Sixth, it has been argued that the trial was unethical because there was no compelling clinical or preclinical evidence that chelation therapy has significant efficacy against atherosclerotic cardiovascular disease, and given that chelation therapy can cause harm, the risk was not minimal. A Bayesian analysis would not look kindly on the results because of the low prior probability of treatment effect (the so-called implausibility argument).6 This is an uncharitable (and unwarranted) interpretation of the data because previous systematic reviews concluded, “insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes among people with atherosclerotic cardiovascular disease.” It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.

From a Bayesian perspective, the strength of evidence is often summarized using a Bayes factor, which is a measure of how well 2 competing hypotheses (the null and the alternate) predict the data. The Bayes factor and the corresponding strength of evidence for the primary end point result in TACT overall, and diabetic cohorts are shown in Table 1. The p-value of 0.035 for TACT overall cohort translates into a Bayes factor of 0.108, which means the evidence supports the null hypothesis ≈1/9th as strongly as it does the alternative. This reduces the null probability from 50% pretrial (justified by suspension of one’s belief in treatment effect) to 10% post-trial. Although this does not represent strong evidence against the null, it does reduce the level of skepticism surrounding chelation therapy. In the diabetic cohort, the nominal p-value of 0.0002 translates into a Bayes factor of 0.002 (1/500), which reduces the extremely skeptical prior null probability of 95% to 4% post- trial, indicating very strong evidence against the null.

In concluding, Dr. Kaul states:

Finally, TACT highlights the double standard when it comes to accepting inconvenient results not aligned with our preconceived notions on so-called dubious quack cures such as chelation…

Closed minds?

Dr. Kaul’s reference “6” above is to a lengthy article that we published in 2008 titled “Why the NIH Trial to Assess Chelation Therapy Should Be Abandoned”. So, it seems, both Drs. Briggs and Kaul were chastising us for our biased, preconceived beliefs about so-called dubious quack cures. Our minds were, apparently, not open. Let’s examine this contention.

Here is the relevant passage from our 2008 article (references in the original, italics added now):

The Likely Outcome
Even if the TACT is completed, which it should not be, it is unlikely to reduce the promotion of reckless uses of Na2EDTA. Whatever the outcome, chelationists have already positioned themselves to continue the practice: By virtue of ridding the body of toxic heavy metals, they claim, chelation is useful for more than 70 conditions. Without exception, chelationists have refused to accept previous results that contradict their beliefs. Their response to the TACT, should it yield definitive, negative results, is unlikely to be different.

The trial, moreover, is unlikely to yield “an informative negative result” even though chelation is almost certainly ineffective for CAD (coronary artery disease). It is more likely to yield ambiguous results. There are multiple endpoints, including subjective quality-of-life measures, and several subgroup analyses. The variety of trial settings increases the likelihood of heterogeneity of procedures and reporting. Promotions of chelation by TACT co-investigators have already introduced unacceptable bias into the trial. There is ample, additional opportunity for mischief, and ample reason to think that several co-investigators are inclined to make it. The statistical analyses will not be Bayesian.

Thus, merely on the basis of chance and bias, it is likely that some outcome data in some subgroups will differ sufficiently, between those receiving Na2EDTA and those receiving placebo, to reassure chelationists that chelation “works” and to sustain “lingering questions of efficacy” in the minds of apologists. Dr. Lamas himself has made much of 2 or 3 “tantalizing positive secondary outcomes” of a previous trial in which only 15 subjects received Na2EDTA, and in which the remaining 30 secondary outcomes and all 7 primary outcomes were unequivocally negative. The all-but-inevitable “tantalizing positive secondary outcomes” of the TACT would likely lead to years of additional, unnecessary trials or, at the very least, unremitting peddling of chelation by practitioners armed with fresh fodder in their perpetual battle against rational standards of care.

Preconceived? Or perhaps just prescient? Dr. Kaul correctly cites our paper as having “argued that the [TACT] was unethical (etc.).” He then opines that our argument was “uncharitable and unwarranted,” because systematic reviews (published after the TACT grant had been approved!) concluded that there was insufficient evidence either for or against chelation for atherosclerotic cardiovascular disease.

Clinical equipoise?

He misses the point, and also missed the pre-existing evidence of the absence of efficacy. The point was made by the TACT investigators themselves, in their pitch for the grant. While acknowledging that every RCT of Na2EDTA for atherosclerotic disease had failed to show an effect, they argued:

The very large number of published case reports and case series support a hypothesis that EDTA chelation therapy provides clinical benefits in atherosclerotic vascular disease.

A very small number of trials of very small sample size have randomized 275 patients in aggregate, a number far too small to reliably detect or exclude the most plausible benefits.

Thus the case for clinical equipoise was not based on previous trials having been too small to exclude a small effect, but on “thousands” of confirming case reports and case series contradicting the disconfirming data from those clinical trials.

Even this, however, was wrong. In our paper we reviewed the purportedly confirming case reports and case series (ours is the only such review that we are aware of), and showed that they were neither credible nor accurately represented by the TACT protocol (the most charitable interpretation is that its authors had never read those case reports). That left only the RCT data and a couple of credible but disconfirming case series, which, even if inadequate to exclude a small effect, were more than adequate to exclude the huge effect claimed by chelationists, including those involved with the TACT—which, after all, was the only reason the trial was being done. They were also more than adequate to exclude, in the absence of favorable phase I and II trials, a $30 million, phase III trial, particularly according to the NCCAM’s own language. These and other considerations also argued strongly against a state of clinical equipoise, as we discussed at some length.

Both Drs. Briggs and Kaul seem innocent of the meaning of clinical equipoise. Dr. Briggs, in particular, appears to believe that “retaining equipoise” is akin to “maintaining an open mind” or “withholding judgment” and, furthermore, that there is value or virtue in doing so. Such are not the case. The long-accepted understanding is as follows:

According to this concept of “clinical equipoise,” the requirement is satisfied if there is genuine uncertainty within the expert medical community—not necessarily on the part of the individual investigator—about the preferred treatment.

Thus one cannot simply choose to “retain equipoise” or “suspend one’s (dis)belief in the treatment effect” in order to be less “uncharitable” than the alternative. Clinical equipoise—necessary to render a clinical trial of an unproven treatment ethical—either does or doesn’t exist for a particular treatment, even if the expert medical community is not unanimous in its opinion, and even if it isn’t always possible to know what that opinion is. In the case of EDTA chelation for CAD, the expert medical community was overwhelmingly skeptical, as we documented (that a small effect of EDTA had not been utterly disproved—what Dr. Kaul calls “the uncertainty associated with the possible benefit of chelation therapy”—is beside the point).

Henry Beecher understood, even if Drs. Briggs and Kaul do not, that this fact cannot be changed retroactively.

Bayes and human studies ethics

Regarding Bayes, our implication that the prior probability of a favorable treatment effect for Na2EDTA ought to be very low was based on a warranted interpretation of the existing data, which were entirely disconfirming, and on theoretical considerations discussed in our paper. It was also based on a lack of trust in the judgments of the only practitioners who believed that chelation works: those practitioners also peddle homeopathy, laetrile, Nambudripad’s Allergy Elimination Technique, and myriad other pseudoscientific nonsense, and have a rich history of corrupt, even criminal, behavior (many of them were also TACT investigators).

All of this is meticulously documented and referenced in our paper. We suggest that of all those who have published papers in the medical literature about the TACT, we are the only ones sufficiently open-minded and unbiased to have comprehensively reviewed the prior evidence and the history of the trial—and that includes the TACT investigators themselves.

We don’t see how Dr. Kaul can justify a “suspension of one’s belief in treatment effect” and thus arrive at a prior probability of 0.5 (or even 0.05). Systematic reviews notwithstanding, there were substantial prior trial data, even discounting our other reasons for judging the treatment implausible. If pushed to do so, we would have chosen a prior considerably less than 0.01. Na2EDTA still has a very low probability of being therapeutic for CAD, even if our opinion is now slightly less skeptical (for diabetics only), as Bayes Theorem dictates.

Laetrile and internal mammary artery ligation

Regarding NIH policy and human studies ethics, the existing evidence against chelation for atherosclerotic disease, as we explained in our paper, was considerably stronger than the evidence against many once-popular claims—we cited laetrile for cancer and internal mammary artery ligation for coronary disease—that no responsible scientist or ethicist would now consider subjecting to human trials. Drs. Kaul and Briggs might consider that if their post hoc reasoning about the TACT were to become the norm at the NIH, numerous dubious claims would be fair game for large human trials, each awaiting only the political arm-twisting that was the real impetus for a chelation trial. Then again, that’s why Congress created the NCCAM. Silly me.

Ironically, the TACT also violated the NCCAM’s own, stated intention to “to elucidate mechanisms of action and conduct small, well-developed phase I and II trials” prior to phase III trials. In 2002, prior to the enrollment of TACT subjects, that plan included “studies of the biology of EDTA chelation therapy in animal models,” which, although dubious, would have been more in accordance not only with sound science and public policy but with accepted ethical preconditions for a large human trial. Those studies, apparently, never happened.

The small effect that the TACT authors have now reported, limited to diabetics, may or may not be real, as Drs. Kaul and Briggs (sort of) acknowledge. Here’s hoping that the NIH doesn’t waste more public money pursuing it, unless some legitimate scientific clue suggests doing so, perhaps stemming from the sort of work described in the previous paragraph.

TACT: the real winners

Dr. Kaul is reassured because he thinks, based on formal reports, that “the presumption that the TACT trial [sic] provides actionable evidence for clinical practice is not endorsed even by the TACT investigators…” Alas, he and most academics have little idea whom they’re dealing with. Here is TACT investigator L. Terry Chappell on his own website (italics added):

The Trial to Assess Chelation Therapy (TACT) showed statistically significant benefits for patients with heart disease…This is the first major randomized clinical trial on chelation for vascular disease, and it is a positive study

I cannot wait to share with our patients and friends what TACT and previous studies mean to current medical science and to those who could benefit from them…

Our experience is that chelation can reduce your chances for blindness, kidney failure, amputation and other vascular complications of diabetes. I believe that ALL diabetics should take chelation, starting about age 30…

I believe that chelation is the most powerful prevention intervention that we have. Everyone should take it to improve his or her chances for living a disease-free life. Scientific evidence is accumulating to back me up…

You do not have to be a doctor, nurse or paramedic to save lives. Just share the vital information contained in this message with others. Bring them to our clinic. Or ask them to set up a free phone consultation with me (Dr. Chappell) to discuss whether we can be of help. See to it that they know what they should know so that they can save their lives too!

Chelation is not just a treatment that is slowly emerging into the spotlight. It is a movement against the forces that are resisting change, especially from powerful economic interests…

TACT is the breakthrough study we needed. More studies will follow, but that will take years…but we want to help people now. Join the movement. Spread the word.

Isn’t it clear what has happened here? It was Dr. Chappell who—as President of the American College for Advancement in Medicine (ACAM), a group of several hundred chelationists—made the original pitch to congressman Dan Burton, who subsequently bullied NHLBI Director Claude Lenfant into accepting a chelation trial. Chappell was also a member, contrary to the NIH conflict of interest policy, of the scientific review committee that approved Dr. Lamas’s application—the same application that had named the ACAM the “the world’s largest and most respected organization of physicians who employ chelation therapy” and Dr. Chappell a “prominent expert.”

Chelationists seem to have got exactly what they’d hoped for from the TACT: a free pass to peddle their favorite, lucrative ‘remedy’—which they tout not only for CAD but for COPD, dementia, schizophrenia, skin wrinkles, and 70 other disparate indications—without being inconvenienced by pesky regulators. If a double standard is highlighted here, it’s a double standard of care, unwittingly encouraged by naive medical academics and a cowardly NIH.

There are numerous additional reasons that the TACT was unethical, including an almost universal lack of informed consent and incompetent medical care given by practitioner/investigators. These will be further explained in future postings.

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

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54 thoughts on “Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

  1. fastbuckartist says:

    NCCAM should drop the “CAM” from their name and be simply known as National Medical Research (NMR). Its a more respectable name for their organisation.

    1. Stephen H says:

      National Medical Research normally involves medicine, not ignoring reality and promoting “ideas” that are 50% wishful thinking and 50% trying to make a fast buck.

      1. tgobbi says:

        Yes, including the word “medical” does infer adherence to accepted/acceptable medical standards. It kinda reminds me of the chiropractic office around the corner that has a sign reading “medical center.”

    2. Windriven says:

      ” Its a more respectable name for their organisation.”

      What an absolutely Orwellian idea. Why am I not surprised?

      WAR IS PEACE
      FREEDOM IS SLAVERY
      IGNORANCE IS STRENGTH

      Take an expensive federal program focused entirely on mutual masturbation and give it a name that obscures its mission.

      “In a time of universal deceit – telling the truth is a revolutionary act.”

      Welcome to SBM. Welcome to the revolution.

      1. dh says:

        Or “arbeit macht frei” (work makes you free), appearing above the gates of the Auschwitz death camp…

        1. Windriven says:

          Indeed. In my reading the translation is closer to ‘work will free you’ or ‘work will make you free.’ Cold no matter the details of translation.

          1. dh says:

            I don’t know German in the original, but I always thought (at least according to my tenth grade german class) that macht was the present tense of “make”, hence “work makes you free” – arbeit macht frei. But I have not google translated it.

      2. WilliamLawrenceUtridge says:

        Windriven, you’re missing an obvious one:

        CAM IS MEDICINE

    3. nyudds says:

      Dr. Briggs is actually seeking a name change from NCCAM to:
      THE NATIONAL CENTER FOR RESEARCH ON COMPLEMENTARY AND INTEGRATIVE HEALTH. She would like your comments!
      http://nccam.nih.gov/about/offices/od/comments

      1. MTDoc says:

        No she wouldn’t.

        1. Windriven says:

          :-)

      2. Stephen H says:

        She already has my comments.

        I’m not sure she likes the NATSCAM suggestion, or telling her that they should front the Senate and ask it to close the agency because science works, but they were what she sought in asking for “feedback from stakeholders and other interested parties…”.

  2. Stephen H says:

    Interesting article. One of the things proponents of chelation and other quackery seem to forget fairly early on is that while an open mind is admirable, an empty mind is not. Ignoring reality merely indicates absence of the ability to cogitate, and a willingness to ignore our evolution-driven biases including the inability to cope with statistics and probability, as well as our habit of seeing patterns in everything.

    I didn’t click all the links, but for some reason chose to click on the Chappell website. After blurting all the garbage you quote, at the bottom of the page and away from the main text is the disclaimer: “The information on this website is only the opinion of COHA. It is not meant to be medical advice. Before you do anything, you should seek the advice of your personal physician. This is information only. No treatment is proposed, no cure is implied, and no claim is made for the effectiveness of any treatment or test”. Seriously? Did the guy think about that while preparing his bullshit above it? When identifying himself as an MD on the same page as he discusses all sorts of non-medical quackery?

    Finally, a quick question: how does one apply for a grant from the NCCAM? I want to investigate the effects of the Sydney Harbour Bridge on those who drive across it twice daily – apparently the coathanger shape, and the confluence of magnetic fields in the area (as well as the influence of the winds directed off the face of the Sydney Opera House) have beneficial effects on motorists with Chronic Lyme Disease. I would like to study the relationship between these benefits and phases of the moon, as well as patients’ vaccination histories.

    1. WilliamLawrenceUtridge says:

      I would want to conduct a similar study, but examining the effects of proximity to the Pantheon and it’s impact on N-rays, influencing mood in middle-class caucasians relocated to a European capital. I predict significant results.

  3. daedalus2u says:

    The IV drug that was used was more complicated than “just chelation”. It contained vitamin C, and thiamine and a bunch of other things. The placebo was saline plus dextrose.

    http://www.ncbi.nlm.nih.gov/pubmed/23532246

    suggests that some of the non-chelation components may have been responsible and suggests that vitamin C may have had some effects.

    The IV drug contained thiamine but it wasn’t specified if it was thiamine hydrochloride or thiamine mononitrate. IV vitamin C plus nitrate could well release nitrite and NO and cause effects independent of any chelation.

    1. rork says:

      Anyone: Why the procaine and heparin – I’m not a doc, or even a quack. I know what those things are, but not why they were included. I believe the paper is silent about why.
      “The active, 10-component chelation solution was selected to most closely match the standard solution used by chelation practitioners(ref 16) and consisted of up to 3 g of disodium EDTA, adjusted downward based on estimated glomerular filtration rate; 7 g of ascorbic acid; 2 g of magnesium chloride; 100 mg of procaine hydrochloride; 2500 U of unfractionated heparin; 2 mEq of potassium chloride; 840 mg of sodium bicarbonate; 250 mg of pantothenic acid; 100 mg of thiamine; 100 mg of pyridoxine; and sterile water to make up 500 mL of solution” from the TACT paper, slightly altered to show the reference clearly. Reminded me a bit of astrology.

      I thought Nissen’s comments about conduct of the trial interesting:
      http://jama.jamanetwork.com/article.aspx?articleid=1672219
      He’s pretty good for not being a statistician.

      1. WilliamLawrenceUtridge says:

        I think procaine is because otherwise it burns going in, but I could be wrong. Heparin presumably because it increases coagulability of the blood.

        1. Windriven says:

          “Heparin presumably because it increases coagulability of the blood.”

          Reduces, actually. Heparin is used to prevent coagulation.

        2. Andrey Pavlov says:

          I think procaine is because otherwise it burns going in, but I could be wrong. Heparin presumably because it increases coagulability of the blood.

          The procaine likely precisely for that reason. The problem is that it is also a cardioactive drug .

          The heparin… nobody knows. It is an anti-coagulant, not pro. I am pretty sure Dr. Gorski talked about it sometime in the past and everyone here was scratching their heads about the use of heparin. Of course, that itself could have also potentially had an effect on cardiac outcomes, but it is arguably a small enough dose that it probably didn’t. But still weird.

          1. CHotel says:

            For non-practitioners looking for a frame of reference, heparin as thromboprophylaxis in surgical patients is normally dosed at 5,000 units given subcutaneously 2 or 3 times a day. So a quarter to a sixth of the daily dose, given weekly. Very unlikely to have a significant effect on outcomes from a therapeutic standpoint.

        3. WilliamLawrenceUtridge says:

          The “it” in my statement was referring to the infusion, not the heparin. As in “Heparin presumably because the chelation infusion increases coagulability of the blood”.

  4. DClarke says:

    Who get’s to decide what treatments are sufficiently plausible to be ethical?

    There was some recent controversy about the use of state funding for a trial of Phil Parker’s ‘Lightning Process’ on children with CFS. Many patient groups were concerned that this was unethical, but their concerns ended up being presented as unreasonable opposition to researchers, while FOI requests about the trial have been presented as ‘harassment’. The trial itself is necessarily non-blinded, and has recently changed it’s primary outcome from school attendance to self-report questionnaires known to be prone to response bias.

    1. MadisonMD says:

      An institutional review board (IRB) decides the ethics of equipoise, based on HHS regulations. At a multi-center trial like TACT, this would generally need to be independently approved at each site. Sometimes, central institutional review boards are used for multi-center trials (despite the paradox inherent in the name since each site is an institution). I have no idea how small CAM detox practices would assemble an IRB, but I would anticipate less rigorous review than at major academic centers that are routinely audited by HHS.

  5. Welcome back, Kimball! It’s good to read some Kimball Atwood content again. Since I suspect this is a one time deal, and we won’t be returning to regular Kimball posts again, I considered not reading this post right away, and saving it for later like a fine wine, but I couldn’t resist popping the cork now.

    “Thus, merely on the basis of chance and bias, it is likely that some outcome data in some subgroups will differ sufficiently, between those receiving Na2EDTA and those receiving placebo, to reassure chelationists that chelation “works” and to sustain “lingering questions of efficacy” in the minds of apologists. ”

    I nominate Kimball Atwood for this year’s Million Dollar Challenge for his psychic predictions regarding TACT.

    1. WilliamLawrenceUtridge says:

      He wouldn’t win, CAM proponents moving the goalposts and refusing to drop ineffective treatments is as inevitable as the sun rising.

  6. nyudds says:

    We may all get an early Christmas present this year: Rep. Dan Burton of Indiana has announced that he is retiring and will not seek reelection. Sen. Tom Harkin of Iowa has announced he will also not seek reelection this year. That means Dr. Briggs has lost two major proponents of NCCAM. Will a new “champion” emerge? My lump of coal candidate is Bernie Sanders, I-Vermont, who chairs the Senate Committee on Veterans’ Affairs and whose sweeping legislative effort might , given the recent controversy at the VA, make it into law:
    http://www.sanders.senate.gov/download/s-1950?inline=file

    Sections 306, 331,332,333 and 334 seek to insert alternative medicine into a system caring for over 8 million veterans /year at 1700 sites. Not a bad breeding ground for all things alternative, complementary or integrative It must obviously include hiring staff “experienced” in these various methods and materials….pick your poison. In addition, he is active outside his committee, while he tests the waters of the Potomac. Is there a “natural” remedy for Potomac fever?

    “Legislative Update – Dr. Briggs briefed Senator Tom Udall (D-NM) on NCCAM activities and was the keynote speaker at a town hall-style Complementary and Alternative Health Care Conference sponsored by Senator Bernie Sanders (I-VT).”

    1. Ed Whitney says:

      Hey nyudds, don’t forget to look on the gloomy side of life! Sen. Harkin is likely to be replaced by a hog castrating, gun toting, Obamacare hating state senator who runs ads in which she points a gun directly at the viewer and promises to take aim at Obamacare (which would entail taking thousands of Iowans off their health insurance plans). Joni Ernst is doing very well in the polls, but how likely is she to come out and say that Iowans should be allowed access to only science-based medicine when she repeals and replaces the ACA? She may take away their basic health coverage, but she will by golly let them keep their guns. And their woo if they want to keep that, too.

      1. nyudds says:

        Ed, “likely” may be too pointed a word for this race. The present front-runner in Iowa is Bruce Braley, a Democrat, who has Harkin’s blessing and a 5+ point lead over Ernst in multiple polls. But much can happen between now and then; Jodi Ernst is running a strong race and is first in the GOP polls. The Americans For Prosperity (Koch Bros.) have targeted this race as a seat Republicans can capture. Fortunately, Braley has more money in the bank than all other candidates combined and he has no problem in the Iowa caucuses. I prefer to look at Jodi Ernst the same way I look at Michelle Bachmann, Sarah Palin and Sharron Angle…not my cup of Tea. The possibility that you could be correct would not surprise me, but it would scare me. The prevailing opinion in GOP circles is that repeal of the ACA will not happen until 2017, if at all. By then, almost 40 million people will be enrolled. IMO, by that time it will be like Medicare; just try to take it away! But hope springs eternal and one game plan is to amend the ACA to death. Another is to convince people to opt out, especially young people. In any event, the ACA is law and it will be tough for a lightweight like Jodi Ernst to scuttle, IMHO. A GOP senate makes it a new ballgame however; the votes are not weighed, they’re simply counted. We live in interesting times.

        1. Ed Whitney says:

          “The present front-runner in Iowa is Bruce Braley, a Democrat, who has Harkin’s blessing and a 5+ point lead over Ernst in multiple polls.”

          I feel a bit better now! Last thing we need is more politicians who think that the entire Constitution is contained in the Second Amendment, and who think that “bear arms” means “pack heat,” and that states have something called “rights.” May you be correct!

    2. Jann Bellamy says:

      Don’t forget Sen. Barbara Milkulski, (D-Maryland) author of the Senate’s “Naturopathic Medicine Week” resolution and a big fan of “integrative” medicine. http://www.sciencebasedmedicine.org/naturopathic-medicine-week-2013

  7. Ed Whitney says:

    Was Chappell a TACT investigator? He was not listed as a co-author for the published studies, nor was he listed as an investigator at the clinicaltrials.gov protocol. Sounds more like he was just an opportunist than a TACT investigator.

    1. Yes, Chappell was a TACT investigator. You’ll find “Celebration of Health Center” in Blufton, OH, on clinical trials.gov. That’s Chappell.

      1. Ed Whitney says:

        Aha! The trouble with clinicaltrials.gov is that you do not see the names of the investigators. There are some reputable centers which participated in TACT but you cannot tell who the participating physicians were. Do you know how to access that information? My curiosity is piqued by the participation of a center not far from me.

        1. Look here for our table of sites and corresponding investigators: http://www.circare.org/tact/tact_studysites.htm
          It also explains how we determined the investigators.

          1. Ed Whitney says:

            Interesting! The cardiology group I was wondering about is not a community chelation practice, and I wonder if it even enrolled any patients into the study. There seem to be a bunch of pain management practices without cardiologists and these places offer familiar stuff like prolotherapy and probably “spinal decompression” with VAX-D and such interventions.

            Thanks for the link. This helps greatly in giving me a sense of how the study was conducted. I would expect that considerations of patient confidentiality would prevent each site from listing how many patients it enrolled, since it is a good bet that n is three or less for many of them. But the numbers from each site who were enrolled and completed the study would still be of great interest. If the lion’s share came from chelation practices with no cardiologists on staff, that would be useful to know.

  8. Calli Arcale says:

    “It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.”

    And so they neatly ignore that it’s also a damn poor argument for wasting time studying it. They’re basically admitting that chelation had just as much prior plausibility as watching MST3K videos as a treatment for shingles. So why the hell waste time, money, and people’s lives (yeah, you’re asking a lot of your test subjects without any real reason, as you’ve literally just admitted, dear TACT investigators) on this stuff?

    Must we have huge human trials studying whether or not eating jellybeans will end global warming? Do we need to send a probe to the Sun to test whether or not the ether is actually real and made of marshmallow? Of course not. You don’t waste time and effort on stuff that’s ludicrous. This is slightly less ludicrous, since at least they’re looking for an effect on the human body by doing something to the human body. But they had zero evidence it could actually be helpful, and piles of evidence that it’s dangerous. There are chelation deaths, after all. You’d think for all the fuss made over Vioxx that testing something with a known risk of death would require a teensy bit more evidence it might be helpful before trying it.

    They’re arguing that you must do every trial as if you know absolutely nothing. Every trial must reinvent the wheel — and badly, judging by their work — or it’s not truly unbiased. Which is, of course, insane, not to mention immensely disingenuous, since only a massive prior bias could’ve led them to even contemplate doing this study at all, much less on such a large scale, and without any prior work in animals.

  9. “and have a rich history of corrupt, even criminal, behavior ”
    This is a function of human behavior not just in alternatives but in all aspects of medicine and science.

    Gee even this “holier than thou” site can be seen as corruptive to health and wellness!!!

    How does no factor out corrupting criminal behavior?? Tough question.

    I wish yall would weed out the good from the bad in both traditional medicine and CAM … that would be very beneficial and allow a more focused discussions then personal belief debates.

    1. WilliamLawrenceUtridge says:

      Gee even this “holier than thou” site can be seen as corruptive to health and wellness!!!

      What makes you say this? Because we don’t simply take you at your word that all the evidence finding acupuncture doesn’t work is all wrong? Not the bloggers’ fault that you can’t muster any evidence to support your beliefs. One might even suggest that it’s your fault for failing to even be aware of the scientific evidence for and against your preferred quackery.

      How does no factor out corrupting criminal behavior?? Tough question.

      Evidence, in particular, assessment of the totality of evidence, the body of supporting research, for a treatment, accounting for quality. For instance – there is no preclinical evidence for TACT. The evidence that does exist is shoddy, and the evidence found in this trial suggests it is useless. If normal treatment protocols had been followed, if politics hadn’t stepped in, TACT would never have wasted $30M. If CAM practitioners were ethical, they would acknowledge that TACT is a waste of money, and dangerous, and abandon it.

      But sadly CAM practitioners, yourself included, are immune to evidence.

      I wish yall would weed out the good from the bad in both traditional medicine and CAM … that would be very beneficial and allow a more focused discussions then personal belief debates.,?blockquote>The larger problem for CAM is the lack of evidence to support the treatments, and moreso – the lack of any method by which most could work.

      1. No one has any pertinent questions for a CAM provider?

        1. WilliamLawrenceUtridge says:

          Why do you keep promoting acupuncture despite a lack of scientific research supporting its efficacy?

          Why do you think scientific research consistently fails to find evidence for acupuncture?

          Why do you ignore the scientific research on acupuncture?

          Why did you put up two massive lists of references that totally failed to support your assertion that acupuncture is effective?

          How do you reconcile your ethical obligation to provide safe, effective health care, with charging your patients for placebos?

          Why do you keep claiming people who disagree with you are “dogmatic” when they are just asking for scientific evidence to support your beliefs?

    2. Stephen H says:

      Stephen, you are absolutely right that corrupt and criminal behaviour can be found everywhere. I suggest to you, though, that if your career is based upon “alternative” medicine then you are well primed for further corrupt and criminal behaviour, being already comfortable in lying to yourself.

      So we get the Andrew Wakefields of the world, lying about research to promote his own product. The people who believe in “laying on hands”, and will do it by phone from 500 miles away as long as you have the money. Preachers who get caught with one hand in the till and the other down the employee’s pants. “Faith” healing psychics who plant stooges in their audiences or instead use the old tried-and-true “brief interview at the door” to find their latest victim.

      And of course the people in all of these groups, and throughout the length and breadth of Supplementary, Complementary and Alternative Medicine (thank you Dr Crislip), who say that their work is “quantum” and therefore not “believing” is the reason it doesn’t work when properly studied.

      In other words, if you bullshit for a living (whether to yourself or others) you are going to find it easier to engage in corrupt and criminal behaviour than someone who does something that has a sound basis in reality.

      1. MTDoc says:

        I knew If I waited long enough, someone would put my thoughts into words much more eloquently than I. SSR ‘s comments are always difficult for me to respond to. But then, I have never achieved the body count in my years of practice that SSR claims using conventional, if imperfect, medicine.

  10. qetzal says:

    Hey! I love MST3K, and I’ve never gotten shingles! Surely that should be enough evidence to secure a $30 million grant for a Phase III trial!

    1. Calli Arcale says:

      You’re right — neither have I! We must get an NCCAM grant to get the RiffTrax guys to shift back into full-on MST3K mode. And buy them big-budget pics to mock while we’re at it. :-D

    2. Angora Rabbit says:

      I watch MST3K and never got shingles either. N=3 means we can run stats! Let’s write the proposal. Oh, wait. Why bother? Let’s just start a website and sell the tapes.

      And while we’re at it, we could get MST3K to review NCCAM proposals. I can just hear Crow at the head of the study section table. Oh, the possibilities.

      “Innovation? Give it a 7. I mean, everyone’s heard about this DNA already. And besides, I don’t have any ’cause I’m a robot.”

      1. Sawyer says:

        MST3K has one of my all time favorite science quotes. Can’t remember exactly what it was in reference to, but it’s somewhere in the Human Duplicator episode:

        Movie character: “There’s a thin line between science fiction and science fact.”
        Crow T. Robot: “…. and science CRAP.”

        Sounds like Crow would be a better judge of NCCAM proposals than the current staff.

        1. Calli Arcale says:

          I used to write MST3K fanfics. There was a whole community of people doing it; probably still is, actually. You take a piece of garbage text and then write a little story where the MST3K cast makes fun of it. It’s like a fisking, but with more comedy. Scientific papers, even junk ones, would be difficult source material as they tend to be very dry, but there’s endless material from the promoters of this stuff.

  11. Mary Richard says:

    Who could shove more BS down the throats of trusting physicians and their patients than the pharmaceutical industry? How many times have they pushed certain medications, have them patented and published studies that say whatever they want them to say? AT this time I can make a list a mile long. But, consider just the statin industry. Everyone has come to believe that cholesterol is something to be fear, demonized and lowered so that Big Pharma can line their fat pockets by pushing statins and other cholesterol lowering drugs which have caused harm to many. Isn’t that why they took Baycol off the market…because of too many cases of the fatal rhabdo? We are still seeing the harsh realities of those who take statins and suffer horrendous side effects. Yet, they are backed up by numerous studies that simply don’t support the real life evidence. Many many more people have been hurt and those injuries are permanent. These peer reviewed studies don’t mean anything when it comes to those who feed at the trough of greed. Statins are the biggest money makers since the birth of modern medicine. Yet, so many people report significant side effects that have been dismissed by doctors since the 90′s of our last century. Give me a break!!!

    1. WilliamLawrenceUtridge says:

      I’m sorry, what does this have to do with TACT? You just wanted to rant? OK then. But generally to be taken seriously, you have to make a comment relevant to the topic at hand.

      Yes, Big Pharma is evil. That’s why Ben Goldacre’s Bad Pharma was so well received here.

      1. Sawyer says:

        As annoyed as I am by off-topic rants, I get a kick out the fact Mary is making the “cholesterol is not bad” argument at the same time another comment thread is experiencing the “animal products are killing us” rant.

        While it’s technically possible for both of these arguments to be true, they certainly do not follow the convergence of evidence standards that real scientists and doctors demand. But convergence of evidence doesn’t matter when there’s a convenient bad guy – Big Pharma, Big Gov, Big Ag, Big Boy restaurants….

        1. WilliamLawrenceUtridge says:

          Humans are way better at telling stories and creating villains than they are at untangling the complex interactions of social contact, let alone the microscopic interconnections of molecular biology.

          It’s easy to blame a convenient villain, it’s way, way harder to accept the fact that sometimes shit simply happens.

    2. Sulivanthepoop says:

      Statins are most likely over prescribed, but that does not mean they aren’t beneficial. Many studies have shown that they reduce the risk of serious cardiac events in at risk people. When statins were new it was not known that if the active ingredient is very hydrophobic it is much more likely to invade muscle tissue and if you also have a gene mutation that causes you to process statins differently then muscle destruction is a huge factor. There were I believe 2 statins taken off the market because of their hydrophobicity and 1 because of actual reports of rhabdomyolysis. Also, specific statins are likely going to approved for treating other disorders with cholesterol storage problem aspects and that wasn’t even the pharmaceutical company scientists idea. Pharmaceutical companies are not always ethical, but luckily they operate in a field where it doesn’t long to find problems because everything is reviewed and rereviewed constantly.

    3. Stephen H says:

      Now Mary, don’t you go talking down statins like that. I read this thing recently on the Statins4Eva page, saying about a guy who was like, really suffering from some serious health issues. And this guy was dying, but when they put him on statins he perked up in, like, 2 weeks.

      I signed straight up for the website’s program. I know some people are saying statins are bad but what about the evidence. This guy was – it was incredible. And there was this video, and some letters from other people who had been in major health trouble until they tried statins.

      Mary, you and the big alt health industry, you’re just being greedy. You’re all about money, and keep asking for proof that things work. Why don’t you just believe in something for once? You should read some of those stories – they’re incredible, they’ll have you crying within five minutes. I signed up for the program, gave them my money, and I feel better already.

      I mean, I heard that someone had done a test to show statins can be dangerous – but who would believe that rubbish? It’s just science, right? And who needs science when we have statins? You just can’t believe those scientists, they’re all so greedy!

      1. n brownlee says:

        Five stars.

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