Categories
Cancer Clinical trials Complementary and alternative medicine Homeopathy Medicine Naturopathy Politics Quackery

Can Alternative and Conventional Medicine Get Along? No.

If there’s one thing that I write that I don’t feel I repeat too much (although some might disagree), it’s that, unlike other centers and institutes at the National Institutes of Health (NIH), there is not, and never was, a compelling scientific justification for the National Center for Complementary and Alternative Medicine (NCCAM) to exist as a separate entity. There is nothing that NCCAM does that couldn’t be done just as well in other parts of the NIH, with the exception of research into modalities with such low prior plausibility and such fantastical proposed mechanisms of working that it’s a waste of money to study them. For example, “complementary and alternative medicine” (CAM) long ago co-opted nutrition and exercise, as well as natural products pharmacology (in the form of herbalism and supplements) as somehow being “alternative.” These could easily be studied in one of any number of other institutes or centers at the NIH, depending on the specific disease process being studied. In contrast, modalities like “energy medicine” (e.g., reiki, therapeutic touch, “bioenergy” and “biofield” medicine) rely on the claimed existence of “life energy” fields that no science has ever been able to detect, much less reliably measure.

The fact is that NCCAM was the creation of some prominent woo-friendly legislators, most prominently Senator Tom Harkin (D-IA), who introduced the original legislation to create the Office of Alternative Medicine, which later became NCCAM in 1998, thanks to legislation that he introduced, largely in response to efforts of then NIH Director Harold Varmus to bring NCCAM under more rigorous scientific control. (Elevating the Office of Alternative Medicine to the level of a Center removed it from the direct control of the NIH Director). Since then, NCCAM has grown into a $125 million a year boondoggle studying a range of treatment modalities that range from sheer quackery to science-based modalities that have been co-opted by CAM, often becoming “woo-ified” in the process. Unfortunately, given the structure of NCCAM, no matter how much the Director tries to impose scientific rigor, there is considerable pushback. I keep asking how NCCAM can continue to exist, but it’s a government agency with powerful political patrons, particularly Tom Harkin. No matter how much critics say say we should take off and nuke the entire center from orbit (it’s the only way to be sure), NCCAM endures. Maybe now that Harkin’s retiring there might be a chance in 2015, but I wouldn’t count on it. Senator Orrin Hatch (R-UT) or Senator Barbara Mikulski (D-MD) could easily pick up the slack.

Unfortunately, the current Director of NCCAM, Josephine Briggs, seems to “get it” less and less. As evidence of how Dr. Briggs doesn’t understand how she is serving the cause of infiltrating quackademic medicine into the most hallowed halls of medical academia, the NIH, I present to you a video web chat in which she participated yesterday, Live Chat: Can Alternative and Conventional Medicine Get Along? It featured Dr. Briggs, as well as an associate editor from Science Translational Medicine, Yevgeniya Nusinovich, M.D., Ph.D., who served as moderator, and a practitioner of “integrative medicine” at Kansas University, Dr. Jeanne Drisko, whose titles include Director, KU Integrative Medicine and the Riordan Endowed Professor of Orthomolecular Medicine. Of course, as I’ve discussed many times before, orthomolecular medicine, which basically posits that if some vitamins are good, more will be better, is pure quackery. In fact, I’ve discussed the infiltration of quackademic medicine at the University of Kansas before in general and Dr. Drisko in particular, less than a year ago, where I mentioned that KUMC offers its patients high dose vitamin C quackery for cancer.

Unfortunately, I couldn’t watch it live yesterday because I was in clinic when it was going on, but the video has been saved so that it was possible for me to take a look at it last night:

My first thought was: WTF? This was as one-sided a presentation as I’ve ever seen. Never was heard a skeptical word, as I had expected when I learned who the participants were going to be. We had the director of the single largest government agency promoting quackademic medicine (with the possible exception of the unfortunately named OCCAM) and the director of an integrative medicine program in which quackery like orthomolecular medicine is “integrated” with science-based medicine in an academic medical center. Add to that an associate editor of a journal that has recently shown a distressing tendency to publish a dubious placebo study by Ted Kaptchuk (blogged about a mere three weeks ago by yours truly). Given that, you know that the answer to the question being asked—Can Alternative and Conventional Medicine Get Along?—is going to be a resounding “yes,” and so it was. This was a discussion whose outcome was every bit as predetermined as that of a professional wrestling match but nowhere near as entertaining.

One thing I found particularly galling depends upon some inside knowledge that few people watching the video chat. Nearly four years ago (and it’s really hard to believe that it’s already been that long), I actually met Dr. Briggs and some of her staff. She had invited Kimball Atwood, Steve Novella, and me to meet with her as critics of NCCAM. Of course, not long after that, she wrote a truly misguided editorial entitled Listening to Differing Voices in which she stated that she had met with “both sides,” namely homeopaths and us, and dumped a classic bit of false equivalence between “skeptics” and CAM advocates in which “advocates would like to see more research dollars supporting various CAM approaches while the skeptics see our research investment as giving undue credibility to unfeasible CAM modalities and want less research funding,” as though the two held equal positions. Apparently she had met with an “international homeopathy team” sometime soon before or after she met with us. In any case, one thing we observed at that meeting was that Dr. Briggs tried as hard as possible to distance herself from the Trial to Assess Chelation Therapy, a massively unethical and pointless clinical trial to test a treatment for heart disease with close to zero prior plausibility and clinical evidence demonstrating that it is unlikely to work. She very pointedly reminded us that TACT started before her tenure as NCCAM director began and that it had been turned over from NCCAM to the National Heart, Lung and Blood Institute (NHLBI). Her eagerness to dissociate herself from TACT was palpable, and she declined to comment on it because it was, according to her, not part of NCCAM.

How her tune has changed in less than four years!

In this video chat, Dr. Briggs and Dr. Drisko gushed over TACT. Dr. Briggs even showed a figure from the study. Why? It’s because she seemed to think that she could spin TACT as a positive trial by focusing on the subgroup analysis that suggested a benefit for chelation therapy in diabetics. I’ve discussed this issue before when I analyzed the results of TACT reported about a year ago. The first problem I noted was that the outcome measure was an composite endpoint consisting of death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. There was no significant difference in any of these individual outcome measures between control groups and test groups. Nada. Zero. Zip. In fact, there wasn’t a difference between the composite adverse cardiovascular event outcome in the overall population, either. The only way the investigators salvaged a seemingly positive result was through subgroup analysis of diabetics, which purported to show a difference, although even in diabetics there was no statistically significant difference in any of the individual cardiovascular endpoints.

This subgroup analysis was tarted up a bit a few months ago in a separate paper (thus reinforcing the concept of the MPU, or “minimal publishable unit”). Nothing new was presented, and the TACT investigators even published a graph virtually identical to the “diabetics vs. non-diabetics” graph in the original JAMA article about TACT. If you don’t believe me, just compare Figure 4 in the original JAMA article to Figure 2 in the new article. The only significant difference is that the new figure is in color and much more appealing to the eye.

Both Dr. Briggs and Drisko keep saying that there is “enough there to say that there’s something helpful.” No, really, there isn’t. It’s just a composite endpoint, and there are no statistically significant differences between any individual endpoints. Moreover, as I described before, there could be other reasons for the apparent difference in composite cardiovascular events. Or it could be a fluke due to how poorly the study was run, the problems with the study having been amply documented by Kimball C. Atwood, Elizabeth Woeckner, Robert Baratz, and Wally Sampson four years before the results of TACT were reported.

Once having done everything she could in private to dissociate herself from TACT, Dr. Briggs now exults over these results, while Dr. Drisko proclaims that it’s time to look for the “mechanism” by which chelation therapy “works” and/or do a larger trial to nail this result down. Really? TACT cost taxpayers $30 million. Does she really think that this probably spurious result is worth spending more than $30 million to chase down in these days of highly constrained NIH funding? I can think of a lot more important things that the NIH should be spending money on than confirming or disconfirming the results of a clinical trial that the government never should have spent $30 million on in the first place. Moreover, I can’t help but point out that Dr. Briggs and Dr. Drisko don’t say the obvious thing that needs to be said about TACT, even if we assume for the sake of discussion that the result seen in the subgroup analysis of diabetics, namely that the result of TACT strongly supports the conclusion that chelation therapy should not be used in non-diabetics with cardiovascular disease because TACT showed that in these patients it clearly doesn’t work. I’ve yet to hear a single CAM proponent say this about TACT, but they do say the same sorts of things that Dr. Drisko and Dr. Briggs say about “intriguing” results in diabetics. It’s pure poppycock.

Next up, our fearless moderator asks which alternative therapies are being “integrated” into the mainstream. I can’t help but notice that she didn’t ask, “Which alternative therapies work?” That’s a very different question, because, thanks to the march of quackademic medicine there are quite a few alternative therapies that are being “integrated” into the mainstream through the pseudospecialty of “integrative medicine” without any compelling evidence that they work. As I like to say, citing Mark Crislip, integrating cow pie with apple pie doesn’t make the apple pie taste better, or, as I like to say, “integrating” pseudoscience and quackery into mainstream medicine doesn’t make mainstream medicine stronger. It dilutes it with quackery. In any case, close to no evidence is discussed indicating that these modalities being “integrated” (such as acupuncture, “mind-body,” massage, and the like) work for the conditions indicated.

A lot of the rest of the video chat had to do with supplements and nutrition. Of course, this is nothing more than the classic “bait and switch” of CAM, or, as I like to call it, the “rebranding.” Basically, CAM advocates rebrand perfectly fine science-based modalities, such as nutrition and exercise, as somehow being “alternative” and thus part of CAM. Since these interventions have a scientific basis and can work for certain conditions, this little trick allows CAM advocates to claim that CAM works, while lumping all the magic, such as reiki, “energy healing,” acupuncture, and the like, in with the rebranded science-based modalities, implying that the magic must work too.

If you want perhaps the most blatant example of this “rebranding” at work, near the end of the video chat, Dr. Briggs cited hospice care as a model of medicine that came from outside the mainstream and is now an accepted part of medicine. At first I thought she was trying to imply that hospice is CAM; so I listened to it again. It turns out that she was just citing hospice as an example of a practice that came from “outside the mainstream” and is now accepted that she could use to imply that CAM practices would soon be mainstream. It was probably the latter, but either way it was totally off base. However, if you go to the National Hospice and Palliative Care Organization website and peruse its history of the hospice movement or a similar page on the National Hospice Foundation website, you’ll see that it’s quite the exaggeration to claim that hospice arose from outside of the mainstream in the same way that CAM arose outside of the mainstream.

After watching the entire video, one thing that I noticed was that both Dr. Drisko and Dr. Briggs admitted that the evidence base behind CAM is very thin indeed. Dr. Briggs couldn’t really come up with a CAM modality that NCCAM had shown to be definitely effective. To explain, Dr. Drisko likened CAM to the situation in medicine in the 1950s, where what we had, according to her, was little more than anecdotal observations and observational studies but were starting to challenge existing practices with more rigorous studies and randomized clinical trials. She thinks we’re at the stage where clinical research will change CAM practices. I disagree. It’s already been shown time and time again by the reaction of CAM practitioners to research showing that their modality doesn’t work that CAM practitioners do not appreciably change practice. Specifically, unlike the case in science-based medicine, it’s always hard to come up with a list of CAM practices that have been abandoned because research showed that they didn’t work. Seriously, homeopathy is still with us. The day I see CAM practitioners completely reject homeopathy as pseudoscience is the day that I might believe someone like Dr. Drisko chirpily predicting that we’re at the dawn of a great new scientific age in CAM. After all, she practices orthomolecular medicine, works with a naturopath, and administers IV vitamin C, even mentioning a study recently published in, yes, Science Translational Medicine, claiming that high dose vitamin C is active against ovarian cancer. (Yes, I do plan on looking into that one.)

Perhaps the most annoying thing is how at the end Dr. Briggs co-opts a favorite saying of skeptics that there is no such thing as “alternative” medicine and that when something “alternative” is shown to work it ceases to be “alternative” and becomes just “medicine.” I’ve said that time and time again myself. I’ve also used that belief to argue that NCCAM shouldn’t exist. After all, there should be no such thing as “alternative” or “complementary” medicine. There should be just medicine. Unfortunately, neither Dr. Drisko, Dr. Briggs, nor the organizers of this web chat seem to understand this.

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]

160 replies on “Can Alternative and Conventional Medicine Get Along? No.”

Receiving a NCCAM grant for the study of CAM is about as much of an honor as being Valedictorian of summer school.
And not the summer school you go to to get early college credit for your core courses. If you want your trials and studies of acupuncture and reiki and whatever other nonsense to be taken seriously, play with the big kids and their rules.

Homoeopathy is currently used in over 80 countries. It has legal recognition as an individual system of medicine in 42 countries and is recognized as a part of complementary and alternative medicine in 28 countries. The World Health Organization has stated that homeopathy is the second most commonly used form of alternative medicine internationally.

The health care industry is a profit driven entity. Because conventional medicine has failed them, health care consumers are educating themselves and choosing to spend their money on what works. Homeopathy offers success, and cures, over hype and failure. The homeopathy skeptics do not yet seem to realize that health care consumers read and digest the evidence on both sides, then make an informed decision. Nothing sells better than sex and success.

@Sandra – just because it is popular (and so is drinking water, btw) doesn’t mean that it actually works….

Sandra… with around 1.6 billion followers, Islam has legal recognition as an individual religion practiced around the world. It is the second largest religion and is one of the top three very popular religions. Islam may be the “right” religion, or Christianity might be, or perhaps the Hindus have got it right. Perhaps none are right. But they can’t all be right, no matter how popular they are. No matter which religion is right, if any are, the vast majority of religious people will still be wrong despite their conviction otherwise.

Reality is not a popularity contest.

Homeopathy is pure bunk, rubbish, junk, garbage and stupid all rolled into one steaming turd that is painted and perfumed and (thanks to legal loopholes excluding homeopathic quack “medicine” from any real regulation/testing) put on way too many shelves in store in the US. Period.

The health care industry is a profit driven entity.

Whereas homeopathic remedies are entirely free, with 9/10 homeopaths operating entirely pro bono.

The health care industry is a profit driven entity.

…whereas homeopaths are driven entirely by the goodness of their hearts. Gotcha.

Homoeopathy is currently used in over 80 countries. It has legal recognition as an individual system of medicine in 42 countries and is recognized as a part of complementary and alternative medicine in 28 countries. The World Health Organization has stated that homeopathy is the second most commonly used form of alternative medicine internationally.

None of which constitutes evidence that homeopathy is effective at treating illness or injury.

Because conventional medicine has failed them, health care consumers are educating themselves and choosing to spend their money on what works.

Unfortunately they’re also spending there money on things that have been proven not to work, like homeopathy.

Homeopathy offers success, and cures, over hype and failure.

there is no evidence that homeopathy is effective at curing anything (with the possible exception of dehydration, where it might perform as well as equal amounts of plain water). If you believe otherwise, please provide actual evidence demonstrating that homepathy is more effective at treating non-self-limiting injuries or diseases than placebos.

In fact, let’s make it as easy as possible for you to respond: in your opinion, what is the single most compelling clinical study demonstrating homeopathy is effective (i.e., more than sham or placebo homeopathy) at addressing non-self limiting illnesses or injuries?

The homeopathy skeptics do not yet seem to realize that health care consumers read and digest the evidence on both sides, then make an informed decision.

Again–what evidence is there than weigh in in favor of homeopathy? Be specific.

Nothing sells better than sex and success.

Homepathy demonstrates that false hope sells just as well.

Sandra Courtney makes me sick. She has allied herself with Patrick Tim Bolen, who refers to all skeptics as “pedophile homosexuals” and he has coined a nickname for Orac that is totally and utterly disgusting.

She has been challenged about her support for Bolen everywhere she posts her pro-homeoquackery comments aound the world, and even after being shown what kind of filthy, lying pig Bolen is, her support for him is unwavering.

Yet SHE rails on about “cyberbullying” and encourages any homeopath who feels butthurt when we ask for evidence to “complain about abuse to Twitter.”

Nice friends you choose to associate with, Sandra. You miserable hypocrite.

I never thought chelation would turn out to be any use – it seems necessary to assert that upfront. However, I recently read comments on TACT by MDs on a conventional-medicine website that said while chelation for CAD in diabetics seemed implausible to cardiologists, who often still effectively believe in a plumbing model of CAD, endocrinologists were more likely to think it might be plausible because they were more familiar with the role of metal ions in abnormal metabolic processes in diabetes. That tidbit, plus the fact that there apparently is some published preliminary evidence for chelation that was used to justify this trial, suggests that perhaps the Bayesian Prior Probability cannot be so easily decreed to be “close to zero” as is always asserted around here. Continuing to declare studies of methods you don’t like Unethical after they have reported significant positive results, while demanding the defunding of further research, gives the appearance that what you want to do is suppress the conduct and publication of any research that might prove your personal beliefs to be incorrect.

Unfortunately, science-as-process doesn’t work that way. Some questions can’t be answered by the methods of science, but for those that can be, there’s no priesthood that gets to dictate that some of those questions should never be asked or answered. People are going to do studies on things you don’t like, and sometimes, it will turn out that those things do work. Demanding that we ignore the actual results of clinical trials because the Prior Probability you pulled out of your … hat … has spoken and told you those results must be wrong only makes you look like Ken Ham in a white coat.

Ms. Courtney: ” Because conventional medicine has failed them, health care consumers are educating themselves and choosing to spend their money on what works. Homeopathy offers success, and cures, over hype and failure.”

Uh, huh. Do tell us all about the successes homeopathy has with measles. Try to answer this time, do not ignore the question. Again.

Do tell us which non-self-limiting disease/condition that homeopathy has proven to work with where real medicine failed. Is it syphilis? Nope. Is it type 1 diabetes? Nope.

Come on, give us an answer. Don’t just post and run away.

Can alternative and conventional medicine get along? A panel of NCCAM advocates are as likely to discover that the answer is “no” as a Templeton-funded panel of accomodationists is likely to conclude that science and religion are indeed in conflict.

And for pretty much the same reasons, and using pretty much the same arguments, and hiding behind pretty much the same strategies, and with pretty much the same smug sense of ‘tolerance’ and ‘respect’ for multiple ‘faiths’ and their different ways of knowing.

If I understand the history of homeopathy it was an improvement over much of what passed as medicine. The magic water of homeopathy is better than blood letting and poisonous remedies.

Homeopathy works every bit as well as doing nothing.

Soothing talk and a gram or two of ascorbic acid can reduce the discomfort from the common cold. Ditto soothing talk and a few green M&Ms.

Some years ago I heard a simple home remedy for diverse feverish aches and pains. Take one shot of whiskey. Repeat as needed until the aches and pains go away. And like Listerine, whiskey kills germs on contact. No need for NCCAM.

The World Health Organization has stated that homeopathy is the second most commonly used form of alternative medicine internationally.

Notice that there’s no statement by the WHO on whether or not homeopathy actually works.

Alternative medicine can accommodate conventional medicine, but the reverse is not true, since conventional medicine is burdened by the need for evidence. If anything, I’d like to see *more* science in conventional medicine, not less. We do not have enough treatments for various ailments, and the ones we have are too expensive; this will not be solved by allowing charlatans to operate. It will only be solved by increasing the amount of active research while simultaneously working to reduce the barriers too many people have to obtaining treatment.

@ Lawrence
Drinking water works. Without it, we could not live. And quacks need it too for their high dilutions.

Andy @ 6

Reality is not a popularity contest.,

Additionally

Philip K. Dick — ‘Reality is that which, when you stop believing in it, doesn’t go away.’

Jane, if your argument is we shouldn’t bash an expensive failed trial because some endocrinologists on a message board said they could hypothetically, possibly, maybe see how chelation would work for diabetics, I think you’re in the wrong place.

The data are here, and they landed with the wet squish of the turds that they are. There was nothing gained by doing this trial, except that once again science did its job and showed something to be useless. That’s great! But now it’s time to acknowledge the reality and move on.

That tidbit, plus the fact that there apparently is some published preliminary evidence for chelation that was used to justify this trial, suggests that perhaps the Bayesian Prior Probability cannot be so easily decreed to be “close to zero” as is always asserted around here. Continuing to declare studies of methods you don’t like Unethical after they have reported significant positive results, while demanding the defunding of further research, gives the appearance that what you want to do is suppress the conduct and publication of any research that might prove your personal beliefs to be incorrect.

Jane, how were these “significant positive results”? What is so compelling about this subgroup analysis that warrants billions more dollars spent when there are so many other research proposals that go unfunded but have far more potential for viable hypothesis testing?

Unfortunately, science-as-process doesn’t work that way. Some questions can’t be answered by the methods of science, but for those that can be, there’s no priesthood that gets to dictate that some of those questions should never be asked or answered.

That’s quite the steaming load of bollocks. This is exactly how the scientific process should work. The question was asked, tested and failed to produce results that warrant further investigation; it happens all the time. Alt med shouldn’t get a pass because of some wooey-mystical nonsense that “the scientific method can’t answer that question”. What are you going on about a “priesthood” preventing anything? Research funding needs to be prioritised and unfortunately not everything gets funded; that’s just reality. If woo-meisters want to whinge about it then they can get funding for their research themselves; no one owes them jack.

@Jane,

Orac’s objections to the TACT trial were expressed by many prior to the trials outcome and publication. You cannot accuse them of rejecting the trial because they did not like the outcome.

An editorial in JAMA accompanies the TACT trial publication and sums up the major objections:

(http://jama.jamanetwork.com/article.aspx?articleid=1672219)

Concluding with:
“Given the numerous concerns with this expensive, federally funded clinical trial, including missing data, potential investigator or patient unmasking, use of subjective end points, and intentional unblinding of the sponsor, the results cannot be accepted as reliable and do not demonstrate a benefit of chelation therapy. The findings of TACT should not be used as a justification for increased use of this controversial therapy.”

Yet we have the director of NCCAM spinning the trial as positive by cherry picking subgroup analysis? That is not a critically thinking mind at work. It is a biased mind.

I read about the intravenous vitamin C study involving Jeanne Drisko in the paper yesterday.

There’s a press release (on NIH and HHS websites, no less). Much of the work involved tissue culture and mice, but there was also a pilot study in 27 patients with stage III or IV ovarian cancer::

“The patients who received intravenous vitamin C along with their chemotherapy reported less toxicity of the brain, bone marrow and major organs, the investigators found.”

“These patients also appeared to add nearly 8.75 months to the time before their disease relapsed and progressed, compared with people who only received chemotherapy. The researchers did note that the study was not designed to test the statistical significance of that finding.”

I’m curious about that significance. Was there objective measurement of toxicity, or just patient reports? What does “appeared to add 8.75 months” mean? Was this a double-blinded study? Hopefully I’ll be able to dig out the journal article for clarification.

Meantime, while other cancer docs are expressing caution about the findings, Dr. Drisko wants us to dive right in, the vitamin C’s fine:

“While she agreed that larger trials need to be conducted, Drisko was not as hesitant.”

“It’s safe. It’s inexpensive. There’s a plausible mechanism we’re investigating for why it works,” she said. “We should be using this in patients, rather than dragging our feet and worrying about using it at all.”:

It’s “plausible” and she thinks it’s great. We don’t need no steenking large-scale trials.

How irresponsible.

Dangerous bacon, I conducted a small study using bottled horse farts in leukaemia, and although not statistically significant, one of the secondary outcomes showed a slight benefit in subjects sleep patterns.
Bottled hours e farts are cheap, so I hope NICCAM will now endorse it’s use without the need for larger trials powered to demonstrate anything of relevance, clinically or significantly.
No point dragging feet, is there?

Some questions can’t be answered by the methods of science, but for those that can be, there’s no priesthood that gets to dictate that some of those questions should never be asked or answered.

What questions are those, exactly? Perhaps questions of the realm of religion, or philosophy, or creative expression (“Who’s the better artist, Wyeth or Klee?”) but it can certainly answer questions within it’s open scope, such as whether or not medical interventions such as homeopathy, reiki, acupuncture, etc. are effective.

And it has done so, finding that they are not effective (or more accurately, no more effective than sham treatments or placebos.)

And you’re correct that there is no preisthood, butno one is arguing questions can’t be asked or answered. Instead they’re noting that the question “Is Homeopathy of any utility in treating disease and injury?” has already been answered (the answer is “not at all”) and we’d be foolish to expend any more resources asking the question over and over again when there so much else they could be usde to investigate to possible benefit.

It featured Dr. Briggs, as well as an associate editor from Science Translational Medicine, Yevgeniya Nusinovich, M.D., Ph.D., who served as moderator, and a practitioner of “integrative medicine” at Kansas University, Dr. Jeanne Drisko, whose titles include Director, KU Integrative Medicine and the Riordan Endowed Professor of Orthomolecular Medicine.

So, like convening a panel of forgers to discuss the question “Can good money and bad money get along?”

Oh, dear. Referring to a *prespecified* subgroup analysis is not “cherry picking.” The reason the diabetic vs. non-diabetic subgroups were prespecified is that there apparently was a priori reason to believe that excessive levels of particular metal ions were more relevant to CAD development in diabetics than in non-diabetics. This is a very different situation from a case in which no subgroups are prespecified but the authors attempt after the study is done to find some portion of patients in which the treatment appeared effective.

Likewise, Orac complains that the primary efficacy outcome was a composite outcome, but in fact, this is virtually universal in cardiology studies. He “whinges” (nice word use) that reductions in the individual types of event that went into the composite outcome were not statistically significant, but a little thought and sixth-grade math will tell you that there had to be numerical differences in more than one of those outcomes. The primary reason for using composite outcomes is to make it easier to accumulate enough cardiovascular events in a finite patient population to achieve statistical significance; this is necessary because even in a putatively high-risk population, the annual risk of having a heart attack, stroke, etc. is much lower than patients are led to believe. (The secondary reason is so that patients can be lectured that the treatment “reduces the risk of death, heart attack and revascularization” when in fact it does not reduce anything but elective stenting.) You cannot pretend that a composite outcome invalidates the results of this study when studies with ten thousand participants regularly use them. This reflects the current culture of a whole field of conventional medical research.

Like I said, I have never had much belief in this treatment, and know nobody who has used or benefited from it. But straw men and scatological namecalls against the researchers, published data, or people who simply read the study without assuming it to be fraudulent are not convincing to me. These are the data, and there is no evidence that they are fraudulent. They show clearly that chelation is worthless in non-diabetics. Hopefully that will put an end to that use, but recent studies have found stenting to be worthless in stable angina, CRT to be far worse than worthless in people without extremely long QRS complexes, etc. etc., and cardiologists keep pushing those things; I imagine that the people who have been pushing chelation will keep doing so, so if this study’s negative results are to make a difference it will be because informed, self-directed patients do their own research.

OTOH, this study does provide adequate reason to think another trial in diabetic patients only would be worthwhile. In my opinion – which I recognized immediately after writing it to involve a value judgement – you can’t claim that Science says the Bayesian probability of something is near-zero when there’s a p<.05 on the table. You have to be willing to go where the data say, or you're not doing science.

By the way, JGC – I completely agree with you about homeopathy; no public money should be wasted on that research. There is very little evidence that it might work and plenty of evidence that it won’t. Now as to acupuncture, the idea that sham acupuncture cannot be bioactive is a matter of dogma, not fact, while the idea that those studies in which acupuncture beats sham acupuncture (or a pharma drug treatment) must be rejected is a straightforward value judgement. Those who do not share your beliefs or values regarding these issues might well like to have more data regarding what benefits they might derive from using acupuncture in various circumstances.

I actually addressed a lot of these issues a year agnclusion of the link to my previous discussion of TACT when it originally came out:

http://respectfulinsolence.com/2012/11/05/the-results-of-the-unethical-and-misbegotten-trial-to-asess-chelation-therapy/

I’ve complained more than once about the use of composite endpoints in cardiovascular studies as being bad science. I’m not alone in that criticism:

http://www.bmj.com/content/334/7597/786

“Use of composite end points appeals to clinical trialists because it increases event rates and statistical power. The fundamental problem with composite end points is, however, the difficulty in interpreting results when the gradient of importance to patients is substantial and a substantial gradient in the magnitude of the treatment effect also exists. Conversely, confident interpretation of composite end point results requires relatively small gradients of importance to patients and similar relative risk reductions across components.3 Our findings suggest that most composite end points used in cardiovascular randomised controlled trials have substantial gradients in both importance to patients and treatment effects across component end points. Furthermore, less important outcomes provide larger contributions to the composite end point event rate and show larger treatment effects. In particular, mortality outcomes, present in almost all cardiovascular composite end points, provide the lowest event rate and show the smallest treatment effects. Thus, an important and plausible risk of misleading conclusions associated with the use of composite end points is to attribute reductions in mortality to interventions that do not, in fact, reduce death rates.

“The common use of inadequately reported composite end points with large gradients in importance to patients, in which end points of least importance contribute most events, and in which treatment fundamentally affects these same components, is problematic. Trialists should report complete data on individual component end points to facilitate appropriate interpretation; clinicians should view with caution the results of cardiovascular trials that use composite end points to report their results. Clinicians and patients are best served when trialists restrict their use of composite end points to end points of similar importance to patients and contexts in which they anticipate that more important end points will contribute a large proportion of study events. If they do not, they risk misleading their audience.”

And this one recommending against the use of the MACE endpoint:

http://content.onlinejacc.org/article.aspx?articleid=1138720

“In light of the approximate prior 15 years use of the term MACE and its wide heterogeneity in definition and research applications, it is unlikely that a consensus definition will either be universally desired or practical for future research. Therefore, we recommend against the routine use of MACE as a composite end point at large. However, if a broad heterogeneous composite end point such as MACE is ultimately desired, minimally, it must be clearly defined, and the individual as well as composite end points need to be analyzed, presented, and discussed. If different definitions are used for even 1 component of the composite end point, rates of the composite end point may vary widely. To illustrate, in TAXUS-I (12), only Q-wave MI was included in the definition of MACE, and there were no MIs at 30 days or 1-year in either the TAXUS or control groups. In contrast, in TAXUS-V among patients with complex disease (25), the 30-day MACE rates of 5.1% and 3.6% in the TAXUS and control groups, respectively, were dominated by the inclusion of non–Q-wave MI rates of 4.4% and 3.3%, respectively.

“Our general recommendation against the use of MACE is consistent with that of the Academic Research Consortium (ARC) (59), which has aimed to establish consensus definitions for both individual and composite DES study end points. The ARC has suggested 2 composite end points for DES trials: a device-oriented and overall patient-oriented end point, whereas for cardiology studies at large (i.e., not restricted to DES trials), we recommend focusing separately on safety and effectiveness outcomes, and constructing separate composite (and sample size calculations, among others) end points that contain well-defined internally coherent components to match these different clinical entities.”

My criticism applies not just to TACT but any cardiovascular trial using composite endpoints, which are in general a bad idea. Any cardiovascular study that uses a composite endpoint but can’t show a statistically significant result in at least one of the components of the composite endpoint is a negative trial, as far as I’m concerned.

you can’t claim that Science says the Bayesian probability of something is near-zero when there’s a p< .05 on the table.

Wanna bet? I can show you homeopathy trials that have a “p<.05 on the table." We know homeopathy has a prior plausibility of as close to zero as you can get.

That tidbit, plus the fact that there apparently is some published preliminary evidence for chelation that was used to justify this trial, suggests that perhaps the Bayesian Prior Probability cannot be so easily decreed to be “close to zero” as is always asserted around here.

Speaking of which, were you planning on getting back to this?

Yet we have the director of NCCAM spinning the trial as positive by cherry picking subgroup analysis? That is not a critically thinking mind at work. It is a biased mind.

It is the mind of someone who knows whence comes her next paycheck.

if I was a subscriber to Science Translational Medicine, all might be revealed. But alas…

Ugh. I’m sorry. I didn’t realize there’s a paywall.

If it’s not against the rules to quote a giant block of text, then here is the caption for Figure 4:

Cp + Pax arm: participants received standard of care chemotherapy for 6 months. Cp + Pax + AA arm: in addition to the Cp + Pax treatment, participants received intravenous AA using a dose-escalating protocol, with final dose of either 75 or 100 g per infusion depending on peak plasma concentration of each individual. The target peak plasma concentration of ascorbate was 350 to 400 mg/dl (20 to 23 mM). Once the dose was determined, participants received ascorbate infusion two times per week for a total of 12 months. The first 6 months were in conjunction with the Cp + Pax chemotherapy. Fourteen subjects were randomized to Cp + Pax arm. Two voluntarily withdrew before receiving any treatment and were excluded from data analysis. Thirteen subjects were randomized to the Cp + Pax + AA arm. Two were noncompliant with tobacco use and were removed from the arm, and another one was removed after in vitro assays detected that the subject was resistant to all chemotherapy. These three subjects received doses of chemotherapy and ascorbate, so their adverse events were counted, but they were excluded from survival follow-up. (A) Average adverse events per encounter for all participants and all toxicity categories. Any and all unwanted events were counted and graded for severity according to NCI CTCAEv3. Records for adverse events include patient interviews, emergency room visits, patients’ oncologist visits, and hospitalization records. The number of adverse events in each grade for each participant was divided by the number of encounters of that participant, and then the adverse events per encounter were averaged in the Cp + Pax arm and the Cp + Pax + AA arm, respectively. (B) Percentage of participants who had toxicities in each arm. Toxicities were categorized by anatomic organ/system according to NCI CTCAEv3. All grades of toxicities were counted. More detailed data on patient toxicities are included in table S1. (C) Kaplan-Meier curves of overall survival at 60 months after diagnosis. (D) Time to disease progression or relapse for each subject. The bars represent median time of each arm.

“If you can get your blood levels of vitamin C very high, it gets driven into the space around the cancer cells,” she (Drisko) explained. “In that space, it’s converted into hydrogen peroxide”.

http://www.health24.com/Medical/Cancer/News/Intravenous-vitamin-C-boosts-chemotherapy-action-20140206

How is it driven there? In a mack truck?
And where did the benzene ring go?
If she is talking about it’s role as an antioxidant, and free radicals generation, she should say so, and explain why it would only target some cells, and not others.

Question: Surely high dose ascorbic acid is not the thing alties want to give cancer patients (who have a mythical need for alkalinisation)?

First of all..who wrote this article??? if they are so SCIENTIFICALLY inclined, what is their CV??? There are more ways to treat symptoms than to put pen to paper and write prescriptions for expensive pharmaceuticals that..buy the way cost $$$$$$ in their their therapeutic value and even more in treating the adverse effects!! What works is what THE PATIENT says works!!! Just like pain, it is their experience that matters!! Yes we need RTC for high risk meds and treatments, but if anyone is so arrogant to think their treatment or cure is the only thing that matters, then they are concerned more about them than the person they are facing!!! Food is medicine…home remedies work…they have proved the test of time…acupuncture has existed longer than conventional medicine…open your minds!!! Great things might happen when therapeutic modalities work together!!!!

@candy

[citation needed], since most CAM modalities have very little evidence of their actual efficacy.

Also, your comment on acupuncture falls under the “argument from antiquity” fallacy, since acupuncture didn’t really come into being until the 1970s.

Also, have you heard about the placebo effect? Just because a patient says that something works doesn’t mean it actually has any beneficial effect.

in what studies has acupuncture been shown to perform better than standard of care science based medical treatment, Jane?

Demonstrably false, candy. As has been pointed out above,
lots of people say homeopathy works despite hard evidence demonstrating it does not.

First of all..who wrote this article??? if they are so SCIENTIFICALLY inclined, what is their CV???

Beginning a comment this way does not instill great faith in Candy’s interest or ability in basic looking-stuff-up skills.

@novalox…Acupuncture actually existed for YEARS prior to that…and was used successfully…If the studies stared later, so he it!!! I am more than aware of the PLACEBO effect as being very powerful!!! Once again…this should be about THE PATIENT…..NOT you!!!!! I am a conventional medical practitioner with a deep interest in Functional medicine… What is with the “What Study”! Questions when your arguments are pointless…people will do what they choose…if you judge them, you will never know the difference!!!! When the have a positive outcome, you might assume you had influence, but really, your attitude may prevent your knowing!!!!

Scroll to the top of the page and click on his blog name…if it was a snake, it would bite you, you gormless nit.

@JGC..what evidence exists to say acupuncture does not work???….Apparently the people without dental pain during usually painful procedures would dispute this..But Oh, oh, forgot about that PLACEBO effect…which I apparently don’t know about, cause according to Herrrdoktor???? I cannot find the author of the original article that caused us all more stress than we need!!!!!
Enjoy you life in a box forum!!!

Suppliers of capital letters, exclamation points and question marks thank Candy for her repeat business.

Readers of Candy’s word stew, not as much.

@Denise Walter
#1

” the unfortunately named OCCAM”

Oh, I know.That’s always bothered me

Just think of OCCAM as a target for Occam’s razor.

@novalox…Acupuncture actually existed for YEARS prior to that…

Candy’s correct. What is known as acupuncture has existed since the 1930s, when Cheng Dan’an got wind of Western medical science on nerve function and simply moved the magic points from blood vessels to nerves. This, along with getting rid of the obvious lancets, manage to rescue a long discredited and dying practice from the scrap heap.

Here, Candy. It may not have as many exclamation points as you’re used to.

what evidence exists to say acupuncture does not work???….Apparently the people without dental pain during usually painful procedures would dispute this..

Perhaps you would like to start here.

I am all in favour of needles during dental procedures. Especially the hollow kind through which anesthetics can be administered.

@candy

Again, where is your evidence? Why should we care about your assertions about treatments, when you don’t have any credible evidence for their efficacy?

Also, why would you treat someone with something that doesn’t have any actual proof. Would that make you selfish and only about you, since you (if you are really a medical professional) would treat someone with what could possibly be a worthless or harmful treatment?

Candy, in which part of Canada do you practice “conventional medicine”? I need to know which bits to avoid on my next visit, in case of emergencies.

Prior to it’s reinvention during the Cultural Revolution acupuncture was a form of bloodletting, candy. it used lancets, not the thin needles we’re familiar with today, applied to very different locations and it was “successful” to the same extent European bloodletting was successful.

As for evidence that acupuncture doesn’t work, the burden of proof is on the other side–that of those claiming it’s anything other than a placebo.

@Shay…resorting to name calling tells me a grat deal about you!! And…a Blog name does not lend anything to credibility. ? Orac…still does not tell anyone who wrote this and what expertise they have to be able to decipher any of this….And I work in one of the best medical systems ever! Even Shamans and traditional aboriginal healers collaborate with medical practitioners…PATIENT centred care!!

Orac…still does not tell anyone who wrote this and what expertise they have to be able to decipher any of this…
Shamans, traditional aboriginal healers and quacks all rely on their Authority to sell their woo. Orac isn’t selling stuff here, so he needn’t flaunt his authority: his articles stand on their own merit.
Even so, you’ve been given more hints than most on how to “discover” Orac’s worst-kept-secret-on-the-internet identity and expertise. So stop complaining about Orac’s identity vs your self-proclaimed authority, hidden behind your ‘nym (with no magic decoder ring), and do some work, if you actually care. Concentrate on the material, not on the authority.

Borkquoted, again. Obviously, the first paragraph of my #59 is quoted from Candy’s #58. Sorry ’bout that, Chief.

Bill..get a life…you would not survive a minute in an aboriginal community calling them Quacks…and if you were fee for service with that attitude, you would be declaring bankruptcy!!

Candy: “Orac…still does not tell anyone who wrote this and what expertise they have to be able to decipher any of this”

It is one of the worst kept “secrets” on the internets. The ability to it has turned into a bit of a test here. You are not doing very well.

Here is another hint: the words in a different color, like blue, are links to other webpages. Hover your mouse over one and then click. Read Shay’s comment, and find that word. Click on it and all will be revealed.

Aargh, I blame family members who insist on talking to me, some words are missing:

The ability to figure it out has turned into a bit of a test here.

“Orac…still does not tell anyone who wrote this and what expertise they have to be able to decipher any of this”

I didn’t think there could be two people as dumb as Greg.

Click Here —> http://bit.ly/1aIDfcn

The headline is ” Can Alternative and Conventional Medicine get along? “No”…….Not sure why I even commented in the flat earth society forum…the answer was already there!!! If you think you can or can’t you’re right…said a great leader!!
Nobody Said Orac was selling stuff…but when you look at the research done by pharmaceutical companies, do you think that they are not publishing results that are not aimed at profit? They are selling stuff. There are a few miracles out there…As one of my colleagues (a very qualified MD ) recently said, Modern Medicine has only really done 4 things that have really made a difference…Sanitation, Vaccines, insulin, Antibiotics. I add in ASA, and also consider contraception for those with an open enough mind to accept that women should have control over their reproduction. That perhaps will start another stream of name calling and belittling….so be it….

@candy

Oh do please show where this so-called name calling is from.

Also, considering you said to Bill “get a life” while at the same time complaining about name calling, I find your holier-than-thou attitude so hypocritical.

Again, where is your evidence? We’ve been waiting, certainly, someone who supposedly is in health care could have come up with some actual evidence by now.

As one of my colleagues (a very qualified MD ) recently said, Modern Medicine has only really done 4 things that have really made a difference…Sanitation, Vaccines, insulin, Antibiotics.

Even if this were true, it’s more than NCCAM and SCAM has brought to the table.

Dumb as Chris??? Etc, etc…should be proud you are so professional! I did manage to click on highlighted blue…no further ahead…very suspicious of anything needed to be that hidden….yet great to know that when you have NO intelligent answers…you resort to bashing!!!

novalox: “We’ve been waiting, certainly, someone who supposedly is in health care could have come up with some actual evidence by now.”

But she has given us lots of ellipses and random capitalization! Does that count?

Candy, you are not doing well here. Step back, relax and review your actions.

Don’t worry, not all is lost. All you have to do is prove to us that you have an actual argument. You can start by actually reading some of Orac’s other articles. Then look at the comments, see what kind of exchanges occur between the regulars. Do they engage in “text speech”, or do they actually compose grammatically correct sentences? Do they blindly accept assertions, or expect some evidence?

Blogs often have their own culture, and it helps to learn what is expected on each particular blog.

Candy: “Dumb as Chris??”

Citation needed. Please provide evidence that someone is as dumb as myself. Or is ending a sentence with three periods the new standard?

Have you figured out who writes this blog yet?

Orac: ‘Mind-body massage’? Is that a joke or a punch-line?

Homeoquackery: Ars.Technica.com did a splendid takedown last year, including a review of the history. Yes, homeoquackery works, better than giving patients arsenic and what-all-else was common back then. It worked as well as giving them purified water to drink in an era when clean water was so rare that people who dared drink the water earned the name Drinkwater, which has since become a last-name along with similar such as Drinkwasser etc.

Chris @13: Homeoquackery for measles: B—– hell!, you’re serious about that. Everyone: go follow the link, it’s not a joke. A few more reviews would be helpful.

Peter B @ 15: Thanks for the word about green M&Ms, I’ll put some in an old medicine bottle and keep them next to the chicken broth. One good placebo deserves another, as long as one is aware of their actual value;-)

Orac @ 31: By ‘composite endpoints’ do you mean conflation of objective measures with subjective measures, or do you mean compounding a quantity of objective measures together? About the former, I’d be highly sceptical; about the latter, I haven’t the background to say.

Where on our godless good green Earth is there a homeoquackery study with a p < .05 in the results?

Re. Bayesian statistics: I'm an unabashed frequentist, and sceptical about 'prior plausibility' as an element in statistical calculations. One shouldn't need 'prior plausibility' to produce null results for quackery.

Candy @ 39: Can I trade you a few of my spare question marks for some of your extra exclamation points???? Oh, wait!!!, I see you have plenty of question marks!!! Would, you, like, a, few, more, commas, instead?

58: Patient-centred care: If the patient comes to your health centre demanding a dollop of dragon dung dropped whilst the Moon is in Pisces, 'tis best to offer them a powerful placebo in its place.

Sometime in democracy, (comma) people get a choice. (Period). My apologies for auto correct. (Period) .

@Candy: OMG!!! You still….can’t…..figure out who writes this blog….well I Guess!!! Doesn’t that tell us a lot…about you???

I mean, like…if you just could you know, mouse over the Word Orac??? I mean, the one that’s, like, hyper-linked???? You know when they put a line under something and it means there’s this really cool information at the other end of the link and maybe you wouldn’t look like such an idiot if you….you know, like, clicked on it!!! And then it would take you like totally ….I mean fer sure…to the page where it gives his name…and what he does for a living???? I mean, like, really!!!

Comments are closed.

%d bloggers like this: