It's no secret that I don't have a high opinion of naturopathy. Just enter the word "naturopathy" into the search box of this blog, and you'll quickly see what I mean. Indeed, when last I mentioned the topic a couple of weeks ago, I was discussing the revelations of Britt Marie Hermes, a former naturopath who realized what a load of pseudoscientific quackery she had bought into, unfortunately, after having finished naturopathy school with a quarter million dollars of debt and having practiced for a while. Her account confirmed my impression of naturopathy as a veritable cornucopia of quackery so massive that it contaminates anything reasonable or science-based within the profession with pure woo. Let's just put it this way. Homeopathy is an integral part of naturopathic education and practice. That should tell you all you need to know about it. Unfortunately, medical academia appears to have been taken in, as evidenced by recent guidelines in "integrative oncology" authored, in part, by a naturopath, and not just by naturopaths' claims that naturopaths can be primary care providers and lifestyle counselors.
Last fall, knowing the quackery that naturopathy is, I was disturbed to discover that an unnamed foundation had awarded the Ottawa Integrative Cancer Center (OICC) $4 million to study whether "whether naturopathic therapies such as acupuncture, massage, exercise and nutritional therapies combined with conventional medicine can help prolong or improve the lives of cancer patients." Specifically, the project is called the Thoracic Peri-Operative Integrative Surgical Care Evaluation (Thoracic POISE) and will study integrative care techniques to use on patients before and after surgery, including a randomized controlled trial to evaluate the techniques and see if they reduce adverse events and improve survival in patients with thoracic malignancies. The trial is being run by Dugald Seely, a naturopath at OICC who has been the topic of discussion here on more than one occasion, most recently for his role in helping to write those misbegotten guidelines by the Society for Integrative Oncology.
Unfortunately, I just found out something that compels me to write again about Dugald Seely and the OICC again, a news report in the Ottawa Citizen entitled Study to assess whether integrative treatment helps cancer patients live longer. When I first saw it, I thought that it was another story on the same study I wrote about last year. I wondered what might have happened to justify a new story. Then I read it:
Can naturopathic therapies help late-stage cancer patients live longer? That question is going to be examined by Canadian and U.S. researchers in the largest study of its kind.
Dugald Seely, executive director of the Ottawa Integrative Cancer Centre and Canadian lead investigator of the Canadian/U.S. Integrative Oncology Study, said 400 people with advanced breast, colorectal, pancreatic and ovarian cancer will be studied at seven clinics across North America over three years. About 100 people from the Ottawa Integrative Cancer Centre are expected to be part of the study.
The observational study should offer “exploratory evidence”, he said, about the effect advanced integrative oncology treatments — naturopathic treatments combined with traditional medical treatment — have on cancer patients. The work, he added, “will provide valuable insight on the role of naturopathic medicine in cancer care and will lead to the conduct of more rigorous randomized controlled trials.”
Now get this. The same unnamed anonymous Canadian foundation that funded the Thoracic POISE study funded this study as well, to the tune of $3 million. Truly, woo has a generous benefactor in this foundation, which is why I'd really, really like to know who's funding these studies. Since I don't (and haven't been able to find out the foundation's identity), there's not much I can say there. So instead I looked at the rest of the story. Unfortunately, there wasn't much detail. What we know is that the study announced this week is going to look at "advanced integrative oncology treatment" (whatever "advanced" means, I have no idea in this context) for patients with late stage cancer. We also know that researchers from the OICC and Bastyr University will jointly conduct the research. Actually, scratch that. I do know what "advanced" integrative treatment means. The news story characterizes it as being aimed at improving survival, enhancing quality of life, reducing side effects from conventional treatment and helping to prevent recurrence. In other words, it's the "integration" of quackery like intravenous vitamin C and other treatments favored by naturopaths with real, science-based cancer treatment.
I looked for more information, starting with the Thoracic POISE study, which, given that it was nearly six months ago that it was announced, I thought might be underway. Searches of ClinicalTrials.gov were in order. So I first started by searching the database for Dugald Seely's name. There are currently only two open studies with his name on them, An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy and Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality. Yes, Seely is studying homeopathic remedies, or, as I like to call it, doing a clinical trial of magic. At first I thought the melatonin study might be part of the Thoracic POISE study, but I saw rapidly that it had been entered in the database back in 2008, long before the grant received by the OICC. The homeopathy trial doesn't specify thoracic malignancies and is open to patients with any cancer who are undergoing chemotherapy. So, no, this doesn't look like it's part of Thoracic POISE either.
Next, I looked up Health Canada's Clinical Trials Database, using Seely's name and various other search terms. I found nothing. Ultimately, I searched for all cancer trials registered in the database. There was nothing that looked like Thoracic POISE there. Why, I can't help but wonder, is there no registration for this trial in ClinicalTrials.gov or the Health Canada Clinical Trials Database.
So next I looked at this new trial, known as the Canadian/US Integrative Oncology Study (CUSIOS) and involving the OICC, the Canadian College of Naturopathic Medicine (CCNM), and Bastyr University:
The goals of CUSIOS are to observe and measure the overall survival of a cohort of late stage (III and IV) cancer patients who receive AIO treatments and, to describe integrative therapies provided by naturopathic doctors across the cohort. A total of 400 people with advanced breast, colorectal, pancreatic and ovarian cancer will be studied in seven clinics across North America over three years. Each selected site provides comprehensive whole-person care in naturopathic oncology, applying science-based treatment for people with late stage cancer.
Integrative oncology aims to combine the best of conventional and whole-person naturopathic care seamlessly and safely to: improve survival, enhance quality of life, reduce side effects from conventional treatment and help prevent recurrence.
AIO therapies used by naturopathic doctors for late stage cancer are directed at multiple mechanisms to slow tumour progression, prevent metastatic spread and improve survival. The therapies are variable but may include intravenous vitamin C, intravenous artemisinin, intravenous dichloroacetate, mistletoe, hyperthermia, nutritional protocols and the use of immunomodulatory, anti-cancer, and anti-inflammatory natural health products.
In other words, it's more of the same, "integrating" quackery with real medicine and studying it, except that this time naturopaths will be plying their quackery on patients with advanced-stage cancer who are far more likely to die of their disease. Of course, just to show how much "integrative" oncology has "rebranded" some science-based treatments as somehow being "alternative" or "integrative," such as nutrition, exercise, and the like. Think of it this way? What is the "natural" about dichloroacetate? What is "integrative" about dichloroacetate? I've written about dichloroacetate many times. It's a targeted chemotherapeutic agent that acts at the level of the Warburg effect, reversing a prominent metabolic derangement present in many cancer cells. It's been studied in rats and humans and shows mild promise. The only reason it became "alternative" or "integrative" is because in the wake of a promising study in rats of DCA versus brain cancers, because DCA is easily synthesized, opportunists began selling it to desperate cancer patients. They started out selling it as "Pet DCA," only to be given to pets with cancer. Of course, those selling Pet DCA knew that humans were buying it for themselves and even representing their self-experimentation as legitimate clinical trials. They were not. Ultimately the FDA shut down the people selling DCA, but its reputation had been hopelessly tainted with quackery, which is why, I suspect, it's now become popular among naturopaths.
And don't even get me started on high dose intravenous vitamin C. In any case, I searched ClinicalTrials.gov for all of Bastyr's currently open studies. There is nothing resembling Thoracic POISE or CUSIOS. So what is going on? I don't know. What I do know is that the OICC has received nearly $7 million to study woo in cancer patients, but I don't see an open clinical trial yet. I can understand why CUSIOS might not be open yet, but I'm rather shocked that Thoracic POISE shows no signs of being open yet, not showing up in the Health Canada Clinical Trials Database or ClinicalTrials.gov yet, unless I've screwed up looking for it, which is always possible. But I doubt it. I searched every variant I could think of. I searched institutions. I searched the American PI of CUSIOS.
Oh, and CUSIOS appears to be a rather pointless study:
“We have chosen to study the outcomes of naturopathic oncology because this area of integrative oncology is currently leading the field in the application of advanced natural medicine therapeutics,” said Leanna Standish, ND, PhD, FABNO, Professor at the Bastyr University Research Institute, and American lead investigator of CUSIOS. “We will collect survival outcomes on late stage cancer patients treated at multiple naturopathic oncology clinics in North America in order to address the fundamentally important question of whether or not AIO has a beneficial impact on survival.”
In other words, they're spending $3 million to do an observational study with no control. How will they know if naturopathic oncology has anything to do with improved survival if they observe good results? Will they wonder if naturopathic oncology is harmful if they observe worse than expected outcomes? How will they know what to expect anyway? Comparison to historical data is always fraught with difficulty, and only very large differences between what is observed and historical controls are even suggestive of a benefit or detriment.
It's depressing to think what a waste of money this is, what this money might have done if it had only been directed towards real research in cancer rather than tooth fairy science about naturopathic medicine. $7 million is a lot of money. That’s at least three or four R01-level projects or even around 10-15 R21 preliminary grants. Heck, this much money is on the order of a Stand Up 2 Cancer “Dream Team” grant, or even more.
Of course, the big difference is that the naturopaths benefiting from this largess are anything but a “dream team," and we don't even know who's funding these projects.
I don't know anything about how much time a clinical trial takes to set up, but judging by reaction of our gracious host less than the span of time between first grant and now, So, is the lakck of registered Thoracic POISE trials a reason to suspect a foul play or just implies incompetence?
Usually, when soliciting a foundation for money you'll already have the clinical trial at least roughly blocked out, leaving just writing the actual protocol and getting it approved by the relevant IRB, which should be doable in 6 months, and you'd want to get started ASAP anyway. Also there were going to be a couple of clinical trials under Thoracic POISE; one of which should have been fairly easy to get through, being an observational trial. Still, for a multicenter trial, it could take a while to set up. I'd give them a year before I started asking real hard questions. Right now, it just strikes me as odd that nothing's registered yet for Thoracic POISE, and there's no evidence yet that the OICC's first trial is open to accrual that I could find. There could be a measure of inexperience, as well. Nothing I see from Seely on ClinicalTrials.gov suggests that he's ever run a trial this big before.
A thought occurred to me when I got up, though. It's possible that this anonymous foundation just dropped the first wad of cash in Seely's lap, more or less unsolicited, and that Seely was unprepared, not having anything written up. That's not usually the way these things go, but then usually foundations who give out $3 and $4 million grants to do clinical research don't keep their identities a secret.
I will be cynical and guess this is the pseudosciency way of saying "boost your immune system", i.e. more nonsensical claims.
Of course, I could be wrong; if so, I'm looking forward to be corrected.
those selling Pet DCA knew that humans were buying it for themselves and even representing their self-experimentation as legitimate clinical trials
The scammers who deal in Gc-MAF have learned from the DCA saga (and indeed include several of the old DCA scammers), and have dealt with their legal difficulties by branching into "GcMAF for Pets (nudge wink)".
Just a cynical passing thought, but if the foundation is anonymous, and the studies do not yet exist, what if the whole grant thing is a fiction as well?
I tend to doubt it, although the anonymity of the foundation doing the donations really raises an eyebrow. Can you imagine how alternative medicine mavens would react if a researcher studying a drug or device announced nearly $7 million worth of clinical trials were going to be funded by a foundation whose identity is being withheld?
Which makes me think again. I wonder if they're having trouble getting the trial through the relevant IRBs, who would want to know who the identity of the funding agency and would likely insist that subjects being enrolled on the trial should be informed who's funding it. Letting subjects know who's funding the trial is a pretty basic requirement in most clinical trials.
Usually, when soliciting a foundation for money you’ll already have the clinical trial at least roughly blocked out, leaving just writing the actual protocol and getting it approved by the relevant IRB, which should be doable in 6 months
A thought that occurred to me as I was reading the post: maybe Seely has tried to get a protocol approved by his IRB, but it failed the laugh test (as it should, if it were anything like the newly announced research program). Is this a plausible explanation for why no trials for Thoracic POISE have been registered yet? I know it wouldn't be if this were a competitive grant application, for which you normally have to have IRB approval if the proposed research would require it. But if this is an anonymous foundation simply giving away money without a competitive process, Seely may not have obtained IRB approval in advance.
I suspect the "foundation" is a private family. There is a lot of that sort of thing in Canada, though many like to have their names prominently displayed. Look around Canadian universities and note the occurrences of "(insert name) School of (typically money changing or medicine).
I suspect Murray Edwards of Canadian Natural Resources Limited - his woo foundation has form for doing sloppy and unethical research giving megavitamins to homeless people as condition of getting dental care. Being super rich often confers Prince Charles style arrogance with respect to science.
I read through the initial description of the trial and wondered how in the world they were going to do a control. I would think that a control would be simple: just have a group of patients on standard treatment for their disease and no woo.
But it looks like they are going to blow a substantial amount of money on a study that shows us nothing.
But let's say that it is, in fact, an actually well-designed study with statistics that make sense and numbers that work. If it shows us what we all suspect, that most of this nonsense is theatrical placebo, how much do you want to bet that people like Seely will ever admit it and say something like "Well, that settles that then. Back to reality based medicine for me!"
@ Slugdoc #10, I think I can predict the conclusion already: More reasearch are needed.
Such research cannot be done at any agency governed by Canada's Tri Council Policy Statement. Page 29 of the TCPS makes clear that informed consent has to include identity of the funder or sponsor.
I was thinking along the lines of doug @ #8, maybe not an arms-length deal, more of a who knows who without due diligence and more for the marketing value.
Look around Canadian universities and note the occurrences of “(insert name) School of (typically money changing or medicine).
Plenty of that around the US as well. Every university I have been affiliated with has a $DONOR School of Business. Including one which replaced its previous $DONOR School of Business with a $MORE_RECENT_DONOR School of Business.
You don't see that as much with medical schools, but you do see departments/divisions called the $DONOR Institute for [whatever $DONOR wants his name associated with], some of which are engaged in biomedical research.
Of course, in the US as well as Canada, such donors rarely wish to remain anonymous. The most prominent exception I can think of is the person (later revealed to be George Eastman of Kodak fame) who anonymously donated a large sum of money to MIT circa 1920.
I'd think that standard medical treament would NOT be a proper control for this kind of study, since they'd have to provide standard care anyway.
A proper comparison would involve having kindly people fussing over you exactly as much as the woo-docs. Giving you such treaments as, naturally, The Comfy Chair! Or better still, giving you fake homeopathic pills (you can use the real ones if you run out, but still), non-approved kinds of laying on of hands, and what have you.
Then you'd know whether any effect was the woo, or just the extra attention.
Even so, you just know that these data will be tortured until they confess. Something. Anything.
"It’s no secret that anyone with an ounce of sense doesn't have a high opinion of naturopathy"
Even so, you just know that these data will be tortured until they confess. Something. Anything.
Hence the Comfy Chair.
Appropriate controls are a must! If the ND treatment being given in conjunction with SBM treatment is acupuncture, you absolutely require a cohort being given SBM and faux acupuncture (using retractable needles, or with genuine needles inserted at the wrong meridian points) for comparison. If the ND treatment given in conjunction is homeopathy, you require a cohort being given SBM and whatever vehicle the homeopathic remedy has been diluted and succussed in.
And you need stringent blinding as well, so the people receiving treatment and the people evaluatiing outcomes have no idea who's received SBM and 'genuine' woo and who's received SBM and fake woo. It would be best if you could blind the practicioners delivering the ND treatments as well somehow.
It wouldn't be an easy trial to design and run, if you wanted to do it right (but apaprently they're not even going to try).
It wouldn’t be an easy trial to design and run, if you wanted to do it right (but apaprently they’re not even going to try).
It doesn't sound too difficult to design. You've done what sounds to me (admittedly a layman) like the hard part: the basic outline of how to run it. And it shouldn't be too hard to get such a study past the IRB. Actually running the study might be hard, however. And I think you are right that this crew isn't really trying.
Eric, such a study will probably be very hard to get by an IRB.
There are all kinds of ethical considerations with IRB approval. Conflicts of interest must be disclosed. Not disclosing the funder of a study is a massive conflict of interest; you just can't get around it.
There needs to be a process to stop the study if it is determined to cause harm to the participants. A careful evaluation of risk to the patient, and an explanation of potential benefits must also be disclosed.
The fact that this is merely an observational study leaves me quite concerned, since I don't know how they are going to determine the validity of their results without doing a control group.
The whole thing is very fishy. If I were on the IRB board, I would not give this study a thumbs up.
An observational trial is all about them getting the best chance to show something promising with a big 'more research needed'. Having an actual control group is too big a risk of showing no benefit or harm. They are smart enough not to do that. Of course, if they did, they would do data torturing. There would be endless subgroup analyses (a la TACT) in order to find the one or two that come up significant through random chance alone. I predict a lot of subgroup analysis anyway since they will have to compare this data to something (probably historical control as Orac noted above really poor choice). This is a $7 million waste of time and resources that could be spent on meaningful research. Or hell, if the guy (girl, entity) really wants to spend this money they could just portion it out to the patients and let them have a magnificent vacation with their families. Probably be at least as meaningful as sticking them with needles or doing a whole lot of useless IV therapy.
To amplify Kiiri @21's point: For the two or three readers who may not have seen it, the xkcd jelly bean comic is germane (and funny).
So when OICC says they want to study " “whether naturopathic therapies such as acupuncture, massage, exercise and nutritional therapies combined with conventional medicine can help prolong or improve the lives of cancer patients.”" basically they're studying one super woo (acupuncture) two pretty normal things (massage and exercise) and one potentially woo-filled thing (nutritional therapies).
Talk about naturpoathy claiming whole chunks of normal medicine!
The hard part about doing it right would be to adequately blind the practicioners providing treatment. It's easily done if the modality is homeopathy--after all, the problem with homepathy is that 'genuine' homeopathic preps are completely indistinguishable from vehicle controls. But when we're talking about acupuncture, massage, exercise?
How do you keep a nutritional counselor from knowing if they're what they're 'administering' is the real thing or some false equivalent?
Just as an eye popping aside, the Daily Kos is touting our friend Mike Adams and his Natural News website as an authority on and guide to protecting yourself against sociopaths.
I will say one thing for Adams, he knows from sociopaths.
"The therapies are variable but may include intravenous vitamin C, intravenous artemisinin, intravenous dichloroacetate, mistletoe, hyperthermia, nutritional protocols and the use of immunomodulatory, anti-cancer, and anti-inflammatory natural health products. "
Good to know they plan on throwing the whole panoply of alternative therapies at this, so they are pretty much guaranteed that something will correlate with positive outcomes, and they can just ignore all the rest, as usual, never taking a negative study as negative.
But, but, but naturopaths indivodualize treatment. Requiring standardization is just other scientists trying to sabotage them.
As Orac points out:
In other words, they’re spending $3 million to do an observational study with no control.
They're really covering their bases to ensure that no meaningful data is gathered but it can be spun positively regardless.
I have an idea for a better use of that money. Use it to fund some CE for naturopatha on prior plausibility.
Everything I attend here that depends on fundraising, rather art, science, or humanities always has a large sum "anonymous" donor. We all think it is Herb Kohl, who is just about the most humble billionaire and former senator in the world. He probably wishes he had bought the Buck's anonymously.
Today's comments were some of the most revealing--and hilarious, thank you palindrome--I have ever read. Of course, homeopathy and its bastard child naturopathy (or is it the other way round?) are always good for laughs. But I truly hate to think of dying patients being subjected to all those useless IV's and needles. I would hope any governing body would question the prior plausibility of the proposed cow pies, er...integrative treatments, to be used, before granting a trial.
I suspect the “foundation” is a private family.
Or perhaps a front for some Big Quacka operation like Boiron? $3m would be loose change to the marketing dept of a billion-dollar outfit like that. Either way, withholding the name of this fishing trip's funders has got to be a huge honking potential COI in-waiting. But apparently that's only a bad thing when Big Pharma does it.
Re. what 'advanced integrative oncology treatment' means:
Volt-Ohm meters are used to measure the electrical potentials across acupuncture meridians, enabling 'vital energy' to be operationalised as microwatts per square centimetre of skin as it's brought back into total harmony with the resonant vibrations of the etheric body.
Computers running 'advanced CAD software' are used to model the structure-activity relationships of homeopathic magic water compared to distilled water and treated sewage. This leads to improved remedies that have no 'water memory' of once having been home to floating turds. Right!
As for the four million dollars, 'always look on the bright side of life.' After the results come back supporting one null hypothesis after another, plus or minus the green jellybeans, other foundations will be that much more reluctant to flush more money down the loo. Regardless of whether their money can or can't be purified of its unpleasant 'water memory.'
Though, Orac, you might want to suggest to that 'integrative cancer centre,' that 'homeopathic money' would be even more powerful, or should I say, 'potent.' What's a 30c dilution of four million dollars? Something like four tenths of a penny? or would that be four hundredths of a penny?
Perhaps we should take up a collection of 'homeopathic money' to fund the replication study, or the next four hundred such, as it were. I'm in for a penny, that should be good for 100 replications. Anyone else?
Put me in for a Hersheba half-dong.
Lurker @30 -- Voltmeters?
I may have posted this earlier, and it's not on-topic, but we're far enough downthread to not irritate our host, and it's still pretty funny:
An observational trial of this type is essentially worthless... I suspect they won't stratify for histology, type of allopathic therapy, etc. The treatment arm will receive lots of extra attention and likely show a small QOL benefit, but I'd be extremely leery of any reported improvement in PFS or OS. If the trial is not randomized... it would be quite easy to manipulate the final conclusions as well.
The treatment arm will receive lots of extra attention and likely show a small QOL benefit
Without a control arm featuring The Comfy Chair, and lots of fussing, the study is ridiculous.
Hell, it'd be ridiculous with the control arm, but still.
That comfy chair adds to QOL after all Palindrom! Heck... if memory serves there was a small massage therapy study I once read. The experimental arm received massages 2-3 times per week compared to none for the control arm.
I could have told you the study would show improved QOL before it was started!
Doesn't help improve the actual outcome tho.
Hellanthus @ 31: Right, got it on the scorecard, no doubt we'll all be in touch here after Orac shreds the first set of null results.
Palindrom @32: Ha, he must live in Flatland or thereabouts. If he had anything remotely real there, he'd have used a microwave detector to make an actual measurement. That whole issue could be dealt with via simple epidemiological studies of the places people hold their mobiles vs. tumour sites, comparing users to non-users. As it is, there's a real correlation between mobile device use and health, which is that idiots who are stuck to their mobiles are at high risk of getting run over by vehicles whilst crossing streets.
I thought I recognised that logo. Up until recently I lived a few blocks away from this place. I would have never guessed they had so many millions running through the place.
It is sad to see all this money going into what appear to be utterly unimpressive studies. People doing woo studies like to do this so often. I guess they know that any study, even a weak and useless one, is going to win over their target audience. Is there really much incentive to come up with a better design? If they did that, the result might not be nearly as impressive.
Ha, small world. I currently live not too far from this place, and I walk or drive by it reasonably often. I assumed from the name it was probably a wretched hive of sCAM and quackery, but I'd never bothered to look into it.
I agree that, as with any medical trial, there should be a control group given placebo pills etc. However, as with allopathic medicine, there can be no claims for or against the effectiveness of the treatment without a trial being conducted.
If naturopathy is simply giving good care to patients as was commented above, then perhaps it should be tested and if positive outcomes are found, it should be implemented as part of every treatment regime. (u15021689)
In any study done an appropriate control group is required. This study does not even reveal the funder of a study which is a huge conflict of interest. Also every study needs to have a process to stop the study if the study causes any harm to the participants in any possible way.
I feel that this study is purely an observational study which alarms me, because I am not sure how they will conclude the validity of the results without a control group?
Interesting article, I also agree that every study a control group need.
I complete agree with orac that this large amount of money could have been better used by other cancer studies. There should be other studies with more potential, not even mentioning that they could be more valid and more scientific.
This study could very easily end up having uncertain results. Good results could end up as an incorrect verification of the treatment, when in reality it could have been caused by other factors or treatments.
One thing that bothers me though is that there was an anonymous sponsor, if a company or person was sponsoring a project or study of some kind shouldn't they be certain and proud about it?