Naturopathic oncology is what I like to call a “pseudospecialty.” It sounds like a medical specialty, at least superficially, and certainly naturopaths try their damnedest make their pseusospecialty sound like a real medical specialty to the rubes. They talk all mediciney and sciencey, while throwing in appeals to nature and “natural cures” as the best way to heal cancer. Then, of course, there’s the fact that all naturopaths are trained in The One Quackery To Rule Them All (homeopathy), and many use homeopathy to treat patients, and you get the picture. “Naturopathic oncologists” shouldn’t be allowed anywhere near cancer patients—just as naturopaths shouldn’t be allowed anywhere near patients. There’s a reason why, when I see the abbreviation “FABNO” that naturopathic oncologists like Not-A-Doctor Dugald Seely have after their name, I say, “FAB? NO!” as I watch them cosplay real doctors.
As much as I detest the quackery in naturopathic oncology (and all naturopathy), it especially irks me to look at attempts by naturopaths to do research that will validate their field. It’s such a massive waste of money, time, patients, and space on PubMed to list the studies. Indeed, I was particularly annoyed when three years ago I learned that a Canadian naturopath, Dugald Seely, received first $4 million and then $3 million to carry out clinical research in naturopathic oncology, all within six months of each other. Dugald Seely, of course, is someone I’ve written about before, thanks to his heavy involvement in the Society for Integrative Oncology and his involvement in writing “integrative oncology” guidelines for breast cancer patients. He runs the Ottawa Integrative Cancer Centre and is a big name in “naturopathic oncology.”
I always wondered what Dugald Seely was doing with all that money. Thanks to Jann Bellamy, I know now. Although I did discuss the broad outlines of the studies, at the time the protocols for the studies themselves hadn’t been published anywhere. For instance, there is Thoracic Peri-Operative Integrative Surgical Care Evaluation (Thoracic POISE), which, or so it was said, was to consist of two parts: an observational study examining integrative care techniques to use on patients before and after surgery and a randomized controlled trial to evaluate the techniques and see if they reduce adverse events and improve survival. The second study is called the Canadian/US Integrative Oncology Study (CUSIOS), and its goal is to “observe and measure the overall survival of a cohort of late stage (III and IV) cancer patients who receive advanced integrative oncology (AIO) treatments and, to describe integrative therapies provided by naturopathic doctors across the cohort.”
I can’t believe it, but in the three intervening years since I initially noted these huge donations, I never thought to follow up to see just what it was that Seely was doing with that money. Jann sent me a link to the ClinicalTrials.gov entry for the CUSIOS trial, but I’m going to start with the Thoracic POISE trial (NCT02845479) first. Here’s its ClinicalTrial.gov entry. What surprised me immediately is that, more than three years later, this study is listed as not yet recruiting. It has an estimated start date of June 2018. Its sites are Ottawa General Hospital and the Ottawa Integrative Cancer Center. Now, clinical trials can take a long time to design and obtain regulatory approval for, but this appears to be only the first part of the study and doesn’t even include the randomized controlled clinical trial. It’s just a single-arm study of 40 patients. It’s described as follows:
Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care.
I had to stop right here. So the rationale of this study is that because complication rates are high after surgery for lung, gastric, and esophageal cancer and there is a significant risk of cancer recurrence and chemotherapy causes serious side effects, all resulting in detrimental effects on the patient’s quality of life, Seely’s hypothesizing that these issues are due to an “ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care”? As a surgical oncologist myself, I almost spit up my iced tea that I was drinking as I wrote this. So the problem behind all the complications from advanced surgery for these cancers, the resection of which involves big operations that can cause big complications, is a lack of quackery? It would seem that Dugald Seely believes this.
So what does Seely want to do to study his hypothesis (if you can call it that)? Well, he wants to start out with this:
The Thoracic-POISE Project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery. This multi-stage project aims to design, pilot-test and evaluate a broad-based, multi-agent, evidence-based integrative care program to be delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. It is hypothesized that this integrative care program will improve HRQoL as well as reduce surgical adverse events and improve cancer survival. Stage I of the project will pilot-test the intervention and outcomes collection in a single-arm, feasibility study.
You want to know how you really improve impacting HRQoL, reduce surgical adverse events, and prolong overall survival? You do it with science-based medicine. You do it by testing new treatments that aren’t based on the vitalistic nonsense that naturopaths practice. And you don’t waste $4 million on a study like this and the followup study that quacks like Dugald Seely concoct after this pilot study to test some naturopathic quackery or other that they identify.
So the first primary outcome is the feasibility of the study protocol, which will be assessed by the percentage of participants who complete all assessments and integrative care appointments. That’s it? But what are the other outcome measures? Here are the secondary outcomes:
- Compliance: supplemental intervention [Time Frame: Enrollment – 1 year post surgery] Count of missed doses assessed by patient diary.
- Compliance: nutritional intervention [Time Frame: Enrollment – 1 year post surgery] Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery
- Compliance: physical intervention [Time Frame: Enrollment – 1 year post surgery] Extent of adherence to physical activity recommendations assessed using a patient diary.
- Compliance: mental/emotional domain [Time Frame: Enrollment – 1 year post surgery] Number of days audio-recordings were used assessed by patient diary.
- Communication between practitioners [Time Frame: Enrollment – 1 year post surgery] Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant
- Qualitative experience of care and study protocol [Time Frame: Enrollment – 1 year post surgery] Semi-structured interviews with thematic analysis
- Feasibility of recruitment [Time Frame: Enrollment] Percentage of participants recruited out of potentially eligible patients invited.
Here are other outcome measures:
- Adverse events [Time Frame: Enrollment – 1 year post surgery] Health Related Quality of Life [Time Frame: Enrollment – 1 year post surgery] Functional Assessment of Cancer Therapy-General Score
- Cancer-related symptoms [Time Frame: Enrollment – 1 year post surgery] Edmonton Symptom Assessment Scale
- Anxiety and Depression [Time Frame: Enrollment – 1 year post surgery] Hospital Anxiety and Depression Scale
- Fatigue [Time Frame: Enrollment – 1 year post surgery] Multidimensional Fatigue Inventory
- Functional exercise capacity [Time Frame: Enrollment – 1 year post surgery] 6 minute walk test
- Change in body mass index [Time Frame: Enrollment – 1 year post surgery]
- Inflammation: Multi-analyte cytokine array. [Time Frame: Enrollment – 1 year post surgery] Plasma concentrations of a panel of cytokines (IL2, IL10, TGF-beta, TNF-alpha, IFN-alpha, and IFN-gamma) will be measured in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery
- Natural kill cell activation [Time Frame: Enrollment – 1 year post surgery] NK cell activity will be measured by NKVue™ in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery
So what we have here is a whole lot of outcomes examined in a small number of patients. It’s basically a fishing expedition. Now, there’s nothing inherently wrong with a fishing expedition in science, as long as it’s clear that that’s what it is and the outcomes researchers are “fishing” in are chosen carefully based on science. This just looks like a shotgun approach. Unfortunately, the protocol isn’t very revealing about what sorts of “integrative medicine” Seely will be testing. Elsewhere, I could find that the interventions are supposed to relate to targeted natural health products; nutritional approaches; fitness improvements (particularly pulmonary fitness); and mind and body medicine and psychological well-being. Whatever that all means. They’re also wasting millions of dollars doing it.
What about the CUSIOS trial (NCT02494037)? This one’s at least as bad and costing $3 million. What is Seely doing for that much money? CUSIOS is doing a multicenter observational study of patients with breast, colorectal, pancreatic, and ovarian cancers. Seely starts out with an appeal to popularity:
It is estimated that between 50 and 80% of cancer patients in the United States (US) supplement their conventional oncology treatment regimen with some form of complementary or alternative medicine therapy or practice. A smaller percentage of these patients receive medical treatment from naturopathic doctors (NDs) who are board certified in naturopathic oncology (Fellows of the American Board of Naturopathic Oncology, FABNO) or have equivalent experience in caring for cancer patients and from traditional Chinese medicine (TCM) providers with advanced training in oncology (DAOM or physicians with training in TCM). This level of care is being defined here as advanced integrative oncology (AIO). AIO clinics provide comprehensive science- and experience-based naturopathic and Chinese medical oncology integrated with each patient’s conventional medical treatment.
Science-based naturopathic oncology? There’s no such thing! Ditto traditional Chinese medicine! As for the “FABNO” designation, it’s akin to graduating from the Hogwart’s School of Witchcraft and Wizardry, with the exception that the magic of J.K. Rowling’s fictional world worked. FAB? NO!
So here’s the study:
Although there have been some studies of complementary and alternative medicine use by cancer patients, little is known about the effectiveness of the naturopathic medicine and TCM provided to people with cancer in an integrative setting. While there is scientific evidence supporting specific treatments that are commonly used, systematic study of their effectiveness (especially when used in combination as commonly recommended) is virtually non-existent. An early step in the evaluation of clinical outcomes associated with AIO is to take a health service approach and seek to answer the question: “Does exposure to AIO services improve the clinical outcomes of patients with advanced stage cancer?”
The survival outcome of consecutively recruited advanced stage breast, colorectal, pancreatic, and ovarian cancer patients treated at multiple naturopathic oncology clinics in North America will be tracked and compared to outcomes published in the current medical literature and by SEER (Surveillance, Epidemiology and End Results) in order to address the fundamentally important question of whether or not AIO has a beneficial impact on survival. Involvement of a total of seven active AIO clinics from Canada and the US will allow the recruitment of a sufficient sample size to address this question as well as provide outcomes that are generalizable for AIO across North America.
So let me get this straight. Seely is going to recruit 400 patients with advanced stage cancer, treat them with quackery in addition to their conventional therapy, and then follow their survival, comparing it with the SEER database? This is what’s known as a trial with a historical control. It can sometimes be valid to compare a single-arm study results to historical controls, but it’s really not very useful. Comparison to historical data is always fraught with difficulty, and large differences between what is observed in a trial compared to historical controls are necessary to be even suggestive of a benefit or detriment. How will they know what to expect anyway? And let’s say they do find something? 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? They might as well throw the $3 million into a shredder. At least then they wouldn’t be using it to produce dubious data that will be used as propaganda to support “integrative oncology” and “naturopathic oncology.”
After all, look at the secondary outcomes. One is nothing more than looking at AIO treatment recommendations for cancer and the conventional oncology treatment data to describe the cancer treatments. Seriously. There is no standardization. Basically, patients will likely get conventional therapy plus whatever magic snake oil naturopaths want to give them. The other secondary outcome will basically be quality of life data.
So what will Seely have at the end of these two studies? What he almost certainly won’t have are data that tell us whether any of the interventions his fellow quack naturopaths (but I repeat myself) have any impact on survival, recurrence, or even quality of life in cancer patients, even if he manages to pull off a randomized trial in the Thoracic POISE project, because he won’t be testing individual interventions. He will, however, have spent $7 million between the two studies. That’s a lot of money, at least three or four R01-level projects or around 10-15 R21 preliminary grants. Indeed, this much money is on the order of a Stand Up 2 Cancer “Dream Team” grant, or various large team science grants offered by the NIH. I weep for what the money could have done for cancer patients if applied to testing science-based treatments instead of fairy dust. In the end, naturopaths like Dugald Seely are cosplaying real doctors and clinical trials are their props.
39 replies on “Dugald Seely: Cosplaying a real oncologist to test naturopathic oncology snake oil”
Has CTCA (Cancer Treatment Centers of America) ever published results of its naturopathic offerings (which include homeopathy)?
Correct me if I’m wrong but it looks as if a fair bit of the data collection in the POISE trial relys on patient diaries. The nutriion compenent seems to rely on two questionaires.
This makes me so angry. In my very small, nowhere near R1 university, I’ve got research faculty trying to do real science working their socks off submitting grant applications. When I think what my entire university could do with seven million dollars…..
The revealing feature of this kind of pseudoscience is how much it relies on self-report. Does anyone really believe that patients can be trusted to keep accurate, verifiable “diaries”? If you ask a dozen people about their quality of life after receiving identical treatment, you’re going to get a dozen different answers. Anecdotes and self-report are not evidence.
Back when I was taking a med, which shall remain unnamed, on the hour, every hour, I kept very detailed records. It’s gotten a lot more haphazard now that my housing situation is unstable. Food diary? No way — I’m a night- and sleep-eater. Cripes, back when I was taking mirtazapine, I would wake up and wonder why the counter was smeared with blue-cheese dressing.
I’ve got research faculty trying to do real science working their socks off submitting grant applications.
Fortunately, anyone with an idea on how to solve the cancer epidemic can participate in the grant process. FYI, I’m currently seeking funding to test the following – preferably through vaccination:
The image used at the beginning of this post shows several doctors/researchers with stethoscopes. This is so old school. It’s time to modernize and replace the stethoscope with a vaccine in hand!
That’s a lot of money! I’m glad though that it’s from an anonymous org not a governmental agency ( i.e. Canadian tax payers).
Wait.. don’t the Dwoskins fund those poseurs in BC?
Lots of faux research. And I always viewed Canada as mostly reality-based (with great scenery)
Unfortunately, some of the loons I survey will quote this as peer reviewed studies.
Most of Canada is reality-based, but there is nothing to prevent some loon who has 7 million loonies lying around and wants them spent on “studies” like these from funding some other loon willing to carry out those “studies”.
Appropriately in this context, the C$1 coin is known as the “loonie”.
I suspect that a lot of these studies of not-medicine are funded by private sponsors with agendas. For example rich nuts who are “true believers,” or looking to make a name for themselves by sponsoring what they hope will be “breakthroughs.”
There is no persuading those people to back SBM. They aren’t going to turn into Marc Benioffs overnight, or even after prolonged clinical intervention;-) (Benioff is the founder of SalesForce, who gave $100 M to build a new children’s hospital in the San Francisco Bay Area)
Benioff deservedly got his name on a hospital that practices real medicine. The sponsors of quackadoodle “research” might, if they’re lucky, get their names on placebos.
Yes we can lament the waste of money peddling pseudoscience. But that money would never have been available for doing real science in the first place. Ultimately what’s needed is a strong enough progressive income tax to enable funding all the urgent needs in society and all the real science that needs to be done, in medicine and every other field.
What gets me is how did Seely manage to con the Ottawa General Hospital into cooperating. I always had the impression that it was a good teaching hospital.
I wonder if it has started going to the woo-side like the hospitals at McMaster?
As I was reading the descriptions I was thinking there seem to be a lot of carts before this horse. Also, depending on patients’ diaries/self reporting seems to open the door for a giant wedge of placebo effects. As for “Will they wonder if naturopathic oncology is harmful if they observe worse than expected outcomes?” ; don’t be silly. The best you can hope for will be “more study is required – send more money.”
What a shame that you are all so small minded. If you took any coursework in Functional Medicine, you might be more open to alternative care methods and how the body really works. Dr Seely is starting with small steps to show some evidence that naturopathic medicine can support conventional medicine. Imagine if he started with trying to prove evidence of a cancer cure – for that I would expect you to be angry. And $7 million? What have you done with your $7 billion that you receive every year to fund cancer research? If you have enough time to scratch out this essay then you have enough time to read about alternative cancer support therapies.
Do enlighten everyone about the scope of your “coursework,” Ms. Andersen.
“What have you done with your $7 billion that you receive every year to fund cancer research?”
I’m sorry, do you think the decades of research required to create the CAR-T therapies was free? Or easy? I mean that only required a half-dozen new technologies and a deep understanding of the basic science of both the human immune system and many different types of cancer.
What about the new chemotherapies? The new surgical techniques? The new proton therapies? New medications to manage side effects and improve quality of life? New biomarkers to help identify which treatments are most effective in which patients, and identify if treatments are working?
That’s a very small part of what’s been done with those $7 billion. (Not that I’m 100% sure that number is correct.) How much of that was discovered by functional medicine?
While we’re at it, let’s fund some alternative, integrative, or functional basic research. But who would carry it out? This goes to the heart of the whole ugly business. There are no alternative researchers (in spite of whatever NCAAM is calling itself these days), just as there are no alternative airline mechanics, traffic controllers, or pilots. Only in medicine do we get this. It’s just an unmet “spiritual” need for some people and I’d be willing to let them have it as long as the practitioners make no claims beyond that and volunteer their services.
BTW, where does the $7 billion come from? The FY 2019 NCI budget is $5.74 billion. That’s more than a rounding error.
Emily if someone came up with a real cancer cure, I would not be angry about it. Far from it.
By the way, which cancer are you referring to? Glioblastoma is not the same as endometrial cancer.
I’ve had contact with functional medicine doctors. Meh. Lots of posturing, lots of testing, and not a whole lot of real medicine that did the patient any real good.
Emily, what is it you would have me read?
Do you think Orac has not read widely on the topics he writes about?
I would bet that he (and many other skeptics) know a hell of a lot more about naturopathy, functional medicine, and the rest than you seem to think. I have no issue with people getting “cancer support” (that is, supportive measures during treatment for cancer).I’m just not so sure it should be called “therapy”, not in the clinical sense anyway.
Take a look at the archives and see what Orac has written about these things and let me know what he and the rest of us should be reading.
Right now I am reading “The Beautiful Cure” by Daniel M Davis, professor of immunology at the University of Manchester in the UK. The book was short-listed for the Booker Prize (a science writing award). The book tells the centuries long story of the research into understanding the immune system and it’s potential for human health, including the treatment of cancer. I’m pretty sure some of the research money you speak of went to this effort. This book is a good follow-up to “The Emperor of All Maladies”, another book that tells the story of cancer, medicine, and research. Both of these books (land there are many more) will tell you where the research money goes.
I for one am glad for Erbitux:
Hope you’re not burdened with a mammalian meat allergy after taking Erbitux, KeithB.
@ Orac’s minions,
Q. Wil Flublok, which uses the insect cell line from the fall armyworm, induce allergies to moths, caterpillars, and butterflies.
MJD: Dude. I think you missed a few things in that product description, such as “baculovirus vector”, “Triton X-100” extraction, “purified by column chromatography”. Maybe you’re not familiar with chromatography purification, so I’ll let you know that it is very specific to the desired protein. Not to mention that the testing on the purified material makes it very easy to identify extraneous proteins.
But I do have to ask, MJD, how many butterflies do you usually eat?
Maybe you’re not familiar with chromatography purification…
Once upon a time, MJD synthesized chirally pure stationary-phases for HPLC columns in an effort to separate enantiomers. The intricate precision of this work often gave me the butterflies in anticipation of the results. I love it when we talk analytical, Justatech..
You have it backwards, MJD. You had a reaction to Erbitux if you have the allergy due to a tick byte.
If only it were amusing to see MJD channeling “Uncle Al.”
Cancer is a nasty business. People die regularly, even with the best modern medicine provides. 50% of patients who die die do so from side effects of their cancer treatment. Modern medicine lacks perfect answers and you people are playing with patients’ lives.
I have seen naturopathic oncology reverse cancers that have failed multiple types of chemotherapy. I’ve seen people live longer and better with naturopathic oncology than they would have otherwise. I’ve seen patients suffer from neuropathy in their hands and feet, sores in their mouths, nausea, intestinal distress snd many other symptoms causing patients to suffer needlessly when they could be easily treated with naturopathic oncology.
How do I know this? I beat stage 3 cancer with the help of naturopathic oncology, using evidence-based science to guide my care.
Bastyr Center for Integrative Cancer here in Seattle has been doing credible research and successfully helped numerous cancer patients who are thankful for the lifesaving care.
How many more people would lose their lives or experience devastating side effects if they listened to you?
When you get cancer, you’ll want to use every tool available to help you, just like the rest of us – it’s easy to be an armchair critic when you have no skin in the game. Don’t deny patients a chance at survival just because you don’t understand what they are doing. There is science and logic involved and dedicated FABNO doctors doing the work.
And the studies for these miraculous cures would be?
Please do elaborate. Did naturopathy cure your cancer or did you also use medicine?
Again, these studies are?
Hahahe. I guess you don’t know who the author of this blog is.
It is possible estimate treatment components’ effects even at n=1 patient, with good preparations, extensive data collection, and stable low noise trends within a particular treatment era, especially with 4 points or more in time per era. Some protocols and patients make better subjects, but the response patterns can be very distinct, as well as correlatable to preclinical data, individual lab tests, and prior papers.
The upshot is that you can get improved results that aren’t possible with some particular standard of care. Somewhat like an improved root finding process for difficult equations.
Have you considered the possibility that you’re full of beans?
^ Your take on Mochizuki’s corollary 3.15 for abc will doubtlessly be fascinating.
^^ 3.12, that is. Just waking up.
Hah, that’s pretty interesting on an academic matter, Narad. It’s great when you show the scholar part. Some posts are a little uneven between the gentleman and old fart parts – beans, indeed. However in the 20th century industrial world, less known, n=1 or undocumented know how was a major resource that often meant the difference between fortune and bankruptcy in a day or a month, or even staying out of jail, for companies and minions. Some surprisingly large, then or later.
In the real world, n=1, maybe some literature sources and/or some small experiments, and insight, are all companies or individuals have before some end-of-the-world crisis before them. Kind of Darwinian who’s who and “right”, quite different than the attributed Pauli’s “not even…”.
The suspension points were unnecessary. I presume that you more or less deliberately skipped the part about mirrors. Even Thunderwood College doesn’t offer a Ph.D. in horseshit.
What science is involved in “FABNO” work? Please provide citations for peer reviewed studies.
If you’re using evidence based medicine along with naturopathy, how do you know it is the naturopathy that made the difference? Did you have surgery? How do you know it wasn’t the surgery that cured you, along with the follow up chemo?
I will see your Stage III and raise you Stage IV. I am still here with nothing but the standard level of care.
If Bastyr really is cruing cancers not successfully treated elsewhere then why the heck haven’t they teamed up with the Hutch to prove all of this and change the standard of care? The Hutch is a non-profit, so you can’t even claim it’s about the money.
You show some proof and watch cancer doctors and researchers spin on a dime to do what works. Because that’s the only thing they care about: helping patients.
If Bastyr really can cure cancer and they haven’t told everyone then they are monsters who are letting people die.
I wish I could volunteer for the CUSIOS study. 5 years ago I had stage IV colon cancer and am obviously here to tell about. I did not use any integrative medicine except for the fact that I stopped wearing colored socks. (The Nurse Navigator said that the chemo might make me more sensitive to the dyes, eh, whatever.)
I also did not lose much hair and missed no work due to sickness or side-effects (only due to appointments and infusions).
KeithB: I’m very glad you’re doing so well! And I’m glad your treatment wasn’t too disruptive.
Pity about the socks though.
[…] cancer care and has two grants worth a total of $7 million dollars from an anonymous donor to try to “prove” that naturopathy improves survival in various cancers. Not surprisingly, Twitter being Twitter, Theriault and Seely were defending naturopathic oncology, […]