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.
from ScienceBlogs http://ift.tt/19JppqB
