Supporters of science-based medicine and keeping pseudoscience out of medicine have a few years to prepare for an onslaught of crappy studies “proving” the value of “integrative” oncology. No doubt at this point you’re wondering just what the heck Orac is talking about. I will tell you. It involves an institution we’ve encountered before and a naturopath we’ve met before, specifically the Ottawa Integrative Cancer Centre and Dugald Seely, ND (translation: Not a Doctor), FABNO (translation: Not an Oncologist). Somehow, Dugald Seely and his brother Andrew have somehow scored some sweet, sweet foundation cash for the purposes of doing…well, whatever passes for research in the world of naturopathy:
The pair will co-lead a major research project that will do what many have long asked for: provide hard data about 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.
The randomized control trials will study the use of integrative treatments for 300 esophageal, gastric and lung cancer patients who will undergo surgery. The 11-year study will take place in Ottawa, Kelowna, B.C., and Hamilton. Exactly which therapies will be offered to the patients in the clinical trials will be determined based on a consensus of which ones are the most evidence based and useful.
The grant that will fund the research — $3.85 million from a Canadian foundation that wants to remain anonymous — is the largest of its kind in the world, Seely says. The research, between the Ottawa Integrative Cancer Centre (which is an arm of the Canadian College of Naturopathic Medicine) and the Ottawa Hospital Research Institute, has the potential to change treatment for some cancer patients. It also represents a major step toward integrating more naturopathic treatments into conventional medicine using scientific rigour.
Nearly four million? To fund research in to woo? It’s a depressing thought, the main reason being that I can’t help but think of how much good that money might have done were it channeled into actual real research, rather than into the parody of research that constitutes most of what passes for “naturopathic research.” That’s well over two, perhaps even as many as three R01-level projects or even around 8 to 10 R21 preliminary grants. Heck, it’s on the order of a Stand Up 2 Cancer “Dream Team” grant. Of course, the big difference is that these two are anything but a “dream team”—well, that, and that, unlike the case for most foundation funding, we don’t know who is funding these research projects.
Normally, I like to emphasize that it is the science that is ultimately the most important, but that doesn’t mean that knowing the funding source is not important. Let’s just put it this way. If alternative medicine practitioners were to find out that a study about a drug was funded by the pharmaceutical company that makes the drug, they’d be outraged. If antivaccine activists were to discover that a vaccine study were funded by an unknown foundation, they’d be quite reasonably suspicious, particularly if the investigator were someone as provaccine as Paul Offit. So now we have two guys, one of whom is heavily into “integrative” oncology, receiving a grant from a foundation unwilling to reveal itself. In addition, as yet, we have no idea what the protocols will be or even very much detail on what the research will involve. This is in marked contrast to other foundations that fund research, such as SU2C or the Gates Foundation. Sure, any foundation can give money to whomever its leadership wants, and it can even request to remain anonymous if it wishes, but it does make you wonder…what does this foundation have to hide? Certainly there can’t be very many Canadian foundations out there with the resources to fund a nearly $4 million grant. It can’t be the Bravewell Consortium, which is based in California, or the Samueli Institute, which is located in Alexandria, VA, Corona del Mar, CA, and Frankfurt, Germany.
One wonders if there’s a new woo foundation in town. Actually, it would appear that there is, but we don’t know who it is yet other than that it is, apparently, Canadian.
The news reports and press releases I have read don’t say much about what this project is about. This news story says:
The project, called the Thoracic Peri-Operative Integrative Surgical Care Evaluation (Thoracic POISE), is divided into two parts.
First, it will use integrative care techniques to use on patients before and after surgery.
The second part includes a randomized controlled trial to evaluate the techniques and see if they reduce adverse events and improve survival.
This is similar to this press release:
“We have assembled an outstanding team of investigators that includes surgeons, oncologists, naturopathic doctors, PhD research specialists and a health economist,” said Dugald Seely, project co-lead, Executive Director OICC, Director of Research CCNM, and affiliate investigator with the Ottawa Hospital Research Institute. “Lung cancer accounts for the highest incidence of cancer deaths in Canada and we know that more than half of all cancer patients use complementary therapies. This research will help determine when complementary care is appropriate and may potentially lead to enhanced standards of medical practice that can positively impact patients’ lives.”
“This study is an innovative whole-person approach involving naturopathic medicine integrated with traditional care. It is more than a single intervention,” said project co-lead Dr. Andrew Seely, an associate scientist at The Ottawa Hospital, director of research for its Division of Thoracic Surgery and an associate professor at the University of Ottawa. “By using a well-designed randomized controlled trial to assess multiple evidence-based interventions that are often found in real-life clinical practice, we hope to show that integrative cancer care improves two critical problems simultaneously, namely adverse events after surgery and long-term cancer outcomes.”
One thing this press release tells me right here is that Seely and his brother must have spent considerable time putting this whole grant proposal together. Another thing it tells me is that the Seelys are using the old alt-med trope that this is “holistic” care, as though conventional primary care and oncology were not. Finally, there is a hint of how this clinical trial will be designed. Note how Seely emphasizes “multiple evidence-based interventions.” In other words, they’re going to throw a whole bunch of stuff against the wall and see what sticks.
Perhaps the best way to predict what the Seelys will do with this money from the unnamed Canadian foundation is to look at what they’ve done in the past, or at least what Dugald Seely has done in the past. We have a very good example from less than a year and a half ago, too. Basically, in this study Dugald Seely and colleagues carried out what they sold as a randomized clinical trial of adding naturopathic interventions to the “usual care” of patients with cardiovascular disease. It’s a study that advocates of “integrative medicine” jumped on as evidence that “integrating” naturopathic quackery with standard of care.
To recap, the study itself was fairly straightforward as randomized trials go. The subjects were all members of the Canadian Union of Postal Workers aged 25 to 65 years who were under the care of a primary care physician who could speak English and were competent to provide informed consent. The study took place at multiple sites, for a total of 246 subjects, 207 of whom completed the study. These subjects were randomized either to either “usual care” by their existing family physician alone or to “usual care” plus naturopathic care. Obviously, the study was not blinded. Rather was was a “pragmatic” trial, which means that pretty much anything goes for both arms. The idea was to compare “usual care” in the community to “usual care” plus naturopathy. I’ve noted time and time again that CAM and “integrative medicine” practitioners (particularly fans of acupuncture) love pragmatic trials to death because they are less rigorous than a true randomized clinical trial. In particular, they are very much prone to placebo effects and other confounders.
There’s a reason why pragmatic trials aren’t usually the first choice of trial design in determining whether an intervention works. The usual order is to do a rigorous randomized clinical trial, placebo controlled if possible, ideally double-blinded. That determines efficacy, which is how well the treatment works compared to placebo or standard of care. However, interventions that show a high degree of efficacy in clinical trials are often disappointing. That’s because, outside of the highly controlled environment of clinical trials in academic medical centers, treatments are used on people who might not have fit the inclusion criteria precisely, people who cover a wider range of severity of condition, and are often not administered according to the exact protocol used in the clinical trial. In other words, the messiness of real world usage intrudes. Enter the pragmatic trial, which are often not blinded and take place in an environment more like what happens in the community. Usually, the apparent effectiveness (and note that “effectiveness” refers to real world effectiveness rather than efficacy). Most of the time, effectiveness is less than efficacy. One time that is not true is for treatments that don’t have specific effects, that are placebo medicines. In the case of such medicines, pragmatic trials are far more likely to show an effect.
See why woo-meisters, particularly acupuncturists, love pragmatic trials so much.
The other thing that Seely did with the cardiovascular trial is something typical of what CAM advocates do: Rebrand, rebrand, rebrand. There were lots of interventions such as weight loss, aerobic and anaerobic exercise, diagphragmatic breathing, and dietary interventions similar to the Mediterranean and Portfolio diets. In other words, there was a lot there that wasn’t part of science-based medicine. True, there were also lots of supplements and less evidence-based interventions, but that’s one more example of how CAM practitioners love to “integrate” quackery with science-based medicine, the latter of which is rebranded as being somehow “alternative.” Cardiologist Dr. David Winchester wrote an awesome takedown of this rebranding:
The goal of this investigation seemed to be to test the hypothesis that naturopathic care is superior to usual care. While the authors have demonstrated that a generous investment in counseling is effective at reducing calculated CHD risk, they have not demonstrated any effect specifically attributable to naturopathic care. Dietary counseling, for example, appears to be effective regardless of the provider (reference originally published in 2005). (2) As a practicing cardiologist, I routinely “deliver diet and health promotion advice” to my patients and “emphasize this form of self- directed care”. As noted in the accompanying editorial, (3) I would welcome the opportunity to spend an additional four hours in consultation with my high CHD risk patients and I suggest such an intervention would have been the appropriate control comparator.
Furthermore, I have concern about the evidence base used to determine which lifestyle interventions would be used. It would appear from the appendix that abstinence from coffee was encouraged. The available literature published prior to the trial registration, however, demonstrated an association between moderate coffee use and both a reduced risk of diabetes (4) and no increase in risk of CHD. (5) Conversely, the evidence cited demonstrating clinical benefit for some of the recommended supplements is sparse or no evidence is provided (cinnamon, pomegranate juice, lutein, etc.).
Now do you see what I mean when I say I expect a whole lot of other trials like this, beginning a few years from now? That’s what this anonymous “foundation” expects; otherwise it wouldn’t have picked Seely. Four million dollars can buy a lot of that.